Product Directory — Diagnostics, Devices & Equipment

Afinion^™ 2
Simply More Efficient.

Improve the way you monitor and manage your patients

The Afinion^™ 2 analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care.

With the Afinion^™ System, there's no need to send test results to the lab or spend time tracking them down. That way you can keep your focus where it belongs – on the patient.

Benefits of the Afinion^™ 2 Analyzer:
Multiple analytes on one instrument

• The Afinion^™ 2 analyzer makes it fast and easy to test quantitative determinations of HbA1c and ACR.
• HbA1c test is CLIA Waived

Short assay times

• HbA1c results in 3 minutes
• ACR results in 5 minutes

Multiple sample types

• The analyzer is designed to enable simple and fast on-the-spot testing, regardless of the sample type, which may be whole blood or urine, and to deliver accurate results during patient consultation for improved patient management.

Connected

• The Afinion^™ 2 analyzer can reliably transfer test information to a HIS or LIS system. The Afinion^™ 2 Analyzer automatically transfers patient and control results via TCP/IP networking using the protocols POCT1-A, HL7, ASTM 1381-85 (low level) or ASTM 1394-97 (high level), selectable by configuration.

All-in-one test cartridge

• The analyzer and Test Cartridges have been precision engineered with each test cartridge containing an integrated sample collection device and all necessary reagents for a single test.

Automatic self-check system

• The Afinion^™ 2 analyzer eliminates erroneous results with integrated error detection and self-check systems.

No additional calibration necessary

• Each Afinion^™ 2 analyzer has a fixed factory calibration. Each lot of an Afinion^™ test includes calibration data stored in the barcode label. The lot calibration data is read by the integrated camera and used for calculating results.

3-Step Procedure

1. Collect the sample with the integrated sampling device.
2. Place the sampling device back in the test cartridge.
3. Place the test cartridge in the analyzer and close the lid. The processing starts automatically

Click Images to View Larger

• Abbott Afinion Analyzer

ABBOTT RAPID DIAGNOSTICS xxxx my street | | concord | NH | Abbott is a world leader in rapid diagnostics at the point of care, with a focus on cardio metabolic disease, infectious disease and toxicology.

Accu-Chek Professional Lancing Devices

Choose the lancet that’s right for your clinical needs.
With Accu-Chek Safe-T-Pro Plus and Accu-Chek Safe-T-Pro Uno lancets, you’re able to choose the best lancet for your patients and your staff–improving patient comfort and workflow efficiencies.

The safety, comfort and convenience of Accu-Chek® lancets- available in two great options:

Accu-Chek Safe-T-Pro Plus
Simplify care and inventory with the only multi-depth, single-use professional lancet.

• 1.3mm, 1.8mm, 2.3mm penetration depths
• Approved for use on adults, children and neonates
• 23G retractable needle
• Single SKU simplifies inventory control

New! Accu-Chek Safe-T-Pro Uno
Improve patient comfort simply, safely and affordably while meeting the need for an adequate blood sample.

• 1.5mm penetration depth
• Approved for use on adults, children and neonates
• 28G retractable needle
• Single-use professional lancet

For care you can count on, the choice is Accu-Chek.

• Accu_Chek Brochure

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways

Accu-Chek Professional Lancing Devices

Choose the lancet that's right for your clinical needs.
With Accu-Chek Safe-T-Pro Plus and Accu-Chek Safe-T-Pro Uno lancets, you're able to choose the best lancet for your patients and your staff–improving patient comfort and workflow efficiencies.

The safety, comfort and convenience of Accu-Chek® lancets- available in two great options:

Accu-Chek Safe-T-Pro Plus
Simplify care and inventory with the only multi-depth, single-use professional lancet.

• 1.3mm, 1.8mm, 2.3mm penetration depths
• Approved for use on adults, children and neonates
• 23G retractable needle
• Single SKU simplifies inventory control

New! Accu-Chek Safe-T-Pro Uno
Improve patient comfort simply, safely and affordably while meeting the need for an adequate blood sample.

• 1.5mm penetration depth
• Approved for use on adults, children and neonates
• 28G retractable needle
• Single-use professional lancet

For care you can count on, the choice is Accu-Chek.

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways

Accu-Chek Professional Lancing Devices

Choose the lancet that's right for your clinical needs.
With Accu-Chek Safe-T-Pro Plus and Accu-Chek Safe-T-Pro Uno lancets, you're able to choose the best lancet for your patients and your staff–improving patient comfort and workflow efficiencies.

The safety, comfort and convenience of Accu-Chek® lancets- available in two great options:

New! Accu-Chek Safe-T-Pro Uno
Improve patient comfort simply, safely and affordably while meeting the need for an adequate blood sample.

• 1.5mm penetration depth
• Approved for use on adults, children and neonates
• 28G retractable needle
• Single-use professional lancet

Accu-Chek Safe-T-Pro Plus
Simplify care and inventory with the only multi-depth, single-use professional lancet.

• 1.3mm, 1.8mm, 2.3mm penetration depths
• Approved for use on adults, children and neonates
• 23G retractable needle
• Single SKU simplifies inventory control

For care you can count on, the choice is Accu-Chek.

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways

in2it™  A1C

Be the Difference
With Fast, Accurate Results

The in2it™  A1C Analyzer offers simple, accurate A1C testing at the point of care. When you are working with patients to manage their diabetes, you need an A1C test that you both can rely on. That means precise results delivered quickly and easily at an attractive reimbursement rate. The in2it™  is designed with those needs in mind, delivering accurate results in just minutes to help you be the difference for every diabetic patient you care for.

• Easy, on-site testing 
• CLIA waived* allows existing staff to perform the test
• Full automation simplifies training, use and lets the operator walkway during testing
• Small fingerstick sample for greater convenience and patient comfort
• Better patient care 
• Results are delivered while your patients wait, enabling same-visit consultations for better patient compliance
• Calibrated to the Diabetes Control and Complications Trial (DCCT) standard for laboratory accurate results
• Laboratory precision provides reproducible results you can trust
• Flexible, to meet all testing situations 
• PC connectivity simplifies result handling and storage
• Ability to capture patient and operator identification provides full result traceability
• Adhesive-backed printed reports eliminates transcription errors and provides permanent result back-up
• Qualifies for CPT code 83037, with a national limit of $13.90

*510(k) cleared for prescription home use and, accordingly, is CLIA waived.

 

BIO-RAD LABORATORIES 4000 Alfred Nobel Drive | | Hercules | CA | Bio-Rad Laboratories has played a leading role in the advancement of scientific discovery for over 50 years by providing a broad range of innovative tools and services to the life science research and clinical diagnostics markets.

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.

Make 2015 Your Best Year Ever.

We invite you to consider becoming the exclusive Core Health System™ center in your area. The Core Health System™ is an easy-to-implement diagnostic and patient management program that transforms patient care and redefines business success and income.

Improve diagnosis, earlier detection, treatment and prognosis for 30 - 50%+ of Primary Care Patients

• Diabetes
• Pre-Diabetes
• Cardiometabolic Risk
• Hypertension
• Tachycardia
• Syncope
• Neuropathies
• Regional Pain
• Sleep Apnea
• Insomnia

Comprehensive Business System

• Area-exclusive Core Health System™ center (limited availability!)
• Distinguish practice as advanced & scientific
• Improve patient loyalty
• New patient generation
• Reactivation of patient base

Advance your care of patients with diabetes, pre-diabetes, hypertension and more – and identify underlying cardiometabolic risk in patients who are pre-symptomatic. Typically 30-50+% of PCP practices are candidates. Testing is recommended by the ADA, NIDDK and others.

Enhance your practice on every business level with advanced non-invasive diagnostic tools and a proven marketing system that helps you attract more patients and improve patient satisfaction.

Gain significant revenues with reimbursement of between $300 to $400+ (national Medicare range is $405). Many patients can be re-tested during the year. Area exclusivity is limited. We are establishing Core Health System™ centers at a rate of 1 per week.

It is not uncommon for average sized practices reached or exceeded $100,000 in collected revenues in the first 5 months.

MOMENTUM PRACTICE GROUP | | | | We invite you to consider becoming the exclusive Core Health System™ center in your area. The Core Health System™ is an easy-to-implement diagnostic and patient management program that transforms patient care and redefines business success and income. Improve diagnosis, earlier detection, treatment and prognosis for 30-50%+ of Primary Care Patients, including diabetes, pre-diabetes, cardiometabolic risk, hypertension and more. And add $300-$400+ in revenue per test.