This month we will continue discussing the common barriers to biomarker testing for cancer patients in the community.
As you may recall, these are the top 10 barriers that I’ve seen to biomarker testing in the community:
- High cost of testing.
- Long turnaround time for results.
- Limited tissue quantity.
- Preanalytical issues with tissue.
- Low biomarker testing rates.
- Lack of standardization in biomarker testing.
- Siloed disciplines.
- Low reimbursement.
- Lengthy complex reports.
- Lack of education on guidelines.
When I go into the community and discuss barriers to biomarker testing while everyone can relate to 1-2 barriers, those barriers are typically not the same at every hospital. However, reimbursement is almost always presented as a barrier to biomarker testing. The reimbursement process may be confusing and there have been recent changes. If everything is not submitted properly, testing may not be covered. Let me start by saying I have no magic bullet to fix the problems with molecular pathology billing and I’m not the expert on billing. I have had to navigate the reimbursement process and can share my experiences.
Let’s start with Medicare as they represent a payer all of us have to work with and we frequently see other insurers make coverage decisions based on Medicare rates. The Medicare coverage for single gene testing has historically covered the testing, albeit maybe not at a rate we consider acceptable. In 2018 Medicare issued a national coverage determination (NCD) for NGS if the patient has stage III or IV cancer and the NGS assay has an FDA-approved or cleared indication for use in that patient’s cancer and results are provided to the treating physician for management of the patient using a report template to specify treatment options (1). This means if you use a reference laboratory that has an assay that is approved as a companion diagnostic for a drug that is approved in the tumor type you are testing, the test could be covered. For the test to be covered the correct CPT code from the AMA would need to be applied, an ICD-10 qualifying code to meet medical necessity, and if your state is covered by the MolDX program you would also need to provide a Z-code that is specific for the test. Confused yet?
There is also a Medicare 14-day rule (formally called Date of Service Regulation 42 C.F.R. §414.510). This rule requires the performing lab to bill the hospital for certain tests that are ordered less than 14 days after an inpatient or outpatient discharge. There was a change as of January 1, 2018 that allows labs to bill for certain molecular pathology tests if the patient was admitted as an outpatient (think biopsy performed in hospital but patient was not admitted as an inpatient). This does not negate the 14 day rule, but it gives us some exceptions so that we may bill for molecular pathology testing ordered after the patient was discharged. This rule also mandates that the performing lab is the billing lab.
For payers that are not Medicare, it is helpful to have a conversation with the medical director or a customer service representative to get information on how to get your test covered. We have presented to the medical directors for private payers. While we did cover the scientific merit of our testing, we also had to go over financials for the payer. It was helpful to speak their language and provide clear information on the financial benefit to NGS over single gene testing.
Many of the reference laboratories will handle the billing for you if your hospital contract with them is written that way. This would allow those of us that are not billing experts to ensure all of the coding is applied properly. Of course you would still need to supply the information to the reference laboratory. These labs also offer low out of pocket costs to the patient. If you are insourcing testing, I would recommend having a molecular billing consultant. There are consultants available that allow you to submit questions and pay per question. This has come in handy for my organization.
Lastly, I urge you to join and get involved with organizations that represent the laboratory community such as CAP, AMP, ASCP, etc. These organizations help address policy change to ensure molecular testing is reimbursed in a fair manner. Molecular pathology results have value for the patient and cost money to be performed. We should expect fair payment for the service rendered.
- National Coverage Analysis (NCA) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). 1/21/19
-Tabetha Sundin, PhD, HCLD (ABB), MB (ASCP)CM, has over 10 years of laboratory experience in clinical molecular diagnostics including oncology, genetics, and infectious diseases. She is the Scientific Director of Molecular Diagnostics and Serology at Sentara Healthcare. Dr. Sundin holds appointments as Adjunct Associate Professor at Old Dominion University and Assistant Professor at Eastern Virginia Medical School and is involved with numerous efforts to support the molecular diagnostics field.