DC

Thank you for the opportunity to comment on the regulatory impact analysis in this proposed rule. In this proposed rule, the Centers for Medicare & Medicaid Services (CMS) and Office of Civil Rights (OCR) do not use actual claims and enrollment data to develop impact analysis for the clinical labs affected. In fact, states that there are 22,671 laboratories in 39 states and territories in the OSCAR system. To calculate the number of laboratories affected by this proposed change, I recommend that CMS calculate the number of active laboratories in each of the 39 States and territories by using information in the Part B claims processing system and/or the Provider Enrollment, Chain and Ownership System to calculate the regulatory impact analysis. In addition, table 4 indicates that 6.1 billion-laboratory test are furnished annually on Medicare fee-for-service beneficiaries; however, this information was self-reported by laboratories without validation. I recommend that CMS furnish actual data on the number of laboratory claims processed within each of the 39 States and territories rather than using unverified data to calculate the regulatory impact analysis.