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CMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin Supplements...

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...more

Hospital and MA Plan Considerations for CMS Final Rule to Remedy 340B Drug Payment Policy

In November 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule, “Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar...more

CMS’s Initial Guidance on Medicare Drug Price Negotiation Program Suggests Familiar Pharmacy Chargeback Process

The Centers for Medicare & Medicaid Services (CMS) recently issued initial guidance on how the agency expects the Medicare Drug Price Negotiation Program (the “Negotiation Program”) to operate. The Negotiation Program was...more

CMS Finalizes Changes to Pharmacy DIR in Part D Starting with Contract Year 2024

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

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

CMS Releases Medicare Advantage and Part D Drug Pricing Proposed Rule for Contract Year 2020

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

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2: Beneficiary...

On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more

OIG Warns Pharmaceutical Manufacturers of Improper Part D Beneficiary Coupon Use

On September 19, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a study showing that pharmaceutical manufacturer safeguards to prevent Medicare Part D (“Part D”)...more

CMS Scaled Back Changes to the Medicare Part D Prescription Drug and Medicare Advantage Programs, but Some Important Revisions...

On May 19, 2014, the Centers for Medicare & Medicaid Services ("CMS") released a final rule ("Final Rule") completing changes to the Medicare Program's outpatient prescription drug benefit ("Part D") program and the Medicare...more

CMS Proposes Far-Reaching Changes to the Medicare Part D Prescription Drug Benefit Program and the Medicare Advantage Program

On January 10, 2014, the Centers for Medicare & Medicaid Services ("CMS") published a proposed rule ("Proposed Rule") setting forth sweeping changes to the Medicare Program's outpatient prescription drug benefit ("Part D")...more

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