News & Analysis as of

Department of Health and Human Services (HHS) Compliance Healthcare Reform

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

White & Case LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more

Bass, Berry & Sims PLC

Healthcare Regulatory & Compliance Summit 2025 Recap

Health Policy Fireside Chat: What to Expect from the New Administration - Bill Mathias, Member at Bass, Berry & Sims, engaged in a fireside chat with Colin Roskey, Principal at FHP Strategies, former Deputy Assistant...more

McDermott Will & Schulte

OIG Nursing Facility Compliance Program Guidance: Renewed Focus on Fraud and Abuse

The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...more

McDermott+

Trump Administration Executive Order Tracker

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Sheppard Mullin Richter & Hampton LLP

Updated: The Future of Gender-Affirming Care – New Legal and Regulatory Considerations for Hospitals Providing These Services

As legal and policy developments continue to evolve, hospitals and health care professionals that provide gender-affirming care face new uncertainties regarding federal funding, compliance, and patient access. While these...more

Husch Blackwell LLP

New Legislation Revises Massachusetts' Determination of Need Statute

Husch Blackwell LLP on

On January 8, 2025, Massachusetts Governor Maura Healey signed into law “An Act Enhancing the Health Care Market Review Process.” Part of this sweeping healthcare oversight law includes changes to the Determination of Need...more

Fox Rothschild LLP

Compliance with HIPAA’s New Protections for Reproductive Health Privacy: What Covered Entities and Business Associates Need to...

Fox Rothschild LLP on

On April 26, 2024, the U.S. Department of Health and Human Services (“HHS”) issued new reproductive healthcare rules, which will go into effect on December 23, 2024. The underlying goals of these rules are to ensure...more

Health Care Compliance Association (HCCA)

An international standard for healthcare quality management

In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...more

Health Care Compliance Association (HCCA)

Hospital Settles CMP Case Over Free APPs; 'Bona Fide' Use Shouldn't Inspire Fear, Lawyer Says

In a case that may hit a raw compliance nerve, Ascension Macomb Oakland Hospital in Michigan has agreed to pay $100,000 in a settlement with the HHS Office of Inspector General (OIG) over free services provided to certain...more

Health Care Compliance Association (HCCA)

News Briefs: September 11, 2023

The HHS Office for Civil Rights (OCR) on Sept. 7 announced a proposed rule to bar discrimination based on disability.[1] “The rule, Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal...more

NAVEX

From Healthcare Sector, a Big Push for CCO Autonomy

NAVEX on

For the better part of a decade, the U.S. Justice Department has led the way on calls for a strong, independent corporate compliance function – until recently, that is. Then the Department of Health and Human Services leaped...more

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

Butler Snow LLP on

Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more

Shumaker, Loop & Kendrick, LLP

How Important is Exclusion Screening for Health Care Providers?

Under its exclusion authority, the Department of Health and Human Services Office of Inspector General (OIG) has the power to exclude certain individuals and entities from receiving compensation from federally funded health...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases Updates to Hospital Pricing Transparency Rule

On April 26, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a fact sheet on Hospital Price Transparency Enforcement Updates (the “Fact Sheet”) under the Hospital Price Transparency Rule (the “Rule”)....more

Sheppard Mullin Richter & Hampton LLP

OIG’s Modernization of Compliance Program Guidance: What to Expect

The Department of Health and Human Services Office of Inspector General (OIG) recently announced changes to its process for informing healthcare industry stakeholders of new or updated Compliance Program Guidance (CPG)....more

Epstein Becker & Green

Why Providers Should Think About the Impact of ICD-10 on Managed Care Reimbursement Now

Epstein Becker & Green on

ICD-10 implementation has been delayed by Medicare until October 2015. Many believe it may be delayed again and are putting off thinking about its impact until it is clear that the updated code set will be implemented by...more

Polsinelli

Don't Delay: Deadline for ICD-10 Compliance for October 1, 2015 Still Underway

Polsinelli on

In a final rule released on July 31, the U.S. Department of Health and Human Services (HHS) confirmed October 1, 2015 as the compliance date for health care providers, health plans, and health care clearinghouses to...more

Baker Donelson

OIG Proposes Updates to Exclusion and CMP Authority

Baker Donelson on

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a pair of proposed regulations to update its exclusion and civil monetary penalty (CMP) authority. The proposed regulations...more

Snell & Wilmer

Government Agencies Release Additional Guidance on Minimum Essential Coverage, Minimum Value and Summary of Benefits and Coverage

Snell & Wilmer on

As discussed in our March 20, 2013 Legal Alert – Health Care Reform’s Large Employer Play or Pay Penalties: A Checklist for Employers, large employers will be subject to a penalty tax if they either: (1) fail to offer...more

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