Statement of Work.docx

STATEMENT OF WORK (SOW)

Pharmacy Medication Repackaging and Dispensing Services on behalf of the VA Salt Lake City Health Care System for the Utah State Veterans Homes

1. Background This contract is between the VA Salt Lake City Health Care System (SLCHCS) Pharmacy and the Third-Party Pharmacy (Contractor) for the bulk medication supply repackaging and dispensing services of pharmaceutical medications for eligible/qualified Veterans under the care of Utah State Veterans Homes. VA SLCHCS will provide all medications to eligible Veterans except when an emergent first fill is required. In those cases, the Contractor shall deliver within 4 hours and limit the emergent quantity to 5 days (or 7 days for the Southern Utah Veterans Home), with the remainder filled by VA SLCHCS. Therefore, VA SLCHCS Pharmacy requires the Third-Party Pharmacy (Contractor) to supply emergency (emergent) medication and perform bulk prescription medication repackaging services to dispense 30-day medication supplies to the Utah State Veterans Homes within the designated time-period. The Contractor must not break the chain of custody by subcontracting the requirements, like dispensing or repackaging, to a different Pharmacy not owned & operated by the Contractor. All pharmacies supplying the medication must be directly owned & operated by the Contractor in order to supply medications to eligible Veterans under the care of the Utah State Veterans Homes on behalf of the VA SLCHCS Pharmacy. The Contractor must pick-up the VA supplied bulk medications from the VA SLCHCS Outpatient Pharmacy, repackage the bulk medications of individual patients, and deliver/distribute them to the Utah State Veterans’ Homes within 24 hours for eligible Veterans. In addition, after receiving a prescription request from the prescriber, the Contractor must supply emergency and controlled medications within 4 Hours to the Utah State Veterans’ Homes for eligible Veterans.

Pursuant to VA Directive 1108.07 and Cleland-Dole Act, VA may furnish drugs and medicines to State Veterans Homes for certain eligible Veterans pursuant to 38 C.F.R. § 51.43 and § 17.96, subject to the § 51.41(c)(2) limitation for Veterans whose nursing home care is paid by VA under a State home care agreement. Drugs furnished must be on the VA National Formulary unless VA determines a non‑formulary drug is medically necessary; packaging will be mutually acceptable to the SVH and VA and set forth in a written agreement.

The Contractor and VA agree they will not knowingly and willfully violate the Anti‑Kickback Statute (42 U.S.C. § 1320a‑7b(b)). The Contractor shall provide at least one hour of annual AKS training to employees/agents who negotiate, structure, approve, or manage pricing, discounts, rebates, referral relationships, or any arrangement that could implicate AKS. The Contractor’s Code of Conduct and AKS policies shall be posted publicly and provided to VA upon request.

2. Scope The Contractor must ensure qualified Veterans under the care of the Utah State Veterans Homes are supplied with prescribed medications in a timely manner per VA Directive 1108.07 and according to the VA Formulary.

3. Specific Tasks

a. The Contractor shall ensure all records/documents (including non-VA pharmacy records) such as prescription records, signature logs, billing statements, patient eligibility records and invoices) are available to the VA upon request.

b. The Contractor shall notify the VA Chief of Pharmacy or designee in writing whenever a malpractice claim involving a patient has been filed against the contracted pharmacy within 3 working days.

c. The Contractor shall notify the Chief of the VA Pharmacy or designee in writing within 3 days of any significant Drug interaction, Adverse Reaction/effect and/or significant effect due to delays in medication delivery on any VA patient receiving medication from the vendor.

d. The Contractor shall provide monthly invoices for review prior to VA SLCHCS Contracting Officer’s Representative (COR) and the State of Utah State Veterans Home representatives to review appropriate billing to meet this standard of work, which includes but not limited to emergent supply standard of 5-days supply to all eligible Veterans except the St. George Utah State Veterans Home which requires a 7-day supply for controlled medications and repackaging fees. Exceptions are units of use greater than 5 to 7 days, for example: inhalers which would be limited to smallest increment for first emergent fill. The VA COR will review the Contractor’s invoices to address any discrepancies. Any invoice discrepancies found by the COR must be addressed and adjusted by the Contractor prior to the Contractor submitting their invoices through the Tungsten e-invoicing platform.

e. The Contractor shall provide a monthly itemized bill per eligible Veteran patient from each Nursing home with Date of supply, the patient's name with last four of the SS#, Name of Medication, Rx cost, quantity (units packaged), packaging cost, and total for each patient, cost per repacking, and total for all patients at the identified home. This includes embedding the VA SLCHCS Pharmacy POC review indicated within step 5. This information will be submitted through the IPPS/ CBO located in Austin, Texas. Any disputed charges will be billed back to the State Veterans Home if ordered by the facility and not approved under the formulary criteria, are not a qualified Veteran or request is a refill and not an emergency fill.

f. The Contractor shall be responsible for maintaining all prescription and drug wholesale transaction electronic records pursuant to the Drug Supply Chain Security Act (DSCSA) for 6 years from the current date.

i. The Contractor must continue to maintain 6 years of all prescription and drug wholesale transaction electronic records pursuant to the DSCSA even if they are no longer the current The Contractor of record.

ii. The data records kept pursuant to Drug Supply Chain Security (DSCSA) shall be provided in an organized manner using DVD, CDR, or retrievable by electronic means without any aid of software that would cause additional cost to VA SLCHCS.

g. In the event that the Contractor determines during the term of the parties’ agreement that the rates and pricing terms for Facility-Pay products and services are less than the Contractor’s actual cost of providing such products and services and/or the fair market value of such products and services, the Contractor may adjust the rates and pricing terms as specified in a written notice from Contractor to the VA’s designated Contracting Officer’s Representative (COR). This action is subject to audited by the VA at any time.

h. Must fill medications according to the VA Formulary and provide the VA Pharmacy with a copy of new, emergency prescriptions.

4. Requirements:

RESPONSIBILITIES OF THE VA:

a. Fill prescription medications from a written, telephone, fax or other electronic prescription format that are submitted to the VA outpatient pharmacy by the Utah State Veterans Homes or the Contractor.

b. VA will ensure that all orders will have the prescriber's name assigned to the prescription.

c. VA will provide pharmacy services from 8 a.m. to 4:30 p.m. Monday through Friday.

d. The VA will reimburse The Contractor for the cost of re-packaging of medications in cards, strip packing or bubble packs for eligible patients upon confirmation from the State Veterans Home and the VA Pharmacy.

e. VA Pharmacy will provide "use by" dates on the prescription label.

f. VA Pharmacy will maintain information of medications sent to the Contractor for repackaging.

g. VA Pharmacy shall reimburse the Contractor for medications that cannot be dispensed in time by the VA Pharmacy for emergency prescriptions. These emergent fills will be for no more than a 5-day supply (exceptions St. George 7 day) and in smallest quantity required for 5- or 7-day supply. Unless the smallest unit of use is a multidose unit with an example being an inhaler. Any residual supply needed to complete the prescription will be provided by the VA Pharmacy.

h. The VA Contracting Officer’s Representative (COR) or designee will certify the Contractor’s invoice and verify with the Utah State Veterans Homes receipt of invoiced items and the Veterans’ eligibility.

i. The VA shall have the right to audit prescription scripts and invoices from the Contractor.

i. The Price/Cost Schedule will be based on the Average Wholesaler Price (AWP) for generic medication and Wholesaler Average Cost (WAC) for brand name medication.

j. The VA will secure all medications in totes and make sure refrigerated products are Packed in appropriate cooled containers when repackaging medications are picked up by the Contractor.

k. The VA pharmacy will be available to assist the Contractor regarding VA policy on medication dispensing, Formulary issues or other VA procedures as needed.

Responsibility of the Contractor (3rd Party Pharmacy):

l. To provide all prescription orders received by the Contractor from the Utah State Veterans Home under the terms of the contract with the VA SLCHCS Pharmacy by in-person delivery, telephone, fax or electronic submission during the VA Pharmacy hours of operation from 8 a.m. to 4:30 p.m. Monday through Friday.

m. To assess that courier did not breach secured container and all appropriate medication containers are accounted for upon receiving.

n. To contact VA Pharmacy POC if any delivery issues occur.

o. To ensure the patient's prescriber is indicated and legible on all prescriptions.

p. To ensure that telephone/verbal orders must be from the prescriber; RN may transcribe per facility policy, but the order must identify the prescriber and meet all legal requirements.

q. To ensure that controlled substances (C-II and C-III) have a prescriber signature, quantity, and indication if used pm on the prescription prior to VA dispense. All C-IV substances will be assigned a 30-day fill equivalent and 5 refills unless otherwise indicated.

r. To adhere to VA National Formulary unless permitted by the VA NF requests must have prescriber information to meet VA NF criteria. The VA NF request is to be submitted to the VA SLCHCS pharmacy for approval prior to dispensing an NF product.

s. To verify with the Utah State Veterans Homes that each individual Veteran meets the requirements of Aid and Attendance, percentage of service connection, catastrophically disabled etc. Along with keeping records up to date and communicating any new Veteran additions or deletions from the Utah State Veterans Homes with the VA COR.

t. To ensure that emergent prescriptions filled do not to exceed a 5- day supply, exception, St. George, 7-day supply. Using the smallest quantity of unit of use for first time fills, example inhalers. To ensure emergency prescriptions are authorized and delivered within 4 hours after notification without the use of a subcontractor.

u. To ensure that the Contractor utilizes low-cost generic equivalent medications. If the Contractor interchanges brand or generic products that potentially may lead to varying serum drug concentrations affecting clinical outcomes. (e.g. Warfarin as Coumadin®, carbamazepine as Tegretol®, phenytoin as Dilantin® etc.) The Contractor shall confirm with the VA pharmacy, so they dispense the same generic by the Contractor if the VA generic is not available and the alternate bio-equivalent product is urgently needed; the Contractor shall contact the prescriber to discuss what will be appropriate to provide.

v. To maintain records of medications received and sent for repackaging.

w. The Contractor must prepare invoices for repackaging of medications and emergency prescriptions filled by the Contractor then submit these invoices monthly to the VA pharmacy.

x. The Contractor shall participate in unscheduled quarterly compliance reviews conducted by VAMC Salt Lake City pharmacy representatives.

i. The Contractor shall provide the quarterly AWP generic and WAC brand name medication information to the COR for any scripts dispensed in the previous quarter.

ii. The Contractor’s biller/accounts receivable team shall submit monthly invoices to the COR prior to submitting into the Tungsten system for payment to verify all charges are correct and no charges have been included that are the responsibility of the Utah State Veterans Home Facility.

y. Will submit all charges through the Tungsten system which the Contractor is responsible for setting up their account at the initiation of the Contract.

5. Performance Monitoring The COR will work with the Utah State Veterans Homes to monitor the Contractor’s performance to ensure medications arrive at the Utah State Veterans Homes facilities and proper invoicing to the VA SLCHCS Pharmacy. Reported failures to supply the emergency and controlled medications within 4 Hours and/or failure supply repackaged medication within 24 hours that results in patient harm would result in a poor performance review. In addition, three (3) or more invoice discrepancies in a billing period may result in a poor performance review.

6. Security Requirements All patient information will be transmitted using approved systems with validated security protocols by VA SLCHCS security. All parties will follow all HIPAA and patient security requirements. The Certification & Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required.

7. Other Pertinent Information or Special Considerations.

All the Contractor sites must be licensed and in good standing with the Utah State Division of Professional Licensing for Pharmacy and Controlled substance pharmacy. All employees handling medications need to be a licensed Pharmacist or Pharmacy Technician in good standing with the Utah State Department of Occupational Licensing (DOPL).

Medications must be transported, handled, and processed while ensuring the chain of custody always remains intact. Patient information will not be shared outside of the Utah State Veterans Home, the Contractor, and the VA SLCHCS Pharmacy.

8. Risk Control The Contractor shall provide staff with proper education and PPE for handling medications according to Utah State Pharmacy guidelines.

9. Locations:

VA Pharmacy:

VA Salt Lake City Health Care System (SLCHCS) Pharmacy Building 1 George E. Wahlen VA Medical Center 500 South Foothill Blvd Salt Lake City, UT 84148

State of Utah Veterans Homes:

George E. Wahlen Veterans Home 1102 North 1200 West Ogden, UT 84404

Central Utah Veterans Home – Payson 1551 North Maine Street Payson, UT 84651

William E. Christofferson Salt Lake Veterans Home 700 S Foothill Blvd Salt Lake City UT, 84113

Southern Utah Veterans Home - Ivins 160 North 200 East Ivins, UT 84738

10. Period of Performance

11. Definitions VA SLCHCS: The Department of Veterans Affairs Salt Lake City Health Care System in this SOW is referring to the Pharmacy Department.

Emergency prescription: A medical emergency first fill that must be delivered within 4 hours.

Complete prescription order: All information required for dispensing, including prescriber authorization and patient identifiers.

Eligible Veteran: A Veteran for whom VA has authorized furnishing of medications under applicable laws and regulations.