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 -

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

OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

by Polsinelli on

Recently, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) issued an Advisory Opinion (17-02) that allows for waivers or reductions of cost-sharing amounts owed by financially needy...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

Six Home Health Providers Agree to Pay $1.8 Million to Settle False Claims Act Liability

by King & Spalding on

On September 5, 2017, the Department of Justice (DOJ) announced that six Tennessee-based home health entities agreed to pay the United States $1.8 million to settle potential violations of the Stark Law and/or Anti-Kickback...more

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

by Arnall Golden Gregory LLP on

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....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

Second Circuit Accepts Appeal of False Claims Act First-To-File Issues

by Farrell Fritz, P.C. on

The Second Circuit recently agreed to accept an interlocutory appeal to decide the question whether a violation of the False Claims Act’s “first-to-file” rule compels dismissal of the complaint or whether it can be cured by...more

Private Equity Investments in Health Care Practices

by Pepper Hamilton LLP on

Private equity funds are generally prohibited from owning entities that employ licensed professionals and may not invest directly in medical or dental practices in many states because of laws that prohibit the corporate...more

Hospitals and Others Respond to “Red Tape Relief Project” Requests

Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with “red tape.” The letters are in response to the first...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

Value-based health care: the role of payors

by Ropes & Gray LLP on

Bill Knowlton, Ropes & Gray health care partner, examines the critically important role of payors in value-based health care programs. ____________ Payors are critically important to value-based health care because they're...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Republican Whitney Westerfield Announces Bid for Kentucky Attorney General- Republican state Senator Whitney Westerfield formally announced his candidacy to become Kentucky AG. He is the first Republican...more

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