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Medicare Market Shares of Diabetes Test Strips From April Through June 2019


In 2011, CMS implemented a Competitive Bidding Program (CBP) for mail-order diabetes test strips (DTS) in limited areas, and in July 2013, CMS expanded the program nationally to include a national mail-order program (the National Mail-Order Program). The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) currently prohibits CMS from awarding a CBP contract to a DTS supplier if the supplier's bid does not cover at least 50 percent, by volume, of the DTS types provided to Medicare beneficiaries. (This is known as the 50-percent rule.) This rule is intended to ensure that Medicare beneficiaries have access to top-selling DTS via the National Mail-Order Program. MIPPA requires OIG to determine the Medicare market shares for DTS before each round of bidding. The Bipartisan Budget Act of 2018 amended the 50 percent rule by requiring that, for bids to furnish DTS on or after January 1, 2019, CMS must use multiple sources of data (from the mail-order and non-mail-order Medicare markets). OIG's analysis assists CMS in determining whether bidding suppliers meet this 50-percent rule. Since 2010, OIG has released nine reports evaluating the Medicare market shares for mail-order and non-mail-order DTS. All CBP contracts expired on December 30, 2018. In October 2018, CMS issued guidance stating there would be a temporary gap in the CBP beginning January 1, 2019. CMS has not yet announced when the National Mail-Order Program for DTS will resume being included in the CBP.


Using CMS's National Claims History file, we identified the population of Medicare Part B paid claims for DTS that had dates of service beginning between April 1, 2019, and June 30, 2019. From these populations, we selected a simple random sample of 600 non-mail-order claims and 600 mail-order claims. We sent documentation requests to the 594 non-mail-order suppliers and the 18 mail-order suppliers associated with the claims in our samples. We received responses from all 594 non-mail-order suppliers documenting 600 claims in our sample, a 100-percent response rate. We received responses from 17 mail-order suppliers documenting 599 claims in our sample, a 99-percent response rate. To estimate the Medicare market share of each type of DTS provided via non-mail order and mail order, we projected our sample data to each of the populations of DTS during the timeframe we reviewed.


Non mail-order claims composed 85 percent of the total Medicare market for DTS during the time period we reviewed. The suppliers in our sample provided 25 types of DTS to Medicare beneficiaries via non-mail order and 21 types of DTS via mail order. The suppliers in our samples provided eight types of DTS to Medicare beneficiaries both via non-mail order and mail order.