Partnership Op-Ed: Medicare’s Protected Drug Classes: A Legacy in Need of Defending

In honor of the 16th anniversary of the codification of the 6PC policy, Dr. Roaya Tyson, CEO of Gracepoint and member of our Clinician Advisory Board, emphasizes the vital role of maintaining the 6PC policy amidst rising healthcare costs and a complex health system. Additionally, she shares the transformative story of a patient whose life was changed by guaranteed access to necessary psychotropic medications.

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Featured Article: Part D Redesign Could Threaten Organ Transplant Recipients’ Second Lease on Life

"As we celebrate World Kidney Day, let us not forget about the 800,000 Americans with end-stage renal disease... By mandating that Part D plans cover “all or substantially all” of the medications treating these life-or-death conditions, the law allows Glenda and tens of thousands of Medicare beneficiaries to stay well longer, keep away from the hospital, and benefit from the peace of mind that the unique drugs their bodies need will always be covered by their Medicare plans."

Commemorating World Kidney Day, The Well News published an important op-ed titled, "Part D Redesign Could Threaten Organ Transplant Recipients’ Second Lease on Life." Authored by Mr. Ira Copperman, Vice President of TRIO, Ira advocates on behalf of his partner, Glenda Daggert, a kidney transplant recipient who has experienced numerous hurdles in receiving access to vital therapies.

To view the op-ed on the website’s online publication, click here.

6PC Featured Op-Ed: This World Aids Day, We Must Protect Access to HIV Medicines

 Dr. James Sosman, a seasoned physician with hands-on experience since the 1980s AIDS crisis, brings a powerful perspective in his latest op-ed titled, "This World AIDS Day, We Must Protect Access to HIV Medicines," published in the Washington Blade. In this compelling piece, Dr. Sosman delves into the transformative journey from a time of fear and uncertainty to an era of hope, where HIV is a manageable condition thanks to a wide array of antiretroviral medications. He emphasizes the critical role of the “six protected classes” policy in ensuring access to these life-saving drugs and raises a timely alarm about the threats to this essential safeguard.

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19 Leading Patient Groups Urge CMS for Continuous Oversight of the Six Protected Classes Policy during Part D Redesign

On September 11, 2023, 19 patient groups sent a letter to the Centers for Medicare and Medicaid Services (CMS) calling on them to reinvigorate their enforcement efforts around the Six Protected Classes. In 2025, the Inflation Reduction Act’s provisions around the redesign of the Part D program will go into effect, and we expect Part D plans to change their approaches in how they structure their plan designs. The Partnership commends this wide range of patient groups for bringing this issue to the attention of CMS. 

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Research Undermines Attacks on Six Protected Classes

A 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

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

The Partnership for Part D Access has released an 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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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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Pew: Changes to 'Six Protected Classes' Unlikely to Produce Savings

The Pew Charitable Trusts concludes in a 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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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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