Can you get lasix over the counter

Start Preamble Health Resources and Services Administration (HRSA), Department of Health and furosemide lasix 40mg tablet Human Services (HHS) can you get lasix over the counter. Notice. In accordance with the Federal Advisory Committee Act, can you get lasix over the counter this notice announces that the Council on Graduate Medical Education (COGME or Council) will hold public meetings for the 2021 calendar year (CY). Information about COGME, agendas, and materials for these meetings can be found on the COGME website at https://www.hrsa.gov/âadvisory-committees/âgraduate-medical-edu/âindex.html.

COGME meetings will be held on April 14, 2021, 8:30 a.m.-5:00 p.m. Eastern Time (ET) and April 15, 2021, 8:30 can you get lasix over the counter a.m.-2:00 p.m. ET. August 19, 2021, 10:00 a.m.-5:00 p.m.

ET. Meetings may be held in-person, by teleconference, and/or Adobe Connect webinar. For updates on how the meeting will be held, visit the COGME website 30 business days before the date of the meeting where instructions for joining meetings either in-person or remotely will also be posted. In-person meetings will be held at 5600 Fishers Lane, Rockville, Maryland 20857.

For meeting information updates, go to the COGME website meeting page at https://www.hrsa.gov/âadvisory-committees/âgraduate-medical-edu/âmeetings/âindex.html. Start Further Info Shane Rogers, Designated Federal Official, Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Room 15N142, Rockville, Maryland 20857. 301-443-5260. Or SRogers@hrsa.gov.

End Further Info End Preamble Start Supplemental Information COGME makes recommendations to the Secretary of HHS (Secretary) and Congress on policy, program development, and other matters of significance as specified by section 762 of Title VII of the Public Health Service (PHS) Act. Issues addressed by COGME include the supply and distribution of the physician workforce in the United States, including any projected shortages or excesses. Foreign medical school graduates. The nature and financing of undergraduate and graduate medical education.

Appropriation levels for certain programs under Title VII of the PHS Act. And deficiencies in databases of the supply and distribution of the physician workforce and postgraduate programs for training physicians. COGME submits reports to the Secretary of HHS. The Senate Committee on Health, Education, Labor and Pensions.

And the House of Representatives Committee on Energy and Commerce. Additionally, COGME encourages entities providing graduate medical education to conduct activities to voluntarily achieve the recommendations of the Council. Since priorities dictate meeting times, be advised that start times, end times, and agenda items are subject to change. For CY 2021 meetings, agenda items may include, but are not limited to, discussion on topics surrounding rural health workforce and training.

Refer to the COGME website listed above for all current and updated information concerning the CY 2021 COGME meetings, including draft agendas and meeting materials that will be posted 30 calendar days before the meeting. Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting(s). Oral comments will be honored in the order they are requested and may be limited as time allows.

Requests to submit a written statement or make oral comments to COGME should be sent to Shane Rogers using the contact information above at least 5 business days before the meeting date(s). Individuals who need special assistance or another reasonable accommodation should notify Shane Rogers using the contact information listed above at least 10 business days before the meeting(s) they wish to attend. If a meeting is held in-person, it will occur in a federal government building and attendees must go through a security check to enter. Non-U.S.

Citizen attendees must notify HRSA of their planned attendance at an in-person meeting at least 20 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry. Start Signature Maria G. Button, Director, Executive Secretariat.

End Signature End Supplemental Information [FR Doc. 2021-00058 Filed 1-7-21. 8:45 am]BILLING CODE 4165-15-P.

What is lasix furosemide used for

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This site what is lasix furosemide used for contains lasix online purchase affiliate links to products. We may receive a commission for purchases made through these links.CBD oils have exploded in popularity over the past few years.What started as a niche treatment for those with epilepsy and other medical issues has blossomed into an industry that people are using for an array of reasons. From simple relaxation to alleviating pain, CBD users report that oils help with improve what is lasix furosemide used for their lives day-in and day-out.

However, despite the positive word of mouth, knowing the best CBD oil to start with can be a tough challenge.As CBDâs popularity has grown, so have the number shady actors surrounding it. Due to this, itâs important to know not only who to trust but also who has the best CBD oil and why. By using a number of different criteria including quality of sourcing, strength of hemp, and reputation what is lasix furosemide used for in the industry, weâve decided to compile this list of the best CBD oils on the market today.

No matter if youâve been into it for a while or a newbie (we wonât judge), this list will inform you on what you need to know about CBD oil. Hereâs what weâve learned:The top brand in CBD, Verma Farms has been winning awards left and what is lasix furosemide used for right for the past couple of years, and 2021 is no exception. This is the gold standard of CBD tinctures.What Verma does well is provide a solution that helps set the standard for how CBD oils should be.

Starting out with very intent-driven oils like Focus, Chill, and Boost, they began diversifying their lineup to include more fruit-flavored varieties as well, such as Lemon Lime, Pineapple, Strawberry, Watermelon, Mango, and Peach. As all of them use natural, vegan ingredients, Verma has stripped down their offering to host only the standards but doing it well, sourcing all their oilâs materials from inside the US.An overall great brand, Verma Farms is an easy number one for any CBD fan out there.Another brand constantly ranked towards the top what is lasix furosemide used for of the industry, Penguin CBD has been at the forefront of CBD research and development. After all, if youâre not familiar, Penguin CBD is one of the most popular brands among Gen Z.For their CBD oil, Penguin CBD remains one of the best at creating a top-tier product.

Hosting oils that range all the way to 2500 mg, their formulas all contain broad spectrum CBD. As trendsetters in what is lasix furosemide used for the industry, Penguin CBD continues to set the bar over almost all the competition.With a name like Evn-CBD, itâs hard to go wrong. Not only do they live up to their reputation but do so with flying colors.Hosting some of our favorite broad-spectrum oils, Evn CBD keeps their product pure, hosting a certified USDA Organic label on every product.

Although slightly higher in price than some what is lasix furosemide used for on this list, itâs also well worth every penny. With a delicious taste, Evn CBD keeps it simple but effective with their selection, hosting high quality CBD in every drop. All in all, itâs hard to miss with Evn CBD, bringing along a selection that other brands claiming to be organic should take note of.A wildly popular name, CBDistillery has an excellent selection of CBD oil thatâs made with the user in mind.

Including varieties such as what is lasix furosemide used for Full Spectrum oils from 500 mg to 2500 mg, CBDistillery also has interesting combinations such as CBD+CBG as well as CBD+CBN. Additionally, if youâre looking for something a little better for day-to-day use, CBDistillery also has a few Broad Spectrum varieties as well. Hosting some of the best combinations for die-hard CBD fans, CBDistillery is a smart choice if youâre trying to dive into what CBD has to offer.Known particularly for their CBD oil, Spruce has a simple menu, but one thatâs an absolute knockout.

Hosting their traditional 750 mg and 2400 mg Max what is lasix furosemide used for Potency varieties, Spruce also has a rare Gingerbread 750 mg small-batch option for the holidays thatâs to die for (just mix it in any eggnog and youâll see). However, interesting combinations aside, Spruce really has driven their reputation via an overall great product.Spruce is a CBD brand thatâs a case study in focusing on quality execution. The result is a CBD oil thatâs hearty and pure, offering everything (and what is lasix furosemide used for more) it says it will.

Plus, with natural honey flavoring added, Gold Bee is swarming in success for their oils.After gaining a lot of recognition on Instagram, Pure Kana has been a brand thatâs celebrated for educating people on what CBD is, as well as what to look for in a company worth trusting. Hosting flavors like Mint, Vanilla, Natural, Fruity, Citrus, and even a Sleep-Aid, Pure Kana also has dosages between 600 mg to 5000 mg, providing a little something for everyone. In many ways, Pure Kana has established a sample CBD oil for every type of consumer, highlighting how they nail every target they attempt hit.In the 1970s, a team what is lasix furosemide used for of Danish researchers published a study claiming that the Innuit population living on the coast of Greenland had lower levels of heart disease and diabetes than residents of Denmark.

The duo attributed these better health outcomes to an Indigenous diet heavy on fish.Decades later, hundreds of studies sparked by this initial paper have largely concluded something similar. Fish is what is lasix furosemide used for good for you. The findings explain, in part, why the current U.S.

Dietary guidelines suggest adults consume two servings of seafood a week. But as the average American falls short of the suggested 8 ounces of fish every week, fish oil pills have taken over their own corner of the supplement what is lasix furosemide used for market â a replacement that science doesnât necessarily support. The upside of eating fish, evidence suggests, has more to do with the entire meal than it does with some miracle ingredient appearing on your plate.

The Underlying EvidenceWhen dietary agencies provide nutritional recommendations, they draw evidence for their suggestions from long-term studies that track groups of people, their food habits, and what kind of health outcomes individuals have, says Maya Vadiveloo, a registered dietitian and nutritional epidemiologist at the University of Rhode Island. This kind what is lasix furosemide used for of research is called an observational study. Scientists keep track of peopleâs choices and what they deal with later in life, like whether or not participants develop heart disease, get cancer, or die prematurely from similar kinds of serious health events.

Large-scale âtrack-the-diet-and-see-what-happensâ studies have associated fish consumption with lower risks of heart what is lasix furosemide used for attacks, heart failure, strokes, and liver cancer. For example, one study that assessed the findings of several of these long-term projects found that individuals who ate fish once a week were 15 percent less likely to die of cardiovascular disease. The agreement among the range of dietary studies about the benefits of fish helped usher in recommendations that Americans eat two servings of seafood a week.

But exactly why people who what is lasix furosemide used for eat fish fare better isnât completely clear yet. ÂThe mechanism for which fish convey protection against cardiovascular disease is still under investigation,â Vadiveloo says. Nutrition companies often bill a particular nutrient thatâs plentiful in some seafood varieties as a kind of superpower dietary factor.

Omega-3 fatty acids what is lasix furosemide used for. These fats are crucial to a range of cell functions, and because our bodies canât make them, we have to find nutritional sources. Of the three main kinds of omega-3s, what is lasix furosemide used for one is commonly found in walnuts, flaxseed, and soybean oil.

The two other versions show up in oily fish like salmon, sardines, and tuna. Some research has suggested that fish rich in omega-3s, in particular, can convey heart health benefits, and the American Heart Association recommends that people should opt for versions high in those fats. The belief that omega-3s what is lasix furosemide used for alone convey heart health benefits explains the popularity of fish oil supplements, too.

But so far, scientific evidence has yet to peg omega-3s as the key nutrient shielding people from heart disease. Studies examining the effects of fish oil capsules on heart health show mixed results. Some found the supplements didnât what is lasix furosemide used for reduce the risk of stroke, heart attacks, or other lethal cardiac diseases.

Other research has determined that individuals already dealing with cardiovascular health issues are most likely to see any benefits from fish oil. ÂCould you pop an omega-3 pill and suddenly reduce your risk of what is lasix furosemide used for heart disease?. Thatâs the answer that people often want, but that's not what the data suggests,â Vadiveloo says.

The Broader Benefits of FishScientific evidence might support the heart health benefits of fish â not omega-3s alone â because making room for the aquatic protein on your plate forces other dietary changes, too. For example, eating fish for dinner means someone likely isnât eating red or processed meats at that meal, Vadiveloo what is lasix furosemide used for says. ÂThe replacement and substitution piece is key.â Steak, bacon, and similar proteins are high in saturated fats that raise cholesterol levels and contribute to heart disease.

Many Americans consume too much of those harmful fats, and eating fish twice a week might mean someone is effectively cutting some saturated fats out of their diet and replacing them with more heart-healthy options. Thereâs also a chance that in research assessing lifelong what is lasix furosemide used for health outcomes for different diets, those who eat fish are making more healthy choices generally, like having more fruits and vegetables and fewer processed grains. Again, long-term studies that help shape dietary guidelines donât determine what participants eat â researchers just keep track and assess outcomes.

While studies try to control for other influencing factors in data analysis, a tendency to eat healthier overall might still explain some of why fish consumption is a positive choice, what is lasix furosemide used for Vadiveloo says. While fish can replace other harmful fats in someoneâs diet and might encourage healthier eating habits, it can have downsides too â namely, environmental toxins that sea creatures absorb. Mercury and chemicals like polychlorinated biphenyls, pollutants that leach from soils into water systems, build up in fish tissue and canât be cooked out or removed.

Dietary guidelines account for how much of different toxins might be in a given serving of fish, what is lasix furosemide used for Vadiveloo says, and intend to limit how much of those harmful substances people consume. Generally, the FDA recommends that certain individuals are choosier about the fish they eat â particularly pregnant women, those who may become pregnant, and small children. The agency advises that those groups select low-mercury options, as dietary sources of the neurotoxin can cause development problems.

Consuming just one what is lasix furosemide used for nutrient found in a food in a capsule â in this case, the oil from sardines, anchovies, and the like â isnât always the same thing as eating the food itself. ÂWe see this fairly consistently when you look at the evidence for vitamin and mineral substances,â says Vadiveloo. ÂWhen we extract, we donât always see the exact same benefits.â And when it comes to fish, what is lasix furosemide used for the same is true.

âA lot of us pick and snack way more than we realize we do,â says Debbie Petitpain, a registered dietician and spokesperson for the Academy of Nutrition and Dietetics.Those few bites here and there can quickly settle on our midlines. And as those of us whoâve tried to lose weight already know, gaining weight is easier than keeping unwanted pounds away for good.Fortunately, diets are easy to find. We can try keto, dump carbs, go Paleo, or try fasting or grazing to boost weight what is lasix furosemide used for loss.

But picking the program is the easy part. Sticking to a diet is hard because our body reacts to fewer what is lasix furosemide used for calories by slowing down our metabolisms. Once weâve been on a diet for a while, our so-called âhunger hormonesâ start to change.

Essentially, levels of hormones that help make us feel full will drop, while hormones that make us feel hungry get a boost. We can also undercut our own efforts by focusing on a target weight thatâs hard to reach and unrealistic for what is lasix furosemide used for us to maintain. Constant dieting, âisnât really ideal for living a pleasant life, which will make it harder to keep dieting,â says Traci Mann, a food psychologist at the University of Minnesota and author of Secrets from the Eating Lab.The Problem With DietingWe always seem to be looking for the next diet, the one that will melt off weight without making us obsess over food in the process.

But we donât need fad diets at all. The answer to weight loss is simple and what is lasix furosemide used for unchanging. We need to add more fruits and vegetables to our diets, while cutting out (or at least cutting down on) processed convenience foods and sweets.

If we only focus on numbers what is lasix furosemide used for on the scale, weâll lose sight of what matters most to our overall health. Making healthy food choices and making exercise a life-long habit. But donât be surprised if the weight does fall off when you adopt this mindset.Even if we manage to lose weight, studies have found that most of us end up regaining the weight within a year.

If you need convincing, Petitpain recommends that you stop by Barnes what is lasix furosemide used for &. Noble and take note of the shelf of diet books that extends the length of the building. Then turn around and look at your fellow Americans, most of whom will be overweight.

ÂSomehow, there what is lasix furosemide used for is a disconnect between the quick fixes offered by diet books, and our abilities to either try them or stick to them,â she says.Weâre hard on ourselves, too, and that doesnât do us any favors. Once weâve noticed those extra pounds, we often decide we must lose that weight really fast so we can be healthy again, says Petitpain. But because we have gained that what is lasix furosemide used for weight over several years, it likely isnât waving goodbye any time soon.

Petitpain says a better approach is taking gradual steps toward healthy choices, such as cutting out processed food, being mindful of portion sizes, and adding physical activity to your routine. And at the end of the day, whether someone is healthy or not goes beyond being fat or thin.âYou can be overweight and physically fit, and disease risk goes down,â Petitpain says. ÂWe know there are people what is lasix furosemide used for in the normal weight range, but who donât eat enough fruits and vegetables, and their disease risk goes up.âBalancing calories in with calories out still matters for dropping pounds, but obsessing about weight can be self-sabotaging.

A better approach, says Mann, would be to accept our bodies â but donât binge eat. Fight weight stigma. Exercise because itâs good for us and eat more veggies.Clear Your CountertopsIf you tried to diet and succeeded for a while before going off course, know that it doesn't mean you're weak what is lasix furosemide used for.

ÂThereâs this idea out there that dieters, or obese people, have worse self-control than everyone else, and thatâs just not how it works,â Mann says. Depriving our bodies of calories wields a powerful force on our biology â and our bodies fight back what is lasix furosemide used for with a variety of physiological processes designed to hold on to the weight. ÂMost people wouldnât even have â¦ the kind of willpower you would need to overcome all of it,â says Mann.

ÂItâs just too much to fight against.âResisting food cravings day in and day out is difficult. A better approach what is lasix furosemide used for is to make tempting food more difficult to grab. If your partner insists on having candy in the house, for example, store those goodies in an opaque container, making them harder to see.

When sweets are out of sight, they tend to be out of mind as well. Or forget about resisting what is lasix furosemide used for your food cravings altogether and try a strategy Mann calls âveggies first.â This ploy is an easy one to incorporate â think a salad before dinner. Before you eat anything â whether itâs a slice of pizza or a steak â put some vegetables on your plate.

Doing this adds nutrition to your diet and it fills you up, making you less likely to overindulge what is lasix furosemide used for on fattening foods.Mann and her team tested this idea in a field study held in an elementary school. The researchers aimed to test whether kids would eat more of a vegetable if that was their only choice, or if the same vegetable was served along with other foods. First, the researchers determined what the baseline consumption of carrots was during a typical school lunch, when they were served alongside other foods.

Then three months later, the same meal was served, but this time the kids were given carrots before what is lasix furosemide used for the rest of their meal. The team found that the kids gobbled up more carrots when the vegetable was served alone, before the rest of their food.The researchers also tested their veggies-first approach on college students and keeping track of their carrot and M&M consumption depending on which food was served first. The students what is lasix furosemide used for ate more carrots when they were served first, and ate less candy as a result.

Slip-ups Arenât SetbacksWhat matters in the long run for health are your overall eating habits, says Petitpain. An occasional splurge meal doesnât negate the healthier choices youâve made on a day-to-day basis. But know that if what is lasix furosemide used for wellness is your goal, you do need to make a regular a habit of consuming health-promoting foods, especially those that are minimally processed.

Theyâre easy to find because theyâre generally anything you can pick up on the perimeter of the supermarket.In addition to Mannâs veggies-first plan, another healthful approach involves adding vegetables to every meal and finding creative swaps. Try adding salsa to eggs, spinach to smoothies, sliced mushrooms to burgers, or having veggies and hummus instead of chips.If youâre making tacos, tortillas can be replaced by a lettuce leaf. Beans make a tasty and high-fiber stand-in for reducing or replacing what is lasix furosemide used for taco meat.

You might not miss cheese and sour cream toppings if you add extra corn, onions and tomatoes. For dessert, what is lasix furosemide used for a similar strategy incorporates fruit. Try pears poached in wine sauce or pineapple with frozen vanilla yogurt.

Or, if you're looking for a portable snack for kids, bring cups of applesauce and dump in the gummy fruit-flavored snacks. These small changes make a big difference over time, says Petitpain.With this approach, thereâs no what is lasix furosemide used for need to do anything radical, like develop a taste for a vegetable you dislike, or force down more veggies at dinner. If you love carrots or broccoli, simply eat them more often and find creative ways to sneak them in meals.Self-Care Now, Diet Later?.

No matter your weight or fitness goals, remember that wellness is more than a diet and exercise regime. Now more than ever, stress plays a vital role on our overall what is lasix furosemide used for wellbeing. If stress and anxiety is causing poor sleep, youâll be too tired to exercise or make the right food decisions.It can be helpful to take a step back and recognize that living through a traumatic year has likely taken a mental and physical toll.

Just view weight loss as one part of an overall plan to get yourself back on track and take small steps to boost your overall health.âMaybe itâs better to think about the overall journey, rather than being so hyper-focused on achieving an endpoint,â says Petitpain.Think about how long it took you to gain that weight and be realistic about how quickly those what is lasix furosemide used for pounds can come off. The American Obesity Society recommends a rate of one-to-two pounds a week, which is sustainable over time, and provides some health benefits. Or find a dietician and get some personalized help.But whatever you do, donât start a diet if youâre not emotionally ready to commit.

ÂIf you donât what is lasix furosemide used for have the bandwidth right now to tackle an aggressive diet, then donât start one, because it might be worse to try and fail. Focus instead on self-care. Try sleeping better, moving a little bit, eating a little healthier at every meal,â says Petitpain.

ÂThese are what is lasix furosemide used for hard times. You really have to prioritize.âIn the midst of an ongoing apocalyptic reality that never seems to end, whatâs in your pots and pans might be the last thing on your mind. But now, more than ever, it might be time to take stock of whatâs in the kitchen and make sure itâs what is lasix furosemide used for safe to cook on.

In recent months, thereâs been an unprecedented return to the home kitchen. In a survey of 1,000 people by the International Food Information Council, half said they were more likely to cook a meal from scratch than they had been at the beginning of the lasix. Thirty percent said what is lasix furosemide used for they tried new recipes.

At the same time, a growing number of consumers are seeking cookware that will get the job done and limit their exposure to humanmade industrial chemicals. But how do the different options on store shelves stack up in terms of health, environmental impact, durability, and ease of use?. Discover asked the experts for their advice on picking pots and pans that can cook up delicious food and not what is lasix furosemide used for add unintended, toxic ingredients to your dish.

Suzanne Fenton, a reproductive endocrinologist at the National Institutes of Environmental Health Sciences (NIEHS). J. Kenji LÃ³pez-Alt, a chef, author of the cooking science book The Food Lab, and chief culinary consultant for Serious Eats.

And Olga Naidenko, vice president of science investigations at the Environmental Working Group (EWG), a nonprofit and nonpartisan advocacy organization.Traditional Nonstick (Credit. Iurii Stepanov/Shutterstock)Nonstick is the cooking surface that is probably the most likely to sound alarm bells in consumersâ minds. This kind of coating, known commercially as Teflon, lines metal pans with a tough, synthetic resin to create a slippery surface.

Its chemical name is polytetrafluoroethylene, or PTFE. Historically, it was made using PFOAs, or perfluorooctanoic acids. PFOAs are part of a group of stubborn chemicals that have been linked with health risks like thyroid problems, possible hormone disruption, kidney disease and immune system issues.

The FDA worked with companies to phase out the use of PFOAs and other similar chemicals in food-contact applications by 2016. However, similar to in the cosmetics industry, manufacturers donât have to disclose every ingredient they use in their coatings. PTFE coating, or Teflon, isnât necessarily dangerous if ingested by accident from scratching or chipping, according to Fenton and Naidenko, though its nonstick properties will weaken if scratched.

Whatâs more worrisome is when a PTFE nonstick pan is used at a high heat â say, searing a steak or leaving a burner on by accident. Molecular bonds in the coating begin to break down at around 500 degrees, according to a presentation on home chemical coatings by Michael Michalczyk, a chemical consultant. Nonstick coatings can then release dangerous fumes that irritate the respiratory system.

According to Naidenko, PTFE coating today is essentially the same as the old versions â just made with much smaller amounts of PFOAs. But she adds that âthe risk of it overheating, and harming our lungs â that risk stays. Those pans should not be overheated [during] their lifetime â that would be a concern.â Both Naidenko and Fenton noted that the health dangers posed by Teflon cookware is a small risk compared to the environmental contamination associated with manufacturing and disposing of these products.

According to the EWG, per- and polyfluoroalkyl substances (or PFAS), a group of chemicals that PFOAs belong to, can be found in the drinking water of many U.S. Cities. PFAS enter the environment from Teflon products breaking down in landfills, and from the production of plastic wrappings, water-repellant items, and things like military firefighting foam.

Although the Environmental Protection Agency says this group of chemicals can be incinerated as a way to keep them from other waste streams, Naikendo said that this can cause an air pollution problem for communities where incineration occurs.LÃ³pez-Alt says he rarely uses nonstick cookware, but when he does itâs for low-heat tasks like cooking an omelet, where nonstick has a big advantage.Ceramic (Credit. Melica/Shutterstock)Some of the most popular new cookware crowding Instagram feeds and online stores are ceramic. These pots and pans boast labels like âPTFE and PFOA-freeâ or ânon-toxic,â and âhealthy.â But because theyâre a relatively new nonstick alternative, our experts say not as much is known about them in terms of the long-term effects on health and the environment.

Pans marketed as ânonstick ceramicâ are not made of pottery or clay, however. Pure ceramic cookware thatâs closer to pottery does exist, but itâs less common. Instead, many products labeled as ceramic include a metal core with a chemically-combined coating that is sprayed on.

Thereâs a good chance a ceramic pan has a coating containing silica â the same mineral that sand and silicone are made out of â and various other substances. The viral Always Pan, along with other popular options in the cookware aisle, are made using sol-gel â a wet-chemical process that forms nanoparticles into solid materials and dehydrates them into ceramic or glasslike surfaces. But a downside to ceramic nonstick is that the coating doesnât last as long as PTFE-based pans.

According to Naidenko, because itâs hard to know what the exact contents of these coatings are, âeven if one has a pan that has not a lot of PTFE in it, they still should not overheat somethingâ in a ceramic pan. Cast Iron(Credit. Natashamam/Shutterstock)It might be time to pay more attention to that friend who wonât stop talking about seasoning their cast-iron skillet.

Thatâs because cast iron cookware is one of the most reliable and time-honored materials that can grace your kitchen. Cast iron cookware is quite heavy â which for some might be enough reason to pass on it. But because of its weight and density, cast iron can retain heat much longer than other metals like aluminum.

However, it doesnât distribute its heat very evenly, according to LÃ³pez-Alt. From a safety perspective, what you see is what you get. Iron alloyed with varying amounts of carbon and silicon, forged into a shape.

ÂSeasoningâ a cast iron pan is the process of adding oil or fat and heating the pan. This creates a reaction with the oil and the iron that forms a somewhat nonstick black layer â a polymer, LÃ³pez-Alt says, which gets built up as it's used. The surface stands up well to most kinds of cooking, and prevents sticking, although acids like tomato and vinegar can break down the coating that forms.

Contrary to popular belief, cast iron can be washed with soap without damaging the surface â but leaving cast iron wet with water can cause it to rust. According to LÃ³pez-Alt, âThe whole idea that you can't clean cast iron with soap is just a complete myth that no longer applies,â he says, noting that older soaps containing lye did affect cast iron, but not modern soaps. ÂI think people just sort of baby their cast iron much more than they have to.â Small amounts of iron do, in fact, end up in food, but for people prone to iron deficiency, this can actually be a benefit.

Carbon Steel and Stainless Steel(Credit. Yevlashkina Anastasiia/Shutterstock)Steel cookware is some of the most common and popular cookware around because of its durability and how well it stores heat energy compared to other metals â a little less than cast iron or copper, but better than others, says LÃ³pez-Alt. Stainless steel usually has more added materials, like chromium or nickel, and a conductive core like aluminum or copper, while carbon steel is just steel.

Carbon steel, which is common for woks and crÃªpe pans, is more similar to cast iron. It has some nonstick properties and is very durable and heat-resistant, but can also rust. Stainless steel can be put in a dishwasher, unlike carbon steel, and it wonât react with acids as much.

But overall, both are scratch-resistant and safe surfaces to cook on. Fenton favors stainless steel pans, while Lopez-Alt says he prefers his carbon steel cookware, which should be seasoned like cast iron. ÂMy real advice would be to learn how to use carbon steel because it's the best,â he says.

Aluminum and Anodized Aluminum(Credit. A. Zhuravleva/Shutterstock)Aluminum might comprise a whole pan, be mixed with other metals, or make up a layer within the pan.

Itâs less dense than metals like steel or iron, so it doesnât retain heat very well. This means that it can cool down quickly, but it does conduct â or transfer â heat very well, making it a popular addition to pans made with other metals. According to LÃ³pez-Alt, chefs in restaurants often use aluminum pans because their industrial burners can maintain stronger heat than a typical home kitchen stove.

Anodization gives aluminum a very hard, non-corrosive surface. Anodized aluminum is made with an electrolytic process that makes it much harder and smooth â the one downside is that you canât put these kinds of pans in the dishwasher or you risk ruining the surface, according to the book Things Cooks Love, by Marie Simmons. While there has been inconclusive research on links between aluminum and Alzheimer's, aluminum cookware is currently not considered to be a health risk.

The CDC says that while aluminum cookware can transfer aluminum into foods, especially acidic ones, âaluminum levels found in processed foods and foods cooked in aluminum pots are generally considered to be safe.âCopper (Credit. FabrikaSimf/Shutterstock)Copper is favored by professional chefs for its superior conductivity, which means it heats up quickly and evenly. But copper should not come into contact with food on its own, because it can react with acidic ingredients like wine, fruit juice, or vinegar and leach into food, according to the FDAâs 2017 Food Code.

ÂWhile copper is very good because of its heating properties, too much copper is not good for the body, especially for children,â says Naidenko. ÂIt can even cause things like diarrhea and nausea.â Many copper pots or pans are lined with a metal like tin or stainless steel for this reason. Tin can wear more easily than steel, so if you have an old tin-lined copper pot, or if you spot one at a yard sale for a good price, Naidenko said itâs a good idea to look for scratches.

A general rule of thumb is to choose cookware that works well for your needs, and steer clear of products if the materials arenât clearly defined. You canât go wrong with basic heavy cookware that is durable and long-lasting. But note that even nonstick cookware has its place in modern kitchens and can be reserved for preparing delicate dishes that are prone to sticking.

If you have the means and must replace a pot or pan, consider cookware that will stand the test of time. And know that even if the materials are considered safe for humans at home, they could become environmental hazards when they break down in landfills at the end of their life. As Fenton said, âIf you're going to invest in cookware, you might as well go for something that's going to be a little bit safer and last you a little bit longer.â And no matter which type of pan you choose, the safest pan for your health may come down to how you wield it in the kitchen.

ÂI think pretty much all the cookware out there right now is pretty safe, as long as you take care of it,â she says..

This site can you get lasix over the counter contains affiliate links to products. We may receive a commission for purchases made through these links.CBD oils have exploded in popularity over the past few years.What started as a niche treatment for those with epilepsy and other medical issues has blossomed into an industry that people are using for an array of reasons. From simple relaxation to alleviating pain, CBD users report can you get lasix over the counter that oils help with improve their lives day-in and day-out. However, despite the positive word of mouth, knowing the best CBD oil to start with can be a tough challenge.As CBDâs popularity has grown, so have the number shady actors surrounding it.

Due to this, itâs important to know not only who to trust but also who has the best CBD oil and why. By using a number of different criteria including quality of sourcing, strength of hemp, and reputation in the can you get lasix over the counter industry, weâve decided to compile this list of the best CBD oils on the market today. No matter if youâve been into it for a while or a newbie (we wonât judge), this list will inform you on what you need to know about CBD oil. Hereâs what weâve learned:The top brand in CBD, Verma Farms has been winning awards left and right for the can you get lasix over the counter past couple of years, and 2021 is no exception.

This is the gold standard of CBD tinctures.What Verma does well is provide a solution that helps set the standard for how CBD oils should be. Starting out with very intent-driven oils like Focus, Chill, and Boost, they began diversifying their lineup to include more fruit-flavored varieties as well, such as Lemon Lime, Pineapple, Strawberry, Watermelon, Mango, and Peach. As all of them use natural, vegan ingredients, Verma has stripped down their offering to host only the standards but doing it well, sourcing all their oilâs materials can you get lasix over the counter from inside the US.An overall great brand, Verma Farms is an easy number one for any CBD fan out there.Another brand constantly ranked towards the top of the industry, Penguin CBD has been at the forefront of CBD research and development. After all, if youâre not familiar, Penguin CBD is one of the most popular brands among Gen Z.For their CBD oil, Penguin CBD remains one of the best at creating a top-tier product.

Hosting oils that range all the way to 2500 mg, their formulas all contain broad spectrum CBD. As trendsetters in the industry, Penguin CBD continues to set the bar over almost all can you get lasix over the counter the competition.With a name like Evn-CBD, itâs hard to go wrong. Not only do they live up to their reputation but do so with flying colors.Hosting some of our favorite broad-spectrum oils, Evn CBD keeps their product pure, hosting a certified USDA Organic label on every product. Although slightly higher in price than can you get lasix over the counter some on this list, itâs also well worth every penny.

With a delicious taste, Evn CBD keeps it simple but effective with their selection, hosting high quality CBD in every drop. All in all, itâs hard to miss with Evn CBD, bringing along a selection that other brands claiming to be organic should take note of.A wildly popular name, CBDistillery has an excellent selection of CBD oil thatâs made with the user in mind. Including varieties such can you get lasix over the counter as Full Spectrum oils from 500 mg to 2500 mg, CBDistillery also has interesting combinations such as CBD+CBG as well as CBD+CBN. Additionally, if youâre looking for something a little better for day-to-day use, CBDistillery also has a few Broad Spectrum varieties as well.

Hosting some of the best combinations for die-hard CBD fans, CBDistillery is a smart choice if youâre trying to dive into what CBD has to offer.Known particularly for their CBD oil, Spruce has a simple menu, but one thatâs an absolute knockout. Hosting their can you get lasix over the counter traditional 750 mg and 2400 mg Max Potency varieties, Spruce also has a rare Gingerbread 750 mg small-batch option for the holidays thatâs to die for (just mix it in any eggnog and youâll see). However, interesting combinations aside, Spruce really has driven their reputation via an overall great product.Spruce is a CBD brand thatâs a case study in focusing on quality execution. The result is a CBD oil thatâs hearty can you get lasix over the counter and pure, offering everything (and more) it says it will.

All in all, itâs hard to miss when dealing with Spruce, as their CBD oil always finds a way to brighten up the day.Gold Bee is quickly becoming a company with a reputation for setting the gold standard. For their CBD oil, they offer a Full Spectrum variety thatâs flavored either naturally or as Kiwi. Although their pricing starts at $109, Gold Bee doesnât hold back on ingredients, only using premium can you get lasix over the counter extract. Plus, with natural honey flavoring added, Gold Bee is swarming in success for their oils.After gaining a lot of recognition on Instagram, Pure Kana has been a brand thatâs celebrated for educating people on what CBD is, as well as what to look for in a company worth trusting.

Hosting flavors like Mint, Vanilla, Natural, Fruity, Citrus, and even a Sleep-Aid, Pure Kana also has dosages between 600 mg to 5000 mg, providing a little something for everyone. In many ways, Pure Kana has established a can you get lasix over the counter sample CBD oil for every type of consumer, highlighting how they nail every target they attempt hit.In the 1970s, a team of Danish researchers published a study claiming that the Innuit population living on the coast of Greenland had lower levels of heart disease and diabetes than residents of Denmark. The duo attributed these better health outcomes to an Indigenous diet heavy on fish.Decades later, hundreds of studies sparked by this initial paper have largely concluded something similar. Fish is can you get lasix over the counter good for you.

The findings explain, in part, why the current U.S. Dietary guidelines suggest adults consume two servings of seafood a week. But as the average American falls short of the suggested 8 ounces of fish every week, fish oil pills have taken over their own corner of the supplement market â a replacement that can you get lasix over the counter science doesnât necessarily support. The upside of eating fish, evidence suggests, has more to do with the entire meal than it does with some miracle ingredient appearing on your plate.

The Underlying EvidenceWhen dietary agencies provide nutritional recommendations, they draw evidence for their suggestions from long-term studies that track groups of people, their food habits, and what kind of health outcomes individuals have, says Maya Vadiveloo, a registered dietitian and nutritional epidemiologist at the University of Rhode Island. This kind can you get lasix over the counter of research is called an observational study. Scientists keep track of peopleâs choices and what they deal with later in life, like whether or not participants develop heart disease, get cancer, or die prematurely from similar kinds of serious health events. Large-scale âtrack-the-diet-and-see-what-happensâ studies have associated fish consumption with lower risks of can you get lasix over the counter heart attacks, heart failure, strokes, and liver cancer.

For example, one study that assessed the findings of several of these long-term projects found that individuals who ate fish once a week were 15 percent less likely to die of cardiovascular disease. The agreement among the range of dietary studies about the benefits of fish helped usher in recommendations that Americans eat two servings of seafood a week. But exactly why people who can you get lasix over the counter eat fish fare better isnât completely clear yet. ÂThe mechanism for which fish convey protection against cardiovascular disease is still under investigation,â Vadiveloo says.

Nutrition companies often bill a particular nutrient thatâs plentiful in some seafood varieties as a kind of superpower dietary factor. Omega-3 fatty acids can you get lasix over the counter. These fats are crucial to a range of cell functions, and because our bodies canât make them, we have to find nutritional sources. Of the three main kinds of can you get lasix over the counter omega-3s, one is commonly found in walnuts, flaxseed, and soybean oil.

The two other versions show up in oily fish like salmon, sardines, and tuna. Some research has suggested that fish rich in omega-3s, in particular, can convey heart health benefits, and the American Heart Association recommends that people should opt for versions high in those fats. The belief that omega-3s alone convey heart health benefits explains the popularity can you get lasix over the counter of fish oil supplements, too. But so far, scientific evidence has yet to peg omega-3s as the key nutrient shielding people from heart disease.

Studies examining the effects of fish oil capsules on heart health show mixed results. Some found the supplements didnât reduce the can you get lasix over the counter risk of stroke, heart attacks, or other lethal cardiac diseases. Other research has determined that individuals already dealing with cardiovascular health issues are most likely to see any benefits from fish oil. ÂCould you can you get lasix over the counter pop an omega-3 pill and suddenly reduce your risk of heart disease?.

Thatâs the answer that people often want, but that's not what the data suggests,â Vadiveloo says. The Broader Benefits of FishScientific evidence might support the heart health benefits of fish â not omega-3s alone â because making room for the aquatic protein on your plate forces other dietary changes, too. For example, eating fish for can you get lasix over the counter dinner means someone likely isnât eating red or processed meats at that meal, Vadiveloo says. ÂThe replacement and substitution piece is key.â Steak, bacon, and similar proteins are high in saturated fats that raise cholesterol levels and contribute to heart disease.

Many Americans consume too much of those harmful fats, and eating fish twice a week might mean someone is effectively cutting some saturated fats out of their diet and replacing them with more heart-healthy options. Thereâs also a can you get lasix over the counter chance that in research assessing lifelong health outcomes for different diets, those who eat fish are making more healthy choices generally, like having more fruits and vegetables and fewer processed grains. Again, long-term studies that help shape dietary guidelines donât determine what participants eat â researchers just keep track and assess outcomes. While studies try to control for other influencing factors in data analysis, a tendency to eat healthier overall might still explain can you get lasix over the counter some of why fish consumption is a positive choice, Vadiveloo says.

While fish can replace other harmful fats in someoneâs diet and might encourage healthier eating habits, it can have downsides too â namely, environmental toxins that sea creatures absorb. Mercury and chemicals like polychlorinated biphenyls, pollutants that leach from soils into water systems, build up in fish tissue and canât be cooked out or removed. Dietary guidelines account for how much of different toxins might be in a given serving of fish, Vadiveloo says, and intend to limit how much of those can you get lasix over the counter harmful substances people consume. Generally, the FDA recommends that certain individuals are choosier about the fish they eat â particularly pregnant women, those who may become pregnant, and small children.

The agency advises that those groups select low-mercury options, as dietary sources of the neurotoxin can cause development problems. Consuming just one nutrient found in a can you get lasix over the counter food in a capsule â in this case, the oil from sardines, anchovies, and the like â isnât always the same thing as eating the food itself. ÂWe see this fairly consistently when you look at the evidence for vitamin and mineral substances,â says Vadiveloo. ÂWhen we extract, we donât always see the exact same benefits.â And when it comes can you get lasix over the counter to fish, the same is true.

Rethinking what's on your plate likely pays off in a way that adding to your medicine cabinet does not.Packing on pounds seems way too easy these days. Working from home has replaced those water-cooler chats â and we eat more when weâre lonely or bored. Plus, those round trips from the computer can you get lasix over the counter to the pantry and back probably donât help much either. âA lot of us pick and snack way more than we realize we do,â says Debbie Petitpain, a registered dietician and spokesperson for the Academy of Nutrition and Dietetics.Those few bites here and there can quickly settle on our midlines.

And as those of us whoâve tried to lose weight already know, gaining weight is easier than keeping unwanted pounds away for good.Fortunately, diets are easy to find. We can try keto, dump carbs, can you get lasix over the counter go Paleo, or try fasting or grazing to boost weight loss. But picking the program is the easy part. Sticking to a diet is hard because our body reacts can you get lasix over the counter to fewer calories by slowing down our metabolisms.

Once weâve been on a diet for a while, our so-called âhunger hormonesâ start to change. Essentially, levels of hormones that help make us feel full will drop, while hormones that make us feel hungry get a boost. We can also undercut our own efforts by focusing can you get lasix over the counter on a target weight thatâs hard to reach and unrealistic for us to maintain. Constant dieting, âisnât really ideal for living a pleasant life, which will make it harder to keep dieting,â says Traci Mann, a food psychologist at the University of Minnesota and author of Secrets from the Eating Lab.The Problem With DietingWe always seem to be looking for the next diet, the one that will melt off weight without making us obsess over food in the process.

But we donât need fad diets at all. The answer to weight loss is can you get lasix over the counter simple and unchanging. We need to add more fruits and vegetables to our diets, while cutting out (or at least cutting down on) processed convenience foods and sweets. If we only focus on numbers on the scale, weâll lose sight can you get lasix over the counter of what matters most to our overall health.

Making healthy food choices and making exercise a life-long habit. But donât be surprised if the weight does fall off when you adopt this mindset.Even if we manage to lose weight, studies have found that most of us end up regaining the weight within a year. If you need convincing, Petitpain can you get lasix over the counter recommends that you stop by Barnes &. Noble and take note of the shelf of diet books that extends the length of the building.

Then turn around and look at your fellow Americans, most of whom will be overweight. ÂSomehow, there is a disconnect between the quick fixes offered by diet can you get lasix over the counter books, and our abilities to either try them or stick to them,â she says.Weâre hard on ourselves, too, and that doesnât do us any favors. Once weâve noticed those extra pounds, we often decide we must lose that weight really fast so we can be healthy again, says Petitpain. But because can you get lasix over the counter we have gained that weight over several years, it likely isnât waving goodbye any time soon.

Petitpain says a better approach is taking gradual steps toward healthy choices, such as cutting out processed food, being mindful of portion sizes, and adding physical activity to your routine. And at the end of the day, whether someone is healthy or not goes beyond being fat or thin.âYou can be overweight and physically fit, and disease risk goes down,â Petitpain says. ÂWe know there are people in the normal weight range, but who donât eat enough fruits and vegetables, and their disease risk goes up.âBalancing calories in with calories out still can you get lasix over the counter matters for dropping pounds, but obsessing about weight can be self-sabotaging. A better approach, says Mann, would be to accept our bodies â but donât binge eat.

Fight weight stigma. Exercise because itâs good can you get lasix over the counter for us and eat more veggies.Clear Your CountertopsIf you tried to diet and succeeded for a while before going off course, know that it doesn't mean you're weak. ÂThereâs this idea out there that dieters, or obese people, have worse self-control than everyone else, and thatâs just not how it works,â Mann says. Depriving our bodies of calories wields a powerful force can you get lasix over the counter on our biology â and our bodies fight back with a variety of physiological processes designed to hold on to the weight.

ÂMost people wouldnât even have â¦ the kind of willpower you would need to overcome all of it,â says Mann. ÂItâs just too much to fight against.âResisting food cravings day in and day out is difficult. A better approach is to make can you get lasix over the counter tempting food more difficult to grab. If your partner insists on having candy in the house, for example, store those goodies in an opaque container, making them harder to see.

When sweets are out of sight, they tend to be out of mind as well. Or forget about resisting your food cravings altogether and try a strategy Mann calls âveggies first.â This ploy is an easy can you get lasix over the counter one to incorporate â think a salad before dinner. Before you eat anything â whether itâs a slice of pizza or a steak â put some vegetables on your plate. Doing this adds nutrition to your diet and it fills you up, making you less likely to overindulge can you get lasix over the counter on fattening foods.Mann and her team tested this idea in a field study held in an elementary school.

The researchers aimed to test whether kids would eat more of a vegetable if that was their only choice, or if the same vegetable was served along with other foods. First, the researchers determined what the baseline consumption of carrots was during a typical school lunch, when they were served alongside other foods. Then three months later, the same meal was served, but this time the kids were given carrots before can you get lasix over the counter the rest of their meal. The team found that the kids gobbled up more carrots when the vegetable was served alone, before the rest of their food.The researchers also tested their veggies-first approach on college students and keeping track of their carrot and M&M consumption depending on which food was served first.

The students ate more carrots when they were served first, and ate can you get lasix over the counter less candy as a result. Slip-ups Arenât SetbacksWhat matters in the long run for health are your overall eating habits, says Petitpain. An occasional splurge meal doesnât negate the healthier choices youâve made on a day-to-day basis. But know that can you get lasix over the counter if wellness is your goal, you do need to make a regular a habit of consuming health-promoting foods, especially those that are minimally processed.

Theyâre easy to find because theyâre generally anything you can pick up on the perimeter of the supermarket.In addition to Mannâs veggies-first plan, another healthful approach involves adding vegetables to every meal and finding creative swaps. Try adding salsa to eggs, spinach to smoothies, sliced mushrooms to burgers, or having veggies and hummus instead of chips.If youâre making tacos, tortillas can be replaced by a lettuce leaf. Beans make a tasty and high-fiber can you get lasix over the counter stand-in for reducing or replacing taco meat. You might not miss cheese and sour cream toppings if you add extra corn, onions and tomatoes.

For dessert, a similar strategy incorporates can you get lasix over the counter fruit. Try pears poached in wine sauce or pineapple with frozen vanilla yogurt. Or, if you're looking for a portable snack for kids, bring cups of applesauce and dump in the gummy fruit-flavored snacks. These small changes make a big difference over time, says Petitpain.With this approach, thereâs no need to do anything radical, like develop a taste for a vegetable you dislike, or can you get lasix over the counter force down more veggies at dinner.

If you love carrots or broccoli, simply eat them more often and find creative ways to sneak them in meals.Self-Care Now, Diet Later?. No matter your weight or fitness goals, remember that wellness is more than a diet and exercise regime. Now more than ever, stress plays a vital role on our can you get lasix over the counter overall wellbeing. If stress and anxiety is causing poor sleep, youâll be too tired to exercise or make the right food decisions.It can be helpful to take a step back and recognize that living through a traumatic year has likely taken a mental and physical toll.

Just view weight loss as one part of an overall plan to get yourself back on track and take small steps to boost your overall health.âMaybe itâs better to think about the overall journey, rather than being so hyper-focused on achieving an endpoint,â says Petitpain.Think about how long it took you to gain that weight can you get lasix over the counter and be realistic about how quickly those pounds can come off. The American Obesity Society recommends a rate of one-to-two pounds a week, which is sustainable over time, and provides some health benefits. Or find a dietician and get some personalized help.But whatever you do, donât start a diet if youâre not emotionally ready to commit. ÂIf you donât have the bandwidth right now to tackle an aggressive diet, then donât start one, because it might be worse to try and can you get lasix over the counter fail.

Focus instead on self-care. Try sleeping better, moving a little bit, eating a little healthier at every meal,â says Petitpain. ÂThese are hard times can you get lasix over the counter. You really have to prioritize.âIn the midst of an ongoing apocalyptic reality that never seems to end, whatâs in your pots and pans might be the last thing on your mind.

But now, can you get lasix over the counter more than ever, it might be time to take stock of whatâs in the kitchen and make sure itâs safe to cook on. In recent months, thereâs been an unprecedented return to the home kitchen. In a survey of 1,000 people by the International Food Information Council, half said they were more likely to cook a meal from scratch than they had been at the beginning of the lasix. Thirty percent can you get lasix over the counter said they tried new recipes.

At the same time, a growing number of consumers are seeking cookware that will get the job done and limit their exposure to humanmade industrial chemicals. But how do the different options on store shelves stack up in terms of health, environmental impact, durability, and ease of use?. Discover asked the experts for their advice on picking pots and pans that can cook can you get lasix over the counter up delicious food and not add unintended, toxic ingredients to your dish. Suzanne Fenton, a reproductive endocrinologist at the National Institutes of Environmental Health Sciences (NIEHS).

J. Kenji LÃ³pez-Alt, a chef, author of the cooking science book The Food Lab, and chief culinary consultant for Serious Eats. And Olga Naidenko, vice president of science investigations at the Environmental Working Group (EWG), a nonprofit and nonpartisan advocacy organization.Traditional Nonstick (Credit. Iurii Stepanov/Shutterstock)Nonstick is the cooking surface that is probably the most likely to sound alarm bells in consumersâ minds.

This kind of coating, known commercially as Teflon, lines metal pans with a tough, synthetic resin to create a slippery surface. Its chemical name is polytetrafluoroethylene, or PTFE. Historically, it was made using PFOAs, or perfluorooctanoic acids. PFOAs are part of a group of stubborn chemicals that have been linked with health risks like thyroid problems, possible hormone disruption, kidney disease and immune system issues.

Molecular bonds in the coating begin to break down at around 500 degrees, according to a presentation on home chemical coatings by Michael Michalczyk, a chemical consultant. Nonstick coatings can then release dangerous fumes that irritate the respiratory system. According to Naidenko, PTFE coating today is essentially the same as the old versions â just made with much smaller amounts of PFOAs. But she adds that âthe risk of it overheating, and harming our lungs â that risk stays.

Those pans should not be overheated [during] their lifetime â that would be a concern.â Both Naidenko and Fenton noted that the health dangers posed by Teflon cookware is a small risk compared to the environmental contamination associated with manufacturing and disposing of these products. According to the EWG, per- and polyfluoroalkyl substances (or PFAS), a group of chemicals that PFOAs belong to, can be found in the drinking water of many U.S. Cities. PFAS enter the environment from Teflon products breaking down in landfills, and from the production of plastic wrappings, water-repellant items, and things like military firefighting foam.

Pure ceramic cookware thatâs closer to pottery does exist, but itâs less common. Instead, many products labeled as ceramic include a metal core with a chemically-combined coating that is sprayed on. Thereâs a good chance a ceramic pan has a coating containing silica â the same mineral that sand and silicone are made out of â and various other substances. The viral Always Pan, along with other popular options in the cookware aisle, are made using sol-gel â a wet-chemical process that forms nanoparticles into solid materials and dehydrates them into ceramic or glasslike surfaces.

But a downside to ceramic nonstick is that the coating doesnât last as long as PTFE-based pans. According to Naidenko, because itâs hard to know what the exact contents of these coatings are, âeven if one has a pan that has not a lot of PTFE in it, they still should not overheat somethingâ in a ceramic pan. Cast Iron(Credit. Natashamam/Shutterstock)It might be time to pay more attention to that friend who wonât stop talking about seasoning their cast-iron skillet.

From a safety perspective, what you see is what you get. Iron alloyed with varying amounts of carbon and silicon, forged into a shape. ÂSeasoningâ a cast iron pan is the process of adding oil or fat and heating the pan. This creates a reaction with the oil and the iron that forms a somewhat nonstick black layer â a polymer, LÃ³pez-Alt says, which gets built up as it's used.

The surface stands up well to most kinds of cooking, and prevents sticking, although acids like tomato and vinegar can break down the coating that forms. Contrary to popular belief, cast iron can be washed with soap without damaging the surface â but leaving cast iron wet with water can cause it to rust. According to LÃ³pez-Alt, âThe whole idea that you can't clean cast iron with soap is just a complete myth that no longer applies,â he says, noting that older soaps containing lye did affect cast iron, but not modern soaps. ÂI think people just sort of baby their cast iron much more than they have to.â Small amounts of iron do, in fact, end up in food, but for people prone to iron deficiency, this can actually be a benefit.

It has some nonstick properties and is very durable and heat-resistant, but can also rust. Stainless steel can be put in a dishwasher, unlike carbon steel, and it wonât react with acids as much. But overall, both are scratch-resistant and safe surfaces to cook on. Fenton favors stainless steel pans, while Lopez-Alt says he prefers his carbon steel cookware, which should be seasoned like cast iron.

ÂMy real advice would be to learn how to use carbon steel because it's the best,â he says. Aluminum and Anodized Aluminum(Credit. A. Zhuravleva/Shutterstock)Aluminum might comprise a whole pan, be mixed with other metals, or make up a layer within the pan.

Anodized aluminum is made with an electrolytic process that makes it much harder and smooth â the one downside is that you canât put these kinds of pans in the dishwasher or you risk ruining the surface, according to the book Things Cooks Love, by Marie Simmons. While there has been inconclusive research on links between aluminum and Alzheimer's, aluminum cookware is currently not considered to be a health risk. The CDC says that while aluminum cookware can transfer aluminum into foods, especially acidic ones, âaluminum levels found in processed foods and foods cooked in aluminum pots are generally considered to be safe.âCopper (Credit. FabrikaSimf/Shutterstock)Copper is favored by professional chefs for its superior conductivity, which means it heats up quickly and evenly.

But copper should not come into contact with food on its own, because it can react with acidic ingredients like wine, fruit juice, or vinegar and leach into food, according to the FDAâs 2017 Food Code. ÂWhile copper is very good because of its heating properties, too much copper is not good for the body, especially for children,â says Naidenko. ÂIt can even cause things like diarrhea and nausea.â Many copper pots or pans are lined with a metal like tin or stainless steel for this reason. Tin can wear more easily than steel, so if you have an old tin-lined copper pot, or if you spot one at a yard sale for a good price, Naidenko said itâs a good idea to look for scratches.

Copper also can be quite expensive and can oxidize in damp air, leaving a green discoloration. Takeaways From the Experts(Credit. Ekkapop Sittiwantana/Shutterstock)Each type of cookware comes with some advantages and drawbacks. A general rule of thumb is to choose cookware that works well for your needs, and steer clear of products if the materials arenât clearly defined.

You canât go wrong with basic heavy cookware that is durable and long-lasting. But note that even nonstick cookware has its place in modern kitchens and can be reserved for preparing delicate dishes that are prone to sticking. If you have the means and must replace a pot or pan, consider cookware that will stand the test of time. And know that even if the materials are considered safe for humans at home, they could become environmental hazards when they break down in landfills at the end of their life.

As Fenton said, âIf you're going to invest in cookware, you might as well go for something that's going to be a little bit safer and last you a little bit longer.â And no matter which type of pan you choose, the safest pan for your health may come down to how you wield it in the kitchen. ÂI think pretty much all the cookware out there right now is pretty safe, as long as you take care of it,â she says..

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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Data Source Online pharmacy viagra Data on all residents of Israel who had been fully vaccinated before June 1, 2021, and who had not can you buy lasix without a prescription been infected before the study period were 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 hypertension medications (see Supplementary can you buy lasix without a prescription 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 hypertension 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 can you buy lasix without a prescription from July 11 through 31, 2021 (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 lasix 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 can you buy lasix without a prescription 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 can you buy lasix without a prescription 40 years of age or older were included in the analysis of severe disease because severe disease was 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 hypertension medications 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.

Most residents who traveled abroad had been vaccinated and were exposed to different populations, so their risk of differed can you buy lasix without a prescription 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 the administration of the second dose 3 weeks after the can you buy lasix without a prescription first dose.

On February 4, 2021, all persons 16 years of age or older became eligible for vaccination. Thus, if they did not belong to a can you buy lasix without a prescription 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 the second dose). All the analyses were stratified according to vaccination period and to age group (16 to 39 years, 40 can you buy lasix without a prescription to 59 years, and â¥60 years). Statistical Analysis The association between the rate of confirmed s and the period of vaccination provides a measure of waning immunity.

Without waning can you buy lasix without a prescription 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 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 hypertension medications and the vaccination period, but for this outcome we used periods of can you buy lasix without a prescription entire months because there were fewer cases of severe disease. To account for possible confounders, we fitted Poisson regressions. The outcome variable was the number of documented hypertension s or cases of severe hypertension medications can you buy lasix without a prescription during the study 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 can you buy lasix without a prescription 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 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 can you buy lasix without a prescription 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 three levels of can you buy lasix without a prescription 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 lasix, differed among these groups.18 Although we restricted the study to dates when can you buy lasix without a prescription the lasix was found throughout the country, we included population sector as a covariate to control for any residual 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 can you buy lasix without a prescription 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 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.

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 can you buy lasix without a prescription 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 can you buy lasix without a prescription in data collection, 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 authorsâ direction.

All the authors had confidentiality agreements with the can you buy lasix without a prescription sponsors. Patients and Procedures Adult patients (â¥18 years of age) who had a positive result on reverse-transcriptaseâpolymerase-chain-reaction or antigen hypertension testing and an onset of hypertension medications symptoms within the previous 5 days were screened for eligibility. Screening was can you buy lasix without a prescription performed within 24 hours before the administration of sotrovimab or placebo.

The patients were at high risk for progression of hypertension medications because of older age (â¥55 years) or because they had at least one of the following risk factors. Diabetes for which medication was warranted, obesity (body-mass index [BMI. The weight in kilograms divided by the square of can you buy lasix without a prescription 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 hypertension medications, 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 can you buy lasix without a prescription. Figure 1.

Trial Design. Patients were stratified according to can you buy lasix without a prescription age (â¤70 years or >70 years), symptom duration (â¤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 1 (Figure 1).

The trial design can you buy lasix without a prescription did not mandate any treatment for hypertension medications 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 any cause through day 29 after randomization.

Secondary efficacy outcomes included the percentage of patients with an emergency department visit, hospitalization, can you buy lasix without a prescription 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 as infusion-related reactions (including hypersensitivity reactions). Immunogenicity testing for antidrug can you buy lasix without a prescription antibodies was performed, and antibody-dependent enhancement was evaluated.

All hospitalizations, including those due to hypertension medications, 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 can you buy lasix without a prescription assess both futility due to lack of efficacy and efficacy.

A LanâDeMets alpha-spending function was used to control type I error, with the use of a Pocock analogue rule for futility and a HwangâShihâDeCani analogue rule for efficacy (with the value of Î³=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 hypertension medications 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 can you buy lasix without a prescription or placebo. The safety analysis 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 for trial agent, duration of symptoms, age, can you buy lasix without a prescription 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 can you buy lasix without a prescription 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. Analyses of all secondary and exploratory outcomes are planned when all the patients have completed day 29.To the Editor.

Ivermectin is approved by the Food can you buy lasix without a prescription and Drug Administration as an oral treatment for intestinal strongyloidiasis and onchocerciasis and as a topical treatment for pediculosis and rosacea. It is also used as a treatment for parasites in pets and livestock. Ivermectin may decrease severe acute respiratory syndrome hypertension 2 (hypertension) replication in vitro,1,2 but randomized, controlled trials have shown no clinical benefit in the prevention or treatment of hypertension disease 2019 (hypertension medications).3 Veterinary use of ivermectin has increased, and the number of can you buy lasix without a prescription prescriptions for use by humans in the United States is 24 times as high as the number before the lasix.

Moreover, the number of such prescriptions in August 2021 was 4 times as high as the number in July 2021.3,4 The Oregon Poison Center is a telephone consultative center staffed by specialty-trained nurses, pharmacists, and physicians who provide treatment advice for the public and comprehensive treatment consultation for health care workers caring for patients in Oregon, Alaska, and Guam. The center has recently received an increasing number of calls regarding ivermectin can you buy lasix without a prescription exposure related to hypertension medications. The rate of calls regarding ivermectin had been 0.25 calls per month in 2020 and had increased to 0.86 calls per month from January through July 2021.

In August 2021, the center received 21 calls. Monthly total call volumes for all can you buy lasix without a prescription poison exposures were stable throughout 2020 and 2021. Of the 21 persons who called in August, 11 were men, and most were older than 60 years of age (median age, 64.

Range, 20 can you buy lasix without a prescription to 81). Approximately half (11 persons) were reported to have used ivermectin to prevent hypertension medications, and the remaining persons had been using the drug to treat hypertension medications symptoms. Three persons had received prescriptions from physicians or veterinarians, and 17 had purchased veterinary formulations.

The source of ivermectin for the remaining person was not confirmed can you buy lasix without a prescription. Symptoms had developed in most persons within 2 hours after a large, single, first-time dose. In 6 persons, can you buy lasix without a prescription symptoms had developed gradually after several days to weeks of repeated doses taken every other day or twice weekly.

One person had also been taking vitamin D to treat or prevent hypertension medications. Reported doses ingested by the persons who had been using veterinary products ranged from 6.8 mg to 125 mg of 1.87% paste and 20 to 50 mg of the 1% solution. The dose of can you buy lasix without a prescription the human-use tablets was 21 mg per dose twice weekly for prevention.

Six of the 21 persons were hospitalized for toxic effects from ivermectin use. All 6 reported preventive use, including the 3 who had obtained can you buy lasix without a prescription the drug by prescription. Four received care in an intensive care unit, and none died.

There is insufficient evidence to support the use of can you buy lasix without a prescription ivermectin to treat or prevent hypertension medications,3 and improper use, as well as the possible occurrence of medication interactions,5 may result in serious side effects requiring hospitalization. Courtney Temple, M.D.Ruby Hoang, D.O.Robert G. Hendrickson, M.D.Oregon Health and Science University, Portland, OR Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.

This letter was published on October can you buy lasix without a prescription 20, 2021, at NEJM.org.5 References1. Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin can you buy lasix without a prescription inhibits the replication of hypertension in vitro.

Antiviral Res 2020;178:104787-104787.2. Lehrer S, Rheinstein PH. Ivermectin docks can you buy lasix without a prescription to the hypertension spike receptor-binding domain attached to ACE2.

In Vivo 2020;34:3023-3026.3. Centers for can you buy lasix without a prescription Disease Control and Prevention. Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat hypertension medications.

CDC Health Alert Network no. CDCHAN-00449. August 26, 2021 (https://emergency.cdc.gov/han/2021/han00449.asp).Google Scholar4.

Lind JN, Lovegrove MC, Geller AI, Uyeki TM, Datta SD, Budnitz DS. Increase in outpatient ivermectin dispensing in the US during the hypertension medications lasix. A cross-sectional analysis.

J Gen Intern Med 2021;36:2909-2911.5. Edwards G. Ivermectin.

Does P-glycoprotein play a role in neurotoxicity?. Filaria J 2003;2:Suppl 1:S8-S8..

Data Source visit site 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 September 2, 2021 can you get lasix over the counter. 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 can you get lasix over the counter all information regarding hypertension medications (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 hypertension s (i.e., positive result on PCR assay) and on the severity of the disease after . We focused on s can you get lasix over the counter that had been documented in the period from July 11 through 31, 2021 (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 lasix 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 can you get lasix over the counter period 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 rare in can you get lasix over the counter 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 hypertension medications 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. Most residents who traveled abroad had been vaccinated and were exposed to different populations, can you get lasix over the counter 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 the administration can you get lasix over the counter 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 only if they belonged to designated groups (e.g., health care workers and severely immunocompromised adults). The eligibility age was reduced to 55 years can you get lasix over the counter on January 12, 2021, and to 40 years on January 19, 2021. On February 4, 2021, all persons 16 years of age or older became eligible for vaccination. Thus, if they can you get lasix over the counter 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 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 can you get lasix over the counter â¥60 years). Statistical Analysis The association 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 can you get lasix over the counter 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 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 hypertension medications and the vaccination period, but for this outcome we can you get lasix over the counter used periods of entire months because there were fewer cases of severe disease. To account for possible confounders, we fitted Poisson regressions. The outcome variable was the number of documented hypertension s or cases of severe hypertension medications can you get lasix over the counter during the study period.

The period of vaccination, which was defined as 7 days after receipt of the second dose of the hypertension medications 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 can you get lasix over the counter effect of the vaccination period for 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 can you get lasix over the counter 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 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 can you get lasix over the counter 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 three can you get lasix over the counter 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 lasix, differed among these groups.18 can you get lasix over the counter Although we restricted the study to dates when the lasix was found throughout the country, we included population sector as a covariate to control for any residual 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 be informative, and also owing to concern regarding nondifferential misclassification (persons with unknown socioeconomic status may have had different rates of vaccination, , can you get lasix over the counter 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 can you get lasix over the counter 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 hypertension medications 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 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 can you get lasix over the counter in accordance with the principles of the Declaration of Helsinki and the 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 can you get lasix over the counter the sponsors and trial investigators participated in data collection, 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 authorsâ direction. All the authors had confidentiality agreements with the can you get lasix over the counter sponsors.

Patients and Procedures Adult patients (â¥18 years of age) who had a positive result on reverse-transcriptaseâpolymerase-chain-reaction or antigen hypertension testing and an onset of hypertension medications symptoms within the previous 5 days were screened for eligibility. Screening was performed can you get lasix over the counter within 24 hours before the administration of sotrovimab or placebo. The patients were at high risk for progression of hypertension medications because of older age (â¥55 years) or because they had at least one of the following risk factors. Diabetes for which 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 can you get lasix over the counter severe hypertension medications, 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 can you get lasix over the counter. Figure 1. Trial Design. Patients were stratified according to age (â¤70 years or >70 years), symptom duration (â¤3 days or 4 or 5 days), and geographic can you get lasix over the counter 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 1 (Figure 1). The trial can you get lasix over the counter design did not mandate any treatment for hypertension medications 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 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 can you get lasix over the counter 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 as infusion-related reactions (including hypersensitivity reactions). Immunogenicity testing for antidrug antibodies was can you get lasix over the counter performed, and antibody-dependent enhancement was evaluated. All hospitalizations, including those due to hypertension medications, 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 can you get lasix over the counter were based on a group-sequential design with two interim analyses to assess both futility due to lack of efficacy and efficacy.

A LanâDeMets alpha-spending function was used to control type I error, with the use of a Pocock analogue rule for futility and a HwangâShihâDeCani analogue rule for efficacy (with the value of Î³=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 hypertension medications 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 can you get lasix over the counter 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 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 can you get lasix over the counter 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 can you get lasix over the counter 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. Analyses of all secondary and exploratory outcomes are planned when all the patients have completed day 29.To the Editor. Ivermectin is approved by can you get lasix over the counter the Food and Drug Administration as an oral treatment for intestinal strongyloidiasis and onchocerciasis and as a topical treatment for pediculosis and rosacea.

It is also used as a treatment for parasites in pets and livestock. Ivermectin may decrease severe acute respiratory syndrome hypertension 2 (hypertension) replication in vitro,1,2 but randomized, controlled trials have shown no clinical benefit in the prevention or treatment of hypertension disease 2019 (hypertension medications).3 Veterinary use of ivermectin has increased, and the number of prescriptions for can you get lasix over the counter use by humans in the United States is 24 times as high as the number before the lasix. Moreover, the number of such prescriptions in August 2021 was 4 times as high as the number in July 2021.3,4 The Oregon Poison Center is a telephone consultative center staffed by specialty-trained nurses, pharmacists, and physicians who provide treatment advice for the public and comprehensive treatment consultation for health care workers caring for patients in Oregon, Alaska, and Guam. The center has recently received an increasing number of calls regarding ivermectin can you get lasix over the counter exposure related to hypertension medications. The rate of calls regarding ivermectin had been 0.25 calls per month in 2020 and had increased to 0.86 calls per month from January through July 2021.

In August 2021, the center received 21 calls. Monthly total call volumes for all poison exposures were stable can you get lasix over the counter throughout 2020 and 2021. Of the 21 persons who called in August, 11 were men, and most were older than 60 years of age (median age, 64. Range, 20 to 81) can you get lasix over the counter. Approximately half (11 persons) were reported to have used ivermectin to prevent hypertension medications, and the remaining persons had been using the drug to treat hypertension medications symptoms.

Three persons had received prescriptions from physicians or veterinarians, and 17 had purchased veterinary formulations. The source of ivermectin for the remaining person was not can you get lasix over the counter confirmed. Symptoms had developed in most persons within 2 hours after a large, single, first-time dose. In 6 persons, symptoms had developed gradually after several days to weeks of repeated doses taken every other day or can you get lasix over the counter twice weekly. One person had also been taking vitamin D to treat or prevent hypertension medications.

Reported doses ingested by the persons who had been using veterinary products ranged from 6.8 mg to 125 mg of 1.87% paste and 20 to 50 mg of the 1% solution. The dose of can you get lasix over the counter the human-use tablets was 21 mg per dose twice weekly for prevention. Six of the 21 persons were hospitalized for toxic effects from ivermectin use. All 6 reported can you get lasix over the counter preventive use, including the 3 who had obtained the drug by prescription. Four received care in an intensive care unit, and none died.

Symptoms were gastrointestinal distress in 4 persons, confusion in 3, ataxia and weakness in 2, hypotension in 2, and seizures in 1. Of the persons who were not admitted to a hospital, most had gastrointestinal distress, dizziness, confusion, vision symptoms, or can you get lasix over the counter rash. These cases illustrate the potential toxic effects of ivermectin, including severe episodes of confusion, ataxia, seizures, and hypotension, and the increasing frequency of inappropriate use. There is insufficient evidence to support the use of ivermectin to treat or prevent hypertension medications,3 and improper use, as well as the possible can you get lasix over the counter occurrence of medication interactions,5 may result in serious side effects requiring hospitalization. Courtney Temple, M.D.Ruby Hoang, D.O.Robert G.

Hendrickson, M.D.Oregon Health and Science University, Portland, OR Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. This letter was published on October can you get lasix over the counter 20, 2021, at NEJM.org.5 References1. Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin can you get lasix over the counter inhibits the replication of hypertension in vitro. Antiviral Res 2020;178:104787-104787.2.

Lehrer S, Rheinstein PH. Ivermectin docks can you get lasix over the counter to the hypertension spike receptor-binding domain attached to ACE2. In Vivo 2020;34:3023-3026.3. Centers for Disease Control and can you get lasix over the counter Prevention. Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat hypertension medications.

CDC Health Alert Network no. CDCHAN-00449. August 26, 2021 (https://emergency.cdc.gov/han/2021/han00449.asp).Google Scholar4. Lind JN, Lovegrove MC, Geller AI, Uyeki TM, Datta SD, Budnitz DS. Increase in outpatient ivermectin dispensing in the US during the hypertension medications lasix.

A cross-sectional analysis. J Gen Intern Med 2021;36:2909-2911.5. Edwards G. Ivermectin. Does P-glycoprotein play a role in neurotoxicity?.

What is lasix used for

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Full time starting salary is normally in the range Â£41,526 to Â£49,553. With potential progression once in post to Â£55,750 a yearClosing Date. 31st January 2021Job PurposeThe post holder will play a key role in the development and evaluation of research into surgical practice as part of the National Institute for Health Research (NIHR) Global Health Research Unit on Global Surgery led by the University of Birmingham.Main ResponsibilitiesProvide expert methodological and statistical advice on the design of clinical trials and observational studies and develop studies in collaboration with Clinical Investigators.Collaborate with Clinical Investigators in the submission of grant applications.Collaborate with Clinical Investigators and Trial Co-ordinators in writing study protocols and developing data collection forms.Collaborate with Programmers and Trial Co-ordinators in the development of data management systems.Determine appropriate statistical analysis of study data and write statistical analysis plans.Supervise the statistical input and analysis to assist Trial Co-ordinators in the running of studies, and the monitoring of data quality of on-going studies.Take overall responsibility for the analysis of study data, preparing and presenting reports for Data Monitoring and Steering Committees, and contribute to presentations and publications of study results.Take overall responsibility for the statistical contributions to publications of research being undertaken, taking the lead when appropriate.Present study results and methodological research at internal and external seminars and national and international conferences.Person SpecificationMSc or PhD in Statistics or Epidemiology, or a relevant higher degree.Significant experience of working as an applied medical statistician or epidemiologist, with experience of applying statistical techniques for medical problems.Significant experience in medical statistics, clinical trials and observational studies, specifically in the design and writing of study protocols and the analysis, reporting and publication of results.Experience of applying statistical techniques e.g. Linear, logistic and Cox regression, analysis of variance, repeated measures, survival analysis.Experience in statistical programming, preferably in SAS and/or STATA.Experience of computer-based database management and data extraction/reporting techniques (preferably Access/SQL).Experience and demonstrated success in planning, undertaking and project managing statistical aspects of clinical research to deliver high quality results.Experience of writing grant applications.Experience in writing reports and papers for publication.For informal inquiries please contact H.L.Walton@bham.ac.uk or Natalie Ives N.j.ives@bham.ac.ukClosing date.

31st January 2021 Reference. 96683To download the full job description and details of this position and submit an electronic application online please click on the Apply Online button below or visit https://bham.taleo.net/careersection/external/jobsearch.ftl?. Lang=en&portal=101430233 Please quote Job Ref 96683 in all enquiries.Valuing excellence, sustaining investmentWe value diversity at The University of Birmingham and welcome applications from all sections of the communityâ.

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Boasting a new modern campus in Zhangjiang can you get lasix over the counter High-tech Park of cosmopolitan Shanghai, ShanghaiTech shall trail-blaze a new education system in China. Besides establishing and maintaining a world-class research profile, faculty candidates are also expected to contribute substantially to both graduate and undergraduate education.â¯ Academic Disciplines. Candidates in all can you get lasix over the counter areas of Biomedical Engineering shall be considered. Our recruitment focuses, but is not limited to:â¯Medical Imaging and Informatics (i.e., MR, CT, PET, Radiotherapy), Intelligent Medicine (using Artificial Intelligence, and Big Data), and Smart Biomedical Instruments (i.e., can you get lasix over the counter Wearable Device and Medical Robotics). Compensation and can you get lasix over the counter Benefits.

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96683To download the full job description and details of this position and submit an electronic application online please click on the Apply Online button below or visit https://bham.taleo.net/careersection/external/jobsearch.ftl?. Lang=en&portal=101430233 Please quote Job Ref 96683 in all enquiries.Valuing excellence, sustaining investmentWe value diversity at The University of Birmingham and welcome applications from all sections of the communityâ.

Is lasix bad for kidneys

Start Preamble is lasix bad for kidneys Centers http://ssbsoftware.com/lasix-street-price for Medicare &. Medicaid Services (CMS), HHS. Proposed rule is lasix bad for kidneys.

This proposed rule would establish a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). After the final rule is effective, the Medicare Coverage of Innovative Technology (MCIT) pathway would begin national Medicare coverage on the date of FDA market authorization and would continue for 4 years. We are also proposing regulatory standards to be used in making reasonable and necessary determinations under section Start Printed Page 543281862(a)(1)(A) of the Social Security Act (the is lasix bad for kidneys Act) for items and services that are furnished under Part A and Part B.

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. On November 2, 2020 is lasix bad for kidneys. In commenting, please refer to file code CMS-3372-P.

Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of three ways (please choose only one of is lasix bad for kidneys the ways listed). 1.

Electronically. You may is lasix bad for kidneys submit electronic comments on this regulation to http://www.regulations.gov. Follow the âSubmit a commentâ instructions.

2. By regular mail. You may mail written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-3372-P, P.O.

Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3.

By express or overnight mail. You may send written comments to the following address ONLY. Centers for Medicare &.

Medicaid Services, Department of Health and Human Services, Attention. CMS-3372-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

Start Further Info Linda Gousis or JoAnna Baldwin, (410) 786-2281 or CAGinquiries@cms.hhs.gov. End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment.

We post all comments received before the close of the comment period on the following website as soon as possible after they have been received. Http://www.regulations.gov. Follow the search instructions on that website to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare &. Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. To 4 p.m.

To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background The Administration is committed to ensuring Medicare beneficiaries have access to new cures and technologies that improve health outcomes.

Section 6 of the October 3, 2019 Executive Order 13890 (E.O. 13890) âExecutive Order on Protecting and Improving Medicare for Our Nation's Seniors,ââ[] directs the Secretary to âpropose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patientsâ including by âstreamlining the approval, coverage, and coding processâ.[] The E.O. 13890 explicitly includes making coverage of breakthrough medical devices âwidely available, consistent with the principles of patient safety, market-based policies, and value for patients.ââ[] The E.O.

Also directs the Secretary to âclarify the application of coverage standards.ââ[] We are responding directly to these directives by proposing a definition of the term âreasonable and necessaryâ to clarify coverage standards and proposing the Medicare Coverage of Innovative Technology (MCIT) pathway to accelerate the coverage of new, innovative breakthrough devices to Medicare beneficiaries. To date, the factors used in making âreasonable and necessaryâ determinations based on section 1862(a)(1)(A) of the Act have not been established in regulations for Medicare coverage purposes. The Secretary has authority to determine whether a particular medical item or service is âreasonable and necessaryâ under section 1862(a)(1)(A) of the Act.

(See Heckler v. Ringer, 466 U.S. 602, 617 (1984).) When making coverage determinations, our policies have long considered whether the item or service is safe and effective, not experimental or investigational, and appropriate.

(For more information see the January 30, 1989 notice of proposed rulemaking (54 FR 4307)). These factors are found in Chapter 13 of the Medicare Program Integrity Manual (PIM) at section 13.5.4âReasonable and Necessary Provisions in LCDs as instructions for Medicare contractors. We are proposing to codify in regulations the Program Integrity Manual definition of âreasonable and necessaryâ with modifications, including to add a reference to Medicare patients and a reference to commercial health insurer coverage policies.

We propose that an item or service would be considered âreasonable and necessaryâ if it isâ(1) safe and effective. (2) not experimental or investigational. And (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it isâ Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.

Furnished in a setting appropriate to the patient's medical needs and condition. Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient's medical need.

And At least as beneficial as an existing and available medically appropriate alternative. We also propose that an item or service would be âappropriate for Medicare patientsâ under (3) if it is covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals. An item or service deemed appropriate for Medicare coverage based on commercial coverage would be covered on that basis without also having to satisfy the bullets listed above.

We believe this definition is a significant step in meeting the E.O.'s directive to bring clarity to coverage standards. Stakeholders have expressed interest in codifying a definition of âreasonable and necessaryâ for many years. This proposed definition is familiar and functional, can satisfy that interest and meet the E.O.'s ask, while also aligning with the goals of MCIT by providing clarity and predictability for innovation, including for beneficiaries and innovators.

The proposed MCIT coverage pathway is specifically for Medicare coverage of devices that are designated as part of the Food and Drug Administration's (FDA) Breakthrough Devices Program (hereafter referred to as âbreakthrough devicesâ) and are FDA market authorized. The MCIT pathway would be voluntary and device manufacturers would notify CMS if they want to utilize this coverage option. We propose that national Medicare coverage under the MCIT pathway would begin immediately upon the date of FDA market authorization (that is, the Start Printed Page 54329date the medical device receives Premarket Approval (PMA).

510(k) clearance. Or the granting of a De Novo classification request) for the breakthrough device. This coverage would occur unless the device does not have a Medicare benefit category or is otherwise excluded from coverage by statute (that is, the Medicare statute does not allow for coverage of the particular device.) This coverage pathway delivers on the Administration's commitment to give Medicare beneficiaries access to the newest innovations on the market, consistent with the statutory definitions of Medicare benefits.

Because Medicare is a defined benefit program, devices that do not fit within the statutory definitions may not be considered for MCIT. As an example, medical equipment for home use by the beneficiary must be durable (that is, withstand repeated use) for it to be coverable by Medicare (as defined in statutes and regulations by the Secretary). At this time, we are limiting MCIT to medical devices because that is a category of products explicitly identified in E.O.

13890, and we have identified that breakthrough devices can experience variable coverage across the nation shortly after market authorization. We propose this MCIT pathway because the prescribed statutory timeframes for the National Coverage Determination (NCD) process limit CMS' ability to institute immediate national coverage policies for new, innovative medical devices. NCDs and Local Coverage Determinations (LCD) take, on average, 9 to 12 months to finalize.

Because of this length of time, there may be coverage uncertainty between the period of FDA market authorization and CMS finalization of an NCD or a Medicare Administrative Contractor's (MACs) finalization of an LCD. During this time period shortly after market authorization, MACs make coverage determinations on a case-by-case (individual beneficiary) basis, but those decisions do not usually establish agency policies for future claims because a case-by-case decision is for a particular beneficiary and their health circumstances. Over the past few years, CMS has heard concerns from stakeholders that breakthrough devices are not automatically covered nationally by Medicare once they are FDA market authorized.

Variation in coverage from one jurisdiction to another is also a concern. To date, 16 breakthrough devices have also been market authorized. The majority of these breakthrough devices (10 devices) experience variability in coverage for two reasons.

One reason is because the breakthrough devices are coverable at MAC discretion, like many other item and services, on a case-by-case basis (that is, the breakthrough device may be covered for one patient, but not for another within the same jurisdiction). The other reason is because breakthrough devices are used by a hospital or other provider that operates under a bundled payment system (such as a diagnosis related group (DRG) system), so there may be no separate coverage policy for each item or service that may be included in the bundled payment. Another example of variable coverage is for one breakthrough device that is non-covered by a local policy in Florida, but coverable at MAC discretion on a case-by-case basis in other jurisdictions.

One breakthrough device has national coverage through an NCD. One breakthrough device has uniform coverage because the same LCD has been adopted in all jurisdictions. There are three breakthrough devices that do not have a Medicare benefit category (for example, certain wearable devices).

Therefore, those breakthrough devices cannot be covered by the Medicare program. In contrast to varied local coverage, the proposed MCIT would create a pathway for immediate national Medicare coverage of any FDA-market authorized breakthrough device if the device meets criteria outlined in this proposal. A.

Statutory Authority We are also proposing to establish in regulations the factors we have historically used in making âreasonable and necessaryâ determinations under section 1862(a)(1)(A) of the Act, with some modification. To summarize, this section explains that Medicare payment may be made under part A or part B for any expenses incurred for items or services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Thus, with some exceptions, section 1862(a)(1)(A) of the Act requires that an item or service be âreasonable and necessaryâ to be covered by Medicare.

The courts have recognized that the Secretary has significant authority to determine whether a particular item or service is âreasonable and necessary.â (Heckler v. Ringer, 466 U.S. 602, 617 (1984).

See also, Yale-New Haven Hospital v. Leavitt, 470 F.3d 71, 84 (2d Cir. 2006).

3d 98, 110 (D.C. 2016) (The statute vests substantial authority in the Secretary.)) So even though section 1862(a)(1)(A) of the Act limits the scope of Medicare coverage, the Secretary has discretion to revise his/her interpretation of the statute in order to ensure adequate coverage for items and services under Part A and Part B. This proposal would provide national Medicare coverage for breakthrough devices that are FDA market-authorized and used consistent with the FDA approved or cleared indication for use (also referred to as the âFDA-required labelingâ).[] This device coverage under the MCIT pathway is reasonable and necessary under section 1862(a)(1)(A) of the Act because the device has met the unique criteria of the FDA Breakthrough Devices Program.

B. FDA Breakthrough Devices Program Under the proposed MCIT coverage pathway, CMS would coordinate with FDA and manufacturers as medical devices move through the FDA regulatory process for Breakthrough Devices to ensure seamless Medicare coverage on the date of FDA market authorization unless CMS determines those devices do not have a Medicare benefit category. The Breakthrough Devices Program is an evolution of the Expedited Access Pathway Program and the Priority Review Program (section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), 21 U.S.C.

360e-3. See also final guidance for industry entitled, âBreakthrough Devices Program,â https://www.fda.gov/âdownloads/âMedicalDevices/âDeviceRegulationandGuidance/âGuidanceDocuments/âUCM581664.pdf). The FDA's Breakthrough Devices Program is not for all new medical devices.

Rather, it is only for those that the FDA determines meet the standards for breakthrough device designation. In accordance with section 3051 of the 21st Century Cures Act (21 U.S.C. 360e-3),[] the Breakthrough Devices Program is for medical devices and device-led combination products that meet two criteria.

The first criterion is that the device provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. The second criterion is that the device must satisfy one of the following elements. It Start Printed Page 54330represents a breakthrough technology.

No approved or cleared alternatives exist. It offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute. Or device availability is in the best interest of patients (for more information see 21 U.S.C.

360e-3(b)(2)). These criteria make breakthrough designated devices unique among all other medical devices.[] The parameters of the breakthrough devices program focus on innovations for patients, in turn, MCIT, focuses on these breakthrough devices consistent with E.O. 13890 and in order to streamline coverage of innovative medical devices.

C. Current Medicare Coverage Pathways Currently, we utilize several coverage pathways for items and services, which includes medical devices. None of the coverage pathways described in this section offer immediate, predictable coverage concurrently with FDA market authorization like the proposed MCIT pathway would do.

We summarize the other coverage pathways here to provide context for MCIT. National Coverage Determinations (NCDs). Section 1862(l)(6)(A) of the Act defines the term national coverage determination as âa determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this title.â In general, NCDs are national policy statements published to identify the circumstances under which particular items and services will be considered covered by Medicare.

Traditionally, CMS relies heavily on health outcomes data to make NCDs. Most NCDs have involved determinations under section 1862(a)(1)(A) of the Act, but NCDs can be made based on other provisions of the Act, and includes a determination that the item or service under consideration has a Medicare benefit category. The NCD pathway, which has statutorily prescribed timeframes, generally takes 9 to 12 months to complete.[] Local Coverage Determinations (LCDs).

Medicare contractors develop LCDs based on section 1862(a)(1)(A) of the Act that apply only within their geographic jurisdictions. (Sections 1862(l)(6)(B) and 1869(f)(2)(B) of the Act.) MACs will not need to develop LCDs for breakthrough devices when they are nationally covered through MCIT. The MACs follow specific guidance for developing LCDs for Medicare coverage in the CMS Program Integrity Manual, and in some instances, an LCD can also take 9 to12 months to develop (MACs must finalize proposed LCDs within 365 days from opening per Chapter 13âLocal Coverage Determinations of the (PIM) 13.5.1).

We note that the MCIT pathway will not alter the existing coverage standards in Chapter 13âLocal Coverage Determinations of the PIM.[] That chapter will continue to be used in making determinations under section 1862(a)(1)(A) of the Act for other items and services at the local level. Claim-by-claim Adjudication. In the absence of an NCD or LCD, MACs would make coverage decisions under section 1862(a)(1)(A) of the Act and may cover or not cover items and services on a claim-by-claim basis.

The majority of claims are handled through the claim adjudication process. Clinical Trial Policy (CTP) NCD 310.1. The CTP pathway can be used for coverage of routine care items and services (but generally not the technology under investigation) in a clinical study that is supported by certain Federal agencies.

The CTP coverage pathway was developed in 2000.[] This coverage pathway has not generally been utilized by device manufacturers because they usually seek coverage of the device, which is not included in this pathway. Parallel Review. Parallel Review is a mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDA's approval of a premarket application or granting of a de novo classification and the subsequent CMS NCD.

Parallel Review has two stages. (1) FDA and CMS meet with the manufacturer to provide feedback on the proposed pivotal clinical trial within the FDA pre-submission process. And (2) FDA and CMS concurrently review (âin parallelâ) the clinical trial results submitted in the PMA, or De Novo request.

FDA and CMS independently review the data to determine whether it meets their respective Agency's standards and communicate with the manufacturer during their respective reviews. This program is most successful for devices that have a significant amount of clinical evidence. (Candidates for parallel review would not be appropriate for simultaneous MCIT consideration.) Even though CMS has multiple coverage pathways, at this time none are readily available to provide immediate national coverage for new breakthrough devices with a Medicare benefit category at the same time as FDA market authorization.

Further, some of these new breakthrough devices are likely to have limited or developing bodies of clinical evidence because of the newness of the device. Therefore, the MCIT pathway can support manufacturers that are interested in combining coverage with their own clinical study to augment clinical evidence of improved health outcomes, particularly for Medicare patients. Given this summary of existing coverage pathways, we seek comment from the public regarding if any of these existing pathways should be modified to achieve the goals set out by E.O.

The MCIT pathway is voluntary (that is, manufacturers would affirmatively opt-in), and would be initiated when a manufacturer notifies CMS of its intention to utilize the MCIT pathway. (This notification process is described further in section III. Of this proposed rule.) We would subsequently coordinate with the manufacturer regarding steps that need to be taken for MCIT implementation purposes.

The frequency of subsequent engagement will be largely driven by whether the manufacturer has questions for CMS, or CMS and FDA. The timing of coverage will depend upon the timing of the FDA's market authorization decision. Engagements can take place in the form of in-person meetings, phone calls, emails, etc.

We intend to put devices that are covered through the MCIT pathway on the CMS website so that all stakeholders will be aware of what is covered through the MCIT pathway. Manufacturers of breakthrough devices will not be obligated or mandated by CMS to conduct clinical studies during Start Printed Page 54331coverage under the proposed MCIT pathway. However, we seek comment as to whether CMS should require or incentivize manufacturers to provide data about outcomes or should be obligated to enter into a clinical study similar to CMS's Coverage with Evidence Development (CED) paradigm.[] We are aware some manufacturers may be required by the FDA to conduct post market data collection as a condition of market authorization, and nothing in this proposed rule would alter that FDA requirement.

Manufacturers are encouraged to develop the clinical evidence base needed for one of the other coverage pathways after the MCIT pathway ends. This evidence is encouraged not only for CMS and private commercial health insurer coverage policies but also to better inform the clinical community and the public generally about the risks and benefits of treatment. CMS encourages early manufacturer engagement, both before and after FDA market authorization, for manufacturers to receive feedback from CMS on potential clinical study designs and clinical endpoints that may produce the evidence needed for a definitive coverage determination after MCIT.

This feedback would not involve CMS predicting specific coverage or non-coverage. In order to further the goals of E.O. 13890, CMS proposes to rely on FDA's breakthrough device designation and market authorization of those devices to define the universe of devices eligible for MCIT, except for those particular devices CMS determines do not have a Medicare benefit category or are statutorily excluded from coverage under Part A or Part B.

In order to provide immediate national coverage to innovative medical devices, we propose to establish a time limit on how long a breakthrough device can be eligible for MCIT (that is, considered a breakthrough device for coverage purposes). MCIT has a time limit on newness similar to our New Technology Add-on Payment (NTAP) policy. Eligibility for the NTAP is also time limited and this time limit applies to all new technologies, including breakthrough devices, for which an application for additional payment is submitted.

Additionally, the time-limited characteristic of MCIT will drive some manufacturers to leverage this period of coverage to demonstrate the value of their device in the competitive marketplace. The 4-year coverage period is particularly important for manufacturers of breakthrough devices that choose to further develop the clinical evidence basis on which the FDA granted marketing authorization. From our experience with clinical studies conducted as part of an NCD, 4 years is approximately the amount of time it takes to complete a study.

At the end of the 4-year MCIT pathway, coverage of the breakthrough device would be subject to one of these possible outcomes. (1) NCD (affirmative coverage, which may include facility or patient criteria). (2) NCD (non-coverage).

Or (3) MAC discretion (claim-by-claim adjudication or LCD). Manufacturers that are interested in a NCD are encouraged to submit a NCD request during the third year of MCIT to allow for sufficient time for NCD development. We seek public comment on whether CMS should open a national coverage analysis if a MAC has not issued an LCD for a breakthrough device within 6 months of the expiration date of the 4-year MCIT period.

In our analysis of the current coverage landscape to determine opportunities for innovation and efficiencies, we also considered modifying the coverage process for non-breakthrough devices (for example, PMAs because they are also new to the market), but ultimately determined that it was the unique characteristics of FDA designated breakthrough devices and their ability to serve unmet needs that resonated most with the E.O.'s direction to encourage innovation for patients. We also considered expedited coverage of newly market authorized and breakthrough devices when used in a clinical study. We seek public comment on the proposed MCIT pathway, the considerations described, whether any of the existing coverage pathways should be modified to achieve the goals set out by the E.O., and alternatives to these proposals.

We specifically seek public comment on whether the MCIT pathway should also include diagnostics, drugs and/or biologics that utilize breakthrough or expedited approaches at the FDA (for example, Breakthrough Therapy, Fast Track, Priority Review, Accelerated Approval)â[] or all diagnostics, drugs and/or biologics. We seek data to support including these additional item categories in the MCIT pathway. Also, we specifically seek manufacturer input on whether an opt-in or opt-out approach would work best for utilizing the MCIT pathway.

We believe manufactures will welcome this new coverage pathway. We want to preserve manufacturers' business judgment and not assume which Medicare coverage pathway a given manufacturer of a breakthrough device would prefer (if any). Therefore, we have proposed an opt-in approach with an email to CMS to indicate affirmative interest in coverage.

We are interested in whether an opt-out approach would be less burdensome for stakeholders. If so, we encourage public comment on a process for stakeholders to opt-out of MCIT that would not be burdensome. Also, we seek public comment on whether, once a manufacturer has opted-out of coverage, it can subsequently opt-in to MCIT.

II. Provision of Proposed Regulations A. Defining âReasonable and Necessaryâ As described in section I.

Of this proposed rule, the Secretary has authority to determine the meaning of âreasonable and necessaryâ under section 1862(a)(1)(A) of the Act. We are proposing to codify the longstanding Program Integrity Manual definition of âreasonable and necessaryâ into our regulations at 42 CFR 405.201(b), with modification. Under the current definition, an item or service is considered âreasonable and necessaryâ if it is (1) safe and effective.

(2) not experimental or investigational. And (3) appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it isâ Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member. Furnished in a setting appropriate to the patient's medical needs and condition.

Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient's medical need. And At least as beneficial as an existing and available medically appropriate alternative.

In addition to codifying the above criteria, we propose to include a separate basis under which an item or service would be appropriate under (3) above that is based on commercial health insurers' coverage policies (that is, non-governmental entities that sponsor health insurance plans). The Start Printed Page 54332commercial market analysis would be initiated if an item/service fails to fulfill the existing factor (3) criteria defining appropriate for Medicare patients but fulfills (1) safe and effective and (2) not experimental or investigational. By considering commercial health insurer coverage policies, CMS would bring together the expertise of private payers and CMS.

For example, in a recent NCD on acupuncture for chronic low back pain, CMS considered the technology assessments and coverage criteria among commercial health insurer coverage policies.[] We believe that this approach would be in line with E.O. 13890 that directs us to make technologies âwidely available, consistent with the principles of patient safety, market-based policies, and value for patients.â Under this separate basis, we propose that an item or service would satisfy factor (3) if it is covered under a plan(s) coverage policy if offered in the commercial insurance market, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant. Under our proposal, we would exclude Medicaid managed care, Medicare Advantage, and other government administered healthcare coverage programs from the types of coverage CMS would consider, as these enrollees are not in the commercial market.

We seek comment on whether beneficiaries, providers, innovators, or others wishing to gain coverage for an item or service demonstrate that the item or service is covered by at least one commercial insurance plan policy. If they can provide CMS with evidence of commercial coverage or if CMS or its MACs identify such coverage from its review of compilations of health insurance offerings or data from other sources, CMS would consider factor (3) to be satisfied. We solicit comment on whether we should limit our consideration of commercial plan offerings or covered lives to a subset of the commercial market in the interest of simplicity, including looking at geographic subsets, subsets based on number of enrollees, subsets based on plan type (HMO, PPO, etc.), or other subsets of plansâincluding utilizing a singular plan.

We also seek comment on whether, given considerations such the variation and distribution of coverage policies and access to innovations, we should only cover an item or service if it is covered for a majority, or a different proportion such as a plurality, of covered lives amongst plans or a majority, plurality, or some other proportion of plan offerings in the commercial market. (A plan offering is a contract an insurer offers to its enrollees, and a single insurance company may provide many different offerings.) We also recognize that plan offerings may impose certain coverage restrictions on an item or service, e.g. Related to clinical criteria, disease stage, or number and frequency of treatment.

As greater access to innovative treatments provides beneficiaries with more opportunity to improve health and drive decisions, we would, when coverage is afforded on the basis of commercial coverage, adopt the least restrictive coverage policy for the item or service amongst the offerings we examine. However, given potential unreasonable or unnecessary utilization, we also solicit comment on whether we should instead adopt the most restrictive coverage policy. We are further considering, as another variation, that if coverage restrictions are largely similar and present across the majority of offerings, CMS would adopt these in its coverage policies.

As a final variation, we could defer, in the absence of an NCD or national policy, to the MACs to tailor the restrictions on coverage based on what they observe in the commercial market, just as we rely on MACs with regards to the current definition. We further solicit comment on whether to grant coverage for an item or service to the extent it meets the first and second factors and the commercial coverage basis for the third factor. Under this approach, we would only use the current definition of âappropriateâ from the current PIM when the exception for clinically relevant differences between Medicare beneficiaries and commercially insured individuals applies (or if the commercial coverage basis is determined by a proportion like a majority and there is insufficient commercial coverage information available).

We note that referring to commercial coverage in this way may expand or narrow the circumstances under which we will cover a particular item or service and therefore solicit comment on whether, under such an approach, we should grandfather our current coverage policies for items and services. We also emphasize that the MACs will continue to make judgements in evaluating individual claims for reimbursement, such that a decision by CMS that an item or service is reasonable and necessary in general does not mean that it is reasonable and necessary in all circumstances with respect to individual claims for reimbursement. We seek public comment on the most appropriate source(s) for these coverage policies.

Further, under our proposal, each MAC would be responsible for reviewing commercial offerings to inform their LCDs or claim by claim decisions, which would include individual medical necessity decisions. We may also allow the MACs to develop approaches to address any or all of the considerations outlined above, parallel to their current practice of making coverage decisions in the absence of an NCD or national policy. We solicit comment on the best role of the MACs, along these lines or otherwise.

We also solicit comment on whether the discretion to use the current criteria in the PIM when there is evidence to believe Medicare beneficiaries have different clinical needs should be exercised through the NCD process or in other ways, as well as what quantum of evidence should be sufficient. In sum, we are proposing to define the term âreasonable and necessaryâ based on the factors currently found in the PIM, plus an alternative basis for meeting factor (3) based on any coverage in the commercial market. We are also soliciting comment on an alternative under whether an item or service satisfies the commercial coverage basis for factor (3) is determined by how it is treated across a majority of covered lives amongst commercial plan offerings, as well as an alternative whereby an item or service would be appropriate for Medicare patients to the extent it is covered in the commercial market.

Start Printed Page 54333When evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant, we would rely on the criteria in the current PIM. We would continue relying on local administration of the program by MACs (including coverage on a claim by claim basis and LCDs) and maintain our discretion to issue NCDs based on the final rule. We solicit comment on this proposed definition of reasonable and necessary, and alternatives outlined above, as well as other mechanisms or definitions we could establish for the term âreasonable and necessaryâ, and the merits and drawbacks associated with each, including the potential impact on Medicare program expenses or complexity.

We may finalize any variation or outgrowth of the policies described in this proposal, or some combination of these options in lieu of or in conjunction with our proposed definition. B. Application of the âReasonable and Necessaryâ Standard to the MCIT Pathway We are proposing that, under the proposed MCIT pathway, an item or service that receives a breakthrough device designation from the FDA would be considered âreasonable and necessaryâ under section 1862(a)(1)(A) of the Act because breakthrough devices have met the FDA's unique breakthrough devices criteria, and they are innovations that serve unmet needs.

While other devices are still considered new to the market, for example, PMAs and even some 510(k)s, the devices designated by the FDA as breakthrough are representative of true innovations in the marketplace. This application of the âreasonable and necessaryâ standard in this way would ensure that the MCIT pathway can provide a fast-track to Medicare coverage of innovative devices that may more effectively treat or diagnose life-threatening or irreversibly debilitating human disease or conditions. MCIT would improve healthcare for Medicare beneficiaries by providing national Medicare coverage for devices receiving the FDA breakthrough device designation, which are FDA market-authorized and used consistent with the FDA approved or cleared indication for use (also referred to as the âFDA required labelingâ),[] so long as the breakthrough device is described in an appropriate Medicare benefit category under Part A or Part B and is not specifically excluded by statute.

We believe the criteria for qualification as a breakthrough device, as defined in section 515B(b) of the Food, Drug and Cosmetic Act (21 U.S.C. 360e-3(b)) is sufficient to satisfy the elements of the âreasonable and necessaryâ standard. The first breakthrough device designation criterion is that a device must âprovide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditionsâ (21 U.S.C.

360e-3(b)(1)). The second criterion is that the device must satisfy one of the following elements. It represents a breakthrough technology.

There are no approved or cleared alternatives. It offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute. Or availability of the device is in the best interest of patients (21 U.S.C.

360e-3(b)(2)). Thus, breakthrough devices are those that HHS has determined may provide better health outcomes for patients facing life-threatening or irreversibly debilitating human disease or conditions. We believe that a device meeting these criteria, once also FDA market authorized, is âreasonable and necessaryâ for purposes of Medicare coverage.

This proposed rule recognizes that the FDA market authorization of breakthrough devices warrants immediate coverage under the âreasonable and necessaryâ clause in section 1862(a)(1)(A) of the Act. We previously stated that FDA determinations were not controlling determinations for Medicare coverage purposes under section 1862(a)(1)(A) of the Act. (For more information see the January 30, 1989 Federal Register (54 FR 4307) (âFDA approval for the marketing of a medical device will not necessarily lead to a favorable coverage recommendation.

. . Â) and the August 7, 2013 Federal Register (78 FR 48165) (âHowever, FDA approval or clearance alone does not entitle that technology to Medicare coverage.â) Under the Secretary's broad authority to interpret section 1862(a)(1)(A) of the Act (supra section I.A.), we are revising our interpretation of the statute because of the practical concerns that our current standards have delayed access to a unique set of innovative devices that FDA has found to be safe and effective, and we believe are âreasonable and necessaryâ for purposes of Medicare coverage.

In light of E.O. 13890, the Secretary has determined that application of the current standards for making âreasonable and necessaryâ determinations may take too long following FDA market authorization of breakthrough devices. More importantly, the existing standard has not always provided Medicare beneficiaries adequate access to certain breakthrough medical devices when needed to improve health outcomes.

We are proposing that breakthrough devices per se meet the reasonable and necessary standard in order to increase access and to reduce the delay from FDA market authorization to Medicare coverage. C. MCIT Pathway We are proposing the MCIT pathway to deliver on the Administration's commitment to provide access to breakthrough devices to Medicare beneficiaries.

The MCIT pathway provides up to 4 years of national coverage to newly FDA market authorized breakthrough devices. We are aware that this coverage may also facilitate evidence development on devices for the Medicare population because manufacturers can gather additional data on utilization of the device during the MCIT coverage period. 1.

Definitions In Â§â405.601(a) we are proposing that the MCIT pathway is voluntary. Operationally, we propose that manufacturers of breakthrough devices notify CMS of their intention to elect MCIT shortly after receiving notice from the FDA of being granted the breakthrough device designation. Ideally, this notification would be sent to CMS within 2 weeks of receiving breakthrough designation.

However, entities would not be penalized for notifying CMS after that time. Alternatively, submitting a notification to CMS shortly before or concurrently with the date of the FDA marketing submission should also afford CMS sufficient time to operationalize MCIT for the device. The CMS Coverage and Analysis Group would establish an email box for these inquires.

This notification alerts CMS to offer guidance to manufacturers about the MCIT pathway and point to resources for coding and payment, which are key conversations to effectuate coverage upon FDA market authorization. We intend to utilize the existing coverage implementation processes to be prepared to offer coverage immediately upon the FDA market authorization. In Â§â405.601(b), we propose the following definitions for the purposes of 42 CFR part 405.

We propose to define Start Printed Page 54334âbreakthrough deviceâ as a medical device that receives such designation by the FDA (section 515B(d)(1) of the FD&C Act (21 U.S.C. 360e-3(d)(1))). We also propose to define, for the sake of clarity in the rule, that the acronym MCIT stands for Medicare Coverage of Innovative Technology.

2. MCIT Pathway Device Eligibility In Â§â405.603(a) we propose that the pathway is available to devices that meet the definitions proposed in Â§â405.601. Based on the explicit mention of devices in E.O.

13890 and our interaction and feedback from stakeholders who expressed their concern that there is more uncertainty of coverage for devices than for other items and services (for example, diagnostics, drugs and biologics), this proposed policy is for devices only. We propose in Â§â405.603(b) that the breakthrough devices that received FDA market authorization no more than 2 calendar years prior to the effective date of this subpart (the date the final rule is finalized) and thereafter will be eligible for coverage for claims submitted on or after the effective date of this rule. Claims for breakthrough devices with dates of service that occurred before the effective date of this rule would not be covered through MCIT.

For example, a hypothetical breakthrough device that was FDA market authorized on October 1, 2018, and utilized on January 1, 2020 would not be eligible for coverage under MCIT because on January 1, 2020, the date of service, the final MCIT rule was not yet legally in effect. In contrast, a claim for utilization of the same hypothetical breakthrough device with a date of service on January 1, 2021 might be eligible for coverage if the claim occurred after the effective date of the rule (assuming that the effective date of the rule was prior to January 1, 2021). Breakthrough devices market authorized prior to the effective date of this rule will not be eligible for all 4 years of coverage.

The 4-year period starts on the date of FDA market authorization. For example, a breakthrough device market authorized on October 1, 2018 would have claims covered through MCIT from the effective date of the final rule until October 1, 2022. If a manufacturer initially chooses to not utilize the MCIT pathway, and then chooses to do so some time after the breakthrough device's market authorization, coverage still only lasts 4 years from the date of FDA market authorization.

We seek comment on this eligibility criterion for devices and specifically the 2 year lookback. We propose in Â§â405.603(c) that to be part of the MCIT pathway, the device must be used according to its FDA approved or cleared indication for use. We propose that the device is only covered for use consistent with its FDA approved or cleared indication for use because that is the indication and conditions for use that were reviewed by the FDA and authorized for marketing.

Data are unlikely to be available to support extending beyond the FDA required labeling for breakthrough devices on the date of marketing authorization. Use of the device for a condition or population that is not labeled (âoff-labelâ) will not be covered as that use would not be FDA authorized. We specifically seek comment on whether off-label use of breakthrough devices should be covered and, if so, under what specific circumstances and/or evidentiary support.

In Â§â405.603(d) and (e), we additionally propose limitations to what is coverable under the Act. In Â§â405.603(e), we are proposing that if CMS has issued an NCD on a particular breakthrough device, that breakthrough device is not eligible for MCIT. We are proposing this because, once the device has been reviewed by CMS for the FDA required approved or cleared indication for use.

CMS has made a coverage determination based on the available evidence for that technology. We believe this would happen rarely because breakthrough devices are new technologies that are not likely to have been previously reviewed through the NCD process. In Â§â405.603(f), we acknowledge that devices in the MCIT pathway may be excluded due to statute or regulation (for example, 42 CFR 411.15, Particular services excluded from coverage) and, like other items and services coverable by Medicare, the device must fall within the scope of a Medicare benefit category under section 1861 of the Act and the implementing regulations.

If the device does not fall within a Medicare benefit category as outlined in the statute and implementing regulations, the device is not eligible for Medicare coverage. Therefore, the device would not be eligible for the MCIT pathway. 3.

General Coverage of Items and Services under the MCIT Pathway We propose in Â§â405.605 that devices covered under the MCIT pathway are covered no differently from devices that are covered outside of MCIT. In other words, provided the items and services are otherwise coverable (that is, not specifically excluded and not found by CMS to be outside the scope of a Medicare benefit category), covered items and services could include the device, reasonable and necessary surgery to implant the device, if implantable, related care and services costs of the device (for example, replacing reasonable and necessary parts of the device such as a battery), and coverage of any reasonable and necessary treatments due to complications arising from use of the device. What the MCIT pathway offers compared to other pathways is predictable national coverage simultaneous with FDA market authorization that will generally last for a set time period.

The proposed MCIT pathway would support and accelerate beneficiary access to certain innovative devices. CMS encourages manufacturers that have breakthrough devices covered under MCIT to develop additional data for the healthcare community. 4.

MCIT Pathway for Breakthrough Devices. 4 Years of Coverage In Â§â405.607(a), we propose that the MCIT pathway for coverage would begin on the same date the device receives FDA market authorization. We propose this point in time to ensure there is no gap between Medicare coverage and FDA market authorization.

This supports the MCIT pathway's focus of ensuring beneficiaries have a predictable access to new devices. We propose in Â§â405.607(b)(1) that the MCIT pathway for breakthrough devices ends 4 years from the date the device received FDA market authorization. We propose this 4 year time period because it could allow manufacturers to develop clinical evidence and data regarding the benefit of the use of their device in a real world setting.

For example, we believe 4 years would allow most manufacturers sufficient time to complete FDA required post-approval or other real-world data collection studies that may have been a condition of FDA market authorization. This assumption is based upon our historical experience with studies conducted through coverage with evidence development (CED). Further, this time period allows Medicare to support manufacturers that, whether required by the FDA or not, have an interest in better understanding the health outcomes of their device in the Medicare population, including impacts on patient-reported and longer-term outcomes.

Further, Â§â405.607(b) proposes reasons that the MCIT pathway may end prior to 4 years. This includes circumstances whereby the device becomes subject to an NCD, regulation, statute, or if the device can no longer be lawfully marketed.Start Printed Page 54335 D. Summary In summary, the MCIT pathway would provide immediate Medicare coverage of newly FDA market authorized breakthrough devices for 4 years.

We are also seeking public comments on our proposal to codify in regulations the standards we have historically used in making reasonable and necessary decisions under Part A and Part B under section 1862(a)(1)(A) of the Act. After considering public comments we would prepare a final rule that we expect would be effective 60 days after publication of the final rule. III.

Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of our agency.

The accuracy of our estimate of the information collection burden. The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We are soliciting public comment on each of the section 3506(c)(2)(A)-required issues for the following sections of this document that contain information collection requirements (ICRs). To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2018 National Occupational Employment and Wage Estimates for all salary estimates (https://www.bls.gov/âoes/âcurrent/âoes131041.htm, released May 2019).

In this regard, the table that follows presents the mean hourly wage, the cost of fringe benefits (calculated at 100 percent of salary), and the adjusted hourly wage. Table 1âNational Occupational Employment and Wage Estimates for MCITOccupation titleOccupation codeMean hourly wage ($/hr)Fringe benefit ($/hr)Adjusted hourly wage ($/hr)Compliance Officer13-104134.8634.8669.72 As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer.

Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. This proposed coverage pathway allows for a voluntary participation and therefore necessitates that manufacturers of breakthrough devices notify CMS of their intent to enter the MCIT pathway. Therefore, the burden associated with notifying CMS is the time and effort it would take for each of the organizations to send CMS an email or letter.

We anticipate two MCIT pathway participants in the first year based upon the number of medical devices that received FY2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles. We estimate notifying CMS of intent to participate in MCIT would involve 15 minutes at $69.72 per hour by a compliance officer. In this regard, we estimate 15 mins per notification at a cost of $17.43 per organization (0.25 hours Ã $69.72).

In aggregate, we estimate 0.5 hours (0.25 hours Ã 2 submissions) at $34.86 ($17.43 Ã 2 submissions). After the anticipated initial 2 submitters, over the next 3 years we expect 3 submitters in year 2, 4 submitters in year 3, and 5 submitters in year 4 to notify CMS of interested in the MCIT pathway. We expect this increase in submitters each year to level off at this point.

In this regard, we estimate the same 0.25 hours per submission at a cost of $17.43 per organization. Similarly, in aggregate, we estimate, for year 2 (0.75 hours at $52.29 an hour), for year 3 (1.0 hour at $69.72 an hour), and for year 4 (1.25 hours at $87.15 an hour). The proposed requirements and burden will be submitted to OMB under control number 0938-NEW.

We are requesting public comments on these information collection and recordkeeping requirements. If you comment on these information collection and recordkeeping requirements, please do either of the following. 1.

Submit your comments electronically as specified in the ADDRESSES section of this proposed rule. Or 2. Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention.

CMS Desk Officer, CMS-3372-P, Fax. (202) 395-6974. Or Email.

OIRA_submission@omb.eop.gov. Comments must be received on/by November 2, 2020. IV.

Regulatory Impact Statement This proposed rule makes Medicare coverage policy updates pursuant to the authority at section 1862(a)(1)(A) of the Act. We are using regulatory action per the October 3, 2019 âExecutive Order on Protecting and Improving Medicare for Our Nation's Seniorsâ to address the increasing need for a swift Medicare coverage mechanism to allow beneficiaries across the nation to access breakthrough devices faster after FDA market authorization. This proposed rule addresses that need by establishing a coverage pathway that will allow immediate beneficiary access to FDA market authorized breakthrough devices.

We have examined the impact of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995.

Pub. L. 104-4), Start Printed Page 54336Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C.

804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year).

This proposed rule does reach the economic threshold and thus is considered a major rule. Regulatory alternatives to this proposed rule were to combine Medicare coverage with clinical evidence development under section 1862(a)(1)(E) of the Act, to take no regulatory action at this time, or to adjust the duration of the MCIT pathway. Combining coverage with clinical evidence development would have met the E.O.

13890 overarching goal of beneficiary access to breakthrough devices. However, this alternative did not meet the other E.O. 13890 aims of minimizing time between FDA market authorization and Medicare coverage and wide availability.

CMS also considered taking no regulatory action and trying to leverage the existing Medicare coverage pathways or proposing sub-regulatory policies to achieve the streamlined coverage process described in E.O. 13890. Taking no action would not have resulted in the desired national coverage and access envisioned in E.O.

13890 because, as described in this preamble, the existing coverage pathways do not consistently provide swift, national beneficiary access to innovative devices. As discussed elsewhere in the preamble, the nature of the problem being addressed by this proposed regulation is a potential delay between a milestone such as FDA market authorization and CMS coverage. As such, we request comment on a policy option of shortening of the duration of the MCIT pathway from the proposed 4 years to 1 year.

In addition to the alternatives just discussed, there are various possibilities regarding how to change the definition of âreasonable and necessaryââfor example, whether to include a new aspect of the proposed definition that focuses on commercial insurance coverage practices. As noted earlier in the preamble, the goal of this revision is to expand coverage. However, the nuances of the definition would affect the magnitude of the impact and we request comment that would facilitate quantification of effects and comparison of alternatives at the final rule stage.

The impact of implementing the MCIT pathway is difficult to determine without knowing the specific technologies that would be covered. In addition, many of these technologies would be eligible for coverage in the absence of this rule, such as through a local or national coverage determination, so the impact for certain items may be the acceleration of coverage or adoption by just a few months. Furthermore, some of these devices would be covered immediately if the MACs decide to pay for them, which would result in no impact on Medicare spending for devices approved under this pathway.

However, it is possible that some of these innovative technologies would not otherwise be eligible for coverage in the absence of this rule. Because it is not known how these new technologies would otherwise come to market and be reimbursed, it is not possible to develop a point estimate of the impact. In general, we believe the MCIT coverage pathway would range in impact from having no impact on Medicare spending, to a temporary cost for innovations that are adopted under an accelerated basis.

The decision to enter the MCIT pathway is voluntary for the manufacturer. Because manufacturers typically join the Medicare coverage pathway that is most beneficial to them, this would result in selection against the existing program coverage pathways (to what degree is unknown at this point). In addition, the past trend of new technology costing more than existing technology could lead to a higher cost for Medicare if this trend continued for technologies enrolling in the MCIT pathway.

Nevertheless, new technology may also mitigate ongoing chronic health issues or improve efficiency of services thereby reducing some costs for Medicare. In order to demonstrate the potential impact on Medicare spending, the CMS Office of the Actuary (OACT) developed three hypothetical scenarios that illustrate the impact of implementing the proposed MCIT pathway. Scenarios two and three assume that the device would not have been eligible for coverage in the absence of this proposed rule.

(See Table 2) The illustration used the new devices that applied for a NTAP in FY 2020 as a proxy for the new devices that would utilize the MCIT pathway. The submitted cost and anticipated utilization for these devices was published in the Federal Register.[] In addition, we assumed that two manufacturers would elect to utilize the MCIT pathway in the first year, three manufacturers in the second year, four manufacturers in the third year, and five manufacturers in the fourth year each year for all three scenarios. This assumption is based on the number of medical devices that received FY 2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles and our impression from the FDA that the number of devices granted breakthrough status is increasing.

For the first scenario, the no-cost scenario, we assumed that all the devices would be eligible for coverage in the absence of the proposed rule. If the devices received payment nationally and at the same time then there would be no additional cost under this pathway. For the second scenario, the low-cost scenario, we assumed that the new technologies would have the average costs ($2,044) and utilization (2,322 patients) of similar technologies included in the FY 2020 NTAP application cycle.

Therefore, to estimate the first year of MCIT, we multiplied the add-on payment for a new device by the anticipated utilization for a new device by the number of anticipated devices in the pathway ($2,044 Ã 2,322 Ã 2 = $ 9.5 million). For the third scenario, the high-cost scenario, we assumed the new technologies would receive the maximum add-on payment from the FY 2020 NTAP application cycle ($22,425) and the highest utilization of a device (6,500 patients). Therefore, to estimate for the first year of MCIT, we estimated similarly ($22,425 Ã 6,500 patients Ã 2 = $ 291.5 million).

For subsequent years, we increased the number of anticipated devices in the pathway by three, four, and five in the last two scenarios until 2024.[] In addition to Start Printed Page 54337not taking into account inflation, the illustration does not reflect any offsets for the costs of these technologies that would be utilized through existing authorities nor the cost of other treatments (except as noted). It is not possible to explicitly quantify these offsetting costs but they could substantially reduce or eliminate the net program cost. However, by assuming that only two to five manufacturers will elect MCIT coverage, we have implicitly assumed that, while more manufacturers could potentially elect coverage under MCIT, the majority of devices would have been covered under a different coverage pathway.

Table 2âIllustrated Impact on the Medicare Program by Proposed MCIT Coverage PathwayâCosts (in millions)FY 2021FY 2022FY 2023FY 2024No-cost Scenario$0$0$0$0Low-cost Scenario9.523.742.766.4High-cost Scenario291.5728.81,311.92,040.7 We believe the assumptions used in the three scenarios are reasonable to show the possible wide range of impacts for implementing this proposed pathway, in particular for a technology that would not have otherwise been eligible for coverage. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions.

Some hospitals and other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. We reviewed the Small Business Administration's Table of Small Business Size Standards Matched to North American Industry Classification System (NAICS) Codes to determine the NAICS U.S.

Industry titles and size standards in millions of dollars and/or number of employees that apply to small businesses that could be impacted by this rule.[] We determined that small businesses potentially impacted may include surgical and medical instrument manufacturers (NAICS code 339112, dollars not provided/1,000 employees), Offices of Physicians (except Mental Health Specialists) (NAICS code 621111, $12 million/employees not provided), and Freestanding Ambulatory Surgical and Emergency Centers (NAICS code 621493, $16.5 million/employees not provided). During the first 4 years of MCIT, we anticipate approximately 14 surgical and medical instrument manufacturers may participate, and based off of U.S. Census data, the majority of this businesses type are small businesses with less than 1,000 employees (968 out of 1,093 businesses have less than 500 employees).[] As such, this proposed rule would impact less than 5 percent of these businesses, and the revenue impact, if any, would not be negative.

Rather, it would be a positive impact because MCIT would provide Medicare coverage (and subsequent payment) to providers who purchase the devices from these manufacturers. For Offices of Physicians (except Mental Health Specialists) and Freestanding Ambulatory Surgical and Emergency Centers that may be providing the breakthrough devices, the majority are small businesses with less than 1,000 employees (4,060 out of 4,385 and 160, 367 out of 161, 286 have less than 500 employees, respectively).[] Given that we estimate, at most in the high-cost scenario, that 6,500 beneficiaries would utilize breakthrough devices through MCIT per year, and even if each beneficiary were to access services at only one of these small businesses (that is, no two beneficiaries used the same office or center), still less than 5 percent of these small businesses would be impacted by MCIT. As such, the revenue impact, if any, would not be negative, rather, it would be a positive impact because MCIT would provide Medicare coverage (and subsequent payment) to providers.

Overall, this proposed rule results in a payment, not a reduction in revenue. We are not preparing a further analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule will not have a significant negative economic impact on a substantial number of small entities because small entities are not being asked to undertake additional effort or take on additional costs outside of the ordinary course of business through this proposed rule. Rather, for small entities that develop or provide breakthrough devices to patients, this proposed rule is a means for the device to be covered through the Medicare program, which does not detract from revenue and could be viewed as a positive economic impact.

With the limited information we had to base this estimate, we solicit public comment on improvements to this estimate for the final rule. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA.

For purposes of section 1102(b) of the Act, we define a small rural hospital Start Printed Page 54338as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals because small rural hospitals are not being asked to undertake additional effort or take on additional costs outside of the ordinary course of business through this proposed rule. Obtaining breakthrough devices for patients is at the discretion of providers.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2020, that threshold was approximately $156 million. This proposed rule would have no consequential effect on State, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable. Executive Order 13771 (E.O.

13771), titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. This proposed rule, if finalized as proposed, is expected to impose no more than de minimis costs and thus be neither an E.O. 13771 regulatory action nor an E.O.

13771 deregulatory action. In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget. V.

Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Start List of Subjects Administrative practice and procedureDiseasesHealth facilitiesHealth professionsMedical devicesMedicareReporting and recordkeeping requirementsRural areasX-rays End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &.

Medicaid Services proposes to amend 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1. The authority for part 405 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k). End Authority Start Amendment Part2.

Section 405.201 is amended in paragraph (b) by adding the definition of âReasonable and necessaryâ in alphabetical order to read as follows. End Amendment Part Scope of subpart and definitions. * * * * * (b) * * * Reasonable and necessary means that an item or service is consideredâ (1) Safe and effective.

(2) Except as set forth in Â§â411.15(o)) of this chapter, not experimental or investigational. And (3) Appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it (i) Meets all of the following criteria. (A) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.

(B) Furnished in a setting appropriate to the patient's medical needs and condition. (C) Ordered and furnished by qualified personnel. (D) One that meets, but does not exceed, the patient's medical need.

And (E) At least as beneficial as an existing and available medically appropriate alternative. Or (ii) Is covered by commercial insurers, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant. * * * * * Start Amendment Part3.

Subpart F, consisting of Â§Â§â405.601-405.607, is added to read as follows. End Amendment Part 405.601 Medicare coverage of innovative technology. 405.603 Medical device eligibility.

405.605 Coverage of items and services. 405.607 Coverage period. Medicare coverage of innovative technology.

(a) Basis and scope. Medicare coverage of innovative technology (MCIT) is a program that provides national, time-limited coverage under section 1862(a)(1)(A) of the Act for certain breakthrough medical devices. Manufacturer participation in the pathway for breakthrough device coverage is voluntary.

(b) Definitions. For the purposes of this subpart, the following definitions are applicable. Breakthrough device means a device that receives such designation by the Food and Drug Administration (FDA) (section 515B(d)(1) of the FD&C Act (21 U.S.C.

360e-3(d)(1)). MCIT stands for Medicare coverage of innovative technology. Medical device eligibility.

The MCIT pathway is available only to medical devices that meet all of the following. (a) That are FDA-designated breakthrough devices. (b) That are FDA market authorized at most [date 2 years prior to effective date of final rule] and thereafter.

(c) That are used according to their FDA approved or cleared indication for use. (d) That are within a Medicare benefit category. (e) That are not the subject of a Medicare national coverage determination.

(f) That are not otherwise excluded from coverage through law or regulation. Coverage of items and services. Covered items and services furnished within the MCIT pathway may include any of the following, if not otherwise excluded from coverage.

(a) The breakthrough device. (b) Any reasonable and necessary procedures to implant the breakthrough device.Start Printed Page 54339 (c) Reasonable and necessary costs to maintain the breakthrough device. (d) Related care and services for the breakthrough device.

(e) Reasonable and necessary services to treat complications arising from use of the breakthrough device. Coverage period. (a) Start of the period.

The MCIT pathway begins on the date the breakthrough device receives FDA market authorization. (b) End of the period. The MCIT pathway for a breakthrough device ends as follows.

(1) No later than 4 years from the date the breakthrough device received FDA market authorization. (2) Prior to 4 years if a manufacturer withdraws the breakthrough device from the MCIT pathway. (3) Prior to 4 years if the breakthrough device becomes the subject of a national coverage determination or otherwise becomes noncovered through law or regulation.

Start Signature Dated. May 4, 2020. Seema Verma, Administrator, Centers for Medicare &.

Alex M. Azar II, Secretary, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc.

2020-19289 Filed 8-31-20. 8:45 am]BILLING CODE 4120-01-P.

Start Preamble click for more Centers for can you get lasix over the counter Medicare &. Medicaid Services (CMS), HHS. Proposed rule can you get lasix over the counter. This proposed rule would establish a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA).

After the final rule is effective, the Medicare Coverage of Innovative Technology (MCIT) pathway would begin national Medicare coverage on the date of FDA market authorization and would continue for 4 years. We are also proposing regulatory standards to be used in making reasonable and necessary determinations under section Start Printed Page 543281862(a)(1)(A) of the Social Security Act (the Act) can you get lasix over the counter for items and services that are furnished under Part A and Part B. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. On November 2, can you get lasix over the counter 2020.

In commenting, please refer to file code CMS-3372-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of can you get lasix over the counter three ways (please choose only one of the ways listed). 1.

Electronically. You may submit electronic comments on this regulation to can you get lasix over the counter http://www.regulations.gov. Follow the âSubmit a commentâ instructions. 2.

By regular mail. You may mail written comments to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention.

CMS-3372-P, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3.

By express or overnight mail. You may send written comments to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention.

CMS-3372-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info Linda Gousis or JoAnna Baldwin, (410) 786-2281 or CAGinquiries@cms.hhs.gov. End Further Info End Preamble Start Supplemental Information Inspection of Public Comments.

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received. Http://www.regulations.gov. Follow the search instructions on that website to view public comments.

I. Background The Administration is committed to ensuring Medicare beneficiaries have access to new cures and technologies that improve health outcomes. Section 6 of the October 3, 2019 Executive Order 13890 (E.O. 13890) âExecutive Order on Protecting and Improving Medicare for Our Nation's Seniors,ââ[] directs the Secretary to âpropose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patientsâ including by âstreamlining the approval, coverage, and coding processâ.[] The E.O.

13890 explicitly includes making coverage of breakthrough medical devices âwidely available, consistent with the principles of patient safety, market-based policies, and value for patients.ââ[] The E.O. Also directs the Secretary to âclarify the application of coverage standards.ââ[] We are responding directly to these directives by proposing a definition of the term âreasonable and necessaryâ to clarify coverage standards and proposing the Medicare Coverage of Innovative Technology (MCIT) pathway to accelerate the coverage of new, innovative breakthrough devices to Medicare beneficiaries. To date, the factors used in making âreasonable and necessaryâ determinations based on section 1862(a)(1)(A) of the Act have not been established in regulations for Medicare coverage purposes. The Secretary has authority to determine whether a particular medical item or service is âreasonable and necessaryâ under section 1862(a)(1)(A) of the Act.

These factors are found in Chapter 13 of the Medicare Program Integrity Manual (PIM) at section 13.5.4âReasonable and Necessary Provisions in LCDs as instructions for Medicare contractors. We are proposing to codify in regulations the Program Integrity Manual definition of âreasonable and necessaryâ with modifications, including to add a reference to Medicare patients and a reference to commercial health insurer coverage policies. We propose that an item or service would be considered âreasonable and necessaryâ if it isâ(1) safe and effective. (2) not experimental or investigational.

And (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it isâ Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member. Furnished in a setting appropriate to the patient's medical needs and condition. Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient's medical need.

Stakeholders have expressed interest in codifying a definition of âreasonable and necessaryâ for many years. This proposed definition is familiar and functional, can satisfy that interest and meet the E.O.'s ask, while also aligning with the goals of MCIT by providing clarity and predictability for innovation, including for beneficiaries and innovators. The proposed MCIT coverage pathway is specifically for Medicare coverage of devices that are designated as part of the Food and Drug Administration's (FDA) Breakthrough Devices Program (hereafter referred to as âbreakthrough devicesâ) and are FDA market authorized. The MCIT pathway would be voluntary and device manufacturers would notify CMS if they want to utilize this coverage option.

We propose that national Medicare coverage under the MCIT pathway would begin immediately upon the date of FDA market authorization (that is, the Start Printed Page 54329date the medical device receives Premarket Approval (PMA). 510(k) clearance. Or the granting of a De Novo classification request) for the breakthrough device. This coverage would occur unless the device does not have a Medicare benefit category or is otherwise excluded from coverage by statute (that is, the Medicare statute does not allow for coverage of the particular device.) This coverage pathway delivers on the Administration's commitment to give Medicare beneficiaries access to the newest innovations on the market, consistent with the statutory definitions of Medicare benefits.

We propose this MCIT pathway because the prescribed statutory timeframes for the National Coverage Determination (NCD) process limit CMS' ability to institute immediate national coverage policies for new, innovative medical devices. NCDs and Local Coverage Determinations (LCD) take, on average, 9 to 12 months to finalize. Because of this length of time, there may be coverage uncertainty between the period of FDA market authorization and CMS finalization of an NCD or a Medicare Administrative Contractor's (MACs) finalization of an LCD. During this time period shortly after market authorization, MACs make coverage determinations on a case-by-case (individual beneficiary) basis, but those decisions do not usually establish agency policies for future claims because a case-by-case decision is for a particular beneficiary and their health circumstances.

Over the past few years, CMS has heard concerns from stakeholders that breakthrough devices are not automatically covered nationally by Medicare once they are FDA market authorized. Variation in coverage from one jurisdiction to another is also a concern. To date, 16 breakthrough devices have also been market authorized. The majority of these breakthrough devices (10 devices) experience variability in coverage for two reasons.

One breakthrough device has uniform coverage because the same LCD has been adopted in all jurisdictions. There are three breakthrough devices that do not have a Medicare benefit category (for example, certain wearable devices). Therefore, those breakthrough devices cannot be covered by the Medicare program. In contrast to varied local coverage, the proposed MCIT would create a pathway for immediate national Medicare coverage of any FDA-market authorized breakthrough device if the device meets criteria outlined in this proposal.

A. Statutory Authority We are also proposing to establish in regulations the factors we have historically used in making âreasonable and necessaryâ determinations under section 1862(a)(1)(A) of the Act, with some modification. To summarize, this section explains that Medicare payment may be made under part A or part B for any expenses incurred for items or services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Thus, with some exceptions, section 1862(a)(1)(A) of the Act requires that an item or service be âreasonable and necessaryâ to be covered by Medicare.

Leavitt, 470 F.3d 71, 84 (2d Cir. 2006). Kort v. Burwell, 209 F.

Supp. 3d 98, 110 (D.C. 2016) (The statute vests substantial authority in the Secretary.)) So even though section 1862(a)(1)(A) of the Act limits the scope of Medicare coverage, the Secretary has discretion to revise his/her interpretation of the statute in order to ensure adequate coverage for items and services under Part A and Part B. This proposal would provide national Medicare coverage for breakthrough devices that are FDA market-authorized and used consistent with the FDA approved or cleared indication for use (also referred to as the âFDA-required labelingâ).[] This device coverage under the MCIT pathway is reasonable and necessary under section 1862(a)(1)(A) of the Act because the device has met the unique criteria of the FDA Breakthrough Devices Program.

See also final guidance for industry entitled, âBreakthrough Devices Program,â https://www.fda.gov/âdownloads/âMedicalDevices/âDeviceRegulationandGuidance/âGuidanceDocuments/âUCM581664.pdf). The FDA's Breakthrough Devices Program is not for all new medical devices. Rather, it is only for those that the FDA determines meet the standards for breakthrough device designation. In accordance with section 3051 of the 21st Century Cures Act (21 U.S.C.

360e-3),[] the Breakthrough Devices Program is for medical devices and device-led combination products that meet two criteria. The first criterion is that the device provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. The second criterion is that the device must satisfy one of the following elements. It Start Printed Page 54330represents a breakthrough technology.

These criteria make breakthrough designated devices unique among all other medical devices.[] The parameters of the breakthrough devices program focus on innovations for patients, in turn, MCIT, focuses on these breakthrough devices consistent with E.O. 13890 and in order to streamline coverage of innovative medical devices. C. Current Medicare Coverage Pathways Currently, we utilize several coverage pathways for items and services, which includes medical devices.

None of the coverage pathways described in this section offer immediate, predictable coverage concurrently with FDA market authorization like the proposed MCIT pathway would do. We summarize the other coverage pathways here to provide context for MCIT. National Coverage Determinations (NCDs). Section 1862(l)(6)(A) of the Act defines the term national coverage determination as âa determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this title.â In general, NCDs are national policy statements published to identify the circumstances under which particular items and services will be considered covered by Medicare.

(Sections 1862(l)(6)(B) and 1869(f)(2)(B) of the Act.) MACs will not need to develop LCDs for breakthrough devices when they are nationally covered through MCIT. The MACs follow specific guidance for developing LCDs for Medicare coverage in the CMS Program Integrity Manual, and in some instances, an LCD can also take 9 to12 months to develop (MACs must finalize proposed LCDs within 365 days from opening per Chapter 13âLocal Coverage Determinations of the (PIM) 13.5.1). We note that the MCIT pathway will not alter the existing coverage standards in Chapter 13âLocal Coverage Determinations of the PIM.[] That chapter will continue to be used in making determinations under section 1862(a)(1)(A) of the Act for other items and services at the local level. Claim-by-claim Adjudication.

In the absence of an NCD or LCD, MACs would make coverage decisions under section 1862(a)(1)(A) of the Act and may cover or not cover items and services on a claim-by-claim basis. The majority of claims are handled through the claim adjudication process. Clinical Trial Policy (CTP) NCD 310.1. The CTP pathway can be used for coverage of routine care items and services (but generally not the technology under investigation) in a clinical study that is supported by certain Federal agencies.

(1) FDA and CMS meet with the manufacturer to provide feedback on the proposed pivotal clinical trial within the FDA pre-submission process. And (2) FDA and CMS concurrently review (âin parallelâ) the clinical trial results submitted in the PMA, or De Novo request. FDA and CMS independently review the data to determine whether it meets their respective Agency's standards and communicate with the manufacturer during their respective reviews. This program is most successful for devices that have a significant amount of clinical evidence.

(Candidates for parallel review would not be appropriate for simultaneous MCIT consideration.) Even though CMS has multiple coverage pathways, at this time none are readily available to provide immediate national coverage for new breakthrough devices with a Medicare benefit category at the same time as FDA market authorization. Further, some of these new breakthrough devices are likely to have limited or developing bodies of clinical evidence because of the newness of the device. Therefore, the MCIT pathway can support manufacturers that are interested in combining coverage with their own clinical study to augment clinical evidence of improved health outcomes, particularly for Medicare patients. Given this summary of existing coverage pathways, we seek comment from the public regarding if any of these existing pathways should be modified to achieve the goals set out by E.O.

13890. D. MCIT Pathway We propose that the MCIT pathway would provide immediate national coverage for breakthrough devices beginning on the date of FDA market authorization and continue for up to 4 years, unless we determine the device does not have a Medicare benefit category as determined by us as part of the MCIT pathway process. The MCIT pathway is voluntary (that is, manufacturers would affirmatively opt-in), and would be initiated when a manufacturer notifies CMS of its intention to utilize the MCIT pathway.

(This notification process is described further in section III. Of this proposed rule.) We would subsequently coordinate with the manufacturer regarding steps that need to be taken for MCIT implementation purposes. The frequency of subsequent engagement will be largely driven by whether the manufacturer has questions for CMS, or CMS and FDA. The timing of coverage will depend upon the timing of the FDA's market authorization decision.

Engagements can take place in the form of in-person meetings, phone calls, emails, etc. We intend to put devices that are covered through the MCIT pathway on the CMS website so that all stakeholders will be aware of what is covered through the MCIT pathway. Manufacturers of breakthrough devices will not be obligated or mandated by CMS to conduct clinical studies during Start Printed Page 54331coverage under the proposed MCIT pathway. However, we seek comment as to whether CMS should require or incentivize manufacturers to provide data about outcomes or should be obligated to enter into a clinical study similar to CMS's Coverage with Evidence Development (CED) paradigm.[] We are aware some manufacturers may be required by the FDA to conduct post market data collection as a condition of market authorization, and nothing in this proposed rule would alter that FDA requirement.

In order to further the goals of E.O. 13890, CMS proposes to rely on FDA's breakthrough device designation and market authorization of those devices to define the universe of devices eligible for MCIT, except for those particular devices CMS determines do not have a Medicare benefit category or are statutorily excluded from coverage under Part A or Part B. In order to provide immediate national coverage to innovative medical devices, we propose to establish a time limit on how long a breakthrough device can be eligible for MCIT (that is, considered a breakthrough device for coverage purposes). MCIT has a time limit on newness similar to our New Technology Add-on Payment (NTAP) policy.

Eligibility for the NTAP is also time limited and this time limit applies to all new technologies, including breakthrough devices, for which an application for additional payment is submitted. Additionally, the time-limited characteristic of MCIT will drive some manufacturers to leverage this period of coverage to demonstrate the value of their device in the competitive marketplace. The 4-year coverage period is particularly important for manufacturers of breakthrough devices that choose to further develop the clinical evidence basis on which the FDA granted marketing authorization. From our experience with clinical studies conducted as part of an NCD, 4 years is approximately the amount of time it takes to complete a study.

Manufacturers that are interested in a NCD are encouraged to submit a NCD request during the third year of MCIT to allow for sufficient time for NCD development. We seek public comment on whether CMS should open a national coverage analysis if a MAC has not issued an LCD for a breakthrough device within 6 months of the expiration date of the 4-year MCIT period. In our analysis of the current coverage landscape to determine opportunities for innovation and efficiencies, we also considered modifying the coverage process for non-breakthrough devices (for example, PMAs because they are also new to the market), but ultimately determined that it was the unique characteristics of FDA designated breakthrough devices and their ability to serve unmet needs that resonated most with the E.O.'s direction to encourage innovation for patients. We also considered expedited coverage of newly market authorized and breakthrough devices when used in a clinical study.

We seek public comment on the proposed MCIT pathway, the considerations described, whether any of the existing coverage pathways should be modified to achieve the goals set out by the E.O., and alternatives to these proposals. We specifically seek public comment on whether the MCIT pathway should also include diagnostics, drugs and/or biologics that utilize breakthrough or expedited approaches at the FDA (for example, Breakthrough Therapy, Fast Track, Priority Review, Accelerated Approval)â[] or all diagnostics, drugs and/or biologics. We seek data to support including these additional item categories in the MCIT pathway. Also, we specifically seek manufacturer input on whether an opt-in or opt-out approach would work best for utilizing the MCIT pathway.

If so, we encourage public comment on a process for stakeholders to opt-out of MCIT that would not be burdensome. Also, we seek public comment on whether, once a manufacturer has opted-out of coverage, it can subsequently opt-in to MCIT. II. Provision of Proposed Regulations A.

Defining âReasonable and Necessaryâ As described in section I. Of this proposed rule, the Secretary has authority to determine the meaning of âreasonable and necessaryâ under section 1862(a)(1)(A) of the Act. We are proposing to codify the longstanding Program Integrity Manual definition of âreasonable and necessaryâ into our regulations at 42 CFR 405.201(b), with modification. Under the current definition, an item or service is considered âreasonable and necessaryâ if it is (1) safe and effective.

One that meets, but does not exceed, the patient's medical need. And At least as beneficial as an existing and available medically appropriate alternative. In addition to codifying the above criteria, we propose to include a separate basis under which an item or service would be appropriate under (3) above that is based on commercial health insurers' coverage policies (that is, non-governmental entities that sponsor health insurance plans). The Start Printed Page 54332commercial market analysis would be initiated if an item/service fails to fulfill the existing factor (3) criteria defining appropriate for Medicare patients but fulfills (1) safe and effective and (2) not experimental or investigational.

By considering commercial health insurer coverage policies, CMS would bring together the expertise of private payers and CMS. For example, in a recent NCD on acupuncture for chronic low back pain, CMS considered the technology assessments and coverage criteria among commercial health insurer coverage policies.[] We believe that this approach would be in line with E.O. 13890 that directs us to make technologies âwidely available, consistent with the principles of patient safety, market-based policies, and value for patients.â Under this separate basis, we propose that an item or service would satisfy factor (3) if it is covered under a plan(s) coverage policy if offered in the commercial insurance market, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant. Under our proposal, we would exclude Medicaid managed care, Medicare Advantage, and other government administered healthcare coverage programs from the types of coverage CMS would consider, as these enrollees are not in the commercial market.

In the following paragraphs, we seek comment on this proposal and on how best to implement this mechanism. We solicit comments on sources of data that could be used to implement this policy, and whether CMS should make this information public and transparent. We seek public comment on the most appropriate source(s) for these coverage policies and the best way to determine which commercial plan(s) we would rely on for Medicare coverage. We seek comment on whether beneficiaries, providers, innovators, or others wishing to gain coverage for an item or service demonstrate that the item or service is covered by at least one commercial insurance plan policy.

If they can provide CMS with evidence of commercial coverage or if CMS or its MACs identify such coverage from its review of compilations of health insurance offerings or data from other sources, CMS would consider factor (3) to be satisfied. We solicit comment on whether we should limit our consideration of commercial plan offerings or covered lives to a subset of the commercial market in the interest of simplicity, including looking at geographic subsets, subsets based on number of enrollees, subsets based on plan type (HMO, PPO, etc.), or other subsets of plansâincluding utilizing a singular plan. We also seek comment on whether, given considerations such the variation and distribution of coverage policies and access to innovations, we should only cover an item or service if it is covered for a majority, or a different proportion such as a plurality, of covered lives amongst plans or a majority, plurality, or some other proportion of plan offerings in the commercial market. (A plan offering is a contract an insurer offers to its enrollees, and a single insurance company may provide many different offerings.) We also recognize that plan offerings may impose certain coverage restrictions on an item or service, e.g.

Related to clinical criteria, disease stage, or number and frequency of treatment. As greater access to innovative treatments provides beneficiaries with more opportunity to improve health and drive decisions, we would, when coverage is afforded on the basis of commercial coverage, adopt the least restrictive coverage policy for the item or service amongst the offerings we examine. However, given potential unreasonable or unnecessary utilization, we also solicit comment on whether we should instead adopt the most restrictive coverage policy. We are further considering, as another variation, that if coverage restrictions are largely similar and present across the majority of offerings, CMS would adopt these in its coverage policies.

We note that such coverage restrictions include the basic requirement for medical necessity at the level of individual patients. Medicare will still only pay for an item or service received by a beneficiary if it is medically necessary for the beneficiary. We seek comment on whether, if we were to take this approach, we should instead use a proportion other than a majority, as low as any offering and as high as all offerings, as a sufficient threshold. As a final variation, we could defer, in the absence of an NCD or national policy, to the MACs to tailor the restrictions on coverage based on what they observe in the commercial market, just as we rely on MACs with regards to the current definition.

We further solicit comment on whether to grant coverage for an item or service to the extent it meets the first and second factors and the commercial coverage basis for the third factor. Under this approach, we would only use the current definition of âappropriateâ from the current PIM when the exception for clinically relevant differences between Medicare beneficiaries and commercially insured individuals applies (or if the commercial coverage basis is determined by a proportion like a majority and there is insufficient commercial coverage information available). We note that referring to commercial coverage in this way may expand or narrow the circumstances under which we will cover a particular item or service and therefore solicit comment on whether, under such an approach, we should grandfather our current coverage policies for items and services. We also emphasize that the MACs will continue to make judgements in evaluating individual claims for reimbursement, such that a decision by CMS that an item or service is reasonable and necessary in general does not mean that it is reasonable and necessary in all circumstances with respect to individual claims for reimbursement.

We seek public comment on the most appropriate source(s) for these coverage policies. Further, under our proposal, each MAC would be responsible for reviewing commercial offerings to inform their LCDs or claim by claim decisions, which would include individual medical necessity decisions. We may also allow the MACs to develop approaches to address any or all of the considerations outlined above, parallel to their current practice of making coverage decisions in the absence of an NCD or national policy. We solicit comment on the best role of the MACs, along these lines or otherwise.

We would continue relying on local administration of the program by MACs (including coverage on a claim by claim basis and LCDs) and maintain our discretion to issue NCDs based on the final rule. We solicit comment on this proposed definition of reasonable and necessary, and alternatives outlined above, as well as other mechanisms or definitions we could establish for the term âreasonable and necessaryâ, and the merits and drawbacks associated with each, including the potential impact on Medicare program expenses or complexity. We may finalize any variation or outgrowth of the policies described in this proposal, or some combination of these options in lieu of or in conjunction with our proposed definition. B.

Application of the âReasonable and Necessaryâ Standard to the MCIT Pathway We are proposing that, under the proposed MCIT pathway, an item or service that receives a breakthrough device designation from the FDA would be considered âreasonable and necessaryâ under section 1862(a)(1)(A) of the Act because breakthrough devices have met the FDA's unique breakthrough devices criteria, and they are innovations that serve unmet needs. While other devices are still considered new to the market, for example, PMAs and even some 510(k)s, the devices designated by the FDA as breakthrough are representative of true innovations in the marketplace. This application of the âreasonable and necessaryâ standard in this way would ensure that the MCIT pathway can provide a fast-track to Medicare coverage of innovative devices that may more effectively treat or diagnose life-threatening or irreversibly debilitating human disease or conditions. MCIT would improve healthcare for Medicare beneficiaries by providing national Medicare coverage for devices receiving the FDA breakthrough device designation, which are FDA market-authorized and used consistent with the FDA approved or cleared indication for use (also referred to as the âFDA required labelingâ),[] so long as the breakthrough device is described in an appropriate Medicare benefit category under Part A or Part B and is not specifically excluded by statute.

The second criterion is that the device must satisfy one of the following elements. It represents a breakthrough technology. There are no approved or cleared alternatives. It offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute.

Or availability of the device is in the best interest of patients (21 U.S.C. 360e-3(b)(2)). Thus, breakthrough devices are those that HHS has determined may provide better health outcomes for patients facing life-threatening or irreversibly debilitating human disease or conditions. We believe that a device meeting these criteria, once also FDA market authorized, is âreasonable and necessaryâ for purposes of Medicare coverage.

. Â) and the August 7, 2013 Federal Register (78 FR 48165) (âHowever, FDA approval or clearance alone does not entitle that technology to Medicare coverage.â) Under the Secretary's broad authority to interpret section 1862(a)(1)(A) of the Act (supra section I.A.), we are revising our interpretation of the statute because of the practical concerns that our current standards have delayed access to a unique set of innovative devices that FDA has found to be safe and effective, and we believe are âreasonable and necessaryâ for purposes of Medicare coverage. In light of E.O. 13890, the Secretary has determined that application of the current standards for making âreasonable and necessaryâ determinations may take too long following FDA market authorization of breakthrough devices.

More importantly, the existing standard has not always provided Medicare beneficiaries adequate access to certain breakthrough medical devices when needed to improve health outcomes. We are proposing that breakthrough devices per se meet the reasonable and necessary standard in order to increase access and to reduce the delay from FDA market authorization to Medicare coverage. C. MCIT Pathway We are proposing the MCIT pathway to deliver on the Administration's commitment to provide access to breakthrough devices to Medicare beneficiaries.

Operationally, we propose that manufacturers of breakthrough devices notify CMS of their intention to elect MCIT shortly after receiving notice from the FDA of being granted the breakthrough device designation. Ideally, this notification would be sent to CMS within 2 weeks of receiving breakthrough designation. However, entities would not be penalized for notifying CMS after that time. Alternatively, submitting a notification to CMS shortly before or concurrently with the date of the FDA marketing submission should also afford CMS sufficient time to operationalize MCIT for the device.

The CMS Coverage and Analysis Group would establish an email box for these inquires. This notification alerts CMS to offer guidance to manufacturers about the MCIT pathway and point to resources for coding and payment, which are key conversations to effectuate coverage upon FDA market authorization. We intend to utilize the existing coverage implementation processes to be prepared to offer coverage immediately upon the FDA market authorization. In Â§â405.601(b), we propose the following definitions for the purposes of 42 CFR part 405.

MCIT Pathway Device Eligibility In Â§â405.603(a) we propose that the pathway is available to devices that meet the definitions proposed in Â§â405.601. Based on the explicit mention of devices in E.O. 13890 and our interaction and feedback from stakeholders who expressed their concern that there is more uncertainty of coverage for devices than for other items and services (for example, diagnostics, drugs and biologics), this proposed policy is for devices only. We propose in Â§â405.603(b) that the breakthrough devices that received FDA market authorization no more than 2 calendar years prior to the effective date of this subpart (the date the final rule is finalized) and thereafter will be eligible for coverage for claims submitted on or after the effective date of this rule.

Claims for breakthrough devices with dates of service that occurred before the effective date of this rule would not be covered through MCIT. For example, a hypothetical breakthrough device that was FDA market authorized on October 1, 2018, and utilized on January 1, 2020 would not be eligible for coverage under MCIT because on January 1, 2020, the date of service, the final MCIT rule was not yet legally in effect. In contrast, a claim for utilization of the same hypothetical breakthrough device with a date of service on January 1, 2021 might be eligible for coverage if the claim occurred after the effective date of the rule (assuming that the effective date of the rule was prior to January 1, 2021). Breakthrough devices market authorized prior to the effective date of this rule will not be eligible for all 4 years of coverage.

We propose in Â§â405.603(c) that to be part of the MCIT pathway, the device must be used according to its FDA approved or cleared indication for use. We propose that the device is only covered for use consistent with its FDA approved or cleared indication for use because that is the indication and conditions for use that were reviewed by the FDA and authorized for marketing. Data are unlikely to be available to support extending beyond the FDA required labeling for breakthrough devices on the date of marketing authorization. Use of the device for a condition or population that is not labeled (âoff-labelâ) will not be covered as that use would not be FDA authorized.

We specifically seek comment on whether off-label use of breakthrough devices should be covered and, if so, under what specific circumstances and/or evidentiary support. In Â§â405.603(d) and (e), we additionally propose limitations to what is coverable under the Act. In Â§â405.603(e), we are proposing that if CMS has issued an NCD on a particular breakthrough device, that breakthrough device is not eligible for MCIT. We are proposing this because, once the device has been reviewed by CMS for the FDA required approved or cleared indication for use.

Therefore, the device would not be eligible for the MCIT pathway. 3. General Coverage of Items and Services under the MCIT Pathway We propose in Â§â405.605 that devices covered under the MCIT pathway are covered no differently from devices that are covered outside of MCIT. In other words, provided the items and services are otherwise coverable (that is, not specifically excluded and not found by CMS to be outside the scope of a Medicare benefit category), covered items and services could include the device, reasonable and necessary surgery to implant the device, if implantable, related care and services costs of the device (for example, replacing reasonable and necessary parts of the device such as a battery), and coverage of any reasonable and necessary treatments due to complications arising from use of the device.

What the MCIT pathway offers compared to other pathways is predictable national coverage simultaneous with FDA market authorization that will generally last for a set time period. The proposed MCIT pathway would support and accelerate beneficiary access to certain innovative devices. CMS encourages manufacturers that have breakthrough devices covered under MCIT to develop additional data for the healthcare community. 4.

We propose in Â§â405.607(b)(1) that the MCIT pathway for breakthrough devices ends 4 years from the date the device received FDA market authorization. We propose this 4 year time period because it could allow manufacturers to develop clinical evidence and data regarding the benefit of the use of their device in a real world setting. For example, we believe 4 years would allow most manufacturers sufficient time to complete FDA required post-approval or other real-world data collection studies that may have been a condition of FDA market authorization. This assumption is based upon our historical experience with studies conducted through coverage with evidence development (CED).

Further, this time period allows Medicare to support manufacturers that, whether required by the FDA or not, have an interest in better understanding the health outcomes of their device in the Medicare population, including impacts on patient-reported and longer-term outcomes. Further, Â§â405.607(b) proposes reasons that the MCIT pathway may end prior to 4 years. This includes circumstances whereby the device becomes subject to an NCD, regulation, statute, or if the device can no longer be lawfully marketed.Start Printed Page 54335 D. Summary In summary, the MCIT pathway would provide immediate Medicare coverage of newly FDA market authorized breakthrough devices for 4 years.

We seek public comment on all of our proposals. In particular, we seek feedback on whether the proposed 4 year coverage period is sufficient. We also look to stakeholders and the public to determine the level of interest and expected use of the proposed MCIT pathway so the agency can begin to estimate the level of needed resources to support successful implementation. We are also seeking public comments on our proposal to codify in regulations the standards we have historically used in making reasonable and necessary decisions under Part A and Part B under section 1862(a)(1)(A) of the Act.

After considering public comments we would prepare a final rule that we expect would be effective 60 days after publication of the final rule. III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues.

The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden. The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

Table 1âNational Occupational Employment and Wage Estimates for MCITOccupation titleOccupation codeMean hourly wage ($/hr)Fringe benefit ($/hr)Adjusted hourly wage ($/hr)Compliance Officer13-104134.8634.8669.72 As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. This proposed coverage pathway allows for a voluntary participation and therefore necessitates that manufacturers of breakthrough devices notify CMS of their intent to enter the MCIT pathway.

Therefore, the burden associated with notifying CMS is the time and effort it would take for each of the organizations to send CMS an email or letter. We anticipate two MCIT pathway participants in the first year based upon the number of medical devices that received FY2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles. We estimate notifying CMS of intent to participate in MCIT would involve 15 minutes at $69.72 per hour by a compliance officer. In this regard, we estimate 15 mins per notification at a cost of $17.43 per organization (0.25 hours Ã $69.72).

Similarly, in aggregate, we estimate, for year 2 (0.75 hours at $52.29 an hour), for year 3 (1.0 hour at $69.72 an hour), and for year 4 (1.25 hours at $87.15 an hour). The proposed requirements and burden will be submitted to OMB under control number 0938-NEW. We are requesting public comments on these information collection and recordkeeping requirements. If you comment on these information collection and recordkeeping requirements, please do either of the following.

1. Submit your comments electronically as specified in the ADDRESSES section of this proposed rule. Or 2. Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention.

CMS Desk Officer, CMS-3372-P, Fax. (202) 395-6974. Or Email. OIRA_submission@omb.eop.gov.

Comments must be received on/by November 2, 2020. IV. Regulatory Impact Statement This proposed rule makes Medicare coverage policy updates pursuant to the authority at section 1862(a)(1)(A) of the Act. We are using regulatory action per the October 3, 2019 âExecutive Order on Protecting and Improving Medicare for Our Nation's Seniorsâ to address the increasing need for a swift Medicare coverage mechanism to allow beneficiaries across the nation to access breakthrough devices faster after FDA market authorization.

This proposed rule addresses that need by establishing a coverage pathway that will allow immediate beneficiary access to FDA market authorized breakthrough devices. We have examined the impact of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995.

Pub. L. 104-4), Start Printed Page 54336Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This proposed rule does reach the economic threshold and thus is considered a major rule. Regulatory alternatives to this proposed rule were to combine Medicare coverage with clinical evidence development under section 1862(a)(1)(E) of the Act, to take no regulatory action at this time, or to adjust the duration of the MCIT pathway.

Combining coverage with clinical evidence development would have met the E.O. 13890 overarching goal of beneficiary access to breakthrough devices. However, this alternative did not meet the other E.O. 13890 aims of minimizing time between FDA market authorization and Medicare coverage and wide availability.

The timing of coverage would depend upon the manufacturer being able to initiate a clinical study and the wide availability of coverage could be an issue if providers did not have the infrastructure necessary to participate in the clinical study. CMS chose to not to pursue combining coverage with evidence development for breakthrough devices because we wanted to meet the timing and wide availability aims of E.O. 13890. CMS also considered taking no regulatory action and trying to leverage the existing Medicare coverage pathways or proposing sub-regulatory policies to achieve the streamlined coverage process described in E.O.

13890. Taking no action would not have resulted in the desired national coverage and access envisioned in E.O. 13890 because, as described in this preamble, the existing coverage pathways do not consistently provide swift, national beneficiary access to innovative devices. As discussed elsewhere in the preamble, the nature of the problem being addressed by this proposed regulation is a potential delay between a milestone such as FDA market authorization and CMS coverage.

As such, we request comment on a policy option of shortening of the duration of the MCIT pathway from the proposed 4 years to 1 year. In addition to the alternatives just discussed, there are various possibilities regarding how to change the definition of âreasonable and necessaryââfor example, whether to include a new aspect of the proposed definition that focuses on commercial insurance coverage practices. As noted earlier in the preamble, the goal of this revision is to expand coverage. However, the nuances of the definition would affect the magnitude of the impact and we request comment that would facilitate quantification of effects and comparison of alternatives at the final rule stage.

Because it is not known how these new technologies would otherwise come to market and be reimbursed, it is not possible to develop a point estimate of the impact. In general, we believe the MCIT coverage pathway would range in impact from having no impact on Medicare spending, to a temporary cost for innovations that are adopted under an accelerated basis. The decision to enter the MCIT pathway is voluntary for the manufacturer. Because manufacturers typically join the Medicare coverage pathway that is most beneficial to them, this would result in selection against the existing program coverage pathways (to what degree is unknown at this point).

In addition, the past trend of new technology costing more than existing technology could lead to a higher cost for Medicare if this trend continued for technologies enrolling in the MCIT pathway. Nevertheless, new technology may also mitigate ongoing chronic health issues or improve efficiency of services thereby reducing some costs for Medicare. In order to demonstrate the potential impact on Medicare spending, the CMS Office of the Actuary (OACT) developed three hypothetical scenarios that illustrate the impact of implementing the proposed MCIT pathway. Scenarios two and three assume that the device would not have been eligible for coverage in the absence of this proposed rule.

If the devices received payment nationally and at the same time then there would be no additional cost under this pathway. For the second scenario, the low-cost scenario, we assumed that the new technologies would have the average costs ($2,044) and utilization (2,322 patients) of similar technologies included in the FY 2020 NTAP application cycle. Therefore, to estimate the first year of MCIT, we multiplied the add-on payment for a new device by the anticipated utilization for a new device by the number of anticipated devices in the pathway ($2,044 Ã 2,322 Ã 2 = $ 9.5 million). For the third scenario, the high-cost scenario, we assumed the new technologies would receive the maximum add-on payment from the FY 2020 NTAP application cycle ($22,425) and the highest utilization of a device (6,500 patients).

Therefore, to estimate for the first year of MCIT, we estimated similarly ($22,425 Ã 6,500 patients Ã 2 = $ 291.5 million). For subsequent years, we increased the number of anticipated devices in the pathway by three, four, and five in the last two scenarios until 2024.[] In addition to Start Printed Page 54337not taking into account inflation, the illustration does not reflect any offsets for the costs of these technologies that would be utilized through existing authorities nor the cost of other treatments (except as noted). It is not possible to explicitly quantify these offsetting costs but they could substantially reduce or eliminate the net program cost. However, by assuming that only two to five manufacturers will elect MCIT coverage, we have implicitly assumed that, while more manufacturers could potentially elect coverage under MCIT, the majority of devices would have been covered under a different coverage pathway.

Therefore, a substantial portion of the offsetting costs are implicitly reflected. Based on this analysis, there is a range of potential impacts of the proposed MCIT coverage pathway as shown in Table 2. The difference between the three estimates demonstrates how sensitive the impact is to the cost and utilization of these unknown devices. Table 2âIllustrated Impact on the Medicare Program by Proposed MCIT Coverage PathwayâCosts (in millions)FY 2021FY 2022FY 2023FY 2024No-cost Scenario$0$0$0$0Low-cost Scenario9.523.742.766.4High-cost Scenario291.5728.81,311.92,040.7 We believe the assumptions used in the three scenarios are reasonable to show the possible wide range of impacts for implementing this proposed pathway, in particular for a technology that would not have otherwise been eligible for coverage.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Some hospitals and other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and States are not included in the definition of a small entity.

We reviewed the Small Business Administration's Table of Small Business Size Standards Matched to North American Industry Classification System (NAICS) Codes to determine the NAICS U.S. Industry titles and size standards in millions of dollars and/or number of employees that apply to small businesses that could be impacted by this rule.[] We determined that small businesses potentially impacted may include surgical and medical instrument manufacturers (NAICS code 339112, dollars not provided/1,000 employees), Offices of Physicians (except Mental Health Specialists) (NAICS code 621111, $12 million/employees not provided), and Freestanding Ambulatory Surgical and Emergency Centers (NAICS code 621493, $16.5 million/employees not provided). During the first 4 years of MCIT, we anticipate approximately 14 surgical and medical instrument manufacturers may participate, and based off of U.S. Census data, the majority of this businesses type are small businesses with less than 1,000 employees (968 out of 1,093 businesses have less than 500 employees).[] As such, this proposed rule would impact less than 5 percent of these businesses, and the revenue impact, if any, would not be negative.

We are not preparing a further analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule will not have a significant negative economic impact on a substantial number of small entities because small entities are not being asked to undertake additional effort or take on additional costs outside of the ordinary course of business through this proposed rule. Rather, for small entities that develop or provide breakthrough devices to patients, this proposed rule is a means for the device to be covered through the Medicare program, which does not detract from revenue and could be viewed as a positive economic impact. With the limited information we had to base this estimate, we solicit public comment on improvements to this estimate for the final rule. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals.

This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital Start Printed Page 54338as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals because small rural hospitals are not being asked to undertake additional effort or take on additional costs outside of the ordinary course of business through this proposed rule. Obtaining breakthrough devices for patients is at the discretion of providers.

We are not requiring the purchase and use of breakthrough devices. Providers should continue to work with their patients to choose the best treatment. For small rural hospitals that provide breakthrough devices to their patients, this proposed rule is a means for the device to be covered through the Medicare program. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation.

In 2020, that threshold was approximately $156 million. This proposed rule would have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable.

Executive Order 13771 (E.O. 13771), titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. This proposed rule, if finalized as proposed, is expected to impose no more than de minimis costs and thus be neither an E.O. 13771 regulatory action nor an E.O.

13771 deregulatory action. In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget. V. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually.

We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Start List of Subjects Administrative practice and procedureDiseasesHealth facilitiesHealth professionsMedical devicesMedicareReporting and recordkeeping requirementsRural areasX-rays End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services proposes to amend 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1.

The authority for part 405 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k). End Authority Start Amendment Part2.

And (3) Appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it (i) Meets all of the following criteria. (A) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member. (B) Furnished in a setting appropriate to the patient's medical needs and condition. (C) Ordered and furnished by qualified personnel.

(D) One that meets, but does not exceed, the patient's medical need. And (E) At least as beneficial as an existing and available medically appropriate alternative. Or (ii) Is covered by commercial insurers, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant. * * * * * Start Amendment Part3.

Subpart F, consisting of Â§Â§â405.601-405.607, is added to read as follows. End Amendment Part 405.601 Medicare coverage of innovative technology. 405.603 Medical device eligibility. 405.605 Coverage of items and services.

405.607 Coverage period. Medicare coverage of innovative technology. (a) Basis and scope. Medicare coverage of innovative technology (MCIT) is a program that provides national, time-limited coverage under section 1862(a)(1)(A) of the Act for certain breakthrough medical devices.

Manufacturer participation in the pathway for breakthrough device coverage is voluntary. (b) Definitions. For the purposes of this subpart, the following definitions are applicable. Breakthrough device means a device that receives such designation by the Food and Drug Administration (FDA) (section 515B(d)(1) of the FD&C Act (21 U.S.C.

360e-3(d)(1)). MCIT stands for Medicare coverage of innovative technology. Medical device eligibility. The MCIT pathway is available only to medical devices that meet all of the following.

(a) That are FDA-designated breakthrough devices. (b) That are FDA market authorized at most [date 2 years prior to effective date of final rule] and thereafter. (c) That are used according to their FDA approved or cleared indication for use. (d) That are within a Medicare benefit category.

(e) That are not the subject of a Medicare national coverage determination. (f) That are not otherwise excluded from coverage through law or regulation. Coverage of items and services. Covered items and services furnished within the MCIT pathway may include any of the following, if not otherwise excluded from coverage.

Coverage period. (a) Start of the period. The MCIT pathway begins on the date the breakthrough device receives FDA market authorization. (b) End of the period.

The MCIT pathway for a breakthrough device ends as follows. (1) No later than 4 years from the date the breakthrough device received FDA market authorization. (2) Prior to 4 years if a manufacturer withdraws the breakthrough device from the MCIT pathway. (3) Prior to 4 years if the breakthrough device becomes the subject of a national coverage determination or otherwise becomes noncovered through law or regulation.

Start Signature Dated. May 4, 2020. Seema Verma, Administrator, Centers for Medicare &. Medicaid Services.

Dated. June 11, 2020. Alex M. Azar II, Secretary, Department of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-19289 Filed 8-31-20. 8:45 am]BILLING CODE 4120-01-P.