Counsyl and UnitedHealthcare (UHC) have not been able to come to terms on the renewal of our network participation agreement and we anticipate that Counsyl will be out of network with UHC as of July 16, 2018.  
UHC medical policy does not support the level of access providers and their patients deserve for important services such as expanded carrier screening (ECS) and non-invasive prenatal screening (NIPS).
Counsyl is in-network with most other health plans. We also have programs in place, to reduce cost barriers for patient access, including the Counsyl Access Program.
We encourage our customers to contact their Counsyl representatives to learn more about this anticipated change and reference the frequently asked questions below.
How could this anticipated change impact my patients?
This anticipated change should not impact your patients’ ability to access Counsyl screening. We are more committed than ever to ensuring appropriate and sustainable patient access for our valuable genetic screening services.
Through the Counsyl Access Program, all Counsyl patients will continue to be notified of their personalized cost estimates via text and/or email within 48 hours of receipt of an order so they can understand their insurance coverage, out-of-pocket responsibilities and options for assistance so there are no surprises.
To help patients with a high out-of-pocket responsibility, the Counsyl Access Program offers:

• No-charge screening for patients who qualify based on their family size, income and medical expenses through our financial assistance program
• Interest-free payment plans
• Option to pay without insurance

Are expanded carrier screening (ECS) and noninvasive prenatal screening (NIPS) important for my patients?
Although UHC medical policy does not currently support full coverage of these services, we believe that these screens provide patients and their providers with actionable information to guide critical and timely health decisions.
While UHC’s medical policy* considers ECS unproven and not medically necessary, Counsyl has published extensive evidence supporting the clinical value of ECS with the Counsyl Foresight™ Carrier Screen, demonstrating:

• Traditional carrier screening is not effective for large patient populations,¹ performing very poorly with ethnicities other than Caucasian.
  • Traditional carrier screening leads to missing 94 percent of affected pregnancies in people of East Asian descent, 91 percent of those of Middle Eastern descent and 79 percent of those of Hispanic descent.¹
• Counsyl’s Foresight Carrier Screen was designed to address these ethnic-based disparities.

In support of this evidence, the American College of Obstetricians and Gynecologists (ACOG) released committee opinion 690 last year recognizing expanded carrier screening as an acceptable screening strategy.²
Additionally, UHC does not cover noninvasive prenatal screening (NIPS) for “average risk” pregnancies in women under 35 years of age even though there is compelling evidence supporting its value.

• NIPS has a 100X lower false positive rate and 20X higher positive predictive value compared to traditional screening in the general obstetric population, leading to fewer unnecessary, costly invasive procedures and avoiding the associated risk for miscarriage.⁴
• Approximately 50% of average risk pregnancies covered by commercial health plans now have coverage for NIPS.
• Counsyl Prelude™ Prenatal Screen has an industry-low test failure rate of 0.1% with fewer redraws, fewer unnecessary invasive procedures, shorter overall turnaround time, and decreased anxiety for patients.³

Leading OBGYN and genetics groups, such as ACOG, the American College of Medical Genetics and Genomics (ACMG), American Society of Human Genetics (ASHG), European Society for Human Genetics (ESHG), International Society for Prenatal Diagnosis (ISPD) and the Society for Maternal Fetal Medicine (SMFM), have provided guidance that suggests that all pregnant women should be informed of the option of NIPS.
How can I help ensure continued access to genetic screening for my patients?
We are participating in various initiatives dedicated to advocating for greater access to genetic screening. Here are some ways that you can have your voice heard by health plans:

• Counsyl has launched an industry initiative called the Action for Access Petition to ensure enhanced patient access to genetic screening tests. Visit ActionforAccess.counsyl.com to sign the petition and join in this collaborative call for change.
• Counsyl is a proud member of the Coalition for Access to Prenatal Screening (CAPS), where clinicians can choose to advocate to insurers for improved access to noninvasive prenatal screening by adding their names to the growing list of those fighting on behalf of their patients.

Have more questions? Contact your Counsyl representative or reach out to [email protected].

REFERENCES:
1. Haque IS, Lazarin GA, Kang HP, Evans EA, Goldberg JD, Wapner RJ. Modeled Fetal Risk of Genetic Diseases Identified by Expanded Carrier Screening. JAMA. 2016;316(7):734-742. doi:10.1001/jama.2016.11139
2. American College of Obstetricians and Gynecologists, Committee Opinion No. 690 & No. 691, March 2017
3. Taneja et al. Noninvasive prenatal testing in the general obstetric population: clinical performance and counseling considerations in over 85000 cases†. Prenatal Diagnosis 2016, 36, 1–7.
4. Norton, M. et al Cell free DNA analysis for noninvasive examination of trisomy. The New England Journal of Medicine April 2015; 372: 1589-1597.
*UnitedHealthcare Commercial Medical Policy: Carrier Testing for Genetic Diseases