Anti-Kickback Statute Dept. of Health and Human Services

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 -
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Health Care Self-Disclosure Protocols – Is It Worth It To Self-Report?

In recent years the federal government has aggressively investigated and prosecuted pharmaceutical companies and health care providers for possible violations of anti-fraud, anti-kickback and other laws. These efforts have...more

OIG: Housing Placement Arrangement for Seniors Does Not Give Rise to Sanctions

The HHS Office of Inspector General (OIG) recently issued a favorable Advisory Opinion (No. 14-01) regarding a contractual arrangement under which a placement agency receives a per-resident fee for referring new residents to...more

CMS and OIG Issue Final Regulations to Extend the Stark Exception and Anti-Kickback Statute Safe Harbor for EHR Donations

On December 27, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of Inspector General (OIG) finalized amendments to the Physician Self-Referral Law (Stark) and...more

CMS and OIG Finalize Extension of Federal Stark Exception and Anti-Kickback Safe Harbor for Electronic Health Record Donations

On Friday, December 27, 2013, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”) of the Department of Health and Human Services published complementary final rules in the...more

Final EHR Donation Rules Issued in Time for the New Year

On December 27, 2013, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) issued final rules revising the Stark exception (42 CFR...more

The Long Sunset: EHR Donations May Continue Until 2021 (With a Few Changes)

Under long-awaited final rules recently published by the federal government, hospitals and other “protected donors” may continue to “donate” interoperable electronic health record items and services without incurring...more

Health Care Law Update: Anti-Kickback Safe Harbor Rule for Electronic Health Records Extended Through 2021

The anti-kickback safe harbor concerning electronic health records (EHR) items and services, which defines certain conduct that is protected from liability under the federal anti-kickback statute (Section 1128B(b) of the...more

HHS's Mixed Messages: Identifying a Federal Healthcare Program When You See It

Recent seemingly contrary determinations by the U.S. Department of Health and Human Services (HHS) have fueled industry speculation regarding whether qualified health plans (QHPs) available on the health insurance exchanges...more

May Providers Pay Health Insurance Premiums for HealthCare.gov Plan Enrollees?

Following last week's declaration that Qualified Health Plans (QHPs) on HealthCare.gov are not "Federal health care programs," and thus are not subject to the federal Anti-Kickback Statute, CMS released additional guidance...more

CMS Creates Clarity and Confusion on Application of Fraud and Abuse Laws to Qualified Health Plans

On October 30, 2013, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius sent a letter to U.S. Representative Jim McDermott stating that HHS does not consider qualified health plans (QHPs) sold...more

The Anti-Kickback Statute And The Affordable Care Act: A Law Enforcement Tool Suddenly Goes Missing

With the aggressive pursuit of cases against the pharmaceutical and device industries (including the recent $2.2 billion settlement with Johnson & Johnson), the implementation of Medicare Fraud Strike Forces in major cities...more

OIG Report Concludes that Physician-owned Distributors Increase Utilization

In response to the U.S. Senate Committee on Finance’s continued questioning of physician-owned distributorships (PODs), the U.S. Department Health and Human Services Office of the Inspector General issued its long-awaited...more

Dodging the AKS: Marketplace Plans Are Not "Federal Health Care Programs"

In an October 30th letter addressed to Congressman Jim McDermott, the Department of Health and Human Services (HHS) Secretary, Kathleen Sebelius, left little to interpretation: Qualified health plans (QHPs) purchased through...more

Sebelius: "Qualified Health Plans Are Not Federal Health Care Programs"

In a letter to Rep. Jim McDermott dated Oct. 30, 2013, Department of Health and Human Services Secretary Kathleen Sebelius clarified that qualified health plans (“QHPs”) available on the health insurance exchanges under the...more

CMS Declares Third Party Payment of QHP Premiums Not OK

On the heels of HHS’s recent announcement that qualified health plans (QHPs) purchased through the Affordable Care Act (ACA) insurance exchanges are not “federal health care programs” for purposes of the federal anti-kickback...more

HHS Clarifies that ACA Qualified Health Plans are Not Subject to Federal Anti-Kickback Statute; Expresses Concern about Providers...

The U.S. Department of Health and Human Services recently announced that Qualified Health Plans (sold on and off the Exchanges) are not “Federal health care programs” for purposes of the federal anti-kickback statute. The...more

Marketplace Plans Not Subject to Anti-Kickback Statute

On October 30, 2013, the Secretary of the Department of Health and Human Services (“DHHS”), Kathleen Sebelius (“Secretary”), released a letter to Congressman Jim McDermott (D-WA) answering the question of whether qualified...more

HHS Announces That ACA Exchange Plans Are Not “Federal Health Care Programs”

In a surprising move late last week, HHS Secretary Kathleen Sebelius announced that qualified health plans (QHPs) purchased through the Affordable Care Act’s (ACA) insurance exchanges are not “federal health care programs”...more

HHS: Providers May Be Able to Subsidize Premiums For Uninsured in Marketplace Plans

An announcement October 30 from Health and Human Services Secretary Kathleen Sebelius could remove the first hurdle for providers wishing to offer premium support for individuals eligible for health insurance on the Health...more

OIG Comes Down Hard on Physician-Owned Distributorship Arrangements

Hospitals and physician-owned entities should consider new report’s cost and utilization concerns. On October 24, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released...more

Health Update -- Oct 23, 2013

Mapping The New Fraud And Abuse Landscape - In an age of increased government scrutiny and enforcement, providers, payers, pharmaceutical companies and medical device manufacturers, along with their business partners,...more

OIG Issues Favorable Opinion Regarding Post-Discharge Services Arrangement

The Department of Health & Human Services Office of Inspector General (OIG) recently issued a favorable advisory opinion regarding an electronic health record vendor’s plan to provide services to hospitals to help manage...more

OIG rejects management arrangement that carves out federal healthcare program patients

The Office of Inspector General of the Department of Health and Human Services recently posted an Advisory Opinion describing a proposed arrangement by a clinical laboratory. ...more

Electronic Health Records Donations: Proposed CMS And OIG Rules Revise Stark Exception And Anti-Kickback Safe Harbor

On April 10, 2013, the Centers for Medicare & Medicaid Services (‘‘CMS'') and the Office of the Inspector General of the Department of Health and Human Services (‘‘OIG'') published twin proposed rules that amend and extend...more

Let The Sunshine In – The Risks To Pharmaceutical And Medical Device Companies From Open Payment Transparency

Pharmaceutical and medical device manufacturers (as well as group purchasing organizations “GPOs”) have a major compliance challenge ahead — the Physician Payment Sunshine Act regulations. ...more

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