Background on Medicare Part D and Six Protected Classes
Medicare Part D is a voluntary outpatient prescription drug benefit to assist people in affording their prescription medications. Part D benefits are provided through private health insurance plans and approved by the federal government. Participants in Part D are able to choose between supplementing their traditional Medicare with a stand-alone prescription drug plan or a Medicare Advantage prescription drug plan that is part of and includes other aspects of Medicare.
Under Part D, all plans are required to cover all (or essentially all) drugs that fall into six specific classes of drugs – known as the six protected classes. These drugs are often used by patients with serious chronic illnesses, including cancer. Since the cost of using medicines within these six protected classes may be high, protections were created to prevent discriminatory practices intended to limit and/or discourage the use of these drugs. The six classes of drugs are:
- Antidepressants (used to treat depression)
- Antipsychotics (used to manage psychosis)
- Anticonvulsants (used to treat seizures)
- Immunosuppressants (antirejection medications for those receiving organ transplants)
- Antiretrovirals (used to manage HIV/AIDS)
- Antineoplastics (used in chemotherapy to kill cancer cells)
Changes Proposed to Medicare Part D Six Protected Classes
In November, 2018 the Centers for Medicare & Medicaid Services (CMS) proposed a new rule for Part D that would have changed the special coverage protections for medications included in the six protected classes. These changes would have allowed the following:
- Broader use of prior authorization and step therapy
- Prior authorization requires your health provider to get approval from your health insurance before he or she is able to prescribe a specific medication for you.
- Step therapy is a process in which health insurance plans require you to begin a medication that is the most cost-effective and you (with the assistance of your health provider) must prove it is ineffective before moving up to a more expensive therapy.
- Exclusion of drugs that represents only a new formulation of an existing single-source drug or biological product (regardless of whether the older formulation remains on the market).
- Exclusion of drugs with price increases over a certain threshold.
The goal behind the proposed rule was to lower drug costs incurred by the health care system. However, if implemented, these changes would have hindered patients’ access to medications, including those designed to target specific conditions that do not have a therapeutic equivalent. Timely access to the most clinically appropriate therapies is essential to achieving the best possible outcomes for cancer patients. Delays in obtaining the most clinically appropriate care results in poorer physical and psychosocial health outcomes, as well as increased out-of-pocket spending.
Decision Not To Implement Changes to Medicare Part D Six Protected Classes
Last week CMS announced it will not proceed with its proposed new rule that would have allowed the changes to Part D outlined above. The Cancer Support Community applauds this decision as essential to ensuring cancer patients, and others with serious health conditions, have access to the treatments most appropriate for them.
To learn more about issues impacting cancer patients and engage in advocacy efforts, sign up to be a member of our Grassroots Advocacy Network.
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