Capitol Hill Update
Both chambers of Congress will be in session this week for a busy legislative work period, headlined by the release of President Joe Biden’s fiscal year (FY) 2023 budget request. The President’s request is expected to be formally unveiled later today, with Office of Management and Budget (OMB) Director Shalanda Young set to testify before the House and Senate Budget Committees to field inquiries from lawmakers on the request. Congressional appropriators are expected to ramp up their appropriations activities in the coming weeks once the budget is released, starting with a House Appropriations Committee hearing on Thursday featuring Secretary Xavier Becerra to review the Department of Health and Human Service’s (HHS) FY 2023 budget request.
On the floor this week, House lawmakers are slated to take up a bipartisan bill out of the Ways and Means Committee that would implement a number of provisions aimed at bolstering access to retirement savings. The Securing a Strong Retirement Act (H.R. 2954) is expected to pass with strong support on both sides of the aisle, but timing for Senate consideration is unclear as of now. Additionally, Members will consider legislation out of the Judiciary Committee that would decriminalize cannabis at the federal level. However, the Marijuana Opportunity Reinvestment and Expungement (MORE) Act (H.R. 3617) is not likely to advance in the 50-50 Senate due to GOP opposition.
Meanwhile, the Senate is slated to vote on final passage of the America Creating Opportunities for Manufacturing Pre-Eminence in Technology and Economic Strength (America COMPETES) Act (H.R. 4521). Once the America COMPETES Act is sent back to the House, lawmakers in both chambers will have the opportunity to go to conference in an effort to produce a final compromise version of the technology research and innovation package. The Senate is also expected to resume consideration of President Biden’s pending nominees, starting with Nani Coloretti to be Deputy OMB Director.
Democrats Look to Push Forward on Insulin Reform
As Democrats’ hopes for large-scale drug pricing reform falter, lawmakers are honing their sights on changes to insulin pricing policy. On Tuesday, Senate Majority Leader Chuck Schumer said that he plans to bring a bill to the floor after Easter that would address the cost of insulin. He confirmed that the legislation would cap out-of-pocket (OOP) costs at $35 per month.
Additionally, Leader Schumer said that he would combine the insulin cap outlined in the Affordable Insulin Now Act (S.3700; H.R.6833) with a forthcoming bill from Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME). While details of the latter bill are still being hammered out, reports suggest that it will focus on policies to compel pharmacy benefit managers (PBM) to bring down the list price of insulin. An eventual combination of these bills will likely invite criticism from Republicans and manufacturer stakeholders, as well as from Democrats who are concerned that an insulin bill will negate momentum for a larger drug pricing package.
FDA to Study DTC Disclosures
On Thursday, the Food and Drug Administration (FDA)confirmed that it will test the impact of accelerated approval pathway disclosures on direct-to-consumer (DTC) websites to consumer understanding of a product’s regulatory context. The FDA’s interest in the connection between accelerated approval disclosures and consumer understanding comes as the accelerated approval pathway is under scrutiny. Manufacturers with drugs approved under the pathway are required to include a label that notes the drug may be less effective due to the approval process. Some drugmakers also disclose this fact on their DTC website for an applicable drug.
Preliminary results from a 2019 FDA study indicated that consumer-friendly disclosures are useful in helping patients understand the context around the disclosures, though study participants generally had low levels of understanding around the accelerated approval pathway. FDA plans to expand this research by conducting two additional studies. However, the Pharmaceutical Research and Manufacturers of America (PhRMA) expressed concern that FDA’s new research initiative will be redundant of the agency’s 2019 study. The group is also worried that a possible mandate on accelerated approval pathways DTC disclosure would contradict the intent of the accelerated pathway by limiting patients’ access to these treatments. Instead, PhRMA asserted that it would be more efficacious for FDA to look at the patient-provider relationship to discuss a drug’s regulatory pathway.
Program to Cover Uninsured COVID-19 Needs Ends
The COVID-19 relief program intended to reimburse providers caring for the uninsured is no longer accepting claims for COVID-19 related testing and treatments and it will no longer process vaccination claims after April 5. Hospitals are growing increasingly concerned as additional COVID-19 funding hangs in the balance of lawmakers’ debates regarding additional pandemic funding. Covering care for uninsured patients stems from the COVID-19 Claims Reimbursement program and is funded through the Provider Relief Fund (PRF). The program reimburses testing, treatment, and vaccination, as well as some durable medical equipment (DME) costs such as oxygen and ventilators. Leadership from the Federation of American Hospitals and America’s Essential Hospitals are focusing their efforts on encouraging House and Senate leadership to replenish the Claims Reimbursement program, while the American Hospital Association is concentrating its Congressional efforts on replenishing the PRF.
Senator Romney Works to Get GOP on Board with Pandemic Relief
Earlier this month, Congress signed a $1.5 trillion government funding bill that excluded over $15 billion in COVID-19 relief being sought by Democrats. Now, lawmakers are going back to the drawing board on pandemic-related policies.
On Thursday, Sen. Mitt Romney (R-UT) confirmed that he is working with his party on crafting a counter proposal to Democrats’ COVID-19 funding wish list. The negotiations are focused on ways to pay the bill’s price tag, though it is unclear what those offsets may contain. Senate Majority Leader Chuck Schumer (D-NY) confirmed that leadership is involved in the talks.
Senate HELP Examines Mental Health, SUD Programs
Last week, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing (TRP summary) to address opportunities for, challenges to, and emerging issues with federal mental health and substance use disorder (SUD) programs. Throughout the hearing, members inquired about ways to increase access to mental and behavioral health support, reduce and prevent SUD and overdose deaths, and strengthen the behavioral health care workforce. Members on both sides of the aisle supported revamping these programs to improve patients’ lives, especially after, and during, the COVID-19 pandemic. Some Republican members focused on increasing data collection efforts and performance measures to evaluate adequate funding appropriations.
Leaders from the Substance Abuse and Mental Health Services Administration (SAMHSA), Health Resources and Services Administration (HRSA), National Institute of Mental Health (NIMH), and National Institute on Drug Abuse (NIDA) joined the Committee to discuss the ways in which the agencies were supporting the Biden administration’s mental health strategy. The witnesses spoke about current programs and research efforts that were aimed at meeting the needs of those, with mental health issues and SUDs, especially the youth population. Notably, the agency leaders supported increasing awareness around mental health issues, integrating behavioral health services into primary care, using medication-assisted treatment (MAT) for those with SUDs, disseminating naloxone more widely, and improving the mental health workforce.
Senate Aging Committee Discusses HCBS Funding, Workforce
On Wednesday, the Senate Committee on Aging held ahearing (TRP summary) to discuss the role of home- and community-based services (HCBS) for older individuals and people with disabilities. During the hearing, members generally supported the notion that increased funding for HCBS would lead to better health outcomes for beneficiaries. Specifically, members suggested that additional funding would provide for enhanced access to services for those who qualify by: (1) reducing the number of individuals on the “waitlist” for home care; and (2) increasing the number of caregivers by providing higher wages and benefits.
Additionally, members called for additional funding to be allocated towards continuing education for the HCBS workforce, highlighting the need to establish workforce compensation rates that allow states to obtain and retain properly trained caregivers. Witnesses echoed many of the comments made by members, advocating for added federal funding to ensure that populations in need of HCBS are able to access these services effectively and efficiently.