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Efforts to implement the upcoming prescription drug benefit under Medicare have picked up pace in recent weeks with the publication of new guidance for prescription drug plans on formulary guidance and access restrictions and the publication this week of final guidelines for the model therapeutic classification system. Taken together,
these two announcements establish important standards for the private sector drug plans that will be offering drug coverage to Medicare beneficiaries beginning in January 2006.
It is expected that the Centers for Medicare and Medicaid Services (CMS) will be publishing final regulations in late January or early February. This will be followed by accelerated efforts by the CMS and the states to begin identifying and enrolling beneficiaries dually eligible for Medicare and Medicaid – the only category of Medicare
beneficiaries who will be required to enroll in the new program.
CMS Formulary Guidance
Late last year, CMS issued guidance on requirements for the formulary (list of covered drugs) that each drug plan is expected to have. These guidelines established a range of standards for plans including non-discrimination and prevention of adverse selection with respect to beneficiaries with chronic illnesses and disabilities. The guidelines
also cover tiering of medications within a formulary (i.e., imposition of higher copayments for certain drugs on a formulary), prior authorization and “fail first” requirements and most utilization review programs. Finally, the guidelines also cover the exception and appeal programs all plans must put in place to allow for access to off-
NAMI is very supportive of these CMS guidelines as a major step forward in ensuring that drug plans offer sufficient coverage for the full range of treatments for severe mental illnesses (including all co morbid medical illnesses) and do not place restrictions on access to medications to disfavor enrollment of beneficiaries with disabilities.
USP Issues Final Model Guidelines
Earlier this week, an independent advisory group issued final recommendations to CMS on the list of therapeutic categories that most prescription drug plans are expected follow under the Medicare pharmacy benefit. Much to NAMI's disappointment, the final list will allow private sector prescription drug plans to exclude covering a broad range of medications to treat depression. Specifically, the list of therapeutic categories lumps 3 separate classes of anti-depressant medications into a single category.
The list, developed by the US Pharmacopoeia (USP), was required under the MMA. The MMA requires all drug plans administering the Medicare drug benefit to offer coverage of at least two medications within each therapeutic class. The MMA required CMS to contract with USP to develop the list of therapeutic classes. While the lest will not be
required, adoption of it is deemed a “safe harbor” and plans using it will be deemed approved.
NAMI remains concerned that the inadequate classification for anti-depressants could lead to Medicare beneficiaries with depression and bipolar disorder from being able to access the full range of treatment options. Specifically, the final USP classification (as did last summer's draft listings) lumps SSRIs (selective serotonin reuptake inhibitors), SNRIs (selective norepinephrine reuptake inhibitors) and tricyclics into a single classification. As a result, drug plans would be able to satisfy the USP list – and qualify for the safe harbor – by completely excluding all SSRIs and SNRIs. Likewise, there are remaining concerns that the USP model guidelines do not protect access to the full range of newer medications to treat schizophrenia.
Click here to read the USP model guidelines.
Click here to read NAMI's comments on the draft model guidelines.