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Advisory Opinions Healthcare

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

Bass, Berry & Sims PLC

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

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On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...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

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

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | December 2023 Recap

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

Harris Beach PLLC

OIG’s Favorable Advisory Opinion: Physician Consulting Firm’s Gift Cards to its Clients for Referring New Physician Practices

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This favorable OIG opinion relates to Requestor who provides consulting services to physician practices and the Requestor’s proposed arrangement (“Proposed Arrangement”) to offer its current physician practice customers...more

Sheppard Mullin Richter & Hampton LLP

New Marketing Possibilities for Vendors Contracted with Medicare Providers and Suppliers Following OIG’s Favorable Advisory...

On December 28, 2023, the Office of Inspector General (the “OIG”) issued a favorable Advisory Opinion (No. 23-15) (the “Opinion”) to a consulting vendor (the “Requestor”) that wanted to provide up to $75 in gift cards to...more

Bass, Berry & Sims PLC

OIG Approves the Use of Gift Cards to Reward Customers' Marketing Efforts

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On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 23-15, approving a physician practice consultant’s proposal to offer gift cards to its customers when...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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

Bass, Berry & Sims PLC

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

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On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

Mintz - Health Care Viewpoints

OIG Issues Unfavorable Advisory Opinion on Free Items to Patients Tied to Reimbursable Services

Perhaps unsurprisingly, the Office of Inspector General for the Department of Health and Human Services (OIG) rejected a manufacturer’s proposal to provide free hearing aids to certain patients if they receive one of the...more

McDermott Will & Emery

OIG Pathology Lab: Don't Pay for Services You Don't Need

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In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services arrangement with referring...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | September 2023 Recap

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

Robinson+Cole Health Law Diagnosis

OIG Issues Favorable Opinion Regarding Physician Group’s Proposal to Pay Bonuses to its Employed Physicians Based on Net Profits

On October 13, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-07 (Advisory Opinion), in which the OIG issued a favorable opinion regarding a physician group employer’s proposal to pay bonuses to its...more

Bass, Berry & Sims PLC

OIG Approves Paying Employed Physicians Profits from ASCs Operated by Employer

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On October 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07, approving a physician practice’s proposal to pay its physician-employees a portion of the...more

Sheppard Mullin Richter & Hampton LLP

OIG Confirms the Broad Protection of Employee Safe Harbor

Late last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) posted Advisory Opinion No. 23-07 affirming the broad protection available for compensation to employed physicians under the...more

Mintz - Health Care Viewpoints

OIG Issues Advisory Opinion Nixing Purchased Services Arrangement Between Certain Anatomic Pathology Laboratories

Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...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

Robinson & Cole LLP

Health Law Diagnosis - Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed...

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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

Bass, Berry & Sims PLC

Expect the Expected: OIG Remains Suspicious of Suspect Contractual Joint Ventures in Advisory Opinion Involving IONM Industry

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On August 18, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-05, finding that an entity’s proposal to facilitate referring surgeons’ ownership of turnkey...more

Haynsworth Sinkler Boyd, P.A.

South Carolina Boards of Medical Examiners, Nursing and Pharmacy Issue Joint Advisory Opinion on Retail IV Therapy Businesses

The IV therapy business is booming across South Carolina—on every corner there seems to be a new IV/hydration/wellness storefront or mobile clinic advertising hangover cures and wellness improvement. But, not all IV therapy...more

Burr & Forman

OIG Issues Favorable Advisory Opinion About Online Health Directories and Advertisements

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Does your practice pay to advertise in online directories? Or do you contract with a website to allow patients to book appointments or look for services? If the answer to these questions is “yes,” you may be interested in a...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review - 2022

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The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) continues to offer valuable insights to the healthcare industry as to how best to approach increasingly complex healthcare fraud...more

Mintz - Health Care Viewpoints

OIG Issues Favorable Advisory Opinion on Gift Cards to Incentivize Patients to Return Samples for At-Home Colorectal Cancer...

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more

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