 As reported today by Politico, a new proposal to weaken Medicare's six protected classes policy could harm national efforts to eradicate HIV — a top priority of the Trump administration and HHS Secretary Alex Azar. "That's according to Precision Health Economics, which argues that applying negotiation tactics for protected classes drugs in Medicare Part D could harm patient access and end up hurting efforts to eradicate HIV. It's the latest in an effort led by AIDS United and other disease advocacy group to keep Medicare requirements to cover all protected class drugs."
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 At a recent hearing of the Energy and Commerce Committee featuring HHS Secretary Alex Azar, at least four key members of the committee raised concerns with the administration's proposal to weaken Medicare's protected classes policy — including Ranking Member Greg Walden (R-OR) and Health Subcommittee Chair Anna Eshoo (D-CA). For example, when talking about the proposal that could require patients who are stabilized on an existing treatment to go through step therapy or prior authorization, Ranking Member Walden emphasized that "no patient wants to go through that, and it’s something we’ve got to pay attention to." Later, Health Subcommittee Chair Eshoo added that "I think both sides hold the same view so we have to move forward and correct that situation.” Transcripts and Video of Key ExchangesRANKING MEMBER WALDEN: “CMS has proposed a rule to change the formularies for patients in Part D protected classes. What assurances can you provide my constituents and those patients they’ll still be able to get access to the medications they need?” SECRETARY AZAR: “Thank you for that question, because there is a lot of misunderstanding there. Of course, with the protected classes, what’s happening we, as a government, have disabled these middlemen — the pharmacy benefit managers — from being able to negotiate against the drug companies to get discounts. So the very drugs in the commercial space may be yielding 30 percent average discounts, we’re getting zero to six percent. So what we’re proposing — and it’s a proposal, we’re getting very important feedback from disease groups in and we’ll look at it — is to allow some of the basic formulary management tools used in the commercial space for regular, commercial employees. For instance step therapy, try this drug before that drug. Prior authorization — make sure this drug is being used for the right indication. Without speedy appeals and exceptions processes and with the choice that’s embedded into Part D where you can pick a plan, if it’s not meeting your needs, you can choose a different one. But we’re hearing the feedback and we’ve heard very vigorous feedback. We want to protect our beneficiaries, of course.” WALDEN: “Because I have heard from some patients today — before this becomes a rule — that they have a drug that works, they change plans, something happens, and they’re told they’ve got to go back through all these drugs they know don’t work to get to the one that does. And no patient wants to go through that, and it’s something we’ve got to pay attention to. AZAR: “I’ve heard that feedback and obviously we’ll take that very seriously. REP. DORIS MATSUI (D-CA): “Let me just say this. I want to reiterate the concerns of Ranking Member Walden regarding the protected classes. I’ve gotten many of my constituents stepping forward that they are really very concerned regarding the step therapy. They have medication that they already know works, and to think that they have to go back again and go through the steps, that would really bring them back to a place they don’t want to be.” ESHOO: “I thank the gentlewoman. I think the issue that Ms. Matsui and Mr. Walden brought up... I think both sides hold the same view so we have to move forward and correct that situation.” REP. RICHARD HUDSON (R-NC): “The president’s pledge in his State of the Union Address to eliminate new HIV infections by 2030 is a far reaching and important goal for U.S. public health. The financial resources proposed in yesterday’s budget released speaks to the president’s commitment to improving diagnosis testing and linkage to care for HIV. I commend the President for taking such a monumental effort and hope to do what I can to support his plan. Given his goal though, I must ask about a problem a number of my constituents that are HIV patients have raised to me. Medicare Part D provides for protected classes where Medicare must generally cover all drugs within that class with HIV drugs being one of the current six classes… My basic question is how does HHS intend on balancing the goal of introducing cost control measures such as prior authorization and step therapy with new eliminations of new HIV infections by maintaining patient adherence to working HIV regimens in the HIV space?”
AZAR: “Happy to get back to you on that in writing if that’s okay?” HUDSON: “It’s an important issue, so I appreciate your response.” ESHOO: “I was expecting a long answer from the Secretary, so we hope that he’ll be able to get back to you.”  This post originally appeared in The Independent on March 8, 2019.
Recently, the Centers for Medicare and Medicaid Services proposed a troubling regulation that would weaken Medicare Part D, the federal program that helps 45 million American seniors and people with disabilities afford prescription drugs. Part D is unique among government programs. The federal government allows people to purchase coverage from private insurers. The government subsidizes these plans but otherwise lets Medicare beneficiaries choose the coverage that’s best for them. Congress did put some guardrails on insurers when it created Part D. It required Part D plans to cover all medications in six “protected classes” of drugs, including antipsychotics, antidepressants, and anticonvulsants. These medicines help treat people with schizophrenia and other psychiatric illnesses.  A series of recent news articles in dozens of publications across the country highlight a myriad of concerns raised by patient advocates over a new proposal that would weaken Medicare Part D's six protected classes policy. As over 140 individual advocacy organizations are noted, it would be extremely dangerous to risk limiting access to medications for patients with the most complex chronic conditions, such as cancer, HIV, mental health conditions, Epilepsy, and others. This new one-pager from the Partnership for Part D Access provides a visual overview of some of the many articles that detail these concerns.
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