HHS OIG Data Brief  November 2016  OEI-04-16-00470 
 
Medicare Market Shares of Mail Order Diabetes Test Strips 
From April to June 2016 
 
The Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) requires the Centers for 
RESULTS AT A GLANCE 
Medicare & Medicaid Services (CMS) to phase in a 
Competitive Bidding Program for durable medical 
 
equipment, prosthetics, orthotics, and supplies (DMEPOS).  
For CMS to consider a  Under this program, suppliers compete to become Medicare 
suppliers bid for the National  contract suppliers for selected DMEPOS items, including 
Mail Order Program, the bid  diabetes test strips provided via mail order.  In July 2013, 
must cover, by volume, at  the program was expanded to include a National Mail 
least 50 percent of all diabetes  Order Program for diabetes testing supplies. 
test strips on the market.  OIG   
analyzed Medicare mail order  The Medicare Improvements for Patients and Providers Act 
market shares from April to  (MIPPA) prohibits CMS from awarding contracts to 
June 2016 to support CMS in  suppliers if their bid does not cover at least 50 percent, by 
evaluating the next round of  volume, of all types of diabetes test strips on the market 
bids.  We found:  (the MIPPA 50-percent rule).  MIPPA requires the Office 
of Inspector General (OIG) to determine the market shares 
 From April to June 2016, 
of the types of diabetes test strips before each round of 
sampled suppliers 
competitive bidding.  CMS uses OIGs data to help ensure 
submitted claims for 
contracted suppliers bids adhere to the 50-percent rule.  
30 types of mail order 
 
diabetes test strips 
On July 1, 2016, CMS began accepting claims for diabetes 
 Two types of strips 
test strips from winning bidders under the recompetition of 
accounted for about half of 
the National Mail Order Program.  (This recompetition is 
the Medicare mail order 
known as the National Mail Order Recompete.)  This report 
market 
provides information on the market shares of Medicare mail 
order diabetes test strip types for the previous 3-month 
 The top 10 types of strips 
period (i.e., April through June 2016).  See Appendix A for 
accounted for 93 percent of 
information on diabetes, Medicares coverage of diabetes 
the Medicare mail order 
test strips, and the Competitive Bidding and the National 
market 
Mail Order Programs.    
 
CMS requested that OIG conduct this study to better 
understand the types of strips provided to beneficiaries prior to this round.  OIG will provide two 
additional reports on the National Mail Order Programs current round.  CMS will use these reports 
to assess contractors bids for the next round, which begins after December 31, 2018, and learn 
more about the types of diabetes test strips provided to Medicare beneficiaries via mail order.  
1 
  RESULTS 
Sampled suppliers provided 30 types of mail order diabetes 
test strips to Medicare beneficiaries; 2 types of the test strips 
accounted for about half of the mail order market 
 
Our representative sample included 30 types of diabetes test strips provided to Medicare 
beneficiaries during the 3 months before the implementation of the current round of the National 
Mail Order Program (i.e., April through June 2016).  Two types of diabetes test strips accounted 
for 51 percent of the Medicare mail order market.  Five types of diabetes test strips accounted for 
81 percent of the market, and 10 types accounted for 93 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 2016.  See Appendix B for a complete alphabetical 
listing of all 30 strip types.  Appendix B also provides the model, manufacturer, and market 
share for each type of diabetes test strip provided.  
 
Table 1:  Top 10 Mail Order Diabetes Test Strip Types Associated With Medicare Claims for the  
3-Month Period of April to June 2016 
 
Model  Manufacturer  Market Share 
Prodigy   Prodigy Diabetes Care  28.2%   
OneTouch Ultra   LifeScan, Inc.  22.8% 
 
Embrace  Omnis Health  11.5% 
 
TRUEtest   Trividia Health, Inc.  11.0% 
 
CareSens Strips  i-Sens, Inc.  7.4% 
Gmate  Philosys  3.1%   
Panasonic Healthcare Holdings Co., 
CONTOUR NEXT  2.6%   
Ltd. 
Panasonic Healthcare Holdings Co., 
CONTOUR  2.6%   
Ltd. 
Advocate Redi-Code+  BroadMaster Bio-Tech Corp.  2.5%   
TRUEmetrix  Trividia Health, Inc.  1.7% 
 
     Total    93.4% 
 
Source:  OIG analysis of supplier documentation and Medicare claims containing HCPCS code 
A4253 KL for the 3-month period of April to June 2016. 
 
 
 
 
2 
  CONCLUSION 
This is the first of three OIG reports to determine the Medicare market shares of diabetes test 
strips for the periods April through June 2016, July through September 2016, and October 
through December 2016, respectively.  This first report fulfills CMSs request for market share 
data for the 3-month period before implementation of the current round of the National Mail 
Order Program (i.e., the National Mail Order Recompete), which started on July 1, 2016.  We 
found that during this timeframe, sampled suppliers provided 30 types of diabetes test strips via 
mail order.  Two types accounted for about half of the mail order market.  Therefore, a suppliers 
bid would meet the MIPPA 50-percent rule if the bid declared that the supplier intended to 
provide either (1) both of these 2 types of strips or (2) at least 1 of these 2 types of strips and a 
combination of certain subsets of the other 28 types of strips sufficient to reach 50-percent.  
Further, we found that five types of diabetes test strips accounted for 81 percent of the Medicare 
mail order market share, and ten types accounted for 93 percent.  
 
The data from this series of reports will inform CMS about the types of diabetes test strips that 
suppliers provided to Medicare beneficiaries via mail order.  This is the most recent report in 
OIGs body of work, which began in 2010, about the composition of the mail order market of 
diabetes test strips supplied to Medicare beneficiaries.  See Appendix C for an overview of 
OIGs past, current, and planned work on this topic.  OIG will conduct future reviews of the 
market share of the various mail order diabetes test strips as required by MIPPA and/or requested 
by CMS. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 
  METHODOLOGY 
Data Collection 
Using CMSs National Claims History file, we identified the population of Medicare Part B 
claims for diabetes test strips that were provided by mail order and had beginning dates of 
service between April 1, 2016 and June 30, 2016.  There were exactly 682,000 claims submitted 
by 39 suppliers during this period.  We then selected a simple random sample of 1,210 of these 
682,000 claims.  To identify the beneficiaries associated with each claim in our sample, we 
matched them with the CMS Beneficiary Enrollment Database. 
 
We sent documentation requests to the 19 suppliers associated with the 1,210 claims in our 
sample.  For each claim, we asked the supplier (1) to indicate the type (model and manufacturer) 
of diabetes test strips it provided to the Medicare beneficiary we identified and (2) to submit 
relevant documentation (such as packing slips or invoices) for the strips.  We received responses 
from all 19 suppliers documenting all 1,210 claims in our sample, yielding a 100-percent 
response rate for these claims.   
 
Data Analysis 
We reviewed claims data, supplier responses, and supplier documentation 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 20 boxes, and data for the 1,210 claims 
provide information for a total of 5,074 boxes of strips.  
 
We categorized types of diabetes test strips by model and manufacturer.  We calculated each 
strip types share of the Medicare mail-order market by determining the total number of 50-count 
boxes of each strip type provided to beneficiaries in our sample and dividing that number by the 
total number of boxes across all strip types in our sample.  To estimate the Medicare market 
share of each type of diabetes test strip provided by mail order, we projected our sample data to 
the population of diabetes test strips provided by mail order during the timeframe we reviewed. 
 
Limitations  
Suppliers have 1 year to submit claims to CMS.  Our study did not include any claims submitted 
after July 29, 2016, the date we collected our Medicare claims.  Therefore, our sample may not 
include all types of mail order diabetes test strips reimbursed by Medicare. 
 
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. 
   
4 
  APPENDIX A 
Information on Diabetes, Medicares Coverage of Diabetes Test Strips, and the 
Competitive Bidding and the National Mail Order Programs 
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.1   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).2   
 
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 diabetes test strip, 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.  People with 
diabetes may need to perform glucose tests several times a day to assist them in maintaining an 
appropriate glucose level. 
 
Medicare Coverage of Diabetes Test Strips.  Medicare covers testing supplies, such as diabetes 
test strips, to help beneficiaries with diabetes manage their condition.3  To be eligible for 
Medicare coverage of diabetes test strips, Medicare beneficiaries with diabetes must be under the 
treatment of a physician for the condition.  The physicians order for diabetes test strips specifies 
the frequency at which the beneficiary should use the strips.  Each box contains 50 strips.  
Because some beneficiaries need to test their glucose levels more frequently than others, the 
number of boxes per claim varies.4   
 
For each beneficiary, the supplier submits a single claim that can cover up to 3 months of 
diabetes test strips.  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 diabetic test strips provided via mail order.5   
 
Purchasing Diabetes Test Strips.  Medicare beneficiaries may purchase their diabetes test strips 
via mail order suppliers or via non-mail order from local pharmacies or supplier storefronts. 
CMS considers all diabetes test strips either shipped or delivered to a beneficiarys residence as 
mail order, regardless of the method of delivery.6  Non-mail order diabetes test strips are those 
that a beneficiary or caregiver picks up in person at a local pharmacy or supplier storefront.  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.     
 
Competitive Bidding Program.  The MMA required CMS to phase in, through several rounds of 
bidding, a Competitive Bidding Program for selected DMEPOS items (including diabetes test 
strips).  Such a program potentially can achieve high savings for the selected DMEPOS items, 
because of the generally high-cost and high-volume nature of sales of these items.  Additionally, 
the Secretary may include items that are determined to have a high savings potential under the 
Competitive Bidding Program.  CMS evaluates submitted bids based upon suppliers eligibility, 
5 
  financial stability, and the bid price.  Generally, CMS awards contracts to the suppliers that offer 
lower bid prices and meet applicable quality standards and financial standards.  The payment 
amounts resulting from winning bids replace the Medicare fee-schedule amounts for the selected 
items.  Generally, contract awards and payment amounts expire every 3 years, and contractors 
must recompete to remain contract suppliers.7  
MIPPA further qualified the competition for diabetes test strips.  The Act requires that, in rounds 
subsequent to the first round, mail order suppliers demonstrate in their bids that they can provide 
at least 50 percent, by volume, of the types of diabetes test strips provided to Medicare 
beneficiaries.  Suppliers do this by declaring in their bids the types of diabetes testing strips they 
intend to provide.  The MIPPA 50-percent rule did not apply to suppliers bids in Round 1 or the 
Round 1 Rebid described below.8 
Round 1 of the Competitive Bidding Program and the Round 1 Rebid.  The MMA required CMS 
to phase in, through several rounds of bidding, a Competitive Bidding Program for DMEPOS 
items (including diabetes test strips).9  Contracts between CMS and suppliers became effective in 
ten selected Competitive Bidding Areas (CBAs) on July 1, 2008.10 
Two weeks after the Round 1 contracts between CMS and suppliers became effective, Congress 
enacted MIPPA, which mandated that CMS enact the following changes to the Competitive 
Bidding Program: 
  terminate contracts awarded to suppliers in Round 1; 
  repeat the Round 1 competition in 2009; and 
  institute the MIPPA 50-percent requirement for mail order diabetes test strips in all 
rounds following the repeat of the Round 1 competition.11  
The repeat of the Round 1 competition is known as the Round 1 Rebid.  The Round 1 Rebid was 
in nine CBAs (the same areas as in Round 1, except Puerto Rico).12  The competition for 
contracts in the Round 1 Rebid began in October 2009, and suppliers began providing 
competitively bid DMEPOS items to beneficiaries in the nine selected CBAs on January 1, 
2011.13  This round ended in December 2013.  Subsequent rounds include implementation of the 
current Round 1 Recompete (January 2014  December 2016) for the nine selected CBAs and 
the forthcoming Round 1 2017 (January 2017  December 2019) for thirteen selected CBAs. 
Before 2011, Medicare reimbursed all suppliers of diabetes test strips on the basis of fee-
schedule amounts that 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-CBA areas was $32.47, and the national average payment 
for non-mail order diabetes test strips was $37.67.  CMS reported that the Competitive Bidding 
Program saved the Medicare program nearly $202.1 million in the first year of implementation, 
including $51.3 million in savings for diabetes supplies provided via mail order.14  
Round 2 of the Competitive Bidding Program and Start of the National Mail Order Program. 
MIPPA required competition for Round 2 of the Competitive Bidding Program to occur in 
6 
  70 additional Metropolitan Statistical Areas (MSAs) and authorized the National Mail Order 
Program.15  The Patient Protection and Affordable Care Act (ACA) further expanded the number 
of MSAs to 91, resulting in 100 CBAs, and required CMS to either expand the DMEPOS 
Competitive Bidding Program nationwide or adjust payment rates using competitively bid rates 
by 2016.16  Round 2 of the Competitive Bidding Program and the initial round of the National 
Mail Order Program began on July 1, 2013, and ended on June 30, 2016.  In accordance with the 
American Taxpayer Relief Act of 2012 (ATRA), CMS set a single payment amount at $10.41 
per box of diabetes test strips  both for those obtained via mail order and those obtained by 
other means.17  CMS reported that the Medicare program saved approximately $3.6 billion 
during the first 2 years of the DMEPOS contracts (i.e., from July 1, 2013 to June 30, 2015) after 
the start of Round 2 of the Competitive Bidding Program.18  
Start of the Round 2 Recompete of the Competitive Bidding Program and the National Mail 
Order Recompete.  On July 15, 2014, CMS announced that it would conduct a recompetition of 
contracts that had been awarded in Round 2 of the Competitive Bidding Program and the 
National Mail Order Program.  The Round 2 Recompete and the National Mail Order Recompete 
occurred in the same geographical locations as the previous round; however, CMS expanded the 
number of CBAs from 100 to 117.19  Contracts for the Round 2 Recompete and National Mail 
Order Recompete became effective on July 1, 2016 and will expire on December 31, 2018.20  
Under this program, diabetes test strips are again reimbursed at the same competitive bidding 
payment rate whether they are provided by mail order or by other means, and this rate was 
reduced to $8.32 per 50-count box.21  See Figure A for a timeline of the Competitive Bidding 
and National Mail Order Programs. 
Figure A: Timeline of Competitive Bidding and National Mail Order Programs 
 
7 
  APPENDIX B 
Table B-1: Model, Manufacturer, and Market Share Estimates for Mail Order Diabetes 
Test Strips, April through June 2016 
 
Model  Manufacturer  Market Share  95-Percent  
Confidence Interval  
ACCU-CHEK 
Roche   0.55%  0.241.27% 
Aviva Plus 
ACCU-CHEK 
Roche   0.37%  0.150.92% 
Compact Plus 
ACCU-CHEK 
Roche   0.30%  0.110.82% 
SmartView* 
ADVOCATE Redi- BroadMaster Bio-Tech 
2.46%  1.623.73% 
Code+  Corp. 
Panasonic Health 
Breeze 2  0.28%  0.080.93% 
Holdings Co., Ltd. 
CareSens N  i-Sens, Inc.  0.16%  0.040.63% 
CareSens Strips  i-Sens, Inc.  7.43%  5.909.31% 
Clever Choice   Simple Diagnostics  0.04%  0.010.28% 
Clever Choice Voice   Simple Diagnostics  0.16%  0.050.52% 
Panasonic Healthcare 
CONTOUR  2.60%  1.753.84% 
Holdings Co., Ltd. 
Panasonic Healthcare 
CONTOUR NEXT  2.64%  1.584.38% 
Holdings Co., Ltd. 
Oak Tree International 
EasyMax   0.04%  0.010.28% 
Holdings, Inc. 
Easy Talk  Home Aide Diagnostics  0.51%  0.221.18% 
Element Compact  Infopia USA LLC  0.63%  0.301.34% 
Element Plus  Infopia USA LLC  0.12%  0.020.84% 
Embrace  Omnis Health  11.49%  9.6513.63% 
GlucoCard Vital  ARKRAY   0.04%  0.010.28% 
Gmate  Philosys  3.09%  2.254.25% 
Nova Max  Nova Biomedical  0.73%  0.301.78% 
On Call Express  ACON Laboratories  0.04%  0.010.28% 
On Call Plus  ACON Laboratories  0.28%  0.080.99% 
OneTouch Ultra   LifeScan, Inc.  22.82%  20.0725.83% 
OneTouch Verio  LifeScan, Inc.  0.24%  0.051.01% 
Prodigy   Prodigy Diabetes Care  28.22%  25.3731.07% 
                          continued on next page 
8 
  Table B-1 (Continued): Model, Manufacturer, and Market Share Estimates for Mail Order 
Diabetes Test Strips, April through June 2016   
           
Model   Manufacturer  Market Share  95-Percent 
Confidence Interval  
Rightest GS 300  Bionime Corporation  0.63%  0.301.31% 
BioSense Medical 
SolusV2  1.16%  0.552.42% 
Devices 
TRUEmetrix  Trividia Health, Inc.  1.69%  1.032.78% 
TRUEtest  Trividia Health, Inc.  10.98%  9.1113.17% 
TRUEtrack  Trividia Health, Inc.  0.04%  0.010.28% 
Unistrip Technologies, 
Unistrip1  0.26%  0.061.06% 
LLC 
     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 2016. 
*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. 
 
Table B-2. Medicare Market Share Estimates for Top 2, Top 5, and Top 10 Types of Mail 
 
Order Diabetes Test Strips, April through June 2016
Groupings of Strip Types with  Market Share  95-Percent  
Largest Market Share*   Confidence Interval  
  Top 2 Strip Types  51.04%  47.7854.30% 
  Top 5 Strip Types  80.94%  78.1783.43% 
  Top 10 Strip Types  93.44%  91.5994.90%  
Source:  OIG analysis of supplier documentation and Medicare claims containing 
HCPCS code A4253 KL for the 3-month period of April to June 2016. 
*Top 2 strips include Prodigy and OneTouch Ultra.  Top 5 strips includes the Top 2 plus 
Embrace, TRUEtest, and CareSens Strips.  Top 10 strips includes the Top 5 plus Gmate, 
CONTOUR NEXT, CONTOUR, Advocate Redi-Code+, and TRUEmetrix. 
 
 
 
 
 
 
 
 
 
9 
  APPENDIX C 
OIGs Past, Current, and Planned Work on Medicare Diabetes Test Strips Market Share 
MIPPA section 154(d)(3)(B) requires OIG to determine the market shares of types of diabetes 
test strips provided by mail order in the Competitive Bidding Program before each new round of 
bidding.  For Round 2, CMS requested that OIG complete an additional report just before the 
start of a new round implementation and another report three months after implementation.  
CMS used these reports to further evaluate the effect of the National Mail Order Program on the 
types of diabetes test strips available to beneficiaries.  For the current Round 2 Recompete, CMS 
has again requested this series of reports.  See Figure C-1 for a timeline of OIG work on the 
Medicare Market Shares Diabetes Test Strips. 
Figure C-1: OIG Work on the Medicare Market Shares of Diabetes Test Strips  
 
10 
  ACKNOWLEDGMENTS 
 
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, Deputy Regional 
Inspector General.  
 
David Samchok 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 Lori Jouty and 
Lucio Verani.  Office of Evaluation and Inspections staff who provided support include 
Kevin Farber, Melissa Medeiros, and Christine Moritz. 
 
   
11 
  ENDNOTES
 
 
1 National Institutes of Health (NIH), Causes of Diabetes. Accessed at https://www.niddk.nih.gov/health-
information/diabetes/causes on November 3, 2016. 
2 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 November 3, 2016. 
3 Other diabetes testing supplies may include batteries, lancets, and control solution. 
4 CMS, MLN Matters Number SE1008 Revised.  Medicare Coverage of Blood Glucose Monitors and Testing 
Supplies. Accessed at http://www.cms.gov/MLNMattersArticles/downloads/SE1008.pdf on July 1, 2016.  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 noninsulin-dependent beneficiaries with diabetes.  Medicare allows 
additional test strips if they are deemed medically necessary and documented in physician records.  Medicare LCD 
for Glucose Monitors (L33822 for DME MAC Jurisdictions A, B, C, and D). 
5 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 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. 
6 42 CFR  414.402 (defining mail order item). 
7 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). 
8 MIPPA, P. L. No. 110-275  154(d)(3)(B) (adding new paragraph Social Security Act,  1847(b)(10)(A), 42 
U.S.C.  1395w-3(b)(10)(A)). 
9 MMA, P.L. No. 108-173  302(b)(1). 
10 The CBAs define the geographic coverage areas of the program according to specific ZIP Codes.  A CBA that is 
identified with a specific Metropolitan Statistical Areas (MSA) may be concurrent with, larger than, or smaller than 
the related MSA. CMS, Medicare Claims Processing Manual, Pub. No. 100-04, ch. 36,  20.2.  The ten CBAs in 
Round 1 were CharlotteGastoniaConcord (North Carolina and South Carolina), CincinnatiMiddletown (Ohio, 
Kentucky, and Indiana), ClevelandElyriaMentor (Ohio), DallasFort WorthArlington (Texas), Kansas City 
(Missouri and Kansas), MiamiFort Lauderdale Pompano Beach (Florida), OrlandoKissimmee (Florida), 
Pittsburgh (Pennsylvania), Riverside San BernardinoOntario (California), and San Juan-Caguas-Guaynabo, 
Puerto Rico.  CMS, MLN Matters Number MM6112 Revised.  Payment for Complex Rehabilitative Power Mobility 
(PMD) Services that Span the Implementation Dates of DMEPOS Competitive Bidding Programs in Competitive 
Bidding Areas.  Accessed at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-
MLN/MLNMattersArticles/downloads/MM6112.pdf on November 16, 2016. 
11 MIPPA, P.L. No. 110-275  154(a)(1) and (d)(3)(B).   
12 Competitive Bidding Areas (CBAs).  Accessed at http://dmecompetitivebid.com/Palmetto/Cbic.Nsf/files/ 
Fact_Sheet_Competitive_Bidding_Areas.pdf/$File/Fact_Sheet_Competitive_Bidding_Areas.pdf on November 16, 
2016. 
13 CMS, Important Dates, Round 1 Rebid Timeline. Accessed at http://dmecompetitivebid.com/palmetto/ 
cbicrd1rebid.nsf/docsCat/Round%201%20Rebid~Important%20Dates~Timeline?open&expand=1&navmenu=Impo
rtant^Dates| on November 16, 2016. 
14 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 September 23, 2016.   
15 MIPPA, P.L. No. 110-275  154(a)(1)(A)((ii) and (iii) (amending Social Security Act,  1847(a)(1)(B)(i)(II) and 
(III), and 42 U.S.C.  1395w-3(a)(1)(B)(i)(II) and (III)). 
16 ACA, P.L. No. 111-148  6410(a)(1) and (b).  ACA expanded the number of Round 2 MSAs from 70 to 91.   
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.  Therefore, there were 100 CBAs in Round 2. CMS, DMEPOS Competitive Bidding 
Program, Round 2 & National Mail-Order. Accessed at http://dmecompetitivebid.com/palmetto/ 
cbicrd2.nsf/DocsCat/Home. 
 
12 
   
17 ATRA, P.L. No. 112-240  636 (adding a new subparagraph Social Security Act,  1834(a)(1)(H), 42 U.S.C.  
1395m(a)(1)(H)).  CMS, DMEPOS Competitive Bidding Program: Single Payment Amounts, National Mail Order 
Diabetic Supplies (effective July 1, 2013). Accessed at http://dmecompetitivebid.com/Palmetto/Cbicrd2.Nsf/ 
files/NMO_SPA_Chart.pdf/$File/NMO_SPA_Chart.pdf on September 23, 2016. 
18 CMS, Competitive Bidding Program Continues to Maintain Access and Quality While Saving Medicare Billions. 
Accessed at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-03-
15.html on July 11, 2016. 
19 In addition to the three largest MSAs (i.e., Chicago, Los Angeles, and New York) that CMS subdivided into 
multiple CBAs during Round 2, for the Round 2 Recompete, CMS redefined CBAs in multi-state MSAs so that 
there are no multi-state CBAs.  CMS, Round 2 Recompete and National Mail-Order Recompete.  Accessed at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSCompetitiveBid/Round-2-Recompete-
and-National-Mail-Order-Recompete/Overview.html on September 23, 2016. 
20 CMS, DMEPOS Competitive Bidding Program.  Accessed at http://www.dmecompetitivebid.com/palmetto/
cbicrd2recompete.nsf/vMasterDID/9KJQN52683 on September 20, 2016. 
21 CMS, Public Use File V0817.  Accessed at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule-Items/DME16-
C.html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending on June 29, 2016. 
13