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ISSUE 1: ~DIN<; OF ~CP.L INVES=G.~CN IN ME UNWED s~2
Peruses We nx~ trials concern raised pST the niece ~ eat
charges In Me ~riro~ for clinical investigation art in
rei~t for patient care may mad to i~asir~ly inadequate
furring of Mini r ~ r ~ (2-7, 12, 13~. I~aslitionally, furry ~ of
clinical investigation in the Uhi~P~ States has been provided from
several sources, including governmental and nonprofit foundation
research grants, support from the pharmace~tin=1 and med;~1 device
industry, and patient care charges. I his last category includes the
direct support of faculty and residents for postgraduate physician
training, and the Medicare I rib education adjustment which was
included in rP~nition of me higher cams of care prairie in an
environment where a great amount of teat am clinical research are
performed. until recently, this category also included indict
subsidies provided by insurance cc ~ antes and other third party payers
through their tacit agreement to pay the costs inourre] by patients
participating in clinical research protocols and the higher costs in
teaching hospit=1s.
m ere are several factors that will affect continued funding of the
patient care costs associates with clinical investigation, including:
l) Changes in support of graduate mP~;~1 education, both
direct costs and the indireab education adjustment
2) Met containment pressures from third parties to reduce
hospital admissions and lengths of stay
3) Selective contracting and c3is~nting by ~6 and Hens
4) Differentials in inpatient and outpatient support of
education and rearm casts.
Over many year'; heath care axe; in me United Stamp have
i~asKI at a pace beyond that of general inflation. For example,
Medicare hospital payments have more than Marbled every five year;
since the program was initiated in 1966 (12~. The reasons for these
increases nave Oxen cletalle~, c~s~, and debate in n~s
studies and forums. Despite major efforts by governmental and
non-governmenta1 bodies during the post six to seven years there Hal
been a continued upward surge in the cost of health care. Thus, it is
expecter that those who pay the medial bills for single indivi~rp~s
and large grcup6 may move vigorously to cut costs by denying payments
for all services where any investigational protocol is involved (2, 3,
5~. Furthermore, the third party payers have been unresponsive to
. . . . .
2See Appendix B:
Hanft, p. 31; Bach, p.
36; and RabRin, p. 48.
6
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arguments that it is in their long term interests to fund clinical
trials and related clinical investigation.
The ~ ittee conclude d that it is wholly inappropriate for third
party payers to deny reimbursement for all appropriate and necessary
patient care costs (not marginal costs owing to investigational
intervention) that would have been incurred in any case simply begat
a patient is on an investigational Prokoool. Such denial would be
tantamount to an abrogation of a con~ractua1 obligation. Medicare
regulations already will not pay for care of Medicare beneficiaries for
investigational therapies that may be the best available treatment
(13~. These policies interfere with the patient-doctor relationship
and patient free choice. They also add a potential burden to the NIH
An funding clinical investigation because of the absence of funding of
necessary and appropriate patient care oosUs an] by limiting patient
access to investigational protocols (14~. Finally, they l mit the
hcspi~a1's able ity to continue to support early clinical investigation
which is a significant portion of the costs of clinical investigation.
. . —
The marginal, incremental costs above standard patient care costs
attributable to the investigational protocol should be borne by the
sponsoring institution -pharmaceutical company, NIH, or a foundation.
The remittee also believes that third Party pavers should seek to
. · · . · · . . .
participate An Bunting of cl ~ con trials above and beyond reimbursing
for standard patient care CONS because of the potential to Increase
the efficacy and cost effectiveness of diagnosis and treatment. While
the short term fiscal benefit achieved by employers, health insurance
policy subscribers, and the public through the denial of Payment for
services involved in clinical investigation is real, the long term
negative impact face failure to support The conduct of clinical
investigation may greatly exceed the short term gains. Excluding the
potential direct economic consequences resulting from a reduction in
human illness, it is possible that the delay of major advances in
medical therapeutics may deny to the public the saving of lives,
increases in societal productivity, and the improvement in the quality
of life for thousands or even millions of individuals.
-A
Reccmmendations
1. Payment of Standard Patient Care Combs
Third party payers (government and non-government) should
pay the necessary and appropriate patient care costs for
beneficiaries enrolled ~ approved clinical investigation
protocols. This requires a clarification in current
Medicare regulations involving definitions of medically
rely care. State regulatory agencies should require
conforming changes by all other third party payer policies.
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2. Payment of Patient Care Casts in Specific Disease Settings
There are d;Ar~CrC for which appropriate and required care
involves investigational protocols. Such disrac-" include
certain types of cancer, genetic doses a, and possibly
other severe, life threatening disPo=-c. In these ~~F=~-'
third party payers (go v o t and non-gov o t) should
pay the standard patient care casts while casts related to
the investigational Lions should be borne by the
sponsoring agency.
3. Payment for Clinical Trials
me Committee believes that third party payers should seek
to participate in funding of clinical trials above an]
beyond reimbursing for standard patient care casts. This
approach provides the potential to increase the efficacy and
cost effectiveness of diagnosis and treatment, thereby
allowing for the possibility of significant financial gain
in the long run.
4.
-
· .
Increase in NIH Funding Clinical Investigation
me data presented to the committee indicated that the
aurx~nt being spent for clinical trials represents
approx~nate~y six to seven percent of the total NUI budget
(15~. Alff~a~h it was not forcible to Foamed the Overall
son being sperrt on clinical irrvestigation, it was the
cc~nittee's j~nt that i~as~ su` - rt for clinical
imrestigation ~1d be valuable, preferably fern new
sac;, but as a product of redistribution if rotary
8
Representative terms from entire chapter:
clinical investigation
