CMS is adopting a Medicare DME minimum lifetime requirement (MLR) and finalizing a 2009 DMEPOS competitive bidding rule as part of its November 10, 2011 ESRD PPS final rule. First, CMS is establishing a 3-year MLR for an item or device to be considered "durable" under the Medicare DME benefit category. The 3-year MLR applies only prospectively, applicable to new items classified as DME after January 1, 2012. In response to comments, CMS confirms that it will not redetermine products currently paid under the DME+ benefit. Moreover, to the extent that a modified (or upgraded) product is not a new product, the 3-year MLR will not be applicable. CMS will consider issuing additional guidance on this issue if necessary. CMS declined to adopt a “rebuttable presumption” that would allow a manufacturer to provide evidence that the 3-year MLR should not be applied automatically in a particular instance. The 3-year MLR will not apply to accessories and supplies (such as blood testing strips or lancets) used with DME. CMS also specifies that the 3-year MLR does not replace the Social Security Act’s reasonable useful lifetime standard used to determine how often payment can be made for replacement items. Second, CMS has finalized its January 16, 2009 interim final rule (in effect since April 19, 2009) that implemented DMEPOS competitive bidding provisions in the Medicare Improvements for Patients and Providers Act of 2008. Among other things, the preamble to the rule addresses: the statutory delay in the DMEPOS bidding timeline; the missing financial documentation feedback process; disclosure of subcontracting information; and exempting certain DMEPOS items from bidding. CMS responds to comments received on the interim final rule but did not adopt regulatory changes.
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