In re:
DCIS No.:

REDACTED, a minor REDACTED

Appearances:
MaryBeth Musumeci, Esq., Community Legal Aid Society, Inc., Counsel for REDACTED
REDACTED, Witness for the Claimant
Neil Kaye, M.D. Witness for the Claimant
Ann Woolfolk, Esq. Deputy Attorney General, Counsel for the Division of Social Services
Joli Martini, Clinical Pharmacist Consultant, EDS, Witness for DSS
Anthony Brazen, D.O, Witness for DSS

I.

REDACTED (sometimes hereinafter "REDACTED" or "the claimant"), through counsel, challenges a decision of the Division of Social Services to decline to pay for the drug Lexapro that he uses.

The Division of Social Services (sometimes herein "DSS") contends that the Delaware Medicaid Program is not required to pay for Lexapro in a dosage that exceeds Food and Drug Administration (FDA) usage guidelines (The parties agree that Oliver J. Yost, M.D. has prescribed Lexapro at 40 mg. per day for the claimant since 2003 and that this dosage is twice the recommended dose for adults under current FDA guidelines.).

The claimant asserts that DSS is improperly applying the FDA drug dosing guidelines as an irrebuttable presumption without taking into account the individual circumstances of REDACTED medical condition and response to treatment. ("Irrebuttable" and conclusive presumptions, when set out in a rulemaking, establish an alleged fact which is not permitted to be overcome by any proof that the fact is other than that asserted by the rule.)

II.

On or about February 8, 2005 EDS, an agent for DSS, issued a notice announcing that the claimant's prior authorization for the use of 40 mg. per day of Lexapro would terminate after 30 days because the safety and efficacy of the dose was not established. [Exhibit # 1]

On February 18, 2005 the claimant's mother REDACTED, filed a request for a fair hearing.

The date of a fair hearing scheduled for April 14, 2005 was changed at the request of counsel for the claimant. The hearing was conducted on May 9, 2005. This is the decision resulting from that hearing.

III.

The Division of Social Services of the Department of Health and Social Services operates the Medicaid Program under Title XIX of the federal Social Security Act and under the authority it derives from 31 Del. C. §502(5), §503 (b), and §505 (3). The Medicaid Program provides support for medical services received by defined groups of low-income families and individuals. Persons who meet income and status eligibility tests, such as age, citizenship, and residency, may participate in the program. Participants qualify for payment for a wide range of medical services.

The issue to be decided as a result of this hearing is whether the Division of Social Services can terminate Medicaid Program coverage for the drug Lexapro for the claimant on the ground that the drug is not recommended for children and the dosage exceeds a recommended dose and is, therefore, experimental.

The essential facts in this case are as follows: REDACTED is 12 years old. He is diagnosed with spina bifida and anxiety disorder with obsessive compulsive features. He is a Delaware Medicaid Program recipient. His doctor, Oliver J. Yost, M.D., has prescribed Lexapro at 40 mg. per day for him since March 2003. This dosage is twice the recommended dose for adults under current FDA guidelines. He is seen weekly by a psychiatrist for cognitive therapy development.

The drug Lexapro was prescribed by Dr. Yost for treatment of the claimant's anxiety disorder. He has also taken Celexa, a closely related drug. The dosage of Lexapro was increased gradually to the current dose of 40 mg. per day while his behavior, anxiety, and mood was observed and appraised.

IV.

Joli Martini is a pharmacist with EDS. EDS is an agent/actor for the State and provides drug management services to DSS. She testified about the pharmacological aspects of Lexapro. Dr. Anthony Brazen is the DSS Medical Director. He testified about the clinical reasons why DSS concluded that the dosage of Lexapro requested for REDACTED is inappropriate. Dr. Brazen and Ms. Martini also testified that in January 2005 DSS embarked on project called "DUR Plus." The project was evidently a result of a Drug Utilization Review Board (The Drug Utilization Board monitors and recommends policies relating to prescription drugs for the Delaware Medicaid Program. It lacks the legal authority to adopt rules to carry out the policies it recommends. That authority is with the Secretary of the Department of Health and Social Services. See 31 Del. C. 107.) recommendation that the Delaware Medicaid Program limit medications to "the specific FDA dosing regiment or guidelines." Ms. Martini characterized the recommendation as "a rule, so to speak."

Ms. Martini testified that EDS received a request for Lexapro from Dr. Yost on February 1, 2005 at a dose of 40 mg. per day. The EDS response to the request was to approve a 30 day supply only. On February 8, 2005 EDS sent a notice to the claimant announcing this decision.

Ms Martini consulted with a pediatric psychiatrist and member of the Drug Utilization Review Board, Dr. Mark Borer, and reviewed a number of online and other documents about the use of Lexapro (I have not included the documents because I find the recorded testimony identifying the documents and their content to be adequate for the hearing record and because the documents themselves are lengthy and, while instructive, do not help to resolve the central problem for this hearing.) in reaching a decision. [Exhibit # 1] She found that 20 mg per day of Lexapro is the recommended dosage for adults and that the drug is not FDA approved for use by children. Ms. Martini's testimony is that the reason EDS required prior approval in REDACTED case was because of the high dose level. While the EDS conclusion was reasonable and based on a thorough examination of the medical literature, I am not sure that it took into account all of the claimant's circumstances

Dr. Neil Kaye is a psychiatrist. He testified about the usage of Lexapro to treat the symptoms of REDACTED disorder and the appropriateness of dosing guidelines when psychiatrists make treatment decisions. He reviewed REDACTED records and talked to Dr. Yost abut REDACTED treatment plan. It is his opinion that 40 mg. of Lexapro daily is safe and effective, is appropriate for REDACTED, and is producing a positive benefit. In his opinion the drug is safe. It has been on the market for a long period of time without serious problems or side effects. There is apparently no market for Lexapro as a "street drug" and it is, in general, not subject to abuse. Significantly, he testified that doctors typically deviate from FDA dosing guidelines when prescribing mental health drugs, that patients with anxiety disorders with obsessive compulsive features require a higher than average dosage to treat the disorder.

REDACTED, the claimant's mother, testified about the claimant's experience with anxiety disorder and his treatment with Lexapro.

Based on the testimony received for the hearing from the medical professionals, and based on the testimony about the claimant's response to treatment with Lexapro, I am unable to find that REDACTED use of 40 mg. per day of Lexapro is detrimental to his well-being or that his use of the drug is not advisable. Based on the testimony I find that he has had a positive outcome as a result of his use of Lexapro.

V.

In addition to the dispute over the use of Lexapro in the claimant's case, I am also asked to determine if the claimant has a right to have the Medicaid Program pay for the drug. For this judgment I am guided by the principle that "[a]djudication is the decision making process for applying preexisting standards to individual circumstances." (Charles H. Koch, Jr., Administrative Law and Practice, Second Edition, §2.11 ) Under the hearing rule at DSSM 5406.1 (1) I am required to decide the issues in dispute based on the rules in effect at the time of an action.

With respect to the existing standards in effect at the time of the decision in dispute, no specific rule is cited in the February 8, 2005 notice as authority for the action with respect to the claimant's use of Lexapro. (DSSM 5301 (4) (b) requires notices to "contain information needed for the claimant to determine from the notice alone the accuracy of the Division's action or intended action." A notice must "provide citation(s) to the regulation(s) supporting the action being taken." DSSM 5301 (4) (b).) [Exhibit # 1] In the amended hearing summary notice sent to the claimant's mother on March 28, 2005 [Exhibit # 3] the State cites Practitioner Manual § 1.11.8. Section 1.11.8 is not a rule but a catchline to a subset of instructions/rules for Medicaid Program providers. It reads: "Prior Authorization Requirements for Medications."

The catchline and following subsections are instructions for providers. They set out reasons why classes of drugs require pre-approval scrutiny: because of their potential for abuse or over utilization, because medical necessity is lacking, because of high cost or experimental use opportunity or other reasons. The specific rule number within this group is not cited in either the February 8, 2005 notice or the amended hearing summary transmitted on March 28, 2005. The catchline at 1.11.8 and the following subsections are procedural and govern the process of payment authorizations to providers. I am unable to find a subsection that is cited for this hearing that specifically restricts or limits payment for drugs only to those that are prescribed within FDA dosing guidelines.

Section 1.11.8, by itself, is not legal authority supporting the action taken.

The notice states that Lexapro is "approved" but only for thirty days. The reason given for this in the notice is that:

• "The requested dose exceeds approved limits. Safety and efficacy have not been proven at this dose and therefore are considered experimental. Your request for the above listed patient has been reviewed. Federal regulations require the DMAP to provide medications in doses that have been proven to be both safe and effective. The FDA generally defines the standards for medications. In order to give your request additional consideration, articles from two peer reviewed journals that demonstrate the preparation and dose being requested has been proven both safe and effective, must be provided for the DMAP clinical staff to review."

Although the explanation is lengthy, the notice is not the "detailed individualized explanation" required by the Court order and by DSSM 5301 (4)(c).

The notice does not cite the referenced federal regulation that requires medications to be in doses "that have been proven to be both safe and effective." Therefore, I am unable to review this asserted authority.

The notice does not cite any State or federal rule as authority. This is fatal to the State's case because the Department of Health and Social Services was enjoined in 1985 by the United State District Court for the District of Delaware from terminating or reducing benefits without an adequate notice and was required to:

• "in all cases requiring action or change of status regarding eligibility or benefit amount for federal public assistance, issue adequate notices to federal public assistance claimants which comply with the federal regulations regarding such notices and due process requirements. The guiding principle shall be that the notice must contain any information needed for the claimant to determine from the notice alone the accuracy of the agency's intended action. At a minimum these notices shall 1) indicate the action to be taken; 2) provide citation(s) to the regulation(s) supporting the action being taken; 3) provide a detailed individualized explanation of the reason(s) for the action being taken which includes, in terms comprehensible to the claimant, an explanation of why the action is being taken" (The quotation is from the United States District Court for the District of Delaware in an order dated August 16, 1985 in Nilsa Ortiz v. Thomas P. Eichler, Civil Action No. 84-16 MMS. See also Ortiz v. Eichler, 616 F. Supp. 1046, 1061 (D. Del. 1985), aff'd 794 F. 2d 889 (Third Circuit 1986))

The action in dispute is the termination of a Medicaid Program service. The claimant has a right to an adequate notice that cites the specific rule governing the Delaware Medicaid Program's drug payment policy. In cases involving the termination of benefits or services program, beneficiaries have a right to a notice in advance of an action and the right to a pre-termination hearing.

The language of the Court's order inhabits the State rule at DSSM 5301.

Section 5301 (4) (b) requires that notices to claimants "provide citation(s) to the regulation(s) supporting the action being taken." Since the February 8, 2005 notice does not cite a specific rule it does not comply with DSSM 5301. DSS will want to correct this and take steps to ensure that service related notices to Medicaid claimants comply with the Court order and with the rules for notices.

It appears to me that DSS has not grasped the significance of an intended effect of the Court order: DHSS needs to have a rule that authorizes or governs a specific action to be able to cite a rule in its notices to claimants. The notice lacks a citation to a rule because there is no State rule to cite. DSS will want to correct this matter so that it is able to comply with the Court order and give adequate notices to claimants.

No specific rule has been brought to my attention for this hearing that authorizes DSS to decline payment for a drug because the dosage exceeds FDA guidelines. I have examined the DSS rules and I am unable to find such a rule.

The provider instruction rule at §1.11.8.3 (not cited by DSS) provides that:

• "The Drug Utilization Review Board will make decisions regarding the medications that will require prior authorization and the criteria to be used. Prior authorization will be based on duration of therapy, quantity, or a combination of both depending on the medication requested. Refer to Appendix N for specific criteria for prior authorization."

There are several problems with this rule. It was not cited in the February 8, 2005 notice. It addresses the circumstances and procedures under which certain drugs may be approved rather than the circumstances under which a prior authorization may be discontinued or terminated. It is a procedural instruction for providers and not a substantive rule governing eligibility for pharmaceutical services.

Based on the testimony received for the hearing, I find that EDS took the action under appeal not as a result of a rulemaking but because of a recommendation by its Drug Utilization Board. Based on the testimony and documentary evidence, I find that EDS relied on the FDA dosing guidelines and Drug Utilization Review Board recommendation exclusively without considering the claimant's circumstances and used the FDA guidelines as an irrebuttable presumption to deny the claimant access to the drug Lexapro in the dosage prescribed by his doctor.

Without a specific rule limiting or restricting drug dosage limits and cited in a notice, the action to cut short REDACTED coverage by terminating his prior authorization is improper because it is not based on a rule. Because it is not based on a rule it is arbitrary and is reversed.

The claimant also cites a 1989 authority in the 8th Circuit that held that a State Medicaid Program had to cover a prescription drug (AZT) which was certified by their physicians as medically necessary but which did not fall within FDA approved guidelines. Weaver v. Reagan, 886 F 2d 194. The facts in this matter are not the same and no similar Court decision from the 3rd Circuit has been brought to my attention.

VI.

If DSS wants to restrict payments only to FDA approved drug dosage, the Department of Health and Social Services needs to assert its authority under 31 Del. C. 107 to promulgate for public comment and adopt a substantive rule under the Delaware Administrative Procedures Act. 29 Del C. Ch. 101.

The Department has authority to adopt a rule that conclusively presumes that drug dosages in excess of FDA guidelines are unsafe and unauthorized or can otherwise refuse payment by proposing the adoption of a rule that asserts that there are no circumstances under which the Delaware Medicaid Program will pay for drugs in dosages that exceed FDA guidelines. DHSS is not a stranger to this process.

DSS has a number of presumptions in its rules included at least one in the subtype of Medicaid that is apparently received by the claimant. (See DSSM 25100 (5))

It is up to the authorities charged with the operation of the Delaware Medicaid Program to consider and measure the effect that the adoption of such a rule may have on the parties and others involved in the delivery of medical care and services.

It is clear from the Delaware Administrative Procedures Act that our lawmakers wanted agencies to propose rules for public scrutiny before they are adopted to address these important matters.

VII.

Because the February 8, 2005 notice did not cite a rule supporting the action the notice announced, the decision to terminate the claimant's prior authorization for Lexapro is reversed.

Date: May 16, 2005
ROGER WATERS
HEARING OFFICER

THE FOREGOING IS THE FINAL DECISION OF THE DIVISION OF SOCIAL SERVICES

RW

cc:
MaryBeth Musumeci, Esq. for REDACTED
Ann Woolfolk, Esq., for DSS

EXHIBITS

Exhibit # 1 (three pages) consists of a facsimile transmission request for a fair hearing date stamped as received February 18, 2005 together with a notice from DSS agent EDS dated February 8, 2005 approving the drug escitalopram oxalate for a period of thirty days only. This is admitted as evidence of a written request for a fair hearing, as evidence of the date on which the request for a fair hearing was received, as evidence of the date of the notice denying continuing approval of Lexapro and as evidence of the reason given by the State for the denial.

Exhibit # 2 is an amended hearing summary dated March 3, 2005. It is not admitted as a business record because it is not signed as required by §5312 and because the dates given for the effective date of the action and for the date of the notice are inconsistent with the documentary and testimonial evidence received for this hearing. It is admitted as evidence of the rule cited as authority for the action under appeal.

Exhibit # 3 (two pages) is a copy of the amended hearing summary date stamped as received on March 24, 2005 together with a cover letter dated March 28, 2005 transmitting the amended fair hearing summary to REDACTED REDACTED. This is included for the purpose of the discussion above.

Exhibit # 4 is the closing argument for the claimant. (10 pages). This is included as part of the hearing record. Counsel for the claimant was asked to submit a closing argument after the hearing pursuant to DSSM 5405 (3) (e). This was because the length of the hearing threatened in interfere with another fair hearing scheduled for the same room and scheduled to begin at 12:00 noon.

Exhibit # 5 (3 pages, revised on May 16, 2005) is the closing argument for the Division of Social Service