DCIS No.: Redacted
Cindy DePue, Esq., Legal Aid
Michele Gillespie, Certified Nurse Practitioner
Ann Woolfolk, DAG
Joli Martini, Clinical Pharmacist Consultant, EDS
Anthony Brazen, III, D.O., Chief Medical Officer/Medical Director, Division of Social Services
Redacted ("Claimant"), by and through counsel, challenges a decision of the Division of Social Services (DSS) to deny her request for approval of Adderall XR, 30 mg, a prescription drug to treat the Claimant's Attention Deficit Hyperactivity Disorder (ADHD), General Anxiety Disorder (GAD), and Major Depressive Disorder (MDD). She asks that the Medicaid Program approve the use of the drug because she states that the drug has been effective in treating her medical condition.
The Division of Social Services contends that while approval of this drug is available under certain criteria, because of the current make up of the Claimant's drug profile, DSS properly denied pre-authorization.
The Division of Social Services of the Department of Health and Social Services operates the Delaware Medical Assistance Program (DMAP). EDS is a State actor/contractor and manages certain of the program's operations.
By notice dated March 10, 2004 EDS, acting for DSS, sent a notice to the Claimant, pending her approval of a Central Nervous System (CNS) stimulant. Again, by notice dated July 28, 2004 EDS, acting for DSS, sent a notice to the Claimant, pending her approval of a Central Nervous System (CNS) stimulant. Finally, by notice dated August 17, 2004, DSS sent a notice to Claimant denying her request for the approval of a CNS stimulant because she was already taking a CNS depressant. (See, State's Exhibit 3)
The Claimant requested a fair hearing to address the adverse decision. (State's Exhibit 4)
By certified letter dated September 15, 2004, Claimant was notified that a fair hearing would be held on September 30, 2004 in Dover, DE. Due to Claimant's involving legal counsel the hearing was first re-scheduled to October 14, 2004 and then to November 5, 2004. The Claimant then requested and received a continuance because of the unavailability of a witness. The hearing was again re-scheduled, this time to January 4, 2005. The hearing was conducted on that date.
This is the decision resulting from that hearing.
Jurisdiction for this hearing is pursuant to §5304 of the Division of Social Services Manual (DSSM). Under §5304:
an opportunity for a hearing will be granted to any applicant who requests a hearing because his/her claim is denied and to any recipient who is aggrieved by any action of the Division of Social Services. Only issues described in the notice of action sent to the appellant or issues fairly presented in the appellant's request for a fair hearing or in the Division's response in its hearing summary may be presented for the hearing officer's review at the hearing.
Joli Martini, Pharm. D., testified that she is a Clinical Pharmacist Consultant for EDS and is responsible for the clinical review of all pre-authorization requests. When she received the request for Adderall XR 30 mg. for the Claimant, she initially did not have enough information and so pended the request. No additional information was provided. Then, a second request for pre-authorization was submitted and again, Ms. Martini requested additional information. This time, when provided with additional information, the request for pre-authorization was denied. (State's Exhibit 3)
Ms. Martini testified that she believed it was counter-intuitive to be prescribing a CNS stimulant when the Claimant was already taking a CNS depressant. She noted that the Claimant had multiple prescribing healthcare providers and she was not aware whether these providers knew what each other was prescribing. In particular, she noted that when Percocet/Endocet is taken with other CNS depressants, the dose of one or both should be reduced. (State's Exhibit 10) In addition, she observed that the Claimant had been using Ambien on a regular basis as a sleep aid since 2001, yet the packaging insert indicates that this medication should be used for the short-term treatment of insomnia - short-term being 7-10 days. (State's Exhibit 11) In short, Ms. Martini testified that the Claimant's long-term use of Ambien could be causing some of the other conditions for which the Claimant is being treated. Finally, Ms. Martini testified that Adderall XR is contraindicated for someone with GAD per the package insert and that the current mix of drugs also raises some concerns because the Claimant is a school bus driver.
On cross-examination, Ms. Martini testified that prior to February 2004, Adderall XR, as well as other drugs being taken by Claimant, was not on the list of medications that required pre-authorization. Medicaid had actually paid for the Adderall XR prior to that time because there had been no reason to review the Claimant's drug profile, based upon the assumption that the Claimant's physician's are acting properly when prescribing medication for their patients. Lastly, she admitted that anxiety is a symptom of general depression.
Next, Dr. Anthony Brazen, Chief Medical Officer and Medical Director for DSS, testified that he was asked to review the Claimant's drug profile in conjunction with the pre-authorization request. He testified that he has been practicing medicine in excess of 20 years and has personally managed and supervised the management of adults with ADHD, GAD, and MDD. With respect to the drug profile of the Claimant, Dr. Brazen testified that this poly-pharmacy was both "alarming" and "troubling." He also testified that the overall drug profile was a "bad combination of drugs" because the Claimant was taking medications that have side effects of anxiety while the person was also being treated for GAD. He could not tell from the information provided whether the Claimant was being treated for underlying diseases or for the symptoms of side effects created by the drugs. He further testified that it appeared that this case was being poorly managed from a medical standpoint and in addition to there being no medical necessity for the use of this drug, there is also a high potential for diversions, misuse, and abuse.
On cross-examination, Dr. Brazen testified that it is common to have patients present with anxiety along with depression and that sometimes it is difficult to differentiate between ADHD and anxiety. Finally, he testified that it is impossible to tell the diagnosis in this case and whether diagnoses are actually being created as a result of the side effects of some of the medications.
Ms. Redacted testified next, indicating that she was diagnosed one (1) year ago with ADHD, clinical depression years ago, and that she began taking Adderall sometime in 2004. She testified that the Adderall helps her concentrate more, making her more effective and on an even balance. She has not been driving a school bus since June 2004, but would like to return to doing so. The testimony of the Claimant provided at the hearing also indicates that she suffers from ADHD, MDD, and GAD that she believes has been effectively managed with Adderall XR, 30 mg. as well as with Endocet, (a generic form of Percocet); Ambien (for sleep); Cyclobenzaprine (a generic for Flexeril - a muscle relaxer); Alprazolam (a generic Xanax for breakthrough anxiety); Lexapro (for depression and anxiety); and, Wellbutrin XL (an anti-depressant).
As to her medical providers, Ms Redacted testified that she sees Dr. Islam for chronic pain associated with her neck surgery in 1999. She has also seen Michael Balzarini, a Certified Nurse Practitioner for Dr. Bose who is her neurosurgeon; Dr. Rowe who performed her laminectomy; Dr. Ameer for pain management (no longer sees him); her family doctor, Dr. Neal; and, Michele Gillespie, a Certified Nurse Practitioner working for FH Everett & Associates. Importantly, the Claimant testified that all of the providers know about each other and all know her current medications. The Claimant also testified that Dr. Islam, who is prescribing the Endocet, frequently tests her urine for narcotic levels to make sure that she is not abusing the medication. Finally, the Claimant testified that her current drug regime is working.
On cross-examination, the Claimant admitted that she had actually been taking Adderall since 2002, not one year ago, and that she has been taking Ambien for about four (4) years. She testified that all of this came about because she was driving a school bus and missing her regular stops, missing turns, and forgetting to drop children off. She indicated that her prescription for Xanax allows her to take the drug up to three (3) times per day, but that she normally takes the drug only several times per week for breakthrough episodes of anxiety.
The last witness was Michele Gillespie, a Certified Nurse Practitioner who holds certificates in Family Medicine, Chemical Dependency and Psychiatry. She testified that she has been treating the Claimant since 2001. She also testified that the Claimant's drugs are monitored carefully, once per month and that the Claimant's current medications are: Adderall XR for ADHD; Lexapro for depression and anxiety; Xanax for breakthrough anxiety; Ambien for sleep; and Wellbutrin for depression. She further testified that she is unaware of any contraindication for using Adderall and Xanax at the same time and that she monitors the Claimant for side effects and substance abuse and has found neither. When asked, she indicated that while the medications could be causing some of the symptoms of other disorders, this was unlikely because she has been managing the Claimant for a number of years.
On cross-examination, Ms. Gillespie testified that while she is not a physician, she has had prescribing authority since 1995. Again, she stated that there was not a problem having Xanax and Adderall prescribed together and that prescribing a CNS depressant and CNS stimulant at the same time is acceptable because the Claimant has different diagnoses. She analogized this to having a viral and bacterial problem. She further indicated that Adderall increases dopamine, a neurotransmitter, to slow down the thought process. When asked how Xanax works, she was unable to explain. When pressed, Ms. Gillespie noted that in addition to treating the Claimant for depression, she is also being treated for anxiety by taking Lexapro, which is a normal treatment for anxiety. Xanax is only being used for breakthrough anxiety.
When questioned about the use of Adderall in patients with significant anxiety, she admitted that the Claimant has intermittent significant anxiety. She indicated that she was familiar with the warning that Adderall should not be used in patients who suffer significant anxiety. In addition, she testified that despite the warning about operating machinery in the Adderall insert, she never specifically cautioned the Claimant, even though she knew that the Claimant drove a school bus.
When asked about the use of Endocet, she indicated that the drug insert notes that it could cause additive sedation when used with other CNS depressants and that the dosing for one or both of the drugs should be reduced. Importantly, Ms. Gillespie testified that despite knowing about the drugs being taken by the Claimant, she was unaware that she was still taking Endocet, believing that the Claimant had been weaned off after her neck surgery. She had been aware that she took it prior to her surgery and just after, but she did not reduce the dosage of the Xanax or Ambien. She also testified that she was familiar with the short-term use indicated in the Ambien packaging, but still continued to prescribe it on a long-term basis. She indicated that her notes show a referral back to pain management in August or September after her surgery. However, as of November 2004, the Claimant was still receiving 3 Endocets/day.
Despite the testimony by the Claimant that she always fills out a form to let her healthcare providers know what medications she is taking, Ms. Gillespie testified that the last time the Claimant advised her of the medications was about 6 months ago. She noted that although she referred the Claimant to pain management in September, she never followed up on that referral, indicating that she is sure it was discussed, but just not in her notes.
Finally, Ms. Gillespie testified that she had considered putting the Claimant on a drug "holiday" but because of her job as a school bus driver, she did not think that wise. She was unaware that the Claimant had not been driving a school bus since June 2004, but rather thought that she was back to work as of September.
Pursuant to Practitioner Provider Policy Manual §1.11.8 entitled, "Prior Authorization Requirements for Medications," prior authorization of medications may be required if medical necessity is lacking or is not clearly evident, the cost of care is higher relative to similar therapies, there is potential for diversions, misuse and abuse, and/or there is experimental use involved. In this case, it is abundantly clear that medical necessity is not clearly evident and that there remains a potential for diversions, misuse and abuse of the Adderall. Counsel for Claimant argues that there has been no misuse or abuse of the drug and that therefore it should be prior authorized. The regulation does not work in that fashion. The regulation requires pre-authorization of those medications that have the potential for misuse and abuse, so that the misuse and abuse does not occur. Moreover, the record before me clearly indicates that the use of Adderall, prior to the pre-authorization, represents a misuse of the drug, and that authorization of the drug would only aid in allowing this drug to continue to be misused by this Claimant.
Accordingly, coverage of Adderall XR, 30 mg. for the Claimant is not supported by the record and was appropriately denied.
For these reasons, the decision of the Division of Social Services to deny pre-authorization approval for the Claimant's use of Adderall XR, 30 mg. is AFFIRMED.
Date: February 21, 2005
STEVEN A. GREENSPAN
THE FOREGOING IS THE FINAL DECISION OF THE DIVISION OF SOCIAL SERVICES
Cindy DePue, Esq., Legal Aid
Ann Woolfolk, DAG
Joli Martini, EDS
Anthony Brazen, D.O., DSS
EXHIBITS FILED IN OR FOR THE PROCEEDING