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 issue in this case is whether the provider, Orietta Medical Equipment, Inc., d/b/a Pharmco Pharmacy (Respondent or Provider) should repay an alleged Medicaid overpayment and, if so, in what amount. The Petitioner’s Final Agency Audit Report (FAAR) claims the Provider must repay $486,879.06.
Findings Of Fact The Petitioner is the state agency charged with the responsibility of administering the Medicaid Program in Florida. As such, the Petitioner monitors payments to Medicaid providers and seeks to recover reimbursements when an overpayment is claimed. At all times material to the allegations of this case, the Respondent was a licensed pharmacy and was designated a “provider” of Medicaid pharmacy services pursuant to its provider agreement with the Petitioner. As a provider of Medicaid pharmacy services, the Respondent was authorized to dispense drugs to Medicaid recipients and to bill the Medicaid Program for the expenses associated with such pharmacy services. The Petitioner may, after-the-fact, seek to verify the claims paid for Medicaid recipients. This “pay and chase” methodology presumes that the Provider will maintain appropriate documentation to support the paid claims. When the Agency audits a provider, records supporting the claims paid must be produced. In this case, the Petitioner elected to perform an “invoice audit” for the audit period June 2, 2003 through May 28, 2004. The Agency sought to review the Provider’s drug acquisition records for the same drugs that were dispensed to Medicaid recipients. The paid claims should compare to the drugs acquired and held in inventory for the subject period of time. After performing a Provisional Agency Audit Report (PAAR) detailing an alleged overpayment, the Provider was notified of the audit results and was provided a spreadsheet of the work papers that detailed the overpayment claim. The Provider was given an opportunity to provide additional documentation to support the Medicaid claims and to establish the inventory to support its claims. After an additional review of the Provider's information, the Agency issued its FAAR dated February 2, 2005, which claimed a Medicaid overpayment in the amount of $486,879.06. This amount has not been repaid to the Petitioner. Instead, the Provider disputed the amount of the overpayment and requested an administrative proceeding. That request was timely submitted. All of the audit results were provided to the Provider at the time of the issuance of the FAAR and were, in fact, attached to the request for hearing submitted by the Provider on or about February 7, 2005. Florida Medicaid providers are required by their agreements with the state to comply with the Florida Medicaid Prescribed Drug Services Coverage, Limitations, and Reimbursement Handbook (the handbook). The handbook is furnished to providers and is also available on-line. The handbook outlines requirements for record keeping, as well as other pertinent information to assist providers. In this case, the Provider was obligated to maintain records to support the Medicaid claims paid by the State. The Agency contracted with Heritage Information Systems, Inc., to conduct the audit in this case. Auditors went to the Provider’s business location in Hialeah, Florida, to analyze the Respondent’s business records. More specifically, the auditors sought the records from the Provider to show that it had acquired sufficient inventory of the specific drugs for which claims had been paid during the audit period. It stands to reason that the drug inventory on hand for the Provider had to exceed the drugs dispensed during the audit period (presumably some of the Provider’s patients were not Medicaid recipients). In fact, in this case, the Provider could not produce inventory records to support the claims paid for the audit period. As the records did not support the claims, the Agency deemed the claims to be overpayments. As such, the Agency maintains the Provider was, under the terms of the guidelines set forth in the handbook, required to reimburse the Petitioner for the overpayment. To compute the overpayment the Agency used a methodology that established the use rate of the product for the audit period. For example, for the drug Acetylcysteine the Medicaid recipient use rate for the audit period was 97.27 percent. Applying this percentage to the units purchased for the audit period would establish the expected claims. Therefore, since the Respondent purchased 16,890 units of this drug, the number of units billed would be expected to be 97.27 percent (the Medicaid use rate) of that amount. Instead, the claims for this drug for the audit period totaled 96,120-- a difference of 79,691 units. The difference (79,691) must then be multiplied by the drug's $.56 cost to show an apparent overcharge in the amount of $44,626.96 for this drug. The Agency applied the same methodology described above for 20 different drugs that were billed during the audit period. The total overcharge for these drugs was $486,879.06. The Respondent presented no evidence to refute the audit findings. No acquisition records were produced to reduce the calculated overpayment. That is to say, no purchase records could demonstrate that the Provider had on hand the number of units of the drugs billed to Medicaid. The Respondent has not disputed that the pharmacy was a provider, was subject to the handbook and pertinent guidelines, was required to maintain records to support the claims, and was paid for claims submitted to the Agency. Moreover, the Respondent does not dispute that the audit, the audit work papers, and the spreadsheets describing the methodology used to compute the overpayment were provided to the Provider more than 14 days prior to the hearing. It claims the trial book of exhibits was not provided 14 days prior to the hearing date. The hearing in this cause was originally scheduled for two days, to commence on August 15, 2006. The Agency provided a trial book of its exhibits to the Respondent on or about 4:00 p.m., August 1, 2006. The Respondent maintains that all evidence presented by the Agency in this cause must be excluded pursuant to Section 409.913(22), Florida Statutes (2005).
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 sustaining the Medicaid overpayment in the amount of $486,879.06. DONE AND ENTERED this 1st day of December, 2006, in Tallahassee, Leon County, Florida. S 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 December, 2006. COPIES FURNISHED: Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Christa Calamas, Secretary Agency for Health Care Administration Fort Knox Building, Suite 3116 2727 Mahan Drive Tallahassee, Florida 32308 David W. Nam, Esquire Agency for Health Care Administration Fort Knox Building, Mail Station 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308 William M. Furlow, III, Esquire Akerman Senterfitt Highpoint Center, Suite 1200 106 East College Avenue Tallahassee, Florida 32301
The Issue Whether Petitioner was overpaid by the Florida Medicaid Program and, if so, the amount of the overpayment.
Findings Of Fact At all times material to this proceeding, Respondent has been the state agency charged with responsibility for overseeing the Florida Medicaid Program, including the recovery of overpayments to Medicaid providers pursuant to Section 409.913, Florida Statutes. At all times material to this proceeding, Petitioner was an authorized Medicaid provider, having been issued provider number 377290000. Petitioner had valid Medicaid Provider Agreements with the Agency for Health Care Administration (AHCA) during the Audit Period, which began on January 1, 1996, and ended on May 10, 1999. Petitioner graduated from the University of Puerto Rico School of Medicine in 1987, did an internship at Tulane University, did a residency in internal medicine at Eastern Virginia Graduate Medical School, and did a fellowship in hematology at Washington Hospital Center. He served as Chief of Hematology for Kessler Medical Center in Biloxi, Mississippi, while serving in the United States Air Force (with the rank of major). At the time of the final hearing, Petitioner was licensed to practice medicine in Florida, Virginia, Puerto Rico, and Washington, D.C. At the time of the final hearing, Petitioner was employed by the National Institutes of Health (NIH) as a Medical Officer, Health Scientist Administrator. Petitioner served as an advisor to the director of the NIH on issues related to HIV (human immunodeficiency virus) and AIDS (acquired immunodeficiency syndrome). Petitioner’s specialty is internal medicine with a sub- specialty in hematology. Petitioner has extensive experience treating persons suffering with HIV and AIDS dating back to 1987. Pursuant to his Medicaid Provider Agreements, Petitioner agreed to: (1) retain for five years complete and accurate medical records that fully justify and disclose the extent of the services rendered and billings made under the Medicaid program; (2) bill Medicaid only for services or goods that are medically necessary; and (3) abide by the Florida Administrative Code, Florida Statutes, policies, procedures, manuals of the Florida Medicaid Program and Federal laws and regulations. Respondent audited Petitioner’s Medicaid claims during the Audit Period and conducted a peer review of Petitioner’s billings and medical records of 25 of Petitioner’s patients as part of that audit.2 Joseph W. Shands, M.D., conducted the peer review of the documentation provided by Petitioner for purposes of the audit conducted by AHCA. Dr. Shands first reviewed documentation provided by Petitioner in 1999. He had no further participation in the audit until he reviewed information in preparation for his deposition in this proceeding. Dr. Shands graduated from medical school in 1956, trained in internal medicine, and worked as a microbiologist for approximately 15 years. He served as Chief of Infectious Diseases at the University of Florida for 23 years and also treated patients through the Alachua County Public Health Department and Shands Hospital at the University of Florida. Dr. Shands' practice was devoted almost entirely to the treatment of patients diagnosed with HIV/AIDS. Dr. Shands retired from the practice of medicine in May 2002. For three years prior to his retirement, Dr. Shands practiced medicine part-time. Petitioner was sent a Preliminary Agency Audit Report (PAAR) dated May 25, 1999, that found an overpayment in the amount of $862,576.72. In response to that PAAR, Petitioner had the attorney representing him at that time respond to AHCA in writing. The letter from the attorney, dated June 2, 1999, requested a copy of AHCA’s supporting materials and clarification of certain matters. AHCA did not respond. AHCA issued its FAAR on January 22, 2004, asserting that Petitioner was overpaid by the Florida Medicaid Program in the total amount of $261,336.14 for services that in whole or in part were not covered by Medicaid. There was no plausible explanation why the FAAR was not issued until 2004, whereas the audit period ended in 1999. The difference between the amount of the alleged overpayment reflected by the PAAR and the amount of the alleged overpayment reflected by the FAAR is attributable to the use of different methodologies in calculating the amounts overpaid. The FAAR used the correct methodology that was not challenged by Petitioner. The FAAR sets forth five categories of alleged overpayments. Each category accurately describes an overpayment based on applicable Medicaid billing criteria. The five categories are as follows: Medicaid policy specifies how medical records must be maintained. A review of your medical records revealed that some service for which you billed and received payment were not documented. Medicaid requires documentation of the services and considers payments made for services not appropriately documented an overpayment. (For ease of reference, this will be referred to as Category I.) Medicaid policy defines the varying levels of care and expertise required for the evaluation and management procedure codes for office visits. The documentation you provided supports a lower level of office visit than the one for which you billed and received payment. The difference between the amount you were paid and the correct payment for the appropriate level of service is considered an overpayment. (For ease of reference, this will be referred to as Category II.) Medicaid policy addresses the type of pathology services covered by Medicaid. You billed and received payment for laboratory tests that were performed outside your facility by an independent laboratory. Payments made to you in these instances are considered overpayments. (For ease of reference, this will be referred to as Category III.) Medicaid policy requires the Medicaid services be provided by or under the personal supervision of a physician. Personal supervision is defined as the physician being in the building when the services are rendered and signing and dating the medical records within twenty-four hours of service delivery. You billed and received payment for services which your medical records reflect you neither personally provided nor supervised. Payment made to you for all or a part of those services is considered an overpayment. (For ease of reference, this will be referred to as Category IV.) Medicaid policy requires services performed be medically necessary for the diagnosis and treatment of an illness. You billed and received payments for services for which the medical records, when reviewed by a Medicaid physician consultant, indicated that the services provided did not meet the Medicaid criteria for medical necessity. The claims which were considered medically unnecessary were disallowed and the money you were paid for these procedures is considered an overpayment. (For ease of reference, this will be referred to as Category V.) CATEGORY I CLAIMS The disputed Category I claims can be separated into two subcategories: services performed while an employee of a corporate employer and services performed while a recipient was hospitalized. As to both subcategories Petitioner argues that he has been prejudiced by Respondent’s delay in issuing the FAAR because Medicaid requires providers to retain medical records only for five years from the date of service.3 Although Respondent was dilatory in prosecuting this matter, Petitioner’s argument that Respondent should be barred (presumably on equitable grounds such as the doctrine of laches) should be rejected. Petitioner has cited no case law in support of his contention, and it is clear that any equitable relief to which Petitioner may be entitled should come from a court of competent jurisdiction, not from this forum or from an administrative agency. All billings for which there are no medical records justifying the services rendered should be denied. CATEGORY II CLAIMS The following findings as to the Category II claims are based on the testimony of the witnesses and on the information contained in the exhibits.4 Although nothing in the record prior to the final hearing reflects that position, Petitioner did not dispute most of the down-codings at the final hearing. Office visits, whether supported by a doctor’s note or a nurse’s note, for the sole purpose of administering IVIG treatment, will be discussed in the section of this Recommended Order dealing with Category V claims. The office visits, which were for the purpose of intravenous immunoglobulin (IVIG) treatment and for other reimbursable medical services, are set forth as part of the Category II disputes. The following findings resolve the Category II disputes. The date listed is the date the service was rendered. The billing code following the date is the billing code that is supported by the greater weight of the evidence. Recipient 1:5 01-20-98 99213 Recipient 2 09-27-96 99214 10-10-96 99213 11-13-96 99214 12-23-96 99212 02-24-97 99214 04-21-97 99213 04-28-97 99214 05-21-97 99213 06-02-97 99213 07-09-97 99213 07-23-97 99212 08-06-97 99213 08-11-97 99212 10-01-97 99213 10-10-97 99213 10-15-97 99214 10-21-97 99214 11-10-97 99213 12-08-97 99213 12-17-97 99213 12-29-97 99213 01-21-98 99213 Recipient 3 10-21-97 99213 11-04-97 99213 11-25-97 99213 12-16-97 99213 01-27-98 99214 02-26-98 99214 Recipient 4 01-03-98 99254 01-04-98 99261 01-05-98 99261 Recipient 5 09-29-97 99204 Recipient 6 11-11-97 99204 11-18-97 99213 Recipient 7 01-26-98 99204 02-23-98 99213 Recipient 8 09-26-96 99214 09-30-96 99213 10-03-96 99213 10-10-96 99212 10-25-96 99214 11-29-96 99213 12-04-96 99213 12-30-96 99213 01-22-97 99214 01-31-97 99211 02-14-97 99212 03-17-97 99214 04-04-97 99213 04-25-97 99212 05-30-97 99211 07-11-97 99213 08-08-97 99213 08-22-97 99213 09-05-97 99212 09-19-97 99214 10-31-97 99214 11-24-97 99214 12-03-97 99213 12-29-97 99213 01-09-98 99214 01-16-98 99213 01-30-98 99214 02-13-98 99214 Recipient 9 11-24-97 99203 Recipient 10 10-14-96 99205 11-04-96 99213 11-11-96 99213 11-25-96 99214 12-30-96 99213 01-27-97 99214 02-24-97 99214 03-10-97 99213 03-24-97 99212 04-07-97 99213 04-21-97 99214 05-05-97 99212 05-19-97 99213 05-21-97 Deny 06-09-97 99213 07-07-97 99212 08-04-97 99213 08-18-97 99213 09-24-97 992136 10-06-97 99213 10-10-97 99214 10-27-97 99213 11-10-97 99213 11-19-97 99214 11-24-97 99213 12-08-97 99213 02-02-98 99213 Recipient 11 06-30-97 99204 11-06-97 Recipient 12 Deny due to lack of documentation. 10-14-97 99213 11-06-97 99204 11-20-97 99213 12-16-97 99213 01-06-98 99213 Recipient 13 There are no Category II billings at issue for this Recipient. Recipient 14 There are no Category II billings at issue for this Recipient. Recipient 15 09-16-97 992157 Recipient 16 02-19-98 99212 Recipient 17 There are no Category II billings at issue for this Recipient. Recipient 18 There are no Category II billings at issue for this Recipient. Recipient 19 09-27-96 99212 10-01-96 99213 10-10-96 99213 10-23-96 99213 11-06-96 99213 11-20-96 99213 12-18-96 99211 12-30-96 Deny due to lack of 01-09-97 documentation. Deny due to lack of 01-22-97 documentation. 99211 02-05-97 99214 03-05-97 99214 03-19-97 99211 03-24-97 99214 03-26-97 04-02-97 Deny due to lack documentation. 99213 of 04-21-97 99213 05-05-97 99212 05-19-97 99213 06-02-97 99212 06-30-97 99213 07-07-97 99213 07-14-97 99213 07-28-97 99212 08-18-97 99213 08-25-97 99213 09-08-97 99213 09-15-97 99214 09-22-97 99213 10-28-97 99214 11-04-97 11-07-97 Deny due to lack documentation. 99213 of 11-24-97 99213 12-29-97 99213 01-12-98 99213 01-26-98 99213 02-19-98 99214 02-23-98 99213 Recipient 20 12-04-96 99204 12-13-96 99213 01-03-97 99213 01-17-97 99213 01-27-97 99213 02-07-97 99214 02-21-97 99213 03-07-97 99214 03-21-97 99212 04-04-97 99214 04-21-97 99212 05-06-97 99213 06-04-97 99213 06-13-97 99213 06-30-97 99213 07-14-97 99213 08-04-97 99213 01-19-98 99213 Recipient 21 04-29-97 99204 05-13-97 99214 05-16-97 99213 05-23-97 99212 06-09-97 99212 06-23-97 99212 07-11-97 99211 07-25-97 99213 08-11-97 99213 09-10-97 99213 11-05-97 99214 11-19-97 99213 12-22-97 99213 01-07-98 99214 01-21-98 99213 02-04-98 99213 Recipient 22 02-16-98 99205 02-20-98 99213 02-23-98 99213 Recipient 23 06-23-97 99215 10-02-97 992138 Recipient 24 There are no Category II billings at issue for this Recipient. Recipient 25 01-24-97 99213 02-07-97 99213 02-24-97 99212 03-10-97 99213 03-24-97 99212 05-05-97 99212 05-19-97 99212 06-02-97 99212 06-16-97 99212 07-14-97 99213 07-23-97 99212 07-28-97 99213 08-18-97 99213 08-25-97 99213 09-15-97 99213 10-01-97 99213 10-13-97 99213 10-27-97 99214 12-08-97 99213 12-22-97 99213 12-29-97 99213 01-13-98 99212 01-19-98 99214 02-02-98 99212 CATEGORY III As set forth in the Physician Coverage and Limitation Handbook (Respondent’s Exhibit 6), Petitioner is not entitled to billings for laboratory tests that were performed outside his facility by an independent laboratory. The only billing arguably in Category III is the billing for Recipient 1 on February 19, 1998. That billing should have been approved because it was for a urinalysis by dip stick or tablet that was administered and analyzed by Petitioner. It was not analyzed by an independent laboratory. CATEGORY IV All Category IV billings pertained to Petitioner’s supervision of his staff while patients were receiving treatments of IVIG. Those billings will be subsumed in the Category V billings discussion. CATEGORY V The alleged Category V overpayments relate to Petitioner’s IVIG treatment of Patients 2, 8, 10, 19, 20, 21, and 25, each of whom was an adult diagnosed with AIDS. In many of these cases a nurse administered the IVIG treatment. A dispute as to whether Petitioner properly supervised the nurse while he or she administered the IVIG treatment is moot because of the findings pertaining to the IVIG treatments set forth in Paragraphs 20 and 21. The Physician Coverage and Limitations Handbook requires that rendered services be medically necessary, as follows: Medicaid reimburses for services that are determined medically necessary and do not duplicate another provider’s service. In addition, the services must meet the following criteria: the services must be individualized, specific, consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the recipient’s needs; the services cannot be experimental or investigational; the services must reflect the level of services that can be safely furnished, and for which no equally effective and more conservative or less costly treatment is available statewide; and the services must be furnished in a manner not primarily intended for the convenience of the recipient, the recipient’s caretaker, or the provider. The use of IVIG in adult AIDS patients is not approved by the Federal Drug Administration (FDA). The use of a drug for a purpose other than the uses approved by the FDA is referred to as an “off-label” use. The off-label use of IVIG in adult AIDS patients is not effective either from a medical standpoint or from an economic standpoint. There was a conflict in the evidence as to whether any of the Recipients at issue in this proceeding had a medical condition or conditions other than AIDS that would justify the IVIG treatment administered by Petitioner. The following finding resolves that conflict. Utilizing applicable Medicaid billing criteria, the medical records produced by Petitioner fail to document that any of the Recipients at issue in this proceeding had a medical condition or conditions that warranted treatment with IVIG.9 All of Petitioner’s billings for IVIG treatments for Recipients 2, 8, 10, 19, 20, 21, and 25 were properly denied under the rationale of the FAAR’s Category V. Included in the billings that were properly denied were billings for office visits (whether documented by a doctor’s note or a nurse’s note) when the sole purpose of the office visit was the administration of an IVIG treatment.
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 adopting the Findings of Fact and Conclusions of Law set forth in this Recommended Order. It is further RECOMMENDED that the Final Order require that Petitioner repay the sum of the overpayment as determined by Respondent’s staff based on the Findings of Fact set forth in this Recommended Order. DONE AND ENTERED this 20th day of January, 2005, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON 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 20th day of January, 2005.
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 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 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.
Findings Of Fact Petitioner is a pharmacist doing business as Dyal's Pharmacy in Daytona Beach, Florida. Petitioner is a Medicaid provider under the rules of the Respondent, operating under Provider No. 1018147. Respondent is a department of the State of Florida, with its principal office in Tallahassee, Leon County, Florida. Respondent is designated as the state agency responsible for the administration of Medicaid funds, and is authorized to provide payments for medical services, pursuant to Section 409.266, Florida Statutes. Pursuant to his responsibilities as a Medicaid provider and a pharmacist, Petitioner has, during the period of March, 1982, through August, 1983, filled 43 prescriptions for nonsteroidal anti-arthritic drugs other than buffered aspirin, which did not have the words "medically necessary" written on the prescription form by the prescribing physician in his own handwriting. Petitioner filed claims with Respondent with regard to the aforementioned prescriptions, and Respondent paid $854.44 to Petitioner as reimbursement. By letter received by Petitioner on December 27, 1983, Respondent has notified Petitioner of its intention to seek repayment of that amount pursuant to Rule 10C- 7.42(4)(b), Florida Administrative Cede. Rule 10C-7.42, Florida Administrative Code, provides, in pertinent part, as follows: (4) Covered Benefits * * * (b) All prescriptions for buffered or enteric coated aspirin must indicate that an arthritic condition is being treated and dispensed in quantities no less than 200. Any nonsteroidal anti-arthritic drug, other than buffered aspirin, must have `medically necessary' written on the prescription by the practioner in his own handwriting. Noncompliance will warrant recoupment. Petitioner has sought an informal hearing regarding Respondent's attempt to recoup amounts previously paid to Petitioner, but in light of the provisions of the challenged rule it is unlikely that he can prevail. The existence of Rule 10C- 7.42(4)(b) is the only basis upon which repayment could be demanded by Respondent from Petitioner. The Florida Medicaid Program is administered through Respondent. In order to receive federal matching funds, Respondent must implement certain mandatory services for indigent. Other services which may qualify for federal funds are optional, and the state may cheese not to implement those programs. The pharmacy program, which this rule purports to regulate, is one such optional service which the State of Florida has chosen to implement. Funds utilized in the Medicaid Program are controlled by the legislature through funding of Respondent's budget. To regulate its budget, Respondent regularly reviews utilization and implements cost containment in various program. In 1981, Respondent was required to reduce its budget, and approximately $2 million of that reduction was required to be made in the Medicaid Program. In considering various options to reduce the Medicaid budget by this amount, the Department reviewed the pharmacy program budget which is the third largest in the Medicaid Program. Options such as limiting the number of prescriptions and requiring full payment were considered since these options had been implemented in other states. Such restrictions were not initiated, however, because Respondent felt that the large elderly population in Florida would forego taking necessary medication and endanger their health. Specific medications which were being paid for through the prescribed drug program were reviewed and certain drugs were eliminated from reimbursement under the program when prescribed for specified reasons, and other drugs were eliminated completely. These categories eliminated were chosen which would have the least detrimental effect on recipients. Additionally, Respondent, in consultation with physicians and pharmacists, considered the use of nonsteroidal anti-inflammatory drugs for the treatment of arthritis. While the drug of choice for treatment of arthritis is aspirin, because it is more effective than most nonsteroidal anti-arthritics, these nonsteroidal anti-arthritic drugs may be necessary for some patients who can't take aspirin. The number of persons who require such drugs instead of aspirin is small, however, and would not justify the large percentage of prescriptions for the nonsteroidal anti-arthritics which Respondent had observed through administering the pharmacy program. Because of their relatively high cost, nonsteroidal anti-arthritic drugs were accounting for 9.6 percent of the pharmacy program budget. Instead of eliminating the entire category of nonsteroidal anti- arthritic drugs from reimbursement under the program, which some states have implemented, Respondent opted to add aspirin to the list of covered benefits when prescribed for arthritis, and to require that the term "medically necessary" be written by the physician on the prescription form for nonsteroidal anti- arthritic drugs in order to be eligible for Medicaid reimbursement. This procedure was initiated in an effort to direct physicians' attention to the cost differential between the two types of drugs to ensure that a physician was making a conscious decision when prescribing the more expensive nonsteroidal anti-arthritic medication. The term "medically necessary" was chosen because physicians were familiar with that phrase through its use under the Florida Generic Drug statute. In response to an inquiry from the Florida Medical Association concerning the use of the term "medically necessary, Respondent indicated to that group that the term "drug of choice" would be an acceptable alternative. The challenged rule had not been amended at the time of final hearing in this cause to reflect this alternative term, nor was there any indication of record that any group other than the Florida Medical Association had been notified of Respondent's policy choice in this regard.
