The Issue Whether the Petitioner was overpaid for Medicaid prescriptions. The Agency for Health Care Administration (AHCA, Agency or Respondent) asserts the Petitioner, Compscript, Inc., d/b/a Compscript (Petitioner or Compscript) failed to maintain proper records to support and document the Medicaid prescription claims paid by the Agency for the audit period. According to the Agency, the audit findings must be extrapolated to the universe of all claims for the audit period. If so, the Agency maintains the Petitioner should reimburse AHCA for a Medicaid overpayment in the amount of $216,974.07 (this is the “recoupment” amount). The Petitioner denies it was overpaid any amount, asserts it kept records in accordance with applicable laws and regulations governing pharmacy records, and maintains that the Agency may not apply the extrapolation accounting procedure in this case.
Findings Of Fact At all times material to the allegations of this case, the Petitioner was a licensed pharmacy authorized to do business in the State of Florida; its pharmacy license number is PH0016271. At all times material to the allegations of this case, the Petitioner was authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Respondent. The Petitioner’s Medicaid provider number is 106629300. The terms of the provider agreement govern the contractual relationship between this provider and the Agency. The parties do not dispute that the provider agreement together with the pertinent laws or regulations controls the relationship between the provider and the Agency. The provider agreement pertinent to this case is a voluntary agreement between AHCA and the Petitioner. Pursuant to the provider agreement, the Petitioner was to “keep, maintain, and make available in a systematic and orderly manner all medical and Medicaid-related records as AHCA requires for a period of at least five (5) years.” In addition to the foregoing, a Medicaid provider must maintain a patient record for each recipient for whom new or refill prescriptions are dispensed. Any Medicaid providers not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. A Medicaid provider must retain all medical, fiscal, professional, and business records on all services provided to a Medicaid recipient. The records may be kept on paper, magnetic material, film, or other media. However, in order to qualify for reimbursement, the records must be signed and dated at the time of service, or otherwise attested to as appropriate to the media. Rubber stamp signatures must be initialed. The records must be accessible, legible and comprehensive. Specific to the issues of this case, a Medicaid provider must also retain prescription records for five years. The Respondent is the state agency charged with the responsibility and authority to administer the Medicaid program in Florida. Pursuant to this authority AHCA conducts audits to assure compliance with the Medicaid provisions and provider agreements. These “integrity” audits are routinely performed and Medicaid providers are aware that they may be audited. At all times material to the allegations of this case, the Medicaid program in Florida was governed by a “pay and chase” procedure. Under this procedure, the Agency paid Medicaid claims submitted by Medicaid providers and then, after-the-fact, audited such providers for accuracy and quality control. These “integrity” audits are to assure that the provider maintains records to support the paid claims. In this case, the audit period is May 28, 1999 through July 18, 2000. The pertinent audit has been designated AHCA audit no. 01-0514-000-3/H/KNH and was initiated on October 23, 2000. The Petitioner does not dispute the Agency’s authority to perform audits such as the one at issue. The Petitioner maintains its records are sufficient to support the paid claims and that the Agency has unreasonably imposed its interpretation of the requirements. The Medicaid provider agreement that governs this case required that the Petitioner comply with all Medicaid handbooks in effect during the audit period. Essentially, this standard dictates the records that must be kept for quality control so that the after-the-fact audit can verify the integrity of the Medicaid claims that were paid by the Agency. During the audit period the Petitioner sold or dispensed drugs to Medicaid recipients. Equally undisputed is the fact that Medicaid claims were paid by the Agency during the audit period. Each claim reviewed and at issue in this cause was a paid Medicaid claim subject to the Petitioner’s provider agreement and the pertinent regulations. The Agency required that each and every claim submitted by the Petitioner during the audit period under the Medicaid program be filed electronically. Each claim submitted was filed electronically. Nevertheless, the Agency also required the Petitioner to retain records supporting the claim. Additionally, the Petitioner was to make such supporting records available to the Agency upon request. The Agency asked the Petitioner to present its records to support the claims for the audit period. The disclosure of the records proved difficult for this Medicaid provider because it does not operate in a conventional pharmacy setting. More specifically, it operates solely to serve a nursing home population. All of the patients whose prescriptions were filled were nursing home residents. Compscript maintains its manner of doing business is slightly different from the conventional pharmacy. Rather than the walk-in patient who presents a written prescription to be filled, this Petitioner receives its pharmacy orders by telephone or facsimile transmission from nursing homes. Typically, the staff at Compscript takes the call, writes down the pertinent information, enters the data into the pharmacy’s computer system, and the item is dispensed and routed to the nursing home via the delivery driver. All drugs are dispensed in sealed containers and are delivered with a manifest listing all the medications by name and patient. Given the volume of prescriptions being prepared and delivered, for the audit period at issue in this case, the Petitioner made 2-3 trips to the nursing home per day. Once the information for the prescription was entered into the Petitioner’s computer system, Compscript had little interest in maintaining the written telephone message or the facsimile sheet that generated the request. In some instances the Compscript employee did not make a written record of the prescription request. In those instances the employee entered the request directly into the Petitioner’s computer system and bypassed the written step altogether. The Compscript computer system tracks the initials of the pharmacist who entered the prescription information and cannot be altered without such alteration being tracked and noted. Since the pharmacy fills “over the counter” items, as well as controlled and non-controlled pharmacy products, the computer record denotes that information along with the patient information. When the Respondent’s audit agents went into the Compscript facility to audit the Medicaid claims, the Petitioner could not readily produce the written documentation to support the dispensed drugs. In fact, many of the records that verified the prescriptions dispensed were found on the nursing home records. The nursing home patient’s physician order sheet specified the item or items requested for the patient. This “physician order sheet” (POS) should theoretically always support the dispensing of the product from the Petitioner. In this case there were instances when the POS did not corroborate the claim. When the auditors from the Agency presented at Compscript, the Petitioner did not have the POS records to produce. Obviously, those records were maintained within the nursing home. Additionally, Compscript did not have the telephone notes or the facsimile transmission sheets to support items dispensed during the audit period. When the hearing in this cause proceeded it was also discovered that records that were generated daily by the Petitioner’s computer system that would have corroborated the claims (and which were allegedly maintained in storage) were not produced or available to support Medicaid claims submitted during the audit period. During the audit the Agency’s auditors requested records from a random sample of the claims submitted during the audit period. The results from that sample where then applied to the universe of claims for the audit period. When this mathematical calculation was performed the audit produced a Medicaid overpayment in the amount of $1,341,466.27. Afterwards, when the Petitioner was able to locate additional records to correspond to and support the prescriptions dispensed, the amount of overpayment was reduced to $217,715.28 (the amount set forth in the parties’ Pre-hearing Stipulation). At hearing, the Agency maintained that the amount of overpayment was $216,974.07 for which the Petitioner could produce no adequate documentation. At hearing, the Petitioner continued to dispute the procedure of applying the audit sample overpayment to the population of claims to mathematically compute the overpayment for the audit period. This “extrapolation” process was admitted into evidence and has been fully considered in the findings reached in this case. The Petitioner was required to maintain Medicaid- related records for a period of 5 years. Thus, for the audit period in this case, any record supporting the claims should have been maintained and made available for the Agency. Such records would have been within the five-year period. The Agency designates Medicaid compliance to its office of Medicaid Program Integrity. In turn, that office contracted with Heritage Information Systems, Inc. (Heritage) to perform and report pharmacy audits of the numerous pharmacy providers within the state. Auditors from Heritage were assigned the Compscript audit. At the time of the audit the Heritage auditors were not privy to any of the POS documents later produced in the case. Ken Yon is the Agency’s administrator who was responsible for managing the instant case and who worked with the Heritage auditors to assure the policies and practices of the Agency were met. In this case, the Heritage auditors presented at Compscript unannounced on October 23, 2000, and sought 250 randomly selected claims for review. By limiting the number of claims, the auditors were not required to sift through the records of 46,000+ claims (the approximate number of claims that the Petitioner submitted during the audit period). For the universe of 46,000+ claims, 250 randomly selected claims is a reasonable sample to audit. The adequacy of the sample number as well as the manner in which it was generated is supported by the weight of credible evidence presented in this matter. Also, the results of a sample of 250 from the universe of 46,000+ would be statistically valid if randomly chosen as they were in this case. In this regard the testimony of Dr. Mark Johnson, an expert in statistical sampling and analysis, has been deemed credible and persuasive as to the issues of the appropriateness of the sample (as to size and how it was generated), the use of the sample overpayment to calculate an overall payment, and the statistical trustworthiness of the amounts claimed in this cause. If anything, as Dr. Johnson asserted, the actual overpayment would be greater than the recoupment amount sought by the Agency. The Agency has used a statistical extrapolation method to compute overpayments for years. The statistical concept and process of applying a sample to a universe to mathematically compute an overpayment is not novel to this case. After the auditors completed their review of the records at the Compscript pharmacy, Kathryn Holland, a licensed pharmacist (who is also a consulting pharmacist) prepared the Respondent’s Final Agency Audit Report. Prior to completing the report, Ms. Holland received and reviewed the information provided by the Petitioner through the auditors. As a result of the review, a number of “can’t find” conclusions were reached. By “can’t find” the auditors and Ms. Holland meant that the original prescription or refill documentation could not be located for the paid Medicaid claim. These “can’t find” claims were reported to the Petitioner, who was given additional time to locate and produce documents to support the claims. In fact, the Agency continued to accept documentation for claims up through the time of hearing. Consequently, the amount sought for overpayment has been substantially reduced. Whether the Agency had the authority to accept documents outside the prescription records maintained by the pharmacy is not an issue. In fact, the Agency did reduce the overpayment amount when subsequent supporting documents were located. A second error in the documentation for the Petitioner’s prescriptions was noted as “no doctor’s address on the prescription.” That expression meant that pursuant to state and federal law the physician’s address is required for a controlled substance and when it was not provided the auditor deemed the documentation incomplete. Although the Petitioner maintained doctor addresses in its computer system, the records did not correspond to the specific prescriptions that were filled for the audited claims. In order to stand as a sufficient prescription form, a writing must be created contemporaneous to the order (phone requests that are transcribed are acceptable), must contain specific information (type of drug, strength, dose, patient, doctor, DEA number, refill, etc.), and it must be kept for the requisite time. It would be acceptable for the prescription to be computer generated so long as it was written contemporaneous to the order and preserved as required by law. In this case, at the conclusion of the audit, the Agency identified 194 discrepant claims within the random sample of 250. The vast majority of those discrepancies were noted as “can’t find.” Had the Agency not accepted other documentation to support the dispensing of the drugs, the calculated overpayment would have been $1,575,707.44. Applying a lower confidence limit of 95 percent to that amount generated the calculated overpayment of $1,341,466.27. The audit findings set forth in the Agency’s Final Agency Audit Report (dated April 6, 2001) is supported by the weight of credible evidence in this case. Nevertheless, the Agency did allow the provider here to supplement the documentation disclosed during the audit. And, to that end, the calculated overpayment was reduced to $216,974.07 (this amount is 95% of the calculated overpayment). In reality, the amount owed by this Petitioner for failure to maintain proper documentation for this audit would be greater than the recoupment amount sought by the Agency. Had the Agency held the Petitioner to a standard of “no prescription, no payment” standard arguably 194 of the 250 audited claims could have been disallowed. That is not the standard applied by the Agency. A “patient record” may include information regarding the patient’s prescription history. The terms “patient record” and “prescription” are not synonymous. For example, while a prescription would contain information such as patient's name, doctor, DEA number, doctor's address, dosage, drug, and whether it may be refilled, it would be expected that the “patient record” would contain additional information not typically found on a prescription. For instance, a “patient record” might contain a historical track of past medications or known patient allergies. In this case, the computer records or “patient records” maintained by the Petitioner did not retain the prescriptions in the format dictated by rule. An electronic imaging recording system may be used when the system captures, stores, and can reproduce the exact image of the prescription, including the reverse side of the prescription if necessary. The Petitioner’s system did not do that. An electronic system must be able to produce a daily hard-copy printout of all original prescriptions dispensed and refilled. If the Petitioner’s system could do that, it did not. An acceptable electronic system must generate the prescription contemporaneous to the dispensing order. The Petitioner’s system did not do that. The Agency has not alleged, and there is no evidence to suggest, fraud in the Petitioner’s failure to maintain its records. The Agency’s interpretation of the requirement that a prescription be reduced to writing is consistent with the rules and regulations in effect at the time of this audit. The last category of discrepant items was “UR” which stood for “unauthorized refills.” These were claims for refills on drugs for which the original prescription could not be located or documentation from the nursing home could not be found. Again, the Petitioner the maintained that within the nursing home setting a physician’s reorder for medications for the patient could be found on the POS. These refill requests were handled orally among the physician, the nursing home staff, and the pharmacy. Nevertheless, because they were not documented in writing the Agency disallowed this claims and included them among the discrepant list. If the Petitioner was able to produce a physician order to support the UR claims, it was removed from the recoupment list. In most instances, the Petitioner did not have the requisite paperwork to support the refill. Instead, the Petitioner relied on its computer records (again not kept in accordance with the applicable standards) to support the UR claims. The Agency has not claimed that the refills were not dispensed, merely that the paperwork to support the claim cannot be produced.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order that accepts an amended Final Agency Action Report to support an overpayment and recoupment against the Petitioner in the amount of $216,974.07. S DONE AND ENTERED this 6th day of October, 2005, in Tallahassee, Leon County, Florida. J. D. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 6th day of October, 2005. COPIES FURNISHED: Richard Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 L. William Porter, II, Esquire Agency for Health Care Administration Fort Knox Executive Center III 2727 Mahan Drive, Building 3, Mail Stop 3 Tallahassee, Florida 32308-5403 Kenneth W. Sukhia, Esquire Fowler, White, Boggs, Banker, P.A. 101 North Monroe Street, Suite 1090 Post Office Box 11240 Tallahassee, Florida 32302 Ralph E. Breitfeller, Esquire McGrath & Breitfeller, LLP 140 East Town Street, Suite 1070 Columbus, Ohio 43215
The Issue Whether an administrative fine should be imposed on the respondent for the violations alleged in Final Agency Audit Report number 94-0367-000-G, and, if so, the appropriate amount of the fine.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Agency for Health Care Administration is the state agency responsible for administering the Medicaid program in Florida. Ch. 93-129, 58, Laws of Fla. (1993). The Agency oversees the activities of Medicaid providers and is authorized in section 409.913(9), Florida Statutes, to impose sanctions for violations of the Medicaid rules and regulations. The division of the Agency responsible for monitoring payments to Medicaid providers is referred to as Medicaid Program Integrity, which is part of the Agency's Office of the Inspector General. Medicaid payments are monitored to ensure that such payments are made in accordance with federal and state rules and regulations. At all times relevant to this proceeding, the respondent was licensed to practice medicine in Florida and was an approved Medicaid treating provider assigned Treating Provider number 065767102. The respondent entered into a Noninstitutional Professional and Technical Medicaid Provider Agreement on October 14, 1981, in which he agreed to "abide by the provisions of the Florida Administrative Rules, Florida Statutes, policies, procedures, manuals of the Florida Medicaid Program and Federal laws and regulations," as provided in paragraph 7 of the agreement. The Medicaid Physician Provider Handbook provides in the introduction to section 11.1 that "[t]he services in this program must be performed for medical necessity for diagnosis and treatment of an illness for an eligible Medicaid recipient." The provider agreement also requires in paragraph 2 that the provider "keep such records as are necessary to fully disclose the extent of services provided to individuals receiving assistance under the State Plan." The Agency audited a random sample of medical records of Medicaid recipients for whom payments were made to Dade Health Services for medical services provided from August 3, 1992 through October 31, 1993. The respondent's name appeared frequently in these records as a treating provider. As a result, the Agency extended its investigation to the respondent. The respondent provided medical services at Dade Health Services from the beginning of the audit period until February 9, 1993, when he terminated his association with the clinic. The medical records of seven Medicaid recipients treated by the respondent were among the Dade Health Services's medical records audited by the Agency. In order to ensure that the Agency had all the medical records relevant to these patients, a letter was sent to the respondent requesting any additional medical records he might have in his possession. The respondent notified the Agency through his attorney that he did not have any medical records relating to the seven patients. The medical records of the seven Medicaid recipients treated by the respondent were reviewed by Dr. John Sullenberger, Chief Medical Consultant for the State of Florida Medicaid Group, to determine if the services provided and billed to Medicaid were medically necessary. Dr. Sullenberger evaluated the medical records in accordance with generally-accepted practices and using generally-accepted tools such as the Current Physician Terminology Handbook. He concluded that certain of the tests and treatments ordered by the respondent were not medically necessary Patient Q.M. was seen by the respondent in an office visit on September 16, 1992. The patient's main complaint was shortness of breath. The respondent ordered spirometry, a test which measures lung function. Shortness of breath can have many causes, among them heart problems. There is no indication in the medical records that a chest x-ray was taken, and nothing in the records supports the medical necessity for a test measuring lung function for shortness of breath alone. Patient J.U. was seen by the respondent in an office visit on January 30, 1993. The patient complained of a dry cough and shortness of breath. The respondent noted that the patient wheezed when he blew air out of his lungs, and he ordered spirometry. Spirometry is contraindicated for wheezing, and there is nothing in the records to support the medical necessity for the test for shortness of breath alone. Patient M.V. was treated on November 11, 13, 16, 18, 20, 23, 25, 27, and 29, 1992, and on December 2 and 7, 1992, with aerosol treatments ordered by the respondent. An aerosol treatment consists of the patient's breathing in a vaporized mist to moisten the nose and the bronchial tubes, and it provides relief for approximately three hours. Aerosol treatments are properly administered every four to six hours, usually to patients who are hospitalized. There is nothing in M.V.'s medical records to support the medical necessity for aerosol treatments, and there is no medical justification for administering these tests every two to three days. Patient D.S. was seen by the respondent in an office visit on January 23, 1993. The medical record of this visit is largely illegible, but it appears that the patient's main complaint was a cough. The respondent ordered spirometry, an electrocardiogram, and radiologic testing. There is nothing in the medical records to support the medical necessity for spirometry, especially since the respondent noted in the records that an examination of the lungs showed that they were within normal limits. There was no legible entry in the medical records to support the medical necessity for an electrocardiogram, which measures, among other things, the rhythm of the heart beat, the rate of the beat, and any blockage of blood passing through the heart. The radiologic testing consisted of a chest x-ray, but there is nothing in the medical records to support the medical necessity for this test. Patient E.R. was seen by the respondent in an office visit on November 2, 1992. The entry in the medical records of this visit for the patient's chief complaint is illegible. The respondent ordered two non-invasive tests, one to measure the blood flow through the arteries of the patient's legs and one to measure the blood flow through the veins of the legs. The respondent also ordered echography to test the patient's peripheral vascular system. Echography uses sound waves to construct a picture or photographic plate of the area being tested. There is no indication in the medical records that the respondent observed any abnormality of the patient's legs or feet or that he took the pulse in the feet to determine if the tests were necessary. The two non- invasive tests and the echography were not justified as medically necessary by the information contained in the medical record of E.R.'s November 2 office visit. Patient E.R. was also seen by the respondent in an office visit on December 19, 1992. The respondent ordered a duplex scan, which is a sonogram of the arteries in the neck that go to the brain. It is unusual to perform such a test on a 45-year-old woman, and there is nothing in the medical records to support the medical necessity for this test. Based on his examination of patient E.R. on December 19, the respondent also ordered aerosol treatments, which were administered on December 21, 23, 26, 28, and 30, 1992, and on January 4, 1993. There is nothing in the medical records to support the medical necessity for aerosol treatments, and there is no medical justification for administering the treatments every two to five days. Patient W.L. was seen by the respondent in an office visit on November 23, 1992. The patient's chief complaint was pain in the legs. There is nothing in the medical records indicating that the respondent examined the patient's legs or took the pulses in the feet, behind the knees, or in the groin. Nevertheless, the respondent diagnosed the patient as having peripheral vascular disease and ordered two non-invasive tests and echography of the peripheral vascular system. There is nothing in the medical record to support a diagnosis of peripheral vascular disease or the medical necessity for the three tests. Patient A.A. was seen by the respondent in an office visit on October 19, 1992. The patient's chief complaint was hemorrhoids, and the respondent noted in the medical records that the patient's lungs were clear. Nevertheless, he ordered aerosol treatments, which were administered October 19, 21, 22, 23, 26, 28, and 30, 1992, and November 2, 4, 6, and 9, 1992. There is nothing in the medical records to support the medical necessity for these treatments, and there is no medical justification for administering the treatments on the prescribed schedule. The evidence is clear and convincing that the respondent administered or ordered administered forty-seven tests and treatments for these seven Medicaid recipients, that Medicaid claims were submitted for these tests and treatments, and that no medical necessity was shown in their respective medical records for these tests and treatments.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order finding that, from August 3, 1992, until February 9, 1993, Jaime Vergel, M.D., committed forty-seven violations of Medicaid rules and regulations and imposing an administrative fine in the amount of $25,000. DONE AND ENTERED at Tallahassee, Leon County, Florida, this 14th day of November 1995. PATRICIA HART MALONO, 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 14th day of November 1995.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to Section 20.165, Florida Statutes; Chapter 455, Florida Statutes; and Chapter 459, Florida Statutes. Respondent is, and has been at all times material hereto, a licensed osteopathic physician, having been issued license number OS 006021 by the State of Florida. Dispensing practitioner inspections are conducted by Petitioner to evaluate compliance with the legal requirements imposed on dispensing practitioners. The complete legal requirements imposed upon dispensing practitioners are listed on the "Investigative Services Inspection Form for Dispensing Practitioners", with citations to the proper authority. Practitioners subject to inspections are provided with copies of the inspection forms. On July 19, 1991, Jeannie Lewis, a Department investigator, conducted a routine dispensing practitioners inspection of Respondent's office and prepared an inspection form. During the July 19, 1991 inspection, the following violations were discovered and reported: Respondent was not writing prescriptions for dispensed medication; Respondent was not certifying drugs prior to patient receipt; Respondent was not on the premises when dispensing of drugs occurred; Respondent failed to post a generic drug sign; Respondent failed to initial and date all controlled drug prescriptions dispensed; Respondent's controlled substance prescriptions failed to include the patient's address; Respondent's controlled substance prescriptions failed to include Respondent's DEA number; Respondent failed to place dispensed medication in a child proof container; Respondent's controlled substance prescriptions were not properly maintained. Respondent had no prescriptions for controlled substances dispensed. A deficiencies form was issued and signed by Respondent, following the July 17, 1991 inspection. A second inspection of Respondent's office was conducted on December 17, 1992, and a second dispensing practitioners inspection form was completed. During the December 17, 1992 inspection, Investigator Lewis was accompanied by Charles C. Lewis, then Senior Pharmacist for Petitioner. During the December 17, 1992 inspection by Investigator Lewis and Charles C. Lewis, the following violations were discovered and reported: Respondent was not writing prescriptions for dispensed medication; Respondent was not certifying drugs prior to patient receipt; Respondent was not on the premises when dispensing of drugs occurred; Respondent failed to post a generic drug sign; Respondent failed to initial and date all controlled drug prescriptions dispensed; Respondent's controlled substance prescriptions failed to include the patient's address; Respondent's controlled substance prescriptions failed to include Respondent's DEA number; Respondent's controlled substance prescriptions were not properly maintained; Respondent's controlled substance purchase records were not properly maintained or readily retrievable; Respondent's DEA 222 forms were not completed properly and not available. Respondent's nurse refilled and dispensed medications when Respondent was not on the premises. On February 9, 1993, a Final Order of the Board of Osteopathic Medicine was entered in the case of DPR v. Richard Heston Beers, D.O., DPR Case Number 00-95528. This Final Order adopted the provisions of a Consent Agreement signed by Respondent on November 6, 1992, in which Respondent agreed to receive a Letter of Concern, pay a $2,000 fine, attend a Continuing Medical Education course on the ethical prescription of abusable drugs, and to utilize sequentially numbered triplicate prescription forms for a year following the date of the Order. The Consent Agreement, adopted into the Final Order, also provided that copies of the triplicate prescription forms were to be made available to Petitioner's investigators upon request. Following the second inspection of Respondent's office and the issuance of the Final Order, Respondent sent a letter to Lewis dated March 26, 1993, claiming compliance with the dispensing practitioners requirements and inviting her to re-inspect his office at any time. At the request of the Board of Osteopathic Medicine, a third inspection of Respondent's office was conducted on July 7, 1993, and a third dispensing practitioners inspection form was completed. During this third inspection, the following violations were discovered and noted: Respondent failed to properly label medication for dispensing; Respondent was not properly maintaining his controlled substance prescriptions, in that Respondent did not stamp them with a red letter "C" and store them separately from non-controlled drug prescriptions; Respondent's DEA 222 forms were not completed properly (not available). Respondent failed to utilize sequentially numbered triplicate prescription forms when dispensing medications.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Respondent be found guilty of violating Sections 459.015(1)(g) and (bb), Florida Statutes. It is further RECOMMENDED that: Respondent shall pay an administrative fine in the amount of five thousand dollars ($5,000.00) to the Board of Osteopathic Medicine within one hundred eighty (180) days of the Final Order of the Board. Respondent shall receive a reprimand from the Board of Osteopathic Medicine. Respondent shall surrender his DEA license for a minimum of two (2) years, and not reapply unless or until he appears before the Board and demonstrates that he can prescribe, maintain, and inventory controlled substances with skill, safety, and within the legal requirements imposed upon dispensing practitioners. Respondent's license to practice medicine shall be placed on probation for a period of one (1) year, including indirect supervision, a review of Respondent's medical records by a monitoring physician, and any additional terms deemed reasonable and necessary by the Board. DONE and ENTERED this 12th day of September, 1994, in Tallahassee, Florida. DANIEL M. KILBRIDE 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 September, 1994. APPENDIX The following constitutes my specific rulings, in accordance with section 120.59, Florida Statutes, on proposed findings of fact submitted by the parties. Proposed findings of fact submitted by Petitioner. Accepted in substance: paragraphs 1 through 20. Proposed findings of fact submitted by Respondent. Respondent did not submit proposed findings of fact. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Richard Heston Beers, D.O. 7505 Aloma Avenue Winter Park, Florida 32792 Harold D. Lewis, Esquire Agency for Health Care Administration 325 John Knox Road Tallahassee, Florida 32303 Sam Power, Agency Clerk Agency for Health Care Administration 325 John Knox Road Tallahassee, Florida 32303
Findings Of Fact Respondent, Gregory Burgess Stone, is a licensed practical nurse holding license number 0463451. Respondent was so licensed at all times relevant to this proceeding. Respondent was employed at Orlando Lutheran Towers Health Care Center, 300 East Church Street, Orlando, Florida, as a practical nurse at all times material hereto. During April, 1982, Respondent acted as the full-time medicine nurse on the 7:00 a.m. through 3:00 p.m. nursing shift at Orlando Lutheran Towers. Orlando Lutheran Towers utilizes the Unidose system of medication administration. The individual who administers the medication is required only to remove the appropriate dosage from the Unidose card which may contain from thirty to sixty doses of medication and thereafter record the administration of the medication on a medication administration record by inserting his initials under the appropriate date on the medication administration record format. Each patient at Orlando Lutheran Towers is assigned a Unidose card for each medication he may require. The patient's name and other pertinent information appear on a label placed on the front of the Unidose card. Respondent was intermittently relieved from duty in April by Gloria Underhill, another nurse-employee of Orlando Lutheran Towers. Underhill worked in place of Respondent on April 8, and the Respondent thereafter worked the intervening period from April 9 through April 12. Underhill returned to work in place of Respondent again on April 13, and in the course of administering medications, she observed that certain prescribed medications had not been administered between April 9 and April 13. Underhill ascertained this information because of the procedure she had previously followed. It was Underhill's general practice to place her initials not only on the medication administration record but also on the Unidose card next to the particular unit of medication she intended to administer. By comparing her initials with the physical presence of the succeeding units of medication in the Unidose card, she determined that the Respondent had apparently failed to administer medication to the following patients: PATIENT MEDICATION UNITS NOT RECEIVED 1. Lowe DDS 100 milligrams 4 2. Doze Corgard 40 milligrams 4 3. Miller TAM/LL 3 The medication administration record, however, indicated by the placement of the Respondent's initials that the foregoing medications had been received. Respondent speculated that he may have administered the medication by utilizing doses not taken by other patients. This possibility was not supported by the evidence and is rejected. Underhill's findings were given to the Director of Nursing and the Administrator of Orlando Lutheran Towers, who thereafter confronted Respondent with the Unidose card discrepancies. Respondent did not offer any explanation for the discrepancies and was therefore discharged from employment at Orlando Lutheran Towers.
Recommendation Based on the foregoing, it is RECOMMENDED: That Petitioner enter a final order finding Respondent guilty of the violations of law charged in the Administrative Complaint and placing his license in a probationary status for two years. DONE and ORDERED this 18th day of March, 1983, in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of March, 1983. COPIES FURNISHED: W. Douglas Moody, Esquire 119 North Monroe Street Tallahassee, Florida 32301 James M. Nicholas, Esquire 170 East Washington Street Orlando, Florida 32801 Helen P. Keefe, Executive Director Board of Nursing Department of Professional Regulation Room 504, 111 East Coastline Drive Jacksonville, Florida 32202 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether Sandra Ann Lindstrom (“Ms. Lindstrom” or “Respondent”), a licensed physician assistant, prescribed Lorcet, a medication containing a controlled substance (hydrocodone), in violation of the Florida Statutes and the Florida Administrative Code as charged in the Amended Administrative Complaint filed at the Department of Health in DOH Case No. 2006-36542 on October 27, 2014. If so, what is the appropriate discipline?
Findings Of Fact The Parties The Department of Health is the state agency responsible for regulating the practice of physician assistants in the State of Florida. The regulation is pursuant to both chapter 456 (“Health Professions and Occupations, General Provisions”) and chapter 458 (“Medical Practice”), Florida Statutes. Respondent is licensed as a physician assistant by the Board of Medicine. Her license number is PA 9103823. The license was effective on August 3, 2006, with an expiration date of March 31, 2008. Her license has been continuously renewed since its effective date. See Pet’r’s Ex. A. Ms. Lindstrom is not licensed to practice medicine as a physician. Id. Physician Assistants Physician assistants are governed by section 458.347, a section within the chapter of the Florida Statutes that governs Medical Practice. Physician assistant licensure is provided for in section 458.347(7), and the Board of Medicine is authorized to “impose any of the penalties authorized under ss. 456.072 and 458.331(2) upon a physician assistant if the physician assistant or the supervising physician has been found guilty of or is being investigated for any act that constitutes a violation of this chapter [Ch. 458] or chapter 456.” § 456.347(7)(g), Fla. Stat. A physician assistant’s supervisory physician may delegate authority to conduct aspects of medical practice to a physician assistant under circumstances expressed in the statutes. The limited medical practice that may be delegated to a physician assistant includes certain practices at county health departments. Whether conducting the delegated practice of medicine at a county health department, or not, physician assistants may be delegated authority to prescribe medications provided they are not listed on a formulary created pursuant to section 458.347(7)(f). See § 458.347(7)(d) and (e), Fla. Stat. The formulary must include “controlled substances as defined in chapter 893.” § 458.347(7)(f)1., Fla. Stat. In sum, physicians may not delegate to physician assistants the prescription of medications which are controlled substances as defined in chapter 893, Florida Statutes. The Department’s Investigative Office The Department has an investigative office charged with looking into regulatory complaints. In a typical regulatory investigation, the investigator discloses his identity to any party interviewed, whether the party is the source of the complaint, a witness, or, if amenable to an interview, the licensee who is the subject of the complaint. Aside from interviews, the investigations include record reviews, the obtaining of evidence, and the preparation of an investigative report. In addition to investigating complaints of regulatory violations by licensed health care practitioners, the investigative office looks into cases of unauthorized practice by unlicensed individuals. Investigations of unlicensed activity are conducted by what is known as the “ULA” section of the office. Commonly, ULA investigations are done by investigators who are “undercover,” that is, the investigators hide their identity as investigators and use pseudonyms rather than their actual names. Typically, undercover ULA investigators present at the offices of the subjects of investigation. If the unlicensed subject of the investigation offers to perform services that require a license or engages in practice that requires a license, the Department pursues remedies, including an order that the subject cease and desist from the unlawful, unlicensed activity. Investigations of a licensee for practicing outside the scope of the licensed activity may be viewed as something of a hybrid of a typical regulatory investigation and a ULA investigation. It is regulatory since the subject is a licensee, but it is usually done undercover in the same manner in which a ULA investigation is conducted. One such investigation was conducted by Ryan Heal, an employee of the Department between August and December of 2006. Mr. Heal conducted the investigation undercover using a pseudonym referred to in Department documents as “RJ.” RJ and the 2006 Investigation of JHS Mr. Heal has been a medical malpractice investigator for the Department since November 2000. During the course of his more than 15 years as a Department investigator, Mr. Heal has investigated both regulatory violations and unauthorized practice violations. In 2006, allegations reached the Department that prescriptions were being written at Jacksonville Health Systems (“JHS”), a clinic located on Baymeadows Road in Jacksonville, Florida, by a physician assistant without the supervision of a physician. In response, the Department launched an investigation. The investigation was conducted undercover by Mr. Heal using his pseudonym RJ. Commenced in August of 2006, the investigation lasted until the following December. August 10, 2006 On August 10, 2006, Mr. Heal, using his fictitious name, presented at JHS. A woman behind the counter in the reception area accepted a cash payment for the visit. She took RJ’s blood pressure and requested the name of the pharmacy for any medicine prescribed. To the best of Mr. Heal’s recollection, the receptionist recorded some of the information. After the interaction with staff in the reception room, Mr. Heal took a seat and waited to be called back to the examination room. Shortly thereafter, Ms. Lindstrom emerged and asked for RJ. Mr. Heal “stood up and went over to her.” Hr’g Tr. 19. Ms. Lindstrom identified herself by her first name and said, “I’m the provider here.” Id. Ms. Lindstrom accompanied Mr. Heal to the examination room where only she and Mr. Heal were present. After Mr. Heal complained of back pain, Ms. Lindstrom asked where in his back the pain was located and what caused it, but she did not conduct a physical examination. As Mr. Heal testified at hearing, “[t]here was no examination. She never touched my back. Never took vitals or anything.” Hr’g Tr. 20. Ms. Lindstrom suggested that Mr. Heal use a chair with lumbar support, try stretching, lose weight, and have an MRI. Ms. Lindstrom then stated that she would prescribe medication to treat the pain: Lorcet, Flexeril, and Motrin. With the visit in the examination room concluded, Ms. Lindstrom took Mr. Heal back to the receptionist. The meeting in the examination room and his first visit to the JHS offices being over, Mr. Heal departed the JHS facility. He did not return until the following October. October 31, 2006 Mr. Heal returned to the JHS facility on October 31, 2006. The process during the second visit was similar to the one followed during the visit the previous August. He presented as “RJ.” A staff member took his blood pressure in the reception area and he paid her $90 in cash. Mr. Heal sat down and waited to be called. Again, Ms. Lindstrom appeared in the reception area and took him to the examination room in the back. The visit was shorter than it had been in August. Ms. Lindstrom asked if his pain had improved and if an MRI had been done. With the intention of calling in his prescriptions, Ms. Lindstrom showed Mr. Heal a list of five pharmacies from which to choose. Mr. Heal, however, took a tack that was different from Ms. Lindstrom’s intention and from his first visit: I explained to her that I did not have reliable transportation and asked [for] . . . handwritten prescriptions . . . so that I could take them to whatever pharmacy was convenient . . . . She agreed that she could write them that time, but that on the next visit, I would have to arrange for proper transportation to get to the pharmacy or wherever they needed to be called into. Hr’g Tr. 23. Ms. Lindstrom wrote out three prescriptions: Two of them were for “Flexeril 10mg (ten) #30 (thirty)” and “Ibprofen (sic) [Ibuprofen] 800mg #120 (one twenty).” Pet’r’s Ex. B. The third prescription was for “Lorcet 10/650 #90 (Ninety).” Id. Ms. Lindstrom explained to Mr. Heal that he should use one of the five pharmacies on her list because “several [of the Clinic’s patients] had been kicked out of pharmacies . . . [that] were refusing to fill the prescriptions.” Hr’g Tr. 25. Ms. Lindstrom also “mentioned that a couple of her patients had been arrested for forging prescriptions.” Hr’g Tr. 25-6. At no time during his visit to JHS on October 31, 2006, did Mr. Heal see a physician. No one entered the examination room where Ms. Lindstrom met with Mr. Heal that day. Nor did Ms. Lindstrom leave the examination room while Mr. Heal was present in the room. Like the first visit the previous August, Ms. Lindstrom recommended that Mr. Heal have an MRI. She explained that results from an MRI were needed “in case the DEA wanted to look at the file, to show that [she and JHS] were actually treating [Mr. Heal] for something.” Hr’g Tr. 28. December 1, 2006 Little more than a month later on December 1, Mr. Heal made a third visit to JHS. The reception process was the same. The receptionist took his blood pressure, he paid $90 in cash, and waited in the reception area for Ms. Lindstrom to call him back. While waiting, he was informed that the number of pharmacies that would accept JHS prescriptions had been drastically reduced. Only one pharmacy would now accept JHS prescriptions: a pharmacy called New Horizon. Subsequent to the third visit, Mr. Heal presented to the pharmacy identified as New Horizon. In the company of law enforcement and with its supervision, Mr. Heal had the prescriptions filled for three medications: Flexeril, Ibuprofen at a prescription-strength dosage, and Lorcet. Supervising Physician and Other Claims At hearing under oath, Ms. Lindstrom admitted that she treated Mr. Heal once at the JHS facility and admitted that she prescribed Flexeril and Ibuprofen for him. She claimed under oath that the supervising physician for the 2006 visit in which she prescribed the two medications was James Hendrick, M.D. The Department produced documentation in the Department’s official business records that shows that Dr. Hendrick cancelled his Professional Liability Insurance Policy effective October 1, 2005, the year before Ms. Lindstrom claims to have seen Mr. Heal at the JHS facility under Dr. Hendrick’s supervision. The reason for the cancellation of the policy is listed on the letter from the insurer to the Department as “Retired.” Pet’r’s Ex. F, letter dated October 17, 2005, from FPIC, First Professionals Insurance Company. Department records also include an “Address Change” form that contains a section entitled “Financial Responsibility” dated November 21, 2005, the year before the incidents in this case. No boxes are checked in the section that shows “Financial Responsibility Coverage.” Under a section on the form entitled, “Category II: Financial Responsibility Exemptions,” Dr. Hendrick checked a box that indicated he was “retired or maintain[ed] part-time practice,” id., at least as of late November 2005, 11 months or more before the October 31, 2006, visit by Mr. Heal. Ms. Lindstrom made other claims with regard to RJ’s visit that she asserted occurred on October 3, 2006, rather than October 31, 2006, as charged. Among them was that she left the examination room after completing the prescriptions for Flexeril and Ibuprofen and partially completing a third prescription by inserting all the information, including her signature, except for the medicine to be prescribed and how often it should be taken. Ms. Lindstrom claimed that she intended to write a prescription for Lodine, but failed to write down “Lodine” on the third prescription form because she was distracted by a discussion with Mr. Heal about the need for RJ to have an MRI. She says she left the room to make arrangements for an MRI and when she returned, RJ was gone, together with the two filled out prescriptions, the third incomplete prescription, and her prescription pad. Ms. Lindstrom’s testimony about the theft of the pad and other details about the event, including when it occurred, is not credible. In contrast, Mr. Heal’s testimony about the visits he made to the JHS facility, seeing Ms. Lindstrom, and her prescription of Lorcet, is credited as truthful. Lorcet Lorcet contains hydrocodone, which is a controlled substance.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: Finding that Respondent Sandra A. Lindstrom, P.A., violated section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-30.008 (2006), as charged in the Amended Administrative Complaint; Imposing a $2,500 fine; and Revoking Respondent’s license as a physician assistant. DONE AND ENTERED this 30th day of March, 2016, in Tallahassee, Leon County, Florida. S DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of March, 2016. COPIES FURNISHED: Sandra Ann Lindstrom 6726 Pomeroy Circle Orlando, Florida 32810 Yolonda Y. Green, Esquire Maciej Lewandowski, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265 (eServed) Andre Ourso, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C03 Tallahassee, Florida 32399-3253 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 (eServed)
Findings Of Fact The following findings of fact are based upon the stipulation of the parties: The Respondent pharmacy, Drug Mart, Inc., of Lake Wales, doing business as Drug Mart, is a corporation holding community pharmacy permit number 0007122. The Respondent Gerald W. Gettel is a pharmacist licensed under the laws of the State of Florida, license number 0015091, whose last known address is 168 Poe Drive, Winter Haven, Florida 33890. Pursuant to Section 465.081, Florida Statutes, Gettel was employed as the pharmacy department manager at Drug Mart, Inc., of Lake Wales, 608 Lake Wales Plaza, Lake Wales, Florida 33853. On or about March 30, 1982, when inspected, the Respondents did not have on file Schedule II controlled substance prescriptions for the period of June 1980 through and including August 1980. If a hearing had been held in this case, Respondent Gettel would have testified that the destruction of the Schedule II controlled substance prescriptions mentioned above was unintentional . Gettel's testimony would have been supported by two witnesses whose affidavits are attached to this Recommended Order as Exhibits A and B. At a hearing, Gettel would have testified he could reproduce from computer records all of the dispensing information contained on the original prescriptions but admits it is accepted practice of pharmacists to maintain the original Schedule II controlled substance prescriptions for a period of two years. It is specifically stipulated that Schedule II controlled substance prescriptions are not subject to the exceptions provided by Section 893.07(4)(b), Florida Statutes. The responsibility for maintaining Schedule II controlled substance records is imposed upon the pharmacy manager (per the stipulation of the parties; however, the law is contrary). The permit holder, Drug Mart, Inc., of Lake Wales, is not directly responsible for the maintenance of said records. The Respondent Gettel notified the Drug Enforcement Administration of the destruction of the subject prescriptions. (See Exhibits C and D attached hereto.) At a hearing, Gettel would have stated that he also notified the Board of Pharmacy and would have introduced a letter and certified mail receipt relating to this notice to the Board. (See Exhibit E attached hereto.) If called to testify, the custodian of records of the Board of Pharmacy would state that the Board does not have a copy of the above-referenced letter (Exhibit E) in Respondent Gettel's file or in the Board's records of correspondence relating to lost or destroyed drugs or records. At a hearing, the Petitioner would offer no testimony contrary to the tendered testimony of Respondent Gettel and the referenced exhibits regarding the destruction of the subject records.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the Administrative Complaint filed against the Respondents be dismissed. DONE AND ENTERED this 3rd day of May, 1984, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of April, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Gerald W. Gettel 168 Poe Drive Winter Haven, Florida 33880 Drug Mart, Inc., of Lake Wales 608 Lake Wales Plaza Lake Wales, Florida 33853 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301
