Kathleen Peterson on Medicaid

CMS Proposes Significant Changes to Medicaid Drug Rebate Program

On May 23, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program...more

5/26/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Care Providers , Medicaid , Medicaid Drug Rebate Program , Pharmaceutical Industry , Section 340B

D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more

5/19/2022 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Health Care Providers , Medicaid , Medicaid Drug Rebate Program , Medicare , Pharmacy Benefit Manager (PBM) , PHRMA

MDRP: CMS issues Manufacturer Release on multiple best prices reporting option for VBPs

Last week, the Centers for Medicare & Medicaid Services (CMS) issued Manufacture Release 116, available here, which provides technical guidance to manufacturers on the multiple best prices (BPs) reporting option for...more

3/29/2022 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Medicaid , Medicaid Drug Rebate Program

Fourth Circuit: Safeco Defense Applies to FCA Claims and Dooms Medicaid Best Price Qui Tam

In a split decision issued January 25, 2022, the Fourth Circuit strongly endorsed a defense to False Claims Act liability for entities that submit claims to the government in today’s complex regulatory environment, finding:...more

1/28/2022 / Centers for Medicare & Medicaid Services (CMS) , False Claims Act (FCA) , Medicaid , Medicaid Drug Rebate Program , Qui Tam , Relators , Reporting Requirements , Scienter

MDRP multiple best prices option and territory exclusion update plus Part B discarded drug refund

While Congress continues to consider significant drug pricing legislation, separate regulatory and statutory changes have been finalized this week with potential implications for manufacturers that report prices into the...more

11/22/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Medicaid , Medicaid Drug Rebate Program , Medicare , Medicare Part B , Pharmaceutical Industry , Prescription Drugs

U.S. House passes drug pricing legislation

This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more

11/22/2021 / Biotechnology , Drug Pricing , Health Care Providers , Life Sciences , Medicaid , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Pharmacies , Prescription Drugs

MDRP and 340B: Updates from last week

On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in...more

10/19/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Medicaid , Medicaid Drug Rebate Program , Medicare Part B , Medicare Part D , OIG , Pharmaceutical Industry , Prescription Drugs , Section 340B

Medicaid Drug Rebate Program proposed rule on value-based pricing, line extension, PBM accumulators

On June 17, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule (link) that would materially modify current Medicaid Drug Rebate Program (MDRP) regulations. Comments are due no later than 5:00 p.m....more

6/23/2020 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , MDRP , Medicaid , Medicaid Drug Rebate Program , Opioid , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Value-Based Purchasing

Medicaid Drug Rebate Program: CMS addresses authorized generics, drug category narrow exception in manufacturer releases 112 and...

The Centers for Medicare & Medicaid Services (CMS) recently issued two manufacturer releases. The first provides further information regarding the treatment of sales of authorized generic drugs in the Average Manufacturer...more

6/10/2020 / Centers for Medicare & Medicaid Services (CMS) , Generic Drugs , Manufacturers , Medicaid , Medicaid Drug Rebate Program

"Double Dip" Effectively Approved by Center for Medicare and Medicaid Services

Last week the Centers for Medicare and Medicaid Services (CMS) issued Release No. 104 to Manufacturers and Release No. 180, which invalidated earlier agency releases addressing the treatment under the Medicaid drug rebate...more

5/12/2017 / Billing , Biologics , Centers for Medicare & Medicaid Services (CMS) , Department of Veterans Affairs , Federal Supply Schedule (FSS) , Healthcare Facilities , Indian Health Service (IHS) , Medicaid , Medicaid Reimbursements , Native American Issues , Prescription Drugs , Regulatory Standards

Kathleen Peterson

Hogan Lovells

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