This post initially appeared on the Care for Your Mind blog on January 15, 2019. 

One of Medicare’s key patient protections – the six protected classes – is under threat by a new proposal from the Trump Administration. Feedback from the public will be critical in deciding whether or not they move forward — that’s why it’s essential that you let your voice be heard.

​In a recent article for National Law Review that examines CMS’ new rule on Part D,the authors cite the Partnership’s recent Avalere report that casts doubt on the proposed rule’s beneficial effects . The piece highlights key data points in Partnership’s report showing that the current system controls costs in a variety of ways, including copayments for expensive brand drugs and promoting generic utilization. “As such, changes to the current system motivated solely by overall cost could be detrimental for certain high risk patients who are receiving treatments including cancer, HIV, and kidney transplants that require expensive drugs with high copayments and no generic options,” the authors point out. “There is further concern that reducing the protections of certain medications will ultimately lead to their exclusion from Part D plan formularies.”

​An article in Patient EngagementHIT covered Partnership’s recent Avalere report, noting that existing utilization management strategies such as formulary tiers and copayment already serve as significant barriers to Medicare Part D drugs. The article notes that the recent proposed rule addressing the 'six protected classes' policy could result in payers implementing more step therapy or prior authorization within the protected classes — a step that could complicate patient access to treatment for those drugs. The piece also points to the data point in the Avalere analysis showing that Part D plans are already using tools within the program to push patients toward lower-cost alternatives. ​“This new study provides overwhelming evidence that Medicare’s protected classes policy strikes an appropriate balance between allowing plans to utilize medication management techniques and preserving a safety net for patients who absolutely need a particular medication,” said Partnership Executive Director Chuck Ingoglia. “Even with these protections in place, patients must overcome layers of restrictive barriers that plans put in place to access needed medications.” 

An article from MedPage Today highlights a recently-commissioned study from Partnership for Part D Access that raises concerns with CMS’s proposed regulation that would allow Medicare plans to increase their use of "utilization management" in Part D. "We found that the story line that says all drugs are supposed to covered is actually not true," said Catherine Finley, who spoke on behalf of the Partnership. "On average, across all classes, only 67% of all drugs are covered," she continued. The article goes on to point out that "while CMS officials say their proposals are aimed at making the Part D drug market more competitive, most of the patients are already using generic versions of brand-name medications."

​An article from the Washington Post highlights the Partnership for Part D Access's recent study that shows that insurers operating Medicare Part D plans have a robust toolkit to manage costs of drugs in the six protected classes. This week’s proposal from the Trump Administration to give insurers new negotiating power is unnecessary and could reduce the ability of patients to access needed medicine. As Catherine Finley, a senior advisor to the Partnership, told the Post, “access to affordable medication is important, but access to an affordable drug that doesn’t work isn’t helpful.” The article noted that the six protected classes were established when Medicare Part D was created in 2003, and that there is widespread agreement that those protections ensure that seniors can access critical drugs without worrying about being denied coverage.

​Politico’s Pulse newsletter prominently featured a study from the Partnership for Part D Access showing that Medicare Part D plans are currently equipped to control costs of critical drugs in the six protected classes. As detailed in the article, the study found that "Part D benefit designs are steering patients to cheaper drugs. More than 90 percent of prescriptions in the protected classes are for lower cost generics, even when accounting for the fact that nearly all HIV drugs are branded medicines. Use of prior authorization also is common — it’s required for nearly half the brand drugs in the protected classes and 36 percent of all protected class drugs. Plans also use formulary tier placement to try and control costs." This shows that the six protected classes safeguard access to critical drugs while not unduly constraining plans’ ability to manage their formularies.

An article for Bloomberg Law touches on a new report from the Partnership for Part D Access which demonstrates that Medicare Part D plans are successfully using tools to push patients toward less expensive drugs under the six protected classes policy. The article notes that the study, conducted by Avalere Health, shows drug plans are tools such as requiring copays for brand drugs in the protected classes to control patient costs and promote access to cost-effective treatments. The piece amplifies the concerns of patient advocates in response to proposed changes from the Administration. “Making changes to the policy because of cost is reckless,” said Chad Worz of the American Society of Consultant Pharmacists.  “It’s not something you play with to get a cheaper drug.”

​A recent article in Fierce Healthcare covered the Partnership for Part D Access’s new report showing Medicare Part D plans are successfully using tools to drive patients into less expensive drugs. The article, which highlights the Partnership’s response to the Trump administration’s new drug pricing proposal, points out that anti-rejection drugs for patients who've received transplants, antiretrovirals for patients with HIV, and anticonvulsants for patients with epilepsy among a few of the many therapies that could get more restricted under this proposed rule. "While on its face, the proposal the administration has put out seems to make tweaks, we as a patient community have concerns that [it] would dramatically impact access," said Partnership Senior Advisor Catherine Finley.

​A recent article in Healthcare Dive featured the new study from the Partnership and Avalere Health, demonstrating that Part D plan sponsors are already using a variety of techniques to limit access to drugs in Medicare's protected classes. The author explains that the Trump Administration’s recently proposed rule looks to use step therapy and prior authorization to better manage pharmaceuticals in the protected classes, despite the fact that "more than 90% of the prescriptions filled across the protected classes were for generic medications." According to the article, "this research shows that plans are aggressively utilizing tier placement and other management tools to drive an overwhelming percent of seniors towards lower cost medications," said Chuck Ingoglia, senior vice president of public policy and practice improvement at the National Council for Behavioral Health​.

​​Washington D.C. — ​The Partnership for Part D Access released a new analysis today (two-page summary) which finds Medicare’s existing protected classes policy is working as intended for Medicare beneficiaries with some of the most complex health conditions: cancer, HIV, transplant recipients, epilepsy, and mental illness among others. Specifically, the findings clearly demonstrate that Medicare drug plans are aggressively employing utilization management and other tools across the six protected classes — meaning patients are directed to use lower-costing medications whenever appropriate.