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 review or analyze the impact of changes in the 11 States have had on patient understanding of their medical condition or the number of request made by patients to request access to clinical laboratory test reports. Thus, the regulatory impact analysis is flawed. I recommend that CMS and OCR review and analyze number of actual Medicare fee-for-service beneficiaries requesting access to their clinical laboratory test results in Delaware, District of Columbia, Maryland, New Hampshire, New Jersey, Nevada, Oregon, Puerto Rico, and West Virginia, to determine the actual cost impacts of this proposed regulation. In this proposed rule, CMS and OCR do not analyze the cost on clinical laboratories of providing access to completed test reports to Medicare beneficiaries. Thus, the regulatory impact analysis is flawed. I recommend that CMS and OCR review and analyze cost associated providing patients with test reports to Medicare fee-for-service patients in Delaware, District of Columbia, Maryland, New Hampshire, New Jersey, Nevada, Oregon, Puerto Rico, and West Virginia, to determine the actual cost impacts of this proposed regulation.