July 8, 2022: National Advocacy Update

On July 1, 2022, the AMA sent a letter in support of S. 445/H.R. 1384, the Mainstreaming Addiction Treatment (MAT) Act to the Senate Health, Education, Labor and Pensions Committee (HELP). The letter (PDF), addressed to Chair Murray (D-WA) and Ranking Member Burr (R-NC), states the AMA’s support of the MAT Act, which would increase access to evidence-based treatment for opioid use disorder and end longstanding administrative barriers to prescribing buprenorphine in-office for the treatment of opioid use disorder. The AMA previously sent another letter (PDF) of support for the MAT Act on April 27, 2021.

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In the letter, the AMA also expresses opposition to S. 2235/H.R. 2067, the Medication Access and Training Expansion (MATE) Act of 2021. Unlike the MAT Act, the MATE Act creates new barriers to care that will not have a meaningful effect on reducing drug-related overdose or death. Additionally, on April 28, 2021, the secretary of the Department of Health and Human Services published a new practice guideline that removed the requirement for physicians who prescribe medication to treat opioid use disorder to complete eight hours of education on treatment and medication management. The MATE Act would reinsert this training requirement barrier to providing care for patients.  

Both the MAT Act and MATE Act were included by amendment in the House passage of H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act of 2022. In advance of the MATE Act inclusion in the package, the AMA communicated our continued opposition to the legislation, sending a letter (PDF) to the House Energy and Commerce Committee on May 6, 2022.   

The AMA continues to work with the Senate HELP Committee to ensure that the MAT Act is included in any final mental health package that will be signed into law, while also continuing to oppose any inclusion or passage of the MATE Act. 

In a recent statement on the Supreme Court opinion restricting the ability of the Environmental Protection Agency to regulate carbon emissions, AMA President Jack Resneck Jr., MD, said, “The American Medical Association is deeply disappointed with today’s U.S. Supreme Court opinion restricting the ability of the Environmental Protection Agency (EPA) to regulate the carbon emissions that cause climate change and harm public health."

“Regulating and reducing greenhouse gas emissions is critical for combating the climate crisis and its major health implications, impacting the respiratory, cardiovascular, and immune systems of the U.S. population, with minoritized populations disproportionately impacted. The AMA has declared climate change a public health crisis that threatens the health and well-being of all people and supports policies that reduce U.S. greenhouse gas emissions aimed at carbon neutrality by 2050." 

"As physicians and leaders in medicine, we recognize the urgency of supporting environmental sustainability efforts to help halt global climate change and the devastating health harms that it is sure to bring. Despite this ruling, we will continue to do our part to protect public health and improve health outcomes for our patients across the nation."

In a statement on the new FDA authorization for pharmacists to prescribe Paxlovid with certain limitations, AMA President Jack Resneck Jr., MD, said, “Paxlovid is an important treatment and critical tool in the fight against COVID-19. While the majority of COVID-19 positive patients will benefit from Paxlovid, it is not for everyone and prescribing it requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving—requirements far beyond a pharmacist’s scope and training. 

“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams—teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one.” 

The Medicare physician payment system needs an overhaul to remedy financial instabilities impacting physician practices due to the pandemic, statutory payment cuts, lack of inflationary updates and significant administrative burdens. To define the goals of reform, the AMA and 120 state medical and national specialty societies created the “Characteristics of a Rational Medicare Physician Payment System.” (PDF)  

Hear what these principles call on Congress to do to improve the Medicare physician payment system in a new AMA Advocacy Insights webinar on Wednesday, July 27 at 10:00 a.m. Central. Hosted by Sandra Fryhofer, MD, chair, AMA Board of Trustees, the webinar will dig deeper into some of the causes of the current systemic issues and chart a path forward. Additional speakers include: 

• Cynthia Brown, vice president, AMA Government Affairs 
• Jason Marino, director, AMA Congressional Affairs 

Register now and learn more about the Medicare physician payment principles.  

Aetna recently announced (PDF) that effective July 1, 2022, it will no longer require prior authorization (PA) for cataract surgery, with the exception of Florida and Georgia Medicare Advantage patients. This change follows a year of tireless advocacy by the American Academy of Ophthalmology (AAO), the American Society of Cataract and Refractive Surgery (ASCRS) and other members of the Federation of Medicine that highlighted the care delays, practice administrative burdens, and patient and public safety concerns associated with this problematic policy.

For more information on other PA reform efforts, including federal legislation that would streamline PA in Medicare Advantage plans (H.R. 3173/S. 3018), visit FixPriorAuth.org. 

For many years, Medicare payments to physicians and other providers have been subject to an across-the-board 2% sequester, which was temporarily suspended in COVID relief packages enacted in 2020 and 2021. Legislation passed last December, the Protecting Medicare and American Farmers from Sequester Cuts Act, began the process of phasing the sequester back in—providing the full 2% relief for the first quarter of 2022, then 1% relief for the second quarter and finally phasing the full 2% payment cut back into effect on July 1, 2022. The reduced rate will be effective for services provided on or after July 1. 

The AMA is closely monitoring the evolving situation with the spread of monkeypox in the U.S. and is aware of a continued increase in case numbers. AMA is in direct contact with the Centers for Disease Control and Prevention (CDC) and is working to provide physicians with the most up-to-date guidance and information regarding diagnosis and treatment of monkeypox. The AMA strongly urges physicians to stay up to date on the latest clinical information regarding monkeypox and to test suspected cases. Case numbers to date have likely been underreported, making it possible that there are higher levels of transmission than currently reported.  

What we currently know is: 

• Clinicians in the U.S. should be alert for patients who have illnesses consistent with monkeypox (rash, fever and lymphadenopathy), regardless of gender or sexual orientation. While the current outbreak appears to have disproportionately impacted the LGBTQ+ community, monkeypox can infect anyone and is likely to spread outside of this community.  
• Testing for monkeypox has been an issue. Initially, testing was only available through public health laboratories. However, CDC recently announced that they have shipped tests to the five major commercial laboratories. LabCorp, Quest Diagnostics, Aegis Science, Mayo Clinic Labs and Sonic Healthcare will begin offering testing soon, which should make testing easier to order and less burdensome for physicians and patients.  
• CDC recommends that clinicians have monkeypox on their differential diagnosis when presented with an STI-associated or STI-like rash, even if it is localized. The rash associated with monkeypox can be confused with other rashes including herpes, syphilis and varicella.  
• Patients with suspected monkeypox infection should isolate and avoid close contact with other people and animals.
• Medical countermeasures developed for the smallpox virus may be used to prevent and treat monkeypox virus infections.   
• The Jynneos and ACAM2000 vaccines are available. The Jynneos vaccine is preferred as the ACAM2000 vaccine has a significant side effect profile. Vaccines will be provided to individuals with confirmed and presumed monkeypox exposures. HHS recently announced a strategy to vaccinate and protect those at-risk of monkeypox, prioritizing vaccines for areas with the highest numbers of cases. Vaccines will be made available through state health departments (PDF). 
• Tecovirimat (TPOXX), may be recommended for people who are more likely to get severely ill, like patients with weakened immune systems. Access to antivirals is available through consultation with CDC at [email protected] or 770-488-7100 by requesting the clinical team consultation.  

The AMA will be working to post additional resources on its website in the coming days and will continue to update physicians with the latest information available. The AMA also urges physicians to monitor the latest information available from the CDC. More information for clinicians is available on the CDC website, through the CDC Health Alert Network (HAN) and in a Dear Colleague letter (PDF) recently issued by CDC Director Rochelle Walensky. 

On June 27, the Food and Drug Administration (FDA) announced a new proposed rule seeking to establish new requirements for manufacturers looking to switch prescription drug products to over-the-counter (OTC) offerings. The FDA claims the new proposal will “broaden the types of drugs that can be approved as non-prescription.” The proposed rule would seek to do so by allowing for drug products that currently are available only with a prescription to move to OTC status by setting additional considerations that would ensure appropriate selection and use by patients.

Under the proposal, when FDA finds that labeling alone would be insufficient to ensure appropriate selection and use by patients in an OTC setting, manufacturers can propose an additional condition of use that a consumer can fulfill to obtain the drug product. This could include, for example, that consumers answer a set of questions on a self-selection test via a mobile phone application or telephone screen in order to purchase the product. FDA will be accepting comments on the new proposal until Oct. 26, 2022.  

The AMA supports OTC availability of some drug products currently available by prescription only, including opioid overdose treatment naloxone, and has new policy supporting OTC availability of oral contraceptives. 

June 30 marked the last day of Medicare's Oncology Care Model (OCM), a six-year pilot program that engaged oncology practices estimated to provide 25% of medical oncology services in the U.S. The model, originally scheduled to end in 2021, was extended during the COVID-19 pandemic and the AMA and oncology community had hoped that the Centers for Medicare & Medicaid Services (CMS) would further extend it or have a new model in place before the OCM ended. The AMA has previously expressed concern about the instability in Medicare alternative payment models. CMS has now announced a new model, Enhancing Oncology Model (EOM), which will start July 1, 2023, and last five years. Applications to participate in EOM are being accepted through Sept. 30, 2022. The AMA has strongly opposed mandatory models and is pleased that EOM will be voluntary. 

Both OCM and EOM allow physicians to bill for a Monthly Enhanced Oncology Services (MEOS) payment during six-month episodes of care when patients are receiving chemotherapy. MEOS payments in OCM were $160 per month but are being reduced to $70 per month in EOM. Participating physicians will also be able to bill an additional $30 per month for patients enrolled in both Medicare and Medicaid. The extra payment is one way that EOM seeks to focus on improving health equity and facilitate efforts to address patients' health-related social needs. 

Under EOM, participating oncology practices will be accountable for financial and quality performance for the six-month episodes, including drug costs. There will be upside and downside risk requirements through which practices may earn performance-based payments but also could be subject to performance-based recoupments. Under the financial model, all participating practices will have to reduce expenditures at least enough to offset the $70 MEOS payments and generate an additional 2% of savings below what CMS estimates it would have been in the absence of the model. Quality performance will be based on measures of patient experience, hospitalization and emergency visit rates, behavioral health, end-of-life care, and adherence to evidence-based clinical pathways. 

Additional information and the Request for Applications are available.

The House of Representatives passed the TRIUMPH for New Moms Act (“TRIUMPH”) as part of the Restoring Hope for Mental Health and Well-Being Act of 2022, a bipartisan mental health and substance abuse package that would reauthorize key programs within the Substance Abuse and Mental Health Services Administration.  

The AMA previously wrote letters to the House of Representatives (PDF) and Senate (PDF) encouraging the passage of the TRIUMPH Act, which would create a Task Force on Maternal Mental Health to identify, evaluate, and make recommendations to coordinate and improve federal responses to maternal mental health conditions, as well as create a national strategic plan for addressing maternal mental health disorders. Perinatal mental illnesses contribute to adverse outcomes during pregnancy and postpartum, including pregnancy-related morbidity and mortality, and can impact both pregnant individuals and their children, not only during pregnancy but potentially for years to follow.

Therefore, a national strategy for maternal health care, as proposed in the TRIUMPH Act, is an important step to improve the mental health of mothers and to ensure positive long-term health outcomes for both the mother and the child. The legislation will now move to the Senate for a vote.   

CMS has begun issuing the 5% lump sum payments to physicians who were Qualified Participants (QPs) in advanced alternative payment models during calendar year 2020. CMS previously released information that the number of QPs rose from 195,564 clinicians in 2019 to 237,315 in 2020. QPs who are eligible for the 2022 payments based on their 2020 payment model participation can now log in to the Quality Payment Program QPP website to see the amount of the payment made for their personal National Provider Identifier (NPI) as well as for their organization. 

CMS has also published a list of 9,611 QPs for whom the agency does not have current billing information and therefore is unable to send their incentive payment to them. Physicians who have not received their payment should look for their name and NPI on the 2022 QP Notice for APM Incentive Payment Zip File and complete the billing information collection form no later than Nov. 1, 2022, in order to receive their incentive payment. 

The Medicare Access and CHIP Reauthorization Act (MACRA) established the QP incentive payments for six years, from 2019 through 2024. As the payments are made two years after physicians have participated in an advanced alternative payment model, this year, 2022, is the last year that physicians can qualify for the incentive payments. The AMA is strongly advocating that Congress extend the QP incentive payments for an additional six years by passing the Value in Health Care Act (H.R. 4587) this year. 

As a condition of accepting general and/or targeted Provider Relief Fund (PRF) payments, physicians must complete reporting to the Health Services and Resources Administration (HRSA). For physicians who received more than $10,000 in the aggregate from Jan. 1, 2021, to June 30, 2021, known as Reporting Period 3, the PRF Reporting Portal is now open and will remain open through Sept. 30, 2022, at 11:59 p.m. Eastern. The AMA urges physicians who are required to report to submit their information early and before the Sept. 30, 2022, deadline. 

New submitters can get started by registering in the PRF Reporting Portal (if not yet completed). Physicians who have previously reported do not need to register again and may log into the portal with their username, TIN and password. Additional information on reporting may be found on the HRSA PRF website, which can be accessed on the PRF Reporting resources page. For specific questions related to reporting, physician practice staff should contact the Provider Support Line at 866-569-3522; for TTY dial 711. Hours of operation are 8 a.m. to 10 p.m. Central, Monday through Friday.  

HRSA will host technical assistance webcasts for new and returning reporting entities. Registration is required to attend. The dates and times of the HRSA webcasts are as follows: 

• New Reporting Entities: PRF Reporting Requirements Introduction: July 12, 2022, 3-4:00 p.m. Eastern 
• Information for Returning Reporters: July 13, 2022, 3-4:00 p.m. Eastern

The AMA will continue to urge the Department of Health and Human Services and HRSA to streamline the reporting process and to augment outreach to providers to ensure physicians are able to retain the PRF payments they received.

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