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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

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

Foley & Lardner LLP

Compliance Compass: The Erlanger Complaint – A Cautionary Reminder About the Importance of FMV

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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

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

Health Care Compliance Association (HCCA)

A partnership with HHS OIG

This year’s annual Compliance Institute (CI) provided a strong reminder of just how fortunate we are to have such a strong relationship with the U.S. Department of Health and Human Services Office of Inspector General (OIG)....more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Baker Donelson

Information Blocking: Disincentives Established for Health Care Providers

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The United States Department of Health and Human Services (HHS) has now established disincentives for certain health care providers if found by the Office of Inspector General (OIG) to have committed information blocking...more

McDermott+

HHS Institutes Information Blocking Disincentives for Healthcare Providers

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The long-awaited final reg is upon us! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final regulation earlier this week...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Ankura

OIG Testimony Puts a Spotlight on Clinical Documentation and Payer Risk

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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

Quarles & Brady LLP

Is Your Employee or Contractor Excluded?

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Employers must check its employees, contractors and vendors to see if an individual or organization is excluded from participating in federal and/or state programs. While there are a variety of exclusion programs at the...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Bass, Berry & Sims PLC

Is Your Compliance House In Order? Tips for Ensuring Private Equity and Portfolio Company Compliance in the Wake of the Recent...

The recent Request for Information by the Federal Trade Commission (FTC), Department of Justice (DOJ) and Department of Health and Human Services (HHS) seeking input on the effects of private equity (PE) investment in the...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 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

McDermott Will & Emery

2024 Chart of Additional Healthcare Regulations

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During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | March 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part II

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In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part I

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In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...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

Health Care Compliance Association (HCCA)

The case for autonomy and resources

There it is on page 39, under “Compliance Leadership and Oversight: The Compliance Officer’s Primary Responsibilities”: “. . . the compliance officer should not lead or report to the entity’s legal or financial...more

Health Care Compliance Association (HCCA)

HHS OIG General Compliance Program Guidance: An empowered and independent compliance function

Corporate Compliance & Ethics Week 2023 kicked off with a gift for healthcare and life sciences compliance practitioners by way of the U.S. Department of Health and Human Services (HHS) Office of Inspector General’s (OIG)...more

Sheppard Mullin Richter & Hampton LLP

District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

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