The Centers for Medicare and Medicaid Services (CMS) issued a final rule that makes no changes to the current six protected classes policy — completely eliminating the potentially damaging changes included in a proposed rule released several months earlier. Instead, the agency finalized current practices that allow for prior authorization (PA) and step therapy (ST) to only be used within the protected classes for new starts. Also consistent with current practice, antiretrovirals remain excluded from utilization management altogether. Importantly, CMS did not finalize exceptions for new formulations of existing drugs or drugs whose prices increase above the urban consumer price index (CPI-U).
A new Medicare regulation could force hundreds-of-thousands of seniors and people with disabilities to lose access to the medications they use to treat conditions including cancer, HIV, mental health conditions, epilepsy, organ transplants, and others. Join this webinar to learn how you can make a difference.
Over 220 HIV providers across the country signed onto a letter from the American Academy of HIV Medicine (AAHIVM) urging the Trump administration to abandon its proposed rule that would weaken Medicare Part D's six protected classes policy. AAHIVM points out that the proposed changes could lead to increased utilization management, resulting in decreased access to lifesaving treatments for Medicare’s most vulnerable beneficiaries. “In HIV, delaying and in some cases blocking patients’ access to tailored treatment is deleterious to not only the patients’ individual health, but also to the broader public health in terms of transmissibility of the virus,” the letter states. “For these reasons, we strongly oppose the Administration’s proposal to weaken the protected classes policy and urge this proposal to be withdrawn.”
Recently, Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma sent a letter to several Members of Congress in response to their concerns about proposed changes to Medicare’s six protected classes. This fact sheet includes key substantive excerpts, each of which are followed by important facts and policy details that policymakers should be aware of.
A key group of 19 Democrats on the influential Energy & Commerce and Ways & Means Committees — which share jurisdiction over health policy — have sent a letter to HHS Secretary Alex Azar urging the Department to withdraw a proposal to weaken Medicare's protected classes policy. The letter, led by Rep. Doris Matsui (D-CA), explains that "the proposed changes to the six protected classes will result in negative outcomes for specific beneficiary populations that utilize drugs under these six classes." The Members go on to emphasize that "with a 91 percent overall generic utilization rate and only one percent of the more than 187 million prescriptions filled coming from specialty tier medications, we strongly believe this policy is working as currently implemented and should not be changed."
In a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma, a bipartisan group of 14 Senators — led by Sens. Marco Rubio (R-FL) and Kyrsten Sinema (D-AZ) — urged the agency to reconsider its proposed changes to Medicare’s six protected classes policy. The Senators emphasized that the protected classes serve as an essential patient safeguard for beneficiaries with complex medical conditions, noting that the policy has long enjoyed bipartisan support among lawmakers. “The proposed rule would allow Part D plans to limit access to critical medicines to patients in need of immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastic medicines, by permitting prior authorization or step therapy,” the letter states. “We urge CMS to reconsider this proposal that would risk the health of our most vulnerable beneficiaries.
A bipartisan group of 73 House lawmakers — led by Reps. Barbara Lee (D-CA) and Will Hurd (R-TX) — penned a letter to Department of Health and Human Services (HHS) Secretary Alex Azar opposing changes to Medicare’s six protected classes policy. The lawmakers stressed that adding additional prior authorization and step therapy requirements could have detrimental effects to beneficiaries who deal with HIV, cancer, mental illness, and other serious health conditions. “…We are concerned that these provisions of the proposed rule will have reverberating effects for patients suffering from multiple conditions that are currently covered and exacerbate health disparities among poor and minority communities,” the letter states. “Considering the public health implications of the proposed changes to Part D protected classes related to prior authorization and step therapies, we respectfully request that you withdraw the relevant portions of the rule.”
At a recent hearing of the Energy and Commerce Committee featuring HHS Secretary Alex Azar, at least four key members of the committee raised concerns with the administration's proposal to weaken Medicare's protected classes policy — including Ranking Member Greg Walden (R-OR) and Health Subcommittee Chair Anna Eshoo (D-CA). For example, when talking about the proposal that could require patients who are stabilized on an existing treatment to go through step therapy or prior authorization, Ranking Member Walden emphasized that "no patient wants to go through that, and it’s something we’ve got to pay attention to." Later, Health Subcommittee Chair Eshoo added that "I think both sides hold the same view so we have to move forward and correct that situation.”
A series of recent news articles in dozens of publications across the country highlight a myriad of concerns raised by patient advocates over a new proposal that would weaken Medicare Part D's six protected classes policy. As over 140 individual advocacy organizations are noted, it would be extremely dangerous to risk limiting access to medications for patients with the most complex chronic conditions, such as cancer, HIV, mental health conditions, Epilepsy, and others. This new one-pager from the Partnership for Part D Access provides a visual overview of some of the many articles that detail these concerns.
Analysis of Medicare claims data reveals that Medicare Part D plans only cover about two-thirds of drugs in the ‘six protected classes,’ often excluding brands when there is a generic alternative.
Medicare prescription drug plans only provide coverage for a select group of drugs — that list of drugs they cover is commonly known as a formulary. These formularies provide plans the ability to exclude coverage of certain medications while favoring others, which they often use as leverage to negotiate discounts from drug manufacturers. These same principles apply within Medicare’s “six protected classes” of medications, even as guardrails help ensure patients with the most complex conditions (ex. mental illness, cancer, HIV, organ transplants, epilepsy) have access to a broader selection of treatments than is available under the standard Medicare benefit.
In a letter to Department of Health and Human Services (HHS) Secretary Alex Azar, House Mental Health Caucus Co-chairs Grace Napolitano (D-NY) and John Katko (R-NY) urged HHS not to move forward with harmful changes to Medicare’s Six Protected Classes Policy. The bipartisan letter — signed by 39 House members — states that the proposed changes are “particularly worrisome” for Medicare beneficiaries living with mental illness, noting that the change “directly targets” some of the program’s most vulnerable populations. “CMS has stated that patients will be able to use the lengthy appeals and exceptions processes to gain coverage for medicines if plans deny access to needed medicines,” the letter states. “However, those processes are difficult for patients to navigate and are likely to become overwhelmed with patients desperate to stay on the medicines they have been using to successfully manage complex conditions.”
Please join the Partnership for Part D Access for a congressional briefing on Wednesday, March 13 to discuss the importance of maintaining beneficiary access to the full range of available medications under Medicare’s “Six Protected Classes.
Fact Sheet: Azar Outlines Concerns With the Use of Step Therapy for Patients Stabilized on an Effective Treatment
In a February 12 speech before the American Medical Association (AMA), HHS Secretary Alex Azar acknowledged the dangers inherent in requiring step therapy for patients who are already stabilized on an effective regimen of medications. Interestingly, his remarks seemed to run counter to his agency’s current proposal to weaken Medicare’s successful “six protected classes” policy. A new fact sheet from the Partnership sheds light on these comments and provides background on their application to the six protected classes policy.
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.
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.”
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