Alice Valder Curran on Centers for Medicare & Medicaid Services (CMS)

White House issues Executive Order directing efforts to lower drug prices

On April 15, 2025, the White House issued an Executive Order (EO) entitled “Lowering Drug Prices by Once Again Putting Americans First.” The EO directs various agencies to engage in a number of distinct efforts to lower...more

4/18/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Medicaid , Medicare , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Trump Administration

CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more

10/8/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Final Guidance , Inflation Reduction Act (IRA) , Manufacturers , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS issues Final Rule adopting some but not all proposed changes to the Medicaid Drug Rebate Program

On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program....more

9/23/2024 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Medicaid , Medicaid Drug Rebate Program , Prescription Drugs

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

7/30/2024 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Manufacturers , Medicare Part B , OIG , Pharmaceutical Industry , Popular , Prescription Drugs

CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the...more

5/7/2024 / Centers for Medicare & Medicaid Services (CMS) , Draft Guidance , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Prescription Drugs

CMS finalizes regulation specifying all covered prescriptions drugs are essential health benefits

On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies applicable to qualified health plans offered...more

4/4/2024 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Essential Health Benefits , Final Rules , Prescription Drugs

CMS Issues Revised Medicare Part B and Part D Inflation Rebate Guidance

On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of...more

12/19/2023 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Manufacturers , Medicaid Drug Rebate Program , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS Issues Final Guidance on the Inflation Reduction Act (IRA) Drug Price Negotiation Program

On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness to adopt stakeholder suggestions...more

7/5/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Popular , Prescription Drugs

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

CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more

3/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS issues Medicare Part B and Part D inflation rebate guidance

On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “initial” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of 2022...more

2/14/2023 / Centers for Medicare & Medicaid Services (CMS) , Inflation Reduction Act (IRA) , Medicare , Medicare Part B , Medicare Part D , Prescription Drugs

HHS OIG issues ASP reports exploring need for guidance and increased oversight in ASP reporting

On January 3, 2023, the Department of Health and Human Services Office of Inspector General (OIG) publicly released two reports with respect to Medicare Part B average sales price (ASP)....more

1/6/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Health Care Providers , Medicare , Medicare Part B , OIG

340B Program: HRSA Proposes to Modify Administrative Dispute Resolution Process

On November 30, 2022, the Health Resources and Services Administration (HRSA) published a proposed rule (Proposed Rule) in the Federal Register that proposes to introduce several changes to the current administrative dispute...more

12/6/2022 / Administrative Review Board , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Dispute Resolution , HRSA , Prescription Drugs , Section 340B

Inflation Reduction Act’s Medicare Part D benefit redesign explained

In the third of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Ken Choe and Melissa Bianchi discussed the Medicare Part D redesign and answered questions from...more

11/1/2022 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicare , Medicare Part D

Inflation Reduction Act’s Medicare Part B and D inflation rebates explained

In the second of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe, as well as David Chan, President and General Manager of...more

10/11/2022 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Care Providers , Inflation Reduction Act (IRA) , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Physicians , Prescription Drug Coverage , Prescription Drugs

Government declines to appeal ruling in PBM accumulator programs MDRP 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

7/20/2022 / Centers for Medicare & Medicaid Services (CMS) , Cost-Sharing , Drug Pricing , Final Rules , Medicaid Drug Rebate Program , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM)

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

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

MDRP: CMS Final Rule on value-based purchasing, line extension definition, PBM accumulator programs

On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that materially modifies current Medicaid Drug Rebate Program (MDRP) regulations, largely finalizing the proposed rule dated June...more

12/24/2020 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Healthcare Reform , MDRP , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Value-Based Purchasing

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

Medicare links Part B payment rates to international prices: Most Favored Nation Model

On November 20, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (IFR) with comment period implementing a mandatory “Most Favored Nation” demonstration model (MFN Model) to test...more

11/24/2020 / Biologics , Centers for Medicare & Medicaid Services (CMS) , Comment Period , Drug Pricing , Health Insurance , Healthcare Reform , Interim Final Rules (IFR) , Medicare Part B , Most-Favored Nations , Pharmaceutical Industry , Prescription Drug Coverage , Reimbursements

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

Alice Valder Curran

Hogan Lovells

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