HHS OIG Data Brief  March 2019  OEI-04-18-00441 
 
Medicare Market Shares of Non-Mail Order Diabetes Test 
Strips From April Through June 2018 
 
This Office of Inspector General (OIG) report lists the Medicare market shares for diabetes test 
strips (DTS) provided through the non-mail order market (i.e., picked up in person at a local 
pharmacy or supplier storefront) from April through June 2018.  A January 2019 OIG report 
(OEI-04-18-00440) lists the Medicare market shares for DTS provided via mail order for the same 
timeframe.  These evaluations will inform future round(s) of the Competitive Bidding Program for 
DTS.  All Competitive Bidding Program contracts expired on December 31, 2018, and new 
contracts are not expected before the end of 2020.   
 
Why OIG Did This Review   
RESULTS AT A GLANCE  The Medicare Improvements for Patients and Providers Act 
of 2008 (MIPPA) prohibits the Centers for Medicare & 
Medicaid Services (CMS) from awarding a Competitive 
OIG analyzed the types of 
Bidding Program contract to a DTS supplier if the 
strips provided via 
suppliers bid does not cover at least 50 percent, by volume, 
non-mail order from April 
of the DTS types provided to Medicare beneficiaries.  This 
through June 2018.  We 
found that during this  is known as the 50-percent rule.  To assist CMS in 
timeframe:   ensuring that bidding suppliers meet the 50-percent rule, 
MIPPA requires OIG to determine the market shares of the 
 Sampled suppliers 
types of DTS before each round of competitive bidding. 
provided 34 types of 
DTS via non-mail order  Initially, compliance with the 50-percent rule was assessed 
to Medicare  using mail order claims only.  The Bipartisan Budget Act of 
beneficiaries.  2018 amended the 50-percent rule by requiring that, for bids 
on or after January 1, 2019, CMS must use data from the 
 The top three strip types 
accounted for 53 percent  non-mail order Medicare market as well as the mail-order 
of the Medicare  one.  Since 2010, OIG has been conducting evaluations of 
non-mail order market.  the Medicare market shares of DTS provided via mail order.  
This is the first OIG evaluation of Medicare market shares 
 The top 10 strip types 
accounted for 93 percent  for DTS provided via non-mail order.  
of the Medicare   
non-mail order market.   See Appendix A for information on diabetes, Medicares 
coverage of DTS, the Competitive Bidding Program, and 
 
the National Mail-Order Program.  See Appendix B for an 
overview of completed OIG work on this topic.  OIG will conduct future evaluations of the market 
shares of the various types of mail-order and non-mail order DTS, as required by MIPPA and/or as 
requested by CMS. 
 
 
  RESULTS 
Sampled suppliers provided 34 types of DTS via 
non-mail order to Medicare beneficiaries; 3 types of test 
strips accounted for 53 percent of the non-mail order market
 
 
Our sample of claims included 34 types of DTS provided to Medicare beneficiaries from 
April through June 2018.  Three types of DTS accounted for approximately 53 percent of the 
Medicare non-mail order market.  Five types of DTS accounted for approximately 74 percent of 
the market, and 10 types accounted for approximately 93 percent of the market.1   
 
Exhibit 1 lists the top 10 types of non-mail order DTS associated with Medicare claims for the 
3-month period of April through June 2018.  See Appendix C for a complete alphabetical listing 
of all 34 strip types.  Appendix C also provides the model, manufacturer, market share, and 
95-percent confidence interval for each type of DTS captured in our sample. 
 
Exhibit 1:  Top 10 Non-Mail Order DTS Types Associated With Medicare Claims for the 
3-Month Period of April Through June 2018* 
Model  Manufacturer  Market Share 
OneTouch Ultra  LifeScan, Inc.  29.12% 
CONTOUR NEXT  Panasonic Healthcare Holdings Co., Ltd.  12.61% 
FreeStyle LITE  Abbott Diabetes Care, Inc.  11.03% 
ACCU-CHEK Aviva Plus  Roche   10.88% 
TRUEmetrix   Trividia Health, Inc.  10.31% 
OneTouch Verio  LifeScan, Inc.   8.31% 
CONTOUR  Panasonic Healthcare Holdings Co., Ltd.  4.14% 
ACCU-CHEK Smartview  Roche  2.81% 
ACCU-CHEK Compact Plus  Roche  1.90% 
Prodigy  Prodigy Diabetes Care  1.68% 
     Total    92.79% 
Source:  OIG analysis of supplier documentation and Medicare claims with the Healthcare Common Procedure Coding 
System (HCPCS) code A4253but without the KL modifierfor the 3-month period of April through June 2018.   
 
   
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              2 
 
 
  CONCLUSION 
This report provides CMS with information on the types of DTS provided to beneficiaries via 
non-mail order from April through June 2018.  We found that during this timeframe, sampled 
suppliers provided 34 types of DTS via non-mail order to Medicare beneficiaries.  The top 3 strip 
types accounted for just over half of the non-mail order market, and the top 10 strip types 
accounted for approximately 93 percent of the non-mail order market.   
 
This is the second of two OIG reports providing the Medicare market shares of DTS from April 
through June 2018.  The first report, released in January 2019, lists the Medicare market shares 
for DTS provided via the National Mail-Order Program for the same timeframe.  These 
evaluations will inform future round(s) of the Competitive Bidding Program for DTS.  All 
Competitive Bidding Program contracts expired on December 31, 2018, and new contracts are 
not expected before the end of 2020.   
 
OIG will conduct future reviews of the market shares of the various types of mail-order and 
non-mail order DTS, as required by MIPPA and/or as requested by CMS.   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              3 
 
 
  METHODOLOGY 
Data Collection and Analysis 
Using CMSs National Claims History file, we identified the population of Medicare Part B paid 
claims for DTS that were provided via non-mail order and had dates of service beginning 
between April 1, 2018, and June 30, 2018.  There were 1,598,926 claims for which Medicare 
paid during this period.  From this population of claims, we selected a simple random sample of 
1,210 claims.  These 1,210 claims were submitted by a total of 1,192 suppliers of non-mail order 
DTS for this period of time.   
 
To identify the beneficiaries associated with each claim in our sample, we matched the 
beneficiary numbers in the claims with beneficiary numbers in the CMS Beneficiary Enrollment 
Database.  We sent documentation requests to the 1,192 suppliers associated with our sampled 
claims.  In some cases, we were able to aggregate individual suppliers under a large retailer chain 
(e.g., CVS Health and Wal-Mart Stores, Inc.).  In these cases, we sent a documentation request to 
the large retailer for a response on behalf of all suppliers that had been aggregated under it.  For 
each claim, we asked the large retailer or individual supplier to (1) indicate the type (model and 
manufacturer) of DTS that it provided to the Medicare beneficiary we identified; (2) indicate 
whether the DTS is sold exclusively by a single retailer; and (3) submit relevant documentation 
(such as prescriptions, prescription box labels, or invoices) for the strips.  For every claim line in 
our sample, we attempted to contact the associated supplier a minimum of three times through 
various types of communication, including email, phone, fax, and/or hard copy letter.  
 
Of the 1,192 suppliers associated with our sampled claims, 1,143 responded, a 96-percent 
response rate by supplier.  These 1,143 responding suppliers provided documentation for 
1,160 of the 1,210 sampled claims, a 96-percent response rate by claim.2  The 49 suppliers that 
did not respond to our requests have been referred to CMS for potential review of their claims.  
 
For the 1,160 claims for which suppliers responded, we reviewed claims data, supplier 
responses, and supplier documentation to determine the quantity of DTS associated with each 
claim.  We also categorized types of DTS by model and manufacturer.  Each of the sampled 
claims for which suppliers responded covered between 1 and 22 boxes of DTS, for a total of 
3,187 boxes. 
 
After we categorized types of DTS by model and manufacturer for the 1,160 sampled claims for 
which suppliers responded, we identified 3 types of DTS that were sold exclusively by a single 
retailer.  These 3 types of DTS accounted for 13 claims and 25 boxes in our sample.  We 
removed these claims from our sample to assist CMS in meeting the Bipartisan Budget Act of 
2018s requirement for CMS to use multiple sources of data, including market-based data 
measuring sales of DTS products that are not sold exclusively by a single retailer.3  This reduced 
our sample of claims from 1,160 to 1,147, with a corresponding total of 3,162 boxes. 
 
We determined the market share estimates for each DTS model type that our sample captured.  
We calculated each strip types share of the Medicare non-mail order market by determining the 
total number of strips across all boxes of that strip type in our sample and dividing that number 
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              4 
 
 
  by the total number of strips across all strip types in our sample.4  To estimate the Medicare 
market share of each type of DTS provided via non-mail order, we projected our sample data to 
the population of DTS provided via non-mail order during the timeframe we reviewed.  In our 
results, we present the market share for each type of DTS to the second decimal place. See 
Appendix C for the market share point estimates and 95-percent confidence intervals for the 
34 strip types that our sample captured.  
 
Limitations  
Suppliers have 1 year to submit claims to CMS.  Our evaluation did not include non-mail order 
claims submitted after August 3, 2018, the date we collected our Medicare claims data.  
Therefore, our analysis may not include all types of non-mail order DTS reimbursed by 
Medicare during our timeframe.  We did not independently verify that these DTS were provided 
via non-mail order.  Additionally, the market share analysis reflects only the suppliers that 
responded to our documentation request.   
 
Standards  
We conducted this study in accordance with the Quality Standards for Inspection and 
Evaluations issued by the Council of the Inspectors General on Integrity and Efficiency.  
   
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              5 
 
 
  APPENDIX A 
Information on Diabetes, Medicares Coverage of DTS, Beneficiaries Purchase of 
DTS, and the Competitive Bidding Program 
 
Diabetes and Blood Glucose Monitoring.  Diabetes is a chronic disease in which a person has 
a high blood sugar (glucose) level either because the body does not produce enough insulin, or 
because cells do not respond properly to the insulin the body does produce.5   Diabetes may be 
managed through a variety of methods, including healthy eating, physical activity, and insulin 
injections to prevent medical complications (e.g., hypoglycemia or cardiovascular disease).6   
 
A person with diabetes can use a hand-held meter to test the concentration of glucose in his or 
her blood.  To do so, the individual pricks his or her skin with a lancet and places the resulting 
drop of blood on a DTS, which is a small piece of plastic meant for one-time use.  The individual 
then inserts the strip into a meter that reads the blood samples glucose level, providing 
information necessary for the individual to manage his or her diabetes.  A person with diabetes 
may need to perform glucose tests several times a day to help maintain an appropriate glucose 
level. 
 
Medicare Coverage of DTS.  Medicare covers testing supplies, such as DTS, to help beneficiaries 
with diabetes manage their condition.7  To be eligible for Medicare coverage of DTS, Medicare 
beneficiaries with diabetes must be under the treatment of a physician for the condition.  The 
physicians order for DTS specifies the frequency at which the beneficiary should use the strips.  
Each box contains 50 or 51 strips.  Because some beneficiaries need to test their glucose levels 
more frequently than others, the number of boxes per claim varies.8   
 
For each beneficiary, the supplier submits a single claim that can cover up to 3 months of DTS.  
The claim indicates the number of boxes provided to the beneficiary for the applicable time 
period, but it does not indicate the type of strips provided.  The modifier KL designates DTS 
provided via mail order.9  Therefore, claims without the KL modifier were provided via non-mail 
order. 
 
Beneficiaries Purchase of DTS.  Medicare beneficiaries may purchase their DTS via non-mail 
order either from local pharmacies or supplier storefronts, or they may purchase their DTS via 
mail order from CBP suppliers.  For both non-mail order and mail-order purchases, Medicare 
pays 80 percent of allowed charges for DTS (less any unmet Part B deductible), and the 
beneficiary is responsible for the remaining 20 percent.  Effective for dates of service on or after 
July 1, 2013, Medicare adjusts the fee-schedule amounts for non-mail order DTS so that they are 
equal to the single payment amounts that the National Mail-Order Program establishes for 
mail-order DTS.10 
 
Competitive Bidding Program.  The Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 requires CMS to phase inthrough several rounds of bidding
a Competitive Bidding Program for selected durable medical equipment, prosthetics, orthotics, 
and supplies (DMEPOS) items (including DTS).11  Suppliers submit bids that CMS evaluates 
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              6 
 
 
  based on the suppliers eligibility, their financial stability, and their bid prices.  Generally, CMS 
awards contracts to the suppliers that offer lower bid prices and meet applicable quality and 
financial standards.  The payment amounts resulting from winning bids replace Medicare 
fee-schedule amounts for the selected items.12  Generally, contract awards and payment amounts 
expire every 3 years, and suppliers must recompete to remain contract suppliers.13   
 
MIPPA added further conditions to the competition for DTS.  MIPPA required that in rounds 
subsequent to the first round, mail-order suppliers must demonstrate in their bids that they can 
provide at least 50 percent, by volume, of the types of DTS provided to Medicare beneficiaries 
via mail order.  This is known as the 50-percent rule.  Suppliers must attest in their bids the 
types of DTS they intend to provide to meet the 50-percent rule.  The Bipartisan Budget Act of 
2018 amended the 50-percent rule by requiring the use of data from mail order and non-mail 
order Medicare markets.14  The Bipartisan Budget Act of 2018 also amended the attestation 
requirement for the 50-percent rule by requiring suppliers to demonstrate their ability to obtain 
the inventory of DTS in their bids.  Evidence supporting this ability may consist of letters of 
intent (or other evidence that the Secretary may determine) or good-faith efforts to obtain such 
letters or other evidence.15   
 
Current Status of the Competitive Bidding Program.  All Competitive Bidding Program contracts 
expired on December 31, 2018.  In October 2018, CMS issued guidance stating that there would 
be a temporary gap in the Competitive Bidding Program, starting January 1, 2019, and expected 
to last until December 31, 2020.16  As a result, beginning January 1, 2019, and until new 
contracts are awarded under the Competitive Bidding Program, beneficiaries may receive DTS 
from any Medicare-enrolled DMEPOS supplier.17  According to CMSs November 2018 final 
rule, during the temporary gap in the Competitive Bidding Program, Medicare will pay for 
mail-order DTS at the single payment amount that was in effect on the last day of the 
Competitive Bidding Program contract period (i.e., December 31, 2018), adjusted for inflation.18  
For non-mail order DTS, Medicare payment will continue to be the single payment amount for 
mail-order DTS that was in effect on December 31, 2018, and those amounts will not be adjusted 
for inflation.19  
 
 
 
 
   
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              7 
 
 
  APPENDIX B 
OIGs Past and Current Work on Medicare DTS Market Share 
Completed Before Round 2 (Contract Period January 1, 2011, to December 31, 2013) 
 
  Release Date  Report Title:  Medicare Market Shares of Mail Order Diabetic Testing Strips (OEI-04-10-00130) 
  Time period covered:  October 2009 through December 2009 
December 2010 
  Results:  75 total typestop 7 types had a 50% share of the market; top 10 types had 62% 
   
Completed Before Round 2 Recompete (Contract Period July 1, 2016, to December 31, 2018) 
 
  Release Date  Report Title: Medicare Market Shares of Mail Order Diabetes Test Strips from July-September 2013 
  June 2014  (OEI-04-13-00680)   
Results: 43 total typestop 3 types had a 59% share of the market; top 10 types had 90% 
 
 
 
Report Title: Medicare Market Shares of Mail Order Diabetes Test Strips Immediately Prior to the 
  Release Date 
National Mail-Order Program (OEI-04-13-00681)  
  June 2014  Time period covered: April 2013 through June 2013 
  Results: 62 total typestop 4 types had a 51% share of the market; top 10 types had 75% 
 
 
  Report Title: Medicare Market Shares of Mail Order Diabetes Test Strips 3-6 Months After the Start of 
Release Date 
  the National Mail-Order Program (OEI-04-13-00682)  
November 2014  Time period covered: October 2013 through December 2013 
 
Results: 41 total typestop 3 types had a 58% share of the market; top 10 types had 91% 
Completed Before Round 2019 (Contracts Expired December 31, 2018) 
 
  Release Date  Report Title: Medicare Market Shares of Mail Order Diabetes Test Strips from April to June 2016 
  November 2016  (OEI-04-16-00470)  
Results: 30 total typestop 2 types had a 51% share of the market; top 10 types had 93% 
 
 
 
  Release Date  Report Title: Medicare Market Shares of Mail-Order Diabetes Test Strips from July Through 
September 2016 (OEI-04-16-00471)  
  February 2017 
Results: 18 total typestop 2 types had a 60% share of the market; top 10 types had 98% 
 
 
 
Report Title: Medicare Market Shares of Mail-Order Diabetes Test Strips from October Through 
  Release Date  December 2016 (OEI-04-16-00473)  
May 2017 
Results: 19 total typestop 2 types had a 53% share of the market; top 11 types had 97% 
Completed Before Next Round (No Contracts as of January 1, 2019)  
 
Release Date  Report Title: Medicare Market Shares of Mail-Order Diabetes Test Strips from April Through 
June 2018 (OEI-04-18-00440)  
January 2019 
Results: 17 total typestop 2 types had a 53% share of the market; top 10 types had 98% 
 
Report Title: Medicare Market Shares of Non-Mail-Order Diabetes Test Strips from April Through 
Release Date           
June 2018 (OEI-04-18-00441) 
March 2019  Results: 34 total typestop 3 types had a 53% share of the market; top 10 types had 93%  
 
 
 
 
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              8 
 
 
   
APPENDIX C 
Exhibit C-1:  Model, Manufacturer, and Market Share Estimates for Non-Mail Order 
DTS, April Through June 2018  
 
Model  Manufacturer  Market Share  95-Percent  
Confidence 
Interval  
ACCU-CHEK Aviva  Roche  0.22%  0.041.21% 
ACCU-CHEK Aviva Plus  Roche  10.88%  8.8813.26% 
ACCU-CHEK Compact 
Roche  1.90%  1.143.15% 
Plus 
ACCU-CHEK Guide  Roche  0.85%  0.411.75% 
ACCU-CHEK SmartView  Roche  2.81%  1.844.27% 
BroadMaster Bio-Tec 
Advocate Redi-Code+  0.19%  0.040.82% 
Corp. 
Breeze2  PHC Holdings Corporation   0.32%  0.100.99% 
CONTOUR   PHC Holdings Corporation   4.14%  3.105.52% 
CONTOUR NEXT  PHC Holdings Corporation   12.61%  9.9215.91% 
Oak Tree International 
EASYMax  0.44%  0.210.93% 
Holdings, Inc. 
EasyTouch  MHC Medical Products  0.16%  0.050.51% 
Embrace  Omnis Health  0.25%  0.100.63% 
EvenCare G2  Medline  0.25%  0.080.84% 
Fora G20  ForaCare, Inc.  0.06%  0.010.45% 
Fora V10/V12  ForaCare, Inc.  0.06%  0.010.45% 
Fora 
ForaCare, Inc.  0.03%  0.000.22% 
V30/G30/PremiumV10 
FreeStyle  Abbott Diabetes Care, Inc.  1.39%  0.772.49 
FreeStyle InsuLinX  Abbott Diabetes Care, Inc.  0.63%  0.221.83% 
FreeStyle LITE  Abbott Diabetes Care, Inc.  11.03%  9.1013.33% 
GE100  Bionime Corporation  0.16%  0.060.45% 
GlucoCard Expression  ARKRAY  0.32%  0.120.82% 
GlucoCard Vital  ARKRAY  0.25%  0.080.84% 
GlucoNavii  SD Biosensor  0.13%  0.030.51% 
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              9 
 
 
  Model  Manufacturer  Market Share  95-Percent  
Confidence 
Interval  
NovaMax  Nova Biomedical  0.03%  0.000.22% 
On Call Express  ACON Laboratories  0.06%  0.010.45% 
On Call Vivid  ACON Laboratories  0.06%  0.010.45% 
OneTouch Ultra  LifeScan, Inc.  29.12%  25.8132.42% 
OneTouch Verio  LifeScan, Inc.  8.31%  6.3010.90% 
Prodigy  Prodigy Diabetes Care  1.68%  0.942.97% 
TRUEbalance  Trividia Health, Inc.  0.13%  0.020.89% 
TRUEmetrix  Trividia Health, Inc.  10.31%  8.5112.43% 
TRUEtrack  Trividia Health, Inc.  0.89%  0.441.78% 
Ultra Trak Pro  Zenith Diagnostics  0.09%  0.020.41% 
WaveSense Presto  AgaMatrix  0.22%  0.080.61% 
Source:  OIG analysis of supplier documentation and Medicare claims containing the Healthcare Common Procedure Coding 
System (HCPCS) code A4253but without the KL modifierfor the 3-month period of April through June 2018. 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              10 
 
 
  Exhibit C-2.  Medicare Market Share Estimates for the Top 3, Top 5, and 
Top 10 Types of Non-Mail Order DTS, April Through June 2018 
Groupings 
of Strip 
Types with  Combined Market  95-Percent Confidence 
Model Names 
Largest  Share   Interval  
Market 
Share  
 
1.  OneTouch Ultra 
Top 3 Strip 
2.  CONTOUR NEXT  52.76%  49.1256.41% 
Types 
3.  FreeStyle LITE 
 
 
1.  OneTouch Ultra 
2.  CONTOUR NEXT 
Top 5 Strip  3.  FreeStyle LITE 
73.94%  70.7677.13% 
Types  4.  ACCU-CHEK 
Aviva Plus 
5.  TRUEmetrix 
 
 
 
1.  OneTouch Ultra 
2.  CONTOUR NEXT 
3.  FreeStyle LITE 
4.  ACCU-CHEK 
Top 10 
Aviva Plus  92.79%  90.9294.30% 
Strip Types 
5.  TRUEmetrix 
6.  OneTouch Verio 
7.  CONTOUR  
8.  ACCU-CHEK 
Smart-View  
 
Source:  OIG analysis of supplier documentation and Medicare claims containing HCPCS code A4253but without the 
KL modifierfor the 3-month period of April through June 2018. 
 
 
 
 
 
 
 
   
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              11 
 
 
  ACKNOWLEDGMENTS 
 
Evan Godfrey served as the team leader for this study.  Other Office of Evaluation and 
Inspections staff from the Atlanta regional office who conducted the study include Lauren Buss 
and Margaret Naughton.  Office of Evaluation and Inspections staff who provided support 
include Kevin Farber, Christine Moritz, and Michael Novello.  
This report was prepared under the direction of Dwayne Grant, Regional Inspector General for 
Evaluation and Inspections in the Atlanta regional office, and Jaime Stewart, Assistant Regional 
Inspector General.   
 
   
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              12 
 
 
   
ENDNOTES
 
 
1 This analysis does not include types of DTS that were exclusively sold by single retailers.  The methodology 
provides additional information about which types of DTS were included in our analysis.  
2 We did not receive responses from 49 suppliers.  Of these, 33 suppliers acknowledged receipt of the 
documentation request but never submitted the required documentation; 15 never responded and appear to still be 
doing business; and 1 never responded and appears to have stopped doing business after the claims included in our 
sample were submitted.  
3  50414(a)(1)(A) of the Bipartisan Budget Act of 2018, P.L. No. 115-123, revising 1847(b)(10)(A) of the Social 
Security Act.  Accessed at https://www.congress.gov/115/bills/hr1892/BILLS-115hr1892enr.pdf on August 17, 
2018. 
4 Generally, each box of DTS contains 50 strips. Some types of DTS are packaged in 51-count boxes instead of 
50-count boxes, but Medicare pays for these boxes as though they were 50-count boxes.  We counted these boxes of 
DTS as containing 51 strips in our analysis. 
5 National Institutes of Health (NIH), What is Diabetes?  Accessed at https://www.niddk.nih.gov/health-
information/diabetes/overview/what-is-diabetes on October 24, 2018. 
6 NIH, Managing Diabetes: 4 Steps to Manage Your Diabetes for Life.  Accessed at 
https://www.niddk.nih.gov/health-information/diabetes/manage-monitoring-diabetes on October 24, 2018. 
7 Other diabetes testing supplies may include batteries, lancets, and control solution. 
8 CMS, MLN [Medicare Learning Network] Matters Number SE1008 Revised.  Medicare Coverage of Blood 
Glucose Monitors and Testing Supplies.  Accessed at 
http://www.cms.gov/MLNMattersArticles/downloads/SE1008.pdf on October 3, 2018.  Medicare covers up to 
100 test strips per month (i.e., two 50-count boxes) for insulin-dependent beneficiaries with diabetes and up to 
100 test strips every 3 months for non-insulin-dependent beneficiaries with diabetes.  Medicare allows additional 
test strips if they are deemed medically necessary and documented in physician records.  Medicare LCD [Local 
Coverage Determination] for Glucose Monitors (L33822 for DME [Durable Medical Equipment] MAC 
Jurisdictions A, B, C, and D). 
9 Suppliers submit claims using Healthcare Common Procedure Coding System (HCPCS) codes to receive Medicare 
reimbursement.  Medicare claims for DTS are billed using HCPCS code A4253.  For DTS provided via mail order, 
the HCPCS code A4253 must be followed by the KL modifier (A4253 KL).  CMS, Medicare Claims Processing 
Manual, Pub. No. 100-04, ch. 36,  20.5.4.1 and 50.6.  A modifier is a code on Medicare claim that further 
describes the services performed or supplies provided to a beneficiary. 
10 American Taxpayer Relief Act of 2012, P.L. No. 112-240  636 (added new paragraph to Social Security Act, 
 1834(a)(1)(H), 42 U.S.C.  1395m(a)(1)(H)).  See also CMS, MLN Matters Number MM8325 Revised.  July 
Quarterly Update for 2013 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee 
Schedule.  Accessed at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-
MLN/MLNMattersArticles/downloads/MM8325.pdf on December 13, 2018.  
11 Medicare Prescription Drug, Improvement, and Modernization Act of 2003, P.L. No. 108-173  302(b)(1). 
12 In November 2018, CMS revised its Competitive Bidding Program rules to change the processes for submitting 
bids, evaluating bids, and calculating single payment amounts.  Specifically, CMS will replace the bidding method 
in effect through 2018in which a supplier submits a bid for each item in the product categorywith what is 
known as lead item pricing.  Under lead item pricing, a bidding supplier would submit a bid for one itemknown 
as the lead itemin the product category.  The maximum winning bid for the lead item would be used to establish 
single payment amounts for both the lead item and all other items in the product category.  83 Fed. Reg. 56922 
(Nov. 14, 2018).  Accessed at https://www.gpo.gov/fdsys/pkg/FR-2018-11-14/pdf/2018-24238.pdf on November 16, 
2018. 
13 CMS must recompete contracts at least once every 3 years.  Social Security Act,  1847(b)(3)(B), 42 U.S.C. 
 1395w-3(b)(3)(B). 
14  50414(a)(1) of the Bipartisan Budget Act of 2018, P.L. No. 115-123.  Accessed at 
https://www.congress.gov/115/bills/hr1892/BILLS-115hr1892enr.pdf on August 17, 2018. 
15 Ibid. 
 
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              13 
 
 
   
16 CMS, Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program:  
Temporary Gap Period.  Accessed at https://www.cms.gov/Outreach-and-
Education/Outreach/Partnerships/Downloads/DMEPOS-Temporary-Gap-Period-Fact-Sheet.pdf on December 13, 
2018. 
17 Ibid. 
18 The single payment rate for mail-order DTS that was in effect on December 31, 2018, will be increased by the 
projected percentage change in the Consumer Price Index for All Urban Consumers for the 12-month period on the 
date after the contract period ended.  42 CFR  414.210(g)(10) (as added by 83 Fed. Reg. 56922, 57071 (Nov. 14, 
2018)).  Accessed at https://www.gpo.gov/fdsys/pkg/FR-2018-11-14/pdf/2018-24238.pdf on November 16, 2018. 
19 83 Fed. Reg. 56922, 57037 (Nov. 14, 2018).  Accessed at https://www.gpo.gov/fdsys/pkg/FR-2018-11-
14/pdf/2018-24238.pdf on November 16, 2018. 
 
Medicare Market Shares of Non-Mail Order Diabetes Test Strips From April Through June 2018                              14