Statement of Work Therapeutic Shoe Program_Sign 2026.pdf

Department of Health and Human Services Indian Health Service

STATEMENT OF WORK (SOW)

Therapeutic Shoe Program

1. PURPOSE OF THE PROJECT

The purpose of this contract is to provide a comprehensive Therapeutic Shoe Program for eligible American Indian and Alaska Native patients receiving healthcare services through the Indian Health Service (IHS), Lawton Service Unit (LSU).

The Contractor shall provide on-site (in-person) services for all necessary personnel, equipment, supplies, materials, and professional services required to assess patient needs, determine appropriate therapeutic footwear and insert requirements, dispense, modify, adjust, and provide follow-up care for medically necessary therapeutic footwear, diabetic inserts, diabetic socks, and related diabetic foot supplies.

The Therapeutic Shoe Program supports the prevention and management of diabetes-related lower extremity complications by providing medically necessary therapeutic footwear and pedorthic services to eligible patients referred by Lawton Service Unit healthcare providers. The program is designed to reduce the incidence of diabetic foot ulcers, infections, hospitalizations, and lower extremity amputations while improving patient mobility, comfort, independence, and quality of life.

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

2.1. The Contractor shall provide a comprehensive Therapeutic Shoe Program for eligible patients referred by authorized Lawton Service Unit healthcare providers.

2.1.1. The Contractor shall provide patient evaluations, measurements, fittings, dispensing, adjustments, modifications, replacements, and follow-up services for therapeutic shoes, custom or prefabricated inserts, diabetic socks, and other medically necessary diabetic foot supplies.

2.1.2. All therapeutic footwear and supplies provided under this contract shall meet applicable Centers for Medicare & Medicaid Services (CMS) Therapeutic Shoes for Persons with Diabetes coverage requirements, applicable Indian Health Service requirements, and accepted industry standards.

2.2. The Contractor shall perform a comprehensive, in-person diabetic foot and footwear evaluation prior to selecting the specific therapeutic footwear, shoes, inserts, or modifications to be provided to the patient. The evaluation shall be used to determine the appropriate type, size, fit, and configuration of therapeutic footwear and inserts based on the patient's documented clinical needs.

2.2.1. Comprehensive diabetic foot and footwear assessments shall include, as clinically appropriate, foot measurements, gait assessment, evaluation of foot deformities, skin integrity assessment, vascular assessment, protective sensation testing, and evaluation of other clinical factors relevant to the selection and fitting of therapeutic footwear.

2.2.2. The Contractor shall document the in-person evaluation and the clinical basis for the therapeutic footwear, inserts, or modifications selected for the patient.

2.3. The Contractor shall provide therapeutic footwear services only to patients who meet applicable CMS coverage and eligibility requirements for therapeutic shoes for persons with diabetes. The patient must have diabetes mellitus and at least one qualifying condition, including peripheral neuropathy with evidence of callus formation, history of pre-ulcerative calluses, history of previous foot ulceration, foot deformity, previous amputation of the foot or part of the foot, or poor circulation.

The certifying physician or other qualifying healthcare provider, as applicable under CMS requirements, shall document that the patient has diabetes mellitus, is being treated under a comprehensive plan of care for diabetes, and requires therapeutic shoes. The required certifying physician visit and certification shall be completed within the applicable CMS timeframes. Eligibility and medical necessity shall be determined and documented by the referring/certifying Lawton Service Unit healthcare provider in accordance with applicable CMS requirements. The Contractor shall not independently certify a patient's eligibility for the CMS therapeutic shoe benefit.

2.4. The Contractor shall provide patient education regarding therapeutic footwear and diabetic foot care.

2.4.1. Patient education shall include proper therapeutic footwear use, break-in procedures, daily foot inspection, diabetic foot care practices, maintenance of footwear, and follow-up recommendations.

2.4.2. The Contractor shall provide an initial follow-up evaluation after dispensing therapeutic footwear at a time appropriate to the patient's clinical needs and the recommended break-in period. Additional follow-up services shall be provided as clinically indicated. Follow-up services shall include evaluation of shoe fit, comfort, function, safety, patient use, and compliance. The Contractor shall perform adjustments, modifications, exchanges, or replacements when medically necessary to ensure proper fit, safety, and functionality. The number and frequency of follow-up services shall be based on the individual patient's clinical needs and shall not be limited to a predetermined number of visits.

2.5. The Contractor shall coordinate services with the Lawton Service Unit Podiatry Clinic, Primary Care Providers, Diabetes Program staff, and the Contracting Officer's Representative (COR).

2.5.1. The Contractor shall maintain complete patient documentation related to evaluations, fittings, products provided, patient education, follow-up services, and compliance with applicable CMS requirements.

2.5.2. At the time therapeutic footwear, inserts, or related items are delivered to the patient, the Contractor shall conduct and document an objective assessment of the fit of the shoes and inserts. The Contractor shall document any adjustments, modifications, exchanges, or other corrective actions necessary to achieve proper fit, safety, and functionality.

3. PERIOD OF PERFORMANCE

The period of performance for this five (5) year BPA shall be September 30, 2026, through September 29, 2031.

4. LEVEL OF EFFORT

4.1. The Contractor shall contact referred patients and schedule appointments within thirty (30) calendar days of receipt of referral from an authorized Lawton Service Unit healthcare provider. Following completion of the patient evaluation and receipt of all required clinical documentation, certification, orders, and authorizations, the Contractor shall dispense the ordered therapeutic footwear and related products within sixty (60) calendar days, unless the Contractor documents circumstances beyond its control, including manufacturer delays, custom fabrication requirements, or other patient-specific clinical requirements. The Contractor shall notify the Contracting Officer's Representative (COR) of any anticipated delay beyond sixty (60) calendar days and provide the reason for the delay and the expected delivery date.

4.2. The Contractor shall provide all required therapeutic shoe program services including patient evaluations, measurements, fittings, dispensing, adjustments, modifications, replacements, follow-up care, and required documentation.

4.3. The Contractor shall maintain sufficient inventory, manufacturer relationships, and qualified personnel to provide timely therapeutic footwear services and minimize delays in patient care.

4.4. The Contractor shall provide multiple therapeutic footwear options appropriate to each patient's clinical needs and shall ensure proper fit and function prior to dispensing.

4.5. The Contractor shall replace improperly fitting footwear within fifteen (15) calendar days when medically necessary and when the footwear remains in acceptable condition.

4.6. The Contractor shall notify the Contracting Officer's Representative (COR) of delays, patient compliance concerns, service interruptions, or other issues affecting delivery of services.

4.7. The Contractor shall provide patient education and instruction related to therapeutic footwear use, diabetic foot care, break-in procedures, and maintenance of therapeutic footwear.

5. SPECIAL REQUIREMENTS

5.1. In accordance with HHSAR 304.1300, Policy- ensure compliance with Homeland Security Presidential Directive-12: Policy for a Common Identification Standard for Federal Employees and Contractors (HSPD-12) and the Presidential Cross Agency Priority for strong authentication.

5.2. The USPHS Lawton Service Unit is a tobacco- and smoke-free environment. No tobacco or smoking use will be permitted on Government property during performance of this contract.

5.3. Contractor personnel shall contact the Government-designated point of contact upon arrival for scheduled onsite patient services, therapeutic shoe clinics, deliveries, or other approved activities. Contractor personnel shall comply with all applicable Lawton Service Unit security procedures, safety requirements, identification requirements, infection prevention requirements, and facility policies while performing services.

5.4. The Contractor shall maintain current accreditation through the Board of Certification/Accreditation (BOC), the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC), or another nationally recognized accrediting organization acceptable to the Government.

5.5. The Contractor shall employ certified pedorthists, orthotists, prosthetists, or other appropriately licensed and credentialed personnel qualified to evaluate, measure, fit, and dispense therapeutic footwear and related diabetic foot supplies. At least one (1) qualified and appropriately credentialed pedorthist shall be physically present on site at the Lawton Indian Hospital for patient fitting and dispensing services. The Contractor shall provide additional qualified personnel as necessary to meet the service requirements, appointment volume, and performance standards established under this Statement of Work and to avoid unreasonable delays in patient care.

5.6. The Contractor shall maintain all required licenses, certifications, insurance, and professional credentials necessary to perform services under this contract.

5.7. The Contractor shall comply with all applicable Centers for Medicare & Medicaid Services (CMS) Therapeutic Shoes for Persons with Diabetes coverage requirements, HIPAA regulations, Occupational Safety and Health Administration (OSHA) standards, Indian Health Service policies, and applicable Federal, State, and local regulations.

5.8. The Contractor shall protect all Personally Identifiable Information (PII) and Protected Health Information (PHI) obtained during contract performance and shall not disclose or disseminate patient information or information concerning Lawton Service Unit operations unless authorized.

5.9. All inquiries, comments, complaints, or requests for information arising from contract performance that require official response or dissemination of Government information shall be directed to the Government-designated representative.

6. DELIVERABLES AND REPORTING REQUIREMENTS

6.1. The Contractor shall coordinate patient appointments, onsite therapeutic shoe clinics, evaluations, fittings, dispensing appointments, and follow-up services with the Government-designated representative.

6.2. The Contractor shall coordinate delivery of therapeutic footwear, inserts, diabetic socks, and related supplies to the appropriate Lawton Service Unit location as directed by the Government.

6.3. Deliveries shall include applicable manufacturer documentation, product information, warranty information, and any required supporting documentation. Contractor personnel making deliveries shall present valid identification upon arrival.

6.4. The Contractor shall provide one designated Point of Contact (POC) responsible for coordination of patient services, scheduling, communication with the Government, delivery coordination, and resolution of contract-related issues.

6.5. The Contractor shall provide a telephone number for patient scheduling and Government coordination.

Telephone support shall be available during normal business hours, Monday through Friday, 8:00 a.m. to 4:30 p.m. Central Standard Time.

6.6. The Contractor shall submit monthly performance reports to the Government-designated representative.

6.7. Monthly reports shall include the number of referrals received, patients evaluated, patients fitted, therapeutic shoes dispensed, inserts dispensed, follow-up visits completed, missed appointments, delays in service delivery, problems encountered, corrective actions implemented, and recommendations for program improvement.

6.8. Monthly invoices shall include patient identifier, date(s) of service, applicable HCPCS/CPT codes when applicable, description of services provided, quantity of therapeutic footwear and supplies dispensed, and applicable charges.

6.9. Invoices shall be submitted within thirty (30) calendar days following completion of services.

6.10. The Contractor shall maintain complete and accurate documentation necessary to demonstrate compliance with applicable CMS requirements, including, as applicable, documentation of the patient's diabetes diagnosis and qualifying condition, comprehensive plan of care, certifying physician documentation, required in-person physician visit, certification, the Contractor's in-person footwear evaluation, clinical rationale for items provided, objective fit assessment at delivery, proof of delivery, and documentation of adjustments, modifications, exchanges, replacements, and follow-up services.

7. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

7.1. In accordance with FAR 52.245-1, the Government shall provide information and services necessary to support performance of this contract, including written referrals from authorized Lawton Service Unit healthcare providers, relevant medical documentation supporting medical necessity, and coordination through the Contracting Officer's Representative (COR). Government clinical space may be made available for scheduled onsite therapeutic shoe clinics based on availability and prior coordination with the Contractor.

7.2. Government-furnished facilities, equipment, supplies, and personnel shall be used only for the purpose of providing services identified within this Statement of Work.

8. CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

8.1. The Contractor shall furnish all personnel, therapeutic footwear, diabetic inserts, diabetic socks, measuring equipment, fitting equipment, supplies, transportation, administrative support, and other materials necessary to perform all requirements under this contract.

8.2. The Contractor shall maintain sufficient inventory and access to multiple manufacturers to provide timely delivery of therapeutic footwear and diabetic foot supplies appropriate to each patient's medical needs.

8.3. The Contractor shall provide all equipment and supplies necessary to complete patient evaluations, measurements, fittings, adjustments, and follow-up services.

9. RATES OF PAYMENT

9.1. Payments for diabetic shoes, therapeutic footwear, inserts, and related diabetic foot supplies and services provided under this contract shall not exceed applicable Indian Health Service (IHS) Medicare-Like Rates (MLR) for the services provided or other negotiated contract rates established by the Government.

9.2. The Contractor shall submit invoices for services no later than thirty (30) calendar days after services have been provided. Invoices shall include all required supporting documentation as specified in this Statement of Work.

9.3. If the Contractor's reimbursement rate changes as a result of notification from the Centers for Medicare & Medicaid Services (CMS), Medicare updates, or applicable cost-to-charge ratio changes, the Contractor shall provide written notification and supporting documentation to the Lawton Service Unit within thirty (30) calendar days of receipt. The Contractor shall provide any applicable CMS documentation and a corrected price list prior to receiving payment at the updated rate.

9.4. The Contractor shall not bill any eligible patient for amounts not paid under this contract unless the patient has been determined by the Indian Health Service to be ineligible for services authorized under this contract.

Patient ineligibility shall be documented through written notification or denial of applicable IHS-authorized program payment.

9.5. The Indian Health Service shall remain the payer of last resort for eligible persons receiving diabetic foot supply and therapeutic footwear services in accordance with applicable Federal laws and regulations.

10. CHANGES TO THE STATEMENT OF WORK (SOW)

10.1. Any changes to this Statement of Work shall be authorized and approved only through written correspondence from the Contracting Officer.

10.2. Costs incurred by the Contractor through actions of parties other than the Contracting Officer shall be borne solely by the Contractor.

11. DELIVERABLES/PERFORMANCE MATRIX

The Contracting Officer's Representative (COR) shall evaluate contractor performance based on the following measurable standards. The COR shall document whether each requirement was satisfactorily completed by selecting Yes or No.

Performance Requirement

Yes No

11.1. Patients contacted and appointments scheduled within thirty (30) calendar days of referral. ☐ ☐

11.2. Comprehensive diabetic foot and footwear evaluations completed in accordance with contract requirements. ☐ ☐

11.3. Therapeutic footwear and inserts properly measured, fitted, adjusted, and dispensed. ☐ ☐

11.4. Therapeutic footwear and diabetic foot supplies provided meet applicable CMS requirements and accepted industry standards. ☐ ☐

11.5. Required modifications, adjustments, exchanges, or replacements completed when medically necessary. ☐ ☐

11.6. Follow-up services completed as clinically appropriate to evaluate shoe fit, comfort, function, safety, and patient satisfaction. ☐ ☐

11.7. Patient education provided regarding therapeutic footwear use, break-in procedures, and diabetic foot care. ☐ ☐

11.8. Monthly performance reports submitted accurately and within required timeframes. ☐ ☐

11.9. Invoices submitted accurately and within required timeframes. ☐ ☐

11.10. Contractor maintained required accreditation, certifications, licenses, and qualified personnel. ☐ ☐

11.11. At least one qualified and appropriately credentialed pedorthist was available on site at the Lawton Indian Hospital for patient fitting and dispensing services. ☐ ☐

11.12. Contractor complied with HIPAA, privacy, security, and Lawton Service Unit facility requirements. ☐ ☐

11.13. Contractor maintained communication with the Lawton Service Unit COR and Government representatives. ☐ ☐

11.14. Services completed in accordance with all requirements of this Statement of Work. ☐ ☐

Department Supervisor Signature: ______________________________________

Date: ____________________