Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
The Centers for Medicare & Medicaid Services (CMS) updated its guidance on the Inflation Reduction Act of 2022’s (P.L. 117-169) (IRA) Medicare Prescription Payment Plan (M3P) with its release of the Final Part Two Guidance on...more
On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more
Before the Thanksgiving holiday, the Centers for Medicare & Medicaid Services (CMS) issued two proposed regs that would make changes to certain health insurance plan policies starting in 2025: one impacting Medicare Advantage...more
The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more
States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...more
The Inflation Reduction Act (IRA) will make arguably the most significant changes to U.S. prescription drug pricing regulations ever, but certainly since the creation of the Medicaid Drug Rebate Program in 1990. For the first...more
Impact on Pharmacies, Part D Payors, Pharmacy Benefit Managers, and Drug Manufacturers - On April 29, 2022, the Centers for Medicare and Medicaid Services (CMS) issued its final rule, Medicare Advantage and Part D Final...more
On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a copay subsidy program to help certain financially eligible Medicare...more
Although delayed as a result of the COVID-19 public health emergency, there are persistent and ongoing efforts to reform the Medicare Part D benefit. Since its June 2016 Report to Congress, the Medicare Payment Advisory...more
Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription...more
The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. ...more
On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more
On November 26, 2018 the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. This proposed rule is the...more
On November 30, 2018, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (“Proposed Rule”) to revise certain existing Medicare Advantage (“MA”) program and Prescription Drug Benefit Program (“Part...more
On November 26, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses” (“Proposed Rule”)....more
The Centers for Medicare and Medicaid Services (“CMS”) released the much-anticipated proposed rule to lower Part D and Medicare Advantage (“MA”) drug prices and beneficiary out-of-pocket expenses on November 26, 2018 (the...more
The Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule to amend Medicare Advantage (MA) regulations and Prescription Drug Benefit program (Part D) regulations. The Proposed Rule will be published on...more
Two pieces of related legislation that would prohibit so called “gag clauses” in contracts between pharmacists and health plans and pharmacy benefit managers (PBM’s) have been passed by both the Senate and the House....more
Throughout his presidential campaign, President Trump championed the need to allow the government to negotiate drug prices on behalf of the Medicare program. However, that third rail for pharmaceutical companies was not...more
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more
• "American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs" outlines actions that the Administration proposes to lower prescription drug prices. • The plan includes...more
On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more