Stark Law

All posts tagged Stark Law

Patient Brokering & Money Laundering: Bieda Arrests Raise Serious Issues

by admin on September 1, 2020 No comments

patient brokering arrest treatment center toxicology lab ownershipThree family members involved in owning an addiction treatment center and/or a toxicology lab were charged in July with patient brokering and money laundering in an alleged scheme involving roughly $2 Million.  The allegations arise out of a complex corporate enterprise involving at least four companies and some common ownership between the treatment center and lab.  While it’s premature to assume that the defendants did anything illegal, there are some interesting things in this case:

Complexity Invites Suspicion.  Every business owner in the addiction treatment and toxicology lab space knows three things:  (1) it’s extremely regulated, (2) law enforcement has an especially sharpened focus on these industries, and (3) insurance companies are very suspect of any situation involving either industry, especially when there is any common ownership.  So why then would one construct an enterprise that even “looks” complex or tricky?  It intensifies suspicion in an already highly scrutinized business space.  This is clearly one of the points of focus in this case.  There’s an old saying woven into the mind of every experienced healthcare lawyer:  if something can’t be done directly, it can’t be done indirectly.  Time will tell if anything in this case was wrong or if there are any good reasons for the corporate structure, but the complexity of the corporate structure certainly invites suspicion.

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Stark Law waived to facilitate COVID related medical services

by admin on April 17, 2020 No comments

stark law waiverBy: Jeff Cohen

The Secretary of Health and Human Services issued blanket waiver of the Stark Law on March 30th in order to facilitate COVID related medical services.  The waivers apply only to financial relationships and referrals related to COVID.  The circumstances and conditions under which the waivers apply are strictly and narrowly described.  Moreover, the waivers have no impact in the presence of fraud or abuse.  With respect to physicians wanting to provide designated health services (e.g. clinical lab services) related to COVID detection and treatment, for instance–

  1. the federal requirement that the DHS be provided in the same building as the physician office is waived; and
  2. the financial relationship limitations between the physician (or family member) and the DHS provider is waived.

The waiver also contains specific examples of waived interactions between providers and hospitals, including—

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EKRA and SUPPORT Act Impact: Legal Breakdown

by admin on March 11, 2019 No comments

By: Susan St. John

Most everyone knows that laws are being implementing in federal and state government to address the opioid crisis in the US. One such law is the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) signed into law in October 2018 by President Trump. While the SUPPORT Act seeks to increase access to treatment for substance use disorders and prevention of substance use disorders, it also contains language to prevent abuse of the process to increase treatment access. Specifically, incorporated into the SUPPORT Act is the Eliminating Kickbacks in Recovery Act (“EKRA”) which directly targets unlawful referrals to recovery homes, clinical treatment facilities, and laboratories.

EKRA is similar to prohibited kickbacks and patient brokering pursuant to Sections 456.054 and 817.505, Florida Statutes, using similar language as both Florida statutes. EKRA makes it unlawful…

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EKRA Affects Marketing Relationships with Labs and Addiction Treatment Businesses

by admin on January 15, 2019 No comments

By: Jeff Cohen

For those following the federal legislative developments on the issue of compensating marketing people who market the services of labs and addiction treatment facilities there is a new update to take note of. Congress passed on October 24, 2018 the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act.”  Yes, that’s a real name!  Part of the law is the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”).

The core aspect of EKRA has to do with how to properly compensate marketing personnel who market the services of labs, addiction treatment facilities and recovery homes.   For those of you already familiar with existing federal law pertaining to compensation arrangements (e.g. the bona fide employee exception (the “BFE”) and the personal services arrangement and management contract safe harbor (the “PSA”)), the EKRA provisions will look familiar!  Key aspects of this law (which has to be read together with similar existing laws) include—

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State Patient Brokering Act Cases to Throw out Legal Advice as Defense

by admin on October 9, 2018 No comments

palm beach county task forceBy: Jeff Cohen

There are two criminal cases pending in Palm Beach County that threaten to put a bullet in the heart of healthcare professionals and businesses and also the law practices that advise them.  Both State v. Simeone and State v. Kigar have a motion from the State pending before them to block any testimony that the defendants received legal advice concerning a contract entered into by an addiction treatment facility and a sober home.  The State alleges that the contract violates the state Patient Brokering Act (PBA) because it was essentially a ruse whereby the addiction treatment facility was just paying for the sober home to refer patients.  Now the State wants to make sure that the entire issue of the defendants being advised by counsel never sees the light of day.

How is this possible?  How can it be that a client can seek legal counsel, get advise (and presumably follow it), and then be blocked from presenting that evidence?  The State argues that the PBA has no wording that requires them to prove intent.  And if intent isn’t an element to be proven, the argument goes, then evidence of the client intending not to violate the law by getting advice beforehand is inadmissible!  

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A New Perspective from CMS? Medicare, Stark Law and Whistleblower Changes on Deck

by admin on October 2, 2018 No comments

medicare stark lawBy: Dave Davidson

Over the past several months, the Centers for Medicare & Medicaid Services (CMS) has taken a number of steps that show an awareness of the regulatory burden placed upon participants in the government’s health care programs, and even some willingness to consider reducing those burdens.  While it remains to be seen whether the recent proposals will have measurable results, the following actions can still be viewed with guarded optimism.

Proposed Changes to Medicare

In July, 2018, CMS proposed significant changes to Medicare, to be included in rules that take effect in 2019.  These changes cover physician fee schedules, streamlining Evaluation & Management (E&M) billing, advancing “virtual care,” decreasing drug costs, revising the MIPS program and establishing the MAQI demonstration project.  The agency also asked for comments on price transparency issues.

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Anti-Kickback Statute and Healthcare Marketing: 3 Legal Considerations

by admin on September 6, 2018 No comments

healthcare marketingBy: Matt Fischer

Healthcare marketing arrangements that violate the Anti-Kickback Statute (AKS) can lead to serious financial and criminal consequences.  Understanding the types of marketing arrangements that courts have found to be in violation of the statute and the potential implications are critical for marketers to know in order to operate in the healthcare industry.

Under the AKS, it is a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce referrals of items or services reimbursable by the Federal health care programs.  Where remuneration is paid purposefully to induce referrals of items or services paid for by a Federal health care program, the AKS is violated.  By its terms, the AKS ascribes criminal liability to parties on both sides of an impermissible transaction.  An example of a highly scrutinized arrangement involves percentage compensation.  For regulators, percentage compensation arrangements provide financial incentives that may encourage overutilization and increase program costs.

Here are 3 important things to know:

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False Claims Act Case Beaten by Bona Fide Employee Arrangement

by admin on August 23, 2018 No comments

false claims actBy: Jeff Cohen     

One healthcare employer’s compensation arrangement with its employees just got much needed support from the 11th Circuit Court of Appeals.  The employer there, which provided AIDS patients certain healthcare related services, paid its employees a bonus of $100 per patient.  The case was brought on the argument that the compensation arrangement constituted an illegal kickback under the federal Anti- Kickback Statute.  The court, however, disagreed because the employees who received the bonuses were “bona fide employees.”

The court’s focus on the plain language of the safe harbor for bona fide employees was refreshingly clear, notably that “any amount paid by an employer to an employee (who has a bona fide employment relationship with such an employer) for employment in the furnishing or any item or service.”  Essentially, any amount paid by an employer to a bona fide employee is not considered to be “remuneration” under the Anti-Kickback Statute.

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DMEPOS Medicare Coverage & Reimbursement

by admin on March 14, 2018 No comments

DME medicareBy: Michael Silverman

Providers need to comply with all the Medicare ‘red tape’ but need not let fear of non-compliance inhibit their practice from offering Durable Medical Equipment Prosthetics & Orthotics Supplies (“DMEPOS”) to Medicare beneficiaries.

Here’s an overview of the steps providers need to take to enroll as a supplier of DMEPOS with Medicare to be eligible for Part B coverage and reimbursement:

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Chiropractic Medical Integration Needs an Adjustment

by admin on February 12, 2018 No comments

chiropractic medical integrationBy: Jeff Cohen

I’d run out of fingers and toes if i had to recount the rash of remarkably bad legal guidance given to well meaning chiropractors looking to integrate various medical services to their practice.  They hook up with an experienced business firm, a Management Company, that specializes in that area, but then get advice from a buddy or a lawyer who simply doesn’t have the depth of experience to correctly advise them.  The Management Company is happy because they don’t know the lawyer is oversimplifying things, which has the effect of a stream of chiropractor clients rolling into the Management Company.  Well done, except it’s often not!

Want some examples?  Ok, how about this—

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