Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) submitted comments in response to the CMS proposed rule, “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” The comments focused on significant concerns about the impact of these proposals on access for the sickest and most vulnerable Medicare Part D beneficiaries. Below are a few key excerpts.
- Overall, the changes to the six protected classes should not be finalized: PhRMA strongly opposes proposed changes to the six protected classes policy. The protected class policy affords access to vital and life-saving medicines for patients with serious and debilitating conditions. The administration is proposing to weaken the current six protected class policy in several ways, notably by allowing health plans to force patients who are stable on a medicine to go through prior authorization or step therapy. We have several concerns with these proposed changes. The proposed changes could have serious health consequences for patients and are unnecessary given that plans already have tools to manage utilization in these classes and significant savings from the proposed changes are unlikely. We also have legal concerns with the proposed changes, which are inconsistent with Part D’s non-discrimination protections.
- Changes jeopardize coverage for vulnerable beneficiaries who need access to the full range of necessary medicines: For beneficiaries relying on one or more medicines in the protected classes, treatments largely are not interchangeable. Instead, patient responses to treatment are-unique and disparate, where seemingly “similar” patients may experience clinically meaningful differences when exposed to the same therapy. For example, for patients with epilepsy, it can take years to find the optimal combination of treatments to manage and prevent seizures. For patients with schizophrenia or depression, it may take several tries to find a medicine that controls symptoms and has manageable side effects. The National Institutes of Health states that when it comes to treating HIV “the best regimen for a person depends on their individual needs,” thereby necessitating that patients have access to the full range of therapies. For transplant patients on anti-rejection drugs, the stakes are obviously very high if they do not have access to the appropriate medicine.
- Weakening the six protected classes is unlikely to result in significant savings because Part D plans already have tools to manage utilization: Cost containment is clearly one of the Administration’s primary motivations in pursuing changes to the protected classes; however, allowing plan sponsors to place additional restrictions on access to medicines in the protected classes is unlikely to produce substantial Part D savings. Plan sponsors are already able to manage access to most drugs in the six protected classes. Although the Administration contends that allowing insurers even more tools to manage utilization or exclude drugs from the six protected classes is necessary to constrain costs, clear evidence shows that the current level of formulary flexibility has been successful in both driving utilization of generics and keeping price growth in check.
- CMS’ proposed exceptions based on cost considerations are a significant, unexplained departure from current policy and would harm patients: The proposed rule exceptions represent a sharp and unexplained change from CMS’ established position which, if finalized and implemented, will have a detrimental impact on the protected class patient population. These proposed exceptions sharply diverge from the understanding of the protected classes policy that CMS and Congress have long shared — that the policy protects vulnerable beneficiaries with serious diseases from interruptions in their therapy and thus reflects “clinical concern[s]”— and contradicts the existing regulation providing that new exceptions will be “based upon scientific evidence and medical standards of practice.”
- Alternative policies could achieve the Administration’s goals without putting patients at risk: If CMS wishes to address patient affordability challenges caused by rising list prices, there are more appropriate policy solutions that would not put patients’ health at risk. The changes to six protected classes being proposed by the administration are unlikely to lower patients’ out-of-pocket costs for brand medicines and could harm patients by introducing access barriers. In PhRMA’s comments on the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, we supported several policies that would promote competition and improve patient affordability. Within Part D, we urge the Administration to lower patient costs by requiring plan sponsors to pass through a share of discounts and rebates to Part D beneficiaries at the point of sale. This is consistent with CMS’s discussion in this proposed rule of passing through pharmacy price concessions. Extending this policy to manufacturer rebates could yield lower out-of-pocket costs immediately (upon taking effect) for millions of beneficiaries while also generating multi-billion dollar savings to the federal government over a ten year window.
- Also included in this rule, step therapy for Part B medicines puts patients at risk: Reversing long-standing policy, CMS is proposing to allow Medicare Advantage plans to use step therapy for Part B medicines. Step therapy policies – often referred to as “fail first” policies – require patients to demonstrate that a medicine preferred by their health plan is not effective or tolerable before receiving the treatment recommended by their provider. Patients who rely on Part B medicines frequently have serious conditions that require intensive management such as cancer, rheumatoid arthritis (RA) and other autoimmune conditions, severe infections, multiple sclerosis, macular degeneration, genetic disorders and other rare diseases. Step therapy puts vulnerable patients who need access to life-saving medicines covered by Part B at risk by increasing access and adherence issues that can lead to poor health outcomes and increased costs. Step therapy policies also interfere with provider autonomy and increase their administrative burden. We strongly oppose the use of step therapy in Part B; moreover, we believe that CMS does not have the legal authority to allow Medicare Advantage plans to impose step therapy restrictions that are not required by Original Medicare.
Medicare Part D has been successfully providing seniors with comprehensive drug coverage for more than a decade, and one of the cornerstones of the program has been to ensure the sickest and most vulnerable patients have access to the clinically critical medicines they rely on, under the six protected classes policy. This proposed rule would weaken that policy to such an extent that the classes could no longer be considered truly “protected.” For patients with serious and complex health conditions like HIV/AIDS, cancer and mental illness, the changes in the rule would reduce adherence to their medicines, jeopardizing their health, increasing their need for inpatient care and resulting in poorer health outcomes for seniors and higher costs for taxpayers.
Read the full comments here.
