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Nov. 13, 2020

Issue Spotlight

Tell Congress now is not the time to cut Medicare payments

A coalition of organizations representing physicians and allied health professionals, including the AMA, sent a letter to Congressional leadership expressing support for H.R. 8702, the "Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020," which was introduced by Reps. Ami Bera, MD (D-CA) and Larry Bucshon, MD (R-IN).

The legislation was drafted in response to the anticipated impact of the 2021 Medicare physician payment schedule rule, slated to be released about Dec. 1, that will cause a significant redistribution in payments beginning in January. In the proposed rule issued last summer, CMS estimated the range of impacts on specialties to range between -11% and +17%, depending on the mix of services provided.

Medicine has been arguing for waiving the budget neutrality requirement, or at least postponing it during the COVID-19 pandemic, given the pandemic's already severe impact on practice revenues. However, due to the budget impact and concerns in Congress about setting a precedent of legislative intervention into statutory budget neutrality requirements, a total waiver is no longer being discussed.

H.R. 8702 would effectively freeze payments at 2020 rates for services scheduled to be cut in 2021 for a period of two years, while allowing the planned E/M payment increases to take place as scheduled. It would also avert steep payment cuts for hospital, nursing home, and critical care visits. At the end of the two-year reprieve, the full budget neutrality adjustment would take effect.

Importantly, all specialties will benefit from higher average payments under H.R. 8702. No specialty would experience a negative impact below 0% (as opposed to a cut of 11% under current law) and specialties anticipating total Medicare payment increases in 2021 will see additional increases. The legislation is broadly, but not universally, supported by physician organizations.

The pandemic has hit all specialties hard, and there is no question that payment reductions in a program as important as Medicare threaten practice viability and must be stopped. The AMA is supporting H.R. 8702 because it will stop very ill-timed Medicare payment cuts while allowing scheduled payment increases to move forward.

Final legislation will be crafted by the committees of jurisdiction; they are watching developments on the Bera-Bucshon legislation closely as a potential solution that does not involve an actual waiver of budget neutrality. AMA will keep you informed of further developments.

Please contact your member of Congress and ask them to support the "Holding Providers Harmless from Medicare Cuts During COVID-19 Act" (H.R. 8207) today!

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National Update

Ongoing AMA advocacy efforts during the COVID-19 pandemic

Throughout the COVID-19 pandemic, the AMA has been the leading physician and patient ally—voicing recommendations to members of the White House Coronavirus Task Force, key Congressional leaders and agency staff, state policymakers and private sector stakeholders. A new document outlines recent COVID-19 advocacy efforts related to financial relief for physician practices, telehealth expansion, personal protective equipment (PPE), expanding insurance coverage, reducing regulatory impediments and addressing workforce issues.

Learn more here.

Physicians request insurer compensation for COVID-19 infection control costs

The AMA, along with close to 130 state medical associations and national medical specialty societies, recently urged both public and private health plans to compensate physician practices for the additional costs associated with providing safe patient care during the COVID-19 public health emergency (PHE). In letters to the Centers for Medicare & Medicaid Services (CMS), insurer trade organizations (America's Health Insurance Plans and Blue Cross Blue Shield Association), and major national commercial insurers (Aetna, Anthem, Cigna, Health Care Service Corporation, Humana, and UnitedHealth Group), the AMA and other physician organizations requested that payers immediately implement and pay for Current Procedural Terminology (CPT®) code 99072 with no patient cost-sharing to compensate physician practices for increased expenditures associated with heightened infection control protocols during the COVID-19 PHE.

According to CPT guidance, 99072 is to be used to report the additional supplies, materials, and clinical staff time over and above the practice expense(s) included in an office visit or other non-facility service(s) when performed during a PHE, as defined by law, due to respiratory-transmitted infectious disease. Payment for these increased expenses is critical to address the financial stresses currently facing many physician practices, as detailed in an AMA survey of 3,500 physicians.

AMA opposes DOL rule increasing wage requirements for H-1B physicians

On Nov. 9, the AMA submitted comments strongly urging the Department of Labor (DOL) to rescind the Interim Final Rule (IFR) titled "Strengthening Wage Protections for the Temporary and Permanent Employment of Certain Aliens in the United States."

Changes included in this IFR discriminate against H-1B physicians and the communities that they serve by drastically altering the distribution of the four-tiered wage system, causing an increase in the required prevailing wage determinations that employers must pay to H-1B employees. As such, this IFR will cause immediate and lasting harm since it will likely make it more difficult to hire H-1B physicians in rural and medically underserved communities across the United States which will worsen our growing physician shortage and make it even harder to serve communities throughout the COVID-19 pandemic. Therefore, the AMA has continued to strongly advocate that current international medical graduates should not be hampered by additional unnecessary regulations especially in the midst of helping the U.S. fight COVID-19.

FDA approves emergency use authorization for COVID-19 monoclonal antibody treatment

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy Bamlanivimab for the treatment of mild-to-moderate COVID-19. The authorization permits Bamlanivimab to be distributed and administered as a single dose intravenously by health care providers.

In the statement provided by the FDA on Nov. 9, the agency notes "[w]hile the safety and effectiveness of this investigational therapy continues to be evaluated, Bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo." This therapy is not indicated for patients hospitalized due to COVID-19 or who may require high-flow oxygen.

Data used to support issuance of this EUA are based on an interim analysis from a phase two randomized, double-blind, placebo-controlled clinical trial. This trial showed promising results from predefined secondary endpoints of COVID-19-related hospitalizations or emergency room visits within 28 days after treatment. For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of Bamlanivimab-treated patients on average compared to 10% in placebo-treated patients.

See FDA's Fact Sheet for Health care Providers regarding the EUA of Bamlanivimab.

FDA provides guidance for false-positive results by rapid detection SARS-CoV-2 antigen testing

On Nov. 3, the FDA released a report alerting clinical laboratory staff and health care providers that false-positive results may occur with antigen testing for rapid detection of SARS-CoV-2. While false positives are more likely to occur when instructions are not followed appropriately, the report notes that "laboratories should expect some false positive results to occur even when very accurate tests are used for screening large populations with a low prevalence of infection." Therefore, diagnostic test results should always be considered carefully in the context of available clinical, diagnostic and epidemiological information.

The FDA highlights several recommendations for physicians who use these antigen tests to help mitigate false positive results:

  • For antigen tests that have been granted an Emergency Use Authorization, laboratories are to follow the manufacturer's instructions for use.
  • Processing multiple specimens in batch mode may make it more challenging to ensure the correct incubation time for each specimen; refer to antigen test package insert for guidance on specimen timing.
  • Minimize risk factors for potential cross contamination of patient specimens including inappropriate use of protective equipment, insufficient cleaning of workspace and disinfection of instruments. See CDC guidance for specimen handling and processing.
  • Consider positive results in combination with clinical observations, patient history and epidemiological information.
  • Authorized Laboratories must report any suspected occurrence of false-positive or false-negative results.

FDA finalizes drug compounding guidelines

On Nov. 6, the FDA finalized long-awaited guidance impacting physician's ability to prepare sterile drug products in their offices. The Insanitary Conditions at Compounding Facilities final guidance represents a significant victory for physicians' in-office preparation of compounded drug products, as the guidance notes that the FDA generally does not intend to regulate physicians so long as those physicians are preparing drug products in the office setting for administration to their own patients within the same office.

The initial draft Insanitary Conditions guidance would have subjected physician offices to significant sterility and engineer control requirements, similar to that of full compounding pharmacies. Physicians have also been largely successful in ensuring the United States Pharmacopoeia (USP) chapters on sterile compounding allow for physician in-office preparation of sterile drug products without overly burdensome requirements. The AMA has worked closely with a large coalition of physician specialty organizations over several years to maintain the ability of physicians to prepare sterile drug products in their offices for administration to their patients.

New AMA survey shows broad use of increased DEA prescribing and treatment flexibility

Eighty percent of pain medicine physicians responding to a new AMA survey said that enhanced flexibilities to use telemedicine for treatment during the COVID-19 pandemic has been helpful to treat patients with pain. The prescribing and treatment flexibilities were authorized by the U.S. Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration early in the COVID-19 Public Health Emergency.

A major finding of the survey is that 80% of physician respondents said that the flexibilities provided by the DEA during the COVID-19 pandemic have been either very helpful or somewhat helpful for treating patients with pain. The AMA strongly supports these flexibilities, including the authority "to allow DEA-registered practitioners to begin issuing prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation," as long as certain requirements are met.

In addition to support for the ability to treat patients with pain via telehealth and telephone visits, and to call in needed controlled substance prescriptions to the pharmacy, survey respondents described their concerns about barriers to care during the pandemic, including:

  • 77% of respondents said they were "very" or "somewhat" concerned about unnecessary delays caused by prior authorization
  • 78% were "very" or "somewhat" concerned about patients waiting too long before making an appointment if they need treatment
  • 79% were "very or "somewhat" concerned about unnecessary delays for new patients in access needed medication

Learn more about the survey here.

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State Update

Public-private partnership seeks to build SUD treatment network throughout Georgia

If people cannot access treatment for a substance use disorder close to where they live, they might not get any treatment, said Justine Welsh, MD, a child and adolescent and addiction psychiatrist and Director of the Emory Healthcare Addiction Service.

Having evidence-based care for substance use disorders throughout Georgia is just one goal of a new partnership between Emory Healthcare and the Hazelden Betty Ford Foundation. The Atlanta-based health system and the national, non-profit addiction treatment provider created the Addiction Alliance of Georgia in a multi-year partnership that seeks to build wide-ranging treatment access for patients with a substance use disorder as well as promote evidence-based research and education efforts for Georgians throughout the state.

"We're going to put treatment where it is needed most by building networks throughout the state," said Dr. Welsh. "This partnership will help to reduce transit times to treatment, enhance telehealth options and help build community-based linkages."

Treatment options, according to Dr. Welsh, will be tailored to the needs of patients, and could include telehealth consultations, hospitalization or intensive outpatient care. Emory already has started to build out pilot programs, and Hazelden Betty Ford is providing its well-established model for addiction care for the planned treatment programs. The alliance also is developing education and training resources for use in the community.

"We're going to build out the program as the partnership grows," said Steve Delisi, MD, an addiction psychiatrist and Medical Director for Hazelden Betty Ford's Professional Education Continuum Solutions. "We're basing our effort on a fully integrated model of care, which includes medications like buprenorphine, and will also include education and prevention in the form of community workshops, school prevention programs and related efforts throughout the state."

While Emory and Hazelden Betty Ford are two well-known names in health care, the partnership's ultimate success will come from its coordination and collaboration with other medical, health care and state leaders, emphasized Sandra Fryhofer, MD, a Georgia physician and member of the AMA Board of Trustees: "We need to be able to serve the addiction needs of the citizens in every corner of our state."

To make the partnership work, Drs. Welsh, Delisi and Fryhofer said that efforts will align with ongoing public and private efforts and work with diverse stakeholders such as the Georgia Department of Public Health, the Georgia Department of Behavioral Health and Developmental Disabilities, Grady Health System, Morehouse School of Medicine, the Medical Association of Georgia and federally qualified health centers throughout the state.

The idea for the alliance was first conceived by Mohawk Industries Chief Financial Officer Frank Boykin, former CNN CEO Tom Johnson and Hazelden Betty Ford executive William C. Moyers in 2018. Johnson and Boykin, both longtime members of the Atlanta business community, helped assemble a wide-ranging, nonpartisan group of community and professional leaders to discuss rising overdose and mortality rates and possible solutions for the people of Georgia. After more than a year of cooperative analysis and discussion between Emory Healthcare and Hazelden Betty Ford, the partnership was formed.

"We're just getting started, so we have a lot of education, research and hard work ahead of us," said Dr. Welsh. "But we have everyone on the same page, and we are confident this will greatly increase access to evidence-based care for patients throughout Georgia."

Research continues to emphasize need for evidence-based treatment for pain and substance use disorders

As the COVID-19 pandemic continues, researchers and others continue to publish data highlighting the need for evidence-based care for patients with pain and those with a substance use disorder. The data also continue to support increased access to naloxone and directly addressing systemic health inequities. The AMA has compiled select research regarding these and related issues. Recent publications include items from the National Center for Health Statistics, Journal of Pain Research, Pew Charitable Trusts and Molecular Psychiatry.

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Judicial Update

7 major downsides if the ACA is overturned by Supreme Court

The U.S. Supreme Court heard arguments in the case of California v. Texas on Nov. 10, and in the coming months will consider legal points pertaining to whether the Affordable Care Act (ACA) can remain in force without the individual mandate. What really is at stake, however, is health insurance coverage for more than 20 million people.

The issue before the court is whether Congress intended to invalidate the entire ACA when it zeroed-out the tax for failure to comply with the law's individual mandate to purchase health insurance and if the district court acted correctly when it ruled the ACA was invalid in its entirety without the tax.

If the high court upholds the district-court ruling, the following would happen:

  • Patients would no longer have guaranteed coverage for pre-existing conditions, including COVID-19.
  • Young adults would no longer have coverage under their parents' health insurance plan until age 26.
  • Insurers would be allowed to generate higher profits and provide even less coverage for patient care.
  • 100% coverage for certain preventive services would cease.
  • Individual marketplace and premium subsidies based on income would be eliminated.
  • Medicaid eligibility expansion would end, as would federal funding for Medicaid expansion.
  • Annual and lifetime caps on coverage could be reinstated, leading to more bankruptcies due to health care costs.

While the court originally declared the ACA constitutional in 2012, three new justices have been added to the court since then, most recently Amy Coney Barrett, who was appointed to replace the late Ruth Bader Ginsburg.

Last December, the 5th U.S. Circuit Court of Appeals agreed partially with the district court. It ruled that the individual mandate was unconstitutional but sent the case back to the district court for further analysis on whether the mandate can be severed from the rest of the ACA.

Earlier this year, 20 leading physician organizations joined the AMA in filing an amicus brief arguing why the Supreme Court should declare the ACA constitutional with or without the tax.

The brief also explains why it would be unwise to strike down a law "serving as the backbone of the safety net for the millions of Americans facing sudden unemployment" due to the COVID-19 pandemic.

"Invalidating provisions that have expanded access to health insurance coverage such as the guaranteed-issue and community rating provisions—or the entire ACA—would have a devastating impact on doctors, patients, and the American health care system in normal times," the amicus brief says. "However, striking down the ACA at a time when the system is struggling to respond to a pandemic ... would be a self-inflicted wound that could take decades to heal."

The ruling is expected to be issued in June 2021.

Read the full story here.

Eviction moratorium key weapon in pandemic fight, physicians say

If landlords are allowed to evict people by the same rules they did before COVID-19 hit, the nation's health will be put at even further risk than it already is during this deadly pandemic, physicians tell a federal court that will decide whether a CDC order to prevent certain residential evictions is constitutional.

Eviction moratoriums help prevent overcrowded living situations, homelessness and housing instability. These are all scenarios that make it difficult for people to comply with some of the best tools the nation has to slow COVID-19's spread now: physical distancing, self-quarantining and hand hygiene, says a brief that the AMA filed with nearly two dozen other national associations and experts in the case, Brown v. Azar.

"Eviction moratoriums are a critical public health tool that should be employed now," the brief tells the court.

Evidence suggests that earlier eviction moratoriums effectively slowed COVID-19's spread and reduced deaths. When protection under the CARES Act expired in August for renters affected by COVID-19, evictions rose quickly. The evictions tapered off after the CDC's September order banning certain evictions.

"There is a close, proven connection between eviction and public health," the brief tells the court, citing a study that showed lifting moratoriums was associated with 1.4 times higher COVID-19 mortality after seven weeks. "The CDC order may be able to help control the pandemic, protect the public health and prevent severe harm for millions of adults and children especially in communities of color."

This case is being heard in the U.S. District Court for the Northern District of Georgia Atlanta, but it is one of several cases filed in federal courts challenging the CDC's order.

"Without a nationwide, uniformly adopted eviction moratorium, evictions will likely increase to unseen heights. This would place families and individuals at risk of contracting COVID-19, as well as related and severe health harms," the AMA brief tells the court, noting that 34% of households with children in Georgia, North Carolina, South Carolina and Virginia told U.S. Census Bureau pollsters in September that they had slight or no confidence in their ability to pay next month's rent as the economy's downturn as hit lower income families especially hard.

People who face the greatest risk of eviction are the same ones likelier to have chronic illnesses and disabilities that already put them at higher risk for serious complications or death if they contract COVID-19, the AMA brief tells the court.

In other words, nullifying the CDC order would have the biggest impact on the same people hardest hit by the pandemic: low-income essential workers and those in communities of color. It would force people into transiency and crowded residential environments and increase the chances of "couch surfing" and staying with relatives and friends who may be at high risk for COVID-19.

Read the full story here.

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Other News

Amid COVID-19, CDC advises on preventing health worker infections

Every day during this COVID-19 pandemic, physicians and other health professionals go to work knowing there is a risk they may be infected with a deadly disease. The CDC is partnering with the AMA on Project Firstline, a new national infection-control training program to lower that risk.

The threat is real. Health care workers account for at least 6% of COVID-19 related hospitalizations, according to an analysis of data collected early in the pandemic from 13 sites in 13 states.

The median age of the hospitalized health care workers was 49, and 27.5% were admitted to an intensive care unit, 5.8% of them required mechanical ventilation, and 4.2% died in the hospital, according to the study, "COVID-19–Associated Hospitalizations Among Health Care Personnel—COVID-NET, 13 States, March 1–May 31, 2020," published in the CDC's Morbidity and Mortality Weekly Report.

These findings highlight "the need for continued infection prevention and control in health care settings as well as community mitigation efforts to reduce transmission," the report states. Project Firstline is a collaborative effort involving the CDC, AMA, state and local health departments, medical associations, health care organizations and academic institutions. It provides front-line health care workers with the training they need to protect themselves while protecting the public from infectious-disease threats.

Mike Bell, MD, deputy director of the CDC's healthcare quality promotion division, talked about Project Firstline with AMA President Susan R. Bailey, MD, during the third installment of an AMA-hosted webinar series for physicians addressing various aspects of the federal government's COVID-19 response.

"We don't have a specific, highly effective antiviral treatment, and we don't have an effective vaccine yet, so that means that there's a large proportion of people who could become very sick without recourse to treatment," Dr. Bell said. "When something is severe and not treatable, we are concerned."

Project Firstline materials will include a series of town hall discussions and online training modules detailing the CDC's infection-control practices and strategies and the science and reasoning behind them. Now, there are modules on hand hygiene and infection-control practices specific to nursing homes and dialysis facilities. The modules will soon be available on the AMA Ed Hub™.

Read the full story here.

New podcast on CMS response to COVID-19

With the widespread impacts of the COVID-19 pandemic, CMS is now offering flexibility for clinicians participating in the Merit-Based Incentive Payment System (MIPS), including a hardship exception that CMS is accepting applications for until Dec. 31.

The AMA strongly recommends applying for a hardship exception to be held harmless from a future MIPS penalty if your practice experienced any of the myriad of hardships presented due to the pandemic.

Learn more in a new AMA-ReachMD podcast, "CMS response to the COVID-19 pandemic."  

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