Patient Advisory - Toe Joint Replacement:

IMPORTANT UPDATE TO AETNA'S POLICY ON COVERAGE:  September 2008

We are pleased to announce that through our discussions and surgeon communications that Aetna has changed its policy to deem our toe implants medically necessary for the treatment of Hallux Rigidus.  We applaud their willingness to listen and work with the scientific data and surgeon thought leaders.  We would expect other carriers to follow Aetna's policy change.

Click here for the direct link to Aetna's policy page.

 The following is the history of our discussions with Aetna:

 “What do I do if my insurance plan is Aetna?”

Aetna’s clinical policy on Metatarsal Phalangeal (MTP) Joint Replacement is effective since 10/28/2005 and underwent it's last review on 12/21/2007.  Aetna has maintained a policy position considering implants for MTP replacement “experimental and investigational for individuals with pain and/or degenerative changes of the first and other metatarsal phalangeal joints”, and therefore has declined reimbursement to physicians and patients for treatment with our MTP Implants.

http://www.aetna.com/cpb/medical/data/700_799/0708.html


As a patient this means that even if your doctor has chosen the HemiCAP^® MTP implant resurfacing system or any other implant as the preferred treatment for your Great Toe, Aetna will not pay for it.

Arthrosurface has contacted Aetna and submitted a formal request to review its policy again with regards to our implants. This submission included the following: 1) a challenge to the Aetna policy position, 2) a comprehensive review of published peer-reviewed medical literature and 3) a recently published study of our implant in a peer-reviewed medical journal.  The full documents are included below.

   1) View Arthrosurface Request for Policy Review (Cover Letter)

   2) View Arthrosurface Discussion of Aetna Policy

 
  3) View Hasselman et al. peer reviewed publication

Reference:
Hasselman CT, Shields N. Resurfacing of the First Metatarsal Head in the Treatment of Hallux Rigidus. Techniques in Foot & Ankle Surgery 7(1):31–40, 2008


Aetna responded stating that they “do not believe a change in Aetna’s policy is warranted” at this time.

   View Aetna's response


Arthrosurface disagrees with Aetna’s interpretation of some of the medical literature that forms the basis of their policy.

Arthrosurface strongly disagrees with Aetna’s interpretation of the specific medical literature that was referenced in their denial of our request.

Aetna referenced the assessment by the National Institute for Health and Clinical Excellence (NICE 2005) of metatarsophalangeal joint (MPJ) replacement of the Hallux. NICE is an independent organization responsible providing for national guidance on the promotion of good health and prevention and treatment of ill health. Aetna failed to recognize that NICE, indeed concluded that available evidence on the safety and effectiveness of MPJ replacement of the hallux appears adequate to support the use of this procedure.

   View NICE recommendation

National Institute for Health and Clinical Excellence. Metatarsophalangeal joint replacement of the hallux. Interventional Procedure Guidance 140.
London, UK: NICE; November 2005c.
Also available at:
http://guidance.nice.org.uk/IPG140/guidance/pdf/English.
Accessed October 17, 2007.


Aetna reviewed the above mentioned publication by Hasselman and Shields (2008). The study included an average follow-up of 20 months in 25 patients treated with metatarsal HemiCAP resurfacing. Patients achieved significant pain reduction and functional improvement and demonstrated a very high satisfaction rate, indicating that all patients would undergo the procedure again. Despite very promising results, Aetna concluded that the study was limited due to the small patient population size, limited follow-up, and lack of internal comparison with arthrodesis.

Arthrosurface further asked Aetna if they would consider approving individual cases on an interim basis based on the need of the individual patient and the specific recommendation of the doctor.  The HemiCAP^® system would be targeted to those patients where maintaining motion of the joint was a critical factor in the patient's occupation or lifestyle.  Aetna did not respond to this request.

   View Arthrosurface request


If you are insured by Aetna, it is likely that you will not have any MTP Implant treatment option afforded by your plan.  Aetna will pay for arthrodesis (fusion) as a treatment for patients with pain and/or degenerative changes of the first or other metatarsal phalangeal joints.  Fusion is a procedure where the metatarsal bone and the phalangeal bones are set at a predetermined angle and permanently fixed with metal screws. 

Be sure to discuss with your doctor what treatment options are available to you under your health care plan. Your human resources or benefits department may have other options available to you, or may benefit from your feedback, and experience with the healthcare plan they have purchased for their employees.

Arthrosurface is not in a legal position, as an implant manufacturer, to cause Aetna to change its policy of denying reimbursement regarding MTP implants.  If you are a participant in an Aetna healthcare plan and have been denied coverage, you may wish to check with your Human Resources or Benefits department to see if you are in a legal position as an Aetna plan participant to further address Aetna's policy position.