The Issue Whether Medicaid overpayments were made to Petitioner and, if so, what is the total amount of those overpayments.
Findings Of Fact Petitioner Petitioner is a Florida-licensed osteopathic physician specializing in internal medicine. He has board certifications in internal medicine and nuclear medicine. In addition, he is certified in the sub-specialty of cardiology. Petitioner graduated from the Kirksville College of Osteopathic Medicine in Kirksville, Missouri in 1962. He has been practicing as an osteopathic internist in Florida since 1966, the year he came to the state after completing his residency at Brentwood Hospital in Cleveland, Ohio. Petitioner's Practice Petitioner's practice is now, and has been at all times material to instant case, located in Miami-Dade County, Florida. Petitioner currently practices at 9765 Southwest 184th Street in Miami Florida. Among Petitioner's current patients are Ira Hershman, D.O., a retired osteopathic physician who, as noted above, testified as a medical expert on Petitioner's behalf in this case, and Dr. Hershman's wife. Dr. Hershman's "career as an active doctor ended in 1997." Dr. Hershman was, and still is, board-certified in family practice medicine. Unlike Petitioner, at no time has he been board-certified in internal medicine. When he was in active practice and needed to consult with an internist, he "utilized [Petitioner's] services."12 From the "mid '60s through the '90s," Dr. Hershman and Petitioner were "on the staff of hospitals" together. They are, and have been over the years, "friends." Furthermore, their "families know each other" and socialize. During the period from March 1, 1996, through March 17, 1998 (Audit Period), Petitioner rendered "primary care" services at 17615 Southwest 97th Avenue, Miami, Florida, in a 30,000 square foot facility known as the Suburban Medical Center (Facility), which he owned and operated. A significant number of Medicaid patients were served at the Facility. Other physicians, hired by Petitioner, saw and otherwise provided services to Petitioner's patients at the Facility. Petitioner considered these physicians, who included Drs. Katzeff and Lubin, to be "independent contractors." On the premises of the Facility, Petitioner had "sophisticated equipment," not typically found in a "primary care" setting, available to perform various diagnostic tests,13 as well as a room equipped with items for urgent care that "very few" primary care physicians have. Petitioner used Dr. Key as a "consultant in radiology" to provide him with the "official reading" of x-rays, CAT scans, mammographies, and other imaging tests done at the Facility. The Provider Agreements During the Audit Period, Petitioner was authorized to provide physician services to eligible Medicaid patients. Petitioner provided such services pursuant to two provider agreements. The first agreement was a Non-Institutional Professional and Technical Medicaid Provider Agreement (First Provider Agreement) that Petitioner had entered into with the Department of Health and Rehabilitative Services, AHCA's predecessor, in 1983.14 The First Provider Agreement contained the following provisions, among others: * * * The provider agrees to keep such records as are necessary to fully disclose the extent of services provided to individuals receiving assistance under the State Plan and agrees to furnish the State Agency upon request such information regarding any payments claimed for providing these services. Access to these pertinent records and facilities by authorized Medicaid Program representatives will be permitted upon a reasonable request. The provider agrees that claims submitted must be for services rendered to eligible recipients of the Florida Medicaid Program and that payment by the program for services rendered will be based on the payment methodology in the applicable Administrative Rule. The Provider also agrees to submit requests for payment in accordance with program policies. * * * Payment by the State agency shall constitute full payment for services rendered to recipients under the Medicaid program except in specific programs when co- insurance is required from the recipient. The provider and the Department agree to abide by the provisions of the Florida Administrative Rules, Florida Statutes, policies, procedures, manuals of the Florida Medicaid Program and Federal laws and regulations. * * * The second agreement was a Medicaid Provider Agreement (Second Provider Agreement) that Petitioner had entered into with AHCA in October of 1996. The Second Provider Agreement contained the following provisions, among others: The Provider agrees to participate in the Florida Medicaid program under the following terms and conditions: * * * Quality of Services. The provider agrees to provide medically necessary services or goods of not less than the scope and quality it provides to the general public. The provider agrees that services or goods billed to the Medicaid program must be medically necessary, of a quality comparable to those furnished by the provider's peers, and within the parameters permitted by the provider's license or certification. The provider further agrees to bill only for the services performed within the specialty or specialties designated in the provider application on file with the Agency. The services or goods must have been actually provided to eligible Medicaid recipients by the provider prior to submitting the claim. Compliance. The provider agrees to comply with all local, state and federal laws, rules, regulations, licensure laws, Medicaid bulletins, manuals, handbooks and Statements of Policy as they my be amended from time to time. Term and signatures. The parties agree that this is a voluntary agreement between the Agency and the provider, in which the provider agrees to furnish services or goods to Medicaid recipients. This provider agreement shall become effective the date the provider's Florida Medicaid Enrollment Application is received by the state or its fiscal agent. It shall remain in effect until July 1, 1999, unless otherwise terminated. This agreement shall be renewable only by mutual consent. The provider understands and agrees that no Agency signature is required to make this Agreement valid and enforceable. Provider Responsibilities. The Medicaid provider shall: * * * (b) Keep and maintain in a systematic and orderly manner all medical and Medicaid related records as the Agency may require and as it determines necessary; make available for state and federal audits for five years, complete and accurate medical, business, and fiscal records that fully justify and disclose the extent of the goods and services rendered and billings made under the Medicaid. The provider agrees that only records made at the time the goods and services were provided will be admissible in evidence in any proceeding relating to the Medicaid program. * * * (d) Except as otherwise provided by law, the provider agrees to provide immediate access to authorized persons (including but not limited to state and federal employees, auditors and investigators) to all Medicaid- related information, which may be in the form of records, logs, documents, or computer files, and all other information pertaining to services or goods billed to the Medicaid program. This shall include access to all patient records and other provider information if the provider cannot easily separate records for Medicaid patients from other records. * * * (f) Within 90 days of receipt, refund any moneys received in error or in excess of the amount to which the provider is entitled from the Medicaid program. * * * Accept Medicaid payment as payment in full . . . . . . . . The provider shall be liable for all overpayments for any reason and pay to the Agency any fine or overpayment imposed by the Agency or a court of competent jurisdiction. Provider agrees to pay interest at 12% per annum on any fine or repayment amount that remains unpaid 30 days from the date of any final order requiring payment to the Agency. * * * Agency Responsibilities. The Agency: (a) Unless claims have been pended for medical review or investigation of suspected fraud or abuse, will make payment within 60 days at the established rate for medically necessary services or goods furnished to an eligible recipient by the provider upon receipt of a properly completed claim. . . . Termination and Equitable Relief. This agreement may be terminated, with or without cause, upon thirty (30) days written notice by either party. . . . * * * (19) Assignability. The provider number is the property of the Agency and the provider may not assign its rights or obligation under this number or this Agreement without the express written consent of the Agency. * * * THE PROVIDER AGREES THAT THIS AGREEMENT SHALL MERGE AND BECOME A PART OF THE PROVIDER APPLICATION . . . . The Provider Reenrollment Request form that Petitioner submitted (with which the Second Provider Agreement "merge[d]") reflected that the "provider['s] name" was "Minkes, Jules G." At no time did Petitioner enroll in the Medicaid program as part of a group practice (consisting of two or more physicians).15 He was enrolled only as an individual provider, and he used his individual provider number (0466301-00) to bill the Medicaid program. All of the Medicaid claims that are the subject of the instant controversy were billed by Petitioner under his individual provider number. Manual and Handbook Provisions Among the "manuals" and "handbooks" Petitioner was required to "abide by" and "comply with" during the Audit Period pursuant to the First and Second Provider Agreements were the Medicaid Provider Reimbursement Handbook, HCFA-1500 (MPR Handbook) and the Physician Coverage and Limitations Handbook (PCL Handbook). Medical Necessity The PCL Handbook provided that the Medicaid program would reimburse for services "determined [to be] medically necessary" and not duplicative of another provider's service, and it went on to state as follows: 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 service must be furnished in a manner not primarily intended for the convenience of the recipient, the recipient's caretaker, or the provider. The fact that a provider has prescribed, recommended, or approved medical or allied care, goods, or services does not, in itself, make such care, goods or services medically necessary or a covered services. Note See Appendix D, Glossary, in the Medicaid Provider Reimbursement Handbook, HCFA-1500 and EPSDT 224, for the definition of medically necessary The term "medically necessary" was defined in Appendix D of the MPR Handbook as follows: Medically Necessary or Medical Necessity Means that the medical or allied care, goods, or services furnished or ordered must: Meet the following conditions: Be necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain; Be individualized specific, and consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the patient's needs; Be consistent with generally accepted professional medical standards as determined by the Medicaid program, and not experimental or investigational; Be reflective of the level of service that can be safely furnished, and for which no equally effective and more conservative or less costly treatment is available statewide; and Be furnished in a manner not primarily intended for the convenience of the recipient, the recipient's caretaker, or the provider. "Medically necessary" or "medical necessity" for inpatient hospital services requires that those services furnished in a hospital on an inpatient basis could not, consistent with the provisions of appropriate medical care, be effectively furnished more economically on an outpatient basis or in an inpatient facility of a different type. The fact that a provider has prescribed, recommended, or approved medical or allied care, goods, or services does not, in itself, make such care, goods or services medically necessary or a medical necessity or a covered service. Documentation Requirements The MPR Handbook required that: "medical records . . . state the necessity for and the extent of services provided"16; and the provider "retain all medical, fiscal, professional, and business records on all services provided to a Medicaid recipient" for "at least five years from the date of service." The handbook further provided that "payments for services that lack[ed] required documentation" would be recouped. Physician Supervision The PCL Handbook provided: Delivery of all services must be done by or under the personal supervision of the physician. Personal supervision means the physician: is in the building when the services are rendered, and signs and dates the medical record within 24 hours of providing the service. Enrollment Requirements The PCL Handbook and the MPR Handbook both mandated that two or more physicians practicing together as a group enroll in the Medicaid program as a "provider group" and that each member of the group enroll in the program as an individual provider. Under the provisions of the MPR Handbook, an "individual provider" was required to "report when the provider bec[ame] a member of a provider group or [was] no longer a member of a provider group." Coding Chapter 3 of the PCL Handbook "describe[d] the procedure codes for the services reimbursable by Medicaid that [had to be] used by physicians providing services to eligible recipients." As explained on the first page of this chapter of the handbook: The procedure codes listed in this chapter [were] Health Care Financing Administration Common Procedure Coding System (HCPCS) Levels 1, 2 and 3. These [were] based on the Physician[]s['] Current Procedural Terminology (CPT) book. The CPT include[d] HCPCS descriptive terms and numeric identifying codes and modifiers for reporting services and procedures. . . . The Physicians' Current Procedural Terminology At all times material to the instant case, the American Medical Association's Physicians' Current Procedural Terminology (or the "CPT") referred to in Chapter 3 of the PCL Handbook contained an "[i]ntroduction," which read, in pertinent part, as follows: Physicians' Current Procedural Terminology (CPT) is a systematic listing and coding of procedures and services performed by physicians. Each procedure is identified by a five digit code. . . . Inclusion of a descriptor and its associated specific five-digit identifying code number in CPT is generally based upon the procedure being consistent with contemporary medical practice and being performed by many physicians in clinical practice in multiple locations. . . . * * * Section Numbers and Their Sequences Evaluation and Management 99201 to 99499 * * * Surgery 10040 to 69979 Radiology (Including Nuclear Medicine and Diagnostic Ultrasound) 70010 to 79999 * * * At all times material to the instant case, the CPT referred to in Chapter 3 of the PCL Handbook had "[e]valuation and [m]anagement (E/M) [s]ervice [g]uidelines" (E/M Guidelines). It was noted on the first page of the E/M Guidelines that: The E/M section is divided into broad categories such as office visits, hospital visits, and consultations. Most of the categories are further divided into two or more subcategories of E/M services. For example, there are two subcategories of office visits (new patient and established patient) and there are two subcategories of hospital visits (initial and subsequent). The subcategories of the E/M services are further classified into levels of E/M services that are identified by specific codes. . . . "New and [e]stablished patient[s]" were described in the E/M Guidelines as follows: A new patient is one who has not received any professional services from the physician or another physician of the same specialty who belongs to the same group practice, within the past three years. An established patient is one who has received professional services from the physician or another physician of the same specialty who belongs to the same group practice, within the past three years. The concept of "[l]evels of E/M [s]ervices" was described, in pertinent part, as follows in the E/M Guidelines: Within each category or subcategory of E/M service, there are three to five levels of E/M services available for reporting purposes. . . . The levels of E/M services include examinations, evaluations, treatments, conferences with or concerning patients, preventative pediatric and adult health supervision, and similar medical services, such as the determination of the need and/or location for appropriate care. Medical screening includes the history, examination, and medical decision-making required to determine the need and/or location for appropriate care and treatment of the patient . . . . The levels of E/M services encompass the wide variations in skill, effort, time, responsibility and medical knowledge required for the prevention or diagnosis and treatment of illness or injury and the promotion of optimal health. Each level of E/M services may be used by all physicians. The descriptors for the levels of E/M services recognize seven components, six of which are used in defining the levels of E/M services. These components are: history; examination; medical decision making; counseling; coordination of care; nature of presenting problem; and time. The first three or these components (history, examination and medical decision making) are considered the key components in selecting a level of E/M services. . . . The next three components (counseling, coordination of care, and the nature of the presenting problem) are considered contributory factors in the majority of encounters. . . . * * * Time . . . . The inclusion of time as an explicit factor beginning in CPT 1992 is done to assist physicians in selecting the most appropriate level of E/M services. It should be recognized that the specific times expressed in the visit code descriptors are averages, and therefore represent a range of times which may be higher or lower depending on actual clinical circumstances. * * * According to the E/M Guidelines, "[l]isted services [could] be modified under certain circumstances," with the "modifying circumstances" being "identified by the addition of [an] appropriate modifier code . . . ." Among the available "modifier codes" was one for "[p]rolonged [e]valuation and [m]anagement [s]ervices," which was explained in the E/M Guidelines as follows: When the face-to-face or floor/unit service(s) provided is prolonged or otherwise greater than that usually required for the highest level of E/M service within a given category, it may be identified by adding the modifier "-21" to the E/M code number or by use of the separate five digit modifier code 09921. A report may also be appropriate. The E/M Guidelines contained "[i]nstructions for [s]electing a [l]evel of E/M [s]ervice," which read, in pertinent part, as follows: * * * Review of Level of E/M Service Descriptors and Examples in the Selected Category or Subcategory The descriptors for the levels of E/M services recognize seven components, six of which are used in defining the levels of E/M services. These components are: history; examination; medical decision making; counseling; coordination of care; nature of presenting problem; and time. The first three or these components (i.e., history, examination and medical decision making) are considered the key components in selecting a level of E/M services. An exception to this rule is in the case of visits which consist predominantly of counseling or coordination of care. . . . The nature of the presenting problem and time are provided in some levels to assist the physician in determining the appropriate level of E/M service. Determine the Extent of History Obtained The extent of history is dependent upon critical judgment and on the nature of the presenting problem(s). The levels of E/M services recognize four types of history that are defined as followed: Problem Focused: chief complaint; brief history of present illness or problem. Expanded Problem Focused: chief complaint; brief history of present illness; problem pertinent system review. Detailed: chief complaint; extended history of present illness; problem pertinent system review extended to include a review of a limited number of additional systems; pertinent past, family and/or social history directly related to the patient's problems. Comprehensive: chief complaint; extended history of present illness; review of systems which is directly related to the problem(s) identified in the history of the present illness plus a review of all additional body systems; complete past, family and social history. * * * Determine the Extent of Examination Performed The extent of the examination performed is dependent on clinical judgment and on the nature of the presenting problem(s). The levels of E/M services recognize four types of examinations that are defined as follows: Problem Focused: a limited examination of the affected body area or organ system. Expanded Problem Focused: a limited examination of the affected body area or organ system and other symptomatic or related organ system(s). Detailed: an extended examination of the affected body area(s) and other symptomatic or related organ system(s). Comprehensive: a general multi-system examination or a complete examination of a single organ system. . . . For the purposes of these CPT definitions, the following body areas are recognized Head, including the face Neck Chest, including breasts and axilla Abdomen Genitalia, groin, buttocks Back Each extremity For the purposes of these CPT definitions, the following organ systems are recognized Eyes Ears, Nose, Mouth and Throat Cardiovascular Respiratory Gastrointestinal Genitourinary Musculoskeletal Skin Neurologic Psychiatric Hematologic/Lymphatic/Immunologic Determine the Complexity of Medical Decision Making Medical decision making refers to the complexity of establishing a diagnosis and/or selecting a management option as measured by: the number of possible diagnoses and/or the number of management options that must be considered; the amount and/or complexity of medical records, diagnostic tests, and/or other information that must be obtained, reviewed and analyzed; and -The risk of significant complications, morbidity and/or mortality, as well as comorbidities, associated with the patient's presenting problem(s), the diagnostic procedure(s) and/or the possible management options. Four types of medical decision making are recognized: straightforward; low complexity; moderate complexity; and high complexity. To qualify for a given type of decision making, two of the three elements [shown] below must be met or exceeded. Type of Decision Making: straightforward; Number of Diagnoses or Management Options: minimal; Amount and/or Complexity of Data to be Reviewed: minimal or none; Risk of Complications and/or Morbidity or Mortality: minimal Type of Decision Making: low complexity; Number of Diagnoses or Management Options: limited; Amount and/or Complexity of Data to be Reviewed: limited; Risk of Complications and/or Morbidity or Mortality: low Type of Decision making: moderate complexity; Number of Diagnoses or Management Options: multiple; Amount and/or Complexity of Data to be Reviewed: moderate; Risk of Complications and/or Morbidity or Mortality: moderate Type of Decision Making: High complexity; Number of Diagnoses or Management Options: extensive; Amount and/or Complexity of Data to be Reviewed: extensive; Risk of Complications and/or Morbidity or Mortality: high Select the Appropriate Level of E/M Services Based on the Following For the following categories/ subcategories, all of the key components, i.e., history, examination, and medical decision making, must meet or exceed the stated requirements to qualify for a particular level of E/M service: office, new patient; . . . For the following categories/ subcategories, two of the three key components, (i.e., history, examination, and medical decision making) must meet or exceed the stated requirements to qualify for a particular level of E/M service: office, established patient; . . . In the case where counseling and/or coordination of care dominates (more than 50%) of the physician/patient and/or family encounter (face-to-face time in the office . . . ), then time is considered the key or controlling factor to qualify for a particular level of E/M services. The extent of counseling and/or coordination of care must be documented in the medical record. At all times material to the instant case, the CPT referred to in Chapter 3 of the PCL Handbook contained the following codes and code descriptions for "E/M" office and other outpatient services: New Patient 99201 Office or other outpatient visit for the evaluation and management of a new patient, which requires these three key components: a problem focused history; a problem focused examination; and straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problems are self- limited or minor. Physicians typically spend 10 minutes face-to-face with the patient and/or family. * * * 99202 Office or other outpatient visit for the evaluation and management of a new patient which requires these three key components: an expanded problem focused history; an expanded problem focused examination; and straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Physicians typically spend 20 minutes face-to-face with the patient and/or family. * * * 99203 Office or other outpatient visit for the evaluation and management of a new patient which requires these three key components: a detailed history; a detailed examination; and medical decision making of low complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate severity. Physicians typically spend 30 minutes face-to-face with the patient and/or family. * * * 99204 Office or other outpatient visit for the evaluation and management of a new patient which requires these three key components: a comprehensive history; a comprehensive examination; and medical decision making of moderate complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Physicians typically spend 45 minutes face-to-face with the patient and/or family. * * * 99205 Office or other outpatient visit for the evaluation and management of a new patient which requires these three key components: a comprehensive history; a comprehensive examination; and medical decision making of high complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problems are of moderate to high severity. Physicians typically spend 60 minutes face-to-face with the patient and/or family. * * * Established Patient 99211 Office or other outpatient visit for the evaluation and management of an established patient that may or may not require the presence of a physician. Usually, the presenting problem(s) are minimal. Typically, 5 minutes are spent performing or supervising these services. * * * 99212 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: a problem focused history; a problem focused examination; straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self- limited or minor. Physicians typically spend 10 minutes face-to-face with the patient and/or family. * * * 99213 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: an expanded problem focused history; an expanded problem focused examination; medical decision making of low complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Physicians typically spend 15 minutes face-to-face with the patient and/or family. * * * 99214 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: a detailed history; a detailed examination; medical decision making of moderate complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Physicians typically spend 25 minutes face-to-face with the patient and/or family. * * * 99215 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: a comprehensive history; a comprehensive examination; medical decision making of high complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Physicians typically spend 40 minutes face-to-face with the patient and/or family. It is a rarity for an osteopathic internist to provide office services at the 99205 or 99215 "E/M" code level. Generally speaking, office services at the 99203 and 99213 "E/M" code levels are the most common types of office services that osteopathic internists provide. Typically, osteopathic internists provide a "higher percentage" of office services at the 99204 and 99214 "E/M" code levels than at the 99202 and 99212 "E/M" code levels.17 The experience or expertise of the provider is not a factor to be taken into consideration in determining the appropriate "E/M" code level. The Audit and Aftermath Commencing in 1998, AHCA conducted an audit of paid Medicaid claims submitted by Petitioner for services assertedly rendered from March 1, 1996, through March 17, 1998. The audit was undertaken because it had been determined, from a review of the Medicaid provider database maintained by AHCA, that Petitioner had billed for more "chest x-rays and various radiology [tests]" than the "average provider."18 Petitioner had submitted 2,571 Medicaid claims for services assertedly rendered during the Audit Period to 314 patients, for which he had received payments totaling $134,597.58. From the 314 Medicaid patients to whom Petitioner had assertedly provided services during the Audit Period, AHCA randomly selected, by computer, a "cluster sample" of 42, and asked Petitioner to produce the medical records he had on file for these 42 patients. Petitioner had submitted a total of 386 claims for services assertedly rendered to the 42 patients in the "cluster sample" during the Audit Period and had received a total of $20,823.33 in Medicaid payments for these services. Each of these claims was reviewed by AHCA to determine whether it was supported by information contained in the medical records produced by Petitioner in response to AHCA's medical records request. Based on a preliminary review conducted by AHCA staff and a physician consultant (John Sullenberger, M.D.), AHCA determined that Petitioner had been overpaid a total $98,545.98 for the Medicaid claims he had submitted for services assertedly rendered during the Audit Period. After having been advised of this preliminary determination, Petitioner sent additional documentation to AHCA. The additional documentation was reviewed by AHCA staff and Dr. Sullenberger. Following this review, the overpayment was recalculated by AHCA and determined to be $94,208.27. As noted above, by letter dated June 29, 1999, Petitioner was notified of this recalculation and advised of his right to request an administrative hearing on the matter. After Petitioner requested such a hearing, in or around March of 2000, as a result of the Legislature's enactment of the "peer review" provisions of Section 409.9131, Florida Statutes, which became effective July 1, 1999, AHCA retained the services of Richard Thacker, D.O., an osteopathic physician, like Petitioner, Board-certified in internal medicine. Dr. Thacker received his medical education at Nova Southeastern University, College of Osteopathic Medicine, from which he graduated in 1992. After graduation, he obtained "internal medicine training" for three years in the internship and residency program at Delaware Valley Medical Center in Langhorne, Pennsylvania. In 1995, he returned to Florida, and has been in "active practice" as an osteopathic physician in the state since his return. His experience includes "working in Medicaid clinics." He currently practices with the Medical Group of North Florida, a Tallahassee "multi-specialty group with primary emphasis on general internal medicine." Aside from his practice, among other things, he serves as: the chairman of the Tallahassee Community Hospital's Department of Medicine; the Medical Director of Outpatient Services at Health South Rehabilitation Hospital of Tallahassee; the Medical Director of Long Term Care at Capital Health Care Center; the Medical Director of American Home Patient Home Health; and an Associate Professor for Clinical Instruction at Florida State University College of Medicine. At AHCA's request, Dr. Thacker reviewed all of the records that Petitioner had provided regarding the 42 patients in the "cluster sample" (including those records that had been furnished after June 29, 1999)19 to determine whether there was documentation to support the Medicaid claims relating to these patients that Petitioner had submitted for services assertedly rendered during the Audit Period.20 On or about May 15, 2000, after Dr. Thacker completed his review, the overpayment was again recalculated by AHCA and determined to be $84,486.25. On or about June 12, 2003, following a meeting between Dr. Thacker and Petitioner held the afternoon of the first day of hearing in this case, AHCA made another downward revision in its overpayment calculation, this time to $70,629.68.21 AHCA has made no additional revisions to its overpayment calculation in the instant case. It maintains that Petitioner received $70,629.68 in Medicaid overpayments for services claimed to have been provided during the Audit Period. Respondent's Exhibit 25 contains spreadsheets prepared by AHCA which identify all of the alleged overpaid claims (of the 386 reviewed) and, for each such claim, specify the amount of the alleged overpayment and AHCA's reason(s) for determining that an overpayment was made. Where AHCA alleges "upcoding" (that is, billing for a higher (and more costly) "level of E/M service" than Petitioner's documentation reveals was actually provided) or "inappropriate cod[ing]" of a surgical or radiological procedure, and no other billing deficiency is asserted, the procedure code deemed appropriate by AHCA, based on the documentation furnished by Petitioner, is also specified. The spreadsheets that comprise Respondent's Exhibit 25 accurately identify (as "not documented") those claims (of the 386 reviewed) that were for services not shown, by the documentation Petitioner has furnished AHCA, to have been actually provided (by anyone). The monies Petitioner received for these claimed, but undocumented, services constitute overpayments. The spreadsheets that comprise Respondent's Exhibit 25 accurately identify (through entries made in the "not group member" columns thereof) those claims (of the 386 reviewed) that were for services not shown, by the documentation Petitioner has furnished AHCA, to have been provided by Petitioner or under his "personal supervision," as that term was described in the materials Petitioner was required to "abide by" and "comply with" during the Audit Period pursuant to the First and Second Provider Agreements. The monies Petitioner received for these claimed services not documented as having been provided by him or under his "personal supervision" as required by the First and Second Provider Agreements constitute overpayments. The spreadsheets that comprise Respondent's Exhibit 25 accurately identify those claims (of the 386 reviewed) that were for services not shown, by the documentation Petitioner has furnished AHCA, to have been "medically necessary," as that term was used in the materials Petitioner was required to "abide by" and "comply with" during the Audit Period pursuant to the First and Second Provider Agreements. The monies Petitioner received for these claimed services not documented as having been "medically necessary" as required by the First and Second Provider Agreements constitute overpayments. The spreadsheets that comprise Respondent's Exhibit 25 accurately identify (through entries made in the "levels of care" columns thereof) those claims (of the 386 reviewed) that were "upcoded."22 The documentation Petitioner has furnished AHCA supports "adjust[ed]" "levels of E/M service" no higher than those indicated in the "adjust" columns of the spreadsheets. For each "upcoded" claim, Petitioner was overpaid in an amount equal to what he received minus what he would have received had he billed at the "adjust[ed]" level specified on Respondent's Exhibit 25. The spreadsheets that comprise Respondent's Exhibit 25 accurately identify those claims for radiological services that, following the meeting between Dr. Thacker and Petitioner, it was agreed were "inappropriate[ly] cod[ed]," and they further reflect the correct codes and reimbursement amounts for these "inappropriate[ly] cod[ed]" services. The difference between the amount Petitioner was reimbursed for each such "inappropriate[ly] cod[ed]" service and the correct reimbursement amount set forth on Respondent's Exhibit 25 represents an overpayment. As Respondent's Exhibit 25 indicates, the office services Petitioner claimed he provided Patient #79 on October 20, 1997, for which he billed Medicaid at the 99214 "E/M" code level, as well as the office services he claimed he provided Patient #203 on February 16, 1998, for which he billed Medicaid at the 99215 "E/M" code level, were wholly non- reimbursable inasmuch as the documentation concerning these office visits does not reveal that, in either case, the patient received services justifying reimbursement at even the lowest "E/M" code level (99211) for an established patient. As Respondent's Exhibit 25 also indicates, Petitioner's claim for the January 7, 1998, excision of a benign lesion from Patient #264's left ankle was "inappropriate[ly] coded." Given what the documentation Petitioner has furnished AHCA reveals about the size of the lesion and what needed to be done to remove it and close the resulting wound, in billing Medicaid for this service, Petitioner should have used the 11401 procedure code, instead of the 11404 procedure code, which has a higher reimbursement rate. In making its final overpayment calculation, AHCA determined, correctly, that Petitioner was overpaid a total of $11,913.23, or $30.86329051 per claim, for the 386 claims he had submitted seeking reimbursement from Medicaid for services assertedly rendered during the Audit Period to the 42 patients in the "cluster sample." Using a statistical formula that Petitioner has admitted is valid, AHCA extended these results to the total "population" of 2,571 Medicaid claims that Petitioner had submitted for services assertedly rendered during the Audit Period, and it correctly calculated that Petitioner had been overpaid a total of $70,629.68. Simple Mistake or Fraud? There has been no allegation made, nor proof submitted, that any of the overbillings referenced above were the product of anything other than simple mistake or inadvertence on Petitioner's part.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that AHCA enter a final order finding that Petitioner received $70,629.68 in Medicaid overpayments for paid claims covering the period from March 1, 1996, through March 17, 1998, and requiring Petitioner to repay this amount to AHCA. DONE AND ENTERED this 28th day of January, 2004, in Tallahassee, Leon County, Florida. S STUART M. LERNER 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 day of January, 2004.
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.
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 The issue in this case concerns whether the Petitioner, H. J. Dental, Inc. (“Petitioner” or "HJD"), is obligated to repay $313,415.44 to the Respondent, Agency for Health Care Administration ("Respondent" or "AHCA") for Medicaid payments that were claimed by and were paid to the Petitioner for services which the AHCA asserts in its audit report were not eligible for payment under the terms of the Medicaid program.
Findings Of Fact At all times material to this case, the Petitioner was an enrolled Medicaid provider, having been enrolled under Provider number 071468200. As an enrolled Medicaid provider, the Petitioner was authorized to provide certain dental services to Medicaid recipients and to bill the Medicaid program for those services. All Medicaid provider agreements, including the one entered into by HJD, contain a specific provision that the provider agrees to abide by the statutes, laws, rules, and policies of the Medicaid Program in connection with the provisions of services to recipients. The "audit period" that is the subject of the AHCA's recoupment effort is January 1, 1998, to December 31, 1998. During this audit period, the Medicaid Program paid the Petitioner $313,415.44 for the dental services that are at issue in this proceeding. The AHCA contends that the entire $313,415.44 is subject to recoupment. On or about March 5, 2000, the AHCA prepared and mailed to HJD a Preliminary Agency Audit Report ("PAAR"). The PAAR advised HJD that the AHCA had "made a preliminary determination that certain claims for which you [HJD] were paid $313,415.44, were for services not covered by Medicaid." The PAAR described the process by which the AHCA had arrived at its audit conclusions and specifically advised HJD of the following specific reasons for the audit conclusion that HJD had been overpaid in the amount of $313,415.44: The documentation submitted for x-ray procedure codes D0220, D0230, D0240, and D0272, whch are not considered to be of diagnostic quality by the Medicaid dental consultant. The Medicaid Dental Coverage and Limitations Handbook states in chapter 2-21, Radiographic Examination: "All radiographs must be of diagnostic quality." Claims for radiographic film that is not considered to be of diagnostic quality are considered overpayments in the sample. You billed and were paid for specific claims in the sample that are not documented as having been actually provided, or that lack sufficient documentation in the recipient's dental records to support the medical necessity for the claims. Claims that lack appropriate documentation are considered overpayments in the sample. The PAAR also described the AHCA's sample methodology (a random sample of 42 Medicaid recipients for whom 306 claims were submitted by HJD), as well as the statistical formula used by the AHCA for cluster sampling. On the last page of the PAAR, HJD was also advised: "Since the findings of our review are provisional, you may submit information that you believe would reduce the amount of improper payments identified." On or about August 18, 2000, the law firm that was then representing HJD mailed to the AHCA a letter responding to the PAAR. The letter of August 18, 2000, criticized the validity of the AHCA's audit methodology and offered to settle the matter for a small fraction of the $313,415.44 sought by the AHCA. The letter of August 18, 2000, did not include any additional information regarding any of the sampled claims that provided the factual basis for the audit conclusions. On or about October 27, 2000, the AHCA issued a Final Agency Audit Report ("FAAR") in this case. The overpayment amount in the FAAR remained the same as in the PAAR, beause HJD did not provide any additional evidence following its receipt of the PAAR. The audit in this case was performed in a manner consistent with the AHCA's established practices and procedures for audits of Medicare Program providers. The audit in this case was performed using accepted and valid auditing, accounting, analytical, statistical, and peer-review methods. During the subject audit period from January 1, 1998, through December 31, 1988, HJD received overpayments from the Medicare Program in the amount of $313,415.44. As of the date of the hearing in this case, HJD has not repaid any of the overpayment amount to the AHCA.
Recommendation On the basis of the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a Final Order be issued in this case concluding that HJD was overpaid by the Medicaid Program in the amount of $313,415.44, and requiring that HJD promptly pay to the AHCA the amount of $313,415.44, plus interest at the statutory rate. DONE AND ENTERED this 1st day of July, 2004, in Tallahassee, Leon County, Florida. S MICHAEL M. 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 July, 2004.
The Issue Whether Petitioner is liable for overpayment of Medicaid claims for the period of January 1, 1997, through December 31, 1998, as stated in Respondent's Final Agency Audit dated March 10, 2000.
Findings Of Fact At all times material hereto, the Agency for Health Care Administration (Respondent) was the state agency charged with administration of the Medicaid program in the State of Florida pursuant to Section 409.907, Florida Statutes (1997). At all times material hereto, C. Dwight Groves, M.D. (Petitioner) was a licensed medical doctor in the State of Florida and was providing medical services to Medicaid recipients. Petitioner provided the medical services pursuant to a contract with Respondent. When first accepted as a Medicaid provider in June of 1995, Petitioner was assigned provider number 3777278-00 and was approved for providing and billing for physician services. The letter notifying Respondent that he was accepted as a Medicaid provider referenced an enclosed handbook which explained how the Medicaid program operates and how to bill Medicaid. At that time Petitioner practiced in Key West, Florida. In October of 1997, Petitioner notified Respondent of a change of address to Southern Group for Women in Lake City, Florida. According to the answers provided to a Medicaid Provider Questionnaire, Petitioner became affiliated with Southern Group for Women on October 16, 1997. Petitioner's medical practice was and is in the area of obstetrics and gynecology. Respondent's witness, Toni Steele, is employed by Respondent in its Medicaid program integrity division. During the audit period in question, she was a senior human services program specialist. Her job responsibility was to ensure that Medicaid providers in Florida adhered to Medicaid policy and rules. Medicaid program integrity uses several detection devices to audit Medicaid provider billing. One such device is what is referred to as a "one and a half report." This type of report will indicate when a provider "spikes" one and a half times his or her normal billings. During December of 1998, Ms. Steele noticed a "spike" in Petitioner's billings. Because of this spike, Medicaid program integrity, ordered an ad hoc sampling of his billings within a two-year billing period, January 1, 1997, through December 31, 1998. She reviewed the sample and, using the Medicaid Management Information System, was able to look at the actual dates of service and view the procedure code that was billed and paid by Medicaid. Ms. Steele then conducted an on-site visit to Petitioner's office. As is her usual practice, she took a tour of Petitioner's office looking at what types of lab equipment were there, the State of Florida license, and the number of medical personnel employed. During the on-site visit, Ms. Steele presented the office manager with a computer-generated list of patients and requested that the office manager provide the medical records of those patients on the list. The requested 31 files were provided to her within the requested time frame. Ms. Steele reviewed the patients' files received from Petitioner's office for the purpose of determining policy violations according to the Medicaid Physician Coverage and Limitations Handbook (Nov. 1997), the Advanced Registered Nurse Practitioner Coverage and Limitations Handbook (Nov. 1997), and the Medicaid Provider Reimbursement Handbook (Nov. 1996). The Medicaid Provider Reimbursement Handbook (Nov. 1996) provides in pertinent part: Introduction: Every facility, individual and group practice must submit an application and sign an agreement in order to provide Medicaid services. Note: See the Coverage and Limitations Handbook for specific enrollment requirements. Group Enrollment: When two or more Medicaid providers form a group practice, a group enrollment application must be filed with the Medicaid fiscal agent. * * * Renewal: A provider agreement is valid for the time period stated in the agreement and must be renewed by the provider by completing a new provider agreement and submitting it to the Medicaid fiscal agent 30 days prior to the expiration date of the existing agreement. The Physician Coverage and Limitations Handbook (Nov. 1997) provides in pertinent part: Other Licensed Health Care Practitioners: If a physician provider employs or contracts with a non-physician health care practitioner who can enroll as a Medicaid provider and that health care provider is treating Medicaid recipients, he or she must enroll as a Medicaid provider. Examples of non-physician health care practitioners who can enroll as Medicaid providers include but are not limited to: physician assistants, advanced registered nurse practitioners, registered nurse first assistants, physician therapists, etc. If the services rendered by a non-physician health care practitioner are billed with that practitioner as the treating provider, the services must be provided in accordance with the policies and limitations contained in that practitioner's program-specific Coverage and Limitations Handbook. * * * Physician Supervision: Delivery of all services must be done by or under the personal supervision of the physician. Personal supervision means the physician: . is in the building when the services are rendered, and . reviews, signs and dates the medical record within 24 hours of providing the service. The Advanced Registered Nurse Practitioner Coverage and Limitations Handbook (November 1997) provides in pertinent part: ARNP in a Physician Group: If an ARNP is employed by or contracts with a physician who can enroll as a Medicaid provider, the physician must enroll as a group provider and the ARNP must enroll as a treating provider within the group. If the services rendered by the ARNP are billed with the ARNP as the treating provider, the services must be provided in accordance with the policies and limitations contained in this handbook. According to answers provided on a Medicaid Provider Questionnaire completed in February of 1999, Anna Hall Kelley, ARNP, became affiliated with Southern Group for Women on October 16, 1997. The answers provided on the Questionnaire indicated that Petitioner and Nurse Kelley formed a partnership and practiced together at Southern Group for Women. Nurse Kelley did not testify at the hearing. In reviewing the requested medical records, Ms. Steele noted that some of the medical records were signed by Nurse Kelley, ARNP, indicating that Nurse Kelley, not Petitioner, performed the services. They were not countersigned by Petitioner. Nurse Kelly was not an enrolled Medicaid provider at the time the services were rendered as her provider number expired on May 31, 1997. Nurse Kelley signed a new enrollment application to be a Medicaid provider in October of 1999. Thus, she was not an enrolled provider from June 1, 1997, through the remainder of the audit period. Nurse Kelley saw patients and billed for those services under Petitioner's individual provider number. Neither Nurse Kelley nor Petitioner applied for a group Medicaid provider number during the audit period. Respondent sent a Preliminary Agency Audit Report to Petitioner on September 21, 1999, notifying him of a preliminary determination of a Medicaid overpayment in the amount of $71,261.92. Respondent sent a Final Agency Audit Report to Petitioner on March 10, 2000, notifying him that the Agency made a determination of a Medicaid overpayment in the amount of $55,829.04. Because of recalculations made by Respondent, the amount of reimbursement sought was reduced to $55,647.92. As a result of a stipulation of the parties prior to the hearing, the amount of reimbursement was further reduced to approximately $51,000. As to the statistical aspect of Respondent's audit, Respondent presented testimony of a statistical expert, Dr. Robert Peirce, who is employed by Respondent as an administrator in the Bureau of Program Integrity. Dr. Peirce's testimony is considered credible. Dr. Peirce developed the statistical methodology used in the statistical sampling of Dr. Groves' medical files. Dr. Peirce studied the methodology used by Respondent in this case, and concluded that the statistical procedures used in the audit of Petitioner were in accordance with customary statistical methodology. The statistical analysis of a Medicaid provider's billing begins with the selection of an audit period, which in Petitioner's case was calendar years 1997 and 1998. During that audit period, Petitioner submitted 3912 claims for Medicaid reimbursement. A random sample of recipients, 31 out of a possible 315, was selected by a computerized random sample generator from the claims submitted by Petitioner during the audit period. All of the claims in the sample were reviewed by an analyst, who determined whether any overpayment existed with respect to those claims. An overpayment totaling $5,130.99 was determined for the 302 claims of the 31 recipients in the sample. The amount of overpayment from the sample was extended to the population of the claims through a widely accepted statistical sampling formula. In extending the results of the 302 claims to the 3,912 claims, the total amount of overpayments was calculated as $55,647.92. The determination of that amount was made at the 95 percent confidence level, meaning that Respondent is confident that the overpayment is the amount that was calculated or more. There is a five percent probability that it might be less and a 95 percent chance that it would be more then the $55,647.92 that was calculated. The process used by Respondent is in accordance with customary statistical methodology. However, the result does not take into account the fact that the audit period began January 1, 1997, whereas Nurse Kelley did not begin to practice at Southern Women's Group until October 16, 1997, and, therefore, worked there only 14 and one-half months (or approximately 60%) of the audit period. Despite the stipulation of the parties that all issues other than the ARNP services had been resolved and that the amount in dispute was now approximately $51,000, no evidence was presented to indicate the exact amount remaining in dispute.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order sustaining the Final Agency Audit Report in part, recalculating the amount of overpayment as indicated and consistent with this Recommended Order, and requiring Petitioner to repay overpayments in the amount determined by the recalculation. DONE AND ENTERED this 21st day of December, 2000, in Tallahassee, Leon County, Florida. BARBARA J. STAROS 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 21st day of December, 2000.
The Issue Whether Medicaid overpayments were made to Petitioner and, if so, what is the total amount of those overpayments. Whether Petitioner should be directed to submit to a "comprehensive follow-up review in six months."
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following findings of fact are made: Petitioner Petitioner is owned by Yuval Levy, a Florida-licensed consultant pharmacist and registered pharmacist since 1990. Mr. Levy has served as Petitioner's president and chief executive officer since the "end of 1995." At all times material to the instant case, Petitioner has operated Colonial Drug (Pharmacy), a Florida-licensed closed system pharmacy located in Broward County, Florida. At all times material to the instant case, Petitioner acquired from pharmaceutical wholesalers licensed under Florida law all of the drugs dispensed through the Pharmacy. During the period from May 23, 1999, through February 23, 2001 (Audit Period), the Pharmacy filled approximately 180,000 prescriptions annually. A quarter of them (25 percent) were dispensed to Medicaid recipients. Petitioner's Participation in the Medicaid Program Petitioner was authorized during the Audit Period to provide pharmacy services to eligible Medicaid recipients in Florida. Petitioner provided such services pursuant to a Medicaid Provider Agreement (Provider Agreement). The Provider Agreement contained the following provisions, among others: The Provider agrees to participate in the Florida Medicaid program under the following terms and conditions: * * * Quality of Service. The provider agrees to provide medically necessary services or goods of not less than the scope and quality it provides to the general public. The provider agrees that services or goods billed to the Medicaid program must be medically necessary, of a quality comparable to those furnished by the provider's peers, and within the parameters permitted by the provider's license or certification. The provider further agrees to bill only for the services performed within the specialty or specialties designated in the provider application on file with the Agency. The services or goods must have been actually provided to eligible Medicaid recipients by the provider prior to submitting the claim. Compliance. The provider agrees to comply with all local, state and federal laws, rules, regulations, licensure laws, Medicaid bulletins, manuals, handbooks and Statements of Policy as they may be amended from time to time. Term and signatures. The parties agree that this is a voluntary agreement between the Agency and the provider, in which the provider agrees to furnish services or goods to Medicaid recipients. . . . Provider Responsibilities. The Medicaid provider shall: * * * (b) Keep and maintain in a systematic and orderly manner all medical and Medicaid related records as the Agency may require and as it determines necessary; make available for state and federal audits for five years, complete and accurate medical, business, and fiscal records that fully justify and disclose the extent of the goods and services rendered and billings made under the Medicaid. The provider agrees that only records made at the time the goods and services were provided will be admissible in evidence in any proceeding relating to the Medicaid program. * * * (d) Except as provided by law, the provider agrees to provide immediate access to authorized persons (included but not limited to state and federal employees, auditors and investigators) to all Medicaid-related information, which may be in the form of records, logs, documents, or computer files, and all other information pertaining to services or goods billed to the Medicaid program. This shall include access to all patient records and other provider information if the provider cannot easily separate records for Medicaid patients from other records. * * * (f) Within 90 days of receipt, refund any moneys received in error or in excess of the amount to which the provider is entitled from the Medicaid program. * * * (i) . . . . The provider shall be liable for all overpayments for any reason and pay interest at 12% per annum on any fine or repayment amount that remains unpaid 30 days from the date of any final order requiring payment to the Agency. * * * (l) If submitting claims to the Agency electronically, abide by the terms of the Standard Electronic Claims Submission Agreement. * * * Petitioner executed such a Standard Electronic Claims Submission Agreement (Submission Agreement), through which it expressed its understanding of and agreement to the following, among other things: * * * 3. Providers must correctly enter the claims data, monitor the data, and certify that the data entered is correct. * * * Providers must have on file the applicable source data to substantiate the claim submitted to the Medicaid program. Providers must allow the Agency or any of its designees . . . to review and copy all records, including source documents and data related to information entered through electronic claims submission. Providers must abide by all Federal and State statutes, rules, regulations, and manuals governing the Florida Medicaid program. Providers must sign and adhere to all conditions of the Medicaid Provider Agreement and be officially enrolled in the Medicaid program to participate in the electronic claims submission. Currently, and at all times material to the instant case, Petitioner "bill[ed] everything electronically." Prescribed Drug Services Coverage, Limitations and Reimbursement Handbook Among the requirements with which Petitioner, in paragraph 3 of the Provider Agreement and in paragraph 7 of the Submission Agreement, agreed to comply were those set forth in the Prescribed Drug Services Coverage, Limitations and Reimbursement Handbook (PDSCLR Handbook). During the Audit Period, Chapter 2 of the PDSCLR Handbook contained substantially the following "record keeping requirements" (with the underlined language reflecting additions to these requirements made effective July 20, 20002): Record Keeping Requirements The provider must retain all medical, fiscal, professional and business records on all services provided to a Medicaid recipient. Records may be kept on paper, magnetic material, film, or other media. In order to qualify as a basis 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 comprehensible. Record Retention Records must be retained for a period of at least five years from the date of service. Types of Records That Must be Retained The following types of records, as appropriate for the type of service provided, must be retained (the list is not all inclusive): Medicaid claim forms and any documents that are attached; Professional records, such as patient treatment plans and patient records; Prior and past authorization, and service authorization information; Prescription records; Business records, such as accounting ledgers, financial statements, purchase/acquisition records, invoices, inventory records, check registers, canceled checks, sales records, etc.; Tax records, including purchase documentation; Patient counseling documentation; and Provider enrollment documentation. Requirements for Prescription Records The pharmacy must maintain a patient record for each recipient for whom new or refill prescriptions are dispensed. The record may be electronic. The pharmacy's patient record system must provide for the immediate retrieval of the information necessary for the pharmacist to identify previously dispensed drugs when dispensing a new or refill prescription. The patient record must contain the following information: The recipient's first and last name, address, date of birth, and gender; A list of all prescriptions that were obtained by the recipient at the pharmacy during the 12 months immediately preceding the most recent service that includes: the name of the drug or device, prescription number, strength of the drug, the quantity, date received, and the prescriber's full name and state license number; Any known allergies, drug reactions, idiosyncrasies, chronic conditions or disease states of the patient, and the identity of any over-the-counter drugs or devices currently being used by the patient that may relate to prospective drug use review; Any related health information indicated by a licensed health care practitioner; and The pharmacist's comments, if any, relevant to the patient's drug therapy. Right to Review Records Authorized state and federal agencies and their authorized representatives may audit or examine a provider's records. This includes all records that AHCA finds necessary to determine whether Medicaid payments were or are due. This requirement applies to the provider's records and records for which the provider is the custodian. The provider must give authorized state and federal agencies and their authorized representatives access to all Medicaid patient records and to other information that cannot be separated from Medicaid-related records. The provider must send, at his or her expense, legible copies of all Medicaid- related information to the authorized state and federal agencies and their authorized representatives. Incomplete Records Providers who are not in compliance with the Medicaid documentation and record retention policies described in this chapter may be subject to administrative sanctions and recoupment of Medicaid payments. Medicaid payments for services that lack required documentation or appropriate signatures will be recouped.[3] Note: See Chapter 5 in this handbook for information on administrative sanctions and Medicaid payment recoupment. During the Audit Period, Chapter 5 of the PDSCLR Handbook contained the following provisions, among others: Provider Abuse Abuse Abuse means provider practices that are inconsistent with generally accepted business or medical practices and that result in an unnecessary cost to the Medicaid program or in reimbursement for goods or services that are not medically necessary or that fail to meet professionally recognized standards for health care. Financial Abuse Financial abuse means abuse resulting in overpayments to providers. Overpayment Overpayment includes any amount that is not authorized to be paid by the Medicaid program whether paid as a result of inaccurate or improper cost reporting, improper claims, unacceptable practices, fraud, abuse, or mistake. * * * Incomplete or Missing Records Incomplete records are records that lack documentation that all requirements or conditions for service provision have been met. Medicaid may recoup payment for services or goods when the provider has incomplete records or cannot locate the records. Note: See Chapter 2 in this handbook for Medicaid record keeping and retention requirements. During the Audit Period, other portions of the PDSCLR Handbook contained requirements regarding the information that providers, in preparing a claim for reimbursement, had to include, while elsewhere in the handbook other billing requirements, as well as billing prohibitions, were discussed. Florida Administrative Code Rule Provisions Additional requirements with which Petitioner, in paragraph 3 of its Provider Agreement and in paragraph 7 of the Submission Agreement, agreed to comply included those contained in the following provisions of the Florida Administrative Code governing the practice of pharmacy: Florida Administrative Code Rule 64B16- 27.103 Only a Florida registered pharmacist or registered pharmacy intern acting under the direct personal supervision of a Florida registered pharmacist may, in the State of Florida, accept an oral prescription of any nature. Upon so accepting such oral prescription it must immediately be reduced to writing, and only a Florida registered pharmacist or registered pharmacy intern acting under the direct personal supervision of a Florida registered pharmacist may, in the State of Florida, prepare a copy of a prescription or read a prescription to any person for purposes of providing reference concerning treatment of the person or animal for whom the prescription was written, and when said copy is given a notation shall be made upon the prescription that a copy has been given, the date given, and to whom given. Florida Administrative Code Rule 64B16- 27.400 * * * (3) Only a Florida licensed pharmacist may make the final check of the completed prescription thereby assuming the complete responsibility for its preparation and accuracy. * * * Florida Administrative Code Rule 64B16- 28.140 (1) Requirements for records maintained in a data processing system. * * * Original prescriptions, including prescriptions received as provided for in Rule 64B16-28.130, F.A.C., Transmission of Prescription Orders, shall be reduced to a hard copy 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 imaging recordkeeping 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 last filling. Original prescriptions shall be maintained in a two or three file system as specified in 21 C.F.R. 1304.04(h). * * * (3) Records of dispensing. Each time a prescription drug order is filled or refilled, a record of such dispensing shall be entered into the data processing system. The data processing system shall have the capacity to produce a daily hard-copy printout of all original prescriptions dispensed and refilled. This hard copy printout shall contain the following information: Unique identification number of the prescription; Date of dispensing; Patient name; Prescribing practitioner's name; Name and strength of the drug product actually dispensed, if generic name, the brand name or manufacturer of drug dispensed; Quantity dispensed; Initials or an identification code of the dispensing pharmacist; and If not immediately retrievable via CRT display, the following shall also be included on the hard-copy printout: Patient's address; Prescribing practitioner's address; Practitioner's DEA registration number, if the prescription drug order is for a controlled substance; Quantity prescribed, if different from the quantity dispensed; Date of issuance of the prescription drug order, if different from the date of dispensing; and Total number of refills dispensed to date for that prescription drug order. The daily hard-copy printout shall be produced within 72 hours of the date on which the prescription drug orders were dispensed and shall be maintained in a separate file at the pharmacy. Records of controlled substances shall be readily retrievable from records of non-controlled substances. Each individual pharmacist who dispenses or refills a prescription drug order shall verify that the data indicated on the daily hard-copy printout is correct, by dating and signing such document in the same manner as signing a check or legal document (e.g., J. H. Smith, or John H. Smith) within seven days from the date of dispensing. In lieu of producing the printout described in subparagraphs (b) and (c) of this section, the pharmacy shall maintain a log book in which each individual pharmacist using the data processing system shall sign a statement each day, attesting to the fact that the information entered into the data processing system that day has been reviewed by him or her and is correct as entered. Such log book shall be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing provided, however, that the data processing system can produce the hard-copy printout on demand by an authorized agent of the Department of Health. If no printer is available on site, the hard-copy printout shall be available within 48 hours with a certification by the individual providing the printout, which states that the printout is true and correct as of the date of entry and such information has not been altered, amended or modified. The prescription department manager and the permit holder are responsible for the proper maintenance of such records and responsible that such data processing system can produce the records outlined in this section and that such system is in compliance with this subsection. Failure to provide the records set out in this section, either on site or within 48 hours for whatever reason, constitutes failure to keep and maintain records. In the event that a pharmacy which uses a data processing system experiences system downtime, the following is applicable: An auxiliary procedure shall ensure that refills are authorized by the original prescription drug order and that the maximum number of refills has not been exceeded or that authorization from the prescribing practitioner has been obtained prior to dispensing a refill; and All of the appropriate data shall be retained for on-line data entry as soon as the system is available for use again. * * * (5) Authorization of additional refills. Practitioner authorization for additional refills of a prescription drug order shall be noted as follows: On the daily hard-copy printout; or Via the CRT display. The Audit and Aftermath Commencing on April 16, 2001, Heritage Information Systems, Inc. (Heritage), on behalf of AHCA, conducted an audit of Petitioner's paid Medicaid claims for the period from May 23, 1999, through February 23, 2001.4 Petitioner had submitted 37,416 such claims (Audit Period Claims), for which it had received payments totaling $2,797,964.36. The purpose of the audit was to determine whether, and if so to what extent, Petitioner was overpaid for these Audit Period Claims. Prior to the audit, Heritage provided Pharmacy personnel a Notice to Medicaid Provider of Initiation of On-Site Audit, which read as follows: The Agency for Health Care Administration (Agency), under federal and state laws, has the responsibility to oversee the activities of Medicaid providers. This is to advise you that an on-site audit of your billings to the Medicaid program has been initiated. Audits are performed in order to determine if Medicaid billings conform to applicable laws, rules, and policies. The fact that an audit is performed carries with it no implication of any wrongdoing. Audits are conducted as part of the responsibility of Medicaid for ensuring the integrity of the program. Medicaid audits generally involve a review of provider medical, professional, financial, and business records as required to determine the propriety of billings. Attachment B is a summary of applicable laws and rules governing the access to required information. If additional information is desired, please notify the auditor named below. In conducting the audit, Heritage performed both a "prescription record review" and "purchase invoice analysis."5 For the "prescription record review," Heritage first selected a non-random, "judgmental sample" of 271 Audit Period Claims, for which Petitioner had received payments totaling $222,559.65. It then selected (from the remaining Audit Period Claims) a "random sample" of 250 claims,6 for which Petitioner had received payments totaling $18,250.05. Thereafter, Petitioner's records were examined to determine whether they contained documentation sufficient to support the claims in the "judgmental sample" and in the "random sample." Heritage's December 10, 2001, Final Report: In-Depth Audit (Final Heritage Report) contained an Executive Summary, which summarized what the audit had revealed to date. This Executive Summary read, in pertinent part, as follows: Heritage Information Systems, Inc. ("Heritage") conducted an in-depth audit of Colonial Drug ("Colonial") at the request of the Florida Agency for Health Care Administration ("AHCA"). The audit documented possible billing, policy and regulatory violations that resulted in apparent overpayments. The audit findings include the following: Auditors sampled 271 judgmental and 250 random prescription claims. A review of the judgmental sample documented $134,926.14 in overcharges. Findings from the random sample extrapolated to $1,568,499.62. The 95% one-sided lower confidence limit extrapolation is $1,189,026.15. Adding the judgmental sample findings to the 95% one- sided lower confidence limit for the extrapolated random sample findings totals $1,323,952.29. The discrepancies identified in the sample include the following: Pharmacy staff was unable to produce hard copy prescription records corresponding to 253 claims ("CF"). Fifteen (15) claims were billed for quantities greater than those ordered by the prescribers or dispensed to the patients ("OBQ"). Days supply amounts for nine (9) claims were billed incorrectly ("DS"). Nine (9) hard copy prescription records for controlled substances did not contain the prescribers' addresses ("NDAD"). Nine (9) hard copy prescriptions for controlled substances did not contain the prescribers' DEA numbers ("NDEA"). Seven (7) quantities were cut resulting in additional dispensing fees paid to the pharmacy ("CQ"). Seven (7) hard copy prescription records for controlled substances did not indicate the quantities of drug to be dispensed ("NQTY"). Two (2) prescription claims were billed for drugs that differed from those ordered by the prescriber (WDB"). * * * Heritage's audit documented apparent overcharges of $1,323,952.29. This figure represents a combination of non-extrapolated findings from the judgmental sample plus the 95% one-sided lower confidence limit for the extrapolated random sample findings. This report is submitted to AHCA for action deemed appropriate. Based on the information Heritage provided, AHCA preliminarily determined that Petitioner had been overpaid a total of $1,323,952.29 for the Audit Period Claims. By letter dated February 20, 2002, which it denominated its Provisional Agency Audit Report, AHCA advised Petitioner of this preliminary determination. AHCA's Provisional Agency Audit Report read, in pertinent part, as follows: An on-site audit of your pharmacy was initiated on April 16, 2001. The Florida Medicaid Program through the Agency for Health Care Administration has determined that you have been overpaid $1,323,952.29 in connection with claims submitted to Medicaid during the audit period(s). This conclusion is supported by the audit results. This review and the determination were made in accordance with the provisions of Chapter 409, Florida Statutes (F.S.), and Chapter 59G, Florida Administrative Code (F.A.C.). In applying for Medicaid reimbursement, providers are required to follow applicable statutes, rules, Medicaid provider handbooks, statements of Medicaid policy, and federal laws and regulations. Medicaid cannot properly pay for claims that do not meet Medicaid requirements. When a provider receives payment in violation of these provisions, those funds must be repaid. This is, however, a provisional finding and we encourage you to submit any additional information or documentation that you may have that you feel may serve to change the overpayment. REVIEW DETERMINATION The audit included a judgmental sample review of selected paid claims and a separate review of a statistical[ly] valid random sample taken from the remaining population of paid claims with dates of service during the audit period. The overpayment found in the random sample was extended to the population using generally accepted statistical formulas and methods. The audit period for this review was from May 23, 1999, through February 23, 2001. This review identified an overpayment of $1,323,952.29. Attached are the overpayment calculations, a summary of documented discrepancies, and an itemized listing of discrepancies noted in the review of the judgmental and random sample. * * * Accordingly, we have determined at this time that you have been overpaid by the Medicaid program in the amount of $1,323,952.29. If you have documentation that you wish to submit that you feel would alter these findings, submit your written explanation and legible copies of the organized documentation to us within 30 days of receipt of this notice. . . . If you concur or accept these findings, please send your check in the amount of $1,323,952.29 for the identified overpayment . . . . If you have not submitted a written explanation and documentation or made payment within 30 days, we will send you notice regarding the agency's final determination. * * * Petitioner subsequently furnished additional documentation to AHCA. On or about May 30, 2002, AHCA sent this additional documentation to Heritage for "review, placement in [Heritage's] file, and action deemed appropriate." By letter dated November 15, 2002, AHCA informed Petitioner of its opportunity "to submit [any] further documentation" it wanted AHCA to consider. The letter read, in pertinent part, as follows: An audit of your pharmacy was initiated on April 16, 2001. The Florida Medicaid Program, through the Agency for Health Care Administration (Agency), issued a Provisional Agency Audit Report, dated February 20, 2002, and made a provisional overpayment determination. Subsequent to this determination, your pharmacy submitted additional documentation. However, the Agency extends to you an opportunity to submit further documentation that has not already been submitted that may change the overpayment. This review and determination were made in accordance with the provisions of Chapter 409, Florida Statutes (F.S.), and Chapter 59G, Florida Administrative Code (F.A.C.). In applying for Medicaid reimbursement, providers are required to follow the applicable statutes, rules, Medicaid provider handbooks, statements of Medicaid policy, and federal laws and regulations. Medicaid cannot properly pay for claims that do not meet Medicaid requirements. We encourage you to submit any additional information or documentation not already sent that you may have that you feel may serve to change the provisional overpayment. * * * Documentation standard for statistical audit review: Documents submitted after the completion of an audit may require an affidavit or other sworn statement, in addition to the documents, as a means to authenticate the documentation. Documentation that appears to be altered, or in any other way appears not to be authentic, will not serve to reduce the overpayment. Furthermore, additional documentation must clearly identify which discrepancy (claim) as set forth in the attached audit findings it purports to support. * * * Having reviewed the additional documentation that Petitioner had provided AHCA, Heritage prepared and submitted to AHCA an Addendum, dated May 13, 2003, to the Final Heritage Report it had previously submitted.7 The Addendum contained an Executive Summary, which stated the following, in pertinent part, regarding the "post audit review" conducted by Heritage: Post Audit Review/Revised Findings Post audit documentation from the pharmacy was forwarded to Heritage by AHCA and received on 1/3/03. Post audit documentation included copies of prescriptions and clinical records. The accepted documentation was incorporated into the audit findings and a revised overcharge amount was calculated. The revised judgmental sample review resulted in documented overcharges of $42,987.50. Revised findings from the random sample extrapolated to $701,790.88. The 95% one- sided lower confidence limit for this extrapolation is $484,189.15. Adding the judgmental sample findings to the 95% one- sided lower confidence limit of the random sample findings totals $527,176.65. Appended to the Addendum were, what Heritage referred to as, "discrepancy listings," accompanied by "edit sheets." The "discrepancy listings" specified those Audit Period Claims in the "judgmental sample" and in the "random sample" that were "discrepant" and, with respect to each such "discrepant" claim, identified, using the following "codes," the nature of the "discrepancy" from which the claim suffered and, in addition, set forth (in the "overcharges" column) the amount of any resulting overpayment: CF (Original hard copy prescription cannot be found on file during the audit)[8] CQ (A quantity less than that prescribed and less than that allowed, is billed and additional refills are dispensed resulting in undue dispensing fees)[9] DS (The days supply value submitted by the pharmacy is not consistent with the quantity and directions) DUP (Multiple claims for the same prescription fill are submitted and paid)[10] NDAD (The hard copy prescription does not include the prescriber's address)[11] NDEAC (The hard copy prescription does not contain a DEA number) NQTYC (The hard copy prescription does not indicate the quantity of drug to be dispensed) OBQ (Quantity paid exceeds the quantity authorized by the prescriber or dispensed to the recipient) UR (The number of refills billed and paid to the pharmacy exceeds the number authorized by the prescriber. Refills are dispensed without documented authorization from the prescriber) WDB (A pharmacy submits a claim for a medication that is different from the medication authorized to be dispensed to the patient)[12] WDBC (A pharmacy submits a claim for a medication that is different from the medication authorized to be dispensed to the patient, but with a showing of cause) WMDC (The claim for the prescription contains an incorrect prescriber license number, but the correct prescriber's name is documented in the pharmacy computer or is similar to the name of the prescriber billed)[13] WPB (The patient identified on a hard copy prescription is not the patient on the paid claim) These "discrepancy listings" are accurate as to all listed claims other than those denominated in Joint Exhibit 1 as "discrepant" claims 26 (August 9, 2000, fill), 52, 56, 61, 81, and 91. There were a total of 190 "discrepant" claims listed (including "discrepant" claims 26 (August 9, 2000, fill), 52, 56, 61, 81, and 91), some of which had "multiple discrepancies"14: 69 coded "CF"15 (with associated "overcharges" equal to the total amount paid for these claims); seven coded "CQ" (with associated "overcharges" equal to the undue "dispensing fees");16 11 coded "DS" (with no associated "overcharges"); four coded "DUP" (with associated "overcharges" equal to the total amount paid for these duplicate claims); nine coded "NDAD" (with no associated "overcharges"); 11 coded "NDEAC" (with associated "overcharges" equal to the "dispensing fees"); 8 coded "NQTYC" (with associated "overcharges" equal to the "dispensing fees"); 30 coded "OBQ" (with associated "overcharges" equal to the amount paid for the quantity in excess of that authorized); 16 coded "UR" (with associated "overcharges" equal to the total amount paid for these claims); one coded "WDB" (with an associated "overcharge" equal to the total amount paid for this claim); two coded "WDBC" (with associated "overcharges" equal to the "dispensing fees"); 59 coded "WMBC" (with associated overcharges " equal to the "dispensing fees"); and two coded "WPB" (with associated "overcharges" equal to the total amount paid for these claims). Of the 190 "discrepant" claims, 96 were in the "judgmental sample" and 94 were in the "random sample." On or about October 31, 2003, AHCA sent Petitioner a letter advising Petitioner of the status of AHCA's audit of the Audit Period Claims. The letter read, in pertinent part, as follows: The Agency for Health Care Administration, Office of Medicaid Program Integrity, with regard to the above-referenced audit, made a preliminary overpayment determination and sent a Preliminary Agency Audit Report to your attention. At this time, the Agency is temporarily placing this audit on hold, pending the outcome of litigation in an unrelated audit. Therefore, please maintain all of your Medicaid-related records and all documentation that supports the claims at issue in this matter until such time as this audit is finalized. Almost two years after having received Heritage's May 13, 2003, Addendum, AHCA prepared and sent to Petitioner its Final Agency Audit Report,17 which was dated April 8, 2005, and read, in pertinent part, as follows: The Agency for Health Care Administration, Office of Medicaid Integrity has completed the review of your Medicaid claims for the procedures specified below for dates of service during the period May 23, 1999, through February 23, 2001. A provisional agency audit report, dated February 20, 2002, was sent to you indicating that we had determined you were overpaid $1,323,952.29. Based upon a review of all documentation submitted, we have determined that you were overpaid $527,176.65 for services that in whole or in part are not covered by Medicaid. This report is not intended to imply any particular claim is or was covered. At a later date, the Agency may again review claims submitted during this period of time. Be advised that pursuant to Section 409.913(23)(a), Florida Statutes (F.S.), the Agency is entitled to recover all investigative, legal, and expert witness costs. Additionally pursuant to Section 409.913, F.S., this letter shall serve as notice of the following sanction(s): The provider is subject to a comprehensive follow-up review in six months. This review and the determinations of overpayment were made in accordance with the provisions of Section 409.913, F.S. In determining payment pursuant to Medicaid policy, the Medicaid program utilizes procedure codes, descriptions, policies, and the limitations and exclusions found in the Medicaid provider handbooks. In applying for Medicaid reimbursement, providers are required to follow the guidelines set forth in the applicable rules and Medicaid fee schedules, as promulgated in the Medicaid policy handbooks, billing bulletins, and the Medicaid provider agreement. Medicaid cannot pay for services that do not meet these guidelines. Below is a discussion of the particular guidelines related to our review of your claims and an explanation of why these claims do not meet Medicaid requirements. The audit work papers are attached, referencing the claims that were reviewed and found to be discrepant by this determination. REVIEW DETERMINATION(S) The audit included the review of a judgmental sample of selected claims and the review of a statistically valid random sample taken from the population of paid claims with dates of service during the audit period. The overpayment found in the random sample was extended to the population using generally accepted statistical formulas and methods. The audit period for this review was from May 23, 1999, through February 23, 2001. This review identified an overpayment of $527,176.65. Attached are the overpayment calculations, a summary of documented discrepancies, and an itemized listing of discrepancies noted in the review of the judgmental and the random sample[s]. * * * If you are not in bankruptcy and you concur with our findings, remit by check in the amount of $527,176.65. . . . * * * You have a right to request a formal or informal hearing pursuant to Section 120.569, F.S. . . . . [I]f a request for a hearing is made, the petition must be received by the Agency within twenty-one (21) days of receipt of this letter. . . . * * * As noted in the Preliminary Statement of this Recommended Order, Petitioner requested a "formal hearing," which ultimately was held on September 6 through 8, 2006. During the course of the hearing, AHCA made another downward revision in its total overpayment calculation (to $480,832.31), after determining that one "discrepant" claim in the "judgmental sample" ("discrepant" claim 26 (August 9, 2000, fill) previously coded "OBQ" should instead be coded "WMDC" (and that therefore the "overcharge" associated with this "discrepant" claim was $4.23, not $601.50), and further determining that five claims in the "random sample" ("discrepant" claims 52, 56, 61, 81, and 91) previously determined to be "discrepant" were in fact not "discrepant" (and that therefore Petitioner was not overpaid anything for these claims). Joint Exhibit 1 reflects this recalculation made by AHCA. The total amount that Petitioner was overpaid for the "discrepant" claims in the "judgmental sample" was $42,310.17. The total amount that Petitioner was overpaid for the 89 "discrepant" claims in the "random sample" was $4,339.32, or 17.36 dollars for each of the 250 claims in the sample. Extrapolating or projecting this result, in accordance with accepted statistical principles, to the entire universe of Audit Period Claims (which numbered 37,416) minus the 271 claims in the "judgmental sample" (a total of 37,145 claims), using a "95% one-sided lower confidence limit," yields an overpayment of $438,522.14. Adding this $438,522.14 overpayment to the $42,310.17 overpayment for the "discrepant" claims in the "judgmental sample" produces a total overpayment of $480,832.31 AHCA has made no additional revisions to its overpayment calculation in the instant case. It continues to maintain (and correctly so) that Petitioner received $480,832.31 in Medicaid overpayments for services claimed to have been provided during the Audit Period.18
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that AHCA enter a final order finding that Petitioner received $480,832.31 in Medicaid overpayments for paid claims covering the period from May 23, 1999, through February 23, 2001, and requiring Petitioner to repay this amount to AHCA; and that AHCA decline to order a "comprehensive follow- up review [of Petitioner] in six months." DONE AND ENTERED this 14th day of December, 2006, in Tallahassee, Leon County, Florida. S STUART M. LERNER 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 14th day of December, 2006.