Dr. Fife –

When we last left our clinician, whose CTP/skin substitute claims were being audited by a Unified Program Integrity Contractor (UPIC) and their Medicare Administrative Contractor (MAC), she had been told that allografts when applied to wounds were not “homologous use,” the products were not FDA-approved, were “experimental and investigational” (in part because they have a Q code), the products lacked published data, and were not reasonable and necessary – all of which meant they were not payable by Medicare.

After 14 months, and three denial decisions, the clinician and consultant were allowed to present counter arguments and evidence to an Administrative Law Judge (ALJ) as part of a third level appeal. The ALJ decision was favorable, 40-pages long, and contained noteworthy comments. The comprehensive rebuke of the auditors’ decisions by this very thoughtful Administrative Law Judge seems important. I have listed below what I thought were the major findings of the ALJ:

1. The Appellant has demonstrated that the application of the amniotic and fish membranes as covers to wounds refractory to conservative measures were NOT experimental and investigational and their uses were supported by peer-reviewed human trials demonstrating their medical efficacy.
2. The Appellant has maintained that unlike most products that require formal FDA approval before being considered medically safe and effective, these products do NOT require FDA approval because they are human cells and tissue and cellular and tissue-based products (HCT/Ps) that are eligible to be marketed under section 361 of the Public Health Service (PHS) Act.
3. Additionally, the Appellant maintains that regardless, there is sufficient support from human clinical trials for safety and effectiveness when used as wound coverings to treat chronic wounds with compromised beneficiaries that fail conservative treatment methods.
4. In conducting our own review, we DISAGREE with the Medicare contractors that there are no peer reviewed studies to suggest these tissue covers have been shown to be safe and effective. An article from Bioengineering Journal, entitled “Placental-Derived Biomaterials and Their Application to Wound Healing: A Review”, Nicole M. Protzman, Yong Mao, et. al, July 12, 2023, 10(7):829; doi 10.3390/bioengineering10070829 aids the Appellant’s case.
   • We find that these studies have application to amniotic products regardless of their different names if approved through the FDA Tissue Group. Those studies show that certainly, the use of the amniotic membrane as a wound covering is safe and effective and enhances the body’s ability to heal more than conservative wound treatment methods alone.
5. Determining whether a medical item is Medicare-covered involves a different determination than whether it has been sanctioned by the FDA. We have to determine, through a hierarchy of sources in declining strength of authority, whether the medical item is eligible to be covered by Medicare.
   • There are no statutes, regulations or NCDs that have the force and effect of law governing the use of amniotic membranes or porcine collagens. Most of the wounds were not diabetic foot or venous stasis ulcers.
   • Thus, we agree with the Medicare contractors for the most part that there were no specific LCDs in the beneficiaries’ jurisdictions regarding the wounds at issue.
   • The next consideration then would be Medicare Manuals. The CMS Medicare Program Integrity Manual (MPIM) 100-08, Chapter 3, §3.6.2.2 establishes the “reasonable and necessary criteria”. However, the fact that there exists a current LCD regarding the use of certain wound coverings, including amniotic membranes, for lower extremity diabetic and pressure ulcers does add some veracity to the Appellant’s point that the wound coverings are not experimental or investigational.

• For a number of the beneficiaries and dates of service, the Appellant has demonstrated the conservative measures utilized prior to the application of the wound coverings, that there was progress and identified the future treatment plans.
• As a matter of law, the identified wound covers determined “favorable” were MEDICALLY REASONABLE AND NECESSARY under §1862(a) of the Social Security Act and the documentation requirements of §1833(e) were sufficiently satisfied so that Medicare must provide reimbursement.

 Michael J. Crouch, CPC, CPMA, CHT-ADMIN
michaelcrouch@cplushealthcareconsulting.com
www.cplushealthcareconsulting.com

Caroline Fife, M.D.

Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos

The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.