Oct. 18, 2024: National Advocacy Update

On Oct. 9, a majority of the House of Representatives officially cosponsored H.R. 8702, the Improving Seniors’ Timely Access to Care Act.  

As of Oct. 16, 221 bipartisan members of Congress (155 Democrats, 86 Republicans) have cosponsored this House bill to reform prior authorization requirements within Medicare Advantage. Introduced by Representatives Mike Kelly (R-PA), Suzan DelBene (D-WA), Ami Bera, MD (D-CA) and Larry Bucshon, MD (R-IN), this important cosponsorship milestone is key to demonstrating to House leadership that this particular bill warrants consideration and passage in the upcoming “lame duck” session. The AMA, physician members and many Federation partners have all worked in tandem to secure support from a majority of House lawmakers. 

In addition to high cosponsor tallies, H.R. 8702 continues to garner broad support amongst key health stakeholders. In fact, nearly 450 health care organizations, including all 50 state medical associations, are currently listed as supporters of the Improving Seniors’ Timely Access to Care Act. The identical Senate companion bill, S. 4532, which was introduced by Senators Roger Marshall, MD (R-KS), Kyrsten Sinema (I-AZ), John Thune (R-SD) and Sherrod Brown (D-OH), enjoys similar cross-party support including 54 bipartisan cosponsors.  

Federal lawmakers continue to wait on an updated cost assessment from the Congressional Budget Office (CBO) to determine if the latest version of the Improving Seniors’ Timely Access to Care Act will “score” as not costing any money. Last Congress, CBO tagged a slightly different version of the prior authorization reform bill with a $16 billion price tag. In the 118th Congress, all but approximately $4 billion of that previous score was folded into the spending baseline following the finalization of a regulation that encompasses much of the Improving Seniors’ Timely Access to Care Act. Although not yet produced, the hope is that the latest CBO score of the revised version of H.R. 8702 will ultimately find that the legislation does not have a cost, thus allowing for the bill to pass both chambers of Congress after lawmakers return to Washington, D.C. following the election. AMA will continue to work with bipartisan members of the House and Senate to ensure this crucial piece of legislation is passed before the conclusion of the 118th Congress.     

The AMA is closely monitoring drug shortages that may increase in severity following recent severe weather events in the southeastern United States. Following Hurricane Helene, a Baxter International manufacturing facility in North Carolina sustained damage resulting in the temporary closure of the facility. The facility is responsible for around 60% of the U.S. supply of intravenous fluids. The sudden manufacturing disruption has thrown these drugs into a severe shortage that is impacting patient care, with many elective surgeries being cancelled and facilities taking extraordinary measures to preserve supply. A survey by hospital care alliance Premier has indicated that up to 86% of providers are impacted by the shortage.  

While many facilities are attempting to find workarounds to continue to provide access, very few facilities have the capabilities to produce these products in their own pharmacies. The federal government is taking all possible action to help increase the supply, including providing guidance to compounding pharmacies to allow them to help fill gaps and approving the import of IV fluids from other major Baxter facilities abroad.  

Physicians can receive updates from the Food and Drug Administration, who will provide continuous updates and guidance for pharmacies, facilities and prescribers.  

The AMA is communicating with federal government officials to receive updates and to communicate ongoing physician concerns. The AMA will continue to share updates with physicians through its numerous communications channels. 

The Centers for Medicare & Medicaid Services (CMS) issued a request for information (RFI) on a new proposal to help lower out-of-pocket drug costs for Medicare beneficiaries. The announcement of the “$2 Drug List Model” flows from Executive Order 14087 “Lowering Prescription Drug Costs for Americans” issued by the Biden administration in 2022.

The model would allow Part D drug plans to offer a low, fixed copayment across all cost-sharing phases of the Part D drug benefit for a standard, Medicare-designed list of generic drugs. With the goal of co-payments not exceeding $2 per month supply, CMS aims to increase affordability, transparency and treatment adherence through the model. The initial proposed drug list for the model includes 101 drugs covering therapeutic uses across 15 categories, including therapeutics for blood pressure/cardiovascular issues, cholesterol, diabetes, mental health, and others.  

CMS is seeking feedback from a range of interested parties on issues such as the development of the $2 Drug List, how to maximize plan participation, and others. Comments are due on Dec. 9, 2024. 

The AMA has received several inquiries from Federation members about the status of rules allowing physicians to prescribe controlled substances when they have not had an in-person encounter with the patient. On March 1, 2023, the Drug Enforcement Administration (DEA) issued proposed rules expanding induction of buprenorphine via telemedicine encounters and outlining permanent policy to replace the COVID-era waivers related to prescribing of controlled substances without an in-person visit. After providing just a 30-day public comment period, the DEA received more than 38,000 comments on its proposals. AMA comments (PDF) sought significant modifications to both proposals, particularly as both would have required patients to have an in-person evaluation within 30 days of their initial prescription. After determining that it needed to do more work on these policies, the DEA held a public listening session (PDF) in Sept. 2023 and extended the COVID-era waivers through the end of 2024. 

In June 2024, the DEA developed a new proposed rule on prescribing of controlled substances when there has not been an in-person evaluation. As with the previous proposed rule, the new one will provide an opportunity for public comment. The DEA has also indicated it plans to issue a final rule expanding induction of buprenorphine (PDF) via telemedicine. To date, however, neither the new proposed rule on controlled substance prescribing nor the final rule on buprenorphine have been released. 

Interested parties have expressed concern that with the current policies set to expire at the end of this year, the delay in issuing the new rules could lead to delays in patients accessing needed care and medications. The DEA has now sent a new notice for review by the White House Office of Management and Budget that would further extend the COVID-era policies while the more permanent rulemaking process continues. The AMA does not yet know how long the next extension will be, but at a minimum, it should allow the longer-term rulemaking process to be completed and the public to provide comments on the new proposals before any new policies take effect. 

• Oct. 18, 2024: State Advocacy Update