Title of Regulation: 12VAC5-191. State Plan for the Children with Special Health Care Needs Program (amending 12VAC5-191-40; adding 12VAC5-191-330, 12VAC5-191-340).

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: May 12, 2021.

Effective Date: May 27, 2021.

Agency Contact: Robin Buskey, Policy Analyst, Office of Family Health Services, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 863-7253, or email robin.buskey@vdh.virginia.gov.

Basis: The State Board of Health is authorized to make, adopt, promulgate, and enforce regulations by § 32.1-12 of the Code of Virginia. Chapter 503 of the 2020 Acts of Assembly requires the board to adopt regulations to implement an adult comprehensive sickle cell clinic network.

Purpose: The purpose of this regulation is to be in compliance with the Code of Virginia and to implement an adult comprehensive sickle cell clinic network. Sickle cell disease (SCD) is a group of inherited, lifelong blood disorders that affects the red blood cells. In the United States, SCD disproportionately affects African Americans and those with a Hispanic background. Throughout the world, the disease affects those from the Middle East, Italy, and Greece. Sickle cell affects every organ in the body. Complications include severe pain, stroke, acute chest syndrome, organ damage, and in some cases premature death. Increased sickle cell-related mortality has been shown in persons 18 to 30 years of age, with the highest rate of acute care encounters and re-hospitalizations in this age group compared to the older group of patients who would be expected to have increased illness and complications due to advancing age. According to Virginia Department of Health data, the rate of emergency department (ED) visits for sickle cell disease in Virginia was highest among persons 18 to 30 years of age at 53.8 ED visits per 10,000 ED visits and 53.1 ED visits per 10,000 ED visits in 2018 and 2019 respectively.

This regulatory action is essential to protect the health, safety, and welfare of Virginians with sickle cell disease. There is a need to improve the coordination of care and transition of young adults with sickle cell from pediatric to adult medical care. Virginia has only one comprehensive adult sickle cell center, which is located at Virginia Commonwealth University. Barriers to a successful transition include lack of comprehensive care programs for adults, lack of adult providers with skills or interest in caring for people with sickle cell, lack of insurance coverage, and poor communication and follow-up between pediatric and adult providers.

The short-term goal of this regulatory change is the establishment of an adult comprehensive sickle cell clinic network. The long-term goal is a reduction in the rate of ED visits for adults with sickle cell among persons 18 to 30 years of age and an increase in the number of adults who continue into specialty care and establish a medical home with a specialty care provider.

Rationale for Using Fast-Track Rulemaking Process: The mandate for this regulatory change is Chapter 503 of the 2020 Acts of Assembly, which directs the board to adopt regulations to implement an adult comprehensive sickle cell clinic network, so this action seems noncontroversial.

Substance: The State Plan for the Children with Special Health Care Needs Program is amended as follows:

12VAC5-191-40 is amended to include language that describes the adult sickle cell population.

12VAC5-191-330 is added to provide language that describes the Adult Comprehensive Sickle Cell Network.

12VAC5-191-340 is added to provide language that describes the scope of the Adult Comprehensive Sickle Cell Network.

Issues: The primary advantage of the proposed regulatory action to the public is that implementing an adult comprehensive sickle cell clinic network will establish the ability for the adult regional network to work with the pediatric network to ensure successful transition of persons with sickle cell disease. The intended result is continuity of services and treatment for this population of the public. There is no known disadvantage to the public associated with this regulatory change.

A primary advantage of the proposed regulatory action to the Commonwealth is that the action aligns with the recommendation from the American Society of Hematology to improve the pediatric to adult transition by ensuring qualified physicians in adult care are available to treat sickle cell disease. The primary disadvantage to the Commonwealth is the resulting cost of establishing and maintaining an adult regional network. Federal funding for sickle cell centers ended in 2008, and third-party reimbursement for clinical services is generally low, requiring existing SCD comprehensive centers to rely on institutional support. The General Assembly approved funding in the amount of $305k to support implementation of the Adult Comprehensive Sickle Cell Clinic Network.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. As directed by legislation, the State Board of Health (Board) proposes to establish provisions for a new Adult Comprehensive Sickle Cell Clinic Network. The proposed text mostly mirrors the existing text for the current Pediatric Comprehensive Sickle Cell Clinic Network.

Background. Sickle cell disease (SCD) is a group of inherited, lifelong blood disorders that affects the red blood cells. SCD affects every organ in the body. Complications include severe pain, stroke, acute chest syndrome, organ damage, and in some cases premature death.

Over the last several decades, pediatric care and medical advances have increased life expectancy for persons with SCD. However, according to the Virginia Department of Health (VDH), health care delivery systems and public health initiatives supporting the optimal transfer from pediatric to adult care have not kept pace with the growing adult population. Increased sickle cell-related mortality has been shown in 18 to 30 year olds, with the highest rate of acute care encounters and re-hospitalizations in this age group compared to the older group of patients who would be expected to have increased illness and complications due to advancing age.¹ VDH believes this demonstrates a need to improve the coordination of care and the transition of young adults with sickle cell from pediatric to adult medical care.

Chapter 503 of the 2020 Acts of Assembly² mandates that the Board adopt regulations to implement an adult and pediatric comprehensive sickle cell clinic network. The current regulation already includes provisions for the Board to work with comprehensive pediatric sickle cell centers to assure early entry into care within the first several months of life to prevent life threatening conditions. This is the Pediatric Comprehensive Sickle Cell Clinic Network (pediatric network). The proposed action would add text to the regulation that mostly mirrors the existing text, but would apply to adults with SCD, and would enable the creation of an Adult Comprehensive Sickle Cell Clinic Network (adult network).

The proposed text describes the adult network as a statewide group of clinics and subspecialty providers that provide comprehensive medical and support services that are collaborative, family centered, culturally competent, community based and outcome oriented for individuals age 18 and older living with sickle cell disease. Further, the proposed text states that the adult network provides the following direct health care services and enabling services:

1. Multidisciplinary evaluation and treatment from a team of professionals that may include a physician, nurse, social worker, community health worker or patient navigator.

2. Partnering with pediatric sickle cell providers to help facilitate and coordinate the transition of adolescents and young adults with sickle cell disease from pediatric to adult care and services.

3. Assistance in linking patients with primary care practitioners, a medical home, and subspecialists.

4. Educational genetic counseling to explain the inheritance pattern of the variants of sickle cell disease and diagnostic studies to ensure the accurate diagnosis of sickle cell disease.

5. Patient and family education related to all aspects of the diagnosis consistent with cultural and language needs.

6. Collaborative care between primary and subspecialty care providers.

7. Information, referral, and partnership with community-based sickle cell support programs.

8. Promotion of peer or family support that may include postsecondary education and vocational assistance.

9. Training and technical assistance to educate community and health care providers about best practices and evidence-informed standards of care for individuals with sickle cell disease.

10. Collection of surveillance data to monitor incidence, prevalence, demographics, morbidity, mortality, health care utilization, and costs in order to identify disease burden in the Commonwealth.

According to VDH, the short-term goal of the proposed regulatory change is the establishment of an adult network. The long-term goals are a reduction in the rate of emergency department visits for adults with sickle cell in the 18 to 30 age group, and an increase in the number of adults who continue into specialty care and establish a medical home with a specialty care provider.

Estimated Benefits and Costs. VDH currently contracts with health care systems to run four regional centers for the pediatric network. Chapter 1289 from the 2020 Acts of Assembly includes $305,000 annually for the adult network.³ VDH would be responsible for overseeing the allocation of the $305,000 to support the cost of implementing the proposed adult network through contracts for adult regional centers. The agency plans to issue a Request for Proposal for this purpose.

While VDH would oversee implementation of the proposed adult network through contracts with health care systems to create and run the regional centers, the health care systems would be responsible for operating the regional centers and the full associated costs beyond the allocated funds. The agency estimates that a total of $2,471,891 annually would be required to fully staff four regional centers.⁴ As currently occurs with the existing pediatric network, costs would be supported by health insurance, as well as sliding scale fees and other resources.⁵

VDH believes that the development of the adult network would substantively improve the care of adult sickle cell patients. In particular, it is expected to increase the likelihood of successful transfer of care from pediatric to adult providers. Improved care coordination within the clinic network can potentially decrease emergency room visits, hospitalizations and readmission rates. Thus, in addition to potentially improved health outcomes for adults with SCD, health care system costs may potentially decrease as well.

Businesses and Other Entities Affected. The proposed regulation would affect people who have SCD, as well as health care systems and providers who deliver health care services to individuals living with SCD. There are approximately 4,909 individuals living with SCD in the Commonwealth.⁶ VDH has indicated that four regional centers are anticipated for the adult network.

Small Businesses Affected. The proposed amendments would not likely adversely affect small businesses.

Localities⁷ Affected.⁸ The proposed regulation would not likely create costs for local governments. Although the proposed adult network would likely have four regional centers intended to cover SCD patients throughout the Commonwealth, it is not yet known in which localities the regional centers would be located.

Projected Impact on Employment. The proposal would likely increase total employment. VDH believes each of four adult regional centers would need to hire a hematologist, a nurse practitioner, a nurse, and a social worker, resulting in 16 additional jobs.

Effects on the Use and Value of Private Property. If private health care systems are among the entities with which VDH contracts for the adult network, their values may increase with the associated increase in business. The proposal would not affect real estate development costs.

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¹Source: VDH

²See https://lis.virginia.gov/cgi-bin/legp604.exe?201 ful CHAP0503

³It is not included as a separate earmark, but VDH states that it is included as part of Item 301 State Health Services. See https://budget.lis.virginia.gov/item/2020/1/HB30/Chapter/1/301/

⁴VDH's estimate is based on assuming that each regional center would employ one hematologist, one nurse practitioner, one nurse, and one social worker. See page six of the Agency Background Document for more detail. https://townhall.virginia.gov/L/GetFile.cfm?File=58\5664\9164\AgencyStatement_VDH_9164_v2.pdf

⁵Source: VDH

⁶Ibid

⁷Locality can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁸§ 2.2-4007.04 defines particularly affected as bearing disproportionate material impact.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

Pursuant to Chapter 503 of the 2020 Acts of Assembly, the amendments implement an adult comprehensive sickle cell clinic network including (i) providing that the State Board of Health work with comprehensive pediatric sickle cell centers to ensure individuals' early entry into care within the first several months of life to prevent life threatening conditions, (ii) creating an adult regional network that mirrors the current Pediatric Comprehensive Sickle Cell Clinic Network, and (iii) ensuring better coordination in transition from pediatric to adult sickle cell treatment.

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. 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.

7. Adult Comprehensive Sickle Cell Clinic Network.

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 21st birthday except that the Virginia Bleeding Disorders Program and the Virginia Sickle Cell Awareness Program serve individuals of all ages, and the Adult Comprehensive Sickle Cell Clinic Network serves individuals 18 years of age and older.

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.

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.

12VAC5-191-330. Description of the Adult Comprehensive Sickle Cell Clinic Network.

The Adult Comprehensive Sickle Cell Clinic Network is a statewide group of clinics and subspecialty providers that provide comprehensive medical and support services that are collaborative, family centered, culturally competent, community based, and outcome oriented for individuals 18 years of age and older living with sickle cell disease.

12VAC5-191-340. Scope and Content of the Adult Comprehensive Sickle Cell Clinic Network.

A. Mission. The Adult Comprehensive Sickle Cell Clinic Network delivers accessible services to provide access to specialty care and promotes the optimal health of adults living in the Commonwealth with sickle cell disease by working in partnership with individuals, families, service providers, community-based sickle cell programs, and the Virginia Sickle Cell Awareness Program.

B. Scope. The Adult Comprehensive Sickle Cell Clinic Network provides the following direct health care services and enabling services:

1. Multidisciplinary evaluation and treatment from a team of professionals, which may include a physician, nurse, social worker, community health worker, or patient navigator.

2. Partnering with pediatric sickle cell providers to help facilitate and coordinate the transition of adolescents and young adults with sickle cell disease from pediatric to adult care and services.

3. Assistance in linking patients with primary care practitioners, a medical home, and subspecialists.

4. Educational genetic counseling to explain the inheritance pattern of the variants of sickle cell disease and diagnostic studies to ensure the accurate diagnosis of sickle cell disease.

5. Patient and family education related to all aspects of the diagnosis consistent with cultural and language needs.

6. Collaborative care between primary and subspecialty care providers.

7. Information, referral, and partnership with community-based sickle cell support programs.

8. Promotion of peer or family support that may include postsecondary education and vocational assistance.

9. Training and technical assistance to educate community and health care providers about best practices and evidence-informed standards of care for individuals with sickle cell disease.

10. Collection of surveillance data to monitor incidence, prevalence, demographics, morbidity, mortality, health care utilization, and costs in order to identify disease burden in the Commonwealth.

C. Criteria to receive services from the Adult Comprehensive Sickle Cell Clinic Network. Individuals are eligible to receive services from the Adult Comprehensive Sickle Cell Clinic Network if they are:

1. Residents of the Commonwealth.

2. 18 years of age and older.

3. Diagnosed with sickle cell disease.

No financial eligibility criteria are required for clients to receive the enabling services. However, clients receiving direct health care services who meet the criteria in this subsection must also meet the financial requirements based on a sliding scale charge schedule of the providers.

D. Goals. The Title V national performance measures, National Institutes of Health and American Society of Hematology standards are used to establish the following program goals:

1. Individuals and families with sickle cell disease will partner in decision making at all levels and will be satisfied with the services they receive.

2. All individuals with sickle cell disease will receive coordinated, ongoing, comprehensive care within a medical home.

3. All individuals with sickle cell disease will have adequate private or public insurance or both to pay for the services they need.

4. Community-based services will be organized so individuals and families can use them easily.

5. All young adults with sickle cell disease will receive the services necessary to make transitions to all aspects of adult life, including adult health care, work and independence.

6. All adults with sickle cell disease will receive proper health maintenance care, management of complications, and chronic pain management.