New Research Undermines Attacks on Six Protected Classes

A new study from the Partnership for Part D Access confirms that the Medicare Part D protected classes policy is an essential pillar of protection for beneficiaries with complex health conditions. Yet, the research also highlights that Medicare prescription drug plans (PDPs) are increasingly limiting access to medications — even for patients with complex, chronic conditions

Stakeholders Agree: Trump Part D Demo Must Be Repealed

The Trump administration's last-minute attempt to weaken Medicare's six protected classes has been widely rebuked by a broad, diverse group of stakeholders within the patient community: 

• Over 130 individual patient groups joined Partnership's letter to HHS Secretary-designate Xavier Becerra;
• ​Nine leading pharmacy stakeholder groups penned a letter to the Acting CMMI Director Amy Bassano;
• Leading Medicare advocacy groups sent a letter to Acting HHS Secretary Norris Cochrane.
• 30 HIV groups sent a letter to HHS Secretary-designate Becerra. 

Key Committee Leaders Express Concern on Protected Classes

At a recent hearing of the Energy and Commerce Committee featuring HHS Secretary Alex Azar, at least four key members 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). 

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Report: High Rates of Low-Cost Generics in Protected Classes

The Partnership for Part D Access has released a new analysis prepared by Avalere Health which finds Medicare’s existing protected classes policy is working as intended for Medicare beneficiaries with some of the most complex health conditions: cancer, HIV, transplant recipients, epilepsy, and mental illness among others. Specifically, the findings clearly demonstrate 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.

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Over 140 Patient Groups Write CMS in Opposition to 'Six Protected Classes' Proposal

A group of more than 140 leading patient advocacy organizations sent a letter 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.

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What You Need to Know About the Six Protected Classes

Every day, millions of Americans rely upon their Medicare drug benefit to help manage their health conditions, including mental illness, organ transplants, epilepsy, Parkinson’s Disease, lupus, cancer and HIV. Because patients with these illnesses react differently to different medicines, access to the full range of effective medications is a crucial component of successful treatment and recovery. Medicare’s “Six Protected Class” policy has long stood as a guarantee to patients that their access to all available medications would never be in doubt.

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67 Members on Bipartisan Mental Health, HIV Caucuses Urge Biden to Protect Part D 

Members of the Congressional Mental Health and HIV Caucuses recently urged the Biden administration to revoke a final-hour request by the last administration to weaken Medicare protected class drug coverage. The bipartisan group of 67 members joined “significant opposition from Congress, patient groups, providers, and other stakeholders” to the potential changes to protections for the six protected classes.

Read the letter

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Fact Sheet: Azar Outlines Concerns With the Use of Step Therapy for Stabilized Patients

​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.

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Pew: Changes to 'Six Protected Classes' Unlikely to Produce Savings

The Pew Charitable Trusts concludes in a new report
that savings from the elimination of protected classes may be minimal within the context of total program spending. The authors conclude that “lack of adequate access to medications can in some circumstances increase costs to other Medicare programs through increased hospitalizations from complications..."

Issue Brief: Unique Incentives in Stand-Alone Drug Plans Necessitate 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.

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Stakeholder Voices

Leading stakeholders from across the ideological spectrum have offered vocal support for Medicare's six protected classes policy. From the Manhattan Institute to the Medicare Rights Center — and everyone in between — leading policymakers and health care advocates have consistently spoken out in support of the protected classes. 

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Issue Brief: Medicare Drug Plans Exclude Coverage for Many Drugs in the ‘Protected Classes’

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.

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