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.
The Issue Whether Petitioner failed to maintain required records to support and document Medicaid prescription claims paid by the Medicaid program for the audit period (June 24, 1998, to June 1, 2000). If so, whether Petitioner received overpayments from the Medicaid program. If so, whether extrapolation was appropriately used to determine the amount of that overpayment (alleged by Respondent to be $1,053,137.49).
Findings Of Fact PETITIONER At all times relevant to the allegations of this case, the Petitioner was licensed pursuant to Chapter 465, Florida Statutes, to provide pharmacy services in Florida with pharmacy license number PH0012223. At all times relevant to this proceeding, Petitioner was an authorized Medicaid provider with provider number 102126500. At all times relevant to this proceeding, Petitioner had a valid Medicaid Provider Agreement with Respondent. During the audit period, Petitioner provided pharmacy services to Medicaid recipients and billed those services to the Medicaid program under its Medicaid provider number. Specifically Petitioner sold or dispensed drugs to Medicaid recipients who resided in nursing homes. Petitioner operated solely to serve nursing home populations. Petitioner usually received pharmacy orders by telephone or facsimile transmission from a nursing home. Typically, the staff at Petitioner’s facility would take the call or receive the facsimile transmission, write down the pertinent information, enter the data into the pharmacy’s computer system, dispense the item, and route the drugs to the nursing home via courier. All drugs are dispensed in sealed containers and are delivered with a manifest listing all the medications by name and patient. Jerry Kelly, a pharmacist employed by Petitioner’s parent corporation, described how nursing home orders or prescriptions were obtained and taken, beginning on line 11, page 716, of Volume VI of the hearing transcript: The vast majority, probably 90, 95 percent, are faxed over from the nursing home by nurses. A few may be called in with the nurse acting under the regulatory authority to act as the agent of the physician. These orders are then reviewed by the pharmacist. An order issue technician will enter that information into the computer, creating the original prescription.[2] The pharmacist then checks that data that was entered into the prescription to make sure all elements are there and the order entry is correct. Labels are then printed, which go to the floor to be filled by technicians. The pharmacist then checks the final product. That product is sent to a staging area where delivery manifests are printed. Those orders are then checked off the delivery manifest to make sure that no orders have been missed. The tote is sealed and then delivered to a nursing home by courier service. At the nursing home, the nurse and the driver check these orders off together, both sign that delivery manifest, and a copy of that delivery manifest comes back to the pharmacy. Q. Can you explain to the Court the typical process at [Petitioner’s parent corporation] by which refills, so to speak, are received and handled. A. Back then refills were handled by pulling a label off of the prescription container, apply it to a refill order sheet or a piece of paper of any kind that would fax . . . those are faxed to the pharmacy, those labels are pulled and faxed to the pharmacy by a nurse acting again under the regulatory authority of a -- to act as the agent of the physician. That’s also verifying to us that those orders are continued for another month. The prescription number is put in by an order entry tech. Those labels are printed and filled. From there on, the process is exactly the same. Prior to the audit period, Petitioner was purchased by another corporation. Subsequent to the audit, Petitioner ceased to operate as a pharmacy. RESPONDENT Respondent is the state agency charged with the responsibility and authority to administer the Medicaid program in Florida. Respondent’s OMPI is responsible for overseeing the integrity of the Medicaid program in Florida. Pursuant to this authority Respondent’s OMPI oversees audits to assure compliance with the Medicaid provisions and provider agreements. These integrity audits are routinely performed and Medicaid providers are aware that they may be audited. At all times material to the allegations of this case, the Medicaid program in Florida was governed by a “pay and chase” procedure. Under this procedure, Respondent paid Medicaid claims submitted by Medicaid providers and then, after- the-fact, OMPI audited such providers for accuracy and quality control. These integrity audits are to assure that the provider maintains records to support the paid claims. HERITAGE In 1999 OMPI contracted with Heritage through Consultec, L.L.C. (Medicaid’s fiscal agent), to perform and report pharmacy audits of pharmacy providers within the state. Auditors from Heritage were assigned Petitioner’s audit. The Heritage employees in charge of the subject audit were experienced and appropriately trained. THE AUDIT Respondent’s audit no 01-1017-00-3/H/JDJ reviewed Petitioner’s Medicaid claims paid by Respondent for the period June 24, 1998, through June 1, 2000. Ken Yon is the OMPI administrator who was responsible for managing the instant case and who worked with the Heritage auditors to assure the policies and practices of Respondent were met. In this case, the Heritage auditors presented at Petitioner’s facility unannounced on July 31, 2000 and sought 250 randomly selected claims for review. By limiting the number of claims, the auditors were not required to sift through the records of 139,036 claims (the total number of claims that the Petitioner submitted during the audit period). For the universe of 139,036 claims, 250 randomly selected claims is a reasonable sample to audit. The adequacy of the sample number as well as the manner in which it was generated is supported by the weight of credible evidence presented in this matter. Also, the results of extrapolating a sample of 250 claims to the universe of 139,036 claims would be statistically valid if the sampled claims were randomly chosen. The 250 sample claims selected for the subject audit were randomly chosen. Heritage asked the Petitioner to present prescription records it was required to retain to support the claims for the audit period. Petitioner offered the auditors its computerized records for many of the 250 samples in lieu of the hard copies the auditors requested. The auditors refused to accept the computerized records and, as reflected by the Audit Report, Petitioner was unable to produce acceptable evidence of prescriptions for a great many of the 250 samples.3 The auditors found that 171 of the 250 claims sampled were discrepant, in that they did not meet standards for payment. The auditors analyzed the number of discrepant claims and determined that the average overcharge per sampled claim was $36.3434 (sic). Multiplying the number of claims in the universe by that average yielded an initial estimate of the overcharge in the amount of $5,053,040.96. The 95% one-sided, lower-confidence limit4 for the initial estimate was determined to be $3,946.215.96, which is the amount of the overpayment alleged in the FAAR. THE FAAR AND SUBSEQUENT COMPUTATIONS After the auditors completed their review of the records at Petitioner’s facility, JoAnn Jackson, a licensed pharmacist with extensive experience in auditing pharmacies, was assigned by Respondent to review Heritage’s audit report and to prepare the Respondent’s FAAR. The vast majority of the discrepant claims (165 of the 171) were categorized as CF, which meant that the auditors could not find required documentation of the subject prescription or could not find required documentation for the refill of a prescription. These findings were reported to the Petitioner, who was given additional time to locate and produce documents to support the claims. Respondent was willing to accept documentation for claims up through the time of hearing.5 Based on additional documentation submitted by Petitioner after the auditors had completed their field work, Respondent’s staff recalculated the amount of the overpayment by the use of extrapolation (including the reduction of the initial estimate to the 95% one-sided, lower confidence limit) to be the amount of $1,053,137.49, which is the amount of the overpayment at issue at the formal hearing. Respondent established that each alleged discrepant claim that it used to recalculate the amount of the overpayment was, in fact, discrepant and did not meet Medicaid record-keeping standards. RECORD RETENTION REQUIREMENTS Although Petitioner’s manner of doing business was different from the conventional pharmacy (the so-called corner drugstore), it was subject to the same Medicaid records retention requirements as a conventional pharmacy that serves as a Medicaid provider. Pursuant to the applicable Medicaid Provider Agreement between Petitioner and Respondent, Petitioner was to comply with all Medicaid handbooks in effect during the audit period. Petitioner was also required to comply with all applicable state and federal Medicaid Program rules and laws in effect during the audit period. For each claim submitted during the audit period by Petitioner to Respondent for payment under the Medicaid Program, Petitioner was required to “keep, maintain, and make available in a systematic and orderly manner all medical and Medicaid- related records as Respondent requires for a period of at least five (5) years.” Petitioner was also required to make these supporting records available to Respondent upon Respondent’s request. A Medicaid provider must retain all medical, fiscal, professional, and business records on all services provided to a Medicaid recipient. In addition to the foregoing, a Medicaid provider must maintain a patient record for each recipient for whom new or refill prescriptions are dispensed. Specific to the issues of this case, a Medicaid provider must retain prescription records for five years from the date the prescription was last filled or refilled. For the audit period in this case, the prescription that authorized the dispensing of each drug for which Petitioner claimed payment under the Medicaid program should have been maintained and made available for the auditors since each prescription would have been within the five-year period. The records may be kept on paper, magnetic material, film, or other media. However, in order to qualify for reimbursement, the records must be signed and dated at the time of service, or otherwise attested to as appropriate to the media. Rubber stamp signatures must be initialed. The records must be accessible, legible and comprehensive. Applicable records that must be kept for quality control so that an after-the-fact audit can verify the integrity of the Medicaid claims that were paid by Respondent. Each claim reviewed and at issue in this cause was a paid Medicaid claim subject to the Petitioner’s provider agreement and the pertinent regulations. In order to stand as a sufficient prescription form, a writing must be created contemporaneous to the order (phone requests that are transcribed are acceptable), must contain specific information (type of drug, strength, dose, patient, doctor, DEA number, refill, etc.), and it must be kept for the requisite time. It would be acceptable for the prescription to be computer generated so long as it was written contemporaneous to the order and preserved as required by law. At the times relevant to this proceeding, Florida Administrative Code Rule 64B16-28.140(1)(d) and (e), provided, in part, as follows: Original prescriptions . . . shall be reduced to writing if not received in written form. All original prescriptions shall be retained for a period of not less than two years from date of last filling. To the extent authorized by 21 C.F.R. Section 1304.04, a pharmacy may, in lieu of retaining the actual original prescriptions, use an electronic imagining record keeping system, provided such system is capable of capturing, storing, and reproducing the exact image of the prescription, including the reverse side of the prescription if necessary, and that such image be retained for a period of no less than two years from the date of the last filling. Original prescriptions shall be maintained in a two or three file system as specified in 21 C.F.R. 1304.04(h). PETITIONER’S COMPUTERIZED RECORDS There was a dispute between the parties as to whether Petitioner’s computer records should have been accepted as evidence that valid prescriptions underlie each dispensed drug within the sample. That dispute is resolved by finding that the computer records maintained by the Petitioner did not retain prescriptions in the format dictated by rule. An electronic imaging recording system may be used when the system captures, stores, and can reproduce the exact image of the prescription, including the reverse side of the prescription if necessary. The Petitioner’s system did not do that. An electronic system must be able to produce a contemporaneous hard-copy printout of all original prescriptions dispensed and refilled. The original prescriptions must be maintained in a two or three file system as specified in 21 C.F.R. 1304.04(h). If the Petitioner’s system could do that, it did not. Fundamentally, a Medicaid claim for a drug that has been dispensed by a Medicaid provider must have as its basis a valid prescription. While Petitioner’s computer records established what drugs had been dispensed, those records did not meet the requirements for establishing that the drugs were dispensed pursuant to valid prescriptions. OVERPAYMENT Any Medicaid providers not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. As set forth in the Conclusions of Law section of this Recommended Order, the term “overpayment” is defined by Section 409.913(1)(d), Florida Statutes (2000). EXTRAPOLATION At hearing, Petitioner continued to dispute the procedure of applying the audit sample overpayment to the population of claims to mathematically compute the overpayment for the audit period. Extensive testimony was taken as to the extrapolation process used in this proceeding. Respondent has used a statistical extrapolation method to compute overpayments for years. The statistical concept and process of applying a sample to a universe to mathematically compute an overpayment is not novel to this case. All testimony, including the testimony of Dr. Intriligator, has been fully considered in the findings reached in this case. The testimony of Dr. Mark Johnson, an expert in statistical sampling and analysis, has been deemed credible and persuasive as to the issues of the appropriateness of the sample (as to size and how it was generated), the use of the sample overpayment to calculate an overall payment, and the statistical trustworthiness of the amounts claimed in this case. The only way to determine the amount of the actual overpayment is to examine each of the 139,036 claims that were made during the audit period. Dr. Johnson’s testimony established that the probability is overwhelming that the amount of the alleged overpayment is substantially less than the actual overpayment. Respondent established that Petitioner received an overpayment during the audit period as alleged in the FAAR and it established that the amount of the overpayment is at least $1,053,137.49.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order that finds that Petitioner has received an overpayment from the Medicaid program in the amount of $1,053,137.49. It is further recommended that the final order require Petitioner to repay that overpayment. DONE AND ENTERED this 28th day of February, 2006, 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 28th of February, 2006.
