The United States House of Representatives Energy and Commerce Committee Subcommittee on Health recently held a hearing, “Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology.” During the hearing, numerous pieces of legislation were discussed that are currently pending in Congress, all with the aim of improving access to medical care for seniors.
During the hearing, Energy & Commerce Committee Chairwoman Cathy McMorris Rodgers issued opening remarks, where she referenced “bureaucratic red tape and a Medicare program that is struggling to keep up with innovation” and that of the legislation that was discussed during the hearing, sixteen bills were bipartisan or led by her Democrat colleagues.
Health Subcommittee Chair Brett Guthrie also offered opening remarks, where he emphasized his desire to “examine specific solutions, which seek to turn the principles and ideas from members, previous expert witnesses, and wide-ranging stakeholder input, into legislation to support millions of seniors across the country.” Guthrie not only spoke in support of several of the policies before the Committee (including H.R. 2407 and H.R. 1691), but also referenced a Government Accountability Office report that found “for 79 of Medicare Part D’s top 100 highly-rebated drugs, seniors or others on seniors’ behalf, spent $21 billion on their drugs versus the $5 billion the plan sponsors spent on these drugs after accounting for drug rebates. Seniors and taxpayers shouldn’t be paying more for a drug than the actual value of the drug.”
Witness Testimony
Dora Hughes, MD, MPH, Acting Director, Center for Clinical Standards and Quality, Acting Chief Medical Officer, U.S. Centers for Medicare and Medicaid Services, testified during the hearing, reiterating the agency’s commitment to “fostering innovation while ensuring that Medicare has fast and consistent coverage processes for emerging treatments and technologies that will improve health outcomes.” Hughes also discussed the agency’s efforts to “ensure that Medicare beneficiaries have timely coverage of innovative treatments and medical technologies that treat life-threatening or irreversibly debilitating diseases and improve patients’ quality of life.”
Mr. John Dicken, Director, Health Care—Public Health and Private Markets, U.S. Government Accountability Office, testified to the role Medicare coverage plays in providing access to new and innovative drugs, medical devices, and technology, particularly the impact Medicare coverage of prescription drugs has on the program’s financial stability and sustainability. In his testimony, he covered five main points: (1) rebate and expenditure information for Part D drugs; (2) rebate arrangements that are negotiated between pharmaceutical manufacturers and Part D plan sponsors; (3) the relationship between rebates and Part D formulary placement; (4) the implications of rebates on various parties to the system; and (5) the way CMS does not consider rebate data as part of its Part D plan formulary oversight mechanisms.
Legislation Discussed
Below are some of the pieces of legislation discussed during the hearing.
- H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (Reps. Wenstrup, Bilirakis, Cardenas, Guthrie, Eshoo). This bipartisan legislation would ensure that FDA-designated breakthrough products are covered by Medicare for four years, during which time CMS would need to make a permanent coverage determination. This legislation would also provide temporary coverage for certain breakthrough devices that did not exist – or were not considered – when Medicare was first introduced, such as digital therapeutics.
- H.R. 2408, the Access to Innovative Treatments Act of 2023 (Reps. Barragan and Joyce). This bipartisan legislation would create a review process within CMS that would allow the agency to consider each drug and its effectiveness individually to determine whether it should be covered by Medicare, as opposed to applying a broad or outdated coverage decision to an entire class of drugs.
- H.R. 133, the Mandating Exclusive Review of Individual Treatments (MERIT) Act (Reps. Buchanan and Barragan). Similar to H.R. 2408, under this bipartisan proposal, CMS would be required to evaluate treatments and cures individually and based on their own merits, not as a broad class of drugs.
- H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (Reps. Arrington, Hudson, and Ruiz). This bipartisan legislation is named for Representative Sewell’s mother and would create a pathway for Medicare to cover emerging blood-based cancer screenings, which would help to potentially catch cancer earlier.
- H.R. 1199, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 (Reps. Dunn, Peters, Trahan, Blunt Rochester, Miller-Meeks, Tonko, Joyce, Kuster, and Bucshon). Under the FIND Act, Medicare beneficiaries’ access to advanced diagnostic imaging procedures that identify dangerous conditions would be protected. This includes heart disease, neurological disorders, and early-stage cancers. The legislation directs the Department of Health and Human Services (HHS) to pay separately for all diagnostic radiopharmaceuticals with a cost threshold of $500 per day or more.
- H.R. 1458, the Access to Prescription Digital Therapeutics Act of 2023 (Reps. Hern, Johnson, and Matsui). Under this bipartisan bill (and its companion bill in the Senate), would add prescription digital therapeutics (PDTs) to the list of services and products that are eligible for coverage under Medicare and Medicaid. It would also direct CMS to establish payment methodologies and product-specific Healthcare Common Procedure Coding System (HCPCS) codes.
- H.R. 2880, the Protecting Patients Against PBM Abuses Act (Reps. Carter and Blunt Rochester). This bipartisan legislation seeks to de-couple PBM compensation from the cost of medications, ban patient steering and spread pricing, increase transparency, and address conflicts of interest.
- H.R. 5376, the Share the Savings with Seniors Act (Reps. Miller-Meeks and Peters). Under this bipartisan legislation, and its companion Senate bill (S.2474) would allow senior patients with chronic medical conditions to directly benefit from the savings that plans and PBMs negotiate on their behalf.
For a complete list of the legislation discussed during the hearing, and for a recording of the hearing, see the Energy and Commerce Committee page here.