Rianna Modi at Hogan Lovells

CMS Proposes Guidance on Use of Real World Data for Coverage with Evidence Development

Real world data (RWD), which is data from actual patient treatments, provides valuable information on safety and effectiveness of innovative new health technologies, often at significantly lower cost than evidence generated...more

2/5/2025 / Centers for Medicare & Medicaid Services (CMS) , Data Collection , Health Technology , Medical Devices , Medicare , New Guidance

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

Breaking News for Breakthrough Devices: CMS Finalizes Transitional Coverage for Emerging Technologies Pathway

On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The long-anticipated Final Notice on the TCET pathway...more

8/14/2024 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Health Care Providers , Medical Devices , Medicare

Tortoise and Hare: Congress may overtake CMS in years-long race to set Medicare breakthrough device coverage

On June 27, 2024, the Ensuring Access to Breakthrough Products Act of 2024 (H.R. 1691) was marked up and reported out of the House Ways and Means Committee. This action brings Medicare beneficiaries one step closer to timely...more

7/3/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Medical Devices , Medicare , Medicare Administrative Contractors (MAC)

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 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

MedTech 2023: Key takeaways from conversations on women’s health, antitrust, and AI

AdvaMed recently hosted its annual MedTech Conference in Anaheim, California, at which Hogan Lovells lawyers and regulatory specialists convened with business leaders, scientists, investors, regulators, and others across the...more

11/20/2023 / Acquisitions , Algorithms , Antitrust Provisions , Artificial Intelligence , Hart-Scott-Rodino Act , Machine Learning , Mergers

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

Rianna Modi

Hogan Lovells

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