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Department of Health and Human Services (HHS) 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

Seyfarth Shaw LLP

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

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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

Quarles & Brady LLP

DEA Publishes Notice of Proposed Rulemaking to Reschedule Marijuana from Schedule I to Schedule III

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The United States Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking to reschedule marijuana from schedule I of the Federal Controlled Substance Act (“CSA”) to schedule III. As a reminder,...more

Morgan Lewis - As Prescribed

From Prohibition to Prescription: DEA Issues Proposed Rule to Reschedule Marijuana

On May 21, 2024, The Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking in the Federal Register (FR) to reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA)....more

Vicente LLP

Cannabis Rescheduling: The DEA's Proposed Rule and the Supporting OLC Opinion

Vicente LLP on

On May 21, 2024, the DEA finally published its proposed rule related to rescheduling marijuana and commenced a 60-day period where the public can submit comments regarding DEA's proposed move to reschedule marijuana (the...more

Bradley Arant Boult Cummings LLP

Now That It Appears Marijuana Is Being Rescheduled, How Does That Process Work?

As we at Budding Trends reported last week, the DEA is set to finally accept the recommendation of the U.S. Department of Health and Human Services (HHS) to reschedule marijuana from Schedule I to Schedule III under the...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

McCarter & English, LLP

ONC Shares Draft Federal Health IT Strategic Plan—A Catalyst for Private Entities

In March 2024, the Department of Health and Human Services—through the Office of the National Coordinator for Health IT (ONC)—released a draft 2024-2030 Federal Health IT Strategic Plan for public comment. A collaborative...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

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Akin Gump Strauss Hauer & Feld LLP

Cannabis in 2024: HHS Rescheduling Recommendation and SAFER Banking

Key Points - The scientific review supporting HHS’s recommendation to DEA that cannabis be reclassified from a Schedule I to a Schedule III drug was published on January 12, 2024. Classifying cannabis as a Schedule III...more

Foley Hoag LLP

CMS Releases Request for Information on Medicare Advantage Data

Foley Hoag LLP on

On January 30, 2024, CMS published in the Federal Register an RFI to seek input from the public regarding increased public releases of MA data to improve transparency in the program. CMS stated responses to this RFI may be...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

Benesch

President Biden’s Executive Order on Artificial Intelligence Provides Important Initial Guidelines in Governmental Regulation for...

Benesch on

With growing concerns related to how artificial intelligence is developed, regulated, and implemented in the United States, this Executive Order represents possibly the first of several governmental actions to address this...more

Troutman Pepper

New Proposed Rules to Combat Health Information Blocking

Troutman Pepper on

The U.S. Department of Health and Human Services (HHS) has just unveiled a proposed rule designed to penalize health care providers engaging in information blocking. Information blocking is a practice where health care...more

McGuireWoods LLP

HHS Proposes Updates to 20-Year-Old Public Health Service Policies on Research Misconduct

McGuireWoods LLP on

The U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) released a notice of proposed rulemaking to update the 2005 Public Health Service (PHS) Policies on Research Misconduct. HHS seeks...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

Benesch

DEA Permits Continuation of Telemedicine Controlled Substances Prescribing: A Temporary Pause of the Proposed Rules or a...

Benesch on

Earlier this year in late February, the Drug Enforcement Administration (DEA) announced proposed rules attempting to change the rules for tele-prescribing controlled drugs that were permitted during the COVID-19 Public Health...more

Bass, Berry & Sims PLC

Proposed Changes to HIPAA Privacy Rule Strengthening PHI Protections for Reproductive Health Care Information Have Broad...

Bass, Berry & Sims PLC on

On April 13, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a Notice of Proposed Rulemaking (NPRM) to amend the HIPAA Privacy Rule, 45 C.F.R. Part 160 and Part 164, Subparts A...more

Holland & Knight LLP

Trucking Industry Group Seeks to Conduct Drug Screening Utilizing Hair Testing

Holland & Knight LLP on

The Federal Motor Carrier Safety Administration (FMCSA) has requested public comment on an application for exemption submitted by The Trucking Alliance that would allow trucking companies to use hair testing in addition to...more

Hogan Lovells

HHS highlights significance of new healthcare technologies in series of regulatory actions

Hogan Lovells on

Recent U.S. Department of Health Human Services (HHS) regulatory actions emphasize the role emerging technologies play in the provision of healthcare, particularly as clinical innovations proliferate in response to the...more

ArentFox Schiff

OCR Seeks Public Comments on HIPAA/HITECH Security and Enforcement Provisions

ArentFox Schiff on

The HHS Office for Civil Rights is requesting comments about HIPAA covered entities’ and business associates’ implementation of “recognized security practices” and payments to “harmed individuals” from funds the agency...more

Faegre Drinker Biddle & Reath LLP

FCC Seeks Comment on HHS/CMS Request for Certainty About Communications Critical to Federal and State Health Insurance Programs...

Reacting quickly to a joint request by the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) (collectively, the Health Agencies) last Thursday, the FCC released a Public...more

Akin Gump Strauss Hauer & Feld LLP

HHS Seeking Public Comment on 2022 Environmental Justice Strategy and Implementation Plan Draft Outline

Key Points: The OASH under HHS is soliciting input from the public on its 2022 Environmental Justice Strategy and Implementation Plan Draft Outline. Comments are due to HHS by May 19, 2022. The 2022 HHS Environmental...more

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