News & Analysis as of

Department of Health and Human Services (HHS) Audits

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Gardner Law

Kickbacks and Consequences: Lessons from the Innovasis Settlement

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On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more

BakerHostetler

Looking in the Mirror: HHS OIG Audit Demonstrates HHS Agency’s Own Need for Focus on Cloud Security

BakerHostetler on

The OIG, the nation’s leader in fighting fraud, waste and abuse of Medicare, Medicaid and other HHS programs, periodically publishes reports on how federal healthcare programs could improve....more

Foley & Lardner LLP

Compliance Compass: The Erlanger Complaint – A Cautionary Reminder About the Importance of FMV

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Although most health care lawyers and compliance officers who review and analyze physician compensation understand that fair market value (FMV) is important, the nuances around FMV are sometimes missed....more

Proskauer - Health Care Law Brief

New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive...

On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more

Ankura

OIG Testimony Puts a Spotlight on Clinical Documentation and Payer Risk

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In recent testimony before the United States House Committee on Energy and Commerce Subcommittee on Oversight and Investigations, Christi A. Grimm, Inspector General of the Department of Health and Human Services (HHS)...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: June 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Holland & Knight LLP

What HIPAA Security Rule Surprises Await Healthcare Providers for the Second Half of 2024?

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The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has, as part of its mandate, the responsibility to enforce the Health Insurance Portability and Accountability Act (HIPAA) Security Rule....more

ArentFox Schiff

Fast Five: Important Law and Policy Updates for US Health Care Transactions

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With the end of the first quarter of 2024, we highlight five developments, changes, or challenges that health systems, hospitals, nursing homes, clinics, physician practices, health insurers, and other health care providers,...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

Epstein Becker & Green

2024 Update: Regulators Use “Carrots and Sticks” to Incentivize Healthcare Sector Cybersecurity Compliance

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Healthcare organizations continue to be prime targets of cyberattacks. It is well-established that cyberattacks can lead to financial loss, reputational damage, and, in some cases, risks to patient care and safety. The recent...more

NAVEX

Addressing Cybersecurity Expectations in Healthcare

NAVEX on

2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

Gardner Law

Highlights from OIG’s New Compliance Program Guidance

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The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. The HHS OIG’s new General Compliance Program Guidance (GCPG) is intended...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: March 2024

The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...more

Baker Donelson

HIPAA Updates: The Obligations Continue to Unfold

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There has been a notable emphasis on proactive enforcement of the privacy and security of protected health information in recent weeks as evidenced by multiple developments regarding compliance with the Health Insurance...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - March 1st, St. Louis, MO

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Gardner Law

CMS Auditing Companies for Sunshine Compliance: Are You Ready?

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As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more

Harris Beach PLLC

HHS OIG Work Plan – January Update – Audits for Optometrists’ Services to Nursing Facility

Harris Beach PLLC on

In its January 16, 2023, Enforcement listserv notice, HHS’s Office of Inspector General (“OIG”) recently published Work Plan Updates for January. Although six updates were published, this article only highlights the...more

Holland & Knight LLP

OIG to Audit CMS Oversight of Nursing Home Surveys by Third-Party Contractors

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), a top federal watchdog tasked with overseeing Medicare, Medicaid and other HHS programs, recently announced that it will audit the...more

NAVEX

Your Questions, Answered – Mastering DOJ Compliance Guidance: Building a Strong Resilient Foundation for Your Organization's...

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NAVEX recently hosted a webinar in partnership with Granite GRC about the recent updates to the U.S. Department of Justice (DOJ) and the current Evaluation of Corporate Compliance Programs (ECCP). This posts answers questions...more

Harris Beach PLLC

HHS OIG Work Plan – December Update – Audits for Medicare Emergency Codes

Harris Beach PLLC on

In its December 18, 2023, Enforcement listserv notice, HHS’s Office of Inspector General (“OIG”) published its Work Plan Updates for December. Although six updates were published, this article will only highlight the...more

Holland & Hart LLP

OIG Issued Updated General Compliance Program Guidance for Healthcare Providers and Stakeholders

Holland & Hart LLP on

On Monday, November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released its General Compliance Program Guidance (“GCPG”) for the general healthcare compliance community and...more

Foley & Lardner LLP

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

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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

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2023

A criminology professor at Florida State University (FSU), dogged by accusations of research misconduct and the subject of multiple probes, was terminated last month, according to a letter published by Retraction Watch. Hired...more

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