DETERMINING EXPERIMENTAL DRUGS AND PROCEDURES:
More and more I am seeing recommendations by authorized treating physicians for treatment modalities not generally accepted in the medical community or for therapies not regularly used to treat a particular illness.
One of the most important defenses available concerning the denial of medical care is that the benefit is not “medically necessary.” The Statute defines “medically necessary” as:
any medical service or medical supply which is used to identify or treat an illness or injury, is appropriate to the patient’s diagnosis and status of recovery, and is consistent with the location of service, the level of care provided, and applicable practice parameters. The service should be widely accepted among practicing health care providers, based on scientific criteria, and determined to be reasonably safe. The service must not be of an experimental, investigative or research nature.
Consequently, you should only consider authorizing medications, therapies and procedures that are not experimental, investigative or research nature.” However, considering the quality of the statutory construction throughout the rest of the statute, it should come as no surprise that the legislature failed to provide any guidance or to define these terms. Consequently, we are forced to look to other laws for insight on this portion of the defense in order to determine its size, scope and application.
Pursuant to Florida Administrative Code in the context of reimbursable Medicaid medical expenses, the terms “Experimental”, “Experimental and clinically unproven” or “Investigational” as related to drugs, devices, medical treatments or procedures all mean that:
- The drug or device cannot be lawfully marketed without approval of the U.S. Food and Drug Administration (FDA) and approval for marketing has not been given at the time the drug or device is furnished; or
- Reliable evidence shows that the drug, device or medical treatment or procedure is the subject of on-going phase I, II or III clinical trials or under study to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis; or
- Reliable evidence shows that the consensus among experts regarding the drug, device, or medical treatment or procedure is that further studies or clinical trials are necessary to determine its maximum tolerated dose, toxicity, safety or efficacy as compared with the standard means of treatment or diagnosis.
- The drug or device is used for a purpose that is not approved by the FDA.
Furthermore, according to Florida Administrative Code Rule 59G-1.010 (2006), “Reliable Evidence” refers to only:
published reports and articles in the authoritative medical and scientific literature; the written protocol or protocols used by the treating facility or the protocol(s) of another facility studying substantially the same drug, device or medical treatment or procedure; or the written informed consent used by the treating facility or by another facility studying substantially the same drug, device or medical treatment or procedure.
NEED TO RESPOND TIMELY TO THE RECOMMENDATION:
Even if your research leads to the justification for the denial of the recommended treatment based on the conclusion that it is not “medically necessary”, you are still governed by Section 440.13(3)(d) which states:
A carrier must respond, by telephone or in writing, to a request for authorization from an authorized health care provider by the close of the third business day after receipt of the request. A carrier who fails to respond to a written request for authorization for referral for medical treatment by the close of the third business day after receipt of the request consents to the medical necessity for such treatment. All such requests must be made to the carrier. Notice to the carrier does not include notice to the employer.
Consequently, if a response is not timely provided, the recommendation is deemed “medically necessary” and you could find yourself compelled to authorize whatever treatment is recommended regardless of its acceptance in the medical community. Essentially, your failure to respond to the request for authorization by the “close of the third business day” creates an irrebuttable presumption that the recommendation is medically necessary.
The question of whether an “irrebuttable presumption” violates the Due Process clause In the Florida and U.S. Constitutions depends upon certain. Specifically, in order to determine the constitutionality of an “irrebuttable presumption, the Court must determine:
- Whether the concern of the legislature was reasonably aroused by the possibility of an abuse which it legitimately desired to avoid;
- Whether there was a reasonable basis for a conclusion that the statute would protect against its occurrence; and
- Whether the expense and other difficulties of individual determinations justify the inherent imprecision of a conclusive presumption.
See Weinberger v. Salfi, 422 U.S. 749, 95 S.Ct. 2457, 45 L.Ed.2d 522 (1975); Gallie v. Wainwright, 362 So.2d 936 (Fla. 1978).
Whenever there is any recommendation for treatment by an authorized treating doctor, it is imperative that you respond by the close of third business day. Note that the statute does not require that you authorize the recommendation or even deny it by then but that you simply “respond.”
Consequently, you should be prepared to transmit a faxed response to the physician who recommended the treatment with language similar to the following:
Dear Dr. ____:
We have received your recent request for authorization of ____. Please know that the causal relationship and medical necessity of your recommendation is presently being investigated. We will provide you with either approval or denial of your recommendation as soon as possible.