Sending Office: Honorable Barbara Lee
Sent By:
Diala.Jadallah@mail.house.gov
Dear Colleague,
We invite you to join us in sending a bipartisan letter to Department of Health and Human Services (HHS) Secretary Alex Azar opposing provisions of the Centers for Medicaid Services’ (CMS) proposed Medicare Part D rule for six categories of drugs (known
as “protected classes”) that would that would push life-saving drugs out of reach for patients in need, including for people living with HIV.
When Congress enacted the Medicare Part D program, it required all Part D plans to have adequate coverage for each therapeutic area. CMS subsequently identified six categories of drugs where patients could face serious risks and complications without access
to medicines, and CMS therefore required Part D plans to cover all or substantially all of the drugs within these categories. This rule has been extremely important to ensuring that patients have access to critical therapies combating HIV, cancer, mental
health conditions, and other serious illnesses. Congress has periodically reviewed the protected classes and reaffirmed the six categories identified by CMS and has done so in a bipartisan manner.
The provisions of this proposed rule, which would require prior authorizations and step therapy requirements, could have devasting health outcomes for those receiving treatment for HIV and the additional 5 protected classes. They could also have reverberating
effects for patients suffering from multiple conditions and exacerbate health disparities in low-income and minority communities. While we all agree that action needs to be taken with regard to drug pricing, pushing critical care out of reach for people living
with HIV and other diseases is not the way to do it.
For questions or to sign on, please contact Diala Jadallah-Redding (Lee) at
diala.jadallah@mail.house.gov or Anton Castaneda (Hurd) at
anton.castaneda@mail.house.gov.
Sincerely,
/s/
BARBARA LEE WILL HURD
Member of Congress Member of Congress
Dear Secretary Azar –
We write to express our strong opposition to certain provisions in the Centers for Medicare and Medicaid Services’ (CMS) proposed rule that would modify Medicare Part D and Medicare Advantage. Specifically, we are concerned that the Department has not adequately
considered and addressed the public health implications of the changes proposed in CMS’s rule dealing with the six protected classes of drugs. While we all agree that high drug pricing must be addressed, we do not believe that these provisions in the proposed
rule would result in significant cost savings and would result in pushing access to critical medication out of reach for patients in need.
When Congress enacted the Medicare Part D program, it required all Part D plans to have adequate coverage for each therapeutic area. CMS subsequently identified six categories of drugs where patients could face serious risks and complications without access
to medicines, and CMS therefore required Part D plans to cover all or substantially all of the drugs within these categories. This rule has been extremely important to ensuring that patients have access to critical therapies combating HIV, cancer, mental
health conditions, and other serious illnesses. Congress has periodically reviewed the protected classes and reaffirmed the six categories identified by CMS.
We are concerned that prior authorization and step therapy requirements could have devastating public health outcomes for those receiving treatment of HIV and the additional 5 protected classes. Today, the most advanced treatments for HIV begin therapy immediately
without testing for viral load and other factors, unlike earlier HIV therapies that required additional lab tests prior to treatment. Research has indicated that rapid start – that is, starting treatment on the same day or within one week of diagnosis – results
in better engagement and retention in care, shorter time to viral suppression, and increased rates of viral suppression.[1] A prior authorization requirement that delays early treatment of HIV could
place patients at risk and reverse the significant gains we have made in reducing new infections and improving HIV-related health outcomes.
Moreover, these provisions of the proposed rule put vulnerable patients at risk of declining health by imposing suboptimal therapies if step therapy is expanded. For example, older generations of HIV therapies have well-known side effects, including depression
and risk of suicide. These side effects are particularly concerning for HIV patients, as data indicate that many patients with HIV already face mental health challenges. [2] Additionally, older therapies generally use
multi-tablet treatment regimens. Multi-tablet regimens have shown lower rates of adherence than newer single-tablet regimens, leading to higher costs, less effective treatment, and increased risk of drug resistance.
Finally, 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. For example,
many people experience co-morbid conditions, such as HIV or cancer and a mental health condition. Without adequate access to appropriate care and treatment for a mental health conditions, achieving positive health outcomes and adherence to medications are
at risk.
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 provisions of the rule.
Thank you for your prompt attention to these important questions.
Sincerely,
[1] Liz Highleyman,
START Trial Shows Benefits of Early Treatment, Supports ART for All, Beta Blog (July 22, 2015),
https://betablog.org/start-trial-shows-benefits-of-early-treatment-supports-art-for-all/.
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