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The fluid creates waves over tiny buy viagra over the counter rows of hair cells, he explains. €œEach hair cell is tonotopically organized—or tuned—to a specific frequency for optimal transmission of the sounds you hear.” Your ear's cells are literally bent over Loud sounds bombard your ears, pushing those hair cells that transmit sound over, DeMari says. For the hair cells, it’s a traumatic experience—they remain bent over, even after there’s no noise, which leads to ringing, fullness, and that temporary loss of hearing.

Football games and other stadium buy viagra over the counter eventsare very loud and can cause TTS. TTS affects your hearing in the higher frequencies—that’s how you hear consonant sounds, which are essential to conveying a word’s meaning in English. (Without being able to hear a consonant, it’s hard to distinguish between words like hat and cat, for instance.) This leads to a situation where you can hear someone, but can’t understand them, DeMari says.

With TTS, however, your hearing buy viagra over the counter levels will return to the baseline after a brief period. Your hearing threshold returns to normal, in other words. DeMari describes a situation where you get your hearing tested before a concert, then experience TTS.

After the TTS abates, however, if you got another hearing test, the results buy viagra over the counter would be the same. (It’s worth noting, however, that there could be damage to your hearing beyond the levels that tests measure, he adds.) How big of a deal is TTS?. That’s a bit tricky to answer.

On the one hand, buy viagra over the counter it’s short-lived. Over time, DeMari says, the effects from TTS will likely go away, and “you’ll be back to normal. Hence the name.

It’s temporary,” buy viagra over the counter he says. But don’t take too much solace in TTS being a temporary situation. It’s not OK to go to concerts regularly and get your ears blown out—or be frequently exposed to any other loud noises without ear protection.

Over time, if you experience TTS frequently, it can become a permanent buy viagra over the counter threshold shift (PTS), according to a review of threshold shifts in the journal Otology and Neurotology. That said, a one-time experience of TTS is unlikely to cause permanent damage, DeMari says. €œWhen they say temporary, they truly do mean temporary,” he says.

Why does TTS occur? buy viagra over the counter. Simply put, TTS occurs due to loud noises. Concerts are a big offender—stand by the speakers at a show, and it might reach 110 decibels, DeMari notes.

“That’s extremely loud,” he says buy viagra over the counter. In general, sounds over 85 decibels can lead to noise-induced hearing loss, according to the National Institute on Deafness and Other Communication Disorders (NIDCD). TTS is essentially a noise-induced hearing loss—just one where the effects aren’t long lasting.

Other situations that can lead to TTS include other exposure to loud noises, such as cranking music through earbuds, a firecracker that goes off right buy viagra over the counter by you, an explosion, the buzz of a lawnmower, and so on. How long does TTS last?. Remember, TTS is a temporary effect.

It might last a few hours, a few days, or even a few weeks, DeMari buy viagra over the counter says. The longer you’re exposed to a noise, and the more intense it is, the more intense and long-lasting the TTS may be, he says. But other factors can also play a role, including a person’s age and sex, prior history of noise exposure, environmental factors, such as smoking, and diseases such as diabetes, according to the Otology and Neurotology review.

As DeMari puts buy viagra over the counter it, people’s susceptibility to TTS and their hearing differ. How can you prevent TTS?. “It's highly unlikely you'll get a temporary threshold shift out of nowhere,” DeMari notes.

Exposure to buy viagra over the counter noise is the culprit. To that end, avoiding exposure to loud noises will prevent TTS. That’s a guideline that seems easy, but can be challenging in the real-world, where you may find yourself unexpectedly exposed to loud machinery, or sitting in a movie theater where sounds can be between 74 and 104 decibels, per the NIDCD.

(That lower range for movie buy viagra over the counter theater sounds is likely fine, but the upper range is quite loud, and can cause harm.) As much as you can, stay away from loud noises. Even small changes can make a difference. If you’re at a concert, sit or stand away from the speakers, instead of dancing in front of them.

Since duration matters, take breaks, too, buy viagra over the counter stepping outside of the concert hall so that your ears aren’t constantly blasted with loud noises. And wear earplugs. If it’s loud noises you don’t need to hear (think.

Fireworks, the lawnmower), go for options that cancel all noise out, choosing buy viagra over the counter earplugs with the highest noise reduction rating (NRR). But if you’re going to a movie theater where the audio is super loud or a concert where you’ll still want to hear the music, look for earplugs designed for musicians, DeMaris suggests. You can find these online, or get custom fitted ones from an audiologist.

These earplugs buy viagra over the counter attenuate the sound, but don’t degrade the music, he says. When to seek out medical attention If you have symptoms associated with TTS, but haven’t experienced a loud event recently, make an appointment with an audiologist, DeMari recommends. But if you’re experiencing TTS after being exposed to noise, give it some time for the effects to abate, he recommends.

If the problem lingers beyond several weeks, check buy viagra over the counter in with an audiologist.Wondering how caffeine intake might affect your hearing, especially when it comes to hearing loss and tinnitus (ringing in the ears)?. What about Meniere's disease?. So far, research has not shown any harmfullinks between caffeine consumption and hearingloss.

This isn't a heavily buy viagra over the counter studied topic of research, and for the most part, it does not seem that caffeine intake plays a big role in hearing health overall. What is caffeine?. Caffeine is a natural stimulant found in coffee, tea, chocolate and many energy drinks as well as some non-prescription cold and allergy medications and pain relievers.

It stimulates the central nervous system, improving circulation and focus and buy viagra over the counter keeps us from feeling tired after a late night on the town. Studies indicate caffeine may reduce the risk of certain cancers, such as liver, mouth and throat as well as type 2 diabetes, Parkinson’s disease and stroke. How does caffeine affect hearing loss?.

For the most part, it does not appear that normal caffeine intake (around 2 cups of coffee day, or less) will have much of an impact on your hearing in the buy viagra over the counter long-term. Caffeine does restrict blood vessels and alter blood pressure, and blood flow is an important part of healthy hearing, so researchers have wondered if there is a relationship. A large Korean observational study found no connection.

In fact, it found that people buy viagra over the counter who drank coffee had lower rates of hearing loss than non-coffee drinkers. Caffeine may worsen temporary hearing loss after noise exposure Ever left a really noisy event and your hearing felt funny and muffled?. You likely experienced temporary threshold shift (TTS), a sign that your the delicate hair cells of your inner ear are overworked and fatigued.

Under normal conditions, your hearing should recover in a few days, if not buy viagra over the counter sooner. It might help to skip any large doses of caffeine until your hearing is back to normal. Daily consumption of caffeine may prolong recovery from TTS, a 2016 study showed.

However, the buy viagra over the counter study was conducted on a small group of guinea pigs, so it likely does not translate to the same effect in people. And some cancer patients should be cautious, too Cancer patients who take the drug cisplatin should be careful combining the drug with caffeine intake. Cisplatin is well-known to cause hearing loss and tinnitus in chemotherapy patients, a phenomenon known as cisplatin-induced hearing loss.

A 2019 study on lab rats showed buy viagra over the counter that adding caffeine increased the risk of hearing loss. The study authors concluded that "these findings highlight a possible drug-drug interaction between caffeine and cisplatin for ototoxicity and suggest that caffeine consumption should be cautioned in cancer patients treated with a chemotherapeutic regimen containing cisplatin." What about tinnitus and caffeine?. No need to abstain, according to research Some tinnitus patients report an improvement in symptoms when they cut back on caffeine.

If you also buy viagra over the counter find it useful, then by all means, cut back. Just keep in mind that so far, research hasn't shown that cutting back will reduce tinnitus. In fact, one study on women actually found lower rates of tinnitus among women who reported heavy coffee use.

This is similar to a previous study finding that indicated "caffeine abstinence" was an ineffective treatment for tinnitus, and in fact, the buy viagra over the counter withdrawal from caffeine might actually be distressing. No evidence was found to justify caffeine abstinence as a therapy to alleviate tinnitus, and acute effects of caffeine withdrawal might even add to the burden of tinnitus, the study authors said. Meniere's disease and caffeine Patients who have Meniere's disease are sometimes told to cut back on alcohol, salt and caffeine to help alleviate symptoms.

Anecdotally, diet changes can be very helpful for some buy viagra over the counter people, especially low-salt diets. But there's scant evidence on the topic, especially when it comes to caffeine and alcohol. Theoretically, "caffeine and alcohol intake can result in constriction of blood vessels (vasoconstriction) and could result in a reduction in the blood supply to the inner ear, which may make patients' symptoms worse," state the authors of an evidence review on Meniere's and dietary changes.

"Many doctors advise dietary changes as a first‐line treatment as buy viagra over the counter it is thought to be a relatively simple and inexpensive option," they added. But frustratingly, the review authors found no high-quality studies on the topic at all. "This intervention is widely recommended to patients without any proven benefit or clear understanding of any potential harms.

This may delay the use of more effective buy viagra over the counter treatment options resulting in disease progression and patient suffering or adverse effects," the authors state. Bottom line. The relationship between caffeine and hearing health has not been studied enough to know what, if any, impact caffeine has on Meniere's disease, hearing loss or tinnitus.

If you enjoy coffee, soda or energy drinks and are otherwise healthy, there is no research indicating you should stop.

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A United Airlines passenger jet takes off with New York City as a backdrop, at Newark Liberty International Airport, New Jersey.Chris Helgren | ReutersIt's time to say goodbye to the $200 ticket-change fee.United Airlines on Sunday said that it will permanently scrap fees to change domestic flights, a big bet that more flexible policies will win over much-needed customers as the pain from the erectile dysfunction viagra's impact on air travel continue to mount.It's a page from the playbook of rival Southwest Airlines, which doesn't charge customers fees to change their flights."Following previous tough times, airlines made difficult decisions to survive, sometimes at buy viagra over the counter the expense of customer service," said United CEO Scott Kirby in a news release. "United Airlines won't be following that same playbook as we come out of this crisis buy viagra over the counter. Instead, we're taking a completely different approach – and looking at new ways to serve our customers better."United's announcement that it will no longer charge travelers the $200 fee comes as airlines buy viagra over the counter are scrambling to find ways to revitalize their businesses, which have been battered by the viagra. This summer, Transportation Security Administration screenings at U.S. Airports are hovering around 30% of last year's levels, as airlines go buy viagra over the counter without much-needed revenue during the peak summer travel season.Customers with standard economy tickets or premium-class tickets will be able to change their flights without paying the fee but they will be responsible for a difference in fare.

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V. Nassar, and Bostock v. Clay County, Georgia. The agency also revised the regulation by adding terms to reflect the full scope of section 11(c)'s prohibition against retaliation. The final rule is effective on Sept.

3, 2021. Learn more about whistleblower protections. # # # Media Contacts. Denisha Braxton, 202-693-5061, braxton.denisha.l@dol.gov Mandy McClure, 202-693-4675, mcclure.mandy.c@dol.gov Release Number. 21-1611-NAT U.S.

Department of Labor news materials are accessible at http://www.dol.gov. The department's Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay).September 1, 2021US Department of Labor finds Ohio automotive steel manufacturer continuesto expose workers to amputations, other hazards at Canton millRepublic Steel placed in OSHA’s Severe Violator Enforcement Program CANTON, OH – Responding to a complaint of unsafe working conditions, federal safety inspectors found a Canton automotive steel mill did not install adequate machine guarding, implement lockout/tagout measures or train workers on safety procedures, all of which exposed workers to amputation hazards. The U.S. Department of Labor’s Occupational Safety and Health Administration cited Republic Steel for one repeat, seven serious and three other-than-serious safety violations.

OSHA determined the company did not train workers to operate cranes and forklifts adequately, failed to repair damaged cranes and follow safe electrical work practices, and exposed workers to slip and fall hazards. OSHA has proposed $220,399 in penalties and placed the company in its Severe Violator Enforcement Program. OSHA last cited Republic Steel for similar machine safety hazards in 2017. €œTo avoid amputations and other severe injuries, employers must install safety guards on machines and train workers on how to control hazardous energy and avoid coming in contact with operating machine parts,” said OSHA Area Director Howard Eberts in Cleveland. €œRepublic Steel is well aware of their responsibility to ensure safety procedures are followed, yet once again, they’ve failed to do so.” In 2018, the Bureau of Labor Statistics noted 58 percent of the 3,500 reported workplace amputations involved machine hazards.

Based in Canton, Republic Steel manufactures steel bars and other products for use in machinery, cars, trucks and other vehicles. The company, a subsidiary of Grupo Simec of Guadalajara, Mexico, employs more than 2,000 workers. The company has 15 business days from receipt of its citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission. Learn more about OSHA. # # # Media Contacts.

Scott Allen, 312-353-4727, allen.scott@dol.govRhonda Burke, 312-353-4807, burke.rhonda@dol.gov Release Number. 21-1580-CHI U.S. Department of Labor news materials are accessible at http://www.dol.gov. The department’s Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay)..

September 3, 2021US Department of Labor buy viagra over the counter publishes final interpretive rule amending one of therules interpreting the OSH Act's anti-retaliation provision WASHINGTON, DC – The U.S. Department of Labor announced today that its Occupational Safety and Health Administration has published a final interpretive rule that changes a rule interpreting the anti-retaliation provision of the Occupational Safety and Health Act of 1970. In 1973, OSHA established Part 1977 - Discrimination against Employees under OSH Act of 1970 buy viagra over the counter that contains interpretive regulations and procedures governing the agency's administration of cases under section 11(c), which prohibits employers from retaliating against employees because they have engaged in protected activity, including complaining about unsafe or unhealthful working conditions. The revised final interpretive rule clarifies the causal connection between the protected activity and the adverse action (29 CFR 1977.6).

This change brings the provision in line with the Supreme Court's holdings in buy viagra over the counter Gross v. FBL Financial Services, Inc., Univ. Of Tex buy viagra over the counter. Sw.

Clay County, Georgia. The agency also revised the regulation by adding terms to reflect the full scope of section 11(c)'s prohibition against retaliation. The final rule is effective on Sept. 3, 2021.

Learn more about whistleblower protections. # # # Media Contacts. Denisha Braxton, 202-693-5061, braxton.denisha.l@dol.gov Mandy McClure, 202-693-4675, mcclure.mandy.c@dol.gov Release Number. 21-1611-NAT U.S.

Department of Labor news materials are accessible at http://www.dol.gov. The department's Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay).September 1, 2021US Department of Labor finds Ohio automotive steel manufacturer continuesto expose workers to amputations, other hazards at Canton millRepublic Steel placed in OSHA’s Severe Violator Enforcement Program CANTON, OH – Responding to a complaint of unsafe working conditions, federal safety inspectors found a Canton automotive steel mill did not install adequate machine guarding, implement lockout/tagout measures or train workers on safety procedures, all of which exposed workers to amputation hazards. The U.S.

Department of Labor’s Occupational Safety and Health Administration cited Republic Steel for one repeat, seven serious and three other-than-serious safety violations. OSHA determined the company did not train workers to operate cranes and forklifts adequately, failed to repair damaged cranes and follow safe electrical work practices, and exposed workers to slip and fall hazards. OSHA has proposed $220,399 in penalties and placed the company in its Severe Violator Enforcement Program. OSHA last cited Republic Steel for similar machine safety hazards in 2017.

€œTo avoid amputations and other severe injuries, employers must install safety guards on machines and train workers on how to control hazardous energy and avoid coming in contact with operating machine parts,” said OSHA Area Director Howard Eberts in Cleveland. €œRepublic Steel is well aware of their responsibility to ensure safety procedures are followed, yet once again, they’ve failed to do so.” In 2018, the Bureau of Labor Statistics noted 58 percent of the 3,500 reported workplace amputations involved machine hazards. Based in Canton, Republic Steel manufactures steel bars and other products for use in machinery, cars, trucks and other vehicles. The company, a subsidiary of Grupo Simec of Guadalajara, Mexico, employs more than 2,000 workers.

The company has 15 business days from receipt of its citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission. Learn more about OSHA. # # # Media Contacts. Scott Allen, 312-353-4727, allen.scott@dol.govRhonda Burke, 312-353-4807, burke.rhonda@dol.gov Release Number.

21-1580-CHI U.S. Department of Labor news materials are accessible at http://www.dol.gov. The department’s Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay)..

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Start Preamble wellbutrin viagra Centers for Medicare &. Medicaid Services (CMS), Health and Human Services (HHS). Notice.

This notice invites all interested parties to submit nominations to fill vacancies on the Advisory Panel on Outreach and Education (APOE). This notice also announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S.

Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare &. Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace®, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

Meeting Date. Wednesday, May 26, 2021 from 12:00 p.m. To 5:00 p.m.

Eastern daylight time (e.d.t). Deadline for Meeting Registration, Presentations, Special Accommodations, and Comments. Wednesday, May 19, 2021, 5:00 p.m.

(e.d.t). Deadline for Submitting Nominations. Nominations will be considered if we receive them at the appropriate address, Start Printed Page 26040provided in the ADDRESSES section of this notice, no later than 5 p.m., (e.d.t.) on June 11, 2021.

Meeting Location. Virtual. All those who RSVP will receive the link to attend.

Nominations, Presentations, and Written Comments. Nominations, presentations, and written comments should be submitted to. Lisa Carr, Designated Federal Official (DFO), Office of Communications, Centers for Medicare &.

Medicaid Services, 200 Independence Avenue SW, Mailstop 325G HHH, Washington, DC 20201, 202-690-5742, or via email at APOE@cms.hhs.gov. Registration. The meeting is open to the public, but attendance is limited to the space available.

Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/​e/​apoe-may-26-2021-virtual-meeting-tickets-150209828641 or by contacting the DFO listed in the FOR FURTHER INFORMATION CONTACT section of this notice, by the date listed in the DATES section of this notice. Individuals requiring sign language interpretation or other special accommodations should contact the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Start Further Info Lisa Carr, Designated Federal Official, Office of Communications, 200 Independence Avenue SW, Mailstop 325G HHH, Washington, DC 20201, 202-690-5742, or via email at APOE@cms.hhs.gov.

Additional information about the APOE is available at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​APOE. Press inquiries are handled through the CMS Press Office at (202) 690-6145.

End Further Info End Preamble Start Supplemental Information I. Background and Charter Renewal Information A. Background The Advisory Panel for Outreach and Education (APOE) (the Panel) is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub.

L. 92-463), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of federal advisory committees.

The Panel is authorized by section 1114(f) of the Social Security Act (the Act) (42 U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 U.S.C. 217a).

The Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) signed the charter establishing the Citizen's Advisory Panel on Medicare Education [] (the predecessor to the APOE) on January 21, 1999 (64 FR 7899) to advise and make recommendations to the Secretary and the Administrator of the Centers for Medicare &. Medicaid Services (CMS) on the effective implementation of national Medicare education programs, including with respect to the Medicare+Choice (M+C) program added by the Balanced Budget Act of 1997 (Pub.

L. 105-33). The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub.

L. 108-173) expanded the existing health plan options and benefits available under the M+C program and renamed it the Medicare Advantage (MA) program. CMS has had substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options available and better tools to evaluate these options.

Successful MA program implementation required CMS to consider the views and policy input from a variety of private sector constituents and to develop a broad range of public-private partnerships. In addition, Title I of the MMA authorized the Secretary and the Administrator of CMS (by delegation) to establish the Medicare prescription drug benefit. The drug benefit allows beneficiaries to obtain qualified prescription drug coverage.

In order to effectively administer the MA program and the Medicare prescription drug benefit, we have substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options and benefits available, and to develop better tools to evaluate these plans and benefits. The Patient Protection and Affordable Care Act (Pub. L.

111-148) and Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively referred to as the Affordable Care Act) expanded the availability of other options for health care coverage and enacted a number of changes to Medicare as well as to Medicaid and CHIP.

Qualified individuals and qualified employers are now able to purchase private health insurance coverage through a competitive marketplace, called an Affordable Insurance Exchange (also called Health Insurance Marketplace®, or Marketplace® [] ). In order to effectively implement and administer these changes, we must provide information to consumers, providers, and other stakeholders through education and outreach programs regarding how existing programs will change and the expanded range of health coverage options available, including private health insurance coverage through the Marketplace®. The APOE allows us to consider a broad range of views and information from interested audiences in connection with this effort and to identify opportunities to enhance the effectiveness of education strategies concerning the Affordable Care Act.

The scope of this Panel also includes advising on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5).

On January 21, 2011, the Panel's charter was renewed and the Panel was renamed the Advisory Panel for Outreach and Education. The Panel's charter was most recently renewed on January 19, 2021, and will terminate on January 19, 2023 unless renewed by appropriate action. B.

Charter Renewal and Copies of the Charter In accordance with the January 19, 2021, charter, the APOE will advise the HHS and CMS on developing and implementing education programs that support individuals who are enrolled in or eligible for Medicare, Medicaid, CHIP, or coverage available through the Health Insurance Marketplace® and other CMS programs. The scope of this FACA group also includes advising on education of providers and stakeholders with respect to health care reform and certain provisions of the HITECH Act enacted as part of the ARRA. The charter will terminate on January 19, 2023, unless renewed by appropriate action.

The APOE was chartered under 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended. The APOE is governed by provisions of Public Law 92-463, as amended (5 U.S.C.

Appendix 2), which sets forth standards for the formation and use of advisory committees. In accordance with the renewed charter, the APOE will advise the Secretary and the CMS Administrator concerning optimal strategies for the following. Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Start Printed Page 26041Medicare, Medicaid, the CHIP, and coverage available through the Health Insurance Marketplace® and other CMS programs.

Enhancing the federal government's effectiveness in informing Medicare, Medicaid, CHIP, or the Health Insurance Marketplace® consumers, issuers, providers, and stakeholders, pursuant to education and outreach programs of issues regarding these programs, including the appropriate use of public-private partnerships to leverage the resources of the private sector in educating beneficiaries, providers, partners and stakeholders. Expanding outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of Medicare, Medicaid, the CHIP and the Health Insurance Marketplace® education programs, and other CMS programs as designated. Assembling and sharing an information base of “best practices” for helping consumers evaluate health coverage options.

Building and leveraging existing community infrastructures for information, counseling, and assistance. Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act. The current members of the Panel as of April 9, 2021, are.

E. Lorraine Bell, Chief Officer, Population Health, Catholic Charities USA. Nazleen Bharmal, Medical Director of Community Partnerships, Cleveland Clinic.

Julie Carter, Senior Federal Policy Associate, Medicare Rights Center. Scott Ferguson, Director of Care Transitions and Population Health, Mount Sinai St. Luke's Hospital.

Leslie Fried, Senior Director, Center for Benefits Access, National Council on Aging. Jean-Venable Robertson Goode, Professor, Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University. Ted Henson, Director of Health Center Performance and Innovation, National Association of Community Health Centers.

Joan Ilardo, Director of Research Initiatives, Michigan State University, College of Human Medicine. Cheri Lattimer, Executive Director, National Transitions of Care Coalition. Cori McMahon, Vice President, Tridiuum.

Alan Meade, Director of Rehab Services, Holston Medical group. Michael Minor, National Director, H.O.P.E. HHS Partnership, National Baptist Convention USA, Incorporated.

Jina Ragland, Associate State Director of Advocacy and Outreach, AARP Nebraska. Morgan Reed, Executive Director, Association for Competitive Technology. Margot Savoy, Chair, Department of Family and Community Medicine, Temple University Physicians.

Congresswoman Allyson Schwartz, President and CEO, Better Medicare Alliance. And. Tia Whitaker, Statewide Director, Outreach and Enrollment, Pennsylvania Association of Community Health Centers.

The Secretary's Charter for the APOE is available on the CMS website at. Https://www.facadatabase.gov/​FACA/​apex/​FACAPublicCommittee?. €‹id=​a10t0000001gzsCAAQ, or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR FURTHER INFORMATION section of this notice.

II. Request for Nominations The APOE shall consist of no more than 20 members. The Chair shall either be appointed from among the 20 members, or a Federal official will be designated to serve as the Chair.

The charter requires that meetings shall be held up to four times per year. Members will be expected to attend all meetings. The members and the Chair shall be selected from authorities knowledgeable in one or more of the following fields.

Senior citizen advocacy Outreach to minority and underserved communities Health communications Disease-related advocacy Disability policy and access Health economics research Health insurers and plans Health IT Direct patient care Matters of labor and retirement Representatives of the general public may also serve on the APOE. This notice also requests nominations for three individuals to serve on the APOE to fill current vacancies and possible vacancies that may become available later in 2021. This notice is an invitation to interested organizations or individuals to submit their nominations for membership (no self-nominations will be accepted).

The CMS Administrator will appoint new members to the APOE from among those candidates determined to have the expertise required to meet specific agency needs, and in a manner to ensure an appropriate balance of membership. We have an interest in ensuring that the interests of both women and men, members of all racial and ethnic groups, and disabled individuals are adequately represented on the APOE. Therefore, we encourage nominations of qualified candidates who can represent these interests.

Any interested organization or person may nominate one or more qualified persons. Each nomination must include a letter stating that the nominee has expressed a willingness to serve as a Panel member and must be accompanied by a curricula vitae and a brief biographical summary of the nominee's experience. While we are looking for experts in a number of fields, our most specific needs are for experts in outreach to minority and underserved communities, health communications, disease-related advocacy, disability policy and access, health economics research, behavioral health, health insurers and plans, Health IT, social media, direct patient care, and matters of labor and retirement.

We are requesting that all submitted curricula vitae include the following. Date of birth Place of birth Title and current position Professional affiliation Home and business address Telephone and fax numbers Email address Areas of expertise Phone interviews of nominees may also be requested after review of the nominations. In order to permit an evaluation of possible sources of conflict of interest, potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts.

Members are invited to serve for 2-year terms, contingent upon the renewal of the APOE by appropriate action prior to its termination. A member may serve after the expiration of that member's term until a successor takes office. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of that term.

III. Meeting Format and Agenda In accordance with section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the May 26, 2021 meeting will include the following.

Welcome and listening session with CMS leadership Recap of the previous (March 31, 2021) meeting CMS programs, initiatives, and priorities An opportunity for public commentStart Printed Page 26042 Meeting summary, review of recommendations, and next steps Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice.

IV. Meeting Participation The meeting is open to the public, but attendance is limited to registered participants. Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/​e/​apoe-may-26-2021-virtual-meeting-tickets-150209828641 or contact the DFO at the address or number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice.

This meeting will be held virtually. Individuals who are not registered in advance will be unable to attend the meeting. V.

Collection of Information This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

The Acting Administrator of the Centers for Medicare &. Medicaid Services (CMS), Elizabeth Richter, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Start Signature Dated.

May 10, 2021. Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services.

End Signature End Supplemental Information [FR Doc. 2021-10118 Filed 5-11-21. 8:45 am]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &.

Medicaid Services (CMS), Health and Human Services, (HHS). Interim final rule with comment period. This interim final rule with comment period (IFC) amends our current regulations to allow hospitals with a rural redesignation under the Social Security Act (the Act) to reclassify through the Medicare Geographic Classification Review Board (MGCRB) using the rural reclassified area as the geographic area in which the hospital is located.

These regulatory changes align our policy with the decision in Bates County Memorial Hospital v. Azar, effective with reclassifications beginning with fiscal year (FY) 2023. We would also apply the policy in this IFC when deciding timely appeals before the Administrator of applications for reclassifications beginning with FY 2022 that were denied by the MGCRB due to the current policy, which does not permit hospitals with rural redesignations to use the rural area's wage data for purposes of reclassifying under the MGCRB.

Effective date. These regulations are effective on May 10, 2021. Comment date.

To be assured consideration, comments must be received at one of the addresses provided below by June 28, 2021. In commenting, please refer to file code CMS-1762-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed). 1. Electronically.

You may (and we encourage you to) submit electronic comments on this regulation to http://www.regulations.gov. Follow the instructions under the “submit a comment” tab. 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-1762-IFC, P.O. Box 8013, Baltimore, MD 21244-1850.

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 via express or overnight mail to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention.

CMS-1762-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, we refer readers to the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info Tehila Lipschutz, (410) 786-1344 or Dan Schroder, (410) 786-7452.

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://regulations.gov. Follow the search instructions on that website to view public comments. Comments received timely will be also 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 A. Wage Index for Acute Care Hospitals Paid Under the Hospital Inpatient Prospective Payment System (IPPS) Under section 1886(d) of the Social Security Act (the Act), hospitals are paid based on prospectively set rates.

To account for geographic area wage level differences, section 1886(d)(3)(E) of the Act requires that the Secretary of the Department of Health and Human Services (the Secretary) adjust the standardized amounts by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital, as compared to the national average hospital wage level. We currently define hospital labor market areas based on the delineations of statistical areas established by the Office of Management and Budget (OMB). The current statistical areas (which were implemented beginning with FY 2015) are based on revised OMB delineations issued on February 28, 2013, in OMB Bulletin No.

13-01, with updates as reflected in OMB Bulletins Nos. 15-01, 17-01, and 18-04. We refer readers to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49951 through 49963) for a full discussion of our implementation of the new OMB labor market area delineations beginning with the FY 2015 wage index, and to the FY 2021 IPPS/LTCH PPS final rule (85 FR 58743 through 58755) for a discussion of the latest updates to these delineations.

Section 1886(d)(3)(E) of the Act requires the Secretary to update the wage index of hospitals annually, and to base the update on a survey of wages and wage-related costs of short-term, acute care hospitals. Under section 1886(d)(8)(D) of the Act, the Secretary is required to adjust the standardized amounts so as to ensure that aggregate payments under the IPPS, after Start Printed Page 24736implementation of the provisions of sections 1886(d)(8)(B), 1886(d)(8)(C), and 1886(d)(10) of the Act, regarding geographic reclassification of hospitals, are equal to the aggregate prospective payments that would have been made absent these provisions. B.

Hospital Reclassifications Under Sections 1886(d)(8)(E) and 1886(d)(10) of the Act Hospitals may seek to have their geographic designation reclassified. Under section 1886(d)(8)(E) of the Act, a qualifying prospective payment hospital located in an urban area may apply for rural status. Specifically, section 1886(d)(8)(E) of the Act states that “[f]or purposes of this subsection, not later than 60 days after the receipt of an application (in a form and manner determined by the Secretary) from a subsection (d) hospital described in clause (ii), the Secretary shall treat the hospital as being located in the rural area (as defined in paragraph (2)(D)) of the state in which the hospital is located.” The regulations governing these geographic redesignations are codified in § 412.103, and such hospitals are commonly referred to as “§ 412.103 hospitals”.

In a separate process, hospitals may also reclassify for purposes of the wage index under the IPPS under section 1886(d)(10) of the Act by applying to the Medicare Geographic Classification Review Board (MGCRB). Hospitals must apply to the MGCRB to reclassify not later than 13 months prior to the start of the fiscal year for which reclassification is sought, generally by September 1. (However, we note that this deadline has been extended for applications for FY 2022 reclassifications to 15 days after the public display date of the FY 2021 IPPS/LTCH final rule at the Office of the Federal Register, using our authority under section 1135(b)(5) the Act due to the erectile dysfunction treatment Public Health Emergency.) Generally, hospitals must be proximate to the labor market area to which they are seeking reclassification and must demonstrate characteristics similar to hospitals located in that area.

The MGCRB issues its decisions by the end of February for reclassifications that become effective for the following fiscal year (beginning October 1). The regulations applicable to reclassifications by the MGCRB are located in §§ 412.230 through 412.280. Prior to a court decision in Geisinger Community Medical v.

Secretary, United States Department of Health and Human Services, 794 F.3d 383 (3d Cir. 2015) (“Geisinger”), hospitals were only able to hold one reclassification at a time. Either under § 412.103 or through the MGCRB under section 1886(d)(10) of the Act.

The Court of Appeals in Geisinger ruled that CMS's prohibition of dual § 412.103 and MGCRB reclassifications was unlawful, since section 1886(d)(8)(E)(i) of the Act requires that “the Secretary shall treat the hospital as being located in the rural area,” inclusive of MGCRB reclassification purposes. Therefore, on April 21, 2016, we published an interim final rule with comment period (the April 21, 2016 IFC) in the Federal Register (81 FR 23428 through 23438) that included provisions amending our regulations to allow hospitals nationwide to have simultaneous § 412.103 and MGCRB reclassifications. II.

Provisions of the Interim Final Rule With Comment Period Pursuant to our April 21, 2016 IFC, for reclassifications effective beginning FY 2018, a hospital may acquire rural status under § 412.103 and subsequently apply for a reclassification under the MGCRB using the distance and average hourly wage criteria designated for rural hospitals. Hospitals with a § 412.103 redesignation seeking additional reclassification under the MGCRB use the rural distance and average hourly wage criteria under § 412.230(b)(1), (d)(1)(iii)(C), and (d)(1)(iv)(E). For example, under our current policy, a § 412.103 hospital geographically located in the urban CBSA of Buffalo-Cheektowaga, NY seeking to reclassify under the MGCRB would demonstrate that their wages are at least 106 percent (and not 108 percent, as urban hospitals must demonstrate) of the average hourly wage of Buffalo-Cheektowaga, NY, to meet the criteria at § 412.230(d)(1)(iii)(C).

However, our current policy compares the average hourly wage of a § 412.103 hospital to its geographic urban location, rather than the rural reclassified area, for purposes of satisfying certain wage comparison criteria. In response to a comment on our April 21, 2016 IFC (81 FR 56925), we stated. €œThe commenter is correct that the rural distance and average hourly wage criteria will be used for hospitals with a § 412.103 redesignation.

However, the commenter's statement that the average hourly wage of a hospital with a § 412.103 redesignation is compared to the average hourly wage of hospitals in the State's rural area under § 412.230(d)(1)(iii)(C) is incorrect. Instead, the hospital's average hourly wage would be compared to the average hourly wage of all other hospitals in its urban geographic location using the rural distance and average hourly wage criteria.” On May 14, 2020, the United States District Court for the District of Columbia issued a decision in Bates County Memorial Hospital v. Azar, 464 F.

Bates County Memorial Hospital and five other geographically urban hospitals were reclassified to rural under § 412.103. They also applied for reclassification under the MGCRB, but were denied because their wages were not at least 106 percent of the geographic urban area in which the hospitals were located. Each of the hospitals' average hourly wages were at least 106 percent of the 3-year average hourly wage of all other hospitals in the rural area of the state in which the hospitals are located.

The Court agreed with the Plaintiffs that the statute at section 1886(d)(8)(E)(i) of Act requires that CMS treat qualifying hospitals as being located in the rural area for purposes of section 1886(d) of the Act, including MGCRB reclassification. The Bates decision requires that CMS consider the rural area to be the area in which the hospital is located for the wage comparisons required for MGCRB reclassifications. For example, pursuant to Bates, a § 412.103 hospital geographically located in the urban CBSA of Buffalo-Cheektowaga, NY seeking to reclassify under the MGCRB would demonstrate that their wages are at least 106 percent of the average hourly wage of rural NY, rather than that of Buffalo-Cheektowaga.

As a result of the Bates court's decision, we are revising our policy so that the redesignated rural area, and not the hospital's geographic urban area, will be considered the area a § 412.103 hospital is located in for purposes of meeting MGCRB reclassification criteria. Similarly, we are revising the regulations to consider the redesignated rural area, and not the geographic urban area, as the area a § 412.103 hospital is located in for the prohibition at § 412.230(a)(5)(i) on reclassifying to an area with a pre-reclassified average hourly wage lower than the pre-reclassified average hourly wage for the area in which the hospital is located. Specifically, to align our policy with the court's decision in Bates, we are amending the regulations at § 412.230(a)(1) by adding (a)(1)(iii) to state that an urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of this section.

We are also making conforming changes to the regulation at § 412.230(a)(5)(i) because Start Printed Page 24737§ 412.230(a)(1) except paragraph (a)(5). Because § 412.230(a)(1) excepts paragraph (a)(5), we believe it is necessary to make a specific conforming revision to § 412.230(a)(5)(i), in addition to the general rule at § 412.230(a)(1)(iii), to clarify that the general rule at § 412.230(a)(1)(iii) applies to § 412.230(a)(5)(i) as well. That is, we are amending the regulation at § 412.230(a)(5)(i) to add language stating that an urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of paragraph (a)(5)(i).

These changes implement the Bates court's interpretation of the requirement at section 1886(d)(8)(E)(i) of the Act that “the Secretary shall treat the hospital as being located in the rural area.” That is, a § 412.103 hospital would be considered to be located in the rural area of the state for all purposes of MGCRB reclassification, including the average hourly wage comparisons required by § 412.230(a)(5)(i) and (d)(1)(iii)(C). For example, for purposes of § 412.230(d)(1)(iii)(C), the § 412.103 hospital would compare its average hourly wage to the average hourly wage of all other hospitals in the state's rural area. In addition, for purposes of § 412.230(a)(5)(i), a § 412.103 hospital may not be redesignated to another area if the pre-classified average hourly wage for that area is lower than the pre-reclassified average hourly wage of the rural area of the state in which the hospital is located (thus, a § 412.103 hospital could potentially reclassify to any area with a pre-reclassified average hourly wage that is higher than the pre-reclassified average hourly wage for the rural area of the state, if it meets all other applicable reclassification criteria).

Therefore, effective for reclassification applications due to the MGCRB on September 1, 2021, for reclassification first effective for FY 2023, a § 412.103 hospital could apply for a reclassification under the MGCRB using the state's rural area as the area in which the hospital is located. We would also apply the policy in this IFC when deciding timely appeals before the Administrator under § 412.278 for reclassifications beginning in FY 2022 that were denied by the MGCRB due to existing policy, which did not permit § 412.103 hospitals to be considered located in the state's rural area. III.

Waiver of Proposed Rulemaking and Delay in Effective Date We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule before the provisions of the rule are finalized, either as proposed or as amended, in response to public comments and take effect, in accordance with the Administrative Procedure Act (APA) (Pub. L. 79-404), 5 U.S.C.

553 and, where applicable, section 1871 of the Act. Specifically, 5 U.S.C. 553 requires the agency to publish a notice of proposed rulemaking in the Federal Register that includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved.

Section 553(c) of the APA further requires the agency to give interested parties the opportunity to participate in the rulemaking through public comment before the provisions of the rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and a period of not less than 60 days for public comment for rulemaking carrying out the administration of the insurance programs under Title XVIII of the Act. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize the agency to waive these procedures, however, if the agency finds good cause that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.

Section 553(d) of the APA ordinarily requires a 30-day delay in the effective date of a final rule from the date of its publication in the Federal Register. This 30-day delay in effective date can be waived, however, if an agency finds good cause to support an earlier effective date. Section 1871(e)(1)(B)(i) of the Act also prohibits a substantive rule from taking effect before the end of the 30-day period beginning on the date the rule is issued or published.

However, section 1871(e)(1)(B)(ii) of the Act permits a substantive rule to take effect before 30 days if the Secretary finds that a waiver of the 30-day period is necessary to comply with statutory requirements or that the 30-day delay would be contrary to the public interest. Finally, the Congressional Review Act (CRA) (Pub. L.

104-121, Title II) requires a 60-day delay in the effective date for major rules unless an agency finds good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, in which case the rule shall take effect at such time as the agency determines 5 U.S.C. 801(a)(3) and 808(2). We find good cause for waiving notice-and comment rulemaking and a delay in effective date given the decision of the district court and the public interest in expeditious implementation of the court's interpretation of the statute.

Revising the regulation text by adding § 412.230(a)(1)(iii) and revising the regulation at § 412.230(a)(5)(i) through an IFC rather than through the normal notice-and comment rulemaking cycle and waiving the delay of effective date will ensure an expeditious implementation of the court's interpretation by allowing this policy to be applied to FY 2023 MGCRB reclassification decisions and cases before the Administrator for reclassifications effective beginning FY 2022. Absent this IFC, the earliest effective date of this revision to the regulations would be October 1, 2021 (FY 2022) following the normal IPPS/LTCH PPS notice-and comment rulemaking cycle. An effective date of FY 2022 would only allow the MGCRB to approve hospitals' applications qualifying under this policy for applications due September 1, 2022 for reclassifications effective beginning FY 2024 (applications are due to the MGCRB 13 months prior to the start of the fiscal year).

Additionally, implementing the court's interpretation via an IFC allows this policy to be applied to cases before the Administrator for reclassifications effective beginning in FY 2022, which supports an expeditious implementation of this policy. Therefore, we find good cause to waive the notice of proposed rulemaking as well as the delay of effective date and to issue this final rule on an interim basis. Even though we are waiving notice of proposed rulemaking requirements and are issuing these provisions on an interim basis, we are providing a 60-day public comment period.

IV. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C.

3501 et seq.). V. Regulatory Impact Statement We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation Start Printed Page 24738and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.

L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub.

L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

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 rule does not reach the economic threshold and thus is not considered a major rule.

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. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $8.0 million to $41.5 million in any 1 year.

Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this IFC would not have a significant economic impact on a substantial number of small entities. Also, our revision to the regulatory text is a consequence of a court decision.

We are amending the regulations to align our policy with the court's decision in Bates and implement the Bates court's interpretation of the requirement at section 1886(d)(8)(E)(i) of the Act that “the Secretary shall treat the hospital as being located in the rural area.” In addition, section 1102(b) of the Act requires us to prepare an RIA 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 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital for Medicare payment regulations as a hospital that is located outside of a Metropolitan Statistical Area 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 IFC would not have a significant impact on the operations of a substantial number of small rural hospitals. 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 2021, that threshold is approximately $158 million.

This rule will 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 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). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule. (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”).

(2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency. (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof. Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

We estimate that this rule is “significant” but not “economically significant,” as measured by the $100 million threshold. However, we have prepared an impact analysis that presents our best estimate of the costs and benefits of this rule for FY 2022 since section 3(f) of Executive Order 12866 defines a “significant regulatory action” as a rule that raises novel legal or policy issues arising out of legal mandates. With regard to our impact analysis, as a result of this IFC, for FY 2022, there are approximately 22 hospitals that may qualify for a reclassification to a new or different urban area with a higher wage index than they might otherwise have received based on the information currently available to us (for example, applications submitted to the MGCRB.) For FY 2022, if these hospitals qualify for and accept reclassification to a new or different urban area with a higher wage index than they might otherwise have received, we estimate a total increase in payments to these hospitals of approximately $50 million in aggregate.

However, wage index adjustments such as these are made in a manner that ensures that aggregate payments to hospitals are unaffected. This is accomplished through the application of a wage index budget neutrality adjustment as described more fully in the FY 2022 IPPS/LTCH proposed rule. Therefore, as a consequence of the court's decision in Bates, even though an urban hospital may be able to qualify for a reclassification to a new or different urban area with a higher wage index, this would not increase aggregate hospital payments.

We estimate that in FY 2022 the wage index budget neutrality adjustment could increase by one-half of a percentage point as a result of an increase in the wage index to these 22 hospitals. We do not know as a result of this IFC. (1) How many additional hospitals will elect to apply to the MGCRB by September 1, 2021 for reclassification beginning FY 2023 that would not otherwise have applied.

(2) how many hospitals that apply will qualify for a wage index higher than they otherwise would have received. (3) for those that qualify for a higher wage index how much higher that wage index will be. And, (4) how many hospitals may elect to retain or acquire § 412.103 urban-to rural reclassification that would not otherwise have done so.

The MGCRB makes determinations on reclassification requests, and hospitals make final decisions whether to accept reclassifications approved by the MGCRB. We also note that OMB requested public comment on the recommendations it received from the Metropolitan and Micropolitan Statistical Area Standards Review Committee for changes to OMB's metropolitan and micropolitan statistical area standards (86 FR 5263). These standards determine the Start Printed Page 24739procedures for delineating and updating the statistical areas as new data become available.

If changes to the standards are adopted by OMB and if those changes would affect the OMB delineations used for the IPPS wage index, we would address any such changes and impacts in future rulemaking. In accordance with the provisions of Executive Order 12866, this IFC was reviewed by the Office of Management and Budget. VI.

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. I, Elizabeth Richter, Acting Administrator of the Centers for Medicare &.

Medicaid Services, approved this document on April 16, 2021. Start List of Subjects Administrative practice and procedureHealth facilitiesMedicarePuerto RicoReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services amends 42 CFR chapter IV, part 412, as follows.

Start Part End Part Start Amendment Part1. The authority for part 412 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302 and 1395hh. End Authority Start Amendment Part2. Section 412.230 is amended by adding paragraph (a)(1)(iii) and revising paragraph (a)(5)(i) to read as follows.

End Amendment Part Criteria for an individual hospital seeking redesignation to another rural area or an urban area. (a) * * * (1) * * * (iii) An urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of this section. * * * * * (5) * * * (i) An individual hospital may not be redesignated to another area for purposes of the wage index if the pre-reclassified average hourly wage for that area is lower than the pre-reclassified average hourly wage for the area in which the hospital is located.

An urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of this paragraph (a)(5)(i). * * * * * Start Signature Dated. April 23, 2021.

Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2021-08889 Filed 4-27-21.

Start Preamble buy viagra over the counter Centers see this website for Medicare &. Medicaid Services (CMS), Health and Human Services (HHS). Notice.

This notice invites all interested parties to submit nominations to fill vacancies on the Advisory Panel on Outreach and Education (APOE). This notice also announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S.

Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare &. Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace®, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

Meeting Date. Wednesday, May 26, 2021 from 12:00 p.m. To 5:00 p.m.

Eastern daylight time (e.d.t). Deadline for Meeting Registration, Presentations, Special Accommodations, and Comments. Wednesday, May 19, 2021, 5:00 p.m.

(e.d.t). Deadline for Submitting Nominations. Nominations will be considered if we receive them at the appropriate address, Start Printed Page 26040provided in the ADDRESSES section of this notice, no later than 5 p.m., (e.d.t.) on June 11, 2021.

Meeting Location. Virtual. All those who RSVP will receive the link to attend.

Nominations, Presentations, and Written Comments. Nominations, presentations, and written comments should be submitted to. Lisa Carr, Designated Federal Official (DFO), Office of Communications, Centers for Medicare &.

Medicaid Services, 200 Independence Avenue SW, Mailstop 325G HHH, Washington, DC 20201, 202-690-5742, or via email at APOE@cms.hhs.gov. Registration. The meeting is open to the public, but attendance is limited to the space available.

Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/​e/​apoe-may-26-2021-virtual-meeting-tickets-150209828641 or by contacting the DFO listed in the FOR FURTHER INFORMATION CONTACT section of this notice, by the date listed in the DATES section of this notice. Individuals requiring sign language interpretation or other special accommodations should contact the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Start Further Info Lisa Carr, Designated Federal Official, Office of Communications, 200 Independence Avenue SW, Mailstop 325G HHH, Washington, DC 20201, 202-690-5742, or via email at APOE@cms.hhs.gov.

Additional information about the APOE is available at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​APOE. Press inquiries are handled through the CMS Press Office at (202) 690-6145.

End Further Info End Preamble Start Supplemental Information I. Background and Charter Renewal Information A. Background The Advisory Panel for Outreach and Education (APOE) (the Panel) is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub.

L. 92-463), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of federal advisory committees.

The Panel is authorized by section 1114(f) of the Social Security Act (the Act) (42 U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 U.S.C. 217a).

The Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) signed the charter establishing the Citizen's Advisory Panel on Medicare Education [] (the predecessor to the APOE) on January 21, 1999 (64 FR 7899) to advise and make recommendations to the Secretary and the Administrator of the Centers for Medicare &. Medicaid Services (CMS) on the effective implementation of national Medicare education programs, including with respect to the Medicare+Choice (M+C) program added by the Balanced Budget Act of 1997 (Pub.

L. 105-33). The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub.

L. 108-173) expanded the existing health plan options and benefits available under the M+C program and renamed it the Medicare Advantage (MA) program. CMS has had substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options available and better tools to evaluate these options.

Successful MA program implementation required CMS to consider the views and policy input from a variety of private sector constituents and to develop a broad range of public-private partnerships. In addition, Title I of the MMA authorized the Secretary and the Administrator of CMS (by delegation) to establish the Medicare prescription drug benefit. The drug benefit allows beneficiaries to obtain qualified prescription drug coverage.

In order to effectively administer the MA program and the Medicare prescription drug benefit, we have substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options and benefits available, and to develop better tools to evaluate these plans and benefits. The Patient Protection and Affordable Care Act (Pub. L.

111-148) and Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively referred to as the Affordable Care Act) expanded the availability of other options for health care coverage and enacted a number of changes to Medicare as well as to Medicaid and CHIP.

Qualified individuals and qualified employers are now able to purchase private health insurance coverage through a competitive marketplace, called an Affordable Insurance Exchange (also called Health Insurance Marketplace®, or Marketplace® [] ). In order to effectively implement and administer these changes, we must provide information to consumers, providers, and other stakeholders through education and outreach programs regarding how existing programs will change and the expanded range of health coverage options available, including private health insurance coverage through the Marketplace®. The APOE allows us to consider a broad range of views and information from interested audiences in connection with this effort and to identify opportunities to enhance the effectiveness of education strategies concerning the Affordable Care Act.

The scope of this Panel also includes advising on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5).

On January 21, 2011, the Panel's charter was renewed and the Panel was renamed the Advisory Panel for Outreach and Education. The Panel's charter was most recently renewed on January 19, 2021, and will terminate on January 19, 2023 unless renewed by appropriate action. B.

Charter Renewal and Copies of the Charter In accordance with the January 19, 2021, charter, the APOE will advise the HHS and CMS on developing and implementing education programs that support individuals who are enrolled in or eligible for Medicare, Medicaid, CHIP, or coverage available through the Health Insurance Marketplace® and other CMS programs. The scope of this FACA group also includes advising on education of providers and stakeholders with respect to health care reform and certain provisions of the HITECH Act enacted as part of the ARRA. The charter will terminate on January 19, 2023, unless renewed by appropriate action.

The APOE was chartered under 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended. The APOE is governed by provisions of Public Law 92-463, as amended (5 U.S.C.

Appendix 2), which sets forth standards for the formation and use of advisory committees. In accordance with the renewed charter, the APOE will advise the Secretary and the CMS Administrator concerning optimal strategies for the following. Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Start Printed Page 26041Medicare, Medicaid, the CHIP, and coverage available through the Health Insurance Marketplace® and other CMS programs.

Enhancing the federal government's effectiveness in informing Medicare, Medicaid, CHIP, or the Health Insurance Marketplace® consumers, issuers, providers, and stakeholders, pursuant to education and outreach programs of issues regarding these programs, including the appropriate use of public-private partnerships to leverage the resources of the private sector in educating beneficiaries, providers, partners and stakeholders. Expanding outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of Medicare, Medicaid, the CHIP and the Health Insurance Marketplace® education programs, and other CMS programs as designated. Assembling and sharing an information base of “best practices” for helping consumers evaluate health coverage options.

Building and leveraging existing community infrastructures for information, counseling, and assistance. Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act. The current members of the Panel as of April 9, 2021, are.

E. Lorraine Bell, Chief Officer, Population Health, Catholic Charities USA. Nazleen Bharmal, Medical Director of Community Partnerships, Cleveland Clinic.

Julie Carter, Senior Federal Policy Associate, Medicare Rights Center. Scott Ferguson, Director of Care Transitions and Population Health, Mount Sinai St. Luke's Hospital.

Leslie Fried, Senior Director, Center for Benefits Access, National Council on Aging. Jean-Venable Robertson Goode, Professor, Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University. Ted Henson, Director of Health Center Performance and Innovation, National Association of Community Health Centers.

Joan Ilardo, Director of Research Initiatives, Michigan State University, College of Human Medicine. Cheri Lattimer, Executive Director, National Transitions of Care Coalition. Cori McMahon, Vice President, Tridiuum.

Alan Meade, Director of Rehab Services, Holston Medical group. Michael Minor, National Director, H.O.P.E. HHS Partnership, National Baptist Convention USA, Incorporated.

Jina Ragland, Associate State Director of Advocacy and Outreach, AARP Nebraska. Morgan Reed, Executive Director, Association for Competitive Technology. Margot Savoy, Chair, Department of Family and Community Medicine, Temple University Physicians.

Congresswoman Allyson Schwartz, President and CEO, Better Medicare Alliance. And. Tia Whitaker, Statewide Director, Outreach and Enrollment, Pennsylvania Association of Community Health Centers.

The Secretary's Charter for the APOE is available on the CMS website at. Https://www.facadatabase.gov/​FACA/​apex/​FACAPublicCommittee?. €‹id=​a10t0000001gzsCAAQ, or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR FURTHER INFORMATION section of this notice.

II. Request for Nominations The APOE shall consist of no more than 20 members. The Chair shall either be appointed from among the 20 members, or a Federal official will be designated to serve as the Chair.

The charter requires that meetings shall be held up to four times per year. Members will be expected to attend all meetings. The members and the Chair shall be selected from authorities knowledgeable in one or more of the following fields.

Senior citizen advocacy Outreach to minority and underserved communities Health communications Disease-related advocacy Disability policy and access Health economics research Health insurers and plans Health IT Direct patient care Matters of labor and retirement Representatives of the general public may also serve on the APOE. This notice also requests nominations for three individuals to serve on the APOE to fill current vacancies and possible vacancies that may become available later in 2021. This notice is an invitation to interested organizations or individuals to submit their nominations for membership (no self-nominations will be accepted).

The CMS Administrator will appoint new members to the APOE from among those candidates determined to have the expertise required to meet specific agency needs, and in a manner to ensure an appropriate balance of membership. We have an interest in ensuring that the interests of both women and men, members of all racial and ethnic groups, and disabled individuals are adequately represented on the APOE. Therefore, we encourage nominations of qualified candidates who can represent these interests.

Any interested organization or person may nominate one or more qualified persons. Each nomination must include a letter stating that the nominee has expressed a willingness to serve as a Panel member and must be accompanied by a curricula vitae and a brief biographical summary of the nominee's experience. While we are looking for experts in a number of fields, our most specific needs are for experts in outreach to minority and underserved communities, health communications, disease-related advocacy, disability policy and access, health economics research, behavioral health, health insurers and plans, Health IT, social media, direct patient care, and matters of labor and retirement.

We are requesting that all submitted curricula vitae include the following. Date of birth Place of birth Title and current position Professional affiliation Home and business address Telephone and fax numbers Email address Areas of expertise Phone interviews of nominees may also be requested after review of the nominations. In order to permit an evaluation of possible sources of conflict of interest, potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts.

Members are invited to serve for 2-year terms, contingent upon the renewal of the APOE by appropriate action prior to its termination. A member may serve after the expiration of that member's term until a successor takes office. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of that term.

III. Meeting Format and Agenda In accordance with section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the May 26, 2021 meeting will include the following.

Welcome and listening session with CMS leadership Recap of the previous (March 31, 2021) meeting CMS programs, initiatives, and priorities An opportunity for public commentStart Printed Page 26042 Meeting summary, review of recommendations, and next steps Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice.

IV. Meeting Participation The meeting is open to the public, but attendance is limited to registered participants. Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/​e/​apoe-may-26-2021-virtual-meeting-tickets-150209828641 or contact the DFO at the address or number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice.

This meeting will be held virtually. Individuals who are not registered in advance will be unable to attend the meeting. V.

Collection of Information This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

The Acting Administrator of the Centers for Medicare &. Medicaid Services (CMS), Elizabeth Richter, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Start Signature Dated.

May 10, 2021. Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services.

End Signature End Supplemental Information [FR Doc. 2021-10118 Filed 5-11-21. 8:45 am]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &.

Medicaid Services (CMS), Health and Human Services, (HHS). Interim final rule with comment period. This interim final rule with comment period (IFC) amends our current regulations to allow hospitals with a rural redesignation under the Social Security Act (the Act) to reclassify through the Medicare Geographic Classification Review Board (MGCRB) using the rural reclassified area as the geographic area in which the hospital is located.

These regulatory changes align our policy with the decision in Bates County Memorial Hospital v. Azar, effective with reclassifications beginning with fiscal year (FY) 2023. We would also apply the policy in this IFC when deciding timely appeals before the Administrator of applications for reclassifications beginning with FY 2022 that were denied by the MGCRB due to the current policy, which does not permit hospitals with rural redesignations to use the rural area's wage data for purposes of reclassifying under the MGCRB.

Effective date. These regulations are effective on May 10, 2021. Comment date.

To be assured consideration, comments must be received at one of the addresses provided below by June 28, 2021. In commenting, please refer to file code CMS-1762-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed). 1. Electronically.

You may (and we encourage you to) submit electronic comments on this regulation to http://www.regulations.gov. Follow the instructions under the “submit a comment” tab. 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-1762-IFC, P.O. Box 8013, Baltimore, MD 21244-1850.

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 via express or overnight mail to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention.

CMS-1762-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, we refer readers to the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info Tehila Lipschutz, (410) 786-1344 or Dan Schroder, (410) 786-7452.

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://regulations.gov. Follow the search instructions on that website to view public comments. Comments received timely will be also 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 A. Wage Index for Acute Care Hospitals Paid Under the Hospital Inpatient Prospective Payment System (IPPS) Under section 1886(d) of the Social Security Act (the Act), hospitals are paid based on prospectively set rates.

To account for geographic area wage level differences, section 1886(d)(3)(E) of the Act requires that the Secretary of the Department of Health and Human Services (the Secretary) adjust the standardized amounts by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital, as compared to the national average hospital wage level. We currently define hospital labor market areas based on the delineations of statistical areas established by the Office of Management and Budget (OMB). The current statistical areas (which were implemented beginning with FY 2015) are based on revised OMB delineations issued on February 28, 2013, in OMB Bulletin No.

13-01, with updates as reflected in OMB Bulletins Nos. 15-01, 17-01, and 18-04. We refer readers to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49951 through 49963) for a full discussion of our implementation of the new OMB labor market area delineations beginning with the FY 2015 wage index, and to the FY 2021 IPPS/LTCH PPS final rule (85 FR 58743 through 58755) for a discussion of the latest updates to these delineations.

Section 1886(d)(3)(E) of the Act requires the Secretary to update the wage index of hospitals annually, and to base the update on a survey of wages and wage-related costs of short-term, acute care hospitals. Under section 1886(d)(8)(D) of the Act, the Secretary is required to adjust the standardized amounts so as to ensure that aggregate payments under the IPPS, after Start Printed Page 24736implementation of the provisions of sections 1886(d)(8)(B), 1886(d)(8)(C), and 1886(d)(10) of the Act, regarding geographic reclassification of hospitals, are equal to the aggregate prospective payments that would have been made absent these provisions. B.

Hospital Reclassifications Under Sections 1886(d)(8)(E) and 1886(d)(10) of the Act Hospitals may seek to have their geographic designation reclassified. Under section 1886(d)(8)(E) of the Act, a qualifying prospective payment hospital located in an urban area may apply for rural status. Specifically, section 1886(d)(8)(E) of the Act states that “[f]or purposes of this subsection, not later than 60 days after the receipt of an application (in a form and manner determined by the Secretary) from a subsection (d) hospital described in clause (ii), the Secretary shall treat the hospital as being located in the rural area (as defined in paragraph (2)(D)) of the state in which the hospital is located.” The regulations governing these geographic redesignations are codified in § 412.103, and such hospitals are commonly referred to as “§ 412.103 hospitals”.

In a separate process, hospitals may also reclassify for purposes of the wage index under the IPPS under section 1886(d)(10) of the Act by applying to the Medicare Geographic Classification Review Board (MGCRB). Hospitals must apply to the MGCRB to reclassify not later than 13 months prior to the start of the fiscal year for which reclassification is sought, generally by September 1. (However, we note that this deadline has been extended for applications for FY 2022 reclassifications to 15 days after the public display date of the FY 2021 IPPS/LTCH final rule at the Office of the Federal Register, using our authority under section 1135(b)(5) the Act due to the erectile dysfunction treatment Public Health Emergency.) Generally, hospitals must be proximate to the labor market area to which they are seeking reclassification and must demonstrate characteristics similar to hospitals located in that area.

The MGCRB issues its decisions by the end of February for reclassifications that become effective for the following fiscal year (beginning October 1). The regulations applicable to reclassifications by the MGCRB are located in §§ 412.230 through 412.280. Prior to a court decision in Geisinger Community Medical v.

Secretary, United States Department of Health and Human Services, 794 F.3d 383 (3d Cir. 2015) (“Geisinger”), hospitals were only able to hold one reclassification at a time. Either under § 412.103 or through the MGCRB under section 1886(d)(10) of the Act.

The Court of Appeals in Geisinger ruled that CMS's prohibition of dual § 412.103 and MGCRB reclassifications was unlawful, since section 1886(d)(8)(E)(i) of the Act requires that “the Secretary shall treat the hospital as being located in the rural area,” inclusive of MGCRB reclassification purposes. Therefore, on April 21, 2016, we published an interim final rule with comment period (the April 21, 2016 IFC) in the Federal Register (81 FR 23428 through 23438) that included provisions amending our regulations to allow hospitals nationwide to have simultaneous § 412.103 and MGCRB reclassifications. II.

Provisions of the Interim Final Rule With Comment Period Pursuant to our April 21, 2016 IFC, for reclassifications effective beginning FY 2018, a hospital may acquire rural status under § 412.103 and subsequently apply for a reclassification under the MGCRB using the distance and average hourly wage criteria designated for rural hospitals. Hospitals with a § 412.103 redesignation seeking additional reclassification under the MGCRB use the rural distance and average hourly wage criteria under § 412.230(b)(1), (d)(1)(iii)(C), and (d)(1)(iv)(E). For example, under our current policy, a § 412.103 hospital geographically located in the urban CBSA of Buffalo-Cheektowaga, NY seeking to reclassify under the MGCRB would demonstrate that their wages are at least 106 percent (and not 108 percent, as urban hospitals must demonstrate) of the average hourly wage of Buffalo-Cheektowaga, NY, to meet the criteria at § 412.230(d)(1)(iii)(C).

However, our current policy compares the average hourly wage of a § 412.103 hospital to its geographic urban location, rather than the rural reclassified area, for purposes of satisfying certain wage comparison criteria. In response to a comment on our April 21, 2016 IFC (81 FR 56925), we stated. €œThe commenter is correct that the rural distance and average hourly wage criteria will be used for hospitals with a § 412.103 redesignation.

However, the commenter's statement that the average hourly wage of a hospital with a § 412.103 redesignation is compared to the average hourly wage of hospitals in the State's rural area under § 412.230(d)(1)(iii)(C) is incorrect. Instead, the hospital's average hourly wage would be compared to the average hourly wage of all other hospitals in its urban geographic location using the rural distance and average hourly wage criteria.” On May 14, 2020, the United States District Court for the District of Columbia issued a decision in Bates County Memorial Hospital v. Azar, 464 F.

Bates County Memorial Hospital and five other geographically urban hospitals were reclassified to rural under § 412.103. They also applied for reclassification under the MGCRB, but were denied because their wages were not at least 106 percent of the geographic urban area in which the hospitals were located. Each of the hospitals' average hourly wages were at least 106 percent of the 3-year average hourly wage of all other hospitals in the rural area of the state in which the hospitals are located.

The Court agreed with the Plaintiffs that the statute at section 1886(d)(8)(E)(i) of Act requires that CMS treat qualifying hospitals as being located in the rural area for purposes of section 1886(d) of the Act, including MGCRB reclassification. The Bates decision requires that CMS consider the rural area to be the area in which the hospital is located for the wage comparisons required for MGCRB reclassifications. For example, pursuant to Bates, a § 412.103 hospital geographically located in the urban CBSA of Buffalo-Cheektowaga, NY seeking to reclassify under the MGCRB would demonstrate that their wages are at least 106 percent of the average hourly wage of rural NY, rather than that of Buffalo-Cheektowaga.

As a result of the Bates court's decision, we are revising our policy so that the redesignated rural area, and not the hospital's geographic urban area, will be considered the area a § 412.103 hospital is located in for purposes of meeting MGCRB reclassification criteria. Similarly, we are revising the regulations to consider the redesignated rural area, and not the geographic urban area, as the area a § 412.103 hospital is located in for the prohibition at § 412.230(a)(5)(i) on reclassifying to an area with a pre-reclassified average hourly wage lower than the pre-reclassified average hourly wage for the area in which the hospital is located. Specifically, to align our policy with the court's decision in Bates, we are amending the regulations at § 412.230(a)(1) by adding (a)(1)(iii) to state that an urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of this section.

We are also making conforming changes to the regulation at § 412.230(a)(5)(i) because Start Printed Page 24737§ 412.230(a)(1) except paragraph (a)(5). Because § 412.230(a)(1) excepts paragraph (a)(5), we believe it is necessary to make a specific conforming revision to § 412.230(a)(5)(i), in addition to the general rule at § 412.230(a)(1)(iii), to clarify that the general rule at § 412.230(a)(1)(iii) applies to § 412.230(a)(5)(i) as well. That is, we are amending the regulation at § 412.230(a)(5)(i) to add language stating that an urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of paragraph (a)(5)(i).

These changes implement the Bates court's interpretation of the requirement at section 1886(d)(8)(E)(i) of the Act that “the Secretary shall treat the hospital as being located in the rural area.” That is, a § 412.103 hospital would be considered to be located in the rural area of the state for all purposes of MGCRB reclassification, including the average hourly wage comparisons required by § 412.230(a)(5)(i) and (d)(1)(iii)(C). For example, for purposes of § 412.230(d)(1)(iii)(C), the § 412.103 hospital would compare its average hourly wage to the average hourly wage of all other hospitals in the state's rural area. In addition, for purposes of § 412.230(a)(5)(i), a § 412.103 hospital may not be redesignated to another area if the pre-classified average hourly wage for that area is lower than the pre-reclassified average hourly wage of the rural area of the state in which the hospital is located (thus, a § 412.103 hospital could potentially reclassify to any area with a pre-reclassified average hourly wage that is higher than the pre-reclassified average hourly wage for the rural area of the state, if it meets all other applicable reclassification criteria).

Therefore, effective for reclassification applications due to the MGCRB on September 1, 2021, for reclassification first effective for FY 2023, a § 412.103 hospital could apply for a reclassification under the MGCRB using the state's rural area as the area in which the hospital is located. We would also apply the policy in this IFC when deciding timely appeals before the Administrator under § 412.278 for reclassifications beginning in FY 2022 that were denied by the MGCRB due to existing policy, which did not permit § 412.103 hospitals to be considered located in the state's rural area. III.

Waiver of Proposed Rulemaking and Delay in Effective Date We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule before the provisions of the rule are finalized, either as proposed or as amended, in response to public comments and take effect, in accordance with the Administrative Procedure Act (APA) (Pub. L. 79-404), 5 U.S.C.

553 and, where applicable, section 1871 of the Act. Specifically, 5 U.S.C. 553 requires the agency to publish a notice of proposed rulemaking in the Federal Register that includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved.

Section 553(c) of the APA further requires the agency to give interested parties the opportunity to participate in the rulemaking through public comment before the provisions of the rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and a period of not less than 60 days for public comment for rulemaking carrying out the administration of the insurance programs under Title XVIII of the Act. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize the agency to waive these procedures, however, if the agency finds good cause that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.

Section 553(d) of the APA ordinarily requires a 30-day delay in the effective date of a final rule from the date of its publication in the Federal Register. This 30-day delay in effective date can be waived, however, if an agency finds good cause to support an earlier effective date. Section 1871(e)(1)(B)(i) of the Act also prohibits a substantive rule from taking effect before the end of the 30-day period beginning on the date the rule is issued or published.

However, section 1871(e)(1)(B)(ii) of the Act permits a substantive rule to take effect before 30 days if the Secretary finds that a waiver of the 30-day period is necessary to comply with statutory requirements or that the 30-day delay would be contrary to the public interest. Finally, the Congressional Review Act (CRA) (Pub. L.

104-121, Title II) requires a 60-day delay in the effective date for major rules unless an agency finds good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, in which case the rule shall take effect at such time as the agency determines 5 U.S.C. 801(a)(3) and 808(2). We find good cause for waiving notice-and comment rulemaking and a delay in effective date given the decision of the district court and the public interest in expeditious implementation of the court's interpretation of the statute.

Revising the regulation text by adding § 412.230(a)(1)(iii) and revising the regulation at § 412.230(a)(5)(i) through an IFC rather than through the normal notice-and comment rulemaking cycle and waiving the delay of effective date will ensure an expeditious implementation of the court's interpretation by allowing this policy to be applied to FY 2023 MGCRB reclassification decisions and cases before the Administrator for reclassifications effective beginning FY 2022. Absent this IFC, the earliest effective date of this revision to the regulations would be October 1, 2021 (FY 2022) following the normal IPPS/LTCH PPS notice-and comment rulemaking cycle. An effective date of FY 2022 would only allow the MGCRB to approve hospitals' applications qualifying under this policy for applications due September 1, 2022 for reclassifications effective beginning FY 2024 (applications are due to the MGCRB 13 months prior to the start of the fiscal year).

Additionally, implementing the court's interpretation via an IFC allows this policy to be applied to cases before the Administrator for reclassifications effective beginning in FY 2022, which supports an expeditious implementation of this policy. Therefore, we find good cause to waive the notice of proposed rulemaking as well as the delay of effective date and to issue this final rule on an interim basis. Even though we are waiving notice of proposed rulemaking requirements and are issuing these provisions on an interim basis, we are providing a 60-day public comment period.

IV. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C.

3501 et seq.). V. Regulatory Impact Statement We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation Start Printed Page 24738and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.

L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub.

L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

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 rule does not reach the economic threshold and thus is not considered a major rule.

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. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $8.0 million to $41.5 million in any 1 year.

Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this IFC would not have a significant economic impact on a substantial number of small entities. Also, our revision to the regulatory text is a consequence of a court decision.

We are amending the regulations to align our policy with the court's decision in Bates and implement the Bates court's interpretation of the requirement at section 1886(d)(8)(E)(i) of the Act that “the Secretary shall treat the hospital as being located in the rural area.” In addition, section 1102(b) of the Act requires us to prepare an RIA 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 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital for Medicare payment regulations as a hospital that is located outside of a Metropolitan Statistical Area 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 IFC would not have a significant impact on the operations of a substantial number of small rural hospitals. 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 2021, that threshold is approximately $158 million.

This rule will 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 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). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule. (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”).

(2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency. (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof. Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

We estimate that this rule is “significant” but not “economically significant,” as measured by the $100 million threshold. However, we have prepared an impact analysis that presents our best estimate of the costs and benefits of this rule for FY 2022 since section 3(f) of Executive Order 12866 defines a “significant regulatory action” as a rule that raises novel legal or policy issues arising out of legal mandates. With regard to our impact analysis, as a result of this IFC, for FY 2022, there are approximately 22 hospitals that may qualify for a reclassification to a new or different urban area with a higher wage index than they might otherwise have received based on the information currently available to us (for example, applications submitted to the MGCRB.) For FY 2022, if these hospitals qualify for and accept reclassification to a new or different urban area with a higher wage index than they might otherwise have received, we estimate a total increase in payments to these hospitals of approximately $50 million in aggregate.

However, wage index adjustments such as these are made in a manner that ensures that aggregate payments to hospitals are unaffected. This is accomplished through the application of a wage index budget neutrality adjustment as described more fully in the FY 2022 IPPS/LTCH proposed rule. Therefore, as a consequence of the court's decision in Bates, even though an urban hospital may be able to qualify for a reclassification to a new or different urban area with a higher wage index, this would not increase aggregate hospital payments.

We estimate that in FY 2022 the wage index budget neutrality adjustment could increase by one-half of a percentage point as a result of an increase in the wage index to these 22 hospitals. We do not know as a result of this IFC. (1) How many additional hospitals will elect to apply to the MGCRB by September 1, 2021 for reclassification beginning FY 2023 that would not otherwise have applied.

(2) how many hospitals that apply will qualify for a wage index higher than they otherwise would have received. (3) for those that qualify for a higher wage index how much higher that wage index will be. And, (4) how many hospitals may elect to retain or acquire § 412.103 urban-to rural reclassification that would not otherwise have done so.

The MGCRB makes determinations on reclassification requests, and hospitals make final decisions whether to accept reclassifications approved by the MGCRB. We also note that OMB requested public comment on the recommendations it received from the Metropolitan and Micropolitan Statistical Area Standards Review Committee for changes to OMB's metropolitan and micropolitan statistical area standards (86 FR 5263). These standards determine the Start Printed Page 24739procedures for delineating and updating the statistical areas as new data become available.

If changes to the standards are adopted by OMB and if those changes would affect the OMB delineations used for the IPPS wage index, we would address any such changes and impacts in future rulemaking. In accordance with the provisions of Executive Order 12866, this IFC was reviewed by the Office of Management and Budget. VI.

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. I, Elizabeth Richter, Acting Administrator of the Centers for Medicare &.

Medicaid Services, approved this document on April 16, 2021. Start List of Subjects Administrative practice and procedureHealth facilitiesMedicarePuerto RicoReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services amends 42 CFR chapter IV, part 412, as follows.

Start Part End Part Start Amendment Part1. The authority for part 412 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302 and 1395hh. End Authority Start Amendment Part2. Section 412.230 is amended by adding paragraph (a)(1)(iii) and revising paragraph (a)(5)(i) to read as follows.

End Amendment Part Criteria for an individual hospital seeking redesignation to another rural area or an urban area. (a) * * * (1) * * * (iii) An urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of this section. * * * * * (5) * * * (i) An individual hospital may not be redesignated to another area for purposes of the wage index if the pre-reclassified average hourly wage for that area is lower than the pre-reclassified average hourly wage for the area in which the hospital is located.

An urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of this paragraph (a)(5)(i). * * * * * Start Signature Dated. April 23, 2021.

Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2021-08889 Filed 4-27-21.

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