Time to ReThink RePackaging Drugs

By: David Hirshfeld

Winston Churchill once commented that “Anyone can rat, but it takes a certain amount of ingenuity to re-rat.”  Well, this sentiment evidently applies to the re-packaging and re-labeling of prescription drugs here in Florida; and the legislature seems to have caught up with the ingenuity.

For years, workers’ compensation insurers have been complaining about the perceived increased cost of repackaged and relabeled drugs.  With CS/SB 662 Florida’s legislature seems to have answered the payors’ cries, and closed a loop-hole in workers’ compensation reimbursement with respect to repackaged and relabeled drugs. Continue reading

Physicians & Facilities Frustrated in Upcharging Lab Fees

Licensed healthcare providers and facilities (including many drug and alcohol recovery businesses) who enter into arrangements with clinical labs to provide services to their patients and who then wish to charge more for those lab services will be very disappointed to learn about the restrictions under Florida law.

Section 456.054, Florida Statutes prohibits “kickbacks” and reads—

(1) As used in this section, the term “kickback” means a remuneration or payment, by or on behalf of a provider of health care services or items, to any person as an incentive or inducement to refer patients for past or future services or items, when the payment is not tax deductible as an ordinary and necessary expense.

(2) It is unlawful for any health care provider or any provider of health care services to offer, pay, solicit, or receive a kickback, directly or indirectly, overtly or covertly, in cash or in kind, for referring or soliciting patients.

(3) Violations of this section shall be considered patient brokering and shall be punishable as provided in s. 817.505.

The issue involved in a provider or facility charging more for lab services than they were charged by the lab itself is that the prohibition above applies to healthcare providers and “any provider of healthcare services.”  Regulators may find any reduced fee by the lab to constitute a kickback in exchange for a volume of patient referrals.

A related issue has to do with Florida insurance laws that pertain to charging more for an item or service than the provider or facility was charged.  For instance, if Lab 1 charges the provider/facility $10 for lab work, and the provider/facility charges an insurer $20, that can be found to constitute insurance fraud.

The key Florida prohibition, however, is found in the Florida Administrative Code, which reads—

59A-7.037 Rebates Prohibited – Penalties.

(1) No owner, director, administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person either directly or indirectly, shall pay or receive any commission, bonus, kickback, rebate or gratuity or engage in any split fee arrangement in any form whatsoever for the referral of a patient. Any violation of Rule 59A-7.037, F.A.C., by a clinical laboratory or administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person acting on behalf of the clinical laboratory will result in action by the agency under Section 483.221, F.S., up to and including revocation of the license of the clinical laboratory. In the case of any party or individual not licensed by the agency acting in violation of this Rule, a fine not exceeding $1,000 shall be levied and, as applicable, the agency shall recommend that disciplinary action be taken by the entity responsible for licensure of such party or individual.

(2) No licensed practitioner of the healing arts or licensed facility is permitted to add to the price charged by any laboratory except for a service or handling charge representing a cost actually incurred as an item of expense. However, the licensed practitioner or licensed facility is entitled to fair compensation for all professional services rendered. The amount of the service or handling charge, if any, shall be set forth clearly in the bill to the patient.

(3) Each licensed laboratory shall develop a fee schedule for laboratory services which shall be available to the patient, the authorized person requesting the test or agency upon request and shall be subject to subsection 59A-7.037(2), F.A.C.

In this era where healthcare providers and facilities are struggling to hold onto dwindling profit margins, it is understandable why some are considering arrangements with clinical labs.  Still, Florida providers and facilities have to be extremely cautious when entering into such arrangements.

 

South Florida Drug, Alcohol & Rehab Business: Big Business, Bigger Rules

The drug and alcohol rehab business is especially abundant in South Florida, yet few entrepreneurs are aware of the many laws that apply.  The recovery business is a highly regulated one, with great intricacy in terms of the options and also the applicable laws.

Substance abuse services in Florida are broadly regulated by Chapter 397, Florida Statutes.  The applicable regulations, however, drill down with remarkable granularity.  For instance—

The broadly crafted Client Rights listed in Section 397.501, like the ones applied to nursing home residents, are very open ended (requiring things like the “Right to Individual Dignity”) and yet create the basis of a lawsuit!  That said, people acting “in good faith, and without negligence” can rest assured they will not be found liable.

Though some may intuitively understand the specificity and seriousness of the regulations dealing with medical detox, residential treatment and Partial Hospitalization Programs (PHPs), including the staffing, service and supervision requirements, it may not be as readily apparent with the lower intensity of service options, like Intensive Outpatient Programs (IOPs).

Even PHP requirements can, however, be confusing.  For instance, it is well known that PHPs are not for people who require 24/7 residential treatment.  They stand somewhere between residential inpatient and intensive outpatient programs.  What is less known is that the staffing requirements are particularly detailed.  For instance, each PHP has to have a paid, awake employee on premises at all times when even one client is on the premises and also must have a paid employee on call when clients are at the community housing location.

Intensive inpatient programs are required to provide detailed services, to include 14 hours of counseling each week and 20 hours of “other structured activities.”  Like IOPs, staff coverage is very specific.  Nursing coverage must be available 24/7.  More specifically, an RN must supervise all nursing staff and an RN or LPN has to be physically present on site.  Finally, a physician has to be on call 24/7.

Outpatient programs have similarly detailed requirements, including the minimum counseling requirements and staffing client ratios.  Intensive Outpatient Programs (IOPs) of course have far greater service requirements (at least nine hours of services each week) and yet share the same staffing ratio as regular outpatient (50 clients per counselor).

One of the more vexing issues the recovery industry faces deals with marketing.  The industry is flush with commission based marketing professionals, and yet there are very detailed state and federal regulations that threaten that practice.  At the federal level, the Anti Kickback Statute, a criminal statute that criminalizes remuneration for patient referral, threatens these percentage based arrangements.  State laws also strike them hard.  For instance, the Florida Patient Brokering Act (PBA) is a criminal statute with serious consequences for violations.  While the PBA does have an exception for federal law compliance, many entrepreneurs may find themselves hard pressed to comply.

Though the term “recovery business” may seem like an oxymoron to some, it is an area of significant business opportunity that many have dug into.  Knowing the regulatory minefields of the industry is, however, an important step forward in both a successful business and a stable platform of care.