Overuse of skin substitutes (CTPs) to help heal wounds/ulcers has especially come under fire in recent years. Medicare spent more than $10 BILLION on these products in 2024 – more than DOUBLE what was spent the year prior.
States and Services Program
- Start Date: January 15, 2026
- End Date: December 31, 2031
- States Involved: Arizona, New Jersey, Ohio, Oklahoma, Texas, Washington
- The WiseR model will require preapproval for the following procedures:
1. Electrical nerve stimulator
2. Sacral nerve stimulator for incontinence
3. Phrenic nerve stimulator
4. Vagus nerve stimulator
5. Hypoglossal nerve stimulator for sleep apnea
6. ESI
7. Induced lesions of nerve tracts
8. Cervical fusion
9. Knee scope
10. Kypho/vertebroplasty
11. Incontinency control devices
12. Impotence procedures
13. Skin/tissue substitute
Skin Substitutes
- Reimbursement Reform: Skin substitutes (CTPs) reclassified as “incident to supplies” rather than premium priced biologics. This would cut payments by an estimated 80 – 90 %.
- Use Limits: No more than 8 applications per 12 – 16 week treatment episode with documentation required after 4 applications for medical necessity.
- Coverage Restrictions: Payment is limited to FDA approved uses for chronic, non-infected diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) unresponsive to 4 weeks of standard, conservative care.
- Documentation Requirements: Providers must absolutely show wound/ulcer progress, prior failed interventions and medical necessity at each encounter.
How the WISeR Model Will Work
Voluntary vs post-service review:
- Providers in the pilot states will have a choice to submit a prior authorization request for targeted services (ie. skin substitutes) or face an automatic pre-payment review after the service has been rendered. The prior authorization path is designed to be more efficient and provide more certainty of payment.
- The preapproval request can be submitted to the provider’s WISeR representative or MAC, via email, fax or portal.
- If you go through the preapproval process, Medicare will either issue an “affirmation” or “non-affirmation” of the requested procedure within three days of receiving the request. If a non-affirmation is issued, Medicare will explain why, and then the provider can resubmit a new preapproval request.
- Technology-enabled review: CMS will use technology, including artificial intelligence (ie. AI), to expedite the review process. However, final decisions to deny a claim will still be made by a licensed clinician, not a machine.
- Exemptions: The new prior authorization requirement will not apply to emergency services, inpatient-only services, or any service where a delay would harm a patient.
Rationale Behind The Change
- The initiative is intended to protect both Medicare beneficiaries and taxpayers from unnecessary services and fraudulent billing.
- By focusing on services with high rates of improper payments, CMS aims to increase efficiency and reduce wasteful spending.
- The model will last for 6 YEARS and will be overseen by the Center for Medicare and Medicaid Innovation (ie. CMMI), which tests new payment and service delivery models.
- Finalized Part B Medicare Administrative Contractor (ie. MAC) coverage policies (LCDs, Associated Articles regarding Billing and Coding) were scheduled to take effect January 1, 2026.
- The revised version of the LCD for the Application of Skin Substitutes since the January 1, 2026, version has been eliminated will not go into effect as planned.
Michael G. Warshaw, DPM, CPC
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