Medicare and Part D

Comments on Guidelines for Reviewing
Prescription Drug Plan Formularies and Procedures

TO: Centers for Medicare and Medicaid Services
FROM: HIV Medicaid/Medicare Working Group Steering Committee
DATE: March 6, 2006

We are submitting comments on of behalf the HIV Medicare/Medicaid Working Group (HMMWG) regarding the guidelines for reviewing prescription drug plan formularies and procedures. HMMWG represents more than 100 national and community-based organizations and includes people living with HIV/AIDS, medical providers, advocates and program administrators that deliver HIV-related healthcare and support services.

As you know, people with HIV/AIDS depend on uninterrupted access to a daily treatment regimen generally comprised of a least three antiretrovirals, referred to as Highly Active Antiretroviral Therapy (HAART). For a majority of Medicare beneficiaries with AIDS, who by definition have been disabled for at least two years, effective treatment often requires four and five drug combinations. The drug combinations that are effective at suppressing HIV vary depending on a number of individual factors including resistance to therapies, co- morbidities and treatment side effects. These and other factors mean that unimpeded access to all available HIV therapies is critical to effectively manage HIV disease. People with HIV/AIDS also have high rates of serious comorbidities such as hepatitis C, heart disease and mental illness and require access to the medication combination most effective at treating these conditions in conjunction with their HIV drug regimen.

We are pleased that the Centers for Medicare and Medicaid Services (CMS) recognized the importance of comprehensive antiretroviral coverage by including it as one of six protected drug classes. We also strongly support continued coverage for all or substantially all drugs in all of the protected classes, particularly the antidepressant and antipsychotic drug classes as access to these medications is critical to people living with AIDS as well.

We appreciate the opportunity to comment on the 2007 formulary guidance and hope that you will grant serious consideration to the following recommendations.

ENSURE ACCESS TO THE HIGHEST STANDARD OF CARE
FOR MEDICARE BENEFICIARIES BY REQUIRING PLANS
TO COVER DRUGS UPON FDA APPROVAL

We strongly urge CMS to require drug plans to cover all antiretrovirals upon approval by the Food and Drug Administration (FDA). We are concerned that drug plans will only be required to cover drugs approved by the FDA as of April 17, 2006. At least two new HIV therapies are expected to become available in 2006 but the FDA is not expected to approve these drugs by April 17th. By virtue of qualifying for Medicare coverage, Medicare beneficiaries are disabled by HIV disease and often sicker and more treatment experienced. They are more likely to have exhausted existing treatment options and to be in need of immediate access to new therapies as they are developed. Under the draft formulary guidance, the population most in need of these new discoveries will not have the opportunity to benefit from them.

Access to new drugs discoveries should be dictated by medical necessity rather than formulary coverage. The current policy that subjects newly approved drugs to the Pharmacy and Therapeutics Committee process that allows for a 90-day review period and 180-day coverage determination period will not work for Medicare beneficiaries with AIDS who have run out of treatment options. Furthermore, if strict requirements are not imposed by CMS, we see little incentive for drug plans to develop mechanisms for rapid coverage of newer, more effective, but potentially more costly, drug therapies. To ensure appropriate coverage, we recommend requiring drug plans to cover all antiretrovirals as they are approved by the FDA.

ENFORCE DRUG PLAN COMPLIANCE
WITH EXISTING FORMULARY PROTECTIONS

We strongly encourage CMS to use its authority to enforce compliance with the formulary guidance, including coverage of the six protected classes and the prohibition against applying utilization management techniques to the antiretroviral drug class. Drug plans that fail to meet the formulary guidelines must be subject to fines or other penalties or we see little incentive for them to adhere to the formulary guidance. Furthermore, as you review drug plans for participation in 2007, compliance with antiretroviral coverage should be a key consideration.

Even with the current protected class status, PDP coverage of antiretrovirals has been considerably less than one hundred percent. In fact, PDP formulary coverage nationwide for Aptivus was reported to be 74 percent and as low as 32 percent in one major state. Drug plans also are controlling antiretrovirals through inappropriate policies ranging from prior authorization to requiring prescriptions to be filled by mail order rather than at the pharmacy. We appreciate the magnitude of implementing a new federal program such as Medicare Part D and the impact of the program’s size on the ability to regulate it; however, the lives of Medicare beneficiaries with HIV/AIDS depend on their ability to access prescription drugs without interruptions through this program.

We also urge CMS to conduct stricter reviews of the placement of antiretrovirals within the cost sharing tier structures. We are concerned that frequently prescribed antiretrovirals are consistently being placed in higher cost sharing tiers by some drug plans. In a review of the 45 Oregon drug plans using the CMS website, only 36 of the 45 drug plans covered all 25 of the FDA-approved antiretrovirals and 72% (18 of 25) of the antiretrovirals were placed in the top two tiers (tiers 4 and 5) by at least some plans.

Furthermore, although drugs plans are instructed to not misuse cost sharing to discourage enrollment by people with higher cost conditions such as HIV/AIDS, the standard that CMS uses to determine discrimination is not defined. We are concerned that drug plans may satisfy the anti-discrimination requirement on paper by placing less commonly prescribed antiretrovirals in the lower cost sharing tiers and more frequently prescribed antiretrovirals in the higher cost sharing tiers. Given the significant flexibility that drug plans have in determining cost sharing, the higher tiers can require beneficiaries to pay hundreds of dollars for a single prescription. These fees seriously impede access to treatment for Medicare beneficiaries with HIV/AIDS who rely on six to eight medications per month to stay alive.

CONTINUE EXCLUSION OF ALL ANTIRETROVIRALS
FROM UTILIZATION MANAGEMENT TECHNIQUES

The CMS decision to prohibit drug plans from applying utilization management techniques such as prior authorization to antiretrovirals is consistent with current standards of clinical practice, which do not permit prior authorization or other utilization management tools to limit prescribers' capacity to prescribe the full range of antiretroviral therapies. Antiretroviral agents are unique compounds that are not interchangeable. People with HIV/AIDS switch antiretorivals because of debilitating side effects, treatment complications and drug resistance. When this occurs, treatment options are limited and access to new medications must be immediate. We also strongly support the CMS decision to support continuity of care by not allowing drug plans to apply utilization management techniques for the other five protected classes to beneficiaries who are stabilized on a drug.

AVOID TREATMENT INTERUPTIONS FOR PEOPLE
OBTAINING DRUGS THROUGH EXPANDED ACCESS PROGRAMS

Many Medicare beneficiaries participate in expanded access programs that allow them to access promising treatments before the FDA approves them. However, these programs are discontinued when the FDA approves the drug, and it is imperative that Medicare beneficiaries do not experience treatment interruptions when this occurs. People with HIV/AIDS that are receiving these drugs before they are FDA-approved are doing so because they have no other treatment options. A mandated switch in therapies or delay in accessing therapy will jeopardize their health. Furthermore, paying out of pocket for these drugs is cost prohibitive, particularly for a Medicare beneficiary with HIV/AIDS who most likely has been unable to work for more than two years. We recommend that CMS require drug plans to cover drugs previously available through expanded access programs immediately upon FDA approval.

EXPLICITLY PROHIBIT PLANS FROM ASSIGNING
ANTIRETROVIRALS TO “SPECIALTY TIERS”

We are concerned that the formulary guidance does not explicitly exclude antiretrovirals or the other five protected classes from the “specialty tier” status and that antiretroviral drugs because of their cost could be designated as specialty drugs by drug plans. In 2006, we have heard from Medicare beneficiaries that their plan had inappropriately designated antiretrovirals as “specialty” drugs that could only be filled via mail order. While CMS corrected the problems when reported, we are very concerned that other plans may have placed similar restrictions on the antiretroviral class that have not been reported because beneficiaries are not aware that this is not allowed. We recommend that CMS more clearly define the drug classes that are appropriate for the specialty tier status and exclude antiretrovirals from this designation.

We appreciate the safeguards that CMS put into place for Medicare beneficiaries with AIDS for 2006 and hope that you will grant serious consideration to our recommendations so that these protections are maintained and strengthened in 2007. Questions may be addressed to Robert Greenwald or Laura Hanen.

HIV Medicare/Medicaid Working Group Steering Committee

AIDS Action, Washington, DC
AIDS Alliance, Washington, DC
AIDS Foundation of Chicago, Chicago
The AIDS Institute, Washington, DC
American Academy of HIV Medicine, Washington, DC
Community HIV/AIDS Mobilization Project (CHAMP), New York, NY
Gay Men’s Health Crisis, New York, NY
HIV Medicine Association, Alexandria, VA
Housing Works, New York, NY
Human Rights Campaign, Washington, DC
National Alliance of State and Territorial AIDS Directors, Washington, DC
National Association of People with AIDS, Silver Spring, MD
National Health Law Program, Los Angeles, CA
Project Inform, San Francisco
San Francisco AIDS Foundation, San Francisco
Title II Community AIDS National Network, Washington, DC
Treatment Access Expansion Project, Boston