In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
Genetic Materials ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
On June 27, 2025, the Supreme Court in Kennedy v. Braidwood Management, Inc. upheld the structure of the U.S. Preventive Services Task Force (USPSTF, or “Task Force”), overturning a Fifth Circuit decision that had ruled that...more
Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including reimbursement issues...more
Remote patient monitoring (RPM) (oftentimes incorporating artificial intelligence (AI) to analyze data) uses technology to track a patient's physiologic data, such as vital signs, medication adherence, and activity levels,...more
On February 6, 2025, the Trump Administration released published a Request for Information (RFI) on behalf of the White House Office of Science and Technology Policy (OSTP) concerning the development of an Artificial...more
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
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
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
We recently hosted our 3rd annual AI Health Law & Policy Summit in Washington, DC where government and industry representatives joined members of the Hogan Lovells team to discuss new and emerging global health care AI...more
The Office of Personnel Management (OPM) along with the Departments of Health and Human Services, Labor, and the Treasury (“the Departments”) announced on January 17, 2024, that they have reopened the public comment period...more
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
While the Medicare statute provides access to healthcare services for our nation’s elderly and disabled populations, it also can serve to foreclose access for those populations when an item or service does not fall within one...more
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
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
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
Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1) emergency services provided by non-participating providers at participating...more
2/17/2021
/ Arbitration ,
Billing ,
Consolidated Appropriations Act (CAA) ,
Cost-Sharing ,
Employee Retirement Income Security Act (ERISA) ,
Health Care Providers ,
Healthcare Reform ,
Internal Revenue Code (IRC) ,
New Legislation ,
Out of Network Provider ,
Out-of-Pocket Expenses ,
PHSA ,
Regulatory Requirements ,
Surprise Medical Bills
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
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
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
Government seeks industry comment on expediting medical product development -
The U.S. Department of Health and Human Services' (HHS) Immediate Office of the Secretary (IOS) has announced it will hold a public meeting...more