JON  2 0 2014 
TO: 	 Marilyn Tavenner 
Administrator 
Centers for Medicare & Medicaid Services 
FROM:  Brian P. Ritchie 
Acting Deputy Inspector General 
for Evaluation and Inspections 
SUBJECT: 	 Memorandum Report:  Medicare Market Shares ofMail Order Diabetes Test 
Strips Immediately Prior to the National Mail Order Program, OEI-04-13-00681 
This report provides information on the types of mail order diabetes test strips associated with 
Medicare claims for the 3-month period of April to June 2013, i.e., the 3-month period 
immediately prior to the start of a national program for mail order diabetic testing supplies on 
July 1, 2013.  The Centers for Medicare & Medicaid Services (CMS) asked the Office of 
Inspector General (OIG) to conduct a study to determine market shares of diabetes test strips for 
this 3-month period.  CMS may choose to use the results of this report for program analysis 
purposes and to evaluate the effect of the Competitive Bidding Program on brand choice. 
SUMMARY 
Medicare covers diabetes test strips provided by mail order suppliers and local pharmacies or 
supplier storefronts.  The Medicare Prescription Drug, Improvement, and Modernization Act of 
2003 (MMA) requires CMS to phase in, with several rounds ofbidding, a Competitive Bidding 
Program for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).  Under 
this program, suppliers compete to become Medicare contract suppliers for selected DMEPOS 
items.  The payment amounts resulting from the competition replace the Medicare fee-schedule 
amounts for these items. 
The Competitive Bidding Program includes diabetes test strips provided by mail order but does 
not include diabetes test strips purchased at a local pharmacy or supplier storefront (i.e., 
non-mail order) . Under the program, "mail order" includes diabetes test strips shipped or 
delivered to the beneficiary's home, regardless of the method of delivery.  Non-mail order 
diabetes test strips are those that a beneficiary picks up in person at a local pharmacy or supplier 
storefront.  The American Taxpayer Relief Act of2012 (ATRA) established equal Medicare 
payment amounts for mail order and non-mail order diabetes test strips purchased after the 
implementation of a national program for mail order diabetes testing supplies (hereinafter  Page 2  Marilyn Tavenner 
referred to as the National Mail Order Program).1  CMS implemented the National Mail Order 
Program on July 1, 2013. 
 
The Medicare Improvements for Patients and Providers Act (MIPPA) prohibits CMS from  
awarding Competitive Bidding Program contracts for mail order diabetes test strips to suppliers  
who do not demonstrate that their bid covers at least 50 percent, by volume, of all types of 
diabetes test strips. (This is referred to as the MIPPA 50-percent requirement.)  Further, MIPPA 
section 154(d)(3)(B) requires OIG to complete a study to determine market shares of diabetes 
test strips in the Competitive Bidding Program before each round of competitive bidding 
following Round 1. 
 
We determined the Medicare market shares for diabetes test strip types associated with a random  
sample of Medicare claims for the 3-month period of April to June 2013, immediately prior to 
implementation of the National Mail Order Program.  Our sample of 1,210 claims was drawn 
from a population of 1,363,668 claims for mail order diabetes test strips provided to beneficiaries 
during this period. We projected our sample data to the population of mail order diabetes test 
strips to estimate the Medicare market shares.   
 
We found that 152 suppliers submitted claims for at least 62 types of mail order diabetes test 
strips for the 3-month period of April to June 2013.  Two types of diabetes test strips accounted 
for 34 percent of the Medicare mail order market share.  Four types of diabetes test strips 
accounted for 51 percent of the Medicare mail order market share, and 10 types accounted for 
75 percent. CMS may choose to consider these data for its informational purposes and to 
evaluate the effect of the National Mail Order Program on brand choice.  
 
BACKGROUND 
 
Diabetes is a chronic disease in which a person has a high blood sugar (i.e., glucose) level either 
because the body does not produce enough insulin, or cells do not respond properly to the insulin  
that the body does produce.2  Diabetes may be managed through a variety of methods, including 
healthy eating, physical activity, and insulin injections.3  If people with diabetes do not properly 
manage their glucose levels, medical complications (e.g., hypoglycemia, cardiovascular disease, 
or renal disease) may occur.   
 
Diabetes disproportionately affects older adults.  Approximately 27 percent of individuals ages 
65 and older report having diabetes, whereas the reported percentage in the overall population is 
8 percent.4  Medicare covers services and testing supplies to help beneficiaries with diabetes 
manage the condition.   
                                                 
1  ATRA, P.L. No. 112-240  636 (adding  Social Security Act,  1834(a)(1)(H), 42 U.S.C.  1395m(a)(1)(H)). 
   
2  National Institutes of Health (NIH), Diabetes Overview:  What is Diabetes?   Accessed at 

http://www.diabetes.niddk.nih.gov/dm/pubs/overview/index.htm on October 11, 2013.  

3 NIH,  Diabetes Overview:  How is Diabetes Managed?   Accessed at 

http://www.diabetes.niddk.nih.gov/dm/pubs/overview/index.htm#managed on  October 11, 2013.  

4 The Centers for Disease Control and Prevention.  Diabetes Self Management Overview. Accessed at 

http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf on October 3, 2013. 
  
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
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A person with diabetes may use a hand-held meter to test the concentration of glucose in his or 
her blood. To do so, the individual inserts a diabetes test strip into the meter.  A diabetes test 
strip is a small, thin, one-time-use piece of plastic on which a sample of blood is placed after 
pricking the skin with a lancet. The meters reading of an individuals glucose level provides the 
information required for that person to manage his or her diabetes.  People with diabetes may 
need to perform glucose tests several times a day to assist them in maintaining appropriate 
glucose levels. 
 
To be eligible for Medicare coverage of diabetes test strips and other diabetes supplies, Medicare 
beneficiaries with diabetes must be under the treatment of a physician for the condition.5  The 
physician must prescribe the frequency of use for diabetes test strips.6  Because some  
beneficiaries should test their glucose more frequently than others, the number of boxes of 
diabetes test strips per Medicare claim varies.7  Each box contains 50 strips. 
 
Suppliers submit one Medicare claim for a beneficiarys supply of diabetes test strips for up to 
3 months at a time.  Each claim indicates the number of boxes provided to the beneficiary for the 
applicable time period.  Suppliers submit claims using Healthcare Common Procedure Coding 
System (HCPCS) codes to receive Medicare reimbursement.  Medicare claims for diabetes test 
strips are billed using HCPCS code A4253.  For diabetes test strips provided by mail order, the 
HCPCS code A4253 must use the KL modifier (A4253 KL).8     
 
Medicare beneficiaries may purchase their diabetes test strips via mail order from suppliers in the 
Competitive Bidding Program or via non-mail order from local pharmacies or supplier 
storefronts. Mail order applies to diabetes test strips shipped or delivered to a beneficiarys 
residence.9  For both mail order and non-mail order, Medicare pays 80 percent of allowed 
charges for diabetes test strips and the beneficiary is responsible for the remaining 20 percent.   
 
The Competitive Bidding Program and National Mail Order Program for Diabetes Test 
Strips  
MMA required CMS to phase in, with several rounds of bidding, the Competitive Bidding 
Program for selected DMEPOS items, including mail order diabetes test strips.10  The selected 
DMEPOS items are generally high-cost and high-volume items that have a high savings potential 
                                                 
5 Other diabetes testing supplies may include  batteries and control solution.  

6 Medicare Local Coverage Determinations (LCDs) for Glucose Monitors (L11530, L27231, L11520, and L196 for
  
Durable Medical Equipment Medicare Administrative Contractor  Jurisdictions  A, B, C, and D respectively).  
 
7 CMS, MLN Matters Number SE1008. An Overview of Medicare Covered Diabetes Supplies and Services. 

Accessed at http://www.cms.gov/MLNMattersArticles/downloads/SE1008.pdf  on October 25, 2013.  Medicare 

covers up to 100 testing strips per month (i.e., two 50-count  boxes)  for insulin-dependent  beneficiaries with diabetes 
 
and up to  100 testing strips every 3 months for noninsulin-dependent beneficiaries with  diabetes.  Medicare allows 

additional testing strips if deemed medically necessary and documented in physician records.  Medicare LCDs for 

Glucose Monitors (L11530, L27231, L11520, and  L196). 

8  Medicare Claims Processing Manual, Pub. No. 100-04,  ch. 36   20.5.4.1 and 50.6.   A modifier is a code on a 
 
Medicare claim  that further describes the services performed or supplies provided to a beneficiary.
 
9 42 CFR   414.402 (defining mail order item).   

10 MMA, P.L. No. 108-173    302(b)(1)  (amending Social Security Act,  1847, 42  U.S.C.   1395w-3). 

 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
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under the Competitive Bidding Program.11  CMS uses bids submitted by DMEPOS suppliers to 
determine the competitive bidding payment amounts.  Bids are evaluated based on suppliers 
eligibility, their financial stability, and the bid price.12  Contracts are awarded to the suppliers 
that generally offer lower prices and meet applicable quality and financial standards.13 Round 1 
of the Competitive Bidding Program began on January 1, 2011.  Round 2 began on July 1, 2013. 
See Appendix A for more information about Rounds 1 and 2 of the Competitive Bidding 
Program. 
 
MIPPA required, after Round 1 of the Competitive Bidding Program, that mail order suppliers 
must demonstrate in their bids that they provide at least 50 percent, by volume, of all types of 
diabetes test strips.14  Further, MIPPA section 154(d)(3)(B) requires OIG to complete a study to 
determine market shares of mail order diabetes test strips in the Competitive Bidding Program  
before each subsequent round of competitive bidding.15    
 
National Mail Order Program.  MIPPA authorized a National Mail Order Program beginning 
July 1, 2013, for mail order diabetes testing supplies, expanding the Competitive Bidding 
Program to all U.S. States and Territories. Additionally, ATRA established equal Medicare 
payment amounts for mail order and non-mail order diabetes test strips provided after 
implementation of the National Mail Order Program.  CMS implemented both the National Mail 
Order Program and Round 2 of the Competitive Bidding Program on July 1, 2013.16  Thus, under 
Round 2 of the Competitive Bidding Program, both mail order and non-mail order diabetes test 
strips are reimbursed at the same competitive bidding payment rate, $10.41 per 50-count box.   
 
Related OIG Work  
In December 2010, OIG completed the first report to fulfill its MIPPA requirement to determine 
market shares of diabetes test strips before 2011.  OIG found that 171 suppliers submitted claims  
                                                 
11 CMS, General Overview of the Final Rule for Competitive Acquisition for Certain  Durable Medical Equipment, 

Prosthetics, Orthotics, and Supplies.  Accessed at https://www.cms.gov/DMEPOSCompetitiveBid/Downloads/ 

DMEPOSRegSumm.pdf on October 4, 2013; 73 Fed. Reg.  17992, 18010 (Apr. 10, 2007). 
 
12 Palmetto GBA, Overview of the DMEPOS  Competitive Bidding Program.  Accessed at 

http://www.dmecompetitivebid.com/palmetto/cbic.nsf/vMasterDID/79NTSG0132 on  October 16, 2013. 
 
13 Palmetto GBA, How a Bid is Evaluated. Accessed at http://www.dmecompetitivebid.com/Palmetto/cbicrd2.nsf/  

files/Webcast_Transcript_Bid_Evaluation.pdf/$File/Webcast_Transcript_Bid_Evaluation.pdf  on February 24, 2014; 
 
CMS, Medicare Claims Processing Manual,  Pub.  No.  100-04,  ch. 36,  40.1.  The payment  amount for an item 
 
furnished  under the competitive  bidding  program is equal to the median of the bids submitted by qualified suppliers 

whose composite bids are equal to or  below the pivotal bid for that product category.   42 CFR   414.416(b).  The 

pivotal bid is the lowest composite bid based  on bids submitted by suppliers that includes a sufficient number of 

suppliers to meet beneficiary  demand for the items in a product category.  42 CFR   414.402.
     
14 Specifically, MIPPA stipulates that suppliers provide at least 50 percent (or such  higher  percentage as the 

Secretary may specify) of all diabetes test strips in the aggregate and taking into account volume for the different 

products.  MIPPA, P.L. No. 110-275    154(d)(3)(B) (adding Social Security Act  1847(b)(10)(A),  42  U.S.C. 

 1395w-3(b)(10)(A)).
   
15  MIPPA,  P.L. No. 110-275  154(d)(3)(B) (adding  Social Security Act  1847(b)(10)(B), 42  U.S.C. 
 
 1395w-3(b)(10)(B)). 
  
16 CMS, Contract Suppliers Selected Under Medicare Competitive Bidding  Program. Accessed at 

http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2013-Press-releases-items/2013-04-092.html  
on February  19, 2014.   Eighteen contracts were awarded to  suppliers to  provide diabetes testing supplies through the 
National Mail Order Program.    
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
Program (OEI-04-13-00681) 
  Page 5  Marilyn Tavenner 
for at least 75 types of mail order diabetes test strips for the 3-month period ending 
December 2009.17  Of these strips, 2 types accounted for approximately 26 percent of the 
Medicare mail order market share, 7 types accounted for approximately 50 percent, and 19 types 
accounted for approximately 81 percent. 
 
In a June 2014 report, OIG determined the market share of diabetes test strips for the 3-month 
period of July to September 2013, beginning with implementation of the National Mail Order 
Program.18  OIG found that 22 suppliers submitted claims for at least 43 types of mail order 
diabetes test strips for that period.  Two types of diabetes test strips accounted for approximately 
45 percent of the Medicare mail order market share.  Three types of diabetes test strips accounted 
for 59 percent of the Medicare mail order market share and 10 types accounted for 90 percent.  
That report fulfilled OIGs MIPPA requirement. 
 
Finally, OIG is working on a study to determine the market share of diabetes test strips for the 
3-month period of October to December 2013, several months after implementation of the 
National Mail Order Program.19  OIG expects to release the report for this study in 
December 2014.  CMS asked OIG to conduct this study so that the results may be used for 
program analysis purposes and to evaluate the effect of the National Mail Order Program on 
brand selection. 
 
METHODOLOGY 
 
Data Collection  
We identified the population of Medicare mail order diabetes test strips claims with a beginning 
date of service from April through June 2013 from CMSs National Claims History file.  This 
timeframe represents the 3-month period immediately prior to the start of the National Mail 
Order Program on July 1, 2013.  There were 1,363,668 claims submitted by 1,294 suppliers in 
this file. We then selected a simple random sample of 1,210 of the 1,363,668 Medicare claims  
for mail order diabetes test strips within our date-of-service range.  To identify the beneficiaries 
associated with each claim in our sample, we matched them with the CMS Beneficiary 
Enrollment Database.   
 
We sent a documentation request to 154 suppliers associated with the claims in our sample.  For 
each claim, we asked the supplier to indicate the type (model and manufacturer) of diabetes test 
strips that it provided to the Medicare beneficiary associated with the claim and to submit 
relevant documentation (e.g., packing slips, invoices for the strips).20  We received responses 
from 152 suppliers associated with 1,199 claims in our sample, a 99-percent response rate.  
                                                 
17 OIG,  Medicare Market  Shares of Mail Order Diabetic Testing Strips (OEI-04-11-00130), December 2010.  

18 OIG,  Medicare Market Shares of Mail Order Diabetes Test Strips From JulySeptember 2013 
 
(OEI-04-13-00680), June  2014. 

19 OEI-04-13-00682, in  progress.    
 
20  We contacted  suppliers up to  three times to obtain this information.  
  
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
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Data Analysis 
We reviewed claims data and supplier documentation and responses to determine the quantity 
and type of mail order diabetes test strips associated with each claim in our sample.  Each claim  
in our sample contained between 1 and 15 boxes, and data for the 1,199 claims provides 
information for a total of 4,357 boxes of diabetes test strips.21  
 
We categorized types of diabetes test strips by model and manufacturer.  We accounted for the 
volume of each type by determining the total number of 50-count boxes of each type of diabetes 
test strip and the percentage of each type across all boxes.  We projected our sample data to the 
population of mail order diabetes test strips during our time period to estimate the Medicare 
market shares of mail order diabetes test strip types.   
 
Limitations  
Suppliers have 1 year to submit claims to CMS.  Types of diabetes test strips associated with 
claims during our time period (i.e., with beginning dates of service in the months of April 
through June 2013) submitted after November 1, 2013the date we collected our Medicare 
claimsare not included. 
 
Standards 
This review was conducted in accordance with the Quality Standards for Inspections approved 
by the Council of the Inspectors General on Integrity and Efficiency. 
 
                                                 
21 Most claims (93 percent) were for 1 to 6 boxes.  
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
Program (OEI-04-13-00681) 
  Page 7  Marilyn Tavenner 
RESULTS  
 
Suppliers Submitted Claims for at Least 62 Types of Mail Order Diabetes Test Strips for 
the 3-Month Period of April to June 2013 
One hundred fifty-two suppliers submitted claims for at least 62 types of mail order diabetes test 
strips for the 3-month period of April to June 2013.  Two types of diabetes test strips accounted 
for 34 percent of the Medicare mail order market share.  Four types of diabetes test strips 
accounted for 51 percent of the Medicare mail order market share, and 10 types accounted for 
75 percent. 
 
Table 1 lists the top 10 types of mail order diabetes test strips associated with Medicare claims  
for the 3-month period of April to June 2013. See Appendix B for a complete alphabetical 
listing of all 62 types. Appendix B also provides the model, manufacturer, percentage of market 
share, and 95-percent confidence intervals for market share for each type of diabetes test strip.  
 
Table 1: Top 10 Mail Order Diabetes Test Strips Types Associated With Medicare Claims for the 
3-Month Period of April to June 2013  
Model  Manufacturer   Percentage of  
Market Share  
Prodigy AutoCode    Prodigy Diabetes Care   19.4%  
TRUEtest   Nipro Diagnostics, Inc.  14.7%  
Gmate  Philosys, Inc.  8.5% 
Embrace  Omnis Health   8.2%  
OneTouch Ultra Blue  LifeScan, Inc.  5.0%  
SolusV2  BioSense Medical Devices  4.7%  
CONTOUR     Bayer HealthCare LLC   4.6%  
OneTouch Ultra   LifeScan, Inc.  4.1%  
FreeStyle Lite   Abbott Diabetes Care   3.1%  
Element  Infopia USA  2.2% 
 Total   74.5%  
 
Source:  OIG analysis of  supplier documentation and Medicare claims containing HCPCS code  A4253 KL   
for the 3-month period of April to June 2013. 
 
CONCLUSION 
 
One hundred fifty-two suppliers submitted claims for at least 62 types of mail order diabetes test 
strips for the 3-month period of April to June 2013, immediately prior to the start of the National 
Mail Order Program.  Two types of diabetes test strips accounted for 34 percent of the Medicare 
mail order market share.  Four types of diabetes test strips accounted for 51 percent of the 
Medicare mail order market share, and 10 types accounted for 75 percent.  CMS may choose to 
consider these data for program analysis purposes and to evaluate the effect of the Competitive 
Bidding Program on brand choice. 
 
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
Program (OEI-04-13-00681) 
  Page 8  Marilyn Tavenner 
This memorandum report is being issued directly in final form because it contains no 
recommendations.  If you have comments or questions about this report, please provide them  
within 60 days. Please refer to report number OEI-04-13-00681 in all correspondence. 
 
 
 
 
 
 
 
 
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
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Appendix A 
 
Round 1 of the Competitive Bidding Program 
The MMA of 2003 required CMS to phase in, with several rounds of bidding, a Competitive 
Bidding Program for DMEPOS.  Suppliers began submitting bids for Round 1 of the 
Competitive Bidding Program on May 15, 2007.  Contracts between CMS and suppliers became 
effective in selected Competitive Bidding Areas (CBAs) on July 1, 2008.22  
 
Two weeks after the Round 1 contracts between CMS and suppliers became effective, Congress 
enacted MIPPA, which mandated the following changes to the Competitive Bidding Program:  
 
 	  the termination of contracts awarded to suppliers in Round 1;  
 
	   the requirement for CMS to repeat the Round 1 competition in 2009; and  
 
	   the institution of the MIPPA 50-percent requirement for mail order diabetes test strips in 
all rounds following the repeat of the Round 1 competition. (The repeat of the Round 1 
competition is known as the Round 1 Rebid.) 23  
 
MIPPA also reduced the 2009 fee-schedule amounts by 9.5 percent for all DMEPOS included in 
Round 1 to offset the estimated cost savings lost by the delayed implementation of the 
Competitive Bidding Program.24  This reduction resulted in an average 2009 fee-schedule 
amount of $32.50 per box of mail order diabetes test strips. 
 
The Round 1 Rebid began in October 2009 and included the previous selected CBAs, except for 
San JuanCaguasGuaynabo (Puerto Rico). CMS announced the winning contract suppliers on 
November 3, 2010, and the suppliers began providing competitively bid DMEPOS items to 
beneficiaries in nine selected CBAs on January 1, 2011.25  Before 2011, Medicare reimbursed all 
diabetes test strips suppliers on the basis of fee-schedule amounts, which were updated annually 
and varied by State. As a result of the Round 1 Rebid, the average Medicare payment for 
2011 mail order diabetes test strips provided to beneficiaries in CBAs was $14.62 per 50-count 
box. In contrast, the national average Medicare payment for mail order strips in non-CBAs was 
                                                 
22 CMS, DMEPOS Competitive Bidding.  Accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-

Payment/DMEPOSCompetitiveBid/index.html?redirect=/DMEPOSCompetitiveBid/01a_MSAs_and_CBAs.asp on 
 
November 5,  2013.  CBAs are defined  by specific ZIP Codes related to Metropolitan  Statistical Areas (MSAs).  

Selected CBAs in Round  1  were CharlotteGastoniaConcord (North Carolina and South  Carolina), Cincinnati 

Middletown (Ohio, Kentucky, and Indiana), ClevelandElyriaMentor (Ohio), DallasFort  WorthArlington
  
(Texas), Kansas City (Missouri and Kansas), MiamiFort Lauderdale Pompano Beach (Florida), Orlando 

Kissimmee (Florida), Pittsburgh (Pennsylvania), and Riverside San BernardinoOntario  (California).   

23 The 50-percent requirement did not apply to  suppliers  bids  in Round 1 or the Round  1 Rebid.  

24 CMS, MLN Matters Number MM6270:  Fee Schedule Update for 2009 for Durable Medical Equipment, 

Prosthetics, Orthotics, and Supplies (DMEPOS). Accessed at http://www.cms.gov/Outreach-and-
Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM6270.pdf on November  20, 

2013.   

25  MMA, P.L.  No. 108-173  302(b)(1), as  amended by  MIPPA,  P.  L. No. 110-174  154.   CMS, Competitive 

Bidding Areas. Accessed at http://www.dmecompetitivebid.com/Palmetto/Cbic.nsf/files/Fact_Sheet_Competitive_ 

Bidding_Areas.pdf/$File/Fact_Sheet_Competitive_Bidding_Areas.pdf  on November 5, 2013. 
  
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
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$32.47, and the national average payment for non-mail order diabetes test strips was $37.67.  
CMS also reported that the Competitive Bidding Program saved the Medicare program nearly 
$202.1 million in the first year of implementation.26  
 
Round 2 of the Competitive Bidding Program 
MIPPA required competition for Round 2 of the Competitive Bidding Program to occur in 2011 
in 70 additional CBAs.27  The Patient Protection and Affordable Care Act of 2010 further 
expanded the number of CBAs to 100 and required CMS to expand the DMEPOS competitive 
bidding program nationwide or to adjust payments to suppliers using competitively bid rates by 
2016.28  Round 2 of the Competitive Bidding Program began on July 1, 2013. 
                                                 
26 CMS, Competitive Bidding UpdateOne Year Implementation Update  April  17, 2012. Accessed at  
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSCompetitiveBid/Downloads/ 

Competitive-Bidding-Update-One-Year-Implementation.pdf  on October 7, 2013. 
   
27  MIPPA,  P.L. No. 110-275  154(d)(3)(A). 

28 CMS, DMEPOS Competitive Bidding Program. Accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-
Service-Payment/DMEPOSCompetitiveBid/  on November 18, 2013.  MIPPA allows  for MSAs that have 
 
populations over 8 million to  be subdivided into multiple CBAs.  Most Round  2 MSAs contain only one CBA; 

however, the three largest MSAsChicago, Los Angeles, and New Yorkare subdivided into multiple CBAs. 

 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
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Appendix B             
 
Market Share Estimates and Their 95-Percent Confidence Intervals for 62 Types of Mail Order 
Diabetes Test Strips for the 3-Month Period of  April to June 2013 
Model   Manufacturer   Percentage  95-Percent 
of Market   Confidence Interval 
Share   for Market Share 
ACCU-CHEK Aviva  Roche Diagnostics  0.14%   0.03%0.25%  
ACCU-CHEK Aviva Plus  Roche Diagnostics  2.13%   1.71%2.56%  
ACCU-CHEK Comfort 
Roche Diagnostics  0.39%   0.21%0.58%  
Curve  
ACCU-CHEK Compact  Roche Diagnostics  1.03%   0.73%1.33%  
ACCU-CHEK Compact 
Roche Diagnostics  0.09%   0.00%0.18%  
Plus  
ACCU-CHEK 
Roche Diagnostics  1.74%   1.36%2.13%  
SmartView*  
Advance Intuition  Arkray  USA  0.05%   0.00%0.11%  
Advocate  Diabetic Supply  of Suncoast, Inc.  0.46%   0.26%0.66%  
Advocate Redi-Code  Diabetic Supply  of Suncoast, Inc.  1.24%   0.91%1.57%  
Advocate Redi-Code +  Diabetic Supply  of Suncoast, Inc.  0.87%   0.60%1.15%  
BREEZE 2   Bayer HealthCare LLC   1.77%   1.38%2.16%  
Care Sens   i-Sens  0.37%   0.19%0.55%  
Care Sens N   i-Sens  0.23%   0.09%0.37%  
Clever Chek   Simple Diagnostics  0.18%   0.06%0.31%  
Clever Choice Pro  Simple Diagnostics  0.32%   0.15%0.49%  
Clever Choice Voice  Simple Diagnostics  0.57%   0.35%0.80%  
Clever Choice Voice 
Simple Diagnostics  0.05%   0.00%0.11%  
Plus  
CONTOUR  Bayer HealthCare  LLC   4.57%   3.95%5.19%  
CONTOUR NEXT   Bayer HealthCare LLC   1.63%   1.25%2.01%  
CONTOUR TS   Bayer HealthCare LLC   1.15%   0.83%1.46%  
EasyGluco G2   US Diagnostics  0.14%   0.03%0.25%  
EasyGluco Plus  US Diagnostics  0.48%   0.28%0.69%  
EASYMAX N   Oak Tree International Holdings  0.69%   0.44%0.93%  
EASYMAX V   Oak Tree International Holdings   0.05%   0.00%0.11%  
Easy Plus II   Home Aide Diagnostics  0.18%   0.06%0.31%  
Easy Step   Home Aide Diagnostics  0.09%   0.00%0.18%  
Easy  Talk  Home Aide Diagnostics  0.23%   0.09%0.37%  
Element  Infopia USA  2.16%   1.73%2.59%  
*This diabetes  test  strip may also be listed as  the ACCU-CHEK Nano SmartView.                       continued on next  page 
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
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Appendix B               
Market Share Estimates and Their 95-Percent Confidence Intervals for 62 Types of Mail Order 
Diabetes Test Strips for the 3-Month Period of  April to June 2013 (continued)  
Model   Manufacturer   Percentage  95-Percent 
of Market   Confidence Interval 
Share   for Market Share 
Embrace  Omnis Health   8.17%   7.36%8.98%  
Evencare G2   Medline Industries, Inc.  0.09%   0.00%0.18%  
V10/D20  ForaCare, Inc.   0.14%   0.03%0.25%  
V30a  ForaCare, Inc.   0.05%   0.00%0.11%  
FreeStyle  Abbott Diabetes Care   0.05%   0.00%0.11%  
FreeStyle InsuLinx  Abbott Diabetes Care   0.32%   0.15%0.49%  
FreeStyle Lite   Abbott Diabetes Care   3.12%   2.61%3.64%  
GE 100   BIONIME USA Corporation   0.14%   0.03%0.25%  
GLUCOCARD 01   Arkray  USA  0.23%   0.09%0.37%  
GLUCOCARD 
Arkray USA  0.92%   0.63%1.20%  
Expression  
GLUCOCARD Vital  Arkray  USA  0.69%   0.44%0.93%  
GlucoNavii  SD Biosensor, Inc.  0.14%   0.03%0.25%  
GM100  BIONIME USA Corporation   0.09%   0.00%0.18%  
GM300  BIONIME USA Corporation   1.61%   1.23%1.98%  
Gmate  Philosys, Inc.  8.54%   7.71%9.37%  
INFINITY  US Diagnostics  0.23%   0.09%0.37%  
Liberty 2   Nipro Diagnostics, Inc.  0.83%   0.56%1.10%  
Liberty Autocode   AgaMatrix, Inc.   0.46%   0.26%0.66%  
NovaMax  Nova Biomedical  0.76%   0.50%1.01%  
On-Call Plus  ACON Laboratories, Inc.  0.18%   0.06%0.31%  
OneTouch Select  LifeScan, Inc.  0.37%   0.19%0.55%  
OneTouch Ultra   LifeScan, Inc.  4.11%   3.52%4.70%  
OneTouch Ultra Blue  LifeScan, Inc.  5.03%   4.38%5.68%  
OneTouch Verio   LifeScan, Inc.  0.25%   0.10%0.40%  
OptiumEZ  Abbott Diabetes Care   0.14%   0.03%0.25%  
Perfect 3   Gluco Perfect   0.05%   0.00%0.11%  
Prodigy AutoCode   Prodigy Diabetes Care   19.44%   18.26%20.62% 
                                                          continued  on  next page 
 
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
Program (OEI-04-13-00681) 
  Page 13  Marilyn Tavenner 
Appendix B               
Market Share Estimates and Their 95-Percent Confidence Intervals for 62 Types of Mail Order 
Diabetes Test Strips for the 3-Month Period of  April to June 2013 (continued)  
Model   Manufacturer   Percentage  95-Percent Confidence 
of Market   Interval for Market 
Share   Share  
Solo V2  BioSense Medical Devices  0.78%   0.52%1.04%  
SolusV2  BioSense Medical Devices  4.71%   4.08%5.33%  
SureEdge   Specialty Medical Supplies  0.05%   0.00%0.11%  
TRUEbalance   Nipro Diagnostics, Inc.  0.50%   0.29%0.72%  
TRUEtest   Nipro Diagnostics, Inc.  14.71%   13.66%15.76%  
TEMCare Medical Design & 
Vero Star TK   0.09%  0.00%0.18%  
Manufacturing, Inc. 
WaveSense Presto  AgaMatrix, Inc.   0.05%   0.00%0.11% 
 
 Total     100.00%**  
Source: OIG analysis of supplier documentation and Medicare claims containing HCPCS code  A4253 KL  for the 3-month  

period of April to  June 2013. 

**Column  does not sum to 100 percent because of  rounding. 

 
 
 
Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the National Mail Order 
Program (OEI-04-13-00681)