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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more
The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more
On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more
On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more
The Centers for Medicare & Medicaid Services (“CMS”) released the Calendar Year 2026 Medicare Physician Fee Schedule (“PFS”) proposed rule on July 16, 2025. (See...more
The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more
Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more
After significant fanfare and anticipation, President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week. The Executive Order seeks to...more
On April 15, 2025, President Trump signed an executive order (EO) aimed at addressing the cost of prescription drugs. This EO, titled “Lowering Drug Prices by Once Again Putting Americans First,” outlines specific directives...more
On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more
The Latham drug pricing and market access team invites you to read this digest of recent developments on healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more
Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more
On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more
On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more
The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more
While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more
This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced...more