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Medicare Covered Entities Reporting Requirements

Hogan Lovells

HRSA issues notice regarding 340B Rebate Model Pilot Program, limited to drugs subject to a maximum fair price (MFP) for 2026

Hogan Lovells on

On July 31, 2025, the Health Resources and Services Administration (HRSA) published a notice in the Federal Register (Rebate Model Notice) announcing a 340B Rebate Model Pilot Program (Pilot Program). Notably, the Pilot...more

Cornerstone Research

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program

Cornerstone Research on

A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more

Venable LLP

Looming CTA Disclosure Requirements and Healthcare Providers

Venable LLP on

The Federal Corporate Transparency Act (the CTA), 31 U.S.C. §5336, will soon require certain entities to disclose to the U.S. Treasury's Financial Crimes Enforcement Network (FinCEN) certain pieces of identifying information...more

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on

The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

Mintz - Health Care Viewpoints

March 2019: Where Are We Now With 340B?

Long time readers of our blog may recall that five years ago, I predicted that 2014 might be a game-changing year for the 340B Drug Discount Program. 2014 saw attempts at regulatory changes, but a successful court challenge...more

Mintz - Health Care Viewpoints

Six Key Follow-Up Questions Asked by Congress in 340B Hearing

Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more

Ballard Spahr LLP

CMS Releases Final Rule on Physician Payment Disclosures

Ballard Spahr LLP on

Public disclosure of payments from pharmaceutical, medical device, biologic, and medical supply manufacturers to physicians and hospitals will begin under a final rule on the Physician Payments Sunshine Act (Sunshine Act)...more

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