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 -

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

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

by Mintz Levin on

In this issue we report on recent qui tam activity and look at three unsealed cases. One case involves allegations of “up coding” by a hospital that allegedly billed routine transport as emergency transport, reimbursed at...more

House Bipartisan Act Would Amend Stark Law and Medicare Part B

On July 25, 2017, the U.S. House of Representatives passed by voice vote a bipartisan bill which is now in the Senate’s hands for consideration, the Medicare Part B Improvement Act of 2017. The bill would amend the Stark Law...more

Chicago U.S. Attorney Creates New Unit to Prosecute Health Fraud

by Clark Hill PLC on

On Thursday, July 20, 2017, acting U.S. Attorney for the Northern District of Illinois, Joel R. Levin, announced his office is increasing its attention on healthcare through a new Health Care Fraud Unit focused on prosecuting...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...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

Concierge Medicine – Is it for you?

by Farrell Fritz, P.C. on

According to the 2016 Kaiser/HERT Employer Health Benefits Survey, the average annual premium for employer-sponsored family health insurance coverage in 2016 was $18,142 – representing a 20% increase since 2011 and a 58%...more

New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical...more

Criminal Prosecutions of Individuals Outside the FCPA

by Michael Volkov on

When you look outside the FCPA arena and examine DOJ criminal prosecutions in healthcare, antitrust, tax, fraud, and other white-collar areas, there is no shortage of cases against individual violators. I am perplexed, to say...more

Avoiding Risks with Referring Physician Compensation Arrangements

by Hinshaw & Culbertson LLP on

The settlement described below highlights the importance of carefully structuring compensation arrangements with referring physicians, and the risk involved in trying to work backwards to achieve a desired level of...more

Reimbursement Manager Pleads Guilty for Prior Authorization Process Issues

by Bass, Berry & Sims PLC on

On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....more

Free Parking, Yes, But No Stark Law Claim

by Ruder Ware on

A federal court recently dealt a victory to a health care provider over whistleblower allegations that free parking and valet service at a medical office building violated the Stark Law and the Anti-Kickback Statute....more

Court Puts the Brakes on Whistleblower's FCA Parking Claims

by Baker Ober Health Law on

The Department of Justice (DOJ) reports that, in fiscal year 2016 ending September 30, it obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims. More than half of this...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

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