The Issue

Every day, millions of Americans rely upon their Medicare drug benefit to help manage their health conditions, including mental illness, organ transplants, epilepsy, Parkinson’s Disease, lupus, cancer and HIV. Because patients with these illnesses react differently to different medicines, access to the full range of effective medications is a crucial component of successful treatment and recovery. Medicare’s “Six Protected Class” policy has long stood as a guarantee to patients that their access to all available medications would never be in doubt.

Unfortunately, in January 2014, the Centers for Medicare and Medicaid (CMS) proposed changes that would have denied access to these vital medications. Under the proposal, CMS would have removed the protected status of antidepressants and immunosuppressants for the 2015 coverage year, and antipsychotics in 2016. It would have also redefined the Part D protected classes policy in such a way as to jeopardize inclusion of the other classes of drugs in future years. In March 2014, in response to strong congressional and stakeholder opposition, CMS Administrator Marilyn Tavenner announced that the agency will not finalize the proposed rule to eliminate protected class status for any drugs under Medicare Part D “at this time.” But Administrator Tavenner noted that CMS may look to advance these proposed changes “in future years.” And in June 2016, the Medicare Payment Advisory Committee (MedPAC) renewed stakeholder concerns by again recommending that two of the protected classes be eliminated.

If the proposal to alter “Six Protected Classes” ever goes into effect, these changes would result in a drastically reduced set of drug options for Medicare beneficiaries and people who are dually enrolled in Medicare and Medicaid. These options would likely not include any of the newest advances in treatment. Patients who have been stabilized for years on a drug regimen could be forced to switch their medications - resulting in health setbacks, hospitalizations, or worse. And for enrollees newly diagnosed with these conditions, the regulation could prevent them from accessing the most appropriate, clinically indicated medication selected by their provider.

Patients Communities


During implementation of the Medicare Modernization Act (MMA), which created the Medicare Part D drug program in 2003, the Centers for Medicare and Medicaid issued guidance directing prescription drug plans to cover “all or substantially all” medications within six classes and categories that the agency identified. These categories included: anticonvulsants, antidepressants, antineoplastic, antipsychotics, antiretrovirals, immunosuppressants.

However, in time, it became clear that the guidance was uneven among plans. Therefore, Congress pursued legislative action, led by Senators Gordon H. Smith (R-OR) and John Kerry (D-MA) to establish a standard for protected classes. In 2008, Congress established the so-called “six protected classes” of drugs under Medicare Part D. Medicare Improvements for Patients and Providers Act (MIPPA) codified CMS’ existing guidance and carried the force of law. It required Medicare Part D drug plans to include in their list of available medications access to all or substantially all drugs in the six identified classes and categories of priority. The law also specified two criteria that CMS had to use in identifying additional prescription classes of concern:

  • restricted access to the drugs in the class would have major or life-threatening consequences for individuals with a disease or disorder treated by drugs in such class; and
  • there is a significant need for such individuals to have access to multiple drugs within a class due to unique chemical actions and pharmacological effects of the drugs within a class.

This policy stood unchanged until enactment of the Affordable Care Act (ACA). Under the ACA, Congress provided the Secretary of Health and Human Services (HHS) with authority to “identify, as appropriate, categories and classes of drugs for which the Secretary determines are of clinical concern.” It added that the Secretary shall have the authority to develop the criteria used to make the designation.

However, the ACA also codified in law the six existing protected classes and categories by name, and expanded coverage to include all drugs within these six classes and categories until such time as the Secretary makes changes. The clear intent of Congress was for the six identified classes of medications to maintain protected status.

CMS’ January 2014 Proposal

As part of a broader proposed rule in January 2014, the Centers for Medicare and Medicaid Services proposed to limit and redefine, based on new criteria, the Part D program’s protected drug classes to exclude antidepressants and immunosuppressants for the 2015 coverage year, and antipsychotics in 2016. In redefining the Part D protected classes policy, CMS laid out its new criteria for deciding whether a class of drugs should have protected status: 1) failure to receive the drug would result in the patient’s hospitalization within 7 days (the timeframe for the appeals process); and 2) drugs in that class are not interchangeable.

The proposed criteria excluded antidepressants and immunosuppresants from protected status beginning in 2015. While CMS Administrator Marilyn Tavenner announced in March 2014 that the agency would not finalize the proposed rule, she indicated that CMS may look to advance these proposed changes “in future years.” CMS argued that many of the drugs within these classes are interchangeable and will not cause hospitalization if patients do not immediately take them upon receiving a prescription. CMS determined that antipsychotics also fail to meet the new criteria, however, they would not have been immediately been excluded from protected status.

MedPAC’s June 2016 Proposal

The Medicare Payment Advisory Committee (MedPAC) reiterated CMS’ troubling proposal in their June 2016 Report to Congress, recommending that the Health and Human Services (HHS) Secretary consider eliminating antidepressants and immunosuppresants from the classes of clinical concern. While MedPAC has asserted that the package of draft Part D recommendations — including the protected-class proposal — would lead to unspecified cost savings, a recent literature review by Avalere Health illuminates the broader implications of rescinding protected-class status and calls into question any claims of reduced Medicare expenditures. The literature review found that managed care formulary restrictions, which would more adversely affect beneficiary access to protected-class medicines if MedPAC’s draft recommendation were adopted, have problematic impacts on utilization, costs, and adherence.

Our Concerns

Proposals from CMS and MedPAC to limit access to certain medications under the Part D program would have a profound impact on the patients who benefit from having access to the full spectrum of treatment options. Medicines in the six protected classes treat serious health conditions, and among these vulnerable beneficiaries - the frail, disabled or those with multiple chronic conditions - many medicines are not interchangeable. Seemingly similar patients often respond differently to the same drug: while one patient will respond well, a similar patient will have a suboptimal response, or worse. Further, drugs in the same class often have different side effects, and patients are often better suited to one particular drug over another.

Also, while CMS suggested in their proposal that this policy was focused on the “typical individual,” the Medicare population is notably diverse. A significant number of Medicare beneficiaries have multiple chronic conditions, and it is essential that policies impacting access to medications account for their unique and challenging health characteristics.

While CMS’ proposal was ostensibly intended to reduce program costs - an estimated $720 million over the five-year period 2015 to 2019 - the agency failed to recognize the significant tangential costs associated with their plan. Limiting beneficiary access to vital medications will drive higher costs in Medicare Part A and Part B and Medicaid by increasing the need for inpatient care and emergency visits due to the destabilization of patients’ conditions. The costs associated with this care otherwise would not be incurred by Medicare or Medicaid.

Patient Communities


Mental Health

Mental illness significantly impacts the Medicare populations. Eliminating robust Part D coverage for this population will leave some of the most vulnerable Medicare beneficiaries, who may already have difficulty managing their disease, without adequate protections to ensure timely access to these therapies.

It is clear from the data that CMS relied upon that their formulary review process is ineffective in providing access to needed medications for complicated diseases. As demonstrated by their data highlighted in the proposed regulation, for persons with mental illness, their standard formulary review process would only require coverage of 9 generic antidepressant and 6 generic antipsychotic medications, for a total of only 15 medications and no brand drugs. In comparison, the current Six Protected Classes policy entitles Medicare beneficiaries to access to 57 medications: 23 generic antidepressants, 7 brand antidepressants, 18 generic antipsychotics and 9 brand antipsychotics.

Why does this matter? Consider depression. Of the 9 symptoms for major depressive disorder (MDD) in the DSM-V, an individual needs a combination of five symptoms to be diagnosed with major depression. That’s well over 200 different possible ways someone could have MDD and one variant would not look like another. Having only one or two drugs to treat the wide-ranging way someone could present with depression is simply inadequate, especially among an older population where depression is a significant predictor of suicide.

The proposed policy also failed to recognize the interrelatedness among complicated illnesses and diseases. Studies have shown that close to 50 percent of individuals with HIV also have a mental illness. According to the American Cancer Society, 1 in 4 individuals with cancer has clinical depression. Further, studies have shown that persons with epilepsy have higher rates of depression and suicide. It is important that doctors have the ability to choose the right mix of medications for patients with such complicated health needs.

Mechanisms to contain costs and steer patients toward lower cost options already exist in the program. Part D Plans are allowed to tier the cost of medications, which has proven effective. Research by the Medicare Payment Advisory Committee (MedPAC) has shown that generic utilization among the Low Income Subsidy (LIS) population, particularly for antidepressants, is comparable to rates among non-LIS populations. Though importantly, individuals requiring more expensive or brand name medications are ensured access without appeal under Six Protected Classes.



Under CMS’ January 2014 proposal, the protected status of anticonvulsant medications could be rescinded in future years. Patients with epilepsy who have their medications switched, (from brand name to generic or from generic to generic) may be at risk for developing breakthrough seizures, especially when the change happens without a physician's oversight and monitoring.

About two-thirds of people diagnosed with epilepsy will become seizure free on the first or second anti-epilepsy drug administered. For elderly epilepsy patients with multiple chronic conditions, it is critical that they have access to a wide range of treatment options.

The proposed rule relied on the current exceptions, appeals and grievance processes to provide timely access to life-saving and life-enhancing medications when a formulary restricts access. The patient community has long expressed concerns with this process, and called on CMS to provide timely, accessible, and consumer-oriented standard appeals policies to ensure patient safety and appropriate access to medically necessary treatments.


Cancer Treatment

Access to oncology drugs (antineoplastics) is crucial for cancer patients because dugs in these classes cannot necessarily be substituted for each other: for instance, oncology patients may respond differently to different treatments, need to switch between treatments based on changes in their condition, or have fewer or more tolerable side-effects if they use one therapy instead of another. The protected class policy helps keep these treatment decisions between a patient and his or her provider.

The law under which the protected class policy was first codified—the Medicare Improvements for Patients and Providers Act of 2008—specifically identifies “drugs used in the treatment of cancer” as an example of a drug class that clearly met the criteria that defined a “protected class” at the time. Even with the current protected class policy in place, patients have trouble accessing the drugs that are most appropriate for them because of discriminatory coinsurance policies: antineoplastics are disproportionately included on plan formulary’s specialty tiers, which require patients to pay a certain percentage of the cost of the drug (coinsurance) rather than a set dollar amount (copay).

Further, the two criteria by which CMS had proposed to judge whether a drug class should be “protected” were overly restrictive and gave CMS leave to eliminate any of the remaining protected classes in the future. Although the proposed rule recommended maintaining protected class status for antineoplastics, there is nothing inherent about the criteria for future assessment that CMS proposed which would limit the agency from excluding antineoplastics as a protected class in the future, thus putting cancer patients in jeopardy of losing access to their preferred treatment.



For people with HIV and so many others, new drug therapies have saved millions of lives and prolonged millions more. The advent of antiretroviral medications in the late ‘90s turned HIV from a near certain death to a more manageable disease if patients have access to quality care and medications. We know that all medications are not the same and each person reacts differently to a particular medication. Doctors and patients together make careful decisions about which therapies are most appropriate on a case by case basis. Some individuals may develop side-effects to a particular drug, while another person may need a certain therapy to avoid a harmful interaction with a drug being taken for another health condition. For people with HIV drug resistance can occur, requiring them the ability to switch to another drug without interruption.

It was for these reasons that when Medicare Part D was first implemented, CMS determined that a minimum of only two drugs in a class was simply not enough for certain patients, including those with HIV, mental illness, cancer, epilepsy, and those undergoing organ transplantation. The “six protected classes” was created so that patients could have access to all the drugs in these classes.

For the past 10 years, Medicare Part D has been working for millions of seniors and people with disabilities, including over 100,000 people with HIV. As part of the Affordable Care Act (ACA), Congress even further codified the “six protected classes.” We see no reason why the protected classes should be changed.


Organ Transplants

The CMS proposal placed persons needing organ transplants at risk for severe medical complications. Immunosuppressive medications are not interchangeable. They are prescribed in combinations tailored to meet the unique needs of the individual transplant recipient in order to achieve sufficient immunosuppression while minimizing the toxicity associated with individual agents. Restrictive formularies limit physicians’ ability to prescribe the right combination of medications to protect the recipient from organ rejection and other serious side effects. This delicate balance was recognized in the original decision to include these medications under protected status.

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