Summary
The House is on recess this week, after Speaker Kevin McCarthy successfully passed The Limit, Save Grow Act, the House Republicans’ plan to raise the debt limit through May of 2024 while also cutting discretionary federal spending by approximately 22% down to FY 2022 levels (text/summary/section by section), rescinding unspent COVID-19 funds, and imposing controversial policies such as requiring Medicaid recipients to work 80 hours a month. Speaker McCarthy managed to pass the bill by a two-vote margin with 4 Republicans voting against it.
The Democratic controlled Senate has pronounced the bill “dead on arrival” and in a letter to Senate Democratic colleagues, Senate Majority Leader Chuck Schumer (D-NY) said the Senate will hold hearings on the bill “to expose the true impact of this reckless legislation on everyday Americans.” However, the power dynamic in the broader negotiations to raise the debt ceiling has been changed as the House Republican package is the only passed legislation that raises the debt ceiling, the Senate has yet to introduce a bill. For now, Senate Democrats the Administration are sticking with their insistence on a clean plan to raise the debt ceiling and avoid default, and any spending cuts be a separate discussion.
Markups:
On Tuesday, the Senate Health, Education, Labor and Pensions (HELP) Committee will have a markup to consider the following legislation aimed at pharmacy benefit managers (PBMs) and generic drugs:
- 1067, Ensuring Timely Access to Generics Act of 2023 – Introduced in the Senate by Sen. Jeanne Shaheen (D-NH) (press release) and cosponsored by Sens. Susan Collins (R-ME), Michael Bennett (D-CO), Marco Rubio (R-FL), Tammy Baldwin (D-WI), and Mike Braun (R-IN). This bipartisan bill would empower the FDA to deny citizen petitions submitted either to primarily delay competition or that do not raise valid scientific or regulatory issues, in order to increase competition in the marketplace and lower costsfor patients.
- 1114, Expanding Access to Low-Cost Generics Act of 2023 – Introduced by Sen. Tina Smith (D-MN) and Sen. Mike Braun (R-IN) (press release), the bill would seek to eliminate the practice of “parking” in which brand name manufacturers agree not to sue “first filers” of generics, so long as the generic applicant agrees to delay bringing the generic competitor to market. The bill allows companies that are not first filers the ability to receive 180-day market exclusivity for their generic if the first filer does not come to market in a timely fashion.
- 1214, RARE Act – Introduced in the Senate by Sen. Tammy Baldwin (D-WI) this bill aims to clarify that the exclusivity period of orphan drugs, which currently lasts for seven years, would prevent the approval of other drugs for the same approved use or indication, rather than for the same disease or condition. This refers to the use or indication licensed under section 351 of the Public HealthService Act for a drug designated under section 526 for a rare disease or condition. The bill would apply to any drug designated under section 526 in the Federal, Drug, and Cosmetic Act, regardless of the date on which the drug was designated, approved, or licensed.
- S____,Pharmacy Benefit Manager Reform Act – Introduced by Sens. Sanders and Cassidy, the bill establishes robust PBM reporting requirements, bans spread pricing, and requires 100 percent rebate pass through.
Hearings
Senate Finance Committee: On Wednesday, May 3, the Senate Finance Committee will hold a hearing titled “Barriers to Mental Health Care: Improving Provider Directory Accuracy to Reduce the Prevalence of Ghost Networks.” Witnesses include Keris Jän Myrick, Inseparable; Jack Resneck Jr., MD, American Medical Association; Robert L. Trestman, Ph.D., MD, Carilion Clinic and Virginia Tech Carilion School of Medicine; Mary Giliberti, Mental Health America, and Jeff Rideout, MD, Integrated Healthcare Association.
Senate Labor-HHS Appropriations: On Thursday, May 4, the Senate Labor-HHS Appropriations Subcommittee will hold a hearing on the FY 2024 NIH budget request. Acting NIH Director Lawrence Tabak will testify, along with Dr. Monica Bertagnolli, Director of the National Cancer Institute; Dr. Joshua Gordon, Director of the National Institutes of Mental Health; Dr. Richard Hodes, Director of the National Institute on Aging; and Dr. Nora Volkow, Director of the National Institute on Drug Abuse.
Senate HELP Committee: On Thursday, the Senate HELP Committee will hold a hearing to examine preparing for the next public health emergency, focusing on reauthorizing the Pandemic and All-Hazards Preparedness Act.
Regulatory Update
The Office of Management and Budget (OMB) has started to review calendar year 2024 Medicare payment policies. Specifically, OMB is reviewing proposed updates to the Physician Fee Schedule and payment and policy updates for hospital outpatient departments and ambulatory surgical centers, home health agencies, and end-stage renal disease facilities. OMB is also reviewing a proposed rule that would establish criteria for an alternative coverage pathways to provide transitional coverage for emerging technologies under Medicare.
Additionally, the Centers for Medicare and Medicaid Services is expected to issue a proposed rule that would roll back Trump-era policies that expanded the availability of short-term limited duration insurance (STLDI) plans. The 2018 final rule expanded the maximum duration