Original Notice.

     Preproposal statement of inquiry was filed as WSR 01-08-091 and 01-08-093.

     Title of Rule: Chapter 246-680 WAC, Prenatal tests -- Congenital and heritable disorders.

     Purpose: Chapter 246-680 WAC establishes (1) State Board of Health (SBOH) standards for screening and diagnostic procedures for prenatal diagnosis of congenital disorders of the fetus, and (2) Department of Health (DOH) criteria and timelines regarding the availability and use of prenatal tests for health care providers to share with pregnant women and couples.

     Other Identifying Information: These rules have been reviewed under Executive Order 97-02, Regulatory Improvement. This proposal combines the rule development processes that were initiated under WSR 01-08-091 and 01-08-093.

     Statutory Authority for Adoption: For WAC 246-680-001 Purpose, is RCW 43.20.050, 70.54.220; for WAC 246-680-010 Definitions, is RCW 48.21.244, 48.44.344, 48.46.375, 70.54.220; and for WAC 246-680-020 Board of health standards for screening and diagnostic tests during pregnancy, is RCW 48.21.244, 48.44.344, 48.46.375.

     Statute Being Implemented: RCW 70.54.220, 43.20.050, 48.21.244, 48.44.344, 48.46.375.

     Summary: The proposal adds time periods within which prenatal tests are to be performed. RCW 70.54.220 directs the department to establish time periods, but not all tests required by rules have time periods set out. RCW 43.20.050, 48.21.244, 48.44.344, and 48.46.375 direct the SBOH to establish standards for prenatal testing. The proposal updates the style of rules; deletes obsolete rules, updates the scope of prenatal genetics testing required for health insurance benefits packages; and adds three new tests: Maternal hepatitis B, and Group B strep, fluorescent in-situ hybridization (FISH).

     Reasons Supporting Proposal: Existing rule does not fully reflect statutory requirements because not all prenatal tests in WAC include time periods within which they need to be made available to pregnant women. These rules have not been updated for ten years. The updates will improve readability and assure the rules are consistent with current standards of practice.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Debra Lochner Doyle, Center Point, Kent, (253) 395-6742.

     Name of Proponent: Department of Health and State Board of Health, governmental.

     Rule is not necessitated by federal law, federal or state court decision.

     Explanation of Rule, its Purpose, and Anticipated Effects: This rule establishes standards of medical necessity for prenatal screening and diagnostic procedures that must be included in maternity benefits when offered by insurance companies, health maintenance organizations and group disability contractors. The purpose of the rule is to assure pregnant women have timely access to prenatal screening and diagnostic procedures.

     The proposal adds time periods within which prenatal tests must be performed under requirements of medical necessity set by the SBOH. The amendments will make the rules responsive to RCW 70.54.220, which directs the department to establish prenatal testing time periods. Not all tests required by rules now have time periods set out. The change will also improve readability and assure that the rule is consistent with current standards of medical practice.

     The anticipated effects of the rule are to enable pregnant women to receive timely information from their health care providers about the availability of prenatal diagnostic tests in order to enable informed decisions about having those tests.

     Proposal Changes the Following Existing Rules: The proposal amends chapter 246-680 WAC. WAC 246-680-001 Purpose, is amended to improve readability. WAC 246-680-010 Definitions, is amended to clarify terms, identify specific tests used to predict congenital or heritable disorders and when the tests should occur. Under WAC 246-680-020, Board of Health standards for screening and diagnostic test during pregnancy, the proposal adds maternal hepatitis B surface antigen, Group B strep and fluorescent in-situ hybridization (FISH) as standards of medical necessity for prenatal testing, and criteria for when prenatal ultrasound should occur. The section also adds, as a recommended procedure, prenatal tissue biopsy/sampling if the nature of the disorder indicates that tissue biopsy is the only means to provide biochemical genetic diagnosis for the purpose of protecting the mother's health, or predicting the prognosis of the fetus.

     A small business economic impact statement has been prepared under chapter 19.85 RCW.

     The amendments to the prenatal screening rule have been evaluated and the DOH has determined that the probable benefits exceed the probable costs, that this rule is the least burdensome for those who are required to comply and that the impacts of the rule amendments, taken together, have a disproportionate impact on small business. The cost minimization required for the small business economic impact statement is discussed in the least burden analysis.

     Prenatal Screening: The amendments to the current prenatal screening rule bring the rule up-to-date with current standards of care. The rule amendment combines requirements for methods of tissue extraction and methods of testing to allow parents to have healthy babies. Appendix A provides a list of the changes to the rule in matrix form and indicates which changes are housekeeping, existing practice, or newly adopted standards of care. This document only evaluates the following substantive changes:¹

     The following changes will produce little or no change in currently provided medical services but they are evaluated because the amendments are substantive:

&sqbul;     Use of laboratory testing called FISH (fluorescent in-situ hybridization).

&sqbul;     Testing for hepatitis B.

     The following change will bring the rule up-to-date with the standard of care being adopted or recommended by the CDC and other professional organizations. It will create an increased impetus to a substantive change that is already going on in the market:

&sqbul;     Testing for Group B strep.

     The amendments augment the rule and allow each of the existing requirements to work better.

     Small Business Economic Impact: The purpose of the amendment is to bring the WAC into conformance with current standards of care. Given this, it is highly likely that the rule will have no impact on costs because doctors and insurers either have incorporated, or are currently incorporating the requirements into their daily actions. However, this rule amendment is being reviewed as if this were not the case because in some areas of the state some practices may not comply with current standards of care. Furthermore, the insurers may not yet have incorporated the newer standards of care into their rate structures. This rule amendment has been reviewed and DOH has determined that if doctors are not currently practicing under recognized standards of care or if insurers have not incorporated the standard shift into their current policies then the amendment has a disproportionate impact on small businesses.

     Many small and large businesses in every SIC² code provide insurance for their employees. They will be affected by the rule through changes in insurance rates.

     This rule will affect the insurance providers directly. But the largest share of costs will accrue to the small businesses that provide insurance to their employees in small insurance pools. The insurance market is fluid and businesses have many options. Companies may provide insurance, may self insure, or may provide a defined contribution for the employee to use for insurance. It is impossible to know how many currently provide each type of coverage and, more importantly, what shifts will be made in the immediate future.

     This rule requires coverage by insurance providers for techniques that will define genetic disorders in a fetus (FISH), for testing of the mother for Group B strep, and for testing of the mother for hepatitis B. Each has different implications for business itself:

     The direct impact of the rule will be on insurance companies in the following SIC. Based on current information, FISH will provide significant savings to the medical structure³ and thus to insurers for all forms of coverage. Its use by reducing costs to insurers could possibly reduce rates if the savings were not already incorporated into the rate structure. This would have a positive impact on businesses that use regular insurance.

		Total	Total	Average employment
SIC	DESCRIPTION	Units	Employment	Small business	Largest 10%
6324	Hospital and medical service plans	48	6,938	11	135

     Over the last year the draft rule has been circulated twice to insurers for feedback. Insurers have not responded to the rule change. They have also been invited to meetings as stakeholders. The purpose of the rule change is to bring the WAC into conformance with current standard of care. It is likely that the national carriers of distributed risk that provide the coverage have already incorporated the cost savings from FISH and the cost increases from Group B strep and HBV standard of care into their rates.

     Testing for Group B strep and HBV will have significant net benefits for the population because children will not be injured but the greatest share of the gain is to the child and not to the medical system. The net medical cost for Group B strep is $15 per child. The HBV screen decreases total medical costs by $346 however the screen is still likely to increase rates. The short-term medical cost for HBV is 22 million or $27 per child. The avoidance of HBV saves $22,000 in medical costs for the adult victim and this will more than offset medical costs but the gain is in the distant future (over twenty to thirty years from now) and is unlikely to be factored into rates. Thus, these requirements are likely to increase rates. This would have a negative impact on insurers and on businesses that use regular insurance.

     Small and large businesses are affected differently by the two shifts. The cost imposition is based on very common medical problems since all mothers will be tested. A cost that applies to all mothers is strictly proportional to the number of women employed. Thus, Group B strep and HBV screening will have a disproportionate impact on companies that employ more women of child-bearing age than other companies. Since the use of FISH is much rarer, the average small company is unlikely to be affected by the cost reduction due to FISH but is highly likely to be affected by the other cost increases. The large company is more likely to be affected by both the cost increases and cost decreases.

     DOH has done a worst-case analysis. The average large company⁴ has one hundred eighty-two employees where an average small company that provides coverage has 30.2 employees.⁵ If the following assumptions are applied then in a ten-year period the small business has only a 7% chance that FISH will produce a savings for their risk pool where the average large company has a 41% chance that FISH will produce a savings.

&sqbul;     Half the employees are female.

&sqbul;     Average percentages are between the age of twenty and thirty-four.⁶

&sqbul;     The average females in these age brackets bears two live children in the fourteen year period.

&sqbul;     Average population frequencies for FISH are applied.

&sqbul;     The small business is in a small risk pool.

     A small company in a limited pool is more likely to experience a cost increase based on HBV and Group B strep screening and a large company in a large pool is more likely to experience a cost decrease based on FISH.

     Thus, the costs of the rule are proportional and the savings are disproportionately accruing to large companies. Therefore, the rule imposes disproportionately higher costs on small business and cost minimization is required.

Probability that the business may benefit from FISH requirement
	Average Employment		Half Female		N likely to give birth		Likelihood for FISH
Large employers with 50 or more employees	181.8		90.9		18.9		41%
Small employers with 20 to 49 employees	30.2		15.1		3.1		7%

     A company with thirty employees, half of which are women and 20% of which are likely to bear two children and none of which use FISH will experience a cost increase of $13 per employee. A large company with one hundred eighty-one employees may experience a cost reduction of $6 per employee. This is disproportionate. It should be recognized however that large companies and small companies insured in large risk pools would experience very similar per employee costs.

Relative Impact for Worst Case Scenario
	$ impact/ child		Number of children		$ impact		$/Employee
Small Business: Screen costs	$ 68.10		6.00		$ (408.60)		$ (13.62)
Large Business: Screen net	$ 30.06		36.36		$1,092.89		$ 6.01

     Insurers have been given early and later copies of the draft rule and have not responded. Given this lack of response from insurers, DOH had no basis to make a determination of actual disproportionate impact within the insurance industry. However, there has been a continuing trend of smaller insurers leaving the business. This indicates that there are economies of scale. Given economies of scale, any amendment that imposes costs proportionately across their female patients of child bearing age, such as the HBV and Group B strep screening, will by definition have a disproportionate impact. DOH assumes that the insurers have already recognized the potential cost savings from FISH and have already incorporated it into their rates. Thus, FISH would have no effect. Based on this, cost minimization would be required.

     Cost Minimization: The committee considered several additions to the rule, which were eliminated because they were too costly. These are listed in the least burden determination section. Each of the listed requirements would have imposed significant costs on businesses such as providers and/or insurers. The reporting requirements for Group B strep would also have imposed costs on the state.

     Consultation with Small Businesses: Two drafts of the amended rule were sent to a stakeholder list of one hundred fifty-seven hospitals, insurers, and primary and specialty providers. The proposed amendment will be sent to this same list of stakeholders, which includes small and large companies, at the time of filing. The information in the SBOH hearing package will also be posted on the Internet.

     Least Burden Analysis: This rule amendment has been reviewed and it is the least burdensome for those who are required to comply. The following amendments were considered but were not selected because they were too burdensome:

     Some stakeholders proposed eliminating any review of prenatal tests on a case-by-case basis, thus requiring insurers to cover all tests and procedures requested. This was rejected because it was felt the costs would be too great and could not be justified.

     Advocates asked for prenatal ultrasound to be authorized per a given schedule that would include:

•     First trimester ultrasound to determine twin status and dates.

•     A second trimester ultrasound to evaluate fetal morphology with serial ultrasounds performed every two to four weeks after, if an abnormality was found.

•     A fetal echocardiograph to evaluate the fetal heart.

     This was requested because it was felt that it would be too costly and the pregnancy management would ultimately be up to the patient and physician.

     Reporting requirements were considered for Group B strep, however, they were not included here since the cost of establishing a reporting system and database was deemed to be too high.

¹ RCW 34.05.328 (c) requires that the department determine that the probable benefits of the rule are greater than its probable costs, taking into account both the qualitative and quantitative benefits and costs and the specific directives of the statute being implemented. This requirement does not apply to the housekeeping portions of the rule.

² Standard Industrial Classification.

³ On a medical cost only basis the net present value of the cost savings is estimated to average approximately $86 per child born in the state over the next ten years. This may be a low estimate because it does not include other direct costs, which may accrue to insurers, especially for children who must eventually be medically institutionalized as adults. This is larger than the net medical cost that may be imposed per child for Group B strep and HBV provision. However, given that the net savings has been known for some time, insurers generally provide the FISH coverage now.

⁴ Based on the Employment Security breakdown of all companies with fifty employees or more.

⁵ Based on Employment Security breakdown of all companies with twenty to forty-nine employees. Companies with more than twenty employees are more likely to provide medical coverage so they were chosen for the worst-case analysis.

⁶ 20.8%, Office of the Forecast Council, 11/2001. Women over thirty-five are heading into the age category with higher risk, more pregnancy analysis and a much higher range of likely existing services including FISH.

     A copy of the statement may be obtained by writing to Debra.LochnerDoyle@DOH.WA.GOV or Debra Lochner Doyle, MS, CGC, State Coordinator for Genetic Services, Washington State Department of Health, 20435 72nd Avenue South, Suite #200, Mailstop K17-8, Kent, WA 98032, phone (253) 395-6742, fax (253) 395-6724.

     RCW 34.05.328 applies to this rule adoption. The rule is legislatively significant under RCW 34.05.328 (5)(c)(iii)(C) because it significantly alters policy by adding maternal hepatitis B surface antigen, Group B strep and fluorescent in-situ hybridization (FISH) as standards of medical necessity for prenatal testing.

     Hearing Location: The Hilton Airport and Conference Center, 17620 Pacific Highway South, Seattle, WA 98188, on December 10, 2002, at 2:30 p.m.

     Assistance for Persons with Disabilities: Contact Desiree Day Robinson by December 2, 2002, TDD 1-800-833-6388 or (360) 236-4107.

     Submit Written Comments to: Debra Lochner Doyle, MS, CGC, State Coordinator for Genetic Services, Washington State Department of Health, 20435 72nd Avenue South, Suite #200, Mailstop K17-8, Kent, WA 98032, fax (253) 395-6737, by December 6, 2002.

     Date of Intended Adoption: December 10, 2002.

M. C. Selecky

Secretary

Department of Health

Don Sloma

Executive Director

State Board of Health

OTS-5522.3

AMENDATORY SECTION(Amending Order 124B, filed 12/27/90, effective 1/31/91)

WAC 246-680-001   Purpose.   The purpose of this chapter is to((:

     (1) Establish department and state board of health description, definition,, and enumeration of prenatal tests under RCW 70.83B.020 (3)(a) and (b);

     (2))) establish standards ((of the Washington state board of health)) for screening and diagnostic procedures for prenatal diagnosis of congenital disorders of the fetus under RCW 48.21.244, 48.44.344, and 48.46.375;

     (((3) Require health care provider to provide information on certain prenatal tests under RCW 70.83B.030 to both their pregnant patients and the department;

     (4) Establish requirements for laboratories to provide information on certain prenatal tests under RCW 70.83B.030 to the department; and

     (5))) and to establish criteria and time lines ((for distribution of educational materials by health care providers related to prenatal tests)) regarding the availability and use of prenatal tests for health care providers to share with pregnant women and couples as required under RCW 70.54.220.

[Statutory Authority: RCW 43.20.050. 91-02-051 (Order 124B), recodified as § 246-680-001, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 48.21.244, 48.44.344 and 48.46.375. 90-02-094 (Order 024), § 248-106-001, filed 1/3/90, effective 2/3/90.]

     (2))) of this chapter, the following definitions apply:

     (1) "Department" means the Washington state department of health.

     (((3))) (2) "Health care providers" means persons licensed or certified by the state of Washington under Title 18 RCW to provide prenatal care or to practice medicine and qualified genetic counselors.

     (((4) "Laboratory" means a private or public person, agency, or organization performing prenatal tests for congenital and heritable disorders.

     (5) "Parental chromosomal)) (3) "Prenatal carrier testing" means a procedure to remove blood or other tissue from one or both parents in order to perform laboratory analysis to establish chromosome constitution or genetic carrier status of the parents.

     (((6))) (4) "Prenatal test" means any test to predict congenital or heritable disorders ((which:

     (a) When improperly utilized, may clearly harm or endanger the health, safety, or welfare of the public;

     (b) Potential harm is easily recognizable and not remote or dependent upon tenuous argument; and

     (c) As determined by the state board of health under RCW 70.83B.020(3) and enumerated by the department, includes procedures and)) that may harm or endanger the health, safety, or welfare of members of the public if improperly utilized and includes preprocedure and post-procedure genetic counseling, laboratory tests, and procedures as follows:

     (((i))) (a) Maternal serum ((alpha-fetoprotein (MSAFP))) marker screening is a procedure involving obtaining blood from a pregnant woman during the fifteenth to ((twentieth completed menstrual)) twenty-second week((s)) of gestation, in order to measure through laboratory tests the level of ((alpha-fetoprotein in the blood)) certain analytes that are associated with increased risks to the fetus or pregnancy such as alpha-fetoprotein, unconjugated estriol, human gonadotropin, inhibin, and/or PAPP-A.

     (b) Maternal hepatitis B surface antigen (HBsAg) screening is a procedure involving obtaining blood from a pregnant woman during the first trimester of pregnancy to test for maternal hepatitis B infection. HBsAg screening should be repeated during the last trimester of pregnancy if a woman is at high risk for hepatitis B infection.

     (c) Group B strep screening per vaginorectal culture at 35-37 weeks gestation is used to screen pregnant women for Group B strep colonization. The swab culture specimen must be grown in selective broth media.

     (((ii))) (d) Amniocentesis is a procedure performed after fourteen weeks of gestation to remove a small amount of amniotic fluid from the uterus of a pregnant woman, in order to perform one or more of the following laboratory tests:

     (((A))) (i) Measure the level of alpha-fetoprotein;

     (((B))) (ii) Measure the level of acetylcholinesterase;

     (((C))) (iii) Cytogenetic studies on fetal cells including fluorescent in-situ hybridization (FISH) if indicated;

     (((D))) (iv) Biochemical studies on fetal cells or amniotic fluid; ((and

     (E))) (v) Deoxyribonucleic Acid (DNA) studies on fetal cells including fetal genotyping for isoimmunization studies; and

     (vi) Infectious disease studies.

     (((iii))) (e) Chorionic villus sampling is a procedure performed from ten to twelve weeks of gestation to remove a small amount of cells from the developing placenta, in order to perform one or more of the following laboratory tests:

     (((A))) (i) Cytogenetic studies on fetal cells including fluorescent in-situ hybridization (FISH) if indicated;

     (((B))) (ii) Biochemical studies on fetal cells; and

     (((C))) (iii) DNA studies on fetal cells.

     (((iv))) (f) Percutaneous umbilical cord blood sampling is a procedure performed typically after fifteen weeks of gestation to obtain blood from the fetus, in order to perform one or more of the following laboratory tests:

     (((A))) (i) Cytogenetic studies including fluorescent in-situ hybridization (FISH) if indicated;

     (((B))) (ii) Viral titer studies;

     (((C))) (iii) Fetal blood typing for isoimmunization studies;

     (((D))) (iv) Prenatal diagnostic tests for hematological disorders;

     (((E))) (v) DNA studies on fetal cells;

     (vi) Biochemical studies on fetal blood.

     (((v))) (g) Prenatal ultrasonography is a procedure performed at any time during pregnancy resulting in visualization of the uterus, the placenta, the fetus, and internal structures through use of sound waves.

     (((d) Includes pre-procedure and post-procedure genetic counseling when required under WAC 248-106-020.

     (7))) (h) "Preprocedure genetic counseling" means individual counseling, which may be part of another ((substantive)) procedure or service, involving a health care provider or a qualified genetic counselor under the direction of a physician, and a pregnant woman with or without other family members, to assess and identify increased risks for congenital abnormalities or pregnancy complications, offer specific carrier or diagnostic tests, discuss the purposes, risks, accuracy, and limitations of a prenatal testing procedure, ((and to)) aid in decision making and to assist in obtaining the desired testing or procedure.

     (((8))) (i) "Post-procedure genetic counseling" means, when test results are available, individual counseling, which may be part of another ((substantive)) procedure or service, involving a health care provider or a qualified genetic counselor under the direction of a physician and a pregnant woman with or without other family members, to discuss((:

     (a))) the ((meaning of the)) results of the prenatal tests done((; and

     (b) Subsequent)), any further testing or procedures available and/or referrals for further consultation or counseling.

     (((9))) (j) "Qualified genetic counselor" means an individual eligible for certification or certified as defined ((in Bulletin of Information, 1984,)) by the American Board of Medical Genetics, Inc., ((as a:

     (a) Genetic counselor;

     (b) Clinical geneticist;

     (c) Ph.D. medical geneticist;

     (d) Clinical cytogeneticist; or

     (e) Clinical biochemical geneticist)) or the American Board of Genetic Counseling.

[Statutory Authority: RCW 43.20.050. 91-02-051 (Order 124B), recodified as § 246-680-010, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 48.21.244, 48.44.344 and 48.46.375. 90-02-094 (Order 024), § 248-106-010, filed 1/3/90, effective 2/3/90.]

     (a) Maternal serum ((alpha-fetoprotein)) marker screening for all pregnant women beginning prenatal care before the twentieth completed ((menstrual)) week of gestation((:

     (i) Without the requirement for case-by-case determination; and

     (ii) Including post-procedure genetic counseling if test result is abnormal.

     (b))).

     (b) Maternal hepatitis B surface antigen (HBsAg) screening for all pregnant women during the first trimester of pregnancy and the last trimester of pregnancy if the woman is at high risk for hepatitis B infection.

     (c) Information about Group B strep should be provided to all pregnant women, including the risk to the newborn, if the woman is identified through screening as potentially colonized with Group B strep. Screening is done through prenatal vaginorectal cultures. Pregnant women who are currently colonized with Group B strep, or who have unknown Group b strep status and preterm labor with significant risk of preterm delivery, or women with amniotic membrane rupture for eighteen hours or more, or intrapartum fever of one hundred point four degrees Fahrenheit or more should receive intrapartum antibiotic prophylaxis. Pregnant women whose prior newborn had Group B strep disease, or women who have Group B strep bacteriuria during the current pregnancy need not be cultured for Group B strep in the prenatal period, but should receive intrapartum antibiotic prophylaxis.

     (d) Prenatal ultrasonography if one or more of the following criteria are met:

     (i) A woman undergoing amniocentesis, chorionic villus sampling, or percutaneous umbilical cord blood sampling or fetal tissue biopsy;

     (ii) ((The results on a maternal serum alpha-fetoprotein screening test are abnormal;

     (iii))) The results of a maternal serum marker screening test indicate an increased risk to the fetus or pregnancy;

     (iii) A woman, or her partner((:

     (A))), has a ((prior child or fetus with)) personal or family history of a congenital abnormality detectable by prenatal ((ultrasonography)) ultrasound; ((or

     (B) Has a family history of congenital abnormality detectable by prenatal ultrasonography; or

     (C) Is affected with a congenital abnormality detectable by prenatal ultrasonography.

     (iv) A woman is suspected to be carrying a fetus with a congenital abnormality; or

     (v))) (iv) An increased risk of a congenital abnormality is present due to an environmental exposure including maternal exposure to alcohol; or

     (v) A medical evaluation indicates the possibility of ((hydramnios)) polyhydramnios or oligohydramnios.

     (((c))) (e) Amniocentesis ((with pre-procedure and post-procedure genetic counseling)) if one or more of the following criteria are met:

     (i) A woman is thirty-five years of age or older at the time of delivery;

     (ii) A woman, or her partner ((having had)) has a previous child or fetus with a chromosomal abnormality or other prenatally diagnosable disorder;

     (iii) A woman, or her partner, has a family history that includes birth defects or developmental delays;

     (iv) A woman or her partner is a carrier of a chromosomal rearrangement ((or anomaly));

     (((iv) A woman or her partner:

     (A) With a neural tube defect; or

     (B) Having had a child or fetus with a neural tube defect.

     (v) A woman or her partner with a history of:

     (A) A sibling with a neural tube defect;

     (B) A parent with a neural tube defect;

     (C) A niece or nephew with a neural tube defect; or

     (D) Other risk factors related to a neural tube defect.

     (vi))) (v) A woman and/or her partner are carriers of, or affected with, a ((prenatal)) prenatally diagnosable inherited disorder;

     (((vii))) (vi) The results ((on)) of a maternal serum ((alpha-fetoprotein)) marker screening test ((are abnormal)) indicate an increased risk to the pregnancy or fetus;

     (((viii))) (vii) A woman ((with)) has a documented history of three or more miscarriages of unknown cause when circumstances prevent parental chromosomal testing;

     (((ix))) (viii) There is an ultrasound diagnosis of fetal anomaly;

     (ix) A medical evaluation indicates an increased risk of fetal infection;

     (x) Fetal blood studies are indicated for isoimmunization studies or therapy.

     (((2) The board recommends the following additional procedures for use of insurers, health service contractors, and health maintenance organizations in determining medical necessity on a case-by-case basis:

     (a))) (f) Chorionic villus sampling with preprocedure and post-procedure genetic counseling if one or more of the following criteria are met:

     (i) A woman is thirty-five years of age or older at the time of delivery;

     (ii) A woman, or her partner ((having had)), has a previous child or fetus with a chromosomal abnormality or other prenatally diagnosable inherited disorder;

     (iii) A woman, or her partner, is a carrier of a chromosomal rearrangement ((or anomaly));

     (iv) A woman, or her partner ((are)), is a carrier((s)) of, or affected with, a ((prenatal)) prenatally diagnosable inherited disorder; ((or))

     (v) A woman ((with)) has a documented history of three or more miscarriages of unknown cause when circumstances prevent parental chromosomal testing((.

     (b))); or

     (vi) Fetal genotyping is indicated to determine risks for isoimmunization.

     (g) Fluorescent in-situ hybridization (FISH) if a medical evaluation indicates a rapid or specific submicroscopic chromosomal diagnosis is required to predict the prognosis for the fetus.

     (2) The board recommends the following additional procedures for use by insurers, health service contractors, and health maintenance organizations in determining medical necessity on a case-by-case basis:

     (a) Percutaneous umbilical cord blood sampling with preprocedure and post-procedure genetic counseling if one or more of the following criteria are met:

     (i) A medical evaluation indicates rapid or ((detailed)) specific submicroscopic chromosomal diagnosis or DNA diagnosis is required to((:

     (A) Protect the health of the mother; or

     (B))) predict prognosis for the fetus((.));

     (ii) A medical evaluation indicates the possibility of a ((prenatal)) prenatally diagnosable fetal infection;

     (iii) Fetal blood studies are medically indicated for isoimmunization studies or therapy;

     (iv) Fetal blood is the only means to provide biochemical genetic diagnosis;

     (v) Prenatal diagnosis of a hematological disorder((s)) is medically indicated.

     (b) Prenatal tissue biopsy if the nature of the disorder in question indicates that fetal liver, skin, or other tissue biopsy is the only means to provide biochemical genetic diagnosis to protect the health of the mother or predict the prognosis of the fetus.

[Statutory Authority: RCW 43.20.050. 91-02-051 (Order 124B), recodified as § 246-680-020, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 48.21.244, 48.44.344 and 48.46.375. 90-02-094 (Order 024), § 248-106-020, filed 1/3/90, effective 2/3/90.]

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