On January 5, 2023, the U.S. Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking entitled “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (the “Proposed Rule“). In this article we provide a brief summary of the Proposed Rule, while also examining the statutory amendments and previous rulemakings that create its foundation.
Patrick Callaghan is an associate in the Corporate Practice Group in the firm's Century City office.
On June 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements” (the “Proposed Rule”). The Proposed Rule is designed to implement statutory amendments to the Medicaid Drug Rebate Program (“MDRP”) statute, and add new regulatory provisions to encourage value-based purchasing (“VBP”) arrangements between drug manufacturers and state Medicaid programs and Medicaid-contracting payors. …
Continue Reading CMS’ Proposed Rule Promoting Value-Based Purchasing for Medicaid-Covered Drugs: The Comments are In!
As discussed in our August 16, 2018 blog post, CMS Proposes Massive Changes to ACO Program – Pushing Providers to Accept Downside Risk, on August 9, 2018, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule referred to as “Pathways to Success” (the “Proposed Rule”) to redesign the Medicare Shared Savings Program (“MSSP” ). As proposed, the redesign would require Accountable Care Organizations (“ACOs”) to accept downside risk or shared losses sooner than was originally scheduled under the then-current MSSP.
Continue Reading “Pathways to Success” Update: CMS Issues Final Rule on Changes to the ACO Program
Why are prescription drug prices so high in the U.S.? While this question can hardly be considered a new topic in American healthcare, the recent clash of words between the Trump Administration and Democratic Senators has once again brought focus to the issue of prescription drug prices. According to the Administration, pharmacy benefit managers (“PBMs”) and drug distributors – who President Trump has dubbed as “middlemen” – are largely to blame for higher drug prices. However, Democratic Senators, PBMs, and drug distributors have recently pushed back against the Administration’s claims, arguing that the Administration’s claims are not supported by any evidence, and, in some cases, are contrary to the core functions of PBMs and drug distributors.
Continue Reading The Blame Game: Senators Clash with the Trump Administration
On Thursday, August 9, 2018, the Centers for Medicare & Medicaid Services (“CMS”) published a Proposed Rule (the “Proposed Rule”) regarding the Medicare Shared Savings Program (“MSSP” ) for Accountable Care Organizations (“ACOs”). The Proposed Rule would require ACOs to accept downside risk or shared losses sooner than under the current MSSP and would promote entities that have shown the greatest cost savings since implementation of the MSSP in 2012. Although not discussed in this article, the Proposed Rule also contains refinements to the methodology concerning ACO benchmarks and a modification to the current approach to risk adjustments, as well as changes to the MSSP’s claims-based assignment methodology and allowing beneficiaries to voluntarily align to ACOs in which their designated primary clinician is an ACO professional.
Continue Reading CMS Proposes Massive Changes to ACO Program – Pushing Providers to Accept Downside Risk