This Week's Dose

The House and Senate were both in session this week. The House Ways & Means Health Subcommittee met to discuss policies inhibiting innovation and patient access, and the House Energy & Commerce Health Subcommittee held a hearing on pandemic preparedness. The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on insulin affordability and continued consideration of four drug pricing bills. President Biden met with congressional leadership regarding the fast-approaching deadline to raise the debt limit. While the meeting did not provide immediate resolution, President Biden and House Speaker McCarthy (R-CA) agreed to meet again to continue the discussion, and staff-level meetings are reportedly underway. Finally, the COVID-19 public health emergency (PHE) declaration, along with many healthcare waivers and flexibilities, ended on May 11.

Congress

Senate HELP Committee Holds Insulin Affordability Hearing and Continues Consideration of Drug Pricing Bills. On May 10, the Senate HELP Committee held a hearing on the need to make insulin affordable for all Americans. Senators questioned drug manufacturers on their insulin pricing practices, and questioned pharmaceutical benefit managers (PBMs) on why rebate savings do not appear to be reaching patients at the pharmacy counter. Senators also expressed concerns about consolidation and vertical integration in the PBM market.

Continued finger-pointing between pharmaceutical manufacturers and PBMs was on display during the hearing, with manufacturers claiming that PBMs have refused to put generics with low list prices on preferential tiers in their drug formularies. PBMs denied this claim and stated that their formularies are based on lowest net cost to the customer and on clinical evaluations.

The committee expressed bipartisan support for addressing these issues, and took steps to do so the next day, when the committee met on May 11 to continue consideration of four bills related to PBM reforms and expanding the availability of low-cost generic drugs. The four bills considered were the Ensuring Timely Access to Generics Act of 2023 (S. 1067), the Expanding Access to Low-Cost Generics Act of 2023 (S. 1114), the RARE Act (S. 1214) and the Pharmacy Benefit Manager Reform Act (S. 1339). Many of the amendments offered by members were focused on lowering drug prices, bringing generic drugs to market faster, regulating PBMs and increasing pharmaceutical manufacturer transparency. Upon completion of votes, the committee moved to adopt all four bills.

House Ways & Means Health Subcommittee Holds Hearing on Innovation and Access. On May 10, the House Ways & Means Health Subcommittee held a hearing focused on various regulatory efforts that determine which drugs, therapeutics and technologies should enter the market and be available to patients.

Several Republican members criticized policies of the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare and Medicaid Innovation (CMMI) as limiting coverage of innovative drugs for patients. They called for CMMI guardrails to be put in place to ensure greater transparency and integrity of model testing. Some members also mentioned the Inflation Reduction Act’s impact on drug negotiation and how this may lead to decreased innovation. Witnesses discussed the importance of breakthrough therapies and having access to these treatments as early as possible.

House Energy & Commerce Health Subcommittee Holds Hearing on Pandemic Preparedness. On May 11, the House Energy & Commerce Health Subcommittee held a hearing on preparing for the next PHE. The hearing focused on the reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA), which is set to expire on September 30 without congressional action.

All committee members and witnesses supported the reauthorization of PAHPA. The hearing also highlighted concerns over the loss of authorities and funding given to federal agencies to handle the COVID-19 pandemic and how this may hinder their ability to prepare for future pandemics.

Administration

The COVID-19 PHE Declaration Ends. On May 11, the COVID-19 PHE declaration officially came to an end. CMS issued an updated frequently asked questions document on preparing for the end of the PHE. This update includes five new questions (14–18) on Medicare telehealth flexibilities for hospitals. CMS is maintaining and updating the COVID-19 resource page, which includes fact sheets on various issues related to the end of the PHE.

The White House also released a fact sheet outlining actions taken by the Administration to ensure continued COVID-19 protections and surge preparedness after the PHE transition. US Department of Health and Human Services (HHS) Secretary Xavier Becerra published a letter to governors thanking them for their partnership and commitment throughout the COVID-19 response and sharing additional information and resources helpful to the transition. HHS also issued another fact sheet on telehealth flexibilities and resources after the end of the PHE.

DEA Publishes Temporary Rule on Extension of Telehealth Flexibilities. On May 9, the US Drug Enforcement Administration (DEA) released a temporary rule related to the prescribing of controlled substances via telemedicine. Reversing course from the DEA’s original proposal, the temporary rule will extend the full set of telemedicine flexibilities adopted during the COVID-19 PHE for six months, through November 11, 2023. For practitioner-patient telemedicine relationships established as of November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications established during the PHE will be extended for one year, through November 11, 2024. This temporary rule is designed to provide time for DEA to conclude rulemaking, after the agency received more than 38,000 comments on the proposed rule.

The temporary rule took effect on May 11, 2023. The DEA press release can be found here, and an analysis from our colleagues at McDermott Will & Emery can be found here.

Quick  Hits

• The US Government Accountability Office (GAO) released a report on the 340B drug pricing program. The information from GAO, which was requested by House Energy and Commerce Committee Chair Rodgers (R-WA), includes details on hospitals that received an exception to the program’s eligibility requirements as a result of the COVID-19 PHE.

• The Congressional Budget Office (CBO) published a presentation titled “Long-Term Projections of Health Care Spending and the Implications for the Federal Budget.” The presentation noted that healthcare spending in the United States has grown over time, and since 1960 it has more than tripled as a percentage of gross domestic product. CBO stated that much of the growth in spending on the major healthcare programs and on Social Security results from the aging of the population. CBO also estimated the additional cost growth in healthcare overall to be 0.6% in 2052.

• US Food and Drug Administration advisers on May 10 unanimously recommended that the agency approve the nation’s first over-the-counter birth control pill, Opill. The 17–0 vote capped a two-day joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee to assess whether consumers would use the pill properly if it were sold on store shelves without a prescription.

Next Week's Diagnosis

The House and Senate will both be in session next week. Committees in the House and Senate will convene to discuss several healthcare issues, including rural health, mental health and substance use disorder care, price transparency, and anticompetitive and consolidated markets. The House Energy and Commerce Health Subcommittee is expected to announce a markup of bills included in its recent legislative hearing. Next week is also the last week that the House and Senate will both be in session prior to the potential June 1 debt limit deadline. While that date could change, there will be continued pressure on debt limit negotiations in the coming days.