On August 1, 2025, the U.S. Department of Health and Human Services (“HHS”) Health Resources and Services Administration (“HRSA”) issued a call for applications for a 340B Rebate Model Pilot Program (the “Pilot Program”)....more
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
8/16/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Prescription Drugs ,
Price Inflation ,
Rebates ,
Section 340B
The Centers for Medicare & Medicaid Services (CMS) recently published the CMS Advancing Interoperability and Improving Prior Authorization Processes Final Rule (“PA Final Rule”) in the Federal Register....more
On October 18, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) to conduct market research regarding the “availability and potential technical ability of health-care related...more
On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few...more
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
On June 2, 2023, the Centers for Medicare & Medicaid Services (CMS) issued instructions for the process by which a manufacturer may submit a request for a qualifying single-source drug to be considered for the Small Biotech...more
On May 12, 2023, the Centers for Medicare & Medicaid Services (CMS) issued Draft Guidance on the Part D Manufacturer Discount Program (“Discount Program”)—a key component of the Part D Redesign provisions of the Inflation...more
On May 11, the U.S. Senate Committee on Health, Education, Labor and Pensions (the “HELP Committee” or the “Committee”) passed a bipartisan bill to expand federal regulation of pharmacy benefit managers (“PBMs”) for group...more
The Centers for Medicare & Medicaid Services (“CMS”) is using its annual rulemaking process to update the CMS payment system rules for fiscal year (“FY”) 2024 as a mechanism to advance health equity systematically across...more
On April 18, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an Information Collection Request (ICR) addressing the “Drug Price Negotiation Process” for the Medicare Drug Price Negotiation Program, including...more
IRA Provision: The Medicare Drug Price Negotiation Program -
The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and initial guidance for the implementation of the Medicare Drug Price Negotiation...more
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
On February 9, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued a fact sheet and its initial guidance documents addressing the Medicare Prescription Drug Inflation Rebate Program for Medicare Parts B and D...more
On July 13, 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury, and the Office of Personnel Management (collectively, “Departments”) published their highly anticipated interim final rule (“First...more
Following months of congressional negotiations, on December 27, 2020, President Trump signed into law the Consolidated Appropriations Act, 2021, a $2.3 trillion piece of legislation that includes $900 billion in federal...more
Through a January 9, 2020, press release, the Department of Justice (“DOJ”) reported more than $3 billion in total recoveries from settlements and judgments from fraud-related civil matters brought under the False Claims Act...more
1/13/2020
/ Department of Justice (DOJ) ,
Enforcement Actions ,
Failure to Comply ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators ,
Stark Law ,
Statistical Analysis
Yesterday, a final rule issued by the Centers for Medicare & Medicaid Services (CMS) establishing new enforcement initiatives aimed at removing and excluding previously sanctioned entities from Medicare, Medicaid, and the...more
11/5/2019
/ Affiliates ,
Bad Actors ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Durable Medical Equipment ,
Enrollment ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Revocation ,
Suppliers