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.
Conclusions THE PARTIES resolved all disputed issues and executed a settlement agreement, which is attached and incorporated by reference. The parties are directed to comply with the terms of the attached settlement agreement. Based on the foregoing, this file is hereby CLOSED. DONE AND ORDERED on this L/f- day of -----' 2010, in Tallahassee, Florida. Thomas W. Arnold, Secretary Agency for Health Care Administration JAIME J. RODRIGUEZ, M.D., INC. - Final Order Provider No. 2556481-00; C. I. No. 06-4516-000Page 1 of3Filed June 9, 2010 1:04 PM Division of Administrative Hearings. AP ARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO A JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY ALONG WITH FILING FEE AS PRESCRIBED BYLAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: Vanessa Reynolds, Esquire Broad and Cassel One Financial Plaza, Suite 2700 100 Southeast 3rd Avenue Fort Lauderdale, Florida 33394 (Via U.S. Mail) Peter Williams, Inspector General Medicaid Program Integrity 2727 Mahan Drive Building 2, Mail Station 6 Tallahassee, Florida 32308 (Interoffice Mail) Tracie L. Hardin, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Mail Station 3 Tallahassee, Florida 32308 (Interoffice Mail) Bureau of Health Quality Assurance 2727 Mahan Drive, Mail Stop 9 Tallahassee, Florida 32308 (Via E-mail Only) Ken Yon, Bureau Chief Medicaid Program Integrity 2727 Mahan Drive Building 2, Mail Station 6 Tallahassee, Florida 32308 (Interoffice Mail) Agency for Health Care Administration Bureau of Finance and Accounting 2727 Mahan Drive Building 2, Mail Station 14 Tallahassee, Florida 32308 (Interoffice Mail) Division of Administrative Hearings The Desoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (Via U.S. Mail) Florida Department of Health License No.: ME58774 (Via Email Only) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished to L 0------ the above named addressees by U.S. Mail, or the method designated, on this the day of CJ"""- ,_ -·2010. Agency Clerk State of Florida Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403 (850) 412-3630
The Issue The central issue in this case is whether the Respondent violated Chapter 458 Florida Statutes as alleged in the Administrative Complaint dated July 11, 1986; and, if so, what penalty should be imposed.
Findings Of Fact Based upon the testimony of the witness and the documentary evidence received at the hearing, I make the following findings of fact: The Respondent, Maria I, Andrakovich, M.D., is a licensed physician in the State of Florida, having been issued license number MEOO2I436. On or about May 1, 1983, Respondent entered into a Service agreement with "The Doctor's Office, Inc." wherein Dr. Andrakovich agreed to provide medical services for the patients at 330 South Dixie Highway, Lake Worth, Florida. Respondent's employment with "The Doctor's Office, Inc." ended in March, 1984. On or about July 12, 1983, Respondent filed with the Board of Medical Examiners an Application for Certification for Physician's Assistant for Jean Eugene Raymond. On August 15, 1983, Mr. Raymond was certified to work under the supervision of Respondent pursuant to Chapter 458 Florida Statutes. On November 22, 1983, Mr. Raymond filed his Biennial Physician's Assistant Certification and reported a change of office address to 1177 Hypo1uxo Road, Lantana, Florida. Respondent executed the affidavit for this certification before a notary public. Respondent never worked at the Hypo1uxo, Road facility. Dr. Andrakovich remained at the prior office location which was approximately five miles from the Hypoluxo site. Prior to his move to the Hypoluxo facility, Mr. Raymond would confer, in person, with Dr. Andrakovich regarding each patient. After moving to the Hypoluxo facility, Mr. Raymond would confer with Dr. Andrakovich by telephone. Respondent relied on Mr. Raymond's judgment that this telephonic system of conferring about patients complied with any legal requirements of their relationship. Respondent did not know the regulations which govern physician's assistants. Many of the patients seen at the facilities on Hypoluxo and Dixie were elderly and suffered heart problems. Respondent's schedule required her to see one patient every fifteen minutes. This patient scheduling rate later increased to one patient every ten minutes. It was difficult for Respondent to confer with Mr. Raymond by telephone and meet the schedule. Respondent assumed Mr. Raymond would confer with the physicians at the Hypoluxo facility. No specific arrangement was made to require physicians at Hypoluxo to supervise Mr. Raymond nor did any physician there assume responsibility for Mr. Raymond's activities. During her employment with "The Doctor's Office, Inc." Respondent treated Norman Shapiro. Mr. Shapiro had a history of heart trouble, diabetes, and hypertension. During the fall of 1983, Mr. Shapiro had complained of increased pain which had resulted in Respondent doubling the strength of Mr. Shapiro's heart medication. Mr. Shapiro's medical record for this period suggested a deterioration in his heart condition. On November 21, 1983, Norman Shapiro went to the Hypoluxo facility and was seen by Mr. Raymond. Mr. Shapiro complained that he was constantly having to take his heart medication by handful amounts. Mr. Raymond recommended no coffee, tea, chocolates or smoking and that the patient should elevate his head 4-6 inches for sleeping. The only additional medication suggested was Maalox. The treatment recommended by Mr. Raymond was consistent with the diagnosis of a hiatal hernia but was inappropriate given the patient's history of heart disease. The minimally acceptable care within the medical community where "The Doctors' Office" was located would have required the patient Shapiro to be hospitalized. Mr. Raymond did not confer with Dr. Andrakovich regarding Mr. Shapiro's visit on November 21, 1983, until after the treatment had been recommended. Had Dr. Andrakovich seen Mr. Shapiro on that day, she would have put him in the hospital. Dr. Andrakovich believed Dr. Conti had treated Mr. Shapiro on November 21, 1983. On November 21, 1983, the electrocardiogram (EKG) for Mr. Shapiro was within normal limits. Despite the EKG, Mr. Shapiro's symptoms were cardiac- related and had a significant potential for morbidity and mortality. In fact, Mr. Shapiro died on November 22, 1983. Frank Colavecchio was president of the "The Doctor's Office Inc." and made all administrative decisions regarding the facilities on Dixie and Hypoluxo. Mr. Colavecchio administratively moved Mr. Raymond to the Hypoluxo office. On March 15, 1984, Dr. Andrahovich terminated employment with the "The Doctor's Office, Inc". Respondent did not notify the Board of Medical Examiners of this change and at no time advised the Board that she would no longer be supervising Mr. Raymond. It is inappropriate and contrary to standards of good medical practice for a physician's assistant to treat heart patients. Dr. Andrakovich knew or should have known that Mr. Raymond was treating heart patients.
Findings Of Fact The PROVIDER received the FAR that gave notice of PROVIDER'S right to an administrative hearing regarding the fine. The PROVIDER filed a petition requesting an administrative hearing, and the administrative hearing case was CLOSED. PROVIDER chose not to dispute the facts set forth in the Final Agency Audit Report dated June 12, 2006. The facts alleged in the FAR are hereby deemed admitted. The Agency hereby adopts the facts as set forth in the FAR, including the fine amount of $2,000.00, the requirement to complete a corrective action plan in the form of provider education, and repayment of the $72,202.51 overpayment and payment of a $2,000.00 fine. The Petitioner entered into a payment Plan Agreement with the Agency on August 13, 2007.
Conclusions THIS CAUSE came before me for issuance of a Final Order on a Final Audit Report ("FAR") dated June 12, 2006 (C.I. No. 06-4078-000). By the Final Audit Report, the Agency for Health Care Administration ("ARCA" or "Agency"), informed the Petitioner, The Pediatric Center, Inc., (hereinafter "PROVIDER"), that the Agency was seeking to recover overpayments in the amount of $72,202.51, a fine. sanction of $2,000.00 pursuant to Sections 409.913(15), (16), and (17), Florida Statutes, and Rule 590-9.070, Florida Administrative Code and a Corrective Action Plan in the form of provider education. The Final Audit Report provided full disclosure and notice to the PROVIDER of procedures for requesting an administrative hearing to contest the sanction. The PROVIDER filed a petition with the Agency requesting a formal administrative hearing on or about June 12, 2006. The Agency forwarded PROVIDER'S hearing request to the Division of Administrative Hearings ("DOAH") for a formal administrative hearing. DOAH closed its file and relinquished jurisdiction to ARCA on October 2, 2006. Page 1 of5 Filed January 11, 2010 4:24 PM Division of Administrative Hearings.
Conclusions Having reviewed the Administrative Complaint dated June 10, 2008, attached hereto and incorporated herein (Exhibit 1) , and all other matters of record, the Agency for Health Care Administration ("Agency") has entered into a Settlement Agreement (Exhibit 2) with the parties to these proceedings, and being otherwise well-advised in the premises, finds and concludes as follows: ORDERED: The attached Settlement Agreement is approved and adopted as part of this Final Order, and the parties are directed to comply with the terms of the Settlement Agreement. Respondent shall pay, within thirty (30) days of the date of rendition of this Order, the amount of five hundred twenty-five dollars ($525.00). Filed July 16, 2010 3:23 PM Division of Administr1ative Hearings. Checks should be made payable to the "Agency for Health Care Administration." The check, along with a reference to this case number, should be sent directly to: Agency for Health Care Administration Office of Finance and Accounting Revenue Management Unit 2727 Mahan Drive, MS #14 Tallahassee, Florida 32308 Unpaid amounts pursuant to this Order will be subject to statutory interest and may be collected by all methods legally available. The Respondent's request for an Administrative proceeding is hereby withdrawn. Each party shall bear its own costs and attorney's fees. The above-styled case is hereby closed. DONE and ORDERED this dday of { in Tallahassee, Leon County, Florida. , 2010, Thomas W. Ar old, Secretary Agency for Ith Care Administration A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW OF PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: David C. Ashburn, Esq. Counsel for Respondent P.O. Drawer 1838 Tallahassee, Florida 32302 (U.S. Mail) Thomas J. Walsh II, Senior Attorney Agency for Health Care Admin. 525 Mirror Lake Drive N. #330H St. Petersburg, Florida 33701 (Interoffice Mail) Jan Mills Agency for Health Care Admin. 2727 Mahan Drive, Bldg #3, MS #3 Tallahassee, Florida 32308 (Interoffice Mail) Agency for Health Care Admin. Office of Finance and Accounting Revenue Management Unit 2727 Mahan Drive, MS #14 Tallahassee, Florida 32308 (Interoffice Mail) Lawrence P. Stevenson Administrative Law Judge Division of Administrative Hearings 1230 Apalachee Parkway Tallahassee, Florida 32399 (U.S. Mail) CERTIFICATE OF SERVICE 7 I HEREBY CERTIFY that a true and correct copy of this Final Order was served on the above-named person(s) and entities by U.S. Mail, or the method designated, on this the ay of , 2010. Richard Shoop, Agency Cieri< Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403 (850) 412-3630
The Issue The issues presented are whether Petitioner is responsible for reimbursing the Agency for Health Care Administration for an overpayment for Medicaid services and, if so, whether administrative sanctions should be applied.
Findings Of Fact From April 19, 1995, through October 30, 1996, Petitioner was a pharmacy licensed to do business in the State of Florida. From April 15, 1995, through October 30, 1996, Petitioner was a Medicaid provider in good standing, pursuant to a Medicaid contract with the Agency. In 1996 Kathryn Holland, an agency employee, conducted an audit of Petitioner's records, using a method which the Agency calls an aggregate analysis. This analysis focuses on the inventory of a Medicaid provider and analyzes invoices and other documentation to determine if the provider had available during the audit period sufficient quantities of goods or products to support the quantity of goods or products billed to Medicaid. Holland analyzed the Agency's records to ascertain the claims filed by Petitioner and the amounts paid to Petitioner. She compiled a list of those drugs most frequently billed to the Agency's Medicaid program by Petitioner and selected 23 medications. She selected April 1, 1995, through October 30, 1996, as the audit period. She contacted Petitioner and requested records showing Petitioner's purchases of the medications on that list. She also contacted Mason Distributors, Inc., and H. I. Moore, Inc., two of Petitioner's primary suppliers, and requested copies of their invoices for medications purchased by Petitioner between May 1, 1995, and October 28, 1996. She prepared charts of the invoices and other documents received as a result of her requests. She reduced the number of audited drugs to 20 based upon adequate documentation provided to her for three of the listed medications. She prepared a preliminary report, which she sent to Petitioner with a request that Petitioner supply her with any additional records to show that additional supplies of the listed medication were available to Petitioner during the audit period. Petitioner responded to that request by providing additional documentation. Holland did not credit Petitioner with additional supplies based upon the additional documentation because the invoices appeared to be for a different pharmacy or appeared to reflect purchases outside the audit period. Further, the cancelled checks were payable to cash, had no notation as to the purpose of the checks, had a notation reflecting only a "business expense," had a notation for medication not on Holland's list, or reflected purchases outside the audit period. Petitioner was unable to document sufficient inventory during the audit period to justify the amount of medication billed to, and paid for by, the Agency. The Agency overpaid Petitioner in the amount of $12,529.11 for the 20 listed medications during the audit period and is entitled to reimbursement by Petitioner in that amount.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered determining that Petitioner is responsible to repay the Agency in the amount of $12,529.11 by a date certain, imposing an administrative fine in the amount of $2,000, and terminating Petitioner from the Medicaid program for a period of two years. DONE AND ENTERED this 20th day of March, 1998, 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 Filed with the Clerk of the Division of Administrative Hearings this 20th day of March, 1998. COPIES FURNISHED: Thomas Falkinburg, Esquire Mark Thomas, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308 William M. Furlow, Esquire Katz, Kutter, Haigler, Alderman, Marks, Bryant & Yon, P.A. Highpoint Center, Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Paul J. Martin, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308
The Issue Whether Respondent’s Rule 59R-11.001, Florida Administrative Code, is an invalid exercise of delegated legislative authority.
Findings Of Fact Chelation therapy is the introduction of a man-made amino acid into a patient’s vein. It has been approved by the U.S. Food and Drug Administration and is used for the treatment of heavy medal toxicity and the removal of lead. American Board of Chelation Therapy (ABCT) is an autonomous organization that provides education and certification to any physician who wishes to become knowledgeable in Chelation therapy. ABCT was established in 1982 for the purpose of establishing the criteria necessary for certification in the area of Chelation therapy. The Board of Medicine is a statutory entity, established by Chapter 458, Florida Statutes, as the primary regulatory authority for the practice of allopathic medicine in the State of Florida. Pursuant to section 458.301, Florida Statutes, the legislature recognizes that the practice of medicine is potentially dangerous to the public if conducted by unsafe and incompetent practitioners. The section further provides that the primary legislative purpose in enacting the medical practices act is to “ensure that every physician practicing in this state meets minimum requirements for safe practice.” In keeping with the legislative mandate to ensure that purpose of the medical practices act, the legislature created the Board of Medicine and authorized the Board to create administrative rules for the purpose of implementing chapter 458. Rule 59R-11.001, Florida Administrative Code, is the advertising rule of the Board of Medicine.3 The rule codifies provisions of section 458.331(1)(d), Florida Statutes, and provides criteria for identifying false, deceptive, or misleading advertising. In particular, the rule governs advertising on physician letterhead and limits the use of the term “specialist” unless the specialty is recognized by (1) a specialty board of the American Board of Medical Specialties (ABMS) or (2) a board that meets the requirements of Rule 59R-11.001, Florida Administrative Code. For those specialties recognized by organizations that do not meet the requirements of the rule, the physicians may still advertise their specialty so long as they provide a disclaimer. By rule the disclaimer must state the following “The Specialty recognition identified herein has been received from a private organization not affiliated with or recognized by the Florida Board of Medicine.” ABMS is generally recognized in the United States as the agency that approves allopathic medical specialty boards and the Board of Medicine has historically relied upon ABMS and its standards and, as reflected in the current rule, continues to rely on ABMS and its standards for approving recognizing agencies. On July 17, 1995, the Petitioner, ABCT submitted an application to Florida Board of Medicine for the purpose of being certified as a “recognizing agency” pursuant to rule 59R-11.001. ABCT is not a specialty board of the ABMS. Because ABCT is not a member board of the ABMS, the Board of Medicine looked to the requirements of rule 59R- 11.001(2)(f) to determine whether ABCT met the criteria enunciated in the rule and whether it is therefore a “recognizing agency” capable of bestowing specialty status on a physician. Rule 59R-11.001(2)(f), Florida Administrative Code, provides that non-ABMS Boards may seek recognition as “recognizing agencies” if they meet the following criteria: The recognizing agency must be an independent body that certifies members as having advanced qualifications in a particular allopathic medical specialty through peer review demonstrations of competence in the specialty being recognized. Specialty recognition must require completion of an allopathic medical residency program approved by either the Accreditation Council of Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada that includes substantial and identifiable training in the allopathic specialty being recognized. Specialty recognition must require successful completion of a comprehensive examination administered by the recognizing agency pursuant to written procedures that ensure adequate security and appropriate grading standards. The recognizing agency, if it is not an ABMS board, must require as part of its certification requirement that each member receiving certification be currently certified by a specialty board of the ABMS. The recognizing agency must have been determined by the Internal Revenue Service of the United States to be a legitimate not for profit entity pursuant to Section 501 (c) of the Internal Revenue Code. The recognizing agency must have full time administrative staff, housed in dedicated office space which is appropriate for the agency’s program and sufficient for responding to consumer or regulatory inquiries. The recognizing agency must have written by-laws, and a code of ethics to guide the practice of its members and an internal review and control process including budgetary practices, to ensure effective utilization of resources. However, a physician may indicate the service offered and may state that practice is limited to one or more types of services when this is in fact the case; On April 15, 1996, the Board of Medicine issued an order denying the ABCT’s application for specialty status. As basis for the denial, the order stated that the application of the ABCT failed to establish compliance with the requirements for approval as set forth in Rule 59R-11.001(2)(f), Florida Administrative Code. Specifically, the order stated: The requirements for diplomat status in ABCT do not require advanced qualifications in a particular allopathic medicine specialty; specialty recognition given by ABCT does not require completion of an allopathic medical residency program approved by the ACGME or the Royal College of Physicians and Surgeons of Canada that include substantial and identifiable training in the allopathic specialty being recognized; specialty recognition provided by the ABCT does not require successful completion of a comprehensive examination pursuant to written procedures that ensure adequate security and appropriate grading standards in that ABCT requires only a score of 60% to pass the examination, the examination consists of true false questions and answers, and the examination is not a medically comprehensive examination; ABCT is not an ABMS board and does not require that each member it certifies be currently certified by an ABMS board; and ABCT has not provided evidence that it is a legitimate not-for-profit entity pursuant to Section 501(c) of the Internal Revenue Code as determined by the Internal Revenue Service. Each of the requirements of rule 59R-11.001(2)(f) were addressed at the administrative hearing. With regard to criteria (1) of rule 59R-11.001(2)(f), advanced qualifications in a particular allopathic medical specialty through peer review, the ABCT does not require an advanced qualification in a particular allopathic medical specialty. Furthermore, ABCT admitted that it does not meet the requirement of rule 59R-11.001(2)(f)(1). Criteria (2) of rule 59R-11.001(2)(f) provides that the specialty recognition must require completion of an allopathic medical residency program approved by either the Accreditation Council of Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada. The ACGME is generally recognized as the organization that sets criteria for graduate medical education in the United States. The Board of Medicine has incorporated that recognition in the rule by requiring that the advanced education component of the rule be ACGME approved. The Royal College of Physicians and Surgeons of Canada is ACGME’s counterpart in Canada. With regard to criteria (2) of rule 59R-11.001(2)(f), ABCT does not require completion of an allopathic residency program approved by either the ACGME or the Royal College of Physicians and Surgeons of Canada. In fact, ABCT has no requirement for a residency program. ABCT reasoned that a there is no need for a residency program for Chelation therapists because Chelation therapy does not require overnight hospital stay. The only requirement remotely relating to residency is an ABCT requirement that applicants for diplomat status administer a minimum of 1000 Chelation treatments. There is no requirement that these treatments be supervised and no requirement for verification that the minimum number of treatments were administered. With regard to criteria (3) of rule 59R-11.001(2)(f), requiring successful completion of a comprehensive examination, ABCT does not require all applicants for diplomat status to complete a written examination in order to obtain certification. Specifically, some candidates are grandfathered in without being required to complete the written examination. For those applicants that are required to submit to an examination, Dr. Arthur L. Koch testified that the examination is composed of approximately sixty percent true/false questions. In addition, Dr. Koch testified that another ten percent of the test is not medically oriented but rather addresses the history and politics of Chelation therapy in the United States. At the hearing, ABCT submitted its Spring 1994 examination as an exhibit. That examination contained a majority true/false questions and a few multiple choice questions. To pass the ABCT diplomat examination, the candidate is required to achieve a score of 62.5 percent. In contrast, the Board of Medicine generally requires a passing score of at least 75%. The Board of Medicine expressed concern about the low passing score accepted by ABCT on its certification examination. The Board of Medicine also expressed concern over the large number of true/false questions used in the example examination submitted by ABCT. Uncontroverted testimony was presented at the hearing to support a finding that an examination consisting of a majority of true/false questions is not a viable method of testing knowledge. With regard to criteria (4) of rule 59R-11.001(2)(f), requiring members of non-ABMS boards to also be certified by a specialty board of the ABMS, the ABCT does not require that each physician seeking diplomat status be currently certified by an ABMS specialty board. Furthermore, ABCT admitted that it does not meet the requirement of rule 59R-11.001(2)(f)(4). With regard to criteria (5) of rule 59R-11.001(2)(f), that the recognizing agency must be a legitimate not for profit entity under the Internal Revenue Code, evidence was presented to verify that ABCT is a non-profit, tax-exempt organization. With regard to criteria (6) of rule 59R-11.001(2)(f), requiring the recognizing agency to have full-time administrative staff sufficient to respond to consumer or regulatory inquiries, no evidence was presented at the hearing relating to this criteria. With regard to criteria (7) of rule 59R-11.001(2)(f), requiring the recognizing agency to have written by-laws and a code of ethics to guide the practice of its members, ABCT submitted its Constitution and Bylaws as adopted in March of 1982 and subsequently amended. The Constitution and bylaws, however, did not include a written code of ethics and therefore did not fully comply with the requirements of the rule.
