When Medi-Cal Says "No" to Serostim
Medi-Cal recipients can obtain Serostim, a human-growth hormone which is prescribed to control HIV wasting syndrome, as one of the drugs covered by the program.
Because HIV wasting syndrome is not simply a decrease in body weight, but in fact involves the loss of lean body mass (skeletal muscle, organ tissue, blood and blood constituents and even intra- and extra-cellular water), it results in muscle weakness, organ failure and eventual death.
Nutritional intervention (a simple increase in the caloric intake each day) is not effective in the severe wasting syndrome cases, because an increase in calories results in an increase in body fat. Use of Serostim results in an increase of the lean body mass, a decrease in body fat and a significant increase in body weight.
Normal Medi-Cal Procedure
When the U.S. Food and Drug Administration approves a drug, it is approved for "label use," or a specific medical purpose. As the drug is prescribed and used, often the medical community and the public discover other effective uses for the drug. The medical community may begin to prescribe the drug for "off-label" uses.
If Medi-Cal has approved coverage of the drug, it approves the drug for label use. If a Medi-Cal recipient needs the drug for an off-label use, the recipient's treating physician has to provide written evidence to Medi-Cal documenting that this "off-label" use of the drug has become a common practice in treatment of the condition. This written evidence also must include literature (such as medical journal articles) that describes the medical research or testing to support this new use of the drug.
Serostim Medi-Cal Procedure
All bets are off when it comes to Medi-Cal approval of Serostim.
Serostim costs between $7,000 and $8,000 per month per recipient. Body-builders use it to increase lean body mass, and trade of the drug on the black market is thriving. Fraudulent attempts to obtain Serostim by Medi-Cal patients who, medically, do not "need" the drug are rising. As of May, the Department of Health Services has informed all Medi-Cal beneficiaries that Serostim, as well as several other drugs, are not available automatically upon the prescription of the medical doctor.
As of May, treating physicians must complete a Treatment Authorization Request (TAR) before Medi-Cal will pay for a Serostim prescription. The TAR includes a list of the recipient's HAART medications, the recipient's current weight, the recipient's height, and the results of a recent body cell mass test.
If the medical information in the TAR supports the treating physician's prescription of Serostim to control severe HIV wasting, then Medi-Cal should approve the TAR and pay for Serostim -- for that month. In the subsequent month, another TAR may be required, with another body cell mass test, to verify that ongoing use of Serostim is medically necessary.
If the treating physician does not submit a new TAR, the recipient probably will be unable to get a Serostim refill at the pharmacy, and the pharmacy may direct the recipient to speak directly with the treating physician.
If the treating physician submits a new TAR, but does not include the height, weight, medications list and body cell mass index, Medi-Cal will "defer" approval of the TAR until this information is received. Unfortunately, the pharmacy may not inform the recipient that the TAR approval is "deferred." The recipient may be told (incorrectly) that the TAR was denied, or the recipient may be told that the TAR was "not approved." The recipient then assumes that the TAR is denied. The recipient may ask the physician to submit another TAR or file an appeal with the California Department of Social Services, requesting a hearing with an Administrative Law Judge.
When a TAR is deferred, and the requested information is not received, the deferment becomes a denial. The recipient will not be able to file an appeal when the TAR is deferred -- only when the TAR is denied. The difficulty is that if the denial is based on a failure to receive requested medical information from the treating physician, the recipient may be unable to win an appeal: if the medical information which Medi-Cal has requested is reasonable, if it is not received within the deadline, and if the TAR therefore is denied, then the denial is likely to be considered valid under Medi-Cal law. Under these circumstances, the recipient has no option other than to request that the treating physician submit a new TAR and to ensure that the supplemental information is included as part of that TAR.
While it may seem like a lot of useless paperwork, the recipient may be required to have a TAR submitted (with that supporting medical information) for each month in which the Serostim is prescribed. Recent fraud cases involving Serostim and its incredible expense make these repeated requests for medical information and a monthly TAR requirement "reasonable" under these circumstances.
What to Do About Denials
Treating physicians may prescribe Serostim for an "off-label" problem or for a wasting condition which Medi-Cal decides is not so severe. This is when the recipient must file the appeal and request the hearing. This is when Medi-Cal may have made a mistake.
There is a problem with Medi-Cal's new approval system for Serostim: If the recipient has received Serostim in the past, has responded to the medication -- and therefore has experienced an improvement in his or her condition, that recipient may not meet the body cell mass and other wasting guidelines to qualify for ongoing Serostim payments by Medi-Cal. This suggests that the recipient's condition must re-deteriorate before Medi-Cal, once again, will cover this medication. If this sounds wrong to you, the doctors are not happy, either, since this could create ethical problems for the doctors who are supposed to prevent deterioration of the recipient's condition.
While Medi-Cal is allowed to implement reasonable regulations on its approval of prescribed medications, Medi-Cal is not allowed to substitute its medical judgment for the judgment of the recipient's treating physician. If the recipient's condition satisfies the "label use" for a Serostim prescription, then Medi-Cal must approve it. If the recipient's condition is for an "off-label" use, such as the reduction of lipodystrophy/the buffalo hump, Medi-Cal still should approve it, if supporting literature and other evidence has been submitted which justifies the use of this medication for this additional ailment. If the recipient's condition has responded to prior use of Serostim, but the treating physician believes that ongoing access to Serostim remains medically necessary, then the recipient has grounds for an appeal, if Medi-Cal denies a subsequent TAR.
If you believe Medi-Cal has denied a Serostim, or any other HIV-related medical prescription, in an improper manner, please call the HALSA intake line: (213) 201-1640 for more information.
If you have general questions about Medi-Cal eligibility, approved drug, and the TAR procedure, contact AIDS Project Los Angeles' Benefits Department at (213) 201-1472 or AIDS Service Center at (626) 441-8495.
Funded by the County of Los Angeles, Department of Health Services, Office of AIDS Programs and Policy.
|Leslie Kline-Capelle is the Public Benefits Staff Attorney at the HIV & AIDS Legal Services Alliance. HALSA can be reached by calling (213) 201-1640.|