01-004078MPI
Agency For Health Care Administration vs.
Pierre Gaston, M.D.
Status: Closed
Recommended Order on Friday, April 19, 2002.
Recommended Order on Friday, April 19, 2002.
1STATE OF FLORIDA
4DIVISION OF ADMINISTRATIVE HEARINGS
8AGENCY FOR HEALTH CARE )
13ADMINISTRATION, )
15)
16Petitioner, )
18)
19vs. ) Case No. 01 - 4078MPI
26)
27PIERRE GASTON, )
30)
31Respondent. )
33______________________________)
34RECOMMENDED ORDER
36Robert E. Meale, Administrative Law Judge of the Division
45of Administrative Hearings, conducted the final hearing by
53videoconference in Tallahassee and Miami, Florida, on January 24
62and 25, 2002.
65APPEARANCES
66For Petitioner: Anthony L. Conticello, S enior Attorney
74Agency for Health Care Administration
792727 Mahan Drive, Suite 3431
84Fort Knox Building III
88Tallahassee, Florida 32308
91For Respondent: Louise T. Je roslow
97Law Offices of Louise T. Jeroslow
1036075 Sunset Drive, Suite 201
108Miami, Florida 33143
111STATEMENT OF THE ISSUES
115The issues are whether Petitioner has overpaid Respondent
123for medical services for which he has obtained re imbursement
133under the Medicaid program and, if so, by how much.
143PRELIMINARY STATEMENT
145By letter dated July 31, 2001, Petitioner notified
153Respondent that it had reviewed his Medicaid claims for
162specified procedures from January 1, 1996, through August 19,
1712000, and determined that Petitioner had overpaid Respondent
179$75,387.91 for claims arising from "off - label" use of immune
191globulin and interleukin 2.
195By Request for Formal Administrative Hearing filed
202September 24, 2001, with Petitioner, Respondent deni ed the
211material allegations and requested a formal hearing.
218At the hearing, Petitioner stipulated that it would reduce
227its overpayment claim by the total of five items listed on page
239two of Petitioner Exhibit 27. These items, bearing a date of
250service of March 14, 1997, state amounts paid of $9.04, $22.41,
261$22.42, $1224.00, and $10.00, for a total of $1287.87. Thus,
271the total alleged overpayment is now $74,100.04.
279At the hearing, Petitioner called three witnesses and
287offered into evidence 24 exhibits: Petitioner Exhibits 1 - 6,
2978 - 9, 11 - 16, and 18 - 27. Respondent called one witness and
312offered into evidence one exhibit: Respondent Exhibit 1. All
321exhibits were admitted.
324FINDINGS OF FACT
3271. Respondent is a licensed physician engaged in the
336practice of me dicine in Florida. From January through November
3461997, Respondent worked a couple of hours each morning at the
357Summit Clinic in Miami before seeing patients at his own office.
3682. At the Summit Clinic, Respondent administered
375intravenous immunoglobulin (I VIG) to adult Medicaid patients who
384were infected with human immunodeficiency virus (HIV).
391Petitioner paid the Summit Clinic, which was using Respondent's
400Medicaid provider number, for these and other medical services.
409Petitioner now claims that these IV IG services were not
419medically necessary, and, pursuant to its "pay - and - chase"
430policy, Petitioner seeks repayment from Respondent.
4363. In general, the administration of IVIG transfers
444antibodies contained in globulin to protect the recipient from
453various i nfectious microorganisms. The United States Food and
462Drug Administration (FDA) has approved the marketing of IVIG for
472the treatment of persons with certain clinical conditions, such
481as idiopathic thrombocytopenic purpura, Kawasaki disease, and
488pediatric H IV infection.
4924. However, the FDA has not approved the marketing of IVIG
503for the treatment of adult HIV infection. The use of a drug to
516treat conditions for which the FDA has not issued its approval
527is known as an off - label use. Some off - label uses are medically
542effective and prevalent, but remain unapproved by the FDA
551because the drug manufacturer cannot feasibly conduct expensive
559clinical trials generally necessary to obtain FDA marketing
567approval. Despite the absence of such clinical trials, not all
577off - label uses are experimental.
5835. In the 20 years that IVIG has been commercially
593available in the United States, medical researchers and
601practitioners have uncovered evidence in support of important
609off - label uses of IVIG. For instance, a common and e ffective
622off - label use of IVIG is for the treatment of Guillain - Barr é
637syndrome. According to the University HealthSystem Consortium,
644the FDA estimates that 50 - 70 percent of IVIG use is off - label,
659but as much as half of the off - label use finds little, if a ny,
675support by clinical studies.
6796. This case raises the question of the medical necessity
689of the off - label use of IVIG for the treatment of HIV - infected
704adults. Unlike adult - onset HIV infections, pediatric HIV
713infections result in systemic immune defici encies because the
722children's immune systems never develop normally. In HIV -
731infected children, IVIG relieves the effects of these systemic
740immune deficiencies by preventing serious bacterial infections.
747For these reasons, the FDA has approved the use of IVIG for HIV -
761infected children.
7637. By letter dated July 31, 2001, Petitioner advised
772Respondent that it had reviewed various Medicaid claims
780submitted under his provider number. As relevant to this case,
790the July 31 letter disallows Medicaid reimbursemen t for the use
801of IVIG on HIV - infected adults. Stating that this use of IVIG
814is not "indicated" and is "investigational," the letter adds:
"823Medicaid policy prohibits payment for experimental procedures
830or non - FDA approved drugs and requires that all servi ces
842rendered to Medicaid recipients be medically necessary."
8498. Chapter 1 of the Physician Coverage and Limitations
858Handbook (Handbook) states: "Medicaid reimburses for services
865that are determined medically necessary . . .. In addition, the
876services mu st meet the following criteria:
883* the services must be individualized,
889specific, consistent with symptoms or
894confirmed diagnosis of the illness or injury
901under treatment, and not in excess of the
909recipient's needs;
911* the services cannot be experimental or
918investigational;
919* the services must reflect the level of
927services that can be safely furnished, and
934for which no equally effective and more
941conservative or less costly treatment is
947available statewide; and
950* the services must be furnished in a
958mann er not primarily intended for the
965convenience of the recipient, the
970recipient's caretaker, or the provider.
9759. The Handbook also provides: "Medicaid does not
983reimburse for non - FDA approved medications. Medicaid does not
993reimburse procedures that are ex perimental or when non - FDA
1004approved medications are included in the procedures."
101110. The Medicaid Provider Reimbursement Handbook
1017(Reimbursement Handbook) defines "experimental or clinically
1023unproven procedures" as: "Those newly developed procedures
1030unde rgoing systematic investigation to establish their role in
1039treatment or procedure that are not yet scientifically
1047established to provide beneficial results for the condition for
1056which they are being used."
106111. Although not directly applicable to the Medic aid
1070program, Section 2049.4 of Chapter II, Part 3, Health Care
1080Financing Administration Carriers Manual (HCFA Manual) states,
1087in part:
1089Use of the drug or biological must be safe
1098and effective and otherwise reasonable and
1104necessary. . . . Drugs or biolog icals
1112approved for marketing by the [FDA] are
1119considered safe and effective for purposes
1125of this requirement when used for
1131indications specified on the labeling.
1136Therefore, you may pay for the use of an FDA
1146approved drug or biological if:
1151* It was injec ted on or after the date of
1162the FDA's approval;
1165* It is reasonable and necessary for the
1173individual patient; and
1176* All other applicable coverage
1181requirements are met.
1184* * *
1187An unlabeled use of a drug is a use that is
1198not i ncluded as an indication on the drug's
1207label as approved by the FDA. FDA approved
1215drugs used for indications other than what
1222is indicated on the official label may be
1230covered under Medicare if the carrier
1236determines the use to be medically accepted,
1243takin g into consideration the major drug
1250compendia, authoritative medical literature
1254and/or accepted standards of medical
1259practice. . . .
126312. Accordingly, the Florida Medicare Local Medical Review
1271Policy manual recognizes the use of IVIG for pediatric HIV
1281in fections, but warns: "IVIG is not indicated for use in adult
1293HIV patients . . .."
129813. Except for the administration of IVIG, Respondent
1306provided state - of - the - art services to HIV - infected adults. The
1321present record contains scant medical evidence of the
1329effectiveness of IVIG in treating HIV - infected adults. Against
1339considerable evidence questioning the medical necessity of IVIG
1347in treating HIV - infected adults, Respondent offered undocumented
1356anecdotal evidence of successful use of IVIG among his adult
1366pa tients and two synopses of undisclosed preliminary data
1375suggesting effectiveness of IVIG in HIV - infected adults.
1384Respondent did not effectively oppose Petitioner's explanation
1391for the differences in IVIG's effectiveness in treating adults
1400and children, no r did Respondent offer any rationale for his
1411claim of IVIG's effectiveness in HIV - infected adults. On this
1422record, Petitioner has demonstrated that the use of IVIG to
1432treat HIV - infected adults is not effective and, thus, not
1443medically necessary.
1445CONCLUSI ONS OF LAW
144914. The Division of Administrative Hearings has
1456jurisdiction over the subject matter. Section 120.57(1),
1463Florida Statutes. (All references to Sections are to Florida
1472Statutes.)
147315. As the parties stipulated, Petitioner has the burden
1482of prov ing that it is entitled to repayment of Medicaid payments
1494that it has made pursuant to claims submitted under Respondent's
1504provider number.
150616. Section 409.905(9) limits reimbursements to services
1513that are "medically necessary" for the treatment of an inj ury,
1524illness, or disease. However, Section 409.905(9) prohibits
1531reimbursements for services that are "clinically unproven,
1538experimental, or for purely cosmetic purposes."
154417. Section 409.913(1)(c) defines "medically necessary"
1550as:
1551any goods or services n ecessary to palliate
1559the effects of a terminal condition, or to
1567prevent, diagnose, correct, cure, alleviate,
1572or preclude deterioration of a condition
1578that threatens life, causes pain or
1584suffering, or results in illness or
1590infirmity, which goods or services are
1596provided in accordance with generally
1601accepted standards of medical practice. For
1607purposes of determining Medicaid
1611reimbursement, the agency is the final
1617arbiter of medical necessity.
1621Determinations of medical necessity must be
1627made by a licensed ph ysician employed by or
1636under contract with the agency and must be
1644based upon information available at the time
1651the goods or services are provided.
165718. Section 409.913(10) states that Petitioner may require
1665that a provider reimburse the Medicaid program f or
"1674inappropriate, medically unnecessary, or excessive goods or
1681services."
168219. The statutes clearly provide that Medicaid
1689reimbursements extend only to services that are medically
1697necessary, as determined by generally accepted standards of
1705medical practic e, and that are not clinically unproven or
1715experimental. The statutes do not address explicitly Medicaid
1723reimbursement for off - label uses of drugs. Nor do the statutes
1735implicitly preclude Medicaid reimbursement for off - label uses of
1745drugs.
174620. Not all o ff - label uses are experimental or
1757investigational. Off - label uses lack the clinical trials that
1767support FDA - approved uses, but significant medical evidence
1776other than that derived from formal clinical trials may support
1786off - label uses. Such off - label use s are no longer experimental
1800or investigational.
180221. Not all off - label uses are medically unnecessary.
1812Many off - label uses, such as the use of IVIG to treat Guillain -
1827Barr é, are effective. Florida statutes do not equate FDA
1837approval with medical necessit y; instead, they refer to
1846generally accepted standards of medical practice.
185222. The Handbook reinforces the requirement of medical
1860necessity. The Handbook's prohibition against reimbursement for
1867non - FDA approved drugs does not prohibit reimbursement for all
1878off - label uses; instead, it prohibits reimbursement for drugs
1888that have not received FDA approval for any use.
189723. The Reimbursement Handbook does not prohibit
1904reimbursement for all off - label uses. The Reimbursement
1913Handbook prohibits reimbursement f or "newly developed" drugs or
1922uses whose efficacy has not been scientifically established.
1930Again, some off - label uses are not newly developed, but are
1942instead supported by significant medical evidence.
194824. The HCFA Manual explicitly recognizes that off - l abel
1959uses may be reimbursed, if such uses are supported by medical
1970evidence.
197125. In sum, the handbooks and manuals do not enlarge upon
1982the statutes by categorically prohibiting reimbursements for all
1990off - label uses. Suggesting a categorical prohibition a gainst
2000Medicaid reimbursement only for drugs that have received no FDA
2010approval for any use whatsoever, the handbooks and manuals allow
2020Medicaid reimbursement for any off - label use whose effectiveness
2030is demonstrated by medical evidence.
203526. On this recor d, Petitioner has proved that
2044Respondent's administration of IVIG to HIV - infected adults was
2054not effective and thus was not medically necessary.
2062RECOMMENDATION
2063It is
2065RECOMMENDED that the Agency for Health Care Administration
2073enter a final order ordering Respondent to reimburse the
2082Medicaid program $74,100.04 in overpayments for services that
2091were not medically necessary.
2095DONE AND ENTERED this 19th day of April, 2002, in
2105Tallahassee, Leon County, Florida.
2109_______________________ ____________
2111ROBERT E. MEALE
2114Administrative Law Judge
2117Division of Administrative Hearings
2121The DeSoto Building
21241230 Apalac hee Parkway
2128Tallahassee, Florida 32399 - 3060
2133(850) 488 - 9675 SUNCOM 278 - 9675
2141Fax Filing (850) 921 - 6847
2147www.doah.state.fl.us
2148Filed with the Clerk of the
2154Division of Administrative Hearings
2158this 19th day of April, 2002.
2164COPIES FURNISHED:
2166Virginia A. Daire, Agency Clerk
2171Agency for Health Care Administration
21762727 Mahan D rive
2180Fort Knox Building, Suite 3431
2185Tallahassee, Florida 32308
2188William Roberts, Acting General Counsel
2193Agency for Health Care Administration
21982727 Mahan Drive
2201Fort Knox Building, Suite 3431
2206Tallahassee, Florida 32308
2209Anthony L. Conticello, Senior Attor ney
2215Agency for Health Care Administration
22202727 Mahan Drive, Suite 3431
2225Fort Knox Building III
2229Tallahassee, Florida 32308
2232Louise T. Jeroslow
2235Law Offices of Louise T. Jeroslow
22416075 Sunset Drive, Suite 201
2246Miami, Florida 33143
2249NOTICE OF RIGHT TO SUBMIT E XCEPTIONS
2256All parties have the right to submit written exceptions within
226615 days from the date of this recommended order. Any exceptions
2277to this recommended order must be filed with the agency that
2288will issue the final order in this case.
- Date
- Proceedings
- PDF:
- Date: 04/19/2002
- Proceedings: Recommended Order issued (hearing held January 24 and 25, 2002) CASE CLOSED.
- PDF:
- Date: 04/19/2002
- Proceedings: Recommended Order cover letter identifying hearing record referred to the Agency sent out.
- Date: 04/08/2002
- Proceedings: Transcript Teleconference Nonjury Hearing, January 24 and 25, 2002 filed.
- PDF:
- Date: 03/28/2002
- Proceedings: Order Setting Deadline for Filing Proposed Recommended Orders issued. (parties shall file their proposed recommended orders by the earlier of ten days after the filing of the transcript or 4/19/02)
- Date: 01/24/2002
- Proceedings: CASE STATUS: Hearing Held; see case file for applicable time frames.
- PDF:
- Date: 01/18/2002
- Proceedings: Amended Notice of Video Teleconference issued. (hearing scheduled for January 24, 2002; 9:00 a.m.; Miami and Tallahassee, FL, amended as to Date and Type of Hearing).
- PDF:
- Date: 01/15/2002
- Proceedings: Amended Notice of Hearing issued. (hearing set for January 25, 2002; 9:00 a.m.; Miami, FL, amended as to Date of Hearing (one day only).
- PDF:
- Date: 11/02/2001
- Proceedings: Notice of Hearing issued (hearing set for January 24 and 25, 2002; 9:00 a.m.; Miami, FL).
Case Information
- Judge:
- ROBERT E. MEALE
- Date Filed:
- 10/17/2001
- Date Assignment:
- 10/22/2001
- Last Docket Entry:
- 10/21/2002
- Location:
- Miami, Florida
- District:
- Southern
- Agency:
- ADOPTED IN TOTO
- Suffix:
- MPI
Counsels
-
Anthony L Conticello, Esquire
Address of Record -
Louise T. Jeroslow, Esquire
Address of Record -
Louise T Jeroslow, Esquire
Address of Record