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Public Comment Department of Health and Human Services (HHS) Health Care Providers

Fisher Phillips

Proposed Updates to HIPAA Security Rule Would Require Entities to Adopt Enhanced Cybersecurity Measures

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The HIPAA Security Rule may soon undergo a big overhaul that would better defend healthcare data from cybersecurity threats – and require much more from covered entities when it comes to establishing and maintaining defenses....more

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

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

King & Spalding

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

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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

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

Foley Hoag LLP

CMS Releases Request for Information on Medicare Advantage Data

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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

Troutman Pepper Locke

New Proposed Rules to Combat Health Information Blocking

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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

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...

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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

Hogan Lovells

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

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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

Hogan Lovells

HHS seeks comment by June 6 on recognized security practices as mitigating factor in HIPAA enforcement

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The US Department of Health Human Services (HHS) is seeking public comments about the appropriate role of “recognized security practices” in enforcement of the HIPAA Security Rule. Congress, through an amendment to the HITECH...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Health Care Compliance Association (HCCA)

Families Detail Years of Anguish, Pain As They Plead for Changes to Privacy Rule

Report on Patient Privacy 21, no. 7 (July, 2021) - ...These heartfelt comments are among those submitted to the HHS Office for Civil Rights (OCR) in response to its January notice of proposed rulemaking (NPRM), which...more

Womble Bond Dickinson

New HHS Rules Would Simplify Emergency Data Sharing Procedures

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Officials at the Department of Health and Human Services (HHS) are proposing modifications to the HIPAA Privacy Rule to ease information sharing in emergencies. Some of the modifications being discussed would provide patients...more

Holland & Knight LLP

HHS Releases Four Major Rules to Lower Drug Prices, Amend Anti-Kickback and Stark Laws

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

Mintz - Health Care Viewpoints

Health Plan Transparency Rule: Comment Period Ends This Week

In November 2019, the U.S. Department of Health and Human Services, along with the U.S. Department of Treasury and the U.S. Department of Labor, (collectively, the Departments) released a proposed rule requiring group health...more

Baker Donelson

CMS Improves Stark Advisory Opinion Process

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The Centers for Medicare & Medicaid Services (CMS) recently updated its advisory opinion regulations, codified at 42 CFR §§ 411.370 through 411.389, in a final rule issued November 15, 2019. The update liberalizes and...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Employers May Need to Provide Cost Data Under Proposed ACA Rules

Employer-sponsored health plans and health insurers may be required to post online - and to provide participants upon request - a range of pricing and cost-sharing information beginning in 2021. Proposed Affordable Care...more

Bass, Berry & Sims PLC

Trump Administration Proposes Transparency Rule for Group Health Plans and Insurers

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On November 15, 2019, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the Departments), unveiled a proposed rule (scheduled to be published on November...more

Seyfarth Shaw LLP

CMS’ Proposed Stark Rule Change and Guidance on “The Big Three”: Fair Market Value, Commercial Reasonableness, and Taking Into...

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As part of a larger “Regulatory Sprint to Coordinated Care” the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health & Human Services (HHS) recently issued a proposed rule aimed at modernizing and...more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

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This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...more

Bass, Berry & Sims PLC

CMS and the OIG Issue Far-Reaching Proposed Rules to the Federal Stark and Anti-Kickback Laws

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In a coordinated effort, CMS and the Office of Inspector General (OIG) published proposed rules to modernize regulations implementing the federal physician-self referral law, commonly referred to as the “Stark Law” (Stark),...more

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