CMS Proposes New Criteria for Determining Part D Protected Drug Classes

The Centers for Medicare and Medicaid Services (CMS) has proposed to revise the formulary requirements for Medicare Part D prescription drug plans (PDPs), which CMS says will have the effect of removing two, and perhaps three, of the six “protected classes” of drugs. Under the new regulation, antidepressants and immunosuppresants would lose protected status in 2015, and anti-psychotic medications would remain a protected class in 2015 only so that CMS can “determine if additional transitional consideration is necessary for any individuals taking these medications” before potentially removing them from the list of protected classes in 2016. The agency says the changes are driven by concern “that requiring essentially open coverage of certain categories and classes of drugs presents both financial disadvantages and patient welfare concerns for the Part D program as a result of increased drug prices and overutilization.” Advocates for people with disabilities have expressed concern that removing these protections will lead to disrupting access to needed medications and will be a threat to beneficiaries’ health and well-being.

Currently, PDPs must include on their formularies “all or substantially all” drugs within six classes:

  • antidepressants (e.g., Prozac, Effexor, Zoloft) used for treating depression,
  • antipsychotics (e.g., Risperdal, Zyprexa, Seroquel) used for treating psychiatric disorders such as schizophrenia and bipolar disorder
  • anticonvulsants (e.g., Depakote, Tegretol, Lamictal) used for preventing or reducing seizures,
  • immunosuppressants used to prevent the rejection of transplants,                   antiretrovirals used in the treatment of HIV and AIDS, and
  • antineoplastics used to treat cancers.

Section 3307 of the Affordable Care Act (ACA) amended the statutory provisions governing the Part D Program by replacing the specific criteria to identify “protected classes” with a requirement that the Secretary “establish criteria through notice and comment rulemaking to identify drug categories or classes of clinical concern.” The criteria CMS proposes to establish are twofold; the new rule would require that, unless an exception applies, “all Part D drugs within a drug category or class be included on the formulary if the drug category or class of drugs for a typical individual with a disease or condition treated by the drugs in the category or class meets both of the following criteria (as determined by CMS):

• 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.”

CMS indicates that it took “other beneficiary access protections,” such as formulary transparency, formulary requirements, reassignment formulary coverage notices, transition supplies and notices, and the coverage determination and appeals processes, into account when developing these criteria. Given these existing protections, CMS believes “clinical concern would arise only if access to drugs within a category or class for the typical individual who is initiating therapy must be obtained in less than 7 days;” in other words, CMS believes that its constellation of beneficiary protections is sufficient to ensure any beneficiary access to a new drug within seven days, but not necessarily sooner. Moreover, CMS believes that “existing protections such as the Part D formulary change restrictions,” and the “transition requirements…which provide for temporary fills and require beneficiary notification of the need to request a coverage determination (including an exception or prior authorization approval) for future fills,” ensure sufficient protection for beneficiaries who may face an interruption in their ongoing therapies as a result of a change in their plan or formulary—meaning that CMS believes already-existing protections ensure that a beneficiary will never suffer a sudden interruption of access to a medicine they are already taking.

The agency then convened a “consensus panel of CMS pharmacists and the Chief Medical Officer for the Center for Medicare” to identify which drug categories or classes met the proposed criteria for clinical concern. For antidepressants, the panel concluded that a 7-day delay in initiation of therapy would generally not put the typical individual at risk of hospitalization, incapacity, disability or death, and thus did not meet the first criterion, and that antidepressants did not meet the second criterion, based on “the similarities of drugs within sub-classes and the lack of unique effects for distinguishing individual drug products when initiating drug therapy for the typical individual in a Part D setting.”

With respect to antipsychotics, the panel determined that, due to the potential that untreated beneficiaries with active psychotic symptoms may be dangerous to themselves or others, a 7-day delay in initiation of therapy met the threshold to put a typical individual with psychotic symptoms at risk. However, the panel also “concluded that antipsychotics did not have unique effects that distinguished one drug from another for the purposes of choosing the appropriate drug to initiate therapy.” The panel concluded that these agents are considered to be generally therapeutically interchangeable when initiating therapy, and based on treatment guidelines, Part D formulary requirements could efficiently ensure appropriate access to antipsychotics without requiring inclusion on the formulary of every drug in the class.

While CMS concludes that “the immunosuppressant, antidepressant and antipsychotic classes all fail to meet the second criterion,” the agency is “deferring any change in formulary requirements for the antipsychotic class at this time and will continue to require all drugs from within this class to be on Part D formularies in 2015 “because the agency wishes “to make certain [it has] not overlooked a need for any transitional considerations,” due to the severe risks associated with untreated psychotic illness. This explanation, coming as it does with a confirmation that CMS does not believe that “the antipsychotic drug class would meet the new proposed criteria,” strongly suggests that, absent a determination that existing transition requirements do not provide adequate protection, CMS will remove this class from protected status for the 2016 plan year.

CMS is asking for public comment on their proposal. Comments must be received by March 7th. In particular, the agency seeks comment “on whether there are additional considerations for transitioning some patients taking [antipsychotic] drugs to alternative drug therapies,” and if so, “what specific patient population(s) or individual patient characteristics would require such additional transition protections and how such population(s) can be consistently identified.” Conversely, CMS also seeks comments on “whether it might be in the best interest of beneficiaries to have their existing antipsychotic therapies reevaluated through utilization management, given…concern with the inappropriate use of these drugs especially in nursing homes and the limited clinical utility of distinctions among agents in this class of drugs,” and “whether the benefits of such a periodic reevaluation that would arise from routine utilization management might outweigh other transitional risks.”

FMI: The Notice of Proposed Rulemaking (NPRM) is available at!documentDetail;D=CMS-2014-0007-0002