Alice Valder Curran at Hogan Lovells

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CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA.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

HRSA Issues 340B Program final rule modifying administrative dispute resolution process

On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process...more

4/22/2024 / Drug Pricing , Final Rules , HRSA , Pharmaceutical Industry , Prescription Drugs , Section 340B

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

Spotlight on the U.S.: Panelists discuss navigating the IRA

Hogan Lovells is hosting a special webinar series for Life Sciences and Health Care companies based in, or with commercial interests in, the Asia-Pacific (APAC) region. The series shares topical insights, cost-effective...more

3/6/2024 / Drug Pricing , Hatch-Waxman , Inflation Reduction Act (IRA) , Intellectual Property Protection , Medicare , Pharmaceutical Industry

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

The Genesis case: The beginning of the end of HRSA’s “patient” definition?

On November 3, 2023, the U.S. District Court for the District of South Carolina issued a decision granting in large part Genesis Health Care’s (Genesis’s) motion for summary judgment in its litigation against the Health...more

11/7/2023 / Covered Entities , Drug Pricing , Health Care Providers , HRSA , Pharmaceutical Industry , Prescription Drugs , Section 340B

Panelists discuss why IP lawyers should care about the IRA

We were pleased to welcome Henry Hadad of Bristol Myers Squibb, who joined Hogan Lovells partners Alice Valder Curran, Miriam Gundt, and Cullen Taylor for our recent webinar presentation on why IP lawyers should care about...more

7/28/2023 / Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Patents , 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

Successful product launches across the EU, UK, and U.S.

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more

5/3/2023 / Biotechnology , EU , Intellectual Property Protection , Life Sciences , Manufacturers , Member State , Pharmaceutical Industry , UK

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

JPM2023 Trendspotting: takeaways from Biotech Showcase

At the recent J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry led in-person discussions with industry experts on topics that will guide...more

2/3/2023 / Biologics , Biosimilars , Biotechnology , Drug Pricing , FDA Approval , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Life Sciences , Pharmaceutical Industry

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

JPM2023 Trendspotting: portfolio valuation in the aftermath of the IRA

As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more

12/28/2022 / Biotechnology , Investment Portfolios , Investors , Popular , Private Equity , Venture Capital

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

Inflation Reduction Act’s Drug Price Negotiation Program explained

In the first 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 discussed the Drug Price Negotiation Program established by...more

10/5/2022 / Biosimilars , Biotechnology , Department of Health and Human Services (HHS) , Drug Pricing , Health Care Providers , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 3: Medicare Part D...

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

8/26/2022 / Continuing Legal Education , Drug Pricing , Health Care Providers , Inflation Reduction Act (IRA) , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Physicians , Prescription Drug Coverage , Prescription Drugs , Rebates , Webinars

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 2: Medicare Part B and...