Health Law News From Arnold & Porter

Health Law News From Arnold & Porter

January 13, 2014
3 min read

CMS proposal would limit availability of Medicare D antidepressants, immunosuppressants

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From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

Physicians may soon face more limited choices of antidepressants and immunosuppressants for their Medicare patients. In a recent proposed rule regarding Medicare Part D and Medicare Advantage programs, CMS proposed eliminating the “protected class” status of these drugs as of 2015.

Part D plans now must include all (or “substantially all”) drugs in six protected classes on their formularies. Essentially all drugs in the six classes have been available on Part D formularies (although protected class drugs can be placed on any tier, so patient cost-sharing can be high). Plans have been unable to impose prior authorization or “fail first” requirements on patients already taking a protected class drug, but can impose these requirements on “new starts.”


Thomas A. Gustafson

If CMS adopts its proposal, antidepressants and immunosuppressants to prevent rejection of transplanted organs would no longer be “protected.” The antineoplastic, anticonvulsant, and antiretroviral classes would retain protected status, as would antipsychotic drugs at least for 2015.

If adopted in CMS’ final rule, these changes would reduce Part D patients’ access to antidepressant and immunosuppressant drugs. Since not all drugs would have to be included on formularies, the range of available treatment options would narrow for patients with depression and for transplant recipients, and bargaining power between plans and manufacturers would shift. Unless brand name drug manufacturers agreed to more favorable rebates, some exclusions and shifts toward generic products would result. CMS’ analysis indicates that formularies could meet other applicable Part D standards with a much smaller presence of branded drugs.


Rosemary Maxwell

Plans could constrain availability of drugs in classes that lose protected status by excluding specific drugs from formularies; by imposing prior authorization or fail first requirements (as they can already, with “new starts”); or by imposing high cost-sharing (as they can already). Plans would therefore have substantial latitude to limit availability of particular drugs.

CMS proposes to limit protected classes to those satisfying these criteria:

  1. “Hospitalization, persistent or significant disability or incapacity, or death likely will result” if a patient does not start therapy within 7 days after the prescription is presented at the pharmacy; AND
  2. “More CMS formulary requirements will not suffice to meet the universe of clinical drug-and-disease-specific applications.”

CMS convened an internal panel (composed of the chief medical officer in CMS’ Center for Medicare, and CMS pharmacists) to determine which drug classes met both of these criteria. Antiretroviral, antineoplastic, and anticonvulsant classes did so. CMS therefore proposes to continue their protected status.


Immunosuppressants met the first test but not the second. Antidepressants failed both tests. CMS quoted the American Psychiatric Association’s 2010 treatment guideline that “the effectiveness of antidepressant medications is generally comparable between classes and within classes of medications” in explaining why its panel felt that antidepressants failed criterion two.

While antipsychotics also failed the second test, CMS proposed to keep protecting them through at least 2015.

CMS expressed concern that protected class status increases plans’ drug costs (partly by reducing manufacturers’ incentive to offer high rebates) and may lead to overutilization because plans cannot use utilization management tools to the same extent as with other drugs. CMS also alluded to safety concerns (regarding antipsychotics) that could be mitigated by narrowing the protected classes.

For those classes that retain protected status, CMS proposes to add several new exceptions to the general requirement to cover all protected class drugs:

  • For drugs that are primarily covered by Medicare Parts A or B.
  • To permit prior authorization to determine whether a drug is being used for a “medically accepted indication” (as defined in the Part D law) or to verify that the drug is not covered under Part A or B as prescribed and dispensed or administered to the patient.
  • For compounded products and FDA-approved fixed dose combination products containing at least one protected class drug (excepting certain antiretrovirals).

CMS also requests comments on whether to continue a currency exception allowing prior authorization for enrollees who are “new starts” on a protected class drug.

Interested parties can comment to CMS on the proposed rule, which is accessible at Comments are due March 7.

Thomas A. Gustafson, PhD, can be reached at Arnold & Porter LLP, 555 12th St. NW, Washington, DC 20004-1206; 202-942-6570; email:

Rosemary Maxwell, JD, can be reached at Arnold & Porter LLP, 555 12th St. NW, Washington, DC 20004-1206; 202-942-6040; email: