READ CAREFULLY. THIS IS THE TRUTH MY FRIEND FROM THE PRESIDENT OF SMITH AND NEPHEW!!!!
July 15, 2014
By Facsimile and Federal Express
Re: Smith & Nephew, Inc.’s RENASYS™ Negative Pressure Wound Therapy Systems (NPWT)
Dear Customer :
As you know, the FDA recently requested Smith & Nephew to obtain additional regulatory
clearances through the premarket notification 510(k) process with respect to certain design
modifications made to the RENASYS NPWT product line in late 2013. Those changes were made in response to customer feedback. At the time the changes were made, we followed our internal procedures and determined that a new clearance was not required. In June, the FDA advised us that such clearance would be required to market the modified RENASYS products. (The original products went through all of the required FDA processes before being
introduced commercially.) We have complied with the FDA request to cease commercial
distribution of the RENASYS product line in the United States until the additional
clearances are obtained.
Subsequent to the request, we raised concerns with the FDA about potential patient
continuity of care, and access to care, issues resulting from the cessation of distribution.
The FDA acknowledged that some institutions and homecare providers may experience an acute shortage of RENASYS products to the detriment of patient care and authorized the limited distribution by Smith & Nephew of these products under a Certificate of Medical Necessity (CMN) program. Details of the CMN program are available from your Smith & Nephew representative or our Customer Care Center.
I am writing to update you on further developments relating to RENASYS systems in the
United States. Smith & Nephew is working collaboratively with the FDA to secure clearance for the modified RENASYS systems. It is now apparent to us that the 510(k) clearances for these products will take longer than we had expected – at least three months and probably longer.
Moreover, in a recent discussion with us, the Medical Director of a regional durable medical
equipment Medicare Administrative Contractor (MAC) expressed his belief that, until the
additional 510(k) clearances are obtained, the modified RENASYS products do not meet the
minimum threshold for eligibility for Medicare coverage – clearance by the FDA. He did not
believe that he has the discretion to decide otherwise, although CMS could make a
determination that additional flexibility is warranted under the circumstances. (Medicare and
other government payors generally do not cover medical devices that are not cleared for
marketing.) We understand the MAC Medical Director shared his thinking with the other DME
MACs. Given the complexity of this issue, we are in the process of contacting the CMS central office in Baltimore to discuss this situation and, if the guidance changes, we will
communicate that to you.
In the meantime, we recommend that you furnish this information to, and consult with, your
reimbursement/billing experts about billing for the use of RENASYS products on federal
health care program patients, such as Medicare, Medicaid, TRICARE, VA and DOD patients, and also federal employee health benefits program patients.
Additionally, you may wish to consult with your reimbursement/billing experts regarding
commercial payors who may also consider the FDA’s communication relevant to assessing
coverage. In the light of these uncertainties, customers should consider transitioning patients to an alternative NPWT device.
We deeply regret the disruption caused by this situation and will continue to assist you as
best we can. If you have any questions, please call the Smith & Nephew Customer Care Center at 1-800-876-1261.
Sincerely,
Francois Fournier
President, North America Advanced Wound Management