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  1. Services
  2. Medicare Certification, Compliance & Enforcement Defense

Insights on Medicare Certification, Compliance & Enforcement Defense

14 total results. Page 1 of 1.

Health Care Counsel Blog
FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court
April 9, 2025
Emily Cowley Leongini, Wayne H. Matelski, Jack R. Bierig, Gayland O. Hethcoat II

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

Health Care Counsel Blog
Top Legal Challenges for the Health Care Industry in 2025
February 20, 2025
David S. Greenberg, Douglas A. Grimm, Annie Chang Lee, Michele L. Gipp, Anne M. Murphy, Stephanie Trunk, Hillary M. Stemple, Gayland O. Hethcoat II, D. Jacques Smith, Daniel J. McQueen, Jeffrey B. Tate , Brian D. Schneider, Moyosore O. Koya, William R. Mitchell, Rebekkah R.N. Stoeckler, Pascal Naples

With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year.

Health Care Counsel Blog
The 2025 Final Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need to Know
November 21, 2024
Stephanie Trunk, Shoshana Golden

This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks.

Alerts
Massachusetts Senior Living Facilities Legislative and Regulatory Fall 2024 Update
November 1, 2024
Anne M. Murphy, Stephen Blake

How Massachusetts senior living providers need to be thinking about the recently enacted Long Term Care Reform Law and a recent Centers for Medicare & Medicaid Services audit of nursing homes.

Investigations Blog
Post-Chevron Health Care Regulations: Using Loper Bright as a Shield in Stark Law Litigation
July 29, 2024
D. Jacques Smith, Hillary M. Stemple, Pascal Naples

Previously, we discussed how the US Supreme Court’s opinion in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce could create opportunities for private litigants to challenge health care-related agency actions.

Investigations Blog
Post-Chevron Health Care Regulations: What May Be in Store for Stark Law Litigation
July 23, 2024
D. Jacques Smith, Hillary M. Stemple, Pascal Naples

The US Supreme Court recently overturned its ruling in Chevron USA, Inc. v. Natural Resources Defense Council, Inc., changing the landscape for federal agency rulemaking and actions, particularly in the health care industry.

Health Care Counsel Blog
The 2025 Proposed Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need to Know
July 17, 2024
Stephanie Trunk, Shoshana Golden

Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules.

Health Care Counsel Blog
Post-Chevron Health Care Regulations: The Dawn of a New Day
July 12, 2024
Douglas A. Grimm, Lowell C. Brown, David S. Greenberg, Pascal Naples

On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute.

Alerts
The 10 Trends and Legal Challenges We Are Tracking Throughout 2024
April 30, 2024
Jo-Ann Marchica, Mindy Pittell Hurwitz, Stephen Blake

With 2024 well underway, this article highlights some of the pressing legal issues impacting the long term care and senior housing industry this year, including trends affecting the industry and emerging issues industry participants likely will face throughout the rest of 2024 and beyond.

Health Care Counsel Blog
Health Care Providers Navigate Fallout of Major Cyberattack on Change Healthcare
March 14, 2024
David S. Greenberg, Douglas A. Grimm, Hillary M. Stemple, Gayland O. Hethcoat II

Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records.

Health Care Counsel Blog
10 Legal Challenges for the Health Care Industry in 2024
January 26, 2024
David S. Greenberg, Douglas A. Grimm, Stephanie Trunk, Jill A. Steinberg, Hillary M. Stemple, Gayland O. Hethcoat II, D. Jacques Smith, Dan H. Renberg, Alison Lima Andersen, Jessica Sprovtsoff, Moyosore O. Koya, Shoshana Golden, Rebekkah R.N. Stoeckler, Oliver Spurgeon III*

With 2024 underway, ArentFox Schiff highlights 10 of the most pressing legal issues facing the health care industry this year.

Health Care Counsel Blog
Medicare Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) Final Rules Released; What Pharma Needs to Know
December 1, 2022
Stephanie Trunk

The Centers for Medicare & Medicaid Services (CMS) has issued its annual final rules related to both the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for calendar year 2023 (the HOPPS Final Rule) and the Physician Fee Schedule Final Rule (the PFS Final Rule)

Events
Medicaid & Government Pricing Congress
May 23, 2022
Stephanie Trunk

Health Care Partner Stephanie Trunk will give a presentation and participate in a Fireside Chat about policy updates surrounding transparency and reporting requirements at the 2022 Informa Connect Medicaid & Government Pricing Congress.

Events
20th Annual Drug Pricing Boot Camp
May 11, 2022
Stephanie Trunk

Health Care Partner Stephanie Trunk will co-chair the American Conference Institute’s 20th Annual Rx Drug Pricing Boot Camp, providing intensive training in the essentials and complexities of pricing calculations, rebates, and reporting under Medicaid, Medicare, and PHS 340B Programs.

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