[Congressional Record Volume 145, Number 40 (Monday, March 15, 1999)]
[Senate]
[Pages S2670-S2672]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS:
  S. 617. A bill to amend title XVIII of the Social Security Act to 
provide for coverage under the medicare program of insulin pumps as 
items of durable medical equipment; to the Committee on Finance.


               medicare insulin pump coverage act of 1999

  Ms. COLLINS. Mr. President, diabetes is a serious and potentially 
life-threatening disease affecting more than 16 million Americans at a 
cost of more than $105 billion annually. Moreover, since 3 million 
elderly Medicare beneficiaries have been diagnosed with diabetes, and 
another 3 million are likely to have the disease but not know it, 
nowhere is the economic impact of diabetes felt more strongly than in 
the Medicare Program.
  Treating these seniors for the often devastating complications 
associated with diabetes accounts for more than one-quarter of all 
Medicare expenditures. Therefore, helping diabetic seniors avoid the 
complications of their disease will not only improve the quality of 
their lives but also help reduce the economic burden that diabetes 
places on Medicare. While there is no known cure, diabetes is largely a 
treatable disease. Many people who have diabetes can often lead 
relatively normal, active lives as long as they stick to a proper diet, 
carefully monitor the amount of sugar or glucose in their blood and 
take their medication, which may or may not include insulin.
  However, if these people with diabetes are unable to follow or do not 
follow this regimen, they put themselves at risk of blindness, loss of 
limbs and have an increased chance of heart disease, kidney failure and 
stroke. Therefore, preventive services for people with diabetes has the 
potential to save a great deal of money that would otherwise go for 
hospitalizations or acute care costs--not to mention a great deal of 
unnecessary pain and suffering.
  Congress recently took a number of important steps to improve 
Medicare coverage of preventive care for diabetics. Prior to the 
enactment of the balanced budget amendment in 1997, Medicare covered 
diabetics' self-maintenance education services in inpatient or 
hospital-based settings and in limited outpatient settings, 
specifically hospital outpatient departments or rural health clinics. 
Medicare did not, however, cover education services if they were given 
in any other outpatient setting, such as a doctor's office. Moreover, 
while Medicare did cover the cost of blood-testing strips used to 
monitor the sugar in the blood, the program did so for only Type I 
diabetics who require insulin to control their disease.
  The balanced budget amendment of 1997 rightly expanded Medicare to 
cover all outpatient self-management training services as well as 
providing uniform coverage of blood-testing strips for all persons with 
diabetes. With the enactment of the balanced budget amendment, we made 
significant progress toward improving care for our senior citizens with 
diabetes. However, there is more that we can do.
  External insulin infusion pumps have proven to be much more effective 
in controlling blood glucose levels than conventional therapy injection 
therapy for insulin-dependent diabetics whose blood sugar levels are 
difficult to control. Such pumps help them to avoid the expensive 
complications and suffering resulting from uncontrolled diabetes. 
However, Medicare currently does not cover these pumps, even when they 
have been prescribed as medically necessary by a patient's physician.
  I am, therefore, pleased to introduce today legislation, the Medicare 
Insulin Pump Coverage Act of 1999, that would expand Medicare coverage 
to include insulin infusion pumps for certain Type I diabetics.
  External insulin pumps are neither investigational nor experimental. 
They are widely accepted by health care professionals involved in 
treating parties with diabetes. Moreover, studies such as the Diabetes 
Control and Complications Trial sponsored by the National Institutes of 
Health have established that maintaining blood glucose levels as close 
to normal as possible is the key to preventing devastating 
complications from this disease. For many patients, the use of an 
infusion pump is the only way that optimal blood glucose control can be 
safely achieved. That is why virtually all other third

[[Page S2671]]

party payers--including many State Medicaid Programs and CHAMPUS--cover 
the device. Moreover, there is precedent in Medicare since it currently 
does cover infusion pumps for numerous cancer drugs, as well as for 
pain control medications.
  The need for this legislation became apparent to me based on my 
attempts to help one of my constituents, Nona Frederich of Raymond, ME. 
She is an example of the Medicare patient who would benefit from the 
pump but who is currently being denied what is for her the most 
effective form of glucose control. Nona has been an insulin-dependent 
diabetic since 1962. Because of her extremely volatile insulin 
sensitivity, her diabetic specialists placed her on an insulin infusion 
pump in January 1982. Until she reached the age of 65, the cost of the 
pump and operating supplies were underwritten in large part by her 
insurer.

  In March of 1995 it became necessary for Nona to purchase a new 
infusion pump. However, by this time, she was now on Medicare and 
Medicare refused to cover it, even though her doctor had prescribed it 
as clearly being medically necessary. With the help of my Portland 
office, the Frederichs worked their way through the Health Care 
Financing Administration system of appeals. Unfortunately, in January 
of last year, they received final notification of a negative decision. 
Their only remaining option is to file a civil suit which they are 
simply not in a position to pursue.
  The Frederichs literally have notebooks filled with documentation of 
the procedures they followed and the evidence they submitted. Moreover, 
they personally paid close to $5,000 in original pump costs and 
supplies for which they received no reimbursement. For a Medicare 
beneficiary with a limited income, these kinds of costs would be 
devastating and would place the pump--the medically necessary pump--
completely out of reach. In such a case, they would be forced to return 
to or to continue with conventional insulin therapy which simply just 
may not be as effective in controlling blood sugar. As a consequence, 
these patients are admitted to the hospital over and over again, and 
Medicare now picks up the bill--a far greater bill than if Medicare had 
simply paid for the pump in the first place.
  While potentially devastating for an individual, the financial costs 
to Medicare of expanding coverage to include the insulin infusion pump 
will not be great. Under my bill, the pump would have to be prescribed 
by a physician and the beneficiary would have to be a Type I diabetic 
experiencing severe swings of high and low blood glucose levels. Of the 
estimated 3 million Medicare beneficiaries with diabetes, only about 5 
percent are Type I, or insulin dependent; of these, it is estimated 
that the pump would be appropriate for only about 4 percent. Mr. 
President, what a difference it would make for those individuals.
  The American Diabetes Association, the Juvenile Diabetes Foundation, 
the American Association of Clinical Endocrinologists and the American 
Association of Diabetes Educators, as well as officials at the Centers 
for Disease Control, all have advocated expanding Medicare to cover 
insulin infusion pumps for Type I diabetics who otherwise would have 
great difficulty in controlling their blood sugars.
  I am pleased to introduce legislation today to do just that. I urge 
all of my colleagues to join me in support of this important 
legislation, legislation that would not cost much money but would 
enrich the lives of those diabetics who need these pumps immeasurably.
  I ask unanimous consent that the text of the legislation as well as 
the letters of support from the American Diabetes Association and the 
Juvenile Diabetes Foundation be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                 S. 617

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Medicare Insulin Pump 
     Coverage Act of 1999''.

     SEC. 2. COVERAGE OF INSULIN PUMPS UNDER MEDICARE.

       (a) Inclusion as Item of Durable Medical Equipment.--
     Section 1861(n) of the Social Security Act (42 U.S.C. 
     1395x(n)) is amended by inserting before the semicolon the 
     following: ``, and includes insulin infusion pumps (as 
     defined in subsection (uu)) prescribed by the physician of an 
     individual with Type I diabetes who is experiencing severe 
     swings of high and low blood glucose levels and has 
     successfully completed a training program that meets 
     standards established by the Secretary or who has used such a 
     pump without interruption for at least 18 months immediately 
     before enrollment under part B''.
       (b) Definition of Insulin Infusion Pump.--Section 1861 of 
     the Social Security Act (42 U.S.C. 1395x) is amended by 
     adding at the end the following:

                        ``Insulin Infusion Pump

       ``(uu) The term `insulin infusion pump' means an infusion 
     pump, approved by the Federal Food and Drug Administration, 
     that provides for the computerized delivery of insulin for 
     individuals with diabetes in lieu of multiple daily manual 
     insulin injections.''.
       (c) Payment for Supplies Relating to Infusion Pumps.--
     Section 1834(a)(2)(A) of the Social Security Act (42 U.S.C. 
     1395m(a)(2)(A)) is amended--
       (1) in clause (ii), by striking ``or'' at the end;
       (2) in clause (iii), by inserting ``or'' at the end; and
       (3) by inserting after clause (iii) the following:
       ``(iv) which is an accessory used in conjunction with an 
     insulin infusion pump (as defined in section 1861(uu)),''.
       (d) Effective Date.--The amendments made by this section 
     shall apply with respect to items of durable medical 
     equipment furnished under title XVIII of the Social Security 
     Act (42 U.S.C. 1395 et seq.) on or after the date of 
     enactment of this Act.
                                  ____


   Statement by the American Diabetes Association in Support of the 
                   Medicare Insulin Pump Coverage Act

       The American Diabetes Association lends its full support to 
     passage of the Medicare Insulin Pump Coverage Act in 
     Congress. Effective maintenance of blood glucose levels is 
     imperative if people with diabetes are to forestall the onset 
     of the complications of diabetes, such as cardiovascular 
     disease, end-stage renal disease, blindness or amputations. 
     External insulin infusion pumps have proven to be more 
     effective in controlling blood glucose levels than 
     conventional injection therapy for insulin-dependent people 
     whose blood sugar levels are difficult to control. Many, 
     including those who have had access to the insulin pump prior 
     to becoming a Medicare beneficiary, need access to the pump 
     for better control. Medicare access to the insulin pump will 
     help Medicare enhance the quality of life for people with 
     diabetes and contain the costly complications of diabetes.
       Diabetes is a disease that requires a lifetime of medical 
     care and self-treatment. People with diabetes must have full 
     access to supplies, equipment and education. The Diabetes 
     Control and Complications Trial (DCCT), a 10-year clinical 
     study conducted by the National Institutes of Health, proved 
     that maintaining blood glucose levels as close to normal as 
     possible is the key to preventing the devastating 
     complications associated with diabetes.
       ``Unfortunately, many health insurance plans, including 
     Medicare, do not provide comprehensive coverage for the 
     supplies and education people with diabetes need to control 
     their disease,'' said Gerald Bernstein, MD, President of the 
     American Diabetes Association. ``For example, Medicare does 
     not provide coverage for the insulin pump,'' Bernstein added.
       According to the Health Care Financing Administration 
     (HCFA), the federal agency responsible for administering the 
     Medicare program, the insulin pump is not covered because 
     ``there [is no] medical advantage to using controlled 
     continuous insulin infusion (via infusion pump) rather than 
     conventional multiple daily injections to treat diabetes.''
       Bernstein added, ``The use of the insulin pump has proven 
     to be effective for individuals who, despite multiple insulin 
     injections and frequent monitoring, have unstable diabetes. 
     For many of these individuals, use of the insulin pump is a 
     life-enhancing decision.'' The Medicare Insulin Pump Coverage 
     Act will require Medicare to cover insulin pumps for 
     beneficiaries with Type 1 diabetes who are experiencing 
     severe swings of high and low blood glucose levels or who 
     have used an insulin pump without interruption for at least 
     18 months immediately before enrollment under Medicare Part 
     B.
       According to Bernstein, ``This legislation is especially 
     important for those individuals who face the prospect of 
     losing their coverage of the pump upon entering Medicare. Now 
     is the right time for HCFA to move forward with coverage of 
     the insulin pump in these limited circumstances.''
       For these reasons the American Diabetes Association 
     strongly supports The Medicare Insulin Pump Coverage Act and 
     applauds Senator Susan M. Collins (R-ME) for introducing this 
     important legislation. Passage of the Collins Bill will 
     dramatically improve the lives of those striving to maintain 
     a healthy life, while at the same time, reducing costly 
     hospital stays.

[[Page S2672]]

     
                                  ____
         Juvenile Diabetes Foundation International, The Diabetes 
           Research Foundation,
                                    Washington, DC, March 8, 1999.
     Hon. Susan M. Collins,
     U.S. Senate,
     Washington, DC.
       Dear Senator Collins: On behalf of the Juvenile Diabetes 
     Foundation International (JDF), I want to express our strong 
     support for your insulin pump legislation which would ensure 
     that pumps are covered by the Medicare program.
       Diabetes is a devastating disease that affects 16 million 
     Americans and 120 million people worldwide. A new case of 
     diabetes is diagnosed every forty seconds, and diabetes kills 
     one American every three minutes. Diabetes is the leading 
     cause of kidney failure, adult blindness, and nontraumatic 
     amputations, and it substantially increases the risk of 
     having a heart attack or stroke. In all, the life expectancy 
     of people with diabetes averages 15 years less than that of 
     people without diabetes.
       As you know, people with diabetes who use insulin take up 
     to five injections daily to treat their diabetes. However, 
     injection therapy does not work will for many diabetes 
     sufferers. In these and other cases, insulin pumps are an 
     effective and critical tool in assisting persons with 
     diabetes in more closely controlling blood glucose levels. 
     Better control of blood glucose levels is likely to lead to 
     fewer health complications from diabetes, and will result in 
     enormous cost savings to the Medicare system where one in 
     four Medicare dollars presently goes to pay for health care 
     of people with diabetes.
       Senator Collins, the JDF applauds you for introducing this 
     important legislation to help our nation's seniors and other 
     Medicare-covered Americans have access to cost-effective and 
     life-improving medical supplies such as the insulin pump.
           Sincerely,
                                                   Leah J. Mullin,
                               Chairman, JDF Government Relations.
                                 ______