The Issue The issues in this case are whether Respondent violated Subsection 458.331(1)(t), Florida Statutes (2002),1 and, if so, what discipline should be imposed.
Findings Of Fact Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2007). At all times material to the Amended Administrative Complaint, Dr. Brignoni was licensed to practice medicine in the State of Florida pursuant to Chapter 458, Florida Statutes, having been issued license number ME 59140. Dr. Brignoni is board-certified in obstetrics and gynecology. On September 5, 2002, patient C.W. presented to Dr. Brignoni, who diagnosed her with severe dysplasia, vulvar intraepithelial neoplasia. Dr. Brignoni recommended that C.W. undergo a wide local excision of vulva/vaginal lesion. On September 12, 2002, C.W. went to Charlotte Regional Medical Center for Dr. Brignoni to perform the wide local excision of vulvar intraepithelial neoplasia. Prior to the surgery, Dr. Brignoni had issued a card which indicated the supplies and instruments that he would need for a procedure such as the one that he was going to perform on C.W. The card is kept at Charlotte Regional Medical Center so that the supplies and instruments can be prepared and available at the time the procedure is scheduled to be performed. The card called for acetic acid to be supplied for the procedure, but no strength was specified. Acetic acid is commonly used during gynecological procedures to highlight abnormal areas. In the instant case, it would be used to highlight the lesion that was to be excised. When acetic acid is used for such a purpose, the acceptable concentration is approximately three-to-five-percent. Typically, when Dr. Brignoni arrives in the operating room to perform a procedure, all liquids and instruments required for the procedure are prepared and ready for use. A surgical technician is responsible for assembling the liquids and instruments needed for the procedure. When Dr. Brignoni began the excision on September 12, 2002, the surgical technician had not placed any acetic acid on the cart which housed the supplies and instruments needed for the procedure. Dr. Brignoni requested that acetic acid be obtained, and the circulating nurse went to the pharmacy to procure the acid. Dr. Brignoni did not request any specific concentration of acetic acid. The circulating nurse came back with a bottle of 100 percent acetic acid and decanted the acid into a container which she gave to the surgical technician. Dr. Brignoni took a piece of gauze saturated with the 100 percent acetic acid and swabbed the vulva area. He immediately noticed that area was peeling. This was not the reaction that would have occurred using a three-to-five-percent solution. Dr. Brignoni asked the surgical staff what solution did they give him, and he was shown the bottle containing a 100 percent concentration of acetic acid. Upon learning that he had applied 100 percent acetic acid to C.W.’s vulva area, Dr. Brignoni irrigated the area with over a liter of sterile water. He determined that he could proceed with the procedure, which he did. Prior to proceeding with the procedure, he did not consult with a physician familiar with chemical burns in determining whether it was appropriate to continue with the procedure. Dr. Brignoni did check with an emergency room physician after the procedure to confirm that he treated the burn correctly by irrigating with sterile water. As a result of the use of 100 percent acetic acid rather than a three-to-five-percent solution, C.W. experienced second degree burns in the area of her vulva and buttock. The normal time for the healing of a wide local excision of the vulva area is four to six weeks. C.W. healed in approximately eight weeks. Edward J. Zelnick, M.D., testified as an expert for the Department. Dr. Zelnick was licensed to practice medicine in Florida in 1975 and is board-certified by the American Board of Obstetrics and Gynecology. Currently, Dr. Zelnick is the chief executive officer and clinical researcher at Horizon Institute for Clinical Research. The last time that Dr. Zelnick performed a surgical procedure was in 1998. James Orr, M.D., testified as an expert for Dr. Brignoni. Dr. Orr has been board-certified in obstetrics and gynecology and gynecologic oncology since 1984. Currently, he is the medical director of Lee Cancer Center at Lee Memorial Hospital in Fort Myers, Florida, and is the director of Gynecologic Oncology and Gynecologic Oncology Research at Lee Cancer Center. He is a former associate professor of Obstetrics and Gynecology at the University of Alabama Birmingham School of Medicine and a clinical professor in the Department of Obstetrics and Gynecology at the University of South Florida. Dr. Orr has performed wide local excisions of the vulva area hundreds of times, and teaches this procedure to residents and medical students. It is Dr. Orr’s opinion that it is not standard procedure for a surgeon to specify the concentration of acetic acid for such a procedure. The normal strength of acetic acid used in a wide local excision of the vulva area is understood to be three-to-five-percent, and the standard-of-care requires a physician to simply ask for acetic acid without specifying the concentration. Dr. Orr’s opinion is credited. It was Dr. Orr’s opinion that Dr. Brignoni correctly irrigated the area after the application of the acetic acid and that there was no reason for Dr. Brignoni to stop the procedure after the irrigation. The biggest risk to the patient would have been stopping the procedure and putting the patient under anesthesia for a second time. Dr. Orr’s opinion is credited.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Brignoni did not violate Subsection 458.331(1)(t), Florida Statutes, and dismissing the Amended Administrative Complaint against Dr. Brignoni. DONE AND ENTERED this 23rd day of April, 2008, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of April, 2008.
The Issue The Administrative Complaint, dated January 22, 1987, alleges that Marvin Lowenhardt violated Section 461.013(1)(t), F.S., relating to gross or repeated malpractice or failure to practice podiatry at a level of care, skill and treatment recognized by a reasonably prudent podiatrist as being acceptable under similar conditions and circumstances. The complaint bases this allegation on the further allegation that Dr. Lowenhardt failed to take more than one X-ray of a patient, Herman Day, and failed to properly diagnose that patient's condition. The issue for determination is whether the violation occurred and, if so, what discipline is appropriate.
Findings Of Fact Marvin E. Lowenhardt is a licensed podiatrist with Florida license number PO 0000775. He has practiced in the State of Florida since 1982, and is currently located at 2087 Sarno Road, in Melbourne, Florida. Herman Day, visited Dr. Lowenhardt on April 30, 1986, with a complaint of swelling and pain in his right ankle. He told Dr. Lowenhardt that he had hit his heel on a dresser about 10 days prior to the visit. Dr. Lowenhardt did not observe any swelling. He took a single X-ray, lateral view of the ankle, and applied a compression bandage with an Unna boot, Gelo cast (a bandage impregnated with zinc oxide which hardens, but does not get rigid). He gave the patient a follow-up appointment on May 5th. Mr. Day appeared for the appointment, but left after a short while because no one was at the office and he had another appointment. The receptionist, who was new, had arrived late to the office to open it and called Mr. Day to apologize. He was irate and refused to make another appointment. On May 26, 1986, Herman Day visited his regular physician, John Viso, M.D., still complaining of trouble with his right ankle. He told Dr. Viso that he had twisted his ankle while strolling on the beach, and that he had been to see Dr. Lowenhardt. He also said he removed the cast himself after about six days. Dr. Viso diagnosed the condition as an old sprain, but he wanted to rule out an old fracture and referred Mr. Day to another physician with X-ray equipment. That physician, Briant Moyles, D.P.M., saw the patient on May 27, 1986. The complaint was pain and swelling in the right ankle due to a twisted foot six or seven weeks prior to the visit. Dr. Moyles found some swelling at a +2 level, which means clear swelling that dimples to the touch. He took five X- rays and concluded that there was a fracture obliquely through the malleolus (the large bump on the ankle) with no separation of the fragments (a "hairline" fracture). Dr. Moyles applied a compression bandage and told Mr. Day to limit his walking activity. Dr. Moyles could not tell when the fracture occurred and suggested that Mr. Day obtain the X-ray taken earlier by Dr. Lowenhardt. Mr. Day accomplished this, but the X-ray was of such poor quality it was impossible to tell whether or not the fracture existed at the time that Dr. Lowenhardt made his examination. Dr. Lowenhardt conceded to the investigator and at hearing that the X- ray was of poor quality. It is blurred and overexposed. The X-ray has deteriorated since it was originally taken, since it was not developed long enough. The view taken would not have revealed the type of injury suffered by Day. Dr. Lowenhardt also admitted to the investigator that he made a misdiagnosis. However, Dr. Lowenhardt claims that, given the patient's history of injury (hitting his heel), the X-ray was unnecessary. He never explained why the X-ray was taken, but after the investigation he apologized to Mr. Day for the mix up regarding the May 5th appointment and refunded all fees paid for his treatment. The history of injury given to Dr. Lowenhardt was somewhat different from that given to Drs. Viso and Moyles later: he hit his heel, rather than twisted his ankle. According to Dr. Lowenhardt and Dr. Moyles, a follow-up after the first visit was very important to the proper treatment of this patient. Dr. Lowenhardt was not informed of the circumstances of Mr. Day's missed appointment until well after the matter was referred to DPR. Dr. Lowenhardt insists that if he had seen Mr. Day again and had heard the continuing complaint and had seen the swelling, he, too, would have taken more X-rays and would likely have discovered the fracture. Dr. Lowenhardt's treatment still may have been the same, the compression bandage. This was Dr. Moyles' treatment, and is generally the treatment of older fractures. At ten days after an injury Dr. Moyles felt he would have had a choice as to whether to apply a rigid case or the compression bandage. Mr. Day did not testify at hearing and the only competent evidence of what he told Dr. Lowenhardt and what his foot looked like on April 30, 1986, is Dr. Lowenhardt's testimony and his office notes.
Recommendation Based on the foregoing, it is, hereby RECOMMENDED: That the Administrative Complaint against Marvin E. Lowenhardt be dismissed. DONE and RECOMMENDED this 31st day of August, 1988, in Tallahassee, Florida. MARY CLARK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of August, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 88-0277 The following constitute my rulings on the parties proposed findings of fact: Petitioner's Proposed Findings Adopted in paragraph #1. Adopted in paragraph #2. Adopted in paragraph #3. 4-6. Adopted in paragraph #7. Adopted in paragraph #5. Adopted in paragraph #6. 9-10. Adopted in paragraph #7. Rejected as irrelevant. It was not established that the circumstances warranted X-rays. Rejected as unsupported by Competent evidence. Respondent's Proposed Findings Adopted in paragraph #1. Adopted in paragraphs #2 and 3, except that the medical history form reflects a complaint of ankle pain. 3-4. Adopted in paragraph #3. Adopted in paragraph #4. Adopted in paragraph #5. Adopted in paragraph #6. Adopted in paragraph #7. Adopted in paragraph #8. Addressed in background statement. COPIES FURNISHED: Robert D. Newell, Esquire Newell & Stahl, P. A. 817 North Gadsden Street Tallahassee, Florida 32303-6313 John A. Baldwin, Esquire Baldwin & Baum, P. A. 7100 South Highway 17-92 Fern Park, Florida 32730 Marcelle Flanagan Executive Director Board of Podiatric Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Lawrence A. Gonzales, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Bruce Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether respondent, a licensed physician, violated provisions of Chapter 458, Florida Statutes, by allegedly (1) failing to keep medical records justifying her course of treatment; (2) prescribing controlled substances (Methaqualone) other than in the scope of her professional practice; (3) prescribing a Scheduled II controlled substance (Methaqualone) for a purpose not allowed by statutes; (4) engaging in gross or repeated malpractice or failing to practice medicine in accordance with medical standards recognized as acceptable by reasonably prudent similar physicians under similar conditions; (5) failing to perform a statutory obligation; (6) making untrue or fraudulent representations or employing a trick or scheme in the practice of medicine, and exploiting patients for financial gain.
Findings Of Fact Respondent, 54, is a female medical doctor licensed to practice medicine in the State of Florida. From August through December 1981, she was the sole physician employed by Northeast Medical Services, Inc. ("the clinic"), a clinic located at 4600 North Federal Highway, Ft. Lauderdale, Florida. The clinic also employed a nurse, a psychologist, and a receptionist. Clinic patients were processed under a standardized office procedure. First, they would fill out personal information and medical history forms, then answer a written "Stress Questioanaire," and sign a "drug potency warning." Next, they would be screened by a psychologist and physically examined by a nurse and respondent. Most patients came to the clinic complaining of stress or stress related symptoms. 1/ Most patients were diagnosed as suffering from stress. The treatment usually consisted of prescribing stress (vitamin) tablets and 45 tablets of 300 mg. Methaqualone, for which patients paid $75 to $100 in cash. During the several months she was employed by the clinic, respondent saw 15 to 20 patients a day, sometimes many more. From August 13, 1981, through October 30, 1981, she wrote at least 378 separate prescriptions for Methaualone (45 tablets, 300 mg.) totaling 17,010 tablets. (Petitioner's Exhibit No. 2) II. Barbara Bennett: Counts 1-24 On September 9, 1981, Barbara Ann Bennett visited respondent at the clinic. She completed the personal information and medical history forms, was screened by the psychologist, and physically examined by respondent. The physical examination included taking her weight, height, pulse, respiration, and blood pressure. Respondent checked her general appearance, skin, head, eyes, ears, nose, throat, heart, lymph nodes and neurological responses. Respondent spoke with her and noted in her progress report that the patient did not like her job as a bartender and did not sleep well. The Stress Questionnaire completed by Ms. Bennett indicated that she came to the clinic for the sole purpose of reducing stress. She checked-off items reflected that, among other symptoms, she had experienced poor sleep, was under a great deal of stress, and was unable to relax. Respondent rendered an initial impression or diagnosis of stress and prescribed stress (vitamin) tablets, 600, No. 30, 30 tablets and Methaqualone, 300 mg., 45 tablets, with directions to take one tablet at bedtime and one-quarter tablet twice a day, as needed. At that time, Chapter 893, Florida Statutes, identified Methaqualone as a Schedule II controlled substance, a substance with a high potential for abuse but which had an accepted but severely restricted medical use and treatment in the United States. This statute recognized that it could be abused and result in severe psychological and physical dependency. In 1981, Methaqualone--a non-barbiturate--was known as a highly potent hypnotic drug which was subject to widespread and growing abuse. It was gaining a reputation as a street drug, and was referred to as quaaludes. For patients diagnosed as suffering from stress, prevailing medical standards (in the area where respondent practiced) dictated the prescription of a mild tranquilizer for daytime use, not a potent hypnotic such as Methaqualone. Generalized complaints of stress, including checked-off items such as contained on the Stress Questionnaire used by respondent, were insufficient to justify prescribing a powerful drug such as Methaqualone, for either night or daytime use. As Dr. Warren Zundell, a qualified physician, testified at hearing: If 100 people were taken off the street and asked if they had stress--100 would say "yes." Prescribing Methaqualone for such patients was, in Dr. Zundell's opinion "like hunting ants with an elephant gun." (TR.-250) For sleeping problems, a milder hypnotic--of which there were several--was the appropriate treatment. Although respondent's initial diagnosis of stress was justified, her prescription of Methaqualone for night and daytime use (though with a lesser dosage) was inappropriate, medically unjustified, and constituted a failure to practice medicine with that level of care which is recognized by reasonably prudent similar physicians as acceptable under similar conditions. Under prevailing medical standards of practice then in effect, the diagnosis of stress did not justify more than the prescription of a mild tranquilizer or sedative. Ms. Bennett's alluded to sleeping problem did not justify the prescribing of Methaqualone when there were many other hypnotics available which were less potent and less subject to abuse. The medical records kept by respondent did not justify her prescribing Methaqualone to Ms. Bennett. The Methaqualone was thus prescribed other than in the course of respondent's professional practice and for other than a legitimate medical purpose. On September 11, 1981, Ms. Bennett was hospitalized at Hollywood Memorial Hospital for a drug overdose. The hospital staff contacted respondent who confirmed that she had issued the September 9, 1981 prescription for Methaqualone. Notation of this call was made in Ms. Bennett's patient records. On or about November 17, 1981, respondent issued Ms. Bennett another prescription for stress tablets and Methaqualone, identical in amount to the September 9, 1981, prescription. Presumably, this prescription was for the purpose of treating the same symptom--stress. It was not medically justified, inappropriate, and outside the scope of her professional practice. The patient's medical records did not justify this prescription. In fact, there are no records of Ms. Bennett's having visited the clinic on November 17, 1981. The prescribing of Methaqualone to Ms. Bennett, especially in light of her prior hospitalization for a drug overdose, constituted a gross failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as accepted under similar conditions. Adrienne Gampel: Counts 25-48 On August 28, 1981, Ms. Adrienne Gampel visited respondent at the clinic. Personal and medical history were taken and the Stress Questionnaire was completed. She acknowledged that she came to the clinic for the sole purpose of reducing stress, and checked off descriptors on the questionnaire indicating that she was under a great deal of pressure at home and had experienced poor sleep. After seeing the psychologist she was given a complete physical examination, similar to that given Ms. Bennett. Respondent rendered a diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets. For the reasons stated in paragraphs 6 and 7 above, the prescription of Methaqualone to Ms. Gampel was inappropriate, not medically justified, and not justified by respondent's medical records. It was outside the scope of her professional practice and constituted a failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as acceptable under similar conditions. In October and November 1981, Ms. Gample revisited respondent at the clinic. It has not been shown, however, that a new Methaqualone prescription was issued on either occasion. Robert Distillator: Counts 49-81 On September 3, 1981, Robert Distillator visited the respondent at the clinic. His personal and medical history were taken, and the Stress Questionnaire was completed. He acknowledged that he came for the sole purpose of reducing stress and checked-off descriptors on the questionnaire indicating that he had experienced loss of appetite, poor sleep, boredom on weekends, difficulty in making decisions, inability to have a good time, and a great deal of pressure. He also indicated he felt tense, depressed, unable to relax, and had more problems than he could handle. A complete physical examination was given him and his blood was analyzed. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg. 45 tablets, with directions identical to those given Ms. Bennett. For the reasons provided in paragraphs 6 and 7 above, respondent's prescribing of Methaqualone for night and daytime use was medically unjustified, inappropriate, not justified by the records, and outside the scope of her professional practice. It constituted a failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as acceptable under similar circumstances. Furthermore, it was inappropriate to prescribe Methaqualone to a patient, such as Mr. Distillator, who indicated depression, since such a symptom would increase the likelihood of self-abuse. On or about October 7, 1981, Mr. Distillator revisited respondent at the clinic. However, it has not been shown that he was issued another Methaqualone prescription on that occasion. On or about November 5, 1981, he revisited respondent at the clinic. His blood was analyzed and he was then issued another prescription for stress tablets and Methaqualone--identical in all respects to his first prescription. This prescription was not even noted by respondent in the patient's medical records. For the reasons stated in paragraphs 6 and 7 above, her prescription of Methaqualone was inappropriate, not medically justified, outside the scope of her professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. On December 14, 1981, respondent issued Mr. Distillator another prescription of stress tablets and Methaqualone, in like amount. The prescription was not noted in his patient records. Presumably, it was given for the continued treatment of stress. For the reasons specified in paragraphs 6 and 7 above, this prescription was inappropriate, medically unjustified, not justified--or even noted--in the patient's medical records, and was outside the scope of professional practice. It constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. Joe Morreale: Counts 81-96 On October 12, 1981, Joe Morreale visited respondent at the clinic. His personal and medical history were taken, the Stress Questionnaire was completed, and a physical was given. He acknowledged on the questionnaire that his sole purpose for coming was to reduce stress, and checked-off descriptors indicating that he had experienced pressure at home and at work, headaches, nightmares, and poor sleep. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone 300 mg., 45 tablets, with her standard instructions--one daily at bedtime and one-quarter tablet, twice a day, as needed. For the reasons specified in paragraphs 6 and 7 above, the prescribing of Methaqualone to Mr. Morreale was inappropriate, medically unjustified, not justified by the records, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar circumstances. On December 11, 1981, Mr. Morreale revisited respondent at the clinic. However, it has not been shown that she issued him another prescription for Methaqualone at that time. Joani Levi: Counts 97-104 On September 30, 1981, Ms. Joani Levi visited respondent at the clinic. A personal medical history was taken, the questionnaire was completed, and a physical was given. On the questionnaire, she indicated that the sole purpose of her visit was to reduce stress, and checked-off descriptors indicating she had experienced poor sleep, marital problems, and pressure at work. Respondent noted in her records that the patient was confused, nervous, and suffering extreme anxiety. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her standard instructions for night and daytime use. For the reasons provided in paragraphs 6 and 7 above, this prescription was inappropriate, not medically justified, not justified by the patient's medical records, and outside the scope of professional practice. It constituted a failure to practice medicine with that level of care which is recognized by reasonably similar prudent physicians as acceptable under similar conditions. Rachel Mack: Counts 105-112 On September 28, 1981, Ms. Rachel Mack visited Respondent at the clinic. Her medical history was taken and the Stress Questionnaire was completed; then she was given a physical. On the questionnaire, she indicated her sole reason for coming was to reduce stress. She checked-off descriptors indicating that she had experienced poor sleep, difficulty in making decisions, disturbing thoughts or fears, pressure at work and at home, and inability to have a good time. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her usual instructions. For the reasons stated in paragraphs 6 and 7 above, the prescribing of Methaqualone to Ms. Mack was inappropriate, medically unjustified, not justified by her patient records, and beyond the scope of professional practice. It constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. Robin Millman: Counts 113-128 On September 14 and 23, 1981, respondent issued Ms. Robin Millman, an employee at the clinic, a prescription for Methaqualone, 300 mg., 45 tablets. The purpose of this prescription was to relieve stress. There are no medical records justifying this treatment. Indeed, there were no patient records for Ms. Millman. For the reasons stated in paragraphs 6 and 7 above, this prescription was medically unjustified, inappropriate, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar circumstances. Brenda Villa: Counts 127-161 On September 5, 9, 14, October 22, and November 12, 1981, respondent issued Ms. Brenda Villa, another employee of the clinic, a prescription for Methaqualone, 300 mg., 45 tablets, for the purpose of treating stress. There were no patient records for Miss Villa, and there were no medical records justifying this prescription. For the reasons stated in paragraphs 6 and 7 above, the prescription was inappropriate, medically unjustified, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably similar prudent physicians under similar conditions. Michael Bransfield: Counts 162-169 On September 24, 1981, Michael Bransfield visited respondent at the clinic. A personal and medical history was taken, the Stress Questionnaire was completed, and a physical was given. On the questionnaire, he indicated that the sole purpose of his visit was to reduce stress. He checked off descriptors indicating he had experienced poor sleep, pressure at home and at work, and inability to relax. Respondent rendered a diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her usual instructions for night and daytime use. For the reasons provided in paragraphs 6 and 7 above, this prescription was inappropriate, not medically justified, not justified by the patient's medical records, and outside the scope of professional practice. It also constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions.
Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be revoked for multiple violations of the Medical Practice Act. DONE and ENTERED this 5th day of April 1984, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 5th day of April 1984.
The Issue The issues concern the question of whether the discovery of certain deficiencies related to the placement of legend drugs at the bedside of residents within the respondent's facility should be classified as a Class II or Class III deficiency within the meaning of Section 400.23, Florida Statutes.
Findings Of Fact On September 19 through 21, 1983, the State of Florida, Department of Health and Rehabilitative Services made an inspection of the Skilled Nursing Facility, operated by Jacksonville Methodist Home, Inc. as part of the Wesley Manor Retirement Village. That inspection was in keeping with the provisions of Chapter 400, Florida Statutes. The location of the facility is in St. Johns County, Florida. In the course of this inspection, in the room of one of the patients, the legend drugs Nitrol Ointment 2 percent and Aristocort A 0.1 percent Creme were discovered at the bedside of that patient. In another room, related to a second patient, the legend drug Timoptic 0.5 percent Eye Drops was found. Finally, in a third room, the legend drug Granulex Spray was found at the bedside of that patient. Although the patients were relatively alert and there was more than the minimum staffing required of such facilities, certain other ambulatory residents within the facility could have gained admittance into the three rooms where patients were residing for whom the various legend drugs had been prescribed. No indication was given that patients other than those for whom the legend drugs had been prescribed had used these legend drugs or of any other such event in the past history of the facility. While the facility in question had not experienced problems with the patients misusing legend drugs, there have been occasions in the experience of the inspector for the State, Patricia Dill, who is a graduate nurse, in which residents in comparable facilities have entered rooms of other patients and taken drugs not prescribed for that intruder. As indicated in the petitioner's Exhibit No. 2 admitted into evidence, there were 55 patients in the facility on September 19, 1983, of which 37 were listed as confused or disoriented, and 19 patients were under a form of restraint. Twelve patients required no assistance with ambulation and 32 required some form of assistance such as wheelchair, cane, or otherwise. Nitrol Ointment is a timed release nitroglycerin, to be used three times a day, which has the effect of release over an eight hour period and is prescribed for persons suffering angina. If used by a patient for whom it was not prescribed it might cause headaches or vomiting, if ingested. Placing the ointment on the skin would cause a lowering of blood pressure in patients for whom it was not prescribed. Aristocort Creme is a steroid, not for ingestion. If ingested it could cause the patient to feel bad, to include possible vomiting. Placement in the eyes would cause a problem with sight. Timoptic Eye Drops are related to the treatment of glaucoma and would not normally cause problems if swallowed, as opposed to being placed in the eyes. Granulex Spray is an enzyme which attacks dead tissue. Properties that present any danger to the patient would be related to spraying into the eyes. It is the aerosol feature of the Granulex Spray which presents that problem. The misuse of the legend drugs in question would not be expected to be a life-threatening event. Based upon the observations of legend drugs within the patient rooms, respondent is said to have violated the provisions of Rule 10D-25.112 (11), Florida Administrative Code. While the respondent concedes such violation, it disagrees with the petitioner's characterization of this violation as a Class II violation, and requested the formal hearing to challenge that classification.
Recommendation Upon a full consideration of the facts found and the conclusions of law reached, it is RECOMMENDED: That a final order be entered which classifies the violations related to the discovery of legend drugs in the rooms of the residents/patients as Class III deficiencies. DONE and ENTERED this 31st day of August, 1984 in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of August, 1984. COPIES FURNISHED: Jonathan S. Grout, Esquire Department of Health and Rehabilitative Services Post Office Box 210 Jacksonville, Florida 32231 R. Grady Snowden, Jr. Administrator Wesley Manor Retirement Village State Road 13 and Julington Creek Road Jacksonville, Florida 32223 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
Findings Of Fact At all times material hereto, Respondent has been a medical doctor having been issued license number 0029773 by the State of Florida. At all times material hereto, Respondent was an employee of the Atlantic Stress and Obesity Clinic, Inc., located in North Miami Beach, Florida. While employed there, Respondent treated Daniel Wolfenstein, Cindy Vegazo, Neal Schoenberg, James F. McDonald, Scott Brown and Virginia Hagerty at the Clinic. On or about October 9, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Daniel Wolfenstein. Respondent did not prescribe the above-described controlled substance to Daniel Wolfenstein for a medically justifiable purpose. That prescription was inappropriate and in an excessive or inappropriate quantity. Between the dates of approximately March 10, 1981, and February 8, 1982, Respondent prescribed 405 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Cindy Vegazo. Respondent did not prescribe the above-described controlled substance to Cindy Vegazo for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately October 9, 1981, and January 5, 1952, Respondent prescribed 90 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Neal Schoenberg. Respondent did not prescribe the above-described controlled substance to Neal Schoenberg for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately September 9, 1981, and January 22, 1952, Respondent prescribed 225 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for James F. McDonald. Respondent did not prescribe the above-described controlled substance to James F. McDonald for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. On or about October 13, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Scott Brown. Respondent did not prescribe the above-described controlled substance to Scott Brown for a medically justifiable purpose. Said prescription was inappropriate and in excessive or inappropriate quantity. Between the dates of approximately August 4, 1981, and December 29, 1981, Respondent prescribed 135 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Virginia Hagerty. Respondent did not prescribe the above-described controlled substance to Virginia Hagerty for a medically justifiable purpose. Said prescriptions were inappropriate and in excessive or inappropriate quantities. The medical records of each of the above-listed patients indicate that each patient was given a prescription for 45 methaqualone tablets each time that patient came to the Atlantic Stress and Obesity Clinic to see Respondent. All patients indicated on the form checklist given to them at the Clinic that they were seeking medical aid because they were depressed, tense, unable to sleep, and/or without ambition. The progress notes for each patient are identical to the notes from prior visits, all progress notes appear in two different handwritings, and all patients are diagnosed as suffering from anxiety and insomnia, thereby requiring 45 more methaqualone tablets. There appears no variation in dosage or in diagnosis. Methaqualone is a depressant, and, therefore, prescribing methaqualone to depressed patients is contraindicted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent guilty of Counts I through XIX of the Administrative Complaint and permanently revoking Respondent's license to practice medicine in the State of Florida. DONE and RECOMMENDED this 27th day of July, 1983, in Tallahassee, Leon County, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of July, 1983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Adolfo Z. Aguila, Esquire Midway Professional Building 55 Grand Canal Drive, Suite 404 Miami, Florida 33144 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy J. Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue is whether the Department’s intended award allowing Metro to proceed to licensure for a methadone Medication-Assisted Treatment (“MAT”) facility in Lake County violated Florida Administrative Code Rule 65D- 30.0141, was arbitrary or capricious, or was otherwise unlawful as alleged in LifeStream’s Petition for Administrative Hearing (“Petition”).
Findings Of Fact Based on the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: PARTIES Petitioner LifeStream is a Florida not-for-profit corporation and provider of substance abuse treatment. LifeStream applied for the ability to proceed to licensure to provide methadone MAT services in Lake County. The Department is the agency with regulatory authority over the provision of substance abuse services. § 397.321(1), Fla. Stat. The Department’s duties include, but are not limited to, the licensing and regulation of the delivery of substance abuse services, including clinical treatment and clinical treatment services such as “medication-assisted treatment for opiate disorder.” §§ 397.321(1) and (6); and 397.311(26)(a)7., Fla. Stat. The Department also promulgates rules governing substance abuse providers. § 397.321(5), Fla. Stat. Metro is a provider of care for opioid use disorder treatment and operates methadone medication treatment centers nationwide, including in the state of Florida. Metro applied for the ability to proceed to licensure to provide methadone MAT services in Lake County. STATUTORY AND REGULATORY FRAMEWORK AND NEEDS ASSESSMENTS The substance abuse regulatory scheme in Florida is designed to provide a statewide system of care for the prevention, treatment, and recovery of children and adults with serious substance abuse disorders. Substance abuse providers, which include methadone MAT clinics, are subject to a strict statutory, regulatory, and licensing scheme, which provides direction for a continuum of community-based services including prevention, treatment, and detoxification services. See chs. 394 and 397, Fla. Stat. MAT is “the use of medications approved by the United States Food and Drug Administration, in combination with counseling and behavioral therapies, to provide a holistic approach to the treatment of substance abuse.” § 397.311(27), Fla. Stat. The Department is responsible for the licensure and oversight of all MAT providers in the state. See § 397.321, Fla. Stat. Further, the Department is required to “determine the need for establishing providers of [MAT]” on an annual basis. New MAT providers may only be established in the state in response to a determination and publication of such need by the Department. § 397.427(2), Fla. Stat. Rule 65D-30.0141 provides the process for determining the need for MAT providers, as follows, in relevant part: Determination of Need. The Department shall annually perform the assessment detailed in the “Methodology of Determination of Need Methadone Medication- Assisted Treatment,” CF-MH 4038, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11993. The Department shall publish the results of the assessment in the Florida Administrative Register by June 30. Facilities owned and operated by the Florida Department of Corrections are exempt from the needs assessment process. However, these facilities must apply for a license to deliver this service. The publication shall direct interested parties to submit a letter of intent to apply for licensure to provide medication-assisted treatment for opioid use disorders to the Regional Office of Substance Abuse and Mental Health where need has been demonstrated. The publication shall provide a closing date for submission of letters of intent. Interested parties must identify the fiscal year of the needs assessment to which they are responding and the number of awards they are applying for per county identified in the assessment in their letter of intent. Within seven (7) business days of the closing date, the Regional Office shall notify parties who submitted a letter of intent on how to proceed. If the number of letters of intent equals or is less than the determined need, parties shall be awarded the opportunity to proceed to licensure by completing an “Application for Licensure to Provide Substance Abuse Services” form, C&F-SA Form 4024, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11996. If the number of letters of intent exceeds the determined need, parties shall be invited to submit a “Methadone Medication-Assisted Treatment (MAT) Application to Proceed to Licensure Application” form, CF-MH 4041, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11995. Applications may not be rolled over for consideration in response to a needs assessment published in a different year and may only be submitted for a current fiscal year needs assessment. The Department shall utilize an evaluation team made up of industry experts to conduct a formal rating of applications as stipulated in the “Methadone Medication-Assisted Treatment (MAT) Application Evaluation” form, CF-MH 4040, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11994. The evaluation team members shall not be affiliated with the Department, current methadone medication-assisted treatment providers operating in Florida, or the applicants. The selection of a provider shall be based on the following criteria: Capability to Serve Selected Area(s) of Need and Priority Populations. Area(s) of Need are the counties identified as having a need for additional clinics. Priority Populations are pregnant women, women with young children, and individuals with financial hardships; Patient Safety and Quality Assurance/Improvement; Scope of Methadone Medication-Assisted Treatment Services; Capability and Experience; and Revenue Sources. Applicants with the highest-scored applications in each county shall be awarded the opportunity to apply for licensure for the number of programs specified in their letter of intent to meet the need of that county. If there is unmet need, the next highest scored applicant(s) will receive an award(s) based on the remaining need and the number of programs specified in their letter of intent. This process will continue until the stated need is met. Regional offices shall inform the highest-scoring applicant(s) in writing of the award. All awarded applicants must submit a letter of intent to apply for licensure to the appropriate regional office within 30 calendar days after the award. If an applicant declines an award or fails to submit the letter of intent within the specified time, the Department shall rescind the award. After the Department rescinds the original award for that selected area of need, the applicant with the next highest score shall receive the award. Awarded applicants must receive at least a probationary license within two (2) years of receipt of an award letter connected to their “Methadone Medication-Assisted Treatment (MAT) Application to Proceed to Licensure Application” form, CF-MH 4041. If an applicant fails to obtain a probationary license within the specified time, the Department shall rescind the award. See Rule 65D-30.0036, F.A.C. for licensure application requirements. Applicants may submit a request to the State Authority and Substance Abuse and Mental Health Program Office for an exception if unable to meet timeframes due to a natural disaster that causes physical damage to the applicant’s building(s). Proof of natural disaster and impact on physical property must accompany the request. Upon receipt of the request for exception and accompanying proof, a one-time extension shall be granted for six (6) months. Providers who are delayed for a reason other than a natural disaster may petition the Department for a rule waiver pursuant to Section 120.542, F.S…. In brief, potential applicants are directed to submit letters of intent to apply for a methadone MAT services license for any county in which the Department’s process demonstrates a need. Should the number of letters of intent received for a certain county be less than or equal to the need found in that county, the potential applicants may proceed directly to licensure. In the event the number of letters of intent is greater than the need found in a particular county, then potential applicants must submit an application form to the Department. The application form is adopted by reference in the rule as Form CF-MH 4041. The rule requires the Department to “utilize an evaluation team made up of industry experts to conduct a formal rating of applications” to determine which applicant, or applicants, may proceed to licensure in a particular county. Such evaluators “shall not be affiliated with the Department, current methadone [MAT] providers operating in Florida, or the applicants.” The scoring form that the evaluators must use is incorporated by reference in the rule as Form CF-MH 4040 (“Scoring Form”). The Scoring Form requires that each application be “independently scored by each member of the evaluation team.” It also mandates that the “same scoring principles must be applied to every application received.” The Scoring Form expressly states that “no attempt by Department personnel, or other evaluators or other persons to influence an evaluator’s scoring shall be tolerated.” There are five general “Criteria” in the Scoring Form upon which applicants are scored, with a number of subsections within each criterion. An application could be awarded a maximum of 220 points. The evaluators were to assign a score ranging from zero to five for each subsection, with some subsections receiving an additional “weighted value” (in which the score given would be multiplied by two). The Department gave the weighted values to provisions upon which it placed a “premium.” The “General Instructions” section of the Scoring Form provides what an applicant must demonstrate to earn a particular score: Superior (5 points): the application demonstrates or describes extensive competency, proven capabilities, an outstanding approach to the subject area, innovative, practical and effective solutions, full responsiveness to the question, a clear and comprehensive understanding of the requirements and planning for the unforeseen. Good (4 points): the application demonstrates or describes clear competency, consistent capability, a reasoned approach to the subject area, feasible solutions, extensive but incomplete responsiveness to the question, and a sound understanding of the requirements. Adequate (3 points): the application demonstrates or describes fundamental competency, adequate capability, a basic approach to the subject area, apparently feasible but somewhat unclear solutions, partial responsiveness to the question, a fair understanding of the requirements and a lack of staff experience and skills in some areas. Poor (2 points): the application demonstrates or describes little competency, minimal capability, an inadequate approach to the subject area, infeasible or ineffective solutions, somewhat unclear, incomplete or non-responsive to the question, a lack of understanding of the requirements and a lack of demonstrated experience and skills. Insufficient (1 point): the application demonstrates or describes a significant or complete lack of understanding, an incomprehensible approach, a significant or complete lack of skill and experience and extensive non-responsiveness to the question. Not Addressed (0 points): the application demonstrates or describes [that the] criteria is not addressed, approach is not described, complete non- responsiveness to the question. Criterion Five of the Scoring Form concerns “Revenue Sources.” It contains two subsections, each worth zero to five points and each given “weighted value,” meaning that a perfect score for each subsection would earn 10 points, or a total of 20 points for Criterion Five. Subsection one asked the following question: 1. How well did the organization detail its accepted forms of payment for treatment services? At a minimum, the response should describe the procedure for each payment method offered: Assess a point for each accepted form of payment (5 maximum points) Self-Pay (1 point) One form of Private Insurance (1 point) Multiple forms of Private Insurance (1 point) Medicaid (1 point) Scholarship or Sliding Fee Scale (1 point) While other sections of the Scoring Form permit the evaluator to subjectively evaluate the responsiveness of the answer, subsection one of Criterion Five is manifestly objective. It directs the evaluator to award one point for each of the five accepted forms of payment addressed by the applicant, up to the maximum of five points. Subsection two of Criterion Five asks, “How well does the application detail how the organization will determine if its pricing is competitive?” This subsection was also worth five points and allowed the evaluator to subjectively address the quality of the applicant’s response. Christopher Weller, Manager of the Licensure and Designation Unit within the Department’s Office of Substance Abuse and Mental Health, testified that Florida MAT providers historically have accepted only out-of- pocket payments for their services, meaning that those who could not afford to pay cash or credit were often left untreated. The Department wanted to ensure that the need for MAT services would be met and that no one needing such services would be priced out of treatment. Therefore, the Department included Criterion Five in the application and gave it weighted value to encourage providers to accept multiple forms of payment. The Department completed a needs assessment and published it in the June 20, 2020, edition of the Florida Administrative Register. The Department then announced that it would begin accepting applications to proceed to licensure. The needs assessment indicated a need for one new MAT clinic in Lake County. Pursuant to rule 65D-30.041(1)(c)2.a., the Department contracted with an outside provider to evaluate the applications received for counties throughout the state, including Lake County. That provider, iSF, established four teams of three evaluators to score the applications and divided the counties with need among the teams. Each evaluation team consisted of a medical professional, a public health policy professional, and an academic professional. Applicant names were redacted so evaluators would not know the identity of the applicant they were scoring. Each iSF evaluator independently evaluated the various applications. THE LAKE COUNTY APPLICATIONS LifeStream and Metro both timely submitted letters of intent and applications for the new methadone MAT clinic needed in Lake County. Four other entities also applied for the one available license in Lake County. LifeStream’s response to subsection one of Criterion Five provided as follows: Our organization has developed a detailed Financial Assistance Policy (FAP) that provides assistance to all individuals served, including insured, uninsured and underinsured individuals whose family income is less than or equal to 240% of the Federal Poverty Level without discrimination on grounds of race, sex, national origin, disability, sexual orientation, immigration status, religious preference, or any other grounds unrelated to an individual’s need for the service or the availability of the service needed for emergency and medically necessary care. Furthermore, all individuals served receive a financial screening by staff knowledgeable of the various funding mechanisms in an effort to identify the best form of payment. No one is turned away for services due to their inability to pay. As a comprehensive provider with a sound financial infrastructure, our organization is able to accept several forms of payment for any of the services provided. This includes self-pay, private insurance (both one form and multiple forms), Medicaid and scholarship or sliding scale fee. All the individuals served are charged based upon a board of directors approved charge master which ensures that all individuals are charged the same fees for the same services. Discounts are available for individuals who qualify for financial assistance using a sliding fee discount. Our organization provides payment flexibility, including payment plans/options. In addition, our staff are trained to assist individuals in obtaining benefits and coverage as appropriate to meet any ongoing needs for treatment. Self-Pay: The proposed clinic will conduct a financial screening in order to determine if an individual qualifies for any of the organization’s accepted forms of payment for treatment services. Individuals will be offered two payment options, by the day or by the week. The fee will include dosing, treatment services and ancillary services. Individuals will be offered the ability to pay using cash or credit card. The organization also has a mechanism to bill the individual if that is his/her preference. This allows the individual to pay for services in a manner that meets his/her current ability and timeframe. Private Insurance (One or Multiple Forms): Our organization has numerous contracts with private insurance providers. This includes major providers such as Aetna, Blue Cross/Blue Shiled, Cigna, Magellan, Tricare, PsycCare, United Health Care and Value Options to name a few. In order to ensure that our organization has the ability to bill private insurance for these services, staff will possess the appropriate credentials, training and experience to allow them to be paneled by the insurance providers. In addition, our organization has staff that conduct financial assessments in order to determine the best funding source for the services provided. They are experienced and knowledgeable about the various private insurance plans and have the ability to determine if one or multiple forms of insurance will be utilized. Medicaid: Our organization is an established Medicaid provider and has the ability to bill Multiple Medicaid Associations (MMAs) as a result of having contracts with several of the organizations such as Prestige, Wellcare, United Healthcare and Sunshine. All of our sites and appropriate staff have the proper credentials to bill for Medicaid services. In addition, the treatment services and ancillary services we propose to offer will be Medicaid credentialed in order to bill for those services as well. Scholarship or Sliding Fee Scale: As stated earlier, our organization has extensive experience working with indigent individuals. As a result of a financial assessment, the level of discount for which an individual is eligible is determined based upon the individual’s family income and family size as a percentage of the FPL. Our developed policies and procedures define the meaning of “uninsured,” “underinsured,” “family income,” and “Federal Poverty Level.” All of our financial policies are listed on our website that address payment for treatment services and are provided in detail for the people we serve. Metro’s response to subsection one of Criterion Five provided as follows: To facilitate the ease of payment by individuals in need of treatment and to minimize financial barriers to treatment, we offer a wide array of payment options that include: Self-Pay—Patients with the financial capacity to pay for their own treatment may pay using cash, credit card, Apple Pay, and/or debit card. Upon receiving the medication portion of their treatment, self-pay patients either tender cash to clinic staff for the cost of treatment or, alternatively, provide a credit card, Apple Pay, or debit card that is entered into a card processing terminal for verification and transaction authorization. Private Insurance—We accept multiple forms of private insurance as we are in network with many private insurers (including, but not limited to, Beacon Health, Triwest, United/Optum, and Aetna). Also, we have established single case agreements with private insurers with whom we are not yet in-network so that the cost to each patient is minimized and keeps the patient in treatment. Procedurally, patients present their private insurance information to clinic staff who verify eligibility, benefits, and individual financial responsibility (e.g., deductibles, co-pays, co- insurance). A patient’s financial responsibility, if any, is collected from the patient pursuant to their insurer’s benefit design, and the treatment services are billed to their health insurer. An assignment of benefits is signed by the patient to permit us to bill and collect directly from their health insurer. Medicaid—Opioid Use Disorder treatment is a covered benefit under Florida Medicaid. As a result, all of our existing clinics are enrolled in the Florida Medicaid network. If our organization is awarded the clinic for this county, we would immediately enroll this clinic in the Florida Medicaid program. Patients covered by Florida Medicaid simply present their Medicaid card to clinic personnel who are able to immediately verify active coverage. Upon verification of coverage, the patient completes an assignment of benefits and is treated without any financial outlay. Treatment services received by the patient are then billed to Florida Medicaid directly for as long as the individual remains Medicaid eligible. Sliding Fee Scale—Patients without the financial capacity to pay for their own treatment, or are without Florida Medicaid or private health insurance coverage, may qualify for our Sliding Fee Scale. The Sliding Fee Scale offers discounted fees to patients in need of treatment. Eligibility is determined based on Federal poverty guidelines, household income, and the number of people in the patient’s household. Patients who are eligible for the Sliding Fee Scale must simply provide the following financial data as a part of their application: Pay stubs for at least the last six months; A copy of their most recent federal income tax return; Proof of current living situation (such as lease documents, or utility bills in the patient’s name); A financial attestation signed by the patient, which our clinic will provide. Upon the establishment of a patient’s eligibility, the patient’s cost of treatment is reduced to the discounted fee per the Sliding Fee Scale. In the event that a patient’s financial status changes, the patient must inform clinic staff of the changes. At a minimum, the clinic staff will review financial status with the patient every six (6) months. Financial status may be reviewed at the request of the patient or clinic at any time. Grants—Our organization routinely pursues, and has secured, grant funding to cover the cost of treatment for patient who are [sic] unable to pay for their treatment and who do not have insurance. Grant finds are awarded through regional Managing Entities. Available grant funds are sought to cover [the] cost of care for eligible patients receiving treatment at our clinics. As mentioned, our organization is currently the recipient of grant funds from multiple Managing Entities in the State of Florida. Eligible patients must simply provide the following financial data as a part of their application: Pay stubs for at least the last six months; A copy of their most recent federal income tax return; Proof of current living situation (such as lease documents, or utility bills in the patient’s name); A financial attestation signed by the patient, which our clinic will provide. Upon the establishment of a patient’s eligibility, the patient’s cost of treatment is reduced in accordance with the grant guidelines. In the event that a patient’s financial status changes, the patient must inform clinic staff of the changes. At a minimum, the clinic staff will review financial status with the patient every six (6) months. Financial status may be reviewed at the request of the patient or clinic at any time. Credit—Patients with the financial capacity to pay for their own treatment via cash, credit card, and/or debit card occasionally find themselves in need of treatment but, for a variety of reasons, are unable to pay. Our organization empowers its clinic Program Directors (i.e., the on-site clinic managers) to extend credit to patients in such situations for a short period (typically one day) with the understanding that the patient will repay the credit amount extended in short order. Upon receiving credit authorization, the patient receives all medically necessary treatment as may be required. Both the LifeStream and Metro proposals appear to have described the procedure for each of the five payment methods listed and appear to be entitled to the maximum score of five points according to the objective standards set forth in subsection one of Criterion Five. At the very least, it would be impossible to justify giving either proposal a score of zero, which is reserved for “complete nonresponsiveness” to the question. LifeStream’s response to subsection two of Criterion Five provided as follows: In order to ensure that pricing is competitive, our organization will review the current environment using several data sources on a regular basis. This will include the Department of Children and Families, our state trade association, Florida Behavioral Health association and discussions with other providers. We also propose to conduct focus groups with the individuals that we serve and our stakeholders to collect input that will be part of this review. On an annual basis, our organization will conduct a pricing study to ensure that the pricing is competitive. As a safety net provider and an organization committed to serving individuals regardless of their ability to pay, we feel that the input from those we serve and our stakeholders is a critical piece in determining if pricing is competitive. Our organization will identify and provide solutions to ensure that those that need care are able to receive the care. We are dedicated to ensuring that the pricing will be reasonable and that options are identified and offered for low income/indigent individuals. More importantly, our organization will commit to supporting the people we serve through a continuum of services that not only addresses their opioid disorders, but also the social determinants that may affect their successful recovery. Our organization is a Medicaid provider and also has access to other funds to ensure that individuals who need this service will receive it regardless of their ability to pay. Metro’s response to subsection two of Criterion Five provided as follows: As a longstanding provider of Opioid Use Disorder treatment services in the State of Florida, our organization is keenly aware of the need to properly price our services given the circumstances typically facing patients battling opioid addiction which include, but are not limited to, financial hardship. Consequently, we recognize that appropriate pricing of our services is critical so as to ensure that individuals in need of care do not perceive that treatment for their disease is unattainable. While a material and increasing number of patients have their treatment paid by Medicaid, private health insurance, and grants (as fully discussed in question 1 of Criteria 5), those patients who pay for treatment out of their own pockets routinely encounter financial barriers which, unfortunately, result in them not seeking treatment, or leaving treatment prematurely. Given our experience operating outpatient clinics in Florida, our organization has developed a substantial amount of year-by-year internal pricing data, which includes specific market economic data, that guides us in pricing our services within a particular Florida region. This data, which is updated annually, is measured against other payer rates (such as Medicaid and private health insurance), and compared to the rates we are paid for opioid addiction treatment services provided by our clinics in other states. Taken together, this data allows us to develop regional benchmarks that we use to price our services fairly and competitively, bearing in mind the financial challenges typically encountered by opioid addicted patients. To be clear, this is a fluid process that takes into account changing market conditions, both inside and outside of Florida, regarding the pricing of opioid addiction treatment. This allows our organization to maintain a current view of what patients can realistically afford to pay and, when necessary, immediately adjust our pricing expectations when the market data indicates that such adjustments are needed to ensure continuity of patient care. In addition to our routine pricing analysis using our historical internal data, we will, prior to opening a new clinic in a particular area, conduct a survey of other opioid treatment clinics within the region (if any). This survey process not only allows us to gain a better understanding of what the pricing for services is in that region, but helps us identify any additional services that should be offered to patients as part of our pricing structure. Once these surveys are completed, we then use this information, along with our internal analysis of historical data, to price our treatment services according to our planned treatment protocol (e.g., timely delivery of service, having the clinic open seven (7) days per week, maintaining a Call Center that is open and available to assist existing and prospective patients 24 hours per day, 7 days a week, etc.) and our analysis of specific market dynamics (e.g., quality of care indicators, availability of qualified clinical professionals, attendant costs of support services in the particular market, etc.). Finally, to ensure our pricing remains competitive, we repeat our outpatient treatment clinic surveys at least annually for each and every market in which our clinics operate, and use this information, along with routine feedback voluntarily provided by our existing patients, to determine if our pricing remains appropriate given the market where the clinic is located. To be clear, we believe that our practice of conducting outpatient clinic surveys relieve patients of having to make pricing and service comparisons while trying to manage their disease. Stated differently, patients can take comfort in knowing that when they inquire as to our treatment pricing, they will receive the identical type and number of services that would typically be offered by all similarly-situated outpatient treatment programs within their geographic region at comparable prices. While this particular process can be burdensome, we have found time and again that the effort is worthwhile given the positive patient feedback we routinely receive regarding the value of services offered at our clinics. If awarded the clinic license for this particular county, we will deploy each of the aforementioned pricing techniques (i.e., internal analysis of historical pricing data, benchmarking using public and private payer rates from within and outside of Florida, and regional pricing surveys) to develop pricing for our services that will not only be competitive, but affordable for the people within the community in need of treatment. These processes have proved tremendously effective for us thus far, and we fully expect them to be successful within this particular county. As noted above, subsection two allowed for a more subjective evaluation of the applications. LifeStream’s response was shorter and more general than Metro’s, but both responses addressed similar themes and procedures for ensuring competitive pricing at their clinics. Both proposals showed the applicants’ understanding of the need for competitive pricing and outlined their plans for setting their prices accordingly. Even allowing for the subjectivity permitted by subsection two, it would be impossible to justify giving either proposal a score of zero, which is reserved for “complete nonresponsiveness” to the question. SCORING OF THE LAKE COUNTY APPLICATIONS As explained above, the applications were given to the four teams of iSF evaluators for scoring. After the evaluators completed their review, iSF provided the Department with a final report that explained the evaluation process and provided a series of tables for each county that identified each applicant’s scores. The Lake County applications were scored by “Team Two” of the iSF evaluators. Team Two also reviewed applications for five other counties. Team Two gave LifeStream a total score of 633.5 for Lake County and gave Metro a total score of 619 for Lake County. Mr. Weller testified that one of his employees found a typographical error in a spreadsheet that iSF produced for the Department. This error prompted Mr. Weller to take a look at the scoring of the proposals by the iSF evaluators. Mr. Weller noted what appeared to be an anomaly. He found a series of scores in Lake County that went “5, 5, 5, zero, 5, 5, which caught my eye as unusual, and we discovered that the answers for both [subsections one and two of Criterion Five] were different in Lake County compared to all of the other ones that the particular evaluator scored for the other counties.” A closer review of the scores revealed that each of the three Team Two evaluators gave LifeStream scores of five in both subsections of Criterion Five in its Lake County application. Two of the three evaluators gave Metro scores of five for both subsections of Criterion Five. However, the medical professional on Team Two gave Metro zeros in both subsections of Criterion Five of its Lake County application. The Criterion Five responses of LifeStream and Metro were essentially identical in all of the six county applications reviewed by Team Two. In the five counties other than Lake County, all of the evaluators, including the medical professional, gave both LifeStream and Metro scores of five for both subsections of Criterion Five. It was only in Lake County that the medical professional decided that Metro’s identical response was completely nonresponsive and deserving of zero points. As found above, it is impossible to justify scores of zero for Metro’s responses to Criterion Five. It was also extremely unusual for the same evaluator to give such radically different scores to the same response made in different applications. Mr. Weller wanted an explanation. He asked iSF to ask the medical evaluator to explain her reasoning for the inconsistency in her scoring of Metro’s Lake County application and to ask whether she wished to amend her score for Metro’s application. On April 27, 2020, iSF’s contract manager, Roger Balettie, sent an email to the Team Two medical evaluator, Linda Saucier. The email requested Ms. Saucier’s response as to four scoring questions raised by the Department’s review, including the following: You have two applicant response questions (Criteria 5 Questions 1 and 2) where an applicant (DCF 12) has two different scores for the same answer across six counties (one with 0s for each question and five with 5s for each question, and your notes are identical). DCF would like for you to review the applicant’s C5Q1 and C5Q2 response (I will provide that section for you) and confirm either that you intended the 6 counties to be different, or that you intended the 6 counties to have consistent scores for those two questions (and provide those scores). On May 1, 2020, Ms. Saucier responded as follows: I just saw your email. It went to my spam folder. I am extremely busy with work. But, I can tell you that the scores are different because of the county or vicinity in which the clinic would be housed and clinicians/service availability. It’s not a cookie cutter process. Later on May 1, 2020, Mr. Balettie sent an email asking Ms. Saucier to confirm that she did not wish to consider changing her scores for any of the four questions raised in his initial email, including Criterion Five in Lake County. Ms. Saucier responded: Correct. Roger, there are so many variables when looking at the submissions. I have written and reviewed grants and similar documents in my position. I realized the proposals were the same for each county, unfortunately not all of the counties share the same similarities. Read in the context of Criterion Five, it is clear that Ms. Saucier did not bother even to look again at her work on these applications before responding to Mr. Balettie. Her response is vague and defensive nonsense. Lake County possesses no unique quality that would render Metro’s pricing strategy and accepted forms of payment completely nonresponsive to Criterion Five, particularly when Ms. Saucier herself found the same responses “superior” in five other counties. Moreover, subsection one of Criterion Five did not give Ms. Saucier the discretion to award zero points to an application that addressed the five listed forms of payment as Metro’s application manifestly did. She violated the instructions of the Scoring Form and offered no real justification for doing so. The Department reasonably believed that it was not possible to rationalize the zeros that were given to Metro’s Lake County response. The Department reasonably believed there were no differences between counties that would have any impact on pricing or payment methods. William Sutton, General Counsel for Metro’s parent entity, Colonial Management Group, LP, testified that he personally worked on the applications Metro filed for the 2018-2019 licensure process. Mr. Sutton testified that the “forms of payment and the process [that Metro uses] to determine whether our pricing is competitive is consistent throughout the state of Florida.” He noted that Metro currently has 80 clinics operating throughout the country and that it is “critical” for the company “to have processes in place to deal with those [payment and pricing] issues consistently.” After digesting the response from iSF, the Department concluded that Ms. Saucier’s scores of zero for Criterion Five of Metro’s Lake County application “could not be justified.” Department personnel met to discuss what action to take regarding the scoring discrepancy. Eventually, the Department decided to override Ms. Saucier’s scores and to assign a score of five to both Criterion Five subsections in Metro’s Lake County application. The score of five was chosen because it was the same score that Ms. Saucier assigned to all of Metro’s other substantively identical Criterion Five responses in the other five counties she reviewed. The Department took this action “in the interests of fairness.” The Department also believed that Metro would challenge any intended award if the scores of zero were left unchanged and that Metro would likely prevail in such a challenge.2 The Department’s adjustment of the score gave Metro a total score of 639 points, reflecting two double-weighted scores of five instead of two scores 2 Mr. Sutton testified that Metro indeed would have raised such a challenge. of zero in the Criterion Five subsections. LifeStream’s total score in Lake County remained 633.5 points.3 On July 10, 2020, the Department published the Notice, which declared its intention to award the new MAT license in Lake County to Metro. The Notice explained the adjustment as follows: During the review of the evaluators scoring process by the Department, it was discovered that the medical evaluator for Team Two provided scores of zero for both responses in Criteria Five for [Metro’s] Lake County application. The two questions responded to pertained to types of payments accepted and competitive pricing. The responses to these questions were identical to Metro’s responses in the other six applications reviewed by the same medical evaluator. Each of the responses in the other six applications were awarded the full point values (5 points each) by the medical evaluator. In addition, the same responses were awarded either 4 or 5 points by both the other Team Two evaluators and by all the evaluators in the other teams. The scoring inconsistency resulted in Metro’s Lake County application losing 20 points (5 points for 2 questions, which were weighted by a factor of 2). Correction of the inconsistency results in Metro having the highest scoring application. Upon the Department learning of the scoring discrepancy, the medical evaluator declined to amend the scores and participate in the public meeting of the evaluators. The responses provided by Metro’s Lake County application were identical to its six non-Lake County applications assigned to Team Two, which were awarded five points each, and identical to all other responses provided by Metro. Thus, the 3 Metro could have received five fewer points through this correction and still received the intended award. Based on the scores possible and the double-weighting of this criterion, any combination of (a) two scores of five, (b) one score of five and one score of four, (c) one score of five and one score of three, or (d) two scores of four would have caused Metro to jump past LifeStream as the successful applicant. recommendation is to override the scores and award the licensure opportunity to Metro. The Department’s actions in reviewing the scores awarded and making the changes to Metro’s Criterion Five scores were reasonable under the facts and circumstances presented. LifeStream was unable to mount a serious defense of Ms. Saucier’s scoring or to offer any tangible evidence that the Department was biased either against LifeStream or in favor of Metro.4 LifeStream’s chief argument is that the Department deviated from its own rule by reviewing the scores submitted by iSF, by asking iSF to inquire as to aspects of the scores and suggesting the evaluator change them, and most egregiously by changing Metro’s score after the iSF evaluator declined to amend her evaluation. This legal argument is discussed below.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the undersigned hereby RECOMMENDS that the Department of Children and Families enter a final order awarding the right to proceed to licensure for a methadone MAT facility in Lake County to Metro Treatment of Florida, L.P., and dismissing the Petition for Administrative Hearing filed by LifeStream Behavioral Center, Inc. DONE AND ENTERED this 1st day of February, 2021, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of February, 2021. COPIES FURNISHED: Daniel Ryan Russell, Esquire Dean Mead and Hall Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Mia L. McKown, Esquire Holland & Knight, LLP Suite 600 315 South Calhoun Street Tallahassee, Florida 32301 William D. Hall, Esquire Dean Mead and Dunbar Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Chad Poppell, Secretary Department of Children and Families Building 1, Room 202 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Javier Enriquez, General Counsel Department of Children and Families Building 2, Room 204F 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Brittany Adams Long, Esquire Radey Law Firm, P.A. Suite 200 301 South Bronough Street Tallahassee, Florida 32301 John L. Wharton, Esquire Dean Mead and Dunbar Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Eddie Williams, III, Esquire Holland & Knight, LLP Suite 600 315 South Calhoun Street Tallahassee, Florida 32301 Lacey Kantor, Agency Clerk Department of Children and Families Building 2, Room 204Z 1317 Winewood Boulevard Tallahassee, Florida 32399-0700
