[Congressional Record (Bound Edition), Volume 145 (1999), Part 8]
[Extensions of Remarks]
[Page 11829]
[From the U.S. Government Publishing Office, www.gpo.gov]



 INTRODUCTION OF THE MEDICARE PATIENT ACCESS TO TECHNOLOGY ACT OF 1999

                                 ______
                                 

                            HON. JIM RAMSTAD

                              of minnesota

                    in the house of representatives

                          Monday, June 7, 1999

  Mr. RAMSTAD. Mr. Speaker, new advances in medical technology are 
improving the lives of millions of Americans every day:
  New implantable devices are restoring and repairing ailing organs.
  New diagnostics are permitting rapid detection of life-threatening 
diseases and allowing physicians to peer inside the human body without 
surgery.
  Miniature surgical devices are allowing patients to recover more 
quickly and new technologies are empowering patients to monitor and 
test their conditions from home and reduce or eliminate pain.
  Yet many of these life-saving and life-enhancing technologies remain 
unavailable to the people who need them most, America's nearly 40 
million Medicare beneficiaries. This is because of the complex, 
interwoven systems that Medicare uses to evaluate, approve and pay for 
new medical technologies.
  That's why I am introducing ``The Medicare Patient Access to 
Technology Act'' to make targeted adjustments in the technical methods 
and systems that Medicare uses to adopt and pay for new medical 
products. By correcting and coordinating the payment levels and 
identification codes, the bill will improve access to needed therapies 
for millions of Medicare patients, both today and in the future.
  As you know, Mr. Speaker, the Food and Drug Administration (FDA) 
reviews medical technologies to ensure that they are ``safe and 
effective.'' After passing through FDA, such technologies must also be 
deemed ``reasonable and necessary'' by HCFA for them to be integrated 
into the portfolio of services that Medicare makes available to its 
beneficiaries.
  After being approved for coverage, technologies must receive a 
``procedure code,'' a four or five digit identifying code that health 
care providers use in submitting claims to payers.
  Finally, Medicare must set a payment level for each technology and 
treatment through another reimbursement system designed for reimbursing 
hospitals, physicians, skilled nursing facilities and other care 
providers.
  Unfortunately, a problem at any of these stages can seriously delay a 
product from reaching Medicare patients.
  For example, Mr. Speaker:
  Exogen, Inc., a small company that developed an ultrasound device for 
healing bone fractures, has encountered 4 years of delays in getting 
Medicare coverage. Oddly enough, the product is currently be reimbursed 
by more than 800 private insurers and health plans, but not by 
Medicare.
  The Cordis Corporation, a division of Johnson & Johnson, encountered 
significant problems in obtaining appropriate Medicare coding and 
payment for coronary stents, which are stainless steel tubes used to 
treat narrowing of the coronary arteries. The company faced challenges 
in obtaining a unique code for the stent procedure from HCFA, and once 
the new code was assigned, Medicare took several more years to place 
the device in the appropriate payment category. Sadly, the reason for 
the delay was Medicare's database was only a partial data set and 
HCFA's precedent did not allow it to use sample data in determining the 
hospital costs of providing the stent.
  A manufacturer of a cochlear ear implant halted active marketing of 
one model and stopped research on another because of inadequate 
Medicare reimbursements. According to an article that appeared in The 
New England Journal of Medicine at the time, payment for the device 
remained well below its average cost, causing hospitals to ``ration the 
availability of the device to Medicare patients because of the 
financial losses involved. Eventually, so few patients received the 
implant that the manufacturer discontinued its production.'' (Nancy M. 
Kane, D.B.A., and Paul D. Manoukian, M.D., M.P.H., ``The Effect of the 
Medicare Prospective Payment System on the Adoption of New 
Technology,'' The New England Journal of Medicine, November 16, 1989, 
pp. 1378 1382.)
  The most distressing problem in all of these cases, as in many others 
just like them, is that Medicare patients are being denied access to 
beneficial therapies.
  I am pleased that HCFA is attempting to address the problems 
associated with its process for making national coverage decisions for 
new technologies. However, unless the shortcomings in the coding and 
payment systems are corrected, HCFA will not fully achieve its ultimate 
goal of improving Medicare's health care delivery system.
  Several distinct issues need to be addressed:
  Medicare's system for creating and assigning procedure codes to 
medical technologies is cumbersome and slow.
  Medicare's methods of updating Medicare payment levels and payment 
groups to accommodate changes in medical technology increase the risk 
that Medicare will lag behind new advances in medical technology.
  Medicare's refusal to use data that are developed outside of the 
Medicare program blinds the program to useful insights about the costs, 
charges and outcomes of medical technologies.
  To address these issues, ``The Patient Access to Medical Technology 
Act of 1999'' would:
  1. Adjust Medicare payment levels and payment categories at least 
annually to reflect changes in medical practice and technology.
  2. Use valid external sources of information to update payment 
categories if Medicare's data are limited or not yet available. More 
specifically, the bill directs HCFA to use a valid, statistically 
representative sample and also to draw on external sources of data when 
its own dataset is inadequate. It directs HCFA to consider 
statistically representative data from such sources as private 
insurers, manufacturers, suppliers and other non-Medicare entities.
  3. Update national procedure codes (HCPCs Level II) more frequently 
to reduce delays and timelags. Without an accurate identifying code, 
technologies and procedures cannot be reimbursed appropriately by 
Medicare. It can take HCFA up to 18 months to approve a new code 
because of the way the agency structures its calendar for making such 
changes. This bill would make the process more efficient by eliminating 
the single annual deadline for applications and permitting such 
requests to be accepted on a rolling, quarterly basis.
  4. Continue to use local procedure codes to ensure availability of 
the most recent advances in medical technology. Most coverage decisions 
are made at the local level by local contractors, which use the ``HCPCS 
Level III Codes'' to describe new technologies that have not yet been 
incorporated into the national coding process. HCFA has proposed 
eliminating these useful codes, but this bill would require HCFA to 
maintain this effective local system.
  5. Establish an advisory committee on Medicare coding and payment to 
ensure that HCFA's coding and payment systems are open, prompt and 
functioning properly. This panel would complement HCFA's newly formed 
Medicare Coverage Advisory Committee.
  Mr. Speaker, this bill will correct a number of complex but 
significant problems that currently plague HCFA's coverage, coding and 
payment systems. Most importantly, it will help ensure that Medicare 
beneficiaries have timely access to life-enhancing and life-saving 
medical advances.
  Mr. Speaker, I urge my colleagues to support this important 
legislation.



                          ____________________