Expected Health Policy Movements in Lame Duck Session

Congress returned to Washington this week with just five weeks left in this year’s legislative calendar. The continuing resolution (CR) deadline is December 20, 2024, and the government must pass either a year-end spending package or a new continuing resolution to continue funding the government. This package may include some medical insurance, including insurance that expires at the end of the year. Essential items are on the agenda, including extending Medicare’s COVID-era telemedicine flexibility and policy changes with broad bipartisan and bicameral support, such as pharmacy benefit manager (PBM) reform and BIOSECURE. It is.

required path

Expanding Telemedicine: Medicare Flexibility

problem

Medicare telehealth flexibilities introduced during the COVID-19 pandemic will expire at the end of this year following a two-year extension in the Consolidated Appropriations Act of 2023. Before the pandemic, telehealth coverage was available only in rural areas with restrictions. These flexibilities include suspending mandatory in-person visits within six months of a prior telehealth appointment for mental health services. Exemption from Geographic Site Restrictions. This will greatly benefit patients in rural and urban areas. Make telehealth services available to all Medicare beneficiaries. Authority to provide audio-only services.

Possible amendment by Congress

Several bills have been introduced and passed through jurisdictional committees to extend these flexibilities. The following may be included in year-end packages:

• HR 7623The Telehealth Modernization Act of 2024, introduced by Rep. Buddy Carter (R-GA-01) and several bipartisan members last March, was introduced in the House Energy and Commerce (E&C) Committee in August. It was passed unanimously. Initially, the bill included a permanent extension of the flexibility, but the PBM reform was amended to a paid two-year extension.
• S. 3967, The Telehealth Modernization Act, introduced by Sen. Tim Scott (R-S.C.) and eight other bipartisan senators, was referred to Senate Finance in March. Like the original bill, this bill seeks to make Medicare telehealth flexibility permanent, but no additional steps have been taken yet.
• HR8261The Maintaining Access to Telemedicine, Hospitals, and Ambulances Act, introduced by Rep. David Schweikert (R-AZ-01) and Rep. Mike Thompson (D-CA-04), would, among other things, It extends the flexibility until December 2026. The bill died in the House Ways and Means Committee in May.

Short-term extensions of these flexibilities, or even making them permanent, have strong bipartisan support in both chambers and are likely to be addressed before they expire.

Pediatric rare disease treatment drug extension coupon

problem

The Rare Pediatric Disease Priority Review Voucher (RPD PRV) is scheduled to expire at the end of the year without further extension or reauthorization (already temporarily extended in the September 30 CR). This 12-year-old program provides incentives for companies to develop treatments for rare pediatric diseases by providing vouchers for expedited review by the U.S. Food and Drug Administration (FDA). The program was created to encourage the development of treatments for rare pediatric diseases, where the number of patients is typically too low to attract investment. These vouchers can be used by the recipient or sold to another company for use and are extremely popular, with fewer than 100 having been awarded to date.

Possible amendment by Congress

HR 7384/S.4583The Hope Reauthorization Act of 2024 is a bipartisan bill introduced in both chambers of Congress in early 2024 that would extend the voucher program through fiscal year 2029. HR 7384, introduced by Rep. Michael McCaul (R-Texas, 10th District) and five additional bipartisan co-sponsors, and Sen. Bob Casey (D-Pa.) and three additional bipartisan co-sponsors. S. 4583, introduced by partisan co-sponsors, was referred to E&C and the Senate. Health, Education, Labor and Pensions (HELP), but no further progress was made on either. There has been little movement on the reauthorization bill, so additional extensions will likely be needed to avoid expiration.

Other expiry provisions

• medicare
  1. extender
     1. Medicare small payment adjustment
     2. Medicare dependent hospital program
     3. Reducing Payment Delays for Medicaid Disproportionate Hospitals (DSH)
  2. Medicare Pay as You Go (PAYGO) Cut
  3. Funding support for low-income programs
• Community Health Center Fund
• Reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA)
• National Health Service Corps
• Advanced Alternative Payment Models Bonus Payments
• Dr. Lorna Breen Healthcare Providers Foundation

May pass

PBM reform

problem

Issues with strong bipartisan, bicameral consensus and reforms to PBM practices are at the top of the “may pass” list. In July 2024, the House Oversight Committee released the following report: report It details how the largest PBMs control more than 80% of the market and are vertically integrated with health insurance companies, pharmacies, and healthcare providers. As a result, patients have fewer options, the quality of care has declined, and costs have significantly increased, the report said. Lawmakers call for more transparency in the process, eliminate vertical integration to increase competition, and target spread pricing and drug incentives that result in higher rebates, ultimately lowering prescription drug costs for patients. I’m asking you to do something.

Possible amendment by Congress

Major committees including E&C, House Ways and Means Committee, House Oversight Committee, House Judiciary Committee, Senate Assistance Committee, Senate Finance Committee, and Senate Judiciary Committee have all held hearings on PBM reform, and several The bill passed the markup, and two bills passed the House. so far. The bills most likely to be included in the year-end package include:

• HR5378The Lower Costs, More Transparency Act passed the House of Representatives in December 2023 with strong bipartisan support. The bill, introduced by E&C Chair Kathy McMorris Rogers, would, among other things:
  • Requires PBMs to submit biannual reports to health plan sponsors on expenditures, rebates, and fees related to covered drugs. Request that your PBM allow you to audit certain billing and cost information.
  • Prohibits spread pricing and requires pass-through pricing models in payment arrangements with PBMs under Medicaid.
• HR4758The Accelerating Access to Care for Children Act was introduced in July 2023 by Representative Lori Trahan (D-MA-03) and Representative Mariannette Miller-Meeks (R-IA-01). It passed the House of Representatives by voice vote. Sent to Senate Finance for consideration in September 2024. Among other provisions, the bill requires pass-through pricing models and prohibits spread pricing for payment arrangements with PBMs under Medicaid.
• S.2973The PBM Accountability Modernization and Ensuring Act, introduced by Senate Finance Chairman Ron Wyden and Senior Representative Mike Crapo in September 2023 and defeated in committee three months later in December, Prohibiting the tying of PBM fees to drug prices in the United States and, among other things, independent auditing and enforcement actions to increase PBM transparency. Senator Wyden is one of many members of Congress who have indicated they intend to focus on PBM reform for the remaining 118 Congresses.^th meeting.
• HR5385/S.2254the “Medicare PBM Accountability Act” was introduced in the House of Representatives by Representative Greg Landsman (D-OH-01) in September 2023 and by Senator Catherine Cortez Masto (D-NV) in July 2023. was introduced in the Senate and would establish more rigorous reporting. Requirements for PBMs under the Medicare Advantage and Medicare Prescription Drug Benefit Programs. The bill gained traction in the House, passing E&C on a 44-0 vote.
• S.1339The Pharmacy Benefit Manager Reform Act, introduced by HELP Chair Bernie Sanders and three additional bipartisan senators in April 2023, passed out of committee in June 2023. This bill would impose stricter requirements on PBMs regarding services provided to health insurance plans. This law is as follows:
  • No spread pricing. Requires PBMs to report information about their services to insurance plan sponsors and to submit biannual reports to sponsors with information about PBM-owned pharmacies.
  • Require PBMs to remit to sponsors all rebates, fees, alternative discounts, and anything else they receive from drug companies.

biosecure law

HR8333Introduced in May 2024 by Rep. Brad Wenstrup (R-OH-02) and Rep. Raja Krishnamoorthi (D-IL-08), the Biosecure Act would require a Procuring or obtaining biotechnology equipment or services that A biotechnology company that is attracting attention. The bill passed the House on a bipartisan vote of 306-81 and was accepted for consideration in the Senate in early September. With strong support from both houses of Congress, it is likely to be passed by the end of the year. BIOSECURE could have a lasting impact on pharmaceutical and biotech companies and could result in retaliation from the Chinese government. For more information about BIOSECURE, see Foley’s detailed article, “The BIOSECURE Act: Expected Developments, Key Provisions, and Expected Impact.”

Medicare Physician Payment Modification

problem

Since the release of the 2025 Medicare Physician Fee Schedule (Compensation Schedule) regulations last July, which included a provision proposing a 2.8% reduction in Medicare physician pay, stakeholders and lawmakers alike have been calling for a five-year Medicare He opposes the plan to reduce doctors’ fees. Conversion factor. almost 7,000 comments Many major provider groups, including the American Medical Association and the American Hospital Association, criticized the Centers for Medicare and Medicaid Services (CMS) for not adjusting payments based on inflation. In early October, a bipartisan House majority of 233 members signed a letter to House leadership calling for a provision in the year-end spending package to protect doctors from these pay cuts.

Possible amendment by Congress

In late October, HR 10073 It was proposed by a bipartisan group of lawmakers. The bill would increase physician payments by 4.73% in 2025 to offset Medicare’s 2.8% reduction in the Medicare Physician Fee Schedule final rule. Sponsors include Rep. Greg Murphy (R-NC), Rep. Mariannette Miller-Meeks (R-IA), Rep. Larry Buchshon (R-IN), and Rep. John Joyce (R-IN). -Pennsylvania), Reps. Jimmy Panetta (D-Calif.), Ami Vera (D-Calif.), Raul Ruiz (D-Calif.), and Kim Schrier (D-Wash.) state). Congress could include some of this increase in its year-end spending plan.

Even before this proposed rule was introduced, jurisdictional committees, including the House Energy and Commerce Committee, the House Ways and Means Committee, and the Senate Finance Committee, along with the House Committee on Documents, had been working on Medicare physician compensation reform this session. We have been focusing on this. The laws introduced include:

• S.4935“Physician Remuneration Stabilization Act” introduced Introduced in August by Sen. John Boozman (R-Ark.) and Sen. Peter Welch (D-Vermont, original co-sponsor), consulted by the Senate Finance Committee, and last updated in 1992. The budget neutrality criteria based on the revised fee schedule will be updated. Increases every five years to $53 million.
• HR6545The Physician Compensation Schedule Update and Improvement Act, introduced in December 2023 by Rep. Mariannette Miller-Meeks (R-IA-01) and a bipartisan list of legislators, would also increase budget neutrality from $20 million to $20 million. The amount is expected to increase to $53 million. The bill passed the E&C on a 64-0 vote.
• HR 2474the “Strengthening Medicare for Patients and Providers Act,” co-sponsored by Rep. Larry Buchshon (R-IN-08), Rep. Amy Vera (D-CA-06), and Mariannette Miller-Meeks (R-IN-06). -IA-01) plans to change payment rates by providing annual updates related to inflation. Medicare Economic Index (MEI). The bill was referred to E&C and attracted 170 co-sponsors.

In March of this year, Congress was able to partially repeal the proposed 3.37% physician fee reduction in the 2024 fee schedule by passing the 2024 Consolidated Appropriations Act. However, this is a temporary fix and will last until the end of 2024. There is strong bipartisan support for permanent reform and could see movement in the next Congress.