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]

Continue Reading More Federal Action in the Pharmaceutical Sector as PBM Bill Advances in the Senate

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

The Centers for Medicare & Medicaid Services (“CMS”) is using its annual rulemaking process to update the CMS payment system rules for fiscal year (“FY”) 2024 as a mechanism to advance health equity systematically across various CMS payment programs. Specifically, CMS is incorporating proposals to advance health equity in its proposed payment rules for inpatient hospitals and long-term care hospitals, skilled nursing facilities, inpatient psychiatric facilities, and hospices, and in the final rate announcement for the Medicare Part C and Part D programs for FY 2024. Significantly, in several instances, CMS is requesting comments, which opens the door for providers to share their input about relevant considerations. This CMS initiative is consistent with key components that were detailed in CMS’s “Framework for Health Equity,” the agency’s 10-year plan to “remedy systemic barriers to equity so that every one [CMS] serve[s] has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.”[1] This post outlines the changes being proposed by CMS, as well as highlights opportunities where providers should consider preparing and submitting comments.

Continue Reading CMS Forwards Its Health Equity Agenda Through Its Annual Prospective Payment System Rulemaking Process

On February 9, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued a fact sheet and its initial guidance documents addressing the Medicare Prescription Drug Inflation Rebate Program for Medicare Parts B and D (the “Inflation Rebates”)—a critical component of the sweeping prescription drug pricing changes enacted through the Inflation Reduction Act of 2022 (the “IRA”). In addition to providing substantial detail regarding CMS’s intended implementation of the Inflation Rebates, the initial program guidance documents (the “Initial Inflation Rebate Guidances” highlight areas where CMS seeks specific feedback. This feedback must be submitted to CMS by March 11, 2023 via email (IRARebateandNegotiation@cms.hhs.gov).

Continue Reading Comments to CMS Guidance on the Medicare Prescription Drug Inflation Rebate Program Due March 11, 2023

In this episode of the Diagnosing Health Care Podcast:   With the recent midterm elections changing the composition of Congress, and the Biden administration’s first opportunities to advance its policy priorities from the very beginning of the rulemaking process, what are the key health care developments to watch out for in 2023?

Epstein Becker Green attorneys Ted Kennedy, Jr.; Alexis Boaz; and Philo Hall discuss the current landscape of health care policy from both the legislative and regulatory perspectives and analyze which key health care issues may arise.

Continue Reading Podcast: 2023 Health Policy Outlook – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  The No Surprises Act (NSA) will go into effect on January 1, 2022. Since our last episode on the topic, the federal government has issued additional interim final rules and guidance to implement the NSA, including the second interim final rule. In addition to describing how the NSA interacts with the plan external review procedures, the second interim final rule describes the independent dispute resolution (IDR) process and how the IDR’s determination is made.

Attorneys Helaine FingoldLesley Yeung, and Alexis Boaz dive into how these changes impact entities subject to the NSA’s balance billing prohibitions.

Continue Reading Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 1) – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  On December 27, 2020, President Trump signed into law the No Surprises Act as part of the $2.3 billion Consolidated Appropriations Act. Recently, the Biden administration issued its first interim final rule in order to implement this act, which will go into effect on January