Download Medical Review Criteria Preimplantation Genetic Testing

Medical Review Criteria
Preimplantation Genetic Testing
Effective Date: May 25, 2016
Subject: Preimplantation Genetic Testing
Policy:
Preimplantation Genetic Testing (PGT) is used in conjunction with In Vitro Fertilization (IVF) and IntraCytoplasmic Sperm Injection (ICSI) to identify and select embryos free of chromosomal abnormalities and specific
genetic disorders for transfer to the uterus.
For members with HPHC Infertility benefits, HPHC covers non-experimental/investigational PGT when such testing
is medically necessary to impact clinical decision-making and/or clinical outcomes for members who have, or are
carriers of, certain genetic disorders or chromosomal abnormalities.
Covered PGT services must be provided in centers where appropriate expertise (i.e., genetic counseling,
molecular genetics, embryology) is available.
Authorization:
Prior authorization is required for all PGT cycles provided to members enrolled in commercial HMO, POS, and PPO
products.
 Relevant information (e.g., name of the consulting genetic specialist, results of genetic testing, genetic
consultation report and relevant notes) must be submitted with the authorization request.
 The requesting provider is responsible for providing the servicing lab with a copy of the HPHC authorization
letter along with the PGT lab request.
Criteria:
HPHC authorizes specific Preimplantation Genetic Testing 1, in conjunction with IVF and ICSI, when results of prior
genetic testing have confirmed ANY of the following:
 A genetic parent has a balanced reciprocal translocation, or Robertsonian translocation;
 A genetic parent is a known carrier of a single gene autosomal dominant disorder listed below;
 The female genetic parent is a known carrier of a single gene X-linked recessive disorder listed below;
 Both genetic parents are known carriers of a listed single gene autosomal recessive disorder.
For members/couples with no prior history of an intrauterine pregnancy, clinical documentation must confirm
there is greater than 5% probability of a live birth using the couple's own eggs and sperm. Required
documentation includes:
 For female partners, normal ovarian reserve assessment (i.e., results of a day 3 Follicle-Stimulating Hormone
[FSH] test and Estradiol levels) and a normal endometrial cavity (i.e., confirmed by saline hysterogram,
hysteroscopy or sonohysterosalpingogram [e.g., FemVue, HyCoSy] within the past 4 years).
 For male partners, semen analysis (performed within the past year) confirming the absence of azoospermia2.
Covered Disorders/Chromosomal Abnormalities
1
Covered PGT may include Florescent In Situ Hybridization (FISH) or Comparative Genomic Hydridization (CGH), as appropriate.
Investigational, unproven genetic testing procedures are not covered.
2
Azoospermia is defined as the absence of sperm in at least two different ejaculate samples.
HPHC Medical Review Criteria
Preimplantation Genetic Testing
Page 1 of 3
HPHC policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members’ unique
clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.
Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please
reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.
Disorder Type
Single Gene Autosomal
Recessive Disorders
Single Gene Autosomal
Dominant Disorders
Single Gene X-Linked
Recessive Disorders
Covered Conditions
ANY of the following:
 B-Thalessemia Syndromes
 Canavan Disease
 Cystic Fibrosis
 Epidermolysis Bullosa Simplex (autosomal recessive type)
 Fanconi Anemia
 Familial Dysautonomia
 Gaucher Disease
 Hurler Syndrome
 Metabolic disorders such as methylmalonic acidemia or proprionic
acidemia
 Sickle Cell Anemia
 Spinal Muscular Atrophy Type I
 Spinocerebellar Ataxia (autosomal recessive type)
 Tay-Sachs Disease
ANY of the following:
 Epidermolysis Bullosa (autosomal dominant type)
 Huntington’s Disease
 Marfan’s Syndrome
 Myotonic Dystrophy
 Neurofibromatosis Type I & II
 Retinoblastoma
 Spinocerebellar Ataxia (autosomal dominant type)
 Tuberous Sclerosis
ANY of the following:
 Adrenoleukodystrophy
 Alport Syndrome
 Choroideremia
 Fabry’s disease
 Fragile X syndrome
 Hemophilia A & B
 Hunter Syndrome
 Incontinentia pigmenti
 Lesch-Nyhan Syndrome
 Muscular Dystrophy
 X-linked mental retardation
Exclusions:
HPHC does not cover PGT for ANY of the following:
 Aneuploidy screening, including in the setting of recurrent miscarriage, advanced maternal age, or repeated
implantation failure during IVF
 Screening for genetic or chromosomal abnormalities in the absence of a known genetic or chromosomal defect
in the genetic parent
 Selecting against conditions or disorders (e.g., autism) in the absence of a known and identifiable
genetic or chromosomal defect in the genetic parent
 Gender selection, or selection of nonmedical traits
 To determine an embryo’s carrier status
 Screening for autosomal recessive disorders when the embryos are created using donor egg or donor sperm
 Detecting genetic or chromosomal abnormalities contributed by donor egg or donor sperm
HPHC Medical Review Criteria
Preimplantation Genetic Testing
Page 2 of 3
HPHC policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members’ unique
clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.
Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please
reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.
 Screening for adult-onset/late-onset disorders or predisposition to disease (e.g., Alzheimer's disease), except
for the specific disorders listed above
 Human leukocyte antigen (HLA) typing of an embryo to identify a future suitable stem cell, tissue or organ
transplantation donor, or otherwise not considered to be medically necessary at this time
 An individual or couple who are using illicit substances or abusing substances known to negatively interfere
with fertility or fetal development (e.g., marijuana, opiates, cocaine, or alcohol).
Coding:
 89290 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic
diagnosis); less than or equal to 5 embryos
 89291 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic
diagnosis); greater than 5 embryos
Summary of Changes:
Date
Revisions
5/16
Added coverage for incontinentia pigmenti; expanded coverage for all types of muscular
dystrophy
5/15
Minor language and formatting changes. Add coding profile.
Approved by UMCPC:
 Revised:
 Initiated:
5/25/16
7/11, 9/12, 10/13, 3/14, 5/15; 5/16
5/26/2010
References:
1. Pregnancy outcome after preimplantation genetic screening or natural conception in couples with
unexplained recurrent miscarriage: a systemic review of the best available evidence. Fert Ster. 2011; 95:
2153-7.
2. ACOG Committee Opinion - Preimplantation Genetic Screening for Aneuploidy. Obs Gyn. 2009; 113:766.
3. Society for Assisted Reproductive Technology and the Practice Committee of the American Society for
Reproductive Medicine. Preimplantation genetic testing: a Practice Committee Opinion. Fert Ster. 2008;
90(suppl 3): S 136-S143.
4. Preimplantation Genetic Testing: Indications and Controversies. Clin Lab Med. 2010; 30: 519-531.
5. Preimplantation genetic diagnosis: State of the ART. Hum Genet. 2012; 131:175-186
6. Schattman, GL. Preimplantation genetic diagnosis. In: UpToDate, Post, TW (ed), Waltham, MA, 2016.
7. Schattman, GL. Preimplantation genetic screening for aneuploidy. In: UpToDate, Post, TW (ed), Waltham,
MA, 2016.
8. Pielop, JA. Vesiculobullous and pustular lesions in the newborn. In: UpToDate, Post, TW (ed), Waltham, MA,
2016.
9. Beukers F, van der Heide M, Middelburg KJ, et al. Morphologic abnormalities in 2-year-old children born after
in vitro fertilization/intracytoplasmic sperm injection with preimplantation genetic screening: follow-up of a
randomized controlled trial. Fertil Steril. Feb 2013;99(2):408-413.
HPHC Medical Review Criteria
Preimplantation Genetic Testing
Page 3 of 3
HPHC policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members’ unique
clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.
Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please
reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.