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I love a great adventure. The anticipation, the rush of getting ready, the exhilaration of pushing your comfort zone and experiencing all that is foreign adds to the thrill. There’s nothing that compares to stepping into the great unknown and pushing your boundaries to the limit. That excites me. So at any given moment I’m always ready for the chaos that comes with being spontaneous. It’s my nature.

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Last Friday, I got the call. Steve in Little Orleans, MD had heard about me four years ago when I rode through his town, in the western part of Maryland, during my cross-country trek on horseback. Steve tracked me down on Friday. Did I know of anyone with a horse trailer who would trailer a horse to West Virginia?

It seems a long rider had left his lead horse with Steve for six weeks while the horse healed. In due time, the rope burn on the horse’s hock had finally healed and the horse was ready to be reunited with its owner.

The long rider, whom Steve described as a short Atilla the Hun and whom I’ll call Jack, started his cross-country trek in Harpers Ferry with a lead horse, a pack horse, and two other men and their horses.

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It probably took Jack five days, give or take a day or two, to journey the 100 miles to Little Orleans. A trip that would normally take an hour and 38 minutes by car takes five days for a long rider on horseback. The long rider’s horse is imperative to the success of the journey. Trying to make 4000 miles over the long-haul, means the long rider needs his horse to pace at 20 miles a day. For me, that averaged out to be three miles an hour—with breaks, fan fare, interviews and the like, I was in the saddle for eight or nine hours a day. Long hard days, but there’s nothing like seeing America at three miles an hour.

The first three weeks of any long rider’s journey are the hardest. Those weeks make or break the long rider, the horse and the journey. It’s not an adventure for the faint of heart. Jack’s companions bailed on him when they arrived in Little Orleans. After three weeks of staying with Steve while his horse was healing, Jack made the decision to push on with his pack horse, alone. Would it be possible for Steve to make arrangements for the horse to meet up with Jack when the horse healed?

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That’s where I came in. Did I know of anyone who would trailer the horse to Jack? You betcha. Me. It was a fellow “wanna-be” long rider in need. So I texted my partner, who was in the Doctor’s office on a late Friday afternoon. Did he want to join me? The Plan—to head out with the truck and trailer with an overnight stop at the Little Orleans Lodge, au gratis, from the owner Steve. In the morning we would load Jack’s horse and head out to Davis, WV where Jack and his pack horse were staying overnight. The trip would take a total of ten hours. Five there. Five back. I had no choice. I had to “pay it forward” for everyone who had been so kind-hearted in my time of need on my journey. This I had to do for them. Plus, I love a good adventure.

My partner, being the great sport that he is, was game. He’d be ready to leave in two hours. With a spring in my step, I packed up, made a picnic dinner to eat in the car and grabbed a great bottle of red, two wine glasses and a corkscrew. After all we were going to be staying in a rustic bed and breakfast for the night.—why not take full advantage of the evening?

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We arrived well into the evening, greeted by Steve, an affable retired post master, who had worked on the lodge since buying it for his wife and children back in the early 70s. When he retired, Steve turned it into a B&B on the C&O canal, a 184.5 mile long trail that winds around the Potomac River following the towpath of the Chesapeake and Ohio Canal. Steve was happy to host the eclectic group of trail-goers who by chance stumbled into his lodge on foot, bicycle or even horseback. Over a glass of wine, he shared the stories of those in his register: hippies, loners and couples, all who had set out on a journey to find themselves.

After a morning breakfast of two eggs over easy, sausage, potatoes and the most mouth-watering, sweetest biscuits I ever had, we loaded up Jack’s horse and headed on down the road to Davis, WV to meet up with the long rider, Jack.

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Steve was wrong. Jack looked more like Johnny Depp in the Pirates of the Caribbean. He acted like him too. In spite of himself, you couldn’t help but like him. Jack was a 31 year-old man with a black bandanna and tongue piercing, trying to figure life out from a horse’s point of view. He was ecstatic to have his lead horse back. I knew the feeling. Rocky, my lead horse, had injured himself when another horse kicked him in Illinois. I had to leave him behind to heal. Parting with him ripped my heart out. When we were reunited three weeks later, the joy in having him back defied description. I was lost without him. I knew the elation that Jack experienced in being reunited with his horse on their great adventure.

Before leaving, Jack asked me to write in his journal, to offer him advice or wisdom that I had garnered on my solo trek. I simply wrote, “Discover the joy, discover the journey, discover yourself.” Because that’s what it’s all about—on any adventure.

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Tomorrow I head out on another adventure. Australia. For two weeks. Part of the journey will be a 4WD trip to the Outback where I’ll be backpacking, tenting and dining with the Aborigines. Wish me luck and hope that I discover the joy, the journey and perhaps even myself. When I return from this Aussie Adventure, I’ll certainly share with you. Till then, G’day mate.

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When someone loses a pet and says to me in grief, “I know it’s not the same as losing a child, but it hurts so much,” my heart aches. Not because I know the pain of losing not one, but two children, but because I also know the pain of losing a dearly loved animal.

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Nothing, and I mean, nothing compares to the pain of losing a child, but that doesn’t diminish the heartache of any loss. Human or animal. The void in life after loss is incredible. Where there was once life, a huge black hole looms when death takes over. Where there was once love, heartache. Smiles. Sadness. Happiness. Loneliness. The loss of life fills your heart with an overwhelming emptiness and pain. The moment of loss—that incredible moment of pain—in the passing of life is unavoidably deep. It rips your heart out. Loss causes heartache and there’s just no getting around that. It’s a part of life.

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This past February I had to put down Eric’s beloved Shadow. It was so painfully hard, perhaps extra so, because it was Eric’s dog, my living link to my dead son. Shadow was the kindest, gentlest black lab I’d ever known. He had a huge heart with big soulful brown eyes. When the decision came to put him down, I left that to my surviving son, Peter. He had taken over Shadow’s care in Eric’s passing.

Shadow had developed brain cancer with severe epileptic seizures and it was Pete’s responsibility to ensure Shadow’s comfort in his final debilitating days. Pete rose to the occasion and gently helped Shadow every time he experienced a seizure. Pete was also there in the middle of the night to clean up the blood and excrement from Shadow’s thrashing. And Pete found the courage to tell me it was time to euthanize him. As Shadow’s big black head with the soulful eyes lay quietly in Peter’s lap as the vet administered the needle, my heart screamed in pain at yet another loss in our lives. Shadow. Eric’s big black lab with the soft soul. My heart ached and I cried.

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I was so thankful he didn’t die alone; Shadow deserved more than that. Nothing should die alone. Any—no all–life deserves more than that.

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This past spring, I was headed down York Road and had to come to a creeping crawl to avoid the growing crowd on the shoulder of the road. Some members of the crowd were crying, others didn’t know what to do, but all eyes looked toward the middle of the road. My eyes followed their gazes. In the middle of the road was a beautiful brindle pit bull, smashed and dying on York Road. No one was near him; he was dying alone. God no. I pulled over and ran to him. “Has anyone comforted the poor thing?” I screamed. “No,” came their replies in unison. “We didn’t know if he’d bite.” I was spitting mad with grief, pain and tears as I watched the poor dog hold on to dear life. Where was their compassion? I didn’t understand. As I knelt down and stroked the dog’s big beautiful head, his blood spilling over onto my knees, his tail gave a tiny wag as he tried to look at me. I held him, comforted him, and loved him in his final moments.

I was so thankful he didn’t die alone. I didn’t know him, but he deserved more than that.

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Monday morning I headed to the farm to tend to my two horses and the other ten horses I’ve cared for over the past five years. My routine always starts out the same. I whistle for my horses and say hi to the others gathered at the gate. Where was Blaze, the leader of the herd? I headed into the stall barn to dish up the grain. Still no Blaze. That’s odd. Where was she? I called for her. No Blaze.

After putting the other 11 horses in their respective feeding stations. I shlepped through the field, over the bridge, over the stream, and into the 50 acre field to find Blaze. There, just beyond the stream, she lay—struggling to get up, bloated, and covered with flies. She had colicked sometime during the night and the others had left her for dead. My God. My God. No. No. No. The poor thing. Tears streamed down my face as I knelt beside her. She moved her head and laid it on my foot, looking at me through bleeding eyes as she let out a soft whinny.

I fumbled for my cell phone and called my girlfriend, leaving a terrifying message, “Call the vet. Call the vet now!” I screamed through my sobs. Then I crumpled beside Blaze in the field and stroked her big beautiful brown head with the white blaze. She labored to breathe. “Hang on. Hang on.” I whispered in her ear. “He’s coming. He’s coming.”

The vet arrived but couldn’t get his SUV across the stream. Could we get her up? Blaze tried, oh she tried so hard, but she didn’t have enough left in her. With a heavy heart the vet returned to his car to get the needle to euthanize her.

“Blaze, get up. Get up. You can do it. Everyone’s waiting on the other side. Don’t die her alone. Come on honey….get up.” I sobbed in her ear. With one valiant effort the gentle leader rose off her barrel belly onto her buckled knees and stood. With painful, labored steps this beautiful beast made her way to the stream where her herd was waiting. It took her fifteen minutes but she finally crossed to the other side where she was greeted with whinies and neighs from her delighted followers. She grew stronger with every painful step through the support and love of her herd, owners and caretakers, and finally made it to the paddock where she was enveloped and loved as she was laid to rest.

An imperial leader, of the gentlest nature, Blaze. I loved Blaze and was thankful she didn’t have to die alone. She deserved more than that, as do all creatures, great and small.

Rest in Peace Blaze, our gentle leader

Rest in Peace Blaze, our gentle leader

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When something turns out way better than expected it brings such joy to life. I love pleasant surprises and this 4th of July weekend has been full of them.

Friday night kicked the weekend off with one. I was driving home from work and saw crabs for $20/doz. at what I thought was a local down and dirty pub with a bad reputation. Or at least that’s what I had been told. Twenty dollars for a dozen crabs was worth the risk of a bad reputation.

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Arriving home, I asked my partner if he wanted to go out for the deal. The catch? He had to at least look the part of a red neck. He couldn’t walk into the down and dirty bar as a prep. Could he do it? He tried. He came bounding down the stairs in an old worn out t-shirt. Perfect. Till my eyes rolled to his bottom half. The crease in the jeans still gave him away. No matter how hard he tries he just can’t look down and dirty. I guess that’s not really a flaw though. I smiled; he tried. He then looked me up and down and said, “Well you’re not really down and dirty either. “Ah, but no,” was my reply, “I just need to look good to a red neck guy.”

When we got out of the car in the parking lot and headed for the bar door, a Harley roared by. My partner said “Man, he couldn’t keep his eyes off you.”  I laughed, “Actually he couldn’t take his eyes off the crease in your jeans.”

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We pulled the door open, expecting the worse. To our pleasant surprise the restaurant was cute, the bar great, and the prices were fabulous. The owner came out, engaged us in conversation, and threw four extra crabs into our to-go bag. We’re definitely going to hit that down and dirty pub up for our weekly cheap date night. Pushing one’s comfort zone is grand.

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Saturday, the 4th of July, started out with a 5:45 am wake up call for me to get ready for my first parade in the Cavalry. My partner, coming along for pure support, rolled out of bed at the ungodly weekend hour to help me get Rocky, my horse, ready for the 4th of July parade in Takoma Park in Washington, DC.

Our first pleasant surprise came as we arrived in Takoma Park. Expecting an urban area with lots of noise, cars and pollution, we were greeted with a charming bedroom community with tree-lined sidewalks stretching in front of historic homes. Lawns were filled with a thousand or more  children, parents and grandparents decked out in red, white and blue, waving flags of all sizes. The weather was perfect and the air was filled with a patriotic hum, no matter which side of the political fence the flag was flying on.

In fact one long-haired silver woman in a purple tye-dyed flowing skirt came up to me in my military dress blues as I was mounting up on Rocky. She leaned in and thanked me for protecting her right to her far different views. She smiled as she pointed to the flower in her hair. I smiled back, knowing what she meant, and thanked her. Two different sides of the fence coming together as Americans to enjoy a parade in a small home-town.

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As we assembled for the parade, the Sergeant who was supposed to be carrying the flag for the hour-long parade was suffering from the flu. He grew weezy and weak and, unfortunately, had to withdraw. My commander turned to me and Rocky and said, “Step up, it’s your honor.” My second pleasant surprise. As we started off with the large flag flapping over Rocky’s ears, the crowd stood and erupted into cheers and applause. My heart surged, filling with pride and patriotism. I whispered to my commander, “I’m going to cry sir. I’m going to lose it.” “Hold on PFC Losey. Hang in there.” And I did, for the hour long ceremony as we paraded through the streets to thousands of red-blooded Americans celebrating our independence. Truth be told, tears streamed down my face, as we celebrated as one.

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After arriving home, we had no plans. So we took an afternoon of leisure hanging out in the pool, swimming side-by-side and then tying two floats together as we held hands and napped. Totally unlike us, and it felt so good, another pleasant surprise. I told my partner it would be a perfect day if I could once again hear the squeal of children playing in a pool. The phone rang.

My sister-in-law from my first marriage, whom I’ve been friends with for 27 years, was at Wegman’s. “Hey,” I said, “Why don’t you grab a 5 lb. bag of Sahlen hot dogs and bring the kids on over for a picnic and swim?” “I already have the hot dogs in the cart, along with cole slaw, strawberries and stuff to make shortcake. Game?” she asked.”You bet I am.” I replied. I ran upstairs and uncovered the goggles, the flippers, the frisbee and ball that Eric and Sam used to play on the beach with Cara and Peter far too many years ago.

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When my in-laws arrived, we baked the shortcake and headed out to the deck to grill the dogs, drink, and listen to the squeal of children once again playing in the pool. I sighed perfectly contented with my weekend full of patriotism and pleasant surprises. God I love the small joys of life.

Takoma Park Parade, July 4th 2009

Takoma Park Parade, July 4th 2009

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Driving the 350 miles up to my hometown of Buffalo for my nephew’s high school graduation, revealed to me an “aha” moment: people handle driving the way they handle life. Lead, follow or get out of the way! Please.

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As I was driving on an open stretch of route 15 in Pennsylvania, a silver Kia sedan sped up as it approached my rearview mirror. As it passed me, I noticed the twenty-something girl behind the wheel, who immediately slowed down once she pulled back into my lane in front of me. As I then pulled out to pass her, she immediately sped up, only to slow down again when I resumed my position behind her. She slowed down. I went to pass. She sped up. I’d pull back in. She’d slow down. This went on for a number of miles, when the “aha” moment hit me. She wanted to lead, but didn’t have the courage to be the leader.

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Along the way, the highway was strewn with state troopers pulling people over as they sped by. The twenty-something girl flying by me wanted to be in the lead but didn’t have the courage to be the lead driver. She wouldn’t commit. She wasn’t willing to take the risk of being pulled over for speeding. But she wanted to BE the leader, forcing the other drivers to either drive her speed or pass her. It was an unsafe practice for those following. Speed up. Slow down. Speed up. Slow down. It was an accident waiting to happen. She was not lead driver material. She needed to be following at a safe speed. I’m confident her approach to driving was the same as her approach to life. A young girl be-bopping along, accelerating, de-accelerating, pulling in and passing, trying to find the rhythm of her life.

When it comes to driving and life, I’m a leader but have no problem following—IF I’m behind a confident leader who makes good decisions. If not, get out of the way, ’cause I’ll take over and pass. I don’t have a lot of patience for hesitant leaders or drivers. Commit. Make a decision or move over and let someone else lead.

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En route to Buffalo, I encountered fierce thunderstorms with pelting rain and winds. Hail storm like conditions, just shy of hailstones coming down. As a pretty fearless driver, severe winter storms don’t stop me, let alone a little rain. Yet people were driving 25 mph hour on an interstate with their flashers on. People, please. It’s a little rain. Well a lot of rain. Eventually most of the drivers pulled over. Ah, relief. An open road where I could go. I led the drivers, confidently, to salvation, er, sunshine. It just took someone willing to commit and lead. I have no problem stepping up if need be. That’s who I am as I driver and who I am in life.

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My partner has an interesting approach to driving and to life. He meanders in both. If there’s a straight line to get from point A to E, he’ll drive from A to D to K to N back to C over to J and eventually he’ll make it to E, his end destination. This is his approach to most things in life. In the meantime, he’s made a lot of stops, said hi to many people and eventually accomplished what he sets out to do. If I’m on a mission and need to get from A to E in record time, and I’m with him, I have to restrain myself from pushing down on his knee to accelerate to 65 mph. It drives me bonkers. But if I’m not on a mission, and willing to meander, it makes for a very pleasant journey. That’s why I think we make good partners—one forces the other to stay on task, the other forces the other to stop and smell the roses.

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Although I stay on task, I am an adventurer. I love the journey, the drive, the discovery, the ability to make choices. My brother has a GPS named Lucille. I hate her. No, I will not turn because you told me to. I’ll turn because I choose to. No wait, I WANTED to go to the Ben and Jerry’s. It’s an unscheduled stop, don’t recalculate. Shut up. Stop it. Let me drive. Let me choose. Let me discover their new Mission to Marzipan flavor. Stop it. Stop it. Stop it. I don’t want to stay on task I want to stop and smell the roses. But she won’t let me, without giving me a huge headache. Big mouth Lucile shows no restraint. Recently, someone stole her. God Bless them.

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Did you know a study recently stated that people with lots of bumper stickers on their cars are aggressive drivers? I find that hilarious, because the cars that I usually see plastered with bumper stickers are Subarus touting world peace.

You’ll be happy to know that I don’t place bumper stickers on my vehicles. But if I were to sport a bumper sticker on my 4×4 F-150 it would simply be, “Visualize whirled peas.”

visualize-whirled-peas-bumper-sticker-5781

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“When the going gets tough, the tough eat donuts”–Ziggy

I love Ziggy. Do you remember him—the fat little bald guy in the 70’s comic strip by Tom Wilson? Ziggy had a “woe is me” perspective on life but offered simple words of wisdom.

The cartoon quote from above was lovingly cut out of the paper by my dad and taped to my mirror when I was 18. I’m sure it’s now tucked away in an attic box piled on top of other boxes from far too many moves. Every time I think of Ziggy, I think of my dad who passed away at an early age of 59, fifteen years ago.

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My dad didn’t cut that cartoon out to suggest I was getting fat. He simply cut it out because the humor struck a chord with him. When I was 18 I worked in the deli of a local grocery store. Oftentimes, at the end of the shift, I had to box up the fresh donuts from the bakery to be put out for the “day old” dollar sale the next day. So each night I’d box them up–and then buy ‘em. My particular favorites were the peanut donuts. Oh my, they were good. But, alas, they are not made anymore because of all the peanut allergen sufferers out there. Sigh. I loved a good peanut donut. The memory of biting into a fresh donut with falling nuts and crumbs waiting to be scooped up, filling my nose with the warm, nutty sensation, still makes my mouth water.

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The humor that my dad found in the comic strip was that I was a love-sick teen who had just broken up with my first forever boyfriend, who brought home a box of donuts at the end of the night to eat away the pain. When the going got tough, I ate donuts. My dad was trying to get me to move through the “woe is me” attitude from the teen-age breakup with humor. I loved that about my dad—he moved through life with humor and I couldn’t help but be sucked into it.

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That particular Ziggy cartoon was based on the quote from Joseph P. Kennedy, father of our 35th president John F. Kennedy, “When the going gets tough, the tough get going.” I’m sure the fiercely ambitious businessman and political figure, who thrived on competition and winning, gave that fatherly advice to his 9 children with a stern striking of his fist with emphasis on every word.

Not my dad. He cut out cartoons from the paper and taped them to my mirror. He peeled off Chiquita banana labels and pasted them somewhere in my school lunch box for me to discover with love. He’d sneak away early from work and show up unexpectedly for the last 15 minutes of my soccer game. He didn’t rule with an iron fist, rather with respect, love and humor.

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The humor that he used to get me through my first forever boyfriend break-up still makes me smile to this day. He was letting me know that life goes on, it’s what you make of it, it’s how you choose to move through it that makes all the difference.

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I had to stop eating donuts, not because they landed on my hips, but because I got sick of them. To this day I have a hard time eating donuts because I ate too much of a good thing way back when. As Marie Lloyd so simply states, ” A little of what you fancy does you good.” The lesson from Ziggy and my dad: taking it to the extreme is not necessarily a good thing. Although I have to admit when I see a “Hot Donuts Now” sign flashing at a Krispy Kreme, my car automatically pulls into the drive-thru. I’m just taking them home to the kids. Honest.

“A LITTLE of what you fancy does you good.” For sure.

Ziggy

Ziggy

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Sock. Shoe. Sock. Shoe. No. Sock. Sock. Shoe. Shoe. I do sock, sock, shoe, shoe. How do you approach your morning routine?In the end does it really matter? In Ted Menton’s After Goodbye, he tells the story of two children in the throes of cancer arguing in the cancer ward about which is better. Sock. Shoe. Sock. Shoe. or Sock. Sock. Shoe. Shoe.

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In spite of the cancer scenario, I find it amusing that two children facing the fight of their lives still find their individual routine’s worth fighting about. Sock. Shoe. vs. Sock. Sock. I have never been a routine person. Not me. In fact, if you ever placed me into a box, I’d scrape and claw my way out of it.

All my life, I’ve been known for my spontaneous nature. Until my children died. Then, I took great comfort in my routine. It was what got me up in the morning. Linda, first put on your sock, then your shoe. Nope. Put on your sock. Now put on your other sock. Okay, put on your shoe. Now your other shoe. Now put one foot in front of the other. Now take a step. Okay. Move the other foot. Move forward. Step by step. Move through the pain. You can do it. Sock. Sock. Shoe. Shoe. Move. Move. And that’s how I’ve moved through the passing pain of losing two children.

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Most of you know Monday marked the five year anniversary of Sam’s passing. My 10 year old son. I have been in a routine for the past five years in learning how to live again through the loss. Sock. Sock. Shoe. Shoe. Move. Move. Don’t you take that routine away from me. Like the children on the cancer ward, I took great comfort in owning my routine. It was the only thing I had control over. God forbid I put on Sock. Shoe. Sock. Shoe. It didn’t feel right. Just like my life without my children. Come to think of it, before the passing of my children I think I did Sock. Shoe. Sock. Shoe. But I couldn’t go back to the same routine. It wasn’t right. I needed a new routine. It was new, but a routine, just the same. Just like living and breathing without half my family. I had to learn to do it all over again. The basics of living.

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Know how I celebrated Sam’s anniversary? The “non-celebration,” as it were, ended up in my mowing the lawn. Now my partner prides himself on the perfectly parallel lines in the lawn. I never got that. I don’t. To me a lawn is a lawn. And this just isn’t a lawn; it’s a field, a three acre field next to a stream. It deserves to be a field. But nope. He wants it to be a lawn. Not me. I want it to be a field with dancing grass blowing in the breeze, next to the stream. I want it mowed three times a season. He wants it mowed once a week. Now I love to mow, so I took on the chore. On Sunday, I started running the perfectly parallel lines of the routine. Sock. Sock. Shoe. Shoe. Up. Down. Up. Down. Forty-five inches over from whence I started. Now another 45 inch wide mowing deck over. Then a dragon fly landed on the dancing grass next to the stream in the field I was cutting into a routine.

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Sam followed me across the country on my horse trip. Thousands of dragon flies followed me. They had my back. As Sam did. I wear a dragon fly bracelet as a remembrance of Sam. So I couldn’t do it. I couldn’t cut the field in parallel lines. I couldn’t cut the field so the dragon fly had no where to land. I couldn’t cut the field by way of routine. So in honor of Sam, I cut whoopsi-doodles. No rhyme or reason. Just by happen-chance, I have a field full of perfectly un-parallel lines. Perfect whoopsi-doodles where dragon flies can land on the missed grass of the 45 inch mowing deck. In the outskirts of the circles where 45 inches didn’t meet the other 45 inches. Where shoes come before socks. Where dragon flies land before parallel lines are cut. Where routines are lost and spirits soar. Where perhaps even socks are worn without shoes. For in the end, it just doesn’t matter.

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“Wow, Linda, you look fabulous and fit!” was the statement I heard Tuesday night at my Toastmaster’s meeting. Little did that person know I have, over the past 4 months, unintentionally dropped 1/5 of my weight.  Now, I’ve never had a problem with weight. I had four children and managed to stay relatively thin chasing after them through the years. But I found it truly ironic that I’m the thinnest I’ve ever been—even before my high school years—and was being rewarded with a “Wow, you look fit and fabulous.”  I didn’t feel it.

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Yesterday I nearly collapsed at work, drove to a 24/7 healthcare center, to be told I’m severely anemic. This coupled with the five other symptoms that have crept up on me over the past four months and the doctor scared me with the big C.

My dad died of cancer and it wasn’t something I was prepared to hear. Now lots more tests need to be done, so don’t get all melodramatic on me. I have lots of years left to live, I know that, and feel that, with every fiber of my being. The point to all of this is that you just don’t know what the day may bring. Are you living the life you were born to lead?

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“Always be a first-rate version of yourself, instead of a second-rate version of somebody else.”
–Judy Garland

This from a woman who played somebody else for 45 of her 47 years. This from a woman who attempted suicide numerous times throughout her tragic life. This from a woman who struggled with insecurities and addictions. This from a woman who was told by her producers that she was unattractive and overweight. This from a woman who died at 47, the same age I’m about to turn in three weeks. Was Judy Garland ever a first-rate version of herself?

Judy Garland will always be remembered as Dorothy in the Wizard of Oz, with her ruby red slippers, clicked three times, as she closed her eyes and chanted,  “There’s no place like home. There’s no place like home. There’s no place like home.” Ironically, Judy Garland never felt at home anywhere. I can only imagine why she never revealed her true self, always hiding it away—for fear that her adoring fans would cast aside the real Judy. They always wanted Dorothy. The cute little, pig-tailed girl from Kansas.

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I also imagine that Judy Garland did live the life she was born to lead. She was a wonderful actress and a beautiful singer with her deep contralto voice. No one does honor to Somewhere Over the Rainbow the way Judy performed it half a century ago. But she never believed she deserved to be Judy Garland and all that she achieved. She was just Frances Ethel Gumm from Grand Rapids, MN. When she was pushed into acting, Frances’ confidence was sucked out of her and for years she was only able to portray a second-rate version of somebody else.

When the big C is thrown at you, your life hits replay over and over again in your mind. “Have you lived the life you wanted? Have you achieved what you set out to achieve? What more do you have left to do?”  It begs the question, “What is your legacy?”

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So what is your legacy? If you were to die tomorrow, did you live the life you were born to lead? Will you leave behind something to remember? Did you live a first-rate version of yourself?

I hope I have.

I know my youngest son Sammy did. On Monday, he’ll be gone 5 years. On June 22. But I still remember his great grin. His aqua blue eyes. His mischevious sense of humor. And his terrific hugs. In his short 10 years, Sammy was a first-rate version of himself. There will never be another.  In the end, all you have are memories, and the ones spent with family and friends are the ones you treasure most.

So as I remember Sammy and Frances Ethel Gumm, who co-incidentally also died on June 22, as I head into the doctors for a follow-up visit to the big C scare, I hope to see a rainbow smiling down on me.

Somewhere Over the Rainbow (click, for a beautiful version by 6 year-old Connie Talbot on YouTube)

Somewhere over the rainbow
Way up high,
There’s a land that I heard of
Once in a lullaby.

Somewhere over the rainbow
Skies are blue,
And the dreams that you dare to dream
Really do come true.

Someday I’ll wish upon a star
And wake up where the clouds are far
Behind me.
Where troubles melt like lemon drops
Away above the chimney tops
That’s where you’ll find me.

Somewhere over the rainbow
Bluebirds fly.
Birds fly over the rainbow.
Why then, oh why can’t I?

If happy little bluebirds fly
Beyond the rainbow
Why, oh why can’t I? 1

I hope we all live the life we were born to lead—the way Sammy did, so beautifully and innocently with a verve for life and love. Love and miss you tons, my little Sammer Dam.

Sam Losey, 3/29/94 - 6/22/2004

Sam Losey, 3/29/94 - 6/22/2004

1 Somewhere Over the Rainbow, music by Harold Arlen and lyrics by E.Y. Harburg

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Many moons ago, when my mother was the age I am now, and I was but a girl of 16, my father came home one memorable day and announced to us that we were moving. To a farm. Although I was a tomboy with three older brothers, I was a city girl through and through. It’s all I had known.

As a family, we would be moving to a 10 acre farm, next to 3000 acres of state land, to a public school with a graduating class of 32.  Yep, I was downsizing as president of my class of 400, to 32 classmates, and upsizing from an 1/8 of an acre lot in the city, to thousands of acres in my backyard.

In order to get me to go without kicking and screaming, my father bribed me with a horse. He was a smart man.

Most of you know that horses are a huge part of my life and I have no problem getting down and dirty with ‘em. And others know me as a gussied up artist, author, and speaker. As Kippling writes, “Never the twain shall meet.” My wardrobe is determined by the activity of the day, yet whatever I’m wearing on the outside, doesn’t change the me I am on the inside. The old idiom, “Don’t judge a book by its cover,” is, well, cliché-like, but, it’s still relevant today.

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A month after we moved to the farm, on a blazingly hot summer day, my father ordered manure from our neighbor’s farm to fertilize the small garden he was tilling. I remember the moment the manure arrived. The fresh droppings reeked and steamed. But that’s not what I remember the most. Our neighbor’s ten year old daughter was sitting plop on top of the manure pile, with a wide grin, happy as a pig in….well you know.

My mother, father and I grabbed our shovels to start pushing the manure off the wagon into the garden. The little girl with the huge smile sitting in the stewing cow chips, looked at my mother incredulously. “What are you afraid to get them rings dirty?” she asked as she pushed the shit off with her bare feet. My mother stared back in horror.

Now my mother is not an outdoor person per se, but she did a great job of humoring her five children and outdoor-loving husband through countless camping trips, homeless animals, moves to the country, etc. But I don’t think I could ever picture her shoveling dung with her feet. On the other-hand I don’t think that grinning girl on top of that manure mountain would ever sit still in a theater either. But I don’t know, I lost track of her. Who am I to judge that she couldn’t or wouldn’t?

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On my solo cross-country journey by horseback, I did a lot of wilderness camping and would go days without eating or showering. Yep, I reeked, I’m sure, like the compost on that hot summer day, but there was something about the solace of the wilderness that helped to heal me on that long journey.

One stop in particular reminded me of that long-ago judgment day with my neighbor’s little girl. Camping for two days in a park outside of a penitentiary in rural Indiana, I was sitting under a tree journaling when a truck hauling a two-horse trailer arrived. I paid them no mind and continued writing. After tacking and mounting up, the owners made their way to me. They were retirees out for a late-summer ride and had never before encountered in their horse park a wild-haired, dirty, lone woman parked under a tree writing with two horses grazing beside her. Was she an escapee from the penitentiary—or worse yet, waiting to help a convict escape on her other horse? Still I paid them no attention as they inched in closer with their mounts—until the wife leaned over and whispered, “Is that a boy or a girl?” I looked up with a smile and said, “I’m a girl with a Master’s and perfectly good hearing.” But I sure didn’t look it.

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Last night, as I was mounting up for a high profile event with my horse, I had to pee. With no facilities around, I sheepishly entered my horse trailer, closed the door, and had to make do sitting plop on top of a manure bucket with freshly steaming dung, just like that little girl from my childhood. Who knew that would be me someday?

This morning after getting all-gussied up for work, I had to stop by my partner’s office to drop something off. He introduced me to the office cleaning lady, a nice enough woman, who totally misread me. She leaned over and said to him, “She’s very pretty, but it looks like she’s afraid to get those nails dirty.” He laughed, “Of anybody I know Linda has no problem getting down and dirty, but she cleans up real ‘purdy!’”

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Although the idiom, “Don’t judge a book by its cover” came about in the journal, American Speech in 1944, the idea has been around for centuries. Heed these wise words written by François Rabelais in La vie de Gargantua et de Pantagruel, “But it’s wrong to be so superficial when you’re weighing men’s work in the balance. Wouldn’t you yourself say that the monk’s robes hardly determine who the monk is? Or that there are some wearing monks’ robes who, on the inside, couldn’t be less monkish? Or that there are people wearing Spanish capes who, when it comes to courage, couldn’t have less of the fearless Spanish in them? And that’s why you have to actually open a book and carefully weigh what’s written there.”1

You have to actually open a book and carefully weigh what’s written there… Relevant words an incredible five centuries later. God, I love words! Down and dirty, but real “purdy!”

1 Wikipedia

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But most of that change was from recategorizing old vaccinations that were previously buy cheap kamagra oral jelly not allocated to specific counties. Hawaii, which already ranked third in the nation for its rural vaccination rate, had the second largest gain last week (expressed as a percentage of the rural population). The state raised its rural vaccination rate by 1 percentage point through a combination of new vaccinations and recategorizing unallocated ones from previous weeks.

The South, which lags the buy cheap kamagra oral jelly rest of the U.S. In vaccinations, had eight additional states on the top 10 list last week. Alabama, Kentucky, Mississippi, Georgia, North Carolina, South Carolina, Florida, Louisiana.

Data is from the Centers for Disease Control and Prevention and the state health departments of Hawaii, Massachusetts, buy cheap kamagra oral jelly and Texas. You Might Also LikeStart Preamble Notice, correction. This document clarifies a term that appeared in the “Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against erectile dysfunction treatment,” including in the final notice published in the Federal Register on September 14, 2021, entitled “Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against erectile dysfunction treatment.” Specifically, this document supplements the references to the Advisory Committee on Immunization Practices (ACIP) with references to the Centers for Disease Control and Prevention (CDC).

This change is being made to clarify that what are commonly referred to as “ACIP recommendations” and “ACIP standard immunization schedules” are in fact buy cheap kamagra oral jelly recommendations and schedules made by the CDC after consultation with ACIP. The addition of “CDC” is also intended to recognize coverage of recommendations issued directly by the CDC. This clarification also applies to related guidance and opinions.

This correction is buy cheap kamagra oral jelly applicable September 30, 2021. Start Further Info L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201.

202-260-0365, paige.ezernack@hhs.gov buy cheap kamagra oral jelly. Corrections Corrections to technical errors that appeared in sections V(d) and (h) and XII of the final notice published in the Federal Register on September 14, 2021 at 86 FR 51160 entitled “Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against erectile dysfunction treatment. These corrections are made to clarify that when the term Advisory Committee on Immunization Practices (ACIP) schedule or recommendation is used in the declaration, that refers to recommendations made to the Centers for Disease Control and Prevention (CDC) by the ACIP in its advisory role under the Federal Advisory Committee Act.

Such recommendations are taken into buy cheap kamagra oral jelly consideration when the CDC issues its recommendations, as adopted by the CDC Director. These have historically been published in CDC's Morbidity and Mortality Weekly Report under the title “ACIP recommendations.” The term “CDC” is added throughout the declaration whenever referring to ACIP recommendations or schedules to also recognizes coverage of recommendations issued directly by the CDC. Subsection V(d) is clarified to read.

(d) A State-licensed pharmacist who orders buy cheap kamagra oral jelly and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the CDC/ACIP recommend [] to persons ages three through 18 according to CDC's/ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the CDC/ACIP recommend to persons aged 19 and older according to CDC's/ACIP's standard immunization schedule. Or (3) FDA authorized or FDA licensed erectile dysfunction treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met.

i buy cheap kamagra oral jelly. The treatment must be authorized, approved, or licensed by the FDA. Ii.

In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered buy cheap kamagra oral jelly according to CDC's/ACIP's erectile dysfunction treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to CDC's/ACIP's standard immunization schedule.

iv buy cheap kamagra oral jelly. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and Start Printed Page 54697 administered according to CDC's/ACIP's standard immunization schedule. v.

In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately buy cheap kamagra oral jelly available to the immunizing qualified pharmacy technician. Vi. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer treatments.

If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least buy cheap kamagra oral jelly 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vii.

The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the buy cheap kamagra oral jelly recognition and treatment of emergency reactions to treatments. viii.

The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] ix. The licensed pharmacist must complete a minimum of two hours of buy cheap kamagra oral jelly ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. X.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi. The licensed pharmacist must inform his or her childhood vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.

And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s). Section V(h) is clarified to read.

(h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph. 1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered.

2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General. 3.

Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering treatments as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered. Subject to the following requirements. I.

The treatment must be authorized, approved, or licensed by the FDA. Ii. Vaccination must be ordered and administered according to CDC's/ACIP's erectile dysfunction treatment recommendation(s).

Iii. The healthcare professionals and students must have documentation of completion of the erectile dysfunction treatment Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. iv.

The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and Start Printed Page 54698 administration of the erectile dysfunction treatment(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; [] vi.

The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s).

Section XII is clarified to read. €œLiability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that CDC/ACIP recommends to persons ages three through 18 according to CDC's/ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October l, 2024, whichever occurs first.” This amendment does not change effective dates under Section XII. Start Signature Karuna Seshasai, Executive Secretary to the Department, U.S.

Department of Health and Human Services. End Signature End Further Info End Preamble [FR Doc.

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Welcome back to the latest edition of the super kamagra 2 in 1 EMJ. It’s high Summer here in the Northern Hemisphere and our hopes that erectile dysfunction treatment would be a distant memory by now are sadly broken. We are in wave n+1 at the moment (where n super kamagra 2 in 1 depends on where you are in the world), but there is hope in sight as treatment roll outs continue around the world.This month our Editor’s choice is the PRIEST study.

This huge observational trial of erectile dysfunction treatment 19 patients presenting to UK emergency departments gave us essential information on risk assessment in the erectile dysfunction treatment kamagra. It’s a fantastic example super kamagra 2 in 1 of how a trial can be rapidly delivered in a kamagra and a lesson in how we need to plan for the kamagra after erectile dysfunction treatment. The study is particularly useful in that it focuses on information available to the emergency clinician in the form of well-known scores such as NEWS2 as opposed to data that may be available much later (such as some laboratory testing).

While therapeutic trials of repurposed drugs such as the RECOVERY and REMAP-CAP trials super kamagra 2 in 1 have received much of the publicity in the wake of erectile dysfunction treatment we must remember that as emergency clinicians it is diagnosis, prognosis, risk assessment and disposition decisions that are at the core of our specialty. The PRIEST study is a great example of how this can be done in a kamagra.Keeping with a erectile dysfunction treatment theme Richards et al examined the evidence for prone positioning for non-intubated hypoxic erectile dysfunction treatment patients. Despite the millions of cases worldwide and the enthusiasm for this technique the evidence base from 31 trials is actually very poor.

There are theoretical physiological advantages of course, and anecdotally short-term improvement can super kamagra 2 in 1 be seen. However, it is still not clear whether this translates into important patient related outcomes. It’s clear super kamagra 2 in 1 from this study that we need more data to support clinical practice and from well-designed clinical trials.Leading a cardiac arrest is a complex task that even experienced clinicians can find cognitively overwhelming.

There is the ‘in the moment’ task of sticking to an algorithm while at the same time trying to figure out a more strategic plan for the patient. Few individuals can do both effectively which is why super kamagra 2 in 1 my colleagues have been teaching the concept of splitting roles to cognitively offload the strategic leader to strategically direct the arrest. I was therefore delighted to see this concept tested in the CANLEAD trial using a simulated model of cardiac arrest and nursing team leaders to run the ALS algorithm.

In 20 simulations involving 120 participants they super kamagra 2 in 1 found improved overall team performance. Whether this would translate to better outcomes for patients in real world settings remains to be seen, but it has face validity and this study supports further work. It’s also a welcome reminder that nurses are perfectly capable of running cardiac arrests, and some of the best resuscitationists I know work with nurses in exactly this manner.Cardiac arrest is a condition (among others) where debriefing is important and so it’s good to see a study of the use of a structured debrief tool from Sugarman et al who report a quality improvement project looking at implementing the ‘TAKE STOCK’ tool, adapted from the Stop5 tool.

QIP reports are relatively new to the journal, and we hope to highlight effective super kamagra 2 in 1 and interesting projects that can make a real difference to clinical care. The QIP shows a broad welcoming of a structured approach to debriefing from all staff members, and articulates a path for their introduction. If you are not already using a debriefing tool then this QIP may well help your department embed this important task.As I write this there is a lot of media attention in the UK regarding the number of paediatric attendances to UK emergency departments with colleagues such as super kamagra 2 in 1 Damian Roland from Leicester working hard to educate the public on what fever really means in the paediatric population.

While most fevers are benign we all know that it can also be a marker of and so we have two paediatric studies looking at this in August. Chong et al looked at children under 3 months which are a notoriously difficult group to differentiate serious from benign disease super kamagra 2 in 1. In their cohort the incidence of severe disease was high (33%), but there are clues in the heart rate variability, temperature, and gender may help.

In a less risky group Mallet et al have looked at the prescription of antibiotics in paediatric sore throat finding a fair amount of variability between clinician choice and more formalised scoring mechanisms. It’s a good story to remind us that research findings (in this case scoring systems) rarely perform or penetrate clinical practice in the way that we would hope or anticipate.Sticking with paediatrics I was interested to read a paper that made me stop and think about my super kamagra 2 in 1 own practice for Toddler’s fractures. My approach has been symptom led varying from the rare use of plaster of Paris through splints, and often very little indeed if the patient is not distressed or in pain.

This month we have a randomised controlled trial from Australia comparing above knee POP super kamagra 2 in 1 to a controlled ankle motion boot. They found that a controlled motion boot is easier to live with and allows a faster return to activities of daily living and without any healing problems. However, I’m still left wondering if either of these levels of intervention are necessary for all patients.There’s lots more in this month’s edition but I’ll end with a reminder that our perceptions of emergency care may differ from those of our super kamagra 2 in 1 patients.

Bull et al.’s systematic review of patient experience in the emergency department is enlightening with two major themes, one of the interactions between patients and staff and the other with the environment of the emergency department. There is much to reflect on here and perhaps time to look at our departments from the patient perspective.Ethics statementsPatient consent for publicationNot required..

Welcome back How much propecia cost to buy cheap kamagra oral jelly the latest edition of the EMJ. It’s high Summer here in the Northern Hemisphere and our hopes that erectile dysfunction treatment would be a distant memory by now are sadly broken. We are in wave n+1 at buy cheap kamagra oral jelly the moment (where n depends on where you are in the world), but there is hope in sight as treatment roll outs continue around the world.This month our Editor’s choice is the PRIEST study.

This huge observational trial of erectile dysfunction treatment 19 patients presenting to UK emergency departments gave us essential information on risk assessment in the erectile dysfunction treatment kamagra. It’s a fantastic example of how a trial can be rapidly delivered in a buy cheap kamagra oral jelly kamagra and a lesson in how we need to plan for the kamagra after erectile dysfunction treatment. The study is particularly useful in that it focuses on information available to the emergency clinician in the form of well-known scores such as NEWS2 as opposed to data that may be available much later (such as some laboratory testing).

While therapeutic trials of repurposed drugs such as the RECOVERY and REMAP-CAP trials have received much of the publicity in the wake of erectile dysfunction treatment we must remember that as emergency buy cheap kamagra oral jelly clinicians it is diagnosis, prognosis, risk assessment and disposition decisions that are at the core of our specialty. The PRIEST study is a great example of how this can be done in a kamagra.Keeping with a erectile dysfunction treatment theme Richards et al examined the evidence for prone positioning for non-intubated hypoxic erectile dysfunction treatment patients. Despite the millions of cases worldwide and the enthusiasm for this technique the evidence base from 31 trials is actually very poor.

There are theoretical physiological advantages of course, and anecdotally short-term buy cheap kamagra oral jelly improvement can be seen. However, it is still not clear whether this translates into important patient related outcomes. It’s clear from this study that we need more data to support clinical practice and from well-designed clinical trials.Leading a cardiac arrest is a complex task that even experienced buy cheap kamagra oral jelly clinicians can find cognitively overwhelming.

There is the ‘in the moment’ task of sticking to an algorithm while at the same time trying to figure out a more strategic plan for the patient. Few individuals can do both effectively which is why my colleagues have been teaching the concept of splitting roles to cognitively offload the strategic leader buy cheap kamagra oral jelly to strategically direct the arrest. I was therefore delighted to see this concept tested in the CANLEAD trial using a simulated model of cardiac arrest and nursing team leaders to run the ALS algorithm.

In 20 simulations involving 120 buy cheap kamagra oral jelly participants they found improved overall team performance. Whether this would translate to better outcomes for patients in real world settings remains to be seen, but it has face validity and this study supports further work. It’s also a welcome reminder that nurses are perfectly capable of running cardiac arrests, and some of the best resuscitationists I know work with nurses in exactly this manner.Cardiac arrest is a condition (among others) where debriefing is important and so it’s good to see a study of the use of a structured debrief tool from Sugarman et al who report a quality improvement project looking at implementing the ‘TAKE STOCK’ tool, adapted from the Stop5 tool.

QIP reports are relatively new to the journal, and we hope to highlight effective and interesting projects that can make a real buy cheap kamagra oral jelly difference to clinical care. The QIP shows a broad welcoming of a structured approach to debriefing from all staff members, and articulates a path for their introduction. If you are not already using a debriefing tool then this QIP may well help your department embed this important task.As I write this there is a lot of media attention in the UK regarding the number of buy cheap kamagra oral jelly paediatric attendances to UK emergency departments with colleagues such as Damian Roland from Leicester working hard to educate the public on what fever really means in the paediatric population.

While most fevers are benign we all know that it can also be a marker of and so we have two paediatric studies looking at this in August. Chong et al looked at children under 3 months which are buy cheap kamagra oral jelly a notoriously difficult group to differentiate serious from benign disease. In their cohort the incidence of severe disease was high (33%), but there are clues in the heart rate variability, temperature, and gender may help.

In a less risky group Mallet et al have looked at the prescription of antibiotics in paediatric sore throat finding a fair amount of variability between clinician choice and more formalised scoring mechanisms. It’s a good story to remind us that research findings (in this case scoring systems) rarely perform or penetrate clinical practice in the way that we would hope or anticipate.Sticking with paediatrics I was interested buy cheap kamagra oral jelly to read a paper that made me stop and think about my own practice for Toddler’s fractures. My approach has been symptom led varying from the rare use of plaster of Paris through splints, and often very little indeed if the patient is not distressed or in pain.

This month we have a randomised controlled trial from Australia comparing above knee POP buy cheap kamagra oral jelly to a controlled ankle motion boot. They found that a controlled motion boot is easier to live with and allows a faster return to activities of daily living and without any healing problems. However, I’m still left wondering if either of these levels of intervention are necessary for all patients.There’s lots more in this month’s edition but I’ll end with a reminder that our perceptions of emergency care may buy cheap kamagra oral jelly differ from those of our patients.

Bull et al.’s systematic review of patient experience in the emergency department is enlightening with two major themes, one of the interactions between patients and staff and the other with the environment of the emergency department. There is much to reflect on here and perhaps time to look at our departments from the patient perspective.Ethics statementsPatient consent for publicationNot required..

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Wealthy nations must do much more, much faster.The United Nations General Assembly in September 2021 will bring countries together at a critical time for kamagra pills for sale marshalling collective action to tackle the global environmental crisis. They will meet again at the biodiversity summit in Kunming, China, and the climate conference (Conference of the Parties kamagra pills for sale (COP)26) in Glasgow, UK. Ahead of these pivotal meetings, we—the editors of health journals worldwide—call for urgent action to keep average global temperature increases below 1.5°C, halt the destruction of nature and protect health.Health is already being harmed by global temperature increases and the destruction of the natural world, a state of affairs health professionals have been bringing attention to for decades.1 The science is unequivocal.

A global increase of 1.5°C above the preindustrial average and the continued loss of biodiversity risk catastrophic harm to health kamagra pills for sale that will be impossible to reverse.2 3 Despite the world’s necessary preoccupation with erectile dysfunction treatment, we cannot wait for the kamagra to pass to rapidly reduce emissions.Reflecting the severity of the moment, this editorial appears in health journals across the world. We are united in recognising that only fundamental and equitable changes to societies will reverse our current trajectory.The risks to health of increases above 1.5°C are now well established.2 Indeed, no temperature rise is ‘safe’. In the past 20 years, heat-related mortality among people aged over 65 has increased by more than 50%.4 Higher temperatures have brought increased dehydration and renal function loss, dermatological malignancies, tropical s, adverse mental health outcomes, pregnancy complications, allergies, and cardiovascular and pulmonary morbidity and mortality.5 6 Harms disproportionately affect the most vulnerable, including children, older populations, ethnic minorities, poorer communities and those with underlying health problems.2 4Global heating is also contributing to kamagra pills for sale the decline in global yield potential for major crops, falling by 1.8%–5.6% since 1981.

This, together with the effects of extreme weather and soil depletion, is hampering efforts to reduce undernutrition.4 Thriving ecosystems are essential to human health, and the widespread destruction of nature, including habitats and species, is eroding water and food security and increasing the chance of kamagras.3 7 8The consequences of the environmental crisis fall disproportionately on those countries and communities that have contributed least to the problem and are least able to mitigate the harms. Yet no country, no matter kamagra pills for sale how wealthy, can shield itself from these impacts. Allowing the consequences to fall disproportionately on the most vulnerable will breed more conflict, food insecurity, forced displacement and zoonotic disease, with kamagra pills for sale severe implications for all countries and communities.

As with the erectile dysfunction treatment kamagra, we are globally as strong as our weakest member.Rises above 1.5°C increase the chance of reaching tipping points in natural systems that could lock the world into an acutely unstable state. This would critically impair our ability to mitigate harms and to prevent catastrophic, runaway environmental change.9 10Global targets are not enoughEncouragingly, many governments, financial institutions and businesses are setting targets to reach net-zero emissions, including kamagra pills for sale targets for 2030. The cost of renewable energy is dropping rapidly.

Many countries are aiming to protect at least 30% of the world’s land and oceans by 2030.11These promises kamagra pills for sale are not enough. Targets are easy to set and hard to achieve. They are yet to be matched with credible short-term and longer-term plans to accelerate cleaner technologies kamagra pills for sale and transform societies.

Emissions reduction plans kamagra pills for sale do not adequately incorporate health considerations.12 Concern is growing that temperature rises above 1.5°C are beginning to be seen as inevitable, or even acceptable, to powerful members of the global community.13 Relatedly, current strategies for reducing emissions to net zero by the middle of the century implausibly assume that the world will acquire great capabilities to remove greenhouse gases from the atmosphere.14 15This insufficient action means that temperature increases are likely to be well in excess of 2°C,16 a catastrophic outcome for health and environmental stability. Critically, the destruction of nature does not have parity of esteem with the climate element of the crisis, and every single global target to restore biodiversity loss by 2020 was missed.17 This is an overall environmental crisis.18Health professionals are united with environmental scientists, businesses and many others in rejecting that this outcome is inevitable. More can kamagra pills for sale and must be done now—in Glasgow and Kunming—and in the immediate years that follow.

We join health professionals worldwide who have already supported calls for rapid action.1 19Equity must be at the centre of the global response. Contributing a fair share to the global effort means that reduction commitments must account for the cumulative, historical contribution each country kamagra pills for sale has made to emissions, as well as its current emissions and capacity to respond. Wealthier countries will have to cut emissions more quickly, making reductions by 2030 beyond those currently proposed20 21 and reaching net-zero emissions before 2050.

Similar targets and emergency action are needed for biodiversity loss and the wider destruction of the natural world.To achieve these targets, governments must make fundamental changes kamagra pills for sale to how our societies and economies are organised and how we live. The current strategy of encouraging markets to swap dirty for cleaner technologies is not enough. Governments must intervene to support the redesign of transport systems, cities, production and distribution of food, markets for financial investments, health systems, and much kamagra pills for sale more.

Global coordination is needed to ensure that the rush for cleaner kamagra pills for sale technologies does not come at the cost of more environmental destruction and human exploitation.Many governments met the threat of the erectile dysfunction treatment kamagra with unprecedented funding. The environmental crisis demands a similar emergency response. Huge investment will be needed, beyond what is being considered or delivered anywhere kamagra pills for sale in the world.

But such investments will produce huge positive health and economic outcomes. These include high-quality kamagra pills for sale jobs, reduced air pollution, increased physical activity, and improved housing and diet. Better air quality alone would realise health benefits that easily offset the global costs of emissions reductions.22These measures will also improve the social and economic determinants of health, the poor state of which may have made populations more vulnerable to the erectile dysfunction treatment kamagra.23 But the changes cannot be achieved through a return to damaging austerity policies or the continuation of the large inequalities of wealth and power within and between countries.Cooperation hinges on wealthy nations doing moreIn particular, countries that have disproportionately created the environmental crisis must do more to support low-income and middle-income countries to build cleaner, healthier and more resilient societies.

High-income countries must meet kamagra pills for sale and go beyond their outstanding commitment to provide $100 billion a year, making up for any shortfall in 2020 and increasing contributions to and beyond 2025. Funding must be equally split between mitigation and adaptation, including improving the resilience kamagra pills for sale of health systems.Financing should be through grants rather than loans, building local capabilities and truly empowering communities, and should come alongside forgiving large debts, which constrain the agency of so many low-income countries. Additional funding must be marshalled to compensate for inevitable loss and damage caused by the consequences of the environmental crisis.As health professionals, we must do all we can to aid the transition to a sustainable, fairer, resilient and healthier world.

Alongside acting to reduce the kamagra pills for sale harm from the environmental crisis, we should proactively contribute to global prevention of further damage and action on the root causes of the crisis. We must hold global leaders to account and continue to educate others about the health risks of the crisis. We must join in the work to achieve environmentally sustainable health systems before 2040, recognising that this kamagra pills for sale will mean changing clinical practice.

Health institutions have already divested more than $42 billion of assets from fossil fuels. Others should join them.4The greatest threat to global public health is the continued failure of world leaders to kamagra pills for sale keep the global temperature rise below 1.5°C and to restore nature. Urgent, society-wide changes must be made and will lead to a fairer and healthier kamagra pills for sale world.

We, as editors of health journals, call for governments and other leaders to act, marking 2021 as the year that the world finally changes course.Ethics statementsPatient consent for publicationNot required.One of the characteristics of the erectile dysfunction treatment kamagra is that much of what is published about it quickly becomes outdated. Such is the rate of change in the kamagra’s course—whether due to the roll-out of the treatment program globally or the evolution of new variants—that the context in kamagra pills for sale which articles are written may be very different by the time of publication.Given that, it’s perhaps important to ‘time-stamp’ this editorial and outline the context at the time of writing. We’re writing this in the late summer of 2021.

The UK is experiencing a third wave of the kamagra, while simultaneously removing almost all erectile dysfunction treatment kamagra pills for sale restrictions (such as limits on public gatherings), having fully vaccinated three-quarters of the adult population and partially vaccinated almost 9 out of 10 adults. Although there are differences, the situation is similar within other countries in Europe and North America, with treatments seemingly weakening the link between , serious illness and death, thereby allowing for loosening of social restrictions.Though the situation at the time you are reading this will no doubt be different, there are some things of which we can be sure. First, erectile dysfunction treatment has already ‘…killed millions, affected billions and cost trillions.’1 impacting all parts of the globe kamagra pills for sale over a prolonged period.

Second, the impact on healthcare services kamagra pills for sale has been immense, whether through the acute pressures on hospital capacity during each wave of the kamagra, the need to redesign service delivery in order to minimise face-to-face interaction, or the long-term consequences of reduced elective and preventative services.There has also been a personal toll on nurses and other healthcare professionals. The WHO estimates that as of May 2021, approximately 115 000 healthcare workers have died from erectile dysfunction treatment.2 The impact of the kamagra on the mental health and well-being on practitioners has been well-documented, with anxiety, depression and post-traumatic stress disorder being reported in nurses,3 along with increased risk of burnout and emotional exhaustion.4 Some healthcare workers, including nurses, have also been subject to bullying and stigma, partly due to the perception that they are more likely to contract and spread erectile dysfunction treatment.5In the short-term then, the nursing profession’s focus must be on supporting its members’ well-being as we hopefully (given the roll-out of vaccinations globally) move into final stages of the kamagra. But what will the legacy of erectile dysfunction treatment be for nurses and nursing in kamagra pills for sale the years to come?.

The delivery of healthcare has changed irreversibly during erectile dysfunction treatment, and nursing will need to adapt accordingly. The rapid shift to technology-mediated healthcare, such as virtual primary care consultations, will require nurses to ensure that they possess not only the technological skills required to manage these new approaches to providing care, but also the communication skills necessary to assess and support kamagra pills for sale patients via different media (eg, videoconferencing. Telephone).

Critically, nurses must also be aware of the potential risk that certain groups of the population, such as older people kamagra pills for sale or those facing digital poverty, may be uncomfortable with—or excluded by—the move to technology-mediated care.6 As advocates for their patients, nurses must ensure that not only is the care they deliver person-centred, but that the modality through which care is provided is adapted according to the patients’ characteristics, abilities and preferences.Complacency with control measures and gaps in public health policies and processes quickly became apparent during the kamagra. This is one area where nursing really showed its worth. Throughout the kamagra, nurses have used their extensive knowledge and skills on control measures, such as kamagra pills for sale the effective use of PPE, to enhance the safety of staff and patients.

Moving forward, nurses need to further define their role kamagra pills for sale in control and ensure that they are centrally involved in related policy development and decision-making.7The public and media profile of nursing has never been higher. Across the globe, we have seen nurses and other practitioners applauded, praised and honoured for their work during the kamagra. There is no kamagra pills for sale question that the contribution of nurses, along with other healthcare professionals and key workers, should be acknowledged by wider society.

However, the raised and changed profile of the nursing profession within society is something of a double-edged sword.One benefit may be that as nursing continues to face a workforce crisis, the public awareness of the profession will increase recruitment to nurse education courses. There are already indications that this could be occurring—in the UK, for example, 2021 saw a 32% year-on-year increase in applications to commence nursing courses (with a 39% increase in applications from the over-35s).8 kamagra pills for sale There are two important caveats with these data. First, it is impossible to know exactly what drives this increase or whether it is a long-term or short-term trend.

For example, it may be due in part to the economic downturn and job insecurity linked to societal lockdowns, so could represent a transient increase in interest in nursing as a profession kamagra pills for sale. Second, any benefit from increased student nurse recruitment kamagra pills for sale may be offset by nurses leaving the profession due to the psychological and physical impact of erectile dysfunction treatment. The International Council of Nurses has highlighted that one-in-five National Nurses Associations report increased numbers of nurses leaving the profession in 2020, with many more reporting higher rates of intention-to-leave.9The enhanced profile of nurses has led to some concerns being raised regarding the nature of the profession’s portrayal in the media and among the public.

This particularly relates to kamagra pills for sale the ‘angels and heroes’ narrative, where nurses are viewed as self-sacrificing, brave and quasi-superhuman. Though this narrative is well-meaning and representative of the public’s gratitude towards nurses, it also risks the high-level skills and knowledge demonstrated by nurses being overlooked, potentially serving to ‘…undermine the professionalism of the nursing workforce, and reinforce the perception that nursing is an innately feminine, nurturing role.’.10 Over the coming years then, nursing needs to shape its profile in such a way that the complexity and skill involved in providing high quality care are at the forefront, while still acknowledging and celebrating the public trust and gratitude demonstrated during the kamagra.There will come a time when we speak of erectile dysfunction treatment in the past tense. When it will be subject to retrospective analysis and debate, rather than being something we continue to kamagra pills for sale live through.

However, the kamagra’s repercussions will be felt for years to come in society, in healthcare and in nursing. As a profession, there kamagra pills for sale has never been a more important time to demonstrate resilience, to adapt to the changed context of care and to highlight nurses’ skills, knowledge and expertise. EBN journal will be focusing on this during October 2021 when the weekly blogs will explore the impact of erectile dysfunction treatment on nurses, nursing and health.Ethics statementsPatient consent for publicationNot required..

Wealthy nations buy cheap kamagra oral jelly must do much more, much faster.The United Nations General Assembly http://ginagarza.com/?p=32 in September 2021 will bring countries together at a critical time for marshalling collective action to tackle the global environmental crisis. They will buy cheap kamagra oral jelly meet again at the biodiversity summit in Kunming, China, and the climate conference (Conference of the Parties (COP)26) in Glasgow, UK. Ahead of these pivotal meetings, we—the editors of health journals worldwide—call for urgent action to keep average global temperature increases below 1.5°C, halt the destruction of nature and protect health.Health is already being harmed by global temperature increases and the destruction of the natural world, a state of affairs health professionals have been bringing attention to for decades.1 The science is unequivocal. A global increase of 1.5°C buy cheap kamagra oral jelly above the preindustrial average and the continued loss of biodiversity risk catastrophic harm to health that will be impossible to reverse.2 3 Despite the world’s necessary preoccupation with erectile dysfunction treatment, we cannot wait for the kamagra to pass to rapidly reduce emissions.Reflecting the severity of the moment, this editorial appears in health journals across the world. We are united in recognising that only fundamental and equitable changes to societies will reverse our current trajectory.The risks to health of increases above 1.5°C are now well established.2 Indeed, no temperature rise is ‘safe’.

In the past 20 years, heat-related mortality among people aged over 65 has increased by more than 50%.4 Higher temperatures have brought increased dehydration and renal function loss, dermatological malignancies, tropical s, adverse mental health outcomes, pregnancy complications, allergies, and cardiovascular and pulmonary morbidity and mortality.5 6 Harms disproportionately affect the most vulnerable, including children, older populations, ethnic minorities, poorer communities and those with underlying health problems.2 4Global heating is also contributing to the decline in global yield potential for major crops, falling by buy cheap kamagra oral jelly 1.8%–5.6% since 1981. This, together with the effects of extreme weather and soil depletion, is hampering efforts to reduce undernutrition.4 Thriving ecosystems are essential to human health, and the widespread destruction of nature, including habitats and species, is eroding water and food security and increasing the chance of kamagras.3 7 8The consequences of the environmental crisis fall disproportionately on those countries and communities that have contributed least to the problem and are least able to mitigate the harms. Yet no country, no buy cheap kamagra oral jelly matter how wealthy, can shield itself from these impacts. Allowing the buy cheap kamagra oral jelly consequences to fall disproportionately on the most vulnerable will breed more conflict, food insecurity, forced displacement and zoonotic disease, with severe implications for all countries and communities. As with the erectile dysfunction treatment kamagra, we are globally as strong as our weakest member.Rises above 1.5°C increase the chance of reaching tipping points in natural systems that could lock the world into an acutely unstable state.

This would buy cheap kamagra oral jelly critically impair our ability to mitigate harms and to prevent catastrophic, runaway environmental change.9 10Global targets are not enoughEncouragingly, many governments, financial institutions and businesses are setting targets to reach net-zero emissions, including targets for 2030. The cost of renewable energy is dropping rapidly. Many countries are aiming to buy cheap kamagra oral jelly protect at least 30% of the world’s land and oceans by 2030.11These promises are not enough. Targets are easy to set and hard to achieve. They are yet to be matched with credible short-term and longer-term plans buy cheap kamagra oral jelly to accelerate cleaner technologies and transform societies.

Emissions reduction plans do not adequately incorporate health considerations.12 Concern is growing that temperature rises above 1.5°C are beginning to be buy cheap kamagra oral jelly seen as inevitable, or even acceptable, to powerful members of the global community.13 Relatedly, current strategies for reducing emissions to net zero by the middle of the century implausibly assume that the world will acquire great capabilities to remove greenhouse gases from the atmosphere.14 15This insufficient action means that temperature increases are likely to be well in excess of 2°C,16 a catastrophic outcome for health and environmental stability. Critically, the destruction of nature does not have parity of esteem with the climate element of the crisis, and every single global target to restore biodiversity loss by 2020 was missed.17 This is an overall environmental crisis.18Health professionals are united with environmental scientists, businesses and many others in rejecting that this outcome is inevitable. More can and must be done now—in Glasgow and buy cheap kamagra oral jelly Kunming—and in the immediate years that follow. We join health professionals worldwide who have already supported calls for rapid action.1 19Equity must be at the centre of the global response. Contributing a fair share to the global effort means that reduction commitments must account for the cumulative, historical contribution each country has made to emissions, as well as its current emissions and buy cheap kamagra oral jelly capacity to respond.

Wealthier countries will have to cut emissions more quickly, making reductions by 2030 beyond those currently proposed20 21 and reaching net-zero emissions before 2050. Similar targets and emergency action are needed for biodiversity loss and the wider destruction of the natural world.To achieve these targets, governments must make fundamental changes to how our buy cheap kamagra oral jelly societies and economies are organised and how we live. The current strategy of encouraging markets to swap dirty for cleaner technologies is not enough. Governments must intervene to support the redesign of transport systems, buy cheap kamagra oral jelly cities, production and distribution of food, markets for financial investments, health systems, and much more. Global coordination is needed to ensure that the rush for buy cheap kamagra oral jelly cleaner technologies does not come at the cost of more environmental destruction and human exploitation.Many governments met the threat of the erectile dysfunction treatment kamagra with unprecedented funding.

The environmental crisis demands a similar emergency response. Huge investment will be needed, beyond what is being considered or delivered anywhere buy cheap kamagra oral jelly in the world. But such investments will produce huge positive health and economic outcomes. These include high-quality jobs, reduced air pollution, increased buy cheap kamagra oral jelly physical activity, and improved housing and diet. Better air quality alone would realise health benefits that easily offset the global costs of emissions reductions.22These measures will also improve the social and economic determinants of health, the poor state of which may have made populations more vulnerable to the erectile dysfunction treatment kamagra.23 But the changes cannot be achieved through a return to damaging austerity policies or the continuation of the large inequalities of wealth and power within and between countries.Cooperation hinges on wealthy nations doing moreIn particular, countries that have disproportionately created the environmental crisis must do more to support low-income and middle-income countries to build cleaner, healthier and more resilient societies.

High-income countries must meet and go beyond their outstanding commitment to provide $100 billion a year, buy cheap kamagra oral jelly making up for any shortfall in 2020 and increasing contributions to and beyond 2025. Funding must be equally split between mitigation and adaptation, including improving the resilience of health systems.Financing should be through grants rather than buy cheap kamagra oral jelly loans, building local capabilities and truly empowering communities, and should come alongside forgiving large debts, which constrain the agency of so many low-income countries. Additional funding must be marshalled to compensate for inevitable loss and damage caused by the consequences of the environmental crisis.As health professionals, we must do all we can to aid the transition to a sustainable, fairer, resilient and healthier world. Alongside acting to reduce the harm from the environmental crisis, we should proactively contribute to global prevention buy cheap kamagra oral jelly of further damage and action on the root causes of the crisis. We must hold global leaders to account and continue to educate others about the health risks of the crisis.

We must join in the work to achieve environmentally sustainable health buy cheap kamagra oral jelly systems before 2040, recognising that this will mean changing clinical practice. Health institutions have already divested more than $42 billion of assets from fossil fuels. Others should join them.4The greatest threat to global public health is the continued failure of world leaders to buy cheap kamagra oral jelly keep the global temperature rise below 1.5°C and to restore nature. Urgent, society-wide changes must be made and will lead to a fairer and healthier buy cheap kamagra oral jelly world. We, as editors of health journals, call for governments and other leaders to act, marking 2021 as the year that the world finally changes course.Ethics statementsPatient consent for publicationNot required.One of the characteristics of the erectile dysfunction treatment kamagra is that much of what is published about it quickly becomes outdated.

Such is the rate of change in the kamagra’s course—whether due to the roll-out of the treatment program globally or the evolution of new variants—that the context in which articles are buy cheap kamagra oral jelly written may be very different by the time of publication.Given that, it’s perhaps important to ‘time-stamp’ this editorial and outline the context at the time of writing. We’re writing this in the late summer of 2021. The UK is experiencing a third wave of the kamagra, while simultaneously removing almost all erectile dysfunction treatment restrictions (such as limits on public gatherings), having fully buy cheap kamagra oral jelly vaccinated three-quarters of the adult population and partially vaccinated almost 9 out of 10 adults. Although there are differences, the situation is similar within other countries in Europe and North America, with treatments seemingly weakening the link between , serious illness and death, thereby allowing for loosening of social restrictions.Though the situation at the time you are reading this will no doubt be different, there are some things of which we can be sure. First, erectile dysfunction treatment has already ‘…killed millions, affected billions and cost trillions.’1 impacting all parts of the globe over a buy cheap kamagra oral jelly prolonged period.

Second, the impact on healthcare services has been immense, whether through the acute pressures on hospital capacity during each wave of the kamagra, the need to redesign service delivery in order to minimise face-to-face buy cheap kamagra oral jelly interaction, or the long-term consequences of reduced elective and preventative services.There has also been a personal toll on nurses and other healthcare professionals. The WHO estimates that as of May 2021, approximately 115 000 healthcare workers have died from erectile dysfunction treatment.2 The impact of the kamagra on the mental health and well-being on practitioners has been well-documented, with anxiety, depression and post-traumatic stress disorder being reported in nurses,3 along with increased risk of burnout and emotional exhaustion.4 Some healthcare workers, including nurses, have also been subject to bullying and stigma, partly due to the perception that they are more likely to contract and spread erectile dysfunction treatment.5In the short-term then, the nursing profession’s focus must be on supporting its members’ well-being as we hopefully (given the roll-out of vaccinations globally) move into final stages of the kamagra. But what will the legacy of erectile dysfunction treatment be for nurses and nursing buy cheap kamagra oral jelly in the years to come?. The delivery of healthcare has changed irreversibly during erectile dysfunction treatment, and nursing will need to adapt accordingly. The rapid shift to technology-mediated healthcare, such as virtual primary care consultations, will require nurses to ensure that they possess not only the technological skills required to manage these new approaches to providing care, but also the communication skills necessary to assess and buy cheap kamagra oral jelly support patients via different media (eg, videoconferencing.

Telephone). Critically, nurses must also be aware of the potential risk that certain groups of the population, such as older people or those facing digital poverty, may be uncomfortable with—or excluded by—the move to technology-mediated care.6 As advocates for their patients, nurses must ensure that not only is the care they deliver person-centred, but that the modality through which care is provided is adapted according to the patients’ characteristics, abilities and preferences.Complacency with control measures and gaps in public health policies and processes quickly became apparent during buy cheap kamagra oral jelly the kamagra. This is one area where nursing really showed its worth. Throughout the kamagra, nurses have used their extensive knowledge and skills on control measures, such as the effective use of PPE, to enhance the safety of staff buy cheap kamagra oral jelly and patients. Moving forward, nurses need to further buy cheap kamagra oral jelly define their role in control and ensure that they are centrally involved in related policy development and decision-making.7The public and media profile of nursing has never been higher.

Across the globe, we have seen nurses and other practitioners applauded, praised and honoured for their work during the kamagra. There is buy cheap kamagra oral jelly no question that the contribution of nurses, along with other healthcare professionals and key workers, should be acknowledged by wider society. However, the raised and changed profile of the nursing profession within society is something of a double-edged sword.One benefit may be that as nursing continues to face a workforce crisis, the public awareness of the profession will increase recruitment to nurse education courses. There are already indications that this could be occurring—in the UK, for example, 2021 saw a 32% year-on-year increase in applications to commence nursing courses (with a 39% increase in applications from the over-35s).8 There buy cheap kamagra oral jelly are two important caveats with these data. First, it is impossible to know exactly what drives this increase or whether it is a long-term or short-term trend.

For example, it may be due in part to the economic downturn and job insecurity linked to societal lockdowns, so could represent a transient increase buy cheap kamagra oral jelly in interest in nursing as a profession. Second, any buy cheap kamagra oral jelly benefit from increased student nurse recruitment may be offset by nurses leaving the profession due to the psychological and physical impact of erectile dysfunction treatment. The International Council of Nurses has highlighted that one-in-five National Nurses Associations report increased numbers of nurses leaving the profession in 2020, with many more reporting higher rates of intention-to-leave.9The enhanced profile of nurses has led to some concerns being raised regarding the nature of the profession’s portrayal in the media and among the public. This particularly relates buy cheap kamagra oral jelly to the ‘angels and heroes’ narrative, where nurses are viewed as self-sacrificing, brave and quasi-superhuman. Though this narrative is well-meaning and representative of the public’s gratitude towards nurses, it also risks the high-level skills and knowledge demonstrated by nurses being overlooked, potentially serving to ‘…undermine the professionalism of the nursing workforce, and reinforce the perception that nursing is an innately feminine, nurturing role.’.10 Over the coming years then, nursing needs to shape its profile in such a way that the complexity and skill involved in providing high quality care are at the forefront, while still acknowledging and celebrating the public trust and gratitude demonstrated during the kamagra.There will come a time when we speak of erectile dysfunction treatment in the past tense.

When it will be subject to retrospective analysis and debate, rather than being something we continue to buy cheap kamagra oral jelly live through. However, the kamagra’s repercussions will be felt for years to come in society, in healthcare and in nursing. As a profession, there has never been a more buy cheap kamagra oral jelly important time to demonstrate resilience, to adapt to the changed context of care and to highlight nurses’ skills, knowledge and expertise. EBN journal will be focusing on this during October 2021 when the weekly blogs will explore the impact of erectile dysfunction treatment on nurses, nursing and health.Ethics statementsPatient consent for publicationNot required..

Buy kamagra gel

Data Source buy kamagra gel Data on all residents of Israel who had been fully vaccinated before June 1, 2021, and who had not been infected before the study period were http://edgebroadcastingnetwork.com/about/ extracted from the Israeli Ministry of Health database on September 2, 2021. We defined fully vaccinated persons as those for whom 7 days or more had passed since receipt of the second dose of the BNT162b2 treatment. We used the Ministry of Health official database that contains all information regarding erectile dysfunction treatment (see Supplementary Methods 1 in the Supplementary Appendix, available with the full text of this article at buy kamagra gel NEJM.org). We extracted from the database information on all documented erectile dysfunction s (i.e., positive result on PCR assay) and on the severity of the disease after . We focused on s that had been documented in the period from July 11 through 31, 2021 (study period), removing from the data buy kamagra gel all confirmed cases that had been documented before that period.

The start date was selected as a time when the kamagra had already spread throughout the entire country and across population sectors. The end date was just after Israel had initiated a campaign regarding the use of a booster treatment (third dose). The study period happened to buy kamagra gel coincide with the school summer vacation. We omitted from all the analyses children and adolescents younger than 16 years of age (most of whom were unvaccinated or had been recently vaccinated). Only persons 40 years of age or older were included in the analysis of severe disease because severe disease was rare in the younger population buy kamagra gel.

Severe disease was defined as a resting respiratory rate of more than 30 breaths per minute, oxygen saturation of less than 94% while the person was breathing ambient air, or a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of less than 300.14 Persons who died from erectile dysfunction treatment during the follow-up period were included in the study and categorized as having had severe disease. During the study period, approximately 10% of the detected s were in residents of Israel returning buy kamagra gel from abroad. Most residents who traveled abroad had been vaccinated and were exposed to different populations, so their risk of differed from that in the rest of the study population. We therefore removed from the analysis all residents who had returned from abroad in July. Vaccination Schedule The official vaccination regimen in Israel involved buy kamagra gel the administration of the second dose 3 weeks after the first dose.

All residents 60 years of age or older were eligible for vaccination starting on December 20, 2020, thus becoming fully vaccinated starting in mid-January 2021. At that time, younger persons were eligible for vaccination buy kamagra gel only if they belonged to designated groups (e.g., health care workers and severely immunocompromised adults). The eligibility age was reduced to 55 years on January 12, 2021, and to 40 years on January 19, 2021. On February 4, 2021, all persons 16 years of age or older buy kamagra gel became eligible for vaccination. Thus, if they did not belong to a designated group, persons 40 to 59 years of age received the second dose starting in mid-February, and those 16 to 39 years of age received the second dose starting in the beginning of March.

On the basis of these dates, we defined our periods of interest in half months starting from January 16. Vaccination periods for individual persons were determined according to the time that they had become fully vaccinated (i.e., 1 week after receipt of buy kamagra gel the second dose). All the analyses were stratified according to vaccination period and to age group (16 to 39 years, 40 to 59 years, and ≥60 years). Statistical Analysis The association between the rate of confirmed s buy kamagra gel and the period of vaccination provides a measure of waning immunity. Without waning of immunity, one would expect to see no differences in rates among persons vaccinated at different times.

To examine the effect of waning immunity during the period when the delta variant was predominant, we compared the rate of confirmed s (per 1000 persons) during the study period (July buy kamagra gel 11 to 31, 2021) among persons who became fully vaccinated during various periods. The 95% confidence intervals for the rates were calculated by multiplying the standard confidence intervals for proportions by 1000. A similar analysis was performed to compare the association between the rate of severe erectile dysfunction treatment and the vaccination period, but for this outcome we used periods of entire months because there were fewer cases of severe disease. To account for possible confounders, we buy kamagra gel fitted Poisson regressions. The outcome variable was the number of documented erectile dysfunction s or cases of severe erectile dysfunction treatment during the study period.

The period of vaccination, buy kamagra gel which was defined as 7 days after receipt of the second dose of the erectile dysfunction treatment, was the primary exposure of interest. The models compared the rates per 1000 persons between different vaccination periods, in which the reference period for each age group was set according to the time at which all persons in that group first became eligible for vaccination. A differential effect of the vaccination period for each age group buy kamagra gel was allowed by the inclusion of an interaction term between age and vaccination period. Additional potential confounders were added as covariates, as described below, and the natural logarithm of the number of persons was added as an offset. For each vaccination period and age group, an adjusted rate was calculated as the expected number of weekly events per 100,000 persons if all the persons in that age group had been vaccinated in that period.

All the analyses were performed with buy kamagra gel the use of the glm function in the R statistical software package.17 In addition to age and sex, the regression analysis included as covariates the following confounders. First, because the event rates were rising rapidly during the study period (Figure 1), we included the week in which the event was recorded. Second, although PCR testing is free in Israel for all residents, compliance with buy kamagra gel PCR-testing recommendations is variable and is a possible source of detection bias. To partially account for this, we stratified persons according to the number of PCR tests that had been performed during the period of March 1 to November 31, 2020, which was before the initiation of the vaccination campaign. We defined buy kamagra gel three levels of use.

Zero, one, and two or more PCR tests. Finally, the three major population groups in Israel (general Jewish, Arab, and ua-Orthodox Jewish) have varying risk factors for . The proportion of vaccinated persons, as well as the level of exposure to the kamagra, differed among these groups.18 Although we restricted the study to dates when the kamagra was found throughout the country, we included population sector as a covariate to control for any residual buy kamagra gel confounding effect. We conducted several secondary analyses to test the robustness of the results, including calculation of the rate of confirmed in a finer, 10-year age grouping and an analysis restricted to the general Jewish population (in which the delta outbreak began), which comprises the majority of persons in Israel. In addition, a model including a measure of socioeconomic status as a covariate was fitted to the data, because this was an important risk factor in a previous study.18 Since socioeconomic status was unknown for 5% of the persons in our study and the missingness of the data seemed to buy kamagra gel be informative, and also owing to concern regarding nondifferential misclassification (persons with unknown socioeconomic status may have had different rates of vaccination, , and severe disease), we did not include socioeconomic status in the main analysis.

Finally, we compared the association between the number of PCR tests that had been conducted before the vaccination campaign (i.e., before December 2020) with the number that were conducted during the study period in order to evaluate the possible magnitude of detection bias in our analysis. A good correlation between past behavior regarding PCR testing and behavior during the study period would provide reassurance that the inclusion of past behavior as a covariate in the model would control, at least in part, for detection bias.Trial Objectives and Oversight In this phase 3, multicenter, randomized, double-blind, placebo-controlled trial, we evaluated a single intravenous infusion of sotrovimab at a dose of 500 mg for the prevention of progression of mild-to-moderate erectile dysfunction treatment in high-risk, nonhospitalized patients. For this prespecified interim analysis, patients were recruited beginning on August 27, 2020, and were followed through March 4, 2021, at 37 trial sites in four countries (the United States, Canada, Brazil, and buy kamagra gel Spain). The protocol and statistical analysis plan are available at NEJM.org, and changes made to these documents after the trial began are summarized in the Supplementary Appendix. The trial, which was sponsored by Vir Biotechnology in collaboration with GlaxoSmithKline, was conducted in accordance with the principles of the Declaration of Helsinki and the ethical guidelines of the Council for International Organizations of buy kamagra gel Medical Sciences, applicable International Council for Harmonisation Good Clinical Practice guidelines, and applicable laws and regulations.

All the patients provided written informed consent. The sponsors designed the trial, and the sponsors and trial investigators participated in data collection, analysis, and interpretation buy kamagra gel. The authors made the decision to submit the manuscript for publication and vouch for the accuracy and completeness of the data presented and for the fidelity of the trial to the protocol. Medical writers who were funded by Vir Biotechnology assisted in drafting the manuscript under the authors’ direction. All the authors had confidentiality buy kamagra gel agreements with the sponsors.

Patients and Procedures Adult patients (≥18 years of age) who had a positive result on reverse-transcriptase–polymerase-chain-reaction or antigen erectile dysfunction testing and an onset of erectile dysfunction treatment symptoms within the previous 5 days were screened for eligibility. Screening was performed within 24 hours before the administration of sotrovimab or placebo buy kamagra gel. The patients were at high risk for progression of erectile dysfunction treatment because of older age (≥55 years) or because they had at least one of the following risk factors. Diabetes for which medication was buy kamagra gel warranted, obesity (body-mass index [BMI. The weight in kilograms divided by the square of the height in meters], >30), chronic kidney disease (estimated glomerular fiation rate, <60 ml per minute per 1.73 m2 of body-surface area),23 congestive heart failure (New York Heart Association class II, III, or IV), chronic obstructive pulmonary disease, and moderate-to-severe asthma.24 Patients with already severe erectile dysfunction treatment, defined as shortness of breath at rest, an oxygen saturation below 94%, or the use of supplemental oxygen, were excluded.

Full inclusion and exclusion criteria are described in the Supplementary Methods section in the Supplementary Appendix. Figure 1 buy kamagra gel. Figure 1. Trial Design buy kamagra gel. Patients were stratified according to age (≤70 years or >70 years), symptom duration (≤3 days or 4 or 5 days), and geographic region.

The trial pharmacists reconstituted and dispensed sotrovimab and placebo within equal time frames in order to maintain blinding.Eligible patients were randomly assigned in a buy kamagra gel 1:1 ratio with the use of an interactive Web-based response system to receive either a single 500-mg, 1-hour infusion of sotrovimab or an equal volume of saline placebo on day 1 (Figure 1). The trial design did not mandate any treatment for erectile dysfunction treatment other than sotrovimab or placebo. As a result, the patients received treatment at the discretion of their physicians according to the local standard of care. Efficacy Assessments The primary outcome was the percentage of patients who were hospitalized for more than 24 hours or who died from buy kamagra gel any cause through day 29 after randomization. Secondary efficacy outcomes included the percentage of patients with an emergency department visit, hospitalization, or death and the percentage of patients who had disease progression that warranted the use of supplemental oxygen.

Safety Assessments The safety buy kamagra gel outcomes included adverse events, serious adverse events, and adverse events of special interest, which were defined as infusion-related reactions (including hypersensitivity reactions). Immunogenicity testing for antidrug antibodies was performed, and antibody-dependent enhancement was evaluated. All hospitalizations, including those due buy kamagra gel to erectile dysfunction treatment, were counted as serious adverse events. Statistical Analysis A prespecified interim analysis for safety, futility, and efficacy was triggered when approximately 41% of the required number of trial patients reached day 29. Sample-size calculations were based on a group-sequential design with two interim analyses to assess both futility due to lack of efficacy and efficacy.

A Lan–DeMets alpha-spending function was used to control type I error, with the use of a Pocock analogue rule for futility and a Hwang–Shih–DeCani analogue rule for efficacy (with the value of γ=1).25 The overall sample of 1360 patients would have provided approximately 90% power to detect a 37.5% relative efficacy in reducing progression of erectile dysfunction treatment through day 29 at the overall two-sided 5% significance level, with an assumed incidence of progression of 16% in the placebo buy kamagra gel group. In the interim analysis, the intention-to-treat population included all the patients who underwent randomization through the prespecified interim analysis cutoff date of January 19, 2021, irrespective of whether they received sotrovimab or placebo. The safety analysis population in the interim analysis included all the patients who received buy kamagra gel sotrovimab or placebo and underwent randomization through February 17, 2021. Patients were grouped according to the actual agent received. The primary outcome was analyzed in the intention-to-treat population with the use of a Poisson regression model with robust sandwich estimators to adjust for trial agent, duration of symptoms, age, and sex buy kamagra gel.

Missing progression status was imputed under a missing-at-random assumption with the use of multiple imputation. On the basis of this analysis model, the statistical significance testing, the relative risk of progression, and its appropriate confidence interval are provided with the adjusted significance level for this interim analysis. An independent data monitoring committee recommended that enrollment in the trial be stopped on March 10, 2021, because of efficacy, at which time 1057 patients had undergone randomization buy kamagra gel. Analyses of all secondary and exploratory outcomes are planned when all the patients have completed day 29.Participants Phase 1 Figure 1. Figure 1 buy kamagra gel.

Screening, Randomization, and treatment and Placebo Administration among 5-to-11-Year-Old Children in the Phase 1 Study and the Phase 2–3 Trial. Participants who buy kamagra gel discontinued the vaccination regimen could remain in the study. In the phase 2–3 trial, reasons for not receiving the first dose included withdrawal (14 children), no longer meeting eligibility criteria (2 children), and protocol deviation (1 child). Discontinuations or withdrawals after the first dose were due to a decision by the parent or guardian or by the participant, except one, for which the reason was classified as “other.” In the phase 2–3 trial, one participant who was randomly assigned to receive placebo was administered BNT162b2 in error for both doses. Therefore, 1518 participants received dose 1 of BNT162b2 and 750 participants received buy kamagra gel dose 1 of placebo.From March 24 through April 14, 2021, a total of 50 children 5 to 11 years of age were screened for inclusion at four U.S.

Sites, and 48 received escalating doses of the BNT162b2 how to buy cheap kamagra online treatment (Figure 1). Half the children were male, buy kamagra gel 79% were White, 6% were Black, 10% were Asian, and 8% were Hispanic or Latinx. The mean age was 7.9 years (Table S2). Phase 2–3 Table 1. Table 1 buy kamagra gel.

Demographic and Clinical Characteristics of Children in the Phase 2–3 Trial. From June 7 through June 19, 2021, a total of 2316 children 5 to 11 years of buy kamagra gel age were screened for inclusion and 2285 underwent randomization across 81 sites in the United States, Spain, Finland, and Poland. 2268 participants received injections, with 1517 randomly assigned to receive BNT162b2 and 751 assigned to receive placebo (Figure 1). One participant who was randomly buy kamagra gel assigned to receive placebo was administered BNT162b2 in error for both doses. Therefore, 1518 participants received dose 1 of BNT162b2 and 750 participants received dose 1 of placebo.

More than 99% of participants received a second dose. At the buy kamagra gel data cutoff date, the median follow-up time was 2.3 months (range, 0 to 2.5). 95% of participants had at least 2 months of available follow-up safety data after the second dose. Overall, 52% buy kamagra gel were male, 79% were White, 6% were Black, 6% were Asian, and 21% were Hispanic or Latinx (Table 1). The mean age was 8.2 years.

20% of children had coexisting buy kamagra gel conditions (including 12% with obesity and approximately 8% with asthma), and 9% were erectile dysfunction–positive at baseline. Apart from younger age and a lower percentage of Black and Hispanic or Latinx 5-to-11-year-olds (6% and 18%, respectively) than 16-to-25-year-olds (12% and 36%, respectively), demographic characteristics were similar among the 5-to-11-year-old and 16-to-25-year-old BNT162b2 recipients who were included in the immunobridging subset (Table S3). Phase 1 Safety and Immunogenicity Most local reactions were mild to moderate, and all were transient (Fig. S1A and Table S4) buy kamagra gel. Fever was more common in the 30-μg dose-level group than in the 10-μg and 20-μg dose-level groups after the first and second doses (Fig.

S1B). All four sentinel participants in the 30-μg dose-level group who received the second 30-μg dose had mild-to-moderate fever within 7 days. The remaining 12 participants in the 30-μg dose-level group received a 10-μg second dose approximately 1 month after the first dose, as recommended by the internal review committee after selection of the phase 2–3 dose. Adverse events from the first dose through 1 month after the second dose were reported by 43.8% of participants who received two 10-μg doses of BNT162b2, 31.3% of those who received two 20-μg doses, and 50.0% of those who received two 30-μg doses (Table S6). One severe adverse event (grade 3 pyrexia) in a 10-year-old participant began the day of the second 20-μg dose of BNT162b2, with temperature reaching 39.7°C (103.5°F) the day after vaccination and resolving the following day.

Antipyretic medications were used, and the investigator considered the event to be related to receipt of the BNT162b2 treatment. Serum neutralizing GMTs 7 days after the second dose were 4163 with the 10-μg dose of BNT162b2 and 4583 with the 20-μg dose (Fig. S2). On the basis of these safety and immunogenicity findings, the 10-μg dose level was selected for further assessment in 5-to-11-year-olds in phase 2–3. Phase 2–3 Safety Figure 2.

Figure 2. Local Reactions and Systemic Events Reported in the Phase 2–3 Trial within 7 Days after Injection of BNT162b2 or Placebo. Panel A shows local reactions and Panel B shows systemic events after the first and second doses in recipients of the BNT162b2 treatment (dose 1, 1511 children. Dose 2, 1501 children) and placebo (dose 1, 748 or 749 children. Dose 2, 740 or 741 children).

The numbers refer to the numbers of children reporting at least one “yes” or “no” response for the specified event after each dose. Responses may not have been reported for every type of event. Severity scales are summarized in Table S5. Fever categories are designated in the key. The numbers above the bars are the percentage of participants in each group with the specified local reaction or systemic event.

Н™¸ bars represent 95% confidence intervals. One participant in the BNT162b2 group had a fever of 40.0°C after the second dose.BNT162b2 recipients reported more local reactions and systemic events than placebo recipients (Figure 2). The reactions and events reported were generally mild to moderate, lasting 1 to 2 days (Table S4). Injection-site pain was the most common local reaction, occurring in 71 to 74% of BNT162b2 recipients. Severe injection-site pain after the first or second dose was reported in 0.6% of BNT162b2 recipients and in no placebo recipients.

Fatigue and headache were the most frequently reported systemic events. Severe fatigue (0.9%), headache (0.3%), chills (0.1%), and muscle pain (0.1%) were also reported after the first or second dose of BNT162b2. Frequencies of fatigue, headache, and chills were similar among BNT162b2 and placebo recipients after the first dose and were more frequent among BNT162b2 recipients than among placebo recipients after the second dose. In general, systemic events were reported more often after the second dose of BNT162b2 than after the first dose. Fever occurred in 8.3% of BNT162b2 recipients after the first or second dose.

Use of an antipyretic among BNT162b2 recipients was more frequent after the second dose than after the first dose. One BNT162b2 recipient had a temperature of 40.0°C (104°F) 2 days after the second dose. Antipyretics were used, and the fever resolved the next day. From the first dose through 1 month after the second dose, adverse events were reported by 10.9% of BNT162b2 recipients and 9.2% of placebo recipients (Table S7). Slightly more BNT162b2 recipients (3.0%) than placebo recipients (2.1%) reported adverse events that were considered by the investigators to be related to the treatment or placebo.

Severe adverse events were reported in 0.1% of BNT162b2 recipients and 0.1% of placebo recipients. Three serious adverse events in two participants were reported by the cutoff date. All three (postinjury abdominal pain and pancreatitis in a placebo recipient and arm fracture in a BNT162b2 recipient) were considered to be unrelated to the treatment or placebo. No deaths or adverse events leading to withdrawal were reported. Lymphadenopathy was reported in 10 BNT162b2 recipients (0.9%) and 1 placebo recipient (0.1%).

No myocarditis, pericarditis, hypersensitivity, or anaphylaxis in BNT162b2 recipients was reported. Four rashes in BNT162b2 recipients (observed on the arm, torso, face, or body, with no consistent pattern) were considered to be related to vaccination. The rashes were mild and self-limiting, and onset was typically 7 days or more after vaccination. No safety differences were apparent when the data were analyzed according to baseline erectile dysfunction status. Phase 2–3 Immunogenicity Table 2.

Table 2. Results of Serum erectile dysfunction Neutralization Assay 1 Month after the Second Dose of BNT162b2 among Participants 5 to 11 and 16 to 25 Yr of Age. The geometric mean ratio of neutralizing GMTs for 10 μg of BNT162b2 in 5-to-11-year-olds to that for 30 μg of BNT162b2 in 16-to-25-year-olds 1 month after the second dose was 1.04 (95% confidence interval [CI], 0.93 to 1.18) (Table 2), a ratio meeting the immunobridging criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67, the predefined point estimate of a geometric mean ratio of 0.8 or greater, and the FDA-requested point estimate criterion of a geometric mean ratio of 1.0 or greater. In both age groups, 99.2% of participants achieved seroresponse 1 month after the second dose. The difference between the percentage of 5-to-11-year-olds who achieved seroresponse and the percentage in 16-to-25-year-olds was 0.0 percentage points (95% CI, –2.0 to 2.2), which also met an immunobridging criterion.

Serum-neutralizing GMTs 1 month after the second dose of BNT162b2 were 1198 in 5-to-11-year-olds and 1147 in 16-to-25-year-olds (Fig. S3). Corresponding GMTs among placebo recipients were 11 and 10. Geometric mean fold rises from baseline to 1 month after the second dose were 118.2 in 5-to-11-year-olds and 111.4 in 16-to-25-year-olds. Corresponding geometric mean fold rises among placebo recipients were 1.1 and 1.0.

Of note, the neutralizing GMTs reported in phase 1 are from serum samples obtained 7 days after the second dose (during immune response expansion) and the GMTs in phase 2–3 are from serum samples obtained 1 month after the second dose. Phase 2–3 Efficacy Figure 3. Figure 3. treatment Efficacy in Children 5 to 11 Years of Age. The graph represents the cumulative incidence of the first occurrence of erectile dysfunction treatment after the first dose of treatment or placebo.

Each symbol represents cases of erectile dysfunction treatment starting on a given day. Results shown in the graph are all available data for the efficacy population, and results shown in the table are those for the efficacy population that could be evaluated (defined in Table S1). Participants without evidence of previous were those who had no medical history of erectile dysfunction treatment and no serologic or virologic evidence of past erectile dysfunction before 7 days after the second dose (i.e., N-binding serum antibody was negative at the first vaccination visit, erectile dysfunction was not detected in nasal swabs by nucleic acid amplification test at the vaccination visits, and nucleic acid amplification tests were negative at any unscheduled visit before 7 days after the second dose). The cutoff date for the efficacy evaluation was October 8, 2021. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.

The time period for erectile dysfunction treatment case accrual was from 7 days after the second dose to the end of the surveillance period. The 95% confidence intervals for treatment efficacy were derived by the Clopper–Pearson method, adjusted for surveillance time.Among participants without evidence of previous erectile dysfunction , there were three cases of erectile dysfunction treatment (with onset 7 days or more after the second dose) among BNT162b2 recipients and 16 among placebo recipients. The observed treatment efficacy was 90.7% (95% CI, 67.7 to 98.3). Among all participants with data that could be evaluated, regardless of evidence of previous erectile dysfunction , no additional cases were reported. The observed treatment efficacy was 90.7% (95% CI, 67.4 to 98.3) (Figure 3).

No cases of severe erectile dysfunction treatment or MIS-C were reported..

Data Source buy cheap kamagra oral jelly Data on all residents of Israel who had been fully vaccinated before June 1, 2021, and who had not been infected before the study period were extracted from the Israeli Ministry of Health database on http://muminahurry.com/blog-hops/ September 2, 2021. We defined fully vaccinated persons as those for whom 7 days or more had passed since receipt of the second dose of the BNT162b2 treatment. We used the Ministry of Health official database buy cheap kamagra oral jelly that contains all information regarding erectile dysfunction treatment (see Supplementary Methods 1 in the Supplementary Appendix, available with the full text of this article at NEJM.org).

We extracted from the database information on all documented erectile dysfunction s (i.e., positive result on PCR assay) and on the severity of the disease after . We focused on s that had been documented in the period from July 11 through 31, 2021 buy cheap kamagra oral jelly (study period), removing from the data all confirmed cases that had been documented before that period. The start date was selected as a time when the kamagra had already spread throughout the entire country and across population sectors.

The end date was just after Israel had initiated a campaign regarding the use of a booster treatment (third dose). The study period buy cheap kamagra oral jelly happened to coincide with the school summer vacation. We omitted from all the analyses children and adolescents younger than 16 years of age (most of whom were unvaccinated or had been recently vaccinated).

Only persons 40 years of age or older were included in the analysis of severe disease because severe disease was buy cheap kamagra oral jelly rare in the younger population. Severe disease was defined as a resting respiratory rate of more than 30 breaths per minute, oxygen saturation of less than 94% while the person was breathing ambient air, or a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of less than 300.14 Persons who died from erectile dysfunction treatment during the follow-up period were included in the study and categorized as having had severe disease. During the study period, approximately 10% of the detected s were in residents of Israel returning from abroad buy cheap kamagra oral jelly.

Most residents who traveled abroad had been vaccinated and were exposed to different populations, so their risk of differed from that in the rest of the study population. We therefore removed from the analysis all residents who had returned from abroad in July. Vaccination Schedule The official buy cheap kamagra oral jelly vaccination regimen in Israel involved the administration of the second dose 3 weeks after the first dose.

All residents 60 years of age or older were eligible for vaccination starting on December 20, 2020, thus becoming fully vaccinated starting in mid-January 2021. At that time, younger persons buy cheap kamagra oral jelly were eligible for vaccination only if they belonged to designated groups (e.g., health care workers and severely immunocompromised adults). The eligibility age was reduced to 55 years on January 12, 2021, and to 40 years on January 19, 2021.

On February 4, 2021, all persons 16 years buy cheap kamagra oral jelly of age or older became eligible for vaccination. Thus, if they did not belong to a designated group, persons 40 to 59 years of age received the second dose starting in mid-February, and those 16 to 39 years of age received the second dose starting in the beginning of March. On the basis of these dates, we defined our periods of interest in half months starting from January 16.

Vaccination periods for individual persons were determined according to the time buy cheap kamagra oral jelly that they had become fully vaccinated (i.e., 1 week after receipt of the second dose). All the analyses were stratified according to vaccination period and to age group (16 to 39 years, 40 to 59 years, and ≥60 years). Statistical Analysis The association buy cheap kamagra oral jelly between the rate of confirmed s and the period of vaccination provides a measure of waning immunity.

Without waning of immunity, one would expect to see no differences in rates among persons vaccinated at different times. To examine the effect of waning immunity during the period when the delta variant was predominant, we compared the rate of confirmed s (per 1000 persons) during the study period (July 11 to 31, 2021) among persons who became fully vaccinated during various buy cheap kamagra oral jelly periods. The 95% confidence intervals for the rates were calculated by multiplying the standard confidence intervals for proportions by 1000.

A similar analysis was performed to compare the association between the rate of severe erectile dysfunction treatment and the vaccination period, but for this outcome we used periods of entire months because there were fewer cases of severe disease. To account for possible buy cheap kamagra oral jelly confounders, we fitted Poisson regressions. The outcome variable was the number of documented erectile dysfunction s or cases of severe erectile dysfunction treatment during the study period.

The period of vaccination, which was defined as 7 days after receipt of the second dose of the erectile dysfunction treatment, was the primary buy cheap kamagra oral jelly exposure of interest. The models compared the rates per 1000 persons between different vaccination periods, in which the reference period for each age group was set according to the time at which all persons in that group first became eligible for vaccination. A differential effect of the vaccination period for buy cheap kamagra oral jelly each age group was allowed by the inclusion of an interaction term between age and vaccination period.

Additional potential confounders were added as covariates, as described below, and the natural logarithm of the number of persons was added as an offset. For each vaccination period and age group, an adjusted rate was calculated as the expected number of weekly events per 100,000 persons if all the persons in that age group had been vaccinated in that period. All the analyses were performed with the use of the glm function in the R statistical software package.17 In addition to buy cheap kamagra oral jelly age and sex, the regression analysis included as covariates the following confounders.

First, because the event rates were rising rapidly during the study period (Figure 1), we included the week in which the event was recorded. Second, although PCR testing buy cheap kamagra oral jelly is free in Israel for all residents, compliance with PCR-testing recommendations is variable and is a possible source of detection bias. To partially account for this, we stratified persons according to the number of PCR tests that had been performed during the period of March 1 to November 31, 2020, which was before the initiation of the vaccination campaign.

We defined buy cheap kamagra oral jelly three levels of use. Zero, one, and two or more PCR tests. Finally, the three major population groups in Israel (general Jewish, Arab, and ua-Orthodox Jewish) have varying risk factors for .

The proportion of vaccinated persons, as well as the level of exposure to the kamagra, differed among these groups.18 Although we restricted the study to dates when the kamagra was found throughout the country, we included population sector as a covariate to control for any residual confounding effect buy cheap kamagra oral jelly. We conducted several secondary analyses to test the robustness of the results, including calculation of the rate of confirmed in a finer, 10-year age grouping and an analysis restricted to the general Jewish population (in which the delta outbreak began), which comprises the majority of persons in Israel. In addition, a model including a measure of socioeconomic status as a covariate was fitted to the data, buy cheap kamagra oral jelly because this was an important risk factor in a previous study.18 Since socioeconomic status was unknown for 5% of the persons in our study and the missingness of the data seemed to be informative, and also owing to concern regarding nondifferential misclassification (persons with unknown socioeconomic status may have had different rates of vaccination, , and severe disease), we did not include socioeconomic status in the main analysis.

Finally, we compared the association between the number of PCR tests that had been conducted before the vaccination campaign (i.e., before December 2020) with the number that were conducted during the study period in order to evaluate the possible magnitude of detection bias in our analysis. A good correlation between past behavior regarding PCR testing and behavior during the study period would provide reassurance that the inclusion of past behavior as a covariate in the model would control, at least in part, for detection bias.Trial Objectives and Oversight In this phase 3, multicenter, randomized, double-blind, placebo-controlled trial, we evaluated a single intravenous infusion of sotrovimab at a dose of 500 mg for the prevention of progression of mild-to-moderate erectile dysfunction treatment in high-risk, nonhospitalized patients. For this prespecified interim analysis, patients were recruited beginning on August 27, 2020, and were followed through March 4, 2021, at buy cheap kamagra oral jelly 37 trial sites in four countries (the United States, Canada, Brazil, and Spain).

The protocol and statistical analysis plan are available at NEJM.org, and changes made to these documents after the trial began are summarized in the Supplementary Appendix. The trial, which was sponsored by Vir Biotechnology in collaboration with GlaxoSmithKline, was conducted in accordance with the principles of the Declaration of Helsinki and the buy cheap kamagra oral jelly ethical guidelines of the Council for International Organizations of Medical Sciences, applicable International Council for Harmonisation Good Clinical Practice guidelines, and applicable laws and regulations. All the patients provided written informed consent.

The sponsors designed the trial, and the sponsors and trial investigators participated in data collection, buy cheap kamagra oral jelly analysis, and interpretation. The authors made the decision to submit the manuscript for publication and vouch for the accuracy and completeness of the data presented and for the fidelity of the trial to the protocol. Medical writers who were funded by Vir Biotechnology assisted in drafting the manuscript under the authors’ direction.

All the buy cheap kamagra oral jelly authors had confidentiality agreements with the sponsors. Patients and Procedures Adult patients (≥18 years of age) who had a positive result on reverse-transcriptase–polymerase-chain-reaction or antigen erectile dysfunction testing and an onset of erectile dysfunction treatment symptoms within the previous 5 days were screened for eligibility. Screening was performed within 24 hours before the buy cheap kamagra oral jelly administration of sotrovimab or placebo.

The patients were at high risk for progression of erectile dysfunction treatment because of older age (≥55 years) or because they had at least one of the following risk factors. Diabetes for which buy cheap kamagra oral jelly medication was warranted, obesity (body-mass index [BMI. The weight in kilograms divided by the square of the height in meters], >30), chronic kidney disease (estimated glomerular fiation rate, <60 ml per minute per 1.73 m2 of body-surface area),23 congestive heart failure (New York Heart Association class II, III, or IV), chronic obstructive pulmonary disease, and moderate-to-severe asthma.24 Patients with already severe erectile dysfunction treatment, defined as shortness of breath at rest, an oxygen saturation below 94%, or the use of supplemental oxygen, were excluded.

Full inclusion and exclusion criteria are described in the Supplementary Methods section in the Supplementary Appendix. Figure 1 buy cheap kamagra oral jelly. Figure 1.

Trial Design buy cheap kamagra oral jelly. Patients were stratified according to age (≤70 years or >70 years), symptom duration (≤3 days or 4 or 5 days), and geographic region. The trial pharmacists reconstituted and dispensed sotrovimab and placebo within equal time frames in order to maintain blinding.Eligible patients were randomly assigned in a 1:1 ratio with the use of an interactive Web-based response system to receive either a single 500-mg, 1-hour infusion of sotrovimab or an equal volume of saline placebo on day buy cheap kamagra oral jelly 1 (Figure 1).

The trial design did not mandate any treatment for erectile dysfunction treatment other than sotrovimab or placebo. As a result, the patients received treatment at the discretion of their physicians according to the local standard of care. Efficacy Assessments The primary outcome was the percentage of patients buy cheap kamagra oral jelly who were hospitalized for more than 24 hours or who died from any cause through day 29 after randomization.

Secondary efficacy outcomes included the percentage of patients with an emergency department visit, hospitalization, or death and the percentage of patients who had disease progression that warranted the use of supplemental oxygen. Safety Assessments The safety outcomes included adverse events, serious adverse events, and adverse events of special interest, which were defined buy cheap kamagra oral jelly as infusion-related reactions (including hypersensitivity reactions). Immunogenicity testing for antidrug antibodies was performed, and antibody-dependent enhancement was evaluated.

All hospitalizations, including those due to erectile dysfunction treatment, were counted as serious buy cheap kamagra oral jelly adverse events. Statistical Analysis A prespecified interim analysis for safety, futility, and efficacy was triggered when approximately 41% of the required number of trial patients reached day 29. Sample-size calculations were based on a group-sequential design with two interim analyses to assess both futility due to lack of efficacy and efficacy.

A Lan–DeMets alpha-spending function was buy cheap kamagra oral jelly used to control type I error, with the use of a Pocock analogue rule for futility and a Hwang–Shih–DeCani analogue rule for efficacy (with the value of γ=1).25 The overall sample of 1360 patients would have provided approximately 90% power to detect a 37.5% relative efficacy in reducing progression of erectile dysfunction treatment through day 29 at the overall two-sided 5% significance level, with an assumed incidence of progression of 16% in the placebo group. In the interim analysis, the intention-to-treat population included all the patients who underwent randomization through the prespecified interim analysis cutoff date of January 19, 2021, irrespective of whether they received sotrovimab or placebo. The safety analysis buy cheap kamagra oral jelly population in the interim analysis included all the patients who received sotrovimab or placebo and underwent randomization through February 17, 2021.

Patients were grouped according to the actual agent received. The primary outcome was analyzed in the intention-to-treat population with the use of a Poisson regression model with robust sandwich estimators to adjust buy cheap kamagra oral jelly for trial agent, duration of symptoms, age, and sex. Missing progression status was imputed under a missing-at-random assumption with the use of multiple imputation.

On the basis of this analysis model, the statistical significance testing, the relative risk of progression, and its appropriate confidence interval are provided with the adjusted significance level for this interim analysis. An independent data monitoring committee recommended that enrollment in the trial be stopped on March buy cheap kamagra oral jelly 10, 2021, because of efficacy, at which time 1057 patients had undergone randomization. Analyses of all secondary and exploratory outcomes are planned when all the patients have completed day 29.Participants Phase 1 Figure 1.

Figure 1 buy cheap kamagra oral jelly. Screening, Randomization, and treatment and Placebo Administration among 5-to-11-Year-Old Children in the Phase 1 Study and the Phase 2–3 Trial. Participants who discontinued the vaccination regimen could remain in the buy cheap kamagra oral jelly study.

In the phase 2–3 trial, reasons for not receiving the first dose included withdrawal (14 children), no longer meeting eligibility criteria (2 children), and protocol deviation (1 child). Discontinuations or withdrawals after the first dose were due to a decision by the parent or guardian or by the participant, except one, for which the reason was classified as “other.” In the phase 2–3 trial, one participant who was randomly assigned to receive placebo was administered BNT162b2 in error for both doses. Therefore, 1518 participants received buy cheap kamagra oral jelly dose 1 of BNT162b2 and 750 participants received dose 1 of placebo.From March 24 through April 14, 2021, a total of 50 children 5 to 11 years of age were screened for inclusion at four U.S.

Sites, and my site 48 received escalating doses of the BNT162b2 treatment (Figure 1). Half the children were male, buy cheap kamagra oral jelly 79% were White, 6% were Black, 10% were Asian, and 8% were Hispanic or Latinx. The mean age was 7.9 years (Table S2).

Phase 2–3 Table 1. Table 1 buy cheap kamagra oral jelly. Demographic and Clinical Characteristics of Children in the Phase 2–3 Trial.

From June 7 through June 19, 2021, a total of 2316 children 5 to 11 years of age were screened for inclusion and 2285 underwent randomization across 81 sites in the United States, Spain, buy cheap kamagra oral jelly Finland, and Poland. 2268 participants received injections, with 1517 randomly assigned to receive BNT162b2 and 751 assigned to receive placebo (Figure 1). One participant who was randomly assigned to receive placebo was buy cheap kamagra oral jelly administered BNT162b2 in error for both doses.

Therefore, 1518 participants received dose 1 of BNT162b2 and 750 participants received dose 1 of placebo. More than 99% of participants received a second dose. At the data cutoff date, the median follow-up time was buy cheap kamagra oral jelly 2.3 months (range, 0 to 2.5).

95% of participants had at least 2 months of available follow-up safety data after the second dose. Overall, 52% were male, 79% were White, 6% were Black, 6% buy cheap kamagra oral jelly were Asian, and 21% were Hispanic or Latinx (Table 1). The mean age was 8.2 years.

20% of children had coexisting conditions (including 12% with obesity and approximately 8% with asthma), and 9% were buy cheap kamagra oral jelly erectile dysfunction–positive at baseline. Apart from younger age and a lower percentage of Black and Hispanic or Latinx 5-to-11-year-olds (6% and 18%, respectively) than 16-to-25-year-olds (12% and 36%, respectively), demographic characteristics were similar among the 5-to-11-year-old and 16-to-25-year-old BNT162b2 recipients who were included in the immunobridging subset (Table S3). Phase 1 Safety and Immunogenicity Most local reactions were mild to moderate, and all were transient (Fig.

S1A and Table buy cheap kamagra oral jelly S4). Fever was more common in the 30-μg dose-level group than in the 10-μg and 20-μg dose-level groups after the first and second doses (Fig. S1B).

All four sentinel participants in the 30-μg dose-level group who received the second 30-μg dose had mild-to-moderate fever within 7 days. The remaining 12 participants in the 30-μg dose-level group received a 10-μg second dose approximately 1 month after the first dose, as recommended by the internal review committee after selection of the phase 2–3 dose. Adverse events from the first dose through 1 month after the second dose were reported by 43.8% of participants who received two 10-μg doses of BNT162b2, 31.3% of those who received two 20-μg doses, and 50.0% of those who received two 30-μg doses (Table S6).

One severe adverse event (grade 3 pyrexia) in a 10-year-old participant began the day of the second 20-μg dose of BNT162b2, with temperature reaching 39.7°C (103.5°F) the day after vaccination and resolving the following day. Antipyretic medications were used, and the investigator considered the event to be related to receipt of the BNT162b2 treatment. Serum neutralizing GMTs 7 days after the second dose were 4163 with the 10-μg dose of BNT162b2 and 4583 with the 20-μg dose (Fig.

S2). On the basis of these safety and immunogenicity findings, the 10-μg dose level was selected for further assessment in 5-to-11-year-olds in phase 2–3. Phase 2–3 Safety Figure 2.

Figure 2. Local Reactions and Systemic Events Reported in the Phase 2–3 Trial within 7 Days after Injection of BNT162b2 or Placebo. Panel A shows local reactions and Panel B shows systemic events after the first and second doses in recipients of the BNT162b2 treatment (dose 1, 1511 children.

Dose 2, 1501 children) and placebo (dose 1, 748 or 749 children. Dose 2, 740 or 741 children). The numbers refer to the numbers of children reporting at least one “yes” or “no” response for the specified event after each dose.

Responses may not have been reported for every type of event. Severity scales are summarized in Table S5. Fever categories are designated in the key.

The numbers above the bars are the percentage of participants in each group with the specified local reaction or systemic event. Н™¸ bars represent 95% confidence intervals. One participant in the BNT162b2 group had a fever of 40.0°C after the second dose.BNT162b2 recipients reported more local reactions and systemic events than placebo recipients (Figure 2).

The reactions and events reported were generally mild to moderate, lasting 1 to 2 days (Table S4). Injection-site pain was the most common local reaction, occurring in 71 to 74% of BNT162b2 recipients. Severe injection-site pain after the first or second dose was reported in 0.6% of BNT162b2 recipients and in no placebo recipients.

Fatigue and headache were the most frequently reported systemic events. Severe fatigue (0.9%), headache (0.3%), chills (0.1%), and muscle pain (0.1%) were also reported after the first or second dose of BNT162b2. Frequencies of fatigue, headache, and chills were similar among BNT162b2 and placebo recipients after the first dose and were more frequent among BNT162b2 recipients than among placebo recipients after the second dose.

In general, systemic events were reported more often after the second dose of BNT162b2 than after the first dose. Fever occurred in 8.3% of BNT162b2 recipients after the first or second dose. Use of an antipyretic among BNT162b2 recipients was more frequent after the second dose than after the first dose.

One BNT162b2 recipient had a temperature of 40.0°C (104°F) 2 days after the second dose. Antipyretics were used, and the fever resolved the next day. From the first dose through 1 month after the second dose, adverse events were reported by 10.9% of BNT162b2 recipients and 9.2% of placebo recipients (Table S7).

Slightly more BNT162b2 recipients (3.0%) than placebo recipients (2.1%) reported adverse events that were considered by the investigators to be related to the treatment or placebo. Severe adverse events were reported in 0.1% of BNT162b2 recipients and 0.1% of placebo recipients. Three serious adverse events in two participants were reported by the cutoff date.

All three (postinjury abdominal pain and pancreatitis in a placebo recipient and arm fracture in a BNT162b2 recipient) were considered to be unrelated to the treatment or placebo. No deaths or adverse events leading to withdrawal were reported. Lymphadenopathy was reported in 10 BNT162b2 recipients (0.9%) and 1 placebo recipient (0.1%).

No myocarditis, pericarditis, hypersensitivity, or anaphylaxis in BNT162b2 recipients was reported. Four rashes in BNT162b2 recipients (observed on the arm, torso, face, or body, with no consistent pattern) were considered to be related to vaccination. The rashes were mild and self-limiting, and onset was typically 7 days or more after vaccination.

No safety differences were apparent when the data were analyzed according to baseline erectile dysfunction status. Phase 2–3 Immunogenicity Table 2. Table 2.

Results of Serum erectile dysfunction Neutralization Assay 1 Month after the Second Dose of BNT162b2 among Participants 5 to 11 and 16 to 25 Yr of Age. The geometric mean ratio of neutralizing GMTs for 10 μg of BNT162b2 in 5-to-11-year-olds to that for 30 μg of BNT162b2 in 16-to-25-year-olds 1 month after the second dose was 1.04 (95% confidence interval [CI], 0.93 to 1.18) (Table 2), a ratio meeting the immunobridging criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67, the predefined point estimate of a geometric mean ratio of 0.8 or greater, and the FDA-requested point estimate criterion of a geometric mean ratio of 1.0 or greater. In both age groups, 99.2% of participants achieved seroresponse 1 month after the second dose.

The difference between the percentage of 5-to-11-year-olds who achieved seroresponse and the percentage in 16-to-25-year-olds was 0.0 percentage points (95% CI, –2.0 to 2.2), which also met an immunobridging criterion. Serum-neutralizing GMTs 1 month after the second dose of BNT162b2 were 1198 in 5-to-11-year-olds and 1147 in 16-to-25-year-olds (Fig. S3).

Corresponding GMTs among placebo recipients were 11 and 10. Geometric mean fold rises from baseline to 1 month after the second dose were 118.2 in 5-to-11-year-olds and 111.4 in 16-to-25-year-olds. Corresponding geometric mean fold rises among placebo recipients were 1.1 and 1.0.

Of note, the neutralizing GMTs reported in phase 1 are from serum samples obtained 7 days after the second dose (during immune response expansion) and the GMTs in phase 2–3 are from serum samples obtained 1 month after the second dose. Phase 2–3 Efficacy Figure 3. Figure 3.

treatment Efficacy in Children 5 to 11 Years of Age. The graph represents the cumulative incidence of the first occurrence of erectile dysfunction treatment after the first dose of treatment or placebo. Each symbol represents cases of erectile dysfunction treatment starting on a given day.

Results shown in the graph are all available data for the efficacy population, and results shown in the table are those for the efficacy population that could be evaluated (defined in Table S1). Participants without evidence of previous were those who had no medical history of erectile dysfunction treatment and no serologic or virologic evidence of past erectile dysfunction before 7 days after the second dose (i.e., N-binding serum antibody was negative at the first vaccination visit, erectile dysfunction was not detected in nasal swabs by nucleic acid amplification test at the vaccination visits, and nucleic acid amplification tests were negative at any unscheduled visit before 7 days after the second dose). The cutoff date for the efficacy evaluation was October 8, 2021.

Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for erectile dysfunction treatment case accrual was from 7 days after the second dose to the end of the surveillance period. The 95% confidence intervals for treatment efficacy were derived by the Clopper–Pearson method, adjusted for surveillance time.Among participants without evidence of previous erectile dysfunction , there were three cases of erectile dysfunction treatment (with onset 7 days or more after the second dose) among BNT162b2 recipients and 16 among placebo recipients.

The observed treatment efficacy was 90.7% (95% CI, 67.7 to 98.3). Among all participants with data that could be evaluated, regardless of evidence of previous erectile dysfunction , no additional cases were reported. The observed treatment efficacy was 90.7% (95% CI, 67.4 to 98.3) (Figure 3).

No cases of severe erectile dysfunction treatment or MIS-C were reported..

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Start Preamble Centers kamagra oral jelly uk suppliers for Medicare check this link right here now &. Medicaid Services, Health and Human Services (HHS). Notice. The Centers for Medicare &. Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public.

Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments must be received by December 21, 2021. When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways.

1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2.

By regular mail. You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention. Document Identifier/OMB Control Number. __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

Start Printed Page 58665 To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following. 1. Access CMS' website address at website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N. Parham at (410) 786-4669.

End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ). CMS-2567 Statement of Deficiency and Plan of Correction CMS-10790 Medicare-Funded GME Residency Positions in accordance with Section 126 of the Consolidated Appropriations Act, 2020 (Pub. L. 116-93) CMS-10463 Cooperative Agreement to Support Navigators in Federally-facilitated Exchanges Under the PRA (44 U.S.C.

3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

Information Collection 1. Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection. Statement of Deficiency and Plan of Correction Use.

The form CMS-2567 is the means by which State and CMS surveyors document findings of compliance or noncompliance (deficiencies) resulting from inspection of Medicare, Medicaid, and Clinical Laboratory Improvement Amendments (CLIA) laboratories. The form CMS-2567 is the legal, documentary basis for CMS' certification of a facility's compliance or noncompliance with the Medicare/Medicaid Conditions of Participation or Coverage, and the requirements for Nursing Home participation and CLIA certification. In December, 2020, Congress passed the Consolidated Appropriations Act, 2021 (CAA, 2021). Section 407 of CAA, 2021, amended Part A of Title XVIII of the Social Security Act (the Act) at section 1822 establishing hospice program survey and enforcement requirements. This amendment, in part, now requires the Accrediting Organizations (AOs) that accredit hospice programs to include the form CMS-2567 to document the findings of their hospice program surveys beginning on October 1, 2021.

As of June 2021, there are three AOs with CMS-approved hospice accreditation programs. The AOs survey approximately half of the over 5,000 Medicare-certified hospice programs, while the SAs survey the remaining half. Form Numbers. CMS-2567 (OMB control number. 0938-0391).

Frequency. Yearly and Occasionally. Affected Public. Private Sector (Business or for-profits and Not-for-profit institutions). Number of Respondents.

65,948. Total Annual Responses. 65,948. Total Annual Hours. 1,187,064.

(For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) 2. Type of Information Collection Request. New collection (Request for a new OMB Control Number). Title of Information Collection. Medicare-Funded GME Residency Positions in accordance with Section 126 of the Consolidated Appropriations Act, 2020 (Pub.

L. 116-93). Use. The requirements in this rule were announced in CMS-1752-P (FY22 IPPS). However, the PRA package has been under development until now.

The plan, approved by OMB and CM, is to have the 60-day publish and then have CMS-1752-F2 serve as the 30-day notice, with the goal of approval in early January 2022. Section 126 of the Consolidated Appropriations Act (CAA), 2021 (Pub. L. 116-93), enacted December 20, 2020, included a key provision affecting Medicare payments for Graduate Medical Education (GME). Section 126(a) of the CAA amended section 1886(h) of the Act by adding a new section 1886(h)(9) requiring the distribution of additional residency positions (slots) to qualifying hospitals.

Section 1886(h)(9)(A) makes an additional 1,000 Medicare funded residency slots available to be phased in beginning in FY 2023 until the aggregate number of 1,000 full-time equivalent residency positions are distributed. This approval request is for CMS to receive electronic applications for Medicare-Funded GME Residency Positions submitted in accordance with Section 126 of the Consolidated Appropriations Act, 2021. The electronic applications will be submitted by the applicants in CMS' new Medicare Electronic Application Request Information SystemTM (MEARISTM). There is no existing, hard copy version of the application. The applications will provide CMS with the critical information necessary for CMS to process and score the applications in accordance with the policies finalized in the upcoming final rule to determine the disbursement of the slots and to announce the awardees by the January 31, 2023 required statutory deadline.

Form Number. CMS-10790 (OMB control number. 0938-NEW). Frequency. Yearly.

Affected Public. Private sector (Business or other for-profits and Not-for-profit institutions), State, Local, or Tribal Governments. Number of Respondents. 1,325. Total Annual Responses.

1,325. Total Annual Hours. 10,600. (For policy questions regarding this collection contact Noel Manlove at 410-786-5161.) 3. Type of Information Collection Request.

Revision of a currently approved collection. Title of Information Collection. Cooperative Agreement to Support Navigators in Federally-facilitated Exchanges. Use. Section 1311(i) of the PPACA requires Exchanges to establish a Navigator grant program under which it awards grants to eligible individuals and entities (as described in Section 1311(i)(2) of the PPACA and 45 CFR 155.210(a) and (c)) applying to serve consumers in States with a FFE.

Navigators assist consumers by providing education about and facilitating selection of qualified health plans (QHPs) within the Exchanges, as well as other required duties. Entities and individuals cannot serve as federally certified Navigators and carry out the required duties without receiving federal cooperative agreement funding. On July 1, 2021, HHS published the Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond Proposed Rule proposed rule. The proposed regulations would amend federal regulations at 45 CFR 155.210(e)(9) to reinstitute the requirement that FFE Navigators provide consumers with information and assistance on access, affordability and certain post-enrollment topics, such Start Printed Page 58666 as the eligibility appeals process, the Exchange-related components of the Premium Tax Credit (PTC) reconciliation process, and the basic concepts and rights of health coverage and how to use it. Under the Terms and Conditions of the Navigator program cooperative agreements, awardees must provide progress reports on a weekly, monthly, quarterly and annual basis during the cooperative agreement period of performance, and a final report at the end of the period of performance.

Awardees will submit their progress reports electronically to CMS staff for evaluation and analysis. The results of this evaluation will provide feedback on the effectiveness of the Navigator program, so that HHS and CMS leadership may evaluate the effectiveness of the program and address any areas that need revisions. CMS will also use the information collected from Navigator grant awardees to inform the public about the availability of application and enrollment assistance services from designated organizations. Form Number. CMS-10463 (OMB control number.

0938-1215). Frequency. Annually, Monthly, Quarterly, Weekly. Affected Public. Private sector.

Number of Respondents. 100. Total Annual Responses. 5,200. Total Annual Hours.

529,000. (For questions regarding this collection contact Gian Johnson at 301-492-4323.) Start Signature Dated. October 19, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.

End Signature End Supplemental Information [FR Doc. 2021-23107 Filed 10-21-21. 8:45 am]BILLING CODE 4120-01-PStart Preamble Start Printed Page 58019 Centers for Medicare &. Medicaid Services (CMS), Department of Health and Human Services (HHS). Final rule.

Correction and correcting amendment. This document corrects technical and typographical errors in the final rule that appeared in the August 13, 2021, issue of the Federal Register titled “Medicare Program. Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates. Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals. Changes to Medicaid Provider Enrollment.

And Changes to the Medicare Shared Savings Program.”   Effective date. The final rule corrections and correcting amendment are effective on October 19, 2021. Applicability date. The final rule corrections and correcting amendment are applicable to discharges occurring on or after October 1, 2021. Start Further Info Donald Thompson, (410) 786-4487, and Michele Hudson, (410) 786-4487, Operating Prospective Payment, Wage Index, Hospital Geographic Reclassifications, Medicare Disproportionate Share Hospital (DSH) Payment Adjustment, Graduate Medical Education, and Critical Access Hospital (CAH) Issues.

Mady Hue, (410) 786-4510, and Andrea Hazeley, (410) 786-3543, MS-DRG Classification Issues. Allison Pompey, (410) 786-2348, New Technology Add-On Payments Issues. Julia Venanzi, julia.venanzi@cms.hhs.gov, Hospital Inpatient Quality Reporting and Hospital Value-Based Purchasing Programs. End Further Info End Preamble Start Supplemental Information I. Background In FR Doc.

2021-16519 of August 13, 2021 (86 FR 44774), there were a number of technical and typographical errors that are identified and corrected in this final rule correction and correcting amendment. The final rule corrections and correcting amendment are applicable to discharges occurring on or after October 1, 2021, as if they had been included in the document that appeared in the August 13, 2021, Federal Register. II. Summary of Errors A. Summary of Errors in the Preamble On page 44878, we are correcting an inadvertent error in the reference to the number of technologies for which we proposed to allow a one-time extension of new technology add-on payments for fiscal year (FY) 2022.

On page 44889, we are correcting an inadvertent typographical error in the International Classification of Disease, 10th Revision, Procedure Coding System (ICD-10-PCS) procedure code describing the percutaneous endoscopic repair of the esophagus. On page 44960, in the table displaying the Medicare-Severity Diagnosis Related Groups (MS-DRGs) subject to the policy for replaced devices offered without cost or with a credit for FY 2022, we are correcting inadvertent typographical errors in the MS-DRGs describing Hip Replacement with Principal Diagnosis of Hip Fracture with and without MCC, respectively. On pages 45047, 45048, and 45049, in our discussion of the new technology add-on payments for FY 2022, we are correcting typographical and technical errors in referencing sections of the final rule. On page 45133, we are correcting an error in the maximum new technology add-on payment for a case involving the use of AprevoTM Intervertebral Body Fusion Device. On page 45150, we inadvertently omitted ICD-10-CM codes from the list of diagnosis codes used to identify cases involving the use of the INTERCEPT Fibrinogen Complex that would be eligible for new technology add-on payments.

On page 45157, we inadvertently omitted the ICD-10-CM diagnosis codes used to identify cases involving the use of FETROJA® for HABP/VABP. On page 45158, we inadvertently omitted the ICD-10-CM diagnosis codes used to identify cases involving the use of RECARBRIOTM for HABP/VABP. On pages 45291, 45293, and 45294, in three tables that display previously established, newly updated, and estimated performance standards for measures included in the Hospital Value-Based Purchasing Program, we are correcting errors in the numerical values for all measures in the Clinical Outcomes Domain that appear in the three tables. On page 45312, in our discussion of payments for indirect and direct graduate medical education costs and Intern and Resident Information System (IRIS) data, we made a typographical error in our response to a comment. On page 45386, we made an inadvertent typographical error in our discussion of the Hospital Inpatient Quality Reporting (IQR) Program Severe Hyperglycemia electronic clinical quality measure (eCQM).

On page 45400, in our discussion of the Hospital Inpatient Quality Reporting (IQR) Program measures for fiscal year (FY) 2024, we mislabeled the table title and inadvertently included a measure not pertaining to the FY 2024 payment determination along with its corresponding footnote. On page 45404, in our discussion the Hospital Inpatient Quality Reporting (IQR) Program, we included a table with the measures for the FY 2025 payment determination. In the notes that immediately followed the table, we made a typographical error in the date associated with the voluntary reporting period for the Hybrid Hospital-Wide All-Cause Risk Standardized Mortality (HWM) measure. B. Summary of Errors in the Regulations Text On page 45521, in the regulations text for § 413.24(f)(5)(i) introductory text and (f)(5)(i)(A) regarding cost reporting forms and teaching hospitals, we inadvertently omitted revisions that were discussed in the preamble.

C. Summary of Errors in the Addendum In the FY 2022 Hospital Inpatient Prospective Payment Systems and Long-Term Care Hospital Prospective Payment System (IPPS/LTCH PPS) final rule (85 FR 45166), we stated that we excluded the wage data for critical access hospitals (CAHs) as discussed in the FY 2004 IPPS final rule (68 FR 45397 through 45398). That is, any hospital that is designated as a CAH by 7 days prior to the publication of the preliminary wage index public use file (PUF) is excluded from the calculation Start Printed Page 58020 of the wage index. We inadvertently excluded a hospital that converted to CAH status after January 24, 2021, the cut-off date for CAH exclusion from the FY 2022 wage index. (CMS Certification Number (CCN) 230118) Therefore, we restored the wage data for this hospital and included it in our calculation of the wage index.

This correction necessitated the recalculation of the FY 2022 wage index for rural Michigan (rural state code 23), as reflected in Table 3, and affected the final FY 2022 wage index for rural Michigan 23 as well as the rural floor for the State of Michigan. As discussed in this section, the final FY 2022 IPPS wage index is used when determining total payments for purposes of all budget neutrality factors (except for the MS-DRG reclassification and recalibration budget neutrality factor) and the final outlier threshold. We note, in the final rule, we correctly listed the number of hospitals with CAH status removed from the FY 2022 wage index (86 FR 45166), the number of hospitals used for the FY 2022 wage index (86 FR 45166) and the number of hospital occupational mix surveys used for the FY 2022 wage index (86 FR 45173). Additionally, the FY 2022 national average hourly wage (unadjusted for occupational mix) (86 FR 45172), the FY 2022 occupational mix adjusted national average hourly wage (86 FR 45173), and the FY 2022 national average hourly wages for the occupational mix nursing subcategories (86 FR 45174) listed in the final rule remain unchanged. Because the numbers and values noted previously are correctly stated in the preamble of the final rule and remain unchanged, we do not include any corrections in section IV.A.

Of this final rule correction and correcting amendment. We made an inadvertent error in the Medicare Geographic Classification Review Board (MGCRB) reclassification status of one hospital in the FY 2022 IPPS/LTCH PPS final rule. Specifically, CCN 360259 is incorrectly listed in Table 2 as reclassified to CBSA 19124. The correct reclassification area is to its geographic “home” of CBSA 45780. This correction necessitated the recalculation of the FY 2022 wage index for CBSA 19124 and affected the final FY 2022 wage index with reclassification.

The final FY 2022 IPPS wage index with reclassification is used when determining total payments for purposes of all budget neutrality factors (except for the MS-DRG reclassification and recalibration budget neutrality factor and the wage index budget neutrality adjustment factor) and the final outlier threshold. As discussed further in section II.E. Of this final rule correction and correcting amendment, we made updates to the calculation of Factor 3 of the uncompensated care payment methodology to reflect updated information on hospital mergers received in response to the final rule and made corrections for report upload errors. Factor 3 determines the total amount of the uncompensated care payment a hospital is eligible to receive for a fiscal year. This hospital-specific payment amount is then used to calculate the amount of the interim uncompensated care payments a hospital receives per discharge.

Per discharge uncompensated care payments are included when determining total payments for purposes of all of the budget neutrality factors and the final outlier threshold. As a result, the revisions made to the calculation of Factor 3 to address additional merger information and report upload errors directly affected the calculation of total payments and required the recalculation of all the budget neutrality factors and the final outlier threshold. Due to the correction of the combination of errors that are discussed previously (correcting the number of hospitals with CAH status, the correction to the MGCRB reclassification status of one hospital, and the revisions to Factor 3 of the uncompensated care payment methodology), we recalculated all IPPS budget neutrality adjustment factors, the fixed-loss cost threshold, the final wage indexes (and geographic adjustment factors (GAFs)), the national operating standardized amounts and capital Federal rate. We note that the fixed-loss cost threshold was unchanged after these recalculations. Therefore, we made conforming changes to the following.

On page 45532, the table titled “Summary of FY 2022 Budget Neutrality Factors”. On page 45537, the estimated total Federal capital payments and the estimated capital outlier payments. On pages 45542 and 45543, the calculation of the outlier fixed-loss cost threshold, total operating Federal payments, total operating outlier payments, the outlier adjustment to the capital Federal rate and the related discussion of the percentage estimates of operating and capital outlier payments. On page 45545, the table titled “Changes from FY 2021 Standardized Amounts to the FY 2022 Standardized Amounts”. On pages 45553 through 45554, in our discussion of the determination of the Federal hospital inpatient capital related prospective payment rate update, due to the recalculation of the GAFs, we have made conforming corrections to the capital Federal rate.

As a result of these changes, we also made conforming corrections in the table showing the comparison of factors and adjustments for the FY 2021 capital Federal rate and FY 2022 capital Federal rate. As we noted in the final rule, the capital Federal rate is calculated using unrounded budget neutrality and outlier adjustment factors. The unrounded GAF/DRG budget neutrality factor, the unrounded Quartile/Cap budget neutrality factor, and the unrounded outlier adjustment to the capital Federal rate were revised because of these errors. However, after rounding these factors to 4 decimal places as displayed in the final rule, the rounded factors were unchanged from the final rule. On pages 45570 and 45571, we are making conforming corrections to the national adjusted operating standardized amounts and capital standard Federal payment rate (which also include the rates payable to hospitals located in Puerto Rico) in Tables 1A, 1B, 1C, and 1D as a result of the conforming corrections to certain budget neutrality factors, as previously described.

D. Summary of Errors in the Appendices On pages 45576 through 45580, 45582 through 45583, and 45598 through 45600, in our regulatory impact analyses, we have made conforming corrections to the factors, values, and tables and accompanying discussion of the changes in operating and capital IPPS payments for FY 2022 and the effects of certain IPPS budget neutrality factors as a result of the technical errors that lead to changes in our calculation of the operating and capital IPPS budget neutrality factors, outlier threshold, final wage indexes, operating standardized amounts, and capital Federal rate (as described in section II.C. Of this final rule correction and correcting amendment). These conforming corrections include changes to the following. On pages 45576 through 45578, the table titled “Table I—Impact Analysis of Changes to the IPPS for Operating Costs for FY 2022”.

On pages 45582 and 45583, the table titled “Table II—Impact Analysis of Changes for FY 2022 Acute Care Hospital Operating Prospective Payment System (Payments per discharge)”. • On pages 45599 and 45600, the table titled “Table III—Comparison of Start Printed Page 58021 Total Payments per Case [FY 2021 Payments Compared to FY 2022 Payments]”. On pages 45584 and 45585 we are correcting the maximum new-technology add-on payment for a case involving the use of Fetroja, Recarbrio, Tecartus, and Abecma and related information in the untitled tables as well as making conforming corrections to the total estimated FY 2022 payments in the accompanying discussion of applications approved or conditionally approved for new technology add-on payments. On pages 45587 through 45589, we are correcting the discussion of the “Effects of the Changes to Medicare DSH and Uncompensated Care Payments for FY 2022” for purposes of the Regulatory Impact Analysis in Appendix A of the FY 2022 IPPS/LTCH PPS final rule, including the table titled “Modeled Uncompensated Care Payments for Estimated FY 2022 DSHs by Hospital Type. Uncompensated Care Payments ($ in Millions)*—from FY 2021 to FY 2022”, in light of the corrections discussed in section II.E.

Of this final rule correction and correcting amendment. On pages 45610 and 45611, we are making conforming corrections to the estimated expenditures under the IPPS as a result of the corrections to the maximum new technology add-on payment for a case involving the use of AprevoTM Intervertebral Body Fusion Device, Fetroja, Recarbrio, Abecma, and Tecartus as described in this section and in section II.A. Of this final rule correction and correcting amendment. E. Summary of Errors in and Corrections to Files and Tables Posted on the CMS Website We are correcting the errors in the following IPPS tables that are listed on pages 45569 and 45570 of the FY 2022 IPPS/LTCH PPS final rule and are available on the internet on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​AcuteInpatientPPS/​index.html.

The tables that are available on the internet have been updated to reflect the revisions discussed in this final rule correction and correcting amendment. Table 2—Case-Mix Index and Wage Index Table by CCN-FY 2022 Final Rule. As discussed in section II.C. Of this final rule correction and correcting amendment, we inadvertently excluded a hospital that converted to CAH status after January 24, 2021, the cut-off date for CAH exclusion from the FY 2022 wage index. (CMS Certification Number (CCN) 230118).

Therefore, we restored provider 230118 to the table. Also, as discussed in section II.C. Of this final rule correction and correcting amendment, CCN 360259 is incorrectly listed as reclassified to CBSA 19124. The correct reclassification area is to its geographic “home” of CBSA 45780. In this table, we are correcting the columns titled “Wage Index Payment CBSA” and “MGCRB Reclass” to accurately reflect its reclassification to CBSA 45780.

This correction necessitated the recalculation of the FY 2022 wage index for CBSA 19124. As also discussed later in this section, because the wage indexes are one of the inputs used to determine the out-migration adjustment, some of the out-migration adjustments changed. Therefore, we are making corresponding changes to the affected values. Table 3.—Wage Index Table by CBSA—FY 2022 Final Rule. As discussed in section II.C.

Of this final rule correction and correcting amendment, we inadvertently excluded a hospital that converted to CAH status after January 24, 2021, the cut-off date for CAH exclusion from the FY 2022 wage index. (CMS Certification Number (CCN) 230118). Therefore, we recalculated the wage index for rural Michigan (rural state code 23), as reflected in Table 3, as well as the rural floor for the State of Michigan. Also, as discussed in section II.C. Of this final rule correction and correcting amendment, CCN 360259 is incorrectly listed as reclassified to CBSA 19124.

The correct reclassification area is to its geographic “home” of CBSA 45780. In this table, we are correcting the values that changed as a result of these corrections as well as any corresponding changes. Table 4A.—List of Counties Eligible for the Out-Migration Adjustment under Section 1886(d)(13) of the Act—FY 2022 Final Rule. As discussed in section II.C. Of this final rule correction and correcting amendment, we inadvertently excluded a hospital that converted to CAH status after January 24, 2021, the cut-off date for CAH exclusion from the FY 2022 wage index.

(CMS Certification Number (CCN) 230118). Also, as discussed in section II.C. Of this final rule correction and correcting amendment, CCN 360259 is incorrectly listed as reclassified to CBSA 19124. The correct reclassification area is to its geographic “home” of CBSA 45780. As a result, as discussed previously, we are making changes to the FY 2022 wage indexes.

Because the wage indexes are one of the inputs used to determine the out-migration adjustment, some of the out-migration adjustments changed. Therefore, we are making corresponding changes to some of the out-migration adjustments listed in Table 4A. Table 6B.—New Procedure Codes—FY 2022. We are correcting this table to reflect the assignment of procedure codes XW033A7 (Introduction of ciltacabtagene autoleucel into peripheral vein, percutaneous approach, new technology group 7) and XW043A7 (Introduction of ciltacabtagene autoleucel into central vein, percutaneous approach, new technology group 7) to Pre-MDC MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell and Other Immunotherapies). Table 6B inadvertently omitted Pre-MDC MS-DRG 018 in Column E (MS-DRG) for assignment of these codes.

Effective with discharges on and after April 1, 2022, conforming changes will be reflected in the Version 39.1 ICD-10 MS-DRG Definitions Manual and ICD-10 MS-DRG Grouper and Medicare Code Editor software. Table 6P.—ICD-10-CM and ICD-10-PCS Codes for MS-DRG Changes—FY 2022. We are correcting Table 6P.1d associated with the final rule to reflect three procedure codes submitted by the requestor that were inadvertently omitted, resulting in 79 procedure codes listed instead of 82 procedure codes as indicated in the final rule (see pages 44808 and 44809). Table 18.—Final FY 2022 Medicare DSH Uncompensated Care Payment Factor 3. For the FY 2022 IPPS/LTCH PPS final rule, we published a list of hospitals that we identified to be subsection (d) hospitals and subsection (d) Puerto Rico hospitals projected to be eligible to receive interim uncompensated care payments for FY 2022.

As stated in the FY 2022 IPPS/LTCH PPS final rule (86 FR 45249), we allowed the public an additional period after the issuance of the final rule to review and submit comments on the accuracy of the list of mergers that we identified in the final rule. Based on the comments received during this additional period, we are updating this table to reflect the merger information received in response to the final rule and to revise the Factor 3 calculations for purposes of determining uncompensated care payments for the FY 2022 IPPS/LTCH PPS final rule. We are revising Factor 3 for all hospitals to reflect the updated merger information received in response to the final rule. We are also revising the amount of the total uncompensated care payment calculated for each DSH eligible hospital. The total uncompensated care payment that a hospital receives is used to calculate the amount of the interim uncompensated care payments the hospital receives per discharge.

Start Printed Page 58022 accordingly, we have also revised these amounts for all DSH eligible hospitals. These corrections will be reflected in Table 18 and the Medicare DSH Supplemental Data File. Per discharge uncompensated care payments are included when determining total payments for purposes of all of the budget neutrality factors and the final outlier threshold. As a result, these corrections to uncompensated care payments required the recalculation of all the budget neutrality factors as well as the outlier fixed-loss cost threshold. We note that the fixed-loss cost threshold was unchanged after these recalculations.

In section IV.C. Of this final rule correction and correcting amendment, we have made corresponding revisions to the discussion of the “Effects of the Changes to Medicare DSH and Uncompensated Care Payments for FY 2022” for purposes of the Regulatory Impact Analysis in Appendix A of the FY 2022 IPPS/LTCH PPS final rule to reflect the corrections discussed previously and to correct minor typographical errors. The files that are available on the internet have been updated to reflect the corrections discussed in this final rule correction and correcting amendment. In addition, we are correcting the inadvertent omission of the following 32 ICD-10-PCS codes describing percutaneous cardiovascular procedures involving one, two, three or four arteries from the GROUPER logic for MS-DRG 246 (Percutaneous Cardiovascular Procedures with Drug-Eluting Stent with MCC or 4+ Arteries or Stents) and MS-DRG 248 (Percutaneous Cardiovascular Procedures with Non-Drug-Eluting Stent with MCC or 4+ Arteries or Stents). ICD-10-PCS codeDescription02703Z6Dilation of coronary artery, one artery, bifurcation, percutaneous approach.02703ZZDilation of coronary artery, one artery, percutaneous approach.02704Z6Dilation of coronary artery, one artery, bifurcation, percutaneous endoscopic approach.02704ZZDilation of coronary artery, one artery, percutaneous endoscopic approach.02C03Z6Extirpation of matter from coronary artery, one artery, bifurcation, percutaneous approach.02C03ZZExtirpation of matter from coronary artery, one artery, percutaneous approach.02C04Z6Extirpation of matter from coronary artery, one artery, bifurcation, percutaneous endoscopic approach.02C04ZZExtirpation of matter from coronary artery, one artery, percutaneous endoscopic approach.02713Z6Dilation of coronary artery, two arteries, bifurcation, percutaneous approach.02713ZZDilation of coronary artery, two arteries, percutaneous approach.02714Z6Dilation of coronary artery, two arteries, bifurcation, percutaneous endoscopic approach.02714ZZDilation of coronary artery, two arteries, percutaneous endoscopic approach.02C13Z6Extirpation of matter from coronary artery, two arteries, bifurcation, percutaneous approach.02C13ZZExtirpation of matter from coronary artery, two arteries, percutaneous approach.02C14Z6Extirpation of matter from coronary artery, two arteries, bifurcation, percutaneous endoscopic approach.02C14ZZExtirpation of matter from coronary artery, two arteries, percutaneous endoscopic approach.02723Z6Dilation of coronary artery, three arteries, bifurcation, percutaneous approach.02723ZZDilation of coronary artery, three arteries, percutaneous approach.02724Z6Dilation of coronary artery, three arteries, bifurcation, percutaneous endoscopic approach.02724ZZDilation of coronary artery, three arteries, percutaneous endoscopic approach.02C23Z6Extirpation of matter from coronary artery, three arteries, bifurcation, percutaneous approach.02C23ZZExtirpation of matter from coronary artery, three arteries, percutaneous approach.02C24Z6Extirpation of matter from coronary artery, three arteries, bifurcation, percutaneous endoscopic approach.02C24ZZExtirpation of matter from coronary artery, three arteries, percutaneous endoscopic approach.02733Z6Dilation of coronary artery, four or more arteries, bifurcation, percutaneous approach.02733ZZDilation of coronary artery, four or more arteries, percutaneous approach.02734Z6Dilation of coronary artery, four or more arteries, bifurcation, percutaneous endoscopic approach.02734ZZDilation of coronary artery, four or more arteries, percutaneous endoscopic approach.02C33Z6Extirpation of matter from coronary artery, four or more arteries, bifurcation, percutaneous approach.02C33ZZExtirpation of matter from coronary artery, four or more arteries, percutaneous approach.02C34Z6Extirpation of matter from coronary artery, four or more arteries, bifurcation, percutaneous endoscopic approach.02C34ZZExtirpation of matter from coronary artery, four or more arteries, percutaneous endoscopic approach.

We have corrected the ICD-10 MS-DRG Definitions Manual Version 39 and the ICD-10 MS-DRG GROUPER and MCE Version 39 Software to correctly reflect the inclusion of these codes in the arterial logic lists for MS-DRGs 246 and 248 for FY 2022. III. Waiver of Proposed Rulemaking and Delay in Effective Date Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rulemaking in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rulemaking in the Federal Register and provide a period of not less than 60 days for public comment.

In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements. In cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.

We believe that this final rule correction and correcting amendment does not constitute a rule that would be subject to the notice and comment or Start Printed Page 58023 delayed effective date requirements. This document corrects technical and typographical errors in the preamble, regulations text, addendum, payment rates, tables, and appendices included or referenced in the FY 2022 IPPS/LTCH PPS final rule, but does not make substantive changes to the policies or payment methodologies that were adopted in the final rule. As a result, this final rule correction and correcting amendment is intended to ensure that the information in the FY 2022 IPPS/LTCH PPS final rule accurately reflects the policies adopted in that document. In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the FY 2022 IPPS/LTCH PPS final rule accurately reflects our policies.

Furthermore, such procedures would be unnecessary, as we are not altering our payment methodologies or policies, but rather, we are simply implementing correctly the methodologies and policies that we previously proposed, requested comment on, and subsequently finalized. This final rule correction and correcting amendment is intended solely to ensure that the FY 2022 IPPS/LTCH PPS final rule accurately reflects these payment methodologies and policies. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements. Moreover, even if these corrections were considered to be retroactive rulemaking, they would be authorized under section 1871(e)(1)(A)(ii) of the Act, which permits the Secretary to issue a rule for the Medicare program with retroactive effect if the failure to do so would be contrary to the public interest. As we have explained previously, we believe it would be contrary to the public interest not to implement the corrections in this final rule correction and correcting amendment because it is in the public's interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the FY 2022 IPPS/LTCH PPS final rule accurately reflects our policies.

IV. Correction of Errors In FR Doc. 2021-16519 of August 13, 2021 (86 FR 44774), we are making the following corrections. A. Correction of Errors in the Preamble 1.

On page 44878, second column, last paragraph, line 10, “15 technologies” is corrected to read “technologies.” 2. On page 44889, lower two-thirds of the page, third column, partial paragraph, line 10, the procedure code “0DQ540ZZ” is corrected to read “0DQ54ZZ.” 3. On page 44960, in the untitled table, last 2 lines are corrected to read as follows. MDCMS-DRGMS-DRG title *         *         *         *         *         *         *08521Hip Replacement with Principal Diagnosis of Hip Fracture with MCC.08522Hip Replacement with Principal Diagnosis of Hip Fracture without MCC. 4.

On page 45047. A. Second column, first full paragraph, lines 21 through 24, the sentence “We summarize comments related to this comment solicitation and provide our responses as well as our finalized policy in section XXX of this final rule.” is corrected to read “We summarize comments related to this comment solicitation and provide our responses in section II.F.7. Of the preamble of this final rule.”. B.

Third column, first full paragraph, line 28, the reference “section XXX” is corrected to read “section II.F.8.”. 5. On page 45048, second column, second full paragraph, lines 20 through 24, the sentence “We summarize comments related to this comment solicitation and provide our responses as well as our finalized policy in section XXX of this final rule.” is corrected to read “We summarize comments related to this comment solicitation and provide our responses in section II.F.7. Of the preamble of this final rule.”. 6.

On page 45049. A. Second column. (1) First full paragraph, line 12, the reference, “section XXX of this final rule” is corrected to read “section II.F.8. Of the preamble of this final rule”.

(2) Second full paragraph, lines 1 and 2, the reference, “section XXX of this final rule” is corrected to read “section II.F.7. J95.851 (Ventilator associated pneumonia) and one of the following. B96.1 (Klebsiella pneumoniae [K. Pneumoniae] as the cause of diseases classified elsewhere), B96.20 (Unspecified Escherichia coli [E. Coli] as the cause of diseases classified elsewhere), B96.21 (Shiga toxin-producing Escherichia coli [E.

Coli] [STEC] O157 as the cause of diseases classified elsewhere), B96.22 (Other specified Shiga toxin-producing Escherichia coli [E. Coli] [STEC] as the cause of diseases classified elsewhere), B96.23 (Unspecified Shiga toxin-producing Escherichia coli [E. Coli] [STEC] as the cause of diseases classified elsewhere, B96.29 (Other Escherichia coli [E. Coli] as the cause of diseases classified elsewhere), B96.3 (Hemophilus influenzae [H. Influenzae] as the cause of diseases classified elsewhere, B96.5 (Pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere), or B96.89 (Other specified bacterial agents as the cause of diseases classified elsewhere) for VABP.” 10.

On page 45158, third column, first partial paragraph, last line the phrase, “technology group 5).” is corrected to read “technology group 5) in combination with the following ICD-10-CM codes. Y95 (Nosocomial condition) and one of the following. J14.0 (Pneumonia due to Hemophilus influenzae) J15.0 (Pneumonia due to Klebsiella pneumoniae), J15.1 (Pneumonia due to Pseudomonas), J15.5 (Pneumonia due to Escherichia coli), J15.6 (Pneumonia due to other Gram-negative bacteria), or J15.8 (Pneumonia due to other specified bacteria) for HABP and ICD10-PCS codes. XW033A6 (Introduction of cefiderocol antinfective into peripheral vein, percutaneous approach, new technology group 6) or XW043A6 (Introduction of cefiderocol anti-infective into central vein, percutaneous approach, new technology group 6) in combination with the following ICD-10-CM codes. J95.851 (Ventilator associated pneumonia) and one of the following.

B96.1 (Klebsiella pneumoniae [K. Pneumoniae] as the cause of diseases classified elsewhere), B96.20 (Unspecified Escherichia coli [E. Coli] as the cause of diseases classified elsewhere), B96.21 (Shiga toxin-producing Escherichia coli [E. Coli] Start Printed Page 58024 [STEC] O157 as the cause of diseases classified elsewhere), B96.22 (Other specified Shiga toxin-producing Escherichia coli [E. Coli] [STEC] as the cause of diseases classified elsewhere), B96.23 (Unspecified Shiga toxin-producing Escherichia coli [E.

Coli] [STEC] as the cause of diseases classified elsewhere, B96.29 (Other Escherichia coli [E. Coli] as the cause of diseases classified elsewhere), B96.3 (Hemophilus influenzae [H. Influenzae] as the cause of diseases classified elsewhere, B96.5 (Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere), or B96.89 (Other specified bacterial agents as the cause of diseases classified elsewhere) for VABP.” 11. On page 45291, middle of the page, the table titled “Table V.H-11. Previously Established and Newly Updated Performance Standards for the FY 2024 Program Year” is corrected to read as follows.

Table V.H-11—Previously Established and Estimated Performance Standards for the FY 2024 Program YearMeasure short nameAchievement thresholdBenchmarkClinical Outcomes DomainMORT-30-AMI #0.8692470.887868MORT-30-HF #0.8823080.907773MORT-30-PN (updated cohort) #0.8402810.872976MORT-30-COPD #0.9164910.934002MORT-30-CABG #0.9694990.980319COMP-HIP-KNEE * #0.0253960.018159♢  As discussed in section V.H.4.b. Of this final rule, we are finalizing the updates to the FY 2024 baseline periods for measures included in the Person and Community Engagement, Safety, and Efficiency and Cost Reduction domains to use CY 2019. Therefore, the performance standards displayed in this table for the Safety domain measures were calculated using CY 2019 data.* Lower values represent better performance.#  Previously established performance standards. 12. On page 45293, top of the page, the table titled “V.H-13 Previously Established and Estimated Performance Standards for the FY 2025 Program Year” is corrected to read as follows.

Table V.H-13—Previously Established and Estimated Performance Standards for the FY 2025 Program YearMeasure short nameAchievement thresholdBenchmarkClinical Outcomes DomainMORT-30-AMI #0.8726240.889994MORT-30-HF #0.8839900.910344MORT-30-PN (updated cohort) #0.8414750.874425MORT-30-COPD #0.9151270.932236MORT-30-CABG #0.9701000.979775COMP-HIP-KNEE * #0.0253320.017946* Lower values represent better performance.#  Previously established performance standards. 13. On page 45294, top of page, the table titled “V.H-14 Previously Established and Estimated Performance Standards for the FY 2026 Program Year” is corrected to read as follows. Table V.H-14—Previously Established and Estimated Performance Standards for the FY 2026 Program YearMeasure short nameAchievement thresholdBenchmarkClinical Outcomes DomainMORT-30-AMI #0.8744260.890687MORT-30-HF #0.8859490.912874MORT-30-PN (updated cohort) #0.8433690.877097MORT-30-COPD #0.9146910.932157MORT-30-CABG #0.9705680.980473COMP-HIP-KNEE * #0.0240190.016873* Lower values represent better performance. Start Printed Page 58025#  Previously established performance standards.

14. On page 45312, second column, first full paragraph, lines 7 through 9, the phrase “rejection of the cost report if the submitted IRIS GME and IME FTEs do match” is corrected to read “rejection of the cost report if the submitted IRIS GME and IME FTEs do not match”. 15. On page 45386, third column, first full paragraph, line 12, the phrase “mellitus and who either” is corrected to read “mellitus, who”. 16.

On page 45400, top of the page, the table titled “Measures for the FY 2024 Payment Determination and Subsequent Years”, is corrected by— a. Correcting the title to read “Measures for the FY 2023 Payment Determination and Subsequent Years”. B. Removing the heading “Claims and Electronic Data Measures” and the entry “Hybrid HWR**” (rows 20 and 21). C.

Following the table, lines 3 through 8, removing the second table note. 17. On page 45404, bottom of the page, after the table titled “Measures for the FY 2025 Payment Determination and Subsequent Years”, in the third note to the table, line 10, the parenthetical phrase “(July 1, 2023-June 30, 2023)” is corrected to read “(July 1, 2022-June 30, 2023)”. B. Correction of Errors in the Addendum 1.

On page 45532, bottom of the page, the table titled “Summary of FY 2022 Budget Neutrality Factors” is corrected to read as follows. Summary of FY 2022 Budget Neutrality FactorsMS-DRG Reclassification and Recalibration Budget Neutrality Factor1.000107Wage Index Budget Neutrality Factor1.000715Reclassification Budget Neutrality Factor0.986741*Rural Floor Budget Neutrality Factor0.992868Rural Demonstration Budget Neutrality Factor0.999361Low Wage Index Hospital Policy Budget Neutrality Factor0.998029Transition Budget Neutrality Factor0.999859* The rural floor budget neutrality factor is applied to the national wage indexes while the rest of the budget neutrality adjustments are applied to the standardized amounts. 2. On page 45537, first column, first full paragraph, lines 4 through 10, the parenthetical phrase “(estimated capital outlier payments of $ 430,689,396 divided by (estimated capital outlier payments of $430,689,396 plus the estimated total capital Federal payment of $7,676,990,253)).” is corrected to read “(estimated capital outlier payments of $430,698,533 divided by (estimated capital outlier payments of $430,698,533 plus the estimated total capital Federal payment of $7,676,964,386)).”. 3.

On page 45542, third column, last paragraph, lines 23 and 24, the figure “$5,326,356,951” is corrected to read “$5,326,379,560”. 4. On page 45543. A. Top of the page, first column, first partial paragraph.

(1) Line 1, the figure “$100,164,666,975” is corrected to read “$100,165,281,272”. (2) Line 17, the figure “$31,108” is corrected to read “$31,109”. B. Middle of the page, the untitled table is corrected to read as follows. €ƒOperating standardized amountsCapital Federal rate *National0.9490.947078* The adjustment factor for the capital Federal rate includes an adjustment to the estimated percentage of FY 2022 capital outlier payments for capital outlier reconciliation, as discussed previously and in section III.

A. 2 in the Addendum of this final rule. 5. On page 45545, the table titled “CHANGES FROM FY 2021 STANDARDIZED AMOUNTS TO THE FY 2022 STANDARDIZED AMOUNTS” is corrected to read as follows. Start Printed Page 58026 6.

On page 45553, second column, last paragraph, line 9, the figure “$472.60” is corrected to read “$472.59”. 7. On page 45554, top of the page, in the table titled “COMPARISON OF FACTORS AND ADJUSTMENTS. FY 2021 CAPITAL FEDERAL RATE AND THE FY 2022 CAPITAL FEDERAL RATE”, the list entry (row 5) is corrected to read as follows. Comparison of Factors and Adjustments.

FY 2021 Capital Federal Rate and the FY 2022 Capital Federal Rate FY 2021FY 2022ChangePercent change *         *         *         *         *         *         *Capital Federal Rate$466.21$472.591.01374  1.37 8. On page 45570. A. The table titled “TABLE 1A.—NATIONAL ADJUSTED OPERATING STANDARDIZED AMOUNTS, LABOR/NONLABOR (67.6 PERCENT LABOR SHARE/32.4 PERCENT NONLABOR SHARE IF WAGE INDEX IS GREATER THAN 1)—FY 2022” is corrected to read as follows. Table 1A—National Adjusted Operating Standardized Amounts, Labor/Nonlabor (67.6 Percent Labor Share/32.4 Percent Nonlabor Share if Wage Index Is Greater Than 1)—FY 2022Hospital submitted quality data and is a meaningful EHR user (update = 2.0 percent)Hospital submitted quality data and is not a meaningful EHR user (update = −0.025 percent)Hospital did not submit quality data and is a meaningful EHR user (update = 1.325 percent)Hospital did not submit quality data and is not a meaningful EHR user (update = −0.7 percent)LaborNonlaborLaborNonlaborLaborNonlaborLaborNonlabor$4,138.24$1,983.41$4,056.08$1,944.03$4,110.85$1,970.28$4,028.70$1,930.91 Start Printed Page 58027 b.

The table titled “TABLE 1B.—NATIONAL ADJUSTED OPERATING STANDARDIZED AMOUNTS, LABOR/NONLABOR (62 PERCENT LABOR SHARE/38 PERCENT NONLABOR SHARE IF WAGE INDEX IS LESS THAN OR EQUAL TO 1)—FY 2022” is corrected to read as follows. Table 1B—National Adjusted Operating Standardized Amounts, Labor/Nonlabor (62 Percent Labor Share/38 Percent Nonlabor Share if Wage Index is Less Than or Equal to 1)—FY 2022Hospital submitted quality data and is a meaningful EHR user (update = 2.0 percent)Hospital submitted quality data and is not a meaningful EHR user (update = −0.025 percent)Hospital did not submit quality data and is a meaningful EHR user (update = 1.325 percent)Hospital did not submit quality data and is not a meaningful EHR user (update = −0.7 percent)LaborNonlaborLaborNonlaborLaborNonlaborLaborNonlabor$3,795.42$2,326.23$3,720.07$2,280.04$3,770.30$2,310.83$3,694.96$2,264.65 9. On page 45571, the top of page. A. The table titled “Table 1C.—ADJUSTED OPERATING STANDARDIZED AMOUNTS FOR HOSPITALS IN PUERTO RICO, LABOR/NONLABOR (NATIONAL.

62 PERCENT LABOR SHARE/38 PERCENT NONLABOR SHARE BECAUSE WAGE INDEX IS LESS THAN OR EQUAL TO 1)—FY 2022” is corrected to read as follows. Table 1C—Adjusted Operating Standardized Amounts for Hospitals in Puerto Rico, Labor/Nonlabor (National. 62 Percent Labor Share/38 Percent Nonlabor Share Because Wage Index Is Less Than or Equal to 1)—FY 2022 Rates if wage index greater than 1Hospital is a meaningful EHR user and wage index less than or equal to 1 (update = 2.0)Hospital is NOT a meaningful EHR user and wage index less than or equal to 1 (update = 1.325)LaborNonlaborLaborNonlaborLaborNonlabor1  NationalNot ApplicableNot Applicable$3,795.42$2,326.23$3,770.30$2,310.831  For FY 2022, there are no CBSAs in Puerto Rico with a national wage index greater than 1. B. The table titled “TABLE 1D.—CAPITAL STANDARD FEDERAL PAYMENT RATE—FY 2022” is corrected to read as follows.

Table 1D—Capital Standard Federal Payment Rate—FY 2022 RateNational$472.59 C. Correction of Errors in the Appendices 1. On pages 45576 through 45578, the table titled “Table I.—Impact Analysis of Changes to the IPPS for Operating Costs for FY 2022” is corrected to read as follows. Start Printed Page 58028 Start Printed Page 58029 Start Printed Page 58030 2. On page 45579, third column, first paragraph, line 23, the figure “1.000712” is corrected to read “1.000715”.

Start Printed Page 58031 3. On page 45580, lower three-fourths of the page, first column, third full paragraph, line 6, the figure “0.986737” is corrected to read “0.986741”. 4. On pages 45582 and 45583, the table titled “Table II.—Impact Analysis of Changes for FY 2022 Acute Care Hospital Operating Prospective Payment System (Payments Per Discharge)” is corrected to read as follows. Table II—Impact Analysis of Changes for FY 2022 Acute Care Hospital Operating Prospective Payment System[Payments per discharge] Number of hospitalsEstimated average FY 2021 payment per dischargeEstimated average FY 2022 payment per dischargeFY 2022 changes (1)(2)(3)(4)All Hospitals3,19513,10913,4482.6By Geographic Location:Urban hospitals2,45913,45413,8002.6Rural hospitals7369,90110,1782.8Bed Size (Urban):0-99 beds63410,72311,0112.7100-199 beds75411,01511,3052.6200-299 beds42712,25112,5512.4300-499 beds42113,49613,8472.6500 or more beds22316,56816,9922.6Bed Size (Rural):0-49 beds3118,5568,9214.350-99 beds2539,4199,6442.4100-149 beds949,78910,0332.5150-199 beds3910,51910,7882.6200 or more beds3911,46511,7842.8Urban by Region:New England11214,85815,2532.7Middle Atlantic30415,43215,8142.5East North Central38112,83813,1502.4West North Central16013,12113,4752.7South Atlantic40211,71012,0492.9East South Central14411,29011,5762.5West South Central36411,80612,0722.3Mountain17213,69814,0542.6Pacific37017,23017,6642.5Puerto Rico508,4918,6371.7Rural by Region:New England1913,99014,4633.4Middle Atlantic509,7369,9882.6East North Central11310,36110,5922.2West North Central8910,63810,9322.8South Atlantic1149,0329,3023East South Central1448,7328,9552.6West South Central1358,2928,5403Mountain4812,13412,3591.9Pacific2413,86514,5885.2By Payment Classification:Urban hospitals1,98312,67313,0032.6Rural areas1,21213,79614,1482.6Teaching Status:Nonteaching2,03110,67710,9632.7Fewer than 100 residents90712,38812,6942.5100 or more residents25718,93819,4372.6Urban DSH:Non-DSH50211,74912,0542.6100 or more beds1,22713,01513,3552.6Less than 100 beds3489,5599,8202.7Rural DSH:SCH26511,90612,2032.5RRC60814,38014,7472.6100 or more beds3012,11512,2981.5Less than 100 beds2157,7788,0253.2Urban teaching and DSH:Both teaching and DSH67914,11614,4832.6Teaching and no DSH7412,82513,1272.4No teaching and DSH89610,85011,1372.6No teaching and no DSH33410,82411,1102.6Special Hospital Types:Start Printed Page 58032RRC52314,47814,8592.6SCH30512,05312,3562.5MDH1539,1699,4042.6SCH and RRC15412,47512,7462.2MDH and RRC2710,62210,8532.2Type of Ownership:Voluntary1,88113,32113,6672.6Proprietary82811,47311,7692.6Government48614,10914,4662.5Medicare Utilization as a Percent of Inpatient Days:0-2564315,15815,5352.525-502,11012,92613,2682.650-6536710,77311,0102.2Over 65508,1328,4313.7FY 2022 Reclassifications by the Medicare Geographic Classification Review Board:All Reclassified Hospitals93413,59213,9442.6Non-Reclassified Hospitals2,26112,77213,1022.6Urban Hospitals Reclassified74914,26114,6192.5Urban Nonreclassified Hospitals1,72312,85113,1872.6Rural Hospitals Reclassified Full Year30010,08710,3412.5Rural Nonreclassified Hospitals Full Year4239,6109,9293.3All Section 401 Reclassified Hospitals53214,96815,3432.5Other Reclassified Hospitals (Section 1886(d)(8)(B))569,1499,4293.1 5.

On page 45584, bottom third of the page, third column, partial paragraph. A. Line 7, the figure “$151 million” is corrected to read “$158 million”. B. Line 10, the figure “$50 million” is corrected to read “$57 million”.

C. Lines 15 and 16, the phrase “for which we are approving new technology add-on payments” is corrected to read “for which we are approving or conditionally approving new technology add-on payments”. 6. On page 45585. A.

Top third of the page. (1) In the untitled table, the third and fourth column headings and the entries at rows 6 and 9 are corrected to read as follows. Technology nameEstimated casesFY 2022 NTAP amountEstimated FY 2022 total impactPathway (QIDP, LPAD, or breakthrough device) *         *         *         *         *         *         *Fetroja (HABP/VABP)379$8,579.84$3,251,759.36QIDP. *         *         *         *         *         *         *Recarbrio (HABP/VABP)9289,576.518,887,001.28QIDP. *         *         *         *         *         *         * (2) Following the first untitled table, second column, partial paragraph, last line, the figure “$498 million” is corrected to read “$514 million”. B. Middle third of the page, in the untitled table, the third and fourth column headings and the entries at rows 2 and 4 are corrected to read as follows.

Technology nameEstimated casesFY 2022 NTAP amountEstimated FY 2022 total impact *         *         *         *         *         *         *Abecma484$272,675.00$131,974,700.00 Start Printed Page 58033*         *         *         *         *         *         *Tecartus15259,350.003,890,250.00 *         *         *         *         *         *         * 7. On pages 45587 and 45588, the table titled “Modeled Uncompensated Care Payments for Estimated FY 2022 DSHs by Hospital Type. Model Uncompensated Care Payments ($ in Millions)—from FY 2021 to FY 2022” is corrected to read as follows. Start Printed Page 58034 Start Printed Page 58035 8. On page 45588, lower half of the page, beginning with the second column, first full paragraph, line 1 with the phrase “Rural hospitals, in general, are projected to experience” and ending in the third column last paragraph with the phrase “15.22 percent.

All” the paragraphs are corrected to read as follows. €œRural hospitals, in general, are projected to experience larger decreases in uncompensated care payments than their urban counterparts. Overall, rural hospitals are projected to receive a 17.28 percent decrease in uncompensated care payments, which is a greater decrease than the overall hospital average, while urban hospitals are projected to receive a 12.99 percent decrease in uncompensated care payments, similar to the overall hospital average. By bed size, smaller rural hospitals are projected to receive the largest decreases in uncompensated care payments. Rural hospitals with 0-99 beds are projected to receive an 18.97 percent payment decrease, and rural hospitals with 100-249 beds are projected to receive a 15.53 percent decrease.

In contrast, larger rural hospitals with 250+ beds are projected to receive a 14.16 percent payment decrease. Among urban hospitals, the smallest urban hospitals, those with 0-99 and 100-249 beds, are projected to receive a decrease in uncompensated care payments that is greater than the overall hospital average, at 15.49 and 15.50 percent, respectively. In contrast, the largest urban hospitals with 250+ beds are projected to receive a 12.02 percent decrease in uncompensated care payments, which is a smaller decrease than the overall hospital average. By region, rural hospitals are expected to receive larger than average decreases in uncompensated care payments in all Regions, except for rural hospitals in New England, which are projected to receive a decrease of 1.27 percent in uncompensated care payments, and rural hospitals in the East South Central Region, which are projected to receive a smaller than average decrease of 13.01 percent. Regionally, urban hospitals are projected to receive a more varied range of payment changes.

Urban hospitals in the New England, Middle Atlantic, and Pacific Regions are projected to receive larger than average decreases in uncompensated care payments. Urban hospitals in the South Atlantic, East North Central, West North Central, West South Central, and Mountain Regions, as well as hospitals in Puerto Rico are projected to receive smaller than average decreases in uncompensated care payments. Urban hospitals in the East South Central Region are projected to receive an average decrease in uncompensated care payments. By payment classification, although hospitals in urban areas overall are expected to receive a 12.74 percent decrease in uncompensated care payments, hospitals in large urban areas are expected to see a decrease in uncompensated care payments of 13.52 percent, while hospitals in other urban areas are expected to receive a decrease in uncompensated care payments of 11.21 percent. Rural hospitals are projected to receive the largest decrease of 14.23 percent.

Nonteaching hospitals are projected to receive a payment decrease of 13.4 percent, teaching hospitals with fewer than 100 residents are projected to receive a payment decrease of 12.94 percent, and teaching hospitals with 100+ residents have a projected payment decrease of 13.39 percent. All of these decreases closely approximate the overall hospital average. Proprietary and voluntary hospitals are projected to receive smaller than average decreases of 11.56 and 12.61 percent respectively, while government hospitals are expected to receive a larger payment decrease of 15.21 percent. All”. 9.

On page 45589, first column, first partial paragraph, the phrase “hospitals with less than 50 percent Medicare utilization are projected to receive decreases in uncompensated care payments consistent with the overall hospital average percent change, while hospitals with 50-65 percent and greater than 65 percent Medicare utilization are projected to receive larger decreases of 20.79 and 32.81 percent, respectively.” is corrected to read as follows. €œhospitals with less than 50 percent Medicare utilization are projected to receive decreases in uncompensated care payments consistent with the overall hospital average percent change, while hospitals with 50-65 percent and greater than 65 percent Medicare utilization are projected to receive larger decreases of 20.85 and 32.86 percent, respectively.” Start Printed Page 58036 10. On page 45598, third column, last paragraph, lines 21 through 23, the sentence “The estimated percentage increase for both rural reclassified and nonreclassified hospitals is 1.4 percent.” is corrected to read “The estimated percentage increase for rural reclassified hospitals is 1.3 percent, while the estimated percentage increase for rural nonreclassified hospitals is 1.4 percent.” 11. On pages 45599 and 45600, the table titled “TABLE III.—COMPARISON OF TOTAL PAYMENTS PER CASE [FY 2021 PAYMENTS COMPARED TO FY 2022 PAYMENTS]” is corrected to read as follows. Start Printed Page 58037 Start Printed Page 58038 12.

On page 45610. A. Second column, first partial paragraph. (1) Line 1, the figure “$2.293” is corrected to read “$2.316”. (2) Line 11, the figure “$0.65” is corrected to read “$0.68”.

B. Third column, last full paragraph, last line, the figure “$2.293” is corrected to read “$2.316”. 13. On page 45611, the table titled “Table V—ACCOUNTING STATEMENT. CLASSIFICATION OF ESTIMATED EXPENDITURES UNDER THE IPPS FROM FY 2021 TO FY 2022” is corrected to read as follows.

Start Printed Page 58039 CategoryTransfersAnnualized Monetized Transfers$2.316 billion.From Whom to WhomFederal Government to IPPS Medicare Providers. Start List of Subjects DiseasesHealth facilitiesMedicarePuerto RicoReporting and recordkeeping requirements End List of Subjects As noted in section II.B. Of the preamble, the Centers for Medicare &. Medicaid Services is making the following correcting amendments to 42 CFR part 413. Start Part End Part Start Amendment Part1.

The authority citation for part 413 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww. End Authority Start Amendment Part2. Amend § 413.24 by.

End Amendment Part Start Amendment Parta. In paragraph (f)(5)(i) introductory text, removing the phrase “except as provided in paragraph (f)(5)(i)(E) of this section:” and adding in its place the phrase “except as provided in paragraphs (f)(5)(i)(A)( 2 )( ii ) and (f)(5)(i)(E) of this section:”. And End Amendment Part Start Amendment Partb. Revising paragraph (f)(5)(i)(A). End Amendment Part The revision reads as follows.

Adequate cost data and cost finding. * * * * * (f) * * * (5) * * * (i) * * * (A) Teaching hospitals. For teaching hospitals, the Intern and Resident Information System (IRIS) data. ( 1 ) Data format. For cost reporting periods beginning on or after October 1, 2021, the IRIS data must be in the new XML IRIS format.

( 2 ) Resident counts. ( i ) Effective for cost reporting periods beginning on or after October 1, 2021, the IRIS data must contain the same total counts of direct GME FTE residents (unweighted and weighted) and IME FTE residents as the total counts of direct GME FTE and IME FTE residents reported in the provider's cost report. ( ii ) For cost reporting periods beginning on or after October 1, 2021, and before October 1, 2022, the cost report is not rejected if the requirement in paragraph (f)(5)(i)(A)( 2 )( i ) of this section is not met. * * * * * Start Signature Karuna Seshasai, Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information BILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-P[FR Doc.

2021-22724 Filed 10-19-21. 8:45 am]BILLING CODE 4120-01-C.

Start Preamble buy cheap kamagra oral jelly Centers for Medicare &. Medicaid Services, Health and Human Services (HHS). Notice.

The Centers for Medicare &. Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action.

Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments must be received by December 21, 2021. When commenting, please reference the document identifier or OMB control number.

To be assured consideration, comments and recommendations must be submitted in any one of the following ways. 1. Electronically.

You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2.

By regular mail. You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention.

Document Identifier/OMB Control Number. __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Start Printed Page 58665 To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following.

1. Access CMS' website address at website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N.

Parham at (410) 786-4669. End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

CMS-2567 Statement of Deficiency and Plan of Correction CMS-10790 Medicare-Funded GME Residency Positions in accordance with Section 126 of the Consolidated Appropriations Act, 2020 (Pub. L. 116-93) CMS-10463 Cooperative Agreement to Support Navigators in Federally-facilitated Exchanges Under the PRA (44 U.S.C.

3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.

Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1.

Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection.

Statement of Deficiency and Plan of Correction Use. The form CMS-2567 is the means by which State and CMS surveyors document findings of compliance or noncompliance (deficiencies) resulting from inspection of Medicare, Medicaid, and Clinical Laboratory Improvement Amendments (CLIA) laboratories. The form CMS-2567 is the legal, documentary basis for CMS' certification of a facility's compliance or noncompliance with the Medicare/Medicaid Conditions of Participation or Coverage, and the requirements for Nursing Home participation and CLIA certification.

In December, 2020, Congress passed the Consolidated Appropriations Act, 2021 (CAA, 2021). Section 407 of CAA, 2021, amended Part A of Title XVIII of the Social Security Act (the Act) at section 1822 establishing hospice program survey and enforcement requirements. This amendment, in part, now requires the Accrediting Organizations (AOs) that accredit hospice programs to include the form CMS-2567 to document the findings of their hospice program surveys beginning on October 1, 2021.

As of June 2021, there are three AOs with CMS-approved hospice accreditation programs. The AOs survey approximately half of the over 5,000 Medicare-certified hospice programs, while the SAs survey the remaining half. Form Numbers.

CMS-2567 (OMB control number. 0938-0391). Frequency.

Yearly and Occasionally. Affected Public. Private Sector (Business or for-profits and Not-for-profit institutions).

Number of Respondents. 65,948. Total Annual Responses.

(For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) 2. Type of Information Collection Request. New collection (Request for a new OMB Control Number).

Title of Information Collection. Medicare-Funded GME Residency Positions in accordance with Section 126 of the Consolidated Appropriations Act, 2020 (Pub. L.

116-93). Use. The requirements in this rule were announced in CMS-1752-P (FY22 IPPS).

However, the PRA package has been under development until now. The plan, approved by OMB and CM, is to have the 60-day publish and then have CMS-1752-F2 serve as the 30-day notice, with the goal of approval in early January 2022. Section 126 of the Consolidated Appropriations Act (CAA), 2021 (Pub.

L. 116-93), enacted December 20, 2020, included a key provision affecting Medicare payments for Graduate Medical Education (GME). Section 126(a) of the CAA amended section 1886(h) of the Act by adding a new section 1886(h)(9) requiring the distribution of additional residency positions (slots) to qualifying hospitals.

Section 1886(h)(9)(A) makes an additional 1,000 Medicare funded residency slots available to be phased in beginning in FY 2023 until the aggregate number of 1,000 full-time equivalent residency positions are distributed. This approval request is for CMS to receive electronic applications for Medicare-Funded GME Residency Positions submitted in accordance with Section 126 of the Consolidated Appropriations Act, 2021. The electronic applications will be submitted by the applicants in CMS' new Medicare Electronic Application Request Information SystemTM (MEARISTM).

There is no existing, hard copy version of the application. The applications will provide CMS with the critical information necessary for CMS to process and score the applications in accordance with the policies finalized in the upcoming final rule to determine the disbursement of the slots and to announce the awardees by the January 31, 2023 required statutory deadline. Form Number.

CMS-10790 (OMB control number. 0938-NEW). Frequency.

Yearly. Affected Public. Private sector (Business or other for-profits and Not-for-profit institutions), State, Local, or Tribal Governments.

Number of Respondents. 1,325. Total Annual Responses.

(For policy questions regarding this collection contact Noel Manlove at 410-786-5161.) 3. Type of Information Collection Request. Revision of a currently approved collection.

Title of Information Collection. Cooperative Agreement to Support Navigators in Federally-facilitated Exchanges. Use.

Section 1311(i) of the PPACA requires Exchanges to establish a Navigator grant program under which it awards grants to eligible individuals and entities (as described in Section 1311(i)(2) of the PPACA and 45 CFR 155.210(a) and (c)) applying to serve consumers in States with a FFE. Navigators assist consumers by providing education about and facilitating selection of qualified health plans (QHPs) within the Exchanges, as well as other required duties. Entities and individuals cannot serve as federally certified Navigators and carry out the required duties without receiving federal cooperative agreement funding.

On July 1, 2021, HHS published the Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond Proposed Rule proposed rule. The proposed regulations would amend federal regulations at 45 CFR 155.210(e)(9) to reinstitute the requirement that FFE Navigators provide consumers with information and assistance on access, affordability and certain post-enrollment topics, such Start Printed Page 58666 as the eligibility appeals process, the Exchange-related components of the Premium Tax Credit (PTC) reconciliation process, and the basic concepts and rights of health coverage and how to use it. Under the Terms and Conditions of the Navigator program cooperative agreements, awardees must provide progress reports on a weekly, monthly, quarterly and annual basis during the cooperative agreement period of performance, and a final report at the end of the period of performance.

Awardees will submit their progress reports electronically to CMS staff for evaluation and analysis. The results of this evaluation will provide feedback on the effectiveness of the Navigator program, so that HHS and CMS leadership may evaluate the effectiveness of the program and address any areas that need revisions. CMS will also use the information collected from Navigator grant awardees to inform the public about the availability of application and enrollment assistance services from designated organizations.

Form Number. CMS-10463 (OMB control number. 0938-1215).

Frequency. Annually, Monthly, Quarterly, Weekly. Affected Public.

Total Annual Responses. 5,200. Total Annual Hours.

529,000. (For questions regarding this collection contact Gian Johnson at 301-492-4323.) Start Signature Dated. October 19, 2021.

William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. End Signature End Supplemental Information [FR Doc.

2021-23107 Filed 10-21-21. 8:45 am]BILLING CODE 4120-01-PStart Preamble Start Printed Page 58019 Centers for Medicare &. Medicaid Services (CMS), Department of Health and Human Services (HHS).

Final rule. Correction and correcting amendment. This document corrects technical and typographical errors in the final rule that appeared in the August 13, 2021, issue of the Federal Register titled “Medicare Program.

Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates. Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals. Changes to Medicaid Provider Enrollment.

And Changes to the Medicare Shared Savings Program.”   Effective date. The final rule corrections and correcting amendment are effective on October 19, 2021. Applicability date.

The final rule corrections and correcting amendment are applicable to discharges occurring on or after October 1, 2021. Start Further Info Donald Thompson, (410) 786-4487, and Michele Hudson, (410) 786-4487, Operating Prospective Payment, Wage Index, Hospital Geographic Reclassifications, Medicare Disproportionate Share Hospital (DSH) Payment Adjustment, Graduate Medical Education, and Critical Access Hospital (CAH) Issues. Mady Hue, (410) 786-4510, and Andrea Hazeley, (410) 786-3543, MS-DRG Classification Issues.

Allison Pompey, (410) 786-2348, New Technology Add-On Payments Issues. Julia Venanzi, julia.venanzi@cms.hhs.gov, Hospital Inpatient Quality Reporting and Hospital Value-Based Purchasing Programs. End Further Info End Preamble Start Supplemental Information I.

Background In FR Doc. 2021-16519 of August 13, 2021 (86 FR 44774), there were a number of technical and typographical errors that are identified and corrected in this final rule correction and correcting amendment. The final rule corrections and correcting amendment are applicable to discharges occurring on or after October 1, 2021, as if they had been included in the document that appeared in the August 13, 2021, Federal Register.

II. Summary of Errors A. Summary of Errors in the Preamble On page 44878, we are correcting an inadvertent error in the reference to the number of technologies for which we proposed to allow a one-time extension of new technology add-on payments for fiscal year (FY) 2022.

On page 44889, we are correcting an inadvertent typographical error in the International Classification of Disease, 10th Revision, Procedure Coding System (ICD-10-PCS) procedure code describing the percutaneous endoscopic repair of the esophagus. On page 44960, in the table displaying the Medicare-Severity Diagnosis Related Groups (MS-DRGs) subject to the policy for replaced devices offered without cost or with a credit for FY 2022, we are correcting inadvertent typographical errors in the MS-DRGs describing Hip Replacement with Principal Diagnosis of Hip Fracture with and without MCC, respectively. On pages 45047, 45048, and 45049, in our discussion of the new technology add-on payments for FY 2022, we are correcting typographical and technical errors in referencing sections of the final rule.

On page 45133, we are correcting an error in the maximum new technology add-on payment for a case involving the use of AprevoTM Intervertebral Body Fusion Device. On page 45150, we inadvertently omitted ICD-10-CM codes from the list of diagnosis codes used to identify cases involving the use of the INTERCEPT Fibrinogen Complex that would be eligible for new technology add-on payments. On page 45157, we inadvertently omitted the ICD-10-CM diagnosis codes used to identify cases involving the use of FETROJA® for HABP/VABP.

On page 45158, we inadvertently omitted the ICD-10-CM diagnosis codes used to identify cases involving the use of RECARBRIOTM for HABP/VABP. On pages 45291, 45293, and 45294, in three tables that display previously established, newly updated, and estimated performance standards for measures included in the Hospital Value-Based Purchasing Program, we are correcting errors in the numerical values for all measures in the Clinical Outcomes Domain that appear in the three tables. On page 45312, in our discussion of payments for indirect and direct graduate medical education costs and Intern and Resident Information System (IRIS) data, we made a typographical error in our response to a comment.

On page 45386, we made an inadvertent typographical error in our discussion of the Hospital Inpatient Quality Reporting (IQR) Program Severe Hyperglycemia electronic clinical quality measure (eCQM). On page 45400, in our discussion of the Hospital Inpatient Quality Reporting (IQR) Program measures for fiscal year (FY) 2024, we mislabeled the table title and inadvertently included a measure not pertaining to the FY 2024 payment determination along with its corresponding footnote. On page 45404, in our discussion the Hospital Inpatient Quality Reporting (IQR) Program, we included a table with the measures for the FY 2025 payment determination.

In the notes that immediately followed the table, we made a typographical error in the date associated with the voluntary reporting period for the Hybrid Hospital-Wide All-Cause Risk Standardized Mortality (HWM) measure. B. Summary of Errors in the Regulations Text On page 45521, in the regulations text for § 413.24(f)(5)(i) introductory text and (f)(5)(i)(A) regarding cost reporting forms and teaching hospitals, we inadvertently omitted revisions that were discussed in the preamble.

C. Summary of Errors in the Addendum In the FY 2022 Hospital Inpatient Prospective Payment Systems and Long-Term Care Hospital Prospective Payment System (IPPS/LTCH PPS) final rule (85 FR 45166), we stated that we excluded the wage data for critical access hospitals (CAHs) as discussed in the FY 2004 IPPS final rule (68 FR 45397 through 45398). That is, any hospital that is designated as a CAH by 7 days prior to the publication of the preliminary wage index public use file (PUF) is excluded from the calculation Start Printed Page 58020 of the wage index.

We inadvertently excluded a hospital that converted to CAH status after January 24, 2021, the cut-off date for CAH exclusion from the FY 2022 wage index. (CMS Certification Number (CCN) 230118) Therefore, we restored the wage data for this hospital and included it in our calculation of the wage index. This correction necessitated the recalculation of the FY 2022 wage index for rural Michigan (rural state code 23), as reflected in Table 3, and affected the final FY 2022 wage index for rural Michigan 23 as well as the rural floor for the State of Michigan.

As discussed in this section, the final FY 2022 IPPS wage index is used when determining total payments for purposes of all budget neutrality factors (except for the MS-DRG reclassification and recalibration budget neutrality factor) and the final outlier threshold. We note, in the final rule, we correctly listed the number of hospitals with CAH status removed from the FY 2022 wage index (86 FR 45166), the number of hospitals used for the FY 2022 wage index (86 FR 45166) and the number of hospital occupational mix surveys used for the FY 2022 wage index (86 FR 45173). Additionally, the FY 2022 national average hourly wage (unadjusted for occupational mix) (86 FR 45172), the FY 2022 occupational mix adjusted national average hourly wage (86 FR 45173), and the FY 2022 national average hourly wages for the occupational mix nursing subcategories (86 FR 45174) listed in the final rule remain unchanged.

Because the numbers and values noted previously are correctly stated in the preamble of the final rule and remain unchanged, we do not include any corrections in section IV.A. Of this final rule correction and correcting amendment. We made an inadvertent error in the Medicare Geographic Classification Review Board (MGCRB) reclassification status of one hospital in the FY 2022 IPPS/LTCH PPS final rule.

Specifically, CCN 360259 is incorrectly listed in Table 2 as reclassified to CBSA 19124. The correct reclassification area is to its geographic “home” of CBSA 45780. This correction necessitated the recalculation of the FY 2022 wage index for CBSA 19124 and affected the final FY 2022 wage index with reclassification.

The final FY 2022 IPPS wage index with reclassification is used when determining total payments for purposes of all budget neutrality factors (except for the MS-DRG reclassification and recalibration budget neutrality factor and the wage index budget neutrality adjustment factor) and the final outlier threshold. As discussed further in section II.E. Of this final rule correction and correcting amendment, we made updates to the calculation of Factor 3 of the uncompensated care payment methodology to reflect updated information on hospital mergers received in response to the final rule and made corrections for report upload errors.

Factor 3 determines the total amount of the uncompensated care payment a hospital is eligible to receive for a fiscal year. This hospital-specific payment amount is then used to calculate the amount of the interim uncompensated care payments a hospital receives per discharge. Per discharge uncompensated care payments are included when determining total payments for purposes of all of the budget neutrality factors and the final outlier threshold.

As a result, the revisions made to the calculation of Factor 3 to address additional merger information and report upload errors directly affected the calculation of total payments and required the recalculation of all the budget neutrality factors and the final outlier threshold. Due to the correction of the combination of errors that are discussed previously (correcting the number of hospitals with CAH status, the correction to the MGCRB reclassification status of one hospital, and the revisions to Factor 3 of the uncompensated care payment methodology), we recalculated all IPPS budget neutrality adjustment factors, the fixed-loss cost threshold, the final wage indexes (and geographic adjustment factors (GAFs)), the national operating standardized amounts and capital Federal rate. We note that the fixed-loss cost threshold was unchanged after these recalculations.

Therefore, we made conforming changes to the following. On page 45532, the table titled “Summary of FY 2022 Budget Neutrality Factors”. On page 45537, the estimated total Federal capital payments and the estimated capital outlier payments.

On pages 45542 and 45543, the calculation of the outlier fixed-loss cost threshold, total operating Federal payments, total operating outlier payments, the outlier adjustment to the capital Federal rate and the related discussion of the percentage estimates of operating and capital outlier payments. On page 45545, the table titled “Changes from FY 2021 Standardized Amounts to the FY 2022 Standardized Amounts”. On pages 45553 through 45554, in our discussion of the determination of the Federal hospital inpatient capital related prospective payment rate update, due to the recalculation of the GAFs, we have made conforming corrections to the capital Federal rate.

As a result of these changes, we also made conforming corrections in the table showing the comparison of factors and adjustments for the FY 2021 capital Federal rate and FY 2022 capital Federal rate. As we noted in the final rule, the capital Federal rate is calculated using unrounded budget neutrality and outlier adjustment factors. The unrounded GAF/DRG budget neutrality factor, the unrounded Quartile/Cap budget neutrality factor, and the unrounded outlier adjustment to the capital Federal rate were revised because of these errors.

However, after rounding these factors to 4 decimal places as displayed in the final rule, the rounded factors were unchanged from the final rule. On pages 45570 and 45571, we are making conforming corrections to the national adjusted operating standardized amounts and capital standard Federal payment rate (which also include the rates payable to hospitals located in Puerto Rico) in Tables 1A, 1B, 1C, and 1D as a result of the conforming corrections to certain budget neutrality factors, as previously described. D.

Summary of Errors in the Appendices On pages 45576 through 45580, 45582 through 45583, and 45598 through 45600, in our regulatory impact analyses, we have made conforming corrections to the factors, values, and tables and accompanying discussion of the changes in operating and capital IPPS payments for FY 2022 and the effects of certain IPPS budget neutrality factors as a result of the technical errors that lead to changes in our calculation of the operating and capital IPPS budget neutrality factors, outlier threshold, final wage indexes, operating standardized amounts, and capital Federal rate (as described in section II.C. Of this final rule correction and correcting amendment). These conforming corrections include changes to the following.

On pages 45576 through 45578, the table titled “Table I—Impact Analysis of Changes to the IPPS for Operating Costs for FY 2022”. On pages 45582 and 45583, the table titled “Table II—Impact Analysis of Changes for FY 2022 Acute Care Hospital Operating Prospective Payment System (Payments per discharge)”. • On pages 45599 and 45600, the table titled “Table III—Comparison of Start Printed Page 58021 Total Payments per Case [FY 2021 Payments Compared to FY 2022 Payments]”.

On pages 45584 and 45585 we are correcting the maximum new-technology add-on payment for a case involving the use of Fetroja, Recarbrio, Tecartus, and Abecma and related information in the untitled tables as well as making conforming corrections to the total estimated FY 2022 payments in the accompanying discussion of applications approved or conditionally approved for new technology add-on payments. On pages 45587 through 45589, we are correcting the discussion of the “Effects of the Changes to Medicare DSH and Uncompensated Care Payments for FY 2022” for purposes of the Regulatory Impact Analysis in Appendix A of the FY 2022 IPPS/LTCH PPS final rule, including the table titled “Modeled Uncompensated Care Payments for Estimated FY 2022 DSHs by Hospital Type. Uncompensated Care Payments ($ in Millions)*—from FY 2021 to FY 2022”, in light of the corrections discussed in section II.E.

Of this final rule correction and correcting amendment. On pages 45610 and 45611, we are making conforming corrections to the estimated expenditures under the IPPS as a result of the corrections to the maximum new technology add-on payment for a case involving the use of AprevoTM Intervertebral Body Fusion Device, Fetroja, Recarbrio, Abecma, and Tecartus as described in this section and in section II.A. Of this final rule correction and correcting amendment.

E. Summary of Errors in and Corrections to Files and Tables Posted on the CMS Website We are correcting the errors in the following IPPS tables that are listed on pages 45569 and 45570 of the FY 2022 IPPS/LTCH PPS final rule and are available on the internet on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​AcuteInpatientPPS/​index.html. The tables that are available on the internet have been updated to reflect the revisions discussed in this final rule correction and correcting amendment.

Table 2—Case-Mix Index and Wage Index Table by CCN-FY 2022 Final Rule. As discussed in section II.C. Of this final rule correction and correcting amendment, we inadvertently excluded a hospital that converted to CAH status after January 24, 2021, the cut-off date for CAH exclusion from the FY 2022 wage index.

(CMS Certification Number (CCN) 230118). Therefore, we restored provider 230118 to the table. Also, as discussed in section II.C.

Of this final rule correction and correcting amendment, CCN 360259 is incorrectly listed as reclassified to CBSA 19124. The correct reclassification area is to its geographic “home” of CBSA 45780. In this table, we are correcting the columns titled “Wage Index Payment CBSA” and “MGCRB Reclass” to accurately reflect its reclassification to CBSA 45780.

This correction necessitated the recalculation of the FY 2022 wage index for CBSA 19124. As also discussed later in this section, because the wage indexes are one of the inputs used to determine the out-migration adjustment, some of the out-migration adjustments changed. Therefore, we are making corresponding changes to the affected values.

Table 3.—Wage Index Table by CBSA—FY 2022 Final Rule. As discussed in section II.C. Of this final rule correction and correcting amendment, we inadvertently excluded a hospital that converted to CAH status after January 24, 2021, the cut-off date for CAH exclusion from the FY 2022 wage index.

(CMS Certification Number (CCN) 230118). Therefore, we recalculated the wage index for rural Michigan (rural state code 23), as reflected in Table 3, as well as the rural floor for the State of Michigan. Also, as discussed in section II.C.

Of this final rule correction and correcting amendment, CCN 360259 is incorrectly listed as reclassified to CBSA 19124. The correct reclassification area is to its geographic “home” of CBSA 45780. In this table, we are correcting the values that changed as a result of these corrections as well as any corresponding changes.

Table 4A.—List of Counties Eligible for the Out-Migration Adjustment under Section 1886(d)(13) of the Act—FY 2022 Final Rule. As discussed in section II.C. Of this final rule correction and correcting amendment, we inadvertently excluded a hospital that converted to CAH status after January 24, 2021, the cut-off date for CAH exclusion from the FY 2022 wage index.

(CMS Certification Number (CCN) 230118). Also, as discussed in section II.C. Of this final rule correction and correcting amendment, CCN 360259 is incorrectly listed as reclassified to CBSA 19124.

The correct reclassification area is to its geographic “home” of CBSA 45780. As a result, as discussed previously, we are making changes to the FY 2022 wage indexes. Because the wage indexes are one of the inputs used to determine the out-migration adjustment, some of the out-migration adjustments changed.

Therefore, we are making corresponding changes to some of the out-migration adjustments listed in Table 4A. Table 6B.—New Procedure Codes—FY 2022. We are correcting this table to reflect the assignment of procedure codes XW033A7 (Introduction of ciltacabtagene autoleucel into peripheral vein, percutaneous approach, new technology group 7) and XW043A7 (Introduction of ciltacabtagene autoleucel into central vein, percutaneous approach, new technology group 7) to Pre-MDC MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell and Other Immunotherapies).

Table 6B inadvertently omitted Pre-MDC MS-DRG 018 in Column E (MS-DRG) for assignment of these codes. Effective with discharges on and after April 1, 2022, conforming changes will be reflected in the Version 39.1 ICD-10 MS-DRG Definitions Manual and ICD-10 MS-DRG Grouper and Medicare Code Editor software. Table 6P.—ICD-10-CM and ICD-10-PCS Codes for MS-DRG Changes—FY 2022.

We are correcting Table 6P.1d associated with the final rule to reflect three procedure codes submitted by the requestor that were inadvertently omitted, resulting in 79 procedure codes listed instead of 82 procedure codes as indicated in the final rule (see pages 44808 and 44809). Table 18.—Final FY 2022 Medicare DSH Uncompensated Care Payment Factor 3. For the FY 2022 IPPS/LTCH PPS final rule, we published a list of hospitals that we identified to be subsection (d) hospitals and subsection (d) Puerto Rico hospitals projected to be eligible to receive interim uncompensated care payments for FY 2022.

As stated in the FY 2022 IPPS/LTCH PPS final rule (86 FR 45249), we allowed the public an additional period after the issuance of the final rule to review and submit comments on the accuracy of the list of mergers that we identified in the final rule. Based on the comments received during this additional period, we are updating this table to reflect the merger information received in response to the final rule and to revise the Factor 3 calculations for purposes of determining uncompensated care payments for the FY 2022 IPPS/LTCH PPS final rule. We are revising Factor 3 for all hospitals to reflect the updated merger information received in response to the final rule.

We are also revising the amount of the total uncompensated care payment calculated for each DSH eligible hospital. The total uncompensated care payment that a hospital receives is used to calculate the amount of the interim uncompensated care payments the hospital receives per discharge. Start Printed Page 58022 accordingly, we have also revised these amounts for all DSH eligible hospitals.

These corrections will be reflected in Table 18 and the Medicare DSH Supplemental Data File. Per discharge uncompensated care payments are included when determining total payments for purposes of all of the budget neutrality factors and the final outlier threshold. As a result, these corrections to uncompensated care payments required the recalculation of all the budget neutrality factors as well as the outlier fixed-loss cost threshold.

We note that the fixed-loss cost threshold was unchanged after these recalculations. In section IV.C. Of this final rule correction and correcting amendment, we have made corresponding revisions to the discussion of the “Effects of the Changes to Medicare DSH and Uncompensated Care Payments for FY 2022” for purposes of the Regulatory Impact Analysis in Appendix A of the FY 2022 IPPS/LTCH PPS final rule to reflect the corrections discussed previously and to correct minor typographical errors.

The files that are available on the internet have been updated to reflect the corrections discussed in this final rule correction and correcting amendment. In addition, we are correcting the inadvertent omission of the following 32 ICD-10-PCS codes describing percutaneous cardiovascular procedures involving one, two, three or four arteries from the GROUPER logic for MS-DRG 246 (Percutaneous Cardiovascular Procedures with Drug-Eluting Stent with MCC or 4+ Arteries or Stents) and MS-DRG 248 (Percutaneous Cardiovascular Procedures with Non-Drug-Eluting Stent with MCC or 4+ Arteries or Stents). ICD-10-PCS codeDescription02703Z6Dilation of coronary artery, one artery, bifurcation, percutaneous approach.02703ZZDilation of coronary artery, one artery, percutaneous approach.02704Z6Dilation of coronary artery, one artery, bifurcation, percutaneous endoscopic approach.02704ZZDilation of coronary artery, one artery, percutaneous endoscopic approach.02C03Z6Extirpation of matter from coronary artery, one artery, bifurcation, percutaneous approach.02C03ZZExtirpation of matter from coronary artery, one artery, percutaneous approach.02C04Z6Extirpation of matter from coronary artery, one artery, bifurcation, percutaneous endoscopic approach.02C04ZZExtirpation of matter from coronary artery, one artery, percutaneous endoscopic approach.02713Z6Dilation of coronary artery, two arteries, bifurcation, percutaneous approach.02713ZZDilation of coronary artery, two arteries, percutaneous approach.02714Z6Dilation of coronary artery, two arteries, bifurcation, percutaneous endoscopic approach.02714ZZDilation of coronary artery, two arteries, percutaneous endoscopic approach.02C13Z6Extirpation of matter from coronary artery, two arteries, bifurcation, percutaneous approach.02C13ZZExtirpation of matter from coronary artery, two arteries, percutaneous approach.02C14Z6Extirpation of matter from coronary artery, two arteries, bifurcation, percutaneous endoscopic approach.02C14ZZExtirpation of matter from coronary artery, two arteries, percutaneous endoscopic approach.02723Z6Dilation of coronary artery, three arteries, bifurcation, percutaneous approach.02723ZZDilation of coronary artery, three arteries, percutaneous approach.02724Z6Dilation of coronary artery, three arteries, bifurcation, percutaneous endoscopic approach.02724ZZDilation of coronary artery, three arteries, percutaneous endoscopic approach.02C23Z6Extirpation of matter from coronary artery, three arteries, bifurcation, percutaneous approach.02C23ZZExtirpation of matter from coronary artery, three arteries, percutaneous approach.02C24Z6Extirpation of matter from coronary artery, three arteries, bifurcation, percutaneous endoscopic approach.02C24ZZExtirpation of matter from coronary artery, three arteries, percutaneous endoscopic approach.02733Z6Dilation of coronary artery, four or more arteries, bifurcation, percutaneous approach.02733ZZDilation of coronary artery, four or more arteries, percutaneous approach.02734Z6Dilation of coronary artery, four or more arteries, bifurcation, percutaneous endoscopic approach.02734ZZDilation of coronary artery, four or more arteries, percutaneous endoscopic approach.02C33Z6Extirpation of matter from coronary artery, four or more arteries, bifurcation, percutaneous approach.02C33ZZExtirpation of matter from coronary artery, four or more arteries, percutaneous approach.02C34Z6Extirpation of matter from coronary artery, four or more arteries, bifurcation, percutaneous endoscopic approach.02C34ZZExtirpation of matter from coronary artery, four or more arteries, percutaneous endoscopic approach.

We have corrected the ICD-10 MS-DRG Definitions Manual Version 39 and the ICD-10 MS-DRG GROUPER and MCE Version 39 Software to correctly reflect the inclusion of these codes in the arterial logic lists for MS-DRGs 246 and 248 for FY 2022. III. Waiver of Proposed Rulemaking and Delay in Effective Date Under 5 U.S.C.

553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rulemaking in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rulemaking in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule.

Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements. In cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest.

In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support. We believe that this final rule correction and correcting amendment does not constitute a rule that would be subject to the notice and comment or Start Printed Page 58023 delayed effective date requirements. This document corrects technical and typographical errors in the preamble, regulations text, addendum, payment rates, tables, and appendices included or referenced in the FY 2022 IPPS/LTCH PPS final rule, but does not make substantive changes to the policies or payment methodologies that were adopted in the final rule.

As a result, this final rule correction and correcting amendment is intended to ensure that the information in the FY 2022 IPPS/LTCH PPS final rule accurately reflects the policies adopted in that document. In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the FY 2022 IPPS/LTCH PPS final rule accurately reflects our policies.

Furthermore, such procedures would be unnecessary, as we are not altering our payment methodologies or policies, but rather, we are simply implementing correctly the methodologies and policies that we previously proposed, requested comment on, and subsequently finalized. This final rule correction and correcting amendment is intended solely to ensure that the FY 2022 IPPS/LTCH PPS final rule accurately reflects these payment methodologies and policies. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements.

Moreover, even if these corrections were considered to be retroactive rulemaking, they would be authorized under section 1871(e)(1)(A)(ii) of the Act, which permits the Secretary to issue a rule for the Medicare program with retroactive effect if the failure to do so would be contrary to the public interest. As we have explained previously, we believe it would be contrary to the public interest not to implement the corrections in this final rule correction and correcting amendment because it is in the public's interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the FY 2022 IPPS/LTCH PPS final rule accurately reflects our policies. IV.

Correction of Errors In FR Doc. 2021-16519 of August 13, 2021 (86 FR 44774), we are making the following corrections. A.

Correction of Errors in the Preamble 1. On page 44878, second column, last paragraph, line 10, “15 technologies” is corrected to read “technologies.” 2. On page 44889, lower two-thirds of the page, third column, partial paragraph, line 10, the procedure code “0DQ540ZZ” is corrected to read “0DQ54ZZ.” 3.

On page 44960, in the untitled table, last 2 lines are corrected to read as follows. MDCMS-DRGMS-DRG title *         *         *         *         *         *         *08521Hip Replacement with Principal Diagnosis of Hip Fracture with MCC.08522Hip Replacement with Principal Diagnosis of Hip Fracture without MCC. 4.

On page 45047. A. Second column, first full paragraph, lines 21 through 24, the sentence “We summarize comments related to this comment solicitation and provide our responses as well as our finalized policy in section XXX of this final rule.” is corrected to read “We summarize comments related to this comment solicitation and provide our responses in section II.F.7.

Of the preamble of this final rule.”. B. Third column, first full paragraph, line 28, the reference “section XXX” is corrected to read “section II.F.8.”.

5. On page 45048, second column, second full paragraph, lines 20 through 24, the sentence “We summarize comments related to this comment solicitation and provide our responses as well as our finalized policy in section XXX of this final rule.” is corrected to read “We summarize comments related to this comment solicitation and provide our responses in section II.F.7. Of the preamble of this final rule.”.

Second column. (1) First full paragraph, line 12, the reference, “section XXX of this final rule” is corrected to read “section II.F.8. Of the preamble of this final rule”.

(2) Second full paragraph, lines 1 and 2, the reference, “section XXX of this final rule” is corrected to read “section II.F.7. J95.851 (Ventilator associated pneumonia) and one of the following. B96.1 (Klebsiella pneumoniae [K.

Pneumoniae] as the cause of diseases classified elsewhere), B96.20 (Unspecified Escherichia coli [E. Coli] as the cause of diseases classified elsewhere), B96.21 (Shiga toxin-producing Escherichia coli [E. Coli] [STEC] O157 as the cause of diseases classified elsewhere), B96.22 (Other specified Shiga toxin-producing Escherichia coli [E.

Coli] [STEC] as the cause of diseases classified elsewhere), B96.23 (Unspecified Shiga toxin-producing Escherichia coli [E. Coli] [STEC] as the cause of diseases classified elsewhere, B96.29 (Other Escherichia coli [E. Coli] as the cause of diseases classified elsewhere), B96.3 (Hemophilus influenzae [H.

Influenzae] as the cause of diseases classified elsewhere, B96.5 (Pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere), or B96.89 (Other specified bacterial agents as the cause of diseases classified elsewhere) for VABP.” 10. On page 45158, third column, first partial paragraph, last line the phrase, “technology group 5).” is corrected to read “technology group 5) in combination with the following ICD-10-CM codes. Y95 (Nosocomial condition) and one of the following.

J14.0 (Pneumonia due to Hemophilus influenzae) J15.0 (Pneumonia due to Klebsiella pneumoniae), J15.1 (Pneumonia due to Pseudomonas), J15.5 (Pneumonia due to Escherichia coli), J15.6 (Pneumonia due to other Gram-negative bacteria), or J15.8 (Pneumonia due to other specified bacteria) for HABP and ICD10-PCS codes. XW033A6 (Introduction of cefiderocol antinfective into peripheral vein, percutaneous approach, new technology group 6) or XW043A6 (Introduction of cefiderocol anti-infective into central vein, percutaneous approach, new technology group 6) in combination with the following ICD-10-CM codes. J95.851 (Ventilator associated pneumonia) and one of the following.

B96.1 (Klebsiella pneumoniae [K. Pneumoniae] as the cause of diseases classified elsewhere), B96.20 (Unspecified Escherichia coli [E. Coli] as the cause of diseases classified elsewhere), B96.21 (Shiga toxin-producing Escherichia coli [E.

Coli] Start Printed Page 58024 [STEC] O157 as the cause of diseases classified elsewhere), B96.22 (Other specified Shiga toxin-producing Escherichia coli [E. Coli] [STEC] as the cause of diseases classified elsewhere), B96.23 (Unspecified Shiga toxin-producing Escherichia coli [E. Coli] [STEC] as the cause of diseases classified elsewhere, B96.29 (Other Escherichia coli [E.

Coli] as the cause of diseases classified elsewhere), B96.3 (Hemophilus influenzae [H. Influenzae] as the cause of diseases classified elsewhere, B96.5 (Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere), or B96.89 (Other specified bacterial agents as the cause of diseases classified elsewhere) for VABP.” 11. On page 45291, middle of the page, the table titled “Table V.H-11.

Previously Established and Newly Updated Performance Standards for the FY 2024 Program Year” is corrected to read as follows. Table V.H-11—Previously Established and Estimated Performance Standards for the FY 2024 Program YearMeasure short nameAchievement thresholdBenchmarkClinical Outcomes DomainMORT-30-AMI #0.8692470.887868MORT-30-HF #0.8823080.907773MORT-30-PN (updated cohort) #0.8402810.872976MORT-30-COPD #0.9164910.934002MORT-30-CABG #0.9694990.980319COMP-HIP-KNEE * #0.0253960.018159♢  As discussed in section V.H.4.b. Of this final rule, we are finalizing the updates to the FY 2024 baseline periods for measures included in the Person and Community Engagement, Safety, and Efficiency and Cost Reduction domains to use CY 2019.

Therefore, the performance standards displayed in this table for the Safety domain measures were calculated using CY 2019 data.* Lower values represent better performance.#  Previously established performance standards. 12. On page 45293, top of the page, the table titled “V.H-13 Previously Established and Estimated Performance Standards for the FY 2025 Program Year” is corrected to read as follows.

Table V.H-13—Previously Established and Estimated Performance Standards for the FY 2025 Program YearMeasure short nameAchievement thresholdBenchmarkClinical Outcomes DomainMORT-30-AMI #0.8726240.889994MORT-30-HF #0.8839900.910344MORT-30-PN (updated cohort) #0.8414750.874425MORT-30-COPD #0.9151270.932236MORT-30-CABG #0.9701000.979775COMP-HIP-KNEE * #0.0253320.017946* Lower values represent better performance.#  Previously established performance standards. 13. On page 45294, top of page, the table titled “V.H-14 Previously Established and Estimated Performance Standards for the FY 2026 Program Year” is corrected to read as follows.

Table V.H-14—Previously Established and Estimated Performance Standards for the FY 2026 Program YearMeasure short nameAchievement thresholdBenchmarkClinical Outcomes DomainMORT-30-AMI #0.8744260.890687MORT-30-HF #0.8859490.912874MORT-30-PN (updated cohort) #0.8433690.877097MORT-30-COPD #0.9146910.932157MORT-30-CABG #0.9705680.980473COMP-HIP-KNEE * #0.0240190.016873* Lower values represent better performance. Start Printed Page 58025#  Previously established performance standards. 14.

On page 45312, second column, first full paragraph, lines 7 through 9, the phrase “rejection of the cost report if the submitted IRIS GME and IME FTEs do match” is corrected to read “rejection of the cost report if the submitted IRIS GME and IME FTEs do not match”. 15. On page 45386, third column, first full paragraph, line 12, the phrase “mellitus and who either” is corrected to read “mellitus, who”.

16. On page 45400, top of the page, the table titled “Measures for the FY 2024 Payment Determination and Subsequent Years”, is corrected by— a. Correcting the title to read “Measures for the FY 2023 Payment Determination and Subsequent Years”.

B. Removing the heading “Claims and Electronic Data Measures” and the entry “Hybrid HWR**” (rows 20 and 21). C.

Following the table, lines 3 through 8, removing the second table note. 17. On page 45404, bottom of the page, after the table titled “Measures for the FY 2025 Payment Determination and Subsequent Years”, in the third note to the table, line 10, the parenthetical phrase “(July 1, 2023-June 30, 2023)” is corrected to read “(July 1, 2022-June 30, 2023)”.

B. Correction of Errors in the Addendum 1. On page 45532, bottom of the page, the table titled “Summary of FY 2022 Budget Neutrality Factors” is corrected to read as follows.

Summary of FY 2022 Budget Neutrality FactorsMS-DRG Reclassification and Recalibration Budget Neutrality Factor1.000107Wage Index Budget Neutrality Factor1.000715Reclassification Budget Neutrality Factor0.986741*Rural Floor Budget Neutrality Factor0.992868Rural Demonstration Budget Neutrality Factor0.999361Low Wage Index Hospital Policy Budget Neutrality Factor0.998029Transition Budget Neutrality Factor0.999859* The rural floor budget neutrality factor is applied to the national wage indexes while the rest of the budget neutrality adjustments are applied to the standardized amounts. 2. On page 45537, first column, first full paragraph, lines 4 through 10, the parenthetical phrase “(estimated capital outlier payments of $ 430,689,396 divided by (estimated capital outlier payments of $430,689,396 plus the estimated total capital Federal payment of $7,676,990,253)).” is corrected to read “(estimated capital outlier payments of $430,698,533 divided by (estimated capital outlier payments of $430,698,533 plus the estimated total capital Federal payment of $7,676,964,386)).”.

3. On page 45542, third column, last paragraph, lines 23 and 24, the figure “$5,326,356,951” is corrected to read “$5,326,379,560”. 4.

On page 45543. A. Top of the page, first column, first partial paragraph.

(1) Line 1, the figure “$100,164,666,975” is corrected to read “$100,165,281,272”. (2) Line 17, the figure “$31,108” is corrected to read “$31,109”. B.

Middle of the page, the untitled table is corrected to read as follows. €ƒOperating standardized amountsCapital Federal rate *National0.9490.947078* The adjustment factor for the capital Federal rate includes an adjustment to the estimated percentage of FY 2022 capital outlier payments for capital outlier reconciliation, as discussed previously and in section III. A.

2 in the Addendum of this final rule. 5. On page 45545, the table titled “CHANGES FROM FY 2021 STANDARDIZED AMOUNTS TO THE FY 2022 STANDARDIZED AMOUNTS” is corrected to read as follows.

Start Printed Page 58026 6. On page 45553, second column, last paragraph, line 9, the figure “$472.60” is corrected to read “$472.59”. 7.

On page 45554, top of the page, in the table titled “COMPARISON OF FACTORS AND ADJUSTMENTS. FY 2021 CAPITAL FEDERAL RATE AND THE FY 2022 CAPITAL FEDERAL RATE”, the list entry (row 5) is corrected to read as follows. Comparison of Factors and Adjustments.

FY 2021 Capital Federal Rate and the FY 2022 Capital Federal Rate FY 2021FY 2022ChangePercent change *         *         *         *         *         *         *Capital Federal Rate$466.21$472.591.01374  1.37 8. On page 45570. A.

The table titled “TABLE 1A.—NATIONAL ADJUSTED OPERATING STANDARDIZED AMOUNTS, LABOR/NONLABOR (67.6 PERCENT LABOR SHARE/32.4 PERCENT NONLABOR SHARE IF WAGE INDEX IS GREATER THAN 1)—FY 2022” is corrected to read as follows. Table 1A—National Adjusted Operating Standardized Amounts, Labor/Nonlabor (67.6 Percent Labor Share/32.4 Percent Nonlabor Share if Wage Index Is Greater Than 1)—FY 2022Hospital submitted quality data and is a meaningful EHR user (update = 2.0 percent)Hospital submitted quality data and is not a meaningful EHR user (update = −0.025 percent)Hospital did not submit quality data and is a meaningful EHR user (update = 1.325 percent)Hospital did not submit quality data and is not a meaningful EHR user (update = −0.7 percent)LaborNonlaborLaborNonlaborLaborNonlaborLaborNonlabor$4,138.24$1,983.41$4,056.08$1,944.03$4,110.85$1,970.28$4,028.70$1,930.91 Start Printed Page 58027 b. The table titled “TABLE 1B.—NATIONAL ADJUSTED OPERATING STANDARDIZED AMOUNTS, LABOR/NONLABOR (62 PERCENT LABOR SHARE/38 PERCENT NONLABOR SHARE IF WAGE INDEX IS LESS THAN OR EQUAL TO 1)—FY 2022” is corrected to read as follows.

Table 1B—National Adjusted Operating Standardized Amounts, Labor/Nonlabor (62 Percent Labor Share/38 Percent Nonlabor Share if Wage Index is Less Than or Equal to 1)—FY 2022Hospital submitted quality data and is a meaningful EHR user (update = 2.0 percent)Hospital submitted quality data and is not a meaningful EHR user (update = −0.025 percent)Hospital did not submit quality data and is a meaningful EHR user (update = 1.325 percent)Hospital did not submit quality data and is not a meaningful EHR user (update = −0.7 percent)LaborNonlaborLaborNonlaborLaborNonlaborLaborNonlabor$3,795.42$2,326.23$3,720.07$2,280.04$3,770.30$2,310.83$3,694.96$2,264.65 9. On page 45571, the top of page. A.

The table titled “Table 1C.—ADJUSTED OPERATING STANDARDIZED AMOUNTS FOR HOSPITALS IN PUERTO RICO, LABOR/NONLABOR (NATIONAL. 62 PERCENT LABOR SHARE/38 PERCENT NONLABOR SHARE BECAUSE WAGE INDEX IS LESS THAN OR EQUAL TO 1)—FY 2022” is corrected to read as follows. Table 1C—Adjusted Operating Standardized Amounts for Hospitals in Puerto Rico, Labor/Nonlabor (National.

62 Percent Labor Share/38 Percent Nonlabor Share Because Wage Index Is Less Than or Equal to 1)—FY 2022 Rates if wage index greater than 1Hospital is a meaningful EHR user and wage index less than or equal to 1 (update = 2.0)Hospital is NOT a meaningful EHR user and wage index less than or equal to 1 (update = 1.325)LaborNonlaborLaborNonlaborLaborNonlabor1  NationalNot ApplicableNot Applicable$3,795.42$2,326.23$3,770.30$2,310.831  For FY 2022, there are no CBSAs in Puerto Rico with a national wage index greater than 1. B. The table titled “TABLE 1D.—CAPITAL STANDARD FEDERAL PAYMENT RATE—FY 2022” is corrected to read as follows.

Table 1D—Capital Standard Federal Payment Rate—FY 2022 RateNational$472.59 C. Correction of Errors in the Appendices 1. On pages 45576 through 45578, the table titled “Table I.—Impact Analysis of Changes to the IPPS for Operating Costs for FY 2022” is corrected to read as follows.

Start Printed Page 58028 Start Printed Page 58029 Start Printed Page 58030 2. On page 45579, third column, first paragraph, line 23, the figure “1.000712” is corrected to read “1.000715”. Start Printed Page 58031 3.

On page 45580, lower three-fourths of the page, first column, third full paragraph, line 6, the figure “0.986737” is corrected to read “0.986741”. 4. On pages 45582 and 45583, the table titled “Table II.—Impact Analysis of Changes for FY 2022 Acute Care Hospital Operating Prospective Payment System (Payments Per Discharge)” is corrected to read as follows.

Table II—Impact Analysis of Changes for FY 2022 Acute Care Hospital Operating Prospective Payment System[Payments per discharge] Number of hospitalsEstimated average FY 2021 payment per dischargeEstimated average FY 2022 payment per dischargeFY 2022 changes (1)(2)(3)(4)All Hospitals3,19513,10913,4482.6By Geographic Location:Urban hospitals2,45913,45413,8002.6Rural hospitals7369,90110,1782.8Bed Size (Urban):0-99 beds63410,72311,0112.7100-199 beds75411,01511,3052.6200-299 beds42712,25112,5512.4300-499 beds42113,49613,8472.6500 or more beds22316,56816,9922.6Bed Size (Rural):0-49 beds3118,5568,9214.350-99 beds2539,4199,6442.4100-149 beds949,78910,0332.5150-199 beds3910,51910,7882.6200 or more beds3911,46511,7842.8Urban by Region:New England11214,85815,2532.7Middle Atlantic30415,43215,8142.5East North Central38112,83813,1502.4West North Central16013,12113,4752.7South Atlantic40211,71012,0492.9East South Central14411,29011,5762.5West South Central36411,80612,0722.3Mountain17213,69814,0542.6Pacific37017,23017,6642.5Puerto Rico508,4918,6371.7Rural by Region:New England1913,99014,4633.4Middle Atlantic509,7369,9882.6East North Central11310,36110,5922.2West North Central8910,63810,9322.8South Atlantic1149,0329,3023East South Central1448,7328,9552.6West South Central1358,2928,5403Mountain4812,13412,3591.9Pacific2413,86514,5885.2By Payment Classification:Urban hospitals1,98312,67313,0032.6Rural areas1,21213,79614,1482.6Teaching Status:Nonteaching2,03110,67710,9632.7Fewer than 100 residents90712,38812,6942.5100 or more residents25718,93819,4372.6Urban DSH:Non-DSH50211,74912,0542.6100 or more beds1,22713,01513,3552.6Less than 100 beds3489,5599,8202.7Rural DSH:SCH26511,90612,2032.5RRC60814,38014,7472.6100 or more beds3012,11512,2981.5Less than 100 beds2157,7788,0253.2Urban teaching and DSH:Both teaching and DSH67914,11614,4832.6Teaching and no DSH7412,82513,1272.4No teaching and DSH89610,85011,1372.6No teaching and no DSH33410,82411,1102.6Special Hospital Types:Start Printed Page 58032RRC52314,47814,8592.6SCH30512,05312,3562.5MDH1539,1699,4042.6SCH and RRC15412,47512,7462.2MDH and RRC2710,62210,8532.2Type of Ownership:Voluntary1,88113,32113,6672.6Proprietary82811,47311,7692.6Government48614,10914,4662.5Medicare Utilization as a Percent of Inpatient Days:0-2564315,15815,5352.525-502,11012,92613,2682.650-6536710,77311,0102.2Over 65508,1328,4313.7FY 2022 Reclassifications by the Medicare Geographic Classification Review Board:All Reclassified Hospitals93413,59213,9442.6Non-Reclassified Hospitals2,26112,77213,1022.6Urban Hospitals Reclassified74914,26114,6192.5Urban Nonreclassified Hospitals1,72312,85113,1872.6Rural Hospitals Reclassified Full Year30010,08710,3412.5Rural Nonreclassified Hospitals Full Year4239,6109,9293.3All Section 401 Reclassified Hospitals53214,96815,3432.5Other Reclassified Hospitals (Section 1886(d)(8)(B))569,1499,4293.1 5. On page 45584, bottom third of the page, third column, partial paragraph. A.

Line 7, the figure “$151 million” is corrected to read “$158 million”. B. Line 10, the figure “$50 million” is corrected to read “$57 million”.

C. Lines 15 and 16, the phrase “for which we are approving new technology add-on payments” is corrected to read “for which we are approving or conditionally approving new technology add-on payments”. 6.

(1) In the untitled table, the third and fourth column headings and the entries at rows 6 and 9 are corrected to read as follows. Technology nameEstimated casesFY 2022 NTAP amountEstimated FY 2022 total impactPathway (QIDP, LPAD, or breakthrough device) *         *         *         *         *         *         *Fetroja (HABP/VABP)379$8,579.84$3,251,759.36QIDP. *         *         *         *         *         *         *Recarbrio (HABP/VABP)9289,576.518,887,001.28QIDP. *         *         *         *         *         *         * (2) Following the first untitled table, second column, partial paragraph, last line, the figure “$498 million” is corrected to read “$514 million”. B.

Middle third of the page, in the untitled table, the third and fourth column headings and the entries at rows 2 and 4 are corrected to read as follows. Technology nameEstimated casesFY 2022 NTAP amountEstimated FY 2022 total impact *         *         *         *         *         *         *Abecma484$272,675.00$131,974,700.00 Start Printed Page 58033*         *         *         *         *         *         *Tecartus15259,350.003,890,250.00 *         *         *         *         *         *         * 7. On pages 45587 and 45588, the table titled “Modeled Uncompensated Care Payments for Estimated FY 2022 DSHs by Hospital Type.

Model Uncompensated Care Payments ($ in Millions)—from FY 2021 to FY 2022” is corrected to read as follows. Start Printed Page 58034 Start Printed Page 58035 8. On page 45588, lower half of the page, beginning with the second column, first full paragraph, line 1 with the phrase “Rural hospitals, in general, are projected to experience” and ending in the third column last paragraph with the phrase “15.22 percent.

All” the paragraphs are corrected to read as follows. €œRural hospitals, in general, are projected to experience larger decreases in uncompensated care payments than their urban counterparts. Overall, rural hospitals are projected to receive a 17.28 percent decrease in uncompensated care payments, which is a greater decrease than the overall hospital average, while urban hospitals are projected to receive a 12.99 percent decrease in uncompensated care payments, similar to the overall hospital average.

By bed size, smaller rural hospitals are projected to receive the largest decreases in uncompensated care payments. Rural hospitals with 0-99 beds are projected to receive an 18.97 percent payment decrease, and rural hospitals with 100-249 beds are projected to receive a 15.53 percent decrease. In contrast, larger rural hospitals with 250+ beds are projected to receive a 14.16 percent payment decrease.

Among urban hospitals, the smallest urban hospitals, those with 0-99 and 100-249 beds, are projected to receive a decrease in uncompensated care payments that is greater than the overall hospital average, at 15.49 and 15.50 percent, respectively. In contrast, the largest urban hospitals with 250+ beds are projected to receive a 12.02 percent decrease in uncompensated care payments, which is a smaller decrease than the overall hospital average. By region, rural hospitals are expected to receive larger than average decreases in uncompensated care payments in all Regions, except for rural hospitals in New England, which are projected to receive a decrease of 1.27 percent in uncompensated care payments, and rural hospitals in the East South Central Region, which are projected to receive a smaller than average decrease of 13.01 percent.

Regionally, urban hospitals are projected to receive a more varied range of payment changes. Urban hospitals in the New England, Middle Atlantic, and Pacific Regions are projected to receive larger than average decreases in uncompensated care payments. Urban hospitals in the South Atlantic, East North Central, West North Central, West South Central, and Mountain Regions, as well as hospitals in Puerto Rico are projected to receive smaller than average decreases in uncompensated care payments.

Urban hospitals in the East South Central Region are projected to receive an average decrease in uncompensated care payments. By payment classification, although hospitals in urban areas overall are expected to receive a 12.74 percent decrease in uncompensated care payments, hospitals in large urban areas are expected to see a decrease in uncompensated care payments of 13.52 percent, while hospitals in other urban areas are expected to receive a decrease in uncompensated care payments of 11.21 percent. Rural hospitals are projected to receive the largest decrease of 14.23 percent.

Nonteaching hospitals are projected to receive a payment decrease of 13.4 percent, teaching hospitals with fewer than 100 residents are projected to receive a payment decrease of 12.94 percent, and teaching hospitals with 100+ residents have a projected payment decrease of 13.39 percent. All of these decreases closely approximate the overall hospital average. Proprietary and voluntary hospitals are projected to receive smaller than average decreases of 11.56 and 12.61 percent respectively, while government hospitals are expected to receive a larger payment decrease of 15.21 percent.

All”. 9. On page 45589, first column, first partial paragraph, the phrase “hospitals with less than 50 percent Medicare utilization are projected to receive decreases in uncompensated care payments consistent with the overall hospital average percent change, while hospitals with 50-65 percent and greater than 65 percent Medicare utilization are projected to receive larger decreases of 20.79 and 32.81 percent, respectively.” is corrected to read as follows.

€œhospitals with less than 50 percent Medicare utilization are projected to receive decreases in uncompensated care payments consistent with the overall hospital average percent change, while hospitals with 50-65 percent and greater than 65 percent Medicare utilization are projected to receive larger decreases of 20.85 and 32.86 percent, respectively.” Start Printed Page 58036 10. On page 45598, third column, last paragraph, lines 21 through 23, the sentence “The estimated percentage increase for both rural reclassified and nonreclassified hospitals is 1.4 percent.” is corrected to read “The estimated percentage increase for rural reclassified hospitals is 1.3 percent, while the estimated percentage increase for rural nonreclassified hospitals is 1.4 percent.” 11. On pages 45599 and 45600, the table titled “TABLE III.—COMPARISON OF TOTAL PAYMENTS PER CASE [FY 2021 PAYMENTS COMPARED TO FY 2022 PAYMENTS]” is corrected to read as follows.

Start Printed Page 58037 Start Printed Page 58038 12. On page 45610. A.

Second column, first partial paragraph. (1) Line 1, the figure “$2.293” is corrected to read “$2.316”. (2) Line 11, the figure “$0.65” is corrected to read “$0.68”.

B. Third column, last full paragraph, last line, the figure “$2.293” is corrected to read “$2.316”. 13.

On page 45611, the table titled “Table V—ACCOUNTING STATEMENT. CLASSIFICATION OF ESTIMATED EXPENDITURES UNDER THE IPPS FROM FY 2021 TO FY 2022” is corrected to read as follows. Start Printed Page 58039 CategoryTransfersAnnualized Monetized Transfers$2.316 billion.From Whom to WhomFederal Government to IPPS Medicare Providers.

Start List of Subjects DiseasesHealth facilitiesMedicarePuerto RicoReporting and recordkeeping requirements End List of Subjects As noted in section II.B. Of the preamble, the Centers for Medicare &. Medicaid Services is making the following correcting amendments to 42 CFR part 413.

Start Part End Part Start Amendment Part1. The authority citation for part 413 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww. End Authority Start Amendment Part2. Amend § 413.24 by.

End Amendment Part Start Amendment Parta. In paragraph (f)(5)(i) introductory text, removing the phrase “except as provided in paragraph (f)(5)(i)(E) of this section:” and adding in its place the phrase “except as provided in paragraphs (f)(5)(i)(A)( 2 )( ii ) and (f)(5)(i)(E) of this section:”. And End Amendment Part Start Amendment Partb.

Revising paragraph (f)(5)(i)(A). End Amendment Part The revision reads as follows. Adequate cost data and cost finding.

* * * * * (f) * * * (5) * * * (i) * * * (A) Teaching hospitals. For teaching hospitals, the Intern and Resident Information System (IRIS) data. ( 1 ) Data format.

For cost reporting periods beginning on or after October 1, 2021, the IRIS data must be in the new XML IRIS format. ( 2 ) Resident counts. ( i ) Effective for cost reporting periods beginning on or after October 1, 2021, the IRIS data must contain the same total counts of direct GME FTE residents (unweighted and weighted) and IME FTE residents as the total counts of direct GME FTE and IME FTE residents reported in the provider's cost report.

( ii ) For cost reporting periods beginning on or after October 1, 2021, and before October 1, 2022, the cost report is not rejected if the requirement in paragraph (f)(5)(i)(A)( 2 )( i ) of this section is not met. * * * * * Start Signature Karuna Seshasai, Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information BILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-P[FR Doc.

2021-22724 Filed 10-19-21. 8:45 am]BILLING CODE 4120-01-C.

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I’ve never understood striving for perfection. It’s unattainable. It’s the pinnacle I never want to reach. For if it’s attained, what more is there to achieve?

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Most know that working and working to achieve perfection is a waste of time, but somewhere along the way striving for perfection was drilled into us. It’s at the very core of our existence. When we were young, we worked and worked at achieving something for the accolades we knew would be coming our way. If only we did it right. If only we worked more, we’d hit the mark and hear our praises sung. Our self-worth became dependent on the compliment or two thrown our way. But in doing so, we hung onto the words of others and worked our hands raw, because as children the mark kept moving higher. You could never, ever truly hit the mark. You just kept working and working toward perfection. As an adult I’m telling you, perfection is unattainable. The mark never stops moving.

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Striving for perfection is an addiction. Most perfection addicts falsely believe that achieving perfection indicates excellence. But perfection and excellence are two different things.

The Merriam-Webster Dictionary states perfection as a) freedom from fault or defect, flawlessness, b) the quality or state of being saintly, c) an unsurpassable degree of accuracy or excellence. Excellence on the other hand is a) very good of its kind, b) eminently good, c) first class. Two similar, but totally different degrees in terms.

Who wants to be saintly or flawless anyway? Not I. No siree. I like being a little devilish, a little flawed. Ok, depending on who you ask, quite flawed. Regardless, I don’t demand perfection, but I do demand excellence.

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The driving force of my excellence comes from within. I know I want to be eminently good. First-class. First rate in anything I do. But I could care less what other people demand of or expect from me. I don’t live for them. I live for me. I answer to my own higher conscience, and if it’s good enough for me, then by golly, I’ve hit my mark. If it’s not good enough for them. No worries, they can spend the time to work it and work it to get it perfect. No skin off my nose.

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As a member of Toastmasters International, a public speaking club, in both my leadership and speaking roles, I strive for excellence to the best of my abilities. And therein lies the difference between excellence and perfection. To the best of your ability.

I was terrified when I stood up to give my first speech. Just tell the audience a little bit about myself. If I had strived for perfection that first time up, I never would have gone back to Toastmasters. I would have run out the door with my tail between my legs, or my hand over my mouth, never to look back. In expecting perfection, I never would have become president of the club, nor gone onto win public speaking contests. But because there were goals outlined in the manual, for newbie speakers, I just wanted to hit the mark for those goals. And I did. I had attained excellence for what I was aiming to achieve that night. Looking back now, I’m sure there were countless ums and ahs, long pauses and stuttering in that first speech. But in the end, who cares? I wasn’t laughed off the stage. I hit my mark. I achieved excellence. But not perfection. And that’s ok. If I had walked off that stage as Little Miss Perfect, I would have missed out on so much in learning from others, in pushing my comfort zone, and in becoming a better speaker.

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A fellow Toastmaster gave his third speech this past Tuesday. Was it perfect? Hell no. But was it excellent? You betcha. Even the content of the speech was right on the mark. He said in this day and age, if you ask an audience how many members believe they give 100% at work, guess how many people raise their hands? One hundred percent raise their hands. Know what that means? The average Joe gives 100%. Everybody does. Or so we think. With those odds, in order to be noticed or to move forward, then you better be giving 110%. Do you need to be perfect? Nope. But do you need to demand excellence? Absolutely.

Excellence I can handle. But I don’t ever want to be perfect. No siree, not me. I rather like being Little Miss un-Perfect.