News & Analysis as of

Anti-Kickback Statute

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 -

Blog: OIG Permits Drug Companies To Provide Free Medications in Limited Circumstances to Patients for 2018 Following Advisory...

by Cooley LLP on

As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that...more

OIG Scrutiny of Patient Assistance Programs

by Shipman & Goodwin LLP on

Last week, one of the largest charity patient assistance programs in the country, Caring Voice Coalition, announced that it would not be offering financial assistance for any of its disease funds in 2018. This announcement...more

OIG Reaffirms Permissibility of Certain Gainsharing Arrangements

The Department of Health and Human Services Office of the Inspector General (OIG) has issued an Advisory Opinion (Opinion) in connection with a hospital’s gainsharing arrangement (Arrangement) with a designated group of...more

United Therapeutics Enters False Claims Act Settlement Pertaining to Patient Assistance Program

by Arnall Golden Gregory LLP on

On December 20, 2017, United Therapeutics Corporation, a Silver Spring, Maryland-based pharmaceutical company that manufactures and sells a number of drugs to treat pulmonary arterial hypertension (PAH), agreed to pay $210...more

OIG Invites Anti-kickback Safe Harbor, Fraud Alert Recommendations

by Reed Smith on

The HHS Office of Inspector General (OIG) has published its annual solicitation of recommendations for new or revised anti-kickback statute safe harbors and new Special Fraud Alerts. The OIG states that in considering any...more

OIG Issues Favorable Gainsharing Advisory Opinion

by King & Spalding on

On December 29, 2017, OIG issued a favorable advisory opinion interpreting the application of the gainsharing civil monetary penalty provision (Gainsharing CMP) and the Anti-Kickback Statute in connection with a proposed...more

OIG Requests Public Input on Anti-Kickback Statute Safe Harbors

by King & Spalding on

In a notification published last week, OIG began soliciting proposals and recommendations for modifying existing and developing new safe harbor provisions under the Federal Anti-Kickback Statute (AKS). Public comments must...more

Debtor’s Subchapter S Status Isn’t Property of the Estate

This post examines an interesting intersection between bankruptcy and tax laws: if a corporation terminates its Subchapter S status pre-bankruptcy, can a bankruptcy trustee bring fraudulent transfer claims against the...more

Health Care Fraud Institute Held at Georgia Bar Headquarters

by Arnall Golden Gregory LLP on

On December 7, 2017, the Institute for Continuing Legal Education (ICLE) of the State Bar of Georgia held its annual Health Care Fraud Institute. Topics discussed at the Institute included recent federal and state fraud and...more

Blog: OIG Revokes Patient Assistance Program Advisory Opinion Protection

by Cooley LLP on

The Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04) on November 28, 2017, retroactive to its original issuance date of April 20, 2006. Opinion 06-04 had been modified by the OIG on December...more

OIG Rescinds Advisory Opinion Regarding a Patient Assistance Charity Program

by King & Spalding on

For the first time in history, OIG rescinded an advisory opinion that had previously protected a patient assistance charity from anti-kickback statute (AKS) liability. In its letter to the charity, OIG stated that it based...more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

OIG Advisory Opinion 17-06: Another Medigap/PHO Arrangement Approved

by Baker Ober Health Law on

Advisory Opinion 17-06 joins a long list of opinions approving arrangements between a Medicare Supplemental Health Insurance (Medigap) insurer and a preferred hospital organization (PHO). While this advisory opinion does not...more

Health Update - November 2017

Fraud and Abuse 2017: Understanding Trends and Avoiding Actions - Editor’s Note: In a recent webinar for Bloomberg BNA, Manatt examined game-changing fraud and abuse trends and cases—and revealed strategies for avoiding...more

Recent Case Highlights Risks of Paying Physicians for Routine Duties - Signed writing required, informal documentation may not be...

by Stinson Leonard Street on

Payments to physicians, even for routine, necessary duties, may cause referrals to the entity making the payments to be "prohibited referrals" under the Stark Law. This means the hospital or other entity should not have...more

“Always a bridesmaid, never a bride” Might Work for Stark Liability but Not the Anti-Kickback Statute

by Nossaman LLP on

Last Thursday, a jury in federal district court in St. Louis handed down a verdict in a False Claims Act (“FCA”) case that presents a laundry list of the challenges which can arise in a FCA case. ...more

Kickback Arrangements – Cause for Alarm Beyond Federal Healthcare Programs

by Farrell Fritz, P.C. on

Few, if any, in the medical industry are unfamiliar with the federal Anti-Kickback Statute (“AKS”). Under AKS, those giving or receiving compensation for referrals for items or services reimbursed by the federal healthcare...more

Physicians in the Bulls-eye

by BakerHostetler on

Several recently reported cases highlight the growing risk physicians face if they succumb to competitive pressures, especially offers of remuneration from labs, pharmacies, home health agencies and other providers to whom...more

CFPB Overreaches in Handling Alleged RESPA ABA Exemption Issues in Meridian

by Foley & Lardner LLP on

On September 27, 2017, the Consumer Financial Protection Bureau (CFPB) announced the settlement of its Real Estate Settlement Procedures Act (RESPA) enforcement action against Meridian Title Corp. (Meridian), an Indiana-based...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: September 2017

by Mintz Levin on

In this month’s issue of our Qui Tam Update, we review an unusual cluster of five cases alleging that common defendants — a health care provider and its subsidiaries — provided medically unnecessary services to hospice,...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

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

A Path Forward: Corporate Integrity Agreement Sheds Light on Manufacturer Interactions With Independent Charitable Foundations

by Hogan Lovells on

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

Pharmacy Chain's Benefit Program Gets OIG Approval in Advisory Opinion 17-05

by Baker Ober Health Law on

The OIG approved a retail pharmacy chain's proposal to expand its benefit program, which allows participating federal health care program beneficiaries to receive discounts and other benefits when purchasing certain products...more

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