Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Petitioner, Stadtlander Drug Company, Inc. (SDC), is a provider of pharmacy services located at 600 Penn Center Boulevard, Pittsburgh, Pennsylvania. It is licensed by respondent, Agency for Health Care Administration (AHCA), as a special non-resident mail order pharmacy having been issued License No. PH 0013072. Petitioner is now enrolled as a Medicaid provider in twenty-three states around the country and provides mail-order drugs in all those states. In addition, it holds at least forty pharmacy licenses in various states, as well as thirty-five drug wholesale licenses. Petitioner's specialty is to target certain "disease states" and provide expensive, "high-tech" drugs to persons with serious, chronic illnesses such as cancer and AIDS. On November 7, 1995, petitioner submitted an application to respondent for enrollment as an out-of-state Medicaid provider. If the application is approved, petitioner would be assigned a Medicaid provider number and be able to provide prescription drugs by mail to Florida residents who reside within the State of Florida. It would then be reimbursed under the state's Medicaid program. After reviewing the application, including a supplemental submission by SDC, on February 28, 1996, AHCA denied the application on the following grounds: (Y)ou have failed to demonstrate that SDC meet the requirements for enrollment of out-of-state providers as outlined in Rule 59G-5.050, Florida Administrative Code (F.A.C.) Furthermore, SDC's locality would create an undo hardship on AHCA for meeting the requirments and oversight duties set forth in applicable federal laws, state statutes, administrative rules, regulations and manuals. For example, conducting on site audit reviews of your pharmacy operations, which requires (that) our field auditors take a physical inventory of the pharmacy department, and enforcing the oversight provisions cited in Section 409.913, Florida Statutes (F.S.), would be difficult and create an unwarranted expense. After receiving this advice, SDC filed a petition for hearing claiming that it had satisfied all pertinent requirements for enrollment. The parties have stipulated that there are no federal laws, administrative rules or manuals that would preclude SDC's enrollment as a Florida Medicaid provider and prevent it from providing prescribed drug services to qualified Medicaid beneficiaries who reside in the State of Florida. Under both federal and state law, AHCA is authorized to conduct audits of Medicaid pharmacy providers. The manner in which such audits are to be performed is set forth in the "Florida Medicaid/Unisys, Inc. Pharmacy Audit Program" manual. As a ground for denial, AHCA contends that, if the application is approved, an undue burden would be placed on the agency in auditing petitioner's records in Pittsburg. SDC acknowledges that there could be some hardship to AHCA in performing its audit responsibilities. SDC has, however, made accommodations to other states in attempting to address their concerns about the need to audit Medicaid pharmacy providers. For example, for the State of California, SDC maintains certified copies of all documents within that state to permit on-site inspection and comparison of records in California by the auditor. SDC has proposed to make the same kind of accommodation for AHCA. In addition to this accommodation, SDC is willing to answer by telephone any questions raised by Medicaid auditors and provide documentation for specific patients. Alternatively, if a Florida auditor found it necessary to make an audit of petitioner's offices in Pittsburg, SDC would willingly allow an on-site inspection. Other than the ground cited in its letter of denial, respondent offered no evidence to rebut SDT's showing that the accommodations are reasonable and adequate. Further, given these accommodations, there is no evidence that AHCA would suffer "an undue hardship" or that it would be unable to perform its auditing responsibilities under the Medicaid manual. Finally, since no Medicaid auditors from any of the twenty-three states in which SDC is certified as a Medicaid provider have found it necessary to make an audit in SDC's home office during the last four years, it is fair to draw an inference that the proffered accommodations would be satisfactory. AHCA has also denied the application on the ground petitioner does not meet any of the four criteria in Rule 59G-5.050(1), Florida Administrative Code. That rule specifies the circumstances under which an out-of-state provider may enroll in the Florida Medicaid program. Those criteria apply, however, when out-of-state providers intend to provide services to Florida recipients who purchase drugs while out of the State of Florida. In this case, petitioner intends to provide services by mail to recipients who reside within the State of Florida. Therefore, the rule does not apply. Because SDC has completed a provider agreement, is not under suspension in Florida or any other state, and has a current pharmacy license from AHCA, and its locality will not create an undue auditing hardship on AHCA, its application for enrollment as an out-of-state Medicaid provider should be approved.
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 granting petitioner's application for enrollment as an out-of-state Medicaid provider. DONE AND ENTERED this 16th day of August, 1996, in Tallahassee, Florida. DONALD R. ALEXANDER, 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 16th day of August, 1996. APPENDIX TO RECOMMENDED
Findings Of Fact At all times material hereto, Dr. Esteban Valdes-Castillo, a Board- certified psychiatrist, was the Medical Director of Progressive Health Center, Inc. Blanche Lear, a psychiatric social worker, was an employee of the Center. Between 1978 and August, 1981, Petitioner paid Respondent $45,627.16 in Medicaid payments for counseling ser- vices rendered by Blanche Lear. A two-way mirror was located in the common wall between Lear's and Valdes-Castillo's offices. Of the Medicaid recipients counseled by Lear, Valdes-Castillo did not meet, interview, counsel or even observe all of the patients for whom payments were made to the Center by Petitioner. Further, Valdes-Castillo only observed Lear's coun- seling sessions approximately once a month over the time period involved and then only upon the specific request of Lear to observe a specific patient for a specific reason.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered by Petitioner directing Respondent Progressive Health Center, Inc., to reimburse to Petitioner the amount of $45,627.16. DONE and RECOMMENDED this 14th day of March, 1983, 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 14th day of March, 1983. COPIES FURNISHED: Robert A. Weiss, Esquire Medicaid Program Office Department of Health and Rehabilitative Services 1317 Winewood Boulevard, Suite 233 Tallahassee, Florida 32301 J. Michael Sara, Esquire 2153 Coral Way, Suite 400 Miami, Florida 33145 David H. Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
The Issue Whether the Respondents were overpaid by Medicaid for radiology and nuclear medicine services provided to Florida Medicaid patients. The Agency for Health Care Administration (AHCA, Agency or Petitioner) asserts that the Respondents, Lazaro Plasencia, M.D., and Ana M. Elosegui, M.D., billed Medicaid for procedures they did not perform in violation of Medicaid policy, the Florida Administrative Code, and Florida Statutes. The Respondents maintain that because of ambiguities in Medicaid policy regarding reimbursement protocols for the radiology services at issue, the Respondents mistakenly believed in good faith that under the applicable Medicaid regulations and guidelines, Medicaid would reimburse the "maximum" fee allowable under the relevant fee schedule. The Respondents acknowledge that the "professional component" of the radiology services at issue was provided by a third-party physician specialist. The Respondents further assert that they are entitled to, at the minimum, payment of the "technical component" of the medically necessary radiological services that they provided to Medicaid recipients. The Petitioner seeks reimbursement from Dr. Plasencia in the amount of $196,129.52 and $122,065.08 from Dr. Elosegui.
Findings Of Fact The Petitioner is the state agency charged with the responsibility of monitoring the Medicaid Program in Florida. At all times material to the allegations of DOAH Case No. 07-2195MPI, the Respondent, Dr. Plasencia, was a licensed medical doctor in good standing with the State of Florida, license #ME49315, and was also a Medicaid provider, #0448125-00. Similarly, at all times material to the allegations of DOAH Case No. 07-2462MPI, the Respondent, Dr. Elosegui, was a licensed medical doctor in good standing with the State of Florida, license #ME85963, and was also a Medicaid provider, #2654636-00. Drs. Elosegui and Plasencia practiced medicine together in a shared office space in Miami, Florida. The Respondents were not members of a "group practice." The Respondents were individual providers who billed Medicaid separately, using their individual Medicaid provider numbers. The doctors performed services for Medicaid recipients and submitted the charges for those services to Medicaid. Medicaid has a "pay and chase" policy of paying Medicaid claims as submitted by providers. Audits performed by the Agency then, after-the-fact, reconcile the amounts paid to providers with the amounts that were payable under the Medicaid guidelines and pertinent rules. If more is paid to the provider than allowable, a recoupment against the provider is sought. In these cases, the Respondents conducted (or supervised) various tests including "Radiological and Nuclear Medicine" services for Florida Medicaid patients in a shared office setting. The services at issue in these cases were billed under the CPT procedure codes of series 70000 and 90000. The Petitioner has not challenged any procedure at issue as not "medically necessary." Moreover, the Petitioner does not dispute that the Respondents performed or supervised the "technical component" of the universe of the radiological services at issue. The "professional component" for the universe of the radiological services at issue in this proceeding was outsourced to third-party physicians. The Respondents contracted with the outside third-party physicians for the "professional component" services to read and interprete the radiological product. These third party physicians were not Medicaid providers, nor were they part of a Medicaid group provider that included the Respondents. When billing for the radiological services, the Respondents billed Medicaid for both the "technical" and "professional" components using the "maximum" fee set forth in the Fee Schedule. The Respondents knew or should have known that they had not performed a global service as they never performed or supervised the "professional" component of the services billed. The Petitioner performed an audit of the radiological claims for Dr. Plasencia for the dates of service July 1, 2001 through December 31, 2005. On December 1, 2006, the Petitioner issued a Final Audit Report that concluded Dr. Plasencia had been overpaid $196,129.52. Additionally, the Petitioner sought an administrative fine against Dr. Plasencia in the amount of $1,000.00. Similarly, the Petitioner performed an audit of the radiological claims submitted by Dr. Elosegui for the dates of service October 11, 2002 through December 31, 2005. On December 1, 2006, the Petitioner issued a Final Audit Report that concluded Dr. Elosegui had been overpaid $122,065.08. The Petitioner also sought an administrative fine against Dr. Elosegui in the amount of $1,000.00. In January 2005, the Fee Schedule applicable to CPT 90000 procedure code services was revised. The Fee Schedule specified a reimbursement amount for the "technical" component of the radiological services in the CPT 90000 code set. Prior to that time, there had been no reimbursable amount for the "technical component" performed separately from the "professional component." The Medicaid provider agreements executed between the parties govern the contractual relationships between these providers and the Agency. The parties do not dispute that those provider agreements, together with the pertinent laws or regulations, control the billing and reimbursement claims that remain at issue. The amounts, if any, that were overpaid were related solely to the radiological services billed under a global or inclusive manner that included the "professional" component within the amount claimed to be owed by Medicaid. The provider agreements pertinent to these cases are voluntary agreements between AHCA and the Respondents. The Fee Schedule adopted by the Petitioner dictates the code and reimbursement amounts authorized to be billed pursuant to the provider agreement. The Respondents performed or supervised the "technical components" for the radiological services billed to Medicaid. The Respondents did not perform the "professional component." For all of the 70000 series billing codes the components can be split and the "technical component" can be identified and paid separately. For these billing codes, the Respondents were given (or paid for) the "technical component" of the 70000 codes. Similarly, for the 90000 billing codes, for the "technical component" portion where it was identifiable and allowable, the Petitioner gave the Respondents credit for that amount. The "technical component" for the 90000 billing codes was not identifiable or allowable prior to 2005. Prior to the amendment to the Fee Schedule the 90000 billing codes were presumed to be performed in a global manner; i.e. the "professional component" and the "technical component" were done together by the Medicaid provider submitting the claim. That was not the factual case in these audits. Respondents were not authorized to bill the 90000 codes in the global manner as they did not perform the "professional component" of the services rendered. Any Medicaid provider whose billing is not in compliance with the Medicaid billing policies may be subject to the recoupment of Medicaid payments. The Petitioner administers the Medicaid program in Florida. Pursuant to its 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. These “integrity” audits are to assure that the provider bill and receive payment in accordance with applicable rules and regulations. The Respondents do not dispute the Agency’s authority to perform audits such as the ones at issue.
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 of recoupment as set forth in the reports at issue. The final order should also impose an administrative fine against each Respondent in the amount of $1,000.00. DONE AND ENTERED this 1st day of April, 2008, 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 1st day of April, 2008. COPIES FURNISHED: Richard Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308 Craig H. Smith, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Holly Benson, Secretary Agency for Health Care Administration Fort Knox Building, Suite 3116 2727 Mahan Drive Tallahassee, Florida 32308 Robert M. Penezic, Esquire Broad and Cassel Post Office Box 14010 Fort Lauderdale, Florida 33302-4010 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 Robert N. Nicholson, Esquire Broad and Cassel Post Office Box 14010 Fort Lauderdale, Florida 33302-4010
The Issue Whether Petitioner, Agency for Health Care Administration (“AHCA”), is entitled to recoup from Respondent, JRM Pharmacy, Inc., d/b/a Super Drugs Pharmacy (“JRM”), $156,657.05 as Medicaid overpayments; and whether investigative, legal, expert witness costs, and fines should be imposed against JRM.
Findings Of Fact AHCA is the designated state agency responsible for administering the Medicaid Program in Florida. At all times material to this case, JRM has been a licensed pharmacy and authorized Medicaid provider pursuant to a Medicaid Provider Agreement with AHCA. The Medicaid Provider Agreement is a voluntary contract between AHCA and JRM. JRM’s Medicaid provider number is 102451500. As an enrolled Medicaid provider, JRM is subject to the duly-enacted federal and state statutes, regulations, rules, policy guidelines, Medicaid provider publications, and the Medicaid Provider Agreement between it and AHCA. At all times during the audit period, JRM was required to follow the Florida Medicaid Prescribed Drugs, Services, Coverage, Limitations, and Reimbursement Handbook (“Prescribed Drugs Services Handbook”). This case involves a Medicaid audit by AHCA of JRM as to dates of service from January 1, 2010, through December 31, 2010 (“audit period”). AHCA’s Bureau of Medicaid Program Integrity (“MPI”), pursuant to its statutory authority, conducted an audit of JRM of paid Medicaid claims for medical goods and services to Medicaid recipients which occurred during the period from January 1, 2010, through December 31, 2010. The audit included a comparison of the amount of prescription medications billed to Medicaid by JRM during the audit period with the units of the corresponding medications JRM purchased from licensed wholesalers. The audit concluded that JRM was overpaid a total of $156,657.05 for various prescription medications it billed to AHCA and received payment from AHCA. The claims which make up the overpayment alleged by AHCA of $156,657.05 were filed and paid by AHCA prior to the institution of this matter. JRM does not dispute that it was overpaid $43,890.02 for various prescription medications, and JRM concedes that AHCA is entitled to recover this amount as an overpayment. However, JRM disputes the remaining balance of AHCA’s alleged overpayment of $112,767.03, which AHCA attributes to an overpayment to JRM for the brand named prescription drug Prevacid 30 mg Capsule DR (“Prevacid”). The audit involved a review of JRM’s purchases of Prevacid from McKesson, and Lansoprazole from Bellco, the authorized wholesalers, during the audit period. The audit established that JRM billed to AHCA and received payment from AHCA for more Prevacid than JRM had available during the audit period to dispense to Medicaid recipients. Specifically, the persuasive evidence adduced at hearing demonstrates JRM was overpaid $112,767.03 for Prevacid. When a Medicaid pharmacy provider submits a claim to Medicaid for payment, Medicaid identifies the prescription drug on the claim by the National Drug Code (“NDC”). The generic form of Prevacid is Lansoprazole. Prevacid and Lansoprazole have different NDC numbers. JRM was required to submit the entire 11-digit NDC number for the actual product dispensed on the claim. During the audit period, JRM billed to Medicaid and was paid by Medicaid for “NDC: 00300304613 PREVACID 30 MG CAPSULE DR, NDC: 00300304619 PREVACID 30 MG CAPSULE DR, AND NDC: 64664004613 PREVACID DR 30 MG CAPSULE.” The persuasive evidence adduced at hearing demonstrates that JRM billed Medicaid and was paid by Medicaid for 31,650 Prevacid capsules. However, JRM only purchased 10,907 units of Prevacid, leaving a shortage of 20,744 capsules of Prevacid and an overpayment of $112,767.03. Thus, JRM received payment from Medicaid for $112,767.03 for Prevacid that JRM did not purchase and did not dispense to Medicaid recipients. There is a significant cost difference between the brand name Prevacid and generic Lansoprazole, with the brand name Prevacid being billed at a much higher rate than the generic Lansoprazole. JRM purchased a large amount of Lansoprazole from Bellco during the audit period, but billed and received payment from Medicaid for Prevacid. Only prescription drugs that are on the Florida Medicaid Preferred Drug List are allowed to be paid for by Medicaid. During the audit period, generic Lansoprazole was not on AHCA’s preferred drug list. However, Prevacid was on AHCA’s preferred drug list. JRM often dispensed Lansoprazole and billed and received payment from Medicaid for dispensing Prevacid.
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 of recoupment of a Medicaid overpayment from JRM in the amount of $156,657.05; impose a fine of $5,000.00; and remand this matter to the undersigned for a determination of the amount of investigative, legal, and expert witness costs, should a final order be entered by AHCA indicating that AHCA ultimately prevailed, and if there is any dispute as to the amount of such costs following the issuance of the final order by AHCA. DONE AND ENTERED this 13th day of January, 2015, in Tallahassee, Leon County, Florida. S DARREN A. SCHWARTZ 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 13th day of January, 2015.
The Issue The issue is whether Respondent failed to maintain a service plan for each of four residents, in violation of the Florida Medicaid Assistive Care Services Coverage and Limitations Handbook. If so, an additional issue is the sanctions that should be imposed.
Findings Of Fact Respondent owns and operates an assisted living facility known as Izquierdo Home Care I. At all material times, Respondent was enrolled in the Medicaid program as a provider authorized to supply assistive living services to Medicaid recipients at Izquierdo Home Care I. At all material times, Respondent was subject to the Florida Medicaid Assistive Care Services Coverage and Limitations Handbook. The handbook imposed upon Respondent the duty to develop a service plan for each Medicaid recipient not less often than annually. On March 27, 2012, Petitioner's inspector conducted a site visit of Izquierdo Home Care I. At the time of the site visit, the facility had six beds, but only four residents. According to a letter from Petitioner dated March 27, 2012, and delivered to Respondent's representative at the time of the inspection, the following four residents were Medicaid recipients: E. C., R. R., J. H., and A. R. However, according to the questionnaire completed by Respondent's representative at the time of the inspection, only two of the four current residents were Medicaid recipients, although the questionnaire does not identify these residents. In fact, A. R. had been discharged from Izquierdo Home Care I in September 2011. At the hearing, Petitioner's inspector confirmed that Respondent had not billed Medicaid for services for A. R. after the date of discharge. The second resident whose Medicaid status is in question was identified, in Respondent's proposed recommended order, as E. C. Respondent contends in its proposed recommended order that E. C. was not receiving Medicaid at the time of the inspection. If the Proposed Recommended Order were the only notice to Petitioner of Respondent's claim that a second resident was not a Medicaid recipient, the Administrative Law Judge would ignore this assertion because it is not evidence, and, as a defense, it was raised too late. However, the questionnaire, which was admitted as one of Petitioner's exhibits, is evidence that two of the four residents were not receiving Medicaid at the time of the inspection. In assessing the evidentiary record in terms of whether it establishes a third Medicaid recipient, the Administrative Law Judge notes: a) Petitioner has alleged a violation concerning A. R., even though A. R. was no longer a Medicaid recipient at the time of the inspection; b) at hearing, Petitioner's inspector was readily able to read the "query" to confirm that Respondent had not submitted a Medicaid billing on account of A. R. after September 2011 (Transcript 49); and c) as discussed in the Conclusions of Law, Petitioner bears the burden of proof by clear and convincing evidence. Under these circumstances, Petitioner has proved only that two residents of the facility were Medicaid recipients at the time of the inspection. There is no dispute that current service plans for two Medicaid recipients did not exist at the time of the March 2012 inspection.
Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order imposing a fine of $2000 against Respondent. DONE AND ENTERED this 26th day of October, 2012, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 26th day of October, 2012. COPIES FURNISHED: Jeffries H. Duvall, Esquire Office of the General Counsel Agency for Health Care Administration Fort Knox Executive Center, Building 3 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308-5403 Julia Arrendell, Qualified Representative 13899 Biscayne Boulevard North Miami Beach, Florida 33181 Elizabeth Dudek, Secretary Office of the General Counsel Agency for Health Care Administration Fort Knox Executive Center, Building 3 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308-5403 Stuart Williams, General Counsel Office of the General Counsel Agency for Health Care Administration Fort Knox Executive Center, Building 3 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308-5403 Richard J. Shoop, Agency Clerk Office of the General Counsel Agency for Health Care Administration Fort Knox Executive Center, Building 3 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308-5403
The Issue The issues in this case are: (1) Whether Respondent violated sections 409.913, Florida Statutes, as alleged in the Sanction Letter dated January 18, 2012, by failing to have documentation evidencing the receipt of Core Assurances training in six employees' files; failing to have documentation evidencing the receipt of required HIPAA training in one employee file; and failing to have documentation evidencing the receipt of Zero Tolerance training in one employee file2/; and (2) if so, the penalty that should be imposed.
Findings Of Fact The Parties Petitioner is the state agency responsible for administering the Florida Medicaid Program pursuant to chapter 409. Petitioner's duties include operating a program to oversee the activities of Medicaid recipients, and providers and their representatives, to ensure that fraudulent and abusive behavior and neglect of recipients occur to the minimum extent possible, and to recover overpayments and impose sanctions as appropriate. § 409.913(1), Fla. Stat. To that end, Petitioner is authorized to conduct investigations of Medicaid providers to determine compliance with the Medicaid program. § 409.913(2), Fla. Stat. Respondent is an enrolled Medicaid provider providing home-based and community-based services to the developmentally disabled in a residential habilitation setting.3/ Respondent became an enrolled Medicaid provider in April 2004, and has been an enrolled Medicaid provider at all times pertinent to this proceeding. Medicaid Provider Agreement To become enrolled as a Medicaid provider for the developmentally disabled in Florida, a provider applies with Petitioner and the Agency for Persons with Disabilities ("APD"). If the provider is approved for enrollment in the Medicaid program, it enters into a Medicaid Provider Agreement ("MPA") with Petitioner. The MPA establishes the terms and conditions of the provider's participation in the Medicaid program. A key condition is that the provider agrees to comply with all federal, state, and local laws, including rules, regulations, and statements of policy applicable to the Medicaid program, including the applicable Medicaid Handbooks. The Florida Medicaid Development Disabilities Waiver Services Coverage and Limitations Handbook, dated November 2010 ("DD Handbook"), and the Florida Medicaid Provider General Handbook, dated July 2008 ("General Handbook"), are applicable to this proceeding. Petitioner's Inspection of Respondent's Facility On September 28, 2011, Ms. Gina Selwitz, an Inspector Specialist with Petitioner's Bureau of Medicaid Program Integrity, conducted an unannounced site inspection at Respondent's facility to review Respondent's employee records and recipient files for compliance with applicable Medicaid program requirements. As part of the inspection, Ms. Selwitz reviewed the records of six employees for documentation that they had received required training in a range of areas, including Core Competency, Health Insurance Portability and Accountability Act ("HIPAA") compliance, and Zero Tolerance Training, as required under state and federal law and rules and the General Handbook and DD Handbook. Ms. Selwitz determined that required documentation showing Core Assurances training was missing from six of Respondent's employees' files. She also determined that required documentation showing HIPAA training was missing from the file of one of Respondent's employees. Additionally, she determined that required documentation showing Zero Tolerance training was missing from the file of one of Respondent's employees. Demand Letter Regarding Submittal of Missing Information While conducting the compliance inspection, Ms. Selwitz hand-delivered to Respondent a demand letter dated September 28, 2011. The demand letter stated in pertinent part: Pursuant to Section 409.913, Florida Statutes (F.S.), this is official notice that the Agency requests the documentation for services paid by the Florida Medicaid program to the above provider number. The Medicaid-related records to substantiate billing for the recipients identified on the enclosed printout are due within fifteen (15) calendar days of your receipt of this notification. In addition, please complete the attached questionnaire and submit it along with the copies of the Medicaid- related records. Please submit the documentation and the attached Certificate of Completeness of Records to the Agency within this timeframe, or other mutually agreed upon timeframe. The referenced questionnaire and printout were not attached to the demand letter. Ms. Selwitz provided Respondent a handwritten list of items that she determined were missing from its files and that needed to be submitted in response to the demand letter. Respondent's Responses to Demand Letter and Sanction Letter On October 12, 2011, Respondent's representative, Mr. Orukotan, sent Ms. Selwitz electronic mail requesting that she send the editable Developmental Services Medicaid Provider Questionnaire form so Respondent could complete and submit it by October 14, 2011. After further electronic mail exchange, Ms. Selwitz provided the form to Mr. Orukotan on October 18, 2011. Respondent submitted the completed Questionnaire on November 3, 2011. In addition, Respondent submitted its Certificate of Completeness of Records and the other items that were requested in Ms. Selwitz's handwritten list provided with the demand letter. The handwritten list did not identify employee training documentation for Core Assurances, HIPAA, and Zero Tolerance as missing from Respondent's files; accordingly, Respondent did not provide that documentation as part of its November 3, 2011, submittal. Subsequently, Petitioner issued a Sanction Letter, dated January 18, 2012, which in part alleged that Respondent failed to have documentation in its files evidencing the receipt of employee training in Core Assurances, HIPAA, and Zero Tolerance. After receiving the Sanction Letter, Respondent submitted documentation of employee training in Core Assurances, HIPAA, and Zero Tolerance to demonstrate its compliance with the Medicaid program documentation requirements. Ms. Selwitz claimed that in addition to the handwritten list, she had given Respondent a typewritten list that identified other specific information, including the employee training documentation, that she determined missing from Respondent's files and needed to be provided pursuant to the demand letter. Respondent credibly testified that he never received this typewritten list of additional requested items. In support of Ms. Selwitz's testimony, Petitioner provided, as a supplemental exhibit, a typewritten form entitled "Residential Rehabilitation Provider." At the top of the form were three spaces to be filled in with the facility's name and the date and time of inspection; however, no information regarding Respondent's facility or its inspection was filled in the spaces, which were left blank. The form generally requested a range of items, including "[a]ll employee records (include Level II (FDLE and FBI) background check information)[4/]" but did not specifically request that Core Assurances, HIPAA, or Zero Tolerance employee training documentation be provided. The form further stated: "please provide the following records so that they may be reviewed on-site . . ."; This statement was followed by a list of items. However, Petitioner's facility inspection checklist and notes did not identify these items as missing from Respondent's files.5/ Rather than comprising an additional list of information that Ms. Selwitz prepared and provided to Respondent to specifically identify missing information to be submitted pursuant to the demand letter, the Residential Rehabilitation Provider list instead appears to be a general form list that Petitioner provides before or at the time of facility inspection. Under any circumstances, the form's lack of specificity regarding employee training documentation for Core Assurances, HIPAA, and Zero Tolerance would not have given Respondent notice that Petitioner had determined such documentation was missing from its files and needed to be provided as part of its response to the demand letter. The credible evidence establishes that Respondent was not given this typewritten form or otherwise notified that Petitioner had determined that employee training documentation for Core Assurances, HIPAA, and Zero Tolerance was missing from its files and needed to be provided pursuant to the demand letter. Respondent's Compliance With Record-Keeping Requirements Section 409.913, Petitioner's rules, the DD and General Handbooks, and federal law require that providers keep and produce as required, specified employee records, including records demonstrating training in a range of areas, including Core Assurances, HIPAA, and Zero Tolerance. Ms. Selwitz testified that if information determined to be missing from a provider's files during a compliance inspection is timely submitted pursuant to the demand letter, the provider is deemed to be in compliance with the applicable record-keeping and document production requirements in state and federal Medicaid law. Here, Petitioner did not notify Respondent that it had determined that certain employee training documentation was missing from its files. Thus, Respondent was not given the opportunity to establish compliance with the record-keeping and document production requirements by timely submitting this documentation in accordance with Petitioner's demand letter. Mr. Orukotan testified that Respondent kept the requested documentation in its employee files and would have provided it, had Petitioner notified Respondent that its inspection determined the documentation was missing. His testimony, which is bolstered by the fact that Respondent did timely submit all information pursuant to the handwritten list provided with the demand letter, is deemed credible and persuasive. As previously noted, Respondent submitted the employee training documentation upon being informed, pursuant to the Sanction Letter, that Petitioner had determined such documentation was missing from its files.6/ Under the present circumstances——where Petitioner failed to afford Respondent an opportunity to demonstrate compliance by timely responding to its demand letter, and where Respondent, when informed of the deficiencies, submitted the requested documentation——the undersigned determines, as a matter of ultimate fact, that Petitioner failed to demonstrate that Respondent violated chapter 409, Petitioner's applicable rules, the DD Handbook, the General Handbook, and federal law, as charged in the January 18, 2012, Sanction Letter.7/
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Agency for Health Care Administration enter a Final Order determining that Respondent did not violate federal and state Medicaid laws as charged in the January 18, 2012 Sanction Letter. DONE AND ENTERED this 2nd day of October, 2012, in Tallahassee, Leon County, Florida. S CATHY M. SELLERS 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 2nd day of October, 2012.
The Issue The issues to be resolved in this proceeding concern whether the Respondent properly maintained and supplied required records to support and document prescription claims, which it billed to Medicaid and for which it received payment from the Medicaid program during the audit period of April 1, 2000 through December 31, 2001. If that is not the case, it must be determined whether the Agency is entitled to recoup from the Respondent the sum it seeks of $108,478.77, as the purported amount overpaid to the Respondent by the Agency. It must also be determined whether the applicable laws and regulations referenced herein were complied with by the Respondent, in terms of its accepting and filling prescriptions, dispensing relevant drugs, and recording and documenting such activities in its pharmacy records. Finally, it must be determined whether the statistical methodologies employed by the Agency, through its audit and investigation of the Respondent, were sufficiently representative and accurate so as to support the calculation of estimated overpayments.
Findings Of Fact The Petitioner is an Agency of the State of Florida charged by the statutes and rules referenced herein with ensuring that proper reimbursement is effected to providers, including pharmacies, by the Medicaid system. Because of its duty to enforce and regulate the Medicaid system, the Petitioner Agency has an audit and oversight function, as well as an enforcement function, to ensure that Medicaid payments and the general operations of the Medicaid system are carried out correctly. It is through this duty imposed by the cited Florida Statutes and rules, as well as the federal regulations it is charged with enforcing, that the Petitioner carried out an audit of the Respondent, Brown Pharmacy, concerning the audit period of April 1, 2000 through December 31, 2001. The Petitioner conducts audits of providers such as Brown in order to ensure compliance with the Medicaid provisions and Medicaid provider agreements. These are called "integrity audits" and are routinely performed by auditors contracted from private firms such as Heritage. Brown Pharmacy (Brown) is licensed in the State of Florida as a pharmacy (license Number PH562). Brown maintained a business location at 312 West 8th Street, Jacksonville, Florida 32206, at times pertinent to this case. During the audit period Brown was an enrolled Medicaid provider authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Agency. The terms of the provider agreement governed the contractual relationship between Brown and the Agency. Pursuant to that provider agreement, Brown was to maintain the Medicaid-related records and documentation for at least five years. Any Medicaid provider, such as Brown, not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. During the audit period, Brown dispensed prescription drugs to Medicaid recipients. Medicaid claims were filed and paid electronically as "point of sale" transactions during the audit period. Each claim reviewed and at issue in this case was a paid Medicaid claim subject to the provider agreement and pertinent regulations. As a condition of participating in the Medicaid program, a Medicaid provider must comply with all provisions of a provider agreement, which is a voluntarily agreement between the Agency and the provider. Those provisions include the provider's agreement to comply with all relevant local, state and federal laws, rules, regulations, licensure laws, bulletins, manuals, and handbooks, etc. The provider must agree to keep and maintain, in a systematic and orderly manner, all Medicaid- related records as may be required by the Agency and make them available for state and federal agencies and review. It must maintain complete and accurate medical, business, and fiscal records that will justify and disclose the extent of goods and services rendered to customers or patients and rendered as billings to the Medicaid system. Florida Administrative Code Rule 59G-4.250 promulgates, as part of the rule, the above-referenced handbook (handbook) which sets out Medicaid polices and rules. The polices and rules govern the rights and responsibilities of drug providers, such as Brown, including coverage and payment methodologies for services and goods rendered to Medicaid recipients and billed to the Medicaid program. The types of records that must be maintained are as follows: Medicaid claim forms, professional records such as patient treatment plans, prior and post authorization information, prescription records, business records, including accounting ledgers, financial statements, purchase and acquisition records etc., tax records, patient counseling information and provider enrollment documentation. Providers who are not in compliance with the Medicaid documentation and record retention policies described in the handbook are subject to administrative sanctions and/or recoupment of Medicaid payments. Medicaid payments for services that lack required documentation and/or appropriate signatures will be recouped. Chapter five of the handbook, in defining overpayment provides that any amount not authorized to be paid by the Medicaid program, whether paid as a result of inaccurate or improper cost reporting, improper claims, unacceptable practices, fraud, abuse or mistake, constitutes overpayment. Incomplete records are records that lack documentation that all requirements or conditions for the providing of services have been met. Medicaid may recoup payments for services or goods when the provider has incomplete records or cannot locate the records. The Agency contracted with Heritage to conduct an on- site audit at Brown. The audit was conducted March 18th through March 20, 2002. Heritage isolated a sample of 205 prescription claims, known as the "judgmental sample" out of a total universe of paid pharmacy claims from Brown totaling 16,727 for the audit period. Heritage also selected 250 random prescription claims out of the remaining total universe of paid pharmacy claims of 16,522, which remained after the 205 judgmental sample claims had been removed or isolated from the remainder of the total claims. With the acquiescence of the Agency, Heritage chose the 205 claims by weighing it in favor of the "high dollar" or more expensive drug prescriptions. Those prescriptions are primarily for HIV and Aids therapy drugs and psychotherapeutic drugs for various mental conditions, including schizophrenia. Weighing of the judgmental sample strongly in favor of the high dollar prescription claims would seem to render the judgmental sample fundamentally unfair against Brown if the judgmental sample had then been extrapolated to the entire universe of claims ($16,727). This was not done, however. The judgmental sample was audited and compiled by doing an actual count and totaling of claim amounts in dollars represented by all the discrepant prescriptions, including all those the Agency and Heritage maintained resulted in "overpayments" to Brown. Therefore, the judgmental sample is an actual number rather than an extrapolated calculation so that weighing the sample in favor of the high dollar prescriptions does not result in an unfair or biased sample, as to the judgmental sample. Because the judgmental sample was drawn from the total pool of audited claims and removed from that claim pool prior to the identification and drawing of the random sample, the two are mutually exclusive and the amounts calculated do not represent a duplication or overlap. Thus the findings from the judgmental sample and then the random sample may be properly added together. The randomly selected claims (random sample) were taken of the remaining 16,522 claims in the audit claim pool after the judgmental sample of 205 claims had been removed. According to the report rendered by Heritage, the 250 randomly selected claims totaled $10,632.59 in paid Medicaid dollars. The Heritage auditors determined that there were 56 discrepant claims out of these which totaled, according to their calculation, $2,450.13 in apparent overpayments. This resulted in an average overcharge per claim of $9.80 (determined by dividing the documented "sanction amount" by the total number of claims in the random sample (250), multiplied by the universe of claims from which the random sample was taken (16,522) which yielded an extrapolated overcharge of $161,924.19. Applying the statistically appropriate 95 percent "one-sided" lower confidence limit of this extrapolation resulted in a purported overpayment extrapolated from the randomly selected claims of $102,700.85. This means that the overpayment amount calculated by Heritage represents an amount statistically 95 percent certain to be the lowest amount overpayment based on the extrapolation of the overpayment represented in the 250 randomly selected claims. The non-extrapolated judgmental findings showed, according to Heritage, that there were 72 discrepant claims. Heritage then determined that, of these, there were $29,381.09 in apparent actual overcharges. The discrepancies determined by Heritage involved the failure to produce documentation of refill authorizations for 80 prescription claims; 31 prescription claims containing an incorrect Medicaid provider number; the failure to produce 12 "hard copy" prescriptions representing 25 claims; four claims that did not have the prescriber's DEA number on the prescription for controlled substances; three claims for prescriptions that did not contain the original date of service; two claims that were billed for quantities greater than that authorized by the physician; one claim that was billed for an incorrect day's supply; one claim that was billed in excess of the maximum allowable quantity of prescription of the drug, set by Medicaid policy; and one prescription claim that was billed for an incorrect prescriber's Medicaid provider number (although this should not be a discrepancy because the correct prescriber was documented in the pharmacy's computer, which the regulations allowed). Additionally, there was one claim billed for a drug different than that prescribed by the physician, according to Heritage in its report. Heritage also conducted an invoice review using utilization reports provided by the Respondent. This was apparently a review of 25 different drugs that purportedly showed that the prorated purchases of those drugs were insufficient to cover the number of units billed to Medicaid for all 25 drugs reviewed, and thus yielded a purported shortage of $87,942.13, representing the amount billed to Medicaid above the amount the records of purchases from suppliers proved that Brown had purchased of those drugs. Based upon the Heritage audit as well as documentation findings and overpayments calculations (see Exhibit 8), the Agency issued a PAAR dated September 27, 2002, determining that Brown had been overpaid $150,036.71 for Medicaid claims during the audit period. That report advised Brown that it was a provisional report only and encouraged Brown to submit any additional information or documentation which might serve to change the overpayment. The report listed examples of documentation that the Agency would consider for a possible reduction in the overpayment amount initially claimed. Thereafter, the Agency agreed to an extension of time for Brown to submit additional documentation and sent a letter to Brown dated October 31, 2003, advising that the audit had been placed in abeyance pending the outcome in a related case, but that the Agency expected to resume the audit and that therefore all Medicaid-related records and documentation regarding paid claims should be maintained and preserved until the audit was finalized. The FAAR was addressed in the testimony of Ms. Stewart for the Agency. Through her testimony it was revealed that certain corrections should be made to the FAAR updating it from the findings in the Heritage initial audit report. The Agency corrected the information in the FAAR for this reason and for the reason that it secured some additional information from the Respondent. Thus, for the audit period it was established that there were 16,727 total claims for prescriptions dispensed by Brown, for which it was paid $795,564.59 during the 21-month audit period, of those claims, 205 were pulled out from the total universe of claims as the judgmental sample. There were some 72 allegedly "discrepant claims" totaling $36,393.51 in dollars paid to Brown. The Agency's position is that $29,381.09 of those are so called "documented overcharges." The random sample of 250 claims was extrapolated to the remaining universe of 16,522 prescription claims. The Agency now takes the position that it found 49 "discrepant claims" in the random sample which totaled $2,154.40 in dollars paid to Brown's pharmacy and of that it maintains that $1,927.55 are "documented overcharges" for the 250 randomly selected claims (for which Brown had been paid $10,632.59). Thus the Agency found an average overcharge for the 250 randomly sampled claims of $7.71 per claim. The $7.71 average per claim overcharge was then multiplied by the remaining universe of 16,522 claims, yielding an extrapolated purported overcharge of $127,387.92. The Agency then applied the 95 percent "one-sided lower confidence limit" to this extrapolation, that is, that it or its statistician, Dr. Johnson, felt that there was a 95 percent chance that the lower confidence limit number it calculated was accurate. That number is $79,097.68. When that number is combined with the Agency's position as to overcharges from the judgmental sample results in a total postulated overcharge of $108,478.77. This is the final amount the Agency claims as an overpayment that must be recouped for Medicaid. The FAAR summarized the discrepant claims for the judgmental sample as follows: 61 claims involve refills which exceeded the authorized number of refills without documentation of reauthorization; 10 claims showed an incorrect prescriber license number but the correct prescriber license number was documented in the pharmacy's computer; and For two claims the hard copy description did not have an original date of service depicted on it and did not reference a DEA number. The discrepant claims shown in the FAAR as to the random sample were as follows: There were 19 claims for refills without documentation of refill authorization (refills had been previously authorized, but for the 19 claims at least one refill had been issued beyond the authorization limit); Fifteen claims showed an incorrect prescriber license number on the claim and the license number was not documented in the Respondent's computer; Seven claims showed an incorrect prescriber license number, but the correct license number was documented in the pharmacy's computer; There were seven claims for which the original hard copy prescriptions could not be found on file during the audit period; For one claim the hard copy prescription did not have an original date of service or DEA number; For one claim the quantity paid exceeded the quantity authorized by the prescriber or dispensed to the recipient; and For one claim the number of days supply submitted by the pharmacy was not consistent with the quantity and directions of the prescriber and the quantity exceeded the limit set by the plan. The most common discrepancies with regard to the judgmental sample and the random sample occurred when the Respondent billed refills in excess of the number authorized by the prescriber, without any written authorization for such being provided in the audit process or later. Concerning the random sample, the second most common discrepancy occurred when the claim depicted an incorrect precriber number on the claim and the license number of the prescriber was not documented in the computer. In the judgmental sample the second most common discrepancy occurred when the claim showed an incorrect prescriber number, but the correct prescriber number was documented in the pharmacy's computer. The discrepancies in the FAAR with the indication "UR", references "unauthorized refills." The records of the pharmacy showed that Brown issued refills of prescriptions to Medicaid recipients in excess of the presriber's limit depicted on the prescriptions but showed no written record of a telephonic or written authorization by the prescriber allowing the additional refill or refills. It is also true that as to some or even many of these the Respondent may have obtained verbal authorization, but failed to document that re- authorization. Medicaid policy, the statutory authority cited herein, and the PDSCLR Handbook provide that all verbal orders authorized by the prescriber of a prescription must be recorded either as a "hard copy" or noted in the pharmacy's computer in order to comply with the relevant law cited herein, for record- keeping and auditing purposes under Medicaid policy. The Agency's Statistical Methodology Mark E. Johnson, Ph.D., testified on behalf of the Petitioner. He was qualified as an expert witness in the area of statistical formulas, statistical methodology, and random sampling, including the random sample statistical methodology employed by the Agency in determining the overpayment amount. He is a professor of statistics at the University of Central Florida. Dr. Johnson reviewed the statistical methodology, numbers and calculations arrived at by the Agency and its extrapolation method of arriving at the overpayment amount. He also used his own independent analysis based upon a software package he commonly uses in the practice of his discipline in testing the methodology employed by the Agency and the random sample employed by the Agency and Heritage. The statistical formula employed by Dr. Johnson and the Agency is a standard one routinely used in Dr. Johnson's profession and statistical sampling. He established through his own testing of the methodology that the random sample was appropriate for Medicaid program integrity audits and determinations as employed in this case. The random sampling, according to Dr. Johnson, was employed because it would be time and cost prohibitive to examine individually each of 16,522 claims regarding overpayment issues. The random sampling methodology using 250 randomly chosen samples is a time and cost saving device and yet still presents a "plausible estimate" as established by Dr. Johnson. He established that for the universe of 16,522 claims which were subjected to the random sample and extrapolation statistical analysis and calculation, that such is a reasonable sample for purposes of this audit and that the 250 random samples employed by the Agency are indeed statistically appropriate random samples. His calculation of overpayment was at variance with the Agency's by 55 cents. He established that is not a significant difference since the 95 percent certainty limit of $79,097.68 for the random sample extrapolation analysis is so much lower than the estimate established at $108,478.22. Dr. Johnson established that the Agency had employed appropriate and valid statistical methods in its determination of the above-referenced overpayment amount based upon the random sample of paid claims. The expert testimony of Dr. Johnson, together with his written report in evidence, is credible and persuasive as to the validity of the random sampling of the claims during the audit period and as to the random sample portion of the analysis employed in arriving at the final overpayment calculation and numbers depicted in the FAAR. Dr. Johnson established the appropriateness of the statistical formula, including extrapolation, used to calculate the overpayment amount, the appropriateness of the sample size relative to the universe of claims, and the improbability that the overpayment amount is attributable to chance causes alone. Thus Dr. Johnson's testimony is accepted as credible and persuasive in establishing the validity of the Agency's method of overpayment calculation, and the overpayment calculation in conjunction with the statistical evidence in this record, except as modified by the findings below.1/ The Respondent's Position Gary Steinberg testified on behalf of the Respondent, Brown Pharmacy. He was accepted as an expert witness in the areas of Medicaid policy, audits and pharmacy practice, including Florida pharmacy practice. Mr. Steinberg acknowledged that Brown had not properly documented all claims that had been paid by the Medicaid program nor maintained all required records. He emphasized in his testimony, however, that Brown had not fraudulently billed the Medicaid program with claims for prescription medications that it had not actually dispensed to the patients or recipients. Rather, all medications involved in the subject prescription claims had actually been dispensed. There is no evidence or claim on the part of the Agency that Brown charged and collected more than the appropriate approved price for the prescriptions at issue. Through the explanation given in his testimony, Mr. Steinberg opined that although Brown was guilty of technical errors in record keeping and documentation as to the prescriptions involved in the subject claims, Brown had made substantial compliance with the Medicaid program requirements of the Medicaid provider agreement and the statutes and rules at issue and policies embodied in the subject handbook. He explained in his testimony that in the pharmacy practice setting in which Brown has operated, whereby it serves a large indigent population in an inner city environment, it is difficult to contact a prescriber at the time when a patient needs a critical prescription refilled in order to get a refill authorization. The prescriptions at issue mostly involve critical medications for HIV/Aids and psychotropic medications for severe mental conditions such as schizophrenia. The patients who need these critical medications (and there are very few patients, since most of the procedures involve filling and refilling for a small number of such recipients) are patients of clinics operated at the nearby university hospital (Shands). In these circumstances, where the patient literally needs the HIV/Aids medication refilled on an immediate basis, possibly even to prevent death, and the mental health patient critically needs a refill in order to prevent harm to the patient or harm to the members of the public if the patient goes without medication and "decompensates," the ethical thing for a pharmacist to do is to refill the prescription and seek authorization later. Mr. Steinberg established that it is often difficult to obtain authorization from the original prescriber since the medication were prescribed by residents practicing in the various clinics at the Shands Hospital and that the residents can not always be identified or contacted easily since they do not maintain a fixed medical practice in the area. Consequently, some of the prescriptions were not documented as to authorization, although in some cases the pharmacy actually obtained authorization and entered it in its computer. In some cases, being unable to obtain re-authorization from the resident who originally prescribed the medication the pharmacy used the DEA license or prescribing number of the hospital itself. He explained that although under the law a pharmacy can refill a prescription on an emergency basis for up to a 72-hour supply, that this is generally impracticable and unsafe for patients in this plight because such indigent, mental health and HIV/Aids patients tend to be non-compliant with their medication regimes quite often anyway, and it is often unreasonable to expect them to return to the pharmacy for another refill within two or three days. He thus opined that the ethical and safe thing for the pharmacist to do was to refill and re-dispense the medical approved medication for up to a 30 or 34-day supply (the normal refill supply duration). He further explained that the Shands Hospital license number was used in some of these circumstances because the resident doctor who originally issued the prescription could not be identified on the Shands Hospital prescription forms and because the resident doctors at the Shands clinics only have and can use Shands Hospital prescription forms in any event. Mr. Steinberg thus established that 35 percent of those prescription claims classified as "WMP," that is the prescription claims contained an incorrect prscriber license number were for these reasons and the pharmacist could only use the Shands Hospital license number because the resident could not be identified from the Shands Hospital prescription forms. He thus opined that 35 percent of the random sample extrapolation amount, the 95 percent statistical confidence limit amount of $79,097.00, should be deleted from that amount in determining the correct amount of overpayment predicated on the random sample. Likewise, with regard to the judgmental sample concerning the HIV/Aids and mental health patient prescriptions and related claims, he opined that, in effect, $19,500.00 of the total $29,381.09 overpayment amount claimed by the Agency pursuant to the judgmental sample portion of the claims, should be deleted from that portion of the overpayment claim by the Agency; this is a result of his explanation regarding "substantial compliance" in the critical refill situation he described concerning the HIV/Aids and mental health patients and their prescription drugs. The preponderant, persuasive evidence does establish (and indeed the Agency acknowledged in its Proposed Recommended Order) with regard to the judgmental sample, that 10 of the claims at issue listed an incorrect prescriber license number, but that the correct prescriber license number was actually documented in the pharmacy's computer record with the name of the prescriber. This circumstances comports with the law referenced below and in the Petitioner's Proposed Recommended Order. This results in a reduction in the overpayment claim with regard to the judgmental sample of 13.88 percent of the judgmental sample claims or a reduction of $4,078.09. Likewise, with regard to the random sample extrapolation calculation of overpaid claims, the preponderant, persuasive evidence, also as acknowledged by the Agency in its Proposed Recommended Order, disclosed that seven claims listed an incorrect prescriber license number on the claims, but had been correctly documented in the pharmacy's computer system and therefore were in compliance with the relevant statutes, rules, and the subject handbook. Thus the discrepant claims and the overpayment amount related to the random sample portion of the audit claims should be reduced by 14.28 percent of the total amount of $79,097.00 for a $11,295.05 reduction of that $79,097.00 random sample overpayment amount. Mr. Steinberg demonstrated that Brown was not overcharging on the drugs prescribed and dispensed and was charging the Medicaid-authorized amount for the drugs involved in the prescription claims at issue. The Agency is not claiming that there was any fraudulent practice or illegal overcharging for the prescriptions involved. In fact, Brown was earning only a very small profit on the drugs dispensed that are the subject of the prescription claims at issue. Mr. Steinberg thus opined that since Brown did indeed dispense all the drugs at issue and was only paid the legal authorized amounts for the drugs and prescriptions at issue that recoupment of the amounts sought by the Agency or, in effect, established in these findings of fact, would be fundamentally unfair. He and the Respondent contend, rather, that since Brown performed substantial compliance, but was guilty of technical non-compliance with the relevant rules, agreement, and Medicaid policy, that the Agency should impose a lesser fine instead of seeking recoupment. In summary, in view of the preponderant persuasive evidence establishing the above facts, it has been shown that the documentation and record-keeping, dispensing errors, and omissions in the manner found above, with regard to the prescription claims and types of claims addressed in the above findings of fact, occurred. If those deficiencies amount to violations of the authority cited and discussed below which justify recoupment, then the amount of overpayment established by the above findings of fact is $93,104.95.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore, RECOMMENDED that a final order be entered by the Agency for Health Care Administration providing for recoupment of $93,104.95, and that the Respondent, Brown Pharmacy, must re-pay that amount to the Petitioner Agency, through a reasonable re- payment plan established between the parties. DONE AND ENTERED this 3rd day of November, 2006, in Tallahassee, Leon County, Florida. S P. MICHAEL RUFF 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 Clerk of the Division of Administrative Hearings this 3rd day of November, 2006.
The Issue The issue for determination is whether Petitioner must reimburse Respondent for payments totaling $1,140,763.88 that Petitioner received from the Medicaid Program in compensation for the provision of prescription drugs between late-August and November of 1998. Respondent contends that Petitioner is not entitled to retain the payments in question because Petitioner allegedly has failed to demonstrate that it had available during the pertinent period a sufficient quantity of the prescription drugs in question.
Findings Of Fact The parties' Joint Stipulation of Facts and the evidence presented at final hearing established the facts that follow. The Parties The Agency for Health Care Administration (the “Agency”) is responsible for administering the Florida Medicaid Program. As one of its duties, the Agency must recover "overpayments . . . as appropriate," the term "overpayment" being statutorily defined to mean "any amount that is not authorized to be paid by the Medicaid program whether paid as a result of inaccurate or improper cost reporting, improper claiming, unacceptable practices, fraud, abuse, or mistake." See Section 409.913(1)(d), Florida Statutes. Palm Beach Pharmacy, Inc. (“PBPI”), d/b/a Eddie’s Drug (“Eddie’s”) was, at all times material hereto, a duly contracted Medicaid provider, having entered into a Medicaid Provider Agreement with the Agency and been assigned a Medicaid Provider Number: 106343000. Eddie’s is a Florida licensed pharmacy.1 As an enrolled Medicaid provider, Eddie’s is authorized to dispense drugs and supplies to Medicaid recipients. In return, Eddie’s has agreed to comply with all governing statutes, rules, and policies, including those policies set forth in the Florida Medicaid Prescribed Drug Services Coverage, Limitations and Reimbursement Handbook (the “Handbook”). The Agency, which prepared the Handbook and furnishes it to Medicaid providers, has incorporated the Handbook by reference into Rule 59G-4.250(2), Florida Administrative Code. PBPI, which owned and operated a number of pharmacies (including Eddie’s), maintained its corporate headquarters in West Palm Beach, Florida. Eddie’s was located in Miami, Florida. On July 1, 1998, PBPI acquired a drug store known as Jay’s Drugs (“Jay’s”). Jay’s was located in Miami, Florida, across the street from Eddie’s. Thus, before both stores came under common ownership, they had been competitors. This case arises out of the Agency's attempt to recover alleged overpayments on Medicaid claims for which Eddie’s was paid several years ago. The "audit period" that is the subject of the Agency's recoupment effort is April 1, 1998 to July 31, 1999, although the actual period in controversy is much shorter. From July 1, 1998, until the end of the audit period, PBPI owned and operated both Eddie’s and Jay’s. The Underlying Facts The transactions at the heart of this case occurred between late-August and November of 1998, during which period (the “Focal Period”) Medicaid reimbursed Eddie’s more than $1 million for prescription drugs including Neupogen and Epogen/Procrit (collectively, the “Drugs”). The Drugs are used to treat AIDS patients and persons infected with HIV. Prior to the Focal Period, Eddie’s had not dispensed $1 million worth of the Drugs——or any figure approaching that amount——in three or four months’ time. The reason for the dramatic spike in Eddie’s business is that Eddie’s was dispensing the Drugs to customers of Jay’s pursuant to an arrangement designed to manipulate PBPI’s contractual obligations to the former owner of Jay’s under the purchase and sale agreement by which PBPI had acquired Jay’s. Essentially, the arrangement was this. Jay’s was dispensing the Drugs to a large number (approximately 150) of Medicaid beneficiaries who were receiving treatment at a nearby clinic. Because the Drugs were administered to the patients via intravenous infusion, the clinic typically obtained the Drugs from Jay’s in bulk. To fill these prescriptions, Jay’s ordered the Drugs from a wholesale supplier, which usually delivered the Drugs to Jay’s the next day. At some point before the Focal Period, arrangements were made to have the clinic present its prescriptions for the Drugs to Eddie’s rather than Jay’s.2 The evidence does not show, exactly, how this was accomplished, but whatever the means, the clinic abruptly began bringing prescriptions for the Drugs to Eddie’s.3 This diversion of Jay’s’ business to Eddie’s was intended to deprive Jay’s of Medicaid reimbursements to which Jay’s’ former owner had access as a source of funds for paying down a note that PBPI had given for the purchase of Jay’s. By having Eddie’s dispense the Drugs and submit the Medicaid claims, Medicaid money flowed into Eddie’s’ bank account (rather than Jay’s’ bank account) and hence was not immediately available to the former owner of Jay’s to reduce PBPI’s debt. During the Focal Period, Eddie’s did not purchase the Drugs from a wholesaler but instead acquired them from Jay’s. The process by which this was accomplished involved a pharmacy technician named Wright, who was employed at Eddie’s, and a pharmacist named Shafor, who worked at Jay’s. Wright (at Eddie’s) accepted the prescriptions for the Drugs as the clinic brought them in Then, she called Shafor (at Jay’s) and told him the quantities needed to fill the prescriptions. Shafor ordered the Drugs from a wholesaler, which delivered them in bulk to Jay’s, usually the next day. Upon receiving the Drugs, Shafor personally delivered them to Wright, who, recall, was across the street at Eddie’s. Wright labeled and dispensed the Drugs. Eddie’s submitted a claim for the Drugs to Medicaid, and Medicaid paid Eddie’s. PBPI maintained separate accounting ledgers for Eddie’s and Jay’s, respectively. The company’s accountants recorded the subject transactions in these ledgers so that Jay’s——not Eddie’s——would “recognize” the sales of the Drugs. In a nutshell, this was done through “inter-company” transfers whereby all of the money that Eddie’s received from Medicaid for the Drugs was moved, on the books, into an account of Jay’s. In this way, any profit from the sales of the Drugs (the difference between the wholesale cost of the Drugs and the Medicaid reimbursement therefor, less overhead) was realized on Jay’s’ books.4 The Medicaid payments to Eddie’s that the Agency seeks to recoup were included in four remittance vouchers dated September 2, 1998; September 30, 1998; October 28, 1998; and November 25, 1998, respectively. The September 2 payment to Eddie’s totaled $287,205.52. Of this amount, $276,033.23 reimbursed Eddie’s for dispensing the Drugs. Eddie’s’ accounting ledger reflects that, as of September 30, 1998, the sum of $276,033.23 had been transferred from an account of Eddie’s to an account of Jay’s. The September 30 payment to Eddie’s totaled $439,175.77, of which $432,700.36 was paid in consideration of the Drugs. The October 28 Medicaid payment was $431,753.82, of which total the Drugs accounted for $424,202.76. Eddie’s’ accounting ledger reflects that, as of October 31, 1998, the sum of $870,929.59 (439,175.77 + 431,753.82) had been transferred from an account of Eddie’s to an account of Jay’s. The November 25 payment to Eddie’s totaled $407,088.00. Of this amount, $393,063.00 reimbursed Eddie’s for dispensing the Drugs. Eddie’s’ accounting ledger reflects that, as of November 30, 1998, the sum of $407,088.00 had been transferred from an account of Eddie’s to an account of Jay’s. The Agency’s Allegations On October 31, 2000, the Agency issued its Final Agency Audit Report (“Audit”) in which Eddie’s was alleged to have received $1,143,612.68 in overpayments relating to the Drugs. In the Audit, the Agency spelled out its theory of the case; indeed, the Audit is the only document in the record that does so. The Agency cited several statutory provisions. First, Section 409.913(7)(e), Florida Statutes, was referenced. This section states: When presenting a claim for payment under the Medicaid program, a provider has an affirmative duty to supervise the provision of, and be responsible for, goods and services claimed to have been provided, to supervise and be responsible for preparation and submission of the claim, and to present a claim that is true and accurate and that is for goods and services that: * * * (e) Are provided in accord with applicable provisions of all Medicaid rules, regulations, handbooks, and policies and in accordance with federal, state, and local law. Section 409.913(7)(e), Florida Statutes. The Agency did not allege (or prove), however, that Eddie’s had violated Section 409.913(7)(e), Florida Statutes.5 Put another way, the Agency did not plead or prove lack of supervision, submission of a false claim, or that the Drugs were not provided in accordance with applicable law. Next, the Agency cited Section 409.913(8), Florida Statutes, which provides: A Medicaid provider shall retain medical, professional, financial, and business records pertaining to services and goods furnished to a Medicaid recipient and billed to Medicaid for a period of 5 years after the date of furnishing such services or goods. The agency may investigate, review, or analyze such records, which must be made available during normal business hours. However, 24-hour notice must be provided if patient treatment would be disrupted. The provider is responsible for furnishing to the agency, and keeping the agency informed of the location of, the provider's Medicaid- related records. The authority of the agency to obtain Medicaid-related records from a provider is neither curtailed nor limited during a period of litigation between the agency and the provider. The Agency further alleged, as fact, that Eddie’s had failed, upon request, “to submit invoices from [its] suppliers to substantiate the availability of drugs that [were] billed to Medicaid” and thus had not “fully substantiated such availability.” The Agency, however, did not invoke any of the available remedial provisions as authority to impose a sanction for this alleged failure to turn over Medicaid-related records. See, e.g., Sections 409.913(14)(b), (c), and (d), Florida Statutes. The Agency cited Section 409.913(10), Florida Statutes, which authorizes the Agency to “require repayment for inappropriate, medically unnecessary, or excessive goods or services from the person furnishing them, the person under whose supervision they were furnished, or the person causing them to be furnished.” There was no allegation (or proof), however, that the Drugs which Eddie’s had purported to dispense (i.e. the Drugs for which it had submitted Medicaid claims) were “inappropriate, medically unnecessary, or excessive.” Thus, Eddie’s was not alleged (or shown) to have violated Section 409.913(10), Florida Statutes. Finally, the Agency relied upon Section 409.913(14)(n), Florida Statutes, which is the basis of the Agency’s legal theory. This section provides: The agency may seek any remedy provided by law, including, but not limited to, the remedies provided in subsections (12) and (15) and s. 812.035, if: * * * (n) The provider fails to demonstrate that it had available during a specific audit or review period sufficient quantities of goods, or sufficient time in the case of services, to support the provider's billings to the Medicaid program[.] The Agency contended, additionally, that “[b]illing Medicaid for drugs that have not been demonstrated as available for dispensing is a violation of the Medicaid laws and regulations and has resulted in the finding that [Eddie’s] ha[s] been overpaid by the Medicaid program.” (Emphasis added). The Agency explained, “Medicaid payments that have been substantiated by documented inventory are assumed to be valid; and payments in excess of that amount are regarded to be invalid.” Thus, the Agency’s theory of recovery is that Eddie’s must forfeit “overpayments” arising from its failure to demonstrate the availability, in inventory, of a sufficient quantity of the Drugs for which claims were submitted, as required by Section 409.913(14)(n), Florida Statutes. After the Audit was issued, the Agency accepted a handwritten note regarding the transfer of a small quantity of Drugs from Jay’s to Eddie’s as sufficient to demonstrate the availability of such amount. This resulted in a slight reduction of the amount of the alleged overpayment, to $1,140,763.88. The Separate Audit of Jay’s The Agency conducted a separate audit of Jay’s, concerning which some evidence was introduced at hearing. Without getting into unnecessary detail, the audit of Jay’s revealed that Jay’s had purchased, during and around the Focal Period, a quantity of the Drugs that exceeded the number of units that Jay’s had billed to Medicaid. It was Eddie’s theory that this “excess inventory” of Jay’s matched, more or less, the alleged inventory shortfall at Eddie’s, thereby corroborating the testimony concerning the transfer of these Drugs from Jay’s to Eddie’s for dispensation. At hearing, the parties sharply disputed whether, in fact, Jay’s had transferred the Drugs to Eddie’s. The Agency, of course, maintained that such transfers were not properly documented; Eddie’s argued that the documents and other evidence, including testimony about the transactions in question, adequately demonstrated that the transfers had, in fact, occurred. There was no dispute, however, that if it were found that such transfers had occurred, and if, further, the documents (and other evidence) pertaining to the inventory of Jay’s were accepted as proof of the quantities of Drugs so transferred, then all but $176,078.30 worth of the Drugs could be accounted for. Thus, as counsel for Eddie’s conceded at hearing, the Agency is entitled to recoup some sum of money. The question is whether that sum is $1,140,763.88 or $176,078.30. Ultimate Factual Determination Based on all of the evidence in the record, including the deposition testimony received through the parties’ joint stipulation, it is determined that, more likely than not, Eddie’s had available during the Focal Period a sufficient quantity of the Drugs to support all but $176,078.30 worth of the claims in dispute.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order requiring Eddie’s to repay the Agency the principal amount of $176,078.30. DONE AND ENTERED this 12th day of March, 2002, in Tallahassee, Leon County, Florida. JOHN G. VAN LANINGHAM 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 12th day of March, 2002.
