Pathology/Lab Coding Alert

Ask payers for reporting/payment instruction.

You have 21 new CPT® codes for “Genomic Sequencing Procedures (GSP) and Other Molecular Multianalyte Assays” in 2015, but that doesn’t mean you can count on reimbursement for the tests. 

Let us help you wade through the layers of coverage and payment determinations to see how they might impact your lab.

Await Medicare’s Payment Rates

Medicare declined to price new GSP codes 81410-81471 on the Clinical Laboratory Fee Schedule (CLFS) this year. Instead, CMS opted to use the gap fill process to establish payment levels for 2016. 

How it works: Medicare Administrative Contractors (MACs) develop carrier-specific pricing recommendations for procedures they choose to cover by April 1, and solicit comments before finalizing the payment amounts on September 30. Once CMS posts these final payment amounts on the website (www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html), the agency will accept reconsideration requests for 30 days. CMS then creates the final payment determination, which will appear on the CLFS for 2016. 

Problem: “If the MACs determine that the procedure is not a covered service for Medicare beneficiaries, then they do not provide pricing information to CMS and the codes go unpriced. This is unfortunate, since CMS pricing of the CPT® codes is a standard that other payers, including private insurers as well as Medicaid, use to help them set prices for their beneficiaries,” says Aaron D. Bossler, MD, PhD, Director of Molecular Pathology Laboratory and Molecular Genetic Pathology Fellowship Program at the University of Iowa Hospitals and Clinics.

What you can do: You can inform your MAC of your lab’s costs for genomic tests, so that the MAC can provide pricing information to CMS. “The Association for Molecular Pathology (AMP) invested in a project to develop cost analyses, or microcosting, of health and economic modeling data for some of the new genomic sequencing procedures. These materials are available on the AMP website, including a template for laboratories and providers to use to determine the costs of their genomic sequencing procedures,” Bossler says. 

Resource: You can find the press release and link to materials for the AMP cost analysis tool at http://www.amp.org/about/press_releases/documents/AMPIntroducesMicroCostingandHealthEconomicGSPModel_clean_final_000.pdf

Contact Payers for Coverage Decisions

Fee schedules aren’t the only thing you have to consider when it comes to getting paid for any tests described by the new GSP codes. 

In fact, the first thing your lab needs to consider is whether your payers will cover the test(s) at all, and if so, under what clinical circumstances.

Medicare and other payers have various established procedures to decide if they’ll cover many molecular tests, including many of the new genomic analyses.  

For instance: Medicare might approve new tests through the national coverage determination (NCD) process, which takes nine to 12 months, the local coverage determination (LCD) process, which takes roughly three months, or a quicker, claim-by-claim adjudication process. Also, administrative contractor Palmetto GBA operates a pilot program, called MolDx, to establish molecular-testing coverage determinations. Medicare may opt to scale up MolDx into a nationwide program.

Look for medical necessity: Most payers cover only medically necessary tests shown to impact diagnosis and treatment choices, and exclude “investigational” tests or therapies from their policies. That leaves insurers the job of evaluating medical necessity for an onslaught of genomic and genetic tests. Payers often depend on evidence-based consensus statements generated from experts and peer-reviewed medical journal articles to define the parameters for covering tests. 

For example: Many payers cover prenatal testing for chromosomal abnormalities associated with Down syndrome, largely because of evidence-based guidelines from the American College of Obstetrics and Gynecology in support of this testing.  

Bottom line: Contact payers to determine coverage parameters before billing for the new genomic tests, and be prepared to discuss evidence for the tests’ medical necessity.