Genetic Test Formularies Powered by ELEVATEGENETICS®

With the help of CGI's expert consultants and industry-leading ELEVATEGENETICS® metrics, CGI helps you craft an evidence based formulary for genetic, genomic, and biomarker laboratory tests.

The Challenge

It is estimated that more than half of genetic and genomic tests being used by physicians fail to meet accuracy, validity, and clinical reporting professional standards1, 2, 3. Payors typically should not be reimbursing for laboratory testing that does not have clinical utility and that does not follow professionally recognized standards for health care, since such clinical testing constitutes abuse of health care 4. Yet physicians, payors, self-insured employers, and Laboratory Benefit Management companies (LBMs) often lack the rare domain expertise that would allow them to confidently determine which genetic, genomic, and complex biomarker tests really do have clinical utility and follow professionally recognized standards, and which do not. Thus physician ordering and subsequent reimbursement for frequently inaccurate and substandard genetic, genomic, and complex biomarker testing is common.

Particularly vexing for decision makers is that a legacy of weak regulation 5 and murky transparency in clinical genetics, genomics, and biomarker testing has created a clinical testing market where:

• Many tests from CLIA Certified and CAP Accredited labs appear legitimate, but are actually substandard 3 and are too frequently inaccurate 6, likely leading to misguided and often costly downstream care.

• Many tests are marketed with clinical utility and accuracy claims that may not be true 7.

• Billing fraud often runs rampant 8. 

With ever increasing spend on more complicated and costly laboratory testing, a growing number of payors, employers, and LBMs are looking for solutions to ensure that dollars are spent wisely. Solutions must not only include cost management, but more importantly must prioritize quality of care.

Our Robust Solution

The independent and nonprofit Center for Genomic Interpretation (CGI) helps health plans, employers, and LBMs implement a genetic, genomic, and biomarker test formulary. Tailored formularies ensure that patients receive high-quality and cutting edge care, while drastically reducing the fraud, waste, and abuse common to the molecular pathology clinical testing sector in US health care.

• CGI's ELEVATEGENETICS® services are unique in that they allow you to determine which genetic, genomic, and biomarker tests follow professionally recognized medical, scientific, and billing standards for health care, and which do not.

• CGI's expert clinical and technical consultants help you to cut through vendor noise and pressures to get a clear picture of clinical utility.

Why CGI's Services Are Leagues Ahead

In short, CGI is the only organization that goes to the heart of the problem to ensure that payors, self-insured employers, and LBMs have the insights necessary to reimburse only the tests that are accurate, valid, have high clinical utility, and are billed truthfully. That's because nobody else looks 'under the hood' like CGI, and knows what they're looking at.

While professional standards of health care are regularly published, laboratory test adherence to those standards have mostly gone unmeasured, resulting in most standards being unenforced. As a result there are many clinical tests being used by physicians that fail accuracy and clinical validity tests when inspected by independent third parties. It is estimated that more than half of genetic and genomic tests fail to meet accuracy, validity, and reporting standards1, 2, 3. Thus patients frequently take new precision medicine drugs, receive regular MRIs and other screenings, have organs surgically removed, terminate pregnancies, and end or continue diagnostic odysseys informed by test results that may or may not be accurate and valid. The human and financial cost of misguided health care following inaccurate or misleading test results likely far eclipse any cost savings a payor might gain from negotiating discounts with laboratories while neglecting to ensure the quality of the labs' tests.

To get to the heart of the problem, CGI's ELEVATEGENETICS services measure the extent to which genetic, genomic, and advanced biomarker tests follow critical professional standards. Tests that adhere to professional medical and scientific standards are more likely to be more accurate and clinically useful than those that don't. Through consulting and the use of ELEVATEGENETICS metrics, CGI helps payors, self-insured employers, and LBMs enforce professional standards to reduce abuse in the healthcare system. After all, "reimbursement for services that are not medically necessary or that fail to meet professionally recognized standards for health care" is the very definition of abuse 4.

The Value of a Genetic Test Formulary Powered by ELEVATEGENETICS®

The life saving benefits and cost savings promised by precision medicine can only be realized when the genetic, genomic, and biomarker tests guiding precision care are accurate, valid, and billed appropriately. Since more than half of genetic and genomic tests fail to meet accuracy, validity, and reporting professional standards when carefully reviewed by independent laboratory and biostatistical experts, it's critical that payors, self-insured employers, and laboratory benefit management companies (LBMs) put safeguards in place. CGI's consulting and ELEVATEGENETICS services are the only services designed to help payors in this way. By phasing in a tailored Genetic Test Formulary powered by ELEVATEGENETICS®, payors can:

• Significantly improve quality of care

• Better control costs

• Reduce fraud, waste, and abuse

To learn how the nonprofit Center for Genomic Interpretation (CGI) can help you better solve the growing challenges of managing genetic, genomic, and biomarker testing, please contact us.