Capitol Hill Update
Both chambers of Congress will resume legislative business this week as leadership looks to break the logjam on a pair of supplemental appropriations requests. While lawmakers have a bipartisan agreement to move as much as $33 billion for Ukrainian military and humanitarian assistance, Democrats and Republicans are still searching for common ground on the $10 billion Bipartisan COVID Supplemental Appropriations Act. Senate Republicans have remained steadfast in their position that the two requests should be addressed separately as opposed to combining the two within the same package — the preferred strategy of Democratic leadership. The two sides will also need to navigate disagreements pertaining to the Biden administration’s rollback of the Title 42 public health directive at the U.S.-Mexico border before the pandemic relief funding can pass the 50-50 Senate.
Meanwhile, the Senate will reconvene this afternoon to begin consideration of legislation that would codify Roe v. Wade abortion protections following the leaked U.S. Supreme Court decision which suggests that the high court is poised to throw out the decades-old precedent. The Women’s Health Protection Act (S. 1975) — which would prohibit governmental restrictions on the provision of, and access to, abortion services — is not expected to advance in the evenly-split upper chamber due to opposition on both sides of the aisle. Meanwhile, House lawmakers will return on Tuesday and are set to consider legislation that would: (1) reauthorize and modernize the Community Services Block Grant program (H.R. 5129); (2) provide federal workers’ compensation to firefighters who contract certain illnesses as a result of their service (H.R. 2499); and (3) modify the workplace rights, protections, and benefits applicable to Transportation Security Administration (TSA) personnel (H.R. 903).
Senate Commerce Deliberates Drug Pricing Transparency, PBMs
On Thursday, the Senate Commerce, Science, and Transportation Subcommittee on Consumer Protection, Product Safety, and Data Security convened ahearing (TRP summary) to discuss transparency in prescription drug markets. Specifically, the hearing focused on the role of pharmacy benefit managers (PBM) and their impact on the cost of drugs. The Subcommittee heard from industry stakeholders and experts on pharmaceutical competition and pricing. Senators asked the panel about several topics, all of which traced back to bipartisan calls for more transparency over PBM practices. Specifically, lawmakers on both sides of the aisle questioned witnesses about potential anticompetitive practices implemented by PBMs and the role that PBMs play in out-of-pocket (OOP) drug costs compared to other actors in the drug pricing supply chain.
Democrats engaged in discussions about rebates and spread pricing, and while a couple of witnesses expressed certainty of their criticism of PBMs, others felt that more insight into the supply chain would be necessary before they could provide definitive responses. Overall, lawmakers on both sides shared critical views of the role played by PBMs. However, Democrats were more focused on implementing the Federal Trade Commission’s (FTC) authority to address PBM concerns and punish bad actors, while Republicans were more supportive of improving transparency into the drug pricing supply chain before altering FTC authority.
House Energy and Commerce Committee Introduces Bipartisan Mental Health, SUD Package
On Friday, House Committee on Energy and Commerce Chair Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA) introduced the Restoring Hope for Mental Health and Well-Being Act of 2022 (text; section-by-section). The package is an amalgamation of previously introduced, bipartisan legislation — as well as other bipartisan policies — geared towards improving mental and behavioral health treatment, as well as providing substance use disorder (SUD) care, in the U.S. Many of the provisions included in the package would reauthorize Substance Abuse and Mental Health Services Administration (SAMHSA) and Health Resources and Services Administration (HRSA) programs.
Growing mental health concerns exacerbated by the COVID-19 pandemic have spurred bipartisan interest in addressing behavioral and mental health needs, as well as high rates of SUD. In addition to mounting concerns, several existing programs would expire at the end of FY 2022 without reauthorization. This legislative package addresses the impending implementation of the 9-8-8 hotline and other crisis-related supports, as well as efforts to aide in SUD treatment, prevention, and recovery. Another key aspect of the package focuses on expanding access to mental health care by improving workforce initiatives, among other avenues. Notably, the bill also includes provisions to address mental health concerns in children. The Energy and Commerce Subcommittee on Health plans to markup and vote on the legislation in the coming days.
House Energy & Commerce Committee Unveils User Fee Reauthorization Package
The House Committee on Energy and Commerce unveiled a long-anticipatedlegislative package (TRP summary; section-by-section) to reauthorize the Food and Drug Administration’s (FDA) user fee agreements (UFA). The Food and Drug Amendments Act of 2022 would update the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), Biosimilar User Fee Act (BsUFA III), and the Medical Device User Fee Amendments (MDUFA V) to continue authorization of these user fee programs. The bill outlines a sizable increase in estimated fees for fiscal year (FY) 2023 compared to the first year of the last UFA reauthorization in 2018.
In addition to the UFAs, the draft bill includes several provisions aimed at increasing diversity in clinical trials. These efforts are focused on requirements and incentives for applicants to focus their trials on diverse patient populations. The bill also contains provisions related to generic drugs in an effort to improve transparency and access to these medications. Research, development, and supply chain initiatives are also included in the bill and are intended to improve FDA inspections — especially in light of the COVID-19 pandemic — and prioritize innovative treatments and technologies. Lastly, the draft legislation focuses more generally on transparency and program integrity as these themes relate to regulatory improvements.
Senate Appropriations Subcommittee Reviews President’s FY 2023 Budget Request for HHS
On Wednesday, the Senate Appropriations subcommittee on Labor, Health and Human Services, Education, and Related Agencies held ahearing (TRP summary) featuring Department of Health and Human Services (HHS) Secretary Xavier Becerra to discuss President Biden’s fiscal year (FY) 2023 budget request (TRP analysis). In late March, the Biden administration released its FY 2023 request, which includes $127 billion in discretionary funding and $1.7 trillion in mandatory funding for HHS and its agencies — an overall increase in funding for the Department.
Throughout the hearing, members inquired about proposals related to expanding access to health care — particularly through the Affordable Care Act (ACA) — as well as funding for substance use disorder (SUD) and mental health prevention and treatment services. With regard to such services, Secretary Becerra asserted that HHS is planning to expand access to Certified Community Behavioral Health Clinics (CCBHC) and highlighted funding provisions within the President’s FY 2023 request aimed at implementing this expansion. Members additionally questioned the Secretary on HHS’ commitment to pandemic preparedness and response, during which bipartisan concern emerged over the dwindling Strategic National Stockpile (SNS).
Senate VA Committee Deliberates Ways to Improve Health Care Workforce
The Senate Veterans’ Affairs Committee held a hearing (TRP summary) to discuss ways to bolster the recruitment and retention of the Department of Veterans Affairs (VA) health care workforce. During the hearing, leaders from the VA answered members’ questions on efforts to address workforce shortages, fill vacancies, improve hiring and onboarding processes, and increase mental health resources. Lawmakers on both sides of the aisle expressed concerns that job vacancies within the VA would decrease the quality and quantity of care provided to veterans.
Notably, members and witnesses advocated for increased flexibility of telehealth capabilities to provide care and of technological advancements to streamline the hiring process. However, VA officials underscored the importance of continuing to provide ample care to veterans through in-person services. Additionally, Republican members raised concerns around the potential deployment of VA health care staff to the border after the expiration of Title 42, due to concerns that such an effort would negatively impact veteran care in the U.S.