Question Title

* 1. April 2, 2011

Dr. William Rogers
Physician regulatory Issues Team for CMS, Washington
T: 202-236-3338

Dr. Paul Deutsch
Medical Director, MAC J-13
National Government Services, Inc
PO Box 7108
Indianapolis, IN 46206-7108
T: 201-836-1312
F: 201-836-8657

Re: Medicare Reimbursement for Sculptra (CPT Q2027) Radiesse (CPT Q2026) and Administration (G0429)

Dear Drs. Rogers and Deutsch:

We are writing to express our concern with Medicare’s payment schedule for Sculptra and Radiesse administration. As you likely know, Sculptra was approved by the FDA on August 3, 2004 with the following specific indication: “for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus”. The approval of Radiesse soon followed with a similar indication. Facial lipoatrophy, a direct cause of HIV infection and its medications, is the debilitating loss of fat on the face, which causes a gaunt stigmatizing look. The physical signs of lipoatrophy resulting from HIV infection and its associated medications can be so distressing that people may discontinue life-preserving treatment due to the associated depression, loss of self-esteem, HIV/AIDS-associated stigma, and resulting social withdrawal and isolation. Sculptra and Radiesse offer these patients an important option for correction of facial shape and contour deficiencies and this treatment typically results in improved quality of life by mitigating the depressive effect of this syndrome.

Although the FDA approved Sculptra and Radiesse in 2004 for the treatment of HIV associated facial lipoatrophy, Medicare approved reimbursement for these critical products and their administration over a year ago. The purpose of approving reimbursement for these products as medically necessary was to improve access for HIV-infected patients to receive these proven treatments for their serious condition.

However, the cost of acquiring and administering the product is higher than the payment amount set by Medicare. As a result, physicians are not accepting Medicare payments for this service, and patient access to these effective therapies remains quite limited at the current reimbursement rates. In 2010 the Medicare allowance of for an injection fee was set at 80% of $99-$115 (depending on which part of the country the service is administered). The procedure typically takes between 45 to 60 minutes of surgery required to administer Sculptra and/or Radiesse.

As of 2011, the allowance for administration of these products has declined to an unacceptable 80% of $97.00, making it unaffordable and impractical for HIV specialists, dermatologists, or plastic surgeons to administer this treatment. .

Additionally, where Medicare has always allowed reimbursement at 106% of the average wholesale price of a purchased medical product or device to cover administrative and processing costs, these products are being reimbursed at only invoice cost after submission of the invoice.

The undersigned HIV/AIDS community and healthcare providers urge Medicare to:
• immediately reassess the unreasonable reimbursements to physicians for CPT codes G0429 and Q2026, Q2027,
• increase reimbursement for G0429 comparable to other plastic surgical restorative procedures of similar complexity and time commitment (eg 21270)- $500 per treatment
• increase reimbursement for Q2027 to at least 15% over the usual invoice purchase price.

Both HIV/AIDS advocates and specialists would be willing to meet with you or whomever you deem the appropriate Medicare authorities to discuss and rectify this important issue.