Success-CMS Backs Off and Transplant Recipient Support Organizations Win The Battle – For Now
In January 2014 CMS proposed changes to the Medicare Part D prescription drug program that currently covers medication for more than 39 million people in the United States. The proposed changes included eliminating the protective status for immunosuppressant medications (prescribed to transplant recipients to protect the transplanted organ from rejection), antidepressant medications and antipsychotic medications.
Medicare has six protected drug categories at this time. The proposal would have removed two of those (immunosuppressant and antidepressant medications) as of January 1, 2015 and considered the removal of protected drug status of antipsychotic medications in 2016.
So, what is “protective status”, anyway?
When a class of medications has a protective status, there is a requirement that Medicare Part D plans include “all or substantially all” drugs within the protective class on their formularies. This allows the physician and patient to have the ability to decide what is best for an individual person. Each person is different and there can be different side effects and effectiveness of various medications regimens.
The rule proposal we are discussing herein would have removed immunosuppressant medications for example, from the list of protected classes. In some cases physicians would not be allowed to choose which medication (even if it’s available as a less expensive generic medication) could be prescribed to a transplant recipient. As you know, transplant recipients must take immunosuppressant medications to prevent the transplanted organ from being rejected. Some of these recipients receive their immunosuppressant medications via Medicare Part D. As transplant recipients, we sometimes require adjustments to our immunosuppressant medication regimen and this can involve changing from one immunosuppressant to another. Transplant recipients and physicians prescribing on behalf of transplant recipients need to have access to all immunosuppressants.
Now that CMS has backed off and withdrawn this proposed rule for now, Medicare Part D insurance must continue to cover all FDA approved immunosuppressive medications.
The policy, known as the “six protected classes” policy, has been in effect since the commencement of Part D and has always had the support of members of Congress.
Who is CMS and why did CMS think that they could easily just remove immunosuppressant medications from their protective status?
CMS is a federal agency that is part of President Obama’s Department of Health and Human Services. CMS is responsible for administrating Medicare and Medicaid. CMS actually stated that they proposed this rule because having a physician forced to prescribe a transplant recipient a different medication (other than the one the physician prefers to prescribe to the patient) would not necessarily cause a hospitalization seven days after not receiving a prescription (to the physician’s first choice of medication to prescribe) so therefore CMS concluded that all immunosuppressant medications are interchangeable.
Long Island TRIO reacted quickly and effectively and was on top of this issue the moment the proposal was released to the public. We joined ten other organizations and those organizations networked to many other patient groups and other healthcare organizations to organize a rapid response. We effectively communicated individual and organizational comments that were delivered to CMS and to members of Congress. This issue was posted on our chapter’s website and on our Facebook group and on twelve other Transplant Facebook groups in which we participate. As the March 7th deadline approached, 370 organizations were on board in this battle. This incredible effort helped abrogate the proposed rule for now.
Members of Congress on both sides of the aisle (Democrats and Republicans) in both houses of Congress overwhelmingly supported our position and stated that they were against the CMS proposals and that for all intents and purposes, their constituents were wholly and unconditionally against the CMS proposed rule. Subsequent to a Congressional hearing, the CMS administrator inventoried a prodigious amount of written comments and had to conclude that there was overwhelming opposition to and disapproval of the proposed rule.
The proposal was open to comments until March 7, 2014. I’d like to especially thank many of our members and volunteers who submitted formal comments about the proposal and also wrote to me letting me know that they took the time to help in this regard. For transplant recipients that receive their immunosuppressant medications via Medicare Part D (some receive immunosuppressant medications via Medicare Part B) this issue is one that is a matter of life and death.
After the rule proposal’s huge number of negative comments by individuals, members of Congress and patient and healthcare organizations, CMS administrator Marilyn Tavenner drafted a letter to Congress promising not to move forward at this with the proposed rule time but keeping open the option of moving forward with the proposed rule in the future.
“Given the complexities of these issues and stakeholder input , we do not plan to finalize these proposals at this time,” Marilyn Tavenner wrote, adding that the CMS will “engage in further stakeholder input before advancing some or all of these changes in these areas in future years.”
Our chapter will stay on top of all future proposals from CMS and other agencies and we know that this issue will likely come up again in the future.
– Mike Sosna