Title of Regulation: 4VAC20-950. Pertaining to Black Sea Bass (amending 4VAC20-950-45).

Statutory Authority: § 28.2-201 of the Code of Virginia.

Effective Date: May 1, 2021.

Agency Contact: Jennifer Farmer, Marine Resources Commission, 380 Fenwick Road, Fort Monroe, VA 23551, telephone (757) 247-2248, or email jennifer.farmer@mrc.virginia.gov.

Summary:

The amendment extends the 2021 recreational black sea bass fishing season from May 15 through May 31 and June 16 through December 31, 2021.

4VAC20-950-45. Recreational possession limits and seasons.

A. It shall be unlawful for any person fishing with hook-and-line, rod and reel, spear, gig, or other recreational gear to possess more than 15 black sea bass. When fishing from a recreational vessel where the entire catch is held in a common hold or container, the possession limit shall be for that vessel and shall be equal to the number of persons on board legally licensed to fish, multiplied by 15. The captain or operator of the vessel shall be responsible for that vessel possession limit. Any black sea bass taken after the possession limit has been reached shall be returned to the water immediately.

B. Possession of any quantity of black sea bass that exceeds the possession limit described in subsection A of this section shall be presumed to be for commercial purposes.

C. The open recreational fishing season shall be from February 1 through the last day of February, May 15 through May 31, and June 22 16 through December 31.

D. It shall be unlawful for any person fishing recreationally to take, catch, or possess any black sea bass, except during an open recreational season.

E. From February 1 through the last day of February, it shall be unlawful for any person to possess or land any black sea bass harvested from a recreational vessel, unless the captain or operator of that recreational vessel has obtained a Recreational Black Sea Bass Permit from the Marine Resources Commission.

1. The captain or operator shall be responsible for reporting for all anglers on the recreational vessel and shall provide that captain's or that operator's Marine Resources Commission identification (MRC ID) number, the date of fishing, the number of persons on board, the mode of fishing, and the number of black sea bass kept or released. That report shall be submitted to the Marine Resources Commission (commission) on forms provided by the commission or through the Virginia Saltwater Fisherman's Journal.

a. It shall be unlawful for any permittee to fail to report each trip where black sea bass were targeted, whether black sea bass were harvested, released, or not caught, by March 15 of the current calendar year.

b. It shall be unlawful for any permittee who did not take any fishing trips to target black sea bass in the February recreational black sea bass season to fail to report lack of participation by March 15 of the current calendar year.

2. It shall be unlawful for any permittee to fail to contact the Law Enforcement Operations at 1-800-541-4646 before or immediately after the start of each fishing trip. The permittee shall provide the Law Enforcement Operations with the permittee's name, MRC ID number, the point of landing, a description of the vessel, estimated return to shore time, and a contact phone number.

3. Any permittee shall allow the commission to sample the vessel's catch to obtain biological information for scientific and management purposes.

VA.R. Doc. No. R21-6769; Filed April 28, 2021, 11:08 a.m.

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TITLE 12. HEALTH

STATE BOARD OF HEALTH

Proposed Regulation

Title of Regulation: 12VAC5-71. Regulations Governing Virginia Newborn Screening Services (amending 12VAC5-71-30).

Statutory Authority: §§ 32.1-12 and 32.1-67 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: July 9, 2021.

Agency Contact: Joseph Hilbert, Deputy Commissioner, Government and Regulatory Affairs, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7001, FAX (804) 864-7022, email joe.hilbert@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. Section 32.1-65 of the Code of Virginia requires newborn screening to be conducted on every infant born in the Commonwealth of Virginia. Section 32.1-67 of the Code of Virginia requires the State Board of Health to promulgate regulations as necessary to implement Newborn Screening Services.

Purpose: Spinal muscular atrophy (SMA) is a genetic disorder characterized by weakness and wasting (atrophy) in muscles used for movement (skeletal muscles). SMA is caused by a loss of specialized nerve cells, called motor neurons, which control muscle movement. SMA affects 9.1 out of every 100,000 births and there are five classification types. Type 0 often leads to fetal loss or newborns with significant involvement and death in early infancy; this is the rarest and most severe form of the condition. Type I, the most common form, leads to progressive weakness in the first six months of life and, without targeted intervention, death prior to two years of age. Type II is associated with progressive weakness by 15 months of life and, without targeted intervention, respiratory failure and death after the third decade of life. Types III and IV are associated with progressive weakness that develops after one year of life or in adulthood, and most individuals have a normal lifespan. Treatment for SMA generally includes a disease-modifying therapy that uses FDA-approved Spinraza, as well as clinical care support therapies such as nutritional support, respiratory support, pulmonary care, orthopedic and rehabilitation care, and palliative care.

X-linked adrenoleukodystrophy (X-ALD) is a genetic disorder that occurs primarily in males, mainly affecting the nervous system and the adrenal glands. In the United States, X-ALD affects six out of every 100,000 births, regardless of sex. There are three distinct types of X-ALD: a childhood cerebral form, an adrenomyeloneuropathy type, and a form called Addison disease only. Childhood cerebral X-ALD is the most serious form of X-ALD and it usually presents between 2.5 and 10 years of age. It is associated with rapid neurologic decline and death or disability an average three years after onset. Signs and symptoms of the adrenomyeloneuropathy type appear between early adulthood and middle age. People with X-ALD whose only symptom is adrenocortical insufficiency are said to have the Addison disease only form, which is the mildest form of the three types. In these individuals, adrenocortical insufficiency can begin anytime between childhood and adulthood. Treatment for X-ALD is difficult to predict since symptom onset varies and, in many cases, might not occur until after infancy. Treatment options include hormone therapy and hematopoietic stem cell transplantation, depending on the severity of the disorder.

All newborns in Virginia would be screened for SMA and X-ALD as a result of this proposed regulatory action. Screening for SMA and X-ALD can provide affected infants the benefit of early diagnosis and treatment. Screening is an effective diagnostic tool since these disorders cannot be detected at birth through a physical examination. Laboratory screening is available at a cost.

The addition of SMA and X-ALD to the core panel will result in an increase to the newborn screening fee. The VDH Office of Family Health Services has a longstanding partnership with the Division of Consolidated Laboratory Services (DCLS) to provide blood spot newborn screening services. The Virginia Newborn Screening Program is solely funded through Enterprise Funding, which is generated from the collection of fees from dried blood spot specimen kits sold to submitting birthing facilities and health care providers statewide. As of October 1, 2019, the newborn screening fee is $138 per card. To implement these two screenings statewide, DCLS will require infrastructure investment that includes additional laboratory equipment; programmatic staff; application development to incorporate screening results; incorporation of new education modules; identification of specialized medical support systems for infants and their families; and family support and case management services for infants diagnosed with SMA or X-ALD. Adding SMA to the newborn screening panel results in an increase of $2.16, and adding X-ALD to the newborn screening results in an increase of $10.84 per sample, for a total of $13 for both of these disorders.

Substance: The proposed changes to 12VAC5-71-30, which lists the specific disorders and genetic diseases that must be screened in Virginia, add SMA and X-ALD to the state's core panel. Currently, DCLS analyzes biological markers that may be indicative of 31 certain disorders that constitute the core panel. Section 32.1-67 of the Code of Virginia requires that this list of screened disorders be in the regulation. Section 32.1-65 of the Code of Virginia requires that Virginia's screening tests are consistent with the panel recommended by the U.S. Secretary of Health and Human Services (HHS) Advisory Committee on Heritable Disorders in Newborns and Children Recommended Uniform Screening Panel.

Issues: The primary advantage of the proposed regulatory action to the public is that screening for SMA and X-ALD can provide affected infants the benefit of early diagnosis and treatment. Screening is an effective diagnostic tool since these disorders cannot be detected at birth through a physical examination. The primary disadvantage to the public is that adding these two screenings to the panel results in a cost increase.

A primary advantage of the proposed regulatory action to the agency is that the action aligns with the recommendation from the Virginia Genetics Advisory Committee to add SMA and X-ALD to the state's core panel. This also aligns with the panel recommended by the U.S. Secretary of HHS Advisory Committee on Heritable Disorders in Newborns and Children Recommended Uniform Screening Panel.

A disadvantage to the regulated community, government officials, and the public is the projected increase in the cost of the two screenings. Newborn screening is a fee-for-service program, and the fee is paid by hospitals and other screeners who must purchase the filter paper kits used for blood spot collection. Most screening is performed in hospitals, with about 10% to 15% of screening performed by private physicians and military facilities. Hospitals do not generally pass on these costs to patients because third-party payers usually pay a negotiated bundled amount per delivery, and Medicaid reimbursed delivery payment is set by the state. Self-pay patients may be responsible to pay the screening fee themselves if they have the resources to do so.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) seeks to amend the existing newborn screening regulation to add spinal muscular atrophy (SMA) and X-linked adrenoleukodystrophy (X-ALD) to the newborn screening panel (NSP). The additions of SMA and X-ALD to the NSP have been recommended by the Virginia Genetics Advisory Committee. Blood spot newborn screening services are provided by the Department of General Services Division of Consolidated Laboratory Services (DCLS) in partnership with the Virginia Department of Health (VDH) Office of Family Health Services, and as required by 12VAC5-71-100.

Background. The Board proposes to amend 12VAC5-71-30, Core Panel of Heritable Disorders and Genetic Diseases, to add SMA and X-ALD. VDH reports that SMA is estimated to occur in approximately 9.1 out of every 100,000 live births and X-ALD is estimated to occur in approximately six out of every 100,000 live births. If these disorders progress undetected, they are known to cause severe disabilities or a severely shortened lifespan.¹ However, treatment for both these genetic disorders are available if they are detected early. Blood spot tests are necessary to detect these disorders as they cannot be detected at birth through physical examinations. Virginia currently screens for 33 genetic disorders: 31 genetic disorders by dried blood spot screening along with critical congenital heart disease and hearing loss by point of care testing. With the addition of X-ALD and SMA, Virginia will be in alignment with the 35 disorders on the Secretary of the U.S. Department of Health and Human Services Recommended Uniform Screening Panel.

Estimated Benefits and Costs. In Virginia, DCLS conducts roughly 99,000 newborn screening tests per year. Thus, the proposed amendments would result in the screening of all newborns in Virginia for these disorders; this would potentially benefit approximately 15 newborns each year who might be born with SMA or X-ALD, as well as their families. The benefits of early detection and treatment include not only the avoidance of disability but also the associated costs and other detrimental effects. These benefits would accrue over the entire lifespan of individuals having these genetic disorders.

However, laboratory screening comes at a cost. The Virginia Newborn Screening Program is solely funded through enterprise funding, which is generated from the collection of fees from dried blood spot specimen kits sold to submitting birthing facilities and health care providers statewide. VDH notes that in order to implement these two screenings statewide, DCLS would require infrastructure investment that includes additional laboratory equipment, programmatic staff, application development to incorporate screening results, incorporation of new education modules, identification of specialized medical support systems for infants and their families, and family support and case management services for infants diagnosed with SMA or X-ALD.

Specifically, adding SMA to the newborn screening panel results in an increase of $2.16, and adding X-ALD to the newborn screening results in an increase of $10.84 per sample, for a total of $13 for both of these disorders per sample. Further, the Board anticipates VDH costs to include one full-time employee for follow-up activities and education, and incurring outreach costs. The Board estimates DCLS costs related to capital equipment, staff, application development and education modules to be $389,631 in start-up costs and $192,262 annually for SMA screenings, and $1,101,568 in start-up costs and $1,073,422 annually for X-ALD screenings. These costs amount to an additional $13-$15 per test, since DCLS conducts roughly 99,000 tests a year.

These projected costs would be funded through a fee increase for the blood spot screening panel, which would need to go into effect 12 months prior to implementation to accrue start-up costs. Therefore, in order to begin including tests for SMA and X-ALD in the NSP in the 2020-2021 fiscal year, DCLS increased the fee for the blood spot specimen kit from $101.20 to $138 effective October 1, 2019. An estimated $26-28 of this increase can be attributed directly to the changes proposed by the Board in this action. The overall fee increase would cover the cost of the two tests as well as other costs DCLS seeks to recoup for the expected addition of other tests in fiscal year 2021. Since the fees for the blood spot screening panel are set by DCLS and not the Board, this action does not directly lead to the introduction of new costs per se.

Businesses and Other Entities Affected. The increased fee directly affects hospitals, birth centers, and midwives who purchase the dried blood spot specimen kits from DCLS, as well as health insurance companies. VDH estimates that there are 58 hospitals, 10 to 15 birth centers, and an unknown number of midwives who would be affected by the fee increase.² Most private health insurance plans include the fee for the NSP in the negotiated reimbursement amount for childbirth. Hence, hospitals and birth centers are unlikely to pass on the increased costs directly to their patients. However, not all midwives accept health insurance and may pass on the increased costs to their patients. Further, the Department of Medical Assistance Services may have to update the reimbursements made on behalf of Medicaid enrollees to cover the increased fee. An adverse impact is indicated for the increased fee, since adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined.

Small Businesses Affected.

Types and Estimated Number of Small Businesses Affected. It is not known if any of the hospitals qualify as small businesses, as many are nonprofits, and those that are for profit may be too large.³ Additionally, affected health insurance companies may be too large to qualify. Birth centers and independent midwives are more likely to meet the definition of a small business. VDH estimates that there are 10 to 15 birth centers in Virginia; the number of midwives is unknown.

Costs and Other Effects. Any hospitals, birth centers, or midwives that do qualify as a small business would likely be adversely affected by the proposed fee increase.

Alternative Method that Minimizes Adverse Impact. There are no clear alternative methods that both reduce adverse impact and meet the intended policy goals.

Localities⁴ Affected.⁵ The proposed amendments do not disproportionately affect any specific localities, nor do they introduce new costs for local governments.

Projected Impact on Employment. The proposed amendments are directly linked to allocations for six full-time employees at DCLS and one full-time employee at VDH. The proposed amendments are unlikely to affect employment at hospitals, birth centers, or health insurance companies more generally.

Effects on the Use and Value of Private Property. Private businesses that end up paying for either part of or all of the fee increase either directly or through reimbursements may be moderately reduced in value. Real estate development costs would not be affected.

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¹Page 3 of the Agency Background Document includes further details about each disorder, including the various sub-types, symptoms, and typical outcomes. See https://townhall.virginia.gov/l/GetFile.cfm?File=58\5259\8965\AgencyStatement_VDH_8965_v1.pdf.

²The Department of Health Professions lists 95 currently licensed midwives, but many of them are likely to be employed by hospitals or birth centers.

³Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million".

^4"Locality" 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.

⁵§ 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:

The proposed amendments add spinal muscular atrophy (SMA) and X-linked adrenoleukodystrophy (X-ALD) to the newborn screening panel. The additions of SMA and X-ALD to the newborn screening panel have been recommended by the Virginia Genetics Advisory Committee. On the national level, these disorders have been added to the core panel of 35 genetic disorders included in the Recommended Uniform Screening Panel of the U.S. Secretary of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children.

12VAC5-71-30. Core panel of heritable disorders and genetic diseases.

A. The Virginia Newborn Screening System, which includes the Virginia Newborn Screening Program, the Virginia Early Hearing Detection and Intervention Program, and the Virginia critical congenital heart disease screening, shall ensure that the core panel of heritable disorders and genetic diseases for which newborn screening is conducted is consistent with but not necessarily identical to the U.S. Department of Health and Human Services Secretary's Recommended Uniform Screening Panel.

B. The department shall review, at least biennially, national recommendations and guidelines and may propose changes to the core panel of heritable disorders and genetic diseases for which newborn dried-blood-spot screening tests are conducted.

C. The Virginia Genetics Advisory Committee may be consulted and provide advice to the commissioner on proposed changes to the core panel of heritable disorders and genetic diseases for which newborn dried-blood-spot screening tests are conducted.

D. Infants under six months of age who are born in Virginia shall be screened in accordance with the provisions set forth in this chapter for the following heritable disorders and genetic diseases, which are identified through newborn dried-blood-spot screening tests:

1. Argininosuccinic aciduria (ASA);

2. Beta-Ketothiolase deficiency (BKT);

3. Biotinidase deficiency (BIOT);

4. Carnitine uptake defect (CUD);

5. Classical galactosemia (galactose-1-phosphate uridyltransferase deficiency) (GALT);

6. Citrullinemia type I (CIT-I);

7. Congenital adrenal hyperplasia (CAH);

8. Cystic fibrosis (CF);

9. Glutaric acidemia type I (GA I);

10. Hb S beta-thalassemia (Hb F,S,A);

11. Hb SC-disease (Hb F,S,C);

12. Hb SS-disease (sickle cell anemia) (Hb F, S);

13. Homocystinuria (HCY);

14. Isovaleric acidemia (IVA);

15. Long chain L-3-Hydroxy acyl-CoA dehydrogenase deficiency (LCHAD);

16. Maple syrup urine disease (MSUD);

17. Medium-chain acyl-CoA dehydrogenase deficiency (MCAD);

18. Methylmalonic acidemia (Methylmalonyl-CoA mutase deficiency) (MUT);

19. Methylmalonic acidemia (Adenosylcobalamin synthesis deficiency) (CBL A, CBL B);

20. Multiple carboxylase deficiency (MCD);

21. Phenylketonuria (PKU);

22. Primary congenital hypothyroidism (CH);

23. Propionic acidemia (PROP);

24. Severe combined immunodeficiency (SCID);

25. Tyrosinemia type I (TYR I);

26. Trifunctional protein deficiency (TFP);

27. Very long-chain acyl-CoA dehydrogenase deficiency (VLCAD);

28. 3-hydroxy 3-methyl glutaric aciduria (HMG);

29. 3-Methylcrotonyl-CoA carboxylase deficiency (3-MCC);

30. Pompe disease; and

31. Mucopolysaccharidosis type I (MPS I);

32. Spinal muscular atrophy (SMA); and

33. X-linked adrenoleukodystrophy (X-ALD).

E. Infants born in Virginia shall be screened for hearing loss in accordance with provisions set forth in §§ 32.1-64.1 and 32.1-64.2 of the Code of Virginia and as governed by 12VAC5-80.

F. Newborns born in Virginia shall be screened for critical congenital heart disease in accordance with provisions set forth in §§ 32.1-65.1 and 32.1-67 of the Code of Virginia and as governed by 12VAC5-71-210 through 12VAC5-71-260.