The Issue The issue is whether the Respondent violated the statutes and rules as alleged in the Administrative Complaint.
Findings Of Fact Lester Henderson is a pharmacist holding license number 0015985 issued by the Department of Professional Regulation. The Respondent's last known address is 4029 Eastridge Drive, Valrico, Florida 33594. At all times relevant to the allegations contained in the Administrative Complaint, the Respondent was the pharmacist of record at Tampa Park Plaza pharmacy, 1497 Nebraska Avenue, Tampa, Florida 33602. On February 16, 1983, an audit of the Tampa Park Plaza Pharmacy was conducted by the Department. This audit revealed seven prescriptions purportedly issued by Dr. Vinai Artyamsoal for the following amounts Schedule II substances prescribed for Carrie (or Connie) Chambers: 5/18/82 Demerol 50 mg. 100 tabs 8/16/84 Demerol 50 mg. 100 tabs 9/10/82 Demerol 50 mg. 100 tabs 10/8/82 Dilaudid 50 mg. 200 tabs 11/23/82 Dilaudid 4 mg. 200 tabs 12/23/82 Dilaudid 4 mg. 100 tabs 1/20/84 Demerol 100 mg. 100 tabs (See petitioner's Exhibit 3(a) through (g). Dr. Vinai Artyamsoal is a physician specializing in obstetrics and gynecology with offices in Plant City and Zephyr Hills, Florida. Notarized affidavits of Dr. Artyamsoal were received, each of which bears a copy of one of the prescriptions described in paragraph above. Each affidavit contains a statement of Dr. Artyamsoal that he did not issue, authorize, or consent to making the prescriptions depicted within the affidavit. The Board's investigator who is a pharmacist stated "it was a good practice" to check with a doctor to see if the prescription was valid if the doctor was from out of town. (T-52). He also thought a pharmacist should scrutinize such prescriptions more carefully. The Respondent testified that he attempted to contact Dr. Artyamsoal to check on one of the subject prescriptions; however, he was unable to contact the doctor. It was the doctor's practice to personally verify prescriptions with pharmacists by talking with the pharmacist directly. A check of the doctor's records revealed no record for a Carrie (or Connie) Chambers. The Respondent admitted that on April 19, 1983, the pharmacy was unlocked while he was not present at the pharmacy and although he was scheduled to work at that time. There was not an appropriate door or similar structure which could be locked to bar access to the prescription department. There was no sign displayed at said time stating the prescription department was closed. There was a theft of controlled substances from the pharmacy. The Respondent reported this theft to the Federal Drug Enforcement Administration. The Respondent also reported the theft to the state authorities. The Respondent, was one of four partners who owned the pharmacy. The FDEA sent certain forms to the Respondent to be filled out about the theft. The Respondent gave these forms to the partner in charge of business paperwork to fill out. The forms were not sent to FDEA. Because the forms were not returned t FDEA, all of the records were not complete concerning the shortage. The Respondent as the managing pharmacist was attempting to carry the sole work load of this business while working full time at another job which he could not do. This was the reason for the failure to get all of the records complete and be on duty as scheduled.
Conclusions Count I alleges that the Respondent violated Section 465.016(1)(i), Florida Statutes which provides as follows: Compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of professional practice of pharmacy. For purposes of this paragraph, it shall be legally presumed that the compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best interests of the patient and is not in the course of the professional practice of pharmacy. This count specifically alleges that the Respondent failed to verify the prescriptions. (See Prehearing Stipulation.) The facts reveal that the Respondent attempted to check the prescriptions on one occasion, and that the Board's own investigator did not say it was unprofessional not to check the prescriptions. It was not alleged and not proven the amounts of the, prescriptions were excessive. Therefore, proof of this Count is wholly dependent upon competent substantial testimony that it is outside the course of professional pharmacy to fill prescriptions without checking with the doctors. The Board's witness did not testify to such a standard. He said it was a good investigative practice to check out of town prescriptions. This is substantially short of stating a professional standard from which a pharmacist cannot depart. This Count was not proven. COUNT II Count II alleges the Respondent was not on duty from 10:15 a.m. until 2:00 p.m., on April 19, 1983 when the pharmacy was inspected. At said time, the pharmacy was not locked and a sign was not posted, contrary to Rule 21S-1.14, FAC, saying the department was closed. This rule says in pertinent part that when a pharmacist is not on duty the pharmacy department is considered closed even if the store is open. When the pharmacy department is closed, a sign shall be displayed saying it is closed. The rule also provides that the pharmacy department shall be locked to prevent entry when it is closed. The Respondent admits that on April 19, 1983 the pharmacy was not locked; that he was supposed to be on duty; that he was not at the pharmacy; that a sign was not so posted; and the pharmacy was not locked. However, the Administrative Complaint does not allege that this violation is punishable under the statute and the rules do not provide a penalty for violation. COUNT III Count III alleges Respondent violated 893.07(1)(b), Florida Statutes by failing to keep all of the records re- quired. The Respondent failed to complete the report of that theft to FDEA, although he reported the theft to federal and state authorities. The Respondent had turned the work over to one of the other partners to be done. It was not done. There was a technical failure to complete the reports to FDEA. The DEA elected not to act upon this violation. Ironically, the Department of Professional Regulation had apparently lost its copies of the Respondent's report of the theft in a move, and the Board did not have all of its records. The Respondent is in technical violation of 465.016(1)(e) MITIGATION The Respondent is a minority business man. He and his partners starred a pharmacy in a predominantly black area of their community. They borrowed money to do this and the Respondent has worked hard; in fact, too hard to make this success. Respondent was working at least one other full-time job and often two jobs to get additional money, for his family to protect the business. Because of this, the recommendation does not levy a civil fine. It does not provide for a suspension which would tend to penalize Respondent who was only one of four partners, at least one other of whom was a pharmacist. It appears many of their violations were the result of Respondent attempting to do too much and inadequate technical knowledge of the rules.
Recommendation Having found the Respondent guilty of a technical violation, as alleged in Count III, it is recommended that the Respondent be placed upon probation for two years during which he would be prohibited from working more than 60 hours per week as a pharmacist or working as a managing pharmacist and be required to take a course on the records required to be kept by Chapter 893 and the Federal DEA. DONE and RECOMMENDED this 24th day of October, 1984 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of October, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Lester Henderson 1497 Nebraska Avenue Tampa, Florida 33602 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact At all times material hereto, Respondent Maria C. Perez has been licensed as a pharmacist under the laws of the State of Florida, having been issued license number 0018025. At all times material hereto, Respondent Perez has been the managing pharmacist at Respondent San Lazaro Pharmacy. At all times material hereto, Respondent San Lazaro Pharmacy has been the holder of a permit to operate a community pharmacy under the laws of the State of Florida, having been issued permit number 0002864. At all times material hereto, Olegario Cepro (or Cepero) was employed at Respondent pharmacy. At no time material hereto was Cepro licensed as a pharmacist or registered as a pharmacy intern in the State of Florida. On March 1, 1983, Georgina Jorge, an investigator with the Department of Professional Regulation, entered the Respondent pharmacy. Jorge asked Cepro for 30 Berocca tablets, 10 Librax capsules, and 5 Darvon Compound capsules. Cepro went into the dispensary department and thereafter delivered to Jorge 45 pills. At no time during this transaction did Jorge present Cepro with a prescription. On March 1, 1983, the pills received were taken to the Metropolitan Dade County Crime Laboratory. A subsequent chemical analysis of the pills revealed the presence of the controlled substance known as chlordiazepoxide, the active ingredient in Librax, a medicinal drug requiring a prescription for dispensing. Another sample which was analyzed revealed the presence of the controlled substance known as dextro propoxyphene, the active ingredient in Darvon Compound, a medicinal drug requiring a prescription to be dispensed. The suspected Berocca was not analyzed. On March 8, 1983, Jorge returned to the Respondent pharmacy. She asked Cepro for 10 penicillin tablets, 20 Valium tablets, and 10 Darvon Compound capsules. Cepro obtained from the pharmacy dispensary and gave to Jorge 10 tablets which appeared to be penicillin, 20 tablets which appeared to be Valium, and 20 capsules which appeared to be Darvon Compound. At that time, Respondent Perez was in the pharmacy dispensary. At no time during this transaction did Jorge present Cepro with a prescription. On March 8, 1983, the above substances were taken to the Metropolitan Dade County Crime Laboratory. A subsequent chemical analysis of the pills revealed in one sample the presence of penicillin, a medicinal drug requiring a prescription for dispensing. Analysis of another substance revealed the presence of the controlled substance diazepam, the active ingredient in Valium, a medicinal drug requiring a prescription for dispensing. On March 25, 1983, Jorge went to the Respondent pharmacy and asked Cepro for prices on bottles of Valium, Mebaral, Lomotil, Ritalin, Trofanil, and Lasix. Prices were quoted to Jorge by Cepro. Thereafter, Cepro delivered to Jorge 20 apparent Valium tablets, 36 apparent Ritalin tablets, 250 apparent Mebaral tablets, and 20 apparent Darvon Compound capsules. On this occasion, Jorge observed Respondent Perez, the licensed managing pharmacist, in the dispensary. At no time during this transaction did Jorge present Cepro with a prescription. On March 25, 1983, the substances which Jorge had received at the Respondent pharmacy were taken to the Metropolitan Dade County Crime Laboratory. A subsequent chemical analysis of the substances revealed the presence of the controlled substance known as methylphenidate, the active ingredient in Ritalin, which is a medicinal drug requiring a prescription to be dispensed. Methylphenidate is a Schedule II controlled substance pursuant to Chapter 893, Florida Statutes. Laboratory analysis of additional substances received from the March 25, 1983, transaction revealed the presence of the controlled substance known as mephobarbital, the active ingredient in Mebaral, a medicinal drug requiring a prescription for dispensing. In addition, one of the 20 capsules received was analyzed and revealed the presence of the controlled substance known as propoxyphene, the active ingredient in Darvon Compound, which is a medicinal drug requiring a prescription for dispensing. On March 28, 1903, Jorge went to the Respondent pharmacy once again. She asked Cepro for 20 Valium tablets and 20 Lomotil tablets. Jorge saw Respondent Perez in the prescription department. Cepro went into the prescription or dispensary department and returned with suspected controlled substances. At no time during this transaction did Jorge present Cepro or Respondent Perez with a prescription. On March 28, 1983, the suspected controlled substances were taken to the Metropolitan Dade County Crime Laboratory for analysis. A subsequent chemical analysis of the tablets revealed the presence of the controlled substance known as diazepam, the active ingredient in Valium, a medicinal drug requiring a prescription for dispensing. On March 28, 1983, an audit of the controlled substances was conducted at the Respondent pharmacy by Edward Bludworth, an investigator with the Department of Professional Regulation. That audit revealed that Respondents could not provide prescriptions or other documentation to show the dispensing of 41 Darvon Compound-65, 1,005 Valium 5 mg., 801 Valium 10 mg., 280 Tranxene 3.75 mg., 33,451 Talwin 50 mg., and 20 Talwin injectable vials. Darvon, Tranxene, Valium, and Talwin are all compounds containing controlled substances as defined in Chapter 893, Florida Statutes. Petitioner presented no evidence concerning the allegations of Count III [sic II; paragraphs 13, 14, 15, and 16] of the Administrative Complaint filed against Respondent Perez in DOAH Case No. 83-2918.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing Count III of the Administrative Complaint filed against Respondent Maria C. Perez, finding her guilty of Counts I and II of the Administrative Complaint filed against her, and revoking her license to practice pharmacy in the State of Florida. It is further RECOMMENDED that a Final Order be entered finding Respondent San Lazaro Pharmacy guilty of each and every count in the Administrative Complaint filed against it and revoking its permit to operate a community pharmacy in the State of Florida. DONE and RECOMMENDED this 27th day of March, 1984, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 27th day of March, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 A. M. Schwitalla, Esquire 135 Almeria Avenue Coral Gables, Florida 33134 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
Conclusions THE PARTIES resolved all disputed issues and executed a Settlement Agreement. The parties are directed to comply with the terms of the attached settlement agreement. Based on the foregoing, this file is CLOSED. DONE and ORDERED on this the£ day of 1=4f=-----·' 2009, m Tallahassee, Florida. r Agency for Health Care Administration 1 Filed July 7, 2009 1:19 PM Division of Administrative Hearings. A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO A JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: L. William Porter II, Esquire Agency for Health Care Administration (Laserfiche) Lewis W. Fishman, Esquire 2 Datran Center 9130 S. Dadeland Boulevard, Suite 1121 Miami, Florida 33156-7848 (U.S. Mail) June C. McKinney Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 Ken Yon, Bureau Chief, Medicaid Program Integrity Diana Coumbe, Medicaid Program Integrity Finance and Accounting 2 CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished to Richard Shoop, Esquire Agency Clerk State of Florida Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403 (850) 922-5873 3
Findings Of Fact Petitioner, South Beach Pharmacy, Inc., d/b/a Southpointe Pharmacy (Southpointe), was at all times material hereto, a pharmacy located in Dade County, Florida, and a provider under the Medicaid program. Respondent, Department of Health and Rehabilitative Services (DHRS), was and is the state agency responsible for regulating the Medicaid program in Florida. Pharmacies participating in the Medicaid program are subject to routine audits, which are coordinated by the DHRS Office of Program Integrity. In early 1989 a routine audit of Southpointe was conducted by the Professional Foundation for Health Care (PFHC) at the request of DHRS. Following that audit, DHRS reasonably determined that further investigation was warranted and asked PFHC to perform an audit referred to as an "aggregate analysis." PFHC performed the aggregate analysis audit as instructed and determined that an overpayment had been made to Southpointe. The PFHC audit was submitted to and reviewed for accuracy and correctness by the Office of Program Integrity. In August 1989, DHRS took proposed final agency action against Southpointe in the form of a letter which, among other things, demanded repayment of funds alleged to have been overpaid under the Medicaid program, assessed an administrative fine against Southpointe, and terminated Southpointe from the Medicaid program for two years. That letter was revised in September 1989 to change the amount of the alleged overpayment. The alleged overpayment was challenged by Southpointe. The matter was submitted to the Division of Administrative Hearings and assigned DOAH Case No. 89-6057. At the times pertinent to this proceeding DHRS had not adopted the "aggregate analysis" methodology by rule. Instead, DHRS relied on incipient, non-rule policy and attempted, without success, to explicate its reasons for relying on this methodology. The first time the "aggregate analysis" methodology was used in an effort to determine the overpayment by Medicaid to a pharmacy was in the case of David's Pharmacy v. Department of Health and Rehabilitative Services, DOAH Case No. 88-1668 (Final Order entered September 15, 1988). The Final Order entered in the David's Pharmacy case specifically recognized that DHRS was not entitled to rely on non-rule policy in imposing sanctions against a provider because of the wording of Section 409.266(11)(g), Florida Statutes (1989), which limits the imposition of sanctions against a Medicaid provider to situations where the provider is not in compliance with the Florida Administrative Code. Further, the Final Order in the David's Pharmacy case concluded that the aggregate analysis methodology was flawed and, consequently, could not be relied upon by DHRS in determining that an overpayment had been made. Although DHRS again attempted to rely on the aggregate analysis methodology in the audit of Southpointe, DHRS had not adopted the aggregate analysis methodology as a rule (even though there were no changes in the governing statute) and it did not cure all the defects in the methodology that were specifically raised by the Final Order in David's Pharmacy. The only material change in the aggregate analysis procedure between the time of the David's Pharmacy final order and the time it was used to audit Southpointe was the elimination of the use of a Medicaid percentage applied to the quantities of audited drugs. The Recommended Order submitted by the undersigned following the formal hearing in the underlying proceeding (DOAH Case No. 89-6057) found that DHRS had not adopted the "aggregate analysis" methodology as a rule and that DHRS had not explicated its policy in attempting to rely on this non-rule policy. The Recommended Order concluded that DHRS had failed to prove any overpayment to Southpointe. The Recommended Order also found that certain data relied on by PFHC in performing the aggregate analysis was unreliable, which resulted in the amount of claimed overpayment being overstated. While DHRS was not aware that this data was unreliable, this data merely affected the amount of the overpayment. It was DHRS's continued reliance on the aggregate analysis that led DHRS to the assertion that there had been an overpayment. DHRS, by its Final Order in DOAH Case No. 89-6057, rejected many of the facts and the conclusion contained in the Recommended Order. Instead, DHRS determined that there had been an overpayment to Southpointe, demanded repayment of the alleged overpayment, imposed an administrative fine in the amount of $250.00, and suspended Southpointe as a Medicaid provider for three months. Thereafter, Southpointe appealed DHRS's Final Order to the First District Court of Appeal. The First District Court of Appeal reversed DHRS and concluded, in pertinent part, as follows: . . . Therefore, as found by the hearing officer, the Department was proceeding not under any existing rule but rather under incipient policy. That finding was based upon competent and substantial evidence, and we hold it was a gross abuse of discretion for the Department to reject that finding of fact. * * * . . . [W]e agree with the hearing officer that HRS failed in its mission to support and defend the aggregate analysis with competent and substantial evidence. In an earlier final order issued by the Department, David's Pharmacy v. Department of Health and Rehabilitative Services, 11 FALR 2935 (HRS 1988), wherein aggregate analysis was utilized for the first time, the Department found HRS had not appropriately explicated this non-rule policy by its failing to produce evidence that would establish a rational, reasonable basis for the procedure. In the instant case, despite rather pat testimony to the effect that the aggregate analysis is indeed contemplated by the rule, it was shown that HRS had not checked a single Medicaid patient to determine if the medication had been dispensed, or a single physician to see if the medication had been prescribed. Robert Peirce testified that the only thing HRS had done since David's Pharmacy, was to delete the requirement of utilizing a "percentage of Medicaid sales" from the formula. As pointed out by Southpointe, none of the other shortcomings of aggregate analysis which were identified in the David's final order were remedied by HRS at the hearing below. For example, neither a beginning nor ending inventory had been taken into consideration, and no consideration was given to whether Southpointe had acquired additional drugs to augment its inventory by means other than direct purchase from its manufacturers 1/ DHRS has failed to establish that it was substantially justified in taking action against Southpointe based on the aggregate analysis methodology. There was no evidence to show that an award of fees and costs to Southpointe would be unjust in this case. Southpointe has become obligated to pay costs and attorney's fees in excess of $15,000.00, the maximum allowable recovery under the Equal Access to Justice Act. The parties stipulated that these costs and fees are reasonable. Petitioner is a prevailing small business within the meaning of Section 57.111, Florida Statutes, and has met all conditions precedent for such an award.
