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Office of the Inspector General Department of Health and Human Services (HHS) 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

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

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)

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

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

Mintz - Health Care Viewpoints

The OIG Urges CMS to Implement Solutions to Reduce Fraud in Medicare Part C and Part D

Recently, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued its 2019 “Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: Top Unimplemented Recommendations.” The OIG...more

Morgan Lewis

OIG Recommends Increased Oversight and Reporting Requirements for Hospice

Morgan Lewis on

In keeping with its recent recommendations to CMS, the Office of Inspector General for the US Department of Health and Human Services (OIG) is recommending increased oversight and compliance reporting requirements for...more

Jones Day

D.C. Circuit Rejects Novel Theory of Reverse False Claims Liability for Reporting Violations

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The Situation: In U.S. ex rel. Kasowitz Benson Torres LLP v. BASF Corporation, the relator alleged reverse false claims liability under the False Claims Act ("FCA") for the defendants' purported failure to comply with...more

ArentFox Schiff

OIG Issues Two Reports Identifying Medicare Hospice Beneficiaries at Risk of Harm from Hospice Deficiencies

ArentFox Schiff on

On July 9, 2019, the US Department of Health and Human Services, Office of Inspector General (OIG) released two reports addressing hospice deficiencies and the risks, potential harm, and actual harm those deficiencies posed...more

Mintz - Health Care Viewpoints

A Deeper Dive: What the Trump Administration Blueprint to Lower Drug Prices Might Mean for Medicaid

It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s Request for Information (RFI) on the Blueprint. We previously posted about the Blueprint’s focus...more

McDermott Will & Emery

Pushing “PAUSE” on the 340B Program: The New Bi-Partisan Bill that Could Reshape the 340B Program

In late December 2017, Republican Rep. Larry Bucshon (with bi-partisan support) introduced the “340B Protecting Access for the Underserved and Safety-net Entities Act” (340B PAUSE Act), legislation that would implement a...more

Mintz - Health Care Viewpoints

Six Key Follow-Up Questions Asked by Congress in 340B Hearing

Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more

Cadwalader, Wickersham & Taft LLP

OIG Issues Stark Warning to Skilled Nursing Facilities: Potential Abuse or Neglect of Residents Receiving Emergency Room Services...

On August 24, 2017, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued an “Early Alert” that disclosed the preliminary results of its ongoing review of abuse of Medicare...more

BakerHostetler

Ch-Ch-Ch-Ch-Changes: Reporting Requirements for Updating Your CMS Provider Enrollment

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With the possibility of significant penalties for improperly reported transactions, it is important to understand how certain changes necessitate specific reporting. Is your organization considering a stock transfer, a...more

Foley & Lardner LLP

Clinical Laboratories: Proposed Rule Implements Requirements for Reporting and Payment Based on Private Payer Rates

Foley & Lardner LLP on

As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more

Holland & Knight LLP

OIG Report Raises Serious Medicare Part D Fraud, Waste and Abuse Concerns

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Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more

Troutman Pepper

OIG Work Plan Midyear Update Adds Activities Related to Medicare Part D and Medicaid Rebates

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The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies. Annually, the Department of Health and Human Services...more

Epstein Becker & Green

Medicare's Proposed Home Health Rule for 2015: CMS Suggests Only Limited Relief to the Face-to-Face Encounter Documentation...

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On July 7, 2014, the Centers for Medicare & Medicaid Services ("CMS") published proposed changes to the Medicare Home Health Prospective Payment System ("HH PPS") for calendar year 2015 ("Proposed Rule"). The Proposed Rule...more

BakerHostetler

Recent OIG Report Underscores Need for Home Health Agencies and Physicians to Comply With Medicare’s Face-to-Face Documentation...

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Medicare overpaid the home health industry $2 billion between January 2011 and December 2012, according to a recent report by the U.S. Department of Health and Human Services, Office of Inspector General (OIG). The OIG’s...more

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