1. 1 Legal Framework for the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) Legal Framework for the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) Beverly Dart, Senior Attorney Department of Health and Human Services Office of the General Counsel January 2012

2. Presentation Overview Background - role of OGC Background - role of OGC Legal Framework for SACHDNC: Legal Framework for SACHDNC: Background - Federal Advisory Committee Act (FACA) Background - Federal Advisory Committee Act (FACA) SACHDNC Authorizing Legislation SACHDNC Authorizing Legislation Section 2713, PHS Act (added by Affordable Care Act) Section 2713, PHS Act (added by Affordable Care Act) 2

3. Office of the General Counsel (OGC) Provides legal advice and assistance to HHS Provides legal advice and assistance to HHS OGC provides legal advice and assistance to HRSA/MCHB and other HHS organizations and officials OGC provides legal advice and assistance to HRSA/MCHB and other HHS organizations and officials Advises and provides assistance to the DFO regarding responsibilities relating to SACHDNC-related management processes Advises and provides assistance to the DFO regarding responsibilities relating to SACHDNC-related management processes 3

4. Federal Advisory Committee Act Public Law 92-463, as amended (5 U.S.C. App. 2) Public Law 92-463, as amended (5 U.S.C. App. 2) Implemented by 41 C.F.R. Parts 101-6, 102-3 Implemented by 41 C.F.R. Parts 101-6, 102-3 4

5. Federal Advisory Committee Act The Federal Advisory Committee Act (FACA) applies when Congress or an agency establishes, manages, or controls a group that includes one or more participants who are not federal employees for the purpose of obtaining the group’s advice or recommendations on agency issues or policies. 5

6. Federal Advisory Committee Act Became law in 1972; establishes how federal advisory committees operate Became law in 1972; establishes how federal advisory committees operate Enacted to ensure that advice provided to the federal government by advisory committees formed over the years is objective and accessible to the public Enacted to ensure that advice provided to the federal government by advisory committees formed over the years is objective and accessible to the public Emphasizes open meetings, chartering, public involvement, and reporting Emphasizes open meetings, chartering, public involvement, and reporting 6

7. Advisory Committees under FACA “Advisory committee” “Advisory committee” any committee, board,… panel, task force, or other similar group, or any subcommittee or other subgroup thereof, which is – (A) established by statute or reorganization plan, or (B) established or utilized by the President, or (C) established or utilized by one or more agencies, any committee, board,… panel, task force, or other similar group, or any subcommittee or other subgroup thereof, which is – (A) established by statute or reorganization plan, or (B) established or utilized by the President, or (C) established or utilized by one or more agencies, in the interest of obtaining advice or recommendations for the President or … agencies or officers of the Federal Government. in the interest of obtaining advice or recommendations for the President or … agencies or officers of the Federal Government. 7

8. Statutory Purpose “… the function of advisory committees should be advisory only, and … all matters under their consideration should be determined, in accordance with law, by the official, agency, or officer involved.” “… the function of advisory committees should be advisory only, and … all matters under their consideration should be determined, in accordance with law, by the official, agency, or officer involved.” 8

9. HHS Statutory Responsibilities Establish uniform administrative guidelines and management controls for advisory committees established by HHS, consistent with General Services Administration (GSA) directives Establish uniform administrative guidelines and management controls for advisory committees established by HHS, consistent with General Services Administration (GSA) directives Maintain systematic information on the nature, functions, and operations of advisory committees within its jurisdiction. Maintain systematic information on the nature, functions, and operations of advisory committees within its jurisdiction. 9

10. Agency Statutory Responsibilities Designate an Advisory Committee Management Officer who shall – Designate an Advisory Committee Management Officer who shall – Exercise control and supervision over the establishment, procedures, and accomplishments of its advisory committees Exercise control and supervision over the establishment, procedures, and accomplishments of its advisory committees Assemble and maintain the reports, records, and other papers of any such committee Assemble and maintain the reports, records, and other papers of any such committee Carry out the provisions of 5 U.S.C. 552 with respect to reports, records, and other papers Carry out the provisions of 5 U.S.C. 552 with respect to reports, records, and other papers 10

11. Agency Statutory Responsibilities HRSA/MCHB performs most such responsibilities relative to SACHDNC on HHS’s behalf HRSA/MCHB performs most such responsibilities relative to SACHDNC on HHS’s behalf 11

12. SACHDNC Authorizing Legislation Section 1111 of the Public Health Service (PHS) Act (42 U.S.C. § 300b-10) Section 1111 of the Public Health Service (PHS) Act (42 U.S.C. § 300b-10) Provides advice, information and recommendations to the Secretary regarding: Provides advice, information and recommendations to the Secretary regarding: newborn and childhood screening newborn and childhood screening development of policies to enhance the abilities of the State and local health agencies development of policies to enhance the abilities of the State and local health agencies the grant program established under 42 U.S.C. § 300b-8 the grant program established under 42 U.S.C. § 300b-8 12

13. Role of SACHDNC Provides advice, information and recommendations to the Secretary of HHS within the parameters set by the authorizing legislation Provides advice, information and recommendations to the Secretary of HHS within the parameters set by the authorizing legislation 13

14. Roles of SACHDNC The authorizing legislation sets the legal standard for what is within its purview and what is not. The authorizing legislation sets the legal standard for what is within its purview and what is not. Within the scope: advice, information, and recommendations to the Secretary in certain identified areas Within the scope: advice, information, and recommendations to the Secretary in certain identified areas Outside the scope: actions not described by the legislation, such as recommendations for action by States or individual HHS OPDIVs Outside the scope: actions not described by the legislation, such as recommendations for action by States or individual HHS OPDIVs 14

15. Preventive Care and Screenings ACA added section 2713 of the Public Health Service Act (42 U.S.C. § 300gg-13). ACA added section 2713 of the Public Health Service Act (42 U.S.C. § 300gg-13). The Recommended Uniform Screening Panel (RUSP) is part of the preventive care and screenings for infants, children, and adolescents provided for in comprehensive guidelines supported by HRSA. The Recommended Uniform Screening Panel (RUSP) is part of the preventive care and screenings for infants, children, and adolescents provided for in comprehensive guidelines supported by HRSA. Such screenings must be covered by non-grandfathered group health plans and health insurance issuers without cost-sharing (i.e., co-pays, deductibles). Such screenings must be covered by non-grandfathered group health plans and health insurance issuers without cost-sharing (i.e., co-pays, deductibles). SACHDNC recommends to the Secretary items for addition to or removal from the RUSP. The Secretary makes the final determination. SACHDNC recommends to the Secretary items for addition to or removal from the RUSP. The Secretary makes the final determination. 15

16. Therefore, … SACHDNC may fulfill its statutory purpose more effectively by assisting in the provision of information, advice, and assistance to the Secretary that may help inform states and other actors SACHDNC may fulfill its statutory purpose more effectively by assisting in the provision of information, advice, and assistance to the Secretary that may help inform states and other actors 16

17. Framing Recommendations Program Take-Aways Addition of conditions to the RUSP Addition of conditions to the RUSP Direction/advice to other HHS agencies Direction/advice to other HHS agencies Direction/advice on how to direct NBSSLA grant program Direction/advice on how to direct NBSSLA grant program 17

18. Framing Recommendations Program Take-Aways Recommendations to States – especially involving funding Recommendations to States – especially involving funding Direct interaction/ recommendations to other entities apart from the Secretary (including non- HHS agencies) Direct interaction/ recommendations to other entities apart from the Secretary (including non- HHS agencies) 18

19. 19 Any questions? Beverly Dart Senior Attorney Public Health Division Office of the General Counsel Beverly.Dart@hhs.gov