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

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!  Continue reading

State Court Ruling on Patient Brokering Act Threatens Healthcare Facilities and Providers

patient brokering actA recent ruling by a state trial court handling the Palm Beach County Sober Home Task Force prosecutions against providers of addiction treatment and sober home services is creating lots of confusion and alarm around the state and could have very far reaching consequences for the entire healthcare industry well beyond addiction treatment.

The issue presented by the prosecution focuses on whether a person charged with violating the state’s Patient Brokering Act (PBA) can be found guilty even if he/she didn’t know what he was doing was unlawful. The PBA broadly prohibits paying someone for patient referrals, very much like the federal Anti-Kickback statute.  If allowed, the client would have gotten legal advice, paid for it, followed it, and still not be able to show a judge or jury that, despite all their best efforts, they simply followed the law as instructed.

Can a healthcare facility or provider be guilty of violating a criminal law [the PBA] if they’d gotten legal advice and followed it?  Traditionally, the answer would be a clear “no.”  The argument against the State’s position would be something like “How can someone intend to violate a criminal law if they got legal advice regarding how to comply with it and then followed that advice?”  The argument of the state might look something like “We don’t even think the judge or jury ought to be able to hear that the person got legal advice and followed it.”  The court punted the issue to the appellate court.Continue reading

Clinical Laboratory Licensure: Florida Repeals State Licensure

clinical laboratory law

clinical laboratory lawBy: Karina Gonzalez

Effective July 1, 2018, Florida’s recent legislation SB 622 repeals the entirety of Chapter 483, Part I of the Florida statutes, and removes the state licensure requirement for clinical laboratories operating in-state and out-of-state. Section 97 of SB 622, approved by the Governor on March 19, 2018, repeals the entirety of Chapter 483, Part I of the Florida statutes, and so eliminates section 59A-7.024(1).Continue reading

Healthcare Compliance: Providers MUST Have Corporate Compliance Programs

healthcare compliance

healthcare complianceBy: Jacqueline Bain

How serious is the federal government that corporate compliance is necessary for healthcare providers?

In late 2015, the Department of Justice (DOJ) hired the agency’s first Compliance Counsel. Then, in early 2017, the DOJ published “common questions” that US Attorneys should ask as part of a criminal investigation when the DOJ evaluates a company’s compliance program. The “common questions” published by the DOJ describe specific factors that prosecutors should consider in conducting an investigation of a corporate entity, determining whether to bring charges, and negotiating plea or other agreements. These factors include “the existence and effectiveness of the corporation’s pre-existing compliance program” and the corporation’s remedial efforts “to implement an effective corporate compliance program or to improve an existing one.”Continue reading

Starting Healthcare Business: What to Consider

By: Jeff Cohen

As a healthcare business lawyer, I’ve seen nearly everything entrepreneurs think might be a good idea.  They usually come to me when starting a healthcare business with questions like:

  1. Do you like an LLC better than an Inc., and if so why;
  2. Does the Stark Law (or the Anti-Kickback Statute) allow us to do this?;
  3. Is it ok to allocate ownership and profit distribution differently?;
  4. Will insurers pay for this?; and
  5. WWMT?  (What Would Medicare Think?).

These are great questions.  And they’re off base.  In fact, they’re not only off base. They’re also out of order.  Here’s one for you–Continue reading

HIPAA Security Basics: Keeping your Medical Web-Based Business Compliant

By: Shobha Lizaso

Medical web-based businesses have been on the rise, while the number of HIPAA enforcement actions by the US Department of Health and Human Services (HHS) has risen exponentially as well. Since the beginning of this year, HHS has announced several large settlements with companies that failed to comply with HIPAA Compliance requirements. For example, in January, HHS announced a $2.2 million settlement with a health insurance company when a breach resulted from a stolen portable USB device containing PHI. Also, In February, HHS announced a penalty of $3.2 million against a medical center for a breach that arose from a theft of an unencrypted laptop containing PHI. This enforcement activity is becoming the norm, so it is best to ensure that your medical website is legally compliant.

If you are handling any PHI on or through your website, you must ensure that your website is up to speed with HIPAA compliance. Here are some recommendations to address the security and privacy of PHI that your website may manage (please note that this is not a comprehensive list):Continue reading

Copay Waiver Questions: OIG Opines that Charities Allowed to Help with Patients’ Insurance Obligations

financial hardshipBy: Jacqueline Bain

In the healthcare business, giving a patient a break on a health insurance copay is often viewed as suspicious. The reasoning for the suspicion is that the financial incentive may give one provider a competitive advantage over another, or persuade a patient to seek services that might not be medically necessary.  Moreover, any person who interferes with a patient’s obligations under his/her health insurance contract may be viewed as tortuously interfering with that contract. However, in an advisory opinion issued on December 28, 2016, the OIG opined that, in certain instances, a non-profit, tax-exempt, charitable organization could provide financial assistance with an individual’s co-payment, health insurance premiums and insurance deductibles when a patient exhibits a financial need.

The party requesting the advisory opinion was a non-profit, tax-exempt, charitable organization that did not provide any healthcare services and served one specified disease. The non-profit, tax-exempt, charitable organization is governed by an independent board of directors with no direct or indirect link to any donor. Donors to the non-profit, tax-exempt, charitable organization may be referral sources or persons in a position to financially gain from increased usage of their services, but may not earmark funds and or have any control over where their donation is directed.Continue reading

PAs and ARNPs and Prescribing Controlled Substances

ARNP controlled substancesBy: Jacqueline Bain

For many years, medical providers and regulators have wrestled with whether Advance Registered Nurse Practitioners (“ARNPs”) and Physician Assistants (“PAs”) should be able to prescribe controlled substances.  This past legislative session, several bills were signed into law allowing ARNPs and PAs to prescribe controlled substances subject to several limitations and restrictions. This article will set forth a broad overview of the bills. However, if your practice intends to use ARNPs or PAs to prescribe controlled substances, we strongly recommend that each practitioner is educated about the boundaries set forth in the new law. For instance, there are restrictions on prescribing certain controlled substances in certain circumstances, prescribing controlled substances within a pain management clinic, and prescribing controlled substances for persons under age 18. It is important that all practitioners are properly educated prior to engaging in prescribing or dispensing any controlled substances.

Advance Registered Nurse Practitioners

ARNPs may prescribe or dispense Schedule II, III or IV controlled substances if they have graduated from a program leading to a master’s or doctoral degree in a clinical nursing specialty area with training in specialized skills and have completed 3 hours of continuing education on the safe and effective prescription of controlled substances. ARNPs must limit their prescriptions of Schedule II controlled substances to a 7-day supply. However, this restriction does not apply to psychiatric ARNPs who are prescribing psychiatric medications.Continue reading

The OIG Addresses Free Patient Transportation Issues

vanBy: Jacqueline Bain

The issue of whether a medical provider can provide free patient transport is one that we are asked to look into a few times every year. Aside from the liability issues that it raises, it is one that we have never been able to justify from an Anti-Kickback and Patient Brokering perspective.  The fact is, even given the good intentions of most providers to allow their patients easier access to healthcare, transporting patients to and from your facility or practice is providing them with something of value in return for coming to see you.  However, under slightly different facts than we are usually asked to consider the question, last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) came to a different conclusion.

The OIG issued an advisory opinion upon the request of a hospital system who had asked whether it could provide free transportation to persons who had limited access to public transportation to access the hospital’s facilities. The hospital system offered that the town had inadequate and infrequent public transportation services which would act as a barrier to healthcare for local residents.  The hospital system offered the following facts for consideration:Continue reading

Addiction Treatment is a Story in Search of a Villain

Compliance With Laws & Regulations

healthcare business

Hastiness and superficiality are the psychic diseases of the twentieth century, and more than anywhere else this disease is reflected in the press— Alexander Solzhenitsyn

By: Jeff Cohen

I read an article in a local paper the other day.  It was about (a) a guy who owned a treatment center (who has not been charged with committing a crime), (b) a lawsuit filed by a large insurance company against a toxicology lab that the insurer owes millions, and (c) the fact that insurance companies pay a lot for toxicology lab testing.  I scratched my head, wondering how there was anything newsworthy there.  The “story” being sold by the paper, however, created a story with a villain (the providers of services to people in recovery from drug and alcohol addiction) and a “victim” (people receiving care for addiction).  I can’t resist responding.

There’s a difference between something that’s interesting and worthy of comment vs. a journalistic attempt to concoct controversy and intrigue that people might buy.  There’s not much of the former, but a lot of the latter.  People in recovery being victimized by horrible, greedy people is an interesting story.  Unfortunately, it’s off the mark and really not helpful to anyone.

There are three pretty safe assumptions we can almost all agree on:  first, there are a lot of people who want to live life without active addiction.  Second, many of them think they need help to create a better life.  Third, some providers of help to people in recovery make a bunch of money providing that service.Continue reading