Product Directory — Diagnostics, Devices & Equipment

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.

The HemoCue® Hemoglobin systems provide an opportunity for quick, simple and reliable quantitative hemoglobin results with the same performance as a large hematology analyzer.
The dual wavelength analyzers correct for lipemia, leucocytosis and other sources of turbidity. Any blood source (capillary, venous or arterial) can be used. The disposable microcuvette collects the exact amount of blood and mixes the sample with the reagents automatically. The microcuvette is placed into the portable analyzer. Results appear on the display in about a minute.

Why to choose a HemoCue® Hemoglobin System

• Produce accurate results in about a minute
• Utilize only 10 µL of capillary, venous or arterial blood
• Precalibrated, portable analyzers that require a minimum of maintenance
• No calibration or instrument manipulation (between cuvette/reagent batches) needed
• Automatically compensate for turbidity due to lipids or leucocytosis
• Can be used by non-laboratory personnel after a brief training session

HemoCue® Hb 201+
This is our second generation, improved standard product. Just as earlier versions, this system combines the precision and accuracy of a laboratory measurement with a quick turn around time and ease of use. The pocket size analyzer also stores results and QC results, together with date and time for up to 600 measurements. The stored data can be printed directly via an external printer or downloaded to a PC.

HemoCue America 40 Empire Drive | | Lake Forest | CA | Since 1982, HemoCue® develops, produces and markets point-of-care medical devices. The unique concept behind each HemoCue® product allows for near-patient testing without sacrificing the precision and accuracy offered by a lab instrument.

This is a new product, however we don’t have an image. Here’s the product description: The HemoCue® Hb 301 system is optimized for use in primary care and blood donation settings with results in approximately 10 seconds and designed for high temperatures and humidity.

The HemoCue® Hemoglobin systems provide an opportunity for quick, simple and reliable quantitative hemoglobin results with lab quality results. The dual wavelength analyzers correct for lipemia, leucocytosis and other sources of turbidity. Any blood source (capillary, venous or arterial whole blood) can be used. The disposable microcuvette collects the exact amount of blood and mixes the sample with the reagents automatically. The microcuvette is placed into the portable analyzer. Results appear on the display screen in about a minute.

HemoCue America 40 Empire Drive | | Lake Forest | CA | Since 1982, HemoCue® develops, produces and markets point-of-care medical devices. The unique concept behind each HemoCue® product allows for near-patient testing without sacrificing the precision and accuracy offered by a lab instrument.

HemoCue® Plasma/Low Hb – Photometer for determination of low hemoglobin levels in plasma, serum, or aqueous solutions. There are many occasions when it is necessary to measure low concentrations of hemoglobin in different media. Until now, time-consuming and complicated methods have had to be used or otherwise reliance has had to be made on imprecise visual judgment. HemoCue® Plasma/Low Hb Photometer is available and is a quick and simple system, that accurately measures low hemoglobin concentrations in the range of 0—3.00 g/dL (0—30.0 g/L, 0—1.90 mmol/L).

Why to choose HemoCue® Plasma/Low Hb System

• Produces accurate results in less than a minute
• Sample volume only 20 µL
• Precalibrated, portable photometer that requires a minimum of maintenance
• No calibration or instrument manipulation (between cuvette/reagent batches) needed
• Can be used by non-laboratory personnel after a brief training session
• Automatically compensates for a certain degree of turbidity due to lipids or leucocytosis

HemoCue America 40 Empire Drive | | Lake Forest | CA | Since 1982, HemoCue® develops, produces and markets point-of-care medical devices. The unique concept behind each HemoCue® product allows for near-patient testing without sacrificing the precision and accuracy offered by a lab instrument.