On October 1, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a proposed rule regarding the Clinical Laboratory Fee Schedule. The proposal restructures payment rates for diagnosing laboratory-testing beginning on January 1, 2017 and creates new reporting requirements for “Applicable Laboratories.” Applicable Laboratories are (1) laboratories as defined by the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”); (2) laboratories that report tax-related information to the IRS under a TIN with which all NPIs are associated; and (3) laboratories that receive (in aggregate with all associated NPI entities) greater than 50% of Medicare revenues from the Clinical Laboratory Fee Schedule or Physician Fee Schedule. New payment rates for diagnostic laboratory tests would be set at the weighted median of private payer rates as reported by Applicable Laboratories.
The proposed law would require Applicable Laboratories collect data for the period between July 1 and December 31, 2015 and report data to CMS from January 1 through March 31, 2016. CMS would use the reported data to determine payment rates for years 2017-2019. Civil monetary penalties would be applied to any Applicable Laboratory that failed to submit required reports.
CMS is taking comments on the proposed rule through Wednesday, November 25, 2015.
Thanks to The Florida Bar, Health Law Section, Elizabeth Scarola, Esq., for providing this summary.
** The Centers for Medicare & Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the State Children’s Health Insurance Program (SCHIP), and health insurance portability standards. In addition to these programs, CMS has other responsibilities, including the administrative simplification standards from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), quality standards in long-term care facilities (more commonly referred to as nursing homes) through its survey and certification process, clinical laboratory quality standards under the Clinical Laboratory Improvement Amendments, and oversight of HealthCare.gov.