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Act Now to Protect Medicare Part D Coverage of Antiretrovirals



With approximately 25 percent of people with HIV who are in care relying Medicare for coverage, the implementation of Medicare Part D drug coverage in 2006 was an important improvement to the program for people with HIV. Administered by private plans receiving federal subsidies and required to meet standards set by the Centers for Medicare and Medicaid Services (CMS) Part D plans are required to cover all or nearly all drugs for “six protected classes” including antiretrovirals. Antiretrovirals have an additional protection in that Part D plans are barred from applying prior authorization or any form of utilization management including step therapy – starting patients on lower cost drugs, and trying more expensive treatment options only when the first drugs fail. In the proposed rule Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses, Part D plans would still be required to cover all or nearly all drugs in the six protected classes, including antiretrovirals. Now, however, CMS is proposing to allow Part D plans to apply prior authorization and utilization management including step therapy to the antiretrovirals drug class to negotiate lower drug prices.

The other protected classes are anticonvulsants, antidepressants, antineoplastics, antipsychotics, and immunosuppressants.


Take Action:

The proposed rule to allow Medicare Part D plans to apply utilization management to antiretrovirals and the other protected classes is open for comment until Jan. 25th at 5 pm ET.  Please consider weighing in to urge CMS not to allow restrictions on Medicare Part D coverage of antiretrovirals and educating them on the risks and harms that could come from allowing Part D to apply prior authorization and step therapy.

Below are template comments. Please modify to reflect your experience treating Medicare patients and your experience with prior authorization and step therapy being applied to antiretrovirals. Please email Andrea Weddle with HIVMA or Anna Forbes with AAHIVM questions.

To submit your comments, cut and paste into this form.

Template Comments:

Re:  File Code CMS-4180-P

To Whom It May Concern:

I am an HIV clinician who cares for Medicare patients with HIV and am writing to share my concerns regarding the proposed rule Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Costs.

The standard for HIV treatment today in the U.S. is to initiate treatment early to achieve and sustain suppression of the virus. Patients who are virally suppressed can stay healthy, require less intensive and less costly healthcare services and treatment, and they do not transmit the virus.

While I support the need to lower drug prices, efforts to control cost should not come at the expense of the health of my patients. Medicare patients by virtue of qualifying for the program are either disabled or older and are likely to have been living with HIV for many years.  For many of them, their treatment options are limited because of co-morbid conditions and due to the development of resistance to some antiretrovirals. In addition, because of drug interactions between HIV medications and drugs used to treat these conditions common in older people with HIV as well as the impact of specific HIV medicines on these co-morbidities, e.g., cardiovascular, renal, bone disease, individualized treatment is especially important when selecting an antiretroviral regimen.

Prior authorization can result in dangerous delays in access to treatment and increases administrative burden and costs for HIV providers and clinics. Applying prior authorization is counterproductive to efforts to start treatment early and to support treatment adherence and can threaten patients achieving and sustaining viral suppression. If applied, prior authorization must be based on the HHS Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Regimens recommended in the HIV Treatment Guidelines should not be subject to prior authorization.

Step therapy is never an appropriate practice or approach to HIV treatment. The consensus strongly supported by the published clinical trial and study data is that starting patients on the most effective, best-tolerated regimen is the best approach to optimizing outcomes.  

Please do not compromise the health of Medicare beneficiaries with HIV and reconsider restricting access to antiretrovirals under Part D.  Please feel free to contact me with questions regarding my comments.





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