UPIC Auditors Demand Skin Substitute Invoices & Rebate Agreements – Guest Blog by Martha Kelso

Here’s a guest blog from Martha Kelso, Chief Regulatory Officer at Wound Care Plus, LLC, providing a heads-up about the documentation demands for her most recent audit of CTPs/CAMPs/skin substitutes – this time a UPIC audit. According to the Medicare Program Integrity Manual, in addition to data analytics of billing practices, the UPIC can identify leads from news media and conferences.  I think we should interpret “conferences” as “manufacturer marketing materials,” which explains why they demanded the items she put in yellow highlights below.

Martha is one of the most engaging and informative speakers I have ever heard, and I got to hear her present at the recent “Hard to Heal” conference sponsored by Convatec where she talked about compliance requirements for the use of “skin substitutes.” Because Martha’s company sees patients in 22 states, she has been audited by just about every Medicare and Medicaid contractor, and with just about every audit tool. She emphasized that audits are ubiquitous among practitioners using CTPs/CAMPs and they will continue to increase with or without the implementation of the LCDs. Her compliance program is so successful that she’s not experienced a claw back, but doing so requires a laser focus on proper documentation. However, as you can see from the list of the 39 items demanded by the auditor below, the UPIC can ask for a lot more than just the patient’s medical record. In addition to a daunting list of medical record requirements, the list of documentation demands includes copies of: all invoices for skin substitutes and wound care products, all order forms for skin substitutes and wound care products, any rebates for skin substitutes and wound care products, any rebate agreements for skin substitutes and wound care products between the provider and any distributor/manufacturer, and any marketing material presented to “you, the provider, or your patients” for skin substitutes and wound care products – over the past 12 months. Remember that the UPIC can refer a case directly to the OIG/Office of Investigations (OI) for consideration of civil and criminal prosecution and/or application of administrative sanctions (see section 4.9, as well as PIM, chapter 8), so this is not a trivial matter. This list dramatically increases the documentation that a practitioner needs to maintain and provide.

Hello Dr. Fife!

As you know, I’m intimately involved in regulations, audits, and forefronts of all things surrounding wound changes, as much as one can be when running their own practice.  We’ve recently received our most updated audit request for 9 charts as part of the UPIC process and we noticed something VERY interesting.  The auditors have CHANGED the items they have requested in the past, and I believe it speaks to the understanding of some of the “games” many CAMPs companies play with unaware providers.  Take a look for yourself and see if you agree the tides have turned.  I’ll bet your readership would be keenly interested in knowing and being made aware of the shifting tides. Of note, these UPIC requests are specific to UPIC Midwestern, consisting of the following states: Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Ohio, and Wisconsin. 

Here is the list from our March 3^rd, 2025, request:

1. Copy of claim, if available
2. Beneficiary Notice of Liability
3. Authorization of Benefits
4. Consent for Treatment
5. Signed HIPAA Privacy Notification Forms
6. Signature card, including the printed names and signatures of all personnel documenting in the beneficiary’s chart, including physicians
7. Electronic Signature Policy
8. Progress notes/visit records detailing service provided for each date of service billed
9. Physician order(s)
10. History and Physical Examination
11. Procedure Note(s), if applicable
12. Laboratory test results, if applicable
13. Radiology reports, if applicable
14. All progress notes including wound measurements
15. Specific wound care orders containing: the type of wound care dressing, frequency of the dressing change and expected duration with the size of the dressing and number to be used at one time (if more than one).
16. Whether the dressing is being used as a primary or secondary dressing or for some noncovered use (e.g., wound cleansing).
17. The type of each wound (e.g., surgical wound, pressure ulcer, burn, etc.), its location, its size {length x width in cm.) and depth, the amount of drainage, and any other relevant information
18. All documentation of the wound care dressing changes.
19. All evaluations of the patient’s wound(s) performed -unless there is documentation in the medical record which justifies why an evaluation could not be done within this timeframe and what other monitoring methods were used to evaluate the patient’s need for dressings/product use.
20. All documentation related to operative procedures performed, including:
    1. Consent forms
    2. Intra-operative or Intra-procedural notes
    3. Anesthesia notes
    4. Nursing notes
    5. Post-anesthesia care notes
    6. Operative or procedural reports
    7. Medication administration records
21. Previous treatment received to include dates, diagnosis for treatment, treatment administered, and progress/response to treatment
22. Copy of the face sheet, including the beneficiary contact information, telephone number(s), address, and emergency contact information
23. Copy of Medicare card and state identification card ( driver’s license or state identification)
24. Patient encounter/visit forms
25. Consultation reports/records
26. Signature card/sheet, including the printed names and signatures of all personnel documenting in the beneficiary’s record
27. Contractual agreements with any Skilled Nursing Facilities, Nursing Homes, Home Health agencies, etc.
28. If electronic signatures used, documentation to verify the entries are appropriately authenticated/dated, the system has safeguards to prevent unauthorized access, and a process is in place for reconstruction
29. If electronic health records (EHR) are used, complete EHR audit trails
30. Any and all medical findings and any other documentation to support the claim(s) and medical necessity of the billed service(s)
31. For all skin substitutes and wound care products, including but not limited to Affinity, Puraply, Nushield and Epifix.
32. Copy of all inventory logs, including lot numbers, for skin substitutes and wound care products in the last 12 months.
33. Copy of all Invoices for skin substitutes and wound care products in the last 12 months
34. Copy of all order forms for skin substitutes and wound care products in the last 12 months
35. Copy of any rebates for skin substitutes and wound care products in the last 12 months
36. Copy of any rebate agreements for skin substitutes and wound care products between the provider and any distributor/manufacturer
37. Any marketing material presented to you, the provider, or your patients for skin substitutes and wound care products
38. A list of any abbreviations and symbols used in documentation
39. Copies of licenses and/or certifications for all personnel documenting in the beneficiary’s chart and/or performing services, including
    1. Physician
    2. Nurse Practitioner
    3. Nursing

Compare the list above to our UPIC request from May 12, 2022:

1. Copy of claim, if available
2. Copy of the face sheet; to include the recipient’s contact information: telephone number(s), address, emergency contact information
3. Copy of Medicaid card and state identification card (driver’s license or state ID)
4. Signature card including the printed names and signatures of all personnel documenting in the recipient’s chart
5. All applicable Minimum Data Set (MDS) assessments for the period(s) billed-this includes the initial MDS and all subsequent MDS assessments that correspond with the billed dates of service
6. All acute hospital discharge summary and transfer forms
7. Physician’s certification and recertification for skilled care
8. Physician’s orders specifying the need for nursing facility care
9. All Physician/mid-level practitioner orders
10. Physician/mid-level practitioner progress notes and visit records
11. Skin and wound care evaluations and notes
12. Results of any diagnostic testing (i.e., laboratory, radiology, electrodiagnostic and pathology reports)
13. Previous treatments received to include dates, diagnosis for treatment, treatment, and progress/response to treatment
14. Treatment records
15. All documentation related to operative procedures performed, including:
    1. Consent forms
    2. Intra-operative or Intra-procedural notes
    3. Anesthesia notes
    4. Nursing notes
    5. Post-anesthesia care notes
    6. Operative and/or procedural notes and reports
    7. Medication administration records
16. History and physical examination
17. Emergency department records, if applicable
18. Discharge summary
19. Occupational, physical, and/or speech therapy rehabilitation therapy notes, including evaluations, re-evaluations, and all progress notes
20. Admission and discharge assessments
21. Transfer forms
22. Resident care plan
23. Respiratory and oxygen records
24. Medication administration records including any IV medications (MARS)
25. Treatment administrations records (TARS)
26. Social services assessments and progress notes
27. Dietician assessments and progress notes
28. Activity assessments and progress notes
29. All treatment records that relate to the condition for which services were rendered that skilled the client for nursing facility coverage
30. Skilled nursing home nursing progress notes
31. Skilled nursing home orders
32. Skilled nursing home medication list
33. Skilled nursing consent for treatment, if applicable
34. Skilled nursing history and physical, if applicable
35. Skilled nursing procedure/treatment notes, if applicable
36. Current and previous treatments received to include dates, diagnosis for treatment, treatment, and progress/response to treatment
37. Consultation reports, if applicable
38. All progress notes, including wound measurements
39. All documentation related to wound care procedures performed
40. All documentation to support services billed
41. A list of any non-standard abbreviations used in documentation
42. Electronic signature policy
43. If electronic signatures are used, provide documentation to verify the entries are appropriately authenticated and dated, the system has safeguards to prevent unauthorized access, and a process for reconstruction
44. If electronic health records (EHR) are used, provide the complete EHR audit trails/logs (chronological records of who accessed the EHR, when it was accessed, where it was accessed, and what was viewed/modified/removed/printed from the EHR, etc.) for each recipient and date(s) of service requested
45. Recipient Notice of Liability
46. Authorization of Benefits
47. Consent for Treatment
48. Signed HIPAA Privacy Notification Forms

Martha R Kelso
Chief Regulatory Officer
Wound Care Plus, LLC

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.