News & Analysis as of

Comment Period Healthcare Public Comment

Tucker Arensberg, P.C.

CMS Unveils 2026 Physician Fee Schedule Proposal: Key Changes Ahead

Tucker Arensberg, P.C. on

On July 14, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2026 Physician Fee Schedule. As expected, there are several meaningful updates that providers, practices, and health systems...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

BakerHostetler on

On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

BakerHostetler

DOJ Antitrust Division Announces Anticompetitive Regulations Task Force

BakerHostetler on

On March 27, 2025, the Department of Justice (DOJ) announced the formation of an Anticompetitive Regulations Task Force. The Task Force broadly aims to eliminate anticompetitive state and federal laws and regulations that...more

Ballard Spahr LLP

HHS Proposes Significant Updates to HIPAA Security Rule

Ballard Spahr LLP on

On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more

Pullman & Comley - Connecticut Health Law

OHS Issues 2024 Statewide Health Care Facilities and Services Plan

The Connecticut Office of Health Strategy (OHS) has released the 2024 Statewide Health Care Facilities and Services Plan, along with a biennial inventory of all Connecticut health care facilities and services (the Plan)....more

McDermott+

CMMI Proposes New Mandatory Episode-Based Payment Model

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) released the Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation. This 1,900+ page annual reg updates Medicare payments and policies...more

Knobbe Martens

Draft Framework for Exercise of March-In Rights under Bayh-Dole Act Targets High Drug Pricing

Knobbe Martens on

The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more

Nelson Mullins Riley & Scarborough LLP

CMS Issues Interim Rule in Response to State Medicaid Disenrollment Trend

When the COVID-19 Public Health Emergency (PHE) ended in April 2023, the Families First Coronavirus Response Act’s Medicaid continuous enrollment condition also came to an end. The condition had allowed states to claim a...more

Nelson Mullins Riley & Scarborough LLP

The Drive for Equitable Healthcare Access: Departments Seek Public Input on Over-the-Counter Preventive Services

On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

Polsinelli

“36-Month Rule” Anticipated to Expand to Hospice

Polsinelli on

On July 10, the Centers for Medicare & Medicaid Services (“CMS”) issued a Proposed Rule that would extend the “36-Month Rule” to Hospice providers. The 36-Month Rule refers to 42 C.F.R. § 424.550(b), which currently...more

Nelson Mullins Riley & Scarborough LLP

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more

Nossaman LLP

CMS Attempts to Reduce Appointment Times for Medicaid and CHIP Patients - How Will This Impact Your Managed Care Plan?

Nossaman LLP on

A recent survey found that the average wait time for a new patient to see a physician in 15 of the largest cities in the U.S. was 26 days, up from 24.1 days in 2017.  Timely access to health care providers has long been an...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Burr & Forman

Proposed Rules Could Impact How Health Care Providers Handle Medical Waste

Burr & Forman on

In August 2022, the Alabama Department of Environmental Management (“ADEM”) published proposed changes to its rules for public comment. Specifically, the rules affect how a healthcare provider stores medical waste. If the...more

Polsinelli

Telehealth: CMS Proposes to Discontinue Audio-Only E/M Services and Virtual Direct Supervision in 2023 Proposed Rule

Polsinelli on

On July 07, 2022 the Centers for Medicare and Medicaid Services (“CMS”) released the 2023 Physician Fee Schedule (“PFS”) Proposed Rule, which proposes several significant changes to Medicare telehealth services....more

Robinson+Cole Health Law Diagnosis

OSHA Taking Comments on Proposed Permanent Healthcare COVID-19 Standard

OSHA has partially reopened the rulemaking record and scheduled an informal public hearing to seek comments on several topics relating to the development of a final standard to protect healthcare and healthcare support...more

McDermott Will & Emery

CMS Final Rule Strengthens Integrity of Medicare Provider Enrollment Process

McDermott Will & Emery on

On September 10, 2019, the US Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) expanding Medicare, Medicaid and Children’s Health Insurance Program...more

King & Spalding

FDA Proposes Regulatory Framework for Artificial Intelligence/Machine Learning Software as a Medical Device

King & Spalding on

On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more

King & Spalding

District Court Says CMS’s 0.2 Percent IPPS Rate Cut Violated APA

King & Spalding on

On September 21, 2015, the United States District Court for the District of Columbia ruled that the Secretary of the U.S. Department of Health and Human Services (HHS) failed to provide a meaningful opportunity to comment on...more

Arnall Golden Gregory LLP

CMS Proposes to Establish Separate Payment for End of Life Planning Services

On July 8, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that updates payment rates and related reimbursement and quality policies for physician services furnished under the Medicare...more

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