Amended Performance based Statement of Work- Orthotics.pdf

36C24124Q0302

Performance-Based Statement of Work

DESCRIPTION

The Veterans Integrated System Network (VISN 1), Department of Veterans Affairs (VA) has an ongoing program to furnish orthotic appliances and related services (including - custom orthotics, braces, diabetic shoes, inserts, elastic supports for joints, stockings, compression garments, other new devices, and repairs) to those Veterans that require them and are eligible for assistance. The range of services shall encompass HCPCS Codes: L0100-L4999; A4466; A5500-A5513; and A6501-A6549.

Notes: VISN One (1) –

• Will pay the A-code pricing for all shoes whether the patient is diabetic or non-diabetic, regardless of the diagnosis.

• Will pay the A-code pricing for non-diabetic ed prefabricated/” off-the-shelf” shoes unless otherwise indicated.

• Encompasses orthotic needs that require scheduling, evaluation (measuring, casting, etc.), fabrication and/or procurement, fitting, follow-up care and modifications.

There are individual VA clinical staff that take casts for foot orthotics and send them out for fabrication; this process is allowed and is not part of this contract.

• In those situations where the Contractor is recommending HCPCS Code changes – if after receiving codes/purchase order from the VA and assessing the VA patient – the Contractor must send the recommended HCPCS codes along with clinical notes and clear explanations that justify the recommendation. The VA retains the final decision on coding and will give due consideration to the Contractor’s recommendation.

It is VA’s intention to solicit quotes and award a five-year multiple award BPA contracts on a competitive basis under the authority of Title 38 U.S.C. Section 8123. The anticipated five-year period of performance is from August 1, 2024, through July 31, 2029.

The orthotic appliances and related services are to be provided to the following facilities, and its associated Community-Based Outpatient Clinics (CBOCs) in VISN One (1):

• Bedford VA Medical Center (station 518), Bedford VAMC, 200 Springs Road, Bedford, MA 01730-1114

• Boston VA Healthcare System (stations under 523*)

• Brockton Campus, 940 Belmont Street, Brockton, MA 02301-5596.

• Jamaica Plain Campus, 150 South Huntington Avenue, Boston, MA 02130-4817.

• West Roxbury Campus, 1400 VFW Parkway, West Roxbury, MA 02132- 4927

• Central Western Massachusetts VA Healthcare System (station 631),

• Northampton VAMC, 421 North Main Street, Leeds, MA 01053-9764

• Connecticut VA Healthcare System (stations under 689)

• West Haven Campus, 950 Campbell Avenue, West Haven, CT 06516-2770.

• Newington Campus, 555 Willard Avenue, Newington, CT 06111-2631

• Maine VA Healthcare System (station 402*), Togus VAMC, 1 VA Center, Augusta, ME 04330-6796

• Manchester VA Medical Center (station 608), Manchester VAMC, 718 Smyth Road, Manchester, NH 03104-7007

• Providence VA Medical Center (station 650), Providence VAMC, 830 Chalkstone Avenue, Providence, RI 02908-4734

• White River Junction VA Medical Center (station 405), White River Junction VAMC, 215 North Main Street, White River Junction, VT 05009-0001

* NOTE: For the VA Facilities with accredited Orthotic Laboratories (Boston & Maine):

1. The Boston HCS will be the primary fabrication and fitting site(s) for the orthotics needed for its patients. When in the best interest of the patient and the VA, the VA may authorize additional Contractor orthotics care that is the most effective.

2. The Maine HCS will provide most of the fabrication and fitting for the orthotics needed for its local patients. When in the best interest of the patient and the VA, the VA may authorize additional Contractor orthotics care that is the most effective.

3. Back-up/urgent orthotic coverage and specific patient orders are requested for the Boston HCS and Maine HCS by contract vendors.

The Government intends to provide orthotics coverage to Veterans for all the counties in the following areas of Connecticut, Rhode Island, Massachusetts, Vermont, New Hampshire, and Maine through this solicitation. For the purposes of this solicitation, a county is considered to have coverage by the Contractor if the county is within 100 miles from a contractor’s location.

BACKGROUND

Using data from the first eleven months of Fiscal Year 2022, the VA Medical Centers listed above are projected to spend an average of $65.64 each for the purchase of 73,979 new orthotic appliances and shoes, on a combined basis. During the same time period, VA is projected to record 5,044 incidences of repair to orthotic appliances and shoes with an average cost of $48.63 per incident, on a combined basis. Category of Items as listed below:

NPPD CATEGORIES/LINES – NEW AND REPAIR ORTHOSIS/ORTHOTICS

400 An ORTHOSIS ANKLE

400 B ORTHOSIS LEG A/K

400 C ORTHOSIS SPINAL

400 D ORTHOSIS AL/OTH

400 E ELAS HOSE

400 F ORTHOSIS KNEE

400 G CORSET/BELT

400 H ORTHOSIS WHO

400 X ORTHOTICS UNKNOWN

SHOES/ORTHOTICS

500 An ARCH SUPT

500 B SHOE INLAY

500 C SHOE MOLDED

500 D SHOE ORTH OTH

500 E INSERTS, SHOE

500 F SHOES A/O

ORTHOSIS

R40 ORTHOSIS TOTAL

SHOES/ORTHOTICS

R50 A ORTH SHOE ALL R50 B SHOE MOD

R50 C A/O ITEM SERV

PRICE SCHEDULE

For fabrication and repair of orthotic appliances, the prices proposed shall not exceed the established A-Code and L-Code prices applicable to the geographic area subject to this solicitation and at the time of performance. It should be noted that repair rates for 15- minute increments are now part of the A-Code and L-Code pricing schedule.

Considering this, please apply the best percentage discount that you offer against the A-Code and L- Code pricing baseline. The different annual periods are to represent proper government funding to be used.

Offerors are required to give a discount on all A-Codes (Orthotic appliances, labor rates for repairs and components*) and L-Codes and provide all items outlined in this contract.

Line Item 1: BASE YEAR:

A-CODE PRICING LESS % DISCOUNT L-CODE PRICING LESS %

DISCOUNT

Line Item 1a: YEAR 2:

Line Item 1b: YEAR 3:

Line Item 1c: YEAR 4:

Line Item 1d: YEAR 5:

* The VA will use A-Code pricing for all shoe requests. The VA will allow a maximum of 3 additional codes to pricing for A5501 (A5503, A5504, A5505, A5506 and A5507).

Example:

L3250 = XXXX (includes 2ea custom molded orthopedic shoes, 6ea shoe modifications, and custom molded orthopedic shoe inserts)

A5501 = XXXX (includes 2ea custom molded orthopedic shoes, 6ea shoe modifications, and 2 additional pair of custom molded orthopedic shoe inserts)

*** It should be noted that A-Code and L-Code pricing are published by the Centers for Medicare and Medicaid Services – Healthcare Common Procedure Coding System (HCPCS). The website for the L-Code & A-Code Pricing: Durable Medical Equipment, Prosthetics/Orthotics & Supplies Fee Schedule | CMS

(DME, Orthotics and Prosthetics). The Codes are updated every year and are released in December, for the following year. The discounts shown in the Schedule above are for the categories as stated in the Description of Services above, with the CMS (Centers for Medicare and Medicaid Services) representing the L-Codes for Orthotics (new and repair) and the A-Codes for shoes, inserts and related items.

**** The VISN Prosthetist-Orthotist can review any Contractor orthotics quotes and clinical notes to ensure proper coding and VA patient follow-up.

Reimbursement for Items Not Having a Dedicated Code:

Not Otherwise Classified or Specified L-Codes

A device that is Not Otherwise Classified or Specified (NOC) is an orthotic device/component that has not been assigned a CMS HCPCS code or received a HCPCS determination; and is mass manufactured and commercially available through manufacturers in which an invoice showing purchase from the manufacturer is available. The VISN 1 Prosthetist/Orthotist will review all orthotics NOC requests for proper coding and documentation.

The VA recognizes only the below NOC L-Codes for use with orthotics and modification of the NOC L-Code language is not permissible:

L2999 – Lower extremity orthoses, not otherwise specified L3999 – Upper limb orthosis, not otherwise specified

L0999 – Addition to spinal orthosis, not otherwise classified

The NOC L-Code is all inclusive and therefore, only one NOC L-Code is authorized per device. Multiple NOC L-Codes may be utilized per orthotics device, only when appropriate and approved by the VISN 1 Prosthetist/Orthotist. The Contractor understands that the VA retains sole discretion to determine whether a device would classify for a NOC L-Code designation.

For NOC L-Codes that do not have L-Code fee schedule published by CMS HCPCS, the Contractor shall be paid subject to the following guidelines:

a. For an item or service that is classified in the CMS HCPCS, the Contractor shall be paid the lesser of the L-Code amount or the Contractor’s billed amount.

b. For an item or service that is not otherwise classified in the CMS HCPCS, VA will temporarily assign an existing similar CMS HCPCS L-Code that best matches the description of the NOC item or VA may assign L2999, L3999 or L0999 until CMS assigns a HCPCS L-Code with fee schedule. The Contractor shall be paid the lesser of the amount for the L-Code temporarily assigned by VA or the Contractor’s billed amount.

c. For an item or service that is not otherwise classified in the CMS HCPCS, and for which VA assigns any miscellaneous or Not Otherwise Classified (NOC) L-Code, the Contractor shall submit a quote. Quotes must be received no later than two (2) business days after receipt of VA’s request for quote. The Contracting Officer or VA Prosthetics POC will issue a fixed price Call Order based on the quote, negotiated if necessary. The Contracting Officer or VA Prosthetic POC may request additional supporting documentation as needed in accordance with FAR 13.106-3.

Guidance – VA Central Office (VACO) Coding Guidance Council

The VA will follow the national guidance of the VACO Coding Guidance and Market Analysis and Research Council. The purpose of the council(s) is to “…to provide coding guidance regarding the provision of orthotic, prosthetic and orthotic goods and services across the Department of Veterans Affairs (VA) Healthcare System, assuring accuracy in decisions that are transparent, standardized, efficient, evidence-based and categorically precise…” which aids in prosthetic limb and custom orthotic device procurement, per VHA Directive 1045(1), dated May 12, 2020, and Amended February 17, 2021. The vendor is responsible for following this guidance, in terms of coding and pricing.

As of March 2024, the VACO Coding Guidance Council has established IGCEs (Independent Government Cost Estimates) for generic orthotics repairs.

ABBREVIATIONS:

A-CODE MEDICARE CODE FOR ORTHOTIC SHOES, INSERTS & ORTHOTIC

SUPPLEMENTS

AAOP AMERICAN ACADEMY OF ORTHOTISTS AND PROSTHETISTS ABC

AMERICAN BOARD FOR CERTIFICATION IN ORTHOTICS,

PROSTHETICS and PEDORTHICS

AOPA THE AMERICAN ORTHOTIC AND PROSTHETIC ASSOCIATION BOC

BOARD OF CERTIFICATION/ACCREDITATION for ORTHOTISTS-

PROSTHETISTS

CAD/CAM COMPUTER-AIDED DESIGN /COMPUTER-AIDED MANUFACTURER

CMS CENTERS FOR MEDICARE AND MEDICAID SERVICES CO VA

CONTRACTING OFFICER

COR VA CONTRACTING OFFICER’S REPRESENTATIVE HCPCS HEALTHCARE

COMMON PROCEDURE CODING SYSTEM

IAOP INTERNATIONAL ASSOCIATION OF ORTHOTICS AND PROSTHETICS

L-CODE MEDICARE CODE FOR ARTIFICIAL LIMBS & ORTHOTIC APPLIANCES/

SERVICES

NAAOP NATIONAL ASSOCIATION FOR THE ADVANCEMENT OF ORTHOTICS AND

PROSTHETICS

NOC NOT OTHERWISE CLASSIFIED OR SPECIFIED NSNA NATURAL SHAPE

NATURAL ALIGNMENT

PDAC PRICING, DATA ANALYSIS AND CODING (for Medicare) PSC

PROSTHETICS SERVICE CARD

QASP VA QUALITY ASSURANCE SURVEILLANCE PLAN VACO VA CENTRAL

OFFICE

DEFINITIONS:

GOOD STANDING: Participates and achieves appropriate continuing education credits and pays dues as determined by Certifying Agency such as ABC or BOC.

PURCHASE CARD/VISA LEVEL II: The contractor must be able to process at a minimum Level II using the appropriate field for the obligation number. If this involves additional machinery or computers, this will be at the Contractor’s expense. No advance payments will be authorized. No charge shall be made until the orthotic appliance is delivered to the Veteran and he/she has signed and dated a delivery acceptance form provided by the Contractor. Each invoice must be submitted to the VA Medical Center Prosthetics Service within three (3) days of the orthotic appliance delivery to the Veteran. Payment of invoices may be delayed if the appropriate information as specified in the contract is not completed and submitted as required.

MULTIPLE AWARDS

The Contracting Officer can award one or more blanket purchase agreements (BPAs) for Orthotic appliances and services. Any VA facility within VISN 1 may order off the BPAs awarded under this solicitation.

GENERAL REQUIREMENTS

1. Standards of Performance

The Contractor shall fabricate all orthotic appliances in strict conformance to the orthotic prescription that has been provided by the VA Clinic Team. Contractors shall not add or substitute components or alter the beneficiary’s orthotic prescription in any way without prior approval and written authority from the VA Clinic Team, Prosthetics Representative/ designee or VISN Certified Prosthetist/Orthotist. If after receiving codes/ PO from the VA and after assessing patients, the contractor finds that changes to coding are necessary, it must send the recommended codes along with clinical note with clear explanation for consideration. The VA has the final say for all coding decisions.

The VA will not reimburse the vendor for work performed that does not follow the prescription and documentation provided to the vendor.

2. Educational and Training Requirements

All contractors shall have a full-time American Board for Certification in Orthotics, Prosthetics and Pedorthics (ABC), or Board of Certification/Accreditation for Orthotists/ Prosthetists (BOC) Orthotist on staff at each of their locations – with current and valid credentials for the State in which he/she practices in good standing. VA reserves the right to verify Orthotist(s) credentials anytime during the term of the BPA. In the event the VA determines that the Contract is not meeting the above requirements, VA may terminate the BPA for cause in accordance with the applicable clauses listed in the contract (see

FAR Clause 52.212-4 paragraph (m)). For all new personnel that are brought on board after the final contract award, submission of all required training must be provided within 30 days of hire.

Special Education Requirements for Certain Orthoses

The fitting and alignment of the following orthoses/services must be performed under the supervision of an Orthotist who has met the applicable educational and training requirements, such as completion of a National Commission on Orthotic and Prosthetic Education (NCOPE) accredited educational program for Orthotics.

At a minimum, this training shall include CAD/CAM, Longs Technique, NSNA, and/or educational seminars specific to the fabrication and servicing of these components that were presented by organizations such as National Association for the Advancement of Orthotics and Prosthetics (NAAOP), American Academy of Orthotists and Prosthetists (AAOP), American Orthotic and Prosthetic Association (AOPA), International Association of Orthotics and Prosthetics (IAOP), or a formal program which is specifically designed to train Orthotists in the fabrication of these items. Examples of advanced Orthotic componentry would include, but not limited to:

(1) Spiral AFO/KAFO designs

(2) Stance control knee joints

(3) RGO’s

(4) Tenodesis orthoses

(5) AFO or other devices that involve electrical stimulation of muscles

(6) Dynamic contracture orthoses

(7) Any device that contains a microprocessor on-board unit

Approved Facilities

All Contractor facilities as well as other fabrication facilities such as commercial central fabrication facilities that will be utilized for this contract shall be listed in the proposal.

(Attachment Facility Location List) All work required under this BPA shall be conducted at the facility locations identified. All the Contractor’s facilities that are part of this BPA shall be accredited either by the ABC or BOC Facility Accreditation Program at the time of proposal submission. The Contractor shall provide current copies of accreditation documents upon request of the COR and will work with their accrediting body (ABC or

BOC) to ensure its information is current and accurate on its websites. VA reserves the right to conduct site visits of the facility and review accreditation and certification documents and standards at any time. Vendor supplied information regarding the location, including space, equipment presents, safety requirements, access/egress, hours of service and other items as needed is disclosed on Attachment VA2793 SHOP DATA SHEET. Attachment VA2793 SHOP DATA SHEET shall be completed for each Contractor facility location and included with submission of proposal.

Throughout the duration of this BPA, the Contractor shall notify the CO and the COR of any facilities that are added, changed/relocated, or closed within 15 calendar days of any such change. Approval for VA patients to be seen at added or changed facilities must be obtained by the Contractor prior to those facilities being authorized for use in this BPA. Added facilities must have ABC or BOC accreditation prior to any Veteran being seen or treated in the facility.

In the event of a future VA Central Office (VACO) contract or provider agreement being implemented for Orthotics, the VACO contract will supersede this document.

SPECIFIC REQUIREMENTS

1. VA Usage of Contract

This BPA encompasses orthotic needs that require scheduling, evaluation (measuring, casting, etc.), fabrication and/or procurement, fitting, follow-up care and modifications.

There are individual VA clinical staff that take casts for foot orthotics and send them out for fabrication; this process is allowed and is not part of this BPA.

2. Solicitation of Beneficiaries

The contractor agrees not to directly or indirectly through agents solicit eligible Veteran beneficiaries, such as, but not limited to, utilizing any advertisements, or mailing lists (see Contract Clause 852.270-4 Commercial Advertising), contacting the Veteran directly, VA clinics, etc. VA personnel shall not direct, guide, or prompt a Veteran beneficiary to a specific contractor except when a physician determines that it is a medical necessity. To assist in the selection of their Orthotist, all eligible Veteran beneficiaries shall be given a current list of contract providers located within the Medical Center jurisdiction. The list of contract providers shall contain the following header statement in boldface type:

YOU HAVE THE RIGHT TO SELECT THE ORTHOTIST CONTRACTOR OF YOUR

CHOICE FROM ANY OF THE VA APPROVED CONTRACTORS. ANY ATTEMPT TO

INFLUENCE YOUR DECISION OR TO DIRECT YOU TO ANY PARTICULAR

CONTRACTOR SHOULD BE REPORTED TO THE MEDICAL CENTER DIRECTOR

OF THIS FACILITY.

It will continue to be VA’s policy to permit all service-connected and non-service-connected Orthotic need Veteran beneficiaries who have continuing eligibility and who have established ties with an existing Orthotist to continue to use that Orthotist provided that the Orthotist is willing to accept all current contract provider terms for the geographic area covered by the contract, follows the same directions as in the VA contract by all contractors and accepts the average Centers for Medicare and Medicaid Services (CMS) discount of the

3. Contractors for the geographic covered area. The non-contracted vendor is subject to providing these current documents to the Chief of Prosthetics and/or COR prior to giving service to the Veteran.

Microprocessor On-Board Unit

Contractors who are qualified to furnish microprocessor on-board units are required to provide a "loaner" unit if a Veteran beneficiary's unit needs repair by the manufacturer.

The contractor shall submit a copy of the invoice from the manufacturer to support the cost of repairing the malfunctioning unit. Any salvage value granted by the manufacturer for a non-repairable unit shall be credited to VA against the cost of a replacement unit.

Some microprocessor on-board units may have up to a three-year warranty for parts from the manufacturer, which shall be credited to the VA.

Salvage

In the event that a Veteran dies prior to delivery and acceptance of an orthotic appliance, VA shall pay the Contractor for the work performed up to the point that they are notified to stop work. The pricing paid shall be mutually agreed upon in writing and shall not exceed the contract price of the orthoses less the salvage value of the unused orthotic appliance.

Battery Charging Units

Contractors who are qualified to furnish orthoses that require battery charging units are required to provide a "loaner" unit if a Veteran beneficiary's unit needs repair by the manufacturer. The contractor shall submit a copy of the invoice from the manufacturer to support the cost of repairing the malfunctioning unit. Any salvage value granted by the manufacturer for a non-repairable unit shall be credited to VA against the cost of a replacement unit. Some battery charging units may have up to a three-year warranty for parts from the manufacturer, which shall be credited to the VA.

PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE

The Contractor performance shall be monitored by the Quality Assurance Surveillance Plan (QASP) located in the Attachment Section. The QASP matrix details performance indicators, the standard, the acceptable quality level, the method of surveillance and incentive/disincentives. The indicators are:

• Delivery time requirement

• Weekly updates on progress with completion of each orthotics request will be provided to each facility, with a copy to the VISN COR. It is preferred this correspondence comes via PKI or RMS/AZURE-encrypted e-mail, fax summary or mail.

Orthotic appliance compliant with VA physician prescription Workmanship free of defect (device fits appropriately and correctly aligned) Patient education Patient acceptance of the device in all aspects (cosmetically and functionally)

Payment shall be rendered for an orthotic appliance or service that satisfactorily meets all the indicators. Payment shall be delayed for any orthotic appliance or service that does not meet one or more of the indicators. The Contractor shall correct all deficiencies of non-compliant orthotic appliances or services within fifteen (15) calendar days of written rejection notification from the COR. The corrected orthotic appliance or service will be re-inspected for acceptance. No invoice shall be submitted until the Government accepts the item or service.

The Contractor shall complete initial delivery of items ordered under this BPA no later than 10 business days after receipt of a BPA call/order. Initial delivery means an ordered item or service is complete and the item is provided to and accepted by the patient. The Contractor shall notify the VA Prosthetics Service/COR if the vendor is unable to contact the patient or family for scheduling within 2 business days. The Contractor will provide a written notification to the CO and COR within 5 calendar days of the receipt of a delivery order to show cause in the event the Contractor is unable to deliver the required items or services in accordance with the Government’s required delivery date. Initial delivery shall not be construed as final delivery or acceptance of an item or service by the Government.

• A weekly update is required on progress with completion of each orthotics request will be provided to each facility, with a copy to the VISN COR. It is preferred this correspondence comes via PKI or RMS-AZURE-encrypted e-mail or fax summary.

Sample:

Date of VA order VA Pt. name S S N Pt. Phone number VA PO number Dollar amount Called Pt./Date Sched. Pt./Left Voicemail Date of Eval.

Delivery Date

The contractor shall obtain a signature and date from the Veteran at the time of delivery of the completed orthotic appliance. However, if the Veteran feels that the orthotic appliance does not fit properly, and further adjustments are required, the contractor will make these corrections/adjustments, if possible, immediately. When further adjustments cannot be accomplished during the Veteran’s visit, the contractor will deliver the readjusted orthotic appliance to the ordering facility for final acceptance and payment.

This record shall be kept in the patient file with no charges processed until delivery is made. At the time of delivery, a copy of this signed and dated form accompanying the copy of the charge that is made for the orthotic appliance shall be mailed or e-mailed (via proper encryption) to the Prosthetics Representative/COR/designee.

EXAMPLE: Vendor Form

(Please fax/e-mail encrypted completed form along with invoice to ensure prompt payment)

1. The Contractor shall not trial any componentry on a VA patient without the written authorization of the VAMC provider, or COR-designee.

2. VA patients/veteran’s family members are not to be solicited in any form for participation in a manufacturer’s trial or vendor study.

3. Checkout – The following information is to be included in writing to the facility Prosthetics Representative/COR:

PATIENT NAME:

VENDOR NAME:

In order to process prompt payment for the prescribed orthosis, you must provide the VA with the following:

1. Date of Initial Patient Visit:

2. Date of Final Delivery:

Final payment will be processed following delivery – with confirmation of the following information:

ACCEPTANCE RECEIPT:

DATE:

The articles and/or services listed herein have been rendered, received as ordered, or as shown by authorized changes indicated below, and are acceptable.

PATIENT

SIGNATURE:

In the event the Government desires expedited delivery, the ordering activity shall telephonically contact the contractor and inquire into the feasibility of obtaining this condition. The contractor shall respond within 24 hours to such request and expedited delivery shall be mutually agreed upon. Any additional costs incurred by the contractor for meeting this requirement shall be negotiated in accordance with clause 48 U.S.C.

52.212-4, Contract Terms and Conditions-- Commercial Items.

(Note: Expedited Delivery terms and conditions, when required, will be determined by the Contracting Officer or Ordering Officer on a case-by-case basis and stated in the individual task or delivery order/call).

Typically, Veteran beneficiaries who are experienced orthosis wearers will normally be measured, fitted, and accept delivery of their orthosis at the contractor’s facility (the contractor will provide a document that the Veteran has signed for receipt/ acceptance of the orthosis and include it with the invoice – see above). Veteran beneficiaries who are not experienced orthosis wearers (first time orthotic user) will normally be measured, fitted, and accept delivery at the ordering VA facility. The conditions of and point of measurement, fitting, delivery, inspection, and acceptance of orthotic appliances shall be at the discretion of the VA Clinic Team, Prosthetic Representative, COR/designee, Orthotist, or prescribing physician and will be determined on a case-by-case basis.

The contractor warrants the orthotic appliances provided against defective material and/or workmanship for a minimum of 180 calendar days from the date of acceptance.

Manufacturer’s warranties of orthotic components that extend beyond the minimum 180-day period shall be in effect and also enforced. The contractor agrees to furnish without additional cost to the government, all labor, and materials necessary to correct defects that were detected during the warranty period. These conditions do not apply to adjustments incidental to the wearing of orthosis, adjustments required by physical change of the wearer, or where there is evidence of deliberate misuse or alteration by anyone other than the contractor.

Recalls:

The contractor shall immediately notify all effected VAMC(s), COR and contracting activities in the event of a product recall, removal, required adjustment, or required modification that is suggested or mandated by the contractor, distributor, manufacturer, or any regulatory or official agency. The information that shall be included in this notification includes:

1. A complete item description, identification, and model/serial number.

2. Administrative identification data including contract number, order numbers, and order date.

3. Reasons for recall, removal, adjustment, or modification.

4. Instructions for appropriate corrective action.

LOANER UNITS:

The Contractor shall not be reimbursed for loaner units. The VAMC should be informed prior to a loaner unit is issued to a Veteran.

CONTRACTOR PERSONNEL

All contractor personnel are required to wear ID Badges during the entire time they are on the VA grounds. ID Badges must have an identification picture and shall state in English the name of the individual and the company represented.

All contractor personnel are required to check into the facility Police and Security Office at each visit to pick up a “Contractor” or “Visitor” badge prior to contacting the Prosthetics Representative/COR/designee.

The contractor shall not employ persons to work on this contract if such employee is identified to the contractor as a potential threat to the health, safety, security, general well- being or operational mission of the installation and its population.

All contractor personnel shall observe the rules and regulations of the VA facility:

1. Smoking is permitted only in designated areas as posted.

2. Parking is permitted in areas designated as Visitor Parking Lots by the facility, or otherwise designated by the Police and Security Office staff.

ORTHOTICS CLINIC ATTENDANCE

(For those VISN 1 facilities who have or may have an established clinic setting or are attending clinic via video conference/Cisco WebEx/Microsoft Teams/ZOOM, etc.)

Who May Attend Clinic:

1. Only ABC or BOC Certified Orthotists or Prosthetists and Board Eligible Residents and NCOPE Preceptorship students may attend the VA clinic.

2. All contractor staff who see Veterans at their office locations shall be ABC or BOC-certified and the facilities shall be ABC or BOC-accredited.

3. Approved VA Residents may also attend the VA Clinic as part of their training.

4. Any non-contractor personnel that needs to attend clinic with their specific patient(s) must have their ABC or BOC certification verified/confirmed by the Prosthetics Representative/ COR/designee upon arrival at the VA Clinic. If the non-contractor personnel does not have a patient(s), he/she is not allowed to attend the VA Clinic.

5. In the absence at a given site of a VA Certified Orthotist or Certified Prosthetist – prior to clinic and by invitation only – the Prosthetics Representative/COR/designee will identify a non-VA Certified Orthotist or Certified Prosthetist to work with the VA Physician/ Clinician chairing the clinic in addressing the Veteran’s needs. Alternatively, as determined by the Prosthetics Representative/COR/designee, the Veteran will be presented to the VA Clinic by the non-VA Certified Orthotist or Certified Prosthetist that has been treating the Veteran.

Prior to the clinic:

6. All contractor personnel should confirm with the Prosthetics Representative/VA Orthotist/ COR/designee that you are attending clinic that day either with a Veteran or as the subject-matter expert.

7. All contractor personnel must wear a VA badge issued by the VA Police and Security Office or a “Contractor’s” or “Visitor’s” badge as approved by the Prosthetics Representative/ VA Orthotist/COR/designee where the VA Clinic is being administered.

Per the VA security guidelines, designated personnel will be identified in the final contract document and will vary per site location.

Clinic Process and Conduct:

1. It is the responsibility of the VA Orthotist/Lab Manager, and/or with the Prosthetics Representative/COR/designee to ensure the clinic is managed efficiently and conducted appropriately.

2. It is the responsibility of the non-VA attendees to comply with VA facility policies and procedures, as well as the VA Clinic’s operating procedures.

3. Contractors may attend the VA Clinic as subject matter experts, when authorized by the Prosthetics Representative/VA Orthotist/COR/designee, or if they have a Veteran scheduled for the VA Clinic. Non-contractor personnel cannot attend the VA Clinic, unless he/she has a patient scheduled specifically for the VA Clinic and can only attend the portion of the clinic applicable to this patient.

4. The Prosthetics Representative/VA Orthotist/Lab Manager/COR/designee will determine the number of vendors who can be present for the VA Clinic at one time. A rotating schedule may be developed, if necessary.

5. The Physician/Clinician chairing the VA Clinic is directly responsible for assessing the patient’s needs through direct communication and physical evaluation, which may also be accomplished in assistance by the VA Orthotist/VA Prosthetist/VA Pedorthist/Lab Manager, if in attendance.

6. The Prosthetics Representative/VA Orthotist/Lab Manager/COR/designee should ensure that the patients flow efficiently in the clinic in a timely manner and communicate with each patient after the evaluation to be sure the patient clearly understands the next step in his/her orthotic treatment.

7. If the Veteran does not already have a standing relationship with contractor or non-contractor personnel or has not been seen within the last year, he or she will be provided a Contractor/Vendor Selection List. The Physician/Lab Manager/VA Orthotist/ Prosthetics Representative/COR/Clinic Assistant/designee will obtain the Veteran’s signature indicating their choice of a contractor. If possible, the patient can be provided the contractor list prior to the VA Clinic; this can allow arrangements to be made to ensure the Veteran’s contractor choice be present during the VA Clinic with the Veteran.

8. Contractor and non-contractor personnel are not allowed to directly address the Veteran or to establish a rapport with the Veteran, unless directed by the Physician/Clinician Chairperson or Prosthetics Representative/VA Orthotist/ Lab Manager/COR/designee. Contractor and non-contractor personnel are not allowed to solicit Veterans in any way, including, but not limited to, by passing out business cards or asking personal questions at the VA facility, in the waiting area and/or during clinic evaluation. All attendees must refrain from making inappropriate comments in the presence of Veterans and/or contractors.

9. Any concerns about the clinic process or an attendee’s conduct should be discussed outside of the VA Clinic setting, unless it is so egregious that immediate action is needed by the Physician/Clinician Chairperson/Prosthetics Representative/VA Orthotist/ Lab Manager/ COR/designee. In any event, the Contracting Officer should be immediate notified of the issues for appropriate action.

10. As determined by the Contracting Officer – in association with the COR/ Prosthetics Representative/VA Orthotist/Physician/Clinician Chairperson/designee, any such action by contractors and non-contract vendors that is deemed inappropriate may result in exclusion from clinic attendance for a period of time or indefinitely. If any VA staff person or Veteran is aware of this behavior, it is to be reported to the facility Prosthetics Representative/VA Orthotist/Lab Manager/COR/Physician/Clinician Chairperson/ designee and to the Contracting Officer.

11. No patient lists may be distributed to non-contractor personnel attending with his/her patient prior to or during the clinic. Additionally, a sign-in sheet where any non-VA staff person would be able to view the names of Veterans being treated is also prohibited.

Both lists are assumed to be a violation of patient privacy laws. No patient information will be allowed to leave the clinic setting unless it’s required by the treating contractor or non-contractor personnel, and only then will the least amount of Veteran information be provided to allow adequate treatment of the Veteran.

12. Per VHA Prosthetics Handbook, a non-contracted Orthotist vendor may be chosen by a Veteran only when he/she is seeking continuity of care. If the Veteran has never had an orthotic appliance, the Veteran must choose a contracted provider or the certified VA Orthotics and Prosthetics Laboratory (if one is present at the facility).

CONTRACT ADMINISTRATION DATA

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this BPA. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of calls under the BPA. In the event the contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the BPA pricing to cover any increase in costs incurred as a result thereof.

1. Contract administration matters will be handled by:

a. CONTRACTOR’S NAME/ADDRESS/CITY/STATE-ZIP (Please print or type):

Point of Contact/Title:

Telephone:

Facsimile #:

E-mail:

DUNS NO:

b. GOVERNMENT:

Telephone:

Facsimile #:

2. CONTRACTOR'S REMITTANCE ADDRESS: All payment by the

Government to the contractor will be made in accordance with Federal Acquisition Regulation (FAR) Clause 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration (31 U.S.C. 3332):

COMPANY’S NAME:

ADDRESS:

Point of Contact/Title:

Telephone:

Facsimile #:

E-mail:

DUNS NO:

3. INVOICES: Invoices shall be submitted in arrears no later than 3 business days after items issued and mailed to the appropriate VA Medical Center: SEE VA PROSTHETIC

AND SENSORY AIDS SERVICE (PSAS) AIDS ADDRESSES (REFER TO

ATTACHMENT A).

INVOICES

Invoices submitted for payment shall include the BPA number, purchase/delivery order number, beneficiary’s name; detail of work accomplished, HCPCS Codes for each item, and the VA contract discount. All invoices will be submitted in accordance with the addresses provided in Attachment A.

The Contractor understands that all price quotations for items and services will be reviewed by the CO or designee. It is understood that in instances of double coding and unnecessary uses of HCPCS L or A-Codes, the Contractor will be asked to resubmit price quotation with appropriate HCPCS L or A-Codes or provide justification for the need for additional HCPCS. VA retains sole discretion to determine appropriate HCPCS coding for orthotics appliances/repairs/services. In addition, the VISN One (1) Prosthetist/ Orthotist will participate in Veteran assessments and treatment plan formulations in the VA Clinic in- person and/or via Telehealth. Reviews of certain orthotic appliance quotes will also be completed by this individual, and his/her decision is final.

Payment to the contractor shall be made utilizing the Government Wide Purchase Card (Purchase Card) primarily; however other methods (e.g., Purchase Orders, 1358s, 2237 invoices through Austin Finance Center) for payment may be used if needed for the convenience of the VA. Vendor must be able to follow OB10 procedures if needed.

Payments made by the VAMC under this BPA shall constitute the total cost of services provided by the contractor. The contractor shall not seek reimbursement from the beneficiary’s family, private insurer, Medicare, or any other entity acting on behalf of the beneficiary.

Government-Wide Purchase Card

The Contractor shall accept the Government-wide Purchase Card for payment in full of any payments made. Minimum Level II data transmission is recommended. The Purchase Card shall be accepted over the phone and/or in person and regardless of dollar amount. Purchase Card usage fees will not be added to the agreed-upon pricing under the BPA for purchases made by a Government Wide Purchase Card.

The contractor should be capable of submitting invoices via electronic encryption/PKI or AZURE transmission to the appropriate VA facility and CO. If this involves additional machinery or computer equipment/software, this will be at the contractor’s expense.

Each invoice must be submitted to the VA Facility within three (3) business days of orthosis delivery to the Veteran. Payment of invoices may be delayed if the appropriate invoices as specified in the contract are not completed and submitted as required.

Contractor invoices will be reviewed by a VA practitioner to ensure they meet the requirements of the VA prescription and have the proper assignment of HCPCS Codes.

Contractors can anticipate contact from a VA practitioner seeking clarification and/or justification for specific items on invoices/quotes.

For those VAs using Government Purchase Card, a credit card receipt with the invoice and signed acceptance receipt must still be forwarded to the appropriate VA facility as soon as the transaction has been completed in accordance with the guidelines and time frames in utilizing the Government Purchase Card. The Government Purchase Card should not be charged until the orthotic appliance is delivered and accepted.

SITE INSPECTION/SAFETY PROCEDURES:

The VA may conduct an inspection of the Contractor’s facilities at any time during normal business hours. The Contractor will permit on site visits by VA to assure compliance with Business Practices (BP), Quality and Performance and/or BAA requirements. The Contractor will make all VA patient(s) records and pending/completed orders accessible for review.

Infection Control and Emergency Preparedness:

In the event of a declared National, State, or other Emergency which affects the Contractor’s ability to perform in accordance with the specifications in the Statement of Work (SOW), the contractor shall have an action plan and protocols in place which comply with local, state, federal and Department of Veterans Affairs requirements. The contractor shall submit a written action plan and protocols and provide notification of implementation of them within 48 hours of declared National or State Emergency to the Contracting Officer, COR and the Facility Chiefs of Prosthetics and Optometry.

• The contractor shall follow VHA and applicable local/state/national public health and infection control guidance and personal protective equipment (PPE) requirements at the VAMC. Contractor shall be responsible for the provision of all required PPE and materials/supplies.

• Devices and spaces used for orthotic fittings should be appropriately cleaned after each patient use in accordance with manufacturer’s recommendations. The Centers for Disease Control and Prevention (CDC) and Professional Orthotic societies may have other guidelines that should be followed pertaining to orthotic fitting, manufacturing, mailing, dispensing, adjustments, and repairs.

• The contractor will provide to the Contracting Officer and COR an electronic copy of all infection control, cleaning, and safety procedures that the contract staff will practice on-site.

• Contractor shall abide by all CDC guidelines regarding social distancing, cleaning of equipment and materials, and personal protection equipment. Updated guidelines can be found on the CDC website:

Community, Work, and School | COVID-19 | CDC

The Contractor must perform the required work in accordance with Joint Commission and CMS standards. The Contractor must demonstrate that he/she has met or exceeded Joint Commission and CMS requirements.

The contractor is required to develop and maintain the following documents for each Contractor employee working on the contract: credentials and qualifications for the job;

a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; includes knowledge and skills required to provide care for certain patient populations, as appropriate.); a current performance evaluation supporting ability of the Contractor employee to successfully perform the work required in this solicitation; and listing of relevant continuing education for the last two years. The Contractor will provide current copies of these records at the time of BPA award and annually on the anniversary date of contract award to the VA Contracting Officer’s Technical Representative (COR), or upon request, for each Contractor employee working on the contract.

The Contractor will be responsible to ensure that Contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

The Contractor is required to maintain records that document competence/performance level of the Contractor employees who participate in this contract are in accordance with Joint Commission, CMS, and other regulatory body requirements. The Contractor will provide a current copy of the competence assessment checklist and annual performance evaluation to the COR for each Contractor employee working on this

When changes in Contractor personnel are approved the Contractor must provide evidence of orientation, the current competence assessment, and current performance evaluation that supports the above.

A copy of these standards may be obtained from the Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd., Oakbrook Terrace, IL 60181. The websites for Joint Commission and CMS are respectively: Leading the Way to Zero | The Joint Commission; Home - Centers for Medicare & Medicaid Services | CMS.

SPECIAL CONTRACT REQUIREMENTS

1. PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS:

The Contractor shall assign to this BPA the following personnel: all individuals providing supplies and services to VA Beneficiaries AND for whom information about education and training is required to be submitted as a part of the response to this Request for Proposal including, but not necessarily limited to, those individuals who must meet the training requirements set forth in the GENERAL REQUIREMENTS SECTION.

a. During the first ninety (90) days of performance, the Contractor shall make NO substitutions of personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (c) to the Contracting Officer at least 15 days prior to making any permanent substitutions.

b. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer.

Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of personnel. If the VA does not agree with the proposed substitutes and their qualifications, then VA will terminate the contract and the contractor will not get the minimum.

c. For temporary substitutions where the person will not be reporting to work for three

(3) consecutive workdays or more, the Contractor will provide a qualified replacement for the person. This substitute shall have comparable qualifications to the person. Any period exceeding two weeks will require the procedure stated in paragraph (b) above. In all cases, the Network COR should be informed of the situation immediately.

Contractor orthotist staff who attends the VA Clinic shall be ABC or BOC certified.

HHS/OIG

To ensure that the individuals providing services under the BPA have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website: Exclusions | Office of Inspector General | U.S. Department of Health and Human Services (hhs.gov) for each person providing services under this BPA. Further the Contractor is required to certify in its proposal that all persons listed in the contractor’s proposal have been compared against the OIG list and are NOT listed. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

CONFIDENTIALITY OF PATIENT RECORDS

The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. The contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362.

Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority…