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 
 

 

 

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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. 

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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 meter’s reading of an individual’s 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 beneficiary’s 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 beneficiary’s 

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). 

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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. 

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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 OIG’s 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 CMS’s 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 July–September 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.
 

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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, 2013—the date we collected our Medicare 

claims—are 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. 

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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 

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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. 

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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 Juan–Caguas–Guaynabo (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-ServicePayment/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 Charlotte–Gastonia–Concord (North Carolina and South Carolina), Cincinnati–
 

Middletown (Ohio, Kentucky, and Indiana), Cleveland–Elyria–Mentor (Ohio), Dallas–Fort Worth–Arlington
 

(Texas), Kansas City (Missouri and Kansas), Miami–Fort Lauderdale– Pompano Beach (Florida), Orlando–
 

Kissimmee (Florida), Pittsburgh (Pennsylvania), and Riverside– San Bernardino–Ontario (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-andEducation/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. 

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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 Update—One 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-forService-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 MSAs—Chicago, Los Angeles, and New York—are subdivided into multiple CBAs. 

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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 

of Market 

Share 

95-Percent 

Confidence Interval 

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 

Curve Roche Diagnostics 0.39% 0.21%–0.58% 

ACCU-CHEK Compact Roche Diagnostics 1.03% 0.73%–1.33% 

ACCU-CHEK Compact 

Plus Roche Diagnostics 0.09% 0.00%–0.18% 

ACCU-CHEK 

SmartView* Roche Diagnostics 1.74% 1.36%–2.13% 

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 

Plus Simple Diagnostics 0.05% 0.00%–0.11% 

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 

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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 

of Market 

Share 

95-Percent 

Confidence Interval 

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 

Expression Arkray USA 0.92% 0.63%–1.20% 

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 

of Market 

Share 

95-Percent Confidence 

Interval for Market 

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% 

Vero Star TK TEMCare Medical Design & 

Manufacturing, Inc. 0.09% 0.00%–0.18% 

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)