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Anti-Kickback Statute › Centers for Medicare & Medicaid Services (CMS) › Advisory Opinions

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
Bass, Berry & Sims PLC

More Losses than Gains? OIG Declines to Approve Certain Medicare Advantage Gainsharing Arrangements in Advisory Opinion 24-08

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On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

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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

Foley & Lardner LLP

OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials

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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

Holland & Knight LLP

Court Upholds OIG Advisory Opinion Shooting Down a Patient Assistance Program

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Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more

Sheppard Mullin Richter & Hampton LLP

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

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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

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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

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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

Sheppard Mullin Richter & Hampton LLP

New OIG Opinion Permits Gift Cards to Beneficiaries in Limited Circumstances

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On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain...more

Mintz - Health Care Viewpoints

EnforceMintz — Significant 2022 Regulatory and Policy Developments

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From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

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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

Healthcare Regulatory Check-Up Newsletter | January - April 2022

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This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

Mintz - Health Care Viewpoints

OIG Approves Physician-Owned Medical Device Company

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On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more

Burr & Forman

Health Care E-Note - January 2022

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HELPFUL HINTS - The Federal No Surprises Act The Federal No Surprises Act (the “Act”) became fully effective on January 1, 2022. The Act protects enrollees in group and individual market plans (including ERISA plans) and...more

King & Spalding

OIG Issues Advisory Opinion for Alzheimer’s Study to Subsidize PET Imaging Coinsurance Costs

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On September 29, 2021, OIG issued Advisory Opinion No. 21-13 analyzing a proposal for a clinical study that would involve subsidizing Medicare beneficiaries’ cost-sharing obligations in connection with a clinical study...more

Holland & Hart - Health Law Blog

Patient Inducements: Gifts, Discounts, Waiving Co-Pays, Free Screening Exams, Etc.

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Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 6: Proposed Changes to the AKS Related to Beneficiary Inducement

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As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and...more

Dorsey & Whitney LLP

A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes...

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Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal...more

Baker Donelson

CMS Proposes Liberalizing the Stark Advisory Opinion Process

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When the Centers for Medicare and Medicaid Services (CMS) sought input on ways to address the undue burdens of the Stark law through a Request for Information (RFI) in June 2018, its anticipated focus was care coordination,...more

Bass, Berry & Sims PLC

Key Takeaways from CMS' New Proposed Rule on Stark Law Advisory Opinions

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While the industry awaits more sweeping value-based related changes to the Stark Law regulations, on July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) took a small step toward updating its Stark Law advisory...more

Holland & Knight LLP

Healthcare Law Update: December 2018

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Regulation - OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor - On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...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 Allows Cost-Sharing Waivers Among Fire Departments for Ambulance Services in Advisory Opinion 18-08

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A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more

Holland & Knight LLP

Healthcare Law Update: March 2017

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Enforcement - OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals - On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more

Baker Donelson

OIG Still Rejects Lab's Free Labeling Services for Dialysis Facilities in Advisory Opinion No. 16-12

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8 Years and New Reimbursement Methodology Later - On November 28, 2016, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued an unfavorable advisory opinion, No. 16-12, regarding a...more

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