Designated health service fall under the federal Physician Self-Referral Law, preventing Medicare referrals where financial conflicts exist. Learn key rules, exceptions, and compliance strategies to avoid penalties and ensure ethical healthcare operations.
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Healthcare laws are complex, and compliance mistakes can cost providers heavily. A trusted healthcare regulatory compliance law firm in Florida helps navigate HIPAA, Anti-Kickback, Stark Law, EMTALA, fraud, and abuse regulations—protecting practices, patients, and reputations while ensuring long-term success in today’s evolving healthcare industry.
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By: Jeff Cohen
FMVs are at the heart of healthcare regulatory compliance when money or anything of value changes hands in a healthcare business setting. Why? Two reasons:
How it Goes—A Six Part Process
Locking down an externally performed FMV (part of the “gold standard” in regulatory compliance) is a process. Here’s what it should look like:
Step 1. The healthcare business person or his/her advisors (often accountants) find someone who specializes in performing FMVs for the specific matter (e.g. compensation, price of a business to be acquired);
Step 2. The LAWYER for the healthcare business is immediately involved in the process BEFORE the FMV firm is engaged;
Step 3. The LAWYER engages the FMV firm on behalf of the healthcare business client;
Step 4. The parties (including the lawyer) get on the phone or in a meeting with the “FMV guy” and has a very extensive conversation re the project;
Step 5. Once the FMV process done, a DRAFT FMV study is prepared and discussed interactively with the healthcare business and the lawyer;
Step 6. Once finalized, an execution copy is prepared and provided to the lawyer.Continue reading
There’s a fine line between gifts and kickbacks within the healthcare setting. Read about the differences and how to properly plan your healthcare marketing in your business.
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Three 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. Continue reading
By: 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–
The waiver also contains specific examples of waived interactions between providers and hospitals, including—Continue reading
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…Continue reading
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—Continue reading
By: 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! Continue reading
By: 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.Continue reading
