A group of more than 140 leading patient advocacy organizations sent a letter today to the Centers for Medicare and Medicaid Services (CMS) in opposition to a recent proposal that would establish broad exceptions to Medicare Part D’s protected classes policy. As the letter explains, these changes to the protected classes policy threaten the well-being of Medicare beneficiaries with chronic conditions, cognitive impairments, and limitations in their activities of daily living. Meanwhile, the groups point out that potential savings CMS could realize from allowing plans to add new, more expansive restrictions on access to drugs in the protected classes would be reversed by increases in costs in other areas of Medicare and lead to undesirable patient outcomes. Specifically, CMS’s analysis overlooks the importance of the costs that could be incurred from disrupting treatment for stabilized patients and restricting access for those patients starting treatment.
Today, Partnership for Part D Access (Partnership) submitted a comment letter to the Centers for Medicare and Medicaid (CMS) expressing concern that the agency’s recent Medicare proposal to weaken Medicare’s six protected classes will ultimately harm patients with the most complex conditions. In the letter, the Partnership highlights several concerns with CMS’ proposed rule, arguing that the agency misunderstands both the congressional intent of the policy and the reality of how it is appropriately working for Medicare patients today. The letter provides ample evidence highlighting the effectiveness of the current protected classes policy, which was created to ensure patients with the most challenging medical conditions have access to the full range of treatment options under Medicare Part D. “The flaws in the proposed approach and the potential for significant harm to patients lead us to respectfully request the agency withdraw each of the three proposed exceptions,” the letter states.
Issue Brief: Unique Incentives in Medicare's Stand-Alone Drug Plans Necessitate Key Patient Protections
Medicare Part D plans don't pay for hospital or physician services. And as research demonstrates, this makes them less invested in keeping people healthy enough to avoid some hospital visits.
The most popular type of Medicare drug coverage is through a stand-alone prescription drug plan (PDP). A stand-alone plan never has to pay for hospital or physician visits — those are covered by traditional Medicare. Another way to get drug benefits from Medicare is through Medicare Advantage (MA) plans, which are private insurance plans subsidized by the government to manage prescription drug benefits alongside other medical benefits. Because of this difference, stand-alone drug plans have less incentive than MA plans to keep people healthy enough to avoid some hospital visits.
On November 26, 2018, the Centers for Medicare and Medicaid Services (CMS) released a new proposed rule on prescription drug pricing in Medicare Part D and Medicare Advantage (MA). The proposal tracks closely with policy changes outlined in the Trump administration’s drug pricing “blueprint,” with a focus on providing Medicare plans with levers that will increase their negotiating power to secure additional price concessions from drug manufacturers.
The Partnership for Part D Access has released a new report (two-page summary) which demonstrates 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. The analysis, which was prepared by Avalere Health and sponsored by the Partnership for Part D Access, examines the tools Medicare Part D plans are currently employing to manage utilization of drugs under Medicare’s six protected classes policy. The study also analyzes variation between brand and generic utilization. This study 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.
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.
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