Advocacy Organizations Call for Medicare Patient Protections in Letter To Members of Congress
Friday October 3, 12:39 pm ET

WASHINGTON, Oct. 3 /PRNewswire/ -- The following letter was sent to Members of Congress dated October 2, 2003 from the
following advocacy organizations, 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 the 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:

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.

Source: NAMI

SOURCE: Yahoo News (press release)
http://biz.yahoo.com/prnews/031003/dcf012_1.html

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