Effective in January 2019, the CDT-2019 includes a new diagnostic code, D0412, “blood glucose level test – in-office using a glucose meter”. While some dental offices already perform this procedure, the new CDT billing code raises questions for our member dentists.
1. Can dentists in New York State perform blood glucose level tests in their offices using a glucometer? As part of their scope of professional practice, dentists licensed in New York State can perform “physical examinations” necessary to provide dental treatment safely and effectively. It is permissible for dentists to do blood glucose testing on their own patients as part of a complete physical examination when necessary. Dentists cannot diagnose diabetes and need to refer any patient with questionable test results to their physician.
2. Are dentists who perform blood glucose level tests in their practices required to register with the New York State Department of Health as “physician owned laboratories”? In a word, “Yes.” Dentists who perform blood glucose level tests (with the equivalent of an at home glucose level monitor) in their practices are required to register with the New York State Department of Health (NYS DOH) as “physician owned laboratories” (POL). Medical laboratories are regulated under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). Dental offices that keep a glucometer in their offices fall under CLIA. As the federal government recognizes that New York’s regulatory requirements for laboratories meet or exceed CLIA standards, New York’s regulatory requirements are exempted from federal control AND the federal government has designated New York State to act as its agent with regard to POLs. Therefore, the NYS DOH administers the registration of laboratories in New York. The NYS DOH follows the same Centers for Medicare and Medicaid Services (CMS) rules and uses the same CMS forms.
3. How do I register my dental office as an “exempt laboratory”? Glucometer testing is categorized as a “CLIA waived procedure”. Private dental offices wholly owned by dentists who provide only CLIA-waived tests to their patients as part of treatment must register with the NYS DOH as an “exempt laboratory”. New York follows the CMS CLIA regulations and enrolls exempt POL laboratories in its POL Evaluation Program (POLEP) using the CMS-116 form. In New York, the CMS-116 is filed with the NYS DOH POLEP, not with CMS.
Dental offices can obtain a CMS-116 from the CMS website, https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf. Dentists applying should note on the form that it performs glucometer testing in the office to check glucose levels before and during dental treatment. Submit the completed CMS Form 116 to: New York State Department of Health, Physician Office Laboratory Evaluation Program, Empire State Plaza, P.O. Box 509, Albany, NY 12201-0509
4. Is there a registration fee? There is a charge for the “waived/exempt lab” designation. Do not submit the fee with the CMS-116 application. The NYS DOH will send a remittance invoice once it processes the application. Currently, the fee is $150 for a 2-year period. Lastly, the dental office must post the CLIA waiver certificate issued by the NYS DOH, just as professional licenses have to be posted.