News & Analysis as of

Department of Health and Human Services (HHS) Reporting Requirements Enforcement Actions

Bricker Graydon LLP

What Goes Around Comes Around: White House Signals Increased Transparency in Coverage Enforcement

Bricker Graydon LLP on

On February 25, 2025, the White House issued a new executive order aimed at implementing many of the Administration's previously issued directives to health plans. ...more

Verrill

The Gag Clause Quandary for Self-Insured Group Health Plans—New FAQ Guidance

Verrill on

The Departments of Labor, Health and Human Services, and the Treasury, with the Office of Personnel Management (the “Departments”) jointly released FAQs About Consolidated Appropriations Act, 2021 Implementation Part 69...more

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

Bass, Berry & Sims PLC on

On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Health Care Compliance Association (HCCA)

Overlapping surgeries: Time for a compliance checkup?

Overlapping surgeries is a practice that has been used for many years by healthcare providers (such as hospitals and surgical centers). This practice generally refers to situations where one lead attending surgeon is...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

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

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

Goodwin on

​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...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...

Verrill on

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 4. In This Month's E-News: April 2020

Report on Research Compliance 17, no. 4 (April 2020) The Food and Drug Administration has accused a University of Michigan physician and professor of conducting research for more than three years after his approval from the...more

Health Care Compliance Association (HCCA)

'Misinterpretation' of Breach Rule, Lack of Internal BAA Cost Hospital Group $2.1M

Report on Patient Privacy 19, no. 12 (December 2019) - Sentara Hospitals, a nonprofit group of 12 medical centers in Virginia and North Carolina, will implement a fairly minimal two-year corrective action plan (CAP) and...more

Poyner Spruill LLP

Brace for Impact – Final HITECH Rules Will Require Substantially More Breach Reporting

Poyner Spruill LLP on

HHS has finally issued its omnibus HITECH Rules. Our firm will issue a comprehensive summary of the rules shortly, but of immediate import is the change to the breach reporting harm threshold. The modification will make it...more

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