[Congressional Record Volume 144, Number 92 (Monday, July 13, 1998)]
[Senate]
[Pages S8056-S8057]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS:
  S. 2292. 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 1998

  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 $137 billion annually. That is more than the cost of 
treating any other disease. Moreover, since 3 million elderly Medicare 
beneficiaries have been diagnosed with diabetes, and another 3 million 
are likely to have it but not realize it at this point, nowhere is the 
economic impact of diabetes felt more strongly than in our Medicare 
Program.
  Treating seniors for the often devastating complications associated 
with diabetes accounts for more than one-quarter of all Medicare 
expenses. Therefore, helping diabetic seniors avoid the complications 
of their disease will not only greatly improve the quality of their 
lives, but also help reduce the economic burden that diabetes places on 
the Medicare Program. This, Mr. President, is essential to the long-
term economic viability of Medicare.
  While there is no known cure, diabetes is largely a treatable 
disease. Many people who have diabetes can lead completely normal, 
active lives as long as they stick to a proper diet, carefully monitor 
the amount of their blood sugar or glucose, and take their medicine, 
which may or may not include insulin.
  However, Mr. President, unfortunately, if a person with diabetes does 
not follow this rather strict regimen, they put themselves at risk of 
blindness, loss of limbs and an increased chance of heart disease, 
kidney failure, and stroke. Therefore, appropriate preventive services 
for diabetes have the potential to save a great deal of money that 
otherwise would go for hospitalization or other acute care costs--not 
to mention a great deal of unnecessary pain and suffering.
  Mr. President, Congress recently took a number of important steps to 
improve Medicare coverage of preventive care for individuals with 
diabetes. Prior to enactment of the Balanced Budget Act of 1997, 
Medicare covered diabetes 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 physician's office. 
Moreover, while Medicare did cover the cost of blood-testing strips 
used to monitor the sugar in the blood, it did so only for type I 
diabetics who required insulin to control their disease. Last year's 
Balanced Budget Act rightly expanded Medicare to cover all outpatient 
self-management training services as well as providing uniform coverage 
of blood-testing strips for all people with diabetes.
  With the enactment of the Balanced Budget Act, we made significant 
progress toward improving care for Medicare beneficiaries with 
diabetes. However, Mr. President, there is more that we can do.
  External insulin infusion pumps have proven to be more effective at 
controlling blood glucose levels than conventional injection therapy 
for many insulin-dependent diabetics. This helps them to avoid the 
expensive complications and the suffering resulting from uncontrolled 
diabetes. However, Mr. President, Medicare currently does not cover 
these pumps, even in cases where they have been prescribed as medically 
necessary by the Medicare beneficiary's physician. I am, therefore, 
today pleased to introduce legislation, the Medicare Insulin Pump 
Coverage Act of 1998, that would expand Medicare coverage to cover 
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 patients with diabetes. Moreover, studies such as the Diabetes 
Control and Complications Trial sponsored by NIH have established that 
maintaining blood glucose levels as close to normal as possible is the 
key to preventing the devastating complications of diabetes.
  For many patients, Mr. President, the use of an infusion pump is the 
only way that optimal blood glucose control can be achieved safely and 
effectively. That is why virtually all other third-party payers--
including most State Medicaid programs and CHAMPUS--cover the device. 
Moreover, there is precedent under the Medicare Program itself for 
covering the pump. Medicare currently covers infusion pumps for 
numerous cancer drugs as well as for pain control medications.

[[Page S8057]]

  Mr. President, I first became interested in this problem because of 
the experience of one of my constituents, Nona Frederich of Raymond, 
ME. She is an example of the kind of Medicare patient who would benefit 
from the pump. She is currently, unfortunately, 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 specialist 
placed her on an insulin infusion pump in January of 1982. Until she 
reached age 65, the cost of the pump and operating supplies was 
underwritten in large part by her insurer, Colorado Blue-Cross-Blue 
Shield, and later by Blue Cross-Blue Shield of Maine.
  In March of 1995, it became necessary for Nona to purchase a new 
infusion pump. By now, however, she was older and on Medicare. Much to 
her surprise, Medicare refused to cover the pump, even though her 
doctor had prescribed it as clearly being medically necessary to help 
control her diabetes. Since then, with the help of my Portland office 
staff, the Frederichs have worked their way through the Health Care 
Financing Administration's system of appeals. Unfortunately, in January 
of this year, they received final notification of a negative decision 
by the Department of Health and Human Services. Their only option now 
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 have followed and the evidence they have submitted. 
Moreover, they have personally paid close to $5,000 in original pump 
costs and supplies for which they have received no reimbursement under 
the Medicare Program. For a Medicare beneficiary with limited income, 
these kinds of costs can be devastating. They can place the pump 
completely out of reach, even though the pump is medically necessary. 
In such a case, such patients would be forced to return to or continue 
with conventional insulin therapy which simply may not be as effective 
in controlling their blood sugar. As a consequence, these patients are 
admitted to the hospital with complications over and over again. The 
irony is that then Medicare will pick up the bill, and a far higher 
bill it will be than if Medicare had paid for the pump in the first 
place.
  While potentially devastating for an individual, the financial cost 
to Medicare of expanding coverage to include the insulin-infusion pump 
would be relatively minor. 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 the pump would be appropriate for only about 4 
percent. But what a difference it would make in the lives of those 4 
percent.
  The American Diabetes Association, the American Association of 
Clinical Endocrinologists and the American Association of Diabetes 
Educators, as well as officials at the Centers for Disease Control, 
have all advocated expanding Medicare to cover insulin pumps for Type-I 
diabetics who would otherwise have great difficulty in controlling 
their blood sugar.
  I am very pleased to be introducing this legislation today to do just 
that. I urge my colleagues to join me as cosponsors.
  I ask that the text of the bill be entered into the record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2292

         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 1998''.

     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 on or after the date of enactment of this Act.
                                 ______