Author: David M. Glaser, Esq. | June 24, 2026
I am often asked whether I’m an expert on lab billing. I always answer “no,” despite the fact that I have spent considerable time digging into the topic.
I would claim to know a lot about lab billing, but deny being an expert. Why? The answer offers important nuance about lab billing, and may help you filter actual experts from pretenders.
The reason I say that I am not an expert on lab billing is that I find the regulation and guidance of it to be confusing and often contradictory. For example, The Medicare Claims Processing Manual, Chapter 16, Section 10.1, defines an independent laboratory as one that “is independent both of an attending or consulting physician’s office and of a hospital” – so an independent lab can’t be associated with a hospital.
That is easy enough to understand.
But just a few sentences before that appears this text: “When a hospital laboratory performs laboratory tests for non-hospital patients, the laboratory is functioning as an independent laboratory.” I’m relatively confident in my ability to analyze text. Those two statements are mutually exclusive. I simply can’t harmonize them. One says independent labs can’t be part of a hospital; the other says the hospital lab is an independent lab when doing tests for nonpatients.
If I can’t explain that, it means I’m not an expert. But it also means that I don’t think anyone in the country is an expert on lab, because I don’t think it is humanly possible to explain that.
Perhaps as importantly, calling yourself an expert doesn’t make it so. Several years ago, I was listening to a self-described lab expert deliver a presentation at a conference. The “expert” explained that a physician clinic lab cannot perform tests for anyone other than a patient of the clinic.
In essence, this lawyer was saying that a physician clinic can’t do lab tests for walk-ins or patients of another clinic. I had researched that very question and reached the opposite conclusion, determining that clinics were permitted to perform tests for non-patients, just as hospitals can.
So, after the talk, I asked for the citation, indicating that I had missed it in my research. Their answer surprised me: “Oh, there’s nothing in writing anywhere, but I called CMS and that’s what they said.” If you’re a regular reader, you know that if it’s not published in a statute or regulation, it’s not binding.
The Centers for Medicare & Medicaid Services (CMS) can’t create some sort of rule by giving an answer to an individual during a phone call. This person describes themselves as a lab expert, but rather than analyzing regulatory text, they’re consulting the oracle of CMS. If, as part of the presentation, they had said “I was unable to find any regulations or even guidance, so I called CMS and they said clinics can’t bill for non-patients, but it is important to recognize that while that is the government’s stated position, there is no law supporting it,” I would understand.
I think the call to CMS is unnecessary, yet I recognize that when your research comes up empty, it can be nerve-wracking. But presenting what CMS said on the phone as binding law is something I consider a rookie mistake – not what I expect from an expert.
I have a few takeaways. First, calling CMS is not legal analysis. Second, if anyone can call themselves an expert, the label is essentially meaningless. And finally, when it comes to lab services, the guidance and regulations are a mess.
Knowing that going in will make your research far less painful.
This article was originally published on RACmonitor.
