Patrick Godbey, MD
April 2020—It is important for pathologists to understand just how much influence the federal government has on our practice of medicine. In last month’s column, I discussed ways in which the government dictates how and whether we are paid for our services. This month I’ll address the role of the federal government in determining where and how we practice.
You probably already know that pathology labs are among the most highly regulated areas within health care, subject to regulations from multiple agencies. The labs we practice in must comply with the federal regulatory requirements of the Clinical Laboratory Improvement Amendments, and CLIA certification is an absolute necessity. Without that Centers for Medicare and Medicaid Services CLIA certificate on my wall, my lab would not be allowed to bill, among others, Medicare or Medicaid—the kiss of death for a pathology lab.
There’s a saying in the financial industry: “Don’t fight the Fed.” While its original meaning was about investments, the sentiment can be applied just as easily to laboratory medicine. Ultimately, the federal government controls where you practice and the tools you are allowed to use when you practice.
As individual pathologists, we have very little influence on the government’s regulation of our labs and tools. But the CAP does have influence, and that is one reason it is so important for all pathologists to be members of the CAP and take an active role.
For example, the CAP regularly engages in discussions with federal agencies including the FDA, the CMS, and Health and Human Services, especially when there are new tools under review. We are currently sharing our expertise about artificial intelligence and other emerging technologies. The federal agencies know that the CAP has valuable insight, and I am proud that we have become a go-to source of reliable information for these groups, helping them understand how pathologists could incorporate new technologies into their practice. The discussions we have at this level can have implications for pathology and laboratory medicine for years.
The CAP also works closely with the federal government to establish metrics that will be used to gauge the quality of the services we provide. We have been part of these discussions since they first began about a decade ago. We worked with the CMS to develop measures by which pathologists could submit data to show they are meeting those quality metrics. On its own, the CAP has invested millions of dollars to build the Pathologists Quality Registry, a cloud-based qualified clinical data registry designed to streamline the reporting of metrics required to demonstrate compliance with the quality criteria set by the federal government. Once again this year, this registry is a “qualified registry.” As such, the federal government will accept submissions through the CAP’s registry, including accepting our proprietary measures. While this registry was designed to meet government requirements, in the future it will also be useful for demonstrating quality of care to private payers and hospital administrators.
In addition, the CAP supports pathologists by advocating for the coverage of new services, which has been especially relevant for molecular testing. We keep a close eye on coverage determinations, responding to draft determinations. The CAP also reaches out to state pathology societies as appropriate to support local coverage determinations, which often influence decisions about whether a new service is covered at the national level.
The CAP is the only organization representing the voice of pathologists with this much influence on the federal government. When it comes to where you practice, which tools you use, and the services you are able to offer, the federal government has tremendous say—but so does the CAP. I encourage you to participate actively with the CAP to help us ensure that we are best able to represent your views in these all-important interactions with government agencies and committees. You may not want to fight the Fed, but with the CAP’s help, you can at least make sure that your voice is heard.
I’m grateful to John Scott from the CAP’s Washington, DC, office and to CAP governor Jonathan Myles, MD, for helping me with this column.
Dr. Godbey welcomes communication from CAP members. Write to him at [email protected].