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Audits Department of Health and Human Services (HHS)

Rivkin Radler LLP

OIG Audit of MACs Finds Deficiencies

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The 12 regional Medicare Administrative Contractors (MACs) were recently audited by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG). Each of the MAC jurisdictions was found by the OIG to...more

McDermott Will & Emery

This Week in 340B: February 4 – 10, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

ArentFox Schiff

Proposed Changes to the HIPAA Security Rule: What Regulated Entities Need to Know

ArentFox Schiff on

In the final days of the Biden Administration, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Security Rule under the Health...more

Kerr Russell

The Difference Between ‘Non-Covered’ vs. ‘Disallowed’ Services

Kerr Russell on

Question: I have had several colleagues describe their experience with dental plan audits. All of them have had to pay something back. Sometimes they say this is due to a service being deemed a “noncovered service.” Other...more

McDermott Will & Emery

This Week in 340B: January 14 – 20, 2025

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

King & Spalding

OIG Publishes the Fall 2024 Semiannual Report to Congress

King & Spalding on

On December 4, 2024, OIG issued its fall 2024 Semiannual Report to Congress (the Report), which provides a comprehensive overview of the agency’s work completed during the reporting period of April 1, 2024, through September...more

Ropes & Gray LLP

A Flurry of Healthcare Sector Cybersecurity Regulatory Developments in 2024

Ropes & Gray LLP on

2024 was a record year for cyberattacks in the healthcare sector. According to the Breach Portal maintained by the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”), to date this year, there...more

Brooks Pierce

OIG Recommends Changes to HIPAA Audit Program to Strengthen Data Protections, Implications for Regulated Entities

Brooks Pierce on

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is required by law to perform periodic audits of covered entities and business associates to ensure their compliance with HIPAA Security Rule...more

Mintz - Health Care Viewpoints

Unpacking Johnson & Johnson’s Lawsuit Over 340B Rebate Model

On November 12, 2024, the drug manufacturer Johnson & Johnson (J&J) filed a lawsuit against the Health Resources and Services Administration (HRSA) in the United States District Court for the District of Columbia. The lawsuit...more

Clark Hill PLC

The Value of an Effective HIPAA Compliance Program Amid OCR HIPAA Audits

Clark Hill PLC on

In 2024, the U.S. Department of Health and Human Services Office of Civil Rights (“OCR”) Director Melanie Fontes Rainer announced that OCR will resume auditing Health Information Portability and Accountability Act (“HIPAA”)...more

Greenbaum, Rowe, Smith & Davis LLP

New Senate Bill Seeks to Amend HIPAA with Mandatory Minimum Healthcare Cybersecurity Standards

On September 26, 2024, the Health Infrastructure Security and Accountability Act was introduced in the U.S. Senate. The bill would amend the Health Insurance Portability and Accountability Act (HIPAA) and direct the U.S....more

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

Foley & Lardner LLP on

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

Ankura on

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?

Holland & Knight LLP on

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

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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

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