STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
LIFELINE PHARMACY, INC.,
Petitioner,
vs.
AGENCY FOR HEALTH CARE ADMINISTRATION,
Respondent.
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) Case No. 01-2153MPI
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RECOMMENDED ORDER
On August 27, 2001, a Final Hearing was held in this case in Miami-Dade County, Florida, before William R. Pfeiffer, a duly-designated Administrative Law Judge.
APPEARANCES
For Petitioner: Craig A. Brand, Esquire
Brand & Fernandez, P.A.
2 Northeast 40th Street Suite 403
Miami, Florida 33137
For Respondent: Kelly A. Bennett, Esquire
Agency for Health Care Administration 2727 Mahan Drive
Fort Knox, Building III Tallahassee, Florida 32308-5403
STATEMENT OF THE ISSUE
Whether Petitioner is liable to Respondent for Medicaid overpayments, fines, interests, and costs, pursuant to the Agency’s Final Agency Audit Letter of May 2, 2001 (hereinafter FAAL), in the amount of $194,526.97.
PRELIMINARY STATEMENT
Petitioner, Lifeline Pharmacy, Inc. (Lifeline Pharmacy), called as witnesses Mr. and Mrs. Martin Calano, Mr. Frank Hernandez, and Dr. William Bebell. Petitioner offered Exhibits 1-7 which were admitted into evidence.
Respondent, Agency for Health Care Administration (AHCA), called as witnesses Mr. William Thomas, Mr. Lewis Elie, and
Ms. Kelly Rubin. Respondent offered into evidence Respondent’s Exhibits 1-35 which were admitted without objection. The two- volume Transcript was filed October 3, 2001. The parties have filed Proposed Recommended Orders which have been carefully considered.
FINDINGS OF FACT
The Parties
Petitioner
Petitioner, Lifeline Pharmacy, is a retail pharmacy formed in early 2000. Martin Calano is the owner and president of Lifeline. It is co-owned by his wife, Barbara Calano, who serves as the treasurer; Frank Hernandez, who oversees the pharmacy operations; and Imada Hernandez.
None of the pharmacy's owners has an educational background in pharmacy or Medicaid regulations.
Dr. William Bebell is the sole pharmacist employed by Lifeline Pharmacy. He is responsible for managing the
prescriptions and has been involved with the practice of pharmacy for 25 years.
Respondent
Respondent, Agency for Health Care Administration (AHCA), is the state agency charged with administration of the Medicaid program in Florida under Section 409.907, Florida Statutes. As one of its duties, Respondent must recover overpayments paid to providers by the Medicaid program. The term "overpayment" is statutorily defined to mean "any amount that is not authorized to be paid by the Medicaid program whether paid as a result of inaccurate or improper cost reporting, improper claiming, unacceptable practices, fraud, abuse, or mistake." See Section 409.913(1)(d), Florida Statutes.
Petitioner participated in the Medicaid program, under contract with Respondent, from December 17, 1999 through
April 21, 2000, and was issued provider number 021780800.
In 1999, Respondent hired Heritage Information Systems ("Heritage") to perform audits of various Medicaid providers. Louis Elie, an auditor employed with Heritage since 1999, is responsible for auditing retail home infusion pharmacies. He is a pharmacist with a degree from Howard University, registered in the State of Virginia, and has practiced for over ten years. He has worked in a retail pharmacy for five years coordinating home
infusion therapies, and has worked at Medical College of Virginia, a teaching institution that has a community pharmacy embedded in a home infusion pharmacy that services the community.
William Thomas is an investigator for Heritage and serves as the project manager for the Florida Medicaid audits. He has a B.A. in economics, a B.S. in pharmacy, and is a licensed pharmacist in Florida.
Kelly Rubin is employed by AHCA within the Medicaid Program Integrity (MPI) office as a pharmacy investigator. The MPI office audits health care providers who participate in the Medicaid program and reviews the provider's compliance with applicable statutes, rules, and policies regarding billing Medicaid for services rendered. Ms. Rubin has been a licensed Florida pharmacist for approximately nine years, and was a pharmacy tech for approximately eight years. She has experience in hospital and retail pharmacy, and has served as the director of a home infusion pharmacy.
As an investigator employed by Respondent, Ms. Rubin reviewed Petitioner's pharmacy records as well as the audit performed by Heritage. Upon review of the records and the Heritage audit, Ms. Rubin and the MPI office calculated the amount of Petitioner's overpayment and issued the FAAL with supporting documentation.
The Audit
During the four-month time period reviewed in the audit, Petitioner submitted 744 prescription claims to Medicaid totaling $445,713.19 and received payment for each of them.
Respondent, acting as the state's enforcement arm of the Medicaid program, chose to audit 329 of Petitioner's 744 claims. Specifically, Respondent selected 128 of the 744 claims to be audited through a judgmental sample analysis and 201 claims from the remaining 616 claims to be audited through a random sample analysis.
On May 15, 2000, Respondent, and its contract auditor Heritage, arrived unannounced at Petitioner's place of business to conduct the in-depth audit. The audit team was met by Petitioner's sole pharmacist, Dr. Bebell, who was responsible for managing the prescription records. Upon their arrival,
Dr. Bebell was provided a list of 329 provider claim prescription numbers selected by Respondent for review. Although the audit team did not specify the precise records it needed, the auditors instructed Dr. Bebell to provide "all" records pertaining to the selected prescriptions, purportedly filled by the pharmacy during the December 17, 1999 through April 21, 2000, audit period.
In response, Dr. Bebell provided the auditors with the prescription records, invoice records, and financial records of
the specific prescriptions requested. It is apparent, however, that at some point during the first day of the audit, Petitioner retrieved some records back from the audit team prior to review.
During the audit, the team reviewed each record provided by Dr. Bebell and occasionally requested Dr. Bebell to produce additional prescription records for a given claim. Any additional records provided by the pharmacist were considered by the auditors.
Although the communication between the parties appeared to be strained, the auditors remained at Petitioner's place of business for four days and interacted with Dr. Bebell on a regular basis. At the conclusion of the audit on the fourth day, the auditors departed the pharmacy. A formal exit conference, involving Petitioner's counsel, was not held.
Audit findings
Judgmental sample
As indicated, the auditors selected 128 of the 744 claims for review through a judgmental sample analysis. Using this technique, the auditors reviewed each claim and identified discrepancies with the rules, laws, and policies governing both the Medicaid Program and the practice of pharmacy, and assessed a monetary sanction for each discrepancy.
In the judgmental sample, the auditors cited 81 alleged discrepancies that were predominately attributed to
unauthorized refills ("UR"), original hard-copy prescriptions that could not be found ("CF"), and oral prescriptions that were not properly documented ("MISC"). The monetary sanctions totaled $172,410.84.
Random sample
The audit team also utilized a mutually exclusive random sample to review claims. The random sample consisted of
201 claims selected at random from the remaining population of 616 Medicaid provider claims.
In the random sample, the auditors again looked at each claim and identified discrepancies with the rules, laws, and policies governing both the Medicaid Program and the practice of pharmacy. However, in this review, the auditors also calculated a claim discrepancy average and multiplied it by the remaining population of 616 claims.
During the random sample review, Respondent discovered
58 discrepancies that averaged $51.546661 per claim.
Thereafter, the random sample average was extended to the remaining population of claims in the judgmental sample and totaled $31,752.71.
For added confidence in the extrapolated findings and to mitigate any "over penalizing," Respondent calculated the 95 percent one-sided lower confidence limit of the extrapolated
random sample and reduced the applied discrepancy amount to
$22,116.13.
The random sample and judgmental sample discrepancy amount were aggregated and a monetary sanction in the amount of
$194,526.97 was assessed against Petitioner for the overpayment.
Respondent's case
At the administrative hearing, during Respondent's case-in-chief, counsel for Respondent introduced an exhaustive list of 35 exhibits relating to the audit, presented the testimony of Mr. Thomas, Mr. Elie, and Ms. Rubin, and explained each discrepancy documented during the audit.
Respondent presented evidence identifying the 152 discrepancies identified in the audit report. Specifically, the auditors cited:
23 "CF" discrepancies where the original hard-copy prescription could not be found on file during the audit;
50 "UR" discrepancies where the number of refills billed and paid to the pharmacy exceeded the number authorized by the prescribing physician;
4 "OBQ" discrepancies where the quantity paid exceeded the quantity authorized by the prescribing physician;
1 "EQL" discrepancy where the quantity paid exceeds the limit set by the Medicaid Plan;
6 "DS" discrepancies where the day's supply value submitted by the pharmacy was not consistent with the quantity and directions prescribed;
1 "WDB" discrepancy where the pharmacy submitted a claim for medication
that was different from the medication dispensed;
1 "NDEA" discrepancy where the hard-copy prescription did not contain a DEA number as required; and
64 "MISC" discrepancies where the telephone prescription orders were not reduced to writing.
Petitioner's Case
Following Respondent's case-in-chief, counsel for Petitioner introduced seven exhibits; presented the testimony of four witnesses including Mr. and Mrs. Calano, Mr. Hernandez and Dr. Bebell; and strenuously attacked the actions, motivations and findings of Respondent.
Specifically, Petitioner alleged that the 23 documented "CF" discrepancies, relating to missing prescriptions, actually existed and were available at the time of the audit. Petitioner argued that the missing prescriptions were subsequently "found," introduced into evidence at hearing, available to Respondent, and entitled them to relief. Petitioner's assertions and the newly found prescriptions are highly suspect and summarily rejected. Respondent proved the 23 "CF" discrepancies by a preponderance of the evidence.
Petitioner also argued that the 50 "UR" discrepancies, representing unauthorized refills, identified in the audit report, were in fact authorized. Specifically, Petitioner claimed that the abbreviation "IV," written in Rx numbers 50619, 50622, 50623, 50631, 50638, and 50641, and cited for 20
discrepancies, stood for "4" refills and not the term "intravenous." Dr. Bebell testified under oath that he utilized the abbreviation in each of the 20 discrepancies to reflect the numeral "4" and not the term "intravenous."
Petitioner's assertion regarding these 20 cited "UR" discrepancies are not accepted for several reasons. First, Respondent demonstrated that the excessive number of refills would have been inappropriate therapy. Second, Petitioner's position does not comport with standard pharmacy practice. Third, Petitioner's assertion and Dr. Bebell's testimony are directly inconsistent with Dr. Bebell's routine use of standard numerals within his written prescriptions. In fact, there appear to be no Roman numerals within any of his prescriptions. And finally, accepting the argument that "IV" actually meant "4" creates unreasonable inconsistencies and ambiguities within
Dr. Bebell's written prescriptions. For these reasons, Petitioner's assertion is without credit. Respondent proved the
20 cited "UR" discrepancies by a preponderance of the evidence.
With respect to the 30 remaining "UR" discrepancies relating to Rx numbers 50624, 50631, 50632, 50633, 50634, 50635, 50723, 50280, and 50330, Petitioner demonstrated that the prescriptions were valid, often included both the prescribing doctor and pharmacist's signature, occasionally were not billed for refill, and in fact were authorized. Respondent failed to
prove the 30 above-cited "UR" discrepancies by a preponderance of the evidence.
Petitioner also contested three of the four "OBQ" discrepancies relating to the quantity paid exceeding the quantity authorized, and specifically conceded to Rx number 50505. Petitioner presented credible evidence that Petitioner properly received Medicaid payment for the precise medicine prescribed by Dr. Contreras in Rx numbers 50331 and 50463, as well as the precise medication (30 tablets plus one refill) prescribed by Dr. Folkerth in Rx number 50548. Respondent proved, by a preponderance of the evidence, the single "OBQ" discrepancy conceded by Petitioner in Rx 50505.
Petitioner argued that Rx number 50678, cited as a discrepancy due to the quantity paid exceeded the Medicaid Plan, was proper. Respondent proved the single "EQL" discrepancy by a preponderance of the evidence.
Petitioner contested the six "DS" discrepancies identified in the audit report relating to Rx numbers 50505, 50331, 50451, 50463, 50548, and 50678, and argued that the day's supply value submitted by the pharmacy was consistent with the quantity and directions provided by the physician. Respondent failed to prove the discrepancies related to Rx numbers 50331, 50463, and 50548, and applied no penalty to Rx number 50451.
Respondent proved the two "DS" discrepancies relating to Rx numbers 50505 and 50678 by a preponderance of the evidence.
Respondent proved, by a preponderance of the evidence, the single "WDB" discrepancy relating to Rx number 50308.
Respondent proved, by a preponderance of the evidence, the single "NDEA" discrepancy relating to Rx number 50740.
And finally, counsel for Petitioner strongly contested the 64 "MISC" discrepancies identified in the audit report that allege Dr. Bebell failed to properly reduce telephone prescriptions to writing. Petitioner suggested that, at best, the "MISC" discrepancies were "technical" and should not be assessed.
While the evidence proves that Petitioner often received its prescriptions via physician telephone orders, it is clear that these records were not received, recorded, managed and maintained in the method provided by law. In fact, at the time of the audit, Petitioner indicated that they were in the initial stages of setting up the pharmacy and had problems with paperwork. Dr. Bebell admitted that he was unfamiliar with the computer system, kept prescription records in patient charts rather than in the computer, and did not understand many of the regulations governing prescription records including telephone orders. He testified that "according to regulation either
myself or one of my staff members reduce the verbal order . . . to writing immediately," notwithstanding the fact that
Dr. Bebell is the only registered pharmacist on staff and the only individual legally permitted to accept and sign the prescription.
While Petitioner further argues that the telephone orders relating to the 64 "MISC" discrepancies were properly reduced to writing and later signed by the pharmacist shortly after taking the order, the evidence demonstrates otherwise. Scanned images of Petitioner's prescription records, taken at the time of the audit, clearly demonstrate that telephone prescription orders were improperly received, signed and recorded. Furthermore, Dr. Bebell admitted that he occasionally did not sign each telephone order prescription as required by law.
Petitioner further asserts that the scanned images were only draft documents and the newly provided, signed prescription documents are the actual prescriptions. Petitioner's new evidence relating to the 64 "MISC" discrepancies is suspect and not accepted.
The 64 "MISC" discrepancies identified verbal orders allegedly taken by a registered pharmacist and not signed by that pharmacist. Standard pharmacy practice, as well as state and federal law, require pharmacists to reduce telephone
prescription orders to writing immediately upon receipt. Respondent proved, by a preponderance of the evidence, all of the 64 "MISC" discrepancies including Rx numbers 563, 565, 602,
639, | 723, | 821, | 829, | 131, | 133, | 271, | 275, | 276, | 278, | 279, | 280, | 281, |
282, | 283, | 284, | 286, | 287, | 296, | 306, | 311, | 330, | 341, | 344, | 365, | 389, |
390, | 411, | 412, | 475, | 477, | 478, | 479, | 529, | 537, | 538, | 539, | 552, | 556, |
557, | 558, | 564, | 676, | 704, | 705, | 706, | 708, | 709, | 713, | 714, | 716, | 740, |
779, and 885. A total recovery for each of those claims to Medicaid is appropriate.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and the subject matter of this proceeding pursuant to Chapter 120, Florida Statutes.
The statutes, rules, policies, and Medicaid Provider Reimbursement Handbook in effect during the period for which the services were provided govern the outcome of the dispute. See Toma v. Agency for Health Care Administration, Case No. 95-2419 (Div. of Admin. Hearings 1996)(as incorporated in Toma v. Agency for Health Care Administration, 18 FALR 4735 (Div. of Admin. Hearings 1996).
The burden of establishing an alleged Medicaid overpayment by a preponderance of the evidence falls on the Agency. South Medical Services, Inc. v. Agency for Health Care Administration, 653 So. 2d 440, 441 (Fla. 3d DCA 1995);
Southpointe Pharmacy v. Department of Health and Rehabilitative
Services, 596 So. 2d 106, 109 (Fla. 1st DCA 1992).
Although the Agency bears the ultimate burden of persuasion and must present a prima facie case through the introduction of competent substantial evidence before the provider is required to respond, Section 409.913(21), Florida Statutes, provides that "[t]he audit report, supported by agency work papers, showing an overpayment to the provider constitutes evidence of the overpayment." Thus, the Agency can make a prima
facie case by merely proffering a properly supported audit report, which must be received in evidence.
Section 409.913, Florida Statutes, further heightens the provider's duty of producing evidence to meet the Agency's prima facie case, by requiring that the provider come forward with written proof to rebut, impeach, or otherwise undermine the Agency's statutorily-authorized evidence.
In addition, Section 409.913, Florida Statutes, grants Respondent the specific authority to conduct or contract for audit services to maintain the integrity of the Medicaid Program and impose penalties for compliance failures.
Section 409.907(1), Florida Statutes, requires Medicaid providers to sign an agreement with Medicaid adhering to the rules and policies of the state, which Petitioner signed and is reflected in Respondent’s Exhibit 12.
Section 409.907(3)(b) and (c), Florida Statutes, requires the Medicaid provider to: "Maintain in a systematic and orderly manner all medical and Medicaid-related records that the agency requires and determines are relevant to the services or goods being provided," as well as "retain all medical and Medicaid-related records for a period of 5 years to satisfy all necessary inquiries by the agency."
Section 465.015(2)(c), Florida Statutes, provides the specific requirements regarding violations and penalties for "CF" (Original hard-copy prescription not found during the audit) and "UR" (Unauthorized Refill) discrepancies. It provides that it is unlawful for any person to sell or dispense drugs "without first being furnished with a prescription."
Rule 64B16-27.103, Florida Administrative Code, addresses the requirements for oral prescriptions and copies and specifically provides:
Only a Florida registered pharmacist or registered pharmacy intern acting under the direct personal supervision of a Florida registered pharmacist may, in the State of Florida, accept an oral prescription of any nature. Upon so accepting such oral prescription it must immediately be reduced to a hard copy, and only a Florida registered pharmacist or registered pharmacy intern acting under the direct personal supervision of a Florida registered pharmacist may, in the State of Florida, prepare a copy of a prescription or read a prescription to any person for purposes of providing reference concerning treatment of the person or animal for whom the
prescription was written, and when said copy is given a notation shall be made upon the prescription that a copy has been given, the date given, and to whom given.
Furthermore, Rule 64B16-28.140(1)(d), Florida Administrative Code, specifically requires a pharmacy to maintain, in a data-processing system,
Original prescriptions, including prescriptions received as provided for in Rule 64B16-28.130, F.A.C. Transmission of Prescription Orders, shall be reduced to a hard copy if not received in written form. All original prescriptions shall be retained for a period of not less than two years from date of last filling. To the extent authorized by 21 C.F.R. Section 1304.04, a pharmacy may, in lieu of retaining the actual original prescriptions, use an electronic imaging record keeping system, provided such system is capable of capturing, storing, and reproducing the exact image of the prescription, including the reverse side of the prescription if necessary, and that such image be retained for a period of no less than two years from the date of last filling.
Rule 64B16-27.400(3), Florida Administrative Code,
provides:
Only a Florida licensed pharmacist may make the final check of the completed prescription thereby assuming the complete responsibility for its preparation and accuracy.
Pursuant to Section 409.913(7)(f), Florida Statutes, the provider must document services: ". . . by records made at the time the goods or services were provided. "
In addition, Section 893.04(1)(c)2, Florida Statutes, specifically provides that "controlled substances upon a written or oral prescription of a practitioner, . . . must be promptly reduced to writing by the pharmacist [and] . . . [t]here shall appear on the face of the prescription or written record thereof for the controlled substance the following information . . . [t]he full name and address of the prescribing practitioner and the practitioner's federal controlled substance registry number shall be printed thereon."
Section 465.003(13), Florida Statutes, relating to definitions of "OBQ" and "WDB" (Quantity paid exceeds the quantity authorized by the prescriber and Wrong Drug Billed), provides:
Practice of the profession of pharmacy includes compounding, dispensing, and consulting . . . . However, nothing in this subsection may be interpreted to permit an alteration of a prescriber's directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of medicine, or the practice of osteopathic medicine, unless otherwise permitted by law.
. . .
Pursuant to Section 465.016(1)(i), Florida Statutes, the following shall constitute grounds for denial of a license or disciplinary action: "Compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of the professional practice of pharmacy. For purposes of this paragraph, it shall be legally
presumed that the compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best interests of the patient and is not in the course of the professional practice of pharmacy."
Section 465.016(1)(g), Florida Statutes, further provides that the following shall constitute grounds for denial of a license or disciplinary action: "Using in the compounding of a prescription, or furnishing upon prescription, an ingredient or article different in any manner from the ingredient or article prescribed, except as authorized in Section 465.019(6) or Section 465.025, Florida Statutes."
Section 465.023(1)(c), Florida Statutes, provides that "[t]he department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee who has . . . [v]iolated any of the requirements of this chapter or any of the rules of the Board of Pharmacy; of chapter 499, known as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss. 301-392, known as the "Federal Food, Drug, and Cosmetic Act"; of 21 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act; or of chapter 893."
Section 409.913(7), Florida Statutes, states that a provider participating in the Medicaid program has an affirmative duty to supervise and be responsible for the
preparation and submission of accurate claims for payment from the program. 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." Section 409.913(7)(e), Florida Statutes (1996).
The provisions of law in effect throughout the audit period clearly and specifically identify the billing procedures and documentation requirements necessary for claims submitted to Medicaid for reimbursement.
Petitioner applied and was approved as a Medicaid provider, executed a contract with Respondent pursuant to Section 409.907, Florida Statutes, and agreed to abide by the clear provisions of the Florida Statutes and the policies, procedures, and manuals of the Florida Medicaid Program.
As Respondent has established, by a preponderance of the evidence, that the specific aforementioned claims were not sufficiently compliant for Medicaid reimbursement purposes, it is entitled to recover from Petitioner the "overpayment" amount paid by Medicaid for those claims.
And finally, pursuant to Section 409.913(24)(b), Florida Statutes, overpayments owed to AHCA bear interest at the rate of ten percent from the date of determination of the overpayment by the Agency.
Based upon the foregoing Findings of Facts and Conclusions of Law, it is recommended that:
Respondent shall recalculate the monetary sanctions, excluding the 30 "UR," three "OBQ," and four "DS" discrepancies identified in the Findings of Fact, utilizing the same statistical formula.
Petitioner shall repay Respondent the recalculated monetary sanction, plus interest derived from April 6, 2001 through December 1, 2002, at the statutory rate, within a reasonable period of time agreed to by both parties. Petitioner shall not be obligated to pay any other costs or fees related to this matter.
DONE AND ENTERED this 8th day of March, 2002, 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 8th day of March, 2002.
COPIES FURNISHED:
Kelly A. Bennett, Esquire
Agency for Health Care Administration 2727 Mahan Drive, Suite 3431
Fort Knox Building III Tallahassee, Florida 32308-5403
Craig A. Brand, Esquire Brand & Fernandez, P.A.
2 Northeast 40th Street Suite 403
Miami, Florida 33137
Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive
Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
Diane Grubbs, Agency Clerk
Agency for Health Care Administration 2727 Mahan Drive
Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Apr. 11, 2002 | Agency Final Order | |
| Mar. 08, 2002 | Recommended Order | Petitioner challenged the agency`s pharmacy Medicaid overpayments allegations; must repay recalculated monetary sanctions plus interest. |
