Coalition for Access to Prenatal Screening: Labs Advocate for Coverage of cfDNA Screening

Five laboratories have banded together to raise awareness about cell free DNA screening and lobby for its coverage by insurers for greater access by expectant mothers. 

The Coalition for Access to Prenatal Screening (“CAPS”) launched in 2017. Its members at the time of the launch were: Illumina, Progenity, Integrated Genetics, Counsyl, and Natera.

CAPS’ mission according to its website reads as follows:

[CAPS] seeks to improve access to state-of-the-art prenatal screening using cell-free DNA (cfDNA)-based noninvasive prenatal testing (NIPT) that is easily accessible to all pregnant women who choose to pursue aneuploidy screening, regardless of their risk factors, income, age or geographic location.

As leading providers of cfDNA-based NIPT, CAPS and its member companies are working together to promote public awareness about the value of this innovative and highly sensitive screening method and to advocate for the highest standards of quality, service and education.

The CAPS Coalition provides reliable and useful information about cfDNA-based NIPT to patients, healthcare providers, and public and private insurers.

CAPS will work to encourage appropriate legislative measures and reimbursement coverage policy changes for this medically actionable testing service, which has the potential to improve personalized patient care.

The statement as it reads seems non-controversial: laboratories offering state-of-the-art prenatal testing want to improve access to that testing by providing more information to patients, providers, and insurers, and ensuring coverage for the testing. A more critical assessment, however, suggests other motivations for the banding of the five select laboratories.

The five laboratories are not the exclusive providers of cfDNA screening laboratories. Notably, Sequenom, the laboratory offering MaterniT21, and Ariosa, which offers Harmony, are not members of CAPS. Instead, with the exception of Natera, the labs are Illumina and those that have licensed Illumina’s verifi cfDNA technology. Sequenom initially had market dominance, having been the first to market with MaterniT21, and therefore having at one point the greatest penetration with providers and insurers. Conversely, Ariosa’s Harmony was seen as the bargain-option of cell free DNA screening, having the lowest cost, and being covered by public insurers to a great extent. Illumina et al., and Natera have been playing catch up with coverage by private and public insurers.

It does not appear that CAPS is a non-profit. Instead, under the rubric of increasing access, CAPS intends to “encourage appropriate legislative measures and reimbursement policy changes.” Undoubtedly, this means efforts to extend both public, i.e. Medicaid, TRICARE, CHAMPUS, etc., and private insurance coverage to the line of Illumina verifi tests and Natera’s Panorama. While increasing insurance coverage will increase access for expectant mothers to have cfDNA screening, increasing the number of covered patients will also increase the revenue the CAPS labs receive for their cfDNA screens.

Just as CAPS is not a non-profit, neither are its member laboratories. Three are publicly traded (Illumina, Integrated Genetics parent organization LabCorp, and Natera) and Progenity and Counsyl are for-profit private companies.  Therefore, each has a profit incentive for maximizing the number of patients that “access” their tests and to maximize those tests being reimbursed by public and private insurers.

This profit incentive colors the mission statement of “provid[ing] reliable and useful information about cfDNA-based NIPT to patients, healthcare providers, and public and private insurers.” The cell-free screen verifi, prior to being acquired by Illumina, had to revise its literature for having represented its specificity as 100%, after a false negative was reported. Natera is the subject of class action lawsuits alleging misrepresentations to its shareholders. These and other factors have lead commentators to express concern about the over-hyping of cell-free DNA screening. If the information being provided to improve access is in the vein of promotion, rather than accurate information, then that information is neither reliable nor useful.

Similarly, in 2016, the American College of Medical Genetics and Genomics issued an updated statement on cell free DNA screening. While it recognized cell free DNA screening as appropriate for all expectant mothers, a point also mentioned in CAPS’ accompanying press release, ACMG further recommended that cell free DNA laboratories provide with test results “easily recognizable and highly visible” detection rates, specificity, and positive and negative predictive value with a screen result. None of the labs provided each of these pieces of information when they launched their tests and not all provide all of the information still.

All that being said, as represented in CAPS’ press release, cell free DNA screening is a highly accurate screening technology that has drastically reduced the number of women who went on to have diagnostic testing, relying on a screen-negative cell free DNA result, and thereby avoiding the risk of miscarriage. While not mentioned in the press release, other expectant mothers have used the information from a cell free DNA result to prepare for the possibility that their child may have a condition. Therefore, the information provided by cell free DNA screening can be, as the CAPS press release describes it, “powerful,” but only if it is accompanied by the equally recommended counseling and information and support resources.

Is CAPS just a band of labs that were not first to market or the bargain choice seeking to increase their market share through legislative and insurance policy coverage changes? Or, will CAPS be a provider of reliable and useful information to patients, providers, and insurers so each may decide whether to have the screening and whether, to what extent, and in what circumstances it will be covered?

CAPS will announce the membership of a clinical advisory board to provide an independent medical perspective during the first half of 2017. Its membership will go towards answering the question of whether CAPS is just seeking to maximize revenue or provide accurate, reliable information to patients, providers, and insurers.