An article in Modern Healthcare highlights the overwhelming response from patient advocacy groups who "lambasted" a new proposal from the Trump Administration to alter Medicare's current 'protected classes' policy. According to the article, the Partnership for Part D Access "came out swinging against the proposed protected classes policy," arguing that it could hurt people with multiple and chronic complications already involved in intricate treatment."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 the Partnership's executive director, Chuck Ingolglia. The article also cites concerns from the AIDS Institute, who noted that "step therapy is unheard of in the treatment of HIV due to the danger of developing resistance to an entire class of drugs and potential side effects."

​A recent article in STAT covered the Trump administration’s new proposal that would allow private Medicare plans to exclude coverage of certain drugs that are currently provided under the "protected classes" policy. The article cites concerns from groups including The Partnership for Part D Access, highlighting the importance of the policy in ensuring that Medicare beneficiaries with the most complex conditions have access to medications they need to manage their complex conditions. “As an essential patient safeguard in Part D, the protected classes stand as a guarantee that patients with the most complex conditions will have access to the full spectrum of medications under Part D," the Partnership states. 

An article in Inside Health Policy reports that seven senior groups are lobbying both Congress and CMS to retain rules that make plans cover all drugs in Medicare’s six protected classes. The article — citing a report by the Alliance for Aging Research, Caregiver Action Network, Caregiver Voices United, HealthyWomen, National Association of Nutrition and Aging Services Programs, Partnership to Fight Chronic Disease, and RetireSafe — notes that the six protected classes policy has been a safety net for some of the most medically fragile and vulnerable Medicare beneficiaries. “These requirements safeguard beneficiary access to treatment options and offer protection against plan designs that could discriminate by discouraging enrollment of people relying on protected classes of medicines,” the report states. 

​As first reported in Politico, “the Partnership for Part D Access, a coalition of drug industry, disease and patient groups, sent a letter to HHS Secretary Alex Azar, asking him not to touch the Medicare Part D protected classes... The letter pushes back on the argument that removing certain drugs from protected class status could save money, saying that studies have shown the changes might lead to [d]rug savings but these savings will likely be offset by increases in spending in other parts of the health system, like hospitalizations.”

An article in Inside Health Policy reports that eliminating the protected drug classes would not result in additional savings to the Medicare program. The article — citing a recent report by The Pew Charitable Trust on the protected classes policy — notes that while health plans would like to see more leverage over drug prices in the protected classes policy, a rollback of the policy would not save the program that much money due to factors such as strong generic drug competition and the ability of Part D plans to restrict drugs in the classes. The article also points out the widespread, bipartisan support that the six protected classes policy currently enjoys. “When CMS proposed eliminating three classes -- antidepressants, immunosuppressants and antipsychotics -- a 200-member coalition opposed the idea, as did Republicans and Democrats in both chambers. CMS subsequently backed off the proposal, then-CMS Administrator Marilyn Tavenner told Congress the agency didn’t plan to revisit it.”

A new study by economists Amanda Starc of Northwestern’s Kellogg School of Management and Robert Town of the University of Texas highlights how “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 the Medicare (ex. hospitalizations). 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 – a stat that does not account for other social costs, such as the inconvenience and suffering of beneficiaries who end up in the hospital.  This study highlights the importance of Medicare’s six protected classes, which ensure 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. ​

​A recent article in Vox examines the challenges in diagnosing proper treatments for people with depression, namely the fact that not all treatments work for every patient. The author hones in on the frustrations depression patients face when they are prescribed medicine or therapy that is designed to help treat depression, but are ineffective to their specific needs, and show varying results from patient to patient due to the complexity of the disease itself. “No one thinks those two people have the same biological problem,” said Conor Liston, a research psychiatrist at Weill Cornell Medical College. “And yet those two people get the same label.” This article underscores the importance of the six protected classes, as proposals to limit access to certain medications under the Part D program which are not interchangable - such as antidepressants - would have a profound impact on the patients who benefit from having access to the full spectrum of treatment options.