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Office of the Inspector General

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Mitchell, Williams, Selig, Gates & Woodyard,...

When The (IRS Refund) Check Isn't In the Mail

A recent spate of mail thefts has left the IRS holding the bag when taxpayer refunds have failed to reach those taxpayers. Congress has begun looking into these thefts. Some have occurred from USPS employee theft, but others...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Drug Cost Subsidies for Certain Low-Income Medicare Enrollees

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more

Orrick, Herrington & Sutcliffe LLP

FHFA’s OIG issues report on FHFA supervision of FHLBanks

On August 19, the OIG for the FHFA released a report evaluating the agency’s supervision of FHLBanks following the issue of four member banks during spring 2023. The report summarized four findings: (i) the FHFA has not...more

Health Care Compliance Association (HCCA)

Missing COI Program, Fabricated Outreach, Job, Health Records: The Many Types of Falsehoods

Report on Research Compliance 21, no. 9 (September, 2024) - How many types of falsehoods might sully applications for research funds and the studies they support? Unfortunately, the most recent semiannual report to...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

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Proposed Patient Assistance Program Operated by a Nonprofit Grant-Making...

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On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more

King & Spalding

OIG Audit Finds Medicare Overpaid Hospitals an Estimated $79 Million for Enrollees Who Had Received Mechanical Ventilation

King & Spalding on

On August 12, 2024, OIG announced the results of an audit of payments made to hospitals for inpatient claims with the Medicare Severity Diagnosis-Related Groups (MS-DRGs) that require ninety-six hours of consecutive...more

Foley & Lardner LLP

Health Care Enforcement: “Tea Leaves” in the 2024 National Health Care Fraud Summer Takedown

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Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more

Holland & Hart LLP

FMV for Provider Contracts: Regulatory Standards

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As a general rule, healthcare employers are required to pay employed physicians and other contracted providers fair market value (FMV) for their services, but many employers do not understand relevant regulatory standards. ...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

Mitchell, Williams, Selig, Gates & Woodyard,...

Jackson, Mississippi Drinking Water: U.S. Environmental Protection Agency Office of Inspector General Report

The United States Environmental Protection Agency (“EPA”) Office of Inspector General (“OIG”) issued an August 12th report titled: State Program Deficiencies and Inadequate EPA Oversight of State Enforcement Contributed...more

Locke Lord LLP

Interoperability and Information ‎Blocking:‎ Impact on Providers and Health Information ‎Networks

Locke Lord LLP on

Information blocking is an emerging area of law that has important implications for health care providers and health information networks. The law of information blocking originated with the 21st Century Cures Act (the “Act”)...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

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Enforcement Compliance Conference - November 18th - 20th, Arlington, VA

Is your compliance strategy aligned with current enforcement priorities? Hear first-hand from government enforcement leaders about regulatory changes, expectations, and key areas of concern. Gain insight into current...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Inquiry Into EPA's Use of Artificial Intelligence: U.S. EPA Office of Inspector General Project Notification

The United States Environmental Protection Agency (“EPA”) Office of Inspector General (“OIG”) issued a July 8th Project Notification titled: Inquiry into EPA’s Use of Artificial Intelligence. (“Notification”)....more

Manatt, Phelps & Phillips, LLP

OIG Concludes Gene Therapy Manufacturers Could Violate Law By Providing Fertility Support to Patient

On July 22 and July 23, Health and Human Services (HHS) Office of Inspector General (OIG) published two advisory opinions for proposals by pharmaceutical manufacturers to provide fertility support to patients receiving their...more

Paul Hastings LLP

Daily Financial Regulation Update -- Monday August 5, 2024

Paul Hastings LLP on

August 2, 2024- The Federal Reserve Board requested comment on a proposed rule that would establish data standards for certain information collections submitted to financial regulatory agencies....more

Arnall Golden Gregory LLP

OIG Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

Hogan Lovells

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

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The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

Morgan Lewis - Health Law Scan

Manufacturers Should Carefully Evaluate OIG’s Approval of Medicare Cost Sharing Subsidies in Clinical Trials

At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device...more

McCarter & English, LLP

More Roadblocks For Information Blocking: HHS Finalizes Rule Establishing Disincentives for Hospitals, Clinicians, and ACOs

On July 31, 2024, the Department of Health and Human Services (HHS) final rule, 89 FR 54662, establishing disincentives for certain healthcare providers that have committed information blocking, will become effective. This...more

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