This post originally appeared in the Daily Memphian on February 27, 2019. 

As we trudge through February’s chill, rain and the ever-present potholes, I can’t help but look forward to the start of baseball season and those summer days having a cold beer while cheering my favorite team. Baseball is unpredictable. A stolen base, a wild pitch or a ninth-inning home run can change the course of the game. Epilepsy, like baseball, is unpredictable. Heat, humidity and exposure to the sun can trigger a seizure, and that’s what happened to a friend of mine who accompanied me to a game last season. The unpredictable nature of the disorder often makes epilepsy difficult to control and manage.

Medicare prescription drug plans only provide coverage for a select group of drugs — that list of drugs they cover is commonly known as a formulary. These formularies provide plans the ability to exclude coverage of certain medications while favoring others, which they often use as leverage to negotiate discounts from drug manufacturers.  These same principles apply within Medicare’s “six protected classes” of medications, even as guardrails help ensure patients with the most complex conditions (ex. mental illness, cancer, HIV, organ transplants, epilepsy) have access to a broader selection of treatments than is available under the standard Medicare benefit.

​Congress codified the six protected classes in 2008 as part of the Medicare Improvements for Patients and Providers Act (MIPPA) to ensure those patients with the most complex health conditions would have access to needed medications.  The original policy required Medicare Part D drug formularies to include “all or substantially all” drugs in the six identified classes. Although the law was updated in 2010 to require coverage of “all” drugs in the protected classes, Medicare regulations have not been updated to reflect the new standard.
 
While Part D plans are required to cover all unique products in the protected classes, this requirement does not result in universal coverage. In fact, often times, plans will opt not to cover brand name drugs when clinically equivalent generic drugs are available. For example, if there is one brand product in a category and three generic products, the health plan may choose to cover just one of the four available drugs in this category. The Centers for Medicare and Medicaid Services (CMS) walks through these exceptions in their Prescription Drug Benefit Manual (see pg. 28), where they detail the following exclusions to coverage within the protected classes:

• multi-source brands of the identical molecular structure;
• extended release products when the immediate-release product is included;
• products that have the same active ingredient or moiety (i.e. brand vs. generic); and
• dosage forms that do not provide a unique route of administration.

 
Utilizing this policy, plans often exclude coverage for a significant amount of medications within the protected classes. In fact, according to Avalere’s analysis of Medicare claims data, Part D plans covered just 67% of available drugs within the protected classes on average (brand and generic combined) and only 60% of brand drugs. Further, in classes where there are more generic medications available, even more branded medications were excluded from formularies. In the class for antidepressants, for example, plans cover only 37% of brand name medications, and for anticonvulsants they cover just 46% of brand name products.
 
This data demonstrates that when there are multiple clinically equivalent drugs available in a class, plans typically choose to cover the lower cost generic products. This ability to exclude coverage of certain medications allows plans to hold down cost and can enhance a plan sponsor’s negotiating power with manufacturers. But still, as detailed in a previous issue brief, guardrails such as the protected classes are necessary to ensure that drug plans are providing access to an appropriate range of medications and keeping people healthy.

​In a letter to Department of Health and Human Services (HHS) Secretary Alex Azar, House Mental Health Caucus Co-chairs Grace Napolitano (D-NY) and John Katko (R-NY) urged HHS not to move forward with harmful changes to Medicare’s Six Protected Classes Policy. The bipartisan letter — signed by 39 House members — states that the proposed changes are “particularly worrisome” for Medicare beneficiaries living with mental illness, noting that the change “directly targets” some of the program’s most vulnerable populations. “CMS has stated that patients will be able to use the lengthy appeals and exceptions processes to gain coverage for medicines if plans deny access to needed medicines,” the letter states. “However, those processes are difficult for patients to navigate and are likely to become overwhelmed with patients desperate to stay on the medicines they have been using to successfully manage complex conditions.” 

The letter in its entirety can be read here. 

This post originally appeared in The Virginia Gazette on February 19, 2019. 

A​t his pre-election campaign rallies, President Trump promised to protect Medicare. But now, his administration quietly embraces drastic changes that could choke off seniors' access to lifesaving treatments. Consider the administration's new guidance for Medicare Advantage, which enables about 20 million Medicare beneficiaries to obtain subsidized health plans from private insurers. The guidance, which took effect in January, allows insurers to force beneficiaries to try older, low-cost medications before they can access more advanced, expensive drugs.

In a February 12 speech before the American Medical Association (AMA), HHS Secretary Alex Azar acknowledged the dangers inherent in requiring step therapy for patients who are already stabilized on an effective regimen of medications. Interestingly, his remarks seemed to run counter to his agency’s current proposal to weaken Medicare’s successful “six protected classes” policy. A new fact sheet from the Partnership sheds light on these comments and provides background on their application to the six protected classes policy. ​

This post originally appeared in Inside Health Policy on February 12, 2019. 
​
HHS may stop the insurance industry practice of making seniors fail on drugs that have already failed for them when switching to a new Medicare drug plan, HHS Secretary Alex Azar told the American Medical Association Tuesday (Feb. 12).The practice is known as step therapy, though patient advocates often call it fail first. Azar learned of that application of the practice in meetings with patients and doctors who are urging against a separate HHS proposal to use step therapy more broadly in six protected drug classes.

This post originally appeared in Modern Healthcare on February 12, 2019. 

HHS Secretary Alex Azar said the agency is exploring cracking down on a practice insurance plans use to make a patient start over on step therapy if they switch plans. Azar's comments before the American Medical Association's Advocacy Conference in Washington on Tuesday comes as the agency is proposing allowing Medicare Advantage plans to apply step therapy and prior authorization to drugs sold in Medicare Part B and Part D. The practice has opposition from some patient groups who fear that the tools hinder patient access. 

The Partnership for Part D Access applauded HHS Secretary Alex Azar for his remarks in a speech today before the American Medical Association (AMA) in which he acknowledged the dangers inherent in requiring step therapy for patients who are already stabilized on an effective regimen of medications. Interestingly, his remarks seemed to run counter to his agency’s current proposal to weaken Medicare’s successful “six protected classes” policy. Given today’s statement, the Partnership urges the Secretary to abandon the administration’s proposal, which countless stakeholders would agree is “penny-wise and pound-foolish.” 

This post originally appeared in Roll Call on February 5, 2019.

President Donald Trump’s plan to eliminate HIV transmission in the United States by 2030, which he announced Tuesday night, would be an ambitious goal that would require his administration to reverse course on a number of policies that potentially hinder access to HIV/AIDS care. “Together, we will defeat AIDS in America,” Trump said in his State of the Union address. He said that his budget will “ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years.”

This op-ed originally appeared in The Hill on February 4, 2019. 

​When then-President Lyndon Johnson signed Medicare into law in the summer of 1965, he declared, “No longer will older Americans be denied the healing miracle of modern medicine.”Johnson’s pledge was as prophetic as it was audacious: Medicare fundamentally transformed health care, giving seniors unprecedented access to the medicine and services they need to live longer, healthier lives.That promise now hangs in the balance. The Trump administration is pushing policies that threaten to undermine Medicare coverage for many of America’s most vulnerable seniors and people with disabilities. The worst of these misguided proposals could kill people. This might sound hyperbolic, but it’s not.​