[Congressional Record Volume 147, Number 35 (Thursday, March 15, 2001)]
[Senate]
[Page S2409]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. Murray (for herself, Ms. Collins, Ms. Mikulski, Ms. 
        Cantwell, Mr. Cochran, and Mr. Chafee):
  S. 554. A bill to amend title XVIII of the Social Security Act to 
expand medicare coverage of certain self-injected biologicals; to the 
Committee on Finance.
  Mrs. MURRAY. Mr. President, today I am pleased to be joined by 
Senators Collins, Mikulski, Cantwell, Cochran, and Chafee in 
introducing the Access to Innovation for Medicare Patients Act of 2001. 
This legislation will give Medicare patients access to innovative 
medical treatments that are convenient and affordable and will remove a 
bureaucratic burden to promising new drugs.
  For many years, patients with diseases like rheumatoid arthritis, 
multiple sclerosis, hepatitis C and deep vein thrombosis could only get 
effective treatments in a doctor's office. This method of drug delivery 
puts a great burden on patients with limited mobility.
  Fortunately, in recent years, new medical technologies have created 
promising drug treatments that patients can use in their own homes. 
These drugs don't have to be administered by a doctor. Patients can 
inject the drugs themselves. So instead of traveling to a doctor's 
office several times a week, patients can now get the same treatments 
in their own homes. These new treatments, known as self-injectible 
biologics, mean patients can save time and have a better quality of 
life.
  Biologics are genetically-engineered proteins that must be infused or 
injected into a patient to be effective. If swallowed orally, biologics 
simply pass through the body during the digestion process and are not 
absorbed into the system. These drugs represent a major breakthrough in 
disease treatment and management.
  Today, many patients with private insurance and those on Medicaid 
have coverage for many self-injectible biologics. Unfortunately, 
patients on Medicare do not. Today, Medicare discriminates against 
these effective medical treatments and patients are feeling the impact.
  The time has come to remove this unfair burden and give Medicare 
patients access to self-injectible biologics. As sponsors of this bill, 
we believe that Medicare should not discriminate against patients who 
are treated with the same drugs either in a doctor's office or at home. 
The bill we are introducing today will correct this mistake and ensure 
that Medicare patients have access to safe, promising drugs.
  Our legislation has been endorsed by the Arthritis Foundation, the 
American Public Health Association, National Association of Retired 
Federal Employees, National Council on the Aging, National Farmers 
Union, National Hispanic Council on Aging, Association of Jewish Aging 
Services and the Visiting Nurses Associations of America.
  I want my colleagues to understand that this bill does not address 
the broader need for prescription drug coverage overall. Congress still 
must address that hole in the Medicare system. But this bill does 
correct a clear mistake in Medicare's payment rules for self-
injectible biologics.

  This unfair policy has several consequences. First, it prevents 
patients from getting the treatments they need. The FDA has recently 
approved several new self injected biologics to treat rheumatoid 
arthritis, multiple sclerosis, hepatitis C and deep vein thrombosis. 
Medicare beneficiaries should have immediate access to these new 
treatments without delay. Many of these diseases hinder a patient's 
mobility and quality of life. It is difficult to explain to these 
patients that in order to have treatments covered they must travel to 
their physicians office once, twice or even three times a week. Many of 
these patients are disabled and depend on family or friends for 
transportation. Patients in rural areas are particularly hurt by this 
policy, where their doctor may be many miles away. These patients might 
have to drive 50 or 60 miles a week. For individuals living on fixed 
income, this policy is especially difficult.
  This outdated policy hits women the hardest. As many of my colleagues 
know, more women are covered by Medicare, and women are twice as likely 
as men to live with a disabling, chronic condition. Women are also 
twice as likely as men to live in poverty after age 65. Older women or 
disabled women simply do not have the same economic resources as men. 
In addition, many of the illnesses that could be treated with self 
injected biologics strike women in larger numbers. Rheumatoid arthritis 
and multiple sclerosis most often affect women. Any policy that limits 
access to new innovative treatments for rheumatoid arthritis and 
multiple sclerosis places women at a severe disadvantage.
  In addition to the impact this policy has on patients, it also affect 
drug development. This practice discourages drug companies from 
offering patients new drugs that are self-injectible. That can hinder 
innovations and developments in biotechnology research. In the future, 
companies may choose not to develop self injected biologics. Our 
policies should promote new drug development, not discourage it.
  As you know, the U.S. Senate has voted overwhelmingly to doubling NIH 
funding to encourage more research. it's one of my top priorities, and 
we are on track. However, I am troubled that patients on Medicare might 
not benefit from our efforts. It is counterproductive to invest in 
medical research, but then deny Medicare beneficiaries the fruits of 
that investment.
  I would like to briefly mention one particular new self-injected 
biologic treatment that has literally changed the lives of hundreds of 
RA patients. This particular treatment, Enbrel, took well over 10 years 
to develop and bring to patients. Since its introduction, however, it 
has dramatically improved the lives of RA suffers. I have heard from 
many patients about how Enbrel has allowed them to remain productive 
and how it has dramatically reduced their daily pain and suffering. 
Since RA can and does lead to disability, preventing or delaying the 
disabled effects of this disease means huge economic savings for all of 
us. Medicare should not discriminate against this new, patient-friendly 
therapy simply because it is self-injected.
  I urge my colleagues to carefully review this legislation and to talk 
to patients and health providers about how an outdated policy hinders 
access and discourages innovation and how the measure we are 
introducing today can give Medicare patients access to innovative 
drugs.
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