Patients’ Comments Matter: HHS Continues 6 Protected Classes in Medicare


Washington, DC, May 21, 2019 (GLOBE NEWSWIRE) -- In a show of solidarity with the millions of patients who would have been adversely affected by a proposed Medicare Part D rule, today the Department of Health and Human Services (HHS) announced that it would continue its policy of protecting patients with serious illnesses like cancer, HIV/AIDS and epilepsy.


National Patient Advocate Foundation (NPAF), along with scores of other patient groups, wrote to HHS with concerns after the department posted a proposed rule that would have broadened the use of utilization management protocols, like step therapy and prior authorization, for drugs within the “six protected classes.” Within the comment letter, NPAF warned that changes to the six protected classes “would result in adverse patient outcomes,” and would come at the “expense of patients who rely on Medicare as a lifeline.”


Within Medicare Part D, the “six protected classes” includes medicines for treatment of conditions like cancer, HIV/AIDS, epilepsy, mental illness and organ transplantations.  Medicare Part D enrollees have always been able to access “all or substantially all” medications within these categories, and does not allow utilization management protocols, such as step therapy, on patients who are stable on an established treatment.  


While HHS had proposed allowing plans to use utilization management more broadly, after impassioned comments from patients, the final rule did not reflect this proposal. Instead, the final rule allows existing restrictions on patients who have not yet been diagnosed or started treatment. Patients currently stable on treatment will not experience broader use of these protocols.


Rebecca Kirch, NPAF executive vice president of health care quality and value, urged Medicare Part D and Advantage plans to take quality of life and personal preferences into full consideration, with a transparent and timely appeals processes to ensure that patients have access to the best possible medication for their condition. “We hope that HHS will evaluate these protocols to ensure that plans preserve treatment decisions between patients and their health care team,” she said. “The standard for efficacy should never be merely “alive,” but one that allows for the fullest quality of life a patient can reasonably expect. Ultimately, we’re encouraged that HHS listened to the concerns of the patient community and revised the proposed rule to reflect our input.”


 About National Patient Advocate Foundation:

National Patient Advocate Foundation, the advocacy affiliate of the Patient Advocate Foundation, amplifies the patient voice through the powerful stories of individuals and the collective needs of the community. Our staff and volunteers work at the local, regional and national level to promote access to affordable, quality health care for people with chronic, debilitating or life-threatening illnesses.


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