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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

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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...more

CMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates

On June 9, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its next list of Part B drugs subject to the Medicare Prescription Drug Inflation Rebate Program’s adjusted coinsurance rates (“Rebatable Drugs”) from...more

CMS Releases Its List of 27 Part B Rebatable Drugs for Q2 of 2023: Inflation Reduction Act Updates

IRA Provision: The Medicare Prescription Drug Inflation Rebate Program - The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and a list of 27 Part B “rebatable drugs”...more

More Changes in Store for Pharmaceutical Supply Chain Following Passage of Inflation Reduction Act

On August 16, 2022, President Biden signed into federal law the Inflation Reduction Act (IRA), which, among other priorities for the Biden administration, addresses prescription drug costs and drug prices in the Medicare...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 Issues Final Rule on Covered Outpatient Drugs

On January 21, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule (“Final Rule”) addressing key areas of Medicaid reimbursement for outpatient drugs and changes made to the Medicaid Drug Rebate...more

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