Resources for Clinical Investigation Report of a Study (1988) / Chapter Skim
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Position Papers on Issue 1: The Funding of Clinical Investigation in the United States
Position Papers on Issue 1: The Funding of Clinical Investigation in the United States
Pages 30-49
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From page 31... ...
Regrettably, There is a paucity of hard data on unfunded direct costs of research Incurred by hospitals and more important, the indirect costs that reflect the increase ~ patient care cost that may result from joint research and patient care activities, not covered In private and public research grants. According to Lave and Anderson, "it is particularly difficult to estimate the incremental patient care costs associated with a.research protocol." m e Ccmmonw~lth Fund Task Force on ~ ademic Health ~ nters (AHC's)
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From page 32... ...
Many faculty who supervise residents perform multiple functions, including clinical investigation. Finally, two reductions have already been made in the M~dirare indirect education adjustment and there is every indication that further reductions are imminent.
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From page 33... ...
Furthermore, the extensive use of preadmission certification and professions standards review, reduces admissions with the potential for reducing the number of patients available in hospitals for clinical research. Again, there is not quantifiable data on the effects of preadmission certification and professional standards review on the patient care associated with clinical research or The costs of clinical investigation.
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From page 34... ...
The movement of services outside The hospital can also affect the availability of a critical mass of human subjects for designing and implementing research protoools, particularly rent roiled clinical trails. Again, there are not quantifiable data on the effects of these changes on clinical investigation.
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From page 35... ...
like New York and Massachusetts with ooncentrations of hospitals that engage in large clinical investigation prc grams. As the recent Commonwealth stay noted quantification of the hidden or Indirect c ~ ts, ~ e hospital Collar ~ ti ~ to clinical ~ wit 1 in order to develop viable and defensible options to support patient care casts aCcnriated with clinical research.
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From page 36... ...
Faced with pressures to restrain medical spending, public and private payers are increasingly denying payment for patient care costs associated with new, yet premising medical technologies. Recently, health Insurers have denied beneficiary access to investigational uses of new drugs such as Leucocyte Activated Killer 36
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From page 37... ...
Payers frequently reimbursed net only the patient care Is associate with the clinical investigations of new products, but also scan of the ire remental costs of research products and protocols. Payment was made for at least too reasons.
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From page 38... ...
Private insurers and Medicaid programs quickly took similar steps, adopting such programs as pre-admission authorization, inpatient length-of-stay review, and increased patient cost sharing. In addition, Health Maintenance Organizations (HMOs)
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From page 39... ...
C Implications of Clinical Research Restrictions Many third party insurers maintain that the benefits of clinical research accrue to the pro duet manufac ~ and future patients, not necessarily to the patient to whom the investigational therapy is provided.
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From page 40... ...
Nat only would this new "cost reduction strategy" greatly impact the practice of medicine, it could not be explained to patients and would lead to patient dissatisfaction with ins firers and the heath care system in general. A patient receiving treatment for an ailment expects the doctor to use all the available tools and the insurer co cover the costs of treats ant.
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From page 41... ...
Short-sighted payer approaches abdicating patient care costs related to investigational new therapies make poor public policy and could Pricusly harm domestic innovation. abbe importantly, patients may be at great risk of losing access to hip q~li~r care and be forced to obtain innovative treatments based on 41
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From page 42... ...
ability to pay. -this eventuality would not be in the i~ts of either Piety or me payer unity, and also raises Trial estions abut statutory and contractual interpretation, as well as cor~ressianal intent.
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From page 43... ...
13. Personal Fornication, Harvard Unity Health Plan and Heal1:h Coloration of Puget Sa=.
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From page 44... ...
cosmetic surgery, noncavered organ transplants, noncc~vered artificial organ implants, etc.)
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From page 45... ...
C After a beneficiary has been discharged f ~ n the hospital stay in which he received nonoovered service=, medical and hospital services required to treat a condition or complication that arises as a result of the prior noncavered services may be covered when they are reasonable and neneC=~ry ~ all other respects.
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From page 46... ...
This exclusion applies when items and services are furnished gratuitously without regard to the beneficiary's ability to pay and without expectation of payment frog any source, such as free x-rays or immunizations provided by hearth organizations. However, Medicare reimbursement is not precluded merely because a physician or supplier waives the charges in the case of a particular patient or a group or class of patients, as the waiver of charges for some patients does not impair the right to charge others, including Medicare patients.
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From page 47... ...
The exceptions to this rule are services covered by automc bile medico or no-fault insurance (S3338ff.) , services rendered during a specified period of up to 12 months to individuals entitled solely on the basis of end stage renal disease who are insured under an filcher group health plan (S335ff.
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From page 48... ...
~ Restrictions could be placed not only on how that DRG was assigned - the limits could be placed on the nature of the hcepit=1 that could use that DRG, the nature of the approval process both inside and beyond the institution that would sanction such an admission, etc., the permissible extent of any such application and the overall total of such days and offer r~r~ allowed, for eagle, In relation to be total inpatient days of the institution or to offer c~arac~ristics. A ~hani~u of this sort wc~c3 allay Medicare to recoc~nize the ~ ~ _ _ Aim___ e ~ ~ ~ ~ ·___ ~ ~ ~ ~ ~ ~ ~ ~ importance of clinical investigation, to support that at: of it not typically supports by specific ~ rch grants nor by Media re today, yes one mechanism coula 1Imlr overall noun One average cost to one payer per experimental admission an]
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From page 49... ...
Hence the creation on an NIH-h~ program would be more useful and, in the Tact analysis, more appropriate since the determination of which institutions ~ ght warrant this support for clinical investigation support could best be done by NIH rather Can the usual third-p~ty payers, including Medicare.
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