News & Analysis as of

Office of the Inspector General Social Security Act

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...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

Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Patient Assistance Funds for Patients With Certain Rare Diseases, Pending Medicare Part D...

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more

Arnall Golden Gregory LLP

OIG Approves Arrangement Incentivizing Medigap Policyholders to Seek Treatment From PHO Network Hospitals

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-01 (the “Opinion”), to a Medicare Supplemental Health Insurance...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

Foley & Lardner LLP

DOJ Antitrust Division and HHS OIG Enter into Partnership to Increase Coordination and Enforcement in Health Care

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On December 9, 2022, the U.S. Department of Justice Antitrust Division (DOJ) and Office of Inspector General of the U.S. Department of Health and Human Services (OIG) announced they had entered a Memorandum of Understanding...more

King & Spalding

OIG Issues Advisory Opinion on Medical Group’s Proposed Employment of Individual Excluded from Participation in Federal Health...

King & Spalding on

On May 25, 2022, OIG posted an Advisory Opinion analyzing a medical group’s proposal to employ an individual excluded from participation in federal health care programs to perform marketing tasks related to workers’...more

Morgan Lewis - Health Law Scan

OIG Launches New Resource Page Featuring Telehealth

Perhaps signaling the increasing likelihood of a permanent telehealth solution for the Medicare program, the Office of Inspector General for the US Department of Health and Human Services (OIG) has established a “Featured...more

ArentFox Schiff

Physician Fee Schedule Proposed Rule for 2022 Released: What Pharmaceutical Manufacturers Need to Know

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more

King & Spalding

OIG Updates COVID-19 Administrative Enforcement FAQs With Question Regarding Ambulance Providers’ Waiver or Discount of Certain...

King & Spalding on

On May 5, 2021, OIG issued guidance on its COVID-19 Administrative Enforcement FAQs page stating that an ambulance provider or supplier waiving or discounting Medicare beneficiary cost-sharing obligations presents a low risk...more

Foley Hoag LLP - Medicaid and the Law

The Availability of a Private Right of Action in Medicaid

A few years ago, we told you about the “ongoing saga” surrounding the ability of a Medicaid beneficiary or a provider of health care services to a Medicaid beneficiary to challenge a state Medicaid agency’s putative violation...more

King & Spalding

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

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Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

King & Spalding

OIG Issues Advisory Opinion on Arrangement for Charitable Organization to Buy and Forgive Patient Debt from Providers

King & Spalding on

On July 24, 2020, OIG issued an Advisory Opinion (AO), AO 20-04, regarding whether an arrangement where a charitable organization purchases or receives donations of unpaid medical debt from health care providers, and then...more

Baker Donelson

OIG's List of Excluded Individuals/Entities – What Employers Need to Know

Baker Donelson on

OIG maintains a list of all currently excluded individuals and entities called the "List of Excluded Individuals/Entities," or LEIE. Covered entities that hire – or continue to employ or work with – an individual or entity on...more

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

Holland & Knight LLP on

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

King & Spalding

OIG Exclusion Regulations Go Into Effect This Month

King & Spalding on

On January 20, 2017, Assistant to President Trump and Chief of Staff Reince Priebus directed Federal agencies to temporarily postpone the effective date of such regulations for sixty days (March 21, 2017) unless such action...more

McDermott Will & Emery

New OIG Exclusion Regulations About to Go into Effect

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Tucker Arensberg, P.C.

HHS Issues Rules Expanding OIG’s Exclusion Authorities

Tucker Arensberg, P.C. on

On January 12, 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issued final rules implementing permissive exclusion authorities authorized by the Affordable Care Act expanding...more

Hogan Lovells

HHS OIG Finalizes New Exclusion Rules as Administration Exits

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With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

McGuireWoods LLP

OIG Raises ‘Nominal Value’ for Gifts to Medicare and Medicaid Beneficiaries

McGuireWoods LLP on

On Dec. 7, 2016, just in time for the holiday season, the Office of Inspector General (OIG) released a policy statement regarding the nominal value of gifts that healthcare providers may give to Medicare and Medicaid...more

Holland & Knight LLP

Ten Things to Know About the CMS Long-Term Care Requirements Final Rule

Holland & Knight LLP on

Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more

Parker Poe Adams & Bernstein LLP

New Exclusion Guidance Includes Presumption of Compliance Plan

Section 1128 of the Social Security Act (42 U.S.C. 1320a–7) (available here) established mandatory and permissive authority for exclusion of health care providers from Federal health care programs based on provider conduct. ...more

Saul Ewing LLP

U.S. Department of Health and Human Services Updates Criteria for Permissive Exclusion Under Section 1128(b)(7) of the Social...

Saul Ewing LLP on

The HHS-OIG issued new guidelines on April 18, 2016 regarding the Secretary's exercise of the Department's permissive exclusion authority pursuant to Section 1128(b)(7) of the Social Security Act. The HHS-OIG's new guidance...more

Cooley LLP

Blog: OIG Releases Criteria For Implementing Exclusion Authority

Cooley LLP on

On April 18, 2016, the Health and Human Services Office of Inspector General (OIG) released updated guidance related to the criteria it may use for evaluating its permissive exclusion authority under Section 1128(b)(7) of the...more

Epstein Becker & Green

OIG Issues New Guidance on Its Evaluation Process and Non-Binding Criteria for Section 1128(b)(7) Exclusions

Epstein Becker & Green on

On April 18, 2016, the Office of Inspector General (“OIG”) of the Department of Health and Human Services issued a revised policy statement applicable to exclusions imposed under Section 1128(b)(7) of the Social Security Act...more

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