Table 3.
Evidence Sources Cited in Coverage Policies
| Clinical Validity Studies | Professional Society Guidelines | Technology Assessment Reports | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| High Risk | Average Risk | ACOG/SMFM (2015) | ACMG (2013) | ISPD (2015) | NSGC (2012) | California Technology Assessment Foruma | BCBSA TEC Report on T21 or T18/T13b,c | |||||
| Palomaki, 2011, Genet Med | Norton (NICE), 2012, AJOG | Bianchi (MELISSA), 2012, Obstet and Gyn | Nicolaides, 2013, Prenatal Diag | Bianchi, 2014, NEJM | Norton (NEXT), 2015, NEJM | |||||||
| Payer 1 | + | + | + | + | + | + | + | − | + | + | − | − |
| Payer 2 | + | + | + | + | + | − | − | + | − | + | − | + |
| Payer 3 | + | − | + | − | − | − | + | − | − | − | + | + |
| Payer 4 | + | + | + | + | + | + | + | + | − | + | − | + |
| Payer 5 | − | + | + | − | + | + | + | + | − | − | + | + |
| Payer 6 | − | − | − | − | − | − | + | + | − | + | + | + |
| Payer 7 | + | + | + | + | − | + | + | + | − | + | + | − |
| Payer 8 | + | + | − | + | + | − | + | + | − | − | − | + |
| Payer 9 | + | + | + | + | − | + | + | + | + | + | − | + |
| Payer 10 | + | + | + | + | + | + | + | + | − | + | − | + |
| Payer 11 | + | + | + | + | − | + | + | + | + | + | − | + |
| Payer 12 | + | + | + | + | + | + | + | + | + | + | − | + |
| Payer 13 | − | + | − | − | − | − | + | + | − | + | + | + |
| Payer 14 | + | − | − | − | − | − | − | − | − | − | − | − |
| Payer 15 | + | + | + | + | + | + | + | + | − | + | − | + |
| Payer 16 | − | − | − | − | − | − | − | − | − | − | − | + |
| Payer 17 | + | + | + | + | + | + | + | + | − | − | − | + |
| Payer 18 | − | − | − | − | + | + | + | − | − | + | + | + |
| Payer 19 | + | + | − | + | − | − | − | − | − | − | − | + |
| Total | 14 | 14 | 12 | 12 | 10 | 11 | 15 | 13 | 4 | 12 | 6 | 16 |
a
Walsh J. California Technology Assessment Forum (CTAF). Fetal Aneuploidy Detection by Maternal Plasma DNA Sequencing, Part 2. October 17, 2012.
b
Blue Cross Blue Shield Technology Evaluation Center (TEC). Noninvasive prenatal cell-free fetal DNA-based screening for aneuploidies other than trisomy 21. Technol Eval Cent Assess Program. 2014 Dec;29(7):1–7.
c
Blue Cross Blue Shield Technology Evaluation Center (TEC). Sequencing-based tests to determine fetal Down syndrome (trisomy 21) from maternal plasma DNA. Technol Eval Cent Assess Program. 2013 Apr;27(10):1–6.