News & Analysis as of

Department of Health and Human Services (HHS) Remuneration

Stevens & Lee

OIG Issues Favorable Opinion Concerning Bonus Payments to Employed Physicians

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The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently considered the question whether an employed physician can be paid bonus compensation relating to procedures performed by the...more

Jones Day

HHS-OIG Issues FAQ Guidance Related to Pharmacy Benefit Manager Arrangements

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The U.S. Department of Health and Human Services, Office of Inspector General ("OIG") has provided insight into the applicability of the discount and group purchasing organization safe harbors to payments retained by pharmacy...more

Proskauer - Health Care Law Brief

Recent FCA and AKS Litigation Highlights Use of Different Standards in Different Circuits

In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...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

Rivkin Radler LLP

OIG Permits Arrangement Involving Physician-Owned Medical Device Company

Rivkin Radler LLP on

In a recent Advisory Opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined that an arrangement involving certain physicians who have an ownership interest in a medical device...more

ArentFox Schiff

Providing Remuneration to Address Physician Burnout: Stark Law Considerations

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Hospitals and Other Providers Should Make Sure Any Items or Services of Value That They Provide to Their Referring Physicians To Alleviate Burnout Comply With the Stark Law - Amidst the ongoing labor market shortages and...more

Bass, Berry & Sims PLC

OIG Approves Arrangement that Provides Cash Equivalents to Patients in Latest Advisory Opinion

On March 2, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-04, approving a program under which the requestor provides digital contingency management...more

Arnall Golden Gregory LLP

The HHS OIG Finds Remuneration That Does Not Warrant the Imposition of the AKS or the Beneficiary Inducements CMP

In a recent Advisory Opinion, the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) stated that, although the Arrangement would generate prohibited remuneration, it would not impose...more

Holland & Knight LLP

OIG Issues Favorable Advisory Opinion on Manufacturer-Provided Travel Assistance

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on July 8, 2021, issued Advisory Opinion No. 21-08, a favorable opinion authorizing a manufacturer of gene therapy to provide...more

Health Care Compliance Association (HCCA)

Hospital, Doctors Pay $3M to Settle CMPL Case Over Cath Lab Lease

Report on Medicare Compliance 30, no. 4 (February 1, 2021) - Saint Peter’s University Hospital and New Brunswick Cardiac Cath Lab LLC in New Jersey have agreed to pay $3.04 million to settle a civil monetary penalty case...more

Mintz - Health Care Viewpoints

HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part IV: Changes to Existing Safe Harbors and...

As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations. To recap, our team provided an overview of...more

Mintz - Health Care Viewpoints

HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements

As promised, our team has been studying the two final rules published by the Department of Health & Human Services (HHS) (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services...more

ArentFox Schiff

OIG Issues Fraud Alert: Should Pharma and Device Companies Cease Speaker Programs?

ArentFox Schiff on

The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more

Akerman LLP - Health Law Rx

Limited Stark and Anti-Kickback Sanction Waivers Issued for Provider Payments During the Pandemic

The COVID-19 pandemic has led to urgent changes to how and where healthcare services are delivered. These changes could require expedited entry into new or modified arrangements for the delivery of essential healthcare goods...more

Greenbaum, Rowe, Smith & Davis LLP

HHS OIG Issues Policy Statement Regarding Temporary Federal Anti-Kickback Statute Waivers in Wake of COVID-19

The U.S. Department of Health and Human Services Office of Inspector General (OIG) has issued a Policy Statement declaring that it will not impose administrative sanctions under the Federal Anti-Kickback Statute for certain...more

McDermott Will & Emery

Special Report - Untangling VBEs, ACOs and CINs - What to Know about CMS and OIG's Proposed Regulations - December 2019

McDermott Will & Emery on

The Centers for Medicare & Medicaid Services and the Office of Inspector General recently released notices of proposed rulemaking relating to the Stark Law and the Anti-Kickback Statute. We break down the new proposed...more

Bricker Graydon LLP

CMS and OIG issue long-awaited rules proposing changes to the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil...

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services Office of Inspector General (HHS-OIG) issued long-awaited proposed changes “to modernize and clarify the...more

McDermott Will & Emery

Remuneration? Not If It’s Fair Market Value, Says Eleventh Circuit

McDermott Will & Emery on

Bingham v. HCA, Inc., a recent Eleventh Circuit case, highlights the centrality of fair market value to Anti-Kickback Statute (AKS) analyses. This decision is significant for several reasons and we expect to see Bingham cited...more

Robinson+Cole Health Law Diagnosis

HHS Issues Favorable Advisory Opinion for Online Healthcare Directory Charging Per-Click Fees

On September 5, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion 19-04 ( Advisory Opinion). The Requestor asked OIG if providing an online healthcare...more

Bass, Berry & Sims PLC

OIG Blesses Hospital Program Seeking to Reduce Inpatient Admissions through Provision of Free, In-Home Care

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On March 6, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued a favorable advisory opinion (AO 19-03) allowing a nonprofit medical center (Requestor) to provide free,...more

Bass, Berry & Sims PLC

Electronic Health Records Company Pays High Price for Software Shortcomings

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Greenway Health LLC, a Tampa-based developer of electronic health records (EHR) software, recently agreed to pay $57.25 million to resolve False Claims Act (FCA) allegations that it overstated the capabilities of and failed...more

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Cooley LLP

Blog: OIG Seeks Comments to Anti-Kickback Statute and Beneficiary Inducements CMP Related to ‘Patient Centered Care’

Cooley LLP on

The Health and Human Services (HHS) Office of Inspector General (OIG) published today a request for information (RFI) seeking ways in which it might modify or add new safe harbors to the federal Anti-Kickback Statute (AKS)...more

Baker Donelson

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

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A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

BakerHostetler

Destination Medicine: Not Just for the Rich and Famous

BakerHostetler on

OIG okays providing modest hotel and meal accommodations for rural and financially needy patients. The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion...more

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