Protect Patient Access to their Mental Health Medicines!

Under Six Protected Classes

The Partnership for Part D Access urges congressional action now to protect access to life-saving and life-enhancing medications, particularly for persons with mental illness.  Patient choice and access to medications under the Medicare Part D program is being threatened by a proposal being circulated by the Centers for Medicare and Medicaid Services (CMS).  Congress must stop CMS from making these changes to the Medicare Six Protected Classes policy. 

Major Concerns with CMS Proposed Regulation –

  • According to the National Institute for Mental Health (NIMH), the number one risk factor for suicide is untreated depression, including persons who are receiving ineffective treatment.  Yet, CMS wants to limit access to anti-depressants placing individuals with mental illness at higher risk for suicide.
  • While the average individual living with a mental illness will respond to most medications within a class or category, approximately 20 percent will not, and we do not have the ability to identify them.  That is why the physician needs access to all medications within the anti-depressant and anti-psychotic classes.
  • Limiting access to the most appropriate medications will drive higher costs in Medicare and Medicaid by increasing admittance to in-patient care and emergency departments.
  • CMS touts DoD and VA formularies (Page 127) as adequate to help persons with mental illness.  However, both agencies are coming up short when it comes to preventing suicide and providing appropriate care to soldiers and veterans with mental illness.
  • It is clear from CMS’ data that their formulary review process is ineffective in providing access to needed medications for persons with mental illness.  As demonstrated by their data highlighted on Page 128 of the proposed regulation – their standard formulary review process would only require coverage of 9 generic anti-depressant and 6 generic anti-psychotic medications, for a total of only 15 medications and no brand drugs.  In comparison, the current six protected classes policy entitles Medicare beneficiaries to access to 57 medications: 23 generic anti-depressants, 7 brand anti-depressants, 18 generic anti-psychotics and 9 brand anti-psychotics.
  • Additionally, CMS’ appeals and grievance process is a quagmire for Medicare beneficiaries.  According to Deputy Chief Administrative Law Judge C.F. Moore, “assignment to an ALJ may be delayed for up to 28 months.”  Further, while the delay is shorter for Part D appeals, advocates find that most cases are not heard within the 10 day requirement – and that does not factor in the flood of cases that would come if anti-depressants and anti-psychotics are removed from the protected classes.

The Regulation –

As part of a broader proposed rule regarding Contract Year 2015 changes to Medicare Advantage and Part D programs, CMS is proposing limiting and redefining, based on new criteria, the Part D program’s protected drug classes to exclude antidepressants and immunosuppressants for the 2015 coverage year, and anti-psychotics in 2016.

In redefining the Part D protected classes policy, CMS said that Medicare has five basic beneficiary protections within the program:

  • formulary transparency,
  • formulary requirements,
  • reassignment formulary,
  • coverage notices,
  • transition supplies and notices, and
  • coverage determination and appeals processes.

For a class or category of medication to qualify for six protected classes, beneficiaries who use the drug must require protections above and beyond these five basic protections.  CMS therefore argues that to be part of the protected classes policy, a class or category of medication must meet both of these new CMS-developed standards:

  • hospitalization, persistent or significant disability or incapacity, or death likely will result if initial administration (including self-administration) of a drug in the category or class does not occur within 7 days of the date the prescription for the drug was presented to the pharmacy to be filled; and
  • more specific CMS formulary requirements will not suffice to meet the universe of clinical drug-and-disease-specific applications due to the diversity of disease or condition manifestations and associated specificity or variability of drug therapies necessary to treat such manifestations.”

History of “Six Protected Classes”–

During implementation of the Medicare Modernization Act (MMA), which created the Medicare Part D drug program in 2003, CMS (at the urging of Congress) issued sub-regulatory guidance directing prescription drug plans (PDPs), through contract provisions, to cover “all or substantially all” medications within six classes and categories that the agency identified.  These included:

  • Anticonvulsants
  • Antidepressants
  • Antineoplastics
  • Antipsychotics
  • Antiretrovirals
  • Immunosuppressants

However, in time it became clear that adherence to the sub-regulatory guidance was uneven among plans.  Therefore, Congress pursued legislative action, led by Senators Gordon H. Smith (R-OR) and John Kerry (D-MA) to establish a statutory standard for protected classes.  In 2008, Congress established under Section 176 of the Medicare Improvements for Patients and Providers Act (MIPPA), the so-called six protected classes of drugs under Medicare Part D.  MIPPA codified CMS’ existing guidance and carried the force of law.  It required Medicare Part D drug plans to include in their formularies access to all or substantially all drugs in the six identified classes and categories of priority.  MIPPA also specified two statutory criteria that CMS had to use in identifying additional classes of clinical concern:

1)    restricted access to the drugs in the class would have major or life-threatening clinical consequences for individuals with a disease or disorder treated by drugs in such class; and

2)    there is a significant need for such individuals to have access to multiple drugs within a class due to unique chemical actions and pharmacological effects of the drugs within a class.

This policy stood unchanged until enactment of the Affordable Care Act (ACA). Under the ACA, Congress provided the Secretary of Health and Human Services (HHS) with authority to “identify, as appropriate, categories and classes of drugs for which the Secretary determines are of clinical concern.”  It added that the Secretary shall have the authority to develop the criteria used to make the designation.  However, the ACA also codified the in law the six existing protected classes and categories by name, and expanded coverage to include all drugs within these six classes and categories until such time as the Secretary makes changes.


We urge Congress to contact CMS Administrator Marilyn Tavenner and Secretary of Health and Human Services Kathleen Sebelius to express your opposition to the changes CMS has proposed to the Medicare Six Protected Classes policy.


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