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A1c Tests... a Huge Opportunity
| Article Date: 5/31/2007 |
A1C TestsÉ.a Huge Opportunity
An incredible 25 million A1C tests are performed every year in the United States - 21 million are done in a referral lab setting and only 4 million are done in physician offices.
As physicians, you already know the clinical advantages of A1C test results -they tell us how stable the patientŐs blood glucose levels have been over the last month. ItŐs fluctuations in glucose levels that cause patient to develop life-threatening complications of diabetes, such as blindness, kidney failure and amputations.
What you may not know and what the remainder of this article will focus on is why in-office testing is better for diabetic patients vs. having A1C tests done at an outside lab. You may also not be aware of the new, higher reimbursement for the test, or the differences between the in-office A1C tests that are available.
In-Office A1C or Referral Lab A1C Results?
Physicians that get rapid A1C results in their office can give immediate, face to face counseling, which is known to be more effective in getting patients to comply with their therapy: diet restrictions, exercise recommendations, etc. If a patientŐs A1C is high, changes in their testing frequency and medications are made, which may help reduce their A1C, which could help reduce their risks for complications. In fact, patients who get immediate feedback may lower their A1C by 1%.1,2 Lowering A1C levels reduces the risks of long term complications; a 1% reduction in A1C lowers risk of eye, kidney and nerve disease by 40%.3
The A1C in-office test is incredibly easy and could be compared to a simple at-home pregnancy test. With a quick finger stick, in five minutes you can have a patientŐs A1C result. Sending A1C tests to an outside lab not only takes much longer, but is harder on the patient: referral lab testing can require as much as 5 Đ 10 ml of blood plus a trip to the lab. This becomes even more daunting with older Medicare patients who may have difficulty getting to your office - let alone the lab.
Additionally, with referral lab testing, the patient wonŐt receive their results until after they have left your office, so face to face counseling isnŐt an option. Changes in the patientŐs treatment may not be made and the proven health benefits associated with rapid, point of care A1C testing are lost.
Physician Petitions Government for Better Reimbursement for In-Office Tests
Another physician, Congressman Charles Boustany (LA), penned an article4 in June for a Capitol Hill publication, touting the role of lab tests for early diagnosis and preventative care. ŇLab Tests: Today's Tools for Detection, Better Treatment and Greater Savings, espouses his take on the value of lab testing to benefit his patients.
He cites specific examples like Hemoglobin A1C for better treatment of diabetes and the low cost ($13) in comparison to its great impact. He talks about the high cost of chronic kidney disease ($8.2 billion each year) and how laboratory tests help patients manage the disease through early diagnosis and treatment. Rep. Boustany cites a 2004 study that found appropriate diagnostic testing for patients with kidney disease reduced expenditures by 50 percent.
In the most powerful section of the article, Rep. Boustany states 'Congress must understand that we have the tools today to reduce the devastating effects of disease. But we will not realize their benefits through policies that reduce payment and coverage for these technologiesÓ.
A1C Reimbursement Update
The clinical benefits of in-office A1C testing are clear. The value proposition for in-office testing is also clear: remember, only when a test is performed in office can a physician bill Medicare for it!
The American Diabetes Association recommends that diabetic patients check their A1C levels every 3 months; Medicare will cover an A1C test every month if treatment changes are made.
This year, some A1C tests that are approved by the FDA for home use were assigned a new CPT code (83037QW, capped at $21.06):
Bio-Rad Micromat II Hemoglobin A1c Prescription Home Use Test;
Cholestech GDX A1C Test Prescription Home Use;Ę
Metrika A1c Now for Prescription Home Use;ĘĘ
Provalis Diagnostics GlycosalTM HbA1c Test; andĘIn2it In-Office Analyzer
The old code (83036QW) is capped at $13.56 and is still required for A1c tests performed by methods not approved for home use.
Types of A1C Tests
There are several in-office A1C systems to choose from. Bayer, Cholestech, Metrika, Axis Shield, Provalis and Bio-Rad all offer in-office A1C testing systems. All systems are CLIA waived, NGSP certified, lab accurate at approximately 99% and reimbursable. Upfront costs and maintenance requirements do vary.
BayerŐs DCA 2000 (www.bayer.com), CholestechŐs GDx (www.cholestech.com) Bio-RadŐs Micromat II (www.bio-rad.com) and Axis ShieldŐs Afinion AS100 (www.abbottdiagnostics.com) analyzers utilize a base system that requires a capital equipment investment, along with a disposable A1C testing cartridge having a list price of around $10.00. A1C test times are quick, ranging from 3-6 minutes.
Metrika Inc.Ős A1cNow+ (www.metrika.com) miniaturizes all of the testing components into a hand-held device. Since there is no capital equipment, calibration or maintenance is not required and the monitors can be taken from room to room. The A1cNow+ test time is 5 minutes and it retails for approximately $10.00 per test.
Whichever test system you choose, we can all agree that A1C tests yield valuable information, and can better reduce the risks of complications associated with diabetes Đ especially when performed in-office. This is an opportunity that is truly worth consideration É and action.
References
Miller CD et al., Rapid A1c availability improves clinical decision-making in an urban primary care clinic. Diabetes Care 2003; 26:1158-1163.
Cagliero E et al., Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Diabetes Care 1999; 22: 1785-1789.
Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2002. Atlanta, GA: U.S.
Department of Health and Human Services, Centers for Disease Control and Prevention, 2003.
Lab tests: today's tools for detection, better treatment and greater savings.Ó
http://thehill.com/leading-the-news/lab-tests-todays-tools-for-detection-better-treatment-and-greater-savings-2007-06-06.html.
An incredible 25 million A1C tests are performed every year in the United States - 21 million are done in a referral lab setting and only 4 million are done in physician offices.
As physicians, you already know the clinical advantages of A1C test results -they tell us how stable the patientŐs blood glucose levels have been over the last month. ItŐs fluctuations in glucose levels that cause patient to develop life-threatening complications of diabetes, such as blindness, kidney failure and amputations.
What you may not know and what the remainder of this article will focus on is why in-office testing is better for diabetic patients vs. having A1C tests done at an outside lab. You may also not be aware of the new, higher reimbursement for the test, or the differences between the in-office A1C tests that are available.
In-Office A1C or Referral Lab A1C Results?
Physicians that get rapid A1C results in their office can give immediate, face to face counseling, which is known to be more effective in getting patients to comply with their therapy: diet restrictions, exercise recommendations, etc. If a patientŐs A1C is high, changes in their testing frequency and medications are made, which may help reduce their A1C, which could help reduce their risks for complications. In fact, patients who get immediate feedback may lower their A1C by 1%.1,2 Lowering A1C levels reduces the risks of long term complications; a 1% reduction in A1C lowers risk of eye, kidney and nerve disease by 40%.3
The A1C in-office test is incredibly easy and could be compared to a simple at-home pregnancy test. With a quick finger stick, in five minutes you can have a patientŐs A1C result. Sending A1C tests to an outside lab not only takes much longer, but is harder on the patient: referral lab testing can require as much as 5 Đ 10 ml of blood plus a trip to the lab. This becomes even more daunting with older Medicare patients who may have difficulty getting to your office - let alone the lab.
Additionally, with referral lab testing, the patient wonŐt receive their results until after they have left your office, so face to face counseling isnŐt an option. Changes in the patientŐs treatment may not be made and the proven health benefits associated with rapid, point of care A1C testing are lost.
Physician Petitions Government for Better Reimbursement for In-Office Tests
Another physician, Congressman Charles Boustany (LA), penned an article4 in June for a Capitol Hill publication, touting the role of lab tests for early diagnosis and preventative care. ŇLab Tests: Today's Tools for Detection, Better Treatment and Greater Savings, espouses his take on the value of lab testing to benefit his patients.
He cites specific examples like Hemoglobin A1C for better treatment of diabetes and the low cost ($13) in comparison to its great impact. He talks about the high cost of chronic kidney disease ($8.2 billion each year) and how laboratory tests help patients manage the disease through early diagnosis and treatment. Rep. Boustany cites a 2004 study that found appropriate diagnostic testing for patients with kidney disease reduced expenditures by 50 percent.
In the most powerful section of the article, Rep. Boustany states 'Congress must understand that we have the tools today to reduce the devastating effects of disease. But we will not realize their benefits through policies that reduce payment and coverage for these technologiesÓ.
A1C Reimbursement Update
The clinical benefits of in-office A1C testing are clear. The value proposition for in-office testing is also clear: remember, only when a test is performed in office can a physician bill Medicare for it!
The American Diabetes Association recommends that diabetic patients check their A1C levels every 3 months; Medicare will cover an A1C test every month if treatment changes are made.
This year, some A1C tests that are approved by the FDA for home use were assigned a new CPT code (83037QW, capped at $21.06):
Bio-Rad Micromat II Hemoglobin A1c Prescription Home Use Test;
Cholestech GDX A1C Test Prescription Home Use;Ę
Metrika A1c Now for Prescription Home Use;ĘĘ
Provalis Diagnostics GlycosalTM HbA1c Test; andĘIn2it In-Office Analyzer
The old code (83036QW) is capped at $13.56 and is still required for A1c tests performed by methods not approved for home use.
Types of A1C Tests
There are several in-office A1C systems to choose from. Bayer, Cholestech, Metrika, Axis Shield, Provalis and Bio-Rad all offer in-office A1C testing systems. All systems are CLIA waived, NGSP certified, lab accurate at approximately 99% and reimbursable. Upfront costs and maintenance requirements do vary.
BayerŐs DCA 2000 (www.bayer.com), CholestechŐs GDx (www.cholestech.com) Bio-RadŐs Micromat II (www.bio-rad.com) and Axis ShieldŐs Afinion AS100 (www.abbottdiagnostics.com) analyzers utilize a base system that requires a capital equipment investment, along with a disposable A1C testing cartridge having a list price of around $10.00. A1C test times are quick, ranging from 3-6 minutes.
Metrika Inc.Ős A1cNow+ (www.metrika.com) miniaturizes all of the testing components into a hand-held device. Since there is no capital equipment, calibration or maintenance is not required and the monitors can be taken from room to room. The A1cNow+ test time is 5 minutes and it retails for approximately $10.00 per test.
Whichever test system you choose, we can all agree that A1C tests yield valuable information, and can better reduce the risks of complications associated with diabetes Đ especially when performed in-office. This is an opportunity that is truly worth consideration É and action.
References
Miller CD et al., Rapid A1c availability improves clinical decision-making in an urban primary care clinic. Diabetes Care 2003; 26:1158-1163.
Cagliero E et al., Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Diabetes Care 1999; 22: 1785-1789.
Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2002. Atlanta, GA: U.S.
Department of Health and Human Services, Centers for Disease Control and Prevention, 2003.
Lab tests: today's tools for detection, better treatment and greater savings.Ó
http://thehill.com/leading-the-news/lab-tests-todays-tools-for-detection-better-treatment-and-greater-savings-2007-06-06.html.