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Office of the Inspector General Food and Drug Administration (FDA) Medicare

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

Alston & Bird

Health Care Week in Review: Senate Finance Committee Releases Plan to Address Workforce Shortages, Court Sides with Manufacturers...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

Alston & Bird

Health Care Week in Review: CMS Releases IPPS Proposed Rule; Congress Holds Hearings on Chronic Care and Telehealth

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: CMS Finalizes Rules for Medicare Advantage, Part D, and Affordable Care Act (ACA) Marketplaces

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Holland & Knight LLP

Key Value-Based Care Developments to Watch in 2024

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The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more

Foley & Lardner LLP

OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials

Foley & Lardner LLP on

In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more

McNees Wallace & Nurick LLC

The OIG Releases Updated General Compliance Program Guidance

As 2023 came to a close, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an updated General Compliance Program Guidance (GCPG) manual, which serves as a reference guide for...more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Harris Beach PLLC

OIG Opinion: DME Supplier Subsidy of Medicare Cost-Sharing in Cardiac Trial OK

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This favorable OIG opinion concludes that although the proposed arrangement (“Proposed Arrangement”) to subsidize Medicare cost-sharing obligations for Medicare patients in a cardiac clinical trial (“Study”) would constitute...more

ArentFox Schiff

CMS Issues Revised Guidance Implementing Medicare Inflation Rebates Under the Inflation Reduction Act

ArentFox Schiff on

The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more

Foley & Lardner LLP

Remote Patient Monitoring: OIG Issues Consumer Alert

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On November 22, 2023, while many were preparing for the Thanksgiving holiday, the Office of Inspector General (OIG) posted a consumer alert (Alert) warning the public about a fraud scheme involving monthly billing for remote...more

McGuireWoods Consulting

Washington Healthcare Update - November 2023 #3

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This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Alston & Bird

Health Care Week in Review: PAHPA Reauthorization Bills Receive House and Senate Markups

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Paul Hastings LLP

Finance in Five Minutes: Healthcare Finance Checkup

Paul Hastings LLP on

While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more

Alston & Bird

Health Care Week In Review: CMS Issues Proposed Rule, CBO Releases Health Insurance Coverage Projections

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

King & Spalding

OIG Issues Favorable Opinion Regarding Pharmaceutical Company’s Free 14-Day Drug Supply to Patients Experiencing a Delay in...

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On February 28, 2023, OIG posted Advisory Opinion 23-02, responding to a request by a pharmaceutical company (the Company) regarding its proposal to offer a free 14-day supply of an enzyme replacement therapy drug to patients...more

Warner Norcross + Judd

Second Circuit Rules Anti-Kickback Statute Means No “Corrupt Intent” Required for Liability

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On January 9, 2023, the U.S. Supreme Court denied Pfizer Inc.’s petition for a writ of certiorari. The denial brought the pharmaceutical company’s lawsuit challenging the breadth of the federal Anti-Kickback Statute (AKS) to...more

Alston & Bird

Health Care Week in Review: Biden Administration Released a Final Rule on Surprise Billing

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Below is Alston & Bird's Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

King & Spalding

DOJ and HHS Issue Healthcare Fraud and Abuse Control Program Fiscal Year 2021 Report

King & Spalding on

Last week, DOJ and HHS-OIG published its annual report regarding the Healthcare Fraud and Abuse Control (HFAC) Program (the Report). The Report summarizes the enforcement activity of DOJ and HHS and states that during Fiscal...more

Holland & Knight LLP

Holland & Knight Health Dose: June 22, 2022

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ...more

Mintz - Health Care Viewpoints

DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more

King & Spalding

OIG Determines That a Program to Provide Free Eye Drops to Eligible Patients Undergoing a Particular Treatment is Not Subject to...

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On December 6, 2021, OIG issued an advisory opinion (Advisory Opinion No. 21-19) to a pharmaceutical manufacturer regarding its arrangement to provide free eye drops to patients who are prescribed one of the manufacturer’s...more

King & Spalding

OIG Issues Advisory Opinion Permitting Cost-Sharing for Medicare-Reimbursable Items and Services in a Clinical Trial

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On November 19, 2021, OIG issued Advisory Opinion No. 21-17 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain Medicare cost-sharing obligations in the context of a...more

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