6515--Supplies - Orthotics - VISN 10 Sites 36C25025Q0517

The Department of Veterans Affairs NCO 10, 24 Frank Lloyd Wright Dr., Ann Arbor, MI 48105 is hereby soliciting offers to provide Orthotics Appliances and Related Services for VISN 10 VA Facilities. NCO 10 anticipates entering into a fixed price 5-year ordering period BPA with the contractors that meet the requirements of the RFQ. This procurement will be conducted using Part 13 of the FAR. NAICS Code is 339113, size standard is 800 employees. The anticipated issue date is June 16, 2025; the anticipated closing date is July 16, 2025.

Full and open competition RFQ.

Questions and Government Answers (in red): Vendor question: Section 2.2.1 Not Otherwise Classified Codes Reimbursement: Firstly, please understand that all manufacturer pricing is proprietary. Vendor has serious concerns that providing you with this competitively sensitive information will unduly expose it and its provider clinics to significant antitrust liability, including price fixing claims, since collecting negotiated rates from every provider would place you in the role of a clearinghouse. Whether knowingly or unknowingly, maintaining such information about each supplier s negotiated prices could lead to the unintended consequence of allowing suppliers to level set their prices and increase their negotiating leverage against providers, thereby increasing the prices they charge to providers. This would also unfairly prejudice the providers in a price squeeze since reimbursement levels are set regardless of the price a provider pays for the items provided. Secondly, we do not buy these items in bulk , and it is inaccurate to represent these items this way. These items are purchased on an as needed basis. Thirdly, please clarify the process for coming to the reimbursement rate for NOC codes. We do not understand how you determine the Overhead percentage and profit percentage . Can you please clarify? Is this amount what will be negotiated? Lastly, you indicate the Labor rate will reflect the CMS rate minus the discount offered in the pricing schedule. However, the manufacturer invoice would already reflect any discounts provided. Why would a second discount be taken on labor for calculating the reimbursement rate on a NOC code? Government Answer: There are national costs estimates in place for certain NOC items. Should a NOC item be provided that has a national cost estimate in place, the price will be accepted as is so long as it falls within that Government national estimate. If the NOC item is more than the national estimate, then the price will be negotiated down to be within that limit. In order to do that, the Government requires the manufacturer invoice. If a NOC item is submitted in which there is not a national estimate in place, the Government will utilize the same factors in place that are used for a national estimate to determine a fair price. In order to do that, the Government requires the manufacturer invoice. No, a second discount is not being requested. If the initial invoice already reflects a discount, it is not expected that another would be provided. Vendor Question: Section 4.3 Contractor Facilities Locations: There are several places in the solicitation that set a timeline for required updates. Would you consider allowing 30 days from the date of an update to provide this information as permitted by CMS and the American Board for Certification in Orthotics, Prosthetics, and Pedorthics? This would apply to the following additional sections: Section 5.1 Key Personnel and Temporary Emergency Substitutions Government Answer: SOW will be updated to reflect a 30 day window to notify the VA of office or staffing changes. (see updated SOW attached changes in red) Vendor Question: Section 8.3 Orthotic Clinic Process and Conduct: Vendor appreciates the importance of running the Orthotic Clinic in a professional manner and that all veterans should be free to see the supplier of their choice. We are concerned about the ability to communicate with the veteran regarding their device and perform the necessary follow up care when applicable. Vendor is an orthotic and prosthetic provider and this includes performing evaluations, clinical fittings, delivery, follow up care, and adjustments. We are concerned this section is limiting our ability to perform necessary follow up care. Can you please clarify how you expect post delivery care communication to be handled? Government Answer: This language does not bar contracted clinicians from communicating with Veterans- this section explains the clinical evaluation process being done at the VA facility and prior to a vendor being selected. Once the Veteran has selected their provider of choice you will have the ability to perform all of the above functions listed, including follow up care and post-delivery care. Vendor Question: Section B.4 Information and Information System Security and Privacy Language for Inclusion in Contracts: We have reviewed the various FARS and it appears FARS 52.227-19 is not applicable to us in providing services under this solicitation and FARS 52.227-14 does not appear to be connected to the types of data we work with as we exclusively deal with Protected Health Information ( PHI ). We need to understand what you mean by the provisions in subsection (h) because we are maintaining records within our Electronic Medical Record System that has already undergone a security risk assessment as it relates to HIPAA. Is this provision indicating that there are requirements stricter than HIPAA? Government Answer: I am not sure if the requirements are stricter per se, but there are more. Minimally, our Veteran s information and EHR is covered by HIPAA, the Privacy Act, 38 USC 5701 and 38 USC 7332. We must protect VA information under all applicable statutes (there can be up to 7). Vendor Question: Section B.5 Records Management Language for Contracts: Do the records created and maintained by Vendor as part of our own requirements fall under these provisions? If yes, is the VA stating these records must be held to a different retention standard than state law requirements for medical record retention? And if so, what is that standard? Government Answer: Records pertaining to VA procurements need to adhere to this section. References in the section provide any necessary details. Vendor Question: Section C.11 VAAR 852.211-72 Technical Industry Standards: Proof of Accreditation with ABC will be provided as part of the offer submission and the charting completed by Vendor will adhere to ABC standards and ABC s Code of Professional Responsibility. Can you please clarify what you mean by proof of conformance to the standard in paragraph (b)? We are not clear what you require here and kindly ask for clarification on any additional documentation you expect to see when providing services under this solicitation. If you require to see an example of our charting we are happy to provide one for review. Government Answer: Per solicitation The Contractor shall submit proof of conformance to the standard. This proof may be a label or seal affixed to the equipment or supplies, warranting that the item(s) have been tested in accordance with the standards and meet the contract requirement . This is interpreted as affixing manufacturers serial numbers or stickers from the items utilized for construction of the orthosis for tracking in the event of a recall or warranty issue. This also confirms that the products being used conform to industry standards for ISO testing etc. Vendor Question: Section C.12 VAAR 852.211-76 Liquidated Damages Reimbursement for Data Breach Costs: As a covered entity, Vendor is obligated under HIPAA to protect PHI from data breaches and would be required to pay our own costs related to any such incident. What scenario would require the VA to pay for costs related to notification, credit monitoring, etc. when this would already be required of Vendor as a covered entity under HIPAA? Government Answer: If the Vendor was the cause of the breach, the Vendor would be responsible to pay the costs associated with the breach. Vendor Question: Section E.9 52.209-7 Information Regarding Responsibility Matters: Vendor has contracts in different VISN regions and in theory the total value could be $10,000,000 or greater based on maximum potential. However, there is no guarantee that the business would reach the ceiling of any given award, and some contracts do not specify a ceiling limit. What is your recommendation on how to properly answer this clause? Government Answer: Please consult your legal department on how you should complete this clause. Vendor Question: Section E.11 52.225-18 Place of Manufacture: Vendor, is not a manufacturer. What is the appropriate response for paragraph (b)(1) or (b)(2) when we do not engage in manufacturing? Any customization to an item is occurring in the United States. Government Answer: Because assembly and substantial transformation in the final product is conducted in the USA, (b)(1) should be checked. Vendor Question: Could you please clarify whether there is an expectation for BPA Holder Clinic staff to be physically present at the Community Outpatient Clinic sites for evaluations and/or the delivery of orthotic items? Alternatively, is it anticipated that these services will be conducted at the BPA Holder s clinic locations? Government Answer: The BPA holders are not expected to be in clinic for the evaluation or delivery of orthotic items and all contracted services with the BPA holders will be conducted at the contractors clinic locations.

Questions and Government Answers (in red): Vendor question: Section 2.2.1 Not Otherwise Classified Codes Reimbursement: Firstly, please understand that all manufacturer pricing is proprietary. Vendor has serious concerns that providing you with this competitively sensitive information will unduly expose it and its provider clinics to significant antitrust liability, including price fixing claims, since collecting negotiated rates from every provider would place you in the role of a clearinghouse. Whether knowingly or unknowingly, maintaining such information about each supplier s negotiated prices could lead to the unintended consequence of allowing suppliers to level set their prices and increase their negotiating leverage against providers, thereby increasing the prices they charge to providers. This would also unfairly prejudice the providers in a price squeeze since reimbursement levels are set regardless of the price a provider pays for the items provided. Secondly, we do not buy these items in bulk , and it is inaccurate to represent these items this way. These items are purchased on an as needed basis. Thirdly, please clarify the process for coming to the reimbursement rate for NOC codes. We do not understand how you determine the Overhead percentage and profit percentage . Can you please clarify? Is this amount what will be negotiated? Lastly, you indicate the Labor rate will reflect the CMS rate minus the discount offered in the pricing schedule. However, the manufacturer invoice would already reflect any discounts provided. Why would a second discount be taken on labor for calculating the reimbursement rate on a NOC code? Government Answer: There are national costs estimates in place for certain NOC items. Should a NOC item be provided that has a national cost estimate in place, the price will be accepted as is so long as it falls within that Government national estimate. If the NOC item is more than the national estimate, then the price will be negotiated down to be within that limit. In order to do that, the Government requires the manufacturer invoice. If a NOC item is submitted in which there is not a national estimate in place, the Government will utilize the same factors in place that are used for a national estimate to determine a fair price. In order to do that, the Government requires the manufacturer invoice. No, a second discount is not being requested. If the initial invoice already reflects a discount, it is not expected that another would be provided. Vendor Question: Section 4.3 Contractor Facilities Locations: There are several places in the solicitation that set a timeline for required updates. Would you consider allowing 30 days from the date of an update to provide this information as permitted by CMS and the American Board for Certification in Orthotics, Prosthetics, and Pedorthics? This would apply to the following additional sections: Section 5.1 Key Personnel and Temporary Emergency Substitutions Government Answer: SOW will be updated to reflect a 30 day window to notify the VA of office or staffing changes. (see updated SOW attached changes in red) Vendor Question: Section 8.3 Orthotic Clinic Process and Conduct: Vendor appreciates the importance of running the Orthotic Clinic in a professional manner and that all veterans should be free to see the supplier of their choice. We are concerned about the ability to communicate with the veteran regarding their device and perform the necessary follow up care when applicable. Vendor is an orthotic and prosthetic provider and this includes performing evaluations, clinical fittings, delivery, follow up care, and adjustments. We are concerned this section is limiting our ability to perform necessary follow up care. Can you please clarify how you expect post delivery care communication to be handled? Government Answer: This language does not bar contracted clinicians from communicating with Veterans- this section explains the clinical evaluation process being done at the VA facility and prior to a vendor being selected. Once the Veteran has selected their provider of choice you will have the ability to perform all of the above functions listed, including follow up care and post-delivery care. Vendor Question: Section B.4 Information and Information System Security and Privacy Language for Inclusion in Contracts: We have reviewed the various FARS and it appears FARS 52.227-19 is not applicable to us in providing services under this solicitation and FARS 52.227-14 does not appear to be connected to the types of data we work with as we exclusively deal with Protected Health Information ( PHI ). We need to understand what you mean by the provisions in subsection (h) because we are maintaining records within our Electronic Medical Record System that has already undergone a security risk assessment as it relates to HIPAA. Is this provision indicating that there are requirements stricter than HIPAA? Government Answer: I am not sure if the requirements are stricter per se, but there are more. Minimally, our Veteran s information and EHR is covered by HIPAA, the Privacy Act, 38 USC 5701 and 38 USC 7332. We must protect VA information under all applicable statutes (there can be up to 7). Vendor Question: Section B.5 Records Management Language for Contracts: Do the records created and maintained by Vendor as part of our own requirements fall under these provisions? If yes, is the VA stating these records must be held to a different retention standard than state law requirements for medical record retention? And if so, what is that standard? Government Answer: Records pertaining to VA procurements need to adhere to this section. References in the section provide any necessary details. Vendor Question: Section C.11 VAAR 852.211-72 Technical Industry Standards: Proof of Accreditation with ABC will be provided as part of the offer submission and the charting completed by Vendor will adhere to ABC standards and ABC s Code of Professional Responsibility. Can you please clarify what you mean by proof of conformance to the standard in paragraph (b)? We are not clear what you require here and kindly ask for clarification on any additional documentation you expect to see when providing services under this solicitation. If you require to see an example of our charting we are happy to provide one for review. Government Answer: Per solicitation The Contractor shall submit proof of conformance to the standard. This proof may be a label or seal affixed to the equipment or supplies, warranting that the item(s) have been tested in accordance with the standards and meet the contract requirement . This is interpreted as affixing manufacturers serial numbers or stickers from the items utilized for construction of the orthosis for tracking in the event of a recall or warranty issue. This also confirms that the products being used conform to industry standards for ISO testing etc. Vendor Question: Section C.12 VAAR 852.211-76 Liquidated Damages Reimbursement for Data Breach Costs: As a covered entity, Vendor is obligated under HIPAA to protect PHI from data breaches and would be required to pay our own costs related to any such incident. What scenario would require the VA to pay for costs related to notification, credit monitoring, etc. when this would already be required of Vendor as a covered entity under HIPAA? Government Answer: If the Vendor was the cause of the breach, the Vendor would be responsible to pay the costs associated with the breach. Vendor Question: Section E.9 52.209-7 Information Regarding Responsibility Matters: Vendor has contracts in different VISN regions and in theory the total value could be $10,000,000 or greater based on maximum potential. However, there is no guarantee that the business would reach the ceiling of any given award, and some contracts do not specify a ceiling limit. What is your recommendation on how to properly answer this clause? Government Answer: Please consult your legal department on how you should complete this clause. Vendor Question: Section E.11 52.225-18 Place of Manufacture: Vendor, is not a manufacturer. What is the appropriate response for paragraph (b)(1) or (b)(2) when we do not engage in manufacturing? Any customization to an item is occurring in the United States. Government Answer: Because assembly and substantial transformation in the final product is conducted in the USA, (b)(1) should be checked. Vendor Question: Could you please clarify whether there is an expectation for BPA Holder Clinic staff to be physically present at the Community Outpatient Clinic sites for evaluations and/or the delivery of orthotic items? Alternatively, is it anticipated that these services will be conducted at the BPA Holder s clinic locations? Government Answer: The BPA holders are not expected to be in clinic for the evaluation or delivery of orthotic items and all contracted services with the BPA holders will be conducted at the contractors clinic locations.

AGREEMENT ON-RAMP This solicitation is considered open for two (2) years from the date issued; however, it will have set dates when quotes are due which will be communicated via Contract Opportunities- https://beta.sam.gov/. Quotes are only being accepted prior to or on those dates following closure of the initial round of submissions. The Government will evaluate the market to determine if it is in the Government s interest to award Orthotic Appliances and Related Services BPAs to additional qualified firms by employing on-ramp procedures following the initial selection and award. The Government reserves the right, based upon the evaluation of the market, to accept new quotes with the intention of adding awarded agreements to provide the Government with better buying power. Quotes will be subject to the same quote instructions and evaluation procedures as contained in the original solicitation. Previously awarded BPAs will be unaffected by on-ramp actions taken to refresh the BPA pool. On-ramping will be accomplished by either issuing an amendment to the solicitation or via a notice to Contract Opportunities- https://beta.sam.gov/. Any Quoter awarded a BPA during an on-ramp will be subject to the established ordering period at initial award and as identified in the STATEMENT OF WORK at the time of initial BPA award.