Title of Regulation: 12VAC5-191. State Plan for the Children with Special Health Care Needs Program (amending 12VAC5-191-10, 12VAC5-191-40, 12VAC5-191-80, 12VAC5-191-90, 12VAC5-191-210, 12VAC5-191-250).

Statutory Authority: §§ 32.1-12 and 32.1-77 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: January 1, 2014.

Effective Date: January 24, 2014.

Agency Contact: Emily McClellan, Manager, Survey and Analysis Unit, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7249, FAX (804) 864-7647, or email emily.mclellan@vdh.virginia.gov.

Basis: Section 32.1-12 of the Code of Virginia authorizes the State Board of Health to make, adopt, promulgate and enforce regulations. Section 32.1-77 of the Code of Virginia (i) authorizes the board to prepare, amend, and submit state plans for maternal and child health services and children's specialty services pursuant to Title V of the United States Social Security Act to the U.S. Secretary of Health and Human Services and (ii) authorizes the State Health Commissioner to administer the plan and to receive and expend federal funds for the administration of the plan in accordance with applicable federal and state laws and regulations.

Section 32.1-64.1 of the Code of Virginia mandates the commissioner to establish and maintain the Virginia Hearing Impairment Identification and Monitoring System for the purpose of identifying and monitoring infants with hearing impairment to ensure that such infants receive appropriate early intervention through treatment, therapy, and education; § 32.1-64.1 D mandates the board to establish regulations for the screening, and § 32.1-64.1 F authorizes the board to promulgate rules and regulations as may be necessary to implement this identification and monitoring system.

Section 32.1-65 of the Code of Virginia mandates certain newborn screening testing of all infants, except for those exempted from testing by law, for specified disorders.

Section 32.1-66 of the Code of Virginia mandates the commissioner to notify the attending physician of any newborn screening test results that indicate a suspicion of a disorder and to perform or provide for any additional testing required to confirm or disprove the diagnosis of the specified disorders.

Section 32.1-67 of the Code of Virginia mandates the board to recommend procedures for the treatment of disorders identified by a newborn screening test.

Section 32.1-68 of the Code of Virginia mandates the commissioner, in cooperation with local health directors, to establish a voluntary program for the screening of individuals for the disease of sickle cell anemia or the sickle cell trait and for such other genetically related diseases and genetic traits and inborn errors of metabolism as the board may deem necessary. The board shall review the program from time to time to determine the appropriate age and the method of screening for such conditions or traits in the light of technological changes. The screening program shall include provisions for education concerning the nature and treatment of sickle cell anemia, other genetically related diseases, and inborn errors of metabolism and provisions for a post-screening counseling program for the treatment of any person determined to have such a condition. The program may include the provision of laboratory testing.

Section 32.1-69.1 of the Code of Virginia mandates the commissioner to establish and maintain a Virginia Congenital Anomalies Reporting and Education System using data from birth certificates filed with the State Registrar of Vital Records and data obtained from hospital medical records. The chief administrative officer of every hospital, as defined in § 32.1-123 of the Code of Virginia, shall make or cause to be made a report to the commissioner of any person under two years of age diagnosed as having a congenital anomaly. Section 32.1-123 B mandates the board to promulgate regulations as may be necessary to implement this reporting and education system. These regulations may include scope of information to be collected and relationships between the reporting and education system and other agencies.

Section 32.1-89 of the Code of Virginia mandates the board to establish a program for the care and treatment of persons suffering from hemophilia and other related bleeding diseases who cannot pay for the entire cost of their needed medical care. Section 32.1-89 B authorizes the board to provide services through cooperative agreements with medical facilities or other appropriate means. This subsection also states that charges for persons receiving care shall be determined by the board.

All of these authorized and mandated programs serve children with special health care needs. Separate regulations 12VAC5-71, Regulations Governing Virginia Newborn Screening Services, and 12VAC5-80, Regulations for Administration of the Virginia Hearing Impairment Identification and Monitoring System, exist for these programs. Relationships among the programs are addressed in 12VAC5-191.

Purpose: A periodic review of 12VAC5-191 was conducted starting on April 6, 2011. The public comment period ended on May 30, 2011. An ad hoc regulatory workgroup met on June 2, 2011, to review the regulation and public comments.

The workgroup recommended amending the regulation through the fast-track rulemaking process to correct references to other regulations, laws, and organizational entities that have changed since the regulation went into effect in 2007.

This regulation is essential to outline program services for children with special health care needs that are made available to eligible residents within available appropriations and to help those residents qualify for federal Title V and other available funds for plan administration. Although the program is neither an entitlement nor a federal, state, or local public benefit, the program does offer certain services and assistance, contingent upon adequate funding, which may affect the rights of individuals.

Other state-mandated initiatives, such as the Virginia Newborn Screening System, Virginia Congenital Anomalies Reporting and Education System, Virginia Sickle Cell Awareness Program, and Pediatric Comprehensive Sickle Cell Clinic Network also identify and serve children with special health care needs. These programs, several of which have separate regulations, are now referenced in this regulation as well.

The amended regulation serves to protect the health and welfare of children with special health care needs.

Rationale for Using Fast-Track Process: Executive Order 14 (2010) allows state agencies to use a fast-track rulemaking process to expedite regulatory changes that are expected to be noncontroversial. The amendments to 12VAC5-191-10, 12VAC5-191-40, 12VAC5-191-80, and 12VAC5-191-210 are not substantive changes. These amendments will update certain terms and references to other regulations, laws, and organizational entities that have changed since 2007. The amendments to 12VAC 5-191-90 and 12VAC 5-191-250 are substantive but are not expected to be controversial.

Substance: The amendments to 12VAC5-191-90 remove multiple specific citations to privacy and confidentiality laws and substitute the term "all applicable federal and state laws and regulations." The amendments to 12VAC5-191-250 reflect changes in organizational structure and functions due to changes in grant funding and activities. Otherwise the amendments are for clarification and to update citations.

Issues: The primary advantage of amending this regulation is to keep references within the regulation current and up to date. There are no primary disadvantages.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health proposes to update references to other regulations, laws, and organizational entities. The proposed changes also reflect the updated functions of genetics and newborn screening services stemming from changes in grant funding.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The State Board of Health proposes to update references to other regulations, laws, and organizational entities. The proposed changes also reflect the updated functions of genetics and newborn screening services stemming from changes in grant funding.

None of the proposed regulations will have an impact on the current practices followed by Virginia Department of Health. Thus, the proposed changes are not expected to have any significant direct economic impact other than improving the clarity and accuracy of the regulatory language.

Businesses and Entities Affected. Currently, approximately 9,900 children under age 21 are served by the Children with Special Health Care Needs Program.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. No significant impact on employment is expected.

Effects on the Use and Value of Private Property. No significant impact on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. No significant costs or other effects on small businesses are expected.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed regulations are not anticipated to have an adverse impact on small businesses.

Real Estate Development Costs. No significant effect on real estate development costs is expected.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health has reviewed the economic impact analysis pertaining to this regulatory action and concurs with its findings.

Summary:

The amendments (i) update references to other regulations and laws and (ii) modify references where organizational structures, names, or functions have changed since the regulation was promulgated in 2007.

12VAC5-191-10. Definitions.

The following words and terms when used in this regulation shall have the following meanings unless the context clearly indicates otherwise:

"Appeal" means the client's right to seek relief from an unfavorable decision in obtaining services or assistance included in the plan.

"Applicant" means an individual who applies for the services under this regulation. An application may be filed for or on behalf of a minor or person under a legal disability by a parent, legal guardian, and attorney in fact, or an attorney at law.

"Bleeding disorders" means inherited problems in coagulation caused by missing or poorly functioning proteins in the blood such as hemophilia and von Willebrand Disease.

"Board" means the State Board of Health.

"Care coordination" means a process that links individuals and their families to services and resources in a coordinated effort to maximize their potential and provide them with optimal health care.

"Center" means a unit providing Care Connection for Children services.

"CCC" means Care Connection for Children.

"Children and youth with special health care needs" means individuals who are ages birth to their twenty-first birthday and have, or are at increased risk for, a chronic physical, developmental, behavioral, or emotional condition and who also require health and related services of a type or amount beyond that required by children generally.

"Client" means an individual who meets all the eligibility criteria for a program and has been accepted for services.

"Commissioner" means the Commissioner of Health.

"Community-based" means a framework within which a variety of programs work together to meet the many, varied needs of children, youth, and families in communities.

"CSHCN" means children with special health care needs.

"Culturally-competent" means the ability to provide services to clients that honor different cultural beliefs, interpersonal styles, attitudes and behaviors and the use of multicultural staff in the policy development, administration, and provision of those services.

"Department" means the state Virginia Department of Health and includes the central office, regional offices, health districts, and local health departments.

"Developmental disorder" means a delay(s) in maturation or deviant maturation of physical, language, sensory, motor, cognitive, social, learning or self-help capabilities to the extent that there is a negative impact on a child's ability to adapt to or cope with the typical environmental demands as expected for chronological age.

"Direct health care services" means medically necessary services for the treatment and monitoring of a condition(s) covered by the program. The services are generally delivered one-on-one between a health care professional and a client in an office, home, clinic, outpatient department, or hospital.

"Director" means the Director, Children with Special Health Care Needs Program.

"Division" means the Division of Child and Adolescent Family Health.

"Enabling services" means support services that allow or provide for access to and the receipt of benefits from an array of basic health care services.

"Family" means the client and other such household members who together constitute one economic unit. An economic unit is one or more individuals who generally reside together and share income.

"Family-centered care" means an approach to the planning, delivery, and evaluation of health care whose cornerstone is active participation between families and professionals. Family-centered care recognizes that families are the ultimate decision makers for their children, with children gradually taking on more and more of this decision-making themselves.

"Family-to-family support" means the provision of information and peer support among families having experience with family members having special health care needs.

"Guardian" means a court-appointed guardian of the person.

"Information and referral services" means assisting clients and their families to find available services, responding to inquiries from the general public, and disseminating information for accessing specific services.

"MCH" means maternal and child health.

"Medical home" means a concept in which the child has an ongoing source of health care from a primary care physician who works together with the family to ensure that the child has accessible, continuous, comprehensive, family-centered, coordinated, compassionate, and culturally effective medical care.

"Parent" means a biological or adoptive parent or a stepparent.

"Plan" means the State Plan for the Children with Special Health Care Needs Program prepared pursuant to Title V of the United States Social Security Act, as amended.

"Pool of funds" means funds designated for payment of direct health care services. Access to the pool is not an entitlement and is subject to availability of funds and guidelines that govern its eligibility and coverage of services.

"Population-based services" means preventive interventions and personal health services developed and available for the entire MCH population of the Commonwealth rather than for individuals in a one-on-one situation.

"Program" means the Children with Special Health Care Needs Program.

"Provider" means an individual or agency that provides a service under an agreement between the individual or agency and the Children with Special Health Care Needs Program or its contractors.

"Resident" means an individual who resides within the geographical boundaries of the Commonwealth.

"Services" means those activities provided or arranged by the various programs within the Children with Special Health Care Needs Program.

"Sickle cell disease" means any inherited hemoglobin pattern with a predominance of hemoglobin (S) in absence of, or greater than normal hemoglobin (A); or hemoglobin S with another hemoglobin variant such as C, D, or E or beta thalassemia.

"Sickle Cell Program Manager" means an employee of the Pediatric Comprehensive Sickle Cell Clinic Network who is designated to be responsible for the administration of the statewide Pediatric Comprehensive Sickle Cell Clinic Network.

"Transition services" means assisting the client and his family in the process of making necessary changes from life as a youth with special health care needs to life as an adult with special health care needs. Aspects to be addressed include health and wellness; education, vocation, and employment; mobility, transportation, and recreation; and legal, insurance, disability benefits, and housing.

"Underinsured" means having medically necessary service needs that exceed an individual's health insurance coverage limits.

"Uninsured" means having no private health insurance or state or federal medical assistance coverage.

12VAC5-191-40. Scope and content of the Children with Special Health Care Needs Program.

A. Mission. The Children with Special Health Care Needs Program promotes the optimal health and development of individuals living in the Commonwealth with special health care needs by working in partnership with families, service providers, and communities.

B. Scope. The scope of the Children with Special Health Care Needs Program includes the following:

1. Direct health care services.

2. Enabling services.

3. Population-based services.

4. Assessment of community health status and available resources.

5. Policy development to support and encourage better health.

C. Networks and Services. The Children with Special Health Care Needs Program administers the following networks and services:

1. Care Connection for Children.

2. Child Development Services.

3. Virginia Bleeding Disorders Program.

4. Pediatric Screening and Genetics Services Genetics and Newborn Screening Services.

a. Virginia Newborn Screening System.

b. Virginia Congenital Anomalies Reporting and Education System.

5. Virginia Sickle Cell Awareness Program.

6. Pediatric Comprehensive Sickle Cell Clinic Network.

C. D. Target population. The target population to receive services from the networks and programs within the Children with Special Health Care Needs Program are the following:

1. Residents of the Commonwealth.

2. Individuals between the ages of birth and their twenty-first birthday except that the Virginia Bleeding Disorders Program and the Virginia Sickle Cell Awareness Program serve individuals of all ages.

3. Individuals diagnosed as having, or are at increased risk for having, a chronic physical, developmental, behavioral, or emotional condition and who also require health and related services of a type or amount beyond that required by children generally.

Each network and program within the CSHCN Program has its own specific eligibility criteria.

D. E. Goals. The Title V national performance measures, as required by the federal Government Performance and Results Act (GPRA-Pub. L. 103-62), are used to establish the program goals.

12VAC5-191-80. Appeal process.

A. An applicant for or client in receipt of services or assistance, as defined in this plan, may appeal the following actions:

1. Denial of services or assistance.

2. Termination of services or assistance.

3. Adverse determination regarding financial eligibility.

There are no further rights of appeal except as set forth in this section. Applicants or clients have no right of appeal of a denial of services or assistance because of a lack of funds.

B. The applicant or client has the right to receive a written statement of the reasons for denial and be informed in writing of the appeal process, including time limits.

C. If a client already receiving services or assistance is denied those services or assistance, a written notice of termination including the reason of denial shall be given 30 days in advance of discontinuing services.

D. First level of appeal: An individual or his representative may make a written or oral appeal to the employee designated to be responsible for the administration of the different programs (the Care Connection for Children Program Director, Administrative Director for the Child Development Services, Bleeding Disorders Program Coordinator, or Sickle Cell Program Manager) within 30 days of the denial of service. The respective program director, administrative director, program coordinator, or program manager shall review and make a written decision to the individual or his representative within 15 days from the date of receipt of the appeal.

E. Second level of appeal: If the individual is not satisfied with the decision provided at the first level of appeal, the individual may appeal the decision in writing to the Director of the Children with Special Health Care Needs Program within 30 days of the denial from the individual program.

F. Upon receipt of the appeal, the director shall review and make written recommendations to the commissioner, or the commissioner's designee, within 15 days. The director shall consider all written information and may confer, as deemed necessary, with the department's adjudication officer in the Office of Family Health Services or other relevant experts.

G. Within 45 days following the date on which an appeal is filed, the commissioner, or commissioner's designee, shall make a final decision.

12VAC5-191-90. Privacy.

A. The Children with Special Health Care Needs Program and program subcontractors shall protect the privacy of the client's personal health information and the confidentiality of medical records in accordance with §§ 2.2-3700 through 2.2-3705.1, 2.2-3705.5, 2.2-3800 through 2.2-3809, 32.1-40, 32.1-41, 32.1-64.2, 32.1-67.1, 32.1-69, 32.1-69.2, 32.1-127.1:03, and 32.1-127.1:04 of the Code of Virginia; the federal Health Insurance Portability and Accountability Act of 1996 (42 USC §§ 1320 d et seq. and 45 CFR Part 164); and Title V of the Social Security Act (42 USC §§ 701-710, Subchapter V, Chapter 7 and 42 CFR 51a.6) all applicable federal and state laws and regulations.

B. Access to minor's minors' health records and the authority to consent to surgical and medical treatment for certain minors shall be administered in accordance with §§ 20-124.6 and 54.1-2969 of the Code of Virginia, respectively.

C. Surveillance and investigation shall be consistent with §§ 32.1-39, 32.1-40, 32.1-41 and 32.1-66 of the Code of Virginia.

D. The department's children Children with special health care needs program Special Health Care Needs Program and its contractors shall maintain security and confidentiality of databases in accordance with applicable federal and state laws and regulations.

12VAC5-191-210. Score Scope and content of the Child Development Services Program.

A. Mission. The Child Development Services Program promotes the optimal physical, language, cognitive, social, learning, self-help, behavioral, and emotional development and well-being of children.

B. Scope of services. The child development clinics provide pediatric services in the specialty area of developmental and behavioral pediatrics. This health care field specializes in the diagnosis and treatment of developmental and psychosocial aspects of pediatric health care including developmental disorders and emotional, behavioral, and psychosomatic problems.

Services offered at each clinic location may vary according to the needs of the community, expertise of the professional staff, and the overall goals and objectives for the current program.

The Child Development Services network provides the following direct health care services and enabling services:

1. Interdisciplinary evaluations that may include a pediatric medical examination, nurse evaluation, psychosocial history, psychological assessment, and educational evaluation.

2. Treatment planning that may include the evaluation team developing a written report that integrates their findings, establishes diagnoses, and formulates recommendations for each client.

3. Care coordination.

4. Consultation.

5. Screenings for early identification of persons with developmental disorders.

6. Screening services to assist other agencies in their program implementation as may be described in a contract or memorandum of agreement.

7. Information and referral.

8. Intervention services that may include medical, psychosocial, educational, or interdisciplinary treatment services.

9. Training and technical assistance for community providers.

C. Criteria to receive services from Child Development Services. Children and youth are eligible to receive services from Child Development Services if they are:

1. Residents of the Commonwealth.

2. Between the ages of birth and their twenty-first birthday.

3. Suspected to have or diagnosed with developmental, emotional or behavioral disorder or presence of severe or multiple risk factors for these conditions.

No financial eligibility criteria are required for clients to receive the enabling services. However, clients who meet the above criteria must also meet the financial requirements to receive direct health care services based on a sliding scale charge schedule. The amount of the required charge shall be in accordance with the State Board of Health Regulation Regulations Governing Eligibility Standards and Charges for Health Medical Care Services to Individuals, 12VAC5-200.

D. Goals. The Title V national performance measures, as required by the federal Government Performance and Results Act (GPRA-Pub. L. 103-62), are used to establish the program goals. The following goals shall change as needed to be consistent with the Title V national performance measures:

1. Children who are at greatest risk for developmental, emotional and behavioral disorders and in need of related services will receive early screening, diagnosis, and assistance in finding and accessing needed services.

2. Other state and local agencies will receive assistance in providing effective coordinated services for persons with special health care needs.

12VAC5-191-250. Pediatric Screening and Genetics Services Genetics and Newborn Screening Services.

The Pediatric Screening and Genetics Services unit Genetics and Newborn Screening Services works to improve the health of children and families by preventing birth defects and developmental disabilities, promoting optimal child development, and promoting health and wellness among children and adolescents living with disabilities.

Pediatric Screening and Genetics Services include several programs, services, and projects, two of which are Genetics and Newborn Screening Services includes the Virginia Newborn Screening System and the Virginia Congenital Anomalies Reporting and Education System.