The following letter is regarding the CMS’ (Center for Medicare and Medicaid Services) opening of a national coverage analysis for the specific use of dermal injections for the treatment of Facial lipodystrophy syndrome (FLS). Doctor Conant urges you to follow the link below and write a comment in support of Medicare coverage for dermal injections (such as Sculptra) based on the fact that the service is reasonable and necessary for the treatment of FLS in HIV infected individuals and greatly improves the quality of life (social interaction, self esteem, etc.) of those affected by FLS.
“On July 16, 2009, CMS announced that treatment of Facial lipodystrophy syndrome (FLS) in association with HIV or AIDS occurring through an injection of fat or other substances into the patient’s face is not statutorily excluded as a cosmetic procedure from Medicare coverage. This benefit category was opened on our request after a client we represented was denied coverage. After over 200 organizations and individuals like you posted comments on the CMS website in favor of coverage for HIV/AIDS related FLS, CMS also announced on July 16, 2009, that the treatment of FLS in association with HIV or AIDs was included in one or more benefit categories.
Now CMS has opened a national coverage analysis for the specific use of dermal injections for the treatment of Facial lipodystrophy syndrome (FLS). (See link below.) On July 16, 2009 CMS announced that it will review the evidence for treating FLS in HIV/AIDS infected patients with dermal injections to determine whether this service is “reasonable and necessary” and therefore warrants coverage.
By way of some guidance, “reasonable and necessary” are terms of art that are used throughout the Medicare statute. 42 USC § 1395y(a)(1)(A). This standard is not the same as the Food and Drug Administration’s “safe and effective” standard. While FDA approval is generally a prerequisite, it is not a guarantee to coverage for a product that is used in treating a patient. With “reasonable and necessary,” the product that is sought to be covered must have clinical value. As Judith Lorette, et al. wrote in Guide to Medicare Coverage Decision-Making and Appeals, Eleanor D. Kinney, Editor, American Bar Association Section of Administrative Law and Regulatory Practice (2002), p.157: . . . “CMS wants to be certain . . .that [the procedure paid for by Medicare] will affect patient management and potentially impact patient outcomes. The collection of data by itself is not sufficient for coverage. In addition, CMS is interested in true functional outcomes, i.e., clinical effects that impact how a patient functions/feels.”
Because we have had success in the past asking others to provide comments during the public comments period in support of coverage, we are asking for help again. Please consider writing a comment in support of Medicare coverage for dermal injections based on the fact that the service is reasonable and necessary for the treatment of FLS in HIV infected individuals. The public comment period is open until 8/15/2009. Please find below the link to the tracking sheet to post comments and a summary of the issue as presented by CMS.
Sincerely,
Dr. Bruce Lord Wilder, Esq.
Prof. Stella L. Smetanka, Esq. and the University of Pittsburgh School of Law Health Law Clinic”
CLICK HERE! (To make a comment, click on the orange button)
