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Coalition Letter Regarding Medicare Prescription Drug Benefit

NAMI has joined a coalition of consumer and patient groups to send the following letter to members of the House-Senate Conference Committee on proposed Medicare reform.


October 2, 2003

The Honorable
US House of Representatives/US Senate
Washington, DC 20515/20510

Dear Conferee:

As representatives of national patient organizations, we commend the work Congress has done thus far to create a long-awaited prescription drug benefit for Medicare. As advocates for the patient community, it is our goal to ensure that Medicare patients have access to the best medicines as determined by their physician. In this regard, it is critical that the Conference includes well-established Medicare patient protections in any new Medicare drug benefit program. While both the House and Senate bills have been improved in many ways in this area, additional changes are necessary if the millions of Medicare patients that our organizations represent are to be ensured the same rights and protections in the new drug program that they already have in the existing Medicare program. These rights and protections are essential to ensuring that all patients have ready access to the medicines they need.

Coverage Standards

To protect patient’s access to the best care possible, we believe it is also essential that Congress establish clear and binding requirements for plans to follow when determining what drugs will and will not be covered. Language in both S.1 and H.R. 1 requiring plan pharmacy and therapeutics (P&T) committees to base formulary decisions on the "strength of scientific evidence and standards of practice," is a very good step in the right direction. However, we are dismayed that this provision also contains language that allows these committees to base their decisions on "any other information they deem appropriate." We are concerned that this weakens the provision and confuses the standards for coverage. It implies that P&T committees could elect to cover inferior drugs simply because they cost less. To make it clear that quality of care considerations should always come first, we would ask your help in striking the "any other information" language.

Medically Inappropriate Coverage Restrictions

A fundamental Medicare patient protection that must be maintained is the right to challenge medically inappropriate coverage restrictions. Under the existing Medicare program, a patient can challenge a policy that inappropriately restricts coverage for medically necessary items or services. If the patient prevails in their challenge, and demonstrates that the policy is not medically appropriate, the policy is invalidated so that other similarly situated patients do not have suffer from the application of the inappropriate restriction – and patients are not forced to appeal the same issue again and again. Under the existing Medicare program, patients can challenge medically inappropriate coverage restrictions that are promulgated by either the Centers for Medicare and Medicaid Services (CMS) itself or one of its contractors.

However, neither the House nor the Senate’s Medicare bills would extend this right to the new outpatient drug program. Consequently, a drug plan’s decision to generally exclude or restrict coverage for a particular medicine could not be challenged – even if it were obviously without clinical merit. While beneficiaries could in certain circumstances appeal for individual relief from the policy (see comments below), the policy – even if patently inappropriate -- could be applied again and again, forcing patients with the same condition and needs to endure the time and expense of appealing the same issue over and over. The conference should correct this oversight, and hold the private companies hired to administer the new drug benefit program accountable to the same standards that now apply to CMS and its contractors in the existing Medicare program.

Appeals Process

A second Medicare protection is the right for individual patients to appeal denials of coverage. Not all patients are the same, and medicines often work differently on different patients depending on their particular genetic profiles and medical conditions. While a policy that generally restricts coverage may well be appropriate for most patients, in some circumstances medical necessity requires that exceptions be made for certain patients. In anticipation of these cases, it is important that all patients have access to a fair and ready appeals process.

In this regard, we ask that the Conference retain and improve upon the House bill's appeals provisions. The House provision is preferable to the Senate provision because it would allow patients to appeal to get a non-preferred drug if their physician determines that the preferred drug would not be effective or would have adverse effects for the patient. This is similar to the current appeal rights afforded patients in the existing Medicare program. The Senate bill however, says a physician must determine that the preferred drug is not effective or that it has adverse effects for the patient before the patient could appeal. The Senate language suggests that patients on established treatments would have to switch medicines and risk unnecessary health complications just to secure the right to an appeal. To protect patients' interests we ask that the House bill's basic language on appeals be retained.

Disclosure of Coverage Rationale

We also ask that the Conference preserve, but refine, the P&T committee disclosure provision in the House passed bill. As it is currently written, it would require each P&T committee to disclose in writing the rationale for excluding a drug from its formulary. This provision is an important addition to this year's Medicare bill. By ensuring the coverage decision process is open, we believe it is more likely that objective clinical criteria will be utilized when coverage policies are developed and, as important, that additional research comparing the effectiveness of different therapies will be commissioned. However, we believe this provision should be improved in two ways. First, it should be amended to apply to any decision to favor one drug over another, especially when it involves placing one drug on a preferred (lower cost-sharing) tier and another on a disfavored (more expensive) tier. Secondly, we would request that the P&T committees be required to disclose the specific "clinical" rationale for their decisions. Currently, the bill permits the disclosure for any basis, which implies that the main reason for preferring certain drugs could be cost --even if a better drug is available.

Informed Choices.

To ensure that patients can make informed choices when selecting a benefit option, plans should be required to tell prospective enrollees what they would have to pay for a specific medicine if they joined the plan. Currently, both the House and Senate bills require plans to disclosure only the average co-pay for an entire class of drugs. Furthermore, to ensure that patients get what they sign up for, plans should be prohibited from removing a drug from its formulary or changing cost-sharing terms (e.g. moving a drug to a less favorable tier) in the middle of the plan year. This is particularly important because the bill would only allow patients to change plans once a year.

Therapeutic Substitution

Finally, we would also ask that the Conference Committee reject language in the House bill requiring Medicare drug plans to maintain "medically appropriate" therapeutic substitution programs. In our view, the federal government should not be encouraging health plans and pharmacists to change the specific medicine that a doctor has prescribed for their patient. To be implemented, this provision would require CMS or a similar agency to determine when it was medically appropriate to allow a patient’s prescribed medication to be switched by a pharmacist while filling the prescription. Unlike generic substitution, therapeutic substitution involves the substitution of a different chemical entity for the one initially selected by the treating doctor. The government should not require plans and physicians to engage in therapeutic substitution. If a plan or pharmacist elects to suggest a therapeutic substitute, they can do that under existing state law in consultation with the treating provider.

We are pleased that a prescription drug benefit for Medicare recipients has been a top priority of Congress. We urge your thoughtful consideration of our concerns to ensure that the benefit derived is a quality one.


Arthritis Foundation

Cancer Research and Prevention Foundation

Colon Cancer Alliance

Cystic Fibrosis Foundation

Epilepsy Foundation of America

Huntington’s Disease Society of America

Kidney Cancer Foundation

Latino Coalition

Latino Gerentological Society

Lupus Foundation

Men's Health Network

National Alliance for Mentally Ill

National Association for Continence

National Coalition for Cancer Survivors

National Coalition for Women with Heart Disease

National Latino Behavioral Health Association

National Medical Association

National Mental Health Association

National Prostate Cancer Coalition

New Black Leadership Coalition

Parkinson's Action Network

Relief Resources

Suicide Awareness Voices of Education (SAVE)

The American Autoimmune Related Diseases Association

The American Foundation for Urologic Disease

The Asthma and Allergy Foundation of America

The National Association of Family Caregivers

The National Grange

National Patient Advocate Foundation

Y-Me National Breast Cancer Organization