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DEPARTMENT OF HEALTH, BOARD OF PHARMACY vs SUNTREE PHARMACY, INC., 20-002764 (2020)
Division of Administrative Hearings, Florida Filed:Sebastian, Florida Jun. 15, 2020 Number: 20-002764 Latest Update: Nov. 11, 2024
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs MICHAEL R. SHOOK, M.D., 10-001733PL (2010)
Division of Administrative Hearings, Florida Filed:Fort Lauderdale, Florida Apr. 01, 2010 Number: 10-001733PL Latest Update: Nov. 11, 2024
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BOARD OF OSTEOPATHIC MEDICAL EXAMINERS vs. E. ROSS HENSON, 86-003336 (1986)
Division of Administrative Hearings, Florida Number: 86-003336 Latest Update: Jun. 24, 1988

The Issue Whether Dr. Henson inappropriately administered repeated injections of vitamin B-12 to his patient, Gertrude Ashton, without documenting their necessity in the patient's medical records? Whether Dr. Henson inappropriately administered repeated injections of steroids to his patient, Gertrude Ashton, without documenting their necessity in the patient's medical records? Whether Dr. Henson inappropriately administered repeated injections of Mandol to his patient, Gertrude Ashton, which were not considered to be therapeutically effective?

Findings Of Fact The parties stipulated to the following findings of fact: The Respondent, D. Ross Henson, D.O., is currently, and at all times relevant to this proceeding was, licensed as an osteopathic physician in the State of Florida; Dr. Henson's license number is OS 0001793; Between December 1979, and September 1983, Dr. Henson treated a patient by the name of Gertrude Ashton. Ms. Ashton's husband died in 1981. Ms. Ashton witnessed Mr. Ashton's death in the back yard of their residence. Mr. Ashton's death caused Ms. Ashton anxiety and depression. Ms. Ashton's business had some financial problems during the period at issue in this case. During the approximately forty-six months at issue in this proceeding, Dr. Henson treated Ms. Ashton on sixty occasions. During this period of time Dr. Henson prescribed 2,000 micrograms of vitamin B-12, to be administered intramuscularly, for Ms. Ashton. Ms. Ashton received injections of vitamin B-12 on sixteen separate occasions from Dr. Henson. When Dr. Henson prescribed vitamin B-12 injections for Ms. Ashton, he documented the various problems which she was having at the time in her medical records. Dr. Henson indicated that the reasons for the injections were that Ms. Ashton was under stress, she had long-standing, ongoing disease processes which produced further stress, she was on antibiotics and she was receiving diuretic therapy. Additionally, on occasion, Ms. Ashton requested vitamin B-12 injections. Generally, vitamin B-12 should be administered intramuscularly only if a patient is suffering from vitamin B-12 deficiency. A vitamin B-12 deficiency may be caused by pernicious anemia or malabsorption of vitamin B-12. If a physician suspects that a patient is suffering from vitamin B-12 deficiency, a simple blood test should be administered to determine if the patient's vitamin B-12 level is low. If it is, the physician should then attempt to determine the cause of the deficiency. Dr. Henson did not determine whether Ms. Ashton was suffering from a vitamin B-12 deficiency. Occasionally vitamin B-12 may be administered to a patient who believes that the vitamin will help him or her feel better. Although vitamin B-12 is included as part of nutritional supplements, it is not taken intramuscularly as a nutritional supplement. If a patient is in need of vitamin B-12, 1,000 micrograms is a sufficient dosage. An injection of 2,000 micrograms of vitamin B-12 is excessive. It would be difficult to harm a patient by injecting the patient with vitamin B-12. The reasons for administering vitamin B-12 injections to Ms. Ashton advanced by Dr. Henson and Dr. Henson's medical records fail to justify all of the vitamin B-12 shots administered to Ms. Ashton. Nowhere in Dr. Henson's records concerning Ms. Ashton is it indicated that Ms. Ashton suffered from a vitamin B-12 deficiency. Nor is any other adequate reason for administering the shots she received indicated. It is true that a few of the vitamin B-12 shots prescribed by Dr. Henson for Ms. Ashton may have been requested by Ms. Ashton because she believed they would help her. Not all of the sixteen shots were requested by Ms. Ashton, however. Nor would all sixteen shots be justified by such a request had it been made. Prescribing 2,000 micrograms of vitamin B-12 for Ms. Ashton was also not justified. The repeated injections of 2,000 micrograms of vitamin B-12 administered to Ms. Ashton were a deviation from the accepted standard of care. Dr. Henson also prescribed 34 intramuscular injections of steroids for Ms. Ashton over the 46 months at issue in this proceeding. Dr. Henson injected Ms. Ashton with methylprednisolone acetate, a form of injectable steroid. The brand name of the methylprednisolone acetate used by Dr. Henson was Depo-Medrol. The 34 injections of methylprednisolone acetate were given in doses of fifty milligrams. Methylprednisolone acetate should be given in doses of twenty to eighty milligrams per injection. Prednisolone tebutate, another form of injectable steroid, should be given in doses of four to forty milligrams. Dr. Henson did not, however, give Ms. Ashton prednisolone tebutate. Dr. Henson noted in his medical records concerning Ms. Ashton that he had given her an injection of "Pred." Identifying the injections as "Pred" was insufficient to inform others of how Ms. Ashton was treated with steroids. Dr. Henson indicated that he gave Ms. Ashton steroid injections for the following problems: Acute synovitis and osteoarthritis of the lumbar and cervical spine, acute contact dermatitis, acute allergic rhinitis and acute polyposis. Steroids can be used to treat bursitis and tendinitis. Usually, an injection of steroids for this type of treatment is administered locally. Ms. Ashton's acute contact dermatitis was attributable to her repeated contact with poison ivy and the use of undiluted bleach which Ms. Ashton bathed in as a treatment of her poison ivy. Ms. Ashton also inhaled the fumes from the bleach. Occasional injections of steroids for the treatment of poison ivy, especially when the area affected has been bathed in undiluted bleach, is appropriate. The weight of the evidence concerning Dr. Henson's treatment of Ms. Ashton with steroids proved that generally, most physicians would have administered the injections locally or orally. The evidence did not prove that Dr. Henson's treatment of Ms. Ashton with steroids was not within acceptable standards of care. Dr. Henson also prescribed three injections of Mandol for Ms. Ashton over the 46 months at issue in this proceeding. Injections of Mandol were administered on March 13, 1980 and November 13 and 16, 1981. The injections of Mandol administered to Ms. Ashton were in doses of 250 milligrams. The recommended dose of Mandol is from 500 milligrams to one gram. A dose of 250 milligrams is sub-therapeutic. Mandol is a cephalosporin, which is a form of antibiotic. The March 13, 1980, injection of Mandol was given for acute bronchitis, acute pyelonephritis and acute cystitis. Ms. Ashton was also taking Ceclor, another cephalosporin, orally at the time the injection of Mandol was given. The November 13 and 16, 1981, injections of Mandol were given for acute bronchitis and acute generalized dermatitis due to poison ivy and exposure to bleach. Ms. Ashton was taking another cephalosporin orally at the time the injections of Mandol were given. If a lower dose of Mandol would be effective, it would be listed by the drug manufacturer as a recommended dose. Although there are possible side effects from treatments with Mandol, Dr. Henson did not establish that those side effects were present in Ms. Ashton's case. Dr. Henson's treatment of Ms. Ashton with Mandol during the period of time at issue in this proceeding deviated from the standard of medical care reasonably acceptable under similar conditions and circumstances. Ms. Ashton subsequently filed a complaint concerning Dr. Henson with the Department. The Department investigated the complaint and found probable cause to formally charge Dr. Henson.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Dr. Henson be found guilty of failing to keep written medical records justifying his treatment of Ms. Ashton with injections of vitamin B-12, steroids and Mandol between December 1979, and September 1983. A fine of $500.00 should be imposed on Dr. Henson for his treatment of Ms. Ashton with excessive doses of vitamin B-12; a fine of $500.00 should be imposed on Dr. Henson for his failure to adequately document the type of steroid administered to Ms. Ashton; and a fine of $500.00 should be imposed on Dr. Henson for his treatment of Ms. Ashton with sub-therapeutic doses of Mandol. Dr. Henson should also receive a reprimand for these three violations of Section 459.015(1)(p), Florida Statutes (1987) It is further RECOMMENDED that Dr. Henson be found guilty of failing to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances with regard to his treatment of Ms. Ashton with injections of vitamin B-12 and Mandol between December 1979, and September 1983. Dr. Henson should be fined $1,000.00 for his violations of Section 459.015(1)(y), Florida Statutes (1987), placed on probation for ninety (90) days and required to successfully complete ten (10) hours of Category I continuing medical education in prescribing controlled substances during the twelve months following the issuance of a final order in this case. It is further RECOMMENDED that the charge that Dr. Henson's treatment of Ms. Ashton with steroids between December 1979, and September 1983, constitutes a violation of Section 459.015(1)(y), Florida Statutes (1987), be dismissed. It is further RECOMMENDED that the charge that Dr. Henson's treatment of Ms. Ashton with vitamin B-12, steroids and Mandol between December, 1979, and September, 1983, constitutes a violation of Section 459.015(1)(u), Florida Statutes (1987), be dismissed. DONE and ENTERED this 24th day of June, 1988, in Tallahassee, Florida. LARRY J. SARTIN 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 day of June, 1988. APPENDIX Case Number 86-3336 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Department's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection 1-2 1. 3-6 Hereby accepted. 7 4. 8 15-16. 9 19. 10 25-26. 11-13 Not relevant to the charges contained in the Administrative Complaint against Dr. Henson in this case. 14 2. 15-25 & 27 Not relevant to the charges contained in the Administrative Complaint against Dr. Henson in this case. 26 33. Dr. Henson's Proposed Findings of Fact Proposed Finding Paragraph Number Recommended Order of Fact Number of Acceptance or Reason for Rejection 1-2 1. 3 Not relevant to this case. 4 2-3. 5 Not relevant to this case or not supported by the weight of the evidence. 6 4-5. 7 5. 8 4-5. 9 Summary of testimony and events which took place during the formal hearing. The facts this testimony supports were not supported by the weight of the evidence. 10 15-19. 11 20. 12-13 22. Not relevant to this case. Summary of testimony. The facts this testimony supports were not supported by the weight of the evidence. 16 25 and 28. 17 26 and 28. The last three sentences are not supported by the weight of the evidence. 18 29. 19 Summary of testimony. The facts this testimony supports were not supported by the weight of the evidence. COPIES FURNISHED: Theodore Doran, Esquire James J. Kearn, Esquire DOPAN & DANIELS, P.A. P. O. Drawer 1231 Daytona Beach, Florida 32015 James W. Smith, Esquire Kim D. Bouck, Esquire SMITH, SCHODER & ROUSE, P.A. 605 S. Ridgewood Avenue Daytona, Florida 32014 Rod Presnell Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Lee Sims Staff Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================

Florida Laws (3) 120.57120.68459.015
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BOARD OF MEDICAL EXAMINERS vs. WALTER L. HURT, 82-002176 (1982)
Division of Administrative Hearings, Florida Number: 82-002176 Latest Update: Aug. 29, 1990

Findings Of Fact The Respondent Walter L. Hurt is a licensed medical doctor having been issued license number ME 0007892. The last known address of the Respondent Hurt is 9871 Indigo Street, Perrine, Florida 33157. The Respondent's medical practice during the period set forth in the Administrative Complaint dealt primarily with weight control. Between approximately February 22, 1980 and August 11, 1981, the Respondent Hurt prescribed to Ms. Gloria Litton the following schedule II controlled substances as defined by Chapter 893, Florida Statutes: DATE DRUG AMOUNT 2/22/80 Sodium Amytal, 50 mg. 30 tablets 2/7/81 Sodium Amytal, 50 mg. 30 tablets 4/6/81 Sodium Amytal, 50 mg. 30 tablets 5/7/81 Sodium Amytal, 50 mg. 30 tablets 6/11/81 Sodium Amytal, 50 mg. 30 tablets 7/12/81 Sodium Amytal, 50 mg. 30 tablets 8/11/81 Sodium Amytal, 50 mg. 30 tablets 12/22/80 Dexedrine Sulfate, 5 mg. 30 tablets 2/26/81 Dexedrine Sulfate, 5 mg. 30 tablets 4/6/81 Dexedrine Sulfate, 5 mg. 30 tablets 5/7/81 Dexedrine Sulfate, 5 mg. 30 tablets 6/11/81 Dexedrine Sulfate, 5 mg. 30 tablets 7/12/81 Dexedrine Sulfate, 5 mg. 30 tablets 8/11/81 Dexedrine Sulfate, 5 mg. 30 tablets 1/14/80 Eskatrol Spans, 15 mg. 30 tablets No Date Tenuate Tabs, 25 mg. 60 tablets These drugs prescribed to Ms. Litton were excessive and inappropriate drugs for the purpose of weight loss. Between October 1, 1980 and December 1, 1980, the Respondent Hurt prescribed 90 tablets of Dexedrine, an amphetamine or sympathomimetic amine drug or compound designated as a schedule II controlled substance pursuant to Chapter 893, Florida Statutes to Ms. Litton for obesity. The drugs prescribed by the Respondent Hurt for Ms. Litton were ineffectual in treating her weight problem. In prescribing the type and quantity of controlled drugs for Ms. Litton, the Respondent failed to practice medicine with that level of care, skill and treatment required by a reasonably prudent similar physician confronted with the same conditions and circumstances. Moreover, the drugs were prescribed for a purpose outside the scope of Section 458.331(1)(cc), Florida Statutes, which prohibits prescribing an amphetamine or sympathomimetic amine drug except for certain enumerated purposes which do not include weight control. On January 29, 1981, the Respondent Hurt issued to Ms. Madeline Lyons a prescription for 30 tablets of Eskatrol Spansules, 15 mg. Further, on July 23, 1981, the Respondent Hurt issued a prescription to Ms. Lyons for 100 tablets of Fastin. These medications are amphetamines or sympathomimetic amine drugs or compounds designated as schedule II controlled substances pursuant to Chapter 893, Florida Statutes, and were given to Ms. Lyons by the Respondent for weight control. In prescribing these schedule II drugs for purposes of weight control, the Respondent failed to practice medicine with the degree of care, skill and treatment which is recognized as acceptable by a reasonably prudent similar physician confronted with similar conditions and circumstances. Moreover, these drugs were prescribed to Ms. Lyons for a purpose outside the scope of Section 458.331(1)(cc), Florida Statutes, which prohibits prescribing amphetamines or sympathomimetic amine drugs except for certain enumerated purposes which do not include weight control. Between approximately June 16, 1980 and October 1, 1981, the Respondent Hurt issued to Mr. Stephen Noel prescriptions for the following controlled substances as defined by Chapter 893, Florida Statutes. DATE DRUG AMOUNT 6/16/80 Preludin Endurets, 75 mg. 100 tablets 8/2/80 Preludin Endurets, 75 mg. 50 tablets 8/19/80 Preludin Endurets, 75 mg. 100 tablets 8/23/80 Preludin Endurets, 75 mg. 45 tablets 9/5/80 Preludin Endurets, 75 mg. 50 tablets 9/11/80 Preludin Endurets, 75 mg. 60 tablets 9/22/80 Preludin Endurets, 75 mg. 60 tablets 10/10/80 Preludin Endurets, 75 mg. 75 tablets 9/3/81 Didrex 100 tablets 9/17/81 Didrex 100 tablets 9/25/81 Didrex 100 tablets 10/1/81 Didrex 100 tablets The prescribing of these controlled substances by the Respondent Hurt to Mr. Noel was excessive and inappropriate for purposes of weight control. In prescribing excessive and inappropriate drugs, the Respondent engaged in gross or repeated malpractice or failed to practice medicine with the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Between approximately July 5, 1980 and October 1, 1981, the Respondent Hurt issued to Mrs. Edna Noel prescriptions for the following controlled substances as defined by Chapter 893, Florida Statutes: DATE DRUG AMOUNT 7/5/80 Preludin Endurets, 75 mg. 15 tablets 7/7/80 Preludin Endurets, 75 mg. 60 tablets 7/10/80 Preludin Endurets, 75 mg. 60 tablets 7/29/80 Preludin Endurets, 75 mg. 100 tablets 8/19/80 Preludin Endurets, 75 mg. 60 tablets 8/29/80 Preludin Endurets, 75 mg. 60 tablets 9/8/80 Preludin Endurets, 75 mg. 60 tablets 9/25/80 Preludin Endurets, 75 mg. 60 tablets 10/4/80 Preludin Endurets, 75 mg. 60 tablets 10/14/80 Preludin Endurets, 75 mg. 60 tablets 9/8/81 Didrex 100 tablets 9/12/81 Didrex 100 tablets 9/21/81 Didrex 100 tablets 9/28/81 Didrex 100 tablets 10/5/81 Didrex 100 tablets The prescribing of these controlled substances to Mrs. Edna Noel for purposes of weight control was excessive and inappropriate. In prescribing excessive and inappropriate controlled medications, the Respondent Hurt failed to practice medicine with the degree of care, skill and treatment which is recognized as acceptable by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The prescriptions issued by the Respondent to Mrs. Edna Noel on October 4 and 14, 1980, for 120 tablets of Preludin Endurets, 75 mg. were for weight control. Preludins are amphetamines or sympathomimetic amine drug or compounds designated as a schedule II controlled substance pursuant to Chapter 893, Florida Statutes. These schedule II controlled substances were prescribed for Mrs. Noel for a purpose outside the scope of Section 458.331(1)(cc), Florida Statutes which prohibits prescribing such drugs except for certain statutorily enumerated purposes.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board of Medical Examiners issue a Final Order finding the Respondent guilty of violating Sections 458.331(1)(q), (t) and (cc), Florida Statutes (1981), and revoking his license. DONE and ORDERED this 28th day of December, 1982, in Tallahassee, Florida. SHARYN L. SMITH, 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 28th day of December, 1982.

Florida Laws (4) 120.57458.331934.03934.06
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs RICARDO JOSE SABATES, M.D., 10-002124PL (2010)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Apr. 19, 2010 Number: 10-002124PL Latest Update: Nov. 11, 2024
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BOARD OF PHARMACY vs. BGJM, INC., D/B/A SAVE ON DRUGS, ET AL., 82-002095 (1982)
Division of Administrative Hearings, Florida Number: 82-002095 Latest Update: Sep. 06, 1983

Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Pharmacy. Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondents. Respondent BGJM, Inc. (hereinafter "Save-on Drugs") holds Permit No. 7171 located at 4282 North State Road 7, Lauderdale Lakes, Florida. Save on Drugs has held said permit at all times material hereto. Respondent Robert E. Levy holds Pharmacy License No. 0017283 and has held said license at all times material hereto. Respondent Levy operated Save on Drugs as the sole proprietor and is the only pharmacist employed at the aforementioned store. Respondent Levy, while working at Save on Drugs, between the dates October 16, 1981 and April 2, 1982, dispensed approximately 139,000 Methaqualone tablets on 3,136 prescriptions. Respondent Levy ceased dispensing Methaqualone tablets approximately three (3) weeks prior to the institution of Petitioner's investigation of Respondent Levy's dispensing of controlled substances. The Respondent dispensed, over a three-month period, some 57,250 units of Methaqualone on behalf of one practitioner, a Dr. Lena. A specific breakdown of Dr. Lena's prescribing activity for part of the relevant period is as follows: DATE PHARMACY DRUG AMOUNT SCRIPT 12/14/81 Save-On Quaa-300 mg. 630 14 12/15 Save-On 720 16 12/16 Save-On 495 11 12/17 Save-On 765 17 12/18 Save-On 1,440 32 12/21 Save-On 945 21 12/22 Save-On 1 x 30 mg. 675 15 12/23 Save-On incl. 1,080 24 12/24 Save-On 1,215 27 12/28 Save-On 1,035 23 12/29 Save-On 1,305 29 12/30 Save-On 1,575 35 12/31 Save-On 1,305 29 Totals 13,185 293 The numerous prescriptions introduced into evidence by the Petitioner reflect circumstances where Respondent Levy failed to properly initial and date Schedule II prescriptions as they were filed. As example, Petitioner offered the following: prescription Nos. 48854, 48052, 50189, 48068, 48856, 48912 and 48905. Louis Fisher 2/ , an employee of the Department of Justice, Drug Enforcement Administration, since approximately November, 1971, has been involved with the regulation of controlled substances. Mr. Fisher works with doctors as well as pharmacists at the retail level. Mr. Fisher is a registered pharmacist and has been charged with drafting regulations for controlled substances. Without question, Methaqualone is a Schedule II drug and is a sedative and hypnotic agent. The drug has a high abuse potential. During the summer of 1982, Methaqualone was changed from Schedule II to a Schedule I controlled substance. After being provided with a hypothetical situation giving the number of prescriptions that Respondent Levy had filled during the time period involved, Mr. Fisher concluded that a pharmacist filling the number of prescriptions within the time period as is here involved by Respondent Levy was, in Mr. Fisher's opinion, unprofessional, excessive, outside the course of good professional practices, and not conduct amounting to professional practice in the patients' best interest. 3/ Dr. Lena was employed by Northeast Medical Services, a stress clinic. In this regard, the parties stipulated that all the prescriptions involved herein were written by a licensed medical doctor. Daniel O'Connell, an investigator with the Department of Professional Regulation, visited the Respondent's store during approximately October 1981, and performed a routine change of ownership inspection. At that time, Respondent Levy engaged in a conversation with investigator O'Connell at which time Respondent Levy was apprised of the problem with respect to dispensing Methaqualone in the south Florida area. Jim R. Golden, an investigator with the Department of Professional Regulation since approximately September 1981, visited Respondent Levy's store during April 1982, to perform a routine inspection to determine the amount of Schedule II drug prescriptions that Respondent was filling. Investigator Golden reviewed a large number of prescriptions that were filled by Respondent for Dr. Lena and inquired of Respondent the reason for dispensing such a large number of prescriptions for Methaqualone tablets. Respondent Levy replied that it was the "money end of it" and that he (Respondent) could fill six (6) Methaqualone prescriptions and do better with those prescriptions from a profit viewpoint than he could with the remainder of his other prescribing activities in the store for the remainder of any given day. Further, Respondent related that he hand to do extensive repairs to make the store operational. (Testimony of Investigator Golden)

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That Respondent BGJM, Inc.'s Permit No.7171 be REVOKED. That Respondent Robert E. Levy's Pharmacy License No. 0017283 be placed on probation for a period of two (2) years. RECOMMENDED this 12th day of May, 1983, in Tallahassee, Florida. JAMES E. BRADWELL, 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 12th day of May, 1983.

Florida Laws (4) 120.57465.018465.023893.04
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BOARD OF MEDICAL EXAMINERS vs. MANUEL P. VILLAFLOR, 86-003256 (1986)
Division of Administrative Hearings, Florida Number: 86-003256 Latest Update: Feb. 18, 1988

The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaint?

Findings Of Fact At all pertinent times, respondent Manuel P. Villaflor, M.D., held a Florida license as a physician, No. ME 0020072. He practices in Daytona Beach, where he has an office on Ridgewood Avenue. UNTIMELY DEATH K.D., a white male, was pronounced dead at 3:59 P.M. on October 19, 1985, a few days shy of his 34th birthday. The autopsy disclosed superficial abrasions, acute blunt trauma to K.D.'s face, scalp and right hand, and acute, diffuse subdural hemorrhage. A paper bag full of prescriptidn medicine containers accompanied the body to the autopsy. Apparently because the labels indicated that Dr. Villaflor had written pain killing prescriptions for K.D., the medical examiner's office notified DPR. Some four months later, analysis of samples of K.D.'s blood and urine revealed that codeine, oxycodone, amitriptyline, also known as Elavil, nortriptyline, also known as Pamelor, and chlordiazepoxide, also known as Librium, had been present in the corpse in quantities "beyond the reference range for therapeutic use." Botting deposition, p. 6. The pathologist amended his initial conclusion that head injuries resulting from "multi-focal blunt trauma," id., p. 7, had caused R.D.'s death, by adding "multiple drug intoxication," id., as another cause of death. As far as the record shows, Dr. Villaflor never prescribed Elavil, Pamelor, Librium or their chemical equivalents for K.D. An osteopath whom K.D. saw toward the end of his life prescribed at least two of these medications, as well as medicine containing oxycodone. CONTROLLED SUBSTANCES UNCONTROLLED On November 15, 1985, Diane Rabideau, an investigator for DPR, called on Dr. Villaflor at his office. He was polite and cooperative. Ms. Rabideau had some difficulty understanding him; he is not a native English speaker, and he had recently suffered a stroke. But she understood well enough Dr. Villaflor's assertions that he did not believe K.D. to have been addicted to any drugs, and that he had not over-prescribed any medicine. Ms. Rabideau inspected the controlled substances kept in Dr. Villaflor's office. She found Tenuate Dospan, Restoril, Darvocet, Valium, Tylenol No. 4, Fiorinal No. 3, Xanax, Vicodin, Tylenol with codeine elixir, Dalmane, Anexsia, Centrax, "Tussend Ex. 1/2 oz.," Limbitrol, Equagesic, Phrenilin with codeine, Novahistine, Naldecon, Ativan, Nucofed, and "P.V. Tussin." When she saw them, they were not under lock and key. No inventory records reflected what was on hand and what had been dispensed. The parties stipulated that Dr. Villaflor "failed to maintain records of the[se] schedule controlled substances . . . as required by Section 893.07, Florida Statutes"; and that he "failed to keep the[se] drugs . . . under lock and key as required by 21 C.F.R. Section 1301.72." When Ms. Rabideau pointed out these omissions, Dr. Villaflor and his wife, who works with him in the office, said they would comply in the future. Mrs. Villaflor said she had not known of these requirements. A subsequent inspection by a DPR investigation found Dr. Villaflor in full compliance with reporting requirements governing controlled substances. K.D.'s PAIN On July 8, 1981, Dr. Villaflor saw K.D., apparently for the first time, at the Halifax Hospital Medical Center emergency room, and admitted him to the hospital. K.D. had sustained an electrical shock when he struck a high voltage power line with an aluminum ladder, as he was hurrying for shelter from a sudden rain. He lost consciousness "surrounded by a bluish flame." Petitioner's Exhibit No. 12. The elecricity burned his feet and made his lower legs tender, as well. Discharged from the hospital, he visited Dr. Villaflor's office on July 15, 1981. In these proceedings, DPR does not question Dr. Villaflor's prescription of Percocet, a combination of Tylenol and oxycodone, for pain on that visit. As a teenager, K.D. had broken his collar bone in falls from motorcycles on two separate occasions. One accident involved a ride over a waterfall. When he was 2l years old, he "was smashed between a construction vehicle and a bulldozer," Petitioner's Exhibit No. 12, suffering "a severe crushing injury to his chest." Some ten years later he "still ha[d] very mobile ribs secondary to this injury," and persistent pain in his back and legs. In November of 1981, Dr. Kolin, a psychiatrist in Orlando, admitted K.D. to Orlando Regional Medical Center. A myelogram "revealed a mild L5 radicular lesion on the left, consistent with chronic myofascial pain and left L5 radiculitis." Petitioner's Exhibit No. 11. During this hospital stay, K.D.'s "narcotic medications were tapered and discontinued." Id. Dr. Villaflor sent copies of his records to Dr. Kolin, to whom Dr. Gillespie in Nashua, New Hampshire, had referred K.D. Apparently Dr. Villaflor never asked and Dr. Kolin never volunteered to forward Dr. Kolin's records to Dr. Villaflor. Gary G. Parsons, a vocation rehabilitation counselor, met K.D. on February 8, 1982. After K.D. made a perfect score on an aptitude test, a state agency subsidized his vocational training at the American Computer Institute. When K.D.'s training there concluded on January 4, 1983, Mr. Parsons tried to assist him in obtaining employment, but eventually concluded that K.D. could not hold a job because "his pain, and his limitation was greater than" (T. 283) Mr. Parsons had originally realized. K.D.'s pain or his physical condition "was primary in his conversation almost every time" (T. 283-4) he and Mr. Parsons spoke. Even after the vocational rehabilitation file was closed on June 26, 1984, he came by Mr. Parsons' office twice. Both times K.D. seemed depressed to Mr. Parsons, who had recommended he go for counseling to the Human Resources Center, a community mental health center. Mr. Parsons saw K.D. for the last time on March 22, 1985. At least as early as August of 1984, K.D. mentioned suicide to Mr. Parsons as a possibility. In March of 1985, K.D. began weekly counselling sessions with Dr. Rafael Parlade, a clinical psychologist at the Human Resources Center. In these sessions "the two issues . . . were his suicidal ideation combination with the depression, and the departure of his live-in girlfriend." (T. 273) He "still had a lot of pain." (T. 274) Dr. Parlade hoped K.D. would "increase his activities," (T. 276) so that with . . . activity in his life more, he would focus away from his pain. Because for a period of time that was all he was living with. (T. 276) Dr. Parlade viewed decreasing the amount of pain medication as a secondary goal (T. 275), a result he hoped would flow from K.D.'s being less preoccupied with the pain he experienced continually. PAIN REMEDIES On January 31, 1983, K.D. visited Dr. Villaflor's office. Dr. Villaflor's notes for that day mentioned K.D.'s "Electrocution High Voltage in 7/81" and reflect a prescription for 50 tablets of Talwin. K.D.'s blood pressure, 120 over 70, is noted, and reference is made to a TENS unit, or transcutaneous nerve stimulator. Somebody at the Orlando Pain Clinic K.D. had visited had recommended one of these electrical devices to K.D., but it had proved ineffective against his pain. At one time or other, K.D. resorted to acupuncture and resumed wearing a corset of the kind originally prescribed for the back pain he experienced in the wake of the cascading motorcycle accident. Dr. Villaflor's office notes of April 15, 1983, record "Back Pain," a second prescription for 50 tablets of Talwin and another prescription for Xanax. On May 11, 1983, Dr. Villaflor's records again note K.D.'s "Back Pain" and indicate prescriptions for Xanax and Percocet. Nothing suggests Dr. Villaflor knew that Talwin had been dispensed to K.D. five days earlier, when K.D. appeared at his office on May 26, 1983. Essentially illegible, Dr. Villaflor's office notes for May 26, 1983, reflect prescriptions for Percocet and Xanax tablets, with which K.D. obtained 30 quarter milligram Xanax tablets on June 6, 1983, and 35 Percocet tablets on June 8, 1983. Xanax, a tranquilizer, is taken three or four times daily. Since Percocet may be taken every four to six hours, it was "very much within reason" (T. 239) for Dr. Villaflor to prescribe more on June 9, 1983. When this prescription was filled on June 22, 1983, K.D. received 45 tablets. On July 7, 1983, Dr. Villaflor saw K.D. at his office for the first time in almost a month, and prescribed 35 more tablets of Percocet, also known as oxycodone with acetaminophen. The same day K.D. had the prescription filled, obtaining 35 tablets. Some three weeks later, on July 29, 1983, Dr. Villaflor again prescribed and K.D. again obtained 35 Percocet tablets. On the same day two other prescriptions Dr. Villaflor wrote for K.D. were filled, one for Atarax, an antihistamine sometimes prescribed in lieu of a tranquilizer, and one for Tylenol with codeine. This 35-tablet Tylenol prescription was refilled on September 7, 1983. With more and less potent pain medications, K.D. could take one or the other, as appropriate, depending upon the intensity of the pain. Since no other prescription for pain killing medication was written or filled until October 4, 1983, these prescriptions were, according to one of the Department's witnesses, "[w]ithin reason." (T. 243) On the October 4 visit, Dr. Villaflor noted "Back Pain from Electrocution" and recorded K.D.'s blood pressure as 138 over 70 or 80, before prescribing 45 Percocet tablets. That day, K.D. obtained the Percocet. He returned to Dr. Villaflor's office on October 13, 1983, complaining not only of back pain, but also of nausea and vomiting. Dr. Villaflor prescribed an additional 30 Percocet tablets. On October 15, 1983, K.D. acquired 50 tablets of the antihistamine Dr. Villaflor had been prescribing for him, "hydroxizine pam." On November 3, 1983, he obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets. On November 12, 1983, the antihistamine prescripton was refilled as was, on November 16, the Tylenol No. 3 prescription. Perhaps Dr. Villaflor wrote the antihistamine prescription two days before it was first filled. The office notes are difficult to decipher. He wrote the Percocet and Tylenol prescriptions when he saw K.D. on November 3, 1983, at which time he recorded his blood pressure (132 over 70) and noted "back injury." On December 2, 1983, Dr. Villaflor's office notes reflect a visit and prescriptions for Tylenol No. 3, Percocet and the antihistamine. With respect to prescriptions filled on and after November 3, 1983, but before December 2, 1983, DPR's witness testified that the amount of medication was "a little high, but it's still, you know, again, acceptable for a person in pain." (T. 246) On December 2, 1983, K.D. obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets, the latter by virtue of a prescription that was refilled on December 14, 1983. On January 3, 1984, K.D. returned to Dr. Villaflor's office where he obtained prescriptions for Percocet and Tylenol No. 3. In March, Dr. Villaflor began prescribing a tranquilizer, Dalmane, instead of the antihistamine, but the new year progressed much as the old year had, in terms of Dr. Villaflor's prescriptions and documentation, and, apparently, of K.D.'s pain, as well, until early August. On August 3, 1984, Dr. Villaflor prescribed for K.D., 200 "Sk- Oxycodone w/Apap" tablets, 200 Tylenol No. 4 tablets and 180 Dalmane capsules. K.D. had asked for them to take along to New England, where he travelled for an extended visit with his parents and others. This represented more than a two months' supply, and the prescriptions inspired a pharmacist, Paul Douglas, to telephone Dr. Villaflor's office before filling them. Mr. Douglas had called once before in the spring of the year, when he noticed that a total of 100 Tylenol (acetaminophen with codeine) No. 3 tablets and 60 tablets of Percocet (or the generic equivalent) had been dispensed to K.D. for use over a 24-day (April 2 to April 26, 1984) period. The pharmacist was concerned on that occasion because K.D. would have needed only 144, not 160, tablets during that period, if he had been taking no more than one every four hours. Back in Daytona Beach, K.D. presented himself at Dr. Villaflor's office on November 5, 1984, and received prescriptions for 45 tablets of Percocet, 55 tablets of Tylenol No. 3 and a quantity of Dalmane. All three prescriptions were filled the same day, and the prescription for Tylenol No. 3 was refilled on November 19, 1984. After his last telephone call to Dr. Villaflor's office, the pharmacist talked to K.D., telling him he would "not fill these medications again . . . until the prescribed number of days." (T. 222). On December 5, 1984, K.D. appeared a second time after his return from up north, and Dr. Villaflor again prescribed all three drugs, this time specifying 50 tablets of Percocet and 50 tablets of Tylenol No. 3. K.D. caused these prescriptions to be filled the day he got them. The office notes for both these visits mention only electrical shock by way of explanation for the prescriptions. On December 19, 1984, Dr. Villaflor suffered a stroke and was hospitalized. Two days later prescriptions he had purportedly written for K.D. were filled, but their authenticity, like that of the prescriptions filled on November 21, 1984, is not certain. While Dr. Villaflor was indisposed on account of the stroke, Dr. Wagid F. Guirgis filled in for him. The day he began, K.D. came in complaining of severe pain in his lower back and legs. Dr. Guirgis prescribed Dalmane, 50 Percocet tablets and 50 Tylenol No. 3 tablets, the latter prescription being twice refillable. Dr. Guirgis suggested to R.D. that he see an orthopedist or a neurologist, and, on January 21, 1985, refused K.D.'s request to prescribe more Percocet. At no time did Dr. Guirgis and Dr. Villaflor discuss K.D. or his treatment. Later the same day K.D. went to Dr. M.H. Ledbetter's office. This osteopath prescribed 30 Percocet tablets to be taken twice daily, as well as Elavil and Tranxene. On February 4, 1985, Dr. Ledbetter prescribed the same medicines. On February 28, 1985, Dr. Ledbetter prescribed Elavil, Librium and 50 tablets of Percocet. On March 22, 1985, he prescribed the same things. On April 19, 1985, K.D. again visited Dr. Ledbetter. The same day he purchased Librium and 60 Percocet tablets at Walgreen's. Dr. Ledbetter prescribed Librium, Elavil and 60 tablets of Percocet, to be taken twice daily, when he saw K.D. on May 16, 1985. In May Dr. Villaflor returned to his office, and K.D. appeared on May 21, 1985, five days after he had seen Dr. Ledbetter. Dr. Villaflor prescribed 60 Percocet and 50 Tylenol No. 3 tablets for K.D., along with Dalmane and a vitamin (Bl2) injection. K.D. weighed 142 pounds that day and his blood pressure was also noted. The office notes report "same complaints." On June 18, 1985, Dr. Villaflor prescribed 60 Percocet tablets, ten fewer than he prescribed on K.D.'s next visit, on July 17, 1985 , when K.D. limped "on left foot." In July, Dr. Villaflor also prescribed Dalmane and 50 Tylenol No. 3 tablets. On both visits K.D.'s weight (142 then 138) and blood pressure (122 then 120 over 80) were noted. On August 19, 1985, K.D.'s weight had fallen to 132 pounds but his blood pressure remained 120 over 80. Sixty Percocet tablets - one every four hours - were prescribed, as were 50 Tylenol No. 3 tablets. The diagnosis indicated in Dr. Villaflor's office notes was "electrocution." On September 16, 1985, Dr. Villaflor again prescribed Dalmane, Tylenol and 60 Percocet tablets. On October 17, 1985, K.D. limped to his last visit to Dr. Villaflor's office. His face bruised, K.D. complained that both feet were swollen, and reported that he had lost his balance and fallen down four stairs and over a concrete wall. For the last time, Dr. Villaflor prescribed Tylenol No. 3 and Percocet for K.D., 30 and 60 tablets respectively. Unbeknownst to Dr. Villaflor, K.D. had continued to visit Dr. Ledbetter, himself unaware of Dr. Villaflor's renewed involvement with K.D. On June 7, July 5, July 26, August 27, September 16 and October 10, 1985, Dr. Ledbetter prescribed Librium, Elavil and Percocet. Dr. Ledbetter's office notes also reflect K.D.'s fall. REQUIRED PRACTICE Keeping complete medical records is important not only as a mnemonic aid for the treating physician, but also to make the patient's history available to other physicians who may succeed or assist the recordkeeper. Although each is "a moderate type of analgesic," (T. 324), both codeine and oxycodone are "narcotic derivatives . . . [and] addictive in nature." Id. Dalmane "can be" (T. 221) "potentially addictive." Id. Because of his depression, K.D. "was not a good candidate" to entrust with several hundred pills at once. A physician who suspects addiction should limit prescriptions to "around ten to fifteen" (T.326) tablets and "start checking with other pharmacies to make sure if a patient is getting drugs from any other source . . . ." Id. He should perform "very close and repeated physical exams" (T. 327) and be alert for "overdose side effects," id., such as dizziness, slurred speech, or staggering. The evidence here fell short of a clear and convincing showing that Dr. Villaflor was remiss in failing to suspect addiction, however, Dr. Ledbetter, who had similar, albeit similarly incomplete, information apparently did not suspect. The evidence did not prove the existence of side effects from the drugs Dr. Villaflor prescribed. Although, on his last visit to Dr. Villaflor's office, K.D. reported dizziness, the cause is unknown. On the other hand, his office records do not suggest that Dr. Villaflor took any steps to determine the cause of K.D.'s dizziness or of his swollen feet. Dr. Villaflor's treatment of K.D. fell below acceptable levels, if he failed to refer K.D. for periodic reevaluations of the underlying orthopedic or neurological problem, which his records suggest he did not do. His treatment was also inadequate for failure periodically to "get the medicine . . . out of the system . . . for a limited time" (T. 337) in an effort to learn what side effects, if any, the drugs he prescribed caused, either singly or in combination. This is so, even though the effort might have been frustrated, if K.D. had acquired the same medicines from other sources.

USC (1) 21 CFR 1301.72 Florida Laws (2) 458.331893.07
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LAWRENCE ABELE vs DEPARTMENT OF MANAGEMENT SERVICES, DIVISION OF STATE GROUP INSURANCE, 20-000056 (2020)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Jan. 07, 2020 Number: 20-000056 Latest Update: May 14, 2020

The Issue The issue to be determined in this proceeding is whether Petitioner is entitled to a refund of the costs paid for prescriptions for compound Midrin.

Findings Of Fact The Division of State Group Insurance (Division) is the executive agency within the Department of Management Services (Department) that is responsible for the administration of the State Group Insurance Program (Program). Petitioner is retired and receives medical benefits through the State Employees’ HMO Standard Medical Plan (the Plan), which is administered by Capital Health Plan (CHP). The State Employees’ Prescription Drug Program is administered by CVS Caremark. Respondent is the state agency responsible for resolving appeals of medical claims denied by Caremark. Background Mr. Abele was employed with the State of Florida until he retired. He was covered by the Plan and his coverage has remained since his retirement. For the past three years, Mr. Abele has filled a prescription for generic Midrin to treat migraine headaches. The medication was prescribed by his primary care physician, John Ness, M.D. The evidence offered at hearing includes a total of 18 claims2 for prescriptions for compound Midrin that Mr. Abele submitted to Caremark for reimbursement. Mr. Abele submitted claims for prescriptions filled in 2018 dated: July 12 and 25, 2018; August 2, 2018; September 7, 2018; October 5 and 22, 2018; November 6 and 26, 2018; December 12, 2018. Mr. Abele also submitted claims for prescriptions filled in 2019 dated: January 9 and 30, 2019; February 12, 2019; March 6, 18, and 29, 2019; April 10 and 25, 2019; and May 10, 2019. Each of the 18 claims was for reimbursement of $105 for a total of $1,890. Relevant Definitions The Plan Booklet and Benefit Document (“Plan”) includes definitions, relevant in part here, as follows: "Covered Services and Supplies" means those health care services and supplies, including pharmaceuticals as described in Section VIII, for which reimbursement is covered under this Plan. "Exclusions" is defined as any provision of the Plan whereby coverage for a specific hazard or condition is entirely eliminated. “Medically Necessary” is defined as any appropriate medical treatment ... as provided by a physician ... which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s illness or injury, and which is: Consistent with the symptom, diagnosis, and treatment of the Health Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable community practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, 2 The claims at issue are those claims submitted by Mr. Abele in support of his request for reimbursement. appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not Experimental or investigational. Medical Necessity Dr. Ness, a family practice physician with 30 years of experience, prescribed generic Midrin for Mr. Abele to treat migraine headaches. Dr. Ness prescribed generic Midrin to treat Mr. Abele based on his assessment that other medications were contraindicated for Mr. Abele due to Mr. Abele’s risk for cardiovascular adverse effects if he uses other medications. Dr. Ness credibly testified that Midrin is medically necessary to treat Mr. Abele’s migraine headaches. Anthony Arnett, M.D., the physician for Caremark responsible for reviewing claims for coverage, determined that Midrin was not medically necessary to treat Mr. Abele’s migraine headaches. However, Dr. Arnett conceded that his decision was based on his general determination that there are other options available for migraine headaches. The undersigned finds Dr. Ness’ testimony more persuasive concerning the determination that Midrin was medically necessary to treat Mr. Abele for migraines. Midrin History At the time Dr. Ness prescribed generic Midrin to Mr. Abele, it was an FDA-approved drug. In fact, Midrin was approved for use in 1948 based on safety and effectiveness. However, in 2017, the United States Food and Drug Administration (the “FDA”) determined that Midrin was no longer safe and effective. On October 12, 2017, the FDA notified manufacturers of prescription drugs containing isometheptene mucate that they should immediately cease distribution of the product. On June 13, 2018, the FDA issued a subsequent notice listing the drugs that were no longer approved by the FDA and that manufacturing companies were required to stop producing. The drug combination for Mr. Abele’s prescription for compound Midrin (acetaminophen, dichloralphenazone, and isometheptene mucate) is on the FDA non-approved list. Midrin Prescription/Coverage Denial In January 2018, Mr. Abele presented his prescription for generic Midrin to his local CVS Pharmacy to be filled but the prescription was refused. Mr. Abele indicated that the pharmacist told him that the manufacturer had stopped producing the drug and suggested that he could have the drug compounded. Since generic Midrin was no longer available, Dr. Ness issued a prescription for the compound Midrin, in capsule form, with a 10-day supply for each prescription. The medication name was listed as “Midrin (ALTERNATE) 325MG/100MG/65MG Capsule,” and the ingredients were listed as acetaminophen, dichloralphenazone, isometheptene mucate, and microcrystalline cellulose3. Mr. Abele filled the prescriptions at a local in- network compounding pharmacy. On January 14, 2018, Mr. Abele contacted Caremark about his compound Midrin prescription and Mr. Abele was told that he would need to submit a claim to determine whether the compound drug ingredients would be covered. There is no evidence that the Caremark representative made any false or misleading representation that Mr. Abele’s compound prescription would be approved. On December 14, 2018, Mr. Abele submitted claims to Caremark for reimbursement for compound Midrin. On December 17, 2018, Caremark notified Mr. Abele by letter that the claims he submitted were not allowed. The reason provided for disallowance was because the drug was not on the plan’s formulary. The letter also notified Mr. Abele that his request for exception did not include the information necessary to approve the request. On February 1, 2019, Dr. Ness, on behalf of Mr. Abele, submitted a non-covered drug formulary exception request seeking approval for compound Midrin. He requested the drug in capsule form for the treatment of Mr. Abele’s migraines. However, the request form did not include a copy of the prescription for the compound formula for Midrin. The form also did not describe the drug as the compound alternative. Dr. Ness testified that it is a common medical practice to use “cap” to refer to the capsule form, even for the compound formula. The Caremark appeals department faxed a response to Dr. Ness as follows: “In researching your fax request, the member’s prescription benefit coverage indicates a [p]rior [a]uthorization is NOT required. For additional questions regarding the medication’s coverage under the member’s plan, please contact Customer Service using the number on the back of the member’s prescription benefit card.” Dr. Anthony Arnett testified that he interpreted the exception request as being for Midrin capsules, rather than the compound form. Based on that interpretation, the response to the exception request was that prior authorization was not necessary. The undersigned finds that even if prior authorization was not required for the prescription, it does not amount to an approval for coverage of the claims. Appeal of Coverage Denial On February 5, 2019, Mr. Abele appealed the denial of reimbursement for compound Midrin. On February 13, 2019, Caremark responded to Mr. Abele instructing him to submit additional information for his claims to be processed. On February 18, 2019, he submitted the requested information and materials. On March 30, 2019, Caremark notified Mr. Abele by letter that his drug coverage request was denied. The basis for the denial was that the 3 Microcrystalline cellulose may be used as a bulking agent in pharmaceutical products. prescription was for a compound drug containing, as relevant here, bulk powder. Mr. Abele then submitted a Level I appeal, also referred to as a clinical appeal4, on April 18, 2019. Dr. Arnett reviewed Mr. Abele’s claims for the Level I appeal. While Dr. Arnett acknowledged that compounding could be approved if no other drug is available for treatment of migraines, he concluded that Mr. Abele’s exception request could not be approved because the compound formula included bulk powder. Caremark denied Mr. Abele’s Level I appeal and notified Mr. Abele by letter of their decision on April 22, 2019. In the letter, Caremark stated that “petitioner’s appeal for Dichloralphenazone Powder Compound has been determined as not medically necessary; and, ‘the plan criteria does not allow coverage of dichloralphenazone Powder Compound’ if the compound contained ‘bulk powder’ as an ingredient.” On May 8, 2019, dissatisfied with the outcome of the Level I appeal, Mr. Abele requested a Level II appeal. The Department denied the Level II appeal on the basis that the compound Midrin “did not meet the medical necessity criteria and non-FDA approved compounds are excluded from the plan.” Limitations and Exclusions The Department's concurrence of Caremark’s decision that coverage for the compound Midrin prescription should be denied was based on the Plan’s general Limitations and Exclusions section, which applies to the Prescription Drug Program. The Prescription Drug Program also outlines specific exclusions related to medications. The Prescription Drug Program, described in Part VIII, provides that covered drugs shall include, but are not limited to, any drug, medicine, medication, or communication that is consumed, administered, or provided at 4 Level I appeals are handled by Caremark by a specific group that focuses on prescriptions appeals. the place where the prescription is given at the medical provider’s office or healthcare facility. The Plan’s limitations and exclusions section provides, “the following services and supplies are excluded from coverage under this Plan unless a specific exception is noted. Exceptions may be subject to certain coverage Limitations.” Under the Plan, the exclusions include “any non-prescription medicine, remedy, biological product, pharmaceutical or chemical compound, vitamins, mineral supplements, fluoride products, health foods, or blood pressure kits, except as specifically provided for in the covered benefits section under prescription drugs.” The Additional Exclusions section provides that bulk powders, bulk chemicals, and proprietary bases used in compound medications and over-the- counter (“OTC”) products used in compound medications are excluded from coverage. Further, the plan excludes services or supplies not medically necessary as determined by the Plan and/or the Prescription Drug Program clinical staff and the state. The Prescription Drug Program provides that the Prescription Drug Program does not cover non-federal legend or OTC products, and bulk powders, bulk chemicals, and proprietary bases used in compounded medications.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Division of State Group Insurance, Department of Management Services, enter a final order denying Lawrence Abele’s request for reimbursement for the claims submitted for his compound Midrin prescription. DONE AND ENTERED this 14th day of May, 2020, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of May, 2020. COPIES FURNISHED: Lawrence Abele 841 Maderia Circle Tallahassee, Florida 32312 (eServed) Erica D. Moore, Esquire Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed) Jacob Koffsky, Esquire Foley & Lardner LLP 2 South Biscayne Boulevard, Suite 1900 Miami, Florida 33131 (eServed) Gayla Grant, Esquire Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed)

Florida Laws (4) 110.123120.569120.57120.68 DOAH Case (2) 13-209520-0056
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