James Huang at Hogan Lovells

Center for Medicare and Medicaid innovation (CMMI) to end four payment models in cost-cutting effort

On March 12, 2025, the Centers for Medicare & Medicaid Services’ (CMS’s) Center for Medicare and Medicaid Innovation (CMMI) announced that it intends to end early four payment models to achieve $750 million in savings: the...more

3/18/2025 / Centers for Medicare & Medicaid Services (CMS) , CMMI , Department of Health and Human Services (HHS) , Health Insurance , Healthcare Reform , Medicaid , Medicare , Value-Based Payments

HHS rescinds policy regarding notice-and-comment rulemaking – implications for health care industry

On February 28, 2025, the Department of Health and Human Services (“HHS” or “the Department”) issued a Policy Statement rescinding long-standing HHS guidance regarding the use of notice-and-comment rulemaking to adopt certain...more

3/4/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Federal Contractors , Medicaid , Medicare , Regulatory Reform , Regulatory Requirements

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

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)

HHS finalizes changes to Section 1557 regulations strengthening anti-discrimination protections

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) finalized updates to regulations implementing Section 1557 of the...more

5/8/2024 / Affordable Care Act , Department of Health and Human Services (HHS) , Health Care Providers , Health Insurance , Non-Discrimination Rules , Section 1557

CMS finalizes new standards and reporting obligations affecting Medicaid and CHIP managed care plans

On April 22, 2024, the Centers for Medicare & Medicaid Services (CMS) published the Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality Final Rule and the Ensuring Access to...more

5/6/2024 / Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Health Care Providers , Managed Care Contracts , Medicaid

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

Court rules for PhRMA in challenge to Oregon drug price transparency law

On February 16, 2024, the U.S. District Court for the District of Oregon issued a ruling in Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi, granting in part PhRMA’s motion for summary judgment in its...more

4/2/2024 / Drug Pricing , Pharmaceutical Industry , PHRMA , Prescription Drugs , Price Transparency

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

NY physician practice, MSO, and other health care transactions affected by new reporting rules

The New York legislature recently enacted new reporting requirements that will affect health care transactions across the state. Effective August 1, 2023, certain “material” mergers, acquisitions, affiliation agreements, and...more

6/23/2023 / Corporate Sales Transactions , Health Care Providers , Healthcare , Hospital Mergers , Joint Venture , New York , Popular , Public Health , Reporting Requirements , Transaction Reporting

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

After the Public Health Emergency: Implications for Medicare and U.S federal health care policies

On January 30, 2020, the Biden Administration announced that it intends to allow the COVID-19 national emergency and public health emergency (collectively, “PHE”) to expire effective on May 11, 2023. The termination of the...more

3/13/2023 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Health Care Providers , OIG , Public Health Emergency

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

CMS proposes sweeping changes to regenerative medicine reimbursement framework

Last month, the Centers for Medicare & Medicaid Services (CMS) released new and significant proposals impacting Medicare coding, coverage, and reimbursement for a class of regenerative medicines known as “skin substitutes,” a...more

8/5/2022 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Regenerative Medicine

World Stem Cell Summit panel compares global trends in regenerative medicine regulations

Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more

7/28/2022 / Biologics , Biotechnology , Clinical Trials , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Regenerative Medicine , Stem cells

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

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

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

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

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

James Huang

Hogan Lovells

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