America Division of Justice (“DOJ”) just lately settled a part of a qui tam lawsuit beneath the False Claims Act for alleged violations of the Medicare “14-Day Rule” for $388,667. From March 2012 to November 2023, a laboratory and well being system allegedly delayed submitting doctor orders for sure laboratory testing till 14 days after sufferers’ hospital discharge in an try to avoid the Facilities for Medicare & Medicaid Companies (“CMS”) bundled protection and billing rule for laboratory providers furnished to hospital sufferers. This enforcement motion highlights the significance of sustaining a billing compliance coverage that captures the necessities of CMS’s laboratory date of service coverage.
What’s the 14-Day Rule?
The overall rule is that the date of service (“DOS”) for medical diagnostic laboratory checks is the date of specimen assortment until the doctor orders the check at the least 14 days following the affected person’s discharge from the hospital (“14-Day Rule”). When the 14-Day Rule applies, the DOS turns into the date the check was carried out, not the date of specimen assortment. There may be an exception to the rule for Superior Diagnostic Laboratory Checks, checks which are cancer-related protein-based Multianalyte Assays with Algorithmic Analyses and checks described by CPT code 81490, the place the DOS is the date of efficiency no matter when the doctor ordered the check. Nonetheless, all the following standards should be met earlier than the exception applies per 42 CFR 414.510:
- The check will need to have been carried out following a hospital outpatient’s discharge;
- The specimen will need to have been collected from an outpatient throughout an encounter;
- It will need to have been medically applicable to gather the pattern;
- The outcomes of the check couldn’t have guided therapy offered through the encounter; and
- The check will need to have been affordable and medically obligatory for the therapy of an sickness.
When the DOS is the date of specimen assortment, the check is taken into account a hospital outpatient service for which the hospital should invoice Medicare, and the performing laboratory should search cost from the hospital. If the submission of doctor orders was delayed, both by holding orders or canceling and resubmitting orders, the well being system didn’t need to pay the lab for testing. Because of the 14-Day Rule, the laboratory check was successfully unbundled from the hospital outpatient encounter, and the performing laboratory was required to invoice Medicare immediately. The DOJ, due to this fact, claimed the laboratory and well being system knowingly triggered the submission of false claims for reimbursement to Medicare. The enforcement of the False Claims Act on this case demonstrates the federal government’s need to disrupt well being care fraud and abuse.
Sensible Takeaways
- Medical laboratories ought to think about enhancing their compliance and billing insurance policies to make sure checks which are topic to the 14-Day Rule are correctly recognized.
- Simply because a laboratory check described above was carried out doesn’t assure that the DOS would be the date of efficiency. Tips must be in place to make sure that every requirement is happy earlier than billing the Medicare program.
- If Medicare is wrongly billed, you must act rapidly to appropriate the motion.
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