36C79118R0022-0003001.docx

36C79118R0022

CONFORMED SOLICITATION AS OF AMENDMENT 0003

SEE LATEST AMENDMENT FOR LATEST TIMELINES ON PROPOSAL SUBMISSION

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C79118R0022 10-29-2018 Alyssa Urquhart 303-273-6214 11-08-2018 5:00 pm MST

Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621

X

621492 $38.5 Million

N/A

Department of Veterans Affairs Commodities & Services Acquisition Svc

555 Corporate Circle Golden CO 80401-5621

Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621

Department of Veterans Affairs Financial Services Center 7600 Metropolis Drive Bldg 5 Austin TX 78744 1-877-353-9791

See CONTINUATION Page Minimum Guarantee is $10,000 per contract; contract value shall not exceed $3,000,000,000 per contract under this solicitation.

All questions must be in writing and sent to the Contracting Officer and Contract Specialist NLT November 1, 2018

Reference B.2 Schedule Contracting Officer: Alyssa.Urquhart@va.gov Contracting Officer: David.Little@va.gov

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C791 Alyssa Urquhart Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center 7600 Metropolis Drive Bldg 5 Austin TX 78744 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 SCHEDULE OF SERVICES

1. The contractor shall provide the community dialysis services nationwide as defined in the Performance Work Statement and throughout this contract, for eligible beneficiaries as authorized by the Ordering Officers assigned ordering responsibility by the Contracting Officer. All contractors shall provide the minimum of in-center hemodialysis. An offeror that proposes CLIN 0004, “Training for Home-Based Modalities” must also propose CLIN 0002, “Home Based Hemodialysis” and/or CLIN 0003 “Peritoneal Dialysis”. The offeror need not provide services nationwide. The intent of this program is to award contracts to multiple contractors to provide an expansive network of dialysis providers to serve thousands of Veterans throughout the United States and its territories. Personnel assigned by the contractor to perform the services covered by this contract shall be licensed in the State, Territory, or Commonwealth of the United States or the District of Columbia where the services are provided, as applicable. All licenses held by the personnel working on this contract shall be full and unrestricted licenses.

2. Pricing shall be based on a percent of the CMS Medicare Program’s Prospective Payment System (PPS) for the respective dialysis services contract line item number (CLIN), and any authorized Current Procedural Terminology (CPT) that applies to the type of services required for that patient. All services will be paid at the contract percent of the CMS Medicare Program for its respective CLIN. The prices shall be all-inclusive of equipment, facility, nursing, technical personnel, laboratory testing, drugs, supplies and professional services (social work and dietary). Nephrologist services are not included in this contract and must be authorized and paid separately. Other arrangements must be made with the VAMC for the authorization and payment of nephrologist services. The CMS Medicare End Stage Renal Disease (ESRD) PPS is the basis from which all claims will be submitted and paid. (Please reference https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Consolidated_Billing.html). VA reserves the right to deviate from the CMS Medicare Program when there is a conflict in policies. Non-ESRD services will not be reimbursed under this contract and must be authorized/coordinated with the VAMC (i.e. vaccines, medications, etc. that are provided during the dialysis session for non-ESRD diagnoses).

3. The CMS Medicare Program allowed amount will be computed in accordance with the rules (1) promulgated by the Centers for Medicare and Medicaid Services (CMS) for the specific Medicare geographic area where the services are provided, (2) in effect at the time of the delivery of service, and (3) including, but not limited to, all CMS Medicare Program payment components (e.g. outliers, etc.) multiplied by the contract percent of Medicare.

4. The Facility List, Attachment 2, must be completed in full and include a complete list of CMS Medicare Program certified facilities included under this contract.

5. Period of Performance

04/01/19-09/30/19

10/01/20-09/30/21 Option III 10/01/21-09/30/22 Option IV 10/01/22-09/30/23 Option V 10/01/23-03/31/2024

B.3 IT CONTRACT SECURITY

-The services provided would be considered and fall under the purview of a HIPAA Covered Entity. Once copies of VA data are transferred, it is considered the contractors data upon receipt and must be protected under HIPAA Rules.

- This acquisition is considered a service provided by a HIPAA covered entity (i.e. "computer systems not owned by or managed within the boundaries of VA, but provide services to VA" and/or the service provided fall under one or more of the following: Health Care Provider, Health Plans or a Health Care Clearinghouse). Contract personnel will perform all work off site.

- Reserved.

- Reserved.

- Reserved.

- Training and background investigations are not needed as the ownership of the data will transfer to the vendor upon receipt and will fall under the HIPAA Rules associated with a HIPAA covered entity.

36C79118R0022 -No Business Associate Agreement (BAA) is required.

Page 1 of Page 1 of B.4 VA HANDBOOK 6500 APPENDIX C: INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS (TAILORED)

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. Reserved.

c. Reserved.

d. Reserved.

e. The contractor or subcontractor must notify the VA Financial Services Center (877) 353-9791 or vafscenterprisesupport@va.gov immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employment. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. Reserved.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. Reserved.

h. Reserved.

i. Reserved.

j. Reserved.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus to the public. This information may be shared with health care providers for treatment purposes.

i. Reserved.

4. Reserved.

5. Reserved.

6. Reserved.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $42 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

8. Reserved.

9. Reserved.

B.5 PERFORMANCE WORK STATEMENT

ACRONYMS/DEFINITIONS: The following terms, when used in this contract, will be interpreted as follows:

1. ADP: Automatic Data Processing

2. Authorization: Same as “task order or order” for the purpose of this contract and clauses contained herein.

3. CAPD: Continuous Ambulatory Peritoneal Dialysis. A manual form of peritoneal dialysis, with no machine.

4. CCPD: Continuous Cycling Peritoneal Dialysis, also known as Automated Peritoneal Dialysis, a form of peritoneal dialysis using a cycler at night.

5. Claim: A request for payment of dialysis services from the contractor to VA. As used in the PWS, this term does not include the meaning of the term “claim” as defined in FAR 2.101.

6. CMS: Centers for Medicare and Medicaid Services

7. CO (Contracting Officer): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

8. COR (Contracting Officer’s Representative): An individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. The COR is responsible for technical administration of the contract and will ensure proper Government surveillance of the contractor’s performance. The COR will keep a quality assurance file. The COR is not empowered to make any contractual obligations or to authorize any contractual changes on the Government’s behalf.

9. CPT (Current Procedural Terminology): A coding system developed by the American Medical Association and a listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians. The purpose of the terminology is to provide a uniform language that will accurately describe medical, surgical, and diagnostic services, and will thereby provide an effective means for reliable nationwide communication among physicians, patients, and third parties.

10. EDI: Electronic Data Interchange

11. EFT: Electronic Funds Transfer

12. EOB: Explanation of Benefits

13. ESRD: End Stage Renal Disease

14. FAR: Federal Acquisition Regulations

15. FSC: Financial Services Center

16. HD: Hemodialysis

17. HHS: Department of Health and Human Services

18. HIPAA: Health Insurance Portability and Accountability Act

19. Modify authorization: Create or adjust the parameters of an authorization by delegated ordering officers when approved by CO/COR when necessary

20. NDSC: Nationwide Dialysis Services Contract

21. NPI: National Provider Identifier

22. OCC: Office of Community Care

23. Ordering Officer: A VA employee, delegated in writing by the CO, to order services under the contract via issuance of Approved Referrals

24. PHI: Personal Health Information

25. PPS: Prospective Payment System

26. QASP: Quality Assurance Surveillance Plan

27. RAS: Referral and Authorization System

28. VA: Department of Veterans Affairs

29. VAMC: Veterans Affairs Medical Center

30. Vendorizing: The act of adding a contractor’s facility into VA systems to provide payment

31. Veteran: VA eligible dialysis patient

32. VHA: Veterans Health Administration

33. VISN: Veterans Integrated Service Network

1. GENERAL INFORMATION

Objective: The Department of Veterans Affairs (VA) has a requirement to purchase chronic dialysis services from community-based dialysis service providers.

The goals of this contract are to:

1. Maintain and augment the VA’s ability to provide these services to Veterans in current and future years by providing improved access to care;

1. Ensure quality driven services; and

1. Realize cost savings through the utilization of consistent billing practices.

The contractor shall meet the requirements of this contract and be in compliance with CMS quality standards. The contractor shall provide, supervise, and monitor outpatient chronic dialysis services to Veterans within the contractor’s facilities and provide home dialysis training to Veterans. Home dialysis training shall be provided in the contractor’s facilities. Home and outpatient based dialysis services shall utilize contractor resources, contractor owned and maintained equipment, contractor staff, and the contractor equipment necessary or required for dialysis services. The contractor shall provide the services and associated healthcare in a manner consistent with the clinical needs of the Veteran and extend the same or superior standards of quality care as delivered to the facility’s Non-VA patients.

Applicable Federal, State and Local Laws: During the course of this contract, the contractor must comply with all federal, state and local laws and regulations.

VA reserves the right to perform random inspections of the accreditation, certification, credentialing, privileging/competency measures, and licensing files for any provider within the Contractor’s network for performance of this contract. Additional information is detailed in the Quality Assurance Surveillance Plan (QASP), Attachment 1.

VA may perform random onsite visits to provider locations through coordination with the Contractor to inspect physical operations and/or review records of VA Veterans, speak with Veterans, review quality and completeness of accreditation, certification, and credentialing, privileging and licensing documentation. Additionally, VA may request records be sent electronically or by mail to support the inspections and/or visits.

It is the VA’s intent to transition dialysis services under the Nationwide Dialysis Services Contract (NDSC) program to the Community Care Network (CCN) contracts providing a wide-array of healthcare services to Veterans. There are four CCN Regions and the contracts will likely not be awarded at the same time. The offerors who are awarded contracts under CCN have a pre-determined amount of time (180 days) to achieve the start of health care delivery (SHCD). For SCHD, the minimum schedule requirement includes full implementation of one (1) VA Urban Site and one (1) VA Rural Site per awarded CCN Region. At the point of SHCD, under each region, the VA may choose not to exercise options on the dialysis contract(s) in the regions where CCN SHCD has been achieved, or the VA may issue a modification to the facility list, Attachment 2, removing facilities, and/or may transition authorizations from the dialysis contracts to the CCN contract(s).

2. SERVICE AREA

Dialysis services are required in the United States, the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana Islands. The contractor shall provide community-based dialysis services within its network of CMS Medicare Program certified dialysis facilities. The contractor shall only include facilities that meet the contractual requirements and are CMS End Stage Renal Disease (ESRD) certified on the Facility List, Attachment 2. The contractor may add or remove facilities to the facilities list in accordance with the process established in Section 6.

The offeror need not provide services nationwide. The intent of this program is to award contracts to multiple contractors to provide an expansive network of dialysis providers to serve thousands of Veterans throughout the United States and its territories.

3. USUAL AND CUSTOMARY TREATMENT UTILIZATION

All treatment modalities delivered must be in accordance with the CMS Medicare Program treatment guidelines to include CMS’ Phase III ESRD Clinical Performance Measures. All treatments must be requested and authorized by the Ordering Officer. The treatments to be provided include the following:

1. Center-Based Hemodialysis (HD): Includes in-center dialysis.

1. Home-Based HD: Care shall be provided using Method I as described by the CMS Medicare Benefit Policy Manual, Chapter 11 – End Stage Renal Disease. Method II is unallowable.

1. Peritoneal Dialysis: This includes the types of Peritoneal Dialysis (CAPD, CCPD, etc.) described in CMS Medicare Benefit Policy Manual, Chapter 11 – End Stage Renal Disease.

1. Training for Home-Based Modalities: Authorization and payment for home dialysis training will be in accordance with the CMS Medicare and Medicaid Programs; Medicare Benefit Policy Manual, Chapter 11 – End Stage Renal Disease, paragraph 30.2. A training authorization is required for all new home-based patients. Additional training must be preauthorized by the Ordering Officer.

4. AUTHORIZATION (ORDERING) PROCESS

1. Authorization Form: VA will utilize VA Form 10-7079, Request for Outpatient Medical Services, as the ordering form. All authorizations will be created by the initiating VAMC’s ordering officers through the Referral and Authorization System (RAS). Contractors shall not perform any services under this contract without prior authorization. Contractors are required to retrieve authorizations via the Provider Portal established by the Financial Services Center (FSC). It is the contractor’s responsibility to ensure all appropriate personnel have access to the system, and are properly trained to sign onto this system and retrieve the necessary authorizations. Authorization effective start and end dates will also be stated on each VA Form 10-7079.

1. Patient Eligibility: VA has sole authority and responsibility to establish and confirm Veteran eligibility prior to issuing an authorization.

1. Veteran Acceptance: VA acknowledges that, depending on the availability of resources at specific contractor facilities at specific times, acceptance of an authorization may not be feasible for the contractor. In that event, the contractor may decline an authorization. If the contractor proposes another contractor facility, VA reserves the right to reject that facility and seek the services from another contractor. If the contractor has determined space is available at another one of its facilities, and the VAMC agrees with the proposed facility, a new authorization will be sent to the contractor.

1. Authorization Process: Ordering Officers will issue written authorizations to the contractor via RAS, or other systems designated by the CO or COR. In accordance with FAR 16.505, Ordering, VA has determined orders will be placed based on Veteran preference, clinical need, contractor’s facility capacity, and price, in descending order of importance.

1. Issuance of VA Authorizations: Ordering Officers will issue an authorization via the FSC automated information processing system (RAS or other designated system by the CO or COR). The contractor shall initiate services upon receipt of an authorization. The contractor is responsible for verifying the accuracy of and accepting the authorization. Elements of an authorization for verification include, but are not limited to:

1. Authorization Period

2. Correct modality (Services Authorized)

3. Facility Name and Address (Cross check with NPI Number)

4. Onset Date

This verification must be within ten (10) business days of receipt of the authorization and the contractor may request any changes in writing via email during this period through the issuing VAMC and the COR. Onset date verification by exception must be 55 business days from the receipt of the authorization. All questions pertaining to the authorization should be addressed to the Ordering Officer listed on the authorization. If the contractor continues to provide services beyond the ten (10) business day review period, without notifying the issuing VAMC of the authorization issue, payment may be denied. There are three types of authorizations applicable to this contract: new, renewal, and transient.

1. New Authorization: A new authorization is created to begin a Veteran’s treatment. The period of validity will be stated in the authorization. The contractor shall obtain a new authorization before changing the Veteran’s treatment modality or servicing facility. Failure to obtain proper authorization prior to changing Veteran’s treatment modality or servicing facility may result in denial of claims for the period and services not authorized.

If the authorization is not populated into the Provider Portal within 10 business days, the Contractor will contact authorizing VAMC, COR or CO to obtain. In the event the Veteran is scheduled for dialysis prior to the 10th business day, the contractor shall follow up with the authorizing VAMC staff, or the Enterprise Help Desk at 877-353-9791,or vafsccshd@mail.va.gov for assistance.

2. Renewal Authorization: A renewal authorization is required to continue treatments once the current authorization has expired. This authorization is initiated by designated Ordering Officer and will be provided to the contractor prior to the authorization expiring. If the contractor does not a receive renewal authorization 15 business days prior to expiration of the previous authorization, the contractor must always notify the VAMC that there is a potential for an interruption of services unless a new authorization is received.

3. Transient Authorization: Transient dialysis treatments are defined as treatments delivered for less than a 60-calendar day period at a contracted facility other than the Veteran’s originally referred facility. A transient authorization is effective for 60-calendar days or less to cover a patient’s travel beyond the normal support of the regular community dialysis unit. There must be close coordination between the regular provider, referring VAMC, and the temporary provider, to ensure uninterrupted dialysis treatments to the Veteran while in a travel status. The transient authorization will be placed based on patient needs and proximity to the Veteran’s transient location; it may or may not be with the same contractor providing services at the Veteran’s regular location. Travel extending beyond 60 calendar days will require a new authorization from the home VAMC’s Ordering Officer.

Note: The VA may modify authorizations to include the allowance to extend previously expired authorizations or to modify an authorization in the event services were provided without a current authorization. The contractor is still responsible for communicating with the VA regarding missing/expired authorizations.

5. PATIENT ORDERING

1. Veteran Acceptance: When the contractor has confirmed the Veteran is accepted to the facility, the VA and contractor’s dialysis facility and its designated representatives e.g., social workers) will collaborate and coordinate on a date to transfer the Veteran to the care of the contractor without disruption of the Veteran’s required dialysis treatment. Along with the scheduling of an appointment at a specific contracted dialysis facility, the Ordering Officer will provide the contractor with a proper authorization PRIOR to the patient arriving at the scheduled contractor’s facility. In the event that the dialysis facility has not received the authorization in the Provider Portal after coordination has been made, the contractor shall contact the VAMC within 10 business days from the authorization date and inquire as to the status of the authorization. If the authorization has been input into RAS, the contractor shall contact the FSC Customer Service Helpdesk at VAFSCCSHD@va.gov, telephone number 1-877-353-9791 for access issues.

1. Secure Transmission of Forms: Veteran patient information shall be sent via secure fax. The contractor shall maintain a secure fax (operable 24/7) for the receipt of this information.

Medical records may be transmitted to/from the VAMC via VLER eHealth Exchange system if and when the contractor acquires this capability or other agreed upon (end to end) secure communication system. The contractor will comply with the applicable VA security certification, integration, and testing requirements at no additional cost to the government.

1. Referral Disruption/Cancellation: As contained within Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule (Reference 42CFR Parts 405, 410, 413, 414, 488, and 494), if the contractor considers the discharge of a Veteran for any reason listed in this final rule, and at any time after the receipt of acceptance or after initiation of treatment of the Veteran, the contractor shall provide a 10 business days termination notice in writing to the designated VAMC personnel, and Contracting Officer’s Representative (COR) as well as required parties stated in this rule. The designated VAMC personnel will review all contractor notices and the Ordering Officer will issue additional authorizations for the Veteran, as needed. The designated VAMC personnel will aid and assist in the transfer of the Veteran to a new facility, as appropriate.

6. CONTRACTOR FACILITY AND EQUIPMENT

The contractor shall comply with CMS 42 CFR Parts 405, 410, 413 et al. Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule, and implement all future revisions to the CMS Conditions for Coverage measures at no cost to the Government. The contractor’s dialysis facilities are required to be CMS Medicare Program certified and comply with all applicable certification standards and levels of care delivered. Upon written request by the Contracting Officer’s Representative (COR) or Contracting Officer, the contractor shall provide a copy of all applicable permits, licenses, and other facility documents.

In compliance with CMS 42 CFR Parts 405, 410, 413 et al. Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule, the contractor shall provide and maintain all dialysis equipment appropriately. Water purity testing must meet the standards of the most current guidelines cited by the Association for the Advancement of Medical Instrumentation.

The contractor should notify the designated VAMC personnel, COR, and Contracting Officer within five (5) business days of notification of adverse action (e.g. Termination Notices) by the CMS Medicare Program or its external monitoring agency to include exclusion from participation from the Medicare program, Medicaid program, and other federal programs by the contractor, its agents, employees, assigns or successors.

Veterans shall not be accepted into facilities for dialysis treatment either in center or at home that are not CMS Medicare Program certified, and claims shall not be paid to contractors that attempt to, or furnish, services administered through in non-CMS Medicare Program certified facilities.

The contractor shall use the facility listing template (Attachment 2) to add or remove facilities, or make changes to existing facilities. The process for facility changes is outlined below.

Administrative Changes The contractor may request any adjustments listed below to current facilities. Contractor requests shall be sent via email to the Contracting Officer’s Representative at OCCDialysis@va.gov with courtesy copies to the affected VAMC and the CO. The contractor shall identify any additions or changes that require immediate attention. The contractor shall notify the CO and the COR as soon as possible and/or within five (5) business days in advance of administrative changes below, but not limited to:

a. National Provider Identifier (NPI)

b. Tax ID Number (TIN)

Facility Address Changes

The contractor shall notify the VAMC, CO, and the COR as soon as possible and/or within five (5) business days in advance of changes of facility address (change of ownership addressed separately below in number 7). The contractor shall provide the VA Medical Staff and COR a list of affected Veterans to ensure no lapse in care.

The request shall include the following information, depending on the type of change:

Facility Additions:

1. Name and address of the facility

1. Applicable VISN

1. Signed attestation statement (Attachment 3)

1. Complete and attach the Facility List (Attachment 2) including only new additions

1. Fill out, Sign, and Forward VA Form 10091, VA-FSC Vendor File Request Form (More information can be found under PWS Paragraph 10. B “Onboarding / Vendorizing”)

Facility Information Changes:

1. Identification of the applicable facility

1. New information including change in address

1. Complete and attach the Facility List (Attachment 2) including only the changes requested

1. Statement that CMS Medicare Program certification is valid and still current with the changes

1. Fill out, Sign, and Forward VA Form 10091, VA-FSC Vendor File Request Form (More information can be found under PWS Paragraph 10. B “Onboarding / Vendorizing”)

Facilities Removal:

1. Provide VAMC, CO and COR 30 calendar days prior notice of intent.

1. Identification of the facility via Attachment #2 – Facility Listing

1. Brief description of the reason for removal

When submitting changes and additions on the Facility List, the contractor shall not make changes to the template provided by the VA.

The COR will ensure the contractor receives an e-mail response indicating the facility change has occurred, along with the effective date of this action.

7. CHANGE IN OWNERSHIP (CHOW)

In the event a Change in Ownership (CHOW) affects a facility under contract, the contractor shall notify the CO, COR and applicable VAMC at least 30 calendar days prior to the expected effective date. Of note, current RAS authorizations will remain valid until specific date of sale.

If the Change of Ownership will result in the facility (facilities) not being Medicare certified as of the date of the sale, the VA may require Veterans to be moved to a contractually compliant facility.

The contractor shall provide:

· Statement of Intent with at least 30 calendar days’ notice

· Selling or purchasing a facility (facilities) – Attachment #2 – Facility Listing

· Date facility (facilities) will no longer be available

· Any other applicable documents requested by the CO or COR

8. CUSTOMER SERVICE AND VETERAN SAFETY

A. Veteran Complaints: The contractor shall notify the authorizing VAMC personnel and COR via email and read receipt within five (5) business day of any Veteran complaint filed with the NDSC contracted facility. The CO or COR may require follow-up actions and/or additional information.

B. Veteran Clinical Safety Event Notification: The contractor shall notify the designated VAMC personnel and the COR telephonically, and by email with read receipts, as well as copying the Contracting Officer and Program Manager within 24 hours after the contractor receives formal notice of, or becomes aware of any Veteran safety event (i.e., adverse events, sentinel events, close calls, death of a Veteran, and intentional unsafe acts). The CO or COR may require follow-up actions and/or additional information.

Reference publicly available VHA National Patient Safety Improvement Handbook, VHA Handbook 1050.1 for definitions and additional information; and/or contact the COR for a copy.

C. Adverse Administrative Events/Reportable Administrative Events: The contractor shall notify the designated VAMC personnel (identified in Attachment 4), COR, and Contracting Officer in writing and include information detailing the reasons for and circumstances related to the loss or adverse impact, in accordance with CMS Medicare Program reporting. The notification should be provided within one business day after the contractor receives formal notice of, or becomes aware of any of the following:

0. Any action affecting the status as a certified CMS Medicare Program provider of dialysis services to Veterans, or any other action affecting any of the dialysis facility’s federal or state licenses and CMS certification;

0. Any investigations by the CMS Medicare Program into the business and/or billing practices of the dialysis facility that results in negative findings;

0. Any other actual or pending legal or Governmental investigation, incident, claim, action, suit, or proceeding against the dialysis facility, which would impact the dialysis facility’s ability to carry out its duties and obligations under this contract;

0. Exclusion from the CMS Medicare Program of any individuals employed by, or contracted with, the dialysis facility for the provision of ESRD services;

0. Revocation of required federal or state licenses of any individuals employed by, or contracted with, the dialysis facility for the provision of ESRD services; and

0. The lapse, for any reason, of the dialysis facility’s medical malpractice insurance coverage.

1. Unexpected Transfer of Patients:

1. VA Initiated – There are times when the VAMC encounters unexpected situations (e.g. contaminated water, power loss, natural disasters, etc.) when they are temporarily unable to provide dialysis services to Veteran patients within their in-house dialysis facilities. In such situations, the VAMC may send an unusually large number of patients to contracted facilities, and possibly only for a short, undetermined, period of time. Once the urgent situation has been resolved, the VAMC will coordinate with the contracted facility to return the treatment of these patients back to the VAMC.

2. Contractor Initiated – There are also unexpected situations when the authorized, contracted facility is unable to provide the Veteran patients continued dialysis treatments at that facility (e.g. contaminated water, power loss, natural disasters, etc.). In such situations, the contractor may temporarily transfer VA patients to a nearby VA-contracted facility, with the VAMC approval, until the originally authorized facility can resume treatments. Or the patient may be transferred to another facility owned and operated by the contractor (coordinated with the VAMC with a temporary authorization). However, the contractor must contact the authorizing VAMC and COR within 24 hours, and/or as soon as practicable due to loss of communication means to obtain a temporary authorization for the new facility. The authorizing VAMC will provide a temporary authorization via the Provider Portal to the contractor.

E. Medically Appropriate Care:

In accordance with CMS Medicare Program guidelines, the contractor’s delivery of care to Veterans shall be in a manner that maximizes patient outcomes. Delivered care shall be Veteran centered and individually focused and tailored to the goals stated in the Veterans’ care plans. Contractor services shall be delivered in accordance with medically accepted professional standards and practices of care. Care delivered to Veterans shall meet or exceed the standard of care delivered to non-VA patients. VA medical personnel maintain the right to render final determination for any care delivered outside of medically accepted professional standards and practices of care.

9. DIAGNOSTIC TESTING, PRESCRIPTIONS, AND OTHER VETERAN

PREVENTATIVE CARE SERVICES

Miscellaneous and Emergency Testing: If a Veteran requires hospitalization, specialized tests, and/or consultation for any medical, surgical, and/or rehabilitation problem that may occur during the performance of this contract, the contractor shall transfer the Veteran’s care to the referring VAMC. In emergent situations, activate the Emergency Management System (EMS) (e.g. call 911). Notify the VAMC within 72 hours of such occurrence. Questions regarding elective procedures should be directed to the designated VAMC personnel or the Veteran’s VAMC primary care physician.

1. Diagnostic Tests: All routine diagnostic tests not stipulated by Medicare to be provided by the contractor in the bundled payment for dialysis treatment will be directed to the authorizing VAMC for approval except in emergent situations (e.g. life threatening or a situation that may result in immediate and/or permanent harm to the patient).

1. Prescriptions: All routine medications not stipulated to be provided by the contractor in the bundled payment for dialysis treatment will be filled by the local VA Pharmacy unless alternative guidance is provided to the Veteran by VA. Routine medications prescribed will follow the VA formulary referenced at: http://www.pbm.va.gov/PBM/NationalFormulary.asp Questions regarding non-formulary medications may be referred to designated VA personnel for assistance with approval, authorization, or appropriate substitution.

1. Vascular Access: Access related issues shall be referred to the designated VA personnel for assistance. VA available resources must be utilized whenever possible. VA will authorize utilization of community resources if it is determined that VA services (vascular surgery or interventional radiology) for Veteran dialysis access intervention is not available. In addition, VA will authorize the use of community resources if lack of VA emergency services threatens access. Authorizations shall be obtained before the care is delivered except in emergent situations.

10. BILLING

For purposes of this PWS, “claim” is defined as an invoice for services rendered in accordance with the terms of the contract. Claims shall be submitted by the contractor to VA on a monthly basis in arrears.

A. Standard Billing: The contractor shall submit invoices in the form of health care claims to VA for payment of services. The health care claims shall be submitted via Health Insurance Portability and Accountability Act (HIPAA) compliant Electronic Data Interchange (EDI) transactions sent through VA’s designated clearinghouse within 180 calendar days from the date of service. Claims filed after this time period may not be paid, unless authorized by the Contracting Officer. Medical claims shall contain the Payer ID for the VA Purchased Care Program, which is VA FSC.

B. Onboarding / Vendorizing: VA requires all vendors to submit a VA Form 10091 prior to submitting claims for services or goods provided to VA. Contact vafscenterprisesupport@va.gov to obtain and submit the form. Contractor should confirm with VA FSC Customer Service Helpdesk that vendorization has been completed prior to submitting claims.

C. Timely Filing: The contractor…