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Office of the Inspector General Civil Monetary Penalty Medicare

McGuireWoods Consulting

CMS Finalizes Rule to Prevent Blocking of Electronic Health Information

On June 24, 2024, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final rule that disincentivizes healthcare providers from...more

Hendershot Cowart P.C.

Doctors: Don’t Fall Victim To Telemedicine Fraud Schemes

Hendershot Cowart P.C. on

Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more

Holland & Hart LLP

Patient Inducements: Law and Limits

Holland & Hart LLP on

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

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

Harris Beach PLLC on

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

Bricker Graydon LLP

A Long-Awaited Change: OIG Updates its Compliance Program Guidances

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From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more

WilmerHale

OIG Issues New Advisory Opinion on Federal Anti-Kickback Statute

WilmerHale on

The Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion that explored the limits of a relatively new safe harbor to the federal Anti-Kickback Statute (AKS) that aims...more

Bass, Berry & Sims PLC

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

Bass, Berry & Sims PLC on

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

Stevens & Lee

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

Harris Beach PLLC

HHS Office of Inspector General September 2023 Enforcement Activity

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The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country.  The enforcement actions reported...more

Epstein Becker & Green

OIG Posts New FAQ and Advisory Opinion Addressing Cash, Cash Equivalents, and Gift Cards

Epstein Becker & Green on

The Department of Health and Human Services Office of Inspector General (OIG) recently published a new frequently asked question (FAQ) and advisory opinion addressing how to analyze arrangements that may involve providing...more

King & Spalding

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

King & Spalding on

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

Foley & Lardner LLP

Public Health Emergency Ends May 11: What Telehealth Companies Need to Know

Foley & Lardner LLP on

On January 30, 2023, the Biden Administration announced its intent to end the COVID-19 public health emergency (PHE) on May 11, 2023. The PHE has been in place for over three years during which time many telehealth and...more

ArentFox Schiff

Increased Federal Attention to Skilled Nursing Facility Compliance and Quality Improvement Results in Modified Program...

ArentFox Schiff on

The Biden Administration has embraced an aggressive and multi-part agenda designed to improve the safety and quality of care nationally in skilled nursing facilities (SNFs). The Biden Administration’s nursing home agenda...more

Health Care Compliance Association (HCCA)

New Hampshire Health System Pays $2.1M in CMP Settlement Over Diagnostic Test Orders

Report on Medicare Compliance 31, no. 35 (September 26, 2022) - For the third time in about 2 1/2 years, hospitals or other providers that are part of Dartmouth-Hitchcock Health, a large health system in New Hampshire,...more

Harris Beach PLLC

OIG Opinion on Gift Cards for Medicare Patients’ Education as Inducements

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This opinion regards the provision of a gift card to certain Medicare Advantage (“MA”) plan enrollees who complete specific steps in an online patient education program....more

Rivkin Radler LLP

OIG Concludes that $25 Patient Gift Card Presents Low Risk of Fraud and Abuse

Rivkin Radler LLP on

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued an Advisory Opinion on offering gift cards to patients for completing an online patient education program....more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Non-Profit Efforts to Provide Financial Assistance and Free Items to Individuals...

King & Spalding on

On May 2, 2022, OIG posted Advisory Opinion 22-10, regarding a proposal to provide financial assistance and free items to individuals with a particular disease. The Requestor, a non-profit organization dedicated to providing...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth Services

On April 27, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-08 (Advisory Opinion) in which it declined to impose sanctions against a federally qualified health center (Requestor) for an arrangement...more

Pullman & Comley - Connecticut Health Law

Short Staffing May Still be Hindering Health Care in Connecticut but OIG's Exclusion Authority Remains Alive and Well

Can a 40-year-old fraud and abuse law that compared to many others is relatively straightforward still get providers into trouble?  Answer: You bet!  In fact, in the first quarter of 2022 alone, the U.S. Attorney for the...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 Favorable Advisory Opinion Regarding Chiropractor Arrangement to Offer Discounts

King & Spalding on

On September 30, 2021, OIG posted Advisory Opinion No. 21-14 regarding a chiropractor’s proposal to extend an existing discount program covering a package of services to include federal health care program beneficiaries. OIG...more

King & Spalding

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

King & Spalding on

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

Health Care Compliance Association (HCCA)

Radiation Therapy Provider Pays $3.6M in CMP Settlement; OIG: 25 CPT Codes ‘Involved’

Report on Medicare Compliance 30, no. 22 (June 14, 2021) - A Colorado radiation therapy provider has agreed to pay $3.569 million in a civil monetary penalty settlement with the HHS Office of Inspector General (OIG). ...more

King & Spalding

OIG Issues Favorable Advisory Opinions Regarding Medigap Plan and Preferred Hospital Organization Arrangements

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Last week, OIG posted Advisory Opinions Nos. 21-03, 21-04, and 21-05 relating to three near-identical arrangements between Medigap plans and Preferred Hospital Organizations (PHOs). The arrangements involve (i) a discount on...more

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