The Florida Board of Medicine reviewed Rule 64B8-9.003, Florida Administrative Code which provides standards for the adequacy of medical records. The underlined portions below are the new standards required for medical records as it relates to compounded medications. These standards are effective September 9, 2013. Continue reading
Via Florida Board of Medicine – – – The Florida Board of Medicine’s Surgical Care/Quality Assurance Committee has been reviewing Rule 64B8-9.007, Florida Administrative Code – Standards of Practice in an effort to reduce the number of wrong patient, wrong site and/or wrong procedure disciplinary cases. This rule outlines requirements for taking a pause prior to beginning surgery to ensure you have the right patient, the right site and are performing the right surgery as described in the Informed Consent signed by the patient. The Board continues to see disciplinary cases in which the required “pause” is performed but surgery is still performed on the wrong patient, wrong site or the wrong procedure is performed. The Committee met three times and heard public testimony. During that testimony, it was determined the definition of surgery also needed to be clarified. Changes to the rule include:
- Physicians are required to confirm the patient’s identity, confirm the procedure being performed and confirm the correct surgical site with another healthcare practitioner
- “Pause” must be performed again if the physician leaves the room at any time during the procedure or surgery
- Clarification of the definition of surgery
These changes are effective January 29, 2013 and are underlined in the rule language below:
64B8-9.007 Standards of Practice.
The Board of Medicine interprets the standard of care requirement of Section 458.331(1)(t), F.S., and the delegation of duties restrictions of Section 458.331(1)(w), F.S., with regard to surgery as follows:
(1) The ultimate responsibility for diagnosing and treating medical and surgical problems is that of the licensed doctor of medicine or osteopathy who is to perform the procedure. In addition, it is the responsibility of the treating physician or an equivalently trained doctor of medicine or osteopathy or a physician practicing within a Board approved postgraduate training program to explain the procedure to and obtain the informed consent of the patient. It is not necessary, however, that the treating physician obtain or witness the signature of the patient on the written form evidencing informed consent.
(2) This rule is intended to prevent wrong site, wrong side, wrong patient and wrong surgeries/procedures by requiring the team to pause prior to the initiation of the surgery/procedure to confirm the side, site, patient identity, and surgery/procedure.
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.