Medicare and Part D

Testimony for Stephen O’Brien, MD at Medicare Beneficiary Protection Hearing

June 22, 2007

Thursday, June 19th, 2007
U.S. House of Representatives Ways & Means Committee
Subcommittee on Health
Room 1102 Longworth House Office Building
U.S. Capitol

Good afternoon. My name is Stephen O’Brien and I am the Medical Director of the Alta Bates Summit East Bay AIDS Center in Oakland, California, which provides primary and specialty medical care to more than 1,300 HIV-infected people, most of who are indigent people of color living in the Oakland area and surrounding counties. I am an HIV specialist in internal medicine, and I serve on the Public Policy Committee of the American Academy of HIV Medicine, a non-profit member organization of HIV specialists throughout the United States.

The American Academy of HIV Medicine is a member of a broader coalition of committed advocates through the nation known as the HIV Medicare & Medicaid Working Group, which is focused on improving the lives of those individuals living with HIV disease and receiving care and treatment from either or both of the Medicare and Medicaid programs.

I. Overview:
By now most Americans are familiar with the dramatic improvements in the treatment of HIV infection that have reduced mortality due to the disease by nearly 80 percent. Once almost always considered a fatal diagnosis, HIV disease can now be managed with consistent and reliable access to a combination of medications known as highly-active antiretroviral therapy (HAART) .

These medications are critical to the health and well-being of patients infected with HIV/AIDS; however, successful viral suppression demands strict adherence to a complex drug regimen that requires multiple doses of three or more highly expensive medications daily. In addition, antiretroviral medications are simply not interchangeable with one another due to individual physiologic factors and differences in toxicity, efficacy, drug interactions, and drug-sensitivity of the patient’s virus. As a result, it is critical that people with HIV/AIDS maintain unhindered access to all of the FDA-approved medications available to treat the disease and its complications. Beyond viral suppression, people with HIV disease often must contend with opportunistic complications and serious co-occurring conditions such as hepatitis C and mental illness, as well as complications such as diabetes, elevated cholesterols, and heart conditions resulting from the HAART medications themselves.

Through the passage of the Medicare Modernization Act of 2003, Medicare now offers prescription drug coverage to approximately 100,000 Medicare-eligible beneficiaries with HIV/AIDS, roughly 20% of those in care. Medicare is the second largest source of federal funding for HIV care and treatment after Medicaid.

While the addition of Medicare drug coverage to those without prior drug coverage is clearly beneficial, for the majority of my 450 California Medicare patients, many of whom had good drug coverage before Medicare Part D, the program has been challenging, often disruptive and more costly. Patients have had trouble accessing antiretrovirals and treatment for opportunistic infections. Patients have gone without medications they can’t afford or can’t access through their new plans. Changes in plans have caused disruption in patient’s access to long term medications. Some patient’s have had to transfer to new medical providers and pharmacies that specialize in the complex authorization processes required by various insurers.

Most antiretrovirals are readily available through most plans. However, some plans have placed some antiretrovirals in higher tiers, thereby making them more expensive or more difficult to access. Most patients, who are not “locked into” plans, have changed plans, those who are locked in have changed during open enrollment; therefore, tiering effectively rids many plans of their expensive AIDS patients.

It is not just the antiretrovirals, however, that patients are having difficulty accessing. For example, we have had many patients have difficulty receiving the antifungal fluconazole to treat cryptococcal meningitis. Fluconazole is the treatment of choice for this common opportunistic infection but many plans delay authorizing this drug or require monthly reauthorizations. This has led to prolonged hospitalizations and gaps in treatment.

Patients with excessive cost sharing burdens for their drugs are sometimes choosing not to take some drugs or to take reduced dosing in order to save money. One patient has chosen to return to a cheaper anti-seizure medication (Dilantin) with more side effects because it is cheaper than the less toxic alternative (Keppra) we had her taking. Many patients with prohibitive cost-sharing for their medical visits and medical equipment are coming to clinic less often and refusing to see subspecialists in order to minimize their out of pocket expenditures. One patient I saw on June 18 has cut her visits to twice per year and is reluctant to see her neurosurgeon for follow up on her brain tumor because she feels she can’t afford her high share of the cost of care.

As a tertiary referral center, we have received several patients in transfer who had to stop seeing their regular community provider because they were unable to dedicate the resources needed to get the frequent authorizations required by Medicare Part D plans. For the same reason, many patients have left their more convenient community pharmacy and transferred to less convenient HIV specialty pharmacies that have the expertise to file the appropriate paper work to get the drugs the patient needs. This didn’t happen when these patient’s were receiving the same drugs through Medicaid or the AIDS Drug Assistance Program (ADAP).

But compare my individual experience with a broader picture of the nation’s HIV patients. The American Academy of HIV Medicine (AAHIVM) and the HIV Medicine Association (HIVMA) recently conducted a joint survey of their HIV medical provider members to obtain information on how Medicare Part D has affected HIV care today.

HIV medical providers reported challenges obtaining antiretroviral and non-antiretroviral medications for their Medicare patients with HIV/AIDS. Many of the problems appear to stem from complex and in some cases inappropriate prior authorization processes; high prescription drug co-payments; inadequate formulary coverage of both antiretroviral and non-antiretroviral medications – such as cholesterol medications, pain medications, medications for HIV-related opportunistic infections and hypertensive medications. Moreover, there have been data system problems at the Centers for Medicaid and Medicare Services (CMS) and at the Medicare prescription drug plans, including incorrect assignment of Low Income Subsidy for beneficiaries. These problems occurred despite the protections for antiretrovirals and the five other drug classes included in the Centers for Medicare and Medicaid (CMS) 2006 and 2007 formulary guidance.

Of particular concern is the high percentage of HIV medical providers who reported that their patients who are dually eligible for Medicare and Medicaid are worse off under Medicare Part D. With Medicaid drug coverage, this population had access to an open drug formulary and in many states were not subject to cost-sharing. (If they were subject to cost sharing, Medicaid law ensures that beneficiaries are not denied access to drugs or other services due to an inability to meet cost-sharing obligations.) Low income people with HIV/AIDS can face significant cost sharing obligations under Medicare Part D, forcing them to forgo necessary medications in lieu of food or rent. The Medicare Modernization Act of 2003 called for CMS to conduct a study of how dual eligibles with HIV/AIDS would fare under Medicare Part D that to this date has not been released publicly. Better monitoring of the dual eligible population is needed along with stronger protections to ensure that they maintain reliable access to lifesaving drug therapies.

What follows are key findings from the joint AAHIVM and HIVMA survey of HIV medical providers.

Medicare Part D Drug Plans are not meeting the needs of beneficiaries with HIV/AIDS.

• 83% of respondents reported that their patients had experienced problems getting their prescriptions since joining a Medicare drug plan. Of those reporting problems for their patients with HIV/AIDS:

• 80% reported one or more of a patient’s drugs were subject to prior authorization.
• 76% reported one or more of a patient’s drugs were not covered by their plan’s formulary.
• 73% reported that patients could not afford the co-payments/cost-sharing.
• 44% reported that a patient’s drugs were subject to quantity limits.

People with HIV/AIDS experienced lapses in medications due to Part D problems.

• Of those reporting problems with Part D, 75% reported that patients with HIV/AIDS went without medications due to Part D problems. Of those who reported specific medication lapses:
o 65% reported patients with HIV/AIDS going without antiretrovirals as well as other medications.
o 11% reported patients with HIV/AIDS going without only antiretrovirals
o 24% respondents reported patients with HIV/AIDS going without only non-antiretroviral medications.

Problems with Part D coverage led to unscheduled medical visits and other adverse health consequences for some patients.

• 60% of respondents who reported problems indicated that patients with HIV/AIDS came in for unscheduled or extra medical visits due to Part D problems.
• 28% of respondents who reported problems indicated that patients with HIV/AIDS
experienced other adverse health consequences due to Part D problems.
• For those who reported problems, the percentage of respondents reporting that patients with HIV/AIDS had trouble accessing medications included: antiretroviral medications (54%); mental health medications (55%); cholesterol medications (55%); pain medications (46%); medications for HIV-related opportunistic infections (36%); hypertensive medications (35%) and hepatitis medications (22%).

II. Protections for HIV Antiretrovirals and other drugs under the Six Protected Classes
CMS has included antiretrovirals as one of six protected drug classes for which Part D plans are required to cover “all or substantially all drugs” available. The formulary guidance prohibits plans from applying utilization management techniques such as prior authorization to HIV antiretrovirals with the exception of one drug, enfuvirtide. Prior authorization is allowed with enfuvirtide only when the patient is new to the drug. Despite the guidance, not all beneficiaries are guaranteed access to these drugs as evidenced by the AAHIVM/HIVMA survey findings and reports from HIV medical providers. Just this past week, Dr. Michael Wong in Massachusetts reported a patient who was denied stavudine, a common antiretroviral, at the pharmacy subject to a prior authorization. The patient has been on this medication for years, and Dr. Wong reported that this has never been an issue before. The patient has end stage renal disease, is on dialysis, and has been on his current ARV regimen for at least a year without problems. Cindy Zoellner, PharmD and HIV Clinical Pharmacy Specialist in Dallas, Texas reported a similar problem with coverage of darunavir in her clinic. The plan faxed her the prior authorization form, which required 13 pages of documentation, including office notes, labs, and genotype test results. Both health plans were in clear violation of the guidance. My colleagues and I have seen other surprises as well, such as the denial of fixed-dose combination drugs such as Truvada (combination of tenofovir and emtricitabine), Combivir (zidovudine and lamivudine), and Epzicom (abacavir and lamivudine) to name a few. The individual component agents are approved, but these combinations that are designed to improve the ease of administration and minimize pill burden are not consistently included in many Part D plans.

In spite of needed improvements, the protection for these six classes is essential for Medicare beneficiaries but is currently only offered as guidance issued by CMS and must be renewed annually. My colleagues and I, the American Academy of HIV Medicine, and the whole of the HIV Medicare & Medicaid Work Group, urge Congress to write into law the protections for the six classes including HIV antiretrovirals that are currently offered in guidance. In seeking codification of these protections, we are united with a wide range of national organizations working to secure access to medications essential in the treatment of serious diseases. These groups include the AIDS Institute, the American Academy of Neurology, the American Psychiatric Association, the Cancer Leadership Council, the Epilepsy Foundation, the HIV Medicine Association, Mental Health America, the National Alliance of State and Territorial AIDS Directors, the National Alliance on Mental Illness, Project Inform, and the TEN Project. In addition, drug plans that consistently violate this provision should be viewed as unfit to participate in the Medicare Part D program. These classes of drugs all represent treatment for very serious conditions and in the case of HIV -- life-threatening illnesses. This protection is critical to patients.

III. Coverage for New HIV Antiretrovirals
Newly approved antiretrovirals (as well as drugs in the other protected classes) are subject to an expedited 90-day review process to be added to patient formularies but for a patient who has exhausted all currently available medication options, 90 days is too long to wait. By virtue of qualifying for Medicare, a majority of Medicare beneficiaries with HIV/AIDS are in advanced stages of disease progression and, therefore, more treatment experienced than persons with HIV/AIDS who do not qualify for Medicare. They are more likely to be resistant to available antiretroviral therapies, which mean that available drugs are no longer effective at suppressing HIV. Antiretroviral agents newly approved by the Food and Drug Administration (FDA) may be essential for many Medicare beneficiaries to maintain an effective anti-HIV treatment protocol.

Newly approved medications in the six protected classes, including antiretrovirals, should be added to all drug plans formularies within 30 days of FDA approval to ensure Medicare beneficiaries have access to new HIV therapies that could literally save their lives.

IV. Cost sharing
People living with HIV/AIDS generally depend on access to 8 to 14 prescriptions a month to suppress HIV, manage treatment side effects and manage co-occurring conditions. Co-payments and other forms of cost sharing, disproportionately burden people who are the sickest, the most in need of drugs and struggling to live on very low monthly incomes that range from $600 to $1,200. For the poorest of patients, even co-payments as low as $3.10 to $5.35 per prescription can add up to $50 to $60 a month that they just do not have, forcing them to make difficult choices between food, shelter and lifesaving health care and treatment.

For patients with income just above the eligibility requirement for the low-income subsidy, the cost-sharing required for their HIV drugs can impede access to vital medications. As an example of the co-payments borne by those who do not qualify for the low income subsidy , let me outline drug costs for a typical, and relatively simple, HIV regimen under the Humana Standard Plan (which is comparable to the other plan options) available in California. The cost sharing before the patient has met the deductible and again during the donut hole would be around $819.60 per month ($353.19 for Combivir and 466.41 for efavirenz); after the patient meets the deductible and before he reaches the donut hole the cost would be $204.90 per month ($88.30 for Combivir and $116.60 for efavirenz). Finally, when the patient’s drug costs reach the out of pocket limit of $3,850, the patient’s co-payments drop to $40.98 ($17.66 for combivir and $23.32 for efavirenz). These costs are in addition to the premiums charged by the plan. Our patients in California and about half of the states often can get help through their AIDS Drug Assistance Program (ADAP) with these costs, if they qualify for the program. This assistance, however, is not readily available in every state, or for every person that might apply.

Congress should consider capping the beneficiary’s monthly cost sharing burden, particularly for those low-income patients who cannot afford co-payments for multiple medications.

V. Enrollment issues: Proper LIS assignment
Enrollment into a prescription drug plan has been difficult for many populations of individuals, but we also have stories to report from within the HIV population—not just enrollment, but dis-enrollment as well. Earlier this spring, one company, Sierra Rx, abruptly dis-enrolled hundreds of HIV patients from coverage their enhanced plan (a plan offering coverage on brand and generic drugs through the coverage gap or donut hole in exchange for a higher monthly premium. The plan made this “mistake” ironically after it was widely reported that the enhanced plan, an attractive option for patients with HIV, who routinely hit the hole in March or April every year, had severe losses during the first three months of operation. The dis-enrollments were unjustified and after time-consuming case-by-case investigations by CMS which found no cause for the abrupt dismissal, CMS mandated re-enrollment for virtually all of the clients that had been dis-enrolled. In several states the ADAPs stepped in and provided medications while CMS was reviewing cases, but the process and was extremely time-consuming and frustrating for clients and case managers. If ADAPs had not been able to intervene to ensure coverage of essential drugs during this period of disruption the patients could have faced drug resistance problems, increased disease morbidity, and other severe problems associated with loss of access to HIV medications.

In California where I am from and in some other states as well, many Medicare beneficiaries with AIDS are eligible for Medicaid through their state Medicaid “medically needy” or “spend down” program. These programs allow people to qualify for Medicaid coverage because their medical expenses are so high that when deducted from their income they meet the Medicaid income eligibility criteria. Under current policy, CMS only automatically enrolls people into the low-income subsidy program who have met the Medicaid spend down requirement during specific “snapshot” months of the calendar year. This policy results in denying access to many who are truly “medically needy” but have lower countable expenses in a CMS “snapshot” month. Fairness and efficiency support enactment of a federal policy that grants access to the low-income subsidy to any person whom a state Medicaid program has certified as a Medicaid-eligible. With such a policy, those who are truly unable to meet the cost sharing required under Medicare Part D will have access to a low income-subsidy and the life-saving prescription drug coverage they need.

VI. ADAP and TrOOP
Many Medicare beneficiaries with HIV/AIDS relied on the Ryan White CARE Act’s AIDS Drug Assistance Program (ADAP) for drug coverage prior to Medicare Part D. Beginning in January 2006, ADAPs were required to enroll all eligible ADAP beneficiaries into Medicare Part D. The US Department of Health and Human Services determined that ADAP expenditures could not count toward the true out of pocket cost limit known as “TrOOP”. Meeting or paying “TrOOP” expenses is the trigger that moves a beneficiary from the coverage gap into a meaningful level of drug coverage, known as catastrophic coverage. Therefore, beneficiaries receiving support from ADAPs will never reach a meaningful level of drug coverage if the ADAP supplements their coverage during the donut hole. ADAP dollars that must be used to supplement Medicare are dollars that cannot be allocated to other needy individuals who do not have Medicare coverage. Federal policy should support efforts to maximize Medicare coverage to meet the needs of Medicare beneficiaries with HIV/AIDS. Our organizations urge Congress to clarify the law to allow expenditures made by AIDS Drug Assistance Programs (ADAPs) to count toward the True-Out-of-Pocket (TrOOP) limit.

VII. Conclusion:
Medicare Part D has been helpful to a few of my patients, yet for many, if not most others, it has been confusing, stressful, and disruptive to their care. From the HIV medical provider perspective, it has been challenging on the best of days, outrageous on the worst. We spend hours on the phone or at our desks on a daily basis, filling out prior authorization request for many different plan and for numerous medications. We often act as the only advocate for patients who otherwise haven’t been heard or cannot navigate the very difficult system. It is not clear how many patients fall through the cracks in this system, but we fear that for every one we hear about, there is at least one other who we don’t. The hours spent on patient advocacy are robbed from our limited time for delivering care , and it is this complicated and time consuming bureaucracy that is inadvertently perpetuating the healthcare disparities that plague this very vulnerable population.

Congress has an opportunity to help, by codifying the six protected classes, increasing surveillance and sanctioning of bad actors, capping monthly cost-sharing, guaranteeing at least one enhanced plan that offers coverage of both brand name and generic drugs through the doughnut hole, and by allowing ADAP expenditures to count towards TrOOP.

I appreciate the opportunity to share my story and the stories of my colleagues and I remain eager to assist this body in the design of possible solutions.

Thank you.