Inflation Reduction Act (IRA) Implementation

Topic(s):

Legislation & Regulation

Signed into law in 2022, the Inflation Reduction Act (IRA) ushered in Medicare prescription drug pricing reforms and imposed caps on out-of-pocket expenses for Part D beneficiaries. While much discussion and analysis has focused on how the IRA will impact Medicare beneficiaries, Part D plans, and government spending, the impact of the legislation will extend to stakeholders across the U.S. health care industry.

Many questions remain about the implementation of this law, which will be done through agency guidance, program instruction, agreements between CMS and drug manufacturers, and notice-and-comment rulemaking.

IRA Implementation milestones:

2025
- January 29, 2025: CMS issued the first press release of the second Trump Administration indicating that CMS intends to continue the IRA’s Medicare Drug Price Negotiation Program to lower prescription drug costs for Americans.
- June 1, 2025: Deadline for CMS to issue initial written offers for the first round of drug negotiations
2026: The first round of price negotiations will occur, with 10 Part D drugs selected for the initial negotiation cycle.
2027: Negotiated prices for the first 10 Part D drugs will take effect.
2028: Negotiations will expand to include both Part D and Part B drugs, with 15 additional drugs selected for negotiation.

Stakeholders continue to navigate the interplay between patient access, formularies, and manufacturer considerations. These changes impact the liability of beneficiaries, manufacturers, and plans—adding a new dynamic to the already-complex interaction between these groups.

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Priority Issue January 19, 2025

Prescription Digital Therapeutics (PDTs Act)

Prescription digital therapeutics (PDTs) are software-based therapies shown to benefit those with mental health conditions like depression. However, many PDTs do not currently fit into one of the statutorily defined coverage categories for the Medicare or Medicaid programs, leaving beneficiaries of those programs—which include some of America’s most vulnerable populations—without access to these effective and accessible treatments. AMCP supports the Access to Prescription Digital Therapeutics Act, an important bipartisan bill that would help remedy this disparity by creating a comprehensive benefit category and expanding Medicare coverage to include PDTs.

Prescription Digital Therapeutics, Legislation & Regulation

Priority Issue January 19, 2025

Medicaid VBPs for Patients Act (MVP Act)

Value-based payments (VBP) systems incentivize providers to improve patient outcomes, reduce costs, and improve the overall patient experience, making them a critical tool for promoting high-quality, affordable care. However, defining and measuring the value of a drug can be complex, especially when considering factors like clinical outcomes, patient characteristics, and population health. AMCP supports the Medicaid VBPs for Patients (MVP) Act to modernize the framework for value-based purchasing arrangements in Medicaid, ensuring that the proper channels exist to connect Medicaid patients with the therapies they need.

Legislation & Regulation, Medicaid Managed Care

Priority Issue January 14, 2025

Equitable Community Access to Pharmacist Services (ECAPS) Act

The Ensuring Community Access to Pharmacist Services (ECAPS) Act of 2025 (H.R. 3164) is an important bipartisan bill that will extend certain COVID-era provisions such as such as testing, vaccination, and common disease treatments that have been a critical lifeline for millions of patients. AMCP urges lawmakers to pass the ECAPS Act to help ensure patients across the country maintain reliable access to testing and treatment for COVID-19, respiratory syncytial virus (RSV), the flu, and potential future threats to public health.

Legislation & Regulation