Stuart Langbein 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

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

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

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 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

A Break for Breakthrough Devices? CMS Issues Transitional Coverage for Emerging Technologies Notice

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice with Comment Period (Notice) proposing a new Transitional Coverage for Emerging Technologies (TCET) pathway. 88 Fed. Reg. 41,633 (Jun. 27,...more

6/28/2023 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Medical Devices , Medicare

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

MEDCAC Coverage with Evidence Development meeting offers CMS guidance on CED study requirements

On February 13-14, 2023, the Centers for Medicare & Medicaid Services (CMS) convened a virtual panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to evaluate changes to the criteria for clinical...more

2/23/2023 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicare

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

Senate Passes Drug Pricing Legislation

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

8/8/2022 / Drug Pricing , Food and Drug Administration (FDA) , Health Care Providers , Life Sciences , Medicare , Pharmaceutical Industry , Prescription Drugs

World Stem Cell Summit panel cautions over stepped up HCT/P enforcement, reimbursement issues

Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving government reimbursement issues for...more

6/30/2022 / Biotechnology , Center for Biologics Evaluation and Research (CBER) , Centers for Medicare & Medicaid Services (CMS) , FDA Approval , Food and Drug Administration (FDA) , Health Care Providers , Medicare , Regenerative Medicine

Panelists discuss present & future reimbursement mechanisms for AI health care products

At our recent Health Care AI Law and Policy Summit, Hogan Lovells partner Stuart Langbein moderated a panel discussion on AI policy and reimbursement issues. Joined by representatives from CMS Medicare Administrative...more

6/29/2022 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicaid , Medicare , Medicare Administrative Contractors (MAC)

Immunoglobulin Therapies in the US: How they are used, a Roundtable Report

On September 9, 2021, a panel of experts convened to discuss the use of immunoglobulin (Ig) therapies, detail the therapeutic benefits of Ig therapies for various disease states, offer practitioner insights on the impact of...more

5/4/2022 / Clinical Trials , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Life Sciences , Medical Research , 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

Expedited breakthrough device coverage, “reasonable and necessary” definition delayed until Dec. 15

On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a display copy of a Final Rule (Final Rule) further delaying the effective date of the Medicare Coverage of Innovative Technology (MCIT) and...more

5/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Medical Devices , Medicare , Medicare Part A , Medicare Part B , Reasonable and Necessary Expenses

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more

4/26/2021 / Biden Administration , Critical Infrastructure Sectors , Department of Health and Human Services (HHS) , Drug Pricing , Healthcare Reform , Legislative Agendas , Medicaid , Medicaid Drug Rebate Program , Medicare , Medicare Part D , Patient Access , Pharmaceutical Industry , Prescription Drugs , Regulatory Agenda

CMS delays “reasonable and necessary” definition, expedited breakthrough device coverage process rule

On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more

3/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , FDA Approval , Food and Drug Administration (FDA) , Innovative Technology , Life Sciences , Medical Devices , Medicare , Pharmaceutical Industry

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

2/24/2021 / Biotechnology , Clinical Trials , Coronavirus/COVID-19 , Cybersecurity , Digital Health , Infectious Diseases , Life Sciences , Pharmaceutical Industry , Pharmaceutical Patents

CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process

On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a particular item or service is “reasonable and...more

1/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Health Technology , Healthcare Reform , Medical Devices , Reasonable and Necessary Expenses

2020 final price reporting developments: stimulus legislation, 340B contract pharmacy Advisory Opinion

As we begin the new year, we wanted to highlight two final developments from December 2020: First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act of 2021 (link), Pub. L. 116‑260...more

1/8/2021 / Civil Monetary Penalty , Consolidated Appropriations Act (CAA) , Drug Pricing , Financial Stimulus , MACPAC , MDRP , MedPAC , New Legislation , OIG , Pharmaceutical Industry , Pharmacies , Section 340B

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

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more

11/20/2020 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Healthcare Reform , Regulatory Agenda , Regulatory Flexibility Act , Regulatory Requirements , Rulemaking Process , Sunset Provisions

CMS proposes “reasonable and necessary” definition, expedited breakthrough device coverage process

On Tuesday, September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule addressing the Medicare coverage standard and expedited coverage for certain medical devices. If finalized, the...more

9/2/2020 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Health Insurance , Healthcare Reform , Medical Devices , Medicare , Medicare Program Integrity Manual (MPIM) , Pharmaceutical Industry , Regulatory Standards , Scope of Coverage

Expanded access to telehealth services during the COVID-19 pandemic

In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state Medicaid programs, and private payers have implemented significant changes to...more

4/2/2020 / Coronavirus/COVID-19 , Health Care Providers , Relief Measures , Telehealth , Telemedicine

Stuart Langbein

Hogan Lovells

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