DIT\RT\11::\T ( >F HI:.\LTII \:\!) Hl "\1 .\:\ SER\"[(;E'-, 

OFFICE OF INSPECTOR GENERAL 

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· JUN 1 3 2014 

TO: 	 Marilyn Tavenner 

Administrator 

Centers for Medicare & Medicaid Services 

FROM: Brian P. Ritchie 

Acting Deputy Inspector General 

for Evaluation and Inspections 

SUBJECT: 	 Memorandum Rep011: Medicare Market Shares ofMail Order Diab etes Test 

Strips From July- September 2013 , OEI -04 -13-00680 

This report provides information on the types of mail order diabetes test strips associated with 

Medicare claims for the 3-month period of July to September 2013. Section 154(d)(3)(B) of the 

Medicare Improvements for Patients and Providers Act of2008 (MIPPA) requires the Office of 

Inspector General (OIG) to complete a study to determine market shares of diabetes test strips 

before each round of competitive bidding following Round 1 of the Competitive Bidding 

Program . This report fulfills the MIPP A requirement for the pending third round of competitive 

bidding; a 20 I 0 OIG report fulfilled the MIPPA requirement to complete a study determining 

market shares of diabetes test strips before 2011. 

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 the Centers for Medicare & Medicaid Services (CMS) to phase in, with 

several rounds of bidding, 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 strip s shipped or 

delivered to the beneficiary's home , regardless of the method of delivery . 
 

 

 

 

Page 2 – Marilyn Tavenner 

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 of 2012 (ATRA) 

established equal Medicare payment amounts for mail order and non-mail order diabetes test 

strips purchased after the implementation of a national competition for mail order diabetes 

testing supplies (hereinafter referred to as the National Mail Order Program).1 CMS 

implemented the National Mail Order Program on July 1, 2013. 

MIPPA prohibits CMS from awarding Competitive Bidding Program contracts for mail order 

diabetes test strips to suppliers that 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 July to September 2013. Our sample of 

1,210 claims was drawn from a population of approximately 505,000 claims for mail order 

diabetes test strips provided to beneficiaries during this period. To estimate the Medicare market 

shares, we projected our sample data to the population of mail order diabetes test strips. 

We found that 22 suppliers submitted at least 43 types of mail order diabetes test strips for the 

3-month period of July to September 2013. 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. CMS may consider these data when determining whether subsequent rounds of 

suppliers’ mail order diabetes test strip bids comply with the MIPPA 50-percent requirement. 

BACKGROUND 

Diabetes is a chronic disease in which a person has a high level of blood sugar (i.e., glucose) 

because either 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 in the United States 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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Page 3 – Marilyn Tavenner 

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 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 for Durable Medical Equipment Medicare Administrative 

Contractor Jurisdictions A, B, C, and D respectively). 

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 C.F.R. § 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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Page 4 – Marilyn Tavenner 

under the Competitive Bidding Program.11 CMS uses bids submitted by DMEPOS suppliers to 

determine the payment amounts under the program. 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 

MIPPA also requires mail order suppliers to demonstrate in their bids that they provide at least 

50 percent, by volume, of all types of diabetes test strips.14 This 50-percent requirement is 

intended to ensure that most beneficiaries can receive their preferred type of diabetes test strips. 

Further, the MIPPA section 154(d)(3)(B) requires the OIG to complete a study to determine 

market shares of mail order diabetes test strips in the Competitive Bidding Program before each 

round of bidding following Round 1.15 

Round 1 of the Competitive Bidding Program. Before 2011, Medicare reimbursed all diabetes 

test strips suppliers on the basis of fee-schedule amounts, which were updated annually and 

varied by State. In January 2011, CMS implemented Round 1 of its Competitive Bidding 

Program for selected DMEPOS in nine Competitive Bidding Areas (CBAs).16 Competitive 

bidding payment amounts replaced the fee schedule amounts for mail order diabetes test strips in 

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 § 154(d)(3)(A). The 50-percent requirement did not apply to suppliers’ bids in Round 1 of the 

Competitive Bidding Program.

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 MMA, P.L. No. 108-173 § 302(b)(1), as amended by MIPPA, P. L. No. 110-275 § 154. CBAs are defined by 

specific ZIP Codes related to Metropolitan Statistical Areas (MSAs). 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. 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). 

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Page 5 – Marilyn Tavenner 

these CBAs. Mail order diabetes test strips were included in Round 1 of the Competitive 

Bidding Program, but non-mail order test strips were not.17 

As a result of Round 1 of the Competitive Bidding Program, the average Medicare payment in 

2011 for 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 diabetes test 

strips in non-CBAs (i.e., areas that were not a part of the Competitive Bidding Program) was 

$32.47, and the national average payment for non-mail order diabetes test strips was $37.67. See 

Appendix A for more information about Round 1 of the Competitive Bidding Program. 

Round 2 of the Competitive Bidding Program and the National Mail Order Program. MIPPA 

required competition for Round 2 of the Competitive Bidding Program to occur in 2011 in 

70 additional CBAs.18 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 2016.19 

MIPPA authorized a National Mail Order Program for mail order diabetes testing supplies, 

expanding the Competitive Bidding Program from the nine CBAs in Round 1 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.20 CMS implemented both the National Mail Order Program and Round 2 of the 

Competitive Bidding Program on July 1, 2013.21 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 

This report fulfills OIG’s MIPPA requirement for the pending third round of competitive bidding 

and is part of a body of work on the Medicare market share of diabetes test strips. CMS 

requested two additional reports—one that determines the market share of diabetes test strips for 

the 3-month period of April to June 2013, immediately preceding the National Mail Order 

17 During Round 1 of the Competitive Bidding Program, mail order diabetes test strips were defined as items ordered 

remotely (that is, by telephone, email, Internet, or mail) and delivered to a beneficiary’s residence by common 

carriers (for example, U.S. Postal Service, Federal Express, United Parcel Service). It did not include items obtained 

by beneficiaries from local storefronts. After Round 1 of the Competitive Bidding Program, CMS expanded the 

definition of mail order to include “any item (for example, diabetes testing supplies) shipped or delivered to the 

beneficiary’s home, regardless of the method of delivery.” 75 Fed. Reg. 73170, 73570, and 73623 (Nov. 29, 2010) 

(revising the definition of “mail order item” in 42 CFR 414.402 and explaining why the new definition will not 

apply to Round 1). 

18 MIPPA, P.L. No. 110-275 § 154(d)(3)(A). 

19 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. 20 ATRA, P.L. No. 112-240 § 636 (adding Social Security Act, § 1834(a)(1)(H), 42 U.S.C. § 1395m(a)(1)(H)). 21 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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Page 6 – Marilyn Tavenner 

Program, and another that determines the market share of diabetes test strips for the 3-month 

period of October to December 2013, several months after the National Mail Order Program 

began.22 CMS requested these additional reports for informational purposes and to evaluate the 

impact of competitive bidding on brand selection. 

Additionally, in 2010, OIG published the first report to fulfill its MIPPA requirement to 

complete a study determining market shares of diabetes test strips before 2011. OIG found that 

171 suppliers submitted claims for at least 75 types of mail order diabetes test strips for the 

3-month period of October to December 2009.23 Of these strips, two types accounted for 

approximately 26 percent of the Medicare mail order market share, 7 types accounted for 

approximately 50 percent of the Medicare mail order market share, and 19 types accounted for 

approximately 81 percent. 

METHODOLOGY 

Data Collection 

We identified the population of Medicare claims for mail order diabetes test strips from CMS’s 

National Claims History file with a beginning date of service from July through September 2013. 

In this file, there were 504,916 claims submitted by 80 suppliers. We then selected a simple 

random sample of 1,210 of these 504,916 claims 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 22 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).24 We received responses 

from 22 suppliers associated with 1,190 claims in our sample, a 98-percent response rate. 

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. The 

1,190 claims each covered from 1 to 19 boxes of strips, and data for these claims provide 

information for a total of 4,656 such boxes.25 

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 strip and 

the percentage 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 

strip types. 

22 OEI-04-13-00681 and OEI-04-13-00682, in progress. 

23 OIG, Medicare Market Shares of Mail Order Diabetic Testing Strips (OEI-04-10-00130), December 2010. 24 We contacted suppliers up to three times to obtain this information.
 25 Most claims (91 percent) were for 1 to 6 boxes.
 

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Page 7 – Marilyn Tavenner 

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 July through 

September 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. 

RESULTS 

Suppliers Submitted Claims for at Least 43 Types of Mail Order Diabetes Test Strips for 

the 3-Month Period of July to September 2013 

Twenty-two suppliers submitted at least 43 types of mail order diabetes test strips for the 

3-month period of July to September 2013. 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. 

Table 1 lists the top 10 types of mail order diabetes test strips associated with Medicare claims 

for the 3-month period of July to September 2013. See Appendix B for a complete alphabetical 

listing of all 43 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 Strip Types Associated With Medicare Claims for the 

3-Month Period of July to September 2013 

Model Manufacturer Percentage of 

Market Share 

Prodigy AutoCode Prodigy Diabetes Care 23.9% 

OneTouch Ultra Blue LifeScan, Inc. 20.7% 

TRUEtest Nipro Diagnostics, Inc. 14.8% 

Embrace Omnis Health 8.5% 

Solus V2 BioSense Medical Devices 6.9% 

Advocate Redi-Code + Diabetic Supply of Suncoast, Inc. 4.6% 

Nova Max Nova Biomedical 4.5% 

CONTOUR Bayer HealthCare LLC 2.2% 

ACCU-CHEK Smartview* Roche Diagnostics 2.1% 

ACCU-CHEK Aviva Plus Roche Diagnostics 2.1%

 Total 90.3% 

Source: OIG analysis of supplier documentation and Medicare claims containing HCPCS code A4253 KL for
 

the 3-month period of July to September 2013. 

*This diabetes test strip may also be listed as the ACCU-CHEK Nano Smartview.
 

Medicare Market Shares of Mail Order Diabetes Test Strips From July–September 2013 (OEI-04-13-00680) 
Page 8 – Marilyn Tavenner 

CONCLUSION 

Twenty-two suppliers submitted at least 43 types of mail order diabetes test strips for the 

3-month period of July to September 2013. 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. CMS may choose to consider these data when determining whether subsequent 

rounds of suppliers’ mail order diabetes test strip bids comply with the MIPPA 50-percent 

requirement. 

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-04-13-00680 in all correspondence. 

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Page 9 – Marilyn Tavenner 

Appendix A 

Round 1 of the Competitive Bidding Program 

The MMA 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 CBAs on July 1, 2008.26 

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.)27 

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.28 This reduction resulted in an average 2009 fee-schedule 

amount of $32.50 per 50-count 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 CBAs on January 1, 2011. 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 $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.29 

26 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. For a list of CBAs in Round 1, see footnote 16. 

27 The 50-percent requirement did not apply to suppliers’ bids in Round 1 or the Round 1 Rebid.
 28 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. 

29 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. 

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Page 10 – Marilyn Tavenner 

Appendix B 

Market Share Estimates for 43 Types of Mail Order Diabetes Test Strips, and the 

95-Percent Confidence Intervals for Those Estimates 

Market Share Estimates for 43 Types of Mail Order Diabetes Test Strips, and the 

95-Percent Confidence Intervals for Those Estimates 

Model Manufacturer Percentage 

of Market 

Share 

95-Percent 

Confidence Interval 

for Market Share 

ACCU-CHEK Aviva Roche Diagnostics 0.71% 0.47–0.95% 

ACCU-CHEK Aviva Plus Roche Diagnostics 2.10% 1.69–2.52% 

ACCU-CHEK Compact Roche Diagnostics 0.30% 0.14–0.46% 

ACCU-CHEK Compact 

Plus 

Roche Diagnostics 0.45% 0.26–0.64% 

ACCU-CHEK 

Smartview* 

Roche Diagnostics 2.13% 1.71–2.54% 

Advocate Diabetic Supply of 

Suncoast, Inc. 

0.34% 0.18–0.51% 

Advocate Redi-Code Diabetic Supply of 

Suncoast, Inc. 

0.17% 0.05–0.29% 

Advocate Redi-Code + Diabetic Supply of 

Suncoast, Inc. 

4.64% 4.04–5.24% 

BREEZE 2 Bayer HealthCare LLC 0.37% 0.19–0.54% 

CONTOUR Bayer HealthCare LLC 2.19% 1.77–2.61% 

CONTOUR NEXT Bayer HealthCare LLC 0.04% 0.00–0.10% 

CareSens N i-Sens, Inc. 0.47% 0.28–0.67% 

Clever Chek Simple Diagnostics 0.26% 0.11–0.40% 

Clever Choice Pro Simple Diagnostics 0.04% 0.00–0.10% 

Clever Choice Voice Simple Diagnostics 0.26% 0.11–0.40% 

EASYMAX V Oak Tree International 

Holdings 

0.30% 0.14–0.46% 

Easy Plus II Home Aide Diagnostics 0.17% 0.05–0.29% 

Easy Step Home Aide Diagnostics 0.17% 0.05–0.29% 

Easy Talk Home Aide Diagnostics 0.21% 0.08–0.35% 

Easy Trak Home Aide Diagnostics 0.34% 0.18–0.51% 

Element Infopia USA 0.69% 0.45–0.92% 

Embrace Omnis Health 8.46% 7.66–9.26% 

FreeStyle Lite Abbot Diabetes Care 0.47% 0.28–0.67% 

continued on next page 

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Market Share Estimates for 43 Types of Mail Order Diabetes Test Strips, and the 

95-Percent Confidence Intervals for Those Estimates (continued) 

Model Manufacturer Percentage 

of Market 

Share 

95-Percent 

Confidence Interval 

for Market Share 

GE 100 Bionime USA Corporation 0.21% 0.08–0.35% 

GLUCOCARD 

Expression 

ARKRAY USA 0.13% 0.03–0.23% 

GLUCOCARD Vital ARKRAY USA 0.56% 0.34–0.77% 

GlucoNavii SD Biosensor, Inc. 0.15% 0.04–0.26% 

Gmate Philosys, Inc. 0.26% 0.11–0.40% 

INFINITY US Diagnostics 0.04% 0.00–0.10% 

Nova Max Nova Biomedical 4.45% 3.85–5.04% 

On Call Plus ACON Laboratories, Inc. 0.13% 0.03–0.23% 

On Call Vivid ACON Laboratories, Inc. 0.09% 0.00–0.17% 

OneTouch Ultra 2 LifeScan, Inc. 0.04% 0.00–0.10% 

OneTouch Ultra Blue LifeScan, Inc. 20.70% 19.54–21.87% 

Perfect 3 Gluco Perfect 0.17% 0.05–0.29% 

Prodigy AutoCode Prodigy Diabetes Care 23.88% 22.66–25.11% 

GM100 Bionime USA Corporation 0.30% 0.14–0.46% 

Solo V2 BioSense Medical Devices 1.33% 1.00–1.66% 

SolusV2 BioSense Medical Devices 6.94% 6.21–7.67% 

TRUEbalance Nipro Diagnostics, Inc. 0.09% 0.00–0.17% 

TRUEtest Nipro Diagnostics, Inc. 14.84% 13.82–15.86% 

TRUEtrack Nipro Diagnostics, Inc. 0.26% 0.11–0.40% 

Vocal Point Specialty Medical Supplies 0.13% 0.02–0.23%

 Total 100.00%** 

Source: OIG analysis of supplier documentation and Medicare claims containing HCPCS code A4253 KL for
 

the 3-month period of July to September 2013. 

*This diabetes test strip may also be listed as the ACCU-CHEK Nano Smartview.
 

**The percentages in this column do not sum to the total because of rounding. 

Medicare Market Shares of Mail Order Diabetes Test Strips From July–September 2013 (OEI-04-13-00680)