Findings Of Fact The parties further stipulated at the hearing that the billing for which Shands seeks payment does not include charges for services rendered during the months Linda Sue Austin was being treated as an out-patient at Shands. All other facts, as stipulated to by the parties and as set forth above, are hereby adopted.
The Issue The issue is whether respondent's license as a physician should be disciplined for the reasons cited in the administrative complaint filed on December 21, 1992.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background Respondent, Kenneth Aung-Din, is a licensed medical doctor having been issued license number ME 0051923 by petitioner, Agency for Health Care Administration, Board of Medicine (Board). He is board certified in emergency medicine having received his certification in 1994. When the events herein occurred, respondent was an emergency room physician at Memorial Medical Center (MMC) in Jacksonville, Florida. On the evening of February 21, 1991, V. P., a thirty-five year old female who was then eight months pregnant, presented herself to the MMC emergency room complaining of lower abdominal discomfort, difficulty urinating, and a five-hour history of nausea and vomiting. After being examined and treated by respondent, and diagnosed as having a urinary tract infection, the patient was released the same evening. Less than an hour later, however, the patient went into labor and delivered a new born. On December 21, 1992, the Board issued a two-count administrative complaint charging that, while treating V. P., respondent failed to practice medicine with that level of care, skill, and treatment which a reasonably prudent similar physician recognizes as acceptable under similar conditions and circumstances in that he "failed to obtain fetal heart tones, determine fetal position, and ausculatate for fetal heart tones with a doppler that was available to him in the ER when he examined (the) patient, who was a high risk near term obstetrical patient." The complaint further alleges that respondent failed to keep written medical records justifying the course of treatment of V. P., "including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations." Respondent denied all material allegations and requested this hearing to contest these charges. Did respondent deviate from the standard of care? On presentment to the emergency room nurse around 8:53 p.m. on February 21, 1991, V. P. complained of generalized abdominal pain and pressure since around 3:30 p.m. that day, with nausea and two episodes of vomiting. She also complained that she was unable to urinate since approximately 2:30 p.m. An additional complaint was allegedly made by the patient, but it is not a part of the nurse's notes and thus is hearsay in nature. The patient further disclosed that this was her second pregnancy. After recording in her notes the patient's complaints, the nurse, on her own volition, conducted a nitrozine test which was negative. It later came to light that the test was improperly conducted by the nurse, but respondent was never told this fact. Respondent first observed the patient around 9:08 p.m. and recalled that she "was obviously in discomfort." Based on V. P.'s complaints, respondent initially suspected that she might be in preterm labor. After obtaining a patient history, respondent palpitated V. P.'s abdomen for any pain, tenderness, abnormalities or contractions. Although V. P. was eight months pregnant, she was nontender and exhibited no signs of active labor. The patient also denied that she was having contractions. Based on V. P.'s primary complaint of urinary retention, respondent asked the nurse to insert a Foley catheter in V. P.'s bladder. Before the nurse did so, V. P. was able to urinate on her own accord. Even so, respondent ordered a catheter inserted around 9:30 p.m. to empty any residual in the bladder. This procedure yielded approximately 200cc. of urine which was used for a urinalysis test. By now, having urinated at least once, and having her bladder emptied, V. P.'s pain and discomfort had gone away, and she appeared to be "totally comfortable and with no complaints." After seeing the results of the nitrozine test around 9:55 p.m., respondent conducted a pelvic examination. Still considering the possibility of preterm labor, respondent inserted a vaginal speculum into the patient to see if there was any bleeding or fluid. Neither was present, and a manual examination of the patient revealed that the opening to her cervix was thick and closed. A patient in preterm labor would generally present signs of bleeding or fluid, and the cervix would have begun to open and "thin out." Given these findings, and the fact that V. P. was exhibiting no signs of labor or discomfort, it was reasonable for respondent to conclude that V. P. was not in preterm labor. The results of the urinalysis were reviewed by respondent around twenty minutes before the patient's discharge. By that time, she had voluntarily urinated at least three times since first arriving at the emergency room. The test results revealed 1+ protein, trace ketones, and 0-2 white and red blood cells. Also, they indicated that a sterile (uncontaminated) specimen had been taken, and that trace bacteria were present. Because trace bacteria, if not treated, can lead to "a very significant" urinary tract infection, and V. P. had previously experienced abdominal "pressure" and an inability to urinate, both signs of an infection, respondent prescribed Ampicillin, an antibiotic, on the assumption V. P. had a urinary tract infection. This diagnosis is not unusual for pregnant women, and even petitioner's expert agreed that V. P. had presented some of the "classical signs" of a urinary tract infection. After having observed the patient for almost two hours, during which time V. P. exhibited no objective clinical signs of active labor, respondent discharged the patient around 10:50 p.m. In doing so, respondent relied not only on the above observations, but also upon the results of his pelvic and abdominal evaluations, the urinalysis test results, and the fact that all of V. P.'s complaints (pain, nausea and vomiting) had been resolved. It was also reasonable to conclude that had the patient been in preterm labor, her symptoms would have progressed, rather than abated, during the two hours she was in the emergency room. At the time of discharge, respondent gave V. P. instructions to make a follow-up visit that week with her primary physician at University Medical Center (UMC), and if her condition did not improve during the interim, to return to MCC or call the "emergency department right away for further assistance." She was also given a prescription for an antibiotic for the urinary tract infection. Just prior to leaving the hospital, V. P. urinated one last time and allegedly told the nurse that she had started "spotting." Even if V. P. actually reported this critical fact, the nurse failed to disclose this to respondent, and he cannot be faulted for the nurse's omission. Had respondent known, or even suspected, that she had just begun bleeding, he would have sent her upstairs to the obstetrical wing for further observation. The complaint levels a number of criticisms at respondent's conduct which, if true, indicate that he failed to meet the appropriate standard of care. In addressing these criticisms, it should be noted that petitioner's own expert agreed that, at best, this was "a difficult case," and one that all emergency room physicians "hate to see." The complaint characterizes V. P. as a "high risk near term obstetrical patient." The use of the term "high risk" is based principally on the fact that an ultrasound conducted at UMC on February 19, 1991, revealed that the fetus was in a breech position. But respondent was never told this fact, and even petitioner's expert conceded that without this information, it was reasonable for respondent to consider V. P. as a normal risk pregnancy. The complaint first alleges that respondent "failed to assess the status of the fetus by neglecting to auscultate for fetal heart tones with a doppler that was available to him in the Emergency Department." A doppler is a device used to listen for fetal heart tones and, while not as effective as other monitoring devices, is nonetheless useful in detecting fetal distress or preterm labor. Here, respondent did not assess the status of V. P.'s fetus because her pain and discomfort had disappeared after her urinary tension was resolved, and she no longer exhibited any signs, clinical or otherwise, of preterm labor. At the same time, while doppler machines were available in emergency rooms, including MMC, during the early 1990's when this incident occurred, it was not prevailing protocol for emergency room physicians to automatically conduct fetus monitoring for what they perceived to be normal risk pregnancies. While the standard for emergency room physicians has subsequently changed, and fetal heart tones are now routinely monitored on all pregnant women twenty weeks and above, respondent did not deviate from the prevailing standard of care in February 1991 by failing to use a doppler. The complaint next alleges that a prudent physician "would have telephoned (V. P.'s) treating physician from UMC, or the obstetrician- gynecologist on call in order to properly assess (her) condition." As to calling V. P.'s treating physician, however, the more persuasive evidence shows that it would have been imprudent to attempt to contact V. P.'s primary treating physician because she had been treated by an unknown resident at another hospital, and at that hour of the night the chance of speaking with that resident was highly improbable. Then, too, since her complaints had been resolved, there was no need to contact another physician. As to respondent's failure to obtain a specialist consultation, the more persuasive evidence shows that the diagnosis of urinary tract infection was reasonable under the circumstances, and after the patient exhibited no signs of distress for at least an hour and a half, her discharge was appropriate. While it is true, as petitioner suggests, that the initial complaints by V. P. of pressure, nausea, vomiting and abdominal pains can be signs of preterm labor, these complaints were resolved after the catheter was inserted, and there were no corroborating indications of labor. Then, too, based on the information at hand, respondent reasonably concluded that V. P. was a normal risk pregnancy. Finally, later inquiry disclosed that during her first pregnancy, V. P. was in labor for only fifteen minutes, a remarkably short period of time. Respondent was not aware of this fact at the time of treatment. As it turned out, V. P. experienced another remarkably short period of labor on the evening of February 21, 1991. In summary, the more persuasive evidence supports a finding that, while treating V. P. in February 1991, respondent practiced medicine with that level of care, skill and treatment which was recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. C. Adequacy of Medical Records The complaint generally alleges that respondent failed to keep written medical records justifying the course of treatment of the patient. In the history section of his notes for patient V. P., which have been made a part of this record, respondent made the following recordations: 2110 - 35-year old white female, eight months pregnant; complaining of unable to urinate; dysuria; feels like pressure; denies vaginal bleeding; no contractions; Under the physical examination portion of his notes, respondent reported as follows: white female, well developed, awake, alert, times 3. Abdomen, pregnant uterus equals 8 months; nontender. Pelvic - zero blood; oz thick and closed. Late entry - 2/26/91, Nitrozine Test performed, which was negative. Finally, under his diagnostic impressions and discharge instructions, respondent wrote as follows: UTI (urinary tract infection) Ampicillin 250 mg, q.i.d., for 7 times. Tylenol if needed. Follow up, UMC this week. Return if any problems. In responding to the charge that his notes were inadequate or incomplete, respondent agreed that the diagnostic impressions section would have been more accurate and complete if he had written "urinary retention- resolved/UTI" rather than "UTI" alone. This is because urinary retention was a secondary diagnosis which was resolved during the patient's visit. In this respect, the records are not adequate. In addition, because the records fail to note that V. P.'s symptoms of abdominal pain and pressure were resolved, they lack completeness. In all other respects, they are found to be adequate.
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 respondent guilty of violating Section 458.331(1)(m), Florida Statutes, as described above, and that he be given a reprimand. Count I should be dismissed. DONE AND ENTERED this 1st day of October, 1996, in Tallahassee, Florida. DONALD R. ALEXANDER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 1st day of October, 1996. COPIES FURNISHED: Dr. Marm Harris, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0770 Kevin W. Crews, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 W. Jerry Foster, Esquire 1342 Timberlane Road, Suite 101-A Tallahassee, Florida 32312-1775 Jerome W. Hoffman, Esquire Agency for Health Care Administration Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue The issue presented is whether Petitioner is entitled to licensure as a clinical laboratory technologist in microbiology.
Findings Of Fact Applications for licensure as a medical technologist in microbiology are available from the Board's office. With the application, the Board staff sends directions for completing the application form, a copy of the relevant statutes and Board rules, the names and addresses of accredited and Board-approved medical technology training programs, and other materials. Petitioner's application for licensure as a medical technologist is dated January 20, 1999. She submitted that application and all required fees for licensure to the Board. Petitioner received her degree as a doctor of medicine from the Higher Institute of Medical Sciences in Havana, Cuba. That degree satisfies the educational requirements for licensure as a medical technologist in the State of Florida. In addition to minimum educational requirements, licensure as a technologist requires certain minimum experience working in a clinical laboratory performing a wide array of tests or completion of a technologist-level accredited or Board- approved medical technology training program. This requirement is clearly set forth in the materials the Board forwarded to Petitioner as part of her application package. The training program Petitioner completed in Cuba is not on the list of the Board's approved or accredited medical technology training programs. Petitioner acknowledges that she has not enrolled in, or completed, a technologist-level accredited or Board-approved technology training program. Therefore, in order to take the licensure examination and qualify for licensure Petitioner must have completed three years of full-time employment in a clinical laboratory performing a wide array of tests. None of Petitioner's work experience has been in the United States. With her application, Petitioner did not submit any employment verification forms from her employers. Instead, Petitioner submitted affidavits from people who knew her in Cuba and in Nicaragua. These affidavits conflict with each other, with Petitioner's resumé she submitted to the Board along with her application, and with Petitioner's testimony at the final hearing. On her application, Petitioner represented under oath that she was employed from June 1994 to July 1996 at the Institute of Tropical Medicine Pedro Kouri in Havana, from August 1996 to July 1997 at the Julio Trigo General Hospital in Havana, and from October 1997 to July 1998 at the National Center of Diagnostic and References in Managua, Nicaragua. She represented that she performed a wide variety of testing at each of these institutions, processing patient samples. However, on her resumé, which she submitted to the Board along with her application, Petitioner represents that at these three institutions, she was employed as a laboratory supervisor, charged with assessing laboratory personnel, and as a researcher. Her resumé also lists extensively the research studies she performed and her teaching experience. In support of her testimony at the final hearing that she possesses the required three years of pertinent clinical experience performing the required testing, Petitioner presented the testimony of Caridad Gonzalez and Biarda Villaverde. Ms. Gonzalez is a licensed medical technologist currently employed in the State of Florida. She testified that she worked with Petitioner at the Institute of Tropical Medicine Pedro Kouri from 1994 through 1996 and at the Julio Trigo General Hospital from 1996 through 1998. These dates conflict with those set forth in two affidavits Gonzalez provided to the Board as part of Petitioner's application for licensure. Further, in her own sworn application for licensure filed with the Board, Gonzalez never mentioned having been employed at the Institute of Tropical Medicine Pedro Kouri. Additionally, Gonzalez left Cuba and came to the United States in April 1997 and was not, therefore, employed in Cuba with Petitioner through 1998. Her testimony at final hearing, therefore, lacks credibility. Biarda Villaverde testified that she worked with Petitioner at the Institute of Tropical Medicine Pedro Kouri from June 1994 to June 1995 in a clinical setting. However, Villaverde and Petitioner worked in different laboratories at that institution. Villaverde, therefore, cannot support Petitioner's testimony as to the work performed by Petitioner since she did not work in the same laboratory. Further, the facility was a diagnostic, research, and teaching facility, where some tests were performed on animals, depending upon the type of research conducted. Villaverde testified that Petitioner was assigned to the research division at this facility. Research does not qualify for the work experience required for licensure as a medical technologist. Even if some of Petitioner's research experience could be counted toward the required clinical experience, Petitioner both admitted and denied at the final hearing that she performed research, primarily representing that she worked full-time performing the required array of testing on patient samples. Several of the accredited or Board-approved technologist training programs are located in South Florida, where Petitioner resides. A training program takes one to two years to complete, depending upon the program. Although Petitioner expressed her unhappiness with the length of time her application for licensure has been pending, she could have completed a program, thus obtaining the minimum required experience for licensure, had she chosen to do so upon learning the minimum requirements for licensure. Petitioner's argument that she should be given credit for her work in the laboratories in Cuba and Nicaragua since they complied with World Health Organization quality control standards is without merit. The World Health Organization does not regulate or set quality control standards for clinical laboratories. The World Health Organization only gathers statistical data and publishes studies.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying Petitioner's application for licensure as a clinical laboratory technologist in microbiology. DONE AND ENTERED this 4thday of December, 2000, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 4th day of December, 2000. COPIES FURNISHED: Zenia Flores de Apodaca 1698 West 65th Street Hialeah, Florida 33012 Mary S. Miller, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 Joe Baker, Jr., Executive Director Board of Clinical Laboratory Personnel Department of Health 4052 Bald Cypress Way Bin A07 Tallahassee, Florida 32399-3257 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way A02 Tallahassee, Florida 32399-1701
The Issue The issue presented for decision herein is whether or not Proposed Rule 10- 5.005(2), Florida Administrative Code, as promulgated by DHRS constitutes an invalid exercise of delegated legislative authority. Based upon the following findings of fact, conclusions and analysis, proposed Rule 10-5.005(2)(a) and (b) is invalid.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I hereby make the following relevant factual findings. DHRS' Office of Health Planning and Development is divided into two separate divisions: The Office of Community Medical Facilities, which administers the State Certificate of Need Program and has responsibility for making recommendations regarding CON applications, and (2) the Office of Comprehensive Health Planning, which has primary responsibility for development of rules pertaining to Certificate of Need policy. Mr. Robert Maryanski, Administrator of the Office of Community Medical Facilities, believes his office made no formal comments (perhaps informal comments,) concerning the proposed rule. Mr. Maryanski considered that the proposed rule was objectionable based on his understanding of the statutes. (TR 33, 54). Elfie Stamm is employed by the Office of Comprehensive Health Planning and has primary responsibility for development of Proposed Rule 10-5.005. The text of the proposed rule is as follows: 10-5.005 Exemptions. * * * (2)(a) Physician offices or physician group practices which do not exist for the primary purpose of providing elective surgical care are exempt from certificate of need requirements for ambulatory surgical centers as specified in 10-5.011(30). This certificate of need exemption applies to offices and associated surgical suites maintained by one or more private physicians or a physician group which is used only by the physician or the physicians of the group practice, and in which 50 percent or more of the patients treated annually are non-surgical patients. (b) Physician offices, or physician group practices applying for designation as an ambulatory surgical center (ASC) by the Health Care Financing Administration (HCFA) and who meet the requirements for exemption from certificate of need review under the provisions delineated under paragraph (2), shall submit a request for exemption from certificate of need to the Department. The physician office or physician group practice shall provide the Department with at least 30 day's written notice of the proposed exemption from the certificate of need requirements for ambulatory surgical centers. Within 30 days of receipt of such written notice, the Department shall determine if the physician office or physician group practice is exempt and advise the applicant of its determination in writing. (Petitioner's Exhibit 6). The proposed rule exempts physician offices and physician group practices from CON requirements for ambulatory surgical centers (ASC) when at least 50 percent of the patients treated annually in these facilities are non- surgical patients. The proposed rule purportedly implements the Federal Health Care Financing Administration's (HCFA) policy allowing physician offices which are exempt from State CON and licensure requirements to apply directly (to HCFA) to receive ASC designation for medical facility reimbursement purposes without first obtaining a CON. Currently, "Ambulatory Surgical Center" means a facility, the primary purpose of which is to provide elective surgical care and in which the patient is admitted to and discharged from such facility within the same working day and which is not part of a hospital. However, a facility existing for the primary purpose of performing therapeutic abortions, an office maintained by a physician for the practice of medicine, or an office maintained for the practice of dentistry shall not be construed to be an ASC. Section 395.002(2), Florida Statutes (1985). DHRS is trying to implement what it believes to be a statutory CON exemption for doctor's offices through the proposed rule. In so doing, HRS considers physicians' offices to be indistinguishable from physician group practices. In this regard, the relevant statutes do not reference physician group practices. Historically, HRS would not certify physician offices as medicare providers (in its role as surveyor for HCFA) because such certification entails the requirement that a physician's office comply with the State ASC Law. In short, a physician's office wishing to become an ASC had to satisfy both CON and State licensure requirements in order to be certified as a medicare providing ASC. Prior to promulgation of the proposed rule, DHRS never had a policy that group practices or physicians with operating suites are excluded from the statutory definition of an ASC. DHRS has no exemptions or exclusions for physicians' groups with surgical suites so that they could become ASCs for medicare certification. (Testimony of Tom Porter, previous supervisor for DHRS' Certificate of Need Program). DHRS took the position that it was without authority to grant an exemption to physician group practices and the related offices as an associated surgical suite without such facility having first obtained a CON as an ASC prior to offering such services. DHRS also took the position that a physician wishing to do minor surgical procedures as a sub-part of his office practice would not be required to obtain a CON as an ASC. These services could be done as an ancillary part of the physician's office. (Testimony of Gene Nelson, former Administrator, Office of Comprehensive Health Planning and Administrator of the Office of Community Medical Facilities prior to Mr. Maryanski's tenure with DHRS). Section 381.495, Florida Statutes, provides for several defined exemptions from CON review. As stated above, the proposed rule purports to grant an exemption to physician offices or to physician group practices from State CON requirements. Section 381.493 (3)(a), Florida Statutes (1985), states, in relevant part, that an office maintained by a physician for the practice of medicine is excluded from the definition of an ASC. The referenced statute does not grant an exemption from the ASC regulation nor has DHRS previously exempted a person or entity from CON review under such circumstances. DHRS has historically distinguished between a physician performing minor surgical procedures as an ancillary part of his office versus a full service ASC. HCFA clarified in Memorandum FQA-731, Ambulatory Surgical Center regulations relating to compliance with state licensure requirements and the application of state CON provisions as a prerequisite for medicare certification. (Pet. Exh. 8) In states where ASC licensure laws are in effect, facilities seeking to participate in medicare must meet such licensure requirements. Thus, 42 CFR Section 416.40 states, in pertinent part, that the ASC must comply with state licensure requirements. CON provisions must be met as a prerequisite for medicare licensure certification for an entity to operate legally within a state and CON approval is required before the decision to award a license is made. In instances where licensure is not required either by virtue of the absence of an ASC Licensure Law or the exemption of certain entities from the licensure law, compliance with CON provisions is not necessary for medicare eligibility as an ASC. It is through a series of correspondence between Mr. Robert Streimer of HCFA and Mr. Marshall Kelley, DHRS' Assistant Secretary for Program Planning that affords the proffered "basis" for the proposed rule. (TR 87). The Streimer letter provides that ASC services performed in a physician's office which is not required by state law to be licensed as an ASC and which meets all medicare ASC requirements would be covered and reimbursed by medicare at the ASC rate. As noted, DHRS historically took a different position. Nowhere in Mr. Kelley's letter to Mr. Streimer did HRS identify the specific criteria that would relate to an exemption request in Florida as currently stated in the proposed rule. DHRS, based on the proposed rule, now takes the position that any physician having a operating room and furnishing surgical procedures for less than 50 percent of his or her patients would be entitled to an exemption from CON requirements and in turn be entitled to apply for certification from HCFA as an ASC for ASC reimbursement (facility fee). The proposed rule allows for surgery currently performed in a physician's office to qualify for higher reimbursement from medicare (i.e., a facility fee). DHRS uses as authority for the proposed rule, Section 381.493(3)(a), Florida Statutes. Prior to receipt of Streimer's letter, DHRS considered HCFA's policy to be that if a facility did not have a CON and was not licensed as an ASC, there would be no medicare certification forthcoming from HCFA. The Streimer letter purportedly clarifies HCFA's policy although it does not represent a change in that policy. (Petitioner's Exhibit 6). The proposed rule defines "primary as 50 percent or more of the patients treated annually as being non-surgical patients. However, according to the 1982 federal regulations, an entity seeking application and certification as a medicare ASC must be dedicated exclusively to the provision of Ambulatory Surgical Services (42 CFR Section 416.2). Federal Rules provide that the requirement for ASC's to be certified in order to receive medicare payments was expected to exclude physicians offices. There appears to be no federal regulation dealing with reimbursement for the surgical procedures which are to be done in physicians' offices. To satisfy HCFA's certification requirements, an applicant must satisfy the relevant state licensure requirements if any, and meet federal certification requirements. As presently codified, it is impossible to simultaneously satisfy the proposed rule and the federal ASC definition contained in 42 CFR Section 416.02. Thus, an entity could not "exclusively" provide ASC services and at the same time not exist for the "primary" purpose of providing elective surgical care on an outpatient basis. They are mutually exclusive since the two definitions are inconsistent. The Streimer letter initiated HRS's evaluation of current statutes and the proposed rule is, according to HRS, designed to implement current statutes. HCFA's policy is that if a facility legally provides or is allowed to provide elective surgical procedures in Florida, without having to be licensed as an ASC or having gone through the CON process, it is inappropriate to require the facility to obtain a CON and be licensed as an ASC as a condition of that facility being approved for medicare reimbursement at the ASC rate. Prior to HCFA's correspondence, HCFA required an applicant for medicare ASC certification to meet State Law and also meet its certification requirements. This is still the case and the HCFA's correspondence to DHRS did not change that requirement. The purpose of the Health Facility and Health Services Planning Act, more commonly known as the CON law, (sometimes called the Act) is to protect the public health, safety and welfare of Floridians. These protections are further defined as a necessary increase in health care, minimizing duplication in health services, and minimizing situations where there is an underutilization of existing health care resources. The proposed rule does not relate to or otherwise address any "need" issue or capacity issue and contrary thereto, allows for uncontrolled growth of surgery suites as long as the physician group practice has 50 percent or more of total patients treated as non-surgical patients. It can be expected that there will be a proliferation of physicians, solo or group practices, with physician surgical practices developing in addition to hospital out-patient surgery. Additionally, there is no physical constraint on the location of the physician and a physician's group practice. Adoption of the proposed rule will also increase the cost of the total health care system in Florida as follows: The average cost per procedure increases when procedures are spread out over a greater number of fixed facilities and because of incentives that would be inherent in this additional capacity for additional unnecessary utilization. Physicians would receive a facility fee in addition to a professional fee. Physicians would thereby receive more money for doing the same procedures they are currently doing in their offices without the facility fee. The effect of the introduction of surgery centers where there is already excess capacity in hospitals and in freestanding surgery centers is to increase the cost of health care to the community. With the addition of new facilities, there are added fixed costs placed into the system that would remain until the facility becomes outmoded. With the addition of fewer procedures spread over more fixed costs, the average cost per procedure likewise increases even though the cost to an individual patient might appear to be lower in an alternative setting. Excess capacity leads to underutilization with the resultant increase in the rates for surgery. Without a capacity constraint, there will be more elective surgery performed. With the approval of the proposed rule, a doctor's office will be eligible for medicare reimbursement for a facility fee. Medicare reimbursement for a facility fee is unique to ASCs and does not apply to surgical procedures performed in a doctor's office. The purpose behind reimbursing for facility fees is that there is considerable overhead associated with performing relatively complex surgical procedures which require an operating room. If procedures are so simple as to be safely performed in a doctor's office, the intent of the rule is to distinguish between these two settings. It is desirable for procedures to be done in a doctor's office that are simple because it is the lower cost setting. Procedures performed in a physician's office will not qualify for the facility fee reimbursement and overhead payment because of the simplistic nature of the procedures and the lack of need for sophisticated equipment which is currently being used in ASCs. The federal regulations were intended to remove hospital surgery to ASCs, if appropriate, and to remove minor surgery to doctors' offices in order to avoid reimbursement for procedures which can be done in a less sophisticated setting. If more procedures are shifted to medicare certified ASCs, there would be an additional facility fee and physicians would be eligible for this reimbursement. An example of the operational effect of the proposed rule is the scenario surrounding Doctor Stephen S. Spector and the Presidential Eye Surgery Center in Palm Beach County. Doctor Spector was denied a CON for an ASC based on a lack of need for additional operating suites in Palm Beach County. After DHRS made its initial decision denying Dr. Spector's CON, he petitioned for a formal administrative hearing. A Recommended Order was entered denying Dr. Spector a CON and HRS then issued a Final Order denying a CON to Dr. Spector. Dr. Spector has since simply requested an exemption for a freestanding ASC pursuant to the proposed rule. DHRS will entertain this request and if granted, Dr. Spector will be entitled to medicare certification and a facility fee for surgical procedures performed in his office. The proposed rule will encourage the massive proliferation of outpatient surgery facilities and outpatient surgery suites. 3/ Evidence adduced at final hearing indicates that CON approved and licensed freestanding ambulatory surgery centers are currently underutilized and not operating at optimal capacity. The result will be increased hospital and ASC costs per unit because fixed costs must then be spread over a smaller patient base. It is likely that there will be underutilization of existing facilities. The proposed rule does not foster the purposes of Florida's CON law and it will not restrain increases in health care costs. The proposed rule will enhance or maximize unnecessary duplication and promote underutilization of existing resources. Pursuant to Section 120.54(2), Florida Statutes (1985), the Department is required to prepare an economic impact statement of the proposed rule. For the proposed rule, HRS states, in part, in its economic impact statement as follows: The proposed amendment is expected to have an economic impact on hospital outpatient departments and ambulatory surgical centers licensed by the State. It is expected that some Medicare patients who previously have been referred to hospital outpatient departments or a freestanding ambulatory surgical center licensed by the State may have their elective surgeries performed in the physician's group practice. In addition, the proposed rule may encourage the development of physician group practices with surgical suites since they are exempted from the certificate of need process and State licensure requirements. The fiscal impact on hospitals and ambulatory surgical centers cannot be estimated since the Department has no data regarding the number of potential applicants under this Rule, the location of those applicants, the volume of surgeries which may be performed by these entities, or the number of surgeries which would have been performed in hospital outpatient departments or State licensed ambulatory surgical centers in the absence of these new entities. (Petitioner's Exhibit 7). The economic impact statement for the proposed rule does not provide any data or method used in making the required economic impact estimates. The statement does not include any data to analyze whether the rule will impact ASCs having less than one million dollars net worth and less than 25 employees or whether the proposed rule will have an economic impact on hospitals and ambulatory surgery centers. Although HRS has indicated that the exact amount of the fiscal impact is impossible to estimate due to the unknowns respecting the number of physician offices or group practices that will qualify for the exemptions and therefore no analysis was undertaken or developed, studies could have been made to determine the effect any level of participation would have on hospital costs and utilization of existing facilities. Although the task of compiling such data would, no doubt, be arduous, evidence adduced at final hearing indicates that DHRS could have, with effort, compiled a data base with a stratified sample which would have been reliable and could forecast the likely effect of the proposed rule within an acceptable margin of error. DHRS did not compile data which would provide an estimate as to the number of patients who would choose the physician's office over other facilities that perform Ambulatory Surgery. DHRS never requested input from hospitals or outpatient surgery centers with respect to pay or patient mix. DHRS conducted no surveys with respect to the number of potential applicants under the proposed rule. DHRS considered it not relevant to examine the capacity of existing freestanding surgery centers or hospitals having outpatient surgery facilities. DHRS conducted no studies to determine the accessibility of existing ASCs and hospital ASCs. No studies were done to examine the impact, as to the cost to patients, that the proposed rule is likely to have on existing providers. No studies were done to assess the impact the proposed rule will have on the medicare trust fund. No studies were done to determine the impact, if any, on Florida small and minority businesses. It is true that a great deal of the needed data was not readily available to HRS whereas, on the other hand, it made no attempt to gather such data. DHRS has the ability to assess the number of surgeries that could be performed in hospital outpatient departments and ASC's since DHRS does such compilations on a day to day basis when it projects the need for new ASCs. DHRS could have commissioned studies to determine the effect any level of participation would have on hospital costs and utilization. Development of an adequate data base and a meaningful economic impact of the proposed rule is paramount in view of the legislative mandate (to DHRS) to contain health care costs. Rules are promulgated to further the purpose and objective of the statutes they implement. To accomplish this, they must be consistent with the statute. Here, the purpose of the statute is cost containment. Evidence adduced at final hearing reveals, without contradiction, that the proposed rule will increase health care costs, contrary to the major purpose for its existence. Finally, DHRS compiled no data as to the impact on the ability of hospitals to provide indigent care under the proposed rule. As example, Florida Hospital projects that it will provide $48,000,000 in uncompensated care for fiscal year 1986. If the hospital were to lose revenue as result of this proposed rule, the level of indigent care will also correspondingly be reduced in order to offset the loss of revenue. Other parties herein provide services to indigent persons. The proposed rule does not require these exempt facilities to provide indigent care. In addition to the above economic impact which will be brought about by the proposed rule on the Health Care system as a whole, the proposed rule will have an economic impact on the existing hospitals and ASC's. (TR 276-277; 438-440). As example, one Petitioner herein advises that if one surgery suite were added by an existing physician group or formed near the hospital, the hospital will lose approximately $481,000 per annum. By letter dated August 29, 1986, DHRS forwarded a copy of the purposed rule to the statewide and local health councils requesting comments by September 12, 1986. The public hearing on the proposed rule was scheduled for October 20, 1986. Neither health council (state or local) participated in the public hearing for the proposed rule nor has either council submitted comments respecting the proposed rule. The notice provided to the local and statewide health councils for comments on the proposed rule was adequate and afforded the various councils an opportunity to voice any concerns or provide input about the proposed rule. Dr. Montgomery, an Intervenor herein, will receive additional medicare reimbursements of $500.00 per patient for a facility fee under the proposed rule. Dr. Montgomery approximated that he performed 320 cataract surgeries per year of which approximately 300 patients are paying patients. Approximately 85 percent of those patients are over 65. Therefore, Dr. Montgomery will receive medicare reimbursement for 255 patients or approximately $127,500.00 in additional fees if his office is certified as exempt under the proposed rule.
Findings Of Fact The facts, as stipulated to by the parties and as set forth above, are hereby adopted.
The Issue The issue in this case is whether Respondent, Park Imaging, Inc., was obligated to file a report and pay an indigent care assessment pursuant to Section 395.1015, Florida Statutes, (1991) and, if so, whether Respondent should be fined or otherwise sanctioned for its failure to do so.
Findings Of Fact Based upon the oral and documentary evidence presented at the final hearing and the entire record in this proceeding, the following findings of fact are made: At all times pertinent to this proceeding, Park Imaging owned and operated a fixed-site diagnostic imaging center in Coral Springs, Florida. Park Imaging also owned and operated a mobile diagnostic service which is described in more detail below. Since 1984, hospitals in Florida have been required to pay an assessment based on net operating revenue to the Public Medical Assistance Trust Fund ("PMATF") for the funding of health care services to indigent persons. See Chapter 84-35, Laws of Florida, codified at Section 395.101, Florida Statutes (1989). Effective July 1, 1991, the statutory requirement to file a report with the AHCA and pay the PMATF assessment was expanded to include certain additional health care entities including "diagnostic imaging centers." See, Section 177, Chapter 91-112, Laws of Florida, codified at Section 395.1015, Florida Statutes (1991). For the health care entities that fell under the 1991 statute, the first reporting period began July 1, 1991 and ran through December 31, 1991. The report was due on or before March 31, 1992 and the assessment was to be paid by April 30, 1992. Park Imaging filed the required report and paid the applicable assessment for its fixed-site diagnostic imaging center. Park Imaging did not file a report or pay any assessment regarding its mobile diagnostic service. Except for diagnostic imaging centers, all of the "health care entities" that were required to file a report and pay an indigent care assessment pursuant to Section 395.1015, Florida Statutes, are licensed or registered by the State. Thus, there was no question as to the need for those entities to comply with the statute. Diagnostic imaging centers, on the other hand, are not licensed or registered and, consequently, there was less certainty as to the types of providers or services that fell into this category. Park Imaging has a separate medical care provider number for its mobile operation. The AHCA has treated the two operations as separate entities and sent Park Imaging separate reporting forms with different identifying numbers for each of the operations. Park Imaging's mobile operation consists of the transportation of ultrasound equipment in vans to private physicians' offices. No services are performed within the vans. The equipment is off-loaded from the van into the physician's office. The physicians utilize the equipment for their patients. All power necessary to operate the equipment is provided by the physician's office. The equipment can be plugged into a standard electrical wall socket in the physician's office. During the period from July 1, 1991 to December 31, 1991, Park Imaging's diagnostic operation provided ultrasound service primarily to cardiac and obstetric patients. In all cases, a physician ordered the test and defined the protocol to be followed during the test. Park Imaging provided technical expertise, including an onsite employee of the company. Park Imaging's technician provided the expertise necessary for running the equipment and executed the protocol established by the physician. The physician was responsible for interpretation of the test results and for managing the outcome of the results of the test and communicating the results to the patient. Section 395.1015, Florida Statutes (1991) defined "diagnostic imaging centers" that were subject to the reporting and assessment requirements as follows: Diagnostic imaging centers that are free- standing outpatient facilities that provide specialized services for the identification or determination of a disease through examination and also provide sophisticated radiological services such as computed tomography scans and magnetic resonance imaging, and in which services are rendered by a physician licensed by the Board of Medicine under Section 458.311, Section 458.313, or Section 458.327, or by an osteopathic physician licensed by the Board of Osteopathic Medical Examiners under Section 459.006, Section 459.007, or Section 459.0075. Park Imaging contends that its mobile operations do not have a "facility" upon which an assessment can be levied under Section 395.1015, Florida Statutes, (1991) (subsequently amended and renumbered as Section 395.7015). Park Imaging also contends that its mobile operations did not provide "sophisticated radiological services" as that term is used in Section 395.1015, Florida Statutes. In this regard, Park Imaging argues that the equipment utilized in the mobile operations was much less sophisticated than many of the other types of services provided in a fixed setting. The evidence established that Park Imaging's mobile operations provided ultrasound services. There is no evidence that Park Imaging's mobile operations provided computed tomography (CT) scans or magnetic resonance imaging (MRI) or any other services other than ultrasound. CT and MRI equipment could not be transported in a van or off-loaded into a physician's office. CT and MRI equipment require special lead-wall shielding in the structure in which they are used. The investment for CT and MRI equipment is significantly higher than ultrasound as are the government reimbursement rates. Park Imaging's decision not to file the report and pay the assessment on its mobile operations was based upon advice of legal counsel. Park Imaging did not attempt to hid or conceal its decision from the AHCA. In several letters to the AHCA in the fall of 1992, Park Imaging advised the AHCA that it did not believe its mobile operations fell within the scope of the statute. By letter dated September 29, 1992 from Carolyn Turner, who at the time was the Administrator of the AHCA's Ambulatory Health Section, to Joseph Burlandi, corporate counsel for Park Imaging, the AHCA notified Park Imaging that it's mobile diagnostic operations were not exempt from the provisions of Section 395.1015, Florida Statutes (1991) and that Park Imaging would be considered delinquent from that time forward if the report was not filed and the assessment was not paid. This position was subsequently reaffirmed in a letter dated October 30, 1992 from Julia P. Forrester, senior attorney for the AHCA, to Joseph Burlandi. In a letter dated November 23, 1992, the Agency once again reaffirmed its position that Park Imaging 's mobile operations fell within the scope of the statute None of these letters from the AHCA to Park Imaging were sent by certified mail. When Park Imaging continued to refuse to file the report and pay the assessment on its mobile operations, the AHCA issued an Administrative Complaint dated February 22, 1993 seeking to impose penalties against Park Imaging for failure to comply with the requirements of what had subsequently been renumbered as Section 395.7015, Florida Statutes, and Rule 59B-6, Florida Administrative Code, for the reporting period July 1, 1991 through December 31, 1991. At the hearing in this matter, Fran Buie, the current Administrator of the AHCA's Ambulatory Health Section, testified that the AHCA has consistently construed and applied Section 395.1015, Florida Statutes (1991) to mobile facilities. She also testified that her review of the Agency's records confirms that a number of mobile units have complied with the statutory requirements. The evidence did not establish the types of services provided by these other mobile operations.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Healthcare Administration enter a final order requiring Respondent, Park Imaging, Inc. to comply with the provisions of Section 395.1015, Florida Statutes (1991) and establishing a due date for the report and assessment after which a fine should be assessed in accordance with the applicable statute and rules. DONE and ENTERED this 9th day of February 1994, at Tallahassee, Leon County, Florida. J. STEPHEN MENTON 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 9th day of February 1994.
The Issue Whether the Petitioner's application to offer a health flex plan pursuant to Section 408.909, Florida Statutes, should be granted or denied.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The OIR and the Agency for Health Care Administration each must "approve or disapprove health flex plans that provide health care coverage for eligible participants." § 408.909(3), Fla. Stat. The purpose of health flex plans is to provide basic and preventive health care services "to low-income uninsured state residents." § 408.909(1), Fla. Stat.7 On November 12, 2004, Comprehensive Medical Access submitted an application to the OIR for approval to participate in the health flex plan pilot program created by the Legislature in Section 408.909, Florida Statutes. Comprehensive Medical Access was formed in 2003 for the purpose of applying for approval to offer a health flex plan. Jack J. Michel, M.D., wholly owns Comprehensive Medical Access, and is its president and chief executive officer. Dr. Michel specializes in the practice of internal medicine, and has been licensed to practice medicine in Florida since 1993. Dr. Michel owns ten healthcare-related companies. In 1998, Dr. Michel purchased Larkin Community Hospital, which is located in South Miami, Florida, and he is the chief executive officer of the hospital in charge of running the hospital. Larkin Community Hospital is a general acute-care hospital that provides surgery facilities and an emergency room. The hospital specializes in providing care to elderly patients, and has an annual operating budget of $30 to $40 million a year, with a monthly payroll of $1.4 million. Larkin is currently approved as a Medicare and Medicaid provider, and it also provides services under contract for federal and state prisoners. In addition, Larkin Hospital and Dr. Michel have been licensed by Florida and the federal government to provide home health services under Medicaid and Medicare. Comprehensive Medical Access, under the management of Dr. Michel, also operates several clinics to serve low-income, elderly, and indigent patients.8 These clinics are designated by the Agency for Health Care Administration as "area of critical need" facilities. This designation allows Comprehensive Medical Access to employ physicians licensed to practice medicine in states other than Florida, including Puerto Rico, who have been issued limited licenses by the Florida Board of Medicine. Comprehensive Medical Access pays these physicians less than it pays those licensed to practice medicine in Florida, and it can, therefore, serve more low-income, elderly, and indigent patients. Currently, Comprehensive Medical Access clinics serve more than 50,000 low-income, elderly, and indigent patients. Many of these patients would be eligible to participate in Comprehensive Medical Access's health flex plan, were its application to be approved. Under Comprehensive Medical Access's business plan for operation as an entity offering a health flex plan, the various clinics it currently operates would provide general health care services for those enrolled in Comprehensive Medical Access's health flex plan, and Larkin Community Hospital would provide hospital services. Under the plan, these services would be provided to individuals participating in the health flex plan, who would pay a monthly fee to Comprehensive Medical Access and co-payments for some services when the services are provided. In its application for approval to offer a health flex plan, Comprehensive Medical Access disclosed that Dr. Michel and his brother, George J. Michel, M.D., who is Comprehensive Medical Access's vice-president and medical director, had been named as defendants in a civil lawsuit filed by the United States of America in the United States District Court for the Southern District of Florida. Numerous defendants were named in the lawsuit, including Larkin Community Hospital and other entities in which Dr. Michel had ownership interests. The 58-page complaint filed in the federal government's civil lawsuit included eight counts relating to two alleged schemes: The first scheme allegedly occurred in 1997 and allegedly involved kickbacks paid by Larkin Community Hospital and related corporations to Dr. Michel, Dr. Michel's practice group, and Dr. George Michel in return for admitting patients to that hospital; many of the patients were allegedly covered by Medicare and many of the admissions were allegedly medically unnecessary. The second scheme allegedly occurred in 1998-1999, after Dr. Michel purchased Larkin Community Hospital, and allegedly involved the fraudulent increase of Medicaid and Medicare revenues by "churning" patients into that hospital from skilled nursing and assisted living facilities, some of which were owned by Dr. Michel, among others; many of the patients allegedly received medically unnecessary treatments while in Larkin Community Hospital. Four counts of the civil complaint charged Dr. Michel and others with violations of the federal False Claims Act, Title 31, Section 3729(1)(1), United States Code, with respect to both the alleged 1997 scheme and the alleged 1998-1999 scheme; one count charged Dr. Michel and others with common law fraud with respect to both alleged schemes; one count charged entities owned by Dr. Michel and others with payment by mistake; one count charged Dr. Michel and others with unjust enrichment; and one count claimed that the government was entitled to "disgorgement of illegally earned monies." The Florida Board of Medicine initiated disciplinary proceedings against Dr. Michel on the basis of the allegations in the civil complaint but dismissed the proceeding before hearing. After the civil complaint was filed, the Agency for Health Care Administration ("AHCA") notified Larkin Hospital that it was suspending Medicaid payments as a result of the allegations in the civil complaint. Comprehensive Medical Access filed a lawsuit in circuit court seeking to enjoin AHCA from suspending Medicaid payments, and a temporary injunction was granted. Dr. Michel testified during the evidentiary hearing conducted by the OIR on June 9, 20059: The allegations in the federal civil complaint arose from testimony given by an associate of the doctor from whom Dr. Michel purchased Larkin Hospital who had been convicted of participation in a kickback scheme in Illinois and who had received a sentence reduction for his testimony regarding Larkin Hospital; The allegations regarding kickbacks were based on misunderstandings about the actual expenses incurred by his practice group relating to the provision of emergency room services at Larkin Hospital under a contract that was never executed, about the reasons for the large number of patient referrals to Larkin Hospital by Dr. Michel and members of his practice group, and about the expenses incurred under the contract between Larkin Hospital and Dr. Michel's practice group for the provision of radiology services to the hospital; The allegations in the civil complaint that Dr. Michel and entities he owned, operated, or controlled billed Medicaid and Medicare for services that were not medically unnecessary were based on audits that disallowed payment for excessive days of hospitalization, but, as a result of appeals, the total number of days disallowed was substantially decreased; and Dr. Michel also testified in June 2005, that the parties in the civil lawsuit had reached a settlement in principal that he expected to be finalized within 60 days, with Larkin Hospital paying $10 million of the total proposed $15 million settlement amount. Dr. Michel categorized the decision to settle the case as a business decision on the part of all parties because it would be difficult to prove or disprove the allegations in the complaint. A settlement had not, however, been finalized at the time of the final administrative hearing in this case. Ultimate finding of fact The filing and pendency in federal court of the civil complaint containing allegations of wrongdoing, including payment of kickbacks and fraud, on the part of Dr. Michel and healthcare-related entities he owned or operated or with which he was associated, are sufficient to raise the issue of Dr. Michel's fitness and trustworthiness as the owner and chief executive officer of Comprehensive Medical Access to operate Comprehensive Medical Access as an entity offering a health flex plan. Dr. Michel did not present any evidence during the hearing relating to the substance of the allegations contained in the civil complaint, but he did establish by credible and persuasive evidence that he is competent to own and operate an entity providing a health flex plan due to his experience in managing entities providing healthcare services, including clinics which primarily service low-income, elderly, and destitute patients; his knowledge about the healthcare services needed by these groups of individuals; and his familiarity with the health flex plan program enacted by the legislature in Section 408.909, Florida Statutes, and how such a plan could be put into operation. In addition, Dr. Michel appears to have in place the facilities and personnel to provide healthcare services under a health flex plan. Nonetheless, the evidence presented by Dr. Michel is not sufficient to overcome the serious concerns regarding Dr. Michel's trustworthiness and fitness to own and operate Comprehensive Medical Access as an entity offering a health flex plan arising as a result of the pendency of the civil complaint filed by the federal government. The explanations provided by Dr. Michel during the investigatory hearing before the OIR are insufficiently persuasive to overcome these reasonable concerns, as is the fact that the settlement pending in June 2005 has yet to be finalized. Comprehensive Medical Access has, therefore, failed to establish with the requisite degree of certainty that Dr. Michel is trustworthy and has not engaged in business operations in bad faith.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Office of Insurance Regulation enter a final order denying the application of Comprehensive Medical Access, Inc., to offer a health flex plan. DONE AND ENTERED this 1st day of November, 2006, in Tallahassee, Leon County, Florida. S PATRICIA M. HART 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 1st day of November, 2006.
The Issue The issue for determination is whether the Petitioner is liable to the Agency for Health Care Administration ("Agency") for Medicaid reimbursement overpayments and related fines, costs, and interest.
Findings Of Fact The Agency is the single state agency charged with administration of the Medicaid program in Florida under Section 409.907, Florida Statutes. The Petitioner provides physician services to Medicaid beneficiaries pursuant to a contract with the Agency under provider number 037381800. The Agency sent the Petitioner a Preliminary Agency Audit report on June 30, 1998, notifying him of a preliminary determination of Medicaid overpayments in the total amount of $21,156.35. The Agency sent the Petitioner a Final Agency Audit Report on October 28, 1998, confirming the Agency's determination of Medicaid overpayments in the total amount of $21,156.35. The Agency's determination of overpayment was based upon findings that obstetrical echography services "were billed and paid in violation of Medicaid policy governing those services." The Agency performed an audit of the Petitioner for the period January 1, 1993, through October 31, 1996. According to the Agency audit report, the Petitioner's records contained violations of two billing policies outlined in the Medicaid Physician Provider Handbook. The first violation was that the Petitioner billed and received payment for more than one initial ultrasound procedure per pregnancy, and the second was that the Petitioner failed to submit documentation of medical necessity for additional procedures. During the years examined by the audit, Medicaid policy allowed providers to bill for more than one complete initial procedure per patient, so long as providers filed supporting documentation of medical necessity. However, the documentation submitted by the Petitioner indicated that the additional ultrasound procedures he conducted were mere follow-up procedures, instead of medically necessary complete procedures. According to the terms of the Medicaid Physician Provider Handbook, "[i]f more than two (or any combination of two) ultrasounds are performed during a pregnancy, they must be billed with modifier-22 and a report documenting the medical necessity for the procedure." The Petitioner submitted bills for more than two ultrasound treatments per recipient without explaining why the procedures were medically necessary. The Agency audit report established that the Petitioner has been overpaid as a result of the Petitioner's erroneous billings. The total overpayment to the Petitioner was calculated as "the difference between what he got paid for a complete procedure and the amount that he should have gotten paid for the follow-up." The Agency records received in evidence and the testimony of the Agency's witness establish that the amount overpaid to the Petitioner totaled $21,156.35. The Petitioner, as an authorized provider of Medicaid services, had signed a Medicaid Provider Agreement. That agreement states, among other things, that the "provider agrees to submit Medicaid claims in accordance with program policies." When the Petitioner became a certified Medicaid provider, he received a handbook outlining billing procedures for the performance of diagnostic ultrasounds. The Petitioner admitted that he knows "little about billing," that he "didn't involve [himself] in the billing at all," and that he has never read the Physicians' Current Procedural Terminology book, which sets forth the universally used billing codes.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Agency issue a final order requiring the Petitioner to reimburse the Agency for overpayments in the total amount of $21,156.35, plus such interest as may accrue as of the date on which payment is made. DONE AND ENTERED this 3rd day of January, 2001, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 3rd day of January, 2001.
