May 31, 2024: National Advocacy Update

On May 30, the AMA responded (PDF) to the Federal Trade Commission’s (FTC) call for comments on its recently announced investigation into drug supply chain “middlemen” and their potential role in creating or exacerbating generic drug shortages.

The investigation, which was announced at the AMA’s National Advocacy Conference in Feb. 2024, aims to gain a better understanding of how group purchasing organizations (GPOs) and drug wholesalers may impact the generic drug market. The investigation seeks to uncover information about contracting practices and how they may impact generic drug pricing and availability. The work will also include consideration of how market concentration in this space may further impact drug access.

The AMA has long been concerned about shortages in the generic drug space, some of which have persisted for years. While drug shortages have many causes depending on the drug in question, economic factors have been one of the significant forces impacting the availability of generic drugs and rendering them very susceptible to shortages. The AMA welcomes the FTC’s investigation into this issue and the role that GPOs, wholesalers and others may play in creating unsustainable market conditions for many generic drug manufacturers. The AMA has also encouraged further investigation into the drug “grey market,” where sham businesses, such as retail pharmacies, buy up available supply of drugs in short supply and sell the product back to middlemen, with significant price hikes happening at each step along the way.

The AMA continues to closely monitor ongoing drug shortages and is working closely with the Food and Drug Administration, FTC and Congress on policy actions to help mitigate ongoing shortages and bolster the generic drug supply chain.

On May 17, the House Energy and Commerce Subcommittee on Health unanimously passed an Amendment in the Nature of a Substitute (AINS) to H.R. 7625 (PDF), the Telehealth Modernization Act of 2024, that would extend the current telehealth flexibilities through 2026. This makes it the second key congressional committee to markup legislation to extend the Medicare telehealth flexibilities before they expire at the end of the year. The amendment was offered by Rep. Buddy Carter (R-GA), the sponsor of H.R. 7625. It largely mirrors the bill that the House Ways and Means Committee approved on May 8 (H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act). This includes:

• Extending exemptions to the outdated rural-only and originating-site requirements on telehealth services so all Medicare beneficiaries can continue to receive services in their homes or any other site where they can access a telecommunications system.
• Continuing the moratorium on requiring an in-person visit within six months of the beneficiary receiving their first telemental health service.
• Providing authority to offer audio-only telehealth services.
• Extending coverage for Acute Hospital at Home services.

The AMA issued a letter of support (PDF). The full Energy and Commerce Committee is expected to consider the legislation in June.

The subcommittee also approved several other amendments to authorize Medicare coverage and payment for telehealth services through 2026 including:

• AINS to H.R. 1406, Sustainable Cardiopulmonary Rehabilitation Services in the Home Act (Reps. Joyce and Peters) (PDF)
• AINS to H.R. 7856, PREVENT Diabetes Act (Rep. Schrier) (PDF)

The AMA has long supported the PREVENT Diabetes Act which would authorize Medicare to cover and pay for telehealth-enabled Diabetes Prevention Program (DPP) services and makes other improvements to the program.

The AMA—alongside the College of Healthcare Information Management Executives, the American Health Information Management Association, and approximately 100 state medical associations and national medical specialty societies—recently sent a letter (PDF) requesting clarification from the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) about how it intends to enforce the Health Insurance Portability and Accountability Act (HIPAA)-related reporting requirements involving the Change Healthcare cyber incident.

In an April 22 press release, United Health Group (UHG) revealed that protected health information (PHI) and personally identifiable information (PII) for a “substantial proportion of people in America” was compromised as a result of the cyberattack.

Although UHG has agreed to “to make notifications and undertake related administrative requirements on behalf of any provider or customer,” the letter highlights the concern that “clinicians and providers have not received sufficient confirmation from OCR that HIPAA breach reporting and notification requirements related to this incident are the responsibility of UHG/Change Healthcare as the HIPAA covered entity which experienced the breach of unsecured PHI.” For this reason, the organizations request that OCR publicly confirm that breach notification requirements are not the responsibility of providers affected by the Change Healthcare breach, and instead are the sole responsibility of UHG.

The HHS OCR published a Final Rule to modify the HIPAA Privacy Rule to support reproductive health care privacy. This action is part of the Biden administration’s efforts to protect access to and privacy of reproductive health care after the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (PDF).

The Final Rule strengthens privacy protections by prohibiting the use or disclosure of protected health information (PHI) that relates to reproductive health care, by a covered health care provider, health plan, health care clearinghouse or their business associate to a requestor to (1) conduct an investigation or impose any liability in order to seek, obtain, provide or facilitate reproductive health care, or (2) identify any person to conduct an investigation or impose a liability.

The Final Rule establishes several conditions and requirements that allow physicians to withhold certain medical information and to require an attestation from requestors stating they will not use PHI in a prohibited manner. The AMA is providing a digest of the rule’s regulatory preamble (PDF) and information pertinent to protect patients, physicians and to be compliant with the regulations. This document will assist you in responding to your members’ questions. Physicians are required to comply with the regulations by Dec. 23, 2024.

Next, the AMA will follow up with a separate, shorter document intended for physicians and their staff to better understand the complexities of the regulations and help them establish policy and procedures to protect PHI and come into compliance. That document will be circulated once it is ready.

For AMA members, their spouses, medical students and residents and state medical association staff who want to become more involved in the campaigning process, the 2024 AMPAC Campaign School will be taking place in-person—July 25-28—at the AMA offices in Washington, DC.

Running an effective campaign can be the difference between winning and losing a race. That is why the Campaign School is designed to give participants the skills and strategic approach needed out on the campaign trail. AMPAC’s team of political experts will teach participants everything they need to know to run a successful campaign.

During the two and a half day in-person portion of the program, under the direction of political experts, participants will be broken into campaign staff teams to run a simulated congressional campaign using what they have learned during group sessions on strategy, vote targeting, social media, advertising and more.

Registration for the 2024 Campaign School is now open. Space is limited and the deadline to register is July 1 (or sooner if maximum capacity is reached).

For more information contact [email protected].

The U.S. is facing a shortage of between 13,500 and 86,000 physicians by 2036—a deficiency that is almost certain to be compounded by rising rates of physician burnout and early retirement. The physician workforce, like our general population, is aging, with nearly 45% of active physicians in the U.S. aged 55 and older. Addressing the physician workforce issue is crucial to ensuring patients have access to care where and when they need it.

View this Advocacy Insights webinar to learn about how increasing residency training slots, addressing visa issues for international medical graduates, ensuring access to care in rural areas, and addressing factors impacting physician burnout—including Medicare physician payment instability and administrative burdens—can help bolster the physician workforce.

Moderator:

• Jesse M. Ehrenfeld, MD, MPH, president, American Medical Association

Speakers:

• John Andrews, MD, vice president of graduate medical education innovations, AMA
• Alexis Pierce, JD, senior attorney, Division of Legislative Counsel, AMA
• Christopher Sherin, assistant director, Division of Congressional Affairs, AMA

• May 31, 2024: Medicare Payment Reform Advocacy Update
• May 31, 2024: State Advocacy Update