CMS Withdraws Revised Policy Article for Medicare's Therapeutic Shoes for Persons with Diabetes
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CMS Withdraws Revised Policy Article for Medicare's Therapeutic Shoes for Persons with Diabetes

Due to the efforts of the Pedorthic Footwear Association (PFA) and others, the Centers for Medicare and Medicaid Services (CMS) has withdraw its June 14, 2009 Policy Article for the therapeutic shoe benefit, which was to have been effective August 1, 2009.  The majority of the changes to the Policy Article was minor and included adding modifiers, revising instructions and clarifying definitions.  However, there were two changes with which PFA took exception.

1.  A section added to the revised Policy Article provided terms used in the definitions for the A5512 and A5513 inserts.  One of the terms defined multiple density to mean "…that there are three or more layers of material, each having a different firmness (durometer).”   The current Policy Article or Local Coverage Determination (LCD) doesn't define multiple density to include a specific number of layers, but the industry standard provides for two layers.

Given the date that the Policy Article was released, PFA was extremely concerned that manufacturers of the multiple density inserts would NOT be able to meet the August 1, 2009 effective date.  Manufacturers of the inserts require a reasonable period of time to retool their manufacturing processes – some of which occurs overseas - ship the product to the States, and begin distribution to the users.  It is unreasonable to expect that manufacturers can accomplish all of this in six weeks.  If there was an interruption in the supply chain between the effective date and the time manufacturers can get their new products into the distribution stream, the most at-risk patients are put at an even greater risk of lower extremity trauma resulting from diabetic complications.  As such, PFA requested a four month delay to the effective date of this portion of the policy article.

2.  An even greater concern to PFA that will impact the integrity of the program at a time when HHS is thoroughly committed to reducing instances of waste, fraud and abuse within Medicare involved the clarified definition of the A5513 insert.

The revised definition in the Policy Article effective August 1, 2009 maintains the definition of the A5512, but expands the A5513 to include two different products:  the A5512 and the A5513.  This essentially provides the opportunity for a less-than-honest supplier to now legally receive reimbursement for an A5513, but only provide a patient with an A5512.

Given HHS' appropriately expanded emphasis on cutting waste, fraud and abuse within the Medicare program, especially within Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS), PFA finds this revised definition wholly unacceptable and contrary to that goal, and requested an immediate return to the earlier definition of the A5513.

CMS has announced that they will revisit the Policy Article and release a revised version in six to eight weeks, taking into account the concerns that were raised by PFA and others after the release of the June 14 version.

PFA will post the new version on its website as soon as it is released.

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