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 -
News & Analysis as of

Summer Fraud and Abuse Roundup

Now that the kids are back in school and summer vacations are in the rearview mirror, it’s time to catch up on recent fraud and abuse developments. The federal government was busy this summer negotiating a pair of settlements...more

Strangest Regulatory Interpretation of the Month

The Massachusetts federal district court is hands-down winner of the August award for strangest regulatory interpretation of the month. The interpretation came in the context of denial of Omnicare’s summary judgment...more

When a Discount May be a Kickback

Healthcare providers of all kinds, as well as medical equipment suppliers, have traditionally relied upon discounts as a legitimate means of attracting patients and commercial clients without running afoul of the federal...more

Compliance Concerns Raised Over Proposed Hospital Outpatient Department Rule

In an August 26, 2016, letter to the Centers for Medicare & Medicaid Services (CMS), the American Hospital Association (AHA) expressed serious concern over the portion of the calendar year 2017 hospital outpatient prospective...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Healthcare Compliance: Juggling Risk Mitigation Strategies

Healthcare organizations – ranging from physician practice groups to large, multi-state hospital systems – face a variety of risks, including fraud and abuse, as well as HIPAA privacy issues. Starting from a baseline risk...more

Also In The News - Health Headlines - August 2016 #3

CMS Releases Medicare Outpatient Observation Notice For Public Comment – CMS announced that the public has the opportunity to comment on the Medicare Outpatient Observation Notice (MOON). The MOON is a standardized form...more

Health Care Matters, Summer 2016

Special Masters in Health Care Antitrust Merger Cases: Resolving the Conflicting Interests - One of the most challenging aspects of antitrust cases in the health care field is the rich mixture of public interest...more

Anti-Kickback Regs Near Approval, After Only 19 Years

The White House is reviewing proposed regulations to ease restrictions on certain financial arrangements between hospitals and physicians and on certain transactions between providers and patients. The proposed regulations,...more

False Claims Act Cases: With No End In Sight, Why You Should Consider Litigating And How To Maximize Your Litigation Advantages

Over the past few years, the government’s emphasis on conducting fraud and abuse investigations – especially in the healthcare industry – has resulted in scores of settlements and billions of dollars paid to the government...more

Don’t Discount the Government’s Recent Statement of Interest in False Claims Act Case

On August 8, 2016, the U.S. government filed a Statement of Interest in an ongoing False Claims Act (FCA)/Anti-Kickback Statute (AKS) case, U.S. ex rel. Herman v. Coloplast Corp., No. 1:11-cv-12131 (D....more

Drug Companies and Charitable Patient Foundations

Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more

The Department of Justice Ups the Ante: Per Claim Penalties for False Claims Act and Anti-Kickback Statute Violations Nearly...

On June 30, 2016, the Department of Justice (“DOJ”) published an interim file rule that dramatically increases the per claim penalties for violations of the False Claims Act (“FCA”) and the Anti-Kickback Statute (“AKS”) among...more

The Physician’s Self-Referral Law – Are Changes Finally Coming?

The Physician Self-Referral Law, also known as the Stark law, prohibits a physician from referring federal health care program patients for “designated health services” to an entity in which the physician (or an immediate...more

OIG Gives Green Light to Hospice Provider’s Payment to Nursing Facilities

Last week, the OIG issued a favorable opinion to a hospice provider seeking to make supplemental payments to skilled nursing facilities. Under the proposed arrangement, the hospice provider would make a supplemental payment...more

Check Up on Healthcare Fraud Prosecutions

Chief compliance officers face an overwhelming level of risk in the healthcare sector. I do not mean to belittle the risks of corruption, AML, sanctions and other risks typically associated with global companies. Healthcare...more

Hospital/Physician Leases Compliance Checklist

LEGAL REQUIREMENTS: A "no" answer to any of the following questions may mean your lease is out of compliance with applicable laws. Is the lease in writing? Is the lease signed by both parties? Does it...more

OIG Permits Copayment Coupon Arrangement for Statutorily Non-Covered Drug in Advisory Opinion 16-07

On June 20, 2016, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable Advisory Opinion 16-07 regarding a savings card program (Card Program) under which Medicare Part D...more

Are Changes to the Stark Law on the Way?

Congress has acknowledged that the Stark law is standing in the way of the healthcare industry's transition to alternative, value-based payment models, and in turn, meaningful reform may soon be on the horizon. Last...more

Flying Pigs and False Claims

On July 7 the Fourth Circuit invoked Flying Pigs to vacate a lower federal court judgment in a Medicaid false claim case, even though neither the lower court nor any of the parties asked it to. The case started in 2007,...more

Department of Justice Imposes Almost 100% Increase in Minimum and Maximum Monetary Penalties Under FCA

On June 30, 2016, the U.S. Department of Justice (“DOJ”) announced an interim final rule almost doubling per-claim penalties under the False Claims Act (“FCA”). The FCA still imposes treble damages for government losses in...more

[Webinar] Healthcare Real Estate: Navigating Stark Law and the Anti-Kickback Statute in Real Estate Leasing - July 20th, 12:00pm...

When healthcare providers are involved in real estate leasing, they bring with them a host of laws and regulations that may be unfamiliar to professionals accustomed to handling traditional real estate leasing....more

Another Court Rejects Statistical Sampling and Rules That Difference of Opinion About Hospice Eligibility Is Insufficient for...

Back in March of this year, in U.S. ex rel. Paradies v. AseraCare, Inc., a district court in Alabama granted summary judgment to a defendant hospice finding that an expert physician’s disagreement with a certifying...more

Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty

The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached...more

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