Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I hereby make the following findings of fact: The Respondent, Zevart Manoyian, M.D. is a licensed physician in the State of Florida, having been issued License No. ME 0003347. Respondent is engaged in the practice of family medicine at 725 Opa Locke Boulevard, Opa Locke, Florida. The Respondent has practiced medicine for the past thirty-eight years. The Respondent treated patient Willie Dawson from October 1981 through May 1984. When interviewed by DPR Investigator Lichtenstein during the initial investigation of this case on October 2, 1986, the Respondent stated that she was treating Dawson for a broken jaw and depression. Based on information contained in hospital records and the Respondent's office records during the period which Dawson was treated by Respondent, the following medical history is disclosed: In 1980, Dawson was hospitalized because of a broken jaw; In 1982, the Respondent diagnosed Dawson as having narcolepsy and began prescribing Preludin. In 1984, Dawson was admitted to the Veteran's Administration Hospital and died due to an "intestinal obstruction." Between December 1983 and September 1984, the Respondent prescribed 180 doses of Preludin and 180 doses of Percodan to Dawson. Narcolepsy is a rare and unusual sleeping disorder and may be treated with Preludin, a Schedule II controlled drug. Percodan, a Schedule II controlled drug, may be prescribed for pain. Percodan could be an appropriate medication to prescribe for lingering pain associated with a previously broken jaw. The Respondent's medical records pertaining to Dawson contained no medical history, given by the patient, allergy history physical examinations or the results thereof, laboratory tests ordered or the results thereof, and no x- rays. The Physicians' Desk Reference (PDR) is accepted by physicians as an authoritative reference source of appropriate drug usage indications and contraindications, The PDR is made up of inserts provided by various drug companies and manufacturers and will indicate the limits and limitations of a particular drug. Although the POP is accepted by physicians as an authoritative reference source, physicians recognize that it is merely a guide and that the treating physician must determine the most appropriate and medically justifiable treatment for a given patient. According to the PDR, the appropriate recommended dosage for Percodan is four per day or one every six hours when medically indicated. However, a physician may increase this dosage if the patient has developed a tolerance to the analgesic effects of the drug or when there is severe pain. The appropriate recommended dosage for Preludin is one per day. The PDR advises that the recommended dosage for Preludin not be exceeded. The amounts of Preludin and Percodan given to Dawson were within the dosage and administration recommendations in the PDR. In addition, the choice of drug, and the amount prescribed, could have been indicated to a reasonably prudent physician based on Dawson's medical conditions. The Respondent treated patient Barbara Gaskill from September 1977 through December 1984. When questioned by DPR Investigator Lichtenstein regarding this patient, the Respondent stated that she was treating Gaskill for lower back pain and obesity. Based on information contained in the Respondent's office records during the period which Gaskill was treated by Respondent, the following medical history is disclosed: In 1977, Gaskill hurt her back, suffered an arthritis attack and had a ruptured sciatica; In 1978, Gaskill was experiencing problems sleeping due to her back conditions; In 1980, Gaskill was involved in an automobile accident; In 1982, Gaskill suffered headaches; In March 1983, Gaskill had an infected tooth in her right jaw; In March 1984, Gaskill injured her back when she tripped and fell; In April 1984, Gaskill suffered from chronic pain in her lower back; Between December 9, 1983, and August 7, 1984, the Respondent prescribed 115 tablets of Tuinal and 102 tablets of Percodan to Gaskill. Tuinal is a Schedule II controlled drug used to help induce sleep. The recommended dosage in the PDR for Tuinal is one per day. Tuinal and Percodan, in the amounts prescribed, could be appropriate drugs with which to treat pain and sleeping problems arising from medical problems such as those with which Gaskill suffered between December 9, 1983 and August 7, 1984. The dosages of Percodan and Tuinal which Respondent prescribed to Gaskill were within the recommended limitations established for those drugs in the PDR. The Respondent's medical records pertaining to Gaskill contained no medical history given by the patient, allergy history, physical examinations or the results thereof, laboratory tests ordered or the results thereof, and no x- rays. The Respondent treated Linda Godfrey from November 1980 through July 1984. When questioned by DPR Investigator Lichtenstein regarding this patient, the Respondent stated that she was treating Gaskill for severe pain. The Respondent stated she knew that Godfrey was addicted to the medication but that she continued to prescribe the medication to alleviate the pain. Based on information contained in hospital records and the Respondent's office records during the period Godfrey was treated by Respondent, the following medical history is disclosed: In 1980, Godfrey was diagnosed as having congenital cerebral palsy and multiple sclerosis. On the same visit, the Respondent noticed that Godfrey had an abscess on her left buttock; In March of 1981, Godfrey was involved in an automobile accident; In August of 1981, Godfrey passed a kidney stone and went to the hospital; In August and September of 1983, Respondent noted that Godfrey was experiencing severe pain "all over"; In April of 1984 Godfrey had an infected ulcer; In June of 1984, Godfrey was admitted to the hospital by the Respondent. The Respondent noted that the patient had a drug addiction, which the patient denied. During Godfrey's hospital stay, the Respondent did not allow her to have visitors because Godfrey was overheard requesting a friend to bring drugs to her in the hospital. Godfrey admitted to snorting cocaine while in the hospital. On June 4, 1984, Godfrey was discharged to North Miami General Hospital in order to be cared for in the drug and detoxification unit. The diagnosis at that time was acute gastritis and drug dependence. On June 3, 1984, the Respondent noted that Godfrey was scheduled for a psychiatric consultation with another physician; In July of 1984, Godfrey was readmitted to the hospital because she fell down a flight of steps and injured her right knee and twisted her lower back. Between December 26, 1983, and July 8, 1984, the Respondent prescribed 10 doses of Percocet, 12 doses of Nembutal, and 377 doses of Perdocan to Godfrey. Percocet is a Schedule II controlled drug which is used in the treatment of pain. Percodan and Percocet are similar except that Percocet has a Tylenol base and Percodan has an aspirin derivative. The PDR's recommended dosages and limitations are the same for Percodan and Percocet. Nembutal is a short-acting or medium-acting barbiturate and is used to help induce sleep. The recommended dosage in the PDR for Nembutal is one per day. Percodan, Prococet and Nembutal, in the amounts prescribed, could be appropriate drugs with which to treat pain and associated sleeping problems arising from medical conditions such as those with which Godfrey suffered between December 26, 1983 and July 8, 1984. The dosages of Percodan, Prococet and Nembutal which Respondent prescribed to Godfrey were within the recommended limitations established for those drugs in the PDR. Respondent's medical records pertaining to Godfrey contain no medical history given by the patient, allergy history, physical examinations or the results thereof, laboratory tests ordered or the results thereof, and no x-rays. The Respondent treated patient Martha Guc from January of 1977 through September of 1984. When questioned by DPR Investigator Lichtenstein regarding her treatment of this patient, the Respondent stated that she was treating Guc for severe back pain. Based on information contained in hospital records and the Respondent's office records during the period which Guc was treated by Respondent, the following medical history is disclosed: In January of 1979 Guc was involved in a serious automobile accident and also suffered from scoliosis. Guc was experiencing cramps in her spine and was unable to sleep as a result of her back pain; In the automobile accident of January 1979, Guc received extensive injuries, including multiple abrasions and lacerations, a broken arm and multiple contusions in her sternum and knee. Plastic surgery was required to repair the facial lacerations and her arm was placed in a cast. In December of 1979, Guc experienced pain in her back and left knee; In 1980, Guc continued to experience back pain; In 1983, Guc was involved in an automobile accident and her head hit the windshield; From March to June 1984, Guc continued to experience back pain; Between January 20, 1984, and August 27, 1984, the Respondent prescribed 580 doses of Percodan to Guc. Percodan, in the amount prescribed, could be an appropriate drug with which to treat pain arising from medical problems and conditions such as those with which Guc suffered between January 20, 1984 and August 27, 1984. The dosages of Percodan which Respondent prescribed to Guc were within the recommended limitations established for that drug in the PDR. The Respondent's medical records pertaining to Guc did not show any medical history, allergy history, physical examination or the results thereof, laboratory tests ordered or the results thereof, and no x-rays. The Respondent treated patient Delores Jones from January of 1969 through October of 1984. When questioned by DPR Investigator Lichtenstein regarding this patient, the Respondent stated that she was treating Jones for back pain. The Respondent stated that she knew that Jones was addicted to narcotics but that the medication was required to relieve the symptoms of pain. Based on information contained in hospital records and the Respondent's office records during the periods which Jones was treated by Respondent, the following medical history is disclosed: In 1969, Jones experienced severe back pain; In 1970, Jones suffered from acute gastritis; In 1974, Jones again experienced severe back pain; In May of 1974, Jones was involved in an automobile accident and injured her back; Additionally, Jones suffered from a hernia, stenosis of the spine and a duodenal ulcer. Between December 1, 1983, and August 28, 1984, the Respondent prescribed 1200 doses of Percocet to Jones. The Respondent was aware that Jones was becoming addicted to narcotics and referred Jones to a Doctor Baldry in Coral Gables for treatment. The Respondent stated that she was not aware if Jones ever followed her referral. Percocet, in the amount prescribed, could be an appropriate drug with which to treat pain associated with medical problems such as those with which Jones suffered between December 1, 1983 and August 28, 1984. The dosages of Percocet which Respondent prescribed to Jones were within the recommended limitations established for that drug in the PDR. The Respondent's medical records pertaining to Jones did not show any medical history, allergy history, physical examinations or the result thereof, laboratory tests ordered or the results thereof, and no x-rays. The Respondent treated patient Cheryl LeBlanc from December of 1983 through October of 1984. When questioned by DPR Investigator Lichtenstein regarding her treatment of this patient, the Respondent stated that Ms. LeBlanc was being treated for pains in the left hip and bursitis. Based on information contained in hospital records and the Respondent's office records during the period in which LeBlanc was treated by Respondent, the following medical history is disclosed: In December of 1983, LeBlanc was diagnosed as having bursitis. Respondent noted that LeBlanc had pains in her left hip and down the posterior portion of her left leg; On January 6, 1984, the Respondent noted that LeBlanc had bursitis in the left hip; In July of 1984, Respondent noted that LeBlanc had a problem with a lymph node; In September of 1984, the Respondent noted that LeBlanc suffered from chronic pain; (f) Prior to being treated by the Respondent, LeBlanc was admitted to North Shore Medical Center in October of 1983 for treatment of infertility and irregular periods. In October of 1983, LeBlanc had a D&C and salpingogram. In November of 1983, she was readmitted to North Shore Medical Center for tubal reconstruction. Between December 13, 1983, and August 2, 1984, the Respondent prescribed 90 doses of Percodan to LeBlanc. Percodan, in the amount prescribed, could be an appropriate drug with which to treat pain arising from medical problems such as those with which LeBlanc suffered between December 13, 1983 and August 2, 1984. The dosages of Percodan which Respondent prescribed to LeBlanc were within the recommended limitations established in the PDR. Respondent's medical records pertaining to LeBlanc did not show any patient medical history, allergy history, physical examinations or the results thereof, laboratory tests ordered or the results thereof, and no x-rays. The Respondent treated patient Gerald LeBlanc, husband of Cheryl LeBlanc, from October of 1983 to October of 1984. When questioned by DPR Investigator Lichtenstein regarding this patient, the Respondent stated that Mr. LeBlanc suffered from severe bursitis in the shoulder and upper back pain. Based on information contained in the Respondent's office records during the period in which LeBlanc was treated by Respondent, the following medical history is disclosed: On October 7, 1983, LeBlanc was treated for muscle spasms in his back; shoulder; On November 9, 1983, LeBlanc was treated for acute bursitis in his On December 6, 1983, Respondent noted that she intended to wait one month and if LeBlanc's shoulder was not better, she was going to have it x- rayed; On December 26, 1983, Respondent noted that LeBlanc's shoulder was still very sore and that he had difficulty working in the cold; On February 17, 1984, the Respondent noted that LeBlanc still had bursitis in his left shoulder; On March 16, 1984, the Respondent indicated that LeBlanc still had bursitis; On April 25, 1984, and September 17, 1984, Respondent noted that LeBlanc was still experiencing severe pain in his shoulder; On October 8, 1984, Respondent noted that LeBlanc refused Tylenol #3, because he stated that it made him sick and nauseous. Between December 1983 to July 9, 1984, the Respondent prescribed 405 doses of Percodan to LeBlanc. Percodan, in the amount prescribed, could be an appropriate drug with which to treat pain associated with medical problems such as those with which LeBlanc suffered between December 1983 and July 9, 1984. The dosages of Percodan which Respondent prescribed to LeBlanc were within the recommended limitations established for those drugs in the PDR. Respondent's medical records pertaining to LeBlanc did not show any medical history, allergy history, physical examinations or the results thereof, laboratory tests ordered or the results thereof, and no x-rays. The Respondent treated patient Betty Mitchell from November of 1981 to August of 1984. When questioned. By DPR Investigator Lichtenstein regarding this patient, Respondent stated that Mitchell suffered from chronic pain. The Respondent stated that Mitchell was drug dependent, but not addicted. Based on the information contained in the Respondent's office records during the period in which Mitchell was treated by Respondent, the following medical history is disclosed: In 1982, Mitchell was shot in her left buttock; On July 21, 1982, Respondent noted that the bullet was still lodged in Mitchell's buttock and that Mitchell had a drainage tube in her abdomen; pain; On September 7, 1982, Mitchell suffered from pelvis and mouth On January 14, 1983, the Respondent noted that Mitchell suffered from pain in the buttocks and back; On April 6, 1984, Respondent noted that Mitchell had pain in her back near her buttock area; On August 7, 1984, Respondent noted that Mitchell was still experiencing back pain; On April 18, 1983, Respondent noted that Mitchell was experiencing pain. Between December 23, 1983, and August 24, 1984, Respondent prescribed 180 doses of Percodan to Mitchell. Respondent was aware that Mitchell was becoming dependent on Percodan. Percodan, in the amount prescribed, could be an appropriate drug with which to treat pain associated with medical problems such as those with which Mitchell suffered between December 23, 1983 and August 24, 1984. The dosages of Percodan which Respondent prescribed to Mitchell were within the recommended limitations established for that drug in the PDR. Respondent treated patient Rhona Molin from September of 1981 to October of 1984. When questioned by Investigator Lichtenstein regarding this patient, the Respondent stated that Molin was being treated "for nervousness and being very high strung." Based on information contained in the Respondent's office records during the period which Molin was treated by Respondent, the following medical history is disclosed: In 1981, Molin suffered from colitis and stomach pain; In 1981, Respondent noted that Molin had bursitis in her right shoulder; In 1982, Molin suffered from right arm pain; On March 16, 1984, Respondent noted sporadic stomach pain; On June 1, 1984, Respondent noted that Molin was nervous and experiencing severe stomach pain; On August 28, 1984, Respondent diagnosed Molin as having colitis. Between December 21, 1983 and August 28, 1984, the Respondent prescribed 300 doses of Tuinal to Molin. Tuinal, in the amount prescribed, could be an appropriate drug with which to treat sleeping problems arising from the medical conditions with which Molin suffered between December 1983 and August 1984. The dosages of Tuinal which Respondent prescribed to Molin were within the recommended limitations established in the PDR. The Respondent's medical records pertaining to Molin do not show any patient medical history, allergy history, physical examinations or the results thereof, laboratory tests ordered or the results thereof, and no x-rays. The Respondent treated patient John Skilles from May of 1981 through October of 1984. When questioned by Investigator Lichtenstein regarding this patient, the Respondent stated that Skilles was being treated for severe pain and bursitis in both shoulders. The Respondent further stated that Skilles was provided two prescriptions for fifty (50) doses of Percodan on the same date because he could not afford to have a prescription for one hundred (100) Percodan filled at one time. Based on information contained in hospital records and the Respondent's office records during the period in which Skilles was treated by Respondent, the following medical history is disclosed: Respondent noted on May 25, 1981, that Skilles was shot five or six times in an accident at Camp Pendelton while he was in the military. Respondent noted that his upper body was full of lead shot; On September 14, 1981, the Respondent noted that Skilles was experiencing pain in both shoulders; On December 7, 1981, the Respondent indicated that Skilles was still experiencing shoulder pain; On August 30, 1982, Respondent noted that Skilles was in an automobile accident and injured the left side of his chest; On October 1, 1982, Respondent noted that Skilles was still experiencing shoulder and chest pain; On June 3, 1983, the Respondent noted that Skilles had pain in both shoulders and was unable to work (Skilles was a painter); On September 6, 1983, the Respondent noted that Skilles was experiencing severe pain in his shoulder. On December 28, 1983, Respondent noted chest pain, and on February 17, 1984, and March 26, 1984, it was noted that Skilles was still experiencing chest pain; On June 13, 1984, the Respondent noted that Skilles had bursitis in both shoulders and was suffering from insomnia; On October 1, 1984, the Respondent noted that Skilles suffered from severe pain in the shoulder and chest. Between August 11, 1983, and September 1, 1984, the Respondent prescribed 90 doses of Tuinal and 600 doses of Percodan to Skilles. Tuinal and Percodan, in the amounts prescribed, could be appropriate drugs with which to treat pain and sleeping problems arising from medical conditions such as those with which Skilles suffered between August 1983 and September 1984. Respondent's medical records pertaining to Skilles do not show any medical history, allergy history, physical examinations or the results thereof, laboratory tests or the results thereof, or x-rays. The Respondent treated patient June Sweeney between February of 1980 and August of 1984. When questioned by Investigator Lichtenstein regarding this patient, Respondent stated that she was treating Sweeney for nervousness and insomnia. Based on information contained in Respondent's office records during the period in which Sweeney was treated by Respondent, the following medical history is disclosed: In 1980, Sweeney was having difficulty sleeping and was experiencing back pain; In 1982, Sweeney was involved in an automobile accident and experienced more back pain; In 1982, Sweeney experienced severe back pain. In August of 1984 Sweeney returned to Respondent's office complaining of pain and insomnia. On August 9, 1984, the Respondent prescribed 30 doses of Percodan and 30 doses of Tuinal to Sweeney. Percodan and Tuinal, in the amounts prescribed, could be appropriate drugs with which to treat pain and sleeping problems arising from medical conditions such as those with which Sweeney suffered. The dosages and Percodan and Tuinal which Respondent prescribed to Sweeney were within the recommended limitations as established for those drugs in the PDR. The Respondent's medical records pertaining to Sweeney did not show any patient medical history, allergy history, physical examinations or the results thereof, laboratory tests ordered or the results thereof, and no x-rays. The Respondent treated patient Mike Sweeney from April of 1979 to October of 1984. When questioned by Investigator Lichtenstein regarding this patient, Respondent stated that she was treating Mr. Sweeney for "various things, including back pain and insomnia." Based on information contained in hospital records and the Respondent's office records during the period in which Sweeney was treated by the Respondent, the following medical history is disclosed: Prior to being seen by Respondent, Sweeney had surgery on his left buttock in 1978. On March 12, 1979, Sweeney fell and injured his back; In May of 1979, Sweeney was beaten up and his left eye was swollen; In 1980, the Respondent noted that Sweeney was still experiencing back pain; On May 11, 1981, the Respondent noted that Sweeney was still experiencing back pain and was experiencing difficulty sleeping as well; On August 4, 1981, Respondent again noted that Sweeney was still experiencing back pain; Between December 1983 and September 1984, Respondent prescribed 240 doses of Tuinal and 48 doses of Percodan to Mike Sweeney. On one occasion, the Respondent prescribed two thirty-dose prescriptions of Percodan to Sweeney on the same day. The Respondent stated that it was cheaper to prescribe multiple prescriptions of thirty doses than one prescription for sixty. Tuinal and Percodan, in the amounts prescribed could be appropriate drugs with which to treat pain and sleeping problems associated with medical conditions such as those with which Mike Sweeney suffered between December 1983 and September 1984. The dosages of Percodan and Tuinal which Respondent prescribed to Sweeney were within the recommended limitations established for those drugs in the PDR. The Respondent treated patient Ivan Weithorn from November of 1970 through September of 1984. When questioned by Investigator Lichtenstein regarding this patient, the Respondent stated that she treated Weithorn for back and shoulder pain and insomnia. Based on information contained in the Respondent's office records during the period in which Weithorn was treated by Respondent, the following medical history is disclosed: In 1977, Respondent recorded that Weithorn had dental work done and a root Canal was done along with oral surgery; In 1978, Respondent noted that Weithorn had pain in his right elbow; In 1982, the Respondent noted that Weithorn fell and hit a table; In August 1983, the Respondent noted that Weithorn had an abscess on his left forearm and in December 1983 noted that he had an infected finger on his left hand; On February 3, 1984, Respondent noted that the patient had sustained a puncture wound in his upper lip. Between December 9, 1983, and August 27, 1984, the Respondent prescribed 360 doses of Tuinal and 600 doses of Percodan to Weithorn. Tuinal and Percodan, in the amounts prescribed, could be appropriate drugs with which to treat pain and sleeping problems arising from medical conditions such as those with which Weithorn suffered between December 1983 and August 1984. The dosages of Percodan which Respondent prescribed to Weithorn were within the recommended limitations established for that drug in the PDR. The dosages of Tunial which Respondent prescribed to Weithorn slightly exceeded the recommended dosage contained in the PDR. The FOR recommends one Tuinal per day. In this instance, 360 Tuinal were prescribed over a 300-day period. It may be appropriate for a physician in the exercise of his or her professional judgment, to slightly exceed the recommended dosage of a particular drug if the patient has developed a tolerance to the effects of the substance. Respondent's medical records pertaining to Weithorn do not show any patient medical history, allergy history, physical examinations or the results thereof, laboratory tests ordered or the results thereof, or x-rays. All of the Respondent's medical records were stored in a plastic shoe- box like container and were maintained on 3 X 5 index cards. The use of small file-type index cards for the maintenance of a physician's office medical records was prevalent about 20 to 25 years ago. Today, most physician's written medical records are maintained in standard size folders and include laboratory tests, examination results, hospital records, discharge summaries and letters from consulting physicians. Although Respondent sometimes indicated a diagnosis on an initial visit, she rarely noted the diagnosis, objective findings or subjective symptoms of the patients on return visits. On some occasions, a subjective complaint such as "pain" was the only symptom recorded. Extensively within the Respondent's medical records upon a return visit of a patient, nothing was recorded except a prescription, the number of doses and the office charge. Occasionally, a blood pressure or temperature reading was recorded by Respondent. Except for the prescription of pain and sleep-inducing medication, the Respondent's written medical records for the patients described herein failed to demonstrate or indicate the Respondent's overall treatment plan for the patients. In order to justify a course of medical treatment which includes the long term use of Schedule II controlled substances, good medical practice requires that a physician's written patient medical records contain subjective findings (i.e. complaint, onset, duration and severity), a patient history and objective, physical findings made by the physician and/or confirmed and disclosed through laboratory tests or x-rays. The medical records maintained by Respondent on the patients described herein contained only anecdotal information about the patients and contained only scant subjective and objective findings, contained no medical histories and no laboratory results or x-rays. The records maintained by Respondent during the periods when Schedule II controlled drugs were prescribed to the patients herein were inadequate and demonstrated a failure to provide medical care at the minimum level of skill and care required of a reasonably prudent physician under similar conditions. Episodic treatment or care is defined as treatment of symptoms or problems as they present themselves in a patient without any consideration of the root causes of the symptoms, the long term affects the problem may have on the patient, and no consideration of a viable treatment plan. Episodic treatment is considered very poor quality medical care and is a type of treatment which is below the standard of care which is recognized by reasonably prudent physicians as being acceptable. This type of treatment is especially unacceptable when provided to a patient on a long term basis. The patients described herein had medical conditions which could have caused moderate to moderately severe pain and/or sleep disorders. Moderate to moderately severe pain may be defined as pain that interferes with a person's ability to lead a normal life and to perform the daily activities of living which they would normally perform. Chronic pain patients present a difficult challenge to the treating physician because pain is not usually a directly measurable disability. Some patients require greater or lesser amounts of pain medication to relieve a similar amount of pain than do other patients. It may be appropriate and ethical for a physician to prescribe a Schedule II controlled drug to relieve a patient's pain even though the patient may have developed a tolerance to or dependence on the substance. In each instance described herein, the Respondent prescribed the medication in question in a good faith effort to either relieve pain or induce sleep in the patients that she was treating. There was no evidence that any of the drugs prescribed to the patients discussed herein were ever resold on the streets or used by anyone other than the patients for whom they were prescribed. Doctors Handwerker and Frazier testified on behalf of the Petitioner. Neither Dr. Handwerker nor Dr. Frazier examined any of the fifteen patients described herein nor had they reviewed or seen any of the patient hospital records. The Respondent has privileges at the North Shore Hospital in Miami and enjoys an excellent reputation among her fellow physicians as a person of good character and as a dedicated provider of medical treatment. In addition, the Respondent is known among her colleagues as a physician that devotes a substantial portion of her time treating indigent patients. The Respondent cooperated fully with DPR Investigator Lichtenstein during the initial investigation of this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law and a consideration of the aggravating and mitigating factors delineated in Rule 21M- 20.01, F.A.C. it is, RECOMMENDED that a Final Order be entered assessing a $2,000 administrative fine. It is further recommended that Respondent's license to practice medicine in the State of Florida be placed on probation for a period of three (3) years under the following terms and conditions: Respondent shall make semi-annual appearances before the board. Respondent shall not use, dispense, administer, or prescribe Schedule II controlled substances, except in a hospital setting. Respondent shall successfully complete fifty (50) hours annually of Category I Continuing Medical Education. The primary subject matter of each course taken must involve Pharmacology, General Medicine and/or Medical Record- Keeping. DONE and ORDERED this 17th day of December, 1986 in Tallahassee, Leon County, Florida. W. MATTHEW STEVENSON 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 17th day of December, 1986. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-0995 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in Finding of Fact 1. Rejected as subordinate. Rejected as subordinate. Rejected as subordinate. Rejected as subordinate. Partially adopted in Findings of Fact 2, 3 and 8. Matters not contained therein are rejected as subordinate and/or unnecessary. Rejected as unnecessary. At the final hearing, the Petitioner was allowed to amend the Administrative Complaint to reflect that Mary Dukes received zero (0) doses of Percodan. Thus, any findings regarding the prescribing of Percodan to patient Mary Dukes is unnecessary. Adopted in Findings of Fact 11 and 13. Adopted in Findings of Fact 18 and 20. Rejected as subordinate. Adopted in Finding of Fact 26. Adopted in Finding of Fact 26. Adopted in Finding of Fact 34. Adopted in Findings of Fact 32 and 35. Adopted in Findings of Fact 38 and 40. Adopted in Findings of Fact 43 and 45. Adopted in Findings of Fact 47 and 49. Adopted in Findings of Fact 53 and 55. At the final hearing the Petitioner was allowed to amend the complaint to reflect that zero (0) doses of Percodan were prescribed to patient James Sams. The Petitioner stated that it was determined by Investigator Lichtenstein after viewing the signature of the Respondent and those upon the prescriptions acquired from the various pharmacies that all prescriptions for patient Sams were forgeries. There- fore, Findings of Fact involving prescriptions to patient James Sams are unnecessary. Partially adopted in Findings of Fact 58 and 60. Matters not contained therein are rejected as unnecessary. Adopted in Findings of Fact 63 and 65. Adopted in Findings of Fact 69 and 71. Adopted in Findings of Fact 74 and 76. Rejected as subordinate and unnecessary. Adopted in Finding of Fact 83. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Addressed in the Procedural Background section. Rejected as a recitation of testimony. Rejected as subordinate and/or unnecessary. Rejected as subordinate and/or unnecessary. Adopted in Finding of Fact 84. Partially adopted in Finding of Fact 7. Matters not contained therein are rejected as subordinate and/or a recitation of testimony. Rejected as a recitation of testimony. Partially adopted in Finding of Fact 83. Matters not contained therein are rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Adopted in Finding of Fact 85. Adopted in Finding of Fact 85. Rejected as a recitation of testimony. Adopted in Finding of Fact 86. Adopted in Findings of Fact 85 and 86. Rejected as a recitation of testimony. Addressed in Procedural Background section. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Adopted in Finding of Fact 82. Addressed in Procedural Background section. Partially adopted in Finding of Fact 86. Matters not contained therein are rejected as subordinate. Partially adopted in Finding of Fact 82. Matters not contained therein are rejected as subordinate. Rejected as a recitation of testimony. Adopted in Finding of Fact 86. Rejected as a recitation of testimony. Addressed in Procedural Background section. Rejected as a recitation of testimony. Addressed in Procedural Background section. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Adopted in Finding of Fact 86. Rejected as a recitation of testimony. Partially adopted in Findings of Fact 7 and 8. Matters not contained therein are rejected as a recitation of testimony. Rejected as a recitation of testimony. Partially adopted in Finding of Fact 9. Matters not contained therein are rejected as a recitation of testimony. Rejected as subordinate and unnecessary. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony and/or subordinate. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Partially adopted in Finding of Fact 37. Matters not contained therein are rejected as a recitation of testimony. Rejected as a recitation of testimony. Partially adopted in Finding of Fact 86. Matters not contained therein are rejected as a recitation of testimony. Rejected as a recitation of testimony. Partially adopted in Finding of Fact 86. Matters not contained therein are rejected as a recitation of testimony. Partially adopted in Finding of Fact 86. Matters not contained therein are rejected as a recitation of testimony. Adopted in Findings of Fact 68 and 86. Rejected as a recitation of testimony. Partially adopted in Findings of Fact 79 and 86. Matters not contained therein are rejected as a recitation of testimony. Partially adopted in Findings of Fact 85 and 86. Matters not contained therein are rejected as a recitation of testimony. Adopted in Finding of Fact 85. Adopted in Finding of Fact 86. Rulings on Proposed Findings of Fact Submitted by the Respondent (The Respondent's Findings of Fact were un-numbered. For the purpose of this Appendix, each paragraph in the Findings of Fact submitted by the Respondent was assigned a number in chronological order beginning with Paragraph Number 1.) Adopted in Finding of Fact 1. Addressed in Conclusions of Law Section. Addressed in Procedural Background section. Partially adopted in Findings of Fact 9 and 87. Matters not contained therein are rejected as not supported by the weight of the evidence. Rejected as argument end/or subordinate. Rejected as argument and/or subordinate. Adopted in substance in Findings of Fact 2, 3, 4, 5, 6, 8, 9 and 10. Rejected as unnecessary. Adopted in substance in Findings of Fact 11, 12, 13, 14, 15 and 16. Adopted in substance in Findings of Fact 18, 19, 20, 21, 22, 23 and 24. Adopted in Finding of Fact 19. Adopted in Finding of Fact 19. Adopted in substance in Findings of Fact 20, 21, 22, 23 and 24. Adopted in substance in Findings of Fact 26 and 27. Adopted in Finding of Fact 27. Adopted in substance in Findings of Fact 27, 28, 29 and 30. Adopted in substance in Findings of Fact 32 and 33. Adopted in substance in Findings of Fact 34, 35 and 36. Adopted in substance in Findings of Fact 38 and 39. Adopted in substance in Finding of Fact 39. Partially adopted in Findings of Fact 40 and 41. Matters not contained therein are rejected as misleading. Adopted in substance in Findings of Fact 43 and 44. Adopted in substance in Finding of Fact 44. Partially adopted in Finding of Fact 46. Matters not contained therein are rejected as misleading. Adopted in substance in Findings of Fact 47 and 48. Adopted in substance in Finding of Fact 48. Partially adopted in Findings of Fact 49, 51 and 52. Matters not contained therein are rejected as mis- leading. Adopted in substance in Findings of Fact 53 and 54. Partially adopted in Findings of Fact 55 and 56. Matters not contained therein are rejected as mis- leading. Rejected as unnecessary. Rejected as unnecessary. Adopted in substance in Findings of Fact 58 and 59. Adopted in substance in Finding of Fact 59. Adopted in substance in Findings of Fact 60 and 61. Adopted in substance in Findings of Fact 63 and 64. 36. Adopted in substance in Findings of Fact 65, 66 and 67. Adopted in substance in Findings of Fact 69 and 70. Adopted in substance in Findings of Fact 71, 72 and 73. Adopted in substance in Findings of Fact 74 and 75. Adopted in substance in Findings of Fact 76, 77 and 78. Rejected as a recitation of testimony and/or subordinate. Rejected as argument. Rejected as a recitation of testimony. Rejected as argument. Adopted in substance in Finding of Fact 88. Partially addressed in Procedural Background section. Matters not contained therein are rejected as recitation of testimony. Adopted in Finding of Fact 5. 48. Rejected as a recitation of testimony. Adopted in substance in Finding of Fact 10. Adopted in substance in Finding of Fact 16. Rejected as argument and/or a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as unnecessary. Rejected as a recitation of testimony. Partially adopted in Finding of Fact 88. Matters not contained therein are rejected as a recitation of testimony. Adopted in substance in Finding of Fact 89. Partially addressed in Procedural Background section. Matters not contained therein are rejected as subordinate. Rejected as a recitation of testimony. Partially adopted in Findings of Fact 6 and 10. Matters not contained therein are rejected as a recitation of testimony. Adopted in substance in Finding of Fact 5. Matters not contained therein are rejected as a recitation of testimony. Partially adopted in Finding of Fact 23. Matters not contained therein are rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as argument and/or a recitation of testimony. Partially adopted in Finding of Fact 82. Matters not contained therein are rejected as subordinate. Addressed in Procedural Background section. Rejected as subordinate. Partially adopted in Finding of Fact 87. Matters not contained therein are rejected as a recitation of testimony. Adopted in substance in Finding of Fact 8. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Partially addressed in Procedural Background section. Matters not contained therein are rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Partially addressed in Procedural Background section. Matters not contained therein are rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Rejected as a recitation of testimony. Partially adopted in Findings of Fact 87 and 88. Matters not contained therein are rejected as argument and/or a recitation of testimony. Rejected as argument. Partially adopted in Finding of Fact 81. Matters not contained therein are rejected as argument. Partially adopted in Finding of Fact 90. Matters not contained therein are rejected as subordinate. COPIES FURNISHED: David F. Bryant, Esquire 1107 E. Jackson Street Suite 104 Tampa, Florida 33602 Michael I. Schwartz, Esquire 119 North Monroe Street Tallahassee, Florida 32301 Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wings S. Benton, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
Findings Of Fact On December 13, 2018, Petitioner filed a Petition for Benefits Pursuant to Florida Statute Section 766.301 et seq. for benefits pursuant to sections 766.301-766.316, Florida Statutes, otherwise known as the Plan. The baby was born on April 1, 2018, at Winnie Palmer Hospital for Women and Babies (Hospital). The circumstances of the labor, delivery, and birth of the minor child are reflected in the medical records the Hospital submitted with the Petition. In the instant case, NICA has retained Donald C. Willis, M.D. as its medical expert specializing in maternal- fetal medicine. Upon examination of the pertinent medical records, Dr. Willis opined: There was no apparent obstetrical event that resulted in oxygen deprivation or mechanical trauma to the baby's brain or spinal cord during labor, delivery or the immediate post-delivery period. Dr. Willis’s medical report dated February 25, 2019, (which reviews additional medical records), are attached to his Affidavit, with the Affidavit being attached to the motion as Exhibit “1”. His Affidavit reflects his ultimate opinion that: The baby suffered cerebral infarction, which appear to have occurred after the period of stabilization during the immediate post delivery period. Medical records do not suggest the cerebral infarction occurred during labor, delivery or the immediate post delivery period. As such, it is my ultimate opinion that there was no apparent obstetrical event that resulted in oxygen deprivation or mechanical trauma to the baby's brain or spinal cord during labor, delivery or the immediate post-delivery period. In the instant case, NICA has retained Michael S. Duchowny, M.D. as its medical expert in pediatric neurology. Upon examination of the child and the pertinent medical records, Dr. Duchowny opined: I reviewed medical records which document Elias's birth at 37 weeks' gestation at Winnie Palmer Hospital. The pregnancy was complicated by pre-eclampsia, asthma, GERD and obesity. The mother had a fever to 101 degrees at time of delivery and was diagnosed with chorioamnionitis. Elias was born vaginally with a birth weight of 5 pounds 10 ounces (2547 grams). Apgar scores were 8 and 9 at 1 and 5 minutes. Elias was admitted to the NICU and found to have a blood glucose of 35. His NICU stay was further complicated by apnea and desaturation that raised concerns for seizures; he was started on Keppra, Elias was never intubated or mechanically ventilated and was maintained on room air. An MRI scan of the brain on DOL #2 revealed multiple ischemic infarcts involving the left lateral temporal lobe, left posterior thalamus and left hippocampal formation. There was adjacent extra-axial hemorrhage over the left temporal lobe. The findings were felt to most likely represent areas of venous infarction. Dr. Duchowny’s medical report is attached to his Affidavit, with the Affidavit being attached to the motion as Exhibit “2”. His Report reflects his ultimate opinion that: A consideration of the findings from today's evaluation and record review lead me to recommend that Elias not be considered for compensation within the NICA program. He has normal motor functions and his stroke was likely acquired prenatally. There is no evidence of either mechanical injury or oxygen deprivation in the course of labor, delivery or the immediate post-delivery period. The Affidavits of Dr. Willis and Dr. Duchowny are the only evidence of record relating to the issue of whether the subject claim is compensable as defined by the statute. As noted, Petitioner did not file a response to the motion, nor submit countervailing affidavits. The Petition, along with the Affidavits attached to the motion, establish that there are no genuine issues of material fact regarding the compensability of this claim.
Other Judicial Opinions Review of a final order of an administrative law judge shall be by appeal to the District Court of Appeal pursuant to section 766.311(1), Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing the original notice of administrative appeal with the agency clerk of the Division of Administrative Hearings within 30 days of rendition of the order to be reviewed, and a copy, accompanied by filing fees prescribed by law, with the clerk of the appropriate District Court of Appeal. See § 766.311(1), Fla. Stat., and Fla. Birth-Related Neurological Injury Comp. Ass'n v. Carreras, 598 So. 2d 299 (Fla. 1st DCA 1992).
The Issue The issue in this case is whether Florida Administrative Code Rule 64B-3.004(2) constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact In 1971, Personal Injury Protection (PIP) coverage was required to be included in automobile insurance policies and was required to be obtained by anyone operating a motor vehicle in Florida. In general, PIP coverage provides payment for medically necessary treatment, lost wages and funeral expenses incurred by persons involved in motor vehicle accidents. The reasons PIP insurance coverage was made mandatory were to provide for the speedy payment of medical expenses, lost wages and burial expenses that an individual might incur as a result of being injured in a motor vehicle accident and to reduce the amount of litigation involved in recovering such expenses. Responsibility for such speedy payment rested with the various insurance companies involved in writing motor vehicle insurance. Until 1980, the PIP system operated in a reasonably cost-efficient manner. However, fraud and paying for medically unnecessary medical tests or treatment were problems under the PIP system. In the past, at the option of a given insurance company, such unnecessary testing or treatment resulted in payment, denial of the claim, and perhaps litigation for the denied claim. By the mid-1980s, for a variety of reasons, the PIP system became less cost efficient. The average Florida PIP claim rose by 33 percent and the amount of premium per insured vehicle needed to cover PIP claims rose by 35 percent. Such increases led to higher premiums for the driving public, as well as larger numbers of motorists not carrying PIP coverage, estimated to be around 22 percent of Florida drivers. Indeed since 1999, State Farm Insurance Company, one of the largest insurers of motor vehicles, has experienced an average $100,000,000.00 loss per year. In 2001, the Legislature enacted a fee schedule for certain medical services and tests, including a fee for SEMG. The legislature did not limit the number of times a particular service or test could be used. The 2001 legislation did not solve the problems of continued claims and payment for tests or services that were not medically necessary or overutilized. The 2001 legislation also did not solve the problem of the cost ineffectiveness of companies litigating the issue of whether a particular test was medically necessary or overused. Consequently, during the 2003 legislative session, the Florida Legislature enacted Section 627.736(5)(b)6., Florida Statutes, which provides: The Department of Health, in consultation with the appropriate professional licensing boards, shall adopt, by rule, a list of diagnostic tests deemed not to be medically necessary for use in the treatment of persons sustaining bodily injury covered by personal injury protection benefits under this section. The initial list shall be adopted by January 1, 2004, and shall be revised from time to time as determined by the Department of Health, in consultation with the respective professional licensing boards. Inclusion of a test on the list of invalid diagnostic tests shall be based on lack of demonstrated medical value and a level of general acceptance by the relevant provider community and shall not be dependent for results entirely upon subjective patient response. Notwithstanding its inclusion on a fee schedule in this subsection, an insurer or insured is not required to pay any charges or reimburse claims for any invalid diagnostic test as determined by the Department of Health. The statute was intended to relieve an insurance company of the burden of paying for or litigating the medical necessity of diagnostic tests that the Department listed in a to-be- developed rule. There was no evidence suggesting that the Legislature intended the words used in the statute to have any meaning other than their ordinary meanings. In order to implement the statute, the Department commenced rulemaking pursuant to the legislative directive in Section 727.736(5)(b)6. Florida Statutes. As a starting point, the Department asked the insurance industry to provide a list of diagnostic tests that the insurance industry believed should be in the rule. The list contained four tests--Spinal Ultrasound, Nerve Conduction Velocity (NCV) Studies, Somatosensory Evoked Potential, and Dermatomal Evoked Potential. SEMG was not included on the insurance industry’s list. SEMG is a method of measuring the electrical output of muscles through the placement of electrical sensors on the skin. In general, a muscle at rest has a lower amount of electrical activity than a muscle that is being worked or contracted. Similarly, muscle spasms have more electrical activity associated with them than a muscle at rest. On the other hand, muscle contracture, which is the condition of a muscle at rest that has been permanently shortened and generally hardened through some process, has a different level of electrical activity associated with it than with muscle spasms. There are two types of SEMG, used for different purposes. Neither type of SEMG relies on subjective patient input. Static EMG uses a hand-held device with probes as an assessment (or muscle scanning) procedure to take a quick measure of muscle tension. Although in most cases hand palpation of a muscle gives a practitioner all the necessary information needed to diagnose a patient, SEMG can augment hand palpation when palpation is not determinative and help differentiate contraction from contracture. SEMG, also can assist in determining the need for the more comprehensive application of dynamic SEMG and generates a graphic, recorded reading of muscle tension. Dynamic SEMG is used to document and verify injury, to determine if the patient is injured, and, in concert with other diagnostic procedures, establish the level or the extent of injury. Once a treatment plan is developed and implemented, SEMG testing is used to monitor a patient's response to treatment. Dynamic SEMG provides an objective tool to evaluate the function of paraspinal muscles of injured persons, including those involved in motor vehicle accidents. On July 25, 2003, the Department published a notice for a workshop for proposed Rule 64B-3.004 in volume 29, no. 30 of the Florida Administrative Weekly. On August 29, 2003, the Department re-noticed the workshop in Volume 9, no. 35 of the Florida Administrative Weekly. The workshop was held on September 9, 2003. The draft rule presented at the workshop listed the four tests submitted by the insurance industry. The draft rule did not include SEMG. However, based on comments made during the workshop, some of which came from a chiropractic representative of the Florida Chiropractic Association, SEMG was included in the next iteration of the draft Rule. The next public iteration of the rule appeared in a Notice of Proposed Rule published on Friday, November 14, 2003, in Volume 29, No. 46 of the Florida Administrative Weekly. SEMG appeared for the first time in the November 14, 2003 notice. The proposed rule was, according to the Notice, based “[u]pon review of the testimony provided at the workshop, input received from the Boards, written opinions by members of the health care and insurance communities, and literature in support thereof.” The Notice also announced a public hearing for 9:00 a.m. on Tuesday, November 18, 2003. Additionally, the record for submitting information regarding the proposed rule was held open for 21 days after the November 14, 2003, publication date to give interested persons an opportunity to submit information. During the time the record was held open, the Department received some evidence and studies indicating that SEMG was not useful, or at a minimum, unnecessarily redundant in the diagnosis of the type of injuries often incurred in an automobile accident. However, the Department also received some evidence and studies that SEMG was useful in the treatment of such injuries, particularly when bio- feedback is being employed in treatment. Oddly, on December 2, 2003, prior to the official closure of the record, the final rule was transmitted to the Secretary of the Department for signature and approval for filing with the Secretary of State. In due course, the rule was filed with the Secretary of State and became effective on January 7, 2004. Rule 64B-3.004, as adopted by the Department states, in relevant part, as follows: 64B-3.004 Diagnostic Testing. For the purposes of Section 627.736(5)(b)6., F.S. (2003), the Department of Health, in consultation with the appropriate licensing boards, hereby adopts the following list of diagnostic tests based on their demonstrated medical value and level of general acceptance by the provider community: * * * (2) Surface EMG is deemed not to be medically necessary for use in the diagnosis of persons sustaining bodily injury covered by personal injury protection benefits. * * * Specific Authority 627.736(5) FS. Law Implemented 627.736(5) FS. History - New 1-7- 04. The rule only applies to SEMG when used for diagnostic purposes. The rule does not apply to SEMG when used in the treatment of PIP-covered automobile accident victims. Petitioner, Richard Merritt, is a Doctor of Chiropractic, licensed in Florida, Texas, and Alabama. Prior to the adoption of Rule 64B-3.004, Dr. Merritt billed $130,000 to $160,000 per year for SEMG tests. Dr. Merritt has used SEMG in his practice since the 1980s. Thirty-five percent of Dr. Merritt’s patients have been involved in motor-vehicle accidents. Curiously, Dr. Merritt performs SEMG on all of those patients for which PIP insurance generally pays. Again, curiously, only ten percent of his remaining patients have SEMG that may or may not be covered by other insurance. However, the evidence was not clear as to the differences between patients sustaining injuries in motor-vehicle accidents and other non-accident patients. Dr. Merritt suggested that motor-vehicle accident patients generally have more complicated or layered medical histories than patients who have not been involved in motor-vehicle accidents. No evidence was presented on this alleged difference which seems to be a very dubious distinction between patients. The Florida Insurance Council, Inc.; the Property Casualty Insurers Association of America; The American Insurance Association; The National Association of Mutual Insurance Companies; The Florida Automobile Joint Underwriting Association; State Farm Mutual Automobile Insurance Company; Allstate Insurance Company; Government Employees Insurance Company; The Florida Farm Bureau Insurance Companies; Liberty Mutual Insurance Group; First Floridian Auto and Home Insurance Company; and United Service Automobile Association have standing to intervene in this proceeding. Florida Insurance Council, Property and Casualty Insurance Association of America, and the American Insurance Association, all have a substantial number of members affected by the rule. These associations exist, in part, to protect their member's interests in legislative and regulatory matters involving insurance. The subject matter of this rule is within the associations' scope of interest and activity and they are often involved in these types of rule challenges. Intervenor, Florida Automobile Joint Underwriters Association (JUA), is the automobile residual market in Florida. The JUA makes PIP available to high-risk customers and operates as a standard insurance company under its governing statutes and rules. All the individual companies that sought to intervene in this proceeding pay claims under PIP provisions. Both the JUA and the individual companies are directly affected by the rule. The rule affects rates and premiums which are calculated based in part on loss experience. Loss costs are affected by the rule because the rule regulates what must be paid under PIP coverage. Additionally, the rule affects the profits and losses of individual companies. The issue in this case is limited to a consideration of whether the inclusion of SEMG on the “list of diagnostic tests deemed not to be medically necessary for use in the treatment of persons sustaining bodily injury covered by personal injury protection benefits” is an invalid exercise of delegated legislative authority. Accordingly, the place to start is with the language of the statute being implemented. § 627.736(5)(b)6., Fla. Stat. As indicated earlier, there was no evidence that the Legislature intended the words used in the statute to have any meanings other than their ordinary meanings. Thus, by reading the statute, it is clear that the tests to be included in any proposed rule must be “diagnostic tests.” It is undisputed that “diagnosis” and “treatment” in the medical area are different procedures and refer to different aspects of providing medical care to a patient. When used in a medical context, the term “diagnosis” means the art of distinguishing one disease from another or the determination of the nature of or cause of disease or injury, whereas the term “treatment” means the management and care of a patient for the purpose of combating disease or disorder. See Dortland’s Illustrated Medical Dictionary, 27th Ed. (1988) and Stedman’s Medical Dictionary, 26th Ed. (1995). In short, there is a diagnosis phase of medical care wherein a practitioner uses various tests, procedures and historical information to determine the nature, i.e. what the patient’s condition is and/or how severe the condition is, and the cause, i.e. automobile accident or fall, of a given disease or condition. Distinct from the diagnostic phase there is a treatment phase of medical care wherein a practitioner, through tests, therapies, procedures and medicines manages or cares for a patient’s condition. However, in their ordinary usage, the terms “diagnosis” and “treatment” can overlap. In ordinary usage, the term “diagnosis” does not differ significantly from the medical term and means the art or act of identifying a disease from its signs and symptoms. Webster’s New Collegiate Dictionary (1984). The term “treatment” means “the act or manner or an instance of treating someone or something: HANDLING, USAGE.” Id. The term “treat” means to “deal with.” Id. In its ordinary sense, “treatment” has a broader meaning than it does in its medical sense and can include diagnosis. Thus, in this case, the tests referred to in the statute are diagnostic tests used in handling or dealing with a person who has been physically hurt in a motor vehicle accident. Also, by giving the term “treatment” its ordinary meaning the Department has the authority to differentiate between the appropriateness of a diagnostic test used in the medical diagnostic phase and the same test used in the medical treatment phase. In this case, SEMG, especially static SEMG, is used as a test in both the medical diagnosis and treatment phases in dealing with persons injured in a motor vehicle accident. Therefore, it is a diagnostic test that may be considered under the other criteria of the statute. For a test to be included in the rule it must be medically unnecessary, based on a lack of demonstrated medical value and a lack of general acceptance by the relevant provider community and not be dependant for results entirely from subjective patient response. As can be seen, the statute does not deal with the overuse of a given test, but only defines medical necessity by the three criteria listed above. In reality, some types of test overuse may only be determined on a case-by-case basis, since whether a generally or occasionally, medically beneficial test is useful or redundant at a particular time in treatment or diagnosis depends greatly on the reasons the test is being employed. Thus, if a test has a degree of medical value, it cannot be on the list; if a test has a level of general acceptance by the relevant provider community which includes the Doctors of Chiropractic, it cannot be on the list; and if a test is not dependent for results entirely on subjective patient response, it cannot be on the list. The medical value of any test is not related in any way to the manner in which payment for that procedure is made. In that regard, the medical validity of a procedure does not vary as to whether the patient is covered by Workers' Compensation, Medicare, private insurance, or PIP. PIP patients typically have injuries to the connecting soft tissues of their spine as well as injuries to organs and broken bones. Muscles, ligaments, and tendons can be stretched or injured, which can lead to a breakdown in spinal-joint motion or a spinal-joint misalignment. Spinal-joint misalignment may cause interference in the patient's nervous system. Soft tissue and misalignment injuries are routinely the subject of chiropractic care. SEMG is effective in recording changes in the electrical activity of muscles associated with spinal injuries known as vertebral subluxations. Vertebral subluxations are commonly associated with automobile accidents, and are diagnosed and treated by chiropractic physicians. In spinal injuries, there is a depolarization that occurs at the cellular level. Electrical activity is generated at the cellular level and runs down the muscle fiber. SEMG measures the surface manifestation of the amount of electrical activity generated and the depolarizations in the area. The purpose is to measure muscle tension. SEMG is objective and quantitative. It eliminates subjective impressions or input and provides an objective and unbiased assessment of the electrical activity of the patient's paraspinal muscles. It allows a medical professional to distinguish objectively between observed muscle tension that is electrically active, which is associated with spasm, from observed muscle tension that is not electrically active, which is associated with contracture. It is debatable whether SEMG provides no more useful information to a practitioner than information gleaned by hand palpation of the injured area. The problem is that hand palpation can sometimes be inconclusive, especially in regard to determining if a muscle is hard from spasm or contracture. The question is one of over or redundant use of a test. Again that question is not part of the criteria for inclusion of a test in the rule. The criteria only include whether a test can be used by the practitioner to make a valid diagnosis or conclusion. In regard to SEMG, published documentary evidence demonstrates that spasm and contracture share a similar physical manifestation, i.e. the muscle is hard to the touch, and may not be distinguished through palpation and that, in the occasional instances where had palpation is inconclusive, SEMG can differentiate the conditions, and “provide[] an important element of diagnostic information.” Specific to automobile-related injuries, when hand palpation is inconclusive, SEMG has medical value to chiropractic physicians in that it allows the treating chiropractic physician to determine if a patient has an injury or does not have an injury, to quantify the extent of the injury, to monitor the patient's response to treatment, and to assess the point of maximum clinical improvement or maximum therapeutic benefit. While its diagnostic usefulness may be limited to certain situations when hand palpation is inconclusive, the evidence demonstrated that SEMG had some utility in the diagnostic phase of medical care. Therefore, SEMG should not be included in the proposed rule. Dynamic SEMG is also utilized on motor vehicle accident victims. Its primary use is to provide the level of documentation for services rendered a person involved in a motor- vehicle accident required to demonstrate injury, permanency of injury, the need for treatment, and the response to treatment before payment will be made under a PIP plan. Overall, SEMG has advanced as a clinical tool from its earliest, more experimental uses in which no computer support was available, through the time in which the best technology available was the Commodore 64 (or earlier) computer, to today, when advances in technology and understanding have resulted in the elimination of problems of electrical interference, bandwidth filtering and electrode placement, and have resulted in a higher threshold of sensitivity. The evidence in this case demonstrates that SEMG has medical value for use in the treatment of persons sustaining bodily injury covered by personal injury protection benefits. The Department admitted and the evidence showed that some surface EMG techniques may be useful in the treatment of persons sustaining bodily injury in motor vehicle accidents in appropriate circumstances. Based on the admissions of the Department, it is clear that SEMG has a degree of demonstrated medical value. Therefore, its inclusion on the list of medically unnecessary tests is arbitrary and capricious; has exceeded the Department’s grant of rulemaking authority; and has enlarged, modified, or contravened the specific provisions of law implemented. The Department also admitted and the evidence showed that SEMG is not dependent for results entirely upon subjective patient response. Therefore, under the terms of the statute, the inclusion of SEMG on the list of medically unnecessary tests has exceeded the Department’s grant of rulemaking authority and has enlarged, modified, or contravened the specific provisions of law implemented. The evidence also demonstrated that SEMG is generally accepted in the relevant provider community. In 1996, the two primary organizations that represent chiropractic physicians in Florida, the Florida Chiropractic Association and the Florida Chiropractic Society, were asked to develop a set of guidelines to apply to the chiropractic profession. Their work resulted in a report and the publication of the Chiropractic Practice Guidelines and Parameters for the State of Florida (CPG). The CPG was unanimously accepted and endorsed by the Florida Board of Chiropractic on August 22, 1996. The CPG was copyrighted and published by the Florida Chiropractic Association, Inc. and the Florida Chiropractic Society, Inc. in 1997. The CPG is a set of rules or guidelines that a practicing chiropractic physician can follow regarding the treatment of chiropractic problems. The CPG constitutes the consensus agreement of the chiropractic profession on many of the procedures that a chiropractor might provide. The CPG references SEMG both in comparison with needle EMG and as to its own merits. As a comparative matter, the CPG provides that “needle techniques are appropriate for the evaluation of specific muscles, while surface electrodes are appropriate for kinesiological studies of the “global” function of groups of muscles.” In terms of test-retest reliability and longitudinal muscle studies, SEMG was found to be superior to needle EMG. The CPG also states that SEMG provides an objective and quantifiable measure of muscular activity in areas of vertebral subluxation. Although the section discussing SEMG concludes with language indicating a degree of qualification, the CMG rates SEMG as “established.” An “established” rating means that SEMG is accepted as appropriate by the practicing chiropractic community for the given indication in the specified patient population. The rating of “established” was made with a Consensus Level of 1, which is the highest level of consensus available. In addition, the rating was supported by various categories of evidence used to analyze a given test, including expert opinion, clinical experience or effectiveness studies (Evidence E), refereed literature or published monographs, legal decisions and/or authority (Evidence L) and available controlled studies (Evidence C). The rating of “established” also requires one or more controlled trials. Therefore, read as a whole, the CMG demonstrates the medical value of SEMG as a clinical and diagnostic tool for evaluating paraspinal muscle activity, quantifying palpation findings, performing longitudinal studies, and detecting muscle spasm. Dr. Jenkins’ testimony regarding the lack of reliability of the CPG and attempt to disown the CPG as an authoritative statement by the Board of Chiropractors cannot be given weight since he was on neither the Florida Committee for Adoption of Guidelines nor the Board of Chiropractic when the CPG was accepted and endorsed. Additionally, during his tenure on the Board stretching back to 1997, the Board has not rescinded or amended the CPG. Finally, the evidence did not demonstrate that the CPG was superceded by the 1999 Universe of Florida Patients with Neck Pain or Injury Medical Practice Guidelines. These Universe Guidelines appear to relate only to medial doctors and not to Chiropractic Physicians. The Guidelines state they are not applicable to Chiropractic Physicians licensed under Chapter 460, Florida Statutes. The fact that the CPG describes SEMG as “[a]ccepted as appropriate by the practicing chiropractic community” provides a strong demonstration of the medical value of the test, and strong evidence of the high level of general acceptance of the test by the relevant provider community. Additionally, the American Medical Association Current Procedural Terminology (CPT) 2004 Manual is a proprietary system of the AMA for reporting medical services and procedures. CPT Codes are the uniform, established system for reporting medical services for reimbursement under government and private insurance programs. CPT coding is mandatory to describe the services a physician renders when submitting that service for payment to an automobile insurance carrier. In order to be assigned a five-digit CPT Code, the procedure must be “consistent with contemporary medical practice and be . . . performed by many practitioners in clinical practice in multiple locations. Code assignment is performed by a CPT Editorial Panel, consisting of 17 physician members, and a larger CPT Advisory Committee of medical and allied health professionals. Among the objectives of the CPT Advisory Committee is to “provide documentation to staff and the CPT Editorial Board regarding the medical appropriateness of various medical and surgical procedures. . . .” (emphasis supplied) Among the considerations for Code assignment are the requirements “that the service/procedure is a distinct service performed by many physicians/practitioners across the United States,” and “that the clinical efficacy of the service/procedure is well established and documented in peer review literature.” Dynamic SEMG has been assigned a five-digit CPT Code 96002. Similarly, The review and interpretation of dynamic SEMG has been assigned a five-digit CPT Code 96004. The fact that SEMG has been found to meet the requirements of the AMA for assignment of five-digit CPT Codes provides evidence of the medical value of the test, and strong evidence of the high level of general acceptance of the test by the relevant provider community. Finally, the rulemaking record for Rule 64B-3.004 contains information regarding SEMG. The literature submitted as part of the rulemaking record reveals, by a preponderance of competent, substantial evidence, that SEMG does not lack demonstrated medical value, and that it has a level of general acceptance by the relevant provider community. The primary documents submitted in the course of rulemaking included the 1993 Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy Conference), the National Guideline Clearinghouse summary of the 1998 Council on Chiropractic Practice Guideline entitled Vertebral subluxation in chiropractic practice, a pair of AAEM Literature Reviews, entitled The Use of Surface EMG in the Diagnosis and Treatment of Nerve and Muscle Disorders and Dynamic Electromyography in Gait and Motion Analysis; the American Academy of Neurology study on Clinical utility of surface EMG; a report from Connie Coleman; two submissions from Dr. Jerome True, and a 2003 literature review, Surface EMG in Chronic Paraspinal Pain. Neither the Mercy Conference Guidelines nor the AAEM Surface EMG Literature Reviews contained any information or analysis more recent than 1993. Those documents did not reflect the current state of technology or understanding of SEMG, and could not form the sole bases for a rule based on SEMG’s demonstrated medical value and level of general acceptance in 2003. The National Guideline Clearinghouse summary of the 1998 Council on Chiropractic Practice Guidelines, and the American Academy of Neurology study on Clinical Utility of Surface EMG both provide support of the medical value for SEMG. As indicated, the 1998 Council on Chiropractic Practice Guidelines, which was subject to external peer review, and which even critics of SEMG recognize as being authoritative, determined that SEMG earned a rating of “established” “for recording changes in the electrical activity of muscles associated with vertebral subluxations” based on expert opinion, literature support, and controlled studies. The American Academy of Neurology study drew three conclusions, one of which was that Surface EMG “is an acceptable tool for kinesiologic (movement) analysis of movement disorders because it is a method for recording and quantifying clinically important muscle-related activity with the least interference on the clinical picture,” and confirmed its usefulness for several maladies, some of which result from automobile accidents. A report from Connie Coleman concluded that SEMG should not be in the rule, based on the American Academy of Neurology study, the AAEM Surface EMG Technology Literature Review, and a position paper authored by Aetna Insurance. Ms. Coleman’s report cannot be given any weight since she cited only the negative recommendations of the American Academy of Neurology study regarding SEMG, but omitted the third, positive recommendation from the study referenced above. Furthermore, as support for her recommendation to include spinal ultrasound in the rule, Ms. Coleman relied on the National Guidelines Clearinghouse document referenced above, which she stated was: a comprehensive database of evidence-based clinical practice guidelines and related documents produced by the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services, in partnership with the American Medical Association (AMA) and the American Association of Health Plans (AAHP). However, Ms. Coleman failed to note that the same National Guidelines Clearinghouse document gave SEMG a rating of established “for recording changes in the electrical activity of muscles associated with vertebral subluxations.” Of the two reports submitted by Dr. True, only one recommended that SEMG should have been on the list, with that recommendation based on a single journal article. Dr. True’s other submission mentioned SEMG, but made no specific recommendation regarding the test. However, Dr. True’s second submission did note that allegations of over utilization and abuse have “nothing to do with determining whether a test is medically valid.” Dr. True also relied on the Chiropractic Practice Guidelines and Parameters for the State of Florida, which recognize the medical validity of SEMG. Finally, David Marcarian, the developer and manufacturer of SEMG equipment, submitted several documents, including a literature review of journal articles ranging in dates from 1982 to 2002. The review discussed each of the journal articles, and concluded that “SEMG is a useful diagnostic tool in the evaluation of spine pain patients, and suggests that it be done routinely in cases where there is a need for disability and impairment determination.” The evidence did not demonstrate that Mr. Marcarian’s materials should be given less weight than older material containing dated information. The evidence submitted in this proceeding demonstrates a definite trend in both the understanding of the medical validity of SEMG and its acceptance by the chiropractic and medical community. Each of the 21 journal articles comprising Petitioner’s Exhibit 8, ranging in dates from 1988 to 2004, used SEMG as a tool to provide an objective measurement of muscle activity. Although many of the articles were focused on the muscular conditions leading to such conditions as low back pain, fibromyalgia, and whiplash disorders, rather than the clinical efficacy of SEMG itself, the fact that SEMG was so widely used as a measure of muscle activity is evidence of its medical value. Additionally, several of the articles focused on SEMG as a diagnostic tool in and of itself. Going back as far as 1988, researchers reported that “clear and consistent surface paraspinal EMG patterns can be discerned between differing groups of lower back pain patients and non-pain controls if the methodological limitations inherent in previous studies are corrected,” and concluded that “[t]he findings of the present study clearly point to the utility of differential diagnosis in lower back pain surface EMG studies,” and that “[r]esults strongly indicate that when careful attention is given to both diagnosis and position, surface EMG recordings can differentiate among the various types of lower back pain, as well as between those with and without lower back pain.” Electromyographic recordings of 5 types of low back pain subjects and non-pain controls in different positions, Arena, et al., "Pain", 37 (1989) pp. 63, 64. Through the early 1990s, researchers began noting the effect that technological advances were having on the medical efficacy of Surface EMG. Researchers during that period were recognizing that advances in surface electromyography (EMG) have prompted a renewed interest in examining the fatigue properties of back muscles. See Fatigue, recovery and low back pain in varsity rowers, Roy, et al., Medicine and Science in Sports and Exercise, vol. 22, no. 4, p. 463. As a result of those advances, those researchers concluded that “the EMG technique is able to correctly identify persons with LBP from two very different populations” [Id. at p. 467] and that “the results of this study have verified the usefulness of a surface EMG measurement technique to identify changes in back muscles that are characteristic of LBP in rowers . . . The technique may be useful to athletic trainers and other health professionals for evaluating the muscular component of LBP in their patients.” (Id. at 468). During that same period, researchers were beginning to conclude that, though not without limitations, "[e]lectromyo- graphic spectral analysis was shown again to be a highly sensitive and highly specific diagnostic test.” Comparison of Spinal Mobility and Isometric Trunk Extensor Forces with Electromyographic Spectral Analysis in Identifying Low Back Pain, Klein, et al., Physical Therapy, vol. 71, no. 6, p. 41 (1991). Other groups noted that contemporaneous research studies “have also shown the reliability of dynamic EMG measurements of paraspinal low back muscles,” and concluded that “[w]e believe that [EMG] is an invaluable aid in detecting and objectifying disturbed function in paraspinal muscles in back pain patients and in general disability. This agrees with recent research which indicates that kinetic EMG patterns (in contrast to static levels) may best show the complex biomechanical events in the lumbar region.” Electric Behavior of Low Back Muscles During Lumbar Pelvic Rhythm in Low Back Pain Patients and Healthy Controls, Sihvonen, et al., Arch. Phys. Med. Rehabil., vol. 72, pp. 1080, 1086 (1991). By the mid to late 1990s, the continuing research, though still recognizing that there were things left to learn, was becoming more conclusive as to the value of SEMG. In 1997, researchers funded by the Department of Veterans’ Affairs stated that “[w]e predict that in the future the concept of surface EMG- based imbalance or load sharing parameters may provide the clinician with important person-specific information already in the acute stage of the injury, to help prevent the development of a chronic disability. Surface EMG provides us with a powerful, noninvasive tool to investigate the status and function of muscles.” Development of new protocols and analysis procedures for the assessment of LBP by surface EMG techniques, Oddsson, et al., Journal of Rehabilitation Research and Development, vol. 34, no. 4, p. 425 (1997). During that same year, researchers in California studying muscular electrical signals, noted the technological advances that were serving to make SEMG more effective. In their study, they found that “[s]uccessful myoelectric recording with surface electrodes during dynamic exercise of the low back is relatively recent. This is largely due to the recent development of small high-competence preamplifiers located close to the muscle which reduces the electronic artifact during dynamic activity to allow analysis of the myoelectric signal.” Relationships Between Myoelectric Activity, Strength, and MRI of Lumbar Extensor Muscles in Back Pain Patients and Normal Subjects, Mooney, et al., Journal of Spinal Disorders, vol. 10, no. 4, p. 354 (1997). By the early 2000s, SEMG was becoming established as a reliable and valuable tool in the assessment and diagnosis of automobile related injury. In a peer-reviewed study regarding whiplash-associated disorders (WAD), the authors concluded that: Patients with whiplash associated disorder Grade II can be distinguished from healthy control subjects according to the presence of cervical muscle dysfunction, as assessed by surface electromyography of the upper trapezius muscles. Particulary the decreased ability to relax the trapezius muscles seems to be a promising feature to identify patients with whiplash associated disorder Grade II. Assessment of the muscle (dys)function by surface electromyography offers a refinement of the whiplash associated disorder classification and provides an indication to a suitable therapeutic approach. Cervical Muscle Dysfunction in the chronic Whiplash Associated Disorder Grade II (WAD II), Nederhand, et al., Spine, vol. 25 (15), p. 8 of 10 (2000). The authors noted that “the use of palpation to assess either muscle point tenderness or muscle spasm is questionable because manually tested musculoskeletal signs have shown poor interexaminer reliability, and very little is known about its diagnostic validity.” Id. The authors found that “SEMG as a measure of the inability to relax the upper trapezius muscles may be useful in diagnostic testing. In the literature this feature was shown to be related to cervical pain and muscle fatigue and therefore supports the clinical importance of this study’s findings.” Id. at p. 8 of 10. Also in 2000, researchers, while still recognizing the lack of absolute precision with all manner of electro-diagnostic testing (including X-rays, MRIs, CT scans, myelograms), stated that “surface electromyography (SEMG) is a non-invasive method of analysis of the degree of muscular activity and function.” Chronic Low Back Pain Assessment Using Surface Electromyography, Ambroz et al., JOEM, vol. 42, no. 6, p. 661 (2000). In recognition of the advances in technology, the authors noted that “[r]ecent technological advancement has overcome the previous limitations of data acquisition and processing.” Id. at 661. That study, while noting the need for accounting for physical conditions including body fat, and recognizing the advantages of further testing and study, made the following findings: More recent investigations have found a significant relationship between pain and SEMG-measured muscle activity in the upper and lower back and have suggested that SEMG can be a valid tool for objectively assessing LBP. Also, although Biederman questioned the reliability of SEMG reading in biofeedback research, two subsequent studies addressing the validity of this technique reported good reliability for the static and dynamic SEMG activities in the assessment of CLBP. By using a rigorous matching protocol that included BMI [body mass index], our study demonstrated a statistically significant difference between CLBP patients and pain free controls. Thus, the results of this study support the previous investigations suggesting that SEMG is a useful diagnostic tool in the assessment of CLBP. Furthermore, in this study the use of one of the latest and more technologically advanced semi devices available has contributed to a more reliable collection and processing of this data, giving more strength to this analysis. Finally, in 2004, the evidence regarding the medical value of SEMG demonstrates that it has achieved a full level of general acceptance. In a study released in June 2004, the authors concluded that “[s]urface electromyography has been shown to be useful in the evaluation of spine pain in much the same way that EKGs have become indispensable for chest pain evaluation. SEMG testing is easy to do, inexpensive, has no morbidity, and provides important information for the pain practitioner.” Objective Documentation of Spine Pain, Ambroz, et al., Practical Pain Management, May/June 2004, p. 36 Thus, it is clear that the evidence in this case demonstrates that there was no “lack” of demonstrated medical value to SEMG, but, that SEMG has a level of general acceptance for use in the treatment of patients by the relevant provider community. The real dispute in this case is how often SEMG is used in the relevant provider community. Therefore, the inclusion of SEMG in Florida Administrative Code Rule 64B-3.004 exceeds the Department’s grant of rulemaking authority, enlarges, modifies, or contravenes the specific provisions of Section 627.736(5)(b)6., Florida Statutes, and is arbitrary and capricious.
Findings Of Fact Stephanie was born at St. Joseph’s on June 7, 2014. She was a child born of single gestation. NICA retained Donald C. Willis, M.D., as a medical expert specializing in maternal-fetal medicine. NICA has submitted his expert report dated August 17, 2019, and affidavit dated August 23, 2019, as Exhibit 1 in support of its Motion. According to Dr. Willis’s expert report, hypertension was noted at Ms. Garriga’s office visit at 36 weeks, but at that time, there was no indication of fetal distress. Labor was induced at 37 weeks for gestational hypertension. Fetal heart rate tracings were reported to be category 1, which indicates no fetal distress. Dr. Willis’s report states that delivery was by spontaneous vaginal birth, with a birth weight of 2,430 grams. Stephanie was depressed at birth, and although she had a “good heart rate,” there was no respiratory effort. Evaluation in the NICU showed overall decreased activity and poor muscle tone. Her chest x-ray revealed streaky infiltrates, consistent with retained lung fluid. Stephanie’s newborn hospital stay was complicated by poor feeding due to a very weak gag reflex, and g-tube feedings were required, with eventual fundoplication performed. Dr. Willis’s report also indicates that an evaluation was performed because of her poor muscle tone, and the neurological evaluation did not identify an etiology for the issue. Other tests were also normal. Dr. Willis’s ultimate opinion is that there was no apparent obstetrical event that resulted in oxygen deprivation or mechanical trauma to the brain or spinal cord during labor, delivery, or the immediate postdelivery period. He also noted that Stephanie’s birth- weight was below the threshold for eligibility for NICA compensation. Dr. Willis’s opinion is credited. Stephanie was also examined by Michael S. Duchowny, M.D., a pediatric neurologist. Dr. Duchowny’s August 14, 2019, expert report and August 26, 2019, affidavit were submitted as Exhibit 2 in support of NICA’s Motion. Dr. Duchowny’s IME occurred when Stephanie was five years old. Upon examination, she could not swallow, sit alone, crawl, or walk. Cognitively, Stephanie speaks well and has achieved age-appropriate speech, and Dr. Duchowny’s neurologic evaluation indicates, Neurologic evaluation reveals a sociable cooperative fully fluent 5-year-old girl. Stephanie was brought to the office in a wheelchair. She is socially interactive and answers questions with accurate verbal content. She correctly identified letters and knew primary and secondary colors. She told me her first and last names. Her speech sounds are fluent and reasonably well articulated, and she maintains an age- appropriate stream of attention. Dr. Duchowny summarized his opinion, which is credited, in his affidavit, stating: In summary, Stephanie’s general physical and neurological examinations reveal profound hypotonia and hypo-reflexia with preserved cognitive status. She is diagnosed with myasthenia gravis (along with her sister), immunodeficiency syndrome neuromuscular scoliosis and bilateral hip dislocations. . . . I reviewed the medical records sent on August 12, 2019. Stephanie was born at 37 weeks’ gestation following a pregnancy complicated by hypertension. She was born floppy with no respiratory effort, but following responded favorably to positive pressure ventilation. Apgar scores were 2, 5, and 6 at 1, 5, and 10 minutes; a venous cord pH was 7.35 with a base excess of -5.6. Severe hypotonia was noted at birth leading to early gastrostomy placement and evaluation into potential genetic causes. A neonatal MR imaging study was read as normal, while a second study at age 4 months revealed delayed myelination.[1/] Based on the record review, clinical diagnoses and the results of the IME, it is my opinion that Stephanie did not suffer an injury to the brain or spinal cord due to oxygen deprivation or mechanical injury in the course of labor, delivery or resuscitation in the immediate postdelivery period which rendered her permanently and substantially mentally and physically impaired. Based on the evidence presented in support of the Motion, Stephanie is not eligible for compensation under the Plan because her birth weight does not meet the criteria established by statute for a birth-related neurological injury. Based upon the evidence presented in support of the Motion, Stephanie has substantial physical impairments. However, the evidence does not indicate that these impairments are caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital. Finally, no evidence presented demonstrates that Stephanie suffers from any mental impairment. Petitioner has presented no evidence in response to the Motion to rebut the opinions of Dr. Willis and Dr. Duchowny as detailed in their affidavits and expert reports.
