Titles of Regulations: 12VAC30-50. Amount, Duration, and Scope of Medical and Remedial Care Services (amending 12VAC30-50-190).

12VAC30-141. Family Access to Medical Insurance Security Plan (amending 12VAC30-141-820).

Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 12, 2016.

Agency Contact: Victoria Simmons, Regulatory Coordinator, Department of Medical Assistance Services, Policy Division, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-6043, FAX (804) 786-1680, TTY (800) 343-0634, or email victoria.simmons@dmas.virginia.gov.

Basis: Section 32.1-325 of the Code of Virginia grants to the Board of Medical Assistance Services the authority to administer and amend the Plan for Medical Assistance. Section 32.1-324 of the Code of Virginia authorizes the Director of the Department of Medical Assistance Services (DMAS) to administer and amend the Plan for Medical Assistance according to the board's requirements. The Medicaid authority as established by § 1902(a) of the Social Security Act (42 USC § 1396a) provides governing authority for payments for services.

In addition, Item 301 LLLL 2 of Chapter 665 of the 2015 Acts of Assembly provides that "The Department of Medical Assistance Services is authorized to amend the State Plan under Title XIX of the Social Security Act to add coverage for comprehensive dental services to pregnant women receiving services under the Medicaid program to include: (i) diagnostic, (ii) preventive, (iii) restorative, (iv) endodontics, (v) periodontics, (vi) prosthodontics both removable and fixed, (vii) oral surgery, and (viii) adjunctive general services." An emergency regulation for this purpose is currently in effect. This proposed regulation would replace the emergency regulation.

Purpose: Prior to this action, only those individuals covered through the Family Access to Medical Insurance Security Plan (FAMIS) or those younger than the age of 21 years who were covered through Medicaid were provided dental services. Dental emergency coverage for adults was also provided. Services are provided to individuals younger than 21 years of age as long as they are routine diagnostic, preventive, or restorative procedures necessary for oral health provided by or under the direct supervision of a dentist in accordance with the State Dental Practice Act.

Due to the need of pregnant women to receive dental care, the Governor approved emergency regulations to provide dental care for about 45,000 adult pregnant women enrolled in Medicaid and FAMIS MOMS who already receive publicly funded Medicaid/FAMIS MOMS health care services. This action seeks to utilize the authority granted by the Governor to make permanent the dental services regulation to allow the department to continue to carry out the Governor's directive.

Substance: In the past, DMAS covered routine dental services through the Smiles for Children (SFC) program only for individuals younger than 21 years of age. Dental services are required by the FAMIS program (12VAC30-141-500 and 12VAC30-141-830) and by the Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) Program (42 CFR 440.40(b) and 12VAC30-50-40 B). The covered services are diagnostic x-rays and exams; preventive cleanings; restorative fillings; endodontics (root canals); periodontics (gum-related treatments); prosthodontics, both removable and fixed (crowns, bridges, partials, and dentures); orthodontia; oral surgery (extractions and other oral surgeries); and adjunctive general services (all covered services that do not fall into specific professional categories). DMAS also covers emergency dental care, with the associated diagnostic tests, for adults.

Control of dental disease during pregnancy has been shown to have positive effect on a pregnancy's outcome. Both the American Congress of Obstetricians and Gynecologists (ACOG) and the American Dental Association (ADA) have published position papers supporting the need for and safety of oral health care during pregnancy.

In furtherance of the Governor's Healthy Virginia Plan, DMAS is working in concert with its dental benefits administrator, DentaQuest, to design an oral health program for adult pregnant women who are enrolled in Medicaid and FAMIS MOMS. The service categories are inclusive of those provided in Virginia's Smiles for Children (SFC) program and, in comparison, are similar in scope to dental services available through the Virginia Department of Human Resources dental benefits for state employees, with the exception of orthodontia services, which will not be covered.

Services for adult pregnant women will include the following when deemed medically appropriate: diagnostic x-rays and exams; preventive cleanings; restorative fillings; endodontics (root canals); periodontics (gum-related treatment); prosthodontics, both removable and fixed (crowns, bridges, partials, and dentures); oral surgery (extractions and other oral surgeries); and adjunctive general services (all covered services that do not fall into specific professional categories). The appropriateness of particular services for an individual pregnant woman will be determined by the dental provider based on the term of the woman's pregnancy.

DMAS estimates that approximately 45,000 adult pregnant women will be eligible for this service. Based on the average per individual expenditure for dental services, DMAS estimates that this new coverage may cost approximately $600,000 in state fiscal year (SFY) 2015 (beginning March 1, 2015) and $3.2 million in SFY 2016. The funds for this service derive from the state general fund and federal matching funds claimed by DMAS.

Issues: Control of dental disease during and after pregnancies may have a positive effect on the overall health of mothers and infants. The advantages to indigent pregnant women will be the availability of dental services. The advantage to the Commonwealth and citizens will be the improved health outcomes with the related cost savings. The disadvantage is a slight increase in Commonwealth expenditures. However, this cost is partially offset by the matching funds received from the Centers for Medicare and Medicaid Services.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to the 2015 Acts of Assembly, Chapter 665¹, Item 301 LLLL(2), the Board of Medical Assistance Services (Board) proposes to add adult pregnant women to the individuals eligible to receive full dental services (excluding orthodontia) through Medicaid and FAMIS MOMS. An emergency regulation for this purpose is currently in effect. This proposed regulation would replace the emergency regulation.

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

Estimated Economic Impact. Prior to the legislation and emergency regulation, the Department of Medical Assistance Services (DMAS) only covered comprehensive dental services including orthodontia (12VAC30-50-190 and 42 CFR 440.100) for individuals under the age of 19 who were covered through the Family Access to Medical Insurance Security (FAMIS) plan and for individuals up to the age of 21 as a required element of the Early and Periodic Screening, Diagnosis, and Treatment program (12VAC30-50-130(B) and 42 CFR 440.40(b)). Only emergency dental care with the associated diagnostic tests was covered for adults (ages 21 and older). The Board proposes to cover dental care, excluding orthodontia, for adult pregnant women enrolled in Medicaid and FAMIS MOMS.

Peer-reviewed studies have found that improved oral health during pregnancy decreases transmission of potentially cariogenic bacteria to infants.² Both the American Congress of Obstetricians and Gynecologists³ and the American Dental Association⁴ have published position papers supporting the need for and safety of oral health care during pregnancy. Thus, providing dental services through Medicaid for adult pregnant women will provide significant health benefits for both the women and their babies.

DMAS calculates that approximately 45,000 adult women are pregnant and enrolled in Medicaid and FAMIS MOMS at any point within a year. The agency also estimates that the state share of the costs of this program would be approximately $1.6 million for fiscal year 2016.

Businesses and Entities Affected. The proposed amendment affects dental practices, the dental benefits administrator DentaQuest, and the approximate 45,000 women who are pregnant and enrolled in Medicaid and FAMIS MOMS at any point within a year.

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendment may moderately increase staffing needs for dental practices.

Effects on the Use and Value of Private Property. The proposed amendment will create additional business for dental practices.

Real Estate Development Costs. The proposed amendment will not affect real estate development costs.

Small Businesses: Definition. Pursuant 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."

Costs and Other Effects. The proposed amendment is unlikely to increase costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendment will not adversely affect small businesses.

Adverse Impacts: Businesses: The proposed amendment will not adversely affect businesses.

Localities: The proposed amendment will not adversely affect localities.

Other Entities: The proposed amendment will cost the Commonwealth (taxpayers) approximately $1.6 million annually.

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¹This is the 2015 Appropriation Act.

²Meyer K, Geurtsen W, Gunay H. "An early oral health care program starting during pregnancy: results of a prospective clinical long-term study." Clin Oral Investig 2010;14:257–64.

Gomez SS,Weber AA. "Effectiveness of a caries preventive program in pregnant women and new mothers on their offspring." Int J Paediatr Dent 2001;11:117–22.

Kohler B, Andreen I, Jonsson B. "The effect of caries-preventive measures in mothers on dental caries and the oral presence of the bacteria Streptococcus mutans and lactobacilli in their children." Arch Oral Biol 1984;29:879–83.

³"Oral health care during pregnancy and through the lifespan." Committee Opinion No. 569. American College of Obstetricians and Gynecologists. Obstet Gynecol 2013;122:417–22.

⁴"Pregnant dental patients: Health groups spread word that dental care is safe, necessary." American Dental Association. ADA News May 20, 2013.

Agency's Response to Economic Impact Analysis: The agency has reviewed the economic impact analysis prepared by the Department of Planning and Budget regarding the regulations concerning Dental Services for Pregnant Women. The agency raises no issues with this analysis.

Summary:

Pursuant to Item 301 LLLL 2 of Chapter 665 of the 2015 Acts of Assembly, the proposed amendments add adult pregnant women to the individuals eligible to receive full dental services, excluding orthodontia, through Medicaid and FAMIS MOMS.

12VAC30-50-190. Dental services.

A. Dental services are limited to recipients under shall be covered for individuals younger than 21 years of age in fulfillment of the treatment requirements under the Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) Program and defined as routine diagnostic, preventive, or restorative procedures necessary for oral health provided by or under the direct supervision of a dentist in accordance with the State Dental Practice Act.

1. The state agency will provide any medically necessary dental service to individuals younger than 21 years of age.

B. 2. Certain dental services, as described in the agency's Office Reference Manual (Smiles for Children, copyright 2005) March 13, 2014), prepared by DMAS' dental benefits administrator, require preauthorization or prepayment review by the state agency or its designee.

3. Dental services for individuals younger than the age of 21 years that do not require preauthorization or prepayment review are initial, periodic, and emergency examinations; required radiography necessary to develop a treatment plan; patient education; dental prophylaxis; fluoride treatments; routine amalgam and composite restorations; stainless steel crowns, prefabricated steel post and temporary (polycarbonate crowns) and stainless steel bands; crown recementation; pulpotomies; emergency endodontics for temporary relief of pain; pulp capping; sedative fillings; therapeutic apical closure; topical palliative treatment for dental pain; removal of foreign body; simple extractions; root recovery; incision and drainage of abscess; surgical exposure of the tooth to aid eruption; sequestrectomy for osteomyelitis; and oral antral fistula closure.

C. B. Dental services determined by the dental provider to be medically appropriate for an adult woman during the term of her pregnancy and through the end of the month following the 60th day postpartum shall be provided to a Medicaid-enrolled pregnant woman. The dental services that shall be covered are (i) diagnostic x-rays and exams; (ii) preventive cleanings; (iii) restorative fillings; (iv) endodontics (root canals); (v) periodontics (gum-related treatments); (vi) prosthodontics, both removable and fixed (crowns, bridges, partial plates, and dentures); (vii) oral surgery (tooth extractions and other oral surgeries); and (viii) adjunctive general services (all covered services that do not fall into specific professional categories). These services require prepayment review by the state agency or its designee.

C. The For the dental services covered for Medicaid-enrolled adult pregnant women, the state agency may place appropriate limits on a service based on medical necessity, for utilization control, or both. Examples of service limitations are: examinations, prophylaxis, fluoride treatment (once/six months); space maintenance appliances; bitewing x-ray—two films (once/12 months); routine amalgam and composite restorations (once/three years); dentures (once/five years); extractions, orthodontics, tooth guidance appliances, permanent crowns and bridges, endodontics, patient education and sealants (once).

D. Limited oral surgery procedures, as defined and covered under Title XVIII (Medicare), are covered for all recipients, and require preauthorization or prepayment review by the state agency or its designee as described in the agency's Office Reference Manual located on the DMAS website at: (http://www.dmas.virginia.gov/downloads/pdfs/dental-office_reference_manual_06-09-05.pdf) http://www.dmas.virginia.gov/Content_atchs/dnt/VA_SFC_ORM_140313.pdf.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC30-50)

Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition DSM-IV-TR, copyright 2000, American Psychiatric Association

Length of Stay by Diagnosis and Operation, Southern Region, 1996, HCIA, Inc.

Guidelines for Perinatal Care, 4th Edition, August 1997, American Academy of Pediatrics and the American College of Obstetricians and Gynecologists

Virginia Supplemental Drug Rebate Agreement Contract and Addenda

Office Reference Manual (Smiles for Children), prepared by DMAS' Dental Benefits Administrator, copyright 2005 (www.dmas.virginia.gov/downloads/pdfs/dental-office_reference_manual_06-09-05.pdf).

Office Reference Manual (Smiles for Children), prepared by DMAS' Dental Benefits Administrator, copyright 2010, dated March 13, 2014 (http://www.dmas.virginia.gov/Content_atchs/dnt/VA_SFC_ORM_140313.pdf)

Patient Placement Criteria for the Treatment of Substance-Related Disorders ASAM PPC-2R, Second Edition, copyright 2001, American Society of Addiction Medicine

Virginia Medicaid Durable Medical Equipment and Supplies Provider Manual, Appendix B (rev. 1/11), Department of Medical Assistance Services

Human Services and Related Fields Approved Degrees/Experience, Department of Behavioral Health and Developmental Services (rev. 5/13)

12VAC30-141-820. Benefit packages.

Pregnant women covered through FAMIS MOMS may receive the same medical and dental services and are subject to the same limitations on services as pregnant women (see 12VAC30-50-190) covered by the Medicaid program as defined in 12VAC30-10-140 and 12VAC30-50-10.