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Hospitals Advisory Opinions

Bass, Berry & Sims PLC

OIG Approves Hospital’s Redemption Offer to Retiring Physician-Owners

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On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 23-12, approving a physician-owned hospital’s offer to redeem over a two-year period the...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint Venture

On August 18, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-05 (Advisory Opinion), in which the OIG warned that it would likely issue sanctions under the Federal anti-kickback statute (AKS) if a...more

Holland & Knight LLP

OIG Says Proposed Neurological Monitoring Arrangement Creates Kickback Risk

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The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable Advisory Opinion on Aug. 15, 2023, involving an intraoperative neuromonitoring (IONM) services arrangement. The Advisory...more

King & Spalding

OIG Issues Favorable Advisory Opinion on a Drug Manufacturer’s Provision to Hospitals of Trial Units of Antipsychotic Medication...

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On December 22, 2022, OIG issued a favorable advisory opinion concluding that it would not impose administrative sanctions on a pharmaceutical manufacturer for providing trial units of a certain antipsychotic drug (Drug) to...more

Bass, Berry & Sims PLC

OIG Approves Hospital Provision of Nurse Practitioner Services in Advisory Opinion

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services recently posted Advisory Opinion 22-20, approving an acute care hospital’s arrangement under which its employed nurse practitioners...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Health System’s Use of Nurse Practitioners for Services Traditionally Performed by...

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On December 19, 2022, OIG posted Advisory Opinion 22-20, responding to a request submitted by an acute care hospital (the Hospital) regarding the utilization of its employed nurse practitioners (NPs) to perform services that...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

McDermott Will & Emery

OIG Issues Unfavorable Opinion on Laboratory Specimen Collection Payments to Hospitals

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OIG has a long history of scrutinizing laboratory arrangements because of the agency’s view that these arrangements are particularly susceptible to fraud and abuse. Much of OIG’s past guidance focused on laboratory...more

Venable LLP

Contractual Safeguards That Fall Short of a Safe Harbor

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According to a recent Advisory Opinion from the Department of Health and Human Services (HHS) Office of Inspector General (OIG), a proposed fee arrangement could run afoul of the Federal anti-kickback statute, 42 USC...more

Bass, Berry & Sims PLC

OIG Declines to Approve Lab’s Payment of Specimen Collection Fees to Hospitals

On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more

Bass, Berry & Sims PLC

OIG Approves a Free Drug Program Limited to Hospital Inpatients

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On November 16, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) published Advisory Opinion 21-16, approving an arrangement under which a pharmaceutical manufacturer provides free...more

Mintz - Health Care Viewpoints

OIG Issues Favorable Advisory Opinion on Hospital’s Warranty Program for Joint Replacement Procedures

On September 15, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a hospital’s proposal to implement a program through which patients...more

King & Spalding

OIG Issues Advisory Opinion Permitting Drug Manufacturer to Provide Travel, Lodging, and Expenses to Patients in Limited...

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On January 15, 2020, OIG issued Advisory Opinion No. 20-02 analyzing an arrangement between a pharmaceutical manufacturer and certain drug recipients whereby the manufacturer provides certain drug recipients with financial...more

Baker Donelson

OIG Approves Warranty Program for Surgical Devices and Wound Care Products in Advisory Opinion 18-10

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In Advisory Opinion 18-10, issued September 10, 2018, the OIG permitted a manufacturer of surgical devices and wound care products to implement a warranty program under which the manufacturer's hospital customers could...more

Holland & Knight LLP

OIG Considers Drug Pricing History in an Unfavorable Advisory Opinion on Free Drugs

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• The OIG issued an unfavorable advisory opinion on a proposed program by which a marketer would provide free drugs to hospitals to utilize in an inpatient setting to treat infantile epilepsy. • Contrary to the typical...more

Robinson+Cole Health Law Diagnosis

OIG Disapproves of Drug Company’s Plan to Provide Hospitals Free Medications in Advisory Opinion

On November 16, 2018, the Office of the Inspector General of the Department of Health and Human Services (OIG) posted an unfavorable Advisory Opinion No. 18-14 regarding an arrangement where a vendor (Requestor) of a commonly...more

Foley & Lardner LLP

Some Helpful Managed Care Guidance Provided in Advisory Opinion 18-11

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Practitioners in the Medicare or Medicaid managed care space place heavy reliance on the protection of the Anti-Kickback Statute (AKS) Safe Harbor found at 42 C.F.R. § 1001.952(t), generally known as the “EMCO [eligible...more

Sheppard Mullin Richter & Hampton LLP

How Broad is the Managed Care Safe Harbor?

In Advisory Opinion No. 18-11, the Department of Health and Human Services Office of the Inspector General (the “OIG”) addressed a Medicaid managed care organization’s (“MCO”) proposal to pay its contracted providers and...more

Mintz - Health Care Viewpoints

OIG Opinion Illustrates the Need for New AKS Safe Harbors

The Department of Health and Human Services Office of the Inspector General (OIG) has issued Advisory Opinion No. 18-10 (Opinion) in response to a proposal by a surgical device and wound care product manufacturer...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Approves Surgical Device Warranty Program Intended to Reduce Readmissions

On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a...more

Holland & Knight LLP

Healthcare Law Update: September 2018

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Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Baker Donelson

OIG Advisory Opinion 18-07 Permits GPO Expansion to Serve Wholly Owned Members

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In Advisory Opinion No. 18-07, issued July 30, 2018, the OIG permitted a group purchasing organization (GPO) to serve health care facilities owned by the same parent organization as the GPO. While acknowledging that the...more

Baker Donelson

OIG Approves (Again) Another Medigap/PHO Arrangement in Advisory Opinion 18-06

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With Advisory Opinion 18-06, issued July 11, 2018, the OIG added to the ever-growing number of favorable advisory opinions addressing an agreement between a Medicare Supplemental Health Insurance (Medigap) insurer and a...more

Baker Donelson

OIG Advisory Opinion 18-04: Another Favorable Medigap/PHO Arrangement

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On June 7, 2018, the OIG issued favorable Advisory Opinion 18-04, thereby approving another arrangement between a group of Medicare Supplemental Health Insurance (Medigap) insurers and a preferred hospital organization (PHO)....more

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