[Congressional Record Volume 141, Number 37 (Tuesday, February 28, 1995)]
[Extensions of Remarks]
[Pages E461-E462]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


    LEGISLATION TO PROVIDE MEDICARE COVERAGE FOR MULTIPLE SCLEROSIS 
                               TREATMENTS

                                 ______


                          HON. JOHN J. LaFALCE

                              of new york

                    in the house of representatives

                       Tuesday, February 28, 1995
  Mr. LaFALCE. Mr. Speaker, today I am reintroducing a bill which is 
truly vital to the hundreds of thousands of people in this country 
suffering from multiple sclerosis, a physically debilitating disease. 
The Multiple Sclerosis Home Treatment Act of 1995 would provide 
Medicare beneficiaries with reimbursement for the cost of beta-
interferons, the most effective treatments for MS we have ever seen and 
the only type of MS treatment approved by the FDA.
  Mr. Speaker, before I describe my bill I would like to tell you a 
little bit about multiple sclerosis and the difficult consequences of 
the disease for its victims and their families.


                     multiple sclerosis: a snapshot

  It has been estimated that today between 250,000 and 350,000 
Americans have MS. The disease usually strikes at the prime of 
productive life--most people are diagnosed between age 20, and age 40. 
For reasons which are unknown as yet, women comprise an estimated 73 
percent of the MS population.
  Although the cause of the disease has yet to be specifically 
determined, we do know that in MS the central nervous system is 
attacked, resulting in inflammation and breakdown of the protective 
covering of the nerves in the brain and spinal cord, and the formation 
of scarring lesions in those areas.
  The disease concurrently results in a multitude of debilitating 
symptoms such as fatigue, impaired vision, loss of muscle coordination, 
tremors, and bowel and bladder dysfunctions. MS is most often 
characterized by recurrent and progressively more acute attacks of 
these symptoms, called exacerbations, between periods of relative 
physical stability. Exacerbations can and often do result in 
hospitalization.
  The long-term effects of MS vary. Some people experience more 
complete recovery between exacerbations--relapsing-remitting MS--while 
others experience significant physical deterioration--relapsing--or 
chronic-progressive MS.
  Still, MS is a disease of physical debilitation. People with MS often 
experience a loss of ability to perform simple daily tasks. In many 
cases the physical consequences of MS force the individuals to quit 
their jobs and leave the work force, requiring them and their families 
to make tough financial choices while continuing to address health care 
needs. An estimated 27 percent of people with MS are bedridden at least 
1 out of every 14 days.


                  betaseron: a breakthrough treatment

  Last year, the Food and Drug Administration approved a treatment, 
beta-interferon 1-b--trade name, Betaseron--for use in relapsing-
remitting MS. The FDA approved Betaseron through their newly created 
fast-track approval process, demonstrating the agency's recognition of 
both the importance of a treatment for MS and the success of Betaseron.
  Betaseron is a type of beta-interferon, a protein genetically 
engineered to resemble similar 
[[Page E462]] proteins in humans. The most significant aspect of 
Betaseron for MS patients is that it reduces the formation of new 
lesions in the brain, an occurrence widely thought to be connected with 
the progression of the disease.
  On a day-to-day basis the results of Betaseron treatments are also 
proving dramatic. For example, Mr. Kevin Cloy of Middleport, NY, is a 
constituent and friend of mine. Mr. Cloy is 32 years old, and was 
diagnosed with MS in 1990. He was forced to quit his job due to the 
disabling effects of MS. In December 1993, Mr. Cloy became one of the 
first people to receive Betaseron treatments.
  The change in his physical condition has been remarkable. The 
frequency of his exacerbations has significantly decreased, and his 
physical condition has stabilized enough that he no longer feels the 
need to be wheelchair-bound. Although he still remains at home during 
the day, he can return to doing simple tasks like walking to the 
mailbox. He is hopeful that the Betaseron treatments will allow him to 
return to the work force someday soon.


                       need for medicare coverage

  Unfortunately, because Betaseron is a high-technology, genetically 
engineered treatment, it is also prohibitively expensive. Betaseron is 
injected under the skin at home every other day, and the injections 
cost approximately $1,000 per month.
  The expense of Betaseron is a grave problem for all people with MS, 
but especially for those like Kevin Cloy who are forced to leave the 
work force due to their MS-induced disability. Not only must they deal 
with the financial constraints of a lost income, but they also lose the 
coverage of any employer-provided health insurance as well. They 
generally become eligible for Medicare, but as we all know, Medicare 
does not cover prescription drugs and self-administrable treatments.
  Mr. Cloy's situation again illustrates the problem. In March of last 
year, after Mr. Cloy left his job, he became eligible for Medicare and 
lost his private insurance coverage, thereby also losing coverage for 
prescription drugs.
  When he became eligible to receive Betaseron treatments, he was 
therefore faced with a difficult choice--either expend all of his 
family's resources to pay for Betaseron, and eventually become 
destitute enough to be eligible for Medicaid--which does cover 
prescriptions--or go without Betaseron, a treatment which has changed 
his life.
  Mr. Cloy has done everything feasible to avoid making that choice. He 
has drained his family's savings as much as possible in order to pay 
for Betaseron. Last spring, the residents of Middleport even organized 
a fundraiser for Kevin at a local restaurant. The fundraiser was 
successful, but the money raised only covers about 9-months worth of 
treatments.
  Mr. Speaker, since the first introduction of my bill last year which 
would have provided Medicare coverage for Betaseron, I have heard from 
people across the Nation who have MS, from New York to California, from 
Arkansas to Illinois. Their stories have been chronicled in major 
newspapers like the Philadelphia Inquirer and the Orlando Sentinel. 
These people have experienced the very beneficial effects of Betaseron, 
and they are desperate for a solution to this problem of access.


                      new scientific developments

  Last year, I introduced legislation to provide Medicare coverage for 
Betaseron, in order to help these people and their families. This year, 
I am expanding the bill to cover all beta-interferons, a consequence of 
recent exciting scientific developments.
  Another constituent and friend, Dr. Lawrence Jacobs, who is an 
esteemed researcher at the Multiple Sclerosis Center at Millard 
Fillmore Hospital in Buffalo, recently announced with his partner, Dr. 
Salazar of the National Institutes of Health, the development of a new 
beta-interferon which is promising to be more effective than Betaseron. 
This new substance would be used as an alternative to Betaseron.
  The new beta-interferon, which will soon be before the FDA for formal 
approval, has been affirmatively proven to reduce the progression of 
the disease. The new substance better mirrors natural substances 
produced in our bodies, and therefore also produces less side-effects 
for the patients. It is also being developed to be injected once a 
week, instead of every other day.
  Mr. Speaker, the preventive health aspects of beta-interferons are 
obvious. We can stop or significantly reduce the progression of the 
disease. We can substantially reduce the number of attacks these people 
experience. Since as estimated 41 percent of hospitals stays of MS 
patients are covered by Medicare, we can also clearly reduce those 
costs to Medicare.
  Moreover, we can reduce all of the other health care costs which are 
a consequence of a severe disability--physician visits, clinic visits, 
home health care, medical equipment, physical therapy--the list goes on 
and on. We may even be able to move many of these people back in to the 
work force, allowing them to leave Medicare altogether, a clear savings 
to taxpayers.
  I believe that providing access to these beta-interferons is an 
excellent example of the successes of preventive health care. In 
slowing the progression of MS, and allowing these individuals to lead 
more productive lives, these treatments provide benefits which, in the 
long term, may far exceed the cost of the injections.
  It is time we act to make these critical treatments available to all 
of those people with MS whose disabilities are so severe that they have 
lost their jobs and their private health insurance. I urge the Congress 
to adopt this important legislation.


                          ____________________