News & Analysis as of

Medicare Part D Medicaid MCOs

Bass, Berry & Sims PLC

CMS Finalizes CY 2025 Medicare Advantage Rule, Confirming Continued Focus on Marketing Practices and Health Equity

Bass, Berry & Sims PLC on

On April 4, the Centers for Medicare & Medicaid Services (CMS) issued the Contract Year (CY) 2025 Medicare Advantage (MA) Final Rule (Final Rule), which will have significant implications for MA plans and other industry...more

Jones Day

Certain Pharmaceutical Discounts No Longer Safe Under the "Safe Harbors"?

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The proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products. On February 6, 2019, the Department of Health and Human Services ("HHS") published...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

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

K&L Gates LLP

HHS Issues Proposed Rule to Remove Safe Harbor for Drug Rebates

K&L Gates LLP on

On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if finalized, would modify the discount safe harbor under the federal Anti-Kickback...more

Epstein Becker & Green

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

Dorsey & Whitney LLP

Drug Rebates Threatened Under Proposed Anti-kickback Rule

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The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more

Skadden, Arps, Slate, Meagher & Flom LLP

Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans

The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more

Bass, Berry & Sims PLC

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

Holland & Knight LLP

Administration Proposes Changes to the Drug Rebate Program

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On Jan. 31, 2019, the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects...more

Baker Donelson

HHS Proposes Removing Anti-Kickback Safe Harbor Protection for PBM Rebates, Proposes Two New Safe Harbors

Baker Donelson on

On January 31, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued for public display a proposed regulation that would subject certain pharmaceutical manufacturer rebates paid to...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 5: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Part D Plan Sponsors’ Access to Medicare Parts A and B Claims Data Extracts - As detailed in previous posts in this series, one major objective that the Centers for Medicare and Medicaid Services (“CMS”) addressed in a...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 3: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Medicare Advantage and Part D Preclusion List - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the...more

Sheppard Mullin Richter & Hampton LLP

Blog Series: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit,...

On October 26, 2018, the Centers for Medicare and Medicaid Services (“CMS”) released for viewing a proposed rule that includes significant changes for Medicare Advantage organizations (“MAOs”), Part D prescription drug plan...more

Baker Donelson

Administration Drug Pricing Proposals Could Reduce Provider Payments

Baker Donelson on

As the Trump Administration moves forward with proposed policy changes to address high drug prices, a common theme is emerging: a number of the proposals have the potential to reduce Medicare reimbursement to hospitals and...more

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