| Click on a question to expand or Show All / Close All - May a nurse practitioner (NP) or physician assistant (PA) create the medical record showing treatment for the diabetic condition and is it then sufficient if the medical doctor (M.D.) or doctor of osteopathy (D.O.) co-signs the medical record?
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There are two scenarios in which an NP may serve as a "Certifying Physician" and one scenario in which a PA may serve as a "Certifying Physician." Only NPs participating in the Primary Care First (PCF) Model Demonstration Project or are practicing "incident to" physician's services are eligible to serve as the "Certifying Physician" for therapeutic shoes and shoe inserts. Only PAs practicing "incident to" physician's services are eligible to serve as the "Certifying Physician" for therapeutic shoes and inserts. See article excerpts below. "Nurse Practitioners and Physician Assistants as Certifying Physicians for Therapeutic Shoes and Inserts" Nurse practitioners (NPs) or physician assistants (PAs) providing ancillary services as auxiliary personnel could meet the "incident to" requirements in their provision of therapeutic shoes to beneficiaries with diabetes if all the requirements are met: - The supervising physician has documented in the medical record the patient is diabetic and has been, and continues to provide, the patient follow-up under a comprehensive management program of that condition; and
- The NP or PA certifies the provision of the therapeutic shoes is part of the comprehensive treatment plan being provided to the patient; and
- The supervising physician must review and verify (sign and date) all of the NP or PA notes in the medical record pertaining to the provision of the therapeutic shoes and inserts, acknowledging their agreement with the actions of the NP or PA
- Practicing "incident to" the supervising physician (M.D. or D.O.)
- In states where the NP may practice independently, the NP's employment situation would require compliance with Medicare "incident to" rules in order to serve as the "Certifying Physician."
"Primary Care First Model Demonstration Project – Nurse Practitioner as Certifying Physicians for Therapeutic Shoes and Inserts" The Centers for Medicare and Medicaid (CMS) is exercising its authority under the Primary Care First (PCF) Model Demonstration Project to waive Section 1861(s) of the Act and the implementing regulations at 42 CFR 410.12: - Effective January 1, 2021 – December 31, 2025
- Allow nurse practitioners (NPs) practicing independently to serve as the "Certifying Physician"
- Complete the face-to-face diabetic exam
- Refer and certify beneficiary for diabetic shoes/inserts
- Obtain, initial and date the exam notes of a podiatrist/other clinician who has documented the qualifying foot exam
- Complete the "Statement of Certifying Physician"
- CMS will launch the PCF model in 26 regions
- Suppliers servicing beneficiaries in the 26 model demonstration regions will need to ensure the nurse practitioner (NP) participates in the Primary Care First (PCF) Model Demonstration Project
Originally published: 04.29.21
Reviewed: 12.08.23 - May a nurse practitioner (NP) or physician assistant (PA) complete and sign, then have an M.D. or D.O. co-sign the Statement of Certifying Physician?
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NPs and PAs practicing "incident to" may complete, sign, and date the Statement of Certifying Physician; however, the supervising physician (M.D. or D.O.) must review and verify (sign and date), acknowledging agreement with the NP or PA. NPs participating in the Primary Care First (PCF) Model Demonstration Project (practicing independently) may complete, sign and date the statement. Originally published: 04.29.21
Reviewed: 12.08.23 - The Statement of Certifying Physician must be signed and dated within three months (90 days) prior to the delivery of diabetic shoes and shoe inserts. Which date will count for documentation guidelines: the date the nurse practitioner (NP) or physician assistant (PA) practicing "incident to" signs and dates the statement? Or the date the M.D./D.O. reviews and verifies (signs and dates) the statement?
- If a medical professional – podiatrist (DPM), nurse practitioner (NP), clinical nurse specialist (CNS), physician assistant (PA), another M.D. or D.O. – other than the "Certifying Physician" conducts a foot examination, does the "Certifying Physician" also have to conduct a foot exam?
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No. If the "Certifying Physician" (M.D., D.O., NP/PA practicing "incident to," or NP participating in the Primary Care First (PCF) Model Demonstration Project) does not personally conduct the foot examination, they must obtain, indicate agreement, sign, and date the foot examination completed by another medical professional. If an NP/PA practicing "incident to" indicates agreement, signs and dates the foot examination completed by another medical professional, the supervising physician (M.D. or D.O.) must also review and verify (sign and date). The foot examination conducted by another medical professional is expected to be detailed, discuss the qualifying foot conditions(s), occur within 6 months prior to delivery of the shoes/inserts, and occur prior to or on the same day the certification statement is signed. Originally published: 04.29.21
Reviewed: 12.08.23 - May a nurse practitioner (NP) or a physician assistant (PA) practicing "incident to" sign some of the documentation and the M.D. or D.O sign other parts of the documentation? Or does it have to be completed by the same person?
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All documentation by the treating practitioner must be authenticated by the author, consistent with the signature requirements in the CMS Program Integrity Manual (Internet-only Manual 100-08), Chapter 3, Section 3.3.2.4 . The supervising physician (M.D., D.O.) must review and verify (sign and date) all the nurse practitioner (NP) or physician assistant (PA) practicing "incident to" notes in the medical record pertaining to the provision of the therapeutic shoes and inserts, acknowledging their agreement with the action of the NP or PA. Originally published: 04.29.21
Reviewed: 12.08.23 - Does the M.D. or D.O. have to be in the office at the time of the actual patient exam by the nurse practitioner (NP) or physician assistant (PA)? Or can the M.D. or D.O. co-sign the note on a different date after the exam even if they were not "directly supervising"?
- May a nurse practitioner (NP) working independently, enrolled in the Primary Care First (PCF) Model Demonstration Project, have the power to be the certifying and prescribing entity, as well as the supplier?
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Nothing about the Primary Care First (PCF) Model Demonstration Project modifies the restriction on the "Certifying Physician" serving as the supplier. As with the M.D. or D.O. restriction, the certifying nurse practitioner (NP) may not serve as the supplier, unless they are practicing in a defined rural area or in a defined health professional shortage area. From the Therapeutic Shoes for Persons with Diabetes Policy Article [A52501): The Supplier is the person or entity that actually furnishes the shoe, modification, and/or insert to the beneficiary and bills Medicare. The supplier may be a podiatrist, pedorthist, orthotist, prosthetist or qualified individual. The "Prescribing Practitioner" may be the supplier. The "Certifying Physician" may only be the supplier if the certifying physician is practicing in a defined rural area or a defined health professional shortage area. (Emphasis Added) Originally published: 04.29.21
Reviewed: 12.08.23 - Who can sign the standard written order (SWO) for diabetic shoes?
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The "Prescribing Practitioner" is the person who writes the order for the therapeutic shoes, modifications, and inserts. This practitioner must be knowledgeable in the fitting of diabetic shoes and inserts. The prescribing practitioner may be a - Podiatrist (DPM)
- M.D. or D.O.
- Nurse Practitioner (NP)
- Clinical Nurse Specialist (CNS)
- Physician Assistant (PA)
The prescribing practitioner may be the supplier (i.e., the one who furnishes the footwear). Originally published: 04.29.21
Reviewed: 12.08.23 - The beneficiary has a systemic diabetic condition visit and foot examination conducted in November 2020, and they received diabetic shoes in December 2020. Can the supplier still use the diabetic condition and foot examination notes to deliver shoes in January 2021?
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The Statement of Certifying Physician must be completed within 3 months of diabetic shoe delivery. The diabetic shoe benefit is a calendar year benefit. As such, it is possible for a beneficiary to receive a pair of shoes late in one calendar year (assuming they have not already received a pair in the calendar year) and an additional pair early in the following calendar year. Also note that the clinical condition of a diabetic foot can change rapidly; therefore, it may be appropriate to have a new foot exam before providing new therapeutic shoes and inserts. *Note: A new certification statement is required for a shoes, inserts or modifications provided more than one year from the most recent certification statement on file. Originally published: 04.29.21
Reviewed: 12.08.23 - If the medical record states "poor circulation," is this enough documentation to meet one of the requirements 2a-2f?
- What is required to show a comprehensive plan of care for the beneficiary's diabetic condition in the "Certifying Physician's" records?
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The "Certifying Physician" – M.D., D.O., nurse practitioner (NP)/physician's assistant (PA) practicing "incident to" or NP part of the Primary Care First (PCF) Model Demonstration Project – managing the beneficiary's systemic diabetic condition must indicate a comprehensive plan of care in the medical record. This is more than a diagnosis in the medical record. Numerous guidelines from clinical organizations related to diabetes care provide detailed information about the various elements of the care plan for persons with diabetes. Originally published: 04.29.21
Reviewed: 12.08.23 - If the beneficiary tries on the shoes and states "they feel great and fit fine," does this meet the requirement of the supplier's in-person evaluation at time of delivery?
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No. An objective assessment must be completed by the supplier. A subjective assessment by the beneficiary, such as the statement in this question, does not meet this requirement. Originally published: 04.29.21
Reviewed: 12.08.23 - What does Medicare consider a valid foot deformity, which meets requirements for diabetic shoes?
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The foot examination should include details of a musculoskeletal evaluation for any gross deformity of the feet and related structures which impact the feet. This may encompass a wide variety of conditions, some of which commonly include (not all-inclusive) - Hammer Toes
- Claw Toes
- Bunions
- Pes Planus (flat foot or fallen arches)
- Charcot Arthropathy
Originally published: 04.29.21
Reviewed: 12.08.23 - Why do suppliers have to take an impression of the beneficiary's feet for custom inserts every year when some manufacturers say the molds are good for "X" number of years?
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As noted above, the clinical condition of a diabetic foot can change rapidly. When providing new custom-molded shoes and/or inserts, making a new impression, cast, or CAD-CAM image(s) ensures that any changes in the beneficiary's foot condition are considered. The Local Coverage Determination (LCD) states the supplier must have an in-person evaluation with the beneficiary at the time of selection. If custom-molded shoes (A5501) and inserts (A5513 or A5514) are ordered, the supplier must make impressions, casts, or CAD-CAM images of the beneficiary's feet which will be used in creating positive models of the feet. Originally published: 04.29.21
Reviewed: 12.08.23 Additional Resources - Dear Physician – Therapeutic Shoes for Diabetics – Physician Documentation Requirements
- Nurse Practitioners and Physician Assistants as Certifying Physicians for Therapeutic Shoes and Inserts
- Primary Care First Model Demonstration Project - Nurse Practitioners as Certifying Physicians for Therapeutic Shoes and Inserts
- Therapeutic Shoes for Persons with Diabetes Documentation Checklist
- Therapeutic Shoes for Persons with Diabetes Activity Timeline
- Therapeutic Shoes for Persons with Diabetes LCD
- Therapeutic Shoes for Persons with Diabetes Policy Article
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