The Issue The Administrative Complaint in DOAH Case No. 99-4377, charged Respondent with violating Section 458.331(1)(t), Florida Statutes (failure to practice medicine with care, skill and treatment); Section 458.331(1)(m), Florida Statutes (failure to keep written records justifying treatment); Section 452.331(1)(x), Florida Statutes (violation of a rule of the Board or Department) by violating Rule 64B8-9.003(2), Florida Administrative Code, relating to legibility of medical records, in connection with Respondent's emergency room treatment of Patient B.W. on July 21, 1995. The Administrative Complaint in DOAH Case No. 99-4378, charges Respondent with violation of Section 458.331(1)(s), Florida Statutes (being unable to practice medicine with reasonable skill and safety to patients by reason of illness, use of any material, or as the result of any mental or physical condition).
Findings Of Fact At all times material to the incidents alleged in the Administrative Complaints, Respondent was a licensed medical physician in the State of Florida, having been issued License No. ME 0016828. Respondent specialized in internal medicine and emergency medicine but has never been board certified in any specialty. Respondent's license has been delinquent since January 31, 2000, but because delinquent licenses may be subject to renewal, the Petitioner has persisted in prosecuting these cases. DOAH Case No. 99-4377 On July 21, 1995, B.W., a 56-year-old female, presented to Respondent in the emergency room of Florida Hospital Waterman, with complaints of chest, epigastric, and left shoulder pain. B.W. had a history of dermatomyositis, for which she had been taking 100 mg of Prednisone for a month, along with other medications. Prednisone in such large doses can cause gastrointestinal irritation, ulceration, and bleeding. The day before, B.W. had been prescribed Imuran by her rheumatologist for immunologic problems. Dermatomyositis is a degenerative disease of skeletal muscle that can lead to a multitude of complications, including rheumatologic problems evidenced by abnormal laboratory results. The standard of care in the examination and treatment of a patient with chest pain requires an emergency physician to obtain a history including a complete medical history, family history, and social history. Additionally, in order to meet the standard of care, the emergency physician must perform a complete physical examination, including a review of systems. The emergency room records for Respondent's treatment of B.W. show the information contained above in Finding of Fact No. 4. The emergency room records do not show that Respondent obtained or documented a complete medical history, family history, or social history of B.W. Respondent violated the standard of care in that he failed to obtain or document a complete medical history, family history, or social history of B.W. Respondent also violated the standard of care in that he failed to perform or document a complete physical examination, including a review of systems. Respondent ordered an electrocardiogram (EKG), a chest X-ray, a complete blood count (CBC), complete cardiac enzymes testing (CPK and CKMB), and a metabolic profile or chemistry panel (MPC). He also did a rectal exam which was negative for blood. He did all appropriate tests. He did not fail to order any appropriate tests. The EKG and the chest X-ray yielded normal results, but B.W.'s blood count revealed several abnormal values, including a decreased platelet of 21,000 and a markedly elevated white count of 24,000. A platelet count of 21,000 is extremely low and grounds for major concern, as is the elevated 24,000 white count. Together, in the presence of the other symptoms and abnormal blood values present, which included low RBC, anemic hemoglobin, and low hemocrit, the standard of care requires that an emergency physician obtain a consultation with a specialist, such as a rheumatologist or a hematologist. In light of all the foregoing results and normal corpuscular volume, which B.W. also had, the emergency physician should have recognized that B.W. did not have simple iron deficiency anemia. Under some circumstances, the emergency room physician's consultation with B.W.'s primary care physician, who in this case was also a rheumatologist, would have been sufficient. Respondent maintained that he had obtained a history from B.W. as set forth in Finding of Fact No. 4, and an oral report from the hospital lab technician to the effect that a blood test ordered by B.W.'s treating rheumatologist the preceding day, July 20, 1995, had shown a platelet count of 18,000, and that because Respondent presumed B.W.'s platelets were increasing with the use of Imuran plus other factors, Respondent did not admit B.W. to the hospital, but, instead, discharged her without even consultation. Despite Respondent's foregoing explanation, it is clear that Respondent did not record or document on B.W.'s chart his oral conversation with the lab technician, if, in fact, such a conversation occurred. This was below the acceptable standard of medical care and record-keeping for an emergency room physician. Respondent stated that he felt that because the treating rheumatologist had not admitted B.W. to the hospital or transfused B.W. the previous day, she should not be admitted or transfused on July 21, 1995. He stated that he also relied on a medical text (Merck's Manual) which allegedly states that platelet transfusions should not be given until the count falls to 10,000. Respondent stated that he ruled out a myocardial infarction on the basis that both the CKMB on B.W. and the CKMB Index were not elevated and B.W.'s EKG was normal. However, Dr. Tober, who is certified in emergency medicine, testified more credibly that he had never seen a CPK test so high; that interpretation of CPK and CKMB in such a patient as B.W. would be confounded by the co-existence of the dermatomyositis, grossly throwing off these tests in an acute cardiac setting, sometimes causing several EKGs to come back normal in the course of a myocardial infarction; that B.W.'s extremely low platelet count should cause great concern about the hemologic system and clotting response if B.W. started to hemorrhage; and that the suspiciously low lymphocytes and all blood parameters should have caused Respondent not to discharge B.W. prior to a consultation with a specialist. Respondent failed to meet the standard of care by the treatment he rendered to B.W., in that he did not obtain a consultation from either the primary care physician, another rheumatologist, or a hematologist, before discharging her. That standard of care requires an emergency physician to determine an appropriate diagnosis and treatment as related to the patient's complaint and results of examinations. Respondent violated the standard of care in that he merely wrote into B.W.'s chart a portion of her medical history, "dermatomyositis," instead of a current diagnosis which addressed her current abnormalities when she presented in the emergency room. Thus, Respondent did not discern an appropriate diagnosis while appropriately treating B.W.6 Respondent's chart on B.W. is illegible to the extent that Dr. Tober was unable to read most of 23 lines of it. Because proper care of patients requires that medical records be sufficiently legible for successive professionals to discern what the writer has done and analyzed, I find that Respondent is guilty of keeping written medical records that are illegible and difficult to decipher. I do not consider Hospital Waterman's failure to provide dictation or transcription equipment and/or personnel to excuse this flaw. DOAH Case No. 99-4378 On or about July 14, 1995, Respondent was convicted of driving under the influence and placed on probation for 12 months, and his driver's license was revoked for 12 months. About two years later, on July 12, 1997, Respondent's vehicle collided with another vehicle. Respondent and the driver of the other car were injured. Blood was drawn from Respondent at the hospital. Laboratory studies performed by the Florida Department of Law Enforcement revealed that Respondent's blood alcohol level was 0.10 grams of ethyl alcohol per 100 ml. Under Florida law, a driver is legally intoxicated when his blood alcohol level is 0.08 grams of ethyl alcohol per 100 ml or higher. On August 12, 1997, Respondent was arrested and charged with one count of serious bodily injury while driving under the influence, and two counts of property damage while driving under the influence. On July 2, 1998, Respondent entered a plea of guilty7 to one count of serious bodily injury while driving under the influence and was sentenced to imprisonment for a period of seven years, one month, and eight days. On or about January 13, 1998, Walter J. Muller, M.D., a board-certified psychiatrist, performed a psychiatric evaluation of Respondent. Dr. Muller diagnosed Respondent with major depression, dysthymic disorder, and alcohol abuse, pursuant to The Diagnostic and Statistical Manual-IV. At that time, these conditions were active and not in remission. The diagnosis of major depression correlates with impaired social and occupational functioning. A diagnosis of dysthymic disorder is an indication of impairment and the inability to practice medicine with skill and safety to patients. A diagnosis of alcohol abuse can be an indication of inability to practice medicine with skill and safety to patients, but would depend upon when the abuse is occurring and how long it has been since the abuse occurred. In the expert opinion of Dr. Raymond Pomm, who is board certified in adult psychiatry and general psychiatry, with added qualifications in addiction psychiatry, and who relied on Dr. Muller's evaluation, the combined three diagnoses of major depression, dysthymic disorder, and alcohol abuse revealed that, to a degree of reasonable medical certainty, Respondent was unable to practice medicine with skill and safety to patients on the date of Dr. Muller's report. Respondent was evaluated at Menninger Clinic in Kansas, on or about May 26, 1998, and diagnosed with alcohol dependence. After six weeks of treatment at the Menninger Clinic, Respondent was released as being "in early remission." The treating physician made a number of recommendations for rehabilitation of Respondent, including treating his alcohol dependence by entering into a monitoring contract with the Physician's Resource Network in Florida and requiring a further evaluation by a neurologist of Respondent's apparently diminished cognitive skills. Dr. Pomm did not have the opportunity to read the entire evaluation by the Menninger Clinic, and did not rely upon it in forming his opinion of Respondent's inability to practice medicine with skill and safety to patients. However, according to Dr. Pomm, there is no cure for alcohol dependence. It is a life-long illness, which is incurable, and which at best, can only be "in remission." In Dr. Pomm's opinion, one who is alcohol-dependent cannot practice with skill and safety to patients without undergoing a monitoring program. While I accept Respondent's testimony that he has remained sober since approximately May 27, 1998, because he has been in prison, I also note that Respondent has not entered into a monitoring contract or been monitored in a recovery program because he has been in prison. Accordingly, there is no evidence that Respondent's circumstances have changed sufficiently since January 13, 1998, so as to demonstrate that he is able to practice medicine with skill and safety to patients in the real world.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of all violations charged, and as a penalty therefore, suspending Respondent's license to practice medicine in Florida until such time as Respondent presents to the Board and proves that he can practice with skill and safety. DONE AND ENTERED this 15th day of June, 2000, in Tallahassee, Leon County, Florida. ELLA JANE P. DAVIS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of June, 2000.
The Issue The issue for determination is whether Petitioner is liable for overpayment of Medicaid claims for the period from 9/1/94 through 9/30/96, as stated in Respondent's Final Agency Audit Report dated May 5, 1998.
Findings Of Fact At all times material hereto, the Agency for Health Care Administration (Respondent) was the state agency charged with administration of the Medicaid program in the State of Florida pursuant to Section 409.907, Florida Statutes. At all times material hereto, Henry M. Rubinstein, D.C., (Petitioner) was a licensed chiropractor in the State of Florida and was providing chiropractic services to Medicaid recipients. Petitioner provided the services pursuant to a contract with Respondent under the Medicaid provider number 0503517-00. His Medicaid patients for years have included children and multi-handicapped children. Petitioner has published in peer review journals and is a board certified chiropractor. Dennis L. Jones, D.C., is a licensed chiropractor in the State of Florida. 1/ He was involved in the creation of Florida's Medicaid program and monitors the Florida Chiropractic Medicaid Program. Dr. Jones also serves as a Medicaid chiropractic consultant, including the issuance of prior authorizations for treatment. Prior authorizations are required for a chiropractor to provide and bill for visits by Medicaid recipients in excess of the set limited number. The maximum number of visits allowed per year prior to July 1, 1994, was 12, and after July 1, 1994, was 24. After July 1, 1994, prior authorization was required for visits beyond 24 for Medicaid recipients under the age of Prior authorization was granted for requests that demonstrated medical necessity. Dr. Jones denied many of Petitioner's requests for prior authorization. He denied the requests on the basis that the treatments were extending for periods of up to two years without detailed explanation of medical necessity to substantiate such extended periods of care. Dr. Jones observed that Petitioner's requests for such extended care routinely lacked substantiation and documentation for such extended care, such as x-rays, orthopedic and neurological findings, and subjective/objective descriptions. However, Dr. Jones granted some of Petitioner's requests for prior authorization to exceed the maximum number of visits. Dr. Jones had concerns as to the sufficiency of the documentation of Petitioner's requests for prior authorizations. As a result, when such requests were granted, Dr. Jones noted on the request forms that supplemental medical necessity needed to be documented more completely in the future. In 1996, Dr. Jones related his concerns about Petitioner in a letter to Respondent and included with the letter prior authorizations for primarily special needs children covering the years 1994 through 1996. Twenty-nine prior authorizations were included, with 25 of them for special needs children. His concerns related primarily to Petitioner's Medicaid patients who were special needs children and for whom Dr. Jones had reviewed only prior authorizations submitted by Petitioner. Further, in his letter, Dr. Jones requested an investigation into possible patient brokering, a criminal act. However, a request from a complainant for an investigation into a particular area of alleged violation does not prevent Respondent from identifying and investigating other areas of possible violation revealed by the documents provided. Dr. Jones' letter was referred to one of Respondent's employees, Judith M. Jensen. At that time, Ms. Jensen was also in the process of reviewing another complaint lodged against Petitioner by Dr. Jones, regarding prior authorizations for children, but covering a different time period--from 1993 through 1995. Ms. Jensen was, and is, employed by Respondent as a Human Services Program Specialist. Her duties include monitoring Medicaid claims and investigating Medicaid complaints and aberrant billings for Respondent's Medicaid Program Integrity Office. In investigating all billing irregularities or specific complaints, a review is typically made of the Medicaid provider's medical records. Substantiation of Medicaid claims that are submitted and paid is by adequate and proper medical record documentation. An audit, based upon a billing irregularity or complaint, is usually begun with the selection of a provider or a group of providers. Next, a sample of the chosen provider's Medicaid claims is chosen for a particular time period, which is the audit period. An analyst for Respondent then requests from the provider the medical records for the Medicaid recipients sampled for the audit period. The medical records are provided to and analyzed by a medical peer reviewer. If the medical peer reviewer recommends denial of payment for any of the claims, resulting in overpayment, Respondent forwards a preliminary audit letter to the Medicaid provider, describing the audit findings and requesting any supplemental medical records. A review of any submitted supplemental medical records is conducted, and the audit findings are adjusted in accordance with the results of the review. If an overpayment continues to be indicated after the review, Respondent forwards a final audit letter to the Medicaid provider. Respondent has a limited number of analysts and medical peer reviewers. Due to such constraints on Respondent, sampling is utilized due to its reliability, cost-effectiveness, and commonly accepted method for review of high volumes of Medicaid claims. Ms. Jensen initiated Respondent's review of Petitioner's Medicaid claims. She began the audit by requesting an ad hoc computer report on Petitioner's billing history for all Medicaid recipients under the age of 21 for the time period from 9/1/94 through 9/30/96. Ms. Jensen's request concentrated only on Medicaid recipients under the age of 21 because Dr. Jones alerted Respondent primarily to prior authorizations for children. Ms. Jensen received the ad hoc computer report, which was a detail of all of Petitioner's Medicaid billings for Medicaid recipients under the age of 21 for the period from 9/1/94 through 9/30/96. The report provided that for the time period indicated, Petitioner billed and was paid for 4,499 claims for 85 recipients, for a total amount of $71,731.30. Having received this information, Ms. Jensen requested a computer-generated selection of a random sample of 20 recipients from the total population of the 85 recipients. Twenty recipients were randomly selected from the total population of the 85 recipients, which showed, among other things, claims totaling 1,307 and payment for the claims totaling $20,710.69. Afterwards, Ms. Jensen requested Petitioner to provide all the medical records for the 20 sampled recipients for the time period from 9/1/94 through 9/30/96. Petitioner complied with Ms. Jensen's request. Having received the medical records, Ms. Jensen engaged a peer review consultant, Dr. Ronald J. Hoffman, D.C., to evaluate the records submitted by Petitioner. She provided the medical records to Dr. Hoffman.. 2/ He was provided with the medical records of only 10 Medicaid recipients on two separate occasions, instead of all 20 at the same time. The Medicaid recipients' medical records were not "sanitized" when they were submitted to Dr. Hoffman, meaning that the names of the Medicaid recipients and provider, Petitioner, were not redacted. Dr. Hoffman, as a peer reviewer, rarely reviews files which have been sanitized. The failure to sanitize the medical records found to be of no consequence to Dr. Hoffman's determinations. Dr. Hoffman is a licensed chiropractor in the State of Florida and has been practicing for over 30 years. His practice includes patients who are pediatric and multi-handicapped, but these patients comprise a very small number of his patients. He performs chiropractic Medicaid utilization review for Respondent and is a Medicaid provider. He has performed chiropractic utilization review for more than 15 years. For the Medicaid program, Dr. Hoffman has been a consultant since 1997, but Petitioner's review was the first peer review performed by Dr. Hoffman for the Medicaid program. When Dr. Hoffman performs peer reviews for Respondent, he relies upon State statutes and Respondent's guidelines, specifically, The Chiropractic Coverage and Limitation Handbook, and his years of experience Dr. Hoffman is knowledgeable about what a medical record should contain in order for the medical record to demonstrate medical necessity for Medicaid reimbursement purposes. The medical record should contain the complete medical history; an examination showing the condition of the patient and why the patient is being treated; symptoms; standardized testing, including orthopedic and neurological tests; treatment notes; a treatment program; objective findings; special procedures; and an evaluation of the patient's progress. 3/ Petitioner agrees that, according to the Medicaid provider reimbursement handbook, the following are requirements for medical records: patient history; chief complaint for each visit; diagnostic tests and results; diagnosis; treatment plan, including prescriptions; medications, supplies, scheduling frequency for follow-up or other services; progress reports, treatment rendered; original signatures and dates; dates of service; and referrals to others. Dr. Hoffman was aware from review of the medical records provided by Petitioner that the Medicaid recipients were special needs children. However, he was unaware of Florida's special needs statutes (Subsections 409.803(1)(c) and 409.9126(1)(b), and Section 409.9121, Florida Statutes), which address, among other things, health care needs for special needs children, and he did not use the statutes in his determination. The failure to use the special needs statutes had little or no effect on Dr. Hoffman's review. The undersigned is persuaded and a finding of fact is made that Dr. Hoffman's failure to use the special needs statutes in his review did not invalidate his determinations. Dr. Hoffman was tendered and is accepted as an expert in chiropractic medicine. He is also found to be an appropriate peer reviewer for Petitioner's situation. Dr. Hoffman's testimony is found to be credible. After having reviewed the medical records, regarding the 20 randomly sampled Medicaid recipients, pursuant to Respondent's Medicaid peer review, Dr. Hoffman produced two reports of his findings. 4/ During his review, Dr. Hoffman considered all of the Medicaid recipients' visits, including those that had been granted prior authorization. Patient 1 was recipient K.K., with a date of birth of 5/18/86. 5/ Dr. Hoffman's opinion was that Patient 1's medical records did not support a finding of medical necessity. The medical records failed to support justification for Patient 1's 198 visits from 11/10/94 through 9/10/96. X-rays contained in the medical records were of such poor quality that they were of no diagnostic value; however, the x-rays were not a factor in the determination of medical necessity. Petitioner's medical notes were practically the same for each visit, with Petitioner noting practically the same comment(s); and there was no recorded orthopedic or neurological testing and no standard chiropractic evaluation forms justifying the number of treatments billed. Patient 1's medical records failed to demonstrate medical necessity for the visits. For Patient 1, 198 claims were paid in the amount of $3,081.30. Prior authorizations granted totaled $2,964. 6/ Patient 2 was recipient N.M., with a date of birth of 8/11/83. Dr. Hoffman's opinion was that Patient 2's medical records lacked documentation demonstrating that the treatments were a medical necessity for Medicaid reimbursement purposes for the 175 visits from 7/12/94 through 6/27/96. The medical records contained no standard medical notes or examination forms and no orthopedic, neurological or chiropractic examination forms to justify treatments; and were redundant and repetitive. X-rays contained in the medical records were of such poor quality that they were of no diagnostic value; but, the x-rays have no impact on the determination of medical necessity. Patient 2's medical records failed to demonstrate medical necessity for the visits. For Patient 2, 175 claims were paid in the amount of $2,726.50. Prior authorizations granted totaled $2,964. Patient 3 was recipient D.A., with a date of birth of 4/6/89. Dr. Hoffman's opinion was that Patient 3's medical records lacked justification for the 173 visits from 8/23/94 through 7/30/96. The medical records contained no standard procedures performed by an acceptable chiropractic physician licensed in the State of Florida. The medical records also indicated that a medical radiologist, Dr. Robert S. Elias, M.D., read the recipient's x-rays for the purpose of a medical diagnosis of treatment and that Dr. Elias' diagnosis directly conflicted with Petitioner's diagnosis; however, the x-rays were not a factor in the determination of medical necessity. Patient 3's medical records failed to demonstrate medical necessity for the visits. For Patient 3, 173 claims were paid in the amount of $2,693.70. Prior authorizations granted totaled $2,604. Patient 6 was recipient T.W., with a date of birth of 2/5/90. Dr. Hoffman's opinion was that Patient 6's medical records lacked justification for the 160 visits from 1/3/95 through 9/3/96. The medical records contained no standardized chiropractic notes, no specified diagnosis, and no routine re- examinations. Furthermore, the medical records failed to show why Petitioner was treating Patient 6. X-rays contained in the medical records were not of diagnostic quality and were, therefore, of no diagnostic value; however, the x-rays had no impact on the determination of medical necessity. Patient 6's medical records failed to demonstrate medical necessity for the visits. For Patient 6, 160 claims were paid in the amount of $2,502.20. Prior authorizations granted totaled $1,882.90. Patient 24 was recipient G.H., with a date of birth of 7/20/95. Dr. Hoffman's opinion was that Patient 24's medical records failed to justify the approximately 73 visits. The medical records contained no standardized chiropractic notes, no objective findings, and no standardized testing, including range of motion, muscle spasms, and orthopedic or neurological tests. For many of the visits, the only documentation contained in the medical records consisted of the same notation or statement: "Patient doing well." Patient 24's medical records failed to demonstrate medical necessity for the visits. For Patient 24, 72 claims were paid in the amount of $1,158.09. The medical records do reflect that any prior authorizations were granted. Patient 25 was recipient O.M., with a date of birth of 4/25/83. Dr. Hoffman's opinion was that Patient 25's medical records failed to justify the 87 visits. The medical records contained no standardized chiropractic notes, no justification of diagnosis, and no standard medical tests. The notes that were recorded were quite sparse and repetitive and typically recorded as "Doing well." Patient 25's medical records failed to demonstrate medical necessity for the visits. For Patient 25, 71 claims were paid in the amount of $1,131.69. Prior authorizations granted totaled $753.60. Patient 27 was recipient C.F., with a date of birth of 2/12/84. Dr. Hoffman's opinion was that Patient 27's medical records failed to justify the 67 visits from 10/11/95 through 3/25/96. The medical records contained no standardized chiropractic notes, no standardized examination forms, and no documentation of Patient 27's progress. Patient 27's medical records failed to demonstrate medical necessity for the visits. For Patient 27, 67 claims were paid in the amount of $1,079.59. The medical records do reflect that any prior authorizations were granted. Patient 28 was recipient K.H., with a date of birth of 8/22/94. Dr. Hoffman's opinion was that Patient 28's medical records failed to justify the 69 visits. The medical records contained no standardized chiropractic notes and no standardized testing, and showed no specific treatment provided based upon the requirements of the Medicaid laws. Patient 28's medical records failed to demonstrate medical necessity for the visits. For Patient 28, 66 claims were paid in the amount of $1,031.79. The medical records do reflect that any prior authorizations were granted. Patient 33 was recipient K.D., with a date of birth of 2/15/84. Dr. Hoffman's opinion was that Patient 33's medical records failed to justify the 73 visits. The medical records contained no standardized chiropractic notes and no standardized testing. Patient 33's medical records failed to demonstrate medical necessity for the visits. For Patient 33, 51 claims were paid in the amount of $800.70. Prior authorizations granted totaled $376.80. Patient 35 was recipient T.M., with a date of birth of 10/15/91. Dr. Hoffman's opinion was that Patient 35's medical records failed to justify the 51 visits from 2/15/95 through 6/10/96. The medical records contained no standardized chiropractic notes justifying the treatment provided. The medical records also stated that Dr. Elias read Patient 35's x- rays for the purposes of medical diagnosis of treatment and that Dr. Elias' diagnosis directly conflicted with Petitioner's diagnosis; however, the x-rays were not a factor in determining medical necessity. Patient 35's medical records failed to demonstrate medical necessity for the visits. For Patient 35, 51 claims were paid in the amount of $828.39. Prior authorizations granted totaled $753.60. Patient 39 was recipient B.T., with a date of birth of 8/8/95. Dr. Hoffman's opinion was that Patient 39's medical records failed to justify the 47 visits from 2/9/95 through 10/19/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 39's medical records failed to demonstrate medical necessity for the visits. For Patient 39, 47 claims were paid in the amount of $765.59. Prior authorizations granted totaled $753.60. Patient 40 was recipient T.H., with a date of birth of 7/11/84. Dr. Hoffman's opinion was that Patient 40's medical records failed to justify the 46 visits from 11/15/94 through 2/28/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. The medical records also indicated that Dr. Elias read the recipient's x-rays for the purposes of medical diagnosis of treatment and that Dr. Elias' diagnosis directly conflicted with Petitioner's diagnosis; however, the x-rays were not a factor in determining medical necessity. Patient 40's medical records failed to demonstrate medical necessity for the visits. For Patient 40, 46 claims were paid in the amount of $731.70. Prior authorizations granted totaled $753.60. Patient 45 was recipient T.W., with a date of birth of 9/26/90. Dr. Hoffman's opinion was that Patient 45's medical records failed to justify the 22 visits from 4/24/95 through 11/15/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 45's medical records failed to demonstrate medical necessity for the visits. For Patient 45, 26 claims were paid in the amount of $408.20. Prior authorizations granted totaled $376.80. Patient 48 was recipient S.L., with a date of birth of 1/31/91. Dr. Hoffman's opinion was that Patient 48's medical records failed to justify the 23 visits from 3/25/96 through 9/11/96. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 48's medical records failed to demonstrate medical necessity for the visits. For Patient 48, 23 claims were paid in the amount of $388.79. The medical records do reflect that any prior authorizations were granted. Patient 54 was recipient H.A., with a date of birth of 1/31/88. Dr. Hoffman's opinion was that Patient 54's medical records failed to justify the 7 visits from 9/6/95 through 10/2/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 54's medical records failed to demonstrate medical necessity for the visits. For Patient 54, 19 claims were paid in the amount of $298.30. The medical records do reflect that any prior authorizations were granted. Patient 58 was recipient T.W., with a date of birth of 11/19/81. Dr. Hoffman's opinion was that Patient 58's medical records failed to justify the 23 visits from 3/25/96 through 9/30/96. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 58's medical records failed to demonstrate medical necessity for the visits. For Patient 58, 17 claims were paid in the amount of $294.59. The medical records do reflect that any prior authorizations were granted. Patient 59 was recipient C.P., with a date of birth of 4/11/93. Dr. Hoffman's opinion was that Patient 59's medical records failed to justify the 22 visits from 4/10/96 through 10/9/96. The medical records contained no standardized chiropractic notes, no documentation of standardized testing of the spine, no documentation of standard tests, including orthopedic and neurological tests, and no medical justification for ongoing care and treatment. Patient 59's medical records failed to demonstrate medical necessity for the visits. For Patient 59, 16 claims were paid in the amount of $278.89. Prior authorizations granted totaled $376.80. Patient 64 was recipient M.L., with a date of birth of 8/20/89. Dr. Hoffman's opinion was that Patient 64's medical records failed to justify the 8 visits from 8/30/95 through 10/2/95. The medical records contained no standardized chiropractic notes, no documentation of standardized testing, and no description of Patient 64's pain or physical condition. Patient 64's medical records failed to demonstrate medical necessity for the visits. For Patient 64, 13 claims were paid in the amount of $204.10. The medical records do reflect that any prior authorizations were granted. Patient 69 was recipient A.L., with a date of birth of 1/14/92. Dr. Hoffman's opinion was that Patient 69's medical records failed to justify the 9 visits from 2/27/95 through 3/20/95. The medical records contained no standardized chiropractic notes, and the documentation contained in the records was minimal and repetitious. Patient 69's medical records failed to demonstrate medical necessity for the visits. For Patient 64, 13 claims were paid in the amount of $204.10. The medical records do reflect that any prior authorizations were granted. Patient 77 was recipient N.J., with a date of birth of 4/16/80. Dr. Hoffman's opinion was that Patient 77's medical records failed to justify the 7 visits from 3/6/95 through 3/29/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 77's medical records failed to demonstrate medical necessity for the visits. For Patient 77, 7 claims were paid in the amount of $137.59. The medical records do reflect that any prior authorizations were granted. Dr. Hoffman recommended denial of all claims for the 20 sampled Medicaid recipients for the period from 9/1/94 through 9/30/96 due to Petitioner's failure to adequately document medical necessity in the recipients' medical records. For the 20 sampled Medicaid recipients for the period from 9/1/94 through 9/30/96, the total of the Medicaid payments was $20,710.69. As a result, the denial amount, the overpayment, for the 20 sampled recipients was the same, $20,710.69. The overpayment for the 20 sampled Medicaid recipients was extrapolated to the entire universe or total population of the 85 Medicaid recipients under the age of 21 for the period from 9/1/94 through 9/30/96, which resulted in a total projected overpayment of $70,518.26. The actual total amount of Medicaid payments for the 85 Medicaid recipients for the covered time period was $71,731.30. Considering the actual total payment of $71,731.30, the projected overpayment of $70,518.26 is very close to the actual total payment and is inherently reasonable. There is an expectation that, because all the claims of the 20 sampled Medicaid recipients were denied, the projected denial for all the claims in the universe of 85 recipients would be very close to the actual total payment. The difference between the projected overpayment of $70,518.26 and the actual amount paid of $71,731.30 is $1,213.04. This difference is negligible and such negligible difference reflects the inherent accuracy and reliability of the statistical methodology utilized. The maximum error range is 5 percent. The difference between the projected overpayment total and the actual payment total is also well within the maximum error range of 5 percent, or $3,587, for a 95 percent statistical confidence interval. To illustrate Respondent's statistical methodology, first, begin with sampled Medicaid recipient Patient 1. As indicated previously, the total number of actual claims for the total population of 85 Medicaid recipients, who were under the age of 21, was 4,499, and the total amount paid for the claims was $71,731.30; the data being taken from Respondent's Medicaid claims database. For Patient 1, 198 claims were audited and $3,081.30 was the total amount paid for the claims. All of the $3,081.30 was denied and determined to be an overpayment. Second, the same process was used with all 20 Medicaid recipients sampled, which produced a total of 1,307 claims, which were all denied, and produced a total of $20,710.69 in overpayment. The total sampled overpayment of $20,710.69 was divided by the total number of sampled claims (1,307) to obtain a mean overpayment per sampled claim of $15.85. The overpayment per sampled claim of $15.85 was multiplied by the number of claims in the total population (4,499) to obtain a point estimate of the total population overpayment, which was $71,291.04. Third, adjusting the point estimate of $71,291.04 for any potential statistical error, Respondent's model reduces the point estimate by 1.73 standard deviations, yielding an error- adjusted total overpayment of $70,518.26. Respondent has a level of confidence that there is 95 percent chance that actual overpayment is a minimum of $70,518.26. The point estimate of $71,291.04 is very close to the actual payment of $70,731.30 for the claims of the total population of the 85 Medicaid recipients; therefore, the overpayment of $70,518.26 is relatively conservative. Respondent's audit was conducted in conformity with Respondent's standards and conformed to Respondent's manner in conducting audits. The audit also had no known deviations or irregularities or deficiencies in the technical processes utilized, except the failure to take into account the prior authorizations granted. As to the statistical aspect of Respondent's audit, Respondent presented the testimony of a statistical expert, Dr. James T. McClave, Ph.D. 7/ Dr. McClave's testimony is considered credible. Using statistical methods in Medicaid overpayment determinations is a common and well-accepted standard of practice. Statistical modeling in Medicaid auditing scientifically and accurately determines the extent of overpayments in a population of payments from a small sample of overpayments drawn from the population of payments. Statistical modeling is capable of providing reliable estimates of the integrity, or lack thereof, of a Medicaid provider's billings, within reasonable time and resource constraints. In the statistical formula, a sample of claims is used to obtain a valid statistical estimate of the overpayment, if any, associated with the entire population of claims from which the sample of claims was drawn. A point estimate, being the best estimate the sample has to offer of the overpayment, is taken; and then a factor, allowing for the uncertainty associated with the sample, is subtracted such that there is a specified level of confidence that what is obtained is the conservative estimate of what the total population overpayment would be. The point estimate is referred to as "the lower 95 percent confidence bound," 8/ and the number obtained is a number which one "can be 95 percent confident that it is an underestimate of what the total overpayment would be" 9/ if the entire population was sampled. Respondent complied with the statistical methodology. The random selection process and the ad hoc computer report were valid and reliable. The results of the sampling and extrapolation were valid and reliable on the basis of the total population of Petitioner's Medicaid patients was pediatric patients and the results were limited to Petitioner's Medicaid patients under the age of 21. Further, the sample size of 20 Medicaid recipients from the total population of 85 was adequate. However, the results of the sampling and extrapolation are not reliable as they pertain to the failure of Respondent to take into consideration the granted prior authorizations. Respondent is compelled and should be provided an opportunity to re-apply its statistical methodology in light of granted prior authorizations not being considered. Uncertainty now exists as to what effect the granted prior authorizations would have on the outcome of the total overpayments. The denial of all of Petitioner's claims was a situation of first impression for Respondent. Prior to the instant case, Respondent had had no chiropractor's Medicaid claims go through peer review and denial recommended. By letter dated February 4, 1998, Respondent forwarded to Petitioner a Preliminary Agency Audit Report (Preliminary Audit Report). The Preliminary Audit Report informed Petitioner, among other things, that Respondent's preliminary determination was that Petitioner had received an overpayment of $70,518.26 due to the claims being determined not medically necessary, and requested, among other things, that Petitioner submit any additional information or documentation which may reduce the overpayment. The Preliminary Audit Report also informed Petitioner of the overpayment calculation and statistical formula used by Respondent. In response to the request for additional information or documentation, Petitioner forwarded to Ms. Jensen a videotape and testimonials. Ms. Jensen did not send the testimonials and videotape to Dr. Hoffman, the peer reviewer, for his review because these items (1) were determined by her to have been created prior to recording of the medical records at issue, and, therefore, did not constitute a medical record for review; and (2) were, consequently, not relevant. The undersigned is persuaded and a finding of fact is made that the testimonials and videotape were not relevant and need not have been submitted to Dr. Hoffman for his review. By letter dated May 5, 1998, Respondent forwarded to Petitioner its Final Agency Audit Report (Final Audit Report). The Final Audit Report, based upon the recommendations of Dr. Hoffman, notified Petitioner, among other things, that the final determination was that he had received an overpayment of $70,518.26, due to the Medicaid claims not being medically necessary. The Final Audit Report also notified Petitioner, among other things, of the overpayment calculation and statistical formula used by Respondent. Moreover, Petitioner was notified that his type of violation warranted termination from the Medicaid program and a $2,000 fine, but that, in lieu of termination from the Medicaid program, he could continue as a provider by paying a $5,000 fine. In a subsequent letter to Petitioner, regarding clarification of continued participation in the Medicaid program, Ms. Jensen explained that, as a requirement for continued participation in the Medicaid program, in addition to the $5,000 fine, Petitioner must comply with Medicaid policy and Florida Statutes and rules. Petitioner was placed on notice that to continue as a Medicaid provider he must abide by Medicaid billing requirements. Respondent's Final Audit Report did not contain any notice of mediation being available. Section 120.573, Florida Statutes, requires notice of whether mediation (settlement) is available in agency action that affects substantial interests. There is no dispute that Respondent's Final Audit Report affects Petitioner's substantial interests. No evidence was presented that either Petitioner inquired about mediation or that Petitioner or Respondent sought or desired mediation. Moreover, no evidence was presented that Petitioner was harmed or suffered as a result of not receiving the notice. No evidence was presented to support a finding that the basis of the audit findings involved a conspiracy. A finding of fact is made that the basis of the audit findings does not involve a conspiracy between Respondent and its employees and Dr. Jones and Dr. Hoffman and Dr. McClave or anyone else. Respondent did not initiate any disciplinary action against Petitioner's license as a chiropractor and, therefore, Subsections 455.225(1) and 455.621(1), Florida Statutes, are not applicable. No evidence was presented that any criminal action was referred or taken against Petitioner as a result of Respondent's audit. No evidence was presented that Respondent suspected Petitioner of having committed a criminal violation, that a criminal act had been committed by Petitioner, or that Respondent had determined that Petitioner had committed a criminal act.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order against Henry M. Rubinstein, D.C. and therein: Sustaining the failure of Dr. Rubinstein's medical records, except as to granted prior authorizations, for Medicaid recipients under the age of 21 for the period from 9/1/94 through 9/30/96, to demonstrate medical necessity. Sustaining the Final Agency Audit Report, except as indicated and consistent with this Recommended Order. Requiring Dr. Rubinstein to repay overpayments, without interest, in an amount subsequently determined in a proceeding by the Agency for Health Care Administration and within a time period under terms and conditions deemed appropriate. Imposing a fine of $5,000. DONE AND ENTERED this 11th day of April, 2000, in Tallahassee, Leon County, Florida. ERROL H. POWELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 11th day of April, 2000.
The Issue At the hearing, DPR dismissed Count II, alleging a violation of subsection 458.331(1)(h) Florida Statutes. The remaining issues for resolution are whether, as alleged in Counts I, III, IV and V, Dr. Robinson violated subsections 458.331(1)(n),(q), and (t) Florida Statutes by failing to maintain adequate records, by inappropriately prescribing controlled substances, and by failing to properly evaluate and treat multiple medical problems.
Findings Of Fact Jerry Mason Robinson, M.D., has been continually licensed (license number ME 0011811) as a physician in the State of Florida since 1965. He was Board-certified in Family Practice in 1973 and was recertified in 1979 and 1985. He has continually practiced medicine since 1967 in Deltona, Florida, as a sole practitioner in family practice. Patient Fleming Dr. Robinson began treating Jesse Fleming when he came to his office on March 14, 1979, with complaints of being unable to breathe, a feeling of suffocation, and inability to sleep. The patient was found to be suffering from refractory heart failure and was admitted that same day to Seminole Memorial Hospital. Jesse Fleming was discharged as improved on March 23, 1979. His final diagnosis, reflected on the discharge summary, was: refractory heart failure, chronic obstructive pulmonary disease, and Pickwickian's syndrome. The notation "Pickwickian Syndrome" also appeared on the first clinical data sheet, dated March 14, 1979, in Dr. Robinson's office records for this patient. Pickwickian Syndrome, in lay terms, is a condition occurring in obese individuals wherein the abdominal fat presses on the diaphragm, cutting off the breathing and causing sleep at odd and inappropriate times. While Dr. Robinson initially felt that the condition was Pickwickian Syndrome, after the patient lost substantial weight in the hospital, he felt the proper diagnosis should be narcolepsy, a similar condition. He started him in the hospital on Dexedrine tablets, 5 mg. each morning, to increase his alertness. Narcolepsy is a very rare disease characterized by periods where the patient falls asleep uncontrollably many times during the day. The patient also has cataplexy, which is episodes of collapse that occur intermittently with emotional stress, laughing, giggling and fear. Another aspect of narcolepsy is called hypnagogic hallucinations, where an individual has vivid dreams. And the fourth part is called sleep paralysis where the patient cannot move on occasion without being touched. While there is no single test available to unconditionally diagnose a case of narcolepsy, the competent experts agree that a complete history and physical examination is required. The patient should be asked about sleeping patterns and about the symptoms described above. Testing through an electroencephalogram (EEG) and polysomnography is helpful. It is also important to specifically eliminate other causes of somnolence such as medications or other physical conditions, such as thyroid disorders or anemia. Dr. Robinson's records for Jesse Fleming are void of any documentation of the basis for his diagnosis of narcolepsy. The hospital discharge summary of his course in the hospital mentions only that the patient was found to be somnolent and sleeping all the time. He was on Valium in the hospital, 2 mg., 4 times a day to reduce anxiety. Valium is considered to be a central nervous system depressant and has drowsiness as one of its components. There is another notation on the records, on the occasion of an office visit, that the patient fell asleep in the office. This alone, does not indicate a case of narcolepsy. Although Dr. Robinson continued Mr. Fleming on Dexedrine or similar drug, Eskatrol, from the time that he was discharged from the hospital in March 1979, the first notation of a diagnosis of narcolepsy does not appear until March 20, 1981. The term appears intermittently as a diagnosis thereafter, but without description of any symptoms. Dexedrine is a Schedule II controlled substance. It is generally considered one of the amphetamines, a central nervous system stimulant. It has a high liability for habituation, or psychological dependence and overwhelming desire to continue to use the medication. It should not be used in those conditions in which it causes unnecessary stress on the vital organs of the body. It increases the demand of the heart for oxygen and can compromise an already failing heart. It is dangerous to give Dexedrine with thyroid hormones because the hormones make the heart more sensitive to Dexedrine and to the body's own form of Dexedrine, which is adrenalin. If given at all with Digoxin or Digitalis, Dexedrine should be given only with great care because these drugs slow the heart rate, an opposite effect of Dexedrine. In the past amphetamines were widely used to assist in weight control. That use was restricted and the treatment of narcolepsy is one of the remaining legitimate uses. And at least one expert in this proceeding, Jacob Green, M.D. would designate Ritalin, or a similar sympathomimetic drug as the treatment of choice for narcolepsy. In late 1981, Eskatrol was no longer available and Dr. Robinson began prescribing Dexedrine spansules, 15 mg., 200 or 100 at a time, at approximately monthly intervals. The patient has continued on this medication through 1985 and up to the time of the hearing. Around June 1979, Dr. Robinson began to prescribe Synthroid, a thyroid hormone, for Fleming's hypothyroidism at the same time that the patient was taking the amphetamine. On one occasion when the patient complained that he could not sleep, Dalmane, a sleeping medication was prescribed. Dexadrine spansules are a time-release medication which allows the effects of the drug to remain in the body for a longer period, including night time, when sleep is appropriate. Also while Fleming was on Eskatrol or Dexedrine, Dr. Robinson intermittently prescribed Brethine (a stimulant) for his lung problems, and on an on-going basis, Digoxin, for his heart condition. Assuming without the medical record basis to substantiate it, that the narcolepsy diagnosis was accurate, the prescription of Dexedrine to Jesse Fleming was dangerous and inappropriate. The patient records for Fleming are replete with references to irregular heart beats. On some occasions the nurse recorded "very irregular" apical pulses. These irregularities are sometimes a harbinger of heart failure and can occur in, or be exacerbated by, amphetamine therapy, especially in combination with thyroid hormones. In his testimony at hearing, Dr. Robinson stated that when he observed the notation of an irregular pulse he would check the patient himself to assure that the patient was alright. However, these observations are not reflected in the chart, except on one occasion when an EKG was taken and was found to be within normal limits. Good medical record-keeping is an essential aspect of a reasonable prudent physician's practice. Records are the mainstay of communications between physicians and provide a reminder to the physician with a busy practice. The records should provide objective findings and, from the patient, subjective findings. They guide the physician into what he was thinking previously and what needs to be done in the future. In a mobile society, when patients move from doctor to doctor, when specialists are brought in for consultation, when a regular doctor is absent, it is essential that another physician be able to view what has happened in the case from the medical records. Everything that is done needs to be justified in and documented in the records. The absence of a notation leads to the justifiable conclusion that the treatment was not undertaken or the test was not performed. Dr. Robinson failed to maintain adequate records to support his treatment of Jesse Fleming. The bases for his diagnosis of narcolepsy was utterly lacking, as was the basis for the decision to persist in prescribing Dexedrine under dangerous and potentially life-threatening conditions. Patient Kipp Fred Kipp was first examined by Dr. Robinson on June 8, 1978. He came to the office to get some prescriptions for medication that he was already taking. He had angina and a bad cold and was getting ready to return to Ohio, his summer residence. The history given by the patient on that first visit indicated that he had undergone two hip operations and an operation on his cervical spine for fusion. He had two aneurysm operations on his aorta, he had a hemorrhoidectomy and an amputation of his left second finger. At various times in the past he had been treated for severe arthritis in his back and foot, angina, hypertension, diabetes, pneumonia and hepatitis. His medications were Naprosyn for arthritis, Isordil for angina, Diabinese for diabetes, Hydrodiural for his hypertension, Percodan for his pain in his back, and Nitroglycerin for his angina. Dr. Robinson examined the patient and refilled his Naprosyn and Isordil. He told him to come back to see him in the fall when he returned to Florida. Fred Kipp returned to Dr. Robinson's office on December 7, 1978, complaining of chest pain. He was admitted to Seminole Memorial Hospital for pre-infarction angina and was discharged on December 11, 1978, with diagnoses of angina pectoris and coronary artery disease. From December 1978, until present, Dr. Robinson has been Fred Kipp's regular family physician. During this time he has treated him for angina or coronary artery disease, arthritis, hip problems, diabetes, back pain, shingles, vascular problems and chronic severe pain associated with all of these conditions. During this period the patient was hospitalized at least six times, primarily with heart trouble, but also for uncontrolled diabetes and impending gangrene. During a September 1984 admission to Central Florida Regional Hospital (formerly known as Seminole Memorial Hospital), the patient was diagnosed as having severe ankylosing spondylitis, a progressive spinal disease where the vertebrae ultimately become fused. The initial diagnosis was based on the patient's statement of his prior history, but the diagnosis was later confirmed by Dr. Robinson with an x-ray and CAT scan. The condition is very painful. During the course of his treatment of Fred Kipp, Dr. Robinson has kept the patient on Percodan for pain, in addition to his various medications for his multiple problems. Percodan is a Schedule II controlled substance containing oxycodone and aspirin. It is an analgesic with opium-like properties and is useful for moderate to moderately-severe types of pain. Because of the nature of the drug it has a potential for habituation and dependency, particularly when used on a regular long-term basis for chronic, as opposed to acute (temporary) pain. In order to avoid the habituation and dependency, less-addictive modalities should be tried before Percodan is selected as the treatment of choice. Dr. Robinson's office records for Fred Kipp do not reflect the consideration of alternatives. However, Dr. Robinson was aware that alternatives such as non-steroidal and anti- inflammatory agents were tried by consulting physicians, including by Dr. Broderick with Seminole Orthopaedic Associates. Fred Kipp is a very large man, approximately six feet, eight inches tall and weighing from 247 to 281 pounds. The dosages of Percodan prescribed for him by Dr. Robinson were not excessive, given the patient's size and physical problems. He has received between 200 and 300 Percodan per month for the last six years. At no time did he ever claim to have lost his prescription in order to get more drugs. Although the use of a strong narcotic with a chronic pain patient is the last resort of a reasonable, prudent physician, the use of Percodan was necessary and appropriate in Fred Kipp's case to allow him to maintain a reasonable quality of life. This finding is based not upon Dr. Robinson's office records, but rather on the competent expert testimony of his witnesses, who examined the patient and his records, and on the hospital records and consulting physicians' records in this case. Dr. Robinson's office records are deficient as to documented analysis of the patient's pain (subjective and objective observation) and efforts with less addictive modalities. While Dr. Robinson claimed that he requested Fred Kipp's records from his prior treating physician, his own records do not reflect that fact, nor was the attempt repeated when the first request was unproductive.
Findings Of Fact At all times material hereto, Respondent has been licensed as an osteopathic physician in the State of Florida, having been issued license number OS-0001053 in 1954. According to Respondent's office records for a patient named Barry Belikoff, Respondent saw Belikoff in his office on twenty-five (25) occasions between September 5, 1980, and July 24, 1981, and during this time wrote twenty-four (24) prescriptions for a total of 344 Quaaludes (Methaqualone) with a dosage of 300 mg. each. According to his patient records, Respondent also saw Belikoff on thirteen (13) occasions between October 31, 1981 and June 18, 1982 and wrote four (4) prescriptions for controlled substances, including Talwin, Restoril, and Percodan. Respondent was treating Belikoff for back pains and insomnia. According to expert testimony, the records kept by Respondent of this patient's office visits were inadequate and do not provide the required documentation which would support and explain the controlled substances prescribed in this case. In addition, a proper course of patient care would not include the on-going prescription of Quaaludes over almost a one year period at a rate of over one a day without a record of additional tests, x-rays, or neurological exams during this period. Belikoff's patient records do not show any such additional tests, x- rays or exams. Without such documentation in the patient's records, the prescriptions for controlled substances written by Respondent for Belikoff were without medical justification, excessive and inappropriate, according to expert testimony. Respondent was treating a patient named Lyndon Ellis during 1981 and 1982. Ellis was hospitalized on four occasions while under Respondent's care, and according to expert testimony the level of care and medical records for this patient, while hospitalized, were excellent. As a result of office visits by Ellis, Respondent wrote thirty-eight (38) prescriptions for controlled substances between April 20, 1981 and September 29, 1982 which included Percocet 5, Demerol, and Fiorinal. Ellis was being treated by Respondent for chronic headaches and pain from accident injuries, and also for a problem with his toe. However, according to expert testimony, the records kept by Respondent on Ellis' office visits were inadequate and do not provide documentation which would support and explain the controlled substances prescribed in this case. The absence of a thorough patient medical history, exam, evaluation, x- rays and lab tests in this patient's office records is explained by Respondent by the fact that this information was available in hospital records for this patient. Nevertheless, Respondent's office records for Ellis are totally inadequate. These office records do reflect that Respondent was aware of Ellis' overuse of controlled substances and the need to detoxify this patient on October 29, 1982. Yet he prescribed Percocet, a controlled substance, on five additional occasions after October 29, 1982. Without adequate documentation in the patient's records, the prescriptions for controlled substances written by Respondent for Ellis were without medical justification, excessive and inappropriate, according to expert testimony. Between July 14, 1980 and April 23, 1982, Respondent treated a patient named Alan Fogler. During this time Respondent wrote twelve (12) prescriptions for a total of 464 Percodan, a controlled substance. Respondent was treating Fogler for headaches, whiplash and a concussion reported by the patient, as well as allergies, but patient records reveal no x- rays, brain scans, lab work or neurological exams. According to expert testimony, patient records in this case are inadequate and do not justify the treatment rendered which consisted primarily of prescriptions for Percodan. Without adequate patient medical records, the prescriptions for controlled substances were without- medical justification, excessive and inappropriate, accordingly to expert testimony. While treating patients Belikoff, Ellis and Fogler, Respondent repeatedly reissued prescriptions for controlled substances without a substantiation of medical reasons in the patients' office medical records. According to expert testimony concerning the standards expected of osteopathic physicians in keeping office medical records on patients, Respondent did not perform with reasonable skill, nor meet the standards expected of physicians in this aspect of their practice. Vicki Cutcliffe, a deputy sheriff with the Broward County Sheriff's Office, saw Respondent in his office on March 30, April 11 and April 25, 1984 using the alias "Vicki Tarra". After taking a brief medical history which revealed that "Tarra" used alcohol daily, Respondent began treating her for situational anxiety by prescribing controlled substances, including Librium and Tranxene. On April 25 "Tarra" told Respondent she wanted some extra pills for her friend named Jo Ann and asked him to write her friend a prescription. Respondent said he could not do that, but did give "Tarra" a prescription for Tranxene and two refills, after initially giving her a prescription which allowed for only one refill. He told her that she could give some of the pills to her friend and then she could refill the prescription twice. Respondent knew that "Tarra" wanted the extra pills for a friend and that she would give them to her friend who was not a patient of Respondent. According to expert testimony, the treatment given to "Tarra" by Respondent, which consisted simply of prescriptions for controlled substances without adequate documentation of the reasons for this course of treatment in the patient's medical records, was totally inappropriate. Increasing a prescription when a patient says they want some extra pills for a friend is never justified and constitutes malpractice, according to expert testimony.
Recommendation Based upon the foregoing it is recommended that a Final Order be issued suspending Respondent's license for a period of two ( 2) years. DONE and ENTERED this 30th day of September, 1985, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 3 2301 (904) 488- 9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of September, 1985. COPIES FURNISHED: Stephanie A. Daniel, Esq. Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 John W. Gaul, D.O. 11360 Tara Drive Plantation, FL 33325 Dorothy Faircloth Executive Director Board of Osteopathic Medical Examiners 130 North Monroe Street Tallahassee, FL 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 Salvatore A. Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 ================================================================ =
The Issue The issues in this case are whether Respondent, a physician specializing in obstetrics and gynecology, committed medical malpractice in delivering a baby and/or failed to maintain medical records justifying the course of the mother's treatment; if so, whether Petitioner should impose discipline on Respondent's medical license within the applicable penalty guidelines or take some other action.
Findings Of Fact At all times relevant to this case, Respondent Mark N. Scheinberg, M.D., was licensed to practice medicine in the state of Florida. He is board-certified in obstetrics and gynecology. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed physicians such as Dr. Scheinberg. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Scheinberg committed two such offenses——namely, medical malpractice and failure to keep records justifying the course of treatment——in connection with the vacuum-assisted vaginal delivery of an infant born to Patient L.G. on February 2, 2005, at West Boca Medical Center. The crux of this case (though not the sole issue) is whether, as the Department contends, the standard of care required Dr. Scheinberg to perform a Caesarean section ("C- section") on L.G. due to the passage of time, instead of allowing her to continue to labor for approximately 13 hours and, ultimately, deliver vaginally. The events giving rise to this dispute began on February 1, 2005, at around 11:00 a.m., when L.G., whose pregnancy was at term, checked into the hospital after having experienced ruptured membranes. At 12:30 p.m. that day, L.G. signed a form bearing the title "Authorization for Medical and/or Surgical Treatment," which manifested her consent to a vaginal delivery or C-section together with, among other things, "such additional operations or procedures as [her physicians might] deem necessary." Immediately above L.G.'s signature on the form is an affirmation: "The above procedures, with their attendant risks, benefits and possible complications and alternatives, have been explained to me " The evidence is not clear as to when, exactly, Dr. Scheinberg first saw L.G., but that fact is unimportant. The medical records reflect that at 8:30 p.m. on February 1, 2005, Dr. Scheinberg gave a telephone order to initiate an IV push of the antibiotic Ampicillin; therefore, he had taken charge of L.G.'s care by that time. The nurses' notes indicate that at 10:00 p.m., L.G.'s cervix had dilated to "rim" or approximately nine centimeters—— meaning that the dilation was complete, or nearly so. At this time, and throughout the duration of L.G.'s labor, an external fetal heart monitor was in place to detect and record the baby's heartbeats and the mother's uterine contractions. An intrauterine pressure catheter ("IUPC")——a device that precisely measures the force of uterine contractions——was not inserted into L.G.'s uterus at any time during this event. The Department argues (although it did not allege in the Complaint) that, at some point during L.G.'s labor, the standard of care required Dr. Scheinberg either to place an IUPC or perform a C-section. Pet. Prop. Rec. Order at 10, ¶36. The Department's expert witness, Dr. John Busowski, testified unequivocally and unconditionally, however, that the standard of care does not require the use of an IUPC. T. 36. The undersigned credits this evidence and finds that Dr. Scheinberg's nonuse of an IUPC did not breach the standard of care. Dr. Scheinberg conducted a physical at around 2:00 a.m. on February 2, 2005, which included taking L.G.'s complete history and performing a vaginal examination. L.G.'s cervix remained dilated to approximately nine centimeters, and her labor had not substantially progressed for about four hours. Dr. Scheinberg noted in L.G.'s chart that the baby was in the posterior position at 2:00 a.m. The Department argues, based on Dr. Busowski's testimony, that as of 2:00 a.m., the standard of care required [Dr. Scheinberg to] choose one of the following options: (1) watch the patient for a few more hours to allow for progress; (2) place an IUPC to determine the adequacy of Patient L.G.'s contractions; (3) start Pitocin without the placement of an IUPC; or (4) perform a C- section. Pet. Prop. Rec. Order at 9-10, ¶ 32. The Department contends that Dr. Scheinberg breached the standard of care by choosing "simply to watch the patient for approximately 10 more hours"—— which was tantamount to "choosing to do nothing." Id. at 10, ¶¶ 33-34. In fact, Dr. Scheinberg chose to watch the patient, which was, according to Dr. Busowski, within the standard of care. Obviously, at 2:00 in the morning on February 2, 2005, Dr. Scheinberg did not choose to wait for 10 more hours, because at that point he (unlike the parties to this litigation) did not know what was about to happen. The nurses' notes reflect that L.G. was under close observation throughout the early morning hours, and that Dr. Scheinberg was following the situation. At 4:30 a.m., L.G. was set up to push and at 4:45 a.m. was pushing well. At 6:15 a.m., the notes indicate that Dr. Scheinberg was aware of the mother's attempts to push. At 6:45 a.m., he reviewed the strips from the fetal heart monitor. At 7:45 a.m., he was present and aware of L.G.'s status. From 7:00 a.m. until 8:00 a.m., no contractions were identifiable on the external monitor. At 8:00 a.m., however, L.G. was comfortable and pushing well. She stopped pushing at 8:30 a.m., but remained comfortable. Dr. Scheinberg then ordered the administration of Pitocin, a medicine which is used to strengthen contractions and hasten delivery. Although the Department faults Dr. Scheinberg for giving L.G. Pitocin at this relatively late stage of her labor, Dr. Busowski (the Department's expert witness) admitted being unable to say "that Dr. Scheinberg should have started Pitocin earlier " T. 72. The Department therefore has no clear evidential basis for second-guessing Dr. Scheinberg's professional judgment in this particular, and neither does the undersigned. At 9:10 a.m., L.G. resumed pushing. The baby's fetal heart tones (heartbeats) were stable. L.G. continued pushing, with her family present, until around 11:00 a.m., at which time Dr. Scheinberg discussed the situation with the patient and her family. Dr. Scheinberg explained to L.G. or her husband the risks of, and alternatives to, performing a vacuum-assisted vaginal delivery. Either L.G. or her husband gave verbal consent to the use of a vacuum device to assist in the delivery. Between 11:00 a.m. and 11:10 a.m., the fetal heart monitor detected some variable decelerations, meaning a decrease in heart rate that could be a sign of fetal distress. Dr. Scheinberg delivered the baby at 11:23 a.m., using a vacuum device to help pull the infant out of the birth canal. In his post-operative notes, Dr. Scheinberg wrote that his "pre-operative diagnosis" was "+3 station — prolonged second stage 2½ hrs." As a "post-operative diagnosis," Dr. Scheinberg recorded, "same + tight cord." He reported the following "findings": "tight cord cut on perineum[;] mec[onium] aspirated on perineum."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Dr. Scheinberg not guilty of the charges set forth in the Complaint. DONE AND ENTERED this 20th day of June, 2011, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of June, 2011.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30 and Chapters 455 and 458, Florida Statutes. Respondent is a licensed physician in the State of Florida and holds license number ME 0043566. Respondent has never been the subject of a previous complaint from the Department of Professional Regulation (now the Department of Business and Professional Regulation). No patient involved in this proceeding incurred injury as a result of any procedure performed by Respondent or as a result of any medical record kept by Respondent, nor did any patient claim injury or make a complaint against Respondent. Respondent derived no financial gain from any act or omission alleged in the administrative complaint. All events pertaining to this proceeding occurred in 1987 or 1988. Prior to February 8, 1988, the effective date of Chapter 88-1, Laws of Florida, Section 458.331(1), Florida Statutes provided, in pertinent part, as follows: The following acts shall constitute grounds for which the disciplinary action specified in subsection (2) may be taken. * * * (m) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results, and test results. * * * (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of s. 768.45 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances", shall not be construed to require more than one instance, event, or act. Section 25 of Chapter 88-1, Florida Statutes, became effective February 8, 1988, and amended the pertinent provisions of Section 458.311(1), Florida Statutes, to read as follows: The following acts shall constitute grounds for which the disciplinary action specified in subsection (2) may be taken. * * * (m) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results, test results, records of drugs prescribed, dispensed, or administered, and reports of consultations and hospitalizations. * * * (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of s. 768.45 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances", shall not be construed to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph. At the times pertinent to this proceeding, Petitioner had adopted no rules pertaining to the keeping of records by a licensed physician. Imperial Point Medical Center (Imperial Point) is a hospital located in Broward County, Florida. Unless otherwise indicated, all hospital records referred to in this matter are from Imperial Point. PATIENT #1 (C.S.) On August 8, 1988, Respondent performed an upper endoscopy on Patient #1, a male, who was 44 years old at the time of the procedure. This procedure was performed at Imperial Point on an outpatient basis. An upper endoscopy is the viewing of the mouth, the pharynx, the esophagus, the stomach and portions of the duodenum with a fiber optic instrument that allows direct visualization of the lining of these structures and allows therapeutic maneuvers. The records kept of this procedure performed on Patient #1 on August 8, 1988, include an outpatient hospital record entitled "Operative Report". The description of the procedure portion of this report includes the following: ". . . The gastric portion was infiltrated with 1:1,000 adrenaline . . ." Adrenaline, also known as epinephrine, is a vasoconstrictor that can be used to control minor bleeding and oozing. It is used regularly in gastroenterology to treat actively bleeding lesions or ulcers with evidence of recent bleeding prior to performing a more permanent type of hemostasis. Dr. Goldberg testified that epinephrine was usually injected into these areas by a needle. Dr. Goldberg was of the opinion that epinephrine should not be used in cases of trivial bleeding or oozing or after routine biopsies unless there is an imminent danger of a significant arterial bleed. The testimony of Dr. Cerda and Dr. Singh established that spraying epinephrine over an area that is subject to bleeding is a precautionary technique some gastroenterologists follow. Dr. Singh and Dr. Cerda have both either used this technique, or have observed its use by other physicians. The expert witnesses agreed that the injection by needle of epinephrine into the gastric wall would be a procedure that falls below an established standard of care. There was a dispute among the expert witnesses as to how the term "infiltrated" should be interpreted. Petitioner contends that the term "infiltrated" is synonymous with the term "injected", and that the medical records should be construed to mean that Respondent injected the gastric wall with a needle, and therefore practiced below the standard of care. This contention is consistent with the testimony of Dr. Goldberg. Respondent asserts that the medical record should be construed to mean that Respondent sprayed the gastric wall as a precautionary measure. This contention is consistent with the testimony of the expert witnesses who testified on behalf of the Respondent. This dispute is resolved by finding that the term "infiltrated" does not have the same meaning as the term "injected" and does not prove that Respondent injected Patient #1's gastric wall with a needle. This conclusion is based, in part, on the definition of the term "infiltrate" and on the context in which epinephrine is sometimes administered by gastroenterologists during this type procedure. According to The American Heritage Dictionary of the English Language, the term "infiltrate" means to pass a liquid or a gas into something through its interstices or to permeate with a liquid or gas passed through interstices. Dorland's Illustrated Medical Dictionary, Twenty Sixth Edition (Dorland) has a similar definition of the term "infiltrate". According to Dorland, an "interstice" is small interval, space, or gap in a tissue or structure. According to Dorland, the term permeate means to penetrate or pass through, as through a filter. Also according to Dorland, the term inject means the act of forcing a liquid into a part, as into the subcutaneous, the vascular tree, or an organ. Based on these definitions, it is found that the use of the term "infiltrate" is more consistent with the practice of spraying epinephrine onto the gastric wall, and that the use of the term "infiltrate" does not prove that Respondent injected the epinephrine into the gastric wall with a needle. It is found that Petitioner failed to prove that the use of epinephrine was improper or that the manner in which Respondent used the epinephrine during the subject procedure was improper. Since Petitioner failed to prove that Respondent injected Patient #1 with epinephrine, its charge that Respondent failed to document his reasons for doing so must also fail. A pathology report dated August 8, 1988 contained in the medical file provided a pathological diagnosis as follows: "esophageal brushings: no evidence of malignancy." Brushings are the result of passing a small brush through the biopsy channel of an endoscope, rubbing it over an area of concern that might have either a malignancy or a fungal infection, taking the brush out of the scope, wiping it on a microscopic slide, and sending the slide to the pathologist for cytological examination. The reference to the "esophageal brushings" in the pathology report was error. The brushings taken from Patient #1 during the procedure on August 8, 1988, came from the stomach, a fact obvious to all of the expert witnesses in light of the operative report and operative drawing made by Respondent. Because Petitioner failed to prove that Respondent took esophageal brushings from Patient #1, its charge that he failed to properly document his reasons for doing so must also fail. 1/ Petitioner proved that Respondent's medical records, including his office notes as to Patient #1 failed to contain an adequate medical history for Patient #1 and failed to reflect the findings of any physical examination of Patient #1 by Respondent. Petitioner further proved that such failures fall below an established standard of care as alleged in Count Two of the Amended Administrative Complaint. PATIENT #2 (R.B.) Patient #2 was a 70 year old male seen by Respondent for a consultation because of the patient's history of hematemesis, which is the vomiting of blood. Respondent prepared a formal consultation note dated September 25, 1988. The consultation note contains a description of the patient's condition, references a rectal exam, which was positive for blood, and indicates that a physical examination of the patient was made. Respondent again saw the patient on September 27, 1988 and performed an upper endoscopy. Dr. Goldberg was critical of the medical records kept by Respondent as to this procedure and was of the opinion that the medical records were inadequate. Other, equally credible expert witnesses were of the opinion that the medical records provided sufficient information to document the procedure. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records pertaining to this patient were inadequate. It is further found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. The records kept of this procedure reflect that Respondent "infiltrated" Patient #2 with epinephrine. This is the identical dispute over the meaning of the term "infiltrated" that pertained to Patient #1 as discussed above. For the reasons given in resolving the dispute as it pertains to Patient #1, it is found that the term "infiltrated" does not have the same meaning as the term "injected" and that the use of the term does not prove that Respondent administered the epinephrine by injecting Patient #2 with a needle. It is found that Petitioner failed to prove that the use of epinephrine was improper or that the manner in which Respondent used the epinephrine during the subject procedure was improper. Since Petitioner failed to prove that Respondent injected Patient #2 with epinephrine, its charge that Respondent failed to document his reasons for doing so must also fail. PATIENT #3 (B.B.) Patient #3, a 65 year old female was admitted to Imperial Point with chest pains by her physician, a Dr. Fanfan. Patient #3 had a history of cancer which included the prior surgical removal of a tumor. On October 3, 1988, Respondent performed a colonoscopy of Patient #3. A colonoscopy is an examination of the colon from the anus to the ileocecal valve using a fiber optic instrument. A colonoscopy is indicated to evaluate abnormal X-rays, changes in bowel habits, evidence of bleeding, suspicions of inflammation, tumors, or polyps. Respondent adequately performed the procedure on Patient #3. The colonoscopy detected that Patient #3 had polyps. Subsequent laboratory results established that these were hyperplastic polyps that required no follow-up. Had the polyp been an adenomatous polyp, which is a true neoplasm with malignant potential, a follow-up for recolonoscopy would have been appropriate in one year. Prior to receiving the pathology reports, on the polyp, Respondent recommended a six month follow-up for the patient. This follow-up recommendation was appropriate at the time it was made. Petitioner failed to prove that the recommendation that a follow-up be performed was below an established standard of care. Petitioner failed to prove that the recommendation that the follow-up for this patient with a history of cancer be in six months as opposed to one year fell below an established standard of care. The barium enema for this patient was originally scheduled by the attending physician, Dr. Fanfan. Dr. Fanfan clearly wrote a note on the same day following Respondent's report of the colonoscopy that the barium enema was pending, yet the attending physician did not cancel the barium enema. There is no disagreement among the experts that the barium enema was unnecessary in light of the findings of the colonoscopy. It is medically unnecessary and inappropriate for both tests to be performed on the same day. Dr. Goldberg was of the opinion that Respondent was responsible for the patient once he began his consultation and that Respondent should have canceled the barium enema. Dr. Cerda, Dr. Eberly and Dr. Singh were of the opinion that the attending physician was responsible for scheduling the barium enema and that the attending physician or the radiologist should have canceled the barium enema. Dr. Eberly testified that as the primary care physician, the admitting physician is the "captain of the ship" and has the responsibility to make final determinations with respect to tests of this nature. Because of the conflicting testimony from equally credible expert witnesses, it is found that Petitioner failed to prove that Respondent violated an established standard of care by not cancelling Patient #3's enema. Dr. Goldberg was of the opinion that Respondent's medical records pertaining to Patient #3 were inadequate. He had several criticisms of the records. Dr. Goldberg opined that there should have been a formal consultation note on Patient #3's chart that included past history, present illness, review of systems, allergies, pertinent laboratories, a thorough organ specific or system examination, an impression, an adequate discussion of the consultant's impression and the consultant's plans. He opined that the indications for Patient #3's procedure were inadequately dictated on the procedure notes and that Respondent's history pertaining to Patient #3 was inadequate because there was no pertinent review of systems or past history, no mention of the previous tumor, no mention of allergies, and an extremely scant examination. Other, equally credible expert witnesses were of the opinion that the medical records were adequate. It is found that Petitioner failed to prove the standard by which the adequacy of this patient's medical records are to be judged, other than the pertinent statutory standards set forth above. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records fell below an established standard of acceptability. PATIENT #4 (E.K.) On October 4, 1988, Patient #4, a 92 year-old female, was admitted to the hospital with an acute onset of vomiting, dehydration, and abdominal pain. Respondent was asked by Patient #4's attending physician to evaluate Patient #4 for a potential small bowel obstruction following an X-ray that was consistent with a small bowel obstruction. Respondent performed an upper endoscopy on Patient #4 on October 7, 1988. An obstruction of the intestines is a blockage in the large or small intestine. The bowel behind the blockage may become inflated with fluid or air and may be seen on X-ray. The obstruction may result from a variety of abnormalities. Dr. Goldberg was of the opinion that the upper endoscopy was contra- indicated and potentially dangerous to the patient because of the X-ray indicating a complete bowel obstruction. Dr. Goldberg was also of the opinion that an upper endoscopy should be used only under compelling circumstances if there is a partial bowel obstruction. Dr. Goldberg was of the opinion that Respondent did the right tests on Patient #4, but in the wrong order since he did not first rule out an obstruction. Prior to performing the upper endoscopy Respondent monitored the patient for several days. During that time period, examinations indicated that the patient was having bowel movements. Both the attending physician's notes, Respondent's notes, and the nurse's notes indicate positive bowel signs on October 5 and 6, indicating that there was not a complete bowel obstruction. Respondent ordered a Golytely preparation administered to the patient, which usually consists of one or two liters of non-absorbable solution that basically washes the bowel out. That preparation would have been improper with a complete bowel obstruction. Dr. Goldberg was of the opinion that the use of a Golytely prep in this patient was a gross judgment error. Dr. Singh was of the opinion that there was no contra-indication for using the preparation in this situation. Petitioner failed to prove that Patient #4 had a complete bowel obstruction or that the procedure, including the use of the Golytely preparation, violated an established standard of care. It is found that Respondent was acting within the scope of his discretion as the consulting physician to order the administration of the Golytely preparation and to perform the upper endoscopy. On October 11, 1988, Respondent performed a colonoscopy on Patient #4. Respondent stated on the operative report that the colonoscopy was indicated because of diverticulitis. Diverticulitis was not mentioned in any of Respondent's notes concerning Patient #4, and there was no notation as to the reasons Respondent thought the patient had diverticulitis. Although Respondent failed to document why he felt that diverticulitis was an appropriate indication for the colonoscope, there is no dispute that a colonoscope was, in fact, indicated. Further, the colonoscope established that the pretest diagnosis of possible diverticulitis was not incorrect. The colonoscopy revealed areas of colitis, and the pathology report noted an ulcer with acute and chronic inflammation. Respondent's experts testified that they were of the opinion that Respondent violated no established standard by listing diverticulitis as an indication for the colonoscopy. It is found that Petitioner failed to prove that Respondent practiced below an established level in listing diverticulitis as an indication for the colonoscope. During the colonoscopy, Respondent found several mildly bleeding areas and infiltrated Patient #4 with epinephrine. For the reasons discussed pertaining to Patient #4, it is found that Petitioner failed to prove that Respondent violated an established standard of care in administering epinephrine to Patient #4. Dr. Goldberg was of the opinion that Respondent's handwritten consultation report was inadequate. Dr. Goldberg bases his conclusion on the following observations. The report was difficult to read and failed to include any significant historical events concerning Patient #4. In his consultation report, the Respondent failed to note anything about having done a rectal examination on this patient, whether or not the abdomen was distended, and whether there were active or inactive bowel sounds. Dr. Goldberg was of the opinion that these findings would help to distinguish between an obstruction and an ileus or paralysis of the bowel. Dr. Goldberg was also of the opinion that the patient's records of the upper endoscopy performed October 7, 1998, fail to reveal any significant findings. Other, equally credible expert witnesses were of the opinion that the medical records were adequate. It is found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. While it may be concluded that Respondent's medical records could be improved, Petitioner failed to prove that the medical records fell below an established standard of acceptability. PATIENT #5 (J.T.) Patient #5, an 89 year-old male, was admitted to Imperial Point with a history of peptic ulcer disease and arthritis. This patient was seen by Respondent on a consulting basis. The patient was vomiting blood and Respondent was asked to see the patient to determine the source of the bleeding. Respondent performed an upper endoscopy on October 13, 1988, and found a significant outlet obstruction. On October 17, 1988, a G.I. series was performed and a repeat upper endoscopy and pyloric dilatation was performed. The procedures performed by Respondent were properly indicated and had a beneficial result to the patient. Back-to-back pyloric dilatations were appropriate and clinical judgment was properly exercised. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to the upper endoscopy of October 13, 1988, in that Respondent's operative report failed to document Respondent's findings in detail. Dr. Goldberg testified that an essential endoscopy report that physicians are trained to do should include the following: indications for the procedure, medication used to sedate the patient, identification of instrument used, description of the anatomical landmarks and their condition as visualized by the physician passing the endoscope, the removal of the scope, the physician's impressions and what the physician plans to do about those impressions, how the patient tolerated the procedure and what the patient's condition was after the procedure, and that the patient was sent to the recovery area. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to the procedures performed on this patient on October 17, 1988, in that Respondent's operative report did not document Respondent's findings in detail and did not indicate if the scope was passed through Patient #5's dilated pylorus into the duodenum. In Respondent's impressions on the second endoscopy, he noted pyloric stenosis and duodenal ulcer. In his procedure note Respondent does not mention whether he passed the scope into the duodenum or how he knew there was a duodenal ulcer. Dr. Goldberg was of the opinion that Respondent did not properly document what he did. On October 18, 1988, Respondent performed a repeat pyloric dilation on Patient #5. Dr. Goldberg was of the opinion that Respondent failed to record the reasons for the second procedure and to document his findings. Dr. Goldberg was of the opinion that the third endoscopy note did not adequately detail the examinations of the esophagus and stomach. Dr. Goldberg was of the opinion that every procedure note stands alone, and that if a physician does an endoscopy on day one and repeats it on day two, the physician still must make that report complete because it is not always going to be part of a document. Dr. Goldberg was of the opinion that Respondent's records did not stand alone. Dr. Goldberg was of the opinion that Respondent's handwritten consultation note was sketchy and should have contained a history of allergies because of the need to give the patient medications for sedation. Dr. Goldberg's criticisms of Respondent's medical records do not prove that the medical records kept by Respondent were inadequate as measured by an established standard. Other, equally credible expert witnesses were of the opinion that the medical records provided sufficient information to document the procedures and that the records were adequate. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records were inadequate. It is further found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. PATIENT #6 (D.Y.) From October 19, 1988, until October 22, 1988, Respondent was consulting physician to Patient #6, a 72 year-old male, who was admitted to Imperial Point with rectal bleeding. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to Patient #6 because a formal consultation note was lacking. The medical records which were reviewed by Dr. Goldberg were incomplete when reviewed by him. A specific reference is made to a consultation note that is not contained in the hospital records. Respondent established that other medical records were missing from the hospital records. In light of the specific reference to the consultation note, it is found that the absence of this consultation note from the hospital records is insufficient to prove that there existed no consultation note. On October 20, 1988, Respondent performed an colonoscopy on this patient and a biopsy was taken in the segmental descending colon area. The colonoscopy could not be completed because the colonoscopy could not pass to the patient's cecum. The following recommendation was made by Respondent (the original is in all capital letters): IN VIEW OF NOT REACHING TO THE CECUM, THE PATIENT WOULD NEED BE (this is an abbreviation for barium enema) AND ALSO IF EVERYTHING IS NEGATIVE, RECOLONOSCOPY IN ONE YEAR AND IF THERE ARE ANY CHANGES IN THE BIOPSY OF THE POLYP, THEN ACCORDINGLY WILL PLAN. On October 21, 1988, the follow-up barium enema was performed by Dr. Nicholas M. Arfaras, a radiologist. The radiology report reflected the following finding: "Also in the sigmoid there is an approximately 1 cm. rounded filling defect identified near the junction with the descending colon. This is felt to be secondary to a polyp." The possible polyp detected by the barium enema should have been followed up. However, it was not established that Respondent was consulted by the attending physician about the results of the barium enema. Dr. Lipton, as the attending physician, would have had the responsibility for following up the recommendations made by Respondent and for bringing Respondent or another gastroenterologist in for further consultations following the barium enema if Dr. Lipton had believed it necessary to do so. This patient was discharged from Imperial Point by Dr. Lipton on October 22, 1988. The final page of the discharge summary for this patient reflected the following notation: "Condition was improved. The patient is to have a follow up in one week in the office with Dr. Lipton and with Dr. Gupta in two weeks." The evidence presented in this proceeding, including Respondent's office notes, does not reflect that Respondent had any involvement with this patient after October 21, 1988, until 1990, when he performed on the patient at North Broward Medical Center a procedure described as a "multiple colonoscopy with multiple biopsies and cauterization." This procedure in 1990 revealed multiple polyps. The polyp removed on colonoscopy in 1988 was an adenomatous polyp, a polyp with significant malignant potential. This patient needed a follow-up colonoscopy in one year. Respondent was the consulting physician and recommended reevaluation of the patient in one year. Follow-up care was not the responsibility of Respondent, but of the treating physician. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records in that Respondent failed to adequately document the indications for the colonoscopy performed on Patient #6 and why the colonoscope could not be passed to Patient #6's cecum. Dr. Goldberg opined that a physician doing a colonoscopy needs to tell why he did not get to the cecum so that the next physician colonoscoping this patient can take appropriate precautions. Other, equally credible expert witnesses were of the opinion that the medical records were adequate and provided sufficient information to document the procedures that were performed. Petitioner failed to prove that the medical records were inadequate. Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. PATIENT #7 (C.R.) Respondent was a consulting physician to Patient #7, a 64 year old male who was hospitalized with rectal bleeding. Respondent saw this patient because of a possible colonic fistula, which is a connection with any piece of the intestine and some other structure. Respondent recommended a barium small bowel X-ray and a barium enema, both appropriate clinical recommendations. On November 11, 1987, Respondent performed a colonoscopy on Patient #7. Petitioner contends that Respondent failed to keep adequate written medical records pertaining to the aforementioned procedure in that Respondent failed to document an adequate history as an indication of Patient #7's colonoscopy. This contention is rejected based on the testimony of Dr. Singh. The medical records provide adequate justification for the procedure. Dr. Goldberg was critical of Respondent's records pertaining to this patient and considered the records inadequate. He was of the opinion that the records should have better detailed his findings and should have recorded any follow-up plans for a repeat colonoscopy on the patient. Other, equally credible expert witnesses were of the opinion that the medical records were adequate and provided sufficient information to document the procedures that were performed. Petitioner failed to prove that the medical records were inadequate. Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Petitioner enter a final order which finds that Respondent violated the provisions of Section 458.331(1)(m), Florida Statutes, by failing to provide a history or physical examination for Patient #1 as alleged in Count Two, which reprimands Respondent for that violation, and which imposes an administrative fine in the amount of $250.00 against the Respondent for that violation. It is further recommended that all other charges against Respondent contained in the Amended Administrative Complaint be dismissed. DONE AND ENTERED this 12th day of October, 1993, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of October, 1993.
The Issue The issues to be determined are whether Respondent overprescribed controlled substances and failed to maintain legible medical records as alleged in the Administrative Complaint and, if so, the appropriate penalty.
Findings Of Fact The Department of Health, through its Board of Osteopathic Medicine, is the state agency charged with regulating the practice of osteopathic medicine in the state of Florida, pursuant to section 20.43, and chapters 456 and 459, Florida Statutes. At all times material to this proceeding, Richard D. Vitalis was a licensed osteopathic physician in the state of Florida, holding license number OS 4823. Respondent’s current address of record is 3774 China Grove Mews Lane, Fairfax, Virginia 22025. At all times material to the Administrative Complaint, Respondent was practicing as an osteopathic physician at All Family Medical in North Lauderdale, Florida, a licensed pain management clinic. On or about January 27, 2011, L.N., a 29-year-old female, and a resident of Biloxi, Mississippi, presented to Respondent at his Fort Lauderdale office with complaints of back pain. Between January 27, 2011, and August 3, 2011, L.N. presented to Respondent on seven occasions. L.N. indicated that she had previously been prescribed oxycodone 15 mg, oxycodone 30 mg, and Xanax 2 mg. She also indicated that she was dependent on her prescriptions, that she needed them every few hours, that she expected to need them the rest of her life, and that they were not helping resolve her medical problems. L.N. underwent a magnetic resonance imaging (MRI) study on January 27, 2011. The MRI diagnostic images showed that L.N.’s spine had no evidence of pathological disease. There was a normal alignment of the vertebral bodies without evidence of compression or spondylolisthesis. There was normal signal throughout the vertebral bodies and within the visualized spinal cord. There was no significant disc disease, evidence of spinal stenosis, or exiting nerve root impingement at L1-2, L2-3, L3-4, or L5-S1. Although the MRI depicted some annular disc bulging at L4-5, there was no spinal stenosis or neural foraminal stenosis. There was no pathology shown on the MRI, and it was, in general, “a normal MRI.” As such, the MRI would not provide support for a conclusion that L.N. would have been in pain. There were no diagnostic images in L.N.’s file to contravene the medical conditions shown in the MRI. The only evidence of anything requiring treatment was L.N.’s complaint of low back pain. Such a complaint would call for muscle relaxers, physical therapy, hot/cold packs, or ultrasound, rather than narcotic pain medications. There was no evidence in the medical records that L.N. exhibited signs of nerve root impingement with pain radiating down the leg. The records did not demonstrate that Respondent performed a comprehensive medical examination of L.N., or that Respondent performed any type of objective testing of L.N., including straight leg raises, checking for deep tendon reflexes, or palpation of the area of concern for spasms. The records did not contain an adequate medical history of L.N., including height, weight, temperature, pulse, respiration, blood pressure, age, date of birth, and medication lists, nor did they contain an assessment of L.N.’s chief complaint or plan of treatment. The intake from L.N.’s first visit to Respondent indicated that she was taking opioids and benzodiazepines, though there was no evidence of prescriptions or prescribing physicians for those substances. The records did not demonstrate that Respondent obtained records of prior treating physicians, nor was there any evidence of an effort to do so. The records do not demonstrate that Respondent consulted with any other physician which, in the case of treatment resulting from an MRI review, would fail to meet the standard of care. The records do not demonstrate that Respondent recommended alternative interventions for L.N.’s pain complaints, including physical therapy, which would have been appropriate, and within the standard of care given the normal MRI results. The only alternatives noted were “heat” and “massage” on January 27, 2011, and “heat” on June 23, 2011. Although it is possible that other alternative interventions were recommended, the illegibility of the intake forms prevents such a finding. The failure to recommend alternative interventions was a failure to meet the standard of care. On L.N.’s first visit to Respondent on January 27, 2011, a urine drug screen was performed. The drug screen tested positive for opioids and benzodiazepines. Subsequent to that first visit, Respondent performed no other drug tests. Such tests can confirm that the patient is taking prescribed medications, and not diverting them, and that the patient is not taking other non-prescribed medications. It is the medical standard of care to perform follow-up drug tests of patients when prescribing high doses of controlled substances, including opioids. The failure to closely monitor L.N. when prescribing high doses of opioids and benzodiazepines was a failure of the standard of care. Respondent did not communicate with L.N.’s pharmacy to ensure that she was not getting prescribed medicines from other doctors. Such information was, in 2010 and 2011, available from pharmacies. It was, during that period, the medical standard of care to communicate with the dispensing pharmacy. Respondent failed to meet that standard of care. There was no evidence to the contrary. Despite the fact that L.N. presented to Respondent with a stated history of opioid use and a positive drug screen, Respondent did not record L.N.’s medication history for the period up to her first visit with Respondent. The failure to take a medication history to substantiate the need and justification for the prescription of high-dose opioids is contrary to the 2010-2011 medical standard of care. Oxycodone was, during the relevant period, a Schedule II controlled substance with a high potential for abuse, and an accepted but severely restricted medical use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence. § 893.03(2), Fla. Stat. Roxicodone is a brand name for oxycodone hydrochloride. It is a short-acting opioid that is rapidly absorbed. Short- acting opioids have a greater potential for abuse. Furthermore, prescription of short-acting opioids, such as Roxicodone, would not be within the standard of care for long-term, chronic pain such as that described by L.N. Xanax is the brand name for alprazolam and is prescribed to treat anxiety. Alprazolam was, during the relevant period, a Schedule IV controlled substance, with a low potential for abuse, and an accepted medical use in treatment in the United States. Abuse of alprazolam may lead to limited physical or psychological dependence. § 893.03(4), Fla. Stat. At L.N.’s initial January 27, 2011, visit, Respondent prescribed medications including 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. The prescribed doses and amounts were consistent with L.N.’s self-reported medications that she was then taking, presumably prescribed by “Dr. Sanchez” in Biloxi. Respondent’s plan of treatment listed the medications L.N. requested and recommended follow-up in one month. The records contain no individualized treatment plan. Respondent’s examination notes are entirely illegible. Respondent’s records lack copies of prescriptions issued to L.N. on January 27, 2011. A patient agreement and informed consent form was included in L.N.’s patient file, but was not signed by L.N. L.N. next presented to Respondent with complaints of chronic lower back pain on February 22, 2011. The intake form is largely illegible, though “overall feels well” is discernable. At that visit, Respondent prescribed 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment was medication refill and follow-up in one month. Again, there was no individualized treatment plan, and the examination notes were largely illegible. L.N. presented to Respondent with further complaints of chronic lower back pain on March 22, 2011. The intake form is largely illegible, though “overall feels well” is discernable. Respondent again prescribed 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment was medication refill and follow-up in one month. Again, there was no individualized treatment plan, and the examination notes were illegible. L.N. presented to Respondent on April 21, 2011. The intake form is largely illegible, though “overall feels well” is discernable. Respondent renewed L.N.’s previous prescriptions. L.N. next presented to Respondent with complaints of chronic lower back pain on May 19, 2011. The intake form is entirely illegible. Respondent prescribed 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment was medication refill and follow-up in an illegible timeframe. There was no individualized treatment plan. Respondent’s examination notes were illegible and minimal. On June 23, 2011, L.N. presented to Respondent. The intake form, though largely illegible, appears to state that “pt feels good pain solved with meds.” The treatment prescribed by Respondent apparently having the desired effect, Respondent renewed L.N.’s prescription for 210 tablets of Roxicodone Oral 30 mg (though in two separate prescriptions for 180 tablets and 30 tablets, respectively), 120 tablets of Roxicodone Oral 15 mg, and 60 tablets of Xanax Oral 2 mg. The prescription originally called for 150 tablets of Xanax, but Respondent struck 90 of those. Respondent’s plan of treatment was medication refill and follow-up at the next appointment on July 23, 2011. A monthly medication dosage evaluation was completed for the June visit, as was a pain management treatment plan medical record. Those records provided little individualized information regarding L.N.’s plan of care. The pain management treatment plan form indicated that drug testing was completed; however, there were no results. L.N.’s final visit to Respondent occurred on August 3, 2011. She indicated, in what appears to be her handwriting, that she had used a “hot bath,” “heat,” and “some exercise.” Her treatment objective continued to be “complete resolution of pain with medication.” At that visit, Respondent prescribed 150 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 60 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment included only a list of medications. The pain management treatment plan form indicated that drug testing was completed; however, there were no results. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent failed to practice medicine with that level of care, skill, and treatment recognized in general law as being acceptable under similar conditions and circumstances in his treatment of L.N. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent prescribed excessive and unnecessary amounts of Roxicodone and Xanax without a justifiable basis to do so, especially since the January 27, 2011, MRI report did not support a determination that L.N. was experiencing back pain so as to justify Respondent’s course of opioid treatment for L.N. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent failed to create and maintain adequate and legible records supporting the course of treatment for L.N., or records documenting performance of a comprehensive physical examination of L.N. proportionate to her diagnoses. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent failed to adequately monitor L.N.’s use of opioid therapies. The findings set forth herein are the result of Dr. Porcase’s undisputed expert testimony regarding the standard of care as it existed in 2010-2011, as well as the undersigned’s independent review of the record. Whether Respondent could have produced evidence to support his treatment of L.N. will remain a mystery, since Respondent essentially abandoned this proceeding. Despite challenging the Department’s Administrative Complaint, Respondent minimally and incompletely responded to written discovery, failed to meaningfully participate in Dr. Porcase’s deposition, twice refused to appear for his own deposition, despite personal service of the notice, and failed to make an appearance at the final hearing. In the absence of any testimony or evidence to counter that of the Department, the evidence presented by the Department, including the testimony of Dr. Porcase, was clear and convincing as to the matters set forth herein. Despite Respondent’s failure to actively contest the allegations in the Administrative Complaint, it must be recognized that the allegations concern a single patient over a total period of scarcely more than 6 months. There was no pattern of misconduct. Furthermore, Dr. Porcase acknowledged that the practices regarding the prescription of opioids in 2010-2011 were far different from those that exist today. Rather, “there was no standards that you were -- individualized your treatment to the pathology on imaging studies and patient’s complaints and their ability to function on medicine.” As to a doctor’s actions to rule out a patient’s drug-seeking behavior, he testified that “[i]t would be the individual physician having to make that determination based on his experience and diagnostic testing . . . and physical exam.” While the undersigned believes and gives weight to Dr. Porcase’s opinions regarding the standard of care, his testimony is equally compelling that the standard was not as clear-cut in 2010-2011 as it is in 2018. Though not affecting the ultimate findings regarding violations of law, it does affect the nature of the penalty that is warranted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Osteopathic Medicine, enter a final order: determining that Respondent violated sections 459.015(1)(x), 459.015(1)(t), and 459.015(1)(o); imposing an administrative fine of $2,000; issuing a letter of reprimand against Respondent’s license to practice osteopathic medicine; and awarding costs incurred in the prosecution of this case to the Department. DONE AND ENTERED this 15th day of May, 2018, in Tallahassee, Leon County, Florida. S E. GARY EARLY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of May, 2018. COPIES FURNISHED: Ann L. Prescott, Esquire Philip Aaron Crawford, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Richard D. Vitalis, D.O. 230 Caddie Court DeBary, Florida 32713 Richard D. Vitalis, D.O. 3774 China Grove Mews Lane Fairfax, Virginia 22025 Kama Monroe, Executive Director Board of Osteopathic Medicine Department of Health 4052 Bald Cypress Way, Bin C-06 Tallahassee, Florida 32399-3257 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed)
