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.
