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Regulatory Reform New Regulations Healthcare

Sheppard Mullin Richter & Hampton LLP

New York Adopts Major Certificate of Need Amendments Effective August 6, 2025

On August 6, 2025, the New York State Department of Health (DOH) finalized amendments to its Certificate of Need (CON) regulations in 10 N.Y.C.R.R. Part 710, raising the financial thresholds for full review, expanding...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

McDermott+

Health Plans’ Commitment to Prior Authorization Improvements: What’s New Versus What’s Already Required

McDermott+ on

Health plan members of AHIP and the Blue Cross and Blue Shield Association made news earlier this week when they announced a series of steps that a broad swath of health insurers will take to improve the prior authorization...more

Sheppard Mullin Richter & Hampton LLP

Proposed Rule on Medicaid Tax Waivers: CMS Moves to Close a Loophole Shifting Costs to the Federal Government

On May 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule, entitled “Preserving Medicaid Funding for Vulnerable Populations – Closing a Health Care-Related Tax Loophole” to address a...more

Epstein Becker & Green

CMS Tells States “No More” Medicaid Section 1115 Matching Funds for Designated State Health Programs (DSHP) and Designated State...

Epstein Becker & Green on

In recent years, the Centers for Medicare & Medicaid Services (CMS) has approved demonstrations under Section 1115 of the Social Security Act, providing federal matching funds for state expenditures for Designated State...more

Groom Law Group, Chartered

This Week From the Hill (February 2 – February 8, 2025)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

Sheppard Mullin Richter & Hampton LLP

New York Adopts Comprehensive Hospital Cybersecurity Requirements

Cyberattacks on healthcare organizations are on the rise, with the number of affected individuals nearly tripling between 2022 and 2024, according to data compiled by the Department of Health and Human Services Office for...more

DLA Piper

New York issues extensive new pharmacy benefit manager regulations

DLA Piper on

On November 27, 2024, the New York State Department of Financial Services (DFS) will be releasing new regulations governing pharmacy benefit managers (PBMs). Beginning with legislation in 2021, New York has been active in...more

Polsinelli

Calling All SNFs… and All of Your Operational Associates – Get Ready Now: Sweeping New Disclosure Requirements Under The Updated...

Polsinelli on

Skilled Nursing Facilities and their operational associates need to prepare themselves now for new disclosure requirements that require much greater disclosure of ownership as well as disclosure from a much broader class of...more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

Stikeman Elliott LLP on

On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

McDermott Will & Schulte

2024 Chart of Additional Healthcare Regulations

During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more

Robinson+Cole Health Law Diagnosis

Additional States Implement Notice Requirements for Healthcare Transactions

In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions. On March 13, 2024, Indiana joined this trend as Indiana Governor Eric Holcomb...more

Akerman LLP

Florida's Prescription Drug Reform Act: What's in it for Florida Pharmacies?

Akerman LLP on

The Florida legislature took aim at pharmacy benefit managers (PBMs) during the 2023 legislative session by enacting the Prescription Drug Reform Act, Chapter 2023-29, Laws of Florida (https://laws.flrules.org/2023/29) (the...more

Perkins Coie

Psilocybin: Updates in Oregon and Around the Country

Perkins Coie on

Oregon is the first state in the country to offer controlled use of psilocybin to the public. As we detailed in a prior Update, the state had finalized regulations. Now, the state has licensed its first psilocybin service...more

Quarles & Brady LLP

Ohio Board of Pharmacy Formalizes a Pathway for Approval of Innovative Pharmacy Arrangements

Quarles & Brady LLP on

Effective March 11, 2022, Ohio Board of Pharmacy (“Board”) enacted a new regulation, Ohio Admin. Code 4729:5-3-20, that creates a procedure for licensees to petition the Board for approval of pilot or research projects...more

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