Report 2015-131 Recommendation 33 Responses

Report 2015-131: California's Foster Care System: The State and Counties Have Failed to Adequately Oversee the Prescription of Psychotropic Medications to Children in Foster Care (Release Date: August 2016)

Recommendation #33 To: Health Care Services, Department of

To increase the State's assurance that foster children do not receive medically inappropriate or unnecessary psychotropic medications, Health Care Services should devise and implement within six months methods to better enforce its prior authorization requirement for the off-label use of psychotropic medications. For example, Health Care Services should revise its claims system to automatically prompt pharmacists to submit treatment authorization requests when filling prescriptions for Medi-Cal beneficiaries under age 18 when the prescribed psychotropic medications have no FDA-approved pediatric uses. Furthermore, as part of its collaboration with Social Services and the counties to develop and implement a reasonable oversight structure, Health Care Services should determine whether information from the Judicial Council's revised court authorization forms would help it better enforce its prior authorization requirements.

Annual Follow-Up Agency Response From October 2019

DHCS has reviewed the information fields on the Judicial Council's revised court authorization forms and determined that the information provided does not meet the prior authorization requirements for approval of diagnosis related, off-label prescriptions as mandated in Title 22, California Code of Regulations (CCR), Section 51313(c)(4), which states, in part:

"Authorization for unlabeled use of drugs shall not be granted unless the requested unlabeled use represents reasonable and current prescribing practices. The determination of reasonable and current prescribing practices shall be based on:

(A) Reference to current medical literature.

(B) Consultation with provider organizations, academic and professional specialists."

Medi-Cal providers requesting "off-label" approval are required to submit documentation supporting the claim that the request meets generally accepted medical standards. Standards of care changes over time and new literature may alter the landscape of what constitutes "reasonable and current prescribing practices." In order to satisfy the requirements of 22 CCR Section 51313(c)(4), the supporting documentation must come from credible, unbiased sources and be based on sound clinical reviews or studies. Anecdotal and/or personal experiences of the requesting provider would not be adequate documentation for purposes of meeting regulatory requirements.

While information contained on the Judicial Council's revised court forms is provided by the prescribing physician, it does not include credible studies and/or reports from current medical literature, nor does it provide clinical guidelines for off-label use adopted and published by child psychiatric provider organizations or academic/professional specialists. It would fail to meet 22 CCR Section 51313(c)(4) standards, and so cannot be utilized.

California State Auditor's Assessment of Annual Follow-Up Status: Fully Implemented

Annual Follow-Up Agency Response From November 2018

In March 2017, DHCS posted a second provider bulletin noting the age-based restrictions imposed on all psychotropic drugs as of January 1, 2017 (which was originally published in the December 2016 provider bulletin). These restrictions enforce the requirement of a TAR when the beneficiary's age is below the approved age recognized by the FDA. The link to this bulletin: http://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/ph201703r.asp

California State Auditor's Assessment of Annual Follow-Up Status: Partially Implemented

Although Health Care Services addressed age-related off-label prescriptions, it did not provide information regarding whether information from the Judicial Council's revised court authorization forms would help it better enforce its prior authorization requirements regarding diagnosis-related off-label prescriptions.

1-Year Agency Response

In March 2017, DHCS posted a second provider bulletin noting the age-based restrictions imposed on all psychotropic drugs as of January 1, 2017 (which was originally published in the December 2016 provider bulletin). These restrictions enforce the requirement of a TAR when the beneficiary's age is below the approved age recognized by the FDA. The link to this bulletin: http://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/ph201703r.asp

California State Auditor's Assessment of 1-Year Status: Partially Implemented

Although Health Care Services addressed age-related off-label prescriptions, it did not provide information regarding whether information from the Judicial Council's revised court authorization forms would help it better enforce its prior authorization requirements regarding diagnosis-related off-label prescriptions.

6-Month Agency Response

In the December 2016 provider bulletin (published 12/30/16), DHCS informed providers that, effective January 1, 2017, age restrictions would be implemented on all non-antipsychotic psychotropic drugs according to their FDA approved ages. The bulletin included links to specific pages within the Medi-cal provider manual listing those drugs effected by this change and informs providers that claims for non-antipsychotic psychotropic drugs that fall outside of these approved ages require an approved treatment authorization request (TAR) with medical justification.

DHCS will publish a 60-day reminder of this policy change in the February 2017 provider bulletin. The bulletin will also remind providers that, in addition to psychotropic medications, unlabeled use of all medications requires an approved TAR.

Using system edits which prevent claims for psychotropic medications that fall outside of FDA approved age guidelines from processing, DHCS feels that the risk of foster children receiving off-label psychotropic medications is adequately mitigated. The system edit will require a Treatment Authorization Request for the medication be submitted for review and approval prior to the claim being processed. Because of this, no additional enforcement actions will be taken at this time.

California State Auditor's Assessment of 6-Month Status: Partially Implemented

Health Care Services has partially implemented our recommendation. Our recommendation "to better enforce its prior authorization requirement for off-label use" pertained to the need to better ensure that pharmacists submitted TARs for both AGE-RELATED off-label prescriptions of psychotropic medications and DIAGNOSIS-RELATED off-label prescriptions, as we discussed on pages 70 through 74 of our report.

Based on the evidence it provided and the actions Health Care Services states it has taken, we conclude that Health Care Services implemented a new system edit to better ensure that pharmacists submit TARs for age-related off-label prescribing of psychotropic medications. However, Health Care Services does not address the steps it will take to better ensure that pharmacists submit TARs for diagnosis-related off-label prescriptions.

In addition, as our recommendation states, as part of its collaboration with Social Services and the counties to develop and implement a reasonable oversight structure, Health Care Services should determine whether information from the Judicial Council's revised court authorization forms would help it better enforce its prior authorization requirements.

All Recommendations in 2015-131

Agency responses received are posted verbatim.