This Week in Washington: HHS Withdraws SUNSET Final Rule



The House and Senate are in recess for Memorial Day.


Rep. Underwood Leads 26 Democratic House Members in Letter Calling for Measures to Lower Healthcare Costs to be Included in Reconciliation Package

On May 23, Rep. Lauren Underwood (D-IL) led a group of 26 Democratic House members in a letter to Speaker Nancy Pelosi (D-CA) and Chuck Schumer (D-NY). In the letter, Rep. Underwood called on House leadership to include measures to lower healthcare costs and expand Medicaid coverage in the upcoming reconciliation legislation. The letter also expressed support for a permanent expansion of the enhanced advance premium tax credits.


Senate Finance Committee Releases Tele-Mental Health Discussion Draft

On May 26, Senators Ron Wyden (D-OR), Mike Crapo (R-ID), Ben Cardin (D-MD) and John Thune (R-SD) released a discussion draft for one of the committee’s mental health initiatives, tele-mental health. This is the first portion of the committee’s work on mental health to be released since the committee began working on mental health policies in February.

The discussion draft includes policies that would:

  • Remove Medicare’s in-person visit requirement for tele-mental health services.
  • Establish benefit transparency for mental health care services delivered via telehealth to inform Americans with Medicare how and when they can access telehealth.
  • Preserve access to audio-only mental health coverage in Medicare when necessary and appropriate.
  • Direct Medicare and Medicaid to promote and support provider use of telehealth.
  • Incentivize states to use their CHIP programs to establish local solutions to serve behavioral health needs in schools, including through telehealth.

Sens. Kaine, Collins, Hassan and Portman Introduce Bill to Increase Interchangeable Biosimilar Competition

On May 25, Sens. Tim Kaine (D-VT), Susan Collins (R-ME), Maggie Hassan (D-NH) and Rob Portman (R-OH) introduced the Interchangeable Biologics Clarity Act. The bill would allow multiple interchangeable biosimilars to share exclusivity if they are approved on the same day. In addition, the bill clarifies that the Food and Drug Administration (FDA) can tentatively approve interchangeable biosimilars while an earlier interchangeable products exclusivity is still pending. The goal of these changes is to speed the rate that interchangeable biosimilars are brought to market.

Sens. Cantwell and Grassley Introduce Bill to Increase Drug Pricing Transparency and Increase Scrutiny of PBMs

On May 24, Sens. Maria Cantwell (D-WA) and Chuck Grassley (R-IA) introduced the Pharmacy Benefit Manager Transparency Act of 2022. The bill would ban pharmacy benefit managers (PBMs) from receiving money back that they have paid to pharmacies for dispensing drugs, unless the concessions are disclosed to health plans and payers and the PBMs share relevant price, reimbursement and rebate information. In addition, the bill would provide the Federal Trade Commission (FTC) with increased authority to improve drug pricing transparency.

FDA User Fee Bill Introduced in the Senate

The Senate Health, Education, Labor and Pensions (HELP) Committee Chair Senator Patty Murray (D-WA) and Ranking Member Senator Richard Burr (R-NC) introduced the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act which would reauthorize the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee agreements. The legislation also includes provisions to strengthen oversight of cosmetics and dietary supplements, modernize the regulation of diagnostic tests, bring more competition to the market, and prepare the FDA for the next generation of medical products.

The Senate FDA user fee bill includes accelerated approval reforms that mirror the House user fee bill with the addition of a new measure to create an “intra-agency coordinating council” to ensure uniform usage of accelerated approvals. This council would periodically review accelerated approvals and issue guidance to ensure that they are applied in a consistent manner.

Legislation Introduced to Study Impact of Non-Profit Drug Manufacturers

On May 27, Sens. Jacky Rosen (D-NV) and Mitt Romney (R-UT) introduced The Advancing Affordable Medicines for Families Act, which would direct the Government Accountability Office (GAO) to study the impact of nonprofit generic drug makers on the drug industry and the barriers to their prominence. The bill would require the GAO to report to Congress on the impact of nonprofit drug makers on drug affordability, drug shortages and patient and federal drug spending. The GAO also would investigate ways nonprofit drug makers could speed development of generics, biosimilars and new biologic drugs and to identify barriers to capital.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.