Federal financial participation is unavailable for the performance of abortions or other medical procedures otherwise provided for under §§ 50.304 and 50.306 if the program or project has paid without first having received the certifications and documentation specified in those sections. [43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979] § 50.308 Drugs and devices and termination of ectopic pregnancies. Federal financial participation is available with respect to the cost of drugs or devices to prevent implantation of the fertilized ovum, and for medical procedures necessary for the termination of an ectopic pregnancy. $50.309 Recordkeeping requirements. Programs or projects to which this subpart applies must maintain copies of the certifications and documentation specified in §§ 50.304 and 50.306 for three years pursuant to the retention and custodial requirements for records at 45 CFR 74.20 et seq. [43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979] § 50.310 Confidentiality. Information in the records or in the possession of programs or projects which is acquired in connection with the requirements of this subpart may not be disclosed in a form which permits the identification of an individual without the individual's consent except as may be necessary for the health of the individual or as may be necessary for the Secretary to monitor the activities of those programs or projects. In any event, any disclosure shall be subject to appropriate safeguards which will minimize the likelihood of disclosures of personal information in identifiable form. Subpart D-Public Health Service Grant Appeals Procedure AUTHORITY: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 U.S.C. 216); 45 CFR 16.3(c). SOURCE: 54 FR 34770, Aug. 22, 1989, unless otherwise noted. § 50.401 What is the purpose of this subpart? This subpart establishes an informal procedure for the resolution of certain postaward grant and cooperative agreement disputes within PHS. § 50.402 To what programs do these regulations apply? This subpart applies to all grant and cooperative agreement programs, except block grants, which are administered by the U.S. Public Health Service, including those administered by the National Institutes of Health; the Health Resources and Services Administration; the Centers for Disease Control; the Agency for Toxic Substances and Disease Registry; the Alcohol, Drug Abuse, and Mental Health Administration; the Food and Drug Administration; the Indian Health Service; the Office of the Assistant Secretary for Health (OASH); and the PHS regional offices. § 50.403 What is the policy basis for these procedures? The Secretary of Health and Human Services has established a Departmental Appeals Board for the purpose of providing a fair and flexible process for the appeal of written final decisions involving certain grant and cooperative agreement programs administered by constituent agencies of the Department. The regulatory provision which establishes the circumstances under which the Board will accept an appeal (45 CFR 16.3) provides, among other things, that the appellant must have exhausted any preliminary appeal process required by regulation before a formal appeal to the Departmental Board will be allowed. These regulations provide such an informal preliminary procedure for resolution of disputes within PHS in order to preclude submission of cases to the Departmental Appeals Board before PHS has had an opportunity to review decisions of its officials and to settle disputes with grantees. $50.404 What disputes are covered by members of review committees for these procedures? (a) These procedures are applicable to the following adverse determinations under PHS discretionary project grants and cooperative agreements (hereinafter both referred to as grants): (1) Termination, in whole or in part, of a grant for failure of the grantee to carry out its approved project in accordance with the applicable law and the terms and conditions of such assistance or for failure of the grantee otherwise to comply with any law, regulation, assurance, term, or condition applicable to the grant. (2) A determination that an expenditure not allowable under the grant has been charged to the grant or that the grantee has otherwise failed to discharge its obligation to account for grant funds. (3) A determination that a grant is void. (4) A denial of a noncompeting continuation award under the project period system of funding where the denial is for failure to comply with the terms of a previous award. (b) A determination subject to this subpart may not be reviewed by the review committee described in §50.405 unless an officer or employee of the agency, OASH, or the regional office has notified the grantee in writing of the adverse determination. The notification must set forth the reasons for the determination in sufficient detail to enable the grantee to respond and must inform the grantee of the opportunity for review under this subpart. $50.405 What is the structure of review committees? The head of each agency or his/her designee shall appoint review committees to review appeals of adverse determinations made by headquarters officials for programs under the jurisdiction of that agency. The Assistant Secretary for Health, or his/her designee, shall appoint review committees to review adverse determinations made by OASH officials and regional officials for programs under their jurisdiction. A minimum of three employees shall be appointed (one of whom shall be designated as chairperson) either on an ad hoc, case-by-case basis, or as regular such terms as may be designated. None of the members of the review committee reviewing any given appeal may be from the office of the responsible official whose adverse determination is being appealed (e.g., project officer, grants specialist, program manager, grants management officer). $50.406 What are the steps in the process? (a) A grantee with respect to whom an adverse determination described in § 50.404(a) above has been made and who desires a review of that determination must submit a request for such review to the head of the appropriate agency or his/her designee (or in the case of an OASH program or regional office determination, to the Assistant Secretary for Health or his/her designee) no later than 30 days after the written notification of the determination is received, except that if the grantee shows good cause why an extension of time should be granted, the head of the appropriate agency or his/her designee (or in the case of an OASH program or regional office determination, the Assistant Secretary for Health or his/her designee) may grant an extension of time. (b) The request for review must include a copy of the adverse determination, must identify the issue(s) in dispute, and must contain a full statement of the grantee's position with respect to such issue(s) and the pertinent facts and reasons in support of the grantee's position. In addition to the required written statement, the grantee shall provide copies of any documents supporting its claim. (c) When a request for review has been filed under this subpart with respect to an adverse determination, no action may be taken by the awarding agency, OASH, or regional office pursuant to such determination until the request has been disposed of, except that the filing of the request shall not affect any authority which the agency, OASH, or regional office may have to suspend assistance or otherwise to withhold or defer payments under the grant during proceedings under this subpart. This paragraph does not require the awarding agency, OASH, or regional office to provide continuation funding during the appeal process to a grantee whose noncompeting continuation award has been denied. (d) Upon receipt of a request for review, the head of the agency or his/her designee (or, if the adverse determination was made in an OASH program or regional office, the Assistant Secretary for Health or his/her designee) will make a decision as to whether the dispute is reviewable under this subpart and will promptly notify the grantee and the office responsible for the adverse determination of this decision. If the head of the agency or his/her designee (or, if applicable, the Assistant Secretary for Health or his/her designee) determines that the dispute is reviewable, he/she will forward the matter to the review committee appointed under § 50.405. (e) The agency, OASH, or regional office involved will provide the review committee appointed under $50.405 with copies of all relevant background materials (including application(s), award(s), summary statement(s), and correspondence) and any additional pertinent information available. These materials must be tabbed and organized chronologically and accompanied by an indexed list identifying each document. (f) The grantee shall be given an opportunity to provide the review committee with additional statements and documentation not provided in the request for review described in paragraph (b) of this section. This additional submission, which must be organized and indexed as indicated under paragraph (e) of this section, should provide only material that is relevant to the review committee's deliberation of the issues in the case. (g) The review committee may, at its discretion, invite the grantee and/or the agency/OASH/regional office staff to discuss the pertinent issues with the committee and to submit such additional information as the committee deems appropriate. (h) Based on its review, the review committee will prepare a written decision to be signed by the chairperson and each of the other committee members. The review committee shall send the written decision with a transmittal letter to the grantee and shall send a copy of both to the official responsible for the adverse determination. If the decision is adverse to the grantee's position, the transmittal letter must state the grantee's right to appeal to the Departmental Appeals Board under 45 CFR part 16. Subpart E-Maximum Allowable Cost for Drugs AUTHORITY: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 U.S.C. 216). SOURCE: 40 FR 34514, Aug. 15, 1975, unless otherwise noted. $50.501 Applicability. This subpart is applicable to programs or projects for health services which are supported in whole or in part by Federal financial assistance, whether by grant or contract, administered by the Public Health Service. It applies to Federal funds and to non-Federal funds which are required to be expended as a condition to receiving Federal funds under such programs or projects. § 50.502 Definitions. As used in this subpart: (a) Public Health Service means the Office of the Assistant Secretary for Health, Health Resources and Services Administration, National Institutes of Health, Centers for Disease Control. Alcohol, Drug Abuse and Menta Health Administration, Food and Drug Administration, and all of their constituent agencies. (b) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Serv ices to whom the authority involved has been delegated. (c) Program funds means (1) Federal funds provided through grant or contract to support a program or project covered by §50.501, and (2) any non-Federal funds that are required as a condition of such grant or contract to be expended to carry out such program or project. (d) Provider means one who furnishes medical or pharmaceutical services or supplies for which program funds may be expended under any of the programs or projects described in §50.501. will take into account: (e) Acquisition cost means the price (b) In determining whether a dispensgenerally and currently paid by providing fee is reasonable, the Secretary ers for a drug marketed or sold by a particular formulator or labeler in the package size of drug most frequently purchased by providers, as determined by the Secretary on the basis of drug price information furnished by the Department. [40 FR 34514, Aug. 15, 1975, as amended at 49 FR 38109, Sept. 27, 1984] $50.503 Policy. It is the policy of the Secretary that program funds which are utilized for the acquisition of drugs be expended in the most economical manner feasible. In furtherance of this policy, the Secretary has established, in 45 CFR part €19, a procedure for determining the Maximum Allowable Cost for drugs which are purchased with program funds. $50.504 Allowable cost of drugs. (a) The maximum amount which may be expended from program funds for the acquisition of any drug shall be the lowest of (1) The maximum allowable cost (MAC) of the drug, if any, established in accordance with 45 CFR part 19, plus a dispensing fee determined by the Secretary in accordance with paragraph (b) of this section, to be reasonable; (2) The acquisition cost of the drug plus a dispensing fee determined by the Secretary, in accordance with paragraph (b) of this section, to be reasonable; or (3) The provider's usual and customary charge to the public for the drug; Provided, That the MAC established for any drug shall not apply to a brand of that drug prescribed for a patient which the prescriber has certified, in accordance with paragraph (c) of this section, is medically necessary for that patient; And Provided further, That where compensation for drug dispensing is included in other costs allowable under the applicable program statute and regulations, the terms and conditions of the grant or contract, and the applicable cost principles prescribed in 45 CFR part 74, no separate dispensing fee will be recognized. (1) Cost components such as overhead, professional services, and profits, (2) Payment practices of third-party payment organizations, including other Federal programs such as titles XVIII and XIX of the Social Security Act; and (3) Any surveys by States, universities or others of costs of pharmacy operations and the fees charged in the particular area. (c) A certification by a prescriber, pursuant to paragraph (a) of this section, that a brand of drug is medically necessary for a particular patient shall be in the prescriber's own handwriting, in such form and manner as the Secretary may prescribe. An example of an acceptable certification is the notation "brand necessary". A procedure for checking a box on a form will not constitute an acceptable certification. 51a.7 What other DHHS regulations apply? 51a.8 What other conditions apply to these grants? AUTHORITY: Sec. 1102 of the Social Security Act, 49 Stat. 647 (42 U.S.C. 1302); sec. 502(a), 502(b)(1)(A), and 506(a)(3) of the Social Security Act, 95 Stat. 819-20 (42 U.S.C. 702(a), 702(b)(1)(A) and 706(a)(3)). SOURCE: 51 FR 7727, Mar. 5, 1986, unless otherwise noted. Health (MCH) Federal Set-Aside project grant programs. Section 502(a) authorizes funding for special projects of regional and national significance (SPRANS), research and training projects with respect to maternal and child health and children with special health care needs (including early intervention training and services development); genetic disease testing, counseling and information programs; comprehensive hemophilia diagnostic and treatment centers; projects for screening and follow-up of newborns for sickle cell anemia and other genetic disorders; and special maternal and child health improvement projects. Section 502(b)(1)(A) authorizes funding for projects termed community integrated service system (CISS) projects for the development and expansion of: maternal and infant health home visiting; projects to increase the participation of obstetricians and pediatricians in title V and title XIX programs; integrated maternal and child health service systems; maternal and child health centers operating under the direction of not-for-profit hospitals; rural maternal and child health programs; and outpatient and community-based services programs for children with special health care needs. [59 FR 36706, July 19, 1994] §51a.2 Definitions. Act means the Social Security Act, as amended. Genetic diseases means inherited disorders caused by the transmission of certain aberrant genes from one generation to another. Hemophilia means a genetically transmitted bleeding disorder resulting from a deficiency of a plasma clotting factor. Institution of higher learning means any college or university accredited by a regionalized body or bodies approved for such purpose by the Secretary of Education, and any teaching hospital which has higher learning among its purposes and functions and which has a formal affiliation with an accredited school of medicine and a full-time academic medical staff holding faculty status in such school of medicine. Secretary means the Secretary of Health and Human Services or his or her designee. $51a.3 Who is eligible to apply for Federal funding? (a) With the exception of training and research, as described in paragraph (b) of this section, any public or pri vate entity, including an Indian tribe or tribal organization (as those terms are defined at 25 U.S.C. 450b) is eligible to apply for federal funding under this Part. (b) Only public or nonprofit private institutions of higher learning may apply for training grants. Only public or nonprofit institutions of higher learning and public or private notprofit agencies engaged in research or in programs relating to maternal and child health and/or services for children with special health care needs may apply for grants contracts or cooperative agreements for research in maternal and child health services or in services for children with special health care needs. [59 FR 36706, July 19, 1994] 851a.4 How is application made for Federal funding? An application for funding under the MCH Federal Set-Aside project grant programs must be submitted to the Secretary at such time and in such manner as the Secretary may prescribe. It must include a budget and narrative plan of the manner in which the project will meet each of the requirements prescribed by the Secretary. The plan must describe the project in sufficient detail to identify clearly the nature, need, and specific objectives of, and methodology for carrying out, the project. (Approved by the Office of Management and Budget under control number 0915-0050) [59 FR 36706, July 19, 1994] §51a.5 What criteria will DHHS use to decide which projects to fund? (a) The Secretary will determine the allocation of funds available under sections 502(a) and 502(b)(1)(A) of the Act for each of the activities described in § 51a.1. |