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Chapter 01 - Health Care Planning

Chapter 01 - Health Care Planning

11.0101 Federally funded programs and projects ASHPDA consideration.


Public health-grant funding agencies, in reviewing applications for federal grants and loans, need to evaluate proposed projects and programs in terms of their consistency with local health goals, objectives, and priorities, and their expected impact on community health needs. The American Samoa Health Planning and Development Agency (ASHPDA) is equally concerned that federally funded projects and programs are consistent with and will support implementation of the American Samoa Plan for Health, and will contribute to the most effective utilization of limited health resources in the territory. Therefore, it is most appropriate, and in the best interest of both the federal funding agency and the territory of American Samoa, that the ASHPDA review and approve/disapprove applications for the proposed use of federal health funds in the territory.

11.0102 Authority – Review procedures and criteria.


(a) Health services agencies (HSAs) are mandated by PL 93-641, § 1513(e) to perform the review and approval/disapproval function for certain proposed uses of federal health funds when the agencies are fully designated and authorized to do so by the Secretary of Health and Human Services. Under the provisions of 1536(d) of the Public Health Services Act, the ASHPDA assumes this function in American Samoa as though the territory were a health service area and the ASHPDA an HSA for the area. Locally, PL 16-26 also provides authority for the ASHPDA to perform this function.

(b) Final rules were issued on 10 Aug 79 governing review and approval/disapproval of certain proposed uses of federal funds. These rules set forth the minimum procedures and criteria for health systems agency (ASHPDA) reviews under 1513(e) of this Public Health Services Act, and became effective 8 Nov 79. The ASHPDA received authorization from the Secretary of HHS to perform this function, effective 1 Jul 79.

11.0103 Purpose.


The purpose of this chapter is to provide and communicate standardized review procedures and criteria for ASHPDA review of health-related grant proposals. The aim is to assure every applicant an objective and fair review and every funding agency a thorough rendering of territorial assessment and judgment.

11.0104 ASHPDA dual role – American Samoa Plan for health.


The ASHPDA performs a dual role in the territory: that of planning, and resources development. The American Samoa Plan for Health, developed in cooperation with the American Samoa health coordinating council, is the principal means of expression of the health care needs of the territory and, when approved by the Governor, becomes a statement of territorial health policy. As a resource allocator, the ASHPDA empts to ensure that resources developed within the territory and flowing into the territory support and are consistent with local needs as expressed in the plan for health and annual implementation plan, and to provide timely technical assistance to potential applicants for federal funds, so as to minimize the likelihood of a completed application being disapproved, either by the ASHPDA or the funding agency.

11.0105 Review required when.


The ASHPDA will review and approve, or disapprove, each proposed use within the territory of federal funds:

(1) appropriated under the Public Health Services Act; the Community Mental Health Centers Act, §§ 409 and 410 of the Drug Abuse Office and Treatment Act, or the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 for grants, contracts, loans, or loan guarantees for the development, expansion, or support of health resources; and

(2) made available by the territory from an allotment to the territory under an act referred to in subsection (1) of this section for grants or contracts for the development, expansion, or support of health resources.

Appendix A contains a list of the proposed uses of federal funds currently subject to review. This list should not be considered to be exhaustive nor static, since funding agencies may from time to time identify on a case-by-case basis those special activities in the programs listed that are not subject to review and approval/disapproval, as well as those programs not listed that are subject to review and approval/disapproval. The list also indicates the role of other territorial and federal agencies in the review process. Appendix A is not a part of this code since the HHS Secretary may, from time to time, add or delete programs from the list.

The ASHPDA will review and comment only on any other application for federal grant funds not included in the list, if requested by the federal funding agency involved.

11.0106 Review not required when – Five-year continuation reviews.


(a) The ASHPDA has no authority to review and approve, or disapprove:

(1) noncompeting extension grant applications;

(2) supplemental grant applications which are for administrative increases in costs;

(3) noncompeting continuation grant applications unless one of the following occurs:

(A) The ASHPDA sends to their federal funding agency its request to review and approve or disapprove the application at least 9 months before the award date,

(B) The applicant proposes a change in funding level of 20% or more,

(C) The applicant or the federal funding agency determines that there has been a substantial change in the proposed or actual use of funds,

(D) if none of the above, every 5 years beginning 8 Nov 79.

(b) The provisions for review and comment on Indian tribe applications does not apply in American Samoa since there are no Indian tribes or Indian reservations in the territory.

11.0107 ASHCC review.


In a parallel manner, § 1524(c) (6) of the Public Health Services Act requires the ASHCC to annually review and approve, or disapprove, any territory program plan and application submitted to HHS as a condition to the receipt of any funds under allotments made to states and territories under the acts cited in 11.0105(1). Procedures and criteria governing those reviews are contained in an ASHCC document entitled “Procedures and Criteria: Review of Territorial Plans and Applications”, which is codified in this chapter. Opportunity for the ASHCC to review and comment on each proposed use of federal funds reviewed by the ASHPDA under 1513(e) is provided for under 11.0118.

11.0108 Reports on proposal development.


Providers of health services and other persons subject to ASHPDA review under § 1513(e) of the Public Health Services Act are required to submit periodic reports to the ASHPDA respecting the developmentofproposals for review.

11.0109 Letter of intent to file federal funds – application.


(a) Prior to the submission of an application for federal funding, the proposal sponsor should send a letter to the ASHPDA indicating:

(1) the nature of the proposal, including the problem or need which the project or program is to meet;

(2) the grant program from which funding is being requested; and

(3) the probable date the application will be filed with the ASHPDA and the funding agency. It is particularly important in the case of construction projects that the letter of intent be submitted at the earliest possible opportunity in the course of planning of such projects. Such letter of intent must be in the form and include all of the information described in Appendix C. This will allow for scheduling of projected workload and provide that any assistance requested of the ASHPDA can be provided in a timely fashion. This will also enable the ASHPDA to determine if the proposed project also requires a review under PL 16-26, Certificate of Need.

(b) While federal funding cycles will largely dictate the scheduling of letter of intent and application submissions, it is recommended that, at a minimum, the letter of intent should be filed no fewer than 30 days prior to formal submission of the application. The ASHPDA will acknowledge receipt of the letter of intent and may schedule a presubmission conference.

(c) Ideally, project or program sponsors should meet with representatives of the ASHPDA during the planning/development phase of project proposals so fat the ASHPDA may make the sponsor aware of the agency’s plans, standards, criteria, and review procedures. In this manner the ASHPDA can share its findings of health status and health system needs with the sponsor and make other pertinent data and information available.

11.0110 Presubmission conference.


If a presubmission conference is scheduled, the staff person assigned to the project will prepare copies of pertinent information for the use of the proposal sponsors. This will include copies of the adopted plans, standards, and criteria relating to the proposed project. At this time the ASHPDA will also inform the sponsor whether or not the proposal also requires review under the provisions of PL 16-26, Certificate of Need.

The ASHPDA will coordinate, to the maximum extent Possible, its reviews of projects under these procedures and its reviews of new institutional health services under PL 16-26 (see 11.0119). This information will be discussed with the proposal sponsor to indicate areas of conformance or nonconformance of the proposed project to the American Samoa Plan for Health and the Territorial Medical Facilities Plan. Hopefully, these considerations will have occurred during the program planning process that resulted in the grant application’s development. In such a situation, the presubmissionconference will be limited largely to review process requirements such as the scheduling of meetings, number of copies required, etc.

11.0111 Applications – Submission.


Applications for federal funds must be submitted at the times and in the form and manner prescribed by the funding agency. At the time the applicant submits the application to the funding agency, 3 copies will be simultaneously submitted to the ASHPDA. The ASHPDA requires that at a minimum the applicant supply the information in Appendix B when making application. If the information required by the funding agency does not include that stipulated in Appendix B, the applicant must preparesupplemental material to be submitted to the ASHPDA with the application. Upon receipt of an application, the ASHPDA staff will review the application for completeness. If the application is determined to be incomplete, the ASHPDA will notify the applicant immediately of the areas of incompleteness. Presubmission conferences will help to ensure that an application will be complete at the time of submission.

11.0112 Applications – Noncompeting continuation grants.


Applications for noncompeting continuation grants will also be submitted to the ASHPDA simultaneously with submission to the federal funding agency. All such applications will be reviewed by the ASHPDA. However, the ASHPDA shall only have approval/disapproval authority over those applications meeting the conditions of 11.0106(a) (3).

11.0113 Applications – Confidential or proprietary information.


If an application contains material which the applicant believes to be confidential or proprietary and therefore believes should not become public, (he applicant may submit a summary of this material to the federal funding agency. Upon determination by the federal funding agency that (1) the material is confidential or proprietary and (2) the summary is full and accurate, the applicant may submit the summary to the ASHPDA along with the application, deleting the portion of the application which has been summarized.

11.0114 Applications – Allotment-fund proposals.


A proposal for using funds available from a territorial allotment which is subject to ASHPDA review under 11.0105(2) must be submitted to the ASHPDA by the territorial program agency (department of health). These proposed projects must be submitted to the ASHPDA at the same time the application for allotment funds is submitted to the ASHCC. The ASHPDA must be allowed a minimum of 60 days to review the proposed uses of allotment funds. The information requirements outlined in 11.0111, as contained in Appendix B, also apply to applications containing proposed uses of allotment funds.

11.0115 Notice of review – Deadline – Content.


(a) Within 7 days of receipt of an application subject to review under 11.0105 or 11.0106, the ASHPDA will send notification to affected persons of the beginning of the review, including a review schedule and the period during which a public hearing may be requested. Such notification shall include:

(1) the proposed schedule for the review;

(2) the period during which a public hearing during the course of the review may be requested by persons directly affected as defined in subsection (b) of this section; and

(3) the manner in which notification of the time and place of any hearing so requested will be provided.

(b) “Affected persons” includes:

(1) the applicant;

(2) major health and health-related institutions and agencies in the territory;

(3) agencies with which the ASHPDA must coordinate its activities pursuant to § 1513(d) of the Public Health Services Act;

(4) territorial health program agencies, if allotment funds are involved;

(5) those members of the public who are to be served by the proposed projects; and

(6) the appropriate federal funding agency.

11.0116 Notice of review – Medium.


Written notification to affected members of the public may be provided through newspapers of general circulation and public information channels. All other affected persons shall be notified by mail.

11.0117 Time allowed for review – Submissions near funding deadlines.


(a) The ASHPDA will be allowed at least 60 days from the date of notification of the beginning of a review to complete its review of any proposal or application. The ASHPDA will complete its review in 60 days or less unless the appropriate federal funding agency or territorial program agency specifies in writing a longer period with respect to a particular program or project.

(b) Where a proposed use of federal funds is submitted to the ASHPDA for review less than 120 days prior to the end of the period of availability of the funds involved, the federal funding agency, at its option, after consultation with the ASHPDA and following its determination that the application could not reasonably have been submitted to the ASHPDA at least 120 days prior to the end of the period of availability of funds, make the grant, loan, or loan guarantee or award the contract so as to preserve the availability of the funds. However, in such cases, no federal funds may be expended until:

(1) the ASHPDA has approved the application; or

(2) the ASHPDA has notified the funding agency that it will not disapprove the application; or

(3) the period for ASHPDA review has passed without the ASHPDA having notified the funding agency of its disapproval; or

(4) the Secretary has determined, notwithstanding the ASHPDA’s disapproval, to make such funds available.

11.0118 Plan implementation committee comment.


The ASHPDA will submit copies of each application under review to the plan implementation committee (PIC) of the ASHCC within 7 days of the beginning of the review. The plan implementation committee will be allowed 14 days from the receipt of the application to submit its comments to the ASHPDA. The ASHPDA will not make its final determination on any application until the time allowed the PIC for comments has elapsed or until such comments have been received, whichever comes first.

11.0119 Coordination with certificate of need reviews.


To the extent possible, and whenever appropriate, the ASHPDA will coordinate its review of proposed uses of federal funds with certificate of need reviews. Applicants who anticipate submitting both applications for certificate of need and use of federal funds for the same project are encouraged to consult with the ASHPDA about coordinated submission of the applications. Approval of a project under one type of review in no way constitutes approval for the same project under another type of review.

11.0120 Notice of review findings.


(a) The ASHPDA will mail, no later than the close of the first business day following the end of the review period, to the applicant and the appropriate federal funding agency or territorial program agency, written notification of its approval or disapproval of the proposed use of federal funds and the reasons for such approval or disapproval.

(b) Any proposed use of federal funds with respect to which notification .has not been provided by the ASHPDA in accordance with these procedures shall be deemed not to have been disapproved by the ASHPDA.

11.0121 Appraisal of applicants and others – Reports of reviews – Public access.


(a) Applicants and other persons subject to ASHPDA review under these procedures shall be notified, upon request, of the status of the agency review of projects, of findings made in the course of such reviews, and other appropriate information respecting such reviews.

(b) At least annually, the ASHPDA shall publish a report of the reviews being conducted (including the status of each review) and of the reviews completed by the agency since the publication of the last report, and a general statement of the findings and decisions made in the course of such reviews.

(c) All applications (or summaries thereof) reviewed by the ASHPDA and all other written materials pertinent to such reviews shall be accessible to the public for viewing or copying at the ASIIPDA office in the LBJ Tropical Medical Center.

11.0122 Public hearing.


(a) The ASHPDA shall provide for a public hearing during the course of any agency review if requested by one or more persons directly affected by the review, if such request is made within 14 days of the notification of the beginning of the review. “Persons directly affected” by the review include:

(1) the applicant;

(2) entities with which the ASHPDA must coordinate its activities pursuant to § 1513(d) of the Public Health Services Act;

(3) entities located in the territory which provide services or conduct activities similar to the proposed services or activities under review or which, prior to the receipt by the ASHPDA of the application for review, have formally indicated an intention to provide similar services or conduct similar activities in the future; and

(4) members of the public who are to be served by the projects.

(b) Anyone may present testimony at a public hearing.

(c) Where such a hearing is requested, the ASHPDA shall, prior to such hearing, provide notice of such hearing, in accordance with 11.0115.

11.0123 Scope of review – Substantial conformance principle – Criteria use.


(a) The role of the ASHPDA under § 15 13(e) of the Public Health Services Act is to approve or disapprove a proposal on the basis of its conformance with the plans and the criteria it has developed and adopted. The ASHPDA will not involve itself in evaluation of the technical or scientific merit of the proposals. It is the place of the federal funding agency, in its review of proposals, to make determinations of technical and scientific merit, to give consideration to program priorities (sometimes established statute) , and to evaluate and judge the relationship of the proposal to other parts of the program.

(b) It is not appropriate to prescribe that a finding of inconsistency with a single criterion requires agency rejection of the project. However, it is not expected that projects which are found to be inconsistent with the plan for health would be approved by the ASHPDA unless exceptional circumstances or significant inaccuracies in the plan were demonstrated. The general principle remains, as in other kinds of review by the ASHPDA, that approvals, disapprovals, and recommendations are to be based on a proposal’s substantial conformance with all applicable criteria taken as a whole.

(c) The criteria set forth in 11.0124 have been adopted by the ASHPDA for utilization in conducting reviews of the proposed uses of federal funds in the territory. The ASHPDA will utilize these criteria as appropriate for the particular review being conducted or the type of health service reviewed.

11.0124 Criteria.


The criteria adopted by the ASHPDA are:

(1) Health Plans Relationship. The relationship of the health services being reviewed to the American Samoa Plan for Health and the ASHPDA annual implementation plan:

(2) Long-range Plans. The relationship of services being reviewed to the long-range development plan (if any) of the persons providing or proposing such services;

(3) Need and Under-served Groups. The need that the population served or to be served has for the services proposed to be offered or expanded, and the extent to which low-income persons, racial and ethnic minorities, women, handicapped persons, and other under-served groups are likely to have access to those services. In the case of a reduction or elimination of a service, including the relocation of a facility or a service, the need that the population presently served has for the service, the extent to which that need will be met adequately by the proposed relocation or by alternative arrangements, and the effect of the reduction, elimination or relocation of the service on the ability of low-income persons, racial and ethnic minorities, women, handicapped persons, and other under-served groups to obtain needed health care;

(4) Alternatives. The availability of alternative, less-costly, or more effective methods of providing such services;

(5) Financial Feasibility and Impact. The immediate and long-term financial feasibility of the proposal and the probable impact of the proposal on the costs of and charges for providing health services in the territory;

(6) Health-care System Relationship. The relationship of the services proposed to be provided to the existing health-care system of the territory;

(7) Resources Availability and Alternative Uses. The availability of resources (including health manpower, management personnel, and funding for capital and operating needs) for the provision of the services proposed to be provided and the availability of alternative uses of such resources for the provision of other health services;

(8) Ancillary or Support Services Relationships. The relationships, including the organizational relationships, of the health services proposed to be provided to ancillary or support services in the territory;

(9) Contribution to the Under-served and Access-restricted. The contribution of the project in meeting the health-related needs of member of medically under-served groups and members of groups which have traditionally experienced difficulties in obtaining equal access to health services (for example, low-income persons, racial and ethnic minorities, women, and handicapped persons) , particularly those needs identified in the applicable health systems plan and annual implementation plan as deserving a priority;

(10) Construction Projects. In the case of a construction project, the relationships of the project to the Territorial Medical Facilities Plan and:

(A) the costs and methods of the proposed construction, including the costs and methods of energy provision; and

(B) the probable impact of the construction project reviewed on the costs of providing health services by the person proposing such construction project;

(11) HMO Needs and Circumstances. The special needs and circumstances of health maintenance organizations (HMOs) for which assistance may be provided under Title XIII of the Public Health Services Act. These needs and circumstances must be limited to:

(A) the needs of enrolled members and reasonably anticipated new members of the HMOs or proposed HMO for the health services, proposed to be provided by the organization;

(B) the availability of these health services from non-HMO providers or other HMOs in a reasonable and cost-effective manner which is consistent with the basic method or operation of the HMOs or proposed HMO. In assessing the availability of such health services from non-HMO providers or other HMO providers, the agency must consider only whether the health services from these providers:

(I) would be available under a contract of at least 5 years duration;

(II) would be available and conveniently accessible through physicians and other health professionals associated with the HMO or proposed HMO. (For example, whether physicians associated with the HMO have or will have full staff privileges at a non-HMO hospital.) ;

(III) would cost no more than if the health services were provided by the HMO or proposed HMO; and

(IV) would be available in a manner which is administratively feasible to the HMO or proposed HMO;

(C) other factors the agency may propose and the Secretary may find to be consistent with the purpose or Title XIII of the Public Health Services Act;

(12) Research Project Needs and Circumstances. The special needs and circumstances of biomedical and behavioral research projects which are designed to meet a national need and for which local conditions offer special advantages;

(13) Nonlocal Provider Needs. The special needs and circumstances of those entities which provide a substantial portion of their services or resources or both to individuals not in the health services areas in which the entities are located or in adjacent health service areas. These entities may include medical and other health profession schools, multidisciplinary clinics, and specialty centers;

(14) Energy Conservation. The special circumstances of health-care institutions with respect to the need for conserving energy.

11.0125 Funding despite disapproval – Review requirement.


If the ASHPDA, in accordance with the applicable provisions of 42 CFR Part 122, Subpart E, disapproves a proposed use in the territory of federal funds, the HHS Secretary may not make such federal funds available for such use until he has made, upon the request of the entity making such proposals, a review of the agency decision.

11.0126 Funding despite disapproval – Review requests.


To be effective, a request for review of an ASHPDA disapproval of proposed use of federal funds must be:

(1) received by the federal funding agency, in such form and manner as may be prescribed by the federal funding agency, not later than 15 days after the provision of notice to the applicant of disapproval of the proposed use of federal funds by the ASHPDA in accordance with 1l.0124;and

(2) accompanied by a justification for approval by the Secretary of the proposed use of federal funds despite the ASHPDA’s disapproval, including detailed responses to the reasons given by the ASHPDA for its disapproval.

11.0127 Funding despite disapproval – Explanation.


The Secretary may make such federal funds available for such use, notwithstanding the disapproval of the ASHPDA. In such an event the Secretary will submit to the applicant and the ASHPDA a detailed statement of the reasons for the decision.

11.0128 Rules amendment – Notice.


When upon its own initiative the ASHPDA proposes to adopt, amend, or repeal all or any part of the procedures and criteria codified in this chapter a notice of such proposal will be published in at least one territorial newspaper of general circulation stating that new/revised procedures and/or criteria have been proposed for adoption and that these proposed procedures are available at the ASHPDA offices for public viewing and/or copying. The term “amend” includes any editorial and/or substantive changes.

11.0129 Rules amendment – Comment period.


Interested persons will be allowed 30 days from the date of publication to comment on the proposed review procedures and criteria.

11.0130 Rules amendment – Distribution of proposals.


Copies of the proposed procedures and criteria will be distributed:

(1) to all entities with which the ASHPDA must coordinate its activities;

(2) to units of territorial government related to health matters;

(3) to the American Samoa health coordinating council.

11.0131 Rules amendment – Adoption.


When the period for public comment has expired the ASHPDA will consider any comments received and will formally adopt the proposed procedures and criteria.

11.0132 Rules amendment – Distribution after adoption.


Adopted procedures and criteria will be distributed to the entities in 11.0130 and to the Region IX HHS offices.

11.0133 Appendix A noncode status.


Appendix A is not a part of this code since the Secretary may, from time to time, add or delete programs from the list.