THIS WEEK’S DOSE

The House held a district work week while the Senate was in session, with plenty of healthcare action at the committee level. The Senate Finance Committee held a hearing on barriers to mental health care. The Senate Health, Education, Labor and Pensions (HELP) Committee briefly met to begin consideration of drug pricing legislation and held a hearing on pandemic preparedness. Debt limit negotiations intensified following Treasury Secretary Janet Yellen’s announcement that the federal government could risk default on the national debt as early as June 1. With the end of the public health emergency (PHE) declaration less than one week away, the Biden Administration announced the winding down of remaining COVID-19 vaccination mandates.

CONGRESS

Senate Finance Committee Holds Mental Health Hearing. On May 3, the Senate Finance Committee held a hearing on mental health care barriers. The hearing focused on ghost networks (i.e., provider directories that are inaccurate and unusable by those seeking mental health care) and potential solutions that would help update provider directories.

As part of the hearing, Chairman Wyden (D-OR) released findings of a secret shopper study conducted by his committee staff. The study showed an 18% success rate for making an appointment with a mental health provider, indicating widespread prevalence of inaccurate provider directories.

Witnesses called for a streamlined system for updating these directories that would ease administrative burden on physicians and improve accuracy. Witnesses and committee members also expressed concerns regarding mental health care shortages, especially in rural areas, that are exacerbated by these inaccurate directories.

Senate HELP Committee Delays Consideration of Drug Pricing Bills. The Senate HELP Committee met briefly on May 2 to begin consideration of four bills related to pharmacy benefit manager (PBM) reforms and expanding the availability of low-cost generic drugs. The executive session was short-lived, however, due to concerns raised on both sides of the aisle about moving ahead without Congressional Budget Office cost estimates, and about the lack of technical assistance from the US Food and Drug Administration (FDA) on the bills and amendments being considered.

Some Senators also expressed hesitation about moving ahead on PBM and drug pricing bills in advance of the HELP Committee’s scheduled May 10 hearing on insulin pricing that will feature testimony from PBMs and pharmaceutical companies.

The executive session is scheduled to reconvene on May 11.

Senate HELP Committee Holds Hearing on Pandemic Preparedness. On May 4, the Senate HELP Committee held a hearing on preparing for the next public health emergency that focused on the reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA), which is set to expire on September 30 without congressional action.

The committee heard testimony from a panel of federal government leaders representing the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention, and the FDA, followed by a panel of academic and expert witnesses.

Senators on both sides of the aisle expressed a commitment to reauthorizing PAHPA before its expiration. The witnesses and senators discussed what Congress can do to prepare for future pandemics and biological threats, and what improvements can be made with respect to real-time threat detection, domestic manufacturing capabilities, and the regulation of laboratory-developed tests and in vitro diagnostics, among other topics.

ADMINISTRATION

White House Announces End of COVID-19 Vaccination Requirements. On May 1, the Biden Administration announced that the federal government will wind down certain remaining COVID-19 vaccination mandates, including those for federal workers, contractors and international air travelers, effective May 11, which is the scheduled end date of the COVID-19 PHE.

HHS will also “start the process” of ending the vaccination requirements for Centers for Medicare & Medicaid Services (CMS) certified healthcare facilities. Also on May 1, CMS issued a Quality, Safety and Oversight memorandum containing wide-reaching guidance pertaining to the end of the PHE. The memorandum indicated that further information regarding the end of the CMS COVID-19 vaccination mandate would be forthcoming after the PHE expires.

Because the process and timeline for winding down the CMS vaccination mandate has not yet been released, it is unclear how quickly the winding down will take effect and how elimination of the mandate will impact the many CMS quality measures tied to COVID-19 vaccinations. Our team continues to monitor this issue and will provide additional updates as further information is released.

DEA Announces Extension of Telehealth Flexibilities. On May 3, the US Drug Enforcement Administration (DEA) announced that it received a record 38,000 comments on its proposed telemedicine rules. Those proposed rules—released in late-February and found here and here—relate to the prescribing of controlled substances via telehealth and sought to set forth policies to replace the flexibilities that have existed under the COVID-19 PHE.

While many stakeholders had hoped to maintain the pandemic-era flexibilities, the DEA’s rules proposed to more strictly limit prescribing via telehealth compared to the flexibilities that have existed under the PHE. Under such limitations, patients who face significant barriers to accessing care without telehealth may face difficulty receiving the controlled medications they need, and many stakeholder comments reflected such concerns.

In response, DEA stated: “We take those comments seriously and are considering them carefully. We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities while we work to find a way forward to give Americans that access with appropriate safeguards.”

The announcement indicated that further details will be made available upon publication of a draft temporary rule.

QUICK HITS

• The US Government Accountability Office announced the appointment of six new members to the Medicaid and CHIP Payment and Access Commission (MACPAC). The newly appointed members are Timothy Hill, Carolyn Ingram, Patti Killingsworth, Adrienne McFadden and Jami Snyder, whose terms expire in April 2026, and John B. McCarthy, who was appointed to serve out Laura Herrera Scott’s remaining term, which expires in April 2024. Current MACPAC member Robert Duncan was named the Commission’s vice chair.
• HHS announced the release of a new Surgeon General Advisory calling attention to the public health crisis of loneliness, isolation and lack of connection in the United States. The advisory lays out a framework for a new National Strategy to Advance Social Connection. In the advisory’s introductory letter, the surgeon general notes that the mortality impact of being socially disconnected is similar to that caused by smoking up to 15 cigarettes a day.

NEXT WEEK’S DIAGNOSIS

The House and Senate will both be in session. President Biden will meet with congressional leadership on negotiations to raise the debt ceiling, and the COVID-19 PHE will end on May 11. The Senate HELP Committee will hold a hearing on insulin prices and is slated to continue its executive session to consider a slate of drug pricing bills. The Senate Finance Committee will hold a hearing on pharmaceutical manufacturers and international tax policy. The House Ways and Means Health Subcommittee will hold a hearing to examine policies that have negative effects on medical innovation and reduce patient access to therapies, and the House Energy and Commerce Committee will hold hearings on PAHPA and drug shortages.

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