Join the letter by emailing kreitan@aidschicago.org with your organization’s name, address, phone number, and official authorizing the sign-on.

Mark B. McClellan, M.D., Ph.D
Administrator Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-4068-P
P.O. Box 8014
Baltimore, MD 21244-8014

Dear Mr. McClellan:

On behalf of thousands of individuals living with HIV/AIDS in Illinois who will be impacted by the Medicare Modernization Act (MMA), the undersigned organizations are sending public comments on docket number CMS-4068-P, Medicare Program; Medicare Prescription Drug Benefit. We appreciate the opportunity to provide this feedback. Our comments will address the following sections of the rules: Eligibility and Enrollment; Benefits and Beneficiary Protections; and Grievances, Coverage Determinations, and Appeals.

Subpart B-Eligibility and Enrollment:

§423.30(d)(1)-Individuals who are dually eligible for Medicare and Medicaid must not be limited to the "average cost plan." Dual eligibles are the most vulnerable individuals impacted by the MMA. They are the sickest and poorest Medicare recipients, and need the most options available to ensure that they can access all FDA-approved HIV/AIDS treatments. By limiting the federal premium subsidy to that of the average cost, these rules prevent dual eligibles from choosing the plan that best suits their needs. We recommend that dual eligible participants be exempted from premiums associated with enrolling in the plan that they, in consultation with their doctor, determine is most appropriate. If a premium must be charged, we recommend that states be allowed to pay them.

§423.44(d)(2)-Protections against disenrollment must be strengthened. The provision allowing drug plans to disenroll beneficiaries for "disruptive, unruly, abusive, uncooperative or threatening" behavior is unclear and gives too much power to drug plans. There is nothing to prevent a plan from labeling a client's behavior as disruptive when they are merely questioning the drug plan's coverage or operating procedures. We recommend that protections be provided to address this issue and to address recipients whose disruptive or threatening behaviors may be attributed to drug interaction, mental illness, or diminished mental capacity caused by HIV/AIDS or another medical condition.

Subpart C-Benefits and Beneficiary Protections:

In regards to the relationship between Medicare drug beneficiaries and the AIDS Drug Assistance Program (ADAP), we urge CMS to reconsider guidance that prohibits the use of ADAP as supplemental coverage for inadequate plans. We recommend that ADAP be allowed to fill gaps left by drug plans that do not include the full range of HIV/AIDS treatments, thus ensuring that beneficiaries have access to appropriate medical care. We also recommend that CMS allow ADAP funds to be used for premiums, deductibles, cost-sharing, and expenditures required during the so called "doughnut hole" period to ensure that the poorest and most vulnerable Medicare beneficiaries will not be denied coverage because they cannot afford it. Finally, we strongly recommend that CMS allow states to count state-appropriated ADAP funds towards incurred costs in the same way that State Pharmaceutical Assistance Programs will be allowed to do.

§423.120-We strongly recommend that CMS designate recipients with HIV/AIDS as a special population requiring access to an open formulary. The advances in HIV/AIDS treatment seen over the last decade have made clear that people living with HIV/AIDS must have unrestricted access to all available medications. The challenges of treating HIV infection—including side effects, poor or harmful drug interactions, co-morbidities, and drug resistance—require that physicians are able to change a patient's prescription as needed. Antiretrovirals and other drugs used to treat HIV infection are not interchangeable and the complexity of the disease and benefits of treatment demand that beneficiaries have access to all available treatment options.

§423.120(B)(1)-Policies that determine drug formularies must be informed by experts in the field of HIV/AIDS. We support the recommendation by CMS that the Pharmaceutical and Therapeutic (P&T) Committees have greater independence, authority, and increased representation by specialized medical providers. Although we agree that these committees should have the authority to make binding formulary decisions, we are concerned that the committees will not be staffed by medical providers who understand the complexity of HIV/AIDS treatment. Requiring at least one independent physician and one independent pharmacist on each committee does not ensure an expertise in HIV/AIDS, and we recommend that CMS require that each P&T Committee include representation from those who specialize in the treatment of HIV/AIDS.

Subpart M-Grievances, Coverage Determinations and Appeal:

The grievance procedures outlined in this section are not adequate and place beneficiaries with HIV/AIDS in danger of interrupted treatment. We recommend that MMA grievance procedures be similar to those allowed to Medicaid recipients and include both mandatory and enforceable provisions allowing for continued treatment during an appeal, notification of the reasons for which medications were denied, and an explanation of the right to appeal.

Again, we appreciate the opportunity to provide comments on these rules, and urge CMS to consider our feedback carefully. This letter is signed by the following organizations:

AIDS Foundation of Chicago
AIDS Legal Council of Chicago
Alderman Mary Ann Smith, Chicago’s 48th Ward
Central Illinois FRIENDS of PWA, Inc.
Chicago Legal Advocacy for Incarcerated Mothers (CLAIM)
Health and Disability Advocates
Howard Area Community Center
Hyde Park Union Church
Medical Advocates for Social Justice
The Night Ministry
Winnebago County Health Department