Action needed to preserve the six protected classes

Tom Wilbur
Tom Wilbur February 3, 2021

Action needed to preserve the six protected classes.

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In the final hours of the previous Administration’s time in office, the Center for Medicare & Medicaid Innovation (the Innovation Center) (CMMI) announced new changes for CY 2022 to an existing five-year Part D Payment Modernization Model. This model would provide “formulary flexibility” by exempting Part D plans in the Model from some of Part D’s normal formulary coverage requirements, including rules for the six “protected classes” and the two drugs per class requirement. This change would ultimately impact the most vulnerable patients, including those with cancer, mental illness, and HIV in the middle of a global health pandemic. PhRMA is strongly opposed to these last-second changes.

Medicare Part D has been successfully providing seniors and people with disabilities with comprehensive drug coverage for nearly 15 years. One of the most important and successful aspects of the Part D program is the six protected classes policy, which ensures the sickest and most vulnerable patients have access to the full array of clinically critical medicines they rely on. Previous proposals to weaken the six protected classes have been met with fierce opposition by a large, diverse, bipartisan group of lawmakers, patient groups, and disability advocates and have been pulled back by prior administrations.

The Biden administration should immediately remove the 2022 changes to this model. Here's why:

  • Access to clinically critical medicines for vulnerable patients has been a cornerstone of the Part D program. Since the beginning of Part D, Congress has recognized that robust access to certain medicines is central to the wellbeing of beneficiaries who need those therapies, and that their prescribers need access to the full range of treatment options.
  • Medicines in the six protected classes treat serious health conditions. Therapies for these conditions have complex interactions, contraindications, side effects and other factors that must be addressed to identify the best course of treatment for an individual patient. Particularly among the most vulnerable beneficiaries – the frail, disabled or those with multiple chronic conditions – many medicines are not interchangeable.
  • It is critical that beneficiaries have access to a full range of therapies. Many patients living with these illnesses must attempt a variety of therapies before they, and their physicians, settle on the most appropriate treatment. This access ensures seniors and people with disabilities are adherent to the medicines they need to manage their chronic conditions and live longer, healthier lives. For example, HIV patients who face drug benefit design changes are nearly six times more likely to face treatment interruptions than those with more stable coverage, increasing their risk of virologic rebound, drug resistance, and increased morbidity and mortality.

  • Part D plans already have effective tools to manage utilization and encourage manufacturer competition in the six protected classes. Part D plans manage beneficiary access to most drugs in the six protected classes through formulary tiering and utilization management. These tools help Part D plans promote competition among manufacturers of medicines in these classes, helping them to negotiate lower rebates that also lower their costs. Part D plans have also been very successful in driving generic utilization in the six protected classes. In fact, the generic utilization rate in the protected classes is as high as 84 percent.

  • Letting plans restrict access to medicines for some of the sickest and most vulnerable patients can reduce use of those medicines. This would potentially jeopardize patient health, increase the need for inpatient hospital care, and result in poorer health outcomes. For example, commercially insured patients who faced benefit restrictions on atypical antipsychotic therapy demonstrated a significant reduction in adherence and persistence to their medications, which could have a dire impact on health outcomes as well as health care costs.

Bottom line: The six protected classes must remain protected since the clinical considerations that made the six protected classes policy necessary originally are as pressing and valid today. PhRMA continues to support solutions that improve Part D affordability without limiting access — such as capping what seniors have to pay out-of-pocket each year for prescription medicines and making those costs more predictable each month.

Topics: Cancer, HIV/AIDS, Part D, Medicare, Mental Health