News & Analysis as of

Department of Health and Human Services (HHS) Compliance Civil Monetary Penalty

Saul Ewing LLP

OCR Imposes $200,000 Civil Money Penalty Against HIPAA-Covered Entity

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On March 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil money penalty (“CMP”) of $200,000 against Oregon Health & Science University (“OHSU”) for failing to...more

Health Care Compliance Association (HCCA)

We’ll Take the Fine: OCR’s ‘Unwarranted,’ Costly Demands Prompted Hospital’s $538K Payment

The saga that led Children’s Hospital Colorado to accept a fine of more than $500,000 imposed by the HHS Office for Civil Rights (OCR) began on July 11, 2017, when a physician’s email account containing details on 3,300...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more

Saul Ewing LLP

Two CMPs and One Settlement Close Out 2024 HIPAA Enforcement

Saul Ewing LLP on

December 2024 was an active month for the U.S. Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"). OCR announced (i) a $1.19 million civil monetary penalty ("CMP") against Gulf Coast Pain...more

Gardner Law

OIG’s Perspective on Discount and Refund Programs

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

Health Care Compliance Association (HCCA)

In Biggest Stark-Based FCA Settlement Ever, Indiana Hospital Pays $345M, Has Unusual CIA

Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more

Bricker Graydon LLP

A Long-Awaited Change: OIG Updates its Compliance Program Guidances

Bricker Graydon LLP on

From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more

Foley & Lardner LLP

HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness

Foley & Lardner LLP on

In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more

ArentFox Schiff

Key Takeaways from OCR’s Latest Annual HIPAA Reports to Congress

ArentFox Schiff on

On February 17, 2023, the US Department of Health and Human Services Office for Civil Rights (OCR) released two companion reports to Congress detailing its actions in 2021 to enforce the privacy, security, and breach...more

Foley & Lardner LLP

HIPAA Breaches and Compliance: Key Findings & Lessons Learned from OCR’s Reports to Congress

Foley & Lardner LLP on

The Office of Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently submitted two annual reports to Congress setting forth a summary of complaints and breaches reported to the OCR during...more

ArentFox Schiff

Increased Federal Attention to Skilled Nursing Facility Compliance and Quality Improvement Results in Modified Program...

ArentFox Schiff on

The Biden Administration has embraced an aggressive and multi-part agenda designed to improve the safety and quality of care nationally in skilled nursing facilities (SNFs). The Biden Administration’s nursing home agenda...more

Steptoe & Johnson PLLC

OCR Enforcement of Right to Access Extends to Dental Practices

Steptoe & Johnson PLLC on

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) continues its enforcement activities to emphasize compliance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule’s...more

Foley & Lardner LLP

Bipartisan Leadership of House Committee of Energy and Commerce and its Health Subcommittee Urge HHS Secretary Becerra to...

Foley & Lardner LLP on

By letter dated April 13, 2021 (Letter), the Democrat and Republican leadership of the House Committee on Energy and Commerce and its Subcommittee on Health, wrote United States Health and Human Services Secretary, Xavier...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 45. News Briefs: December 2020 #2

Report on Medicare Compliance 29, no. 45 (December 21, 2020) - CMS said Dec. 18 it will audit a sample of hospitals for compliance with price transparency requirements, which take effect Jan. 1, according to MLN Connects....more

Bradley Arant Boult Cummings LLP

Information Blocking Rule Compliance Date Extended Due to Pandemic

The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the...more

King & Spalding

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

King & Spalding on

Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 20. News Briefs: June 2020

Report on Medicare Compliance 29, no. 20 (June 1, 2020) - The HHS Office of Inspector General (OIG) has unveiled its “OIG Strategic Plan: Oversight of COVID-19 Response and Recovery.” Its goals are protecting people, funds...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 16. News Briefs: April 2020 #3

Report on Medicare Compliance 29, no. 16 (April 27, 2020) - The HHS Office of Inspector General (OIG) has proposed a rule on civil monetary penalties (CMPs) for information blocking and fraud related to HHS grants, contracts...more

Baker Donelson

No Time to Rest: HHS Marches Ahead with Interoperability and Information Blocking Updates

Baker Donelson on

On April 21, 2020, the U.S. Department of Health and Human Services released a series of announcements signaling its intention to finalize and enforce certain aspects of the Office of the National Coordinator (ONC) Cures Act...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 15. News Briefs: April 2020 #2

Report on Medicare Compliance 29, no. 15 (April 20, 2020) - Maury Regional Medical Center in Tennessee has agreed to pay $1.7 million to settle false claims allegations over MS-DRG coding, the U.S. Attorney’s Office for...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 2. News Briefs: January 2020 #2

Report on Medicare Compliance 29, no. 2 (January 20, 2020) - - The HHS Office of Inspector General has updated its Work Plan, which includes an item on early discharges from inpatient rehabilitation facilities to home...more

Health Care Compliance Association (HCCA)

'Misinterpretation' of Breach Rule, Lack of Internal BAA Cost Hospital Group $2.1M

Report on Patient Privacy 19, no. 12 (December 2019) - Sentara Hospitals, a nonprofit group of 12 medical centers in Virginia and North Carolina, will implement a fairly minimal two-year corrective action plan (CAP) and...more

Health Care Compliance Association (HCCA)

First HIPAA Right of Access Initiative settlement announced by OCR

Compliance Today (November 2019) - On September 9, 2019, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced its first enforcement action and settlement in its Right of Access...more

Skadden, Arps, Slate, Meagher & Flom LLP

Health Care Investigation Trends: Corporate Integrity Agreements No Longer a Given

2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more

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