Briefing Memo: “Protected Classes”

The Medicare Access for Patients Rx (MAPRx) Coalition, comprised of more than fifty-five beneficiary advocacy organizations, urges the Centers for Medicare and Medicaid Services (CMS) to reverse its proposed policy changes to the Medicare Part D six “protected classes.”  Proposed changes will limit access to medications under the Part D benefit for Medicare’s most vulnerable beneficiaries.  Prescription medications are not interchangeable for every person, and doctors prescribe treatments to meet the unique needs of each patient.  Eliminating the protected classes will lead to restrictive formularies and limit beneficiary access to vital, life-saving medications.


Medicare’s Voluntary Prescription Drug Benefit Program (Part D) formulary development process is governed both by legislation and regulation to ensure adequate representation of all necessary Part D drug categories and classes for the Medicare population.  Specifically, the Centers for Medicare and Medicaid Services (CMS) require plans to comply with established formulary development protocols, including utilization of Pharmacy and Therapeutics (P&T) committees.  P&T committees assess clinical evidence to inform recommendations for plan coverage and formulary management, though committee processes and decisions are heavily influenced by CMS’ comprehensive formulary review process.   Upon plan formulary submission, CMS conducts a three step formulary review process to verify formulary compliance with Part D standards, including plan coverage of all drugs from the six classes of clinical concern (“protected classes”).

Evolution of the Protected Class Policy

The Medicare Modernization Act (MMA) of 2003 established Medicare’s prescription drug benefit, which would provide drug coverage to approximately over 20 million Medicare beneficiaries, including six million dual (Medicare/Medicaid) beneficiaries upon program implementation in 2006.  Given the influx of beneficiaries, CMS recognized the need to establish certain patient protections to ensure adequate patient drug access, especially given that the Part D program would be administered by private plans with extensive experience managing drug costs through advanced formulary and utilization management techniques.

In 2005, CMS released the Medicare Prescription Drug Benefit Manual to govern the Part D program.  The manual instituted the “protected class policy” to mandate that Part D plans offer a robust formulary design, thus ensuring that beneficiaries reliant upon drugs in classes of clinical concern would not be substantially discouraged from enrolling in Part D plans. The policy required formularies to include “all or substantially all” drugs from six classes of clinical concern, or “protected classes”: anticonvulsants, antidepressants, antipsychotics, antiretrovirals, and immunosuppressants (for non-Medicare approved transplant rejection).  Additionally, Part D plans may not impose step therapy or prior authorization requirements for these drugs for beneficiaries who are currently taking the drug.

The protected class policy evolved in 2008 under section 176 of the Medicare Improvements for Patients and Providers Act (MIPPA), which authorized CMS to establish a new regulatory review process for the purpose of identifying those drug classes for which a Part D plan would be required to include all drugs on its formulary.  Though MIPPA did not reference the existing six protected classes, language within the bill directed the Health and Human Services Secretary to identify those categories and classes of drugs which meet two criteria:

(1)   Restrictions on that class would have major or life threatening consequences; and

(2)   There is a significant need for individuals which a disease or disorder treated by the drugs in the class to have access to multiple drugs within that class.

In January 2009, CMS published an interim final rule responding to provisions set forth in MIPPA requiring that, effective for plan year 2010, CMS reevaluate the six protected classes.  This rule did not define which classes should be included or excluded from the protected class policy, but instead identified a multi-level process by which CMS would eventually choose these categories and classes:

(1)   For the first stage of review, CMS will select a contractor to examine widely used treatment guidelines and review data on beneficiary drug utilization.

(2)   For the second stage of review, an expert panel of physicians and pharmacists will convene to review data from the contractor and offer recommendations on the identification of protected categories and classes as defined by statute.

In 2010, section 3307 of the Affordable Care Act (ACA) codified reliance on the two-prong test established under MIPPA, and kept intact the existing six protected classes until the Secretary established more formal criteria for designating these classes. 

Proposed Changes to Protected Class Policy

On January 6, 2014, CMS released a proposed Part D rule (CMS-4159-P) in which the Agency proposes to interpret several of the statutory terms in section 3307 of the ACA to better define the scope of the protections of the classes of clinical concern.   CMS cited rising program costs and patient protection concerns as the primary justifications for altering the protected class policy, and rationalized that the five existing beneficiary protections are sufficient for ensuring access to drug therapies in certain protected classes. More specifically, CMS seeks to redefine the clinical classes of concern criteria to only identify those drug categories or classes for which access cannot be adequately ensured by beneficiary protections that otherwise apply.  CMS proposes to alter the two-prong criteria to identify drug classes of clinical concern to read:

(1)   A typical beneficiary, who is initiating therapy must administer a drug within the category or class in less than 7 days or failure to do so will lead to hospitalization, incapacity, disability or death; and

(2)   Other CMS formulary requirements are not sufficient to ensure the access to an appropriate range of therapies, either due to the diversity of disease or condition manifestations or the associated specificity or variability of drug therapies necessary to treat such manifestations

Applying this new two-prong test to the universe of Part D drugs, the CMS expert panel (established in the 2009 interim rule) identified just three categories or classes of drugs for which unrestricted access remains appropriate: antiretrovirals, antineoplastics, and anticonvulsants.  Conversely, application of the new criteria would result in the elimination of the antidepressant and immunosuppressant drug classes from the list of classes of clinical concern effective January 1, 2015.  CMS also proposes to remove the antipsychotic drug class from the list of protected classes, but will defer any change to Plan Year 2016 as the agency continues to evaluate the need for additional considerations regarding transitions for individuals already taking these medications. 

Impact on Patient Access

If finalized, the proposed protected class policy change could prove detrimental for patients who rely on antidepressants and immunosuppressants (and antipsychotics in 2016):

  • CMS’ own analysis in the rule found that Part D plan coverage of these classes could be significantly less generous moving forward, and could result in patients taking medications no longer on their plan’s formulary.  Under this scenario, patients could be charged for the full cost of the therapy or require them to postpone therapy until they are able to obtain a formulary exception from their Part D plan.
  • The proposed regulation cites potential cost savings and adequate existing patient protections as the primary justifications for changing the protected class policy.  Since implementation of the Part D benefit in 2006, this policy has successfully ensured Medicare beneficiary access to critical drugs within the six protected classes.  Further, in a February 5, 2014 letter to CMS, the Senate Finance Committee (SFC) expressed concerns that the proposal will “diminish access to needed medication”, and “remain unconvinced significant cost savings will be achieved.” Given the patient access concerns, MAPRx does not recognize potential cost savings alone as an adequate rationalization for finalizing the proposed changes to this historically effective policy.
  • The standard Part D formulary review process will not adequately ensure Medicare beneficiary access to antidepressants and antipsychotics if these classes are no longer protected.  According to CMS analysis presented in the proposed rule, the combined number of antidepressants and antipsychotics available to patients would be reduced to 15 total drugs, and would not require formulary inclusion of any brand name drugs, even those without generic equivalents.  By comparison, the current policy guarantees beneficiary to access to 57 drugs, including 41 single-source brands.  Given that antidepressant and antipsychotic therapies are often ineffective or cause side effects, a wide range of available treatments in these classes is necessary to ensure optimal care.
  • Despite evidence suggesting the contrary, CMS accepts that the existing exceptions, appeals, and grievance processes will sufficiently enable timely access to necessary medication when access is restricted by formulary.  However, recent CMS audits have shown consistent failure by plans to efficiently adjudicate the appeals and grievances processes.  Further, a recent Medicare Payment Advisory Commission (MedPAC) analysis found that most beneficiaries are unaware of how the exceptions and appeals process works.   If finalized, the proposed changes to the protected class policy will increase both the frequency of appeals and the rate at which patients must navigate the unfamiliar appeals process.  CMS should improve the Part D appeals process prior to making any changes to the protected class policy.
  • The proposed changes in the rule rely on application of the protected class policy to “typical individuals.”  This narrow application ignores the fact that Medicare beneficiaries are unique from typical individuals in that they are often living with chronic conditions, significant disabilities, and complicated comorbidities.  The complexity of both physical and mental care required for these patients are inappropriately ignored in CMS’ proposal to remove antidepressants, immunosuppressants, and antipsychotics from the list of protected classes.
  • A potential unintended consequence of removal of protected status for antidepressant, immunosuppressant, and antipsychotic classes is the increase in beneficiary out-of-pocket costs and overall costs to the Medicare program if beneficiaries require more frequent physician visits or are hospitalized.  In November 2012, the Congressional Budget Office (CBO) acknowledged that increased access to prescription drugs decreases spending for medical services, such as hospital admissions.

To preserve patient access to these medically necessary drugs, CMS should reconsider removal of antidepressants, immunosuppressants, and antipsychotics from the list of protected classes.