Services for Patients Involved in National Institutes of Health-Supported Research:

How Should They Be Classified and Who Should Pay for Them

HRD-78-21: Published: Dec 22, 1977. Publicly Released: Dec 22, 1977.

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The National Institutes of Health (NIH) incurs costs for the care of patients participating in research that should be paid by patients or insurers. NIH often does not know whether grantees are charging it reasonable rates for patient care services because of inadequate monitoring of financial management aspects of grants involving such services.

There are no Institute-wide guidelines on what patient care services can be paid with research and contract funds. NIH does not take sufficient action to ensure that grantees submit information required for grant administrators to make sound financial decisions.

Matter for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: Incorporated in the OMB budget cuts for FY 1984 is the requirement that NIH start charging room and board to patients treated at the NIH Clinical Center. Congressional approval of this budget would address the GAO recommendation that the Public Health Service Act be clarified.

    Matter: Congress should clarify section 301(e) of the Public Health Service Act to specificlally state whether study patients at Public Health Service institutions, hospitals, and stations can be charged for any services they receive.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of Health, Education, and Welfare (HEW) should require the Director of NIH to establish a uniform NIH-wide policy on patient care costs with implementing guidelines on allocation of charges for patient care between NIH and the patient or other parties.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of HEW should require the Director of NIH to require that contract and grant officials enforce the new guidelines.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of HEW should strengthen procedures for negotiating rates and obtaining reports by requiring that patient care rates be negotiated within a certain time.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Not Implemented

    Comments: Although NIH policy on patient care costs requires submission of information which relates to computing costs, NIH believes that OMB, in restricting grant awarding agencies from requiring submission of categorized reports of expenditure, has limited the availability of financial data to support patient care charges to grants.

    Recommendation: The Secretary of HEW should require the Director of NIH to require all contractors and grantees, as part of the guidelines, to submit information on how they computed patient care costs charged to NIH, such as is now required by the Division of Research Resources in annual reports from General Clinical Research Centers.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Not Implemented

    Comments: HEW did not believe NIH should do its own negotiations believing that these negotiations should be centralized in one office and did not address the adequacy of regional comptrollers' negotiations.

    Recommendation: The Secretary of HEW should strengthen procedures for negotiating rates and obtaining reports by determining whether the regional comptrollers are adequately negotiating patient care rates or whether NIH should develop the capability to negotiate its own rates.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of HEW should instruct the Director of NIH to require NIH organizations, with guidelines for charging patient care services to their grants, to require that grantees comply with these guidelines so that improper payments for nonresearch services provided by grantees will be minimized.

    Agency Affected: Department of Health and Human Services

  7. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of HEW should instruct the Director of NIH to require the National Heart, Lung, and Blood Institute to discontinue placing in grant awards the provision for allowing grantees to use ordinary hospital rates for computing charges to the grant for patient care.

    Agency Affected: Department of Health and Human Services

  8. Status: Closed - Not Implemented

    Comments: HEW explained that the problem in obtaining reports of expenditure and annual reports is the delay in negotiating patient care rates, but that if regional comptrollers notified NIH of delinquent rate proposals cooperation would be provided. HEW did not address the issue of strengthening or imposing penalties for noncompliance. GAO is currently doing a survey on NIH and this issue.

    Recommendation: The Secretary of HEW should strengthen procedures for negotiating rates and obtaining reports by requiring the Director of NIH to more vigorously enforce the requirement for grantees to submit satsifactory rate proposals, reports of expenditures, and annual reports; strengthen the penalties for noncompliance; and impose the penalty permitted in the regulations when grantees fail to cooperate.

    Agency Affected: Department of Health and Human Services

  9. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of HEW should require the Director of NIH to establish criteria for evaluating use of clinical research centers, The criteria should include, but not be limited to, consideration of occupancy rates, the number of researchers using the centers, and training programs provided by the centers.

    Agency Affected: Department of Health and Human Services

 

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