QUESTION:
What is a Medicare NCD and why would an NCD be relevant to the delineation of hospital clinical privileges for certain procedures?
OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
A National Coverage Determination (“NCD”) is a general outline of coverage which is applicable regardless of which Medicare Administrative Contractor (“MAC”) is administering Medicare claims for a particular region. According to CMS, NCDs are made through an evidence-based process and in some cases are supplemented by outside assistance in order to establish nationwide Medicare payment conditions for the treatment or procedure subject to the NCD.
Medicare does not have the authority to dictate the practice of medicine. However, the Medicare program does have the authority to define what it will pay for, and under what conditions. That is where the NCDs (as well as LCDs which are Local Coverage Determinations and are specific to a particular MAC) become relevant to clinical privilege delineations.
For example, the NCD for Percutaneous Left Atrial Appendage Closure (“LAAC”) describes the conditions under which Medicare will pay for LAAC technical and professional services. Among the requirements of the current NCD, the LAAC must be performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who satisfies the following criteria:
(1) Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and
(2) Has performed ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum; and
(3) Continues to perform ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a 2-year period.
What happens if you do not use the NCD in your delineation of clinical privileges for an LAAC? That is not unlawful. But neither the Hospital’s nor the physician’s claim will be reimbursed by Medicare if the physician who performs the LAAC does not at least satisfy the requirements in the NCD (or any other procedure where an NCD or LCD specifies certain training and/or experience).
If a claim has been submitted for such a procedure by a physician who did not satisfy the NCD or LCD’s criteria, then both the technical and the professional fees paid by the Medicare program for that procedure must be refunded. Submitting a claim to Medicare in reckless disregard or in deliberate ignorance of Medicare’s conditions of payment constitutes a False Claim. Keeping the reimbursement for a claim that should not have been submitted to Medicare because it did not satisfy the requirements of an NCD or LCD constitutes a “reverse false claim.” The penalty for a violation of the False Claims Act is three times the amount of the claim plus a possible per claim penalty of between $13,508-$27,018.
Therefore, a prudent hospital will be aware of Medicare’s conditions of payment, where they exist, and will make their delineation of clinical privileges for an LAAC, or any other procedure where physician qualifications are defined in an NCD or LCD, so that at a minimum, the clinical privileges needed to perform that procedure in the hospital meet or exceed the requirements in any relevant NCD or LCD.
If you have a quick question about this, e-mail Henry Casale at hcasale@hortyspringer.com.
If you want to learn more about the False Claims Act, Anti-Kickback Statute, the Stark law, amendments to the regulations of those laws, and much more, consider joining Dan Mulholland and Henry Casale in Phoenix November 16-18, 2023, for our next seminar.
In the interim, be sure to check out “The Kickback Chronicles” on the Health Law Expressions Podcast featuring Hala Mouzaffar and Henry Casale, so you can learn from the misfortune of others.