Performance Work Statement - Beckley Orthotics.docx

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER

Orthotics Appliances and Related Services

1. BACKGROUND:

The Beckley VA Medical Center (VAMC) has an ongoing requirement to furnish orthotic appliances and related services (including custom orthotics, braces, diabetic shoes, inserts, elastic supports for joints, stockings, compression garments, and other new devices and repairs) to those Veterans that require them and are eligible for assistance.

2. SCOPE:

Beckley VAMC has an ongoing program to furnish Orthotic Appliances and Related Services to those Veterans that require them and are eligible for assistance. Beckley VAMC is seeking to acquire Orthotic Appliances and Related Services to support the Veterans in need. It is the VA’s intent to issue a Multiple Award Indefinite Delivery/Indefinite Quantity (IDIQ). Anticipated period of performance is August 26, 2024 through August 25, 2029.

A. General Requirements:

(1) Standards of Performance. The Contractor shall fabricate all orthotic appliances in strict conformance to the orthotic prescription that has been submitted by the designated VA requesting provider. 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 appropriate VA Clinic Team Orthotic Representative or Contacting Officer. Contractor shall provide delivery certification to Prosthetics and Sensory Aids Service (PSAS) the same day the service is provided.

(2) Educational and Training Requirements. All contractors shall have a full-time Orthotist on staff at each of their locations with current and valid credentials provided by the American Board Certification (ABC), or Board for Orthotist-Prosthetist Certification (BOC). A waiver for this requirement may be granted on a case-by-case basis for branch offices only in the event that VA determines this requirement would place an undue burden on the veteran. VA reserves the right to verify Orthotist(s) credentials any time during the term of this contact. In the event that VA determines that the contractor is not meeting the above requirements, VA may terminate the contract for cause in accordance with FAR Clause 52.212-4 paragraph (m).

(3) Approved Facilities. The contractor’s facilities shall be approved by the Facility Accreditation Program of the American Board for Certification in Orthotics and Prosthetics, Inc. (ABC), the Accredited Facilities Program of the Board of Certification (BOC) or have successfully passed inspection by local VA Orthotic Service.

B. Specific Requirements:

(a) Solicitation of Beneficiaries. The Contractor agrees not to directly or indirectly through agents solicit eligible veteran beneficiaries. 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 the preferred providers that are located in the Medical Center jurisdiction. Each list of preferred providers shall contain the following header statement in boldface type:

“YOU HAVE THE RIGHT TO SELECT THE ORTHOTIC APPLIANCE 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 Orthotist is willing to accept the current preferred 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 discount of the contractors for the geographic covered area. The non-contracted contractor is subject to providing these current documents to the Chief of Prosthetics and/or COR prior to giving service to the Veteran.

(b) Salvage. In the event that a veteran beneficiary dies prior to delivery and acceptance of an orthosis, 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 and shall not exceed the contract price of the orthotic appliance less the salvage value of the unused orthosis.

(c) Same Day Service. Contractor shall keep the following items in contractor’s facility inventory for same day issuance to Veterans:

A5512 - Multi Den Insert Form A5500 - Diabetic Shoe for Density Insert L0628 - LSO NO RI Stays Pre OTS (Lumbosacral Orthosis) L3221 - Orthopedic Mens Shoes DPTH L3040 - FT Arch Support Premold Longit

a. National Prosthetic Patient Database (NPPD) Categories/lines – new and repairs:

I. ORTHOSIS/ORTHOTICS

400 A 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

II. SHOES/ORTHOTICS

500 A ARCH SUPT

500 B SHOE INLAY

500 C SHOE MOLDED

500 D SHOE ORTH OTH

500 E INSERTS, SHOE

500 F SHOES A/O

III. ORTHOSIS

R40 ORTHOSIS TOTAL

IV. SHOES/ORTHOTICS

R50 A ORTH SHOE ALL

R50 B SHOE MOD

R50 C A/O ITEM SERV

C. Pricing

For fabrication and repair of orthotic appliances, the prices proposed shall not exceed the established 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 L-Code pricing schedule. Considering this, please apply the best percentage discount that you offer against the L-Code pricing baseline.

Offerors are encouraged to give a discount on all L-Codes and A-Codes (Orthotic appliances, labor rates for repairs and components*).

Line Item 1: BASE YEAR

L-CODE PRICING LESS _________% DISCOUNT / A-CODE PRICING LESS _________% DISCOUNT Line Item 1a: OPTION YEAR 1 L-CODE PRICING LESS _________% DISCOUNT / A-CODE PRICING LESS _________% DISCOUNT Line Item 1b: OPTION YEAR 2 L-CODE PRICING LESS _________% DISCOUNT / A-CODE PRICING LESS _________% DISCOUNT Line Item 1c: OPTION YEAR 3 L-CODE PRICING LESS _________% DISCOUNT / A-CODE PRICING LESS _________% DISCOUNT Line Item 1d: OPTION YEAR 4:

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

Note: *It should be noted that L-Code and A-Code pricing are published by the Centers for Medicare and Medicaid Services (CMS) – Healthcare Common Procedure Coding System (HCPCS). The website for the L-Code & A-Code Pricing: List of CPT/HCPCS Codes | 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 representing the L-Codes for Orthotics (new and repair) and the A-Codes for shoes, inserts and related items.

a. Reimbursement for Items Not Having a Dedicated Code:

Reimbursement for New Technology Components Not Having Dedicated HCPCS codes for new technology components not yet reviewed by the Medicare Pricing, Data Analysis and Coding contractor (PDAC) for the Centers for Medicare and Medicaid Services, the maximum allowable reimbursement will be 150% of the contracted vendors invoice for the item. The reimbursement shall include the technical labor and the clinical time to attach, adjust, modify and/or program the component through the initial fittings. The contractor’s invoices shall be submitted with the quote for review with the FL10-90 Form.

Offerors are encouraged to submit their best discounts off of the CMS pricing schedule to be considered for a contract award (a discount must be provided to be considered for a contract award). The Contracting Officer reserves the right to make a contract award without discussions, thus making it in the offeror’s best interest to submit the absolute best discount when submitting the proposal.

D. Warranty

The Contractor shall warrant the Orthotic Appliances and Related Services provided against defective material and/or workmanship for a minimum of 90 calendar days from the date of acceptance by VA. The minimum warranty period shall commence after the final check out at the VAMC Clinic Team and deliverable acceptance by the VA Clinical Team Prosthetic Representative or COR. Manufacturer’s warranties of Orthotic Appliances and Related Services that extend beyond the minimum 90 calendar day period shall be in effect and be enforced. The Contractor shall furnish, without additional cost to the Government, all materials and labor necessary to correct defects that were detected during the warranty period.

E. Recalls

The Contractor shall immediately notify all affected VAMC(s), COR(s), and CO in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Contractor, distributor, manufacturer, or any regulatory or Government agency. The following information shall be included in this notification:

• A complete item description and identification;

• Administrative identification data including contract number, order numbers and order date;

• Removal, adjustment, or modification reasons for recall; and

• Instructions for appropriate corrective action.

F. Educational and Training Requirements:

All Contractors shall have a full-time American Board Certified (ABC), or Board for Orthotist-Prosthetist Certification (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. A waiver for these requirements may be granted on a case-by-case basis for branch offices, only in the event that VA determines this requirement would place an undue burden on the veteran. The VA reserves the right to verify Orthotist(s) credentials anytime during the term of this contract. A copy of the ABC/BOC Orthotist Certification with which location he/she is on full-time staff must be included in the Technical Proposal submission of this solicitation. In the event the VA determines that the Contractor is not meeting the above requirements, VA may terminate the contract 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 60 days of hire.

a. 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. For all new personnel that are brought on board after the final contract award, submission of all required training must be provided within 60 days of hire.

At a minimum, this training shall include Computer Aided Design/Computer Aided Manufacturing (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 Orthotics and Prosthetics (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 Ankle Foot Orthosis (AFO)/Knee Ankle Foot Orthosis (KAFO) designs

(2) Stance control knee joints

(3) Reciprocating Gait Orthosis (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

Additionally, due to the nature of personal information involved in the Contractor carrying out required duties, all Contractor personnel will be required to complete Privacy Policy training annually. This can be their own internal education or VA-approved, but documentation of completion should be provided to the COR annually.

G. Approved Facilities:

The Contractor’s facilities shall be approved by the Facility Accreditation Program of the American Board for Certification in Orthotics and Prosthetics, Inc. (ABC), the Accredited Facilities Program of the Board of Certification (BOC), and follow applicable CMS standards. A copy of the ABC/BOC Facility Certification for each Contractor facility location must be included in the Contractor’s Technical Proposal submission of this solicitation. All contractor facility locations used in this contract are subject to VA inspection at any time during the contract period by the Chief of Prosthetics or designee whose location is closest to the contractor’s facility.

Throughout the duration of this contract, notification of any facilities which are added, changed, or closed must be immediately conveyed to both the Contracting Officer (CO) and the Contracting Officer Representative (COR) to obtain approval before it may be used for this contract. Added new facilities must be ABC or BOC certified prior to any veteran being seen or treated in the facility.

The Contractor(s) must have a facility located within 40 miles of the Beckley VAMC to include Princeton and/or Greenbrier Community-Based Outpatient Clinics (CBOC). The Offeror must provide address(es) of all facilities that will be used in the service of this contract.

H. Days/Hours of Operations

The VA VAMC /VISN 5 Medical Centers operate during normal business hours - Monday through Friday, 8:00am – 4:00pm. Clinic sessions will be established at each VA Facility by the Prosthetics Representative/Lab Manager/VA Orthotist/COR/designee, in association with the Physician/Clinician. A clinic contractor rotation schedule may be implemented depending upon the number of vendors selected for contracts.

a. Federal Holidays:

The eleven holidays observed by the Federal Government are:

New Year’s Day – January 1st Martin Luther King’s Birthday – Third Monday of January Presidents’ Day – Third Monday of February Memorial Day – Last Monday of May Juneteenth – June 19th Independence Day – July 4th Labor Day – First Monday of September Columbus Day – Second Monday of October Veterans Day – November 11th Thanksgiving Day – Fourth Thursday of November Christmas Day – December 25th

When a Federal Holiday falls on a Sunday, the following Monday shall be observed as a Federal Holiday. When a Federal Holiday falls on a Saturday, the preceding Friday is observed as a Federal Holiday. Also included – any other day specifically declared by the President of the United States of America to be a Federal Holiday.

I. 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, the Contractor is a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, the 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 from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C. 552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants’ records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over the Contractor, may have access to VA’s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

J. VA SENSITIVE INFORMATION

VA sensitive information is all Department data, on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, records about individuals requiring protection under various confidentiality provisions such as the Privacy Act and the HIPAA Privacy rule, and information that can be withheld under the Freedom of Information Act. Examples of VA sensitive information include the following: individually identifiable medical, benefits, and personnel information; financial, budgetary, research, quality assurance; confidential commercial, critical infrastructure, investigatory, and law enforcement information; information that is confidential and privileged in litigation such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney client privilege; and other information which, if released, could result in violation of law or harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of federal programs.

K. INVOICES:

Invoices shall be submitted monthly, in arrears and mailed to:

Beckley VAMC 200 Veterans Avenue Beckley, WV 25801

Invoices submitted for payment shall include the contract 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 above. The preferred method of payment will be the Government Purchase/Visa Credit Card or Pay only card – using the appropriate field for the obligation number - and the Contractor must be capable of accepting it for payment. The contractor will also need to be able to process at Level II. If this involves additional machinery or computers, this will be at the contractor’s expense. No advance payments shall be authorized. No charge shall be made until the orthosis is delivered to the veteran and he/she has signed and dated an acceptance form provided by the contractor. Each invoice must be submitted to the VA Facility within three (3) business or calendar 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.

A credit card receipt with the invoice and signed acceptance receipt must be forwarded to Beckley VAMC as soon as the transaction has been completed in accordance with the guidelines and time frames in utilizing the Government Purchase/Visa Credit Card/Pay only card. The Government Purchase Card/Pay only card should not be charged until the orthosis(es) is delivered and accepted.

1. 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: Enhanced data is the additional information that accompanies charge card transactions. However, enhanced data is not required for processing financial transactions or for settlement of that transaction. Level II provides additional summary data that accompanies Level I (minimum amount of data required to clear and settle a financial transaction) through the clearing and settlement process.

2. ABBREVIATIONS:

A-CODE Medicare Code for Orthotic Shoes, Inserts & Orthotic Supplements L-CODE Medicare Code for Artificial Limbs & Orthotic Appliances/Services AAOP American Academy of Orthotics and Prosthetics ABC American Board Certified AOPA American Orthotic and Prosthetic Association BOC Board for Orthotist Prosthetist Certification IAOP International Association of Orthotics and Prosthetics CMS Centers for Medicare and Medicaid Services CO Contracting Officer COR Contracting Officer Representative HCPCS Healthcare Common Procedure Coding System NAAOP National Association for the Advancement of Orthotics and Prosthetics NCOPE National Commission on Orthotic and Prosthetic Education NPPD National Prosthetic Patient Database PSAS Prosthetic and Sensory Aids Service

L. PERFORMANCE, DELIVERY, INSPECTION, AND ACCEPTANCE:

Contractor shall deliver items ordered under this contract no later than 21 calendar days after acceptance of a purchase/delivery order. The Contractor shall notify the VA Orthotic Representative and show cause in the event they are unable to deliver the required items in accordance with the Government’s required delivery date. Such notice shall be given in writing within 5 calendar days after receipt of order. Failure by the Contractor to provide such notice within the time specified shall constitute acceptance of the order. Delivery includes patient education on all issued items, to include, but not limited to, demonstration of proper donning and doffing of and wear and care of the issued device and question/answer session. All issued orthosis/devices must be acceptable to patient in all aspects (cosmetically and functionally).

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 52.212-4, Contract Terms and Conditions--Commercial Products and Commercial Services. Failure by the contractor to deliver the ordered orthotic appliances on an expedited basis, or otherwise fulfill the agreed upon requirements shall constitute an event of default, and the Contracting Officer shall undertake any action authorized pursuant to this solicitation, or otherwise in accordance with applicable statutes and regulations.

Veteran beneficiaries will be measured, fitted, and accept delivery of their orthosis at the contractor’s facility. The conditions of and point of measurement, fitting, delivery, inspection, and acceptance of orthotic appliances shall be at the discretion of the appropriate VA Clinical Team, Orthotic Representative, Chief of Orthotics, or prescribing physician and handled on a case-by-case basis.

The contractor warrants the orthotic appliances against defective material and/or workmanship for a minimum of 90 calendar days from the date of acceptance. Manufacturer’s warranties of orthotic components that extend beyond the minimum 90-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.

The Contractor shall immediately notify all effected VAMC(s) 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.

(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.

VA CONTACT INFORMATION: