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THE CHILDREN`S OFFICE, INC. vs AGENCY FOR HEALTH CARE ADMINISTRATION, 05-000807MPI (2005)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Mar. 03, 2005 Number: 05-000807MPI Latest Update: Jan. 05, 2007

The Issue The issue for determination is whether Petitioner must reimburse Respondent an amount up to $1,048,242.62, which sum Petitioner received from the Florida Medicaid Program in payment of claims arising from Petitioner's treating of pediatric patients between October 28, 2000 and October 25, 2002. Respondent alleges that the amount in controversy represents an overpayment arising from Petitioner's submission of claims that were not covered by Medicaid, in whole or in part.

Findings Of Fact Respondent Agency for Health Care Administration ("AHCA" or the "Agency") is the state agency responsible for administering the Florida Medicaid Program ("Medicaid"). Petitioner The Children's Office, Inc. ("TCO") was, at all relevant times, a Medicaid provider authorized to receive reimbursement for covered services rendered to Medicaid beneficiaries. From time to time, therefore, TCO had entered into various written contracts with the Agency, which will be referred to collectively as the "Provider Agreement." Exercising its statutory authority to oversee the integrity of Medicaid, the Agency conducted a review or audit of TCO's medical records to verify that claims paid by Medicaid during the period from October 28, 2000 to October 25, 2002 (the "Audit Period") had not exceeded authorized amounts. During the Audit Period, TCO had submitted 30,193 claims for services rendered to 3,148 patients (or recipients), on which Medicaid had paid a total of $1,593,881.86. Rather than examine the records of all 3,148 recipients served, the Agency selected a sample of 30 patients, whose records were reviewed first by a nurse consultant, and then by a physician "peer reviewer." TCO had submitted 260 claims during the Audit Period in connection with the 30 patients in the sample population. Medicaid had paid a total of $13,582.78 on these claims. The Agency's reviewers determined that, for various reasons, TCO had received a total of $9,740.10 in reimbursement of claims in the sample for services not covered by Medicaid, in whole or in part. Having discovered this "empirical overpayment" of $9,740.10, the Agency employed a statistical formula to ascertain the "probable total overpayment" that TCO had received from Medicaid in connection with the 30,193 claims presented during the Audit Period.1 (TCO does not dispute the methodology that AHCA used in determining the probable total overpayment based on the empirical overpayment associated with the sample population. The parties agreed at hearing that if the undersigned were to find that the empirical overpayment should be adjusted, then the Agency——not the undersigned——would recalculate the probable total overpayment using the same statistical formula.) The statistical analysis revealed a probable total overpayment of $1,048,242.62. This is the amount that AHCA seeks to recoup from TCO. TCO's resistance to the Agency's proposed action proceeds along two main fronts. One involves systemic or global challenges to the audit as a whole, the aim being to land a knockout blow that would preclude that Agency from recouping any amount. The other entails fact-specific disputes about the reimbursement of individual claims in the sample, the goal being to reduce the empirical overpayment——and thereby reduce the probable total overpayment.2 The Systemic Challenges TCO's systemic challenges to the audit are largely, if not exclusively, legal in nature. Indeed, the relevant facts are not in dispute. The factual bases (including the pertinent statutory and regulatory language) for TCO's arguments are set forth below. 1. Florida Administrative Code Rule 59G-1.010(22) provides as follows: (22) "Audit" means: an examination of "records for audit" supporting amounts reported in the annual cost report or in order to determine the correctness and propriety of the report; or an analysis of "records for audit" supporting a provider's claim activity for a recipient's services during a year or less of claims activity in order to determine whether Medicaid payments are or were due and the amounts thereof, with claim activity for each separate year constituting a separate audit. The term "audit" also comprehends discussions and interviews related to said examination or analysis. Also see "records for audit."[3] (Emphasis added.) TCO asserts that the foregoing definition of the term "audit" limits AHCA to reviewing periods of no greater than one year at a time, per provider, when investigating possible fraud, abuse, or overpayment as part of its Medicaid oversight responsibility. Because the Audit Period is approximately two years, TCO argues that the audit should be deemed void.4 2. Section 409.9131(5)(a), Florida Statutes, requires that the Agency, in making a determination of overpayment to a physician, must, among other things, "make every effort to consider the physician's patient case mix, including, but not limited to, patient age and whether individual patients are clients of the Children's Medical Services Network." Many of TCO's patients were clients of the Children's Medical Services Network ("CMS"), a fact that, TCO contends, the Agency's reviewers failed adequately to take into account. Though the evidence on this issue is limited, the undersigned agrees with TCO——and finds——that, in general, AHCA's reviewers placed little weight on whether a particular patient participated in CMS. The Agency did, however, consider TCO's overall "case mix" and factors relevant thereto. The undersigned determines, as a matter of fact, that the Agency put forth a reasonable effort under the circumstances to "consider [TCO's] patient case mix" in accordance with the statute. The undersigned further determines that, in any event, "case mix" considerations are not dispositive of the disputed reimbursement issues at hand. 3. Section 409.913(5), Florida Statutes, provides that all Medicaid providers are subject to having goods and services that are paid for by the Medicaid program reviewed by an appropriate peer-review organization designated by the agency. The written findings of the applicable peer- review organization are admissible in any court or administrative proceeding as evidence of medical necessity or the lack thereof. (Emphasis added.) Section 409.9131(5)(b), Florida Statutes, adds that "when the agency's preliminary analysis indicates that an evaluation of the medical necessity, appropriateness, and quality of care needs to be undertaken to determine a potential overpayment" to a physician, the Agency must refer the claims at issue for "peer review." The term "peer review" is defined, for purposes of Section 409.9131, as follows: "Peer review" means an evaluation of the professional practices of a Medicaid physician provider by a peer or peers in order to assess the medical necessity, appropriateness, and quality of care provided, as such care is compared to that customarily furnished by the physician's peers and to recognized health care standards, and, in cases involving determination of medical necessity, to determine whether the documentation in the physician's records is adequate. § 409.9131(2)(d), Fla. Stat. (emphasis added). TCO argues that Section 409.913(5) "clearly requires" the use of a peer-review organization (rather than an individual peer) when auditing "non-physician claims," and it contends that this "requirement" should be held applicable, as well, to the review of physician service claims pursuant to Section 409.9131(5). In this case, the peer review of physician service claims was performed, not by an organization, but by Dr. Larry Deeb, a Florida-licensed pediatrician. Thus, TCO urges that the audit be declared invalid in its entirety. 4. It is undisputed that approximately four years elapsed from the beginning of the Audit Period to the issuance, on November 30, 2004, of the Final Agency Audit Report, which latter gave TCO a clear point of entry to challenge the Agency's overpayment determination. TCO contends that this four-year "delay" was prejudicial to TCO's ability to defend against AHCA's recoupment effort. Thus, TCO argues that this proceeding should be deemed time-barred. 5. TCO asserts, and AHCA did not genuinely dispute, that the medical records provided to the Agency during the audit reveal a number of Medicaid compensable services for which TCO never submitted claims. TCO argues that if an investigation into possible Medicaid overpayments yields information demonstrating the existence of valid, yet unmade claims, then the Agency is under a legal duty either to pay those claims or set them off against any overpayment that might be found. The Fact-Specific Disputes In addition to challenging the validity of the audit as a whole, TCO disputes, in the alternative, the Agency's determinations regarding 13 specific claims; it also urges that several miscellaneous adjustments be made as well.5 These will be examined below. First, however, it is necessary to make some preliminary findings, to place the disputed claims in context. The disputed claims involve what are known as "evaluation and management services" ("E/M services") provided in the doctor's office or other outpatient setting to new or established patients. E/M services are billed to Medicaid using codes that reflect the intensity level of service provided. The codes are called "CPT codes"——"CPT" being short for Current Procedural Terminology. Medicaid reimburses providers for E/M services pursuant to fee schedules that specify the amount payable for each level of service according to the CPT codes. It is the provider's responsibility, in presenting a claim to Medicaid for payment, to determine the appropriate CPT code for the service provided. Medicaid generally pays claims upon receipt, without second-guessing the provider's judgment regarding the level of care. When the Agency conducts an investigation to determine possible overpayment to a provider, however, one thing it might review is whether the provider's claims were properly "coded"—— that is, whether the CPT codes on the bills accurately reflected the level of service provided to the patients, as documented in the medical records. If the Agency determines that the level of service provided was lower than that claimed, then it will "downcode" the claim to the proper level and seek to recoup from the provider, as an overpayment, the difference between what Medicaid paid on the claim as originally coded and what it would have paid on the claim as downcoded. In this case, each of the 13 disputed claim determinations involves a downcode with which TCO disagrees. The following CPT codes are relevant to the claims in dispute: NEW PATIENT 99201 Office and 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 and 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 problems are low to moderate severity. Physicians typically spend 20 minutes face-to-face with the patient and/or family. 99203 Office and 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 problems are of moderate severity. Physicians typically spend 30 minutes face-to-face with the patient and/or family. 99204 Office and 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 problems are low to moderate severity. Physicians typically spend 45 minutes face-to-face with the patient and/or family. 99205 Office and 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 moderate to high severity. Physicians typically spend 60 minutes face-to-face with the patient and/or family. ESTABLISHED PATIENT 99211 Office and other outpatient visit for the evaluation and management of an established patient, that 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 and 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; 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. 99213 Office and 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 focusedhistory;? 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 problems are low to moderate severity. Physicians typically spend 15 minutes face-to-face with the patient and/or family. 99214 Office and 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; 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 problems are of moderate severity. Physicians typically spend 25 minutes face-to-face with the patient and/or family. 99215 Office and 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; 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 problems are low to moderate severity. Physicians typically spend 40 minutes face-to-face with the patient and/or family. American Medical Association, Evaluation and Management (E/M) Services Guidelines at 9-10 (2001). Turning now to the 13 disputed claims, the following is a summary discussion of each, sorted by recipient and date of service. Recipient No. 2 Date of Service ("DOS") 03/05/01. Nurse Practitioner Beverly Armstrong saw this patient, then aged 10, on March 5, 2001, because he was experiencing nasal drainage and a cough. Ms. Armstrong diagnosed sinusitis and bronchitis and prescribed appropriate medications for those conditions. The child is profoundly developmentally delayed, which complicated the examination and medical decision-making process. TCO billed this visit to Medicaid under CPT Code 99215——the highest level of E/M services for an established patient——and was reimbursed $60.95. It is undisputed, however, that Medicaid does not permit an advanced registered nurse practitioner ("ARNP") to bill any visit at the 99215 level. (If a physician co-signs the medical record, then the claim can be properly submitted as a 99215 visit, but that did not happen on this claim or any other disputed claim here involving the services of an ARNP.) Thus, there is no dispute that this claim must be downcoded. The Agency contends that the claim properly should be reimbursed as a 99213 visit; TCO contends that 99214 is the correct level of service. It is concluded that this visit met the criteria for reimbursement at the 99214 level. The Medicaid fee for ARNP services in connection with a 99214-level visit was $32.82 in March 2001, which is $28.13 less than Medicaid paid on this claim. The Agency based its probable total overpayment determination on an alleged overcharge of $35.90. Thus, the empirical overpayment should be reduced by $7.77. DOS 05/16/02. This patient was seen by Dr. Barbara Chamberlain on May 16, 2005, because he was having difficulty sleeping and was waking up scared. TCO submitted the claim for this visit to Medicaid under CPT Code 99214 and was reimbursed the established fee for that level of service. During the instant audit, the Agency downcoded the visit to 99213, resulting in an alleged overpayment of $15.71 on the claim. At hearing, however, the Agency's counsel conceded that, in view of Dr. Deeb's deposition testimony, the claim had been properly coded as a 99214 visit. Therefore, the empirical overpayment should be reduced by $15.71. Recipient No. 13 DOS 11/01/00. This patient, aged 4, presented on November 1, 2000, with a cough and fever, and was seen by Nurse Armstrong, who diagnosed bronchitis and prescribed treatment therefor. TCO presented this claim to Medicaid as a 99215 visit, which was improper because ARNP services are not authorized for payment at such level, and was reimbursed $59.43. AHCA contends that the claim should be downcoded to 99213, giving rise to an alleged overpayment of $34.38. The undersigned determines, however, that 99214 is the proper code, based on the overall complexity of the case as reflected in the medical records. The appropriate reimbursement, therefore, is $31.85, resulting in an overpayment on this claim of $27.58. The empirical overpayment should, accordingly, be reduced by $6.80. DOS 04/27/01. The patient was seen by Nurse Armstrong on April 27, 2001, complaining of fever and a recent history of vomiting and diarrhea. He was diagnosed with a middle ear infection and allergic rhinitis. After the visit, on the night of April 27, a call was made on this patient's behalf to the on- call nurse to report an ongoing high fever; the patient was encouraged to go to the emergency room for treatment. TCO improperly billed this claim for nursing services as a 99215 visit and was paid $60.95. The undersigned is persuaded by Dr. Deeb's deposition testimony that the appropriate service level on this claim is 99213, as the Agency contends. When it calculated the probable total overpayment, however, the Agency assumed, incorrectly, that the fee for ARNP services on a 99213 claim in April 2001 was $25.05. In fact, such claims were reimbursed at the rate of $21.03 per visit. Thus, for this claim, the empirical overpayment should be increased by $4.02. DOS 04/30/01. The patient presented again on April 30, 2001, with a high fever and nasal congestion. He was seen by Nurse Armstrong, who ordered blood and urine tests and prescribed additional treatment. TCO billed the visit, improperly, as a 99215 and was paid $60.95. Based on the medical records, which document a high fever that was not responding as expected to treatment, the undersigned determines that 99214 is the proper code for this visit. The applicable fee for such a visit, at the time, was $32.82. Thus, the overpayment on this claim is $28.13, not $35.90 as AHCA alleged. The empirical overpayment should be reduced by $7.77. Recipient No. 17 Nurse Armstrong saw this three-year-old on November 29, 2000. The patient came in with redness and swelling of the eyelid. The ARNP referred the patient to an ophthalmologist. TCO submitted a claim to Medicaid, reporting the visit under CPT Code 99215, which was improper because, to repeat for emphasis, nursing services cannot be billed at this level——a point that TCO conceded at hearing. Medicaid paid TCO $59.43 for the visit. The Agency asserts, and the undersigned finds, that this claim should be reimbursed at the 99213 level. The key fact here is that the patient was referred to a specialist. While this was no doubt an appropriate disposition, deciding to make a routine referral to an eye doctor for evaluation of a possible eye infection or injury should be a relatively easy medical task. The fee for ARNP services on a 99213 claim was $20.80 in November 2000. In calculating the probable total overpayment, the Agency incorrectly assumed that the applicable fee was $25.05. Thus, the empirical overpayment should be increased by $4.25 to account for this claim, properly adjusted. Recipient No. 18 DOS 07/17/02. This patient, aged 5, was seen by Dr. Chamberlain on July 17, 2002, for treatment of a cough and low- grade fever. The doctor diagnosed pharyngitis and prescribed an antibiotic. TCO billed Medicaid for a 99215 visit and was reimbursed $63.37. The Agency contends that this claim should be downcoded to 99213. The undersigned agrees, because the medical record documents a routine visit involving a straightforward diagnosis and plan of treatment. Thus, there should be no change to the empirical overpayment on account of this claim. DOS 08/08/02. Dr. Chamberlain saw this patient on August 8, 2002, because he had a fever. The doctor again diagnosed pharyngitis and offered an antibiotic injection, which the patient's mother refused. Dr. Chamberlain spent additional time counseling the mother, but she continued to decline the recommended treatment, against medical advice. TCO presented a claim to Medicaid for a 99214 visit. The Agency urges that this visit be downcoded to 99213, creating an alleged overpayment of $15.71. The undersigned finds, however, that 99214 was the appropriate code for this claim, primarily because of the need for additional counseling as a result of the mother's refusal of treatment. Thus, the empirical overpayment should be reduced by $15.71 for this claim. Patient No. 19 DOS 05/17/02. Nurse Armstrong saw this medically complex three-year-old as a new patient on May 17, 2002. The medical record does not document the specific medical complaint that drove the visit, but states that the patient wanted a nebulizer machine. The nurse examined the patient in some detail and decided to stay the course charted by other providers, directing that the patient continue taking the same medications. TCO reported the visit to Medicaid as a 99205 claim and received $85.00. This was improper on its face because nursing services cannot be billed at this level. The Agency contends that the claim should be downcoded to 99203, and the undersigned agrees. Based on the evidence presented, it is found that the medical decision-making required for this visit should not have exceeded a low level of complexity, especially since no material changes were made to the preexisting treatment plan. The fee for ARNP services on a 99203 visit was $40.23 in May 2002, not $38.70 as shown in the Agency's work papers. Consequently, the empirical overpayment should be reduced by $1.53 to reflect the adjustment of this claim. DOS 06/05/02. Dr. Chamberlain saw the patient on June 5, 2002, because she was vomiting, sleeping too much, and experiencing a loss of appetite. The doctor ordered emergency blood work, which revealed that one of the medications that the patient was taking had reached a toxic level in her bloodstream. This was a potentially life-threatening situation that required prompt medical attention. TCO billed this visit at the 99215 level. AHCA argues that the claim should be downcoded to 99213, at which level an alleged overpayment of $30.81 would result. The undersigned agrees with TCO, however, that 99215 was the proper code under the circumstances. The empirical overpayment should be reduced by $30.81 for this claim. DOS 07/08/02. The patient was seen by Dr. Chamberlain on July 8, 2002, for a "pre-op" examination ahead of a scheduled surgery to repair a hernia. The visit was billed to Medicaid as a 99215 claim, and TCO received $63.37. In this proceeding, TCO has conceded that 99215 was excessive, but it presses for a downcode only to 99214. The Agency asserts that 99213 is the proper code for this claim. The undersigned is persuaded that this focused pre-op examination should not have required a level of care beyond 99213. In July 2002, the fee for a physician's services on a 99213 visit was $32.56. The overpayment on this claim therefore is $30.81. Because the Agency mistakenly recorded the overpayment as $37.32 in its work papers and used that figure in calculating the probable total overpayment, the empirical overpayment should be reduced by $6.51. DOS 07/25/02. On this day, the medical records show that the patient was seen by Nurse Armstrong for "labs only" and to have a form completed for school. TCO submitted a claim to Medicaid for a 99215 visit (which was facially improper) and was reimbursed $63.37. AHCA now seeks to deny the claim in its entirety based on the absence of a medical record. Yet, as TCO points out, there is a record of this visit. It reflects that minimal services were performed and no examination of the patient was conducted. Thus, the claim should be downcoded to 99211. For ARNP services at this level, Medicaid paid $10.37 at the relevant time. Thus, the empirical overpayment should be reduced by $10.37 to account for this claim. DOS 09/04/02. Nurse Armstrong saw the patient, who presented with a fever and cough, on September 4, 2002. This visit took place a couple of weeks after the patient's hernia had been surgically repaired. The nurse diagnosed pharyngitis or tonsillitis. TCO presented the claim to Medicaid, improperly, as a level 99215 visit and received $63.37. AHCA contends that the claim should be downcoded to 99213. This would have been the appropriate code, the undersigned believes, but for the fact that the child had recently undergone surgery, which added an element of complexity to the case. The undersigned finds that the proper code for this claim is 99214. At the time, Medicaid paid $34.52 for ARNP services on a 99214 claim. Thus, the overpayment on this claim is $28.85. Because AHCA based its determination of the probable total overpayment on an alleged overpayment of $37.32 on this claim, the empirical overpayment should be reduced by $8.47. Miscellaneous Adjustments TCO has identified a number of alleged errors in the Agency's work papers, which will be discussed below. Recipient No. 15, DOS 12/07/00. This claim for a doctor's services was coded 99664. Medicaid paid TCO $8.00 on the claim. As part of the audit, AHCA reduced the allowable fee to $6.40, because the services at issue were in fact performed by an ARNP. This created an alleged overpayment on the claim of $1.60. TCO does not dispute that an ARNP performed the services; it asserts that the applicable fee is more than $6.40. TCO is correct. The fee for ARNP services on a 99664 claim was, in December 2000, $8.57. Thus, the empirical overpayment should be reduced by $2.17 (0.57 + 1.60). Recipient No. 30, DOS 05/03/02. TCO billed Medicaid for a doctor's services at the 99203 level and was reimbursed $50.30. AHCA determined in the audit that an ARNP actually performed the services in question and reduced the allowable fee to $40.24, resulting in an alleged overpayment of $10.06. The applicable ARNP fee schedule shows an allowable fee of $40.23. Thus, the empirical overpayment should be increased by 0.01 to account for this claim. Recipient No. 18, DOS 08/09/02. TCO correctly notes that, contrary to the Agency's allegation, there is a medical record for this visit, which shows that the ARNP gave the patient a shot of antibiotic medicine. Thus, while the Agency properly determined that TCO's claim for a physician's services at level 99215 resulted in an overpayment, it should have downcoded the claim to 99211, rather than denied the claim in its entirety, and allowed reimbursement at the ARNP fee of $10.37. Accordingly, the empirical overpayment should be reduced by $10.37. Recipient No. 17, DOS 07/10/01. TCO has identified a typographical error in a one of the Agency's work papers, where the date of service for this claim incorrectly was recorded as July 10, 2000, instead of July 10, 2001. This error did not affect the overpayment calculations, however, and thus no adjustment to the empirical overpayment is required. Recipient No. 22, DOS 09/03/02. TCO alleges that the allowed fee of $48.27 "is wrong." According to the applicable fee schedule, however, this is indeed the correct figure. Therefore, no change in the Agency's calculations is warranted. Recipient No. 23, DOS 08/07/02. TCO points out that a work paper of the Agency fails to mention the allowed CPT Code for this claim. The omission had no effect on the Agency's overpayment calculations. Recipient No. 26, DOS 07/20/01. TCO notes a typographical error in a work paper that had no effect on the Agency's overpayment calculations. Recipient No. 26, DOS 03/13/01. TCO notes a typographical error in a work paper that had no effect on the Agency's overpayment calculations. Other Discrepancies In the course of reviewing the Agency's work papers and the medical records in evidence, the undersigned discovered several minor discrepancies that should be corrected in recalculating the probable total overpayment. Recipient No. 2. The total alleged overpayment for this patient, before making any of the adjustments described above, is $1,571.93, not $1,594.42, which latter figure was used by the Agency in determining the probable total overpayment. Therefore, the empirical overpayment should be reduced by $22.49. Recipient No. 5. The total alleged overpayment for this patient, before making any of the adjustments described above, is $27.63, not $26.38, which latter figure was used by the Agency in determining the probable total overpayment. Therefore, the empirical overpayment should be increased by $1.25. Recipient No. 15. The total alleged overpayment for this patient, before making any of the adjustments described above, is $367.35, not $372.44, which latter figure was used by the Agency in determining the probable total overpayment. Therefore, the empirical overpayment should be reduced by $5.09. Recipient No. 30. The total alleged overpayment for this patient, before making any of the adjustments described above, is $42.62, not $44.16, which latter figure was used by the Agency in determining the probable total overpayment. Therefore, the empirical overpayment should be reduced by $1.54. Summary The Agency based its determination of the probable total overpayment on an empirical overpayment of $9,740.10. In accordance with the foregoing findings, it is determined that this figure should be increased by a total of $9.53, and reduced by a total of $153.11, making a net empirical overpayment of $9,596.52. In other words, the undersigned finds that, of the $13,582.78 which TCO received from Medicaid for the 260 total claims submitted during the Audit Period in connection with medical services provided to the sample population of 30 patients, $9,596.52 constituted an overpayment. Thus, it is this figure——$9,596.52——that should be used in calculating the probable total overpayment arising from the 30,193 claims presented during the Audit Period, for which Medicaid paid TCO a grand total of $1,593,881.86.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency recalculate the probable total overpayment using the statistical formula previously employed but substituting $9,596.52 in place of $9,740.10 as the empirical overpayment, and enter a final order requiring TCO to repay the Agency the principal amount determined through such recalculation. DONE AND ENTERED this 3rd day of February, 2006, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of February, 2006.

Florida Laws (7) 120.569120.57409.907409.908409.913409.9131465.188
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MAZ PHARMACEUTICALS, INC., D/B/A MAZ PHARMACY vs AGENCY FOR HEALTH CARE ADMINISTRATION, 97-003791 (1997)
Division of Administrative Hearings, Florida Filed:Miami, Florida Aug. 13, 1997 Number: 97-003791 Latest Update: Jun. 26, 1998

The Issue The issues presented are whether Petitioner is responsible for reimbursing the Agency for Health Care Administration for an overpayment for Medicaid services and, if so, whether administrative sanctions should be applied.

Findings Of Fact From April 19, 1995, through October 30, 1996, Petitioner was a pharmacy licensed to do business in the State of Florida. From April 15, 1995, through October 30, 1996, Petitioner was a Medicaid provider in good standing, pursuant to a Medicaid contract with the Agency. In 1996 Kathryn Holland, an agency employee, conducted an audit of Petitioner's records, using a method which the Agency calls an aggregate analysis. This analysis focuses on the inventory of a Medicaid provider and analyzes invoices and other documentation to determine if the provider had available during the audit period sufficient quantities of goods or products to support the quantity of goods or products billed to Medicaid. Holland analyzed the Agency's records to ascertain the claims filed by Petitioner and the amounts paid to Petitioner. She compiled a list of those drugs most frequently billed to the Agency's Medicaid program by Petitioner and selected 23 medications. She selected April 1, 1995, through October 30, 1996, as the audit period. She contacted Petitioner and requested records showing Petitioner's purchases of the medications on that list. She also contacted Mason Distributors, Inc., and H. I. Moore, Inc., two of Petitioner's primary suppliers, and requested copies of their invoices for medications purchased by Petitioner between May 1, 1995, and October 28, 1996. She prepared charts of the invoices and other documents received as a result of her requests. She reduced the number of audited drugs to 20 based upon adequate documentation provided to her for three of the listed medications. She prepared a preliminary report, which she sent to Petitioner with a request that Petitioner supply her with any additional records to show that additional supplies of the listed medication were available to Petitioner during the audit period. Petitioner responded to that request by providing additional documentation. Holland did not credit Petitioner with additional supplies based upon the additional documentation because the invoices appeared to be for a different pharmacy or appeared to reflect purchases outside the audit period. Further, the cancelled checks were payable to cash, had no notation as to the purpose of the checks, had a notation reflecting only a "business expense," had a notation for medication not on Holland's list, or reflected purchases outside the audit period. Petitioner was unable to document sufficient inventory during the audit period to justify the amount of medication billed to, and paid for by, the Agency. The Agency overpaid Petitioner in the amount of $12,529.11 for the 20 listed medications during the audit period and is entitled to reimbursement by Petitioner in that amount.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered determining that Petitioner is responsible to repay the Agency in the amount of $12,529.11 by a date certain, imposing an administrative fine in the amount of $2,000, and terminating Petitioner from the Medicaid program for a period of two years. DONE AND ENTERED this 20th day of March, 1998, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 Filed with the Clerk of the Division of Administrative Hearings this 20th day of March, 1998. COPIES FURNISHED: Thomas Falkinburg, Esquire Mark Thomas, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308 William M. Furlow, Esquire Katz, Kutter, Haigler, Alderman, Marks, Bryant & Yon, P.A. Highpoint Center, Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Paul J. Martin, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308

Florida Laws (3) 120.569120.57409.913
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THE DOCTOR`S OFFICE, D/B/A THE CHILDREN`S OFFICE vs AGENCY FOR HEALTH CARE ADMINISTRATION, 01-002831MPI (2001)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Jul. 17, 2001 Number: 01-002831MPI Latest Update: Mar. 23, 2006

The Issue The issues in this case are whether Petitioner received Medicaid overpayments, and, if so, what is the aggregate amount of the overpayments.

Findings Of Fact The Parties Respondent, the Agency for Health Care Administration, is the single state agency charged with administration of the Medicaid program in Florida under Section 409.907, Florida Statutes. Petitioner, The Doctor's Office, was a Florida corporation approved by the Agency to provide group Medicaid services. At all times relevant to this matter, Petitioner was owned entirely by non-physicians who employed salaried physicians to provide Medicaid services. Petitioner, at all times relevant to this matter, offered physician services to Medicaid beneficiaries pursuant to a contract with the Agency under provider number 371236P-00. Petitioner, pursuant to the specific terms in the contract with the Agency, agreed to abide by the Florida Administrative Code, Florida Statutes, policies, procedures, manuals of the Florida Medicaid Program, and Federal laws and regulations. Petitioner, pursuant to its contract with the Agency, agreed to only seek reimbursement from the Medicaid program for services that were "medically necessary" and "Medicaid compensable." The Audit In mid-1996, the Agency, pursuant to its statutory responsibility, advised Petitioner that it intended to audit Petitioner's paid Medicaid claims for the alleged medical services it provided between July 1, 1994 and June 30, 1996. In September 1996, the Agency conducted an initial audit site visit, and randomly selected 61 patient files for review. The complete patient files, provided by Petitioner, were reviewed by Sharon Dewey, a registered nurse consultant and Agency employee, as well as Dr. Solenberger, a physician consultant and Agency employee. In accordance with its procedure, the Agency determined that Petitioner had submitted a total of 580 claims for reimbursement relating to the 61 patient files and had received full payment from the Medicaid program for each claim. On March 3, 1997, the Agency issued a Preliminary Agency Audit Report (PAAR), and advised Petitioner that it had over-billed Medicaid and received an overpayment from the program. Shortly thereafter, the Agency auditors, Dr. Solenberger and Ms. Dewey, met with Frank Colavecchio, Petitioner's Corporate Representative, and discussed the Medicaid violations alleged in the review. During the meeting, the Agency requested Mr. Colavecchio to instruct Petitioner's staff physicians to review their records and provide a written rebuttal to the Agency's initial determinations. Within days, and prior to any further action, the Agency placed the audit on indefinite hold. The Agency decided to delay the audit until certain proposed legislation relating to peer review and the integrity of the Medicaid reimbursement program was enacted. Two years later, Section 409.9131, Florida Statutes, was enacted during the 1999 legislative session and became law. Shortly thereafter, in 1999, the Agency hired Dr. Larry Deeb, a board-certified, practicing pediatrician, to perform a peer review of Petitioner's practices and procedures. Dr. Deeb has performed similar medical records reviews for the Medicaid program since 1981 and possesses a thorough understanding of CPT coding and the EPSDT requirements. Dr. Deeb received the medical files provided by Petitioner, and reviewed each patient file in the random sample, including the medical services and Medicaid-related claim records. On November 11, 1999, Dr. Deeb completed his peer review of 564 of the 580 claims provided in the random sample and forwarded his findings to the Agency. Dr. Deeb advised the Agency that 16 reimbursement claims involved adult patients and he therefore did not review them. Utilizing Dr. Deebs findings, the Agency employed appropriate and valid auditing and statistical methods, and calculated the total Medicaid overpayment that Petitioner received during the two year audit period. On July 17, 2000, approximately four years after the original audit notification, the Agency issued its Final Agency Audit Report (FAAR). The Agency advised Petitioner that, based upon its review of the random sample of 61 patients for whom Petitioner submitted 580 claims for payment between 1994 and 1996, Petitioner received $875,261.03 in total overpayment from the Medicaid program during the audit period. Petitioner denied the overpayment and requested a formal administrative hearing. Following the initial commencement of the final hearing in this matter in December 2001, Dr. Deeb, again, reviewed the disputed claims and modified his opinion relating to 6 claims. Thereafter, the Agency recalculated the alleged overpayment and demanded Petitioner to pay $870,748.31. The Allegations The Agency alleges that specific claims submitted by Petitioner, which were paid by the Medicaid program, fail to comply with specific Medicaid requirements and therefore must be reimbursed. Since its inception, the Medicaid program has required providers to meet the Medicaid program's policies and procedures as set forth in federal, state, and local law. To qualify for payment, it is the provider's duty to ensure that all claims "[a]re provided in accord with applicable provisions of all Medicaid rules, regulations, handbooks, and policies and in accordance with . . . state . . . law." Section 409.913(5)(e), Florida Statutes (1993). Medicaid manuals are available to all Providers. Petitioner, as a condition of providing Medicaid services pursuant to the Medicaid program, is bound by the requirements and restrictions specified in the manuals, and under the contract, is required to reimburse the Medicaid program for any paid claims found to be in violation of Medicaid policies and procedures. The evidence presented at hearing established that Petitioner frequently violated various Medicaid policies and procedures. First, Petitioner repeatedly failed to comply with Section 10.9 of the Medicaid Physician's Provider Handbook, (MPPH), and Sections 409.905(9), 409.913(5)(e), 409.913(7)(e), and 409.913(7)(f), (1993, 1994 Supp. 1995, and 1996), Florida Statutes, which require all medical services to be rendered by, or supervised by a physician, and attested to by the physician's signature. Medical records reflecting services for paid claims must be physician signature certified and dated, or the services are not defined as physician's services. In addition, Petitioner routinely failed to correctly document the provision of certain physician's assistant (P.A.) Medicaid services that require the personal supervision of a physician or osteopath. See Chapter 1 of the Physician Assistant Coverage and Limitations Handbook, March 1995, and Appendix D (Glossary) in the Medicaid Provider Reimbursement Handbook, HCFA-1500 (HCFA-1500). In addition, Petitioner failed to comply with Medicaid regulations that require an approved physician to be present in the facility when certain P.A. services are delivered and to attest to it by signature within twenty-four hours of service. See Section 11.1 of the MPPH, effective July 1994, and Sections 409.905, and 409.913 (1993, 1994 Supp., 1995, and 1996 Supp.), Florida Statutes. The evidence presented at hearing also demonstrates that Petitioner repeatedly violated specific record keeping requirements located in Section 10.9 of the MPPH, Sections 10.6 and 11.5 of the Medicaid EPSDT Provider Handbook (EPSDT), and Sections 409.913(5)(e), 409.913(7)(e), and 409.913(7)(f), (1993, 1994 Supp., 1995, and 1996), Florida Statutes. In addition, the Agency demonstrated that Petitioner occasionally failed to document support for the necessity of certain services or simply billed for services that were not medically necessary. As indicated, Medicaid policy limits a physician to bill only for services that are medically necessary and defines the circumstances and varying levels of care authorized. In fact, Section 11.1 of the MPPH, effective July 1994, provides in part: The physician services program pays for services performed by a licensed physician or osteopath within the scope of the practice of medicine or osteopathy as defined by state law . . . . The services in this program must be performed for medical necessity for diagnosis and treatment of an illness on an eligible Medicaid recipient. Delivery of all services in this handbook must be done by or under the personal supervision of a physician or osteopath . . . at any place of service . . . . Each service type listed has special policy requirements that apply specifically to it. These must be adhered to for payment. The manual further provides clear guidelines defining authorized services for reimbursement which Petitioner apparently overlooked. For example, the manual defines the four types of medical history exams that Medicaid providers may conduct, the nature of the problems presented, and the appropriate and authorized tests. The manual also identifies the varying degrees of medical decision-making complexity related to Medicaid services and provides instructions relating to the method of selecting the correct evaluation and management code for billing. Petitioner consistently violated coding restrictions. Moreover, the Medicaid policy manual also outlines the specific procedures and billing requirements necessary for seeking payment for medical services including the early periodic screening for diagnosis and treatment (EPSDT) services. Chapter 10 and 11 of the MPPH specifically state that services that do not include all listed components of the EPSDT are not defined as an EPSDT, and upon audit, the Agency re-calculated Petitioner's medical services at the appropriate procedure code. Stipulation Prior to the commencement of the hearing, the parties stipulated that certain paid claims were correctly determined by the Agency to be overpayments. Specifically, the parties agreed that portions of samples 1, 3, 14, 21, 28, 41, 46, 47, 51, 53, and 56 could not be claimed for reimbursement since lab services which are part of an office visit reimbursement and/or lab service fees performed by an independent outside lab are not permitted. In addition, the parties agreed that specific portions of samples 1, 13, 14, 27, 28, 33, 35, 43, 46, 47, 52, 53, and 55 could not be claimed since Modifier 26 billing, the professional component, is only appropriate when the service is rendered in a hospital and Petitioner's services were rendered in an office. Pediatric Sample With regard to the random sample of pediatric files, upon careful review, the evidence presented at hearing sufficiently demonstrates that Petitioner was overpaid the following amounts on the following paid claims for the following reasons: The prolonged physician's services billed to Medicaid were not documented as having been provided or medically necessary. Cluster Number Date of Service Procedure Code Billed and Paid Overpayment 1 1/18/1996 99354 $ 36.64 1 5/14/1996 99354 $ 36.64 13 9/25/1995 99354 $ 36.64 19 9/28/1994 99354 $ 39.50 21 12/18/1995 99354 $ 36.64 28 3/06/1995 99354 $ 36.64 42 6/04/1996 99354 $ 36.64 43 12/19/1994 99354 $ 36.64 47 9/28/1994 99354 $ 39.50 47 10/17/1995 99354 $ 36.64 51 4/05/1995 99354 $ 36.64 53 11/02/1995 99354 $ 36.64 56 5/01/1996 99354 $ 36.64 The level of care billed to and reimbursed by Medicaid at the 99215 office visit procedure code level was improper since the level of care provided was at the 99213 office visit procedure code level. Cluster Number Date of Service Overpayment 1 9/14/1995 $ 34.14 1 1/18/1996 $ 34.14 1 5/14/1996 $ 34.14 33 9/28/1994 $ 20.00 47 10/17/1995 $ 34.14 The level of care billed and paid at the 99215 office visit procedure code level was improper since the level of care that was provided was at the 99214 office visit procedure code level. Cluster Number Date of Service Overpayment 53 5/31/1995 $ 21.69 The level of care billed and paid at the 99205 office visit procedure code level was improper since the level of care that was provided was at the 99204 office visit procedure code level. Cluster Number Date of Service Overpayment 25 7/27/1994 $ 2.00 The level of care that was billed and paid at the 99205 office visit procedure code level was improper since the level of care that was provided was at the 99203 office visit procedure code level. Cluster Number Date of Service Overpayment 35 5/11/1995 $ 37.96 51 12/08/1994 $ 15.00 55 11/21/1995 $ 37.96 58 9/22/1995 $ 37.96 The level of care that was billed and paid at the 99215 office visit procedure code level was improper since the level of care that was provided was at the 99204 office visit procedure code level. Cluster Number Date of Service Overpayment 43 12/11/1994 ($ 3.00) credit The level of care that was billed and paid at the 99205 office visit procedure code level was improper since the medical services provided and documentation supported an EPSDT visit. Cluster Number Date of Service Overpayment 53 2/06/1995 $ 16.53 The required components of the EPSDT were not documented as being performed at the office visit that had been claimed and paid as an EPSDT and therefore, the difference between the EPSDT payment received and the value of the procedure code for the documented level of office visit that occurred (i.e., 99214, 99213, 99212, 99211, or 99203), is deemed an overpayment. Cluster Number Date of Service Level of Visit Overpayment 1 7/28/1995 99213 $ 39.82 3 6/28/1995 99213 $ 39.82 5 3/03/1995 99203 $ 21.43 6 7/07/1994 99213 $ 5.00 10 8/17/1995 99212 $ 43.82 12 1/31/1996 99204 $ 0.00 14 5/31/1995 99213 $ 39.82 18 10/04/1994 99213 $ 5.00 18 1/29/1996 99214 $ 27.37 20 8/25/1994 99213 $ 5.00 21 12/11/1995 99214 $ 27.37 29 8/17/1994 99212 $ 9.00 Cluster Number Date of Service Level of Visit Overpayment 29 9/06/1995 99213 $ 39.82 40 7/25/1994 99203 $ 0.00 41 5/06/1996 99214 $ 27.37 46 9/19/1994 99213 $ 5.00 46 10/19/1995 99213 $ 39.82 47 11/02/1994 99213 $ 5.00 51 9/07/1995 99213 $ 39.82 53 7/10/1995 99213 $ 39.82 53 1/19/1995 99213 $ 39.82 59 5/02/1996 99203 $ 43.39 Adult Samples At hearing, Petitioner disputed all of the Agency's findings relating to patients over the age of 21 and objected to Dr. Deeb, a pediatrician, performing any review of their files. While Dr. Deeb is not the appropriate peer to review adult patient files, the following adult claims did not require substantive peer review and resulted in overpayment due to the stated reason: There were not any medical records in existence to indicate that any medical services were performed. Cluster Number Date of Service Procedure Code Billed and Paid Overpayment 2 2/20/1995 99215 $ 53.00 2 7/11/1995 99215 $ 59.14 2 8/09/1995 99215 $ 57.14 2 9/07/1995 99213 $ 23.00 2 10/11/1995 99213 $ 23.00 2 1/02/1996 99213 $ 23.00 2 3/22/1996 73560/Rad.Ex. $ 16.36 2 4/01/1996 99215 $ 57.14 2 4/05/1996 99213 $ 23.00 2 4/23/1996 99213 $ 23.00 15 2/16/1996 99213 $ 23.00 15 2/19/1996 99215 $ 57.14 16 5/14/1996 Blood Count $ 8.00 Cluster Number Date of Service Procedure Code Billed and Paid Overpayment 16 5/14/1996 UA $ 3.00 16 5/14/1996 99215 $ 57.14 23 7/28/1994 99213 $ 23.00 23 5/09/1995 72069/26 Rad.Ex. $ 6.98 23 5/09/1995 72069/Rad.Ex. $ 17.45 23 10/20/1995 99213 $ 23.00 34 4/24/1996 99214 $ 35.45 57 11/17/1995 99215 $ 59.14 60 4/10/1996 99215 $ 57.14 61 5/22/1995 99213 $ 23.00 The medical records failed to contain the required physician's signature and date authenticating the fact that the services billed were performed by either P.A. Olsen or P.A. Avidon under physician supervision. The services provided by the non-physician employee were reviewed and down-coded by the Agency to the appropriate level physician's office visit code. Cluster Number Date of Service Proc. Code Pd./ P. Code Allowed Overpayment 2 6/30/1995 99215/99212 $ 36.14 2 7/20/1995 99215/99213 $ 34.14 2 7/28/1995 99215/99213 $ 34.14 2 9/05/1995 99215/99212 $ 36.14 8 4/17/1995 99205/99203 $ 35.96 17 3/27/1995 99205/99203 $ 35.96 23 5/09/1995 99215/99213 $ 32.14 23 6/09/1995 99215/99213 $ 32.14 34 4/23/1996 99205/99203 $ 35.96 The medical records failed to contain the required physician signature authenticating the fact that the services were provided by a physician. The services provided were reviewed and down-coded by the Agency to the appropriate level physician's office visit code. Procedure Code Cluster Number Date of Service Billed and Paid Overpayment 2 6/14/1995 99215/99211 $ 45.14 16 5/15/1996 99215/99211 $ 45.14 61 5/05/1995 99205/99204 $ 14.53 The provider improperly sought payment for lab services that were part of the office visit reimbursement and/or lab services performed by an independent outside lab. Cluster Number Date of Service Procedure Billed and Paid Overpayment 2 3/08/1996 UA $ 3.00 2 4/03/1996 UA $ 3.00 15 2/08/1996 UA $ 3.00 16 5/15/1996 Blood Count $ 8.50 16 5/15/1996 Blood Count $ 8.00 The provider improperly sought payment for Modifier 26 billings (professional component) which are only appropriate when the service is rendered in a hospital. Cluster Number Date of Service Procedure Billed and Paid Overpayment 2 2/17/1995 Radiologic exam $ 6.98 2 6/14/1995 Radiologic exam $ 7.20 8 4/17/1995 Tympanometry $ 9.00 16 5/13/1996 Radiologic exam $ 5.45 16 5/15/1996 Radiologic exam $ 6.98 In addition to the policy and procedural violations, Petitioner, in egregious violation of the Medicaid program, admittedly submitted Medicaid claims for the services of specialist physicians (such as an allergist, OB/GYN, podiatrist, psychologists, and ophthalmologists) not within its Provider group, collected Medicaid funds based on those claims, and reimbursed the respective specialist. While Petitioner's corporate representative, Mr. Colavecchio, was admittedly responsible for the coding and billing of the Medicaid services submitted for reimbursement, he was minimally aware of the Medicaid policy requirements and possessed limited working knowledge of CPT coding and EPSDT billing. In addition, Petitioner's employees, Dr. Keith Wintermeyer and Dr. Marcia Malcolm, were only moderately familiar with the CPT coding and EPSDT component requirements. They provided little input to Petitioner regarding CPT coding and the sufficiency of certain physician's services relating to EPSDT billing.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency re-calculate the overpayment consistent with the Findings of Fact, and include only those identified violations in the cluster samples of the adult patient files, and issue a Final Order requiring Petitioner to reimburse, within 60 days, the Agency for the Medicaid overpayments plus any interest that may accrue after entry of the Final Order. DONE AND ENTERED this 14th day of February, 2003, in Tallahassee, Leon County, Florida. WILLIAM R. PFEIFFER 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 February, 2003. COPIES FURNISHED: Susan Felker-Little, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308 Charles D. Jamieson, Esquire Ward, Damon & Posner, P.A. 4420 Beacon Circle West Palm Beach, Florida 33407 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308

Florida Laws (8) 120.5716.53261.03409.905409.907409.913409.91317.20
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AGENCY FOR HEALTH CARE ADMINISTRATION vs DR. ANTHONY J. GENTILE, 07-001891MPI (2007)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Apr. 30, 2007 Number: 07-001891MPI Latest Update: Jan. 11, 2025
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WESTCHESTER PHARMACY vs DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 89-007004 (1989)
Division of Administrative Hearings, Florida Filed:Miami, Florida Dec. 21, 1989 Number: 89-007004 Latest Update: Jan. 18, 1991

Findings Of Fact The Parties The Petitioner is the state agency that administers the Florida Medicaid program, which includes pharmacies that participate in the program. The Petitioner's Office of Program Integrity is responsible for insuring that the goods and services billed to the Medicaid program are those that are actually provided to Medicaid recipients. Medicaid is a joint program, funded by the federal government and by the State of Florida, and is administered pursuant to both state and federal statutes and rules. All services or goods billed to the program must be necessary, Medicaid compensable, and must also have actually been provided to eligible recipients by providers prior to submitting claims. Any payment made by the Medicaid program for goods or services not actually provided to an eligible recipient is subject to recoupment by the Petitioner, and the provider is also subject to the imposition of administrative fines and exclusion from the program for a specified period of time. The Respondent is a community pharmacy located in a hispanic section of Miami, Florida, which has been owned and operated for the past six years by Frances Larin, a licensed pharmacist, who makes all drug purchases and does all Medicaid billings at the pharmacy herself. Most of Respondent's customers have limited financial resources and are Medicaid recipients. The Respondent has participated in the Medicaid program for approximately eight years, and has not previously been charged with overbilling the Medicaid program. The Respondent has cooperated fully with the Petitioner throughout these proceedings. Prior Review From February to April 1988, the Petitioner's Office of Program Integrity had a review performed of the Respondent's billings to Medicaid from March 1, 1987 to December 31, 1987. This review was conducted for the Petitioner by the Foundation for Health Care, Inc. (Foundation), contract auditors, and resulted in the determination that the Respondent had overbilled the Medicaid program for prescription drugs dispensed to program recipients during the review period. In performing this review, the Foundation used an across-the-board Medicaid percentage of 54% in determining the available units of the various drugs on hand for dispensing to Medicaid recipients. Based upon the Foundation's review, the Petitioner sought recoupment for overpayments in the amount of $28,649.99 by letter to the Respondent dated July 20, 1988, as well as an administrative fine of $7,162.49, and a three month suspension from the program. The Respondent timely sought a formal administrative hearing in which it disputed the results of the Foundation review. However, after the matter was referred to the Division of Administrative Hearings, the Petitioner withdrew its notice of overpayment and imposition of administrative sanctions, and thus, without a determination on the merits, the Division of Administrative Hearings file was closed and jurisdiction was relinquished to the Petitioner. Subsequently, the Petitioner entered a Final Order which provided that the Respondent would be re-audited. The Respondent timely sought judicial review of this Final Order in which it challenged that Petitioner's right to conduct a further review of the period March 1, 1987 to December 31, 1987. However, the District Court of Appeal of Florida, Third District, dismissed the Respondent's appeal, and the Petitioner proceeded with a further review. The KPMG Review (a) For purposes of its further review, the Petitioner employed the public accounting and management consulting firm of KPMG Peat Marwick which designed a statistically valid sampling methodology to determine the Respondent's Medicaid percentage for each drug, and also to perform a management review of the Respondent. It was established by competent substantial evidence in the record, and in particular by the expert testimony in statistics from Dr. Robert Ladner and Robert Peirce, that the KPMG methodology was statistically valid. The KPMG review was conducted during the latter half of 1989, and included developing a Medicaid percentage for individual drugs based upon an analysis of prescriptions for all drugs in question to determine the portion of each drug's total sales that went to Medicaid recipients, calculating the total units claimed for each drug for which the Respondent sought reimbursement during the audit period, and calculating the total units purchased by the Respondent for each drug claimed for reimbursement during the audit period. The Medicaid percentage of each drug was then applied to total purchases for each specific drug to determine the amount of each drug that was on hand at the Respondent's pharmacy for dispensing to Medicaid recipients. This number of available units was then compared with the total units claimed for reimbursement. Where the units claimed exceeded the units available for dispensing, a positive variance was noted, and this number of excess units claimed was then multiplied by the per unit reimbursement amount for that particular drug in order to obtain the amount of the apparent overbilling for that particular drug. Where the total units available for dispensing exceeded the total units claimed for a particular drug, a negative variance was noted. It was stipulated by the parties that negative variances did not indicate underpayments, and the evidence, including specifically the testimony and report of Dr. Victor Pestien, an expert in statistics, does not establish that such negative variances should be offset against the positive variances or that they in any way reduce the positive variances. This is the first instance in which this methodology has been utilized by the Petitioner in seeking a recoupment of an alleged Medicaid overpayment from a pharmacy, and this methodology was not set forth in any rule or regulation of the Petitioner that had been adopted at any time material hereto. Previous audits used an overall Medicaid percentage to calculate the portion of a pharmacy's business that was comprised of Medicaid recipients, and the quantity of drugs that were available to them. Using a drug specific Medicaid percentage, however, is a more accurate and conservative approach to determining overpayments than using a fixed percentage. Based upon the consideration of all evidence in the record, it is specifically found that the greater weight of evidence establishes that the methodology used by KPMG in this review for calculating Medicaid percentages was sound and reasonable, and in no way precluded the Respondent from presenting additional competent substantial evidence to the Petitioner, or at hearing, which would have established different Medicaid percentages for particular drugs. (a) The type of review conducted by KPMG is known as an aggregate analysis, a generally accepted type of statistical analysis, in which drugs that have been billed to and paid for by the Medicaid program are reviewed to determine whether the pharmacy under review purchased or otherwise acquired a sufficient quantity of drugs to justify its billings to Medicaid. Interchangeable brand-name drugs and generic equivalents were grouped together so that in conducting this review, whole equivalent groups of drugs were considered as one type of drug, regardless of differences in individual product names. To obtain a statistically random sample, prescriptions were put in numerical order and every fourth prescription for the review period was examined, and since prescriptions may be refilled for up to a year after they are originally filled, reviewers also examined every prescription for the year prior to the review period. Competent substantial evidence establishes that KPMG performed an appropriate and valid statistical analysis, and that they used an acceptable sampling methodology which produced a truly random result. The underlying assumption of this analysis is that before a drug can be claimed to have been dispensed and billed to Medicaid, the pharmacy under review must have that drug in its possession. (b) The approach taken by KPMG and the Petitioner was to be as conservative as possible in resolving all uncertainties and questions which arose during the course of this review in favor of the Respondent. KPMG did not conduct a financial audit of the Respondent, but did prepare a management report based upon its review of Respondent's operations during the audit period. Data used by KPMG in its methodology in calculating the amount paid by Medicaid to the Respondent, the unit price of drugs dispensed, and the quantity claimed by Respondent for payment by Medicaid, was derived from computer based information provided by the Petitioner's fiscal agent. During the period of time being reviewed in this case, Electronic Data Systems (EDS) was the Petitioner's fiscal agent, while Consultec was the Petitioner's fiscal agent during the period when the KPMG review was actually being performed. When Consultec was selected as the Petitioner's fiscal agent and replaced EDS on January 1, 1989, EDS turned over its computer records to the new agent by copying all of its magnetic, computer files, along with supporting microfiche documentation, which it then provided to Consultec under the supervision of the Petitioner. Upon receipt of these magnetic tapes, Consultec placed them in a controlled environment vault, and then later converted the information on these tapes to a new format used by Consultec. It was established by competent substantial evidence that in this process, no data was added, deleted or changed in any manner. The "units claimed" data was subsequently provided by computer download from the Consultec claims data base directly to the Petitioner's Office of Program Integrity. It was established by competent substantial evidence that data regarding claims which originated with EDS passed through Consultec to the Petitioner's Office of Program Integrity unchanged. Specific information regarding Respondent, including the claimed quantity of drugs dispensed and amounts paid, was accessed by staff in the Office of Program Integrity, randomly verified, and then made available to KPMG. Both Consultec and EDS are nationally recognized data processing and management companies. Competent substantial evidence established that the claims processing function utilized by the Petitioner in the Medicaid program during the period at issue was subject to several quality control checks to insure that claims were properly processed and appropriate payments were made. On occasion claim adjustments were made, but these were reasonable and for good cause, such as a substantiated underpayment. The computer hardware utilized in this process was reliable and properly maintained. In order to verify the data used by KPMG concerning the dollar amount of claims paid and the quantity of units of medication claimed, an "audit trail" was performed using 140 randomly selected sample claims by tracing each claim from its claim reference number to its associated remittance voucher and cancelled checks, where available. This audit trail verified that the data used as the basis for quantity claimed and total dollars paid was valid and reliable. The KPMG review was not limited to the top 100 drugs, by volume claimed, during the audit period, but included each drug dispensed by the Respondent to Medicaid recipients during the audit period. In its report dated November 20, 1989, KPMG calculated a total Medicaid overpayment to Respondent of $30,452.59, and based thereon, the Petitioner notified the Respondent that it was seeking recoupment of this amount, as well as an administrative fine of $2,000 and termination from the Medicaid program for at least two years. Subsequently, however, the Petitioner and KPMG reviewed and considered additional invoices documenting additional purchases of drugs in question by the Respondent during the audit period, and prepared a revised report dated August 30, 1990. Based upon this revised report, the Petitioner sought recoupment of a revised, reduced overpayment calculated to be $21,939.93, as well as a $2,000 administrative fine and a minimum two year termination from the program, and it was on this basis that this matter proceeded to final hearing. The Top 100 Drugs Subsequent to the final hearing, the Petitioner issued an amended recoupment letter dated October 17, 1990, which limited the recoupment it is seeking in this matter to the top 100 drugs, by dollar volume of claims, plus their generic equivalents. This resulted in the elimination of many individual drugs with relatively small overpayments from the list of overpayments, and left only five instances among these top 100 drugs where the difference between the quantity available, adjusted for standard error, and the quantity claimed is less than 100 units. In many instances the difference is well in excess of 1,000 units. The sanctions being sought in this amended recoupment letter further reduced the recoupment being sought to $12,643.11, reduced the administrative fine to $1,400, and reduced the period of exclusion from the program that is being sought to 16 months. However, due to an error in calculating the top 100 drugs and equivalents, the Petitioner issued a second amended recoupment letter dated October 26, 1990, further reducing the administrative fine sought to $1,200 and reducing the period of exclusion to 14 months. Inventory Analysis In performing its review, KPMG obtained information concerning the quantities of drugs purchased during the review period by the Respondent directly from the pharmacy's wholesalers and from a review of invoices retained by the Respondent for a period that included one month prior to the review period through one month after the review period (February 1, 1987, to January 31, 1988). The effect of seasonal variations in pharmacy sales and ordering patterns was also taken into account, and balanced, by extending this period to a full twelve months. All documentation concerning drug acquisitions was requested from Respondent, and the information received and considered by KPMG and the Petitioner was checked for reasonableness by a consultant pharmacist and cross validated by two reviewers. It was stipulated by the parties that the Respondent's main wholesaler, Gulf Distribution, Inc., had and maintained accurate information and records regarding its sales to the Respondent, and that it properly transferred that information to computer disks which were provided to KPMG. Subsequent thereto, additional invoices were discovered and were also made available to KPMG. The Petitioner stipulated that these additional invoices from Gulf did not reduce the number of drug units purchased by, and invoiced to, Respondent. Pharmacies in Florida which choose to participate in the Medicaid program are required to maintain complete and accurate patient and fiscal records which fully substantiate the extent of services rendered and billings made for a period of five years from the date of billing or service, and are also required to retain all invoices from wholesalers, or from the transfer or receipt of drugs through barter or exchange, for a period of five years. (a) Actual beginning and ending inventories of the top 100 drugs reviewed by KPMG for which the Petitioner now seeks recoupment in the amount of $12,643.11 were not determined. Rather, an estimate of inventory on hand was derived by counting invoices of all drug acquisitions through purchase, transfer or exchange made by the Respondent during the review period, as well as invoices of acquisitions made one month prior to and one month after the review period. Additionally, all documentation provided by the Respondent of bulk, or large, acquisitions made during or prior to the review period was also considered and included in the Petitioner's estimate of inventory. It was established by competent substantial evidence that pharmacies generally keep a drug inventory consisting of a two to two-and-a-half week supply on hand, and acquire drugs in anticipation of future sales rather than as a replacement of inventory depletion from past sales. Therefore, a basic assumption of the KPMG methodology, relied upon and accepted by the Petitioner, that Respondent had only those drugs available for dispensing which were obtained by invoiced purchase from wholesalers, or through transfer or exchange, between February 1, 1987 and January 31, 1988, as well as documented invoiced bulk purchases prior to this time period, is reasonable. At hearing, the Respondent established that a significant quantity of nine specific drugs were purchased during the review period from suppliers other than Gulf that were not considered by KPMG. These drugs include Xanax (.5 mg.), Inderal (10 mg.), Tagamet (300 mg.), Nitrostat (.4 mg.), Trental (400 mg.), Motrin (400 mg.), Motrin (600 mg.), Quinamm (260 mg.), and Quinidine Sulfate (200 mg.). It is, therefore, found that the overpayment of $2,902.19 calculated by KPMG and relied upon by the Petitioner for these particular drugs has not been supported by competent substantial evidence. Frances Larin, Respondent's owner and operator, testified that she did not follow the generally accepted practice of retaining only a two to two-and-a- half week supply of drugs on hand. Rather, she testified that for a significant number of the top 100 drugs at issue in this proceeding, she would purchase large quantites in bulk, and was thus able to draw down on these inventories without making additional purchases of particular drugs for over a year. The Respondent sought to establish that due to very large beginning inventories of particular drugs at issue, it was able to legitimately dispense more units during the review period than it purchased during the same time. However, the Respondent did not produce evidence in support of its position, such as invoices for bulk purchases which KPMG or the Petitioner did not consider, or complete records of bartering or transfers which had not been considered, and which would have supported its claim of a significantly larger beginning inventory for these particular drugs than would be the generally accepted practice. To the contrary, competent substantial evidence in the record, as well as the demeanor of Larin while testifying, establishes that Respondent's claim is unreasonable and lacks credibility. The deposition testimony of JoAnn Padell is outweighed by the testimony of Deborah Launer, Susan McCleod, and Robert Peirce. A review of the Respondent's purchasing patterns clearly shows that Respondent generally and routinely kept low inventories of drugs on hand, placing daily orders with Gulf to obtain drugs on an as-needed basis. Recoupment Based upon the foregoing, it is found that competent substantial evidence establishes that the Respondent overbilled the Medicaid program during the review period at issue in this case in the amount of $9,740.92 ($12,643.11 claimed in the second amended recoupment letter minus the $2,902.19 claim associated with the nine specific drugs for which significant purchases were omitted from the KPMG review, as found above at Finding 13). Petitioner is authorized to recoup the established overpayment of $9,740.92 from the Respondent. Sanctions (a) In determining the sanctions stated in the second amended recoupment letter which Petitioner seeks to impose upon the Respondent, the Petitioner considered the provisions of Section 409.266(13), Florida Statutes, as well as the impact which sanctioning this Medicaid provider would have upon Medicaid recipients. Competent substantial evidence establishes that there are eight pharmacies which accept Medicaid within a one mile radius from the Respondent's location, and twenty-six such pharmacies within a two mile radius. Medicaid recipients are issued new cards each month and may transfer pharmacies at the beginning of each month. Therefore, it is found that Medicaid recipients would not be substantially affected by the imposition of sanctions upon the Respondent. The parties stipulated that the sanction matrix set forth in Rule10C- 7.063, Florida Administrative Code, was not applied by the Petitioner against the Respondent in this case because it was not in effect at the time of this review. The sanctions which the Petitioner seeks to impose against the Respondent, therefore, are based upon non-rule policy which must be explicated in this proceeding. In seeking to explicate its non-rule policy upon which the sanctions set forth in the second amended recoupment letter are based, the Petitioner established that it was concerned that sanctions imposed in prior cases, as well as in the original recoupment letter which had been sent to the Respondent in this case, had been too lenient in view of the seriousness of Medicaid violations. The Petitioner developed its non-rule sanctions policy after the KPMG review had been completed, and based its proposal upon the maximum sanctions set forth in state and federal statutes and rules. Specifically, Section 409.266(12), Florida Statutes, provides for a maximum fine of $10,000; the maximum exclusion period applied in previous cases by the Office of Program Integrity is ten years, and the minimum exclusionary period imposed by the federal government has been five years for the failure to supply payment information. At hearing, the Petitioner explained that it first determined the percent of Respondent's total Medicaid payments that the overpayment represented, and then applied that percentage to these maximum sanctions allowed under law and existing policy. The overpayment of $12,643.11 claimed by the Petitioner in its second amended letter of recoupment is 12% of the total payment of $100,397.88 made by the Petitioner to Respondent for the review period, and 12% of the maximum fine and exclusion period is $1,200 and 14 months, respectively. While the Petitioner explained the manner by which this exclusionary period and fine were calculated, it did not explicate its non-rule policy by establishing a reasonable, rational basis for applying the percentage of Medicaid overbillings to the maximum fine and exclusionary period. Certainly, the arithmetic calculation used to arrive at these proposed sanctions is clear, but there was no explication through competent substantial evidence which would establish that there is a basis in fact or logic for this calculation. Therefore, it is found that the Petitioner's non-rule policy used to propose these sanctions is arbitrary and capricious. Due to the lack of any evidentiary basis in the record which would support the imposition of the sanctions of an administrative fine or a period of exclusion from the Medicaid program, the Petitioner is not authorized to impose sanctions on the Respondent.

Recommendation Based upon the foregoing, it is recommended that Petitioner enter a Final Order which requires that Respondent to repay the Petitioner for Medicaid overbillings in the amount of $9,704.92, but which does not impose sanctions consisting of either an administrative fine or period of exclusion. DONE AND ENTERED this 18th day of January, 1991 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 18th day of January, 1991. APPENDIX TO RECOMMENDED ORDER Rulings on the Petitioner's Proposed Findings of Fact: Adopted in Finding 1. Adopted in Finding 2. Adopted in Finding 3. Adopted in Finding 1. Adopted in Finding 4. Adopted in Findings 4 and 5. 7-10. Adopted in Findings 6 and 7, but otherwise Rejected as unnecessary. 11-17. Rejected as unnecessary. 18-20. Adopted in Findings 6 and 7. 21-24. Adopted in Finding 12. 25. Adopted in Finding 2. 26-28. This is a conclusion of law and not a proposed finding. 29-30. Adopted in Finding 8. 31-32. Adopted in Findings 7 and 10. Adopted in Finding 6. Rejected as unnecessary. 35-39. Adopted in Finding 7. 40-47. Adopted in Finding 7, but otherwise Rejected as unnecessary. 48. Rejected as unnecessary and immaterial 49-51. Adopted in Finding 7, but otherwise Rejected as unnecessary. 52-53. Rejected as unnecessary. 54-63. Adopted in Finding 12, but otherwise Rejected as unnecessary. Adopted in Finding 8. Adopted in Finding 9. 66-67. Adopted in Finding 8, but otherwise Rejected as unnecessary. 68-69. Adopted in Finding 9. 70-78. Adopted in Finding 8, but otherwise Rejected as unnecessary. 79-82. Adopted in Finding 8. 83-85. Rejected as unnecessary. 86-93. Adopted in Finding 13, but otherwise Rejected as unnecessary. 94-97. Adopted in Finding 14, but otherwise Rejected as unnecessary. 98-103. Adopted in Finding 14. 104-105 Rejected as unnecessary and immaterial. 106-107 Adopted in Finding 12. 108. Adopted in Findings 12 and 13. 109-112 Rejected as unnecessary and immaterial. 113-115 Adopted in Finding 13, but otherwise Rejected as immaterial. This is a conclusion of law and not a proposed finding. Adopted in Finding 11. 118-119 Rejected as unnecessary and immaterial 120-122 Adopted in Finding 11. Rejected as unnecessary. Adopted in Finding 6. 125-128 Rejected as unnecessary. 129. Adopted in Finding 6. 130-132 Adopted in Finding 9. Adopted in Finding 11. This is a conclusion of law and not a proposed finding. 135-147 Adopted in Finding 16, but otherwise Rejected as unnecessary and immaterial. 148. Adopted in Finding 11. 149-150 Adopted in Finding 16, but otherwise Rejected as unnecessary. 151-152 Rejected as unnecessary. 153. Rejected as unnecessary and cumulative. Rulings on the Respondent's Proposed Findings of Fact: 1. Adopted in Finding 4. 2-3. Adopted in Finding 5, but otherwise Rejected as unnecessary and not based on competent substantial evidence. 4-5. Adopted in Findings 3, 6 and 7. 6-7. Adopted in Finding 10, but otherwise Rejected as unnecessary. 8-9. Adopted in Finding 11. 10-11. Adopted in Finding 3, but otherwise Rejected as unnecessary. Adopted in Finding 6. Rejected as immaterial and unnecessary. 14-15. Rejected as argument on the evidence rather than a proposed finding, and otherwise as not based on competent substantial evidence. Adopted in Finding 7, but otherwise Rejected as argument on the evidence rather than a proposed finding. Rejected as repetitive and otherwise as immaterial. Adopted in Finding 13, but Rejected in Finding 14 and otherwise as argument on the evidence rather than a proposed finding and as not based on competent substantial evidence. Rejected in Finding 14, as immaterial, speculative, and as not based on competent substantial evidence. 20-21. Rejected in Finding 6, as immaterial, and as not based on competent substantial evidence. 22-23. Rejected in Findings 13 and 14, and otherwise as immaterial and not based on competent substantial evidence. Rejected as repetitive and otherwise as argument on the evidence rather than a proposed finding. Rejected in Findings 13 and 14. 26-30. Rejected as a statement of the Respondent's position and not a proposed finding, as speculative and contrary to competent substantial evidence, and as totally without citation to authority in the record as required by Rule 22I-6.031(3), Florida Administrative Code. 31-35. Rejected in Finding 6, and as not based on competent substantial evidence and as unnecessary. 36-38. Adopted in Findings 12 and 13. 39-41. Adopted in Finding 8. 42. Rejected as immaterial. 43-44. Rejected in Finding 9. 45. Rejected as simply a summation of testimony and not a proposed finding. 46-48. Rejected in Finding 9, and otherwise as immaterial and not based on competent substantial evidence. 49-50. Rejected as unnecessary and immaterial. 51. Adopted in Finding 16, but otherwise Rejected as immaterial. 52-53. Rejected as unnecessary and immaterial. Rejected as not based on competent substantial evidence. Adopted and Rejected in part in Finding 16. 56-57. Adopted in Finding 16. 58-61. Rejected as immaterial and irrelevant. 62. Adopted and Rejected in part in Finding 15. COPIES FURNISHED: David G. Pius, Esquire Building Six, Room 233 1317 Winewood Boulevard Tallahassee, FL 32399-0700 James J. Breen, Esquire Michael P. Scian, Esquire 900 Sun Bank Building 777 Brickell Avenue Miami, FL 33131 R. S. Power, Agency Clerk 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Linda Harris, Acting General Counsel 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Robert B. Williams, Acting Secretary 1323 Winewood Boulevard Tallahassee, FL 32399-0700

Florida Laws (2) 120.57902.19
# 5
AGENCY FOR HEALTH CARE ADMINISTRATION vs BROWN PHARMACY, 05-003366MPI (2005)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Sep. 16, 2005 Number: 05-003366MPI Latest Update: Oct. 08, 2015

The Issue The issues to be resolved in this proceeding concern whether the Respondent properly maintained and supplied required records to support and document prescription claims, which it billed to Medicaid and for which it received payment from the Medicaid program during the audit period of April 1, 2000 through December 31, 2001. If that is not the case, it must be determined whether the Agency is entitled to recoup from the Respondent the sum it seeks of $108,478.77, as the purported amount overpaid to the Respondent by the Agency. It must also be determined whether the applicable laws and regulations referenced herein were complied with by the Respondent, in terms of its accepting and filling prescriptions, dispensing relevant drugs, and recording and documenting such activities in its pharmacy records. Finally, it must be determined whether the statistical methodologies employed by the Agency, through its audit and investigation of the Respondent, were sufficiently representative and accurate so as to support the calculation of estimated overpayments.

Findings Of Fact The Petitioner is an Agency of the State of Florida charged by the statutes and rules referenced herein with ensuring that proper reimbursement is effected to providers, including pharmacies, by the Medicaid system. Because of its duty to enforce and regulate the Medicaid system, the Petitioner Agency has an audit and oversight function, as well as an enforcement function, to ensure that Medicaid payments and the general operations of the Medicaid system are carried out correctly. It is through this duty imposed by the cited Florida Statutes and rules, as well as the federal regulations it is charged with enforcing, that the Petitioner carried out an audit of the Respondent, Brown Pharmacy, concerning the audit period of April 1, 2000 through December 31, 2001. The Petitioner conducts audits of providers such as Brown in order to ensure compliance with the Medicaid provisions and Medicaid provider agreements. These are called "integrity audits" and are routinely performed by auditors contracted from private firms such as Heritage. Brown Pharmacy (Brown) is licensed in the State of Florida as a pharmacy (license Number PH562). Brown maintained a business location at 312 West 8th Street, Jacksonville, Florida 32206, at times pertinent to this case. During the audit period Brown was an enrolled Medicaid provider authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Agency. The terms of the provider agreement governed the contractual relationship between Brown and the Agency. Pursuant to that provider agreement, Brown was to maintain the Medicaid-related records and documentation for at least five years. Any Medicaid provider, such as Brown, not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. During the audit period, Brown dispensed prescription drugs to Medicaid recipients. Medicaid claims were filed and paid electronically as "point of sale" transactions during the audit period. Each claim reviewed and at issue in this case was a paid Medicaid claim subject to the provider agreement and pertinent regulations. As a condition of participating in the Medicaid program, a Medicaid provider must comply with all provisions of a provider agreement, which is a voluntarily agreement between the Agency and the provider. Those provisions include the provider's agreement to comply with all relevant local, state and federal laws, rules, regulations, licensure laws, bulletins, manuals, and handbooks, etc. The provider must agree to keep and maintain, in a systematic and orderly manner, all Medicaid- related records as may be required by the Agency and make them available for state and federal agencies and review. It must maintain complete and accurate medical, business, and fiscal records that will justify and disclose the extent of goods and services rendered to customers or patients and rendered as billings to the Medicaid system. Florida Administrative Code Rule 59G-4.250 promulgates, as part of the rule, the above-referenced handbook (handbook) which sets out Medicaid polices and rules. The polices and rules govern the rights and responsibilities of drug providers, such as Brown, including coverage and payment methodologies for services and goods rendered to Medicaid recipients and billed to the Medicaid program. The types of records that must be maintained are as follows: Medicaid claim forms, professional records such as patient treatment plans, prior and post authorization information, prescription records, business records, including accounting ledgers, financial statements, purchase and acquisition records etc., tax records, patient counseling information and provider enrollment documentation. Providers who are not in compliance with the Medicaid documentation and record retention policies described in the handbook are subject to administrative sanctions and/or recoupment of Medicaid payments. Medicaid payments for services that lack required documentation and/or appropriate signatures will be recouped. Chapter five of the handbook, in defining overpayment provides that any amount not authorized to be paid by the Medicaid program, whether paid as a result of inaccurate or improper cost reporting, improper claims, unacceptable practices, fraud, abuse or mistake, constitutes overpayment. Incomplete records are records that lack documentation that all requirements or conditions for the providing of services have been met. Medicaid may recoup payments for services or goods when the provider has incomplete records or cannot locate the records. The Agency contracted with Heritage to conduct an on- site audit at Brown. The audit was conducted March 18th through March 20, 2002. Heritage isolated a sample of 205 prescription claims, known as the "judgmental sample" out of a total universe of paid pharmacy claims from Brown totaling 16,727 for the audit period. Heritage also selected 250 random prescription claims out of the remaining total universe of paid pharmacy claims of 16,522, which remained after the 205 judgmental sample claims had been removed or isolated from the remainder of the total claims. With the acquiescence of the Agency, Heritage chose the 205 claims by weighing it in favor of the "high dollar" or more expensive drug prescriptions. Those prescriptions are primarily for HIV and Aids therapy drugs and psychotherapeutic drugs for various mental conditions, including schizophrenia. Weighing of the judgmental sample strongly in favor of the high dollar prescription claims would seem to render the judgmental sample fundamentally unfair against Brown if the judgmental sample had then been extrapolated to the entire universe of claims ($16,727). This was not done, however. The judgmental sample was audited and compiled by doing an actual count and totaling of claim amounts in dollars represented by all the discrepant prescriptions, including all those the Agency and Heritage maintained resulted in "overpayments" to Brown. Therefore, the judgmental sample is an actual number rather than an extrapolated calculation so that weighing the sample in favor of the high dollar prescriptions does not result in an unfair or biased sample, as to the judgmental sample. Because the judgmental sample was drawn from the total pool of audited claims and removed from that claim pool prior to the identification and drawing of the random sample, the two are mutually exclusive and the amounts calculated do not represent a duplication or overlap. Thus the findings from the judgmental sample and then the random sample may be properly added together. The randomly selected claims (random sample) were taken of the remaining 16,522 claims in the audit claim pool after the judgmental sample of 205 claims had been removed. According to the report rendered by Heritage, the 250 randomly selected claims totaled $10,632.59 in paid Medicaid dollars. The Heritage auditors determined that there were 56 discrepant claims out of these which totaled, according to their calculation, $2,450.13 in apparent overpayments. This resulted in an average overcharge per claim of $9.80 (determined by dividing the documented "sanction amount" by the total number of claims in the random sample (250), multiplied by the universe of claims from which the random sample was taken (16,522) which yielded an extrapolated overcharge of $161,924.19. Applying the statistically appropriate 95 percent "one-sided" lower confidence limit of this extrapolation resulted in a purported overpayment extrapolated from the randomly selected claims of $102,700.85. This means that the overpayment amount calculated by Heritage represents an amount statistically 95 percent certain to be the lowest amount overpayment based on the extrapolation of the overpayment represented in the 250 randomly selected claims. The non-extrapolated judgmental findings showed, according to Heritage, that there were 72 discrepant claims. Heritage then determined that, of these, there were $29,381.09 in apparent actual overcharges. The discrepancies determined by Heritage involved the failure to produce documentation of refill authorizations for 80 prescription claims; 31 prescription claims containing an incorrect Medicaid provider number; the failure to produce 12 "hard copy" prescriptions representing 25 claims; four claims that did not have the prescriber's DEA number on the prescription for controlled substances; three claims for prescriptions that did not contain the original date of service; two claims that were billed for quantities greater than that authorized by the physician; one claim that was billed for an incorrect day's supply; one claim that was billed in excess of the maximum allowable quantity of prescription of the drug, set by Medicaid policy; and one prescription claim that was billed for an incorrect prescriber's Medicaid provider number (although this should not be a discrepancy because the correct prescriber was documented in the pharmacy's computer, which the regulations allowed). Additionally, there was one claim billed for a drug different than that prescribed by the physician, according to Heritage in its report. Heritage also conducted an invoice review using utilization reports provided by the Respondent. This was apparently a review of 25 different drugs that purportedly showed that the prorated purchases of those drugs were insufficient to cover the number of units billed to Medicaid for all 25 drugs reviewed, and thus yielded a purported shortage of $87,942.13, representing the amount billed to Medicaid above the amount the records of purchases from suppliers proved that Brown had purchased of those drugs. Based upon the Heritage audit as well as documentation findings and overpayments calculations (see Exhibit 8), the Agency issued a PAAR dated September 27, 2002, determining that Brown had been overpaid $150,036.71 for Medicaid claims during the audit period. That report advised Brown that it was a provisional report only and encouraged Brown to submit any additional information or documentation which might serve to change the overpayment. The report listed examples of documentation that the Agency would consider for a possible reduction in the overpayment amount initially claimed. Thereafter, the Agency agreed to an extension of time for Brown to submit additional documentation and sent a letter to Brown dated October 31, 2003, advising that the audit had been placed in abeyance pending the outcome in a related case, but that the Agency expected to resume the audit and that therefore all Medicaid-related records and documentation regarding paid claims should be maintained and preserved until the audit was finalized. The FAAR was addressed in the testimony of Ms. Stewart for the Agency. Through her testimony it was revealed that certain corrections should be made to the FAAR updating it from the findings in the Heritage initial audit report. The Agency corrected the information in the FAAR for this reason and for the reason that it secured some additional information from the Respondent. Thus, for the audit period it was established that there were 16,727 total claims for prescriptions dispensed by Brown, for which it was paid $795,564.59 during the 21-month audit period, of those claims, 205 were pulled out from the total universe of claims as the judgmental sample. There were some 72 allegedly "discrepant claims" totaling $36,393.51 in dollars paid to Brown. The Agency's position is that $29,381.09 of those are so called "documented overcharges." The random sample of 250 claims was extrapolated to the remaining universe of 16,522 prescription claims. The Agency now takes the position that it found 49 "discrepant claims" in the random sample which totaled $2,154.40 in dollars paid to Brown's pharmacy and of that it maintains that $1,927.55 are "documented overcharges" for the 250 randomly selected claims (for which Brown had been paid $10,632.59). Thus the Agency found an average overcharge for the 250 randomly sampled claims of $7.71 per claim. The $7.71 average per claim overcharge was then multiplied by the remaining universe of 16,522 claims, yielding an extrapolated purported overcharge of $127,387.92. The Agency then applied the 95 percent "one-sided lower confidence limit" to this extrapolation, that is, that it or its statistician, Dr. Johnson, felt that there was a 95 percent chance that the lower confidence limit number it calculated was accurate. That number is $79,097.68. When that number is combined with the Agency's position as to overcharges from the judgmental sample results in a total postulated overcharge of $108,478.77. This is the final amount the Agency claims as an overpayment that must be recouped for Medicaid. The FAAR summarized the discrepant claims for the judgmental sample as follows: 61 claims involve refills which exceeded the authorized number of refills without documentation of reauthorization; 10 claims showed an incorrect prescriber license number but the correct prescriber license number was documented in the pharmacy's computer; and For two claims the hard copy description did not have an original date of service depicted on it and did not reference a DEA number. The discrepant claims shown in the FAAR as to the random sample were as follows: There were 19 claims for refills without documentation of refill authorization (refills had been previously authorized, but for the 19 claims at least one refill had been issued beyond the authorization limit); Fifteen claims showed an incorrect prescriber license number on the claim and the license number was not documented in the Respondent's computer; Seven claims showed an incorrect prescriber license number, but the correct license number was documented in the pharmacy's computer; There were seven claims for which the original hard copy prescriptions could not be found on file during the audit period; For one claim the hard copy prescription did not have an original date of service or DEA number; For one claim the quantity paid exceeded the quantity authorized by the prescriber or dispensed to the recipient; and For one claim the number of days supply submitted by the pharmacy was not consistent with the quantity and directions of the prescriber and the quantity exceeded the limit set by the plan. The most common discrepancies with regard to the judgmental sample and the random sample occurred when the Respondent billed refills in excess of the number authorized by the prescriber, without any written authorization for such being provided in the audit process or later. Concerning the random sample, the second most common discrepancy occurred when the claim depicted an incorrect precriber number on the claim and the license number of the prescriber was not documented in the computer. In the judgmental sample the second most common discrepancy occurred when the claim showed an incorrect prescriber number, but the correct prescriber number was documented in the pharmacy's computer. The discrepancies in the FAAR with the indication "UR", references "unauthorized refills." The records of the pharmacy showed that Brown issued refills of prescriptions to Medicaid recipients in excess of the presriber's limit depicted on the prescriptions but showed no written record of a telephonic or written authorization by the prescriber allowing the additional refill or refills. It is also true that as to some or even many of these the Respondent may have obtained verbal authorization, but failed to document that re- authorization. Medicaid policy, the statutory authority cited herein, and the PDSCLR Handbook provide that all verbal orders authorized by the prescriber of a prescription must be recorded either as a "hard copy" or noted in the pharmacy's computer in order to comply with the relevant law cited herein, for record- keeping and auditing purposes under Medicaid policy. The Agency's Statistical Methodology Mark E. Johnson, Ph.D., testified on behalf of the Petitioner. He was qualified as an expert witness in the area of statistical formulas, statistical methodology, and random sampling, including the random sample statistical methodology employed by the Agency in determining the overpayment amount. He is a professor of statistics at the University of Central Florida. Dr. Johnson reviewed the statistical methodology, numbers and calculations arrived at by the Agency and its extrapolation method of arriving at the overpayment amount. He also used his own independent analysis based upon a software package he commonly uses in the practice of his discipline in testing the methodology employed by the Agency and the random sample employed by the Agency and Heritage. The statistical formula employed by Dr. Johnson and the Agency is a standard one routinely used in Dr. Johnson's profession and statistical sampling. He established through his own testing of the methodology that the random sample was appropriate for Medicaid program integrity audits and determinations as employed in this case. The random sampling, according to Dr. Johnson, was employed because it would be time and cost prohibitive to examine individually each of 16,522 claims regarding overpayment issues. The random sampling methodology using 250 randomly chosen samples is a time and cost saving device and yet still presents a "plausible estimate" as established by Dr. Johnson. He established that for the universe of 16,522 claims which were subjected to the random sample and extrapolation statistical analysis and calculation, that such is a reasonable sample for purposes of this audit and that the 250 random samples employed by the Agency are indeed statistically appropriate random samples. His calculation of overpayment was at variance with the Agency's by 55 cents. He established that is not a significant difference since the 95 percent certainty limit of $79,097.68 for the random sample extrapolation analysis is so much lower than the estimate established at $108,478.22. Dr. Johnson established that the Agency had employed appropriate and valid statistical methods in its determination of the above-referenced overpayment amount based upon the random sample of paid claims. The expert testimony of Dr. Johnson, together with his written report in evidence, is credible and persuasive as to the validity of the random sampling of the claims during the audit period and as to the random sample portion of the analysis employed in arriving at the final overpayment calculation and numbers depicted in the FAAR. Dr. Johnson established the appropriateness of the statistical formula, including extrapolation, used to calculate the overpayment amount, the appropriateness of the sample size relative to the universe of claims, and the improbability that the overpayment amount is attributable to chance causes alone. Thus Dr. Johnson's testimony is accepted as credible and persuasive in establishing the validity of the Agency's method of overpayment calculation, and the overpayment calculation in conjunction with the statistical evidence in this record, except as modified by the findings below.1/ The Respondent's Position Gary Steinberg testified on behalf of the Respondent, Brown Pharmacy. He was accepted as an expert witness in the areas of Medicaid policy, audits and pharmacy practice, including Florida pharmacy practice. Mr. Steinberg acknowledged that Brown had not properly documented all claims that had been paid by the Medicaid program nor maintained all required records. He emphasized in his testimony, however, that Brown had not fraudulently billed the Medicaid program with claims for prescription medications that it had not actually dispensed to the patients or recipients. Rather, all medications involved in the subject prescription claims had actually been dispensed. There is no evidence or claim on the part of the Agency that Brown charged and collected more than the appropriate approved price for the prescriptions at issue. Through the explanation given in his testimony, Mr. Steinberg opined that although Brown was guilty of technical errors in record keeping and documentation as to the prescriptions involved in the subject claims, Brown had made substantial compliance with the Medicaid program requirements of the Medicaid provider agreement and the statutes and rules at issue and policies embodied in the subject handbook. He explained in his testimony that in the pharmacy practice setting in which Brown has operated, whereby it serves a large indigent population in an inner city environment, it is difficult to contact a prescriber at the time when a patient needs a critical prescription refilled in order to get a refill authorization. The prescriptions at issue mostly involve critical medications for HIV/Aids and psychotropic medications for severe mental conditions such as schizophrenia. The patients who need these critical medications (and there are very few patients, since most of the procedures involve filling and refilling for a small number of such recipients) are patients of clinics operated at the nearby university hospital (Shands). In these circumstances, where the patient literally needs the HIV/Aids medication refilled on an immediate basis, possibly even to prevent death, and the mental health patient critically needs a refill in order to prevent harm to the patient or harm to the members of the public if the patient goes without medication and "decompensates," the ethical thing for a pharmacist to do is to refill the prescription and seek authorization later. Mr. Steinberg established that it is often difficult to obtain authorization from the original prescriber since the medication were prescribed by residents practicing in the various clinics at the Shands Hospital and that the residents can not always be identified or contacted easily since they do not maintain a fixed medical practice in the area. Consequently, some of the prescriptions were not documented as to authorization, although in some cases the pharmacy actually obtained authorization and entered it in its computer. In some cases, being unable to obtain re-authorization from the resident who originally prescribed the medication the pharmacy used the DEA license or prescribing number of the hospital itself. He explained that although under the law a pharmacy can refill a prescription on an emergency basis for up to a 72-hour supply, that this is generally impracticable and unsafe for patients in this plight because such indigent, mental health and HIV/Aids patients tend to be non-compliant with their medication regimes quite often anyway, and it is often unreasonable to expect them to return to the pharmacy for another refill within two or three days. He thus opined that the ethical and safe thing for the pharmacist to do was to refill and re-dispense the medical approved medication for up to a 30 or 34-day supply (the normal refill supply duration). He further explained that the Shands Hospital license number was used in some of these circumstances because the resident doctor who originally issued the prescription could not be identified on the Shands Hospital prescription forms and because the resident doctors at the Shands clinics only have and can use Shands Hospital prescription forms in any event. Mr. Steinberg thus established that 35 percent of those prescription claims classified as "WMP," that is the prescription claims contained an incorrect prscriber license number were for these reasons and the pharmacist could only use the Shands Hospital license number because the resident could not be identified from the Shands Hospital prescription forms. He thus opined that 35 percent of the random sample extrapolation amount, the 95 percent statistical confidence limit amount of $79,097.00, should be deleted from that amount in determining the correct amount of overpayment predicated on the random sample. Likewise, with regard to the judgmental sample concerning the HIV/Aids and mental health patient prescriptions and related claims, he opined that, in effect, $19,500.00 of the total $29,381.09 overpayment amount claimed by the Agency pursuant to the judgmental sample portion of the claims, should be deleted from that portion of the overpayment claim by the Agency; this is a result of his explanation regarding "substantial compliance" in the critical refill situation he described concerning the HIV/Aids and mental health patients and their prescription drugs. The preponderant, persuasive evidence does establish (and indeed the Agency acknowledged in its Proposed Recommended Order) with regard to the judgmental sample, that 10 of the claims at issue listed an incorrect prescriber license number, but that the correct prescriber license number was actually documented in the pharmacy's computer record with the name of the prescriber. This circumstances comports with the law referenced below and in the Petitioner's Proposed Recommended Order. This results in a reduction in the overpayment claim with regard to the judgmental sample of 13.88 percent of the judgmental sample claims or a reduction of $4,078.09. Likewise, with regard to the random sample extrapolation calculation of overpaid claims, the preponderant, persuasive evidence, also as acknowledged by the Agency in its Proposed Recommended Order, disclosed that seven claims listed an incorrect prescriber license number on the claims, but had been correctly documented in the pharmacy's computer system and therefore were in compliance with the relevant statutes, rules, and the subject handbook. Thus the discrepant claims and the overpayment amount related to the random sample portion of the audit claims should be reduced by 14.28 percent of the total amount of $79,097.00 for a $11,295.05 reduction of that $79,097.00 random sample overpayment amount. Mr. Steinberg demonstrated that Brown was not overcharging on the drugs prescribed and dispensed and was charging the Medicaid-authorized amount for the drugs involved in the prescription claims at issue. The Agency is not claiming that there was any fraudulent practice or illegal overcharging for the prescriptions involved. In fact, Brown was earning only a very small profit on the drugs dispensed that are the subject of the prescription claims at issue. Mr. Steinberg thus opined that since Brown did indeed dispense all the drugs at issue and was only paid the legal authorized amounts for the drugs and prescriptions at issue that recoupment of the amounts sought by the Agency or, in effect, established in these findings of fact, would be fundamentally unfair. He and the Respondent contend, rather, that since Brown performed substantial compliance, but was guilty of technical non-compliance with the relevant rules, agreement, and Medicaid policy, that the Agency should impose a lesser fine instead of seeking recoupment. In summary, in view of the preponderant persuasive evidence establishing the above facts, it has been shown that the documentation and record-keeping, dispensing errors, and omissions in the manner found above, with regard to the prescription claims and types of claims addressed in the above findings of fact, occurred. If those deficiencies amount to violations of the authority cited and discussed below which justify recoupment, then the amount of overpayment established by the above findings of fact is $93,104.95.

Recommendation Having considered the foregoing findings of fact, conclusions of law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore, RECOMMENDED that a final order be entered by the Agency for Health Care Administration providing for recoupment of $93,104.95, and that the Respondent, Brown Pharmacy, must re-pay that amount to the Petitioner Agency, through a reasonable re- payment plan established between the parties. DONE AND ENTERED this 3rd day of November, 2006, in Tallahassee, Leon County, Florida. S P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with Clerk of the Division of Administrative Hearings this 3rd day of November, 2006.

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ARNALDO R. QUINONES, M.D. vs AGENCY FOR HEALTH CARE ADMINISTRATION, 04-001279MPI (2004)
Division of Administrative Hearings, Florida Filed:Miami, Florida Apr. 12, 2004 Number: 04-001279MPI Latest Update: Apr. 29, 2005

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.

Florida Laws (3) 120.569120.57409.913
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BOARD OF MEDICAL EXAMINERS vs. WILLIAM R. GRECO, 86-003974 (1986)
Division of Administrative Hearings, Florida Number: 86-003974 Latest Update: Dec. 30, 1986

Findings Of Fact Respondent was originally licensed to practice medicine in Florida on August 15, 1956. Respondent's license was placed on inactive status on December 13, 1979, and currently remains on inactive status. Respondent's last known address is 6201 Riverdale Road, Riverdale, Maryland 20801 (Petitioner's Exhibit No. 1). On May 6, 1983 Respondent, by Indictment No. 18312601, was indicted for six counts of Medicaid fraud, three counts of false pretenses and one count of theft in the Circuit Court for Baltimore City, Maryland (Petitioner's Exhibit No. 2). On March 12, 1984, after Respondent's bench trial, the Circuit Court for Baltimore City ordered a judgment of conviction as to the six counts of Medicaid fraud. Respondent was acquitted of the other four counts of the indictment (Petitioner's Exhibit No. 2, P. 39 of the memorandum opinion). Respondent's conviction resulted from the inclusion of nonallowable costs in applications for Medicaid funds submitted by Magnolia Gardens Nursing Home while Respondent was the administrator and a 50 percent owner of the nursing home. The trial court specifically found that Respondent knew that nonreimbursable costs for construction done to Respondent's personal residences and medical office building were included in applications for Medicaid payments (Petitioner's Exhibit No. 2, p. 39 of memorandum opinion). Use of Medicaid funds for improvements to a private physician's office is a violation of Maryland state law which clearly relates to the practice of medicine. As a result of Respondent's conviction for Medicaid fraud, he was sentenced to concurrent five-year terms of imprisonment on each of the six counts. All but 18 months of the sentence was suspended. Respondent was placed on 18 months of work release and 18 months of community service after work release at the rate of 20 hours per week. Respondent was also fined $60,000 and ordered to pay $50,000 restitution. Additionally, Respondent was placed on two years of unsupervised probation (See docket entry of April 23, 1984, Petitioner's Exhibit No. 2). On April 30, 1984 Respondent appealed his conviction to the Court of Special Appeals of Maryland (See docket entry of April 30, 1984, Petitioner's Exhibit No. 2). On November 6, 1985 the Maryland Court of Special Appeals rendered its opinion in William R. Greco v. State of Maryland, Case No. 171 (Petitioner's Exhibit No. 2). Respondent's conviction was affirmed in all aspects and Respondent's sentence was affirmed as to the order to make restitution which was vacated (See Mandate of the Court of Special Appeals of Maryland, dated December 6, 1985, Petitioner's Exhibit No. 2). On October 3, 1986, the Court of Appeals of Maryland affirmed the decision of the Court of Special Appeals. Greco v. State, 307 Md. 470, 515 A.2d 220 (1986). On December 4, 1984 Respondent was suspended from participation in the federal Medicare and Medicaid programs for a period of ten years (Petitioner's Exhibit No. 3).

Recommendation It is recommended that Respondent's license to practice medicine be revoked. DONE and ORDERED this 30 day of December, 1986 in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of December, 1986. COPIES FURNISHED: Stephanie A. Daniel, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 William W. Cahill, Jr., Esquire WEINBERG and GREEN 100 South Charles Street Baltimore, Maryland 21201 Dr. William R. Greco 6201 Riverdale Road Riverdale, Maryland 20737 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore Carpino, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301

Florida Laws (1) 458.331
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