(B) Those Federal governmental third-party programs, such as Medicare and Medicaid, to the extent that the applicant is entitled to reimbursement at reasonable cost under a formula established in accordance with applicable Federal law.

(ii) Take such additional steps as may be necessary to ensure that admission to and services of the facility will be available to beneficiaries of the governmental programs specified in paragraph (d)(2)(i) of this section without discrimination (or preference) on account of their being such beneficiaries.

(e) Reports. The annual statement required by section 646 of the Act and § 53.128(q), a copy of which must be submitted to the State agency in accordwith the requirements of § 53.111(e)(1), shall set forth the amount of the reimbursement received pursuant to each arrangement with a principal governmental third-party payor.

ance

(f) Evaluation and enforcement. The State plan shall provide for evaluation and enforcement of the community service assurance in accordance with the following requirements:

(1) The State agency shall,

(i) At least annually, evaluate the compliance of facilities with such assurance; and

(ii) Establish procedures for the investigation of complaints that such assurance is not being complied with.

(2) The State plan shall provide for adequate methods of enforcement of the assurance, including effective sanctions to be applied against any facility which fails to comply with such assurance. Such sanctions may include, but need not be limited to, license revocation, termination of State assistance and court action.

(g) Reports. (1) The State agency shall, not less often than annually, report in writing to the Secretary its general evaluation of facilities' compliance with the assurance, the disposition of each complaint received by the State agency, proposed remedial action with respect to each facility found by the State agency to be not in compliance with the assurance, and the status of such remedial action.

(2) In addition, the State agency shall promptly report to the Regional Attorney and Regional Health Director

of the Department of Health and Human Services the institution of any legal action against a facility or the State agency involving compliance with the assurance.

[39 FR 31767, Aug. 30, 1974, as amended at 42 FR 16780, Mar. 30, 1977]

Subpart M [Reserved]

Subpart N Loan Guarantees and Direct Loans

§ 53.154 Waiver of right of recovery.

In determining whether there is good cause for waiver of any right of recovery which he may have against a nonprofit private agency by reason of any payments made pursuant to a loan guarantee, or against a public agency by reason of the failure of such agency to make payments of principal and interest on a direct loan to such agency, the Secretary shall take into consideration the extent to which:

(a) The facility with respect to which the loan guarantee or direct loan was made will continue to be devoted by the applicant or other owner to use for the purpose for which it was constructed or another public or nonprofit purpose which will promote the purposes of the Act;

(b) There are reasonable assurances that for the remainder of the repayment period of the loan other public or non-profit facilities not previously utilized for the purpose for which the facility was constructed will be so utilized and are substantially equivalent in nature and extent for such purposes; and

(c) Such recovery would seriously curtail the provision of medical services to persons in need of such services in the area.

[37 FR 182, Jan. 6, 1972]

$53.155 Modification of loans.

No official of the Department of Health and Human Services will approve any proposal to modify the terms of a loan guaranteed under title VI of the Public Health Service Act (42 U.S.C. 291 et seq.) and this subpart which would permit the use of the guaranteed loan (or the guarantee) as

collateral for an issue of tax-exempt securities.

[48 FR 42984, Sept. 21, 1983]

$53.156 Fees for modification requests.

(a) Fees will be charged for the processing of requests for parity, and for major and minor modifications of the terms of documents evidencing and securing direct and guaranteed loans. In accordance with the requirements of the User Charge Statute, 31 U.S.C. 9701(b), the Secretary determines the amount of the application fee that must be submitted with each type of modification.

(1) As used in this section, a request for parity allows new debt to share lien position (i.e. collateral) with an existing Hill-Burton loan.

(2) As used in this section, a major modification is any modification involving the release of $100,000 or more of collateral; a corporate restructuring that involves a transfer of assets; master indenture requests; modifications to a sinking fund; defeasance requests and requests for additional secured indebtedness; and any, other modification that involves a comparably significant use of Department resources.

(3) As used in this section, a minor modification is any modification involving the release of less than $100,000 of collateral; an easement; and any other modification that involves a comparable use of Department resources.

(b) A request for modification is to be accompanied by a certified check or money order in the amount of the appropriate fee, payable to the U.S. Treasury. The fees for modification requests submitted on or after October 28, 1986 are as follows:

(1) $1,500 for a minor modification, (2) $4,500 for a major modification, and

(3) $5,500 for a request for parity.

(c) A submitter may withdraw its request for modification within 10 business days following its receipt and receive a refund of the fee.

(d) If the Secretary determines that a change in the amount of a fee is appropriate, the Department will issue a notice of proposed rulemaking in the

Act, as used in this part, means the Federal Mine Safety and Health Act of 1977, as amended (30 U.S.C. 801 et seq.).

Secretary means the Secretary of Health and Human Services and any other officer or empolyee of the Department of Health and Human Services to whom the authority involved has been delegated.

Miner or coal miner means any individual who works or has worked in or around a coal mine or coal preparation facility in the extraction or preparation of coal. The term also includes an individual who works or has worked in coal mine construction or transportation in or around a coal mine, to the

extent that the individual was exposed to coal dust as a result of employment.

§ 55a.102 Who is eligible to apply for a Black Lung clinics grant?

Any State or public or private entity may apply for a grant under this part. § 55a.103 What criteria has HHS established for deciding which grant application to fund?

(a) The Secretary will give preference to a State, which meets the requirements of this part and applies for a grant under this part, over other applicants in that State.

(b) Within the limits of funds available for these purposes the Secretary may award grants to assist in the carrying out of those programs which will in the Secretary's judgment best promote the purposes of section 427(a) of the Act, taking into account;

(1) The number of miners to be served and their needs; and

(2) The quality and breadth of services to be provided.

§ 55a.104 What confidentiality requirements must be met?

All information as to personal facts and circumstances obtained by the grantee's staff about recipients of services shall be held confidential and shall not be disclosed without the individual's consent except as may be required by law or as may be necessary to provide service to the individual or to provide for audits with appropriate safeguards for confidentiality of patient records. Otherwise, information may be disclosed only in summary, statistical, or other form which does not identify particular individuals.

§ 55a.105 How must grantees carrry out their projects?

Grantees must carry out their projects in accordance with their applications and the provisions of this part.

§ 55a.106 Provision for waiver by the Secretary.

The Secretary may, for good cause shown, waive provisions of these regulations.

Other regulations which apply to the Black Lung Clinics Program include, but are not limited to, the following:

42 CFR part 50, subpart D-Public Health Service grant appeals procedure;

42 CFR part 50, subpart E-Maximum allowable cost for drugs;

45 CFR part 16-Procedures of the Departmental Grant Appeals Board;

45 CFR part 19-Limitations on payment or reimbursement for drugs;

45 CFR part 74-Administration of grants; 45 CFR part 75-Informal grant appeals procedures;

45 CFR part 80-Nondiscrimination under programs receiving Federal assistance through the Department of Health and Human Services effectuation of title VI of the Civil Rights Act of 1964;

45 CFR part 81-Practice and procedure for hearings under part 80;

45 CFR part 84-Nondiscrimination on the basis of handicap in programs and activities receiving or benefiting from Federal financial assistance; and

45 CFR part 91-Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance.

Subpart B-Grants to States

§ 55a.201 What is required for a State application?

An approvable State application must contain assurances that the State will:

(a) Provide the following services for active and inactive miners in the State:

(1) Primary care;

(2) Patient and family education and counseling;

(3) Outreach;

(4) Patient care coordination, including individual patient care plans for all patients;

(5) Antismoking advice; and

(6) Other symptomatic treatments. (b) Provide medical services in consultation with a physician with special training or experience in the diagnosis and treatment of respiratory diseases.

(c) Meet all criteria for approval and designation by the Department of Labor under 20 CFR part 725 to perform disability examination and provide treatment under the Act.

(d) Use grant funds under this part to supplement and not supplant existing services of the State.

(e) Provide the services described above for those miners previously served by a Black Lung Clinic in the State for which grant support expires during the funding period of the State's grant.

(f) Provide services described above regardless of a person's ability to pay. (g) Audit its expenditures from amounts received under this part in accordance with the provisions of Attachment P, Audit Requirements, of Office of Management and Budget Circular A102, Uniform Requirements for Assistance to State and Local Governments, as adopted for the Department of Health and Human Services by 45 CFR part 74.

(Approved by the Office of Management and Budget under control number 0915-0081)

[50 FR 7913, Feb. 27, 1985, as amended at 50 FR 53156, Dec. 30, 1985]

Subpart C-Grants to Entities
Other Than States

§ 55a.301 What is required for an application from an entity other than a State?

An approvable application must contain the following:

(a) A plan for the provision of the services required by §55a.201(a), consistent with the requirements of § 55a.201 (b) and (c). The plan must also contain at least the following elements:

(1) A description of the target population to whom services are to be provided, including a statement of the need for services;

(2) An assurance that charges shall be made for services rendered as follows:

(i) A schedule shall be maintained listing fees or payments for the provision of services, designed to cover reasonable costs of operations;

(ii) A schedule of discounts adjusted on the basis of a patient's ability to pay shall be maintained. The schedule of discounts must provide for a full discount to individuals and families with annual incomes at or below the poverty line established in accordance with sec

tion 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)), (except that nominal fees for service may be requested, but not required, from individuals and families with annual incomes at or below the poverty line). No discounts shall be provided to individuals and families with annual incomes greater than twice the poverty line; and

(iii) Where third-party payors (including Government Agencies) are authorized or under a legal obligation to pay all or a portion of such charges, all services covered by that reimbursement plan will be billed and every reasonable effort will be made to obtain payment.

(b) An assurance that no person will be denied services because of inability to pay.

(c) An assurance that grant funds received under this part will be used to supplement and not supplant existing services of the grantee.

(Approved by the Office of Management and Budget under control number 0915-0081)

[50 FR 7913, Feb. 27, 1985, as amended at 50 FR 53156, Dec. 30, 1985]

(b)(1) Agriculture means farming in all its branches, including

(i) Cultivation and tillage of the soil; (ii) The production, cultivation, growing, and harvesting of any commodity grown on, in, or as an adjunct to or part of a commodity grown in, or on, the land; and

(iii) Any practice (including preparation and processing for market and delivery to storage or to market or to carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an activity described in subsection (ii).

(c) Catchment area means the geographic area served by a project funded under section 319 of the Act.

(d) Environmental health services means the detection and alleviation of unhealthful conditions of the environment of the persons served by the project, such as problems associated with water supply, sewage treatment, solid waste disposal, rodent and parasite infestation, field sanitation, and housing conditions and the treatment of medical conditions arising therefrom. For the purposes of this part, the detection and alleviation of unhealthful conditions of the environment includes the notification of appropriate Federal, State, or local authorities responsible for correcting such conditions and the making of arrangements therefor with such authorities.

(e) Health professionals means professionals (such as physicians, dentists, nurses, podiatrists, optometrists, and physicians' extenders) who are engaged in the delivery of health services and who meet all applicable Federal or State requirements to provide their professional services.

(f) High impact area means a catchment area which has not less than 6,000 migratory agricultural workers, seasonal agricultural workers, and members of the families of such workers residing within its boundaries for more than two months in the most recent calendar year for which statistical data acceptable to the Secretary is available.

(g)(1) Migrant health center means an entity which either through its staff and supporting resources or through contracts or cooperative arrangements