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 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 and accepted industry standards.

2.2. The Contractor shall perform comprehensive diabetic foot assessments to determine appropriate therapeutic footwear and insert requirements.

2.2.1. Comprehensive diabetic foot assessments shall include foot measurements, gait analysis, evaluation of foot deformities, skin integrity assessment, vascular assessment, and protective sensation testing.

2.3. The Contractor shall provide therapeutic footwear services to patients diagnosed with diabetes mellitus who have qualifying lower extremity conditions, including but not limited to peripheral neuropathy, peripheral artery disease (PAD), previous pedal amputations, foot deformities, Charcot arthropathy, end-stage renal disease (ESRD), pre-ulcerative calluses, history of foot ulceration, poor circulation, and other medically qualifying conditions identified by the referring Lawton Service Unit healthcare provider.

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.

2.5. The Contractor shall provide follow-up services to ensure therapeutic footwear remains appropriate, functional, and properly fitted.

2.5.1. Follow-up services shall include evaluation of shoe fit, comfort, function, patient satisfaction, and compliance. The Contractor shall perform adjustments, modifications, exchanges, or replacements when medically necessary to ensure proper fit, safety, and functionality.

2.6. 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).

2.6.1. The Contractor shall maintain complete patient documentation related to evaluations, fittings, products provided, patient education, and follow-up services.

3. PERIOD OF PERFORMANCE

The Base Year Period of Performance shall be twelve (12) months from the date of award with three (3) additional twelve (12) month option periods.

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.

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 manufacturer policies permit, and 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(b), non-routine contractor employees shall comply with OPDIV DHHS/SE Region – Human Resources, Security Clearance Guidance – Visitors (3/29/12) policy for the contract performance period. Contractor employees performing onsite services shall obtain a visitor’s pass upon arrival through Facilities Management and comply with all applicable facility access requirements.

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.

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.

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 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 to evaluate shoe fit, comfort, function, 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. Contractor complied with HIPAA, privacy, security, and Lawton Service Unit facility requirements. ☐ ☐

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

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

Department Supervisor Signature:_________________________