Medicare’s six protected classes policy guarantees access to treatments for Medicare patients with the most complex conditions, including cancer, mental health conditions, epilepsy, Parkinson’s, HIV/AIDS, and organ transplants.

WASHINGTON, DC, November 27, 2018 /24-7PressRelease/ — The Partnership for Part D Access, a broad-based coalition of health care stakeholders including over 20 diverse patient advocacy organizations, today expressed concern with a new Medicare drug pricing proposal that would ultimately harm patients with the most complex conditions. The proposed rule would weaken Medicare’s “protected classes” policy, which was created to ensure patients with the most challenging medical conditions have access to the full range of treatment options under Medicare Part D. The proposal will be subject to a 60-day public comment period before the administration determines whether to move forward with finalizing these changes.

Currently, Medicare drug plans aggressively employ a range of tools including utilization management (i.e. prior authorization and step therapy), tier placement, and coinsurance to drive patients toward lower-cost medications. Moreover, despite the current requirement that prescription drug plans cover “all or substantially all” drugs in the protected classes, most Medicare plans come well short of meeting this standard. By focusing only on costs under Medicare’s prescription drug benefit (Part D), this proposal neglects to recognize the added costs to the entire Medicare program (Parts A and B) from higher costs associated with patients who become destabilized when changing their currently effective treatment regimens.

“For many patients with complex and hard-to-treat conditions, once they are on an effective regimen of prescription medications, they can manage their illness and achieve a high quality-of-life without the utilization of expensive inpatient or emergency department care,” said Chuck Ingolglia, Sr. Vice President of Public Policy and Practice Improvement at the National Council for Behavioral Health, who serves as Executive Director of the Partnership. “We look forward to working with the administration to ensure that patients with the most complex conditions — including cancer, mental illness, HIV-AIDS, epilepsy, Parkinson’s, and organ transplantation — have access to the regimen of medications that works best for them.”

ADDITIONAL BACKGROUND

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.

Additionally, while proposals to alter the protected classes have frequently been suggested in the context of reducing program costs, their analysis often fails to recognize the significant tangential costs associated with limiting drug access. Independent third-party analysts have frequently acknowledged that 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.

As detailed in a study from researchers at Northwestern University and the University of Texas, “profit-maximizing” Part D plans are incentivized to limit benefits or increase costs for Medicare beneficiaries because they are not responsible for costs incurred by other parts of Medicare. As detailed in the study, Part D plans are motivated by incentives that are sometimes counter to the best interests of patients: they are explicitly incentivized to reduce drug spending, while they have no financial responsibility for the holistic health of the patient. In the study, the authors conclude that in covering drugs less generously, Part D plans end up costing traditional Medicare $475 million per year. This study emphasized the importance of Medicare’s protected classes policy, which ensures that patients with the most complex conditions are guaranteed access to the full range of drugs under Medicare Part D — limiting future medical complications, hospitalizations, and additional costs to the Medicare program.

This conclusion was also reinforced in a recent report from The Pew Charitable Trusts, which concludes that savings from the elimination of protected classes may be minimal within the context of total program spending. While the report notes that removing coverage requirements for some of the protected classes may provide Part D Plans with greater ability to negotiate rebates, “protected classes had low utilization of brand-name drugs without generic equivalents, limiting the potential savings from removing those drugs from formularies.” Additionally, the report correctly highlights the significance of the protected classes in ensuring patient access to medications, and concludes that “lack of adequate access to medications can in some circumstances increase costs to other Medicare programs through increased hospitalizations from complications or increased physician visits to manage medications.”

Who We Are

The Partnership for Part D Access is a collection of healthcare stakeholders, including patient groups, advocacy organizations and allied members of industry, who are committed to maintaining beneficiary access to the full range of available medications under Medicare Part D. We represent and care about individuals who would have been negatively impacted if the Centers for Medicare and Medicaid Services (CMS) were to move forward with a January 2014 proposal to end protected status for certain types of drugs under Medicare’s Six Protected Class policy, and to set the stage for removing others in the future. If this policy proposal—which CMS has decided to delay for consideration “in future years”—were to move forward, it would directly, and negatively, impact persons with mental illness, as well as those needing organ transplants. It could also affect people with epilepsy, Parkinson’s Disease, lupus, HIV/AIDS and cancer.


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