CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acceptable evidence that their genetic test is accurate and that it produces information
Tag: CLIA certificationSkip to articles
CLIA certification is the requirement under the Clinical Laboratory Improvement Amendments of 1988 that all entities that perform even one test, including waived tests, on … “materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings” meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.
The CLIA certification application collects information about a medical laboratory’s operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed.
All types of CLIA certifications are effective for two years, and the different types of certificates are:
- Certificate of Waiver – Issued to a laboratory that performs only CLIA waived tests
- Certificate for Provider Performed Microscopy (PPM) procedures – Issued to a laboratory in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during the course of a patient’s visit. A limited list of microscopy procedures is included under this certificate type and these are categorized as moderate complexity.
- Certificate of Registration – Issued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration.
- Certificate of Compliance – Issued to a laboratory after an inspection by the state Department of Health that finds the laboratory to be in compliance with all applicable CLIA requirements
- Certificate of Accreditation – Issued to a laboratory on the basis of the laboratory’s accreditation by an accreditation organization approved by CMS. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.
There are six CMS-approved accreditation or organizations:
- American Osteopathic Association
- American Society of Histocompatibility and Immunogenetics
- College of American Pathologists (CAP)
- Joint Commission on Accreditation of Healthcare Organizations
Laboratories that apply for accreditation by one of the CMS-approved accreditation organizations must also apply to CMS for a COA at the same time. Laboratories must apply for the highest-level CLIA certification that covers the tests they perform.
Any laboratory located in a state that has a CMS-approved laboratory program is exempt from CLIA certification. Currently, there are two states with approved programs: Washington and New York (partial exemption).
If CMS or the State Agency receives a complaint against a laboratory, the laboratory may receive an unannounced on site survey, even though it only perform waived tests or PPM procedures.
The following exceptions to CLIA certification apply regardless of a laboratory’s location:
- Any laboratory that only performs testing for forensic purposes
- Research laboratories that test human specimens but do not report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, individual patients
- Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed that meets SAMHSA guidelines and regulations. However, a CLIA certification is needed for all other testing conducted by a SAMHSA-certified laboratory.
CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers and Medicare to reimburse for pharmacogenomic tests, Avera Institute for Human Genetics (AIHG) in
This is an excerpt from a 2,700-word article in the January 30 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: One essential element of precision medicine — the wave of the future in
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the American Association of Laboratory Accreditation (A2LA). While it was undergoing ISO 15189 accreditation, the organization began to prepare for CLIA accreditation through A2LA, both for a single price.
CEO SUMMARY: Lab executives asked to join UnitedHealth’s new BeaconLBS lab benefit management system soon to launch in Florida have multiple and serious concerns. The primary issue is that BeaconLBS is a subsidiary of LabCorp—their major competitor. These executives understand why a payer wants to implement a prior authorization program for expensive lab tests. But
CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of proficiency testing (PT) procedures. Revocation of lab’s CLIA certification lasts for one year, and also
CEO SUMMARY: A California hospital challenged CMS in federal court over the threatened loss of its lab’s CLIA certificate. CMS threatened to revoke the certificate in 2007 and stop paying the hospital’s Medicare and Medi-Cal lab bills. In January, Victor Valley Community Hospital won a court injunction preventing CMS from revoking its CLIA certificate. Now
CEO SUMMARY: When pathologist Raman Sukumar, M.D. founded a generalist pathology practice in 2003, he was convinced that local doctors would support his vision of pathology at the point of care. That vision was validated by rapid acceptance of his mobile pathology laboratory and a steady flow of new specimens. Doctors Pathology Services now employs
CEO SUMMARY: Doctors Pathology Services in Delaware is successful for two reasons. First it runs the largest pathology lab in the state. But more important, it runs one of the few successful mobile pathology services anywhere. The Mobile Intraoperative Consultation Service(MICS)allows the pathologist to do pathology work on site at ambulatory surgery centers, physicians’ offices,
CEO SUMMARY: Urologists are motivated to operate anatomic pathology laboratory condominiums as a way to replace lost income after Medicare imposed a major reimbursement cut for a key urology procedure. Capturing revenue from ancillary services is a hot topic within the urology profession. Here are details about this exploding trend and why there is interest