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Showing Products For: CLIA Waived

A1CNow+ BAYER HEALTHCARE
A1CNow+ is a portable, easy-to-use system that provides on-the-spot HbA1c result in 5 minutes.  This enables the healthcare provider to make immediate treatment decisions and discuss them with patients face-to-face during their visits. The A1CNow+ is portable which enables testing in multiple exam rooms and requires no capital investment.  No maintenance, CLIA waived, NGSP certified and reimbursable.

Purchasing A1CNow+

A1CNow+ is sold exclusively though our network of distributors in the United States and abroad. If you're interested in learning more about purchasing A1CNow+ for your practice, please visit our A1CNow+ distributor listings.

Billing for A1CNow+

Billing for A1CNow+ is simple, as well-established billing codes and procedures are used.

1) CPT (Current Procedure Terminology) Codes

83037QW (must use QW). The Medicare National Limitation Amount (NLA) is $21.06, in most states.

36416 Collection of capillary blood specimen (e.g. finger, heel, ear stick). Medicare does not reimburse for 36416. Private pay average payment varies ($3 to $10). The A1CNow+ is approved for use with either a capillary or venous blood specimen.

36415 Collection of venous blood by venipuncture. Medicare reimbursement for a venipuncture is $3. Private pay average payment may vary. The A1CNow+ is approved for use with either a capillary or venous blood specimen.

Note 1: The CPT code 83037QW service may be billed when performed in a physician's office using a device cleared by the FDA for home use. CPT code 83037QW is not intended to report an A1C test that is obtained in the patient's home or by the patient or family. CPT code 83037QW may not be reported when the test is performed using a desk top analyzer or other devices not approved by the FDA for home use. It would be unusual for a clinical laboratory to report 83037QW.

Note 2: 83037 should be used with the QW modifier when used in the physician office setting. The QW modifier (e.g. 83037QW) indicates that the test and the laboratory has received a CLIA certificate of waiver. The A1CNow+ has been categorized as a waived test under the 1988 CLIA regulations.

Note 3: CPT code 83037QW became available in 2006, and some insurers have already implemented and utilized this new code. Other insurers continue to use 83036QW. Physicians should check with local insurers to confirm CPT and ICD-9 codes that are appropriate. See also Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report (Section 190.21 - Glycated Hemoglobin/Glycated Protein).

The Centers for Medicare and Medicaid Services (CMS) has indicated the availability of this code and the use of the QW modifier.

2) Medicare Coverage Policies on Frequency of Testing

CMS has issued national Medicare policies for coverage of glycated hemoglobin/glycated protein clinical laboratory tests:

  • The test is also valuable to assess hyperglycemia, a history of hyperglycemia or dangerous hyperglycemia.
  • The test may not be reasonable and necessary to perform more often than every three months on a controlled diabetic patient to determine if metabolic control is within range.
  • The test may not be covered if performed more frequently than once a month for diabetic pregnant women.
  • Testing for uncontrolled Type 1 or Type 2 diabetes may require testing more than 4 times per year.
  • Testing every 1-2 months may be appropriate in the patients whose diabetes regimen has been altered to improve control.
  • Testing pregnant women with diabetes or gestational diabetes every month may be reasonable and necessary.
  • Medical necessity documentation must support such testing in excess of the above guidelines.

    3) E & M Code (Evaluation and Management Code)

    Physician interpretation of test results is considered to be part of the evaluation and management services provided to a patient during an office visit and is not separately billable. For existing patients, codes 99212 - 99215 should be billed and the code used depends on the complexity of the visit (use codes 99201 - 99204 for new patients).

    E & M Code 99211 'Clinic Days'
    If a patient sees a nurse or other non-physician health care professional for the purpose of HbA1C testing (for example, to monitor insulin therapy) and the nurse takes vital signs, compares the results of the HbA1C test to predetermined guide lines, and advises the patient accordingly, E & M code 99211 may be billed.

    4) ICD-9 Codes

    An appropriate diagnosis (ICD-9) code (or narrative description) must be identified in the patient's medical record and reported on the claim form to the patient's insurer for each service or supply billed under Medicare Part B. ICD-9-CM is an acronym for International Classification of Diseases, 9th Revision, Clinical Modification. When a patient presents with an illness, the ICD-9 code is determined by the 'signs and symptoms' that most accurately describe the patient's condition.

    5) Certificate of CLIA Waiver

    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, performance of waived category tests require only a CLIA Certificate of Waiver. Certificate of Waiver labs must register with Medicare, pay the fee every two years and agree to follow manufacturer's instructions in performing clinical lab tests.

    To apply for a Certificate of Waiver, click on www.cms.hhs.gov/clia/cliaapp.asp, and download a CLIA application form (CMS-116), follow the instructions provided, then send it to the appropriate state agency. A list of State Agency addresses is also available on the Internet at www.cms.hhs.gov/clia/ssa-map.asp.
BAYER HEALTHCARE 510 Oakmead Parkway | | Sunnyvale | CA | Bayer's A1CNow provides a fast and easy way of obtaining accurate A1C results.
Status BTA Lifesign
Status BTA provides accurate urology tests results with superior sensitivity and specificity


Status BTA

A Rapid Test For the Qualitative Detection of Bladder Tumor Associated Antigen in Human Urine
  • CLIA Waived
  • Uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine
  • Simple procedure requires only adding urine to test device
  • Accurate test results with superior sensitivity and specificity
  • Detects early stage recurrence cancer that cytology may miss
  • Results available in 5 minutes
  • Adjunct test to cystoscopy
Lifesign 85 Orchard Rd | | Skillman | NJ | A Rapid Test For the Qualitative Detection of Bladder Tumor Associated Antigen in Human Urine
Hemoccult® Fecal Occult Blood Test BECKMAN COULTER, INC.
For thirty years, the Hemoccult® fecal occult blood test (FOBT) has been aiding physicians in detecting hidden blood in stool specimens as an early indication of colorectal cancer. More than 300 studies using Hemoccult¨ products many of which were conducted over long periods of time with large numbers of participants- have been published in leading medical journals around the world. As a result of these studies, the American Cancer Society and other healthcare and medical agencies now recommend
Hemoccult is the #1 brand in FOBTs.

Used with confidence by physicians for over 40 years, Hemoccult brand products are supported in over 300 clinical publications The American Cancer Society recommends the use of high-sensitivity guaiac-based FOBTs (such as Hemoccult SENSA) or fecal immunochemical tests (FIT) as an effective screening method for CRC. Rigorous prequalification of raw materials and a unique quality control system yields a high degree of lot- to-lot consistency. Hemoccult products are used and trusted by top American medical institutions and healthcare professionals and millions of people have been screened with Hemoccult products, resulting in many lives saved.
BECKMAN COULTER, INC. 200 South Kraemer Blvd. M/S M-362 | PO Box 8000 | Brea | CA | Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing.