The Issue The issues in this case are whether Respondent violated Section 458.331(1)(t), Florida Statutes (1997), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances (the standard of care); and, if so, what penalty, if any, should be imposed against Respondent's license to practice medicine. (All chapter and section references are to Florida Statutes (1997) unless otherwise stated).
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida pursuant to Section 20.43, Chapter 458, and Chapter 456, Florida Statutes (2001). Respondent is licensed as a physician in the state pursuant to license number ME 0043324. The Administrative Complaint involves one male patient who underwent emergency surgery in 1997 at Tampa General Hospital (TGH). The record identifies the patient as D.Y. in order to preserve the patient's confidentiality. The Administrative Complaint, in relevant part, alleges that Respondent failed to keep written medical records justifying the course of treatment of D.Y. in violation of Section 458.331(1)(m) and departed from the standard of care in violation of Section 458.331(1)(t). At the administrative hearing, however, Petitioner voluntarily dismissed the charge that Respondent failed to keep adequate medical records in violation of Section 458.331(1)(m). The only remaining issue in the Administrative Complaint is whether Respondent deviated from the standard of care by failing to ensure that the attending residents performed surgery on the correct side of D.Y.'s head, i.e., "at the correct site." Respondent is Board certified in Neurology and Neurological Surgery and is a professor and Chairman of the Department of Neurosurgery at the University of South Florida College of Medicine (USF). Respondent is the founder of the residency program in neurological surgery at USF. Respondent performs approximately 300 to 400 neurosurgical procedures each year and has done so for more than 15 years. In 1997, Respondent was the Director of the USF residency program in Neurological Surgery. The residency program required residents to complete six to seven post- doctoral years. The record refers to post-doctoral years alternatively as post graduate years or as PGY-1 through PGY-7. TGH was the primary teaching hospital for USF in 1997 and operates in that capacity today. In March 1997, two resident physicians in the USF neurology program performed surgery on D.Y. at TGH. The record identifies the resident physicians as Drs. Etebar and Makoui. Drs. Etebar and Makoui were authorized and qualified to perform the task each performed during the surgery on D.Y. Respondent was the attending physician of record for D.Y., but TGH protocol did not require Respondent to be present in the operating room during the surgery. Although Respondent was present in the operating room at some point during the surgery, Respondent did not participate in the surgery. On March 25, 1997, D.Y. was 44 years old and involved in an automobile accident. Airmed Flight Service (Airmed), a helicopter flight service, transported D.Y. to TGH. The Airmed Flight Service record indicates that D.Y. had a history of progressive lethargy and suffered a right side subdural hemorrhage. TGH admitted D.Y. under the care of Respondent. The admitting nurse conducted an initial evaluation of D.Y. that included a neurological assessment. D.Y. was extremely lethargic, obeyed only simple commands, and was non-verbal. Dr. Makoui conducted a physical examination of D.Y. D.Y. responded to stimulus but was unable to follow commands and was dysphasic. A magnetic resonance image (MRI) revealed a large subdural hematoma on the left side of D.Y.'s head. A subdural hematoma is a blood clot between the surface of the brain and the dural membrane that covers the brain. While D.Y. was in the MRI suite, the patient herniated and became comatose. He developed seizure activity, and his heart rate dropped below 30 from a normal rate of 75 to 125. Herniation in a patient suffering from a subdural hematoma indicates that a portion of the patient's brain has shifted over a fixed membrane inside the skull and is pressing on the brain stem. It is a life-threatening event because the upper brain stem malfunctions and impacts vital functions, including respiration. Surgical intervention was critical or D.Y. would have died. Respondent ordered D.Y. to be transported to the operating room for evacuation of the subdural hematoma. One means of removing a subdural hematoma is by a surgical procedure known as a burr hole evacuation. In the operating room, the medical team prepared D.Y. for a "burr hole evacuation of hematoma and placement of intracranial pressure monitor." The operating record listed Respondent as the attending surgeon, Dr. Etebar as the surgeon, and Dr. Makoui as an assistant. However, Respondent did not participate in the surgery. Respondent did not enter the operating room until after D.Y. was in the operating room. Drs. Makoui and Etebar were in the operating room with D.Y. when Respondent entered the operating room. The operating room record indicates that Respondent approved the positioning of the patient in the "supine" position, i.e., facing straight up. However, the nurse who made the entry in the operating record customarily lists the name of the attending physician of record as the person who approves the position of the patient. Dr. Makoui shaved D.Y.'s scalp in preparation for the surgery. Dr. Etebar then made two one-inch-long scalp incisions in the frontal and parietal areas on the right side of D.Y.'s head. Respondent did not make any incision in D.Y., including the incorrect incision on the right side of D.Y.'s head. At an undetermined point in the surgery, the surgical team became aware that the incisions made by Dr. Etebar on the right side of D.Y.'s head were incorrect. Respondent was present in the surgical suite when it was first noted that the initial incisions had been made on the incorrect side of D.Y.'s head. Dr. Etebar closed the incisions on the right side of D.Y.'s head and repositioned D.Y. with the left side of the patient's head facing up. Dr. Etebar then made burr hole incisions on the left side of D.Y.'s head and evacuated a large amount of liquid clot. Dr. Etebar placed two drains subdurally on the left side of D.Y.'s head and closed the wounds. Dr. Etebar placed drains in the left side of the brain to prevent any reoccurrence of hematoma. The surgical team repositioned D.Y. neutrally. Dr. Etebar then placed a burr hole and a ventriculostomy catheter on the right side of D.Y.'s head to monitor intracranial pressure. It was medically necessary to monitor intracranial pressure with a pressure monitor because the patient was comatose and could not be monitored clinically for the development of pressure. Respondent and the surgeons at TGH routinely place intracranial pressure monitors in a patient who is suffering from a subdural hematoma and who is comatose preoperatively. Postoperatively, the surgical team transported D.Y. to the neurosurgical intensive care unit where he remained for several days while recovering. On March 31, 1997, TGH discharged D.Y. in stable condition with instructions to follow up with Respondent in two weeks. D.Y. suffered no complication or permanent injury as a result of the incisions by Dr. Etebar in the right side of D.Y.'s head. Respondent did not cause any harm to the patient. Respondent did not personally commit any act or omission that deviated from the standard of care. Nor did Respondent improperly delegate responsibility to Drs. Etebar or Makoui. Four experts, in addition to Respondent, reviewed Respondent's care of D.Y., rendered opinions, and testified in this case. Two of the experts are Drs. Lohse and Rydell. Drs. Lohse and Rydell are experts within the meaning of Section 90.702. Dr. Lohse is Board-certified in neurological surgery and treats subdural hematomas. Dr. Rydell is Board-certified in neurological surgery and provides treatment for subdural hematomas including burr hole evacuations. Dr. Daniel P. Robertson is Petitioner's expert witness. Dr. Robert Snow is Respondent's expert witness. All four experts agree. In providing medical care to D.Y., Respondent did not engage in a direct act or omission that violated the standard of care. Nor did Respondent improperly delegate responsibility to the residents who performed the surgery on D.Y. A burr hole evacuation of a subdural hematoma is the simplest operation performed by neurosurgeons. Dr. Etebar and Dr. Makoui were each competent in 1997 to perform the evacuation of the subdural hematoma using the burr hole procedure. Dr. Makoui was a PGY-2 in his second post graduate year. Dr. Etebar was a fellow in his 7th post-doctorate year of training and was classified as a PGY-7. A fellow in USF neurological surgery has completed the residency program, is at least a PGY-7, is Board-eligible in neurosurgery, and wishes to complete additional training. Dr. Etebar was a Board-eligible neurosurgeon who had completed the residency program and could have easily performed burr hole surgery in any community hospital in the country. Dr. Makoui was in his second year of the residency program and competent to perform the tasks he performed during the surgery. The burr hole procedure performed on D.Y. was a very basic procedure that was performed by a Fellow. A PGY-2 physician in training was also present. Under the terms of the TGH "Scope of Practice" protocol for neurological surgery, a PGY-2 or above could perform the procedure in question without the presence of an attending physician. Although the TGH "Scope of Practice" protocol did not require the presence of Respondent in the operating room, Respondent's normal practice was to walk into the surgical suite to make sure things were going well. Dr. Robertson is Petitioner's expert witness in this case. Dr. Robertson provided an expert opinion letter to Petitioner and testified during two different depositions taken by Respondent. Dr. Robertson could not identify anything that Respondent did personally that deviated from the standard of care. An excerpt from one of Dr. Robertson's depositions is illustrative. Q. . . . is there anything that Dr. Cahill did or failed to do, that you can identify, that constituted a deviation from acceptable standards as opposed to just being responsible for the residents? A. Other than being responsible for the resident's action, no. Petitioner's Exhibit 2 (P-2), at page 41. See also P-3 at 10-11. Dr. Robertson concluded that Respondent did not commit any act or omission that deviated from the standard of care but that Respondent was responsible for the acts or omissions of Drs. Etebar and Makoui. The issue of whether a member of the faculty at a teaching hospital may be liable for the acts or omissions of resident physicians is a legal issue that is beyond the scope of the expertise of the witness. It is not a factual issue of whether the faculty member committed an act or omission that deviated from the standard of care. Even if the issue of Respondent's liability for the acts or omissions of Drs. Etebar and Makoui were a factual issue within the scope of Dr. Robertson's expertise, Dr. Robertson's opinion is based on facts not in evidence. Dr. Robertson assumed that Respondent supervised Drs. Etebar and Makoui and instructed each resident on what to do to D.Y. During Dr. Roberson's testimony, he testified: Q. What is the basis of your opinion that [Respondent] is responsible for the actions of the residents? A. . . . when a surgery is done under a mentor's supervision, then the mentor is ultimately responsible for what occurs in the operating room. * * * . . . what do you mean by "responsible?" A. That the resident is doing what the supervising surgeon is instructing him to do. P-2, at 39-40. Respondent did not supervise and instruct Drs. Etebar and Makoui during the surgical procedure performed on D.Y. Hospital protocol did not require Respondent to be present in the operating room. Although Respondent was present in the operating room at some juncture, Respondent did not participate in the surgery. During the administrative hearing, Respondent submitted the written opinions of Drs. Lohse and Rydell and their deposition testimony for admission into evidence. Petitioner objected to the admissibility of the evidence on the grounds that it is hearsay, irrelevant, and cumulative, and that the witnesses are not qualified as experts. The ALJ stated on the record, as a preliminary observation, that a cursory review suggested the evidence was relevant and not cumulative and that the written expert opinions of Drs. Lohse and Rydell were admissions within the meaning of Section 90.803(18). However, the ALJ reserved final ruling in order to study the evidence more thoroughly and allowed both parties to submit argument and supporting legal authority in their respective PROs. Petitioner's PRO raises a new objection that Petitioner did not raise during the administrative hearing. Petitioner objects to the admissibility of the written opinions of Drs. Lohse and Rydell and to the admissibility of their deposition testimony on the grounds that the evidence constitutes work product that is protected from discovery by Rule 1.280(b)(4)(B). The ALJ deemed the assertion of the work product doctrine in Petitioner's PRO to be an objection to the admissibility of evidence based on the lawyer-client privilege in Section 90.502. The parties filed a joint stipulation of facts and submitted legal memoranda on the evidentiary issues. The written opinions of Drs. Lohse and Rydell are not work product. Petitioner did not obtain the opinion letters in anticipation of litigation within the meaning of Rule 1.280(b)(4)(B). Rather, Petitioner obtained the opinion letters on September 3, 1998, and June 28, 2000, in connection with the investigation of this matter and prior to a determination of probable cause within the meaning of Section 456.073(10), Florida Statutes (2001)(hereinafter, Section 456.073(10)). Section 456.073(10) requires Petitioner to produce the opinion letters of experts obtained in connection with the investigation of the case. In relevant part, Section 456.073(10) provides: . . . Upon completion of the investigation and a recommendation by the department to find probable cause, and pursuant to a written request by the subject or the subject's attorney, the department shall provide the subject an opportunity to inspect the investigative file or, at the subject's expense, forward to the subject a copy of the investigative file. Notwithstanding s. 456.07, the subject may inspect or receive a copy of any expert witness report or patient record connected with the investigation. (emphasis supplied) The written expert opinions rendered by Drs. Lohse and Rydell are contained in Petitioner's complaint investigation file. Petitioner obtained the written expert opinions of Drs. Lohse and Rydell on September 3, 1998, and June 28, 2000, respectively; long before the determination of probable cause that was required before Petitioner could file the Administrative Complaint on December 12, 2001. The opinion letters are not part of Petitioner's theories, mental impressions, or conclusions produced in anticipation of litigation. Assuming arguendo that the written opinions of Drs. Lohse and Rydell are work product, Petitioner argues that the statutory mandate in Section 456.073(10) to disclose the expert opinions to Respondent deprives Petitioner of the volition required to voluntarily waive the work product doctrine within the meaning of Section 90.507. Findings regarding the voluntary nature of the disclosure mandated by Section 456.073(10) are unnecessary because there is no statutory mandate for Petitioner to allow Respondent to take the depositions of Drs. Lohse and Rydell. Petitioner consented to the depositions of Drs. Lohse and Rydell. Petitioner did not oppose the depositions, did not file a motion for protective order, and did not object during the deposition to questions designed to disclose the expert opinions. The consensual deposition testimony of Drs. Lohse and Rydell disclosed their respective opinions and thereby waived the protection that Petitioner claims under the work product doctrine within the meaning of Section 90.507. The written opinions of Drs. Lohse and Rydell are admissions within the meaning of Section 90.803(18)(d). The written opinions are statements by Petitioner's agent or servant concerning a matter within the scope of the agency or employment that is made during the existence of the relationship. In 1998, Petitioner, through its agent, Medimetrics Corporation, Inc. (Medimetrics), solicited an opinion from Dr. Lohse in regard to the care provided by Respondent to D.Y. Dr. Lohse issued a written expert opinion by letter dated September 3, 1998. Sometime prior to June 28, 2000, Petitioner, through Medimetrics, contacted Dr. Rydell and requested that he provide an expert opinion in this matter. On June 28, 2000, Dr. Rydell provided a written expert opinion letter to Medimetrics. Both opinion letters state that Respondent met the standard of care in the treatment, care, and diagnosis of D.Y. Respondent submitted both opinion letters into evidence against the interest of Petitioner. The expert opinions of Drs. Lohse and Rydell are not cumulative of the opinion of Respondent's expert witness, Dr. Snow. Only the opinions of Drs. Lohse and Rydell constitute exculpatory evidence developed by a prosecuting agency during the investigative phase of an administrative proceeding that is penal in nature. The expert opinions of Drs. Lohse and Rydell are not cumulative of each other. Each shows that the other is not an anomaly and that Petitioner had evidence of Respondent's innocence from two different sources that were separated by time and community.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED, that Petitioner enter a Final Order finding Respondent not guilty of the allegations in the Administrative Complaint and dismissing the Complaint. DONE AND ENTERED this 14th day of August, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 14th day of August, 2002. COPIES FURNISHED: William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Kim Kluck, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Bruce D. Lamb, Esquire Ruden, McClosky, Smith, Schuster & Russell, P.A. 401 East Jackson Street, 27th Floor Tampa, Florida 33602 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701
Findings Of Fact Respondent received his registration in 1955 as a civil engineer and as an architect in 1956. Since his registration, the Respondent has been instrumental in the drawings and designs of numerous outstanding structures in and around the Tampa Bay area. (See Respondent's Composite Exhibits 1 and 2.) Prior to the incident involved herein, the Respondent has not been the subject of any disciplinary proceedings involving the Petitioner. Respondent, by and through counsel, takes the position that inasmuch as his conviction of the charges set forth herein- above, to-wit: racketeering, mail fraud and conspiracy, is not a proper basis upon which a suspension or revocation of his registration can properly stand inasmuch as he is in the process of appealing the conviction. Respondent contends that unless and until the judgment of the lower court is affirmed by the appellate court, there is no basis upon which a suspension and/or revocation of his registration can rest. Section 471.26, Florida Statutes, provides in pertinent part that: "(1) The Board shall have the power to revoke or suspend the certificate of registration. . . of a person registered under this chapter. . .should such registrant. . .be found guilty of: . . . (c) any felony or crime involving moral turpitude." Petitioner's Exhibit No. 1 received into evidence reveals that the Respondent was convicted of four separate counts of criminal activity and sentenced to imprisonment for a period of ten years on two counts, to run concurrently, and five years on two counts, to run concurrently with each other and with the ten-year count. Based thereon, it is concluded that sufficient basis exists upon which a finding should be entered recommending that the Respondent's registration be suspended. I shall so recommend. 1/
Recommendation Based on the foregoing findings of fact and conclusions of law, it is hereby, RECOMMENDED: That the registration of Respondent (No. 5354) as a professional engineer be suspended for a period of two (2) years. In making such a recommendation, the undersigned considered all the mitigating factors introduced by and on behalf of the Respondent. ENTERED this 28th day of February, 1979, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings Room 101, Collins Building 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675
The Issue Whether the amount sought to be recovered from Petitioner for Medicaid overpayments by the Agency is correct.
Findings Of Fact Petitioner is a licensed pediatrician who provided services to Medicaid beneficiaries. Petitioner voluntarily signed a Medicaid Provider Agreement, and was subject to all of the duly-enacted statutes, rules, and policies pertaining to Medicaid providers. On January 10, 2001, the Agency issued a Final Agency Audit Report (Audit Report), requesting Petitioner to reimburse the Agency $42,713.15, for certain services Petitioner rendered to Medicaid recipients between October 19, 1997, and October 19, 1999. (R-4, pg. 1) The determination of overpayment was based upon audit findings that the services provided by Petitioner did not meet the Medicaid criteria. These criteria include: lack of medical necessity; lack of documentation for the services rendered to support the higher level of office visit billed; medical records inappropriately maintained; the required elements for early periodic screening for diagnosis and treatment services not performed; services erroneously coded on submitted claims; evaluation and management services improperly documented in the medical records; laboratory tests improperly billed; two billing codes used in instances in which one code incorporates the elements of the other; new patient billing codes used for patients who did not meet the requisite new patient criteria; and evaluation and management services billed absent the requisite face-to-face encounter. (R-4, pgs. 2-3) Testimony of Brenda Turner Brenda Turner testified at hearing on May 22, 2001, in Tallahassee, Florida. Ms. Turner is a human services program specialist employed by the Bureau of Medicaid Program Integrity at the Agency. As a human services program specialist, Ms. Turner's primary responsibility is to conduct audits of Medicaid providers. The Agency performed an audit of Petitioner's Medicaid billings for the period October 1997 through October 1999. As part of this audit, the Agency generated a list of 31 Medicaid recipients (cluster sample) rendered services by Petitioner during the audit period. These medical records (R-6) were examined by Ms. Turner, Ms. Johnson, and Dr. Deeb. In addition, the Agency generated work papers of the total amount Petitioner billed during the audit period, the total number of recipients Petitioner rendered services to during the audit period, and the total times Petitioner billed any claim. (R-11) Ms. Turner completed a summary report of her on-site visit. The primary finding of her report was that Petitioner did not have on-site the appropriate equipment for certain services for which Petitioner had submitted claims. Subsequent to an on-site visit of Petitioner's office in December 1999 by Agency staff, Petitioner was asked to provide the Agency with answers to a questionnaire and medical records relating to the cluster sample. Petitioner submitted medical records for the cluster sample as requested by the Agency. These records were given to an Agency registered nursing consultant, Margerite Johnson, and physician consultant, Dr. Larry Deeb, for review. After their review, Ms. Johnson and Dr. Deeb provided Ms. Turner with worksheets outlining their review findings and a medical record review report. (R-16) Based upon the information contained in the worksheets and medical record review report, including the total claims, the total amount billed, and the total amount disallowed, Ms. Turner used a statistical program to calculate with a computer the amount Petitioner was overpaid during the audit period. The statistical methodology utilized by the Agency in determining the overpayment amount was not contested and was not an issue. Petitioner was sent a preliminary letter notifying him of the calculated overpayment amount. Subsequent to his receipt of the preliminary letter, Petitioner submitted additional documentation to contest the audit findings. Petitioner's additional documentation was submitted to Ms. Johnson and Dr. Deeb for review. Ms. Johnson and Dr. Deeb produced a second medical record report review containing findings which they gave to Ms. Turner. (R-16) Based upon the conclusions of the second medical record report, Ms. Turner recalculated the amount Petitioner was overpaid during the audit period. (R-10) The Agency sent Petitioner a final agency action letter on January 10, 2001, setting forth the recalculated overpayment amount of $42,713.15. Testimony of Margerite Johnson Margerite Johnson testified at hearing on May 22, 2001, in Tallahassee, Florida. Ms. Johnson is a registered nursing consultant employed by the Bureau of Medicaid Program Integrity at the Agency. As part of her duties with the Agency, Ms. Johnson reviews medical records to determine whether they are compliant with the current Physician's Procedural Terminology Manual and Medicaid policies, including the Medicaid Provider Reimbursement Handbook, HCFA-1500 and Child Health Check-Up, the Physician's Coverage and Limitations Handbook, and the EPSDT Coverage and Limitations Handbook. Ms. Johnson received medical record review sheets listing all of the claims submitted by Petitioner for the cluster sample during the audit period. She also received the medical records submitted by Petitioner pertaining to the cluster sample. Ms. Johnson reviewed these materials to ensure that documentation was provided for each service listed on the review sheets and that the medical records complied with Medicaid policy. Ms. Johnson wrote a report of the policy violations she observed during her review of the medical record review sheets and corresponding medical records. She then transmitted to Dr. Deeb for further review, her report, the medical record review sheets, and the medical records provided by Petitioner. Subsequent to Dr. Deeb's review, the medical records and medical record review sheets with Dr. Deeb's comments were returned to Ms. Johnson. Based on Dr. Deeb's notations on the medical record review sheets, Ms. Johnson indicated on the medical record review sheets whether a claim should be allowed, adjusted, or denied. For those claims on which a determination was made that the claim should be adjusted or denied, Ms. Johnson indicated the difference between the amount the Agency paid for the claim and the amount the Florida Medicaid Management System providers should have been paid for the type of service rendered. Ms. Johnson also indicated the reason for the denial of the claim on the medical record review sheets. Using the information from the medical record review sheets, Ms. Johnson prepared a report that sets forth the policy findings by Ms. Johnson and the medical necessity and level of care findings by Dr. Deeb. (R-16) As indicated on the medical record review report (R-16), Ms. Johnson identified several claims from the cluster sample where the medical records maintained by Petitioner did not contain appropriate documentation of the billed services. (R-46) After reviewing all of the documentation provided by Petitioner, including the additional documentation that was not contemporaneous with the actual date of services, Ms. Johnson determined that there were no records in the files for the claims set forth in Respondent's Exhibit No. 46. An examination of the entries on R-46 for the Patients 1, 3, and 7, and comparison with the record of visits in R-6 reveal that there are records present for all the visits except those for Patient #1 and Patient #7 on 9-1-98. Having discovered so many records which were supposedly present, R-46 was determined to be grossly inaccurate as a listing of visits without records and rejected. Because Ms. Johnson determined that there were no records in the files for the claims set forth in Respondent's Exhibit No. 46 as required by the Medicaid Provider Reimbursement Handbooks, she concluded that said claims should be denied. This was clearly an error in fact. In addition, Ms. Johnson identified ten claims that were an early and periodic screening diagnosis and treatment (EPSDT), or well-child examinations. Chapter 3 of the EPSDT Coverage and Limitations Handbook provides regarding EPSDT reimbursement that, "The fee includes all the screening components and the diagnosis and treatment of problems that can be diagnosed and treated during screening, such as early otitis media." However, it goes on to say, "Under federal law, Florida must provide medically necessary treatments, as described below, for all medical conditions that are diagnosed during EPSDT screening. Once the recipient is screened, any further diagnoses and treatments are provided through the applicable Medicaid program, such as physician services." See Page 2-2, Chapter 2. There are numerous components in the EPSDT screening. If the provider "vaguely mentions" the required components, Ms. Johnson will approve the corresponding claims. Ms. Johnson's three claims involved lead screenings, which were not performed during an EPSDT visit. Page 2-13, Chapter 2, states regarding required laboratory tests for lead, "Providers must perform lead poisoning and risk assessment, blood lead testing, and counseling and document the results in the recipient's medical record." Regarding Blood Lead Testing, Page 3-2, Chapter 3 of the EPSDT Coverage and Limitations Handbook provides regarding EPSDT Reimbursement, "Certain providers may also be reimbursed for blood lead testing and other laboratory services." On the same page, Chapter 3, goes on to state, "In addition to the EPSDT screening, certain providers may be reimbursed blood lead testing through their provider specific Medicaid programs, such as physician services." Petitioner pointed out without contradiction that his clinic was too far from the laboratory to perform a blood test for lead because the test is time critical. He could assess risk and could counsel patients, but he could not submit a valid test for blood lead. Petitioner referred patients to the Health Department for lead testing. The fee for the EPSDT examination was reduced by $40 to pay an amount equal to the 213 service code. There is no suggestion that the value of the lead blood test is $40. The EPSDT screening requires taking various examinations, extensive history, and counseling of the parent. As pointed out elsewhere, the examinations are part of and compensated as part of the EPSDT screen. Although the visit fee was reduced, there is no evidence that Petitioner was compensated for audiometry, and similar tests included in the EPSDT screen fee. The audit revealed EPSDT screening billed on the same date as evaluation and management services or office visit. (R-51) Page 2-62 of the November 1997 Physician Coverage and Limitations Handbook provides that Code W9881, the code for an EPSDT screening, is considered a visit code and is "not reimbursable in addition to an office, home, or hospital visit." (R-27, pg. 4) Page 2-3 of the July 1997 EPSDT Coverage and Limitations Handbook provides that "[b]ased on his medical discretion, a provider should not perform an EPSDT screening on an obviously sick recipient, because the illness may distort the screening results." If the patient is sick when he or she presents for an EPSDT visit, the provider should treat or refer the recipient for the illness and reschedule the screening appointment. (R-32, pg. 3) Dr. Deeb reviewed the records submitted by Petitioner for those claims where an EPSDT screening and evaluation and management services were simultaneously billed, and determined that both procedures were not medically necessary. Ms. Johnson gave Petitioner credit for the more expensive of the two billed procedures when an EPSDT and an office visits were billed for the same recipient on the same date of service, but not both. As stated above, the record does not reflect Petitioner was similarly credited with tests normally included in EPSDT screens which are not part of an office visit. (R-16, pg. 1, 3) Ms. Johnson identified 12 claims from the cluster sample that were erroneously coded. (R-49, pg. 1) However, the Agency concedes and withdraws its allegations that the 12 claims listed in Respondent's Exhibit No. 49 were in error. Ms. Johnson also identified two claims from the cluster sample where Petitioner billed for an office visit when immunizations were the only documented services rendered. Page 2-37 of the Physician's Coverage and Limitations Handbook provides that "[e]valuation and management (E&M) services are reimbursable in addition to the injectable medicine service, provided the visit is for a separate and identifiable service and the services are documented in the medical record." There was no indication in Petitioner's records that a separate and identifiable service was also rendered on the date the immunizations were provided. (R-41) Accordingly, the claims for an office visit where immunizations were the only documented services rendered should be denied. (R-16) Ms. Johnson identified four claims from the cluster sample where Petitioner billed for hemoglobin and hematocrit tests as procedures separate from the general office visit. (R-43) These were improper billings since the costs for the hematocrit and hemoglobin procedures were included in the amount of money Petitioner was already reimbursed for an office visit. Page 2-49 of the January 1996 Physician's Coverage and Limitations Handbook provides that ". . . fingerstick hemoglobin and hematocrit performed as part of a physician visit are not reimbursed in addition to the physician visit. The provider may not bill for them as separate procedures." This same language appears on page 2-63 of the November 1997 Physician's Coverage and Limitations Handbook. Page 2-73 of the January 1999 Physician's Coverage and Limitations Handbook provides that ". . . hemoglobin and hematocrit performed as part of a physician visit are not reimbursed in addition to the physician visit. The provider may not bill for them as separate procedures." Petitioner submitted claims for a pure tone audiometry, procedure code 92552, on the same day and for the same recipients that he submitted claims for EPSDT. (R-48) EPSDT, or early and periodic screening diagnosis and treatment, is a multiple component comprehensive exam of a well-child, and includes a standardized hearing test. Pure tone audiometry is included in the billing code for an EPSDT screening, and the audiometry and EPSDT screening should not be billed simultaneously. Page 2-12 of the December 1996 and the July 1997 EPSDT Coverage and Limitations Handbooks provide that a Medicaid provider "must perform a hearing screening on all recipients at each EPSDT screening." (R-32, pg. 11) Accordingly, Ms. Johnson concluded that the claims for a pure tone audiometry submitted simultaneously with the EPSDT screenings should be denied. (R-16, pg. 2, 4) Ms. Johnson identified one claim in which Petitioner billed for a new patient visit for a patient who had been previously seen by Petitioner. (R-42) The Physician's Coverage and Limitations Handbook defines a new patient as "one who has not received any professional services from a physician or another physician of the same specialty who belongs to the same group practice, within the past three years." An established patient "is one who has received professional services from a physician . . . within the past three years." The Handbook provides that only "[o]ne new patient visit may be reimbursed once per recipient." Accordingly, Ms. Johnson concluded that the claim for a new patient who was previously rendered services should be denied. (R-16, pg. 4) However, Ms. Johnson treated the visit as a relatively simple doctor's visit, a 213. The records reveal the patient, an infant, presented holding both ears, spitting up since its formula was changed, and had continual constipation. Petitioner spent a great deal of time diagnosing and treating the patient. Under the criteria stated by Dr. Deeb, the patient presented with more than one problem involving more than one body system, and required a complex diagnosis. This visit was not a simple 213 office visit. In her Medical Record Review Report, Ms. Johnson determined that Petitioner had billed Medicaid "for dipstick urine, which is all-inclusive in the office visit." (R-16 & 44) Page 2-49 of the January 1996 Physician's Coverage and Limitations Handbook provides that "[d]ipstick urine . . . performed as part of a physician visit are not reimbursed in addition to the physician visit. The provider may not bill for them as separate procedures." This same language appears on Page 2-63 of the November 1997 Physician's Coverage and Limitations Handbook. Page 2-73 of the January 1999 Physician's Coverage and Limitations Handbook provides that "[m]annual or automated dipstick urine . . . performed as part of a physician visit are not reimbursed in addition to the physician visit. The provider may not bill for them as separate procedures." Accordingly, Ms. Johnson concluded that the claims for dipstick urine in addition to the physician visit should be denied. (R-16, pg. 4) Ms. Johnson identified one claim in which Petitioner billed Medicaid for a test performed by an independent lab. (R-47, pg. 1) Page 2-45 of the January 1996 Physician's Coverage and Limitations Handbook provides that services for specimens sent to an independent laboratory are reimbursed to the independent laboratory. (R-47, pg. 2) This same language appears on Pages 2-57 of the November 1997 Physician's Coverage and Limitations Handbook and Pages 2-67 of the January 1999 Physician's Coverage and Limitations Handbook. (R-47, pg. 3, 5) Accordingly, Ms. Johnson concluded that the claim for the test performed by the independent laboratory should be denied. (R-16, pg. 4) Ms. Johnson identified one claim in which Petitioner billed Medicaid for an office visit where no patient contact was documented. (R-16, pg. 2; R-45) However, the Agency concedes on this issue, and would adjust its claim accordingly. The Medical Record Review Report, Respondent's Exhibit No. 16, reflects the sum of Ms. Johnson's conclusions after conducting two reviews of Petitioner's records regarding why certain claims should be denied. The totals stated in R-16, which is a compilation of the other exhibits including R-46, are wrong. Testimony of Dr. Larry Deeb Dr. Larry Deeb testified at hearing on May 22, 2001, in Tallahassee, Florida. In addition, the deposition of Dr. Deeb on January 31, 2002; February 4, 2002; February 14, 2002; and February 15, 2002, was offered in lieu of trial testimony. (Notice of Continuing Deposition, 2/7/02) Dr. Deeb is a licensed pediatrician, certified by the American Board of Pediatrics in both pediatrics and pediatric endocrinology. (R-1) Dr. Deeb currently practices pediatric medicine. Dr. Deeb is a peer of Petitioner. In addition, Dr. Deeb has served as a consultant for the Medicaid program since 1981. Dr. Deeb testified that he has conducted peer reviews of Medicaid providers for the Agency for 20 years. Medical records of the audited patients were introduced. Testimony from the auditors indicated that some records were initially obtained from Petitioner, and in reply to their initial letter, additional records were provided. There was also testimony that only contemporaneous records could be considered in substantiating whether a procedure or services were medically necessary. All materials included in Respondent's Exhibit No. 6, to include those documents indicated to be "Additional Documents," were examined and considered. Dr. Deeb was provided a set of documents, which were entered into evidence as Respondent's Exhibit No. 6, by the Agency. Dr. Deeb was asked by Ms. Johnson to review Respondent's Exhibit No. 6 and determine "the level of service provided for the actual visits, and . . . the medical necessity of the visits and/or the ancillary services provided." After conducting his initial review of Petitioner's records, Dr. Deeb reviewed all of the additional documentation Petitioner provided to rebut Dr. Deeb's initial conclusions. After Dr. Deeb concluded his review of the documents included in Respondent's Exhibit No. 6, he returned the documents, his notations on the medical record review sheets, and a short memo of his conclusions to Ms. Johnson. (R-16) In reviewing Petitioner's records, Dr. Deeb determined that the claims submitted to Medicaid reflected a "significant inflation of the level of service," included charges for "prolonged physician attendance" without justification, and contained "wholesale billing for tympanometry." Dr. Deeb observed that "[v]irtually every patient had a tympanometry," regardless of the condition or symptoms the patient demonstrated to Petitioner. A tympanogram is a graph of how well the ear drum moves and is used to diagnose inner ear infections or otitis media. Dr. Deeb concluded that Petitioner repeatedly billed Medicaid for tympanometry services when the documentation in the medical records did not indicate that the services were medically necessary. Petitioner admitted that he gave a tympanogram to nearly every patient he saw without regard to their presenting complaint based upon his experience with young patients. Dr. Deeb testified concerning medically appropriate conditions for billing tympanometry. It is medically necessary to confirm a diagnosis when one is not sure, and to confirm if the patient has improved. A review of the 31 patient records reveals that 211 tympanograms were performed. Of these, the Agency found that seven were reimbursable. The Agency would deny compensation for 17 of 18 tympanograms performed during well-child visits because they are included in the services and fees to be provided. It would approve one procedure which was performed during a well- child visit and reveal the patient had an inner ear infection. A careful review of the 211 tympanograms performed reveals 98 other instances in which the tympanogram performed revealed a child had an inner ear infection or in which the procedure was performed to respond to a specific complaint related to the patient's ears, and was appropriately billed and paid under the principles outlined by Dr. Deeb. See Vol. I, Page 93 of Transcript of Proceedings. When making a determination about level of service, Dr. Deeb relies on the current Procedural Terminology Handbook published by the American Medical Association. The current Procedural Terminology Handbook is used by the medical community, the Agency, the Health Care Financing Administration, and most private insurers "as the methodology for billing and payment." The level of service codes varies according to the complexity of the office visit. The level of service code depends upon three elements: "the complexity of the history, the detail of the physical examination, and the medical decision-making complexity." There are five levels of service for repeat office visits, ranging from 99211 through 99215, depending upon the complexity of the visit. A 211 is a visit in which the patient is seen by staff and a 212 would be a very simple case, i.e., taking out stitches and checking a wound. In Dr. Deeb's experience, "the vast majority of visits in a pediatrician's office are 213s." Dr. Deeb observed "there were significant numbers of 99214s and 215s billed where the complexity and the data provided didn't justify" in the records he examined. Mentioned specifically and emphatically was the failure to take a detailed history on a follow-up visit. A review of the records indicates that Petitioner took careful histories on his patients' past medical involvement, family histories, and social histories upon initially examining a patient or when the patient presented with a complaint. His notes frequently reflect detailed interaction with a patient presenting with a sore throat regarding the patients hyper- activity, behavior in school, and grades. The records also reveal patients who developed over time more complex medical problems. Further, these records indicate time spent was spent on some medical condition the patient had and which was mentioned in the clinical notes maintained by Petitioner. This conforms to Dr. Deeb's working definition provided for "medical necessity." Dr. Deeb testified that Petitioner's records contained no documentation that Petitioner spent additional time with the patient. The Physician's current Procedural Terminology Handbook "allows the physician to charge when they are there for additional time." The records contained in R-6 reveal that in the overwhelming majority of cases Petitioner documented additional time spent with his patients. The treatment by the Agency of Petitioner's billing for Patient #8 is particularly at odds with the standards which the Agency maintains that it follows. Patient #8 was a nine- day-old infant who presented for an EPSDT visit. The visit revealed a cardiac problem which resulted in its transfer to Shand's Emergency Room by ambulance. All Petitioner's notes apparently were not copied because they state "over," indicating added notes were made on the back of the form; however, there are sufficient notes contained in the record to support Petitioner's claim for extra time and for a complex visit. Continuing with Patient #8, the record reflects a patient with significant continuing problems who was transported to the emergency room on two more occasions, once after the infant stopped breathing. The Agency wants to reduce this code for this patient's visits to 214 on the occasion of its transport to Shand's and again after it stopped breathing. The Agency wants to reduce the code for the visit when cardiac testing was repeated from 215 to 213. The notes reflect that the child was in for testing, but presented with a cough it had had since birth and was still prone to super ventricular tachycardia. In sum, Patient #8 was a complex patient with complex problems requiring high level thinking, the criteria for a high level visit. Dr. Deeb indicated in his testimony the scale ran from 212, a re-check visit, to 213, a simple medical problem, to 214, a more complex medical problem or multiple medical problems, to 215, which were very complex problem or problems. The reductions proposed in the billing codes for many of Petitioner's patient visits are inconsistent with the standards expressed by Dr. Deeb, as evidenced by the audit recommendations with regard to Patient #8. A similar pattern occurs with other patients generally or with regard to specific visits. It should be remembered that some patients' conditions changed over time to become more complex. Others presented on one occasion with several things occurring at the same time. In either instance, they presented a situation beyond that of a simple patient. See Patients 9(4-12-99), 12, 15, 16(6-8-99), 17, 23, 24, 25, 26(1-21-99 & 4-6-99), 27, 28(5-28-99 & 6-17-99), 29(9-3-99), and 30(4-21-97). The auditors proposed to reduce not only the code applicable to the visit, but to deny the claim for additional time. A review of the record reveals instances in which, even if a reduction in the code were warranted, there was a medical need for spending additional time with the patient and it was documented in Petitioner's records. This included time spent counseling patients, obtaining added history about their behavior and performance in school, and discussing referrals with parents. In most instances, Petitioner's spending extra time coincided with a complex patient presenting with more complex medical problems. The auditors conclusions regarding Patient #26's visit of 5-11-99 is consistent with Dr. Deeb's testimony. Unfortunately, the audit conclusions with regard to treatment of Patient #26 on other dates are consistent with Dr. Deeb's testimony regarding the standards of review, as are the conclusions reached with regard to other patients. Using the standard applied to the visit of 5-11-99 of Patient #26, very few of the proposed reductions would be as deep as the agency would propose, and others would not be reduced at all.
Recommendation Based on the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED: That Respondent recompute the claim and re-file against the Petitioner, who would have a limited right to contest the new claim. DONE AND ENTERED this 19th day of July, 2002, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN 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 19th day of July, 2002. COPIES FURNISHED: Anthony L. Conticello, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308-5403 Tony C. Rich 1710 Northwest 42nd Street Gainesville, Florida 32605 Virginia A. Daire, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
The Issue At issue in this proceeding is whether the proposed amendments set forth in the Notice of Proposed Rule published on May 15, 2013, in the Florida Administrative Register, Vol. 39, No. 95, pages 2609 through 2610 and modified by the Notice of Change, published on March 12, 2015, in the Florida Administrative Register, Vol. 41, No. 49, pages 1236 through 1237, constitute an invalid exercise of delegated legislative authority,1/ and, if so, whether costs and attorney’s fees should be assessed against Respondent and paid to Petitioner.
Findings Of Fact The Petition Petitioners have challenged the Notice of Proposed Rule and Notice of Change as an invalid exercise of delegated legislative authority. The petitions request that a formal hearing be conducted, a final order be entered determining that the proposed rule is an invalid exercise of delegated legislative authority, award petitioners’ costs and attorneys’ fees, and provide such other relief as deemed necessary. The Parties Petitioner Fernandez is a Florida resident and patient with ongoing medical issues that requires him to request and obtain his medical records from his attending or treating physicians from time to time. Petitioner Dax J. Lonetto, Sr., PPLC, is a Florida-based law firm. Dax Lonetto is a Florida-licensed attorney and sole shareholder of the Lonetto PPLC law firm. Eighty-five to 90 percent of Mr. Lonetto’s practice involves social security disability benefits, and the remainder of his practice involves veteran’s benefits and other basic personal injury claims.6/ In order to pursue and obtain social security benefits or veteran’s benefits for clients, Mr. Lonetto must first obtain his clients’ medical records. Petitioner FJA is a statewide, not-for-profit, professional association of approximately 2,500 plaintiff trial attorneys. FJA’s purpose is engaging in advocacy efforts on behalf of its membership, strengthening and upholding Florida’s civil justice system, and protecting the rights of Florida’s citizens and consumers. Paul D. Jess is a Florida-licensed attorney who serves as the general counsel and deputy executive director for FJA. Mr. Jess provided no documentary evidence to support the position that most physician “offices or vendors would charge the maximum [amount] permitted [by the rule].” Mr. Jess admitted that FJA is not “directly injured by this price hike as an association or as a corporation,” because FJA does not order medical records. However, Mr. Jess testified that for the majority of FJA’s members, ordering medical records is a routine practice on behalf of their clients. Further, Mr. Jess believed that a majority of FJA members would be adversely impacted by this proposed rule, based on the increased costs in obtaining their clients’ medical records. Petitioner FCAN is a Florida not-for-profit grassroots organization dedicated to advocating for the rights of Florida consumers. William Newton served as the corporate representative for FCAN. Mr. Newton previously relinquished the full-time executive director’s position and now currently works part-time as FCAN’s deputy director. FCAN currently has about 7,000 individual members. FCAN is a nonpartisan organization which represents Florida consumers in four major issue areas: utilities, insurance, health care, and the environment.7/ With respect to the health care area, FCAN stands for affordable and available health care for everyone, with a focus on trying to improve accessibility, as well as to control the price of health care. Mr. Newton did not know how many of FCAN’s 7,000 members would be affected by the proposed rule change; however, he believed that “almost all of them would be” because they go to the doctor. The Board regulates the practice of medicine in Florida pursuant to chapters 456 and 458, Florida Statutes, and is the agency that is proposing the rule amendments at issue. Intervener BACTES is a release of information (ROI) provider that contracts with physicians in Florida and throughout the country to process and fulfill requests for medical records received by such physicians. William Bailey founded BACTES and served as its CEO from 1991 until July 2013, when he assumed a consultant status with the provider. Mr. Bailey confirmed that BACTES is currently operating in Florida with three offices located in Orlando, Ft. Myers, and Jacksonville. BACTES has no plans to discontinue doing business in Florida.8/ Intervener HealthPort is also an ROI provider that contracts with physicians in Florida and throughout the country to process and fulfill requests for medical records received by such physicians. Kyle Probst, HealthPort’s counsel and director of government relations, confirmed that HealthPort engaged Cynthia Henderson to approach the Board regarding making changes to the rule to “clear up some apparent confusion about how medical records should be billed in the state of Florida.” Intervener FMA is a professional association dedicated to the service and assistance of allopathic and osteopathic physicians in Florida. Approximately 20,000 licensed Florida physicians are members of the FMA. The parties agreed there are approximately 75,000 physicians licensed and regulated by the Board. Not all 75,000 Florida licensed physicians are currently practicing in Florida. The Statute and Current Rule Section 456.057(17), Florida Statutes, provides: A health care practitioner or records owner furnishing copies of reports or records or making the reports or records available for digital scanning pursuant to this section shall charge no more than the actual cost of copying, including reasonable staff time, or the amount specified in administrative rule by the appropriate board, or the department when there is no board. Section 458.309(1) provides in pertinent part: The board has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter conferring duties upon it. Florida Administrative Code Rule 64B8-10.003 is the Board’s rule governing the costs of reproducing medical records. The rule was first adopted on November 11, 1987, as rule 21M-26.003. It was transferred to rule 61F6-26.003, then to rule 59R-10.003, amended on May 12, 1988, amended on March 9, 2009, and then finally transferred to rule 64B8-10.003. The rule currently provides: Costs of Reproducing Medical Records. Recognizing that patient access to medical records is important and necessary to assure continuity of patient care, the Board of Medicine urges physicians to provide their patients a copy of their medical records, upon request, without cost, especially when the patient is economically disadvantaged. The Board, however, also recognizes that the cost of reproducing voluminous medical records may be financially burdensome to some practitioners. Therefore, the following rule sets forth the permitted costs for the reproduction of medical records. Any person licensed pursuant to Chapter 458, F.S., required to release copies of patient medical records may condition such release upon payment by the requesting party of the reasonable costs of reproducing the records. For patients and governmental entities, the reasonable costs of reproducing copies of written or typed documents or reports shall not be more than the following: For the first 25 pages, the cost shall be $1.00 per page. For each page in excess of 25 pages, the cost shall be 25 cents. For other entities, the reasonable costs of reproducing copies of written or typed documents or reports shall not be more than $1.00 per page. Reasonable costs of reproducing x- rays, and such other special kinds of records shall be the actual costs. The phrase “actual costs” means the cost of the material and supplies used to duplicate the record, as well as the labor costs and overhead costs associated with such duplication. Specific Authority 456.057(18),9/ 458.309 FS. Law Implemented 456.057(18) FS. History-New 11-17-87, Amended 5-12- 88, Formerly 21M-26.003, 61F6-26.003, 59R-10.003, Amended 3-9-09. This rule was first created in 1987 and was effective in May 1988. In pertinent part, that first rule provided that chapter 458 licensees could condition the release of copies of patient medical records “upon payment . . . of reasonable costs of reproducing the records.” The rule then defined “reasonable costs of reproducing copies . . . [should] not be more than” a $1.00 for the first 25 pages and 25 cents per page in excess of 25 pages. In 2009, the rule was revised to allow patients and governmental entities to get copies of medical records at that same rate. For all other entities the “reasonable costs of reproducing copies . . . [should] not be more than $1.00 per page.” Over the course of 26 months, the Board had access to as much information as the Board staff and interested parties could provide it. The Board heard testimony in no fewer than nine public hearings.10/ The proposed rule language was dissected and discussed on multiple levels, and the Board devoted countless hours to listening to and evaluating those comments. Rule Development In June 2012, the Department of Health (Department) and the Board received an email correspondence on behalf of HealthPort requesting clarification on the costs for reproducing electronic medical records. That correspondence, the current rule 64B8-10.003, and the applicable statutes were placed on the agenda for the Board’s August 2012 Rules/Legislative Committee (RLC or Committee) meeting. At the August RLC meeting, the Committee discussed the requested action and heard from an attorney representing HealthPort. The Committee voted to table the item and seek additional information. The Board commenced rulemaking to amend rule 64B8-10.003 in early October 2012. At the RLC meeting on October 11, 2012, the Committee voted unanimously to recommend noticing this proposed change for rule development. The Board’s counsel was to draft language for a proposed rule change to be presented at the next RLC meeting. On October 30, 2012, a Notice of Development of Rulemaking (Notice) was published in the Florida Administrative Register. The Notice listed the “PURPOSE AND EFFECT: [as] The Board proposed the development of rule amendments to address the cost of reproduction of medical records which are stored in an electronic format.” At the November 2012 RLC meeting, the Committee received a draft rule proposal, excerpts of the October RLC meeting report, and materials from the October meeting. The Committee heard from various speakers on the proposed rule language. One Committee member suggested that the RLC would benefit from knowing what other state medical boards allowed physicians to charge. Another suggested the Board staff look at a different charge for paper versus electronic production. Following the discussion, the Committee approved two motions: one to move to one rate (but undecided on what that rate would be); and the second to have then Executive Director, Alison Dudley, “come back to [the RLC] with the aspects of what costs are elsewhere so that [the RLC could] make that decision about what that rate and particular medium” is, in order to move forward. The Board’s staff prepared a survey that was sent to administrators in medicine via a web portal, asking the following specific questions: Does your board have a rule or law that outlines what a physician can charge for medical records? Flat rate or per page? Does that law or rule delineate different charges for paper medical records versus electronic medical records? What are the charges? Does the law or rule delineate different charges for producing the medical records on paper versus on a CD? What are the charges? Does the law or rule contemplate charges for other services such as diagnostic tests or X-rays? What are the charges? Does your law or rule define “electronic medical record?” If so, what is that definition? Can you share your law and/or rule with us? Thank you for your responses. Of the 50 or so administrators contacted, the Board staff received 13 responses. Those responses were provided to the RLC for review. At the January 31, 2013, RLC meeting, the agenda included multiple items for the Committee’s consideration: the transcript from the November 29, 2013, RLC meeting; excerpts of the RLC report dated December 2012; an email from Ms. Henderson; a 2003 White paper; the costs charged by Florida Clerk of Courts, Florida hospitals, and other Florida health care boards; costs charged by other state medical boards; and all the materials presented at the prior meetings. The Committee received testimony from individuals regarding their understanding of how the proposed changes to the rule would or could affect their patient/clients. As a result of those comments and the RLC’s discussion, the Committee voted to have draft language prepared that included one fee for any records release with the following specific language: “stored and delivered in any format or medium.” The draft language was to be presented at the next RLC meeting. At the April 4, 2013, RLC meeting, the Committee agenda included excerpts from its January meeting, draft language, and an article regarding the federal Health Portability and Accountability Act (HIPAA) requirements. The Committee heard from individuals again and considered the various recommendations regarding the appropriate language for the proposed rule. The draft language presented at this RLC meeting, in the underline/strike-through method, provided the following: Costs of Reproducing Medical Records. Recognizing that patient access to medical records is important and necessary to assure continuity of patient care, the Board of Medicine urges physicians to provide their patients a copy of their medical records, upon request, without cost, especially when the patient is economically disadvantaged. The Board, however, also recognizes that the cost of reproducing voluminous medical records may be financially burdensome to some practitioners. Therefore, the following rule sets forth the permitted costs for the reproduction of medical records stored and delivered in any format or medium. Any person licensed pursuant to Chapter 458, F.S., required to release copies of patient medical records may condition such release upon payment by the requesting party of the reasonable costs of reproducing the records. For patients and governmental entities, the reasonable costs of reproducing copies of written or typed documents or reports shall not be more than the following: For the first 25 pages, the cost shall be $1.00 per page. For each page in excess of 25 pages, the cost shall be 25 cents. (2)(3) The For other entities, the reasonable costs of reproducing copies of written or typed documents or reports shall not be more than $1.00 per page. (3)(4) Reasonable costs of reproducing x-rays, and such other special kinds of records shall be the actual costs. The phrase “actual costs” means the cost of the material and supplies used to duplicate the record, as well as the labor costs and overhead costs associated with such duplication. Additionally, the Committee discussed the anticipated financial impact that the proposed changes would have on small businesses, including whether or not a statement of estimated regulatory costs (SERC)11/ was necessary. The Department staff could not say whether the proposed change would increase the Department’s cost in excess of $200,000 a year. Following the discussion, the Committee voted to table the SERC decision until additional information could be brought before the Board and the proposed draft rule language was approved. The full Board met on April 5 and approved the RLC report which included the approval of the draft rule language. Additionally, the Department staff reported that, after conferring with other staff in Tallahassee, the Department did not feel that the cost associated with the draft rule language would exceed $200,000 a year in the aggregate. The Board voted that a SERC was not required. Between the October 2012 Notice and the May 2013 publication of the proposed rule changes, the RLC met in noticed public meetings discussing the potential rule revision. The rule record is clear that the proposed changes were discussed extensively by Committee members with input from attorneys, residents, association representatives and corporate representatives. On May 15, 2013, a Notice of Proposed Rule (using the proposed language found in paragraph 26 above) was published in the Florida Administrative Register, Vol. 39, No. 95. The purpose for the proposed rule was to provide a single fee for reproducing medical records. The Board received a request for a hearing and numerous comments from the public on the proposed changes. The rule hearing was scheduled for the next available Board meeting. On August 2, 2013, the Board held a public hearing on the proposed rule in Deerfield Beach. The Board agenda included: the proposed rule 64B8-10.003; the rule hearing request; the rule hearing notice; a summary of the issue for Board consideration submitted by Ms. Henderson; copies of the notices sent regarding the hearing; meeting reports from the RLC meetings held on August 2, 2012, October 11, 2012, November 29, 2012, January 31, 2013, and April 4, 2013; and over 60 written comments. At the Board meeting over 15 people addressed the Board, expressing either opposition to or support of the proposed changes. As a result of the testimony received, the Board chair directed that the public rule hearing be transcribed and the transcript be sent to the RLC for its consideration and determination. At the Orlando RLC meeting on October 3, 2013, the Committee conducted a rule hearing on the proposed rule language. The RLC’s agenda included: draft proposed language for the rule; a draft RLC meeting report; a transcript from the August 2, 2013, rule hearing; an article regarding Florida doctors and medical records; and additional comments from seven different sources. The Committee was charged to consider the testimony from the August 2013 public rule hearing, as well as the testimony from this rule hearing to make recommendations to the full Board. The Committee heard testimony from individuals who either opposed or supported the proposed rule. The Committee members asked questions of the various presenters, and provided education to those presenters and attendees as to the multiplicity of medical practices, attendant issues, and personal experiences in dealing with medical records requests. The Committee agreed that the rule should be as set forth in the draft rule language. The Committee also agreed that there might be an “adverse impact” on small businesses, and that a SERC should be prepared. In November 2013, Board staff distributed a survey to 1,41912/ Florida-licensed physicians seeking responses to the following questions: Do you handle the copying of your medical records with your own staff? If yes continue to 1a. If no, go to Question 2. Yes. No. 1a. Do you have a designated staff person who only handles the review and copying of medical records? If yes, continue to 1b. If no, continue to 1c. Yes. No. 1b. How much do you pay this person on a monthly basis, including any benefits that are provided? 1c. How much do you spend on special equipment and supplies (copier, paper etc.) for the copying of medical records annually? If you send your medical records for copying by a service, how much do you pay each month for this service? On average, how many requests for copies of medical records do you receive each month? The Board staff received 28 responses from the 1,419 surveys sent out. Of those 28 responses, 27 handled the copying of medical records in-house. Twelve practitioners had a designated staff person to review and copy medical records, while 15 did not. Fifteen declined to provide how much their personnel were paid. There was a wide range of pay for the others. The costs associated for special equipment and supplies to provide copies of medical records ranged from $120 to $20,000 per month. Only one practitioner responded that medical records were sent out to a copying service. The number of medical record requests varied from one to more than 600 per month. The next public hearing was held in Orlando on December 6, 2013. The Board materials included: the hearing notice for December 6, 2013; proposed rule language; the transcript of the October 3, 2013, meeting; section 164.524, Access of Individuals to Protected Health Information; new comments received; the survey results; and material from the previous public hearings and meetings. The Board considered the testimony from the public hearings that had been held on August 2 and October 3. Each speaker was afforded the opportunity to express their position and comments received were either “opposed” or “supported” the proposed rule changes. Following the testimony, the Board voted to change proposed subsection (2) by adding the following language, which is underscored: [t]he reasonable costs of reproducing copies of written or typed documents or reports shall not be more than $1.00 per page, but shall not exceed actual costs. Thereafter, the Board again revisited the question of whether a SERC was necessary. The Board considered whether the newly revised language would adversely affect, or was likely to directly or indirectly increase regulatory costs to any entity in excess of $200,000 in the aggregate in Florida within one year of the implementation of the rule. The Board determined that a SERC was necessary. On February 6, 2014, the RLC met in Kissimmee for another public hearing on the proposed rule amendments. The Committee was to consider changes authorized by the Board during its December meeting. The agenda materials included: draft language of the rule; additional correspondence; and the materials from the prior meetings/hearings. If the draft rule language was approved, two questions had to be addressed: would the proposed rule have an adverse impact on small businesses; and would the proposed rule be likely to directly or indirectly increase regulatory costs to any entity in excess of $200,000 in the aggregate in Florida within one year after its implementation? Testimony was received from several individuals. Following the testimony, the Committee members had a discussion about the terms “actual costs” versus “reasonable costs.” The Committee voted to revise the draft rule language to “reasonable costs” and approved a “Notice of Change” to be published. The Committee also determined that the amendment would not have an adverse impact on small businesses, nor was it likely to directly or indirectly increase regulatory costs in excess of $200,000. On April 3, 2014, the RLC held another public hearing in Deerfield Beach on the proposed rule. There remained some inconsistencies in the changes that were approved and the Committee reconsidered the proposed rule language. The material in the RLC’s agenda included: materials presented at previous meetings including correspondence; draft changes to the rule; the hearing notice; an article regarding electronic records; an excerpt of the February 2014 meeting; and the transcript of the February 2014 meeting. The Committee received testimony from several speakers who pointed out concerns about the proposed rule, and provided alternatives to it. After the testimony, the Committee voted to have new language prepared addressing those concerns and, in some instances, incorporated alternative suggestions. Additionally, the Committee understood that an additional public hearing would be necessary, and that the SERC might need to be revised. On June 5, 2014, the RLC met in Tampa for another public hearing to consider the revised draft rule language. The agenda included: the hearing notice; the proposed draft language; a proposed SERC; multiple written comments; transcripts from prior RLC and Board meetings where the proposed rule was discussed; and RLC meeting reports. The Committee voted to table the discussion of the proposed rule until another hearing could be held in South Florida. On October 9, 2014, the RLC met in Deerfield Beach and held a rule hearing regarding the revised rule language. The Committee received additional testimony from concerned individuals. The Committee voted to accumulate all the comments and present everything to the full Board at the December 2014 meeting. In October 2014, Ms. Dudley was asked to speak at the Capital Medical Society in Tallahassee. Ms. Dudley took the opportunity to hand out the survey (found in paragraph 34) to the participants. Although she received four additional responses to the survey, the audience was not physicians, but staff who primarily handled the medical records for medical offices. On December 4, 2014, the RLC met in St. Petersburg for an additional rule hearing on the proposed rule language. The Committee was to review all the comments submitted. The RLC’s agenda material included: the hearing notice; the suggested changes to the draft proposed rule from March and May 2014; the excerpt of the RLC meeting report in October 2014; multiple correspondence from concerned individuals; survey responses from physician offices (including the four additional surveys); materials from the prior hearings and RLC meetings; and the proposed SERC. At the beginning of this rule hearing, the Board’s executive director provided a suggested revision to the proposed rule by adding a new paragraph: “(4) Accessing medical records through patient portals does not constitute the reproduction of medical records.” Testimony was received from various individuals regarding the proposed rule language. The Committee reviewed all the comments submitted. The Committee determined that a SERC should be prepared. The Board held another rule hearing on the proposed rule language on February 6, 2015, in Stuart. The agenda material included: the hearing notice; the draft changes; the excerpt of the RLC meeting; survey responses from physician offices; newly received written comments; a proposed SERC; and materials presented at the previous hearings and meetings. The Board heard testimony from several individuals who either opposed or supported the proposed rule language. The Board reviewed the changes to the proposed rule and the proposed SERC, and heard testimony from presenters. Based on that testimony, the Board members further discussed the proposed rule language and voted to modify it again. After the proposed rule language discussion, the Board then addressed whether it believed, with the latest revision to the draft rule, that a SERC was necessary. The Board voted to accept the SERC as presented. On February 17, 2015, the Joint Administrative Procedures Committee (JAPC) wrote the Board regarding the SERC and inquired as to whether the draft rule would require legislative ratification. As a result of the JAPC inquiry on March 4, 2015, the Board held a telephonic conference meeting. The Board heard from three individuals regarding whether the proposed rule required legislative ratification and the status of the SERC. The Board determined that the rule would require legislative ratification and the SERC needed to be revised. The Board approved the following changes to the proposed rule (the initial paragraph and sections (1) and (2) are found in paragraph 26 above): (4) Reasonable costs of reproducing x- rays, and such other special kinds of records shall be the actual costs. The phrase “actual costs” means the cost of the material and supplies used to duplicate the record, as well as the labor costs and overhead costs associated with duplication, plus postage. Accessing medical records through patient portals does not constitute the reproduction of medical records. On March 12, 2015, the Notice of Change was published in the Florida Administrative Register, and the four petitions were filed. Following the filing of the petitions at DOAH, the parties requested a continuance to allow the Petitioners the opportunity to present their lower-cost alternatives to the Board. At the April 10, 2015, Board meeting, the Board addressed an allegation that the Board had failed to consider five lower-cost regulatory alternatives (Alternatives). The Board had not considered the Alternatives because they had not been filed for the Board’s consideration. Once the Alternatives were filed, they were placed on the next available Board agenda. The first Alternative was to leave the rule in its current state. After hearing from interested parties, the Board determined that it had evaluated the issues around the rule and the costs during the prior hearings and meetings. The Board agreed that the status quo was not viable for a variety of reasons. The Board voted to reject this Alternative. The second Alternative asked that the medical record holder only be allowed to charge the actual cost of copying, including reasonable staff time consistent with section 457.057(17). The Board discussed that through the multiple public hearings it had determined that it would be impossible to determine the actual charge for copying. The actual cost for an urban multi-partner physician would be different than a solo practitioner’s office in a rural location. The Board voted unanimously to reject this Alternative. The third Alternative asked the Board to conduct an evaluation or study regarding what the actual costs of copying are for medical record holders based on the type of request, type of medical record, the format of the record, and the format of the record to be delivered. The Board discussed what it had heard about in the prior meetings: other states allowed higher levels of reimbursing; and hospitals charged $1.00 per page as authorized by statute. The Board attempted to obtain the data sought but was unsuccessful in obtaining any significant response. Further, the Board does not have the statutory authority to require physicians to respond to any data or survey requests. The Board voted unanimously to reject this Alternative. The fourth Alternative asked the Board to eliminate the per-page price and impose a restriction that the prices could not exceed the maximum price authorized by HIPAA. The Board did not concur that HIPAA set an exact amount, and trying to determine the costs for each practitioner in each type of practice would be frustrating to all involved. The Board voted unanimously to reject this Alternative. The fifth Alternative asked the Board to keep the current rule, but separate the costs for electronic versus digital copies. The Board discussed the movement towards all electronic medical records, but paper records and other records will still exist. The Board determined that there is a need for the proposed rule to address the current circumstance. The Board voted unanimously to reject this Alternative. Those opposed to the alleged increase testified there was no basis for the change, that the proposed change quadrupled the price for patients and governmental entities, and that it was arbitrary and capricious, especially with respect to electronic records. These opponents fail to recognize changes in medicine. HIPAA brought patient confidentiality and the need to maintain that confidentiality into sharp focus. Medical practitioners are required to ensure that confidential patient information is not disseminated to unauthorized persons. Physicians must pay to have medical records copied, whether it is done “in-house” or by an ROI provider. Labor costs have increased and the tedious review to ensure that confidential information remains confidential is time-consuming and costly. Medical practices can be quite varied in type, size, sophistication, location, and much more. Petitioners’ claim that the proposed rule should be the “actual cost” to the practitioner is impracticable. A general practitioner in a rural solo practice, who receives one request for medical records, might be able to ascertain the “actual cost” to produce that one medical record. A specialist in an urban multi-partner practice group, who receives multiple requests for medical records, would find it nearly impossible to ascertain the “actual cost” to produce each requested medical record without extensive business record-keeping. This proposed rule retains the suggestion that physicians “provide their patients with a copy of their medical records, upon request, without cost, especially when the patient is economically disadvantaged.” Physicians provide medical records, free of charge, to subsequent or specialty physicians to ensure care. However, physicians are not in the business of repeatedly producing medical records. Those in favor of the proposed rule testified that the cost to physicians for reproducing medical records has not increased in years. The stringent HIPAA requirements placed an additional requirement on health care providers to ensure that private individual health data is kept confidential. The process to release medical records is not simply to pull a paper, digital or electronic medical record, copy it, and send it out the door. The process, as explained, takes valuable time from practitioners and their staff. In a simplified fashion once the request is made: staff must verify the requester’s identity and right to obtain the copy; the request must be logged into a HIPAA log; staff must locate and retrieve the medical record in whatever format it is in; staff must redact confidential information; staff must review for specific health treatment records (mental health, alcohol or drug treatment, HIV status) that cannot be provided pursuant to statute; a copy may need to be made or a paper copy may need to be scanned to an electronic disc; and the practitioner must review it to make sure it can be provided as requested. It is a time-consuming process.
The Issue The issues for determination are whether Respondent failed to make reasonable efforts to ensure that a prescription for a resident was refilled in a timely manner in violation of Florida Administrative Code Rule 58A-5.0185(7)(f); and, if so, whether Respondent should reclassify Respondent's license from standard to conditional, impose an administrative fine of $2,000, and impose a survey fee of $500 pursuant to Sections 400.419(1)(b) and 400.419(9), Florida Statutes (2001). (All references to chapters and statutes are to Florida Statutes (2001) unless otherwise stated. Unless otherwise stated, all references to rules are to rules promulgated in the Florida Administrative Code in effect on the date of this Recommended Order.)
Findings Of Fact Petitioner is the state agency responsible for regulating assisted living facilities (ALFs) and for investigating complaints received anonymously by a state hotline in accordance with Chapter 400, Part III, and Rule 58A-5. Respondent is an ALF located at 312 East 124th Avenue, Tampa, Florida 33612 (the facility). Petitioner conducted a complaint survey of the facility on August 10, 2001. Petitioner noted the results of the survey on a form entitled Form 3020-0001 "Statement of Deficiencies and Plan of Correction" (the 3020). The 3020 is the document used to charge ALFs with deficiencies that violate applicable law. The 3020 identifies each alleged deficiency by reference to a tag number. Each tag number on the 3020 includes a narrative description of the allegations against the ALF and cites a provision of the relevant rule or rules that the alleged deficiency violates. The 3020 in this case involves one allegation in Tag A630. Tag A630 alleges that Respondent violated Rule 58A- 5.0185(7)(f) by failing to make every reasonable effort to ensure that prescriptions for residents who receive assistance with self-administration or medication administration are "refilled" in a timely manner. Resident 2 receives assistance with the self- administration of medication. Resident 2 suffers from dementia and chronic obstructive pulmonary disease. Tag A630 alleges that Respondent failed to make reasonable efforts to ensure that a prescription for an antibiotic known as Tequin was refilled in a timely manner on or about August 2, 2001. University Community Hospital (the hospital) admitted Resident 2 on June 27, 2001, with relevant diagnoses of urinary tract infection and sepsis. The hospital administered Tequin to Resident 2 intravenously and discharged Resident 2 to the facility on August 2, 2001. On August 6, 2001, the hospital readmitted Resident 2 for treatment of the urinary tract infection. The discharge instructions from the hospital on August 2, 2001, included instructions for several medications. The instructions indicated that Resident 2 was to continue taking Tequin 200 mg one tab a day for 11 days; Prednisone 20 mg tab take as needed; Albuterol and Atrovent nebulizer every 6 hours as needed; and home O2 2 liters by nasal canula [sic] 24 hours. Resident 2 had prescriptions for all of the medications included in the discharge instructions except Tequin. The hospital discharged Resident 2 late in the evening on August 2, 2001. The next morning, the facility manager faxed the new prescriptions for Resident 2 to the pharmacy that the facility used in the ordinary course of its business. The pharmacy timely filled the new prescriptions. Facility staff never saw a written prescription for Tequin. Resident 2 was in good spirits and had no signs of a urinary tract infection or other signs of infection such as a change in mental status or a loss of appetite. Facility personnel reasonably believed that the hospital had successfully treated the urinary tract infection. Petitioner's surveyor testified that he saw a prescription for Tequin in the facility files for Resident 2 and wrote down the exact wording of the prescription. That testimony is neither credible nor persuasive. Even if the testimony of Petitioner's surveyor were credible and persuasive, other evidence in the case outweighs that testimony. Neither Petitioner's agents, the facility Manager, the facility administrator, the owner of the facility, the hospital, the discharging physician, nor the pharmacy, is able to produce a prescription for Tequin, a copy of the prescription, or a record that the physician ever wrote such a prescription. In addition, a discharge instruction is not a prescription. Finally, Petitioner admits in its PRO that a prescription for Tequin was "missing" when Resident 2 returned to the facility. Respondent could not have failed to refill a prescription for Tequin because there is no credible and persuasive evidence that a prescription for Tequin ever existed between August 2 and 6, 2001. The facility Manager did not compare the discharge instructions with the written prescriptions that accompanied Resident 2 on her discharge from the hospital. While that omission may constitute a violation of some law or rule, it is not the violation alleged in the Administrative Complaint and Tag A630. The omission alleged in the Administrative Complaint and Tag A630 is that Respondent failed to ensure that an existing prescription for Tequin was "refilled." That allegation, in the context of this case, requires Petitioner to show that Respondent failed to ensure that the pharmacist refilled an existing prescription previously issued by a physician and on file with the pharmacist. Petitioner failed to prove that factual allegation. The factual allegations that Petitioner sought to prove in the administrative hearing are substantially different from those contained in either the Administrative Complaint or Tag A630. The Administrative Complaint alleges at paragraph 8 that Respondent failed to make reasonable efforts to ensure that a prescription for Resident 2 was refilled. Tag A630 alleges in relevant part: Based on a review of resident records and on interview with the facility's Owner, Administrator and Manager, the facility failed to fill a prescription for one resident upon the resident's return from the hospital. Per interview with the three employees noted above, on 8/10/01 at 12:45pm, and based on a review of the Resident's files, Resident #2 was admitted to University Community Hospital on 7/27/01, and was there diagnosed with a urinary tract infection and sepsis . . . The Resident was discharged from UCH on 8/2/01, with the following medication instructions; Tequin 200mg one tab a day for 11 X days. . . . These discharge instructions were found in the Resident's file. Also observed in the Resident's file were the prescriptions for the above-noted medications. However, when asked, none of the three employees noted above were aware of the prescription for the wide-spectrum antibiotic; each stated the belief that the Resident's infections had been treated and resolved in the hospital and that an antibiotic wasn't needed. A review of the Resident's Medication Observation Record for 8/01 showed the entry of the other medications per the discharge instructions except for the Tequin. On 8/7/01 the Resident was readmitted to the hospital with symptoms of a urinary tract infection, per Owner, the Administrator and the Manager. (emphasis supplied) It can be reasonably assumed that the facility's failure to note either the Resident's discharge instructions or the prescription slip for the antibiotic (Tequin) resulted in the Resident's continued suffering of a urinary tract infection and the Resident's return to the hospital. Regardless of whether this failure to give the Resident his prescribed medication was primarily responsible for the Resident's continued UTI, the facility failed to properly note the physician's orders and to fill the prescription. Petitioner's Exhibit 4 at pages 2-3. Before the administrative hearing, Tag A630 expressly alleged that a prescription for Tequin existed in the file of Resident 2 at the facility and charged that Respondent failed to fill the existing prescription. The Administrative Complaint alleges that the failure to fill an existing prescription violates the requirement in Rule 58A-5.0185(7)(f) to ensure that prescriptions are refilled. At the hearing, Petitioner sought to prove factual allegations that are different from those in Tag A630 and the Administrative Complaint. Rather than proving that Respondent failed to fill a prescription that existed in the file of Resident 2, as alleged in Tag A630, Petitioner sought to prove that Respondent failed to compare the discharge instructions with the prescriptions issued by the treating physician, remind the physician that he or she failed to issue a prescription for Tequin, retrieve the pretermitted prescription, deliver it to the pharmacist, and then ensure that the pharmacist timely "filled" the new prescription. Petitioner cannot put Respondent on notice in the Administrative Complaint and Tag A630 that Respondent must be prepared to defend the factual allegation that Respondent failed to refill an existing prescription and then prove at the administrative hearing that Respondent committed acts or omissions not alleged in either the Administrative Complaint or Tag A630. To do so, is a violation of fundamental notions of due process and adequate notice of the charges against Respondent in a penal proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Respondent not guilty of the acts and omissions alleged in the Administrative Complaint and Tag A630 and restoring Respondent's previous license rating nunc pro tunc. DONE AND ENTERED this 21st day of October, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 21st day of October, 2002. COPIES FURNISHED: Colleen O'Rouke, Esquire Riley Law Firm, P.A. 4805 West Laurel Street, Suite 230 Tampa, Florida 33607 Michael P. Sasso, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Suite 330K St. Petersburg, Florida 33701 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308
The Issue Whether Respondent committed the offenses set forth in the Administrative Complaint and, if so, the penalty, if any, which should be imposed.
Findings Of Fact At all times pertinent to this proceeding Respondent, CHARLES E. FINKEL, was licensed by Petitioner to practice dentistry in the State of Florida. Petitioner is the State agency governing the practice of dentistry in the State of Florida. At all times pertinent to this proceeding, Respondent was engaged in the general practice of dentistry in Plantation, Florida. During the course of his practice, Respondent performs a surgical procedure for the treatment of periodontitis known as osseous surgery and a surgical procedure for the treatment of gingivitis known as a gingivectomy. Osseous surgery involves recontouring or reshaping bone in the mouth. Gingivectomy involves the surgical removal of diseased gum tissue. Osseous surgeries and gingivectomies are typically performed in the dentist's office. Both procedures can be performed during the same treatment session. At all times pertinent to this proceeding, Priscilla DeLeon, Joanne Manda, and Nanette Bevilacqua were employees of Albertson's, Inc. and covered by its group dental insurance plan. Ms. Bevilacqua first went to Respondent August 30, 1983, to have a filling restored in one of her front teeth. Respondent was chosen by Ms. Bevilacqua because he accepted Albertson's dental insurance plan. During the first visit, Respondent examined her dental condition, took a full mouth series of x-rays and restored the filling for her front tooth. Respondent discussed with Ms. Bevilacqua her general dental condition and advised her that she had pyorrhea and periodontitis. Respondent's examination revealed that Ms. Bevilacqua had periopockets ranging from 5 to 7 millimeters in depth. A periopocket of 6 millimeters or greater is an indication of a need for surgical intervention. Respondent advised Ms. Bevilacqua during her office visit of August 30, 1983, that she should seek treatment for her condition and discussed with her different treatment modalities including treatment through the use of osseous surgery. Respondent explained to Ms. Bevilacqua the risks and benefits of the surgical procedure during her first office visit, and she agreed during the first visit to undergo the surgical procedure at a later date. Ms. Bevilacqua returned to Respondent on September 29, 1983, because she continued to experience pain in the front tooth that he had filled on August 30, 1983. Respondent advised her that she needed a root canal on the subject tooth, which she agreed to undergo. Ms. Bevilacqua did not understand from Respondent's discussions with her on September 29, 1983, that he intended to perform during that office visit, in addition to the root canal, the surgical treatment that they had discussed on August 30, 1983. She would have consented to having the surgical procedure performed on September 29, 1983, had she been asked to do so. On September 29, 1983, Respondent performed the root canal and osseous surgery on Ms. Bevilacqua. Respondent also performed a gingivectomy as a part of this surgical treatment by trimming her gum level. Respondent was justified in performing the osseous surgery and gingivectomy based on the findings made during his examination of Ms. Bevilacqua on August 30, 1983. Entry for the osseous surgery was made through use of an envelope flap, which is a means of lifting the gum tissue from the bone structure. The bone structure was then recontoured with a rotary instrument. Respondent reduced the width of the bone and made a slight reduction in the height of the bone Respondent closed the wound produced by the surgery with a periopack. A periopack is a medicated bandage which may be used to close certain surgical wounds without the use of sutures. Respondent did not consider it necessary to use sutures to close the incision. The procedures Respondent followed in performing the surgery are acceptable dental procedures. Respondent thereafter submitted a claim to Ms. Bevilacqua's insurance carrier for osseous surgery. On July 5, 1985, Ms. DeLeon visited Respondent for the purpose of having a restoration (filling) of two of her teeth. Respondent advised Ms. DeLeon that she needed to have a root canal performed. Respondent did not discuss with the patient the nature of the procedure or the risks and benefits of the root canal procedure. Nevertheless, Ms. DeLeon consented to undergo the root canal therapy, which was begun on her first visit. Respondent's examination of this patient revealed periopockets with depths from 6 to 8 millimeters. Ms. DeLeon returned to see Respondent on July 16, 1985, to have the root canal completed. During this second visit Respondent also performed a frenectomy on Ms. DeLeon's upper front teeth (a procedure to which she had consented) and osseous surgery on her lower right and her lower left quadrants. Respondent failed to discuss with Ms. DeLeon, that he planned to perform osseous surgery on her, he did not explain the risks and benefits of the procedure to her, and she did not consent to the procedure. The osseous surgery came as a complete surprise to Ms. DeLeon. The osseous surgery was performed through the use of an envelope flap, recontouring of the bone structure, and closing of the incision with a periopack. The procedures followed by Respondent while performing the osseous surgery are acceptable dental procedures. The surgical procedure was justified based on Respondent's findings made during his examination of her. Respondent did not recommend to Ms. DeLeon that she have periodontal surgery on her upper quadrant. Respondent thereafter submitted a claim to Ms. DeLeon's insurance carrier for osseous surgery. Joanne Manda first visited Respondent on August 13, 1985, because she had an upper left bridge that needed repair. Respondent observed that she had pyorrhea and periodontal disease throughout her mouth and recommended periodontal surgery on her two upper quadrants. There was no recommendation that she have periodontal surgery on her lower quadrants. Ms. Manda returned to Respondent on August 29, 1985, at which time her teeth were cleaned and her course of treatment was discussed. Ms. Manda was told to return on September 10, 1985, at which time the recommended surgical procedure would be performed. Respondent had, prior to September 10, 1985, discussed with Ms. Manda the risks and benefits of the surgical procedure and the alternatives thereto. Ms. Manda did not understand the treatment plan as explained to her by Respondent, which led to her misunderstanding that the purpose of the September 10 appointment was to have her gums cleaned. Respondent had, however, provided Ms. Manda with sufficient information to enable her to make an informed consent to undergo the recommended surgical treatment. Because Ms. Manda agreed to make the appointment for September 10 and because she kept the appointment, Respondent was justified in his belief that Ms. Manda had made an informed consent to undergo the surgical procedure. Respondent performed osseous surgery on Ms. Manda on September 10, 1985. This procedure was justified by the depth of the periopockets, which measured up to 6 millimeters on examination. The procedure consisted of exposing the bone structure by use of an envelope flap, recontouring the bone structure, and closing the incision with a periopack. The procedures followed by Respondent in performing the surgery are acceptable dental procedures. Respondent thereafter submitted a claim to Ms. Manda's insurance carrier for osseous surgery. Respondent timely requested a formal hearing after the Administrative Complaint, which was subsequently amended, was served upon him.
Recommendation Based on the foregoing findings of fact and conclusions of law it is RECOMMENDED that the Department of Professional Regulation, Board of Dentistry enter a final order which finds Charles R. Finkel guilty of having violated the provisions of Section 466.028(1)(p), Florida Statutes, which reprimands him for said violation, which places his licensure on probation for a period of 6 months, and which imposes an administrative fine in the amount of $1,000.00. DONE and ENTERED this 12th day of December, 1989, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of December, 1989. APPENDIX TO THE RECOMMENDED ORDER IN CASE NO 89-0776 The following rulings are made on the findings of fact submitted on behalf of Petitioner: 1. The proposed findings of fact in paragraph 1 are adopted in material part by paragraph 1 of the Recommended Order. 2. The proposed findings of fact in paragraph 2 are adopted in material part by paragraph 1 of the Recommended Order. 3. The proposed findings of fact in paragraph 3 are adopted in material part by paragraph 8 of the Recommended Order, 4. The proposed findings of fact in paragraph 4 are adopted in material part by paragraph 8 of the Recommended Order. The proposed finding that Ms. DeLeon's consent to undergo the root canal was not informed consent is rejected. Although Respondent did not explain the root canal procedure to her, there was no showing that this patient did not otherwise have sufficient information to make an informed consent to the procedure. The proposed findings of fact in paragraph 5 are adopted in material part by paragraphs 9 and 10 of the Recommended Order. The proposed findings of fact in paragraph 6 are adopted in material part by paragraphs 9 and 10 of the Recommended Order. The proposed findings of fact in paragraph 7 are adopted in part by paragraph 11 of the Recommended Order and are rejected in part as being contrary to the findings made. The proposed findings of fact in paragraph 8 are rejected as being contrary to the findings made. The proposed findings of fact in paragraph 9(a) are adopted as a conclusion of law, but are rejected as a finding of fact. The remaining findings of fact of paragraph 9 are rejected as being contrary to the findings made or to the conclusions reached. The proposed findings of fact in paragraph 10 are adopted in material part by paragraph 12 of the Recommended Order. The proposed findings of fact in paragraph 11 are rejected as being contrary to the findings made. The proposed findings of fact in paragraph 12 are adopted in part by paragraph 13 of the Recommended Order and are rejected in part as being contrary to the findings made. The proposed findings of fact in the second sentence of paragraph 13 are rejected as being contrary to the findings made. The proposed findings of fact in the other two sentences of paragraph 13 are rejected as being unnecessary to the conclusions reached. The proposed findings of fact in paragraph 14 are rejected as being contrary to the findings made. The proposed findings of fact in paragraph 15 are rejected as being contrary to the findings made. The proposed findings of fact in paragraph 16 are adopted in material part by paragraph 4 of the Recommended Order. The date specified in this proposed finding of fact is rejected as being contrary to the evidence. The proposed findings of fact in paragraph 17 are adopted in material part by paragraph 6 of the Recommended Order. The proposed findings of fact in paragraph 18 are adopted in material part by paragraph 6 of the Recommended Order. The proposed findings of fact in paragraph 19 are rejected as being contrary to the findings made. The proposed findings of fact in paragraph 7 are adopted in part by paragraph 7 of the Recommended Order and are rejected in part as being contrary to the findings made. The proposed findings of fact in paragraphs 21-24 are rejected as being contrary to the evidence. The following rulings are made on the findings of fact submitted on behalf of Respondent: The proposed findings of fact in the first sentence of paragraph 1 are adopted in material part by paragraph 8 of the Recommended Order. The proposed findings contained in the remainder of paragraph 1 are rejected as being unnecessary to the findings made or as being subordinate to the findings made. The proposed findings of fact in paragraph 2 are rejected as being recitation of testimony or as being subordinate to the findings made in paragraphs 12 and 13. The proposed findings of fact in paragraphs 3 and 4 are rejected as being subordinate to the findings made in paragraphs 4-7, as being unnecessary to the findings made, or as being recitation of testimony. The proposed findings of fact under the section styled General Office Procedures is rejected as being subordinate to the findings made. The proposed findings of fact under the section styled Gingivectomy or Osseous Surgery are rejected as being subordinate to the findings made or as being the recitation of testimony. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 730 South Sterling, Suite 201 Tampa, Florida 33609 Salvatore A. Carpino, Esquire One Urban Centre, Suite 750 4830 West Kennedy Boulevard Tampa, Florida 33609 William Buckhalt Executive Director Board of Dentistry Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
