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Genetic Testing HIPAA Warning: Legal Considerations

January 14th, 2019 by

genetic testing hipaaBy: Jacqueline Bain

You might have recently received a holiday gift of a direct-to-consumer genetic testing kit from Ancestry.com or 23andMe.com (or any other number of companies). So exciting! In our melting pot society, one can’t help but be curious about where they come from and if they are more likely than any other person to be subject to any number of ailments.

Not so fast though! Before you swab yourself and send away your genes for testing, you might consider what you’re exposing yourself to. Direct-to-consumer genetic testing companies, which provide genetic testing directly to consumers without any intervening healthcare provider, are not bound by HIPAA. They are not considered “covered entities”, and therefore not required to use the same protections for genetic information the way a hospital or your doctor would. read more

Physician Employment Contracts: Hidden Terms

January 11th, 2019 by

physician employment contractBy: David Davidson

Over the past few years, it seems like physician employment agreements are getting shorter and shorter.  While I applaud all efforts towards efficiency and economy, you should not always take those documents at face value.  For example, I recently reviewed a one page employment contract for a client.  That single page basically said, “We are hiring you as our employee for a term of one year, with an annual salary of $$$.”

At first glance, the simplicity of that document might seem refreshing.  That’s especially true if you’re worried about how much time it’s going to take for your lawyer to get through it!  My client’s second glance revealed a multitude of unanswered (and essential) questions.  There was no mention of expected duties, schedules, standards, renewals, terminations, insurance, benefits, vacation time, sick leave, CME, etc. in the employment contract  However, when we reviewed the contract together, we discovered that although those points were not even referenced on that single page, they were still legally, “in there.” read more

Second Proposed Stem Cell Bill Goes to Florida House of Representatives

January 2nd, 2019 by

stem cell billBy: Matt Fischer

On November 29, 2018, Florida Representative Chuck Clemons proposed house bill 65 (“HB 65”) that would significantly tighten regulation on the use of stem cells.  If the stem cell bill is signed into law, Florida will join other states (e.g. California, Texas and Washington) in passing some type of stem cell regulation.  While some bills around the country have centered the regulation on informing prospective customers of the risks associated with these treatments, HB 65 takes a more stringent approach with the threat of criminal exposure and includes certain protections for providers in the form of a “right-to-try” law.

Some of the highlights of HB 65 include: read more

OIG Unveils Latest Tool for Evaluating Fraud Risk

November 12th, 2018 by
OIG fraud risk

https://oig.hhs.gov/compliance/corporate-integrity-agreements/risk.asp

By: Karina Gonzalez

The Office of Inspector General (OIG) announced the launch of a new tool on its website titled the “Fraud Risk Indicator”.  The OIG has stated that the purpose for the tool is to provide guidance on how it has evaluated risk in settling False Claims Act (FCA) cases and to publicize information about where FCA defendants fall on the OIG’s risk spectrum.  This tool can benefit patients, healthcare industry professionals and other individuals who may find this information relevant.   This tool will also benefit the public with information about providers charged under the FCA that are at high risk for committing healthcare fraud. The Indicator shows the Risk Spectrum from Highest Risk to Lower Risk. read more

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

October 9th, 2018 by

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!   read more

The Latest Healthcare Fraud Enforcement Tool: The Travel Act

October 9th, 2018 by

healthcare fraudBy: Matt Fischer

Federal law enforcement has traditionally prosecuted individuals utilizing healthcare fraud and abuse laws such as the Federal Anti-Kickback Statute, the False Claims Act, the Physician Self-Referral Law also known as the Stark Law as well as other administrative tools including exclusions and civil monetary penalties.  In addition to these laws, federal law enforcement also has at their disposal other fraudulent act statutes such as mail and wire fraud.  The facts of a case, however, may not provide for federal standing.  For example, when individuals take out federal government payors out of the picture or from an arrangement as a way of avoiding federal jurisdiction.  The new solution to this issue…a law enacted in 1961, the Travel Act. read more

Anti-Kickback Statute and Healthcare Marketing: 3 Legal Considerations

September 6th, 2018 by

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: read more

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

July 25th, 2018 by

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. read more

Behavioral Analysis Medicaid Providers: Florida’s Latest Enforcement Target

July 20th, 2018 by

behavioral analysis medicaidBy: Matt Fischer

Florida’s Agency for Health Care Administration (“AHCA”) is the state’s chief health policy and planning organization.  AHCA is also responsible for the state’s Medicaid program.  One of the agency’s latest targets are behavioral analysis providers who treat children with autism.  Recently, AHCA imposed a temporary six-month moratorium on enrollment of new providers due to newly discovered fraud and abuse.  AHCA states that the temporary moratorium will allow the agency the time to complete a full assessment of the current provider population.  In other words, all behavioral analysis providers will experience heightened scrutiny in the coming months if not already.  This can include in-person interviews and requests for records.  Given this increased regulatory action, it is important for behavioral analysis business owners to be aware of the audit process and to prepare for likely future reviews.

Here are a few of the notable findings cited by AHCA regarding the identified fraud and abuse: read more

I Want to Start a Stem Cell Distribution Business…Now What?

June 20th, 2018 by

By: Matthew Fischer

Jumping into the stem cell industry can be an exciting venture.  However, with this emerging industry comes a mine field of legal pitfalls and potential problems.  The keys to a successful business not only include selecting a strong product and building strong relationships with clients but being able to navigate the regulatory framework that accompanies this type of product.

FDA regulations require establishments that perform one or more steps in the manufacturing process of HCT/Ps (i.e. Human Cells, Tissues, and Cellular and Tissue-Based Products) to register and submit a list of products with the agency.  If so, you have five days to register after beginning operations.  When I mention “manufacturing” to clients they usually interject with “I only want to distribute.”  Good point.  However, the FDA defines “manufacture” as any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue.  These registrations must be updated annually and in the event of a change of ownership, within 30 days of the change.  read more