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“Despite Part D’s success and the effectiveness of the six protected classes policy, the Medicare Payment Advisory Commission (MedPAC) report released recently included a recommendation to make changes to this popular policy…We maintain serious concerns with MedPAC’s recent proposal and urge CMS to maintain the six protected classes policy as it currently exists.”
-Senators Chuck Grassley and Sherrod Brown |
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"[Research] soundly refutes claims that protected classes are driving up costs in the Medicare program because it allows unfettered access to the most expensive medications. In fact, 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."
-Chuck Ingoglia, Senior Vice President of Public Policy and Practice Improvement for the National Council |
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"Altering those categories would be tantamount to backdoor discrimination, where plans could be designed to exclude treatment for certain conditions. Advances in cancer treatment have resulted in many therapies that are designed to target very specific conditions and oftentimes have no therapeutic equivalent. Allowing plans to cover just one drug per class or subclass could result in the exclusion of many unique cancer therapies, leaving patients unable to find a plan that will cover the only potentially lifesaving drug to treat their condition."
-American Cancer Society, Cancer Action Network |
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“These classes of medications are protected for a reason. Epilepsy is a spectrum condition with a wide range of seizure types and anticonvulsants are not interchangeable… Forcing people with serious and life threatening conditions to go through additional hurdles, like step therapy or an exceptions process, is not the answer. For people with epilepsy, creating burdensome barriers to anticonvulsants can result in breakthrough seizures, accidents or even death.”
-The Epilepsy Foundation |
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“CMS' proposal, however, would weaken the current protections for cancer drugs and potentially create access issues for patients. In particular, provisions in the proposal that would allow step therapy and other potentially restrictive utilization management strategies could not only delay patient access to proper treatments, they could potentially lead to irreversible disease progression and other significant patient health risks.”
-American Society of Clinical Oncology |
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“Family caregivers rely upon the six-protected classes of medications to make sure that critical treatments for their loved ones living with a variety of chronic illnesses are covered. This proposal from the Centers for Medicare and Medicaid Services (CMS) may disrupt current treatment regimens for our family members, and could create barriers between patients and the most effective medications to treat their individual needs.”
-Caregiver Action Network |
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"For the first time ever, Medicare patients with cancer and other serious diseases that rely on drugs in these protected therapeutic categories, will no longer have guaranteed access to potentially life-saving drugs. Instead, they will be subjected to “fail first” step therapy and formulary restrictions that potentially restrict them from receiving the evidence-based therapies that their trained physicians prescribe as first line cancer treatment."
-Community Oncology Alliance |
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“CMS proposed rule would create new exceptions to The Six Protected Classes policy to allow insurers to institute new prior authorization or step therapy requirements or exclude medications entirely under some circumstances. MHA is concerned that limitations on medication access driven by cost (rather than any compelling clinical reason), will hurt individuals with mental health and substance use conditions in the short-term, and actually increase health care spending in the long-term.”
-Mental Health America |
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"Not all patients respond the same to just one or two combinations of medications. Often, the first prescribed drug combination needs to be adjusted or replaced altogether, further underscoring the need to have all drugs available under Part D plans. While we understand the need to control healthcare spending, this is not the way to achieve savings." -The National Kidney Foundation |
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“The National Minority Quality Forum (NMQF) believes that the value of policy and regulatory changes must be assessed by examining the impact of those changes on the outcomes of care in patients and communities. NMQF is concerned that CMS' proposed changes will reduce these protections, threatening the health and welfare of millions of seniors.”
-National Minority Quality Forum |
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“Older Americans, who have been confident that those drugs in the six protected classes would always be available no matter which drug plan they choose, no longer have that guarantee. The care delaying step therapy process will be a government induced road block that will have a real impact on the health of seniors. This disingenuous and politically motivated change, to a part of Medicare that has worked for 13 years, is a real threat to the health of seniors and needs to be stopped.”
-RetireSafe |
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“In all candor, our nation is struggling to provide appropriate care for people with schizophrenia and other psychotic illnesses. Already, these patients die ten (10) to twenty (28) years sooner than other Americans and tens of thousands of people with severe mental illnesses have been ‘re-institutionalized’ in state prisons and county jails. The real-life consequences of reducing access to anti-psychotic medicines is frightening… And, ultimately, you can’t quantify additional human suffering for patients as well as their family members. I urge Congress – as quickly as possible – to move legislation halting this implementation of the CMS rule.”
-Schizophrenia and Related Disorders Alliance of America |
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"Not all HIV medications are the same, and not very person living with HIV is the same. Providers are best able to prescribe the HIV drug that works best for the patient, who may have resistance to certain drugs, comorbidities, or side-effects that dictate the drug that they are able to take. The Medicare Part D Program is working well for people living with HIV, and there is no reason to take these draconian actions."
-The AIDS Institute |
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“..We urge HHS and the Centers for Medicare & Medicaid Services (CMS) to seriously consider the negative impacts their proposed changes to the Medicare Part D program may have on some of the most vulnerable populations who benefit from the program. Patients in the six protected disease state classes need personalized treatments more than any others and we do not believe that limiting what is available to them will create a better drug supply chain for patients.”
-US Rural Health Network |
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“They (Medicare beneficiaries) are a more vulnerable patient population as a whole, and having access to a full range of therapies is crucial to ensure that they are able to get the care that they need.”
-Emily Shetty from the Leukemia and Lymphoma Society |
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"By undoing one of Medicare’s signature protections for persons with mental illness, attacks against the protected classes and Part D disregard scientific understanding that psychiatric medications are not interchangeable. A medication that works for one person does not necessarily work for another person. Prescribing decisions must be individualized, based on clinical history, side effect profiles and personal preferences. Medications are a critical component of an array of services and supports vital to health and recovery for many people with mental illness."
-Ron Honberg, Director of Policy and Legal Affairs at the National Alliance on Mental Illness |
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“…it is imperative now and in any future expansions that no medications in the protected classes or medications that are vital to protecting public health (e.g. anti-retroviral medications) be subject to lock-in. Nor should any medications that treat substance abuse disorders be included in the lock-in." -Lindsey Copeland & Casey Schwarz of the Medicare Rights Center |
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"DBSA advocates for the right of people with mental health conditions like depression or bipolar disorder to choose their own paths to mental, emotional, and physical wellness. “Implementation of this proposed ruling has the potential not only to undermine hard-won treatment advances a person with a mental health condition may have made, but also to undermine a person’s ability to choose the right treatment that a clinician identifies as the best fit for a serious, life-threatening condition."
-Allan Doederlein, President of the Depression and Bipolar Support Alliance |
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"The logic in maintaining these protected classes is inarguable. Medicare beneficiaries coping with serious, chronic illnesses should have access to the medications that they and their physicians have deemed the most effective treatment for their conditions. Medications are not interchangeable. One drug can have vastly different effects, and side effects, on different patients. Thus, Medicare Part D is structured to ensure that patients who require antidepressants, antipsychotics and immunosuppressants (critical drugs for patients who have undergone organ transplants) have access to the unique medicines they need to protect their lives and health."
-Kenneth Thorpe, Chairman of the Partnership to fight Chronic Disease |
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"The effectiveness and tolerability of antidepressants can vary greatly among people who choose this treatment option. Our extensive clinical experience demonstrates that the best therapy for one person may be ineffective or poorly tolerated in another individual. Moreover, successful treatment frequently involves trial of several different medications in a quest to find the best treatment in terms of efficacy and tolerability. As a result, it is important that people with mental health conditions have access to a wide variety of treatments and that clear information about these options is available both to clinicians and the individuals they serve and treat."
-Dr. Joseph R. Calabrese of Case Western Reserve University |
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"TSO is a patient-oriented support group dedicated to the long-term well-being of our members who have received organ, eye, and tissue transplants. The stability of medications guaranteed by the Part D protected classes is paramount to this goal. TSO strongly advocates no change to the protected class provisions for any of the six classes of patients who would be adversely affected."
- Ira Copperman, Co-President of the Transplant Support Organization |
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"The Transplant Recipients International Organization (TRIO) is committed to improving the quality of life for transplant candidates, recipients, their families and the families or organ and tissue donors. Access to life and transplant sustaining drugs through Medicare Part D is critical to achieving and maintaining this goal. TRIO advocates keeping in place all of the benefits and protections of all six protected classes in Part D to maintain the support need by transplant and other patients for life sustaining medications."
- Jim Gleason, President of TRIO |