Wednesday, 16 July 2014

CLIA Certificate of Waiver - Who can apply for certificate

Securing a CLIA Certificate of Waiver

The Metrika A1cNow is classified as a CLIA Waived Category test by the FDA. A CLIA certificate is required any time a clinical laboratory test is performed; however, waived category tests require only a CLIA Certificate of Waiver. Certificate of Waiver labs must register with Medicare, pay a $150.00 fee every two years and agree to follow manufacture’s instructions. No inspections or other CLIA regulations apply.

Who Can Apply for a Certificate of Waiver.

Anyone can apply for a Certificate of Waiver unless your state has imposed additional restrictions. Under CLIA, there are no personnel qualifications for the Laboratory Director or individuals who perform waived tests. 

For example, Pharmacists may be granted a Certificate of Waiver in all states except NY and PA. However, a number of states require them to comply with additional requirements (AL, AZ, FL, ME, MD. MA, NJ, OR, TN and RI). Always check with your State Agency if the Director for the Certificate of Waiver laboratory is not an MD or other licensed health care provider.

To apply for a Certificate of Waiver, go to the internet at www.hcfa.gov/medicaid/clia and download a CLIA application form (HCFA-116) and follow the instructions provided, or complete the attached application form and send it to the appropriate state agency. A list of State Agency addresses is attached and is also available on the internet at www.hcfa.gov/medicaid/clia/saaddres.

Type of CLIA certificate

CLIA Certificates 

Five types of certificates may be issued to providers, who perform waived, moderate, or high complexity tests and procedures: 

Certificate of waiver – Issued to a laboratory to perform only waived tests (i.e., simple examinations or procedures that use methodologies that are so simple and accurate that the likelihood of erroneous results is negligible and poses no reasonable risk of harm to the patient if the test is performed incorrectly). 

Certificate for Provider-Performed Microscopy Procedures (PPMP) – Issued to a laboratory in which a physician, midlevel practitioner or dentist performs no tests other than the microscopy procedure (a procedure categorized as moderately complex where the primary instrument for per- forming the test is a microscope). This certificate permits the laboratory to also perform waived tests. 

Certificate of registration – Issued to a laboratory that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined by survey to be in compliance with the CLIA regulations. 

Certificate of compliance – Issued to a laboratory after an inspection 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 organization approved by CMS.

What is CLIA number

Clinical Laboratory Improvement Amendments 

The Clinical Laboratory Improvement Amendments (CLIA), passed by Congress in 1988, established quality standards for all laboratory testing. CLIA ensures the accuracy, reliability, and timeliness of patient test results, wherever a test is performed. 

A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. CLIA is user-fee funded; therefore, all costs of administering the program are covered by the regulated facilities. 

CLIA standards are national and are not Medicare-exclusive. CLIA applies to all providers rendering clinical laboratory and certain other diagnostic services, whether or not claims are filed to Medicare.

CLIA Quality Standards 

CLIA defines quality standards for proficiency testing (PT), patient test management, quality control, personnel qualifications, and quality assurance, as well as specific cytology provisions. 

The Centers for Medicare & Medicaid Services (CMS) administers CLIA, including laboratory registration, fee collection, surveys, surveyor guidelines and training, enforcement, approvals of PT providers, accrediting organizations, and exempt states. The Centers for Disease Control and Prevention (CDC) are responsible for test categorization and CLIA studies.

CLIA Number 

Upon certification, each laboratory is assigned an individual and unique CLIA number. Each CLIA number consists of ten alphanumeric positions. The CLIA number must be on all claims for laboratory services, or the claim will be returned as un- processable. The CLIA number must be entered in block 23 of Form CMS-1500 or the applicable electronic field.

CLIA approved CPT lab code list

CLIA requires that for each test it performs, a laboratory facility must be appropriately certified. To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level. 

The Current Procedural Terminology (CPT) codes that the Centers for Medicare & Medicaid (CMS) considers to be laboratory tests under CLIA (and thus requiring certification) change each year. Make sure your billing staffs are aware of these changes.

Listed below are the latest tests approved by the FDA as waived tests under CLIA. The CPT codes for the following new tests must have the modifier QW to be recognized as a waived test. However, the CPT codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651 do not require a QW modifier to be recognized as a waived test.

CPT Code Effective Date Description

G0434QW from August 21, 2015 to December 31, 2015 Healgen Scientific LLC, Healgen Multi-Drug Urine Test Dip Card
G0477QW on and after January 1, 2016 Healgen Scientific LLC, Healgen Multi-Drug Urine Test Dip Card
G0477QW March 8, 2016 Tanner Scientific Multi-Panel Drug Test Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Easy Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Split Key Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Test Cassette
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Test Dip Card
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Easy Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Split Key Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Test Cassette
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Test Dip Card
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Easy Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Split Key Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Test Cassette
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Test Dip Card
87338QW March 22, 2016 Meridian Bioscience Immunocard STAT! HpSA (Stool)
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Amphetamine Dip Card
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Amphetamine Quick Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Amphetamine Strip
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Amphetamine Turn-Key Split Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Cocaine Dip Card
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Cocaine Quick Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Cocaine Strip
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Cocaine TurnKey Split Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Morphine Dip Card
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Morphine Quick Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Morphine  Strip
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Morphine Turn-Key Split Cup
G0477QW April 21, 2016 Chemtron Biotech, Inc. Chemtrue Multi-Pane Drug Screen Cup Tests
G0477QW April 21, 2016 Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Cup with OPI 2000 Tests

The new waived complexity code 87338QW [Qualitative or semiquantitative detection test for helicobacter pylori in stool, multiple-step method] was assigned for the detection of Helicobacter pylori antigens in stool performed using the Meridian Bioscience Immunocard STAT! HpSA (Stool) test

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