News & Analysis as of

Reimbursements Medicare Manufacturers

Blank Rome LLP

CMS Proposes New Rules for Calculating Average Sales Price for Medicare Part B Drug Reimbursement

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The Centers for Medicare & Medicaid Services (“CMS”) released the Calendar Year 2026 Medicare Physician Fee Schedule (“PFS”) proposed rule on July 16, 2025. (See...more

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

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The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

ArentFox Schiff on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

Hogan Lovells

Medicare proposed rules include government pricing surprises: ASP changes and maximum fair price, new bona fide service fee and...

Hogan Lovells on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more

Quarles & Brady LLP

Part D Pharmacies Required to Enroll in Data Exchange Module to Help Drug Price Negotiation Cash Flow Issue

Quarles & Brady LLP on

On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more

ArentFox Schiff

Investigations Newsletter: Medical Device Manufacturer THD Pays $700,000 to Resolve FCA Allegations

ArentFox Schiff on

Medical Device Manufacturer THD Pays $700,000 to Resolve FCA Allegations - On September 6, the US Attorney’s Office for the District of Maryland announced that THD America, Inc., and its parent company, THD SpA of Italy,...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q3 2022

Bass, Berry & Sims PLC on

The third quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several over $20 million and one in the high nine figures. This post summarizes key settlements of interest to healthcare...more

King & Spalding

OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial

King & Spalding on

On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical...

On March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay...more

Baker Donelson

Medicare Issues Interim Final Rule to Lower Payments to Hospitals and Physicians for Certain Drugs Starting January 1, 2021

Baker Donelson on

On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period (IFC) to implement a payment model that will significantly reduce Medicare reimbursement rates for...more

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