Compounding Pharmacies and Alleged Tricare Abuses Back in the Spotlight

compounding pharmacyBy: Jacqueline Bain

On Thursday, February 11, 2016, the United States Attorneys’ Office from the Middle District of Florida announced a $10 million settlement with 4 physicians and 2 pharmacies regarding alleged abuses of Tricare program.  The case against these physicians and pharmacies was prosecuted as part of the United States government’s large-scale effort to combat questionable compounding practices.  Investigations revealed that patients were often prescribed compounded drugs that they never used, and that Tricare paid a mark-up cost of nearly 90% for compounded drugs over and above the pharmacy’s actual costs of making the drug.  Roughly 40% of the claims submitted by the pharmacies in question were written by 4 physicians with an ownership or financial interest in the pharmacies.

Tricare is a federal health care program designed to insure active duty military service members, reservists, members of the National Guard, retirees, survivors and their families.  Tricare outpatient costs have almost doubled in the last 5 years, and compound drugs have accounted for a large portion of that increase.  Continue reading

Act or React? Rehab Industry Transformation

florida healthcare lawyerBy: Jeff Cohen

By now, it’s not news in Florida that drug and alcohol recovery providers are staring devastation in the face as payers continue to mount non-payment offensives.  As payers one by one march on the industry and starve providers of cash flow for operations, many providers can be expected to shut down.  To make matters worse, as the popular media continues to act as a conduit for gross misrepresentations of industry providers, the public’s affection for the industry can’t be expected to improve.  This makes the future look especially bleak for the industry, and yet the silence and stillness of providers is baffling.

Given the breadth of the payer problem (many simply aren’t paying providers), why are we not seeing a slew of lawsuits filed by providers?  In nearly 30 years as a Florida healthcare lawyer, I’ve never seen a healthcare sector so hammered by insurance companies.  And I’ve never seen it unanswered in court. 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

Recent Governmental Enforcement and Regulatory Developments

Headshot - DDBy: Dave Davidson

The last few weeks have seen some significant examples of the federal government’s vigilance in policing the healthcare market.  These events serve as a reminder of the highly regulated and scrutinized industry in which we work.  They are also a reminder to physicians and other providers to make sure their practices and contractual arrangements can pass this scrutiny.

The most significant recent event is the $115 million settlement between the government and the Adventist Health System.  This settlement resolved two whistleblower cases brought against the system by three employees.  The lawsuits alleged that the Adventist Health System violated the Stark law, which generally prohibits payments to physicians for making referrals unless an exception to the law is met.  The specific allegations against the Adventist Health System were that the compensation paid by the health system to some of its employed physicians exceeded fair market value; that the structure of the practice of the employed physicians did not meet the “group practice” exception; that physician compensation improperly included payment work not performed by the physicians; and that the physicians were paid for making referrals to the system.  Continue reading

The Anti-Kickback Statute: What Constitutes a “Referral”?

anti kickbackBy: Jackie Bain

Providers of healthcare items or services are well-served to take note: a Federal Court of Appeals has recently held that “the Anti-Kickback Statute prohibits a doctor from receiving kickbacks that are made in return for a referral. It does not require that the referral be made in return for a kickback.”  Thus, receiving any unauthorized payment from a health care provider to whom you send patients is a very bad idea.

The Federal Anti-Kickback Statute, 42 USCS § 1320a-7b(b) states, in pertinent part, that a person may not knowingly or willfully solicit or receive any remuneration directly or indirectly, overtly or covertly, in cash or in kind, in return for referring an individual for the furnishing of a healthcare item or service that is payable in whole or in part by a Federal healthcare program. In laymen’s terms, a person cannot pay or receive anything of value in return for furnishing a Medicare patient to receive a healthcare item or service. (Note, however, that the law does set forth examples of permissible payments, or “safe harbors,” but we won’t address those in this article.) Continue reading

The Reality of the “Economic Realities Test”

contractBy: Valerie Shahriari & Jacqueline Bain

Across the healthcare industry, providers and healthcare businesses are consistently faced with the decision of whether to employ or contract with their workers.  Whether it’s a physician working with a group practice, or a marketer on behalf of a healthcare service, correctly structuring relationships between healthcare businesses and their workers is important.  For tax reasons, many workers strongly prefer to enter into independent contractor relationships.  However, simply calling oneself an independent contractor is not enough to solidify the relationship.  Many times, workers who call themselves independent contractors are actually employees in the minds of the government.  And sometimes, so-called “employees” with several part-time positions are actually viewed as independent contractors.

On July 15, 2015 the Administrator of the Department of Labor’s Wage and Hour Division (WHD) provided additional guidance regarding the application of the standards for determining who is an employee under the Fair Labor Standards Act (FLSA).  The goal of the guidance is to help the regulated community in classifying workers and decreasing misclassification.  The Administrator’s Interpretation reviews the pertinent FLSA definitions and the breadth of employment relationships covered by the FLSA.  The Administrator’s Interpretation then addresses each of the factors of the “economic realities test”.

According to the Administrator, when determining whether a worker is an employee or independent contractor, the application of the economic realities factors should be guided by the FLSA’s statutory directive that the scope of the employment is very broad.  The FLSA’s definitions establish the scope of the employment relationship under the Act and provide the basis for distinguishing between employees and independent contractor.

The Supreme Court and Circuit Court of Appeals have developed a multi-factorial “economic realities” test to make the determination whether a worker is an employee or an independent contractor under the FLSA.  The test focuses on whether the worker is economically dependent on the employer or in business for him or herself.  The factors include: Continue reading

Tuomey Court Has A Lot to Say

bcbs lawsuit

 

By: Jeff Cohen

The Tuomey decision, U.S. Court of Appeals case out of South Carolina, contains important lessons for physicians, especially as it relates to (1) compensation arrangements with hospitals, (2) proper compensation arising in connection with the provision of designated health services (“DHS”), and (3) the advice of counsel defense.

The concept of DHS arises largely in the context of the federal Stark Law, which in pertinent part (1) forbids physicians from owning and referring to providers of DHS (e.g. PT, rehab, diagnostic imaging, home health, DME, clinical laboratory, inpatient and outpatient hospital services), (2) describes how medical practices can provide DHS to their own patients, and (3) forbids even physicians within a practice from allocating DHS profits on the basis of who ordered or referred to them.

The Tuomey case involves a whistleblower action filed against a not for profit hospital system.  The original jury in that case decided that the system didn’t violate the False Claims Act, but the appellate court set aside the verdict using facts and testimony that had be excluded from the jury trial, Tuomey Healthcare System was found to have knowingly submitted over 21,000 false claims to Medicare and the government was awarded over $237 Million (most of it in the form of punitive damages).  The government (which often advances the plaintiff’s—“relator” case in whistleblower cases) filed a motion for a new trial, which the trial court granted and the appellate court affirmed.

The case involves the following: Continue reading