[44 FR 17921, Mar. 23, 1979, as amended at 45 FR 31095, May 12, 1980]

§§ 54a.508-54a.509 [Reserved]

§ 54a.510 Additional conditions.

The Secretary may with respect to any grant award impose additional conditions prior to or at the time of any award when in his judgment those conditions are necessary to assure or protect advancement of the approved program, the interest of public health or the conservation of grant funds.

PART 55α-PROGRAM GRANTS FOR BLACK LUNG CLINICS

Sec.

55a.1 To whom do these regulations apply? 55a.2 Definitions.

55a.3 Who is eligible to apply for a Black Lung Clinics grant?

55a.4 What must an application for a Black Lung Clinics grant contain? 55a.5 What requirements must a Black Lung Clinic meet?

55a.6 What criteria has HHS established for deciding which grant applications to fund?

55a.7 How may project funds be used? 55a.8 What other HHS regulations apply? 55a.9 What confidentiality requirements must be met?

AUTHORITY: Sec. 508, 83 Stat. 803 (30 U.S.C. 957), unless otherwise noted.

SOURCE: 45 FR 72161, Oct. 31, 1980, unless otherwise noted.

an application for a grant under this part.

"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.

"Secretary" means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved may be delegated.

[45 FR 72161, Oct. 31, 1980, as amended at 47 FR 53012, Nov. 24, 1982]

§ 55a.3 Who is eligible to apply for a Black Lung Clinics grant?

(a) Any public or private entity may apply for a grant under this part.

(b) Eligible projects: grants pursuant to section 427(a) of the Act and this part may be made to eligible applicants for carrying out area or statewide clinical services for the analysis, examination, and treatment of occupational respiratory and pulmonary impairments in coal miners.

[45 FR 72161, Oct. 31, 1980, as amended at 47 FR 53012, Nov. 24, 1982]

33-147 0-84--18

how progress toward their achievement will be measured;

(4) A description of how existing resources in the community will be utilized to maximize the effectiveness and efficiency of the use of grant funds; and

(5) Letters of intent from each entity which is expected to provide any service under the Black Lung Clinics Program, including a statement that, contingent upon a grant award, services will be provided in accordance with the requirements under this part.

(b) An assurance that, should an award be made, the grantee will enter into binding agreements with each of the listed clinics providing letters of intent which shall include provisions that:

(1) No person will be denied services because of inability to pay;

(2) Services will be made available regardless of how long the miner has lived in the service area or whether anyone referred the miner to the clinic;

(3) Services will be made available in a manner calculated to preserve human dignity and to maximize acceptability and utilization of services;

(4) 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 operation;

(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 levels set forth in the most recent Community Services Administration Income Poverty Guidelines at 42 CFR 1060.2 (except that nominal fees for service may be collected from individuals and families with annual incomes at or below those levels if imposition of the fees is consistent with project goals). No discounts shall be provided to individuals and families with annual incomes greater than twice those set forth in the Guidelines;

(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; and

(iv) Where the cost of care and services furnished under the program is to be reimbursed under Title XIX of the Social Security Act, a written agreement with the Title XIX agency will be obtained by the clinic unless the Title XIX agency refuses to enter into the agreement and the clinic provides evidence of the refusal to the grantee. (5) Grant funds will be used to supplement and not supplant existing services.

(6) Medical services will be performed in consultation with a physician with special training or experience in the diagnosis and treatment of respiratory diseases.

(c) A description of how each clinic or group of clinics will assure consumer participation in the development of policy applicable to the administration and delivery of black lung clinic services through a policy board or an advisory committee to the policy board. If the policy board consists of a majority of miners or miner-selected representatives, this requirement is satisfied. If this is not the case, an advisory committee to the policy board with a majority of miners or miner-selected representatives, but also including interested parties, such as health care providers, coal industry employers, representatives of third-party payors, and the general public, must be established. Procedures for the functioning of the advisory committee must be adopted which assure continued ability to represent the varied points of view, including that of consumers, and that committee recommendations are promptly referred to the policy board for consideration.

(d) Evidence that a copy of the application was forwarded to each of the affected health systems agencies designated under Title XV of the Public Health Service Act with a request that the agency review and approve the application and forward its comments to the Secretary. Regulations applying to health systems agencies appear in 42 CFR Part 122.

(Sec. 427(a), Federal Mine Safety and Health Act of 1977, 92 Stat. 100 (30 U.S.C. 937(a)).

[45 FR 72161, Oct. 31, 1980, as amended at 48 FR 29202, June 24, 1983; 48 FR 45558, Oct. 6, 1983]

§ 55a.5 What requirements must a Black Lung Clinic meet?

For inclusion in an applicant's plan, clinics must now, or with grant assistance be able to:

(a) Provide for the following services:

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

§ 55a.6

What criteria has HHS established for deciding which grant applications to fund?

(a) 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;

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

(3) The degree to which other resources are committed to the program; (4) The applicant's ability to manage the proposed program, including its experience with the delivery of medical services by clinical facilities and its ability to make rapid and effective use of the grant funds; and

(5) Whether proposed services are complementary to and nonduplicative of existing services, particularly in States or Regions where there are existing programs which are determined to be meeting or making satisfactory progress toward meeting identified needs.

(b) The notice of grant award specifies how long the Secretary intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 3 to 5 years.

(c) Generally the grant initially will be for 1 year and subsequent continuation awards also will be for 1 year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by the Secretary that continued funding is in the best interest of the Federal Government.

(d) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.

§ 55a.7 How may project funds be used?

A grantee shall only spend funds it receives under this part according to the approved application and budget, the authorizing legislation, terms and conditions of the grant award, applicable cost principles specified in Subpart Q of 45 CFR Part 74, and the regulations of this part.

§ 55a.8 What other HHS regulations apply?

Several other HHS regulations apply to grants under this part. These include, but are not limited to:

42 CFR Part 50-Policies of general applicability

42 CFR Part 122-Health systems agency reviews of certain proposed uses of Federal health funds

45 CFR Part 16-Department grant appeals process

45 CFR Part 19-Limitation on payments or reimbursements 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, Education, and Welfare-Effectuation of Title VI of the Civil Rights Act of 1964

45 CFR Part 81-Practice and procedures for hearings under Part 80 of this title

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

45 CFR Part 911-Nondiscrimination on the basis of age in Department programs or activities receiving Federal financial assist

ance

§ 55a.9 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 medical audits by the Secretary 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.

§ 56.102

Definitions.

As used in this part:

(a) “Act” means the Public Health Service Act (42 U.S.C. 201 et seq.), as amended.

(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.

cal 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 with other public or private entities provides for migratory agricultural workers, seasonal agricultural workers, and the members of the families of such workers, within its catchment area:

(i) Primary health services;

(ii) As determined by the Secretary to be appropriate for particular centers, supplemental health services necessary for the adequate support of primary health services;

(iii) Referral to providers of supplemental health services and payment, as determined by the Secretary to be appropriate and feasible, for the provision of such services;

(iv) Environmental health services, as determined by the Secretary to be appropriate for particular centers;

(v) As determined by the Secretary to be appropriate for particular centers, infectious and parasitic disease screening and control services;

(vi) As determined by the Secretary to be appropriate for particular centers, accident prevention programs, including prevention of excessive exposure to pesticides through, but not limited to, notification of appropriate Federal, State or local authorities of hazardous conditions due to pesticide use; and

(vii) Information on the availability and proper use of health services.

(2) For purposes of paragraph (g)(1) of this section, the provision of a given service by a center will be determined by the Secretary to be appropriate where

(i) There is a need, as determined by the Secretary, for the provision of such service to individuals described in paragraph (g)(1) of this section in the catchment area; and

(ii) The provision of such service by the center is feasible, taking into consideration the center's projected revenues, other resources, and grant support under this part.

(h) "Migratory agricultural worker" means an individual whose principal employment is in agriculture on a sea