Tag Archives: CLIA

HHS Proposes Updates to CLIA Proficiency Testing Rules

The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have proposed updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) proficiency testing (PT) regulations to address the evolution in laboratory testing technology since the CLIA PT regulations were initially established in 1992.  The proposed rule would, … Continue Reading

CMS Mulling Changes to CLIA Personnel, Proficiency Testing Referral Rules

CMS is requesting information from the public on potential changes to longstanding Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel, histocompatibility, and related policies, which have not been comprehensively updated since 1992. With regard to personnel requirements, CMS seeks information that will enable it to revise the regulations to “better reflect current knowledge, changes in … Continue Reading

CMS Adopts PPS for Federally Qualified Health Centers (FQHCs), Amends CLIA Rules

CMS published a final rule on May 2, 2014 setting forth the methodology and payment rates for the new prospective payment system for FQHC services under Medicare Part B. FQHCs will transition to the new payment system beginning October 1, 2014, based on their cost reporting periods. Under the rule, Medicare generally will pay FQHCs a … Continue Reading

Individualized Quality Control Plan for CLIA Laboratory Non-Waived Testing (May 19)

CMS is hosting a provider call on May 19, 2014 regarding the Clinical Laboratory Improvement Amendments (CLIA) Individualized Quality Control Plan (IQCP), which is a new, voluntary quality-control option for laboratories performing non-waived testing. The IQCP is intended to provide laboratories with more flexibility in customizing Quality Control (QC) policies and procedures according to test method … Continue Reading

Final HIPAA Rule Gives Patients Right to Access Test Results Directly from Labs

On February 6, 2014, the Department of Health & Human Services (HHS) published a final rule making changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations to provide individuals with a greater ability to directly access their laboratory test reports. The rule is … Continue Reading

CMS Proposes Rules for Medicare FQHC PPS, CLIA Amendments

On September 23, 2013, CMS published a proposed rule that would establish the methodology and payment rates for the new Medicare Federally Qualified Health Center (FQHC) PPS, as mandated by the ACA. Under the proposed rule, FQHCs would be paid a single encounter-based per diem rate per Medicare beneficiary, which currently is estimated to be … Continue Reading

CMS Proposes Reforms to Reduce Provider Regulatory Burdens

The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on February 7, 2013 that it estimates would save health care providers $676 million annually by streamlining unnecessary, obsolete, or excessively burdensome regulations and making reforms to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The provisions of the wide-ranging proposal would affect … Continue Reading

House Approves “Taking Essential Steps for Testing (TEST) Act”

On September 19, 2012, the House approved H.R. 6118, the TEST Act, which would provide CMS with more flexibility in enforcing prohibitions against improper referrals of proficiency testing under the Clinical Laboratory Improvement Amendments (CLIA). Under current law, CMS must revoke the CLIA certificate of any laboratory that intentionally refers its proficiency testing samples to … Continue Reading