THIS WEEK’S DOSE

• The US House of Representatives returned from recess this week and held a legislative hearing on drug shortages.
• Senate Health, Education, Labor and Pensions (HELP) Committee Chair Sanders (I-VT) and Senator Marshall (R-KS) released the Bipartisan Primary Care and Health Workforce Act.
• The Senate Judiciary Committee held a hearing on artificial intelligence (AI).
• The Drug Enforcement Administration (DEA) held listening sessions on prescribing controlled substances via telemedicine.

CONGRESS

Senators Sanders and Marshall Release Bipartisan Primary Care and Health Workforce Act. Released on September 14, the legislation would reauthorize funding for a number of healthcare workforce programs that are due to expire on September 30, including Community Health Centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education program, among others.

The bill also includes several miscellaneous health policy provisions, including banning anticompetitive terms in facility and insurance contracts; requiring identification numbers for off-campus outpatient departments; and prohibiting the billing of facility fees for any telehealth service, including evaluation and management (E/M), as well as for any E/M service provided in the emergency department except for current procedural terminology codes 99281–99285. In addition, it includes a Government Accountability Office (GAO) report on the effectiveness of the National Health Service Corps at attracting healthcare professionals to Health Professional Shortage Areas. A full summary of the bill’s provisions can be found here.

The HELP Committee will take up the bill during a markup scheduled for September 21. Notably, the Sanders-Marshall bill was not endorsed by HELP Committee Ranking Member Cassidy (R-LA), who criticized the effort as “unfinished and haphazardly drafted” and noted that it lacks a specific plan or list of scored proposals to pay for the funding increases. Senator Cassidy has his own legislation to extend these expiring programs.

Senate Examines AI. On September 12, the Senate Judiciary Committee’s Privacy, Technology, and the Law Subcommittee convened to discuss the expansion of AI and the potential threat it poses to national security. Members and witnesses discussed concerns of AI use, including misinformation, potential negative impacts on children and the use of AI overseas where there are different regulations than in the United States. Committee members emphasized the need for bipartisan support of legislation that will provide full-measure regulations on AI use.

Senate Majority Leader Schumer (D-NY) hosted an AI Insight Forum on September 13, featuring top voices in business, civil rights, defense, research, labor and the arts, to discuss how Congress can tackle AI. More than 60% of Senators attended, and stakeholder attendees included Sundar Pichai (CEO of Google), Elon Musk (CEO of SpaceX and Tesla Motors), Mark Zuckerberg (CEO of Facebook) and Sam Altman (CEO of OpenAI). Read Majority Leader Schumer’s remarks here. The forum was part of the Senate’s ongoing initiatives to understand and compile an AI regulatory framework.

On the healthcare AI front, HELP Committee Ranking Member Cassidy released a report requesting feedback on a flexible framework for AI in healthcare, support for medical innovation, and medical ethics and protecting patients. Comments are due September 22, and can be submitted to HELPGOP_AIComments@help.senate.gov.

House Ways and Means Committee Holds Member Day Hearing. On September 14, the House Ways and Means Committee held a Member Day hearing to receive testimony from off-committee members on a broad spectrum of topics falling within the committee’s jurisdiction.

Healthcare-specific issues raised during the hearing included the importance of affordable and accessible healthcare for all Americans, and the challenges faced by rural residents and communities of color. Representatives proposed legislative solutions, including revising the Medicare rule requiring a three-day inpatient stay for skilled nursing coverage (H.R. 5138) and ensuring that prior authorization decisions are made by physicians (H.R. 5213). Additionally, representatives raised concerns about high prescription drug prices and the role of pharmacy benefit managers (PBMs) in driving up costs, along with the need for legislation to ensure fair reimbursement for patients’ medications (H.R. 2880). Focusing on lowering patient expenses, representatives also discussed how the government should promote competition in healthcare by removing obstacles for new providers and eliminating the inpatient-only service list (H.R. 2862).

House Energy and Commerce Health Subcommittee Holds Hearing on Drug Shortages. On September 14, the Health Subcommittee held a legislative hearing focused on generic drug shortages. The hearing agenda included five bills aimed at addressing the multifactorial causes of drug shortages that occur at various points across the pharmaceutical supply chain.

While there is bipartisan agreement that shortages of essential, life-saving drugs must be addressed, there has not been agreement among Energy and Commerce Committee Republicans and Democrats on a path forward. Democrats pushed for drug shortages to be addressed during the committee’s consideration of legislation to reauthorize the Pandemic and All-Hazards Preparedness Act over the summer, though Republicans chose to address the issue separately.

During the hearing, there was support for measures to improve the supply chain of generic, sterile, and injectable drugs. In addition, several members expressed concern about the low price of certain drugs in shortage and the lack of incentives for drug companies to produce those drugs. Further, Republican and Democratic members disagreed on the need to exempt drugs that are in shortage from the 340B program.

ADMINISTRATION

DEA Holds Telemedicine Listening Sessions. Under the COVID-19 public health emergency (PHE), flexibilities were created to permit the prescribing of controlled substances through telemedicine without an in-person visit. Earlier this year, the DEA issued a proposal to roll back the flexibilities ahead of the PHE’s May 11 expiration and received strong opposition from stakeholders and Congress. The DEA then extended the pandemic flexibilities through November 11, to reconsider its proposal and review input from the 38,000 comments received.

On September 12 and 13, the DEA convened stakeholders for two days of meetings on the topic. Stakeholders provided input on reimbursement models, data collection in prescribing, and clinical guidelines and prescribing controls.

During these listening sessions, the agency announced that there would be an additional written comment period this fall for its telemedicine prescribing rules proposal, signaling it may again need to extend pandemic rules beyond the current November 11 expiration date.

The temporary rule extending COVID-19 telemedicine flexibilities for the prescription of controlled medicines can be found here.

White House Cancer Moonshot Announces New Actions and Commitments. On September 13, President Joe Biden and First Lady Jill Biden convened a meeting of the Cancer Cabinet to announce new actions to advance the mission of the White House Cancer Moonshot. The announcement included a number of new commitments, including:

• $240 million in additional investment this year to accelerate new ways to prevent, detect, treat and survive cancer
• A new “biomedical data fabric toolbox” to advance cancer research progress
• A new nationwide health innovation network to bring cancer clinical trials to underserved communities and drive research progress
• A new pilot program to increase veteran engagement in tobacco-use treatment
• A new oncology professional navigator curricula and certification program created by the American Cancer Society
• A new CVS Health expanded smoking cessation program.

CMS Holds National Nursing Home Stakeholder Call. On September 14, the Centers for Medicare & Medicaid Services (CMS) held a stakeholder call to receive input on the recently released minimum staffing standards proposed rule. Staff noted that the proposed standards are meant to reduce the risk of unsafe and low-quality care in long-term care (LTC) facilities. Staff highlighted that they recognize the unique challenges certain LTC facilities may face, especially if they are in rural areas. CMS noted that they have included staggered implementation provisions for this reason. Stakeholders asked what evidence CMS used to justify the proposed rule. CMS noted they referenced a 2022 nursing home staffing study, public listening sessions, survey data and other existing literature.

CMS will post the presentation slides and recording here.

QUICK HITS

• FDA Approves Updated mRNA COVID Vaccines. The US Food and Drug Administration approved and authorized for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and better protect against serious consequences of COVID-19. Shortly thereafter, the Centers for Disease Control and Prevention formally recommended the updated vaccines for everyone six months and older.
• HHS OIG Releases Report on Improper Medicare Payments. The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report on its audit to determine whether Medicare properly paid acute-care hospitals’ inpatient claims subject to the transfer policy from January 1, 2019, through December 31, 2022. OIG found that Medicare improperly paid $41.4 million to acute-care hospitals for inpatient claims subject to the transfer policy. OIG recommended that CMS direct the Medicare contractors to recover from acute-care hospitals the $41.4 million in overpayments and instruct the Medicare contractors to notify appropriate providers so that they can exercise reasonable diligence to identify, report and return any overpayments in accordance with the 60-day rule.
• US Census Bureau Releases Health Insurance Data for 2022. Released each year, the data for 2022 shows that 27 states had increased health insurance coverage compared to 2021, with only Maine seeing an increase in the number of uninsured. However, it is important to remember that this data precedes Medicaid unwinding, which began in 2023.
• CMS Announces the List of 34 Drugs for Which Cost Sharing Will Be Lowered in the Last Quarter of 2023. Details can be seen here. The action is pursuant to an Inflation Reduction Act provision that permits CMS to lower coinsurance for some Part B drugs if the drugs’ prices increase faster than the rate of inflation.
• GAO Releases Report on Protecting Against Political Interference. GAO released a report on safeguards to help HHS agencies protect against potential political interference. The report noted that HHS agencies were at the forefront of the government’s response to the COVID-19 pandemic and, like most federal agencies, HHS leadership consists of both political appointees and career officials who work together to oversee agency operations and implement the administration’s policy priorities. GAO convened a roundtable and identified safeguards that could help selected HHS agencies protect against potential political interference, including increased documentation and transparency, training on scientific integrity processes, and strengthening institutional structures.

NEXT WEEK’S DIAGNOSIS

The House is scheduled to consider the Lower Prices, Increased Transparency Act (H.R. 5378) on the floor. It is scheduled to be considered on the suspension calendar, which prohibits amendments and requires support of two-thirds of the House for passage. A flurry of healthcare activity will also occur at the committee level next week, including hearings on PBMs, Medicare innovation, surprise medical billing, aging in place and Inflation Reduction Act implementation. The Senate remains focused on appropriations bills outside of the health arena. Additionally, focus next week will remain on whether lawmakers can negotiate a stopgap continuing resolution prior to September 30, to prevent a government shutdown.