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CY 2023 Proposed HOPPS Rule– What Drug Manufacturers Need To Know

The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for 2023 (the HOPPS Proposed Rule) on...more

Physician Fee Schedule Proposed Rule for 2023 Released: What Pharmaceutical Manufacturers Need To Know

The Centers for Medicare & Medicaid Services (CMS) calendar year 2023 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more

Physician Fee Schedule Final Rule for 2022: What Pharma Needs To Know

The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule finalizing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Final Rule) was published on November 19, 2021....more

340B “Saga” Works Its Way Through the Courts: What Manufacturers Need to Know

A handful of recent court decisions have brought a small degree of resolution and simultaneously a large degree of uncertainty to what we at Arent Fox affectionately refer to as the “340B Saga.” It’s a dispute lasting...more

Drug Manufacturers Take Note: Updated PhRMA Code Released

The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals”...more

North Dakota Becomes Latest State to Enact Drug Transparency Law

Similar to the laws of several other states, the North Dakota law contains three main disclosure requirements that apply to “drug manufacturers” - The Governor of North Dakota signed House Bill 1032 into law on April 27,...more

Texas Medicaid Program – Update for Drug Manufacturers

Texas Health and Human Services announced that beginning April 1, 2021, drug manufacturers who wish for their products to be added to the Texas Drug Code Index (the Texas Medicaid formulary) must create an electronic account...more

CMS Launches Part D Senior Savings Model for Insulin Products

On March 11, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a voluntary model within the Medicare Part D program that would allow certain Part D plans to cap Medicare beneficiaries’ out-of-pocket costs for...more

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