James Huang on Department of Health and Human Services (HHS)

White House raises more questions than answers in Executive Order directing Most Favored Nation drug pricing

On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more

5/14/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Medicaid , Medicare , Pharmaceutical Industry , Proposed Rules , Rulemaking Process , Trump Administration

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

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

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

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

U.S. Supreme Court ruling expands scope of Medicare notice-and-comment requirement

On 3 June 2019 the U.S. Supreme Court held in Azar v. Allina Health Services that Medicare interpretive guidance must go through notice-and-comment if it establishes or changes a substantive legal standard governing payment,...more

6/10/2019 / Administrative Procedure Act , Azar v Allina Health Services , Department of Health and Human Services (HHS) , Hospitals , Low-Income Issues , Medicare , Medicare Advantage , Medicare Part A , Medicare Part C , Notice and Comment , Pay Reductions , Provider Payments , Reaffirmation , Retroactive Application , SCOTUS , Substantive Rule , Vacated

First Steps: Trump Administration's Initial Executive Actions Target the Affordable Care Act and Obama Administration's Midnight...

On Friday, January 20, 2017—within hours of President Trump’s inauguration—the new Administration took its first executive actions. These executive actions included: President Trump's issuance of an Executive Order...more

1/23/2017 / Affordable Care Act , Department of Health and Human Services (HHS) , Employee Benefits , Employer Mandates , Executive Orders , Federal Register , Health Insurance , Healthcare , Healthcare Reform , Regulatory Oversight , Trump Administration

James Huang

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