• Industry Says FDA Requirements Clash With CMS’ Competitive Bid Focus

    Posted: July 26, 2010

    Industry officials, including leadership at the Advanced Medical Technology Association, are calling on FDA and CMS to improve coordination to prevent mixed messaging as part of the competitive bidding process, with FDA recently acknowledging divergent focuses from the two agencies, according to informed industry sources. The disconnect — with CMS and health reformers focusing on lowest prices of products, and FDA stressing more support services — leads to planning confusion for manufacturers of sophisticated therapy products for the home, sources said.

    Manufacturers don’t know whether to develop lowest cost products to win CMS competitions or to strive to meet FDA standards for product support.

  • Harsh Grassroots Criticism of CMS’ Competitive Bidding Implementation Contractor

     An almost two-year old notice on the California American Academy of Family Physicians’ website regarding Palmetto GBA taking over as Medicare Part A/B contractor continues to generate harsh criticism of the organization that also serves as CMS’ Competitive Bidding Implementation Contractor (CBIC).  Examples of relatively recent postings include:

    “We are in Sacramento, does anyone have a name of an attny we can contact. Haven’t been paid since Jan.”

    “I have spoken to an attorney friend about legal action against Palmetto for many of the reasons mentioned all over a simple change of address.”

  • CMS States Small Businesses Receive Less Than Half of Contracts

    CMS has issued a press release stating that small DME suppliers, as defined by CMS not SBA, received only 48% of the Round 1 Rebid contracts.   In their 2008 Notice of Proposed Rulemaking, CMS stated that they “estimate that approximately 90 percent of registered DMEPOS suppliers are considered small according to the SBA definition.

     The complete text of the press release may be found on Bid News at http://www.thecre.com/BidNews/?p=1124