Florida Medicaid Open Flood Gates to Drug Children

Pharmalot

Florida Medicaid, Antipsychotics And Small Children

By Ed Silverman
December 17th, 2008

At a time when growing use of atypical antipyschotics in children is under a microscope, Florida’s Medicaid program recently revised rules that makes it possible for doctors to write prescriptions for children of all ages - including those younger than six years old.

Most of these drugs can lead to weight gain and diabetes, and one prominent study found they were no more effective than older meds. Yet the drugs are increasingly prescribed for children, with Medicaid programs in several states reporting rising expenditures for antipsychotics, sometimes to treat ADD or ADHD, which are unapproved uses (look here and here).

In general, the atypical antipsychotics - a newer class that includes AstraZeneca’s Seroquel; Bristol-Myers Squibb’s Abilify; Pfizer’s Geodon; Lilly’s Zyprexa and Johnson & Johnson’s Risperdal - were not approved by the FDA to treat small children, or those younger than 10 years old. Risperdal has been approved for children older than 5 years of age, but only for those with autistic disorder. To be eligible for Medicaid reimbursement, a drug has to be used for a medically accepted indication, which means the drug has to be approved for a specific use or supported by specific compendia (this link indicates the three compendia do not list any use of the atypicals in children younger than 5 years old).

In Florida, meanwhile, the number of children in the state Medicaid program prescribed the drugs nearly doubled between 2000 and 2006 (and the most common diagnosis was ADHD). Such trends recently prompted an FDA advisory panel to chastise the agency for not doing more to discourage such prescribing (back story) and a group of state Medicaid directors to evaluate the use of the drugs in children on state Medicaid rolls to ensure that they are being properly prescribed (look here).

Despite such concerns, the state’s Agency for HealthCare Administration last month made good on earlier promises and modified a rule that now makes it possible for doctors to prescribe the meds to children of any age - if doctors obtain prior authorization. Here is the rule:

“To be reimbursed by Medicaid, a drug must be medically necessary and either (a) prescribed for medically accepted indications and dosages found in the drug labeling or drug compendia in accordance with Section 1927(k)(6) of the Social Security Act, or (b) prior authorized by a qualified clinical specialist approved by the Agency.” [The language about prior authorization is new].

In an e-mail to a source, Mary Elizabeth Jones, a senior pharmacist with the AHCA’s Medicaid Pharmacy Services, wrote this explanation: “Physicians sometimes prescribe medications for special populations that are not included in the official FDA approved indications. This is a decision made between the prescribing physician, the patient and the parent or guardian. AHCA reimburses for medications on the Florida Preferred Drug List (PDL) that are prescribed by qualified, licensed professionals.

“The prior authorization process is activated when a physician prescribes a medication that is not found on the PDL or is prior authorized for a special population. The prior authorization requirement for atypical anti-psychotics in children under the age of 6 years is an example of prior authorization for a special population.

“The AHCA initiated this process to allow review of the request by a qualified clinical specialist prior to approval or denial of medication reimbursement. Clinical review processes help promote safe prescribing practices and help ensure non-medication therapies are applied prior to or along with medication therapies. The reimbursement of antipsychotic medications by Florida Medicaid for children is appropriate and is supported by Medicaid Reimbursement Rules.”

Not every state allows prescribing to small children. In California, for instance, the state Department of Health Care Services’ Medi-Cal has restrictions that prohibit reimbursement for antipsychotics prescribed to children younger than six years old (please see this link and look up the chemical name for each drug; Risperdal, for example, can be seen by searching for Risperidone).

Florida’s AHCA was supposed to hold a meeting on Friday to review its rule change, but that has been cancelled. Anne Wells, the Medicaid Pharmacy Services bureau chief, wrote us this explanation: “It has been determined by the Agency for Health Care Administration that sufficient information has been received to prepare a final report. The previously held public meeting on June 25, 2008 and written comments mailed to the AHCA for a period of one week following the meeting provided opportunity for input from all the stakeholders.

The AHCA has requested a ‘Review of the Topic’ to be prepared by a group of Child and Adolescent psychiatrists who participated in the development of the Florida Best Practice Guidelines for the use of psychotherapeutic medications in children. Some of these group members performed the atypical antipsychotic prior authorization reviews required by the Agency for Health Care Administration for children under the age of 6 years.”

“When this summary report has been completed it will be provided to the Ad Hoc group members for review. The report is expected to be completed before the end of the year.”