Health Law Advisor

On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments” (“CY25 PFS Proposed Rule”).

The CY25 PFS Proposed Rule came on the heels of another CMS rule, published on July 22, covering “Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems”—and more (“CY25 OPPS Proposed Rule”). Both rules have a comment period that closes on September 9.

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others—to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug Pricing Program (the “340B Program” or the “Program”). Specifically, industry stakeholders have until April 1^st to submit comments to legislators regarding the Discussion Draft Explanatory Statement and Supplemental RFI (the “RFI”) of the “Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now ...

From our Thought Leaders in Health Law video series: The Inflation Reduction Act (IRA) introduces significant changes in prescription drug pricing, including the establishment of the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program to control drug prices.

The IRA includes a redesign of the Medicare Part D benefit, which began with the announcement of 10 Medicare Part D drugs open for negotiation. This video highlights the challenges and complexities during the multi-year IRA implementation and emphasizes the penalties for ...

On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few days before the September 1, 2023, statutory deadline imposed by the Inflation Reduction Act (IRA). The negotiated pricing will go into effect in 2026.

In its announcement, CMS included details about upcoming opportunities for public input regarding the Program, including a series of patient-focused listening sessions CMS plans to hold for each ...

In this episode of the Diagnosing Health Care Podcast:  In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA).

How can stakeholders respond to, implement, and comply with all these new provisions? On this episode, hear from special guest Sylvia Yu, Vice President and Senior Counsel of Federal Programs at PhRMA.

Sylvia and Epstein Becker Green attorneys Connie Wilkinson and Alexis Boaz discuss the recent updates on the quickly moving implementation of the drug pricing provisions under the IRA and the industry’s response.

On May 11, the U.S.  Senate Committee on Health, Education, Labor and Pensions (the “HELP Committee” or the “Committee”) passed a bipartisan bill to expand federal regulation of pharmacy benefit managers (“PBMs”) for group health plans.[1]  As a compromise by Health Sub-Committee Chair Bernie Sanders (I-VT) and ranking Republican Bill Cassidy (LA), the Pharmacy Benefit Manager Act (S. 1339) reflects the overarching legislative push by members from both sides of the aisle and chambers of Congress to address drug pricing issues through federal fixes to the PBM framework . Further, Congress’ efforts build on the momentum from the enactment of the high-profile Medicare prescription drug pricing provisions of the Inflation Reduction Act (the “IRA”) in 2022. [2]

In this episode of the Diagnosing Health Care Podcast:  The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions.

What key compliance issues must industry stakeholders consider as these provisions are put into effect?

On this episode, Epstein Becker Green attorneys Leslie Norwalk, Connie Wilkinson, and Alexis Boaz discuss key considerations for the health care and life sciences industry as the Centers for Medicare & Medicaid Services works its way through the initial stages of ...

On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of elements in the drug price negotiation process, including the manufacturer specific data elements that it will review in potential adjusting its view of the appropriate price. 

While other data elements also deserve manufacturers’ attention, CMS’s approach to accounting for manufacturer costs associated with research, development and manufacturing will have profound implications for biopharmaceutical manufacturers. The agency’s proposed factors omit substantial investments while improperly treating others as sunk costs. As innovators prepare to comment on CMS’s guidance, they will want to convey the need for more fulsome consideration of these investments in the upcoming negotiations.