In a letter responding to the Department of Health and Human Services drug pricing request for information (RFI), the Partnership for Part D access outlined the overwhelming evidence that reinforces the importance of the ‘six protected classes’ as they currently stand. Despite widespread bipartisan backing and a history of longstanding support from patients, this new proposal designed to address prescription drug prices could potentially undermine Medicare's vital 'protected classes' policy. Partnership's letter to HHS emphasizes that the six protected classes policy is an essential patient safeguard in Part D, and stand as a guarantee that patients with the most complex conditions will have access to the full spectrum of medications under Part D.
A new study published in the American Journal of Managed Care concludes that medications in Medicare’s six protected classes are the most likely to be subject to various utilization management techniques — such as step therapy or prior authorization — that are employed by Part D plans. Among their findings, the authors found that antipsychotic drugs – one of the six protected classes – is among the most likely classes of drugs to have step therapy imposed upon formulary placement. The study authors also reported that antipsychotics along with antiepileptics are among the most likely drug classes to require prior authorization upon formulary placement.
A new report from The Pew Charitable Trusts concludes that savings from the elimination of protected classes may be minimal within the context of total program spending. While the report notes that removing coverage requirements for some of the protected classes may provide Part D Plans with greater ability to negotiate rebates, “protected classes had low utilization of brand-name drugs without generic equivalents, limiting the potential savings from removing those drugs from formularies.” Additionally, the report correctly highlights the significance of the protected classes in ensuring patient access to medications, and concludes that “lack of adequate access to medications can in some circumstances increase costs to other Medicare programs through increased hospitalizations from complications or increased physician visits to manage medications.
Partnership for Part D Access Submits Comments Urging CMS to Rescind Proposed Change to Six Protected Classes
On March 7, 2014, the Partnership for Part D Access filed comments urging the Centers for Medicare and Medicaid Services (CMS) to rescind the proposed rule that would eliminate protected class status for several categories of drugs under Medicare Part D. The comment letter notes that in the proposed rule, CMS fundamentally misinterprets the intent of the Affordable Care Act (ACA) by weakening the protected classes policy and transforming a legislative directive to identify classes of clinical concern into one targeting classes of alleged cost concern. The studies cited by the agency do not support its own cost savings assumptions and the rule ignores the substantial spending associated with the destabilization of patient care that it will precipitate. By using it as a tool for cutting costs at the expense of the most vulnerable Medicare beneficiaries, CMS contradicts Congress’s intent to improve and expand the protected classes policy. Click ‘Read More’ to view the comments.
On January 25, 2018, the Partnership for Part D access submitted a letter to in response to a recent Department of Health and Human Services’ (HHS) Request for Information (RFI) seeking information from stakeholders about the Medicare program. The letter urges HHS to retain the Medicare Part D protected classes policy, touting its overwhelming success in providing access to certain medications for the most vulnerable beneficiaries within Medicare. “The six classes of clinical concern, also known as protected classes, is a vital policy that ensures patients with high-risk complicated conditions receive access to the most appropriate medication,” the letter states. “As you evaluate the program, we urge you to retain this policy.” The letter also highlights the consistent support that the protected classes policy enjoys among policymakers and beneficiaries.
On Friday, September 8, 2017, the Partnership for Part D Access presented a letter — cosigned by 111 individual patient advocacy organizations — to Department of Health and Human Services Secretary Tom Price, highlighting the importance to patients of the Medicare six protected classes policy. “The protected classes policy is essential for maintaining access to proper treatment for Medicare beneficiaries,” the letter states. “Patients with a condition in one of the protected classes have very complicated medical needs, and many of these patients must attempt a variety of therapies before coming to a decision with their physicians about what is the most appropriate treatment.” The letter delivers a strong and clear message to the Administration that the protected classes policy continues to provide essential access to medication for Medicare beneficiaries, enjoys widespread, bipartisan support, and should not be changed.
A recent study by economists Amanda Starc of Northwestern’s Kellogg School of Management and Robert Town of the University of Texas highlights how “profit-maximizing” Part D plans are incentivized to limit benefits or increase costs for Medicare beneficiaries because they are not responsible for costs incurred by other parts of the Medicare (ex. hospitalizations). As detailed in the study, Part D plans are motivated by incentives that are sometimes counter to the best interests of patients; they are explicitly incentivized to reduce drug spending, while they have no financial responsibility for the holistic health of the patient. In the study, the authors conclude that in covering drugs less generously, Part D plans end up costing traditional Medicare $475 million per year – a stat that does not account for other social costs, such as the inconvenience and suffering of beneficiaries who end up in the hospital. This study highlights the importance of Medicare’s six protected classes, which ensure that patients with the most complex conditions are guaranteed access to the full range of drugs under Medicare Part D – limiting future medical complications, hospitalizations, and additional costs to the Medicare program.
On June 30, 2016, Sen. Chuck Grassley of Iowa and Sen. Sherrod Brown of Ohio wrote a letter urging the Centers for Medicare and Medicaid Services (CMS) to maintain current policy requiring that Medicare prescription drug plans carry six categories of prescription drugs offered to participating beneficiaries. Senators Grassley and Brown, the sponsors of legislation requiring the maintenance of the “six protected classes,” contend that the policy is meant to “safeguard access to lifesaving medicines for vulnerable Medicare beneficiaries who rely on these classes of prescription drugs to protect them from potential challenges associated with any interruption of therapy.” The Senators go on to note that “MedPAC acknowledges ‘the degree to which plans could achieve potential savings is unclear.’ Regardless of potential savings, we maintain serious concerns with MedPAC’s recent proposal and urge CMS to maintain the six protected classes policy as it currently exists.”
On March 30, 2016, in a letter to Medicare Payment Advisory Commission (MedPAC) Executive Director Mark Miller, the Partnership for Part D Access announced its opposition to a MedPAC proposal that would remove existing protections guaranteeing Medicare beneficiaries access to the full range of anti-depressant and immunosuppressant medicines. The letter notes the detrimental impact removal of these medications from the six classes protected by federal law could have on patients suffering from serious diseases – such as epilepsy, mental illness, cancer, and HIV-AIDS. In recommending that MedPAC abandon the proposal, the Partnership explains that such a change would fail to achieve any significant cost savings for the Medicare program; hold possibly “devastating health implications” for some beneficiaries; contradict Congressional intent; and ignore the “substantial flexibility” that already exists in Part D plans to help manage costs for protected-class medicines.
On Tuesday, September 30, 2014, the Partnership for Part D Access hosted two congressional staff briefings—one on each side of the Capitol—to share patient and healthcare provider experiences that demonstrate the essential importance of protecting beneficiary access to proper care under the Six Protected Classes policy. Held before overflowing hearing room crowds, the briefings featured a pair of courageous patient advocates for the mental health and epilepsy communities, respectively, Trudy Lapin and Carlton Zeigler. The panel, which was moderated by Chuck Ingoglia of the National Council for Behavioral Health, also featured Dr. Nicole Brandt, Senior Care Pharmacist and Professor at the University of Maryland, Dr. Ray Martins, Chief Medical Officer of Whitman-Walker Health, Dr. Jeanie Tse, Associate Chief Medical Officer of the Institute for Community Living, Dr. Matthew Cooper, Director of Kidney and Pancreas Transplantation, MedStar Georgetown, and Dr. Joanne Buzaglo of the Research and Training Institute of the Cancer Support Community.
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