Group Opposes CMS Rule Threatening Patient Protections

WASHINGTON, D.C. -  Leaders on the House Energy and Commerce Committee and the House Ways and Means Committee today lead a bipartisan group of nearly 50 lawmakers in opposing a proposed Center for Medicare and Medicaid Services rule that would eliminate protected class status for several categories of drugs under Medicare Part D, among other harmful provisions.  The group wrote Health and Human Services Secretary Kathleen Sebelius and CMS Administrator Marilyn Tavenner saying that the rule “will place harmful limits on Medicare beneficiaries’ access to necessary medications that would otherwise be covered.”   The group stated that Part D has “demonstrated the ability to provide access to important life-saving and life-enhancing medications for the vast majority of America’s seniors and non-elderly people with severe disabilities.”

“The Administration has proposed drastic changes to the popular Medicare Part D program, which will harm senior citizens across the Nation,” said Congressman Leonard Lance (NJ-07), a member of the Energy and Commerce Committee and its Health Subcommittee. “Since its creation in 2003, Part D has provided access to important life-saving and life-enhancing medications for the vast majority of America’s senior citizens and has routinely come in under budget.  The protected status of these six classes ensures clinically necessary access to needed medications and the proposed rule will put unneeded limits in the way of patient care.  The Administration should leave programs that work well alone.

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“Sadly, this Administration continues to recklessly tamper with the healthcare that our seniors rely on,” said Congressman Diane Black (TN-06), a registered Nurse of more than 40 years. “The Medicare Part D program is overwhelmingly popular and this entire rule undermines the program that is relied upon by seniors across this country to help with their medical needs. It is completely unacceptable for the Obama Administration to remove these important protections that help our nation’s most vulnerable.”

“The protected classes policy has proven to be an effective tool in enhancing patient access to quality care,” said Congressman Gene Green (TX-29), Health Subcommittee member of the House Energy and Commerce Committee. “Removing the protections for anti-depressants, immunosuppressants, and anti-psychotics would undermine Medicare beneficiaries’ access to necessary medications that would otherwise be covered by protected status.”

"I have concerns about these significant changes in Medicare Part D prescription drug policy and what they will mean for the millions of Americans who depend on these medications. No one wants to see their premiums go up or the access denied. My other worry is the potential impact the rule change could have on the economy. The biotechnology community pumps billions of dollars into our economy and employs thousands of people. What are the immediate consequences to this critically important industry? As a member of the committee of jurisdiction over Medicare, these are some of the concerns I intend to raise with the administration at the earliest opportunity," said Congressman Richard E. Neal (MA-01).

Many patient advocate organizations weighed in with their support.

 “The proposed CMS rule will decrease access to medication and jeopardize patient health, especially for those beneficiaries living with mental illness. We applaud these members of the House of Representatives for taking this vitally important stand and for helping to protect vulnerable patient populations,” said Chuck Ingoglia, Senior Vice President of the National Council for Behavioral Health, which is spearheading the recently formed Partnership for Part D Access.

“Medicare Part D, including the Six Protected Classes, is working,” said Carl Schmid, Deputy Executive Director of The AIDS Institute. “Beneficiaries, including those with HIV, are able to access the medications that their doctors prescribe. We don’t understand why the Obama Administration would propose to diminish that access.”

"The Epilepsy Foundation is extremely troubled by the proposed changes from CMS to the protected classes. Weakening patient protections for some of the most medically fragile Medicare beneficiaries at a time when we should be strengthening access is not only disappointing but dangerous. We strongly urge CMS to not only rescind these changes but consider strengthening the class through policies that ensure there are no unnecessary administrative barriers," said Angela Ostrom, Vice President, Public Policy and Advocacy, Epilepsy Foundation.


March 4, 2014

Dear Secretary Sebelius and Administrator Tavenner,

Congress created the Medicare Part D program in 2003 with an emphasis on creating a prescription drug benefit that would provide access to prescription medications for all Medicare beneficiaries.  Congress deliberated over this policy for many years before finally enacting the Medicare Modernization Act.  While Part D was not originally supported by all Members of Congress, it has in time demonstrated the ability to provide access to important life-saving and life-enhancing medications for the vast majority of America’s seniors and non-elderly people with severe disabilities. 

A critically important component of what has made Part D successful over the past eight years is the six protected classes policy.  Created by CMS in 2005 through subregulatory guidance, and later codified by Congress in 2008, the six protected classes policy has enjoyed strong bipartisan, bicameral support.  The six classes of medications were deemed by Congress to be the correct classes for inclusion in 2008 and that position was reaffirmed in 2010. 

For this reason, we are extremely troubled by the proposed rule CMS issued regarding Medicare parts C & D on January 6, which removed the protections for anti-depressants, immunosuppressants used for organ rejection and anti-psychotics.  We believe this proposed policy will place harmful limits on Medicare beneficiaries’ access to necessary medications that would otherwise be covered by protected status. 

We also believe these policy changes will inextricably tie the hands of physicians who treat these individuals, many of whom have complex medical needs.  For instance, limiting the type of immunosuppressants a physician can prescribe places a transplant patient at risk for organ rejection or other health complications.  Similarly, hindering access to anti-depressants, and eventually anti-psychotics, may put someone with mental illness at greater risk for suicide and destabilization of their condition.  These restrictions on appropriate access also impact persons with other challenging health conditions like cancer, HIV or epilepsy that have higher rates of depression as a comorbidity.

Furthermore, the proposed rule relies upon what is widely known to be ineffective exceptions, appeals, and grievance processes to ensure sick individuals enjoy timely access to necessary medications. Removal of protected status for the anti-psychotic, anti-depressant and immunosuppressant classes and allowing coverage of as few as two medications in these classes is certain to overwhelm an already overburdened process under Part D.

Finally, given the broad public support for increasing patient access to care, especially in the area of mental health, and recognizing further the significant challenges your Department faces in its efforts to implement healthcare reform, we are perplexed by your decision to move forward with such a proposal.  Given the overwhelming evidence that all six classes of the current six protected classes policy are appropriate and necessary to ensure clinically necessary access to needed medications, we urge you to maintain this important policy and not finalize this proposed rule.

Thank you for your prompt attention to this critical matter. We look forward to your response.