News & Analysis as of

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 -

HHS-OIG blesses product replacement program

by Dentons on

The federal health care program anti-kickback statute, 42 U.S.C. § 1320a-7b(b) (AKS), in addition to prohibiting payments for patient referrals, prohibits one party (such as a manufacturer) from providing anything of value to...more

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

by Baker Ober Health Law on

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

OIG Signs Up for Customer Loyalty Program

by BakerHostetler on

In Advisory Opinion 17-05, posted by the U.S. Department of Health and Human Services Office of Inspector General (OIG) on September 7, 2017, the OIG approved a pharmacy’s customer loyalty/discount program (Benefit Program)....more

OIG Issues Advisory Opinion to Pharmacy

On September 7, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion to the owner of a retail pharmacy chain (Pharmacy) that would allow Federal health care program beneficiaries to participate in a paid...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

OIG’s Expanded Interpretation of Warranty Safe Harbor Portends Well for Value-Based Health Care

by Ropes & Gray LLP on

In a new advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) clarified the scope of the Anti-Kickback Statute (“AKS”) warranty safe harbor (the “Warranty Safe Harbor”). In...more

HHS-OIG Issues Favorable Opinion on Pharmaceutical Spoilage Replacement Program

by McGuireWoods LLP on

On Aug. 25, 2017, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a favorable advisory opinion regarding a pharmaceutical manufacturer’s proposed replacement program for spoiled...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

EHR Vendors Beware: eClinicalWorks Settles with DOJ for $155 Million

by Dorsey & Whitney LLP on

The Department of Justice (“DOJ”) announced on May 31, 2017, a $155 million settlement of its lawsuit alleging False Claims Act (“FCA”) and Anti-Kickback Statute (“AKS”) violations committed by eClinicalWorks (“eCW”), one of...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

FCA Issues to Watch: Intersection of the FCA and the Anti-Kickback Statute

by Bass, Berry & Sims PLC on

In the recent past, the government has racked up a number of FCA settlements based on alleged violations of the Anti-Kickback Statute (AKS). This focus undoubtedly will remain a high enforcement priority....more

New OIG Rules Change Patient Incentive Program Landscape: Where Are the Limits Now?

by McDermott Will & Emery on

With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more

New Safe Harbor Permits Some Free Transportation to Patients

by Ruder Ware on

A new safe harbor was recently issued by the Health and Human Services (HHS) Office of Inspector General (OIG) that permits eligible health care providers to offer free or discounted transportation to established patients....more

When to Use the OIG’s Self Disclosure Protocols

by Ruder Ware on

The HHS Office of Inspector General offers providers an opportunity to self-disclose certain violations in exchange for avoiding some of the more draconian penalties that may otherwise apply under applicable regulations. ...more

Drug and Device Makers Suggest Anti-Kickback Safe Harbor Clarifications to Encourage Value-Based Health Care Arrangements

by Ropes & Gray LLP on

In response to the annual solicitation by the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) for developing new, and modifying existing, safe harbors to the anti-kickback...more

What’s in Your Local Transportation Policy?

by Nossaman LLP on

Those in the business of providing healthcare services to Medicare and Medicaid beneficiaries are all too familiar with the federal Anti-kickback Statute (AKS). Among other dreadful sanctions, it imposes criminal penalties on...more

New OIG Exclusion Regulations About to Go into Effect

by McDermott Will & Emery on

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

OIG Finalizes Expanded Exclusion Authorities under ACA (Updated)

by Reed Smith on

On January 12, 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services issued the final rule implementing its statutory authority under the Affordable Care Act (ACA) to expand the exclusion...more

Stretching the Rules: HHS-OIG Expands its Exclusionary Authority

by Arnall Golden Gregory LLP on

On January 12, 2017, the Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule expanding its authority to exclude providers from participation in federal healthcare programs. This...more

OIG Expands Exclusionary Authority

The Department of Health and Human Services, Office of Inspector General (OIG) published a final rule on January 12, 2017, expanding the OIG’s authority to exclude providers from participation in federal healthcare programs....more

Health Law Insights: January Newsletter

by Roetzel & Andress on

ALERT: Health Reform Outlook for 2017: A Year of Major Uncertainty - Fulfilling their promises, Congressional Republicans moved to repeal the Affordable Care Act (ACA) on the first day of the new Congress when Senate...more

Analysis of HHS OIG Final Rule to Amend the Anti-Kickback Safe Harbors and CMP Rules on Beneficiary Inducements

by Reed Smith on

On December 7, 2016, the Office of Inspector General of the Department of Health and Human Services published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP)...more

New Year, New Resolutions, New Safe Harbors

by Akerman LLP on

As we welcome the new year and its endless possibilities, we also welcome some new Anti-Kickback Statute safe harbors and concomitant business possibilities. In December, the U.S. Department of Health and Human Services...more

OIG Rings in the New Year With New Anti-Kickback Statute Safe Harbors

by Foley & Lardner LLP on

Just in time for the New Year, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued final regulations (Final Regulations) that revised two existing Anti-Kickback Statute safe...more

OIG Interprets and Incorporates Statutory Exceptions to CMP Law

by Dorsey & Whitney LLP on

As of January 6, 2017, final rules published by the United States Department of Health and Human Services Office of the Inspector General (the “OIG”) implementing certain exceptions to the Civil Monetary Penalty law (“CMP”)...more

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