News & Analysis as of

Healthcare Comment Period

McDermott+

Responses to the PFS Proposed Reg Are In: 10 Major Comments

McDermott+ on

McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. September 19, 2024 – Comments on the calendar year (CY) 2025 physician fee...more

Bass, Berry & Sims PLC

CMS Solicits Comments to Clarify Parameters on MAC Downcoding of Complex Drug Administration Infusion Services

In the proposed CY 2025 Physician Fee Schedule (PFS) published in the Federal Register on July 31, the Centers for Medicare & Medicaid Services (CMS) is soliciting comments on a proposal to revise the Medicare Claims...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

Quarles & Brady LLP

Kentucky Refiles Controversial Non-Resident Pharmacist License Regulation

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On April 15, 2024, the Kentucky Board of Pharmacy (“Board”) posted a suite of proposed non-resident pharmacist rules that will require any pharmacist working in another state and who provides services on a Kentucky citizen’s...more

Burr & Forman

Proposed Revisions to Title II of the ADA Impacting Healthcare Facilities

Burr & Forman on

The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...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

Mayer Brown

Private Equity in Healthcare: Increased Scrutiny from FTC, DOJ, and HHS

Mayer Brown on

Private equity acquisitions in healthcare will likely face increased scrutiny from multiple federal departments, as well as from state antitrust enforcement officials....more

McDermott Will & Emery

The SUSTAIN 340B Act: A Summary and Guide for Reviewing and Providing Comments

McDermott Will & Emery on

On February 2, 2024, six senators known as the “Gang of Six” – John Thune, Debbie Stabenow, Shelley Moore Capito, Tammy Baldwin, Jerry Moran and Ben Cardin – released a discussion draft bill intended to preserve the 340B...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

Sheppard Mullin Richter & Hampton LLP

Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen

On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...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

Sheppard Mullin Richter & Hampton LLP

OHCA Published Near-Final Draft of Regulations Requiring Notice and Review of Material Healthcare Transactions in 2024

In the final days of November, the Office of Health Care Affordability (OHCA) published three updates related to its proposed regulations regarding the review of certain healthcare transactions in California: 1. the...more

McDermott Will & Emery

Final Comment Period Anticipated Next Week for Emergency Regulations on California’s New Healthcare Transaction Notice Law

McDermott Will & Emery on

On November 28, 2023, California’s Office of Health Care Affordability (OHCA) published a notification of proposed emergency regulatory action indicating that OHCA is planning to submit the proposed regulations to the Office...more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

Jones Day on

The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

Sheppard Mullin Richter & Hampton LLP

From Good Reprint Practices to SIUU Communications: What Firms Need to Know

On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

Bass, Berry & Sims PLC on

On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Husch Blackwell LLP

Revised California Regulations for Reporting Health Care Transactions

Husch Blackwell LLP on

In July of this year, the California Office of Health Care Affordability (“OHCA”) released draft regulations requiring the advance reporting of certain healthcare transactions that could affect the cost of healthcare or...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

Foley Hoag LLP

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

Foley Hoag LLP on

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...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

Troutman Pepper

Another Critical Item for Long-Term Care Facilities to Add to Their To-Do List — New Staffing Mandates

Troutman Pepper on

On September 1, the Centers for Medicare & Medicaid Services (CMS) released the Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting proposed rule. This...more

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