News & Analysis as of

Office of the Inspector General Reporting Requirements

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

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

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

Arnall Golden Gregory LLP

Changing With the Times: OIG’s New “General Compliance Program Guidance” Expands Focus to New Industry Stakeholders and Updates...

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently published a new resource titled General Compliance Program Guidance (“GCPG”), which is described as a reference guide for the...more

Mintz - Health Care Viewpoints

HHS Proposes Appropriate Disincentives for Health Care Providers That Commit Information Blocking

In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more

Akin Gump Strauss Hauer & Feld LLP

Research Security: New NIH Policy Requires Foreign Subrecipients to Share Lab Notebooks & Research Data With the U.S. Prime...

On September 15, 2023, the National Institutes of Health (NIH) moved forward with a controversial new policy requiring foreign subrecipients to provide, at least once per year, copies of lab notebooks, data and documentation...more

Health Care Compliance Association (HCCA)

Where’s the Proof? NSF OIG Provides Insights on Crafting That All-Important Investigation Report

Report on Research Compliance Volume 20, no. 10 (October, 2023) Please don’t send uncorrected transcripts of interviews conducted via Zoom or other means to the National Science Foundation (NSF) Office of Inspector General...more

BakerHostetler

Are You Complying with ClinicalTrials.gov Reporting Obligations?

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Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more

McDermott Will & Emery

Special Report - A Million Reasons to Share: OIG’s Final Rule on Information Blocking Enforcement

McDermott Will & Emery on

On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more

Health Care Compliance Association (HCCA)

NSF Suspends 18 Awards, Receives Repayments Related to Foreign Ties, Research Misconduct

One university lost 14 awards; another, four. An investigator was suspended governmentwide. A public institution paid back more than $850,000, while two others returned nearly a million dollars....more

Hogan Lovells

OIG audit finds lack of compliance with ClinicalTrials.gov reporting requirements from NIH studies

Hogan Lovells on

A newly released audit by the Office of Inspector General (OIG) found that for clinical trials funded by the National Institutes of Health (NIH) for which responsible parties were required to submit results to...more

Womble Bond Dickinson

EPA to Increase Review of Voluntary Self-Disclosures of Violations

Womble Bond Dickinson on

On June 30, 2022 the EPA Office of Inspector General (“OIG”) issued the results of an evaluation to determine if EPA’s process for screening self-reported environmental violations through electronic disclosure is effective....more

Mintz - Health Care Viewpoints

OIG Revises and Renames the Provider Self-Disclosure Protocol

For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more

K&L Gates LLP

Health Care Triage: Understanding OIG and CMS Audits

K&L Gates LLP on

Richard Church interviews Stephen Bittinger about the scope and authority of OIG and CMS audits, outlining the similarities and differences between the two from a provider perspective. The presenters discuss the key...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more

Morrison & Foerster LLP - Government...

Levels Of Accountability: What Federal Contractors Should Know About Small Business Subcontracting Plans And Compliance Reviews

Every year, the U.S. federal government establishes goals for the awards of prime contracts and subcontracts to small business concerns. While agencies are responsible for achieving these goals by awarding prime contracts to...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Managed Care Compliance Conference - February 1st - 3rd, 9:30 am - 3:45 pm CST

The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more

Health Care Compliance Association (HCCA)

Hospitals Were Overpaid $33M Over Device Credits; Policy May Change

Report on Medicare Compliance 29, no. 42 (November 23, 2020) - Medicare administrative contractors (MACs) will be coming to 911 hospitals for overpayments caused by unreported manufacturer credits for recalled or...more

Verrill

“If I’ve told you once, I’ve told you eight times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits...

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Each year, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues dozens of audit reports. While each is important in its own way, some stand out with language that appears to reflect...more

Polsinelli

OIG Issues Guidance on Speaker Programs By Drug and Device Companies

Polsinelli on

This week, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert providing insight into speaker programs put on by drug and medical device companies that the OIG considers signs of potential fraud. Generally,...more

Vinson & Elkins LLP

To Tell The Cyber-Truth: DHS OIG Report Reveals Details On Government Contractor Suspension After Cyberattack And Data Breach

Vinson & Elkins LLP on

In June 2019, U.S. Customs and Border Protection (“CBP”) suspended a government contractor, Perceptics, LLC, after it suffered a highly publicized cyberattack that resulted in a breach of sensitive data collected from...more

Dechert LLP

SEC Updates Rule 17H Risk Assessment Thresholds for Certain Broker Dealers

Dechert LLP on

The Securities and Exchange Commission issued an order (Order)1 on June 29, 2020, under Section 17(h)(4) of the Securities Exchange Act of 1934, raising the thresholds for compliance with the recordkeeping and reporting...more

Holland & Knight LLP

How to Compile the "Interim" Report Due July 17 on Expenditures Related to COVID-19

Holland & Knight LLP on

The U.S. Department of the Treasury's Office of Inspector General (OIG) released a memorandum on July 2, 2020, that lays out the reporting and document retention requirements that the OIG intends to apply to recipients of...more

Baker Donelson

CARES Act Coronavirus Relief Fund Compliance: Enter the OIG

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On July 2, 2020, the U.S. Department of Treasury Office of Inspector General (OIG) issued a memorandum providing a glimpse into how it will monitor the receipt, disbursement, and use of financial assistance from the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

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