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Healthcare Public Comment

Quarles & Brady LLP

Justice Department’s New Task Force on Health Care Monopolies and Collusion

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DOJ recently formed the Antitrust Division’s (the “Division”) Task Force on Health Care Monopolies and Collusion (“HCMC”), signaling anticompetitive activity in health care markets as an enforcement priority....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

Morrison & Foerster LLP

The FTC and DOJ Enlist the Public in Latest Attack on Serial Acquisition Strategies

On May 23, 2024, the Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”) Antitrust Division announced a Request for Information (“RFI”) seeking information from the public to “identify serial acquisitions...more

Seyfarth Shaw LLP

FTC and DOJ Seek Public Help Identifying “Serial Acquisition Strategy” Targets

Seyfarth Shaw LLP on

The Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) announced on Thursday, May 23, that they are expanding their search for businesses using “roll up” strategies to consolidate...more

Seyfarth Shaw LLP

All Gas No Brakes – The FTC, DOJ, and HHS Unveil Online Reporting Portal as Latest Effort to Combat Unfair and Anticompetitive...

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On April 18, 2024, the Federal Trade Commission (“FTC”), Justice Department (“DOJ”), and the U.S. Department of Health and Human Services (“HHS”) launched an online reporting portal, HealthyCompetition.gov, for the public to...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

King & Spalding

FTC and DOJ Increase Scrutiny of Private Equity’s Role in Healthcare

King & Spalding on

On March 5, 2024, the Federal Trade Commission (FTC) hosted a virtual workshop titled “Private Capital, Public Impact: an FTC Workshop on Private Equity in Healthcare” (the Workshop). The agenda, together with a recording of...more

McDermott Will & Emery

Top Takeaways | FTC Hosts Workshop, Solicits Public Comments on Private Equity in Healthcare

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On March 5, 2024, the Federal Trade Commission (FTC) hosted “Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care” to examine the role of private equity investment in healthcare markets. The same...more

Bradley Arant Boult Cummings LLP

Spotlight on Minimum Staffing Standards in Long Term Care Facilities

The long term care industry is currently in the midst of a labor crisis, with nursing homes in particular experiencing chronic and severe staffing shortages. Even before the COVID-19 pandemic, a rapidly aging population,...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

McDermott Will & Emery

Biden Administration Proposes New Framework for Exercising March-In Rights on Government-Funded Inventions; Drug Pricing May Be...

McDermott Will & Emery on

Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...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

Mintz - Health Care Viewpoints

California Revises Proposed Regulations for the Pre-Closing Review of Health Care Transactions: Pubic Comment Period Ends October...

California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care transactions beginning January 1, 2024. As further explained in our previous post, subject to...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

McDermott Will & Emery

CMS Pushes to Expand Hospital Price Transparency Requirements, Enforcement Activity

McDermott Will & Emery on

On July 26, 2023, two days after the Centers for Medicare and Medicaid Services (CMS) issued its second largest civil monetary penalty for noncompliance with the hospital price transparency rule, CMS hosted a webinar...more

McDermott Will & Emery

California Publishes Draft Regulations on Filing Requirement for Healthcare Entity Transactions

McDermott Will & Emery on

California’s Office of Health Care Affordability (OHCA) has published draft regulations on the healthcare transaction notice requirement that will become effective on April 1, 2024. Entities entering into healthcare...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?

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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

Manatt, Phelps & Phillips, LLP

FTC Proposal Restricts Health Tech and Digital Health Companies’ Use of Auto-Renewal Provisions

Many health tech and digital health companies offer subscription or membership services to clients and patients on an auto-renewal basis. Under this model, a subscriber’s credit card is automatically charged on a monthly,...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

Nelson Mullins Riley & Scarborough LLP

FDA Revises Recommendations Regarding Electronic Systems, Records, and Signatures in Clinical Investigations

On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more

Bradley Arant Boult Cummings LLP

FTC Proposes Rule to Strike Noncompete Agreements Nationwide

On January 5, 2023, the Federal Trade Commission (FTC) announced a proposed new rule that would effectively prohibit employers from requiring employees to agree to noncompete clauses. The public is invited to submit comments...more

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