It is no secret that we are making great strides in reducing the mortality of lung cancer. From improving screening rates which have reduced the chances of dying from lung cancer due to earlier detection, increased adoption of minimally invasive surgical techniques, and exciting new drugs that have been shown to improve survival even in metastatic disease, there is reason to be hopeful in what has usually been a devastating and fatal diagnosis. These newer drugs, such as immunotherapies and kinase inhibitors, typically require advanced molecular testing to help find the right drugs for a patient’s unique cancer, like finding the right key for a lock. Despite their proven efficacy, however, getting Medicare and other payors to pay for this molecular testing has proven to be an opaque process not well-understood by physicians. To mangle a quote from Alexandre Dumas, Medicare fraud, like treason, is a matter of dates.
The 14-day rule is designed to prevent laboratories from billing Medicare for tests performed on specimens if a physician ordered the test within 14 days of the patient’s inpatient discharge. At the time of its enactment, one could see the logic, as it was designed to reduce costs by bundling inpatient-related charges to inpatient-related payments. Times change, however, and with the widespread adoption of molecular testing, we are now in a place where we collect specimens as an inpatient that will then need to be analyzed to direct long-term outpatient treatment, and as with all things, the question becomes, “Who will pay for it?” To use my own clinical experience as an example, if I resect a lung cancer that might meet the criteria for additional treatment with one of these newer drugs, I have to wait 14 days until after the date of discharge (not the date of surgery) before I can send molecular testing to help guide the patient’s additional systemic therapy. If I order it before those 14 days have passed, and the laboratory attempts to bill Medicare for performing that test, that laboratory has committed Medicare fraud. This is an illogical and archaic rule, but it has not stopped the Department of Justice from aggressively pursuing laboratories that violate this law.
To Medicare’s credit, the rule was even worse up until 2018, when they made an update. Previously, the 14-day rule applied to both inpatient and outpatient testing, meaning that previously, if someone had an outpatient biopsy and was discharged the same day, the person ordering the molecular testing still had to wait 14 days before they could order it. That rule was modified in 2018 so that it no longer applied to outpatient procedures meeting specific criteria but only to inpatient. For patients who need additional treatment, however, this unnecessary 14-day wait frequently leads to additional delays as it is usually up to the medical oncologists to order in their follow-up visits, frequently delaying ordering, delivery of results, and ultimately treatment. In a survey published in 2022 of ASCO members regarding their own reasons for not ordering molecular testing for advanced lung cancer patients, more than half cited their own concerns about delaying treatment as a reason for not ordering molecular testing. My current institution has developed legally compliant pathways that meet these requirements while minimizing delays for appropriate patients, but only through significant work.
Although my experience is primarily in the lung cancer space, molecular testing has a role in most types of cancer by this point, but illogical rules hidden behind layers of red tape keep most physicians from understanding the specific obstacles that their patients face to treatment. Medicare needs to create an exception to the 14-day rule for molecular testing for cancer to minimize physician administrative burden and help patients get the treatment they need faster. The era of personalized medicine is finally upon us, now we just need to Medicare to catch up.
Sean Jordan is a thoracic surgeon.
