Proposed Changes to the Medicare Part D Prescription Drug Program

Published Monday, March 3, 2014

March 3, 2014                       

The Honorable Marilyn B. Tavenner, Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Attention:  CMS-4159-P
P.O. Box 8013
Baltimore, MD  21244-8013

Dear Administrator Tavenner:

Thank you for the opportunity to share our views on CMS's proposed changes to the Medicare Part D prescription drug program.  The American Association for Geriatric Psychiatry (AAGP) is a national association representing and serving its members and the field of geriatric psychiatry. AAGP promotes the mental health and well-being of older people through professional education, public advocacy, and support of career development for clinicians, educators, and researchers in geriatric psychiatry and mental health.

As an advocate for improving the mental health of older adults, the AAGP believes that access to safe, tolerable and effective medications, including antidepressant and antipsychotic medications, is crucial. Depression in older adults is known to be associated with increased medical morbidity, disability, and suicide and non-suicide mortality. When inadequately treated, depression causes suffering and has been shown to increase overall health care costs.  The goal in treating older adults with psychotic symptoms is to provide humane and appropriate treatment and to ensure that they are not in distress, and/or danger to themselves or others. At times, these symptoms require the use of antipsychotic medications to control their symptoms and safeguard these patients from distress.

We are deeply concerned that the proposed CMS rule would no longer require that all antidepressant drugs in the class be included in the formula and we are confident that this proposal would have a disproportionate impact on older adults.  Furthermore, we would suggest that this program change would decrease a beneficiaries’ access to affordable health plans and necessary medications. AAGP strongly recommends that CMS withdraw the proposal that would have unintended consequences for the national’s seniors with mental illness.

Research has demonstrated that adults with late life depression have lower rates of antidepressant treatment response and remission compared to young and middle aged adults with depression, and that a step-wise approach to treating older depressed adults that emphasizes alternate antidepressants is optimal. Drugs that have been shown to be efficacious in controlled clinical trials may fail to be effective for individual elderly patients. Current practice guidelines for the treatment of depression emphasize the need for individual treatment to improve clinical outcomes and maximize the likelihood of achieving full remission. For our geriatric patients, individualized care is among the important indicators of high quality care. Therefore, when first-line treatment fails, geriatric patients need ready access to the full range of drugs with alternative mechanisms of action. This must include drugs that are typically used as primary agents for the treatment of depression, as well as those that have been shown to be helpful as augmentation agents.

Older adults treated by our member psychiatrists and psychiatric nurse practitioners and other health providers are also known to have a high prevalence of medical-psychiatric co-morbidity and are often taking multiple medications, which makes them more vulnerable to adverse disease-drug and drug-drug interactions. The choice of an antidepressant drug for a geriatric patient must, therefore, take into consideration not only drug efficacy and individual effectiveness, but also safety and tolerability. Although clinical trials have not demonstrated substantial differences in overall clinical efficacy among FDA-approved antidepressants, there are substantial differences in the side effect profile among these drugs. Consequently, a frequent challenge for prescribing clinicians who treat geriatric patients is to find the optimal match between the patient’s medical profile and the side effect profile of available drug interventions. 

AAGP believes it is critical for CMS to maintain the recognized class of antidepressants and ensure that substantially all of the antidepressants within that class are readily available to the prescribing clinician and ultimately the patient. To provided high quality individualized care for an elderly patient, physicians and other health providers must have ready access to the safest and most effective options for those patients.

AAGP is concerned about CMS’s future plan to modify the availability of antipsychotics through Medicare Part D starting in 2016.  AAGP has been very active in the discussion on the use of antipsychotics by the elderly population and we offer our thought leaders with expertise in this area to dialogue with CMS on this critical issue.  Our initial response is that the proposal, as currently worded, is not only unwarranted, but possibly dangerous.  We would note that CMS’s own initiative, CMS Partnership to Improve Dementia Care in Nursing Homes, has had positive results in the decreased utilization of antipsychotics in nursing homes without punitive impact on the patient population.  We are concerned that if an anti-psychotic medication that was prescribed under the old plan were to be excluded under a new rule, the impact would be dangerous to the patient with a severe mental illness, and in some cases could require that the patient be switched back to a drug that had previously been ineffective, poorly tolerated, or had negative consequences on the health of the patient, e.g., increasing diabetes risk. We would also note that much antipsychotic use in nursing homes is a result of those medications being started in a hospital setting, and maintenance therapy is needed as they transition to a sub-acute nursing home setting.  Abruptly discontinuing these medications will have an extremely negative effect on the patient’s health.

AAGP would welcome the opportunity to dialogue with CMS staff on issues raised in the proposal including which patient populations warrant additional protection and criteria that could be used to distinguish antipsychotic medication including the side effect profiles.  While we would agree that there are incidents of inappropriate use of anti-psychotics among the elderly population, increasing barriers to access these medications only harm those patients with legitimate needs suffering from mental disorders.

In summary, AAGP urges CMS to withdraw the proposed rule because it will undermine the success of the Medicare Part D program and force patients to deviate from their current stable and clinically effective interventions.  Decreased access to anti-depressant medications for our nation’s elderly will lead to disruptions in the delivery of quality health care. AAGP strongly asserts that both antidepressants and antipsychotics must remain categories of concern on Part D formularies.  We look forward to working with you to assure that Medicare continues to offer affordable, high-quality health coverage and accessible medications.

Sincerely yours,

David C. Steffens, MD