APA Takes Steps to Shape Medicare Rule for Psychoactive Drugs
APA is working with allies in the mental health field to ensure that the Medicare Modernization Act of 2003 (MMA) will allow beneficiaries access to a full range of psychotropic medications.
When Congress passed the MMA last December, the establishment of a new prescription drug benefit made the nation's headlines.
But unnoticed by the wider public, the Centers for Medicare and Medicaid Services (CMS) is issuing a series of regulatory rules that will govern how the landmark legislation will actually be implemented—rules that will affect everything from how much physicians are paid to the kinds of drugs that specific classes of beneficiaries will be able to access.
The proposed rules related to the new prescription drug benefit—Medicare's new “Part D” program—were issued on August 3. The deadline for public comments on the rule is October 4.
Those rules will have a significant effect on patients with mental illness, and APA's Department of Government Relations and Office of Healthcare Systems and Financing are reviewing the 1,300-page proposed rule, with the goal of helping to ensure full and appropriate access to psychotropic medicines.
(Separate rules establishing a new Medicare fee schedule for physicians—also implementing the MMA—were issued on August 5 with a comment deadline of September 24 [Psychiatric News, August 20]).
The regulatory rule-making process is a kind of work-in-progress, and the CMS rule issued on August 3 does not specifically address mental illness or psychotropic drugs. However, it does refer to those diagnosed with mental illness as a “vulnerable population” and invites comment on whether there should be special provisions—such as an alternative or open formulary that accounts for unique medical needs and/or special rules that may be needed by these populations but not by other Part D enrollees.
A July 14 letter to CMS signed by APA Medical Director James H. Scully Jr., M.D., and three other mental health leaders outlined general concerns related to formulary coverage and pharmacy management for those with mental illness.
The three other leaders were Michael J. Fitzpatrick, M.S.W., executive director of the National Alliance for the Mentally Ill; Michael M. Faenza, M.S.S.W., president and chief executive officer of the National Mental Health Association; and Robert Glover, Ph.D., executive director of the National Association of State Mental Health Program Directors.
The letter outlines the following issues:
Beneficiaries must have access to a comprehensive range of drugs in all therapeutic categories and classes used to treat mental illness. | |||||
Continuity of care must be assured so that a patient who may already be taking a nonformulary drug upon enrollment may be permitted to secure coverage for that drug. | |||||
Pharmacy management techniques must not be unduly restrictive for people with mental illness, and inappropriate techniques such as“ fail-first” policies—which require an individual to try and fail on a medication before being prescribed another— should be prohibited. | |||||
Special protections and appeal procedures must be in place to ensure that beneficiaries have access to nonformulary coverage and exceptions to tiered formulary provisions. The latter refer to provisions that may require different copayments for different classes, or tiers, of drugs. | |||||
Risk-adjustment methods must be developed so that plans enrolling beneficiaries with mental illness and co-occurring medical disorders—which are liable to require more expensive medications—will receive higher payments. | |||||
Meaningful criteria must be developed for assessing whether a plan's features would discourage enrollment or otherwise discriminate against beneficiaries with mental illness. | |||||
Enrollment provisions must be put in place to account for the special needs of beneficiaries with mental illness. | |||||
“Inadequate provisions covering these... concerns will in all likelihood mean that Medicare beneficiaries with mental illness will be unable to access medically necessary medications,” Scully and the other authors said in their letter. “Any intended cost savings realized by the prescription drug benefit program will be offset by increased hospital expenses or other increased expenses associated with poorer health outcomes and will be borne by Parts A and B of the Medicare program.”
The full text of the letter is posted online at<www.psych.org/advocacy-policy/reg-comments/CommRgdImplementofMedicarePartD.pdf>. The proposed CMS rule, with information about providing comments, is posted at<http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-17234.htm>.▪
