36C24418Q9641-001.docx

36C24418Q9641

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

36C24418Q9641 08-24 -2018 Kevin Balser kevin.balser@va.gov 570-824-3521 X 4071 09-30-2019 00244 Department of Veterans Affairs Network Contracting Office 4

621410 $11 Million X N/A X As determined by need

00244 Department of Veterans Affairs Network Contracting Office 4

Austin Payment Center

PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page Blanket Purchase Agreement for In-vitro Fertilization (IVF)/ Assisted Reproductive Technology services (ART) services as contained herein for a period of 5 years.

See CONTINUATION Page X X Frederick C. Hilliard Contracting Officer 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 36C244 Frederick C. Hilliard

Network Contracting Office 4

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.

Austin Payment Center Department of Veterans Affairs PO Box 149971 Austin TX 78714-9971

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-4 Notice of Price Evaluation Preference for HubZone Small Business Concerns. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

B.4 IVF/ ART SOW Contract—DRAFT—Version 1

XX. In-vitro Fertilization (IVF)/ Assisted Reproductive Technology services (ART).

The VA has a requirement for a In-vitro Fertilization (IVF)/ Assisted Reproductive Technology services (ART) pricing agreement with multiple facilities as the need may arise. The government intends to award multiple Blanket Purchase Agreements

The VA will reimburse, under this contract only, for In-vitro Fertilization (IVF)/ Assisted Reproductive Technology services (ART), and infertility services covered under the medical benefits package, for a Veteran and their spouse; whom VA authorizes for treatment. Treatment may begin only upon receipt of an authorization from the Office of Community Care (OCC) at the VA Medical Center (VAMC) local to the ART provider.

A. See attachments D.2 and D.3 for explanation of IVF/ ART services covered; the list below is not all inclusive but intended to be used as a general guide:

· stimulation of ovulation

· monitoring of ovulation stimulation

· oocyte retrieval

· laboratory studies

· embryo assessment and transfer

· luteal phase support

· embryo cryopreservation

· cryopreservation of sperm, oocytes if medically indicated )

· Sperm retrieval

· Preimplantation genetic diagnosis if medically indicated B. Ancillary services are required for the IVF procedure and are covered under this contract.

C. Any additional medical and/or surgical treatments directly related to optimization of treatment outcomes (e.g. salpingectomy of severely damaged fallopian tubes prior to IVF, normalization of the uterine cavity prior to embryo transfer, etc.) or complications resulting from covered treatments are covered services under this contract.

Per 38 CFR § 17.38(c)(3) VA will NOT reimburse for related services outlined below. Drugs, biologicals, and medical devices not approved by the Food and Drug Administration unless the treating medical facility is conducting formal clinical trials under an Investigational Device Exemption (IDE) or an Investigational New Drug (IND) application, or the drugs, biologicals, or medical devices are prescribed under a compassionate use exemption.

Limits on services

1. A maximum of six cycle attempts to achieve three (3) completed IVF cycles will be reimbursed for the female Veteran and her spouse or the male Veteran and his spouse. A cycle is completed when embryo transfer occurs.

2. Costs of cryopreservation and storage are covered indefinitely. .

3. The non-Veteran spouse receiving ART services, including IVF, will not be provided treatment by VA for the resulting pregnancy up to beyond 110 weeks post egg retrieval. (approximately 10 weeks gestation), see Infertility-ART-IVF Female SEOC 1.0.2.

4. Excluded are donor sperm, donor eggs, and donor embryo and surrogacy services.

Providers: Requirements for providers already covered under this contract remain in effect (such as Physicians, Advanced Practice Nurses, Physician Assistants, lab staff,). Reproductive Endocrinologist and Infertility (REI) providers are an allowable subspecialty. REI’s are Medical Physicians with advanced training in the science of fertility and its evaluation and treatment, and should be credentialed as such.

Ordering and Authorization Process The Contractor/provider shall provide a management infrastructure and processes to support order of authorized care by VA. VA ordering officials may submit consult order (authorization) to the Contractor/provider via VA approved secure transmission methods.

1. Consult orders shall be accompanied by VA Authorization Form 10-7079, which is the only valid VA authorization form, found in Appendix XXAttachment D.4.

NOTE: Contractor IVF Provider will receive a consult order and 10-7079 Authorization with the embedded Standard Episode of Care (SEOC) which provides the approved services for both; the service connected Veteran and legal opposite-sex spouse.

2. Contractor/provider will return medical records pertinent to the episode of care to the VA using VA approved secure transmission methods.

3. The 10-7079 form will detail the health care services authorized and shall contain the following information:

a. Veteran’ name and contact information

b. Purpose of authorization and relevant diagnoses and other medical documentation

c. Type and amount of services requested (e.g. number of visits/procedures/treatments)

d. Preferred appointment date, if specified by Veteran

e. Date by which return of information is needed

f. Preferred gender of provider

g. VA point of contact for emergency situations or additional information/authorization needs

h. Where to submit required medical documentation

i. Station and authorization number

j. Authorization validity period

k. Contractor/provider assigned as vendor

l. Contract number

5. If the authorization is incomplete, and the Contractor/provider is unable to secure the required information, the Contractor/provider should return the authorization immediately to the referring/authorizing facility and inform the VAMC of the problem via follow-up with the designated VA points of contact provided on the 10-7079 form.

6. The provision of heath care services shall be limited to that set forth in the authorization form and accompanying standard episode of care (SEOC), see Appendix XX.Attachments D.2 and D.3. Any health care treatment requests recommended by the Contractor/provider shall be approved and coordinated by the VA authorizing medical facility by issuance of a new unique authorization prior to the treatment being initiated by the Contactor/provider under Secondary Authorization Request (SAR). The Contractor/provider shall submit request for additional services or additional timeframe and VA will require the SAR for review. If approved, the request will be added to the original authorization and sent to the contract/provider. If is not approved, the contractor/provider will be notified the SAR was not approved. If the SAR was not part of the SEOC approved services, VA Office of Community Care will determine if a new Community Care Consult is placed and falls under the required approval process. .

Pricing In-Vitro Fertilization (IVF)/ ART Health Care Services as part of an authorized episode of care and irrespective to any applicable Medicare rate. Begin use of this pricing upon execution date of this contract . This pricing is to be used for all health care and providers associated with the IVF/ ART VA authorization type. VA will pay up to 100 percent of billed charges for the services performed on service-connected Veteran and/or legal spouse .

Period of Performance

If awarded a BPA will remain in effect for 5 years from date of award unless superseded by the creation of a national In-vitro Fertilization (IVF)/ Assisted Reproductive Technology services (ART) contract.

Dissolvability This Blanket Purchase Agreement may be cancelled at any time at the convenience of the government due to lack of need or to begin operations under a new contract. Individual authorizations serve as a binding order under the BPA if issued prior to dissolution of the BPA. Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after the end of the contracted period of performance. The contractor shall have two days from date an order is received for the order(Authorization) to be refused or declined.

Claims/billing Healthcare claims must conform to currently utilized Medicare billing requirements. Valid claims submissions are:

1.HIPAA complaint EDI transaction sets (preferred method), or

2. Paper CMS 1450 (UB92/UB04) or CMS 1500 forms, depending on the type of care provided- only Red and White (original) claim forms may be used. Photocopied forms or printed forms which do not meet industry standards for OCR processing will delay payment 3.Claims, regardless of format, must contain full and complete administrative, clinical and financial data necessary to adjudicate the claim. Place VA authorization numbers in Prior Authorization fields. Incomplete or invalid data will delay payment.

3. Contractors and providers, including ancillary providers, /providers shall provide the authorizing station and the contract number within the Claim Note field. VA will provide claim submission directions on the authorization.

4. Contractors/providers shall utilize the designated VA clearinghouse, i.e. Change Healthcare – VA Payer ID: 12115, and comply with any requirements of the clearinghouse for the submission of the claims.

6. Billing for no shows – A Veteran shall not be billed for any services or supplies furnished under this contract. If a facility sets up in preparation for a medical treatment, but the medical treatment is never started, e.g. Veteran never arrives, there can be no service claim or other fee by the Contractor/provider for those intended services, and there will be no payment or penalty fee by the Government. The Contractor/provider shall not bill the Veteran and/or the Veteran’s other insurance (if applicable) for these services.

7. IVF ART services may be billed after establishment and completion of the first date of service (appointment), and upon medical documentation return for the initial visit. Each date of service thereafter may be billed respectively.

Quality Control and Internal Controls

1i. The contractor will provide their quality control program documentation to VA upon request. .

2iii.. TThe contractor shall employ industry best practices that monitor compliance and support internal controls to prevent fraud, waste, abuse, and improper payments.

3iv. The contractor’s quality control program shall address quality control and internal controls.

4VII. The Contractor/provider shall temporarily remove providers from providing care under this contract once notified by VA with concerns or issues with that provider until such time when that concern has been resolved.

5VIII. VA may perform random onsite visits to Contractor/provider locations 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.

Licensure General Requirements

1. All services, facilities, and providers shall be in compliance with all applicable federal and state regulatory requirements. Any provider on the Centers for Medicare and Medicaid Services (CMS) exclusionary list shall be prohibited from participation under this contract. See http://oig.hhs.gov/exclusions/index.asp for further detail. Contractors shall provide copies of certifications/licensing for facilities and services with response to this solicitation.

2. In accordance with requirements outlined in the OIG’s Compliance Program Guidance for Hospitals (https://oig.hhs.gov/compliance/compliance-guidance/index.asp) and USSC Sentencing Guidelines ((http://www.ussc.gov/Guidelines/2011_guidelines/index.cfm), all services, facilities, and providers shall have a compliance program in place that includes the seven elements of an effective compliance program.

3. Providers must have a full, current, active, unrestricted license in the state where the services are delivered;

4. Providers have a current National Provider Identifier (NPI) number;

5. As applicable, any prescribing provider has a Drug Enforcement Agency (DEA) number.

6. Provider Certification. If the provider is or has been licensed, registered, or certified in more than one State, the provider must certify that none of those States has terminated such license, registration, or certification for cause, and that the provider has not voluntarily relinquished such license, registration, or certification in any of those States after being notified in writing by that State of potential termination for cause.

7. Notification of License Termination. The provider must notify VA within 15 days if any State in which the provider is licensed, registered, or certified terminates such license, registration, or certification for cause, or if the provider voluntarily relinquishes such license, registration, or certification after being notified in writing by that State of potential termination for cause. Such termination or relinquishment is cause for immediate termination of this contract agreement.

REI Providers REI’s are Medical Physicians who have completed an obstetrics and gynecologist residency and fellowship training in reproductive and endocrinology and infertility. They should be credentialed as subspecialists in reproductive endocrinology and infertility in accordance with state and local requirements. Requirements for ancillary providers already covered under this contract remain in effect (such as Physicians, Advanced Practice Nurses, Physician Assistants, anesthesia, lab staff ).Reproductive Endocrinologist and Infertility (REI) providers are a subspecialty. REI’s are Medical Physicians with fellowship training in the science of fertility, its evaluation and treatment, and are should be credentialed as subspecialist in reproductive endocrinology and infertility. Requirements for providers already covered under this contract remain in effect (such as Physicians, Advanced Practice Nurses, Physician Assistants, lab staff).

Privileging

1. TThe Provider/Contractor shall ensure that every procedure, test, or other aspect of clinical care shall be performed by providers with demonstrated current competence, either through current unrestricted privileges to provide the care as required by Medicare CoP and CfC , as applicable, or other measures of demonstrated competency. The Provider/Contractor shall make available all evidence of current credentialing and competency upon written request by VA, CO or COR.

Medical Documentation and Critical Findings Return of Medical Documentation

1. Medical documentation recording an authorized episode of outpatient care shall be submitted to VA within 14 calendar days after completion of the initial appointment. If additional appointments are conducted, medical documentation shall be submitted to VA within 30 calendar days upon completion of the episode of care.

2. Communication of information by telephone may be required when results or clinical findings necessitate an urgent response. This shall be followed up by submission of complete medical documentation within 14 calendar days.

Content of Medical Documentation to be Transmitted to VA

1.Basic minimum requirements for content of medical documentation for this contract’s authorizations, as applicable to the care, are provided below:

I. An executive summary of the encounter to include any procedures performed and recommendations for further testing or follow–up;

II. Results of community testing or imaging such as MRI, CT scan;

III. Actual Results of any ancillary studies/procedures which would impact Recommended follow up such as biopsy results ( i.e. positive biopsy results from EoC GI provider who recommends a follow up such as surgery); and information regarding cycle outcome including pregnancy test results.

IV. Any recommended prescriptions and treatment plans.

2. Medical documentation shall contain the Veteran’s name, date of birth and last four digits of the Veteran’s social security number on each page of the documentation and be returned to VA in PDF format via VA-acceptable secure transmission (i.e. secure fax, encrypted email, etc.)

Critical Findings 1.Critical findings on outpatient imaging or laboratory testing, or during evaluation and treatment, shall be transmitted to VA by phone within 24 hours upon completion of the test/evaluation/treatment. Contact with VA (i.e., name of person contacted, date and time of contact) shall be documented in the impression section of the diagnostic imaging report, or elsewhere in the medical documentation for non-imaging-related critical findings. VA point of contact information will be included on the authorization.

2. Newly-identified suicide risk in a Veteran not referred for inpatient mental health treatment shall be considered a critical finding.

3. A new diagnosis of cancer shall be reported to VA within 48 hours of diagnosis.

4. Immediate notification (within 24 hours) to authorizing VA facility if provider determines that referred Veteran requires:

a. Urgent follow-up after completion of authorized episode of care, or

b. Urgent additional care during the authorized episode of care.

Pharmacy

1.VA is primarily responsible for supplying the Veteran with all prescribed non-urgent/emergent medications, medical/surgical supplies and nutritional products. These must be prescribed in accordance with the VA National Formulary Handbook, which includes provisions for requesting non-formulary drugs https://www.pbm.va.gov/NationalFormulary.asp. Prescriptions must be transmitted by fax or other agreed-upon electronic method to VA for processing. Incomplete prescriptions will not be processed and will be returned to the prescribing provider.

2. The Contractor/provider may prescribe medications to be filled at a VA pharmacy or Consolidated Mail Outpatient Pharmacy (CMOP) as a part of the health care treatment authorized by VA under this contract. However, prior to a VA pharmacy filling such prescriptions, the Contractor shall provide the following information from the prescribing provider:

a. Prescribing provider’s name

b. Prescribing provider’s address

c. Prescribing provider’s PERSONAL DEA number (NOT a generic facility number)

d. Prescribing provider’s phone number

e. Prescribing provider’s fax number

f. Prescribing provider’s National Provider Identifier (NPI) number

g. Prescribing provider’s Social Security Number

h. Prescribing provider’s date of birth

i. Prescribing provider’s gender

3. When there is an urgent/emergent need to start a medication and it is not possible to obtain the medication from a VA pharmacy in the timeframe needed, the prescribing provider shall write a prescription for up to a 14 day supply (without refills). The Veteran should be informed by the provider that an emergency prescription may be obtained from a non-contracted source and VA will reimburse the Veteran directly.

4. If the urgently/emergently needed medication is filled in a non-VA pharmacy and is expected to be continued beyond 14-days, a second prescription for the remainder of the quantity should be submitted to a VA pharmacy for processing. If that medication is not on VA’s drug formulary, the Contractor/provider may write the initial 14-day non-formulary prescription but, for the second prescription, the Contractor/provider shall request non-formulary drugs using the process for requesting for non-formulary drugs described above.

5. The contractor/ provider is required to provide the Veteran a copy of the VA authorization along with any prescription(s) issued under this contract.

Complaints/Grievances and Customer Service

1. The Contractor/provider shall perform customer functions with knowledgeable, courteous and responsive staff who can answer questions related to billing or quality of care from the provider.

2.The Contractor/provider will ensure an effective twenty-four (24) hour on-call coverage.

3. The Contractor/provider will submit all Veteran complaints about any aspect of care to the authorizing VA point of contact within one business day of receipt.

4. The Contractor shall work with the VA to resolve complaints associated with billing issues, quality of care, patient safety, sentinel event, and or adverse events/ adverse drug events.

5. VA reserves the right to audit oral and written complaints and handling of complaints.

6. The Contractor/provider shall forward Congressional inquiries associated with the provision of health care services under this contract to the authorizing VA point of contact within one business day of receipt.

Privacy of Health Records and Records Storage

A. Electronic Files: In the performance of official duties, contractor employees and any agents with regular access to printed and electronic files containing sensitive Veteran data shall protect that information under the provisions of the Privacy Act of 1974 (5 USC 552a) and other applicable laws, federal regulations, VA statutes and policies.

The contractor employees and any agents are responsible for protecting that data from unauthorized release or from loss, alteration, or unauthorized deletion.

B. HIPAA Compliance: The contractor and any agents shall adhere to the provisions of Public Law 104-191, HIPAA of 1996. This includes both Privacy and Security Rules published by the Department of Health and Human Services (HHS). As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities. The covered entity component of VA is the VHA.

C. Handling and Storing of VA Data by Contractors and Agents: VA 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 Contracting Officer. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data – Special Works, FAR 52.227-14(d)(1).

VA information should not be co-mingled, if possible, with any other data on the Contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the Contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on-site inspections of Contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

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 Contracting Officer. 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 Contracting Officer within 30 days of termination of the contract.

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 Contractor shall implement the information confidentiality and security laws, regulations and policies in this contract.

The Contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the contract 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.

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 cause under Federal Acquisition Regulation (FAR) part 12.

The contractor is responsible for ensuring that their employees and agents safeguard sensitive Veteran information in accordance with VHA policies in effect during the contract period. Those policies may be found in the VA Handbook 6500.6.

D. Release of Information: In responding to a Veteran’s request that copies of the Veteran records be released to a third party, the contractor shall direct the Veteran to the referring VAMC for release of the records. Upon request, the contractor shall provide the Veteran with a blank VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, or other form furnished by the VA. The contractor or community provider may not use or disclose any health information related to HIV, sickle cell anemia, drug abuse or alcohol abuse contained in the attacheds health records for a purpose other than health care or treatment of the patient or as permitted by law.

The contractor shall ensure the confidentiality of all Veteran medical records. Private hospital or physician records which are generated in the course of their business (providing health care) and are subject to the disclosure provisions of the Privacy Act and the HIPAA Privacy Rule. Individuals requesting this type of record should be encouraged to obtain the information from the hospital or physician’s office from which the information originated.

E. Security Incident Investigation Reporting Requirements

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The term “sensitive information” means any information about an individual maintained by VA, including the following: (1) Education, financial transactions, medical history, and criminal or employment history; and/or (2) Information that can be used to distinguish or trace the individual’s identity, including name, social security number, date and place of birth, mother’s maiden name, or biometric records.

b. The Contractor/ subcontractor shall within one business day notify the CO, the COR, Health and Human Services (HHS), the authorizing VAMC, the designated ISO and Privacy Officer simultaneously. Notification shall be in writing of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the Contractor/ subcontractor has access.

Incident Reporting Procedures:

1. As a HIPAA Covered entity the contractor shall report the complaint/incident/breach to the Department of Health and Human Services at: https://www.hhs.gov/hipaa/filing-a-complaint/index.html

2. Provide a notification copy of the incident to VHA CO IVF ContractsCO RS@ VHACOIVFCONTRACTS@VA.GOV (??????????????????), VHA OCC Privacy @ VHA.OCC.PO@VA.GOV, and Information Security Officer @ HAC.ISO@VA.GOV

3. Provide a 10 day report to all the above in addition to HHS requirements

c. To the extent known by the Contractor/subcontractor, the Contractor/ subcontractor's notice to VA shall identify the assets or sensitive information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the Contractor/subcontractor considers relevant.

d. In instances of theft or break-in or other criminal activity, the Contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The Contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The Contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

F. Liquidated Damages for Data Breach

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to VA sensitive 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 shall 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 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 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 termination for cause.

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 determination by the Department of Health and Human Services (an independent risk analysis), the Contractor shall be responsible for paying to the VA liquidated damages in the amount of $42.00 per incident, adjusted annually for inflation in accordance with the Consumer Price Index published by the U.S. Department of Labor, per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

Identity Theft Insurance –Victims of identity theft, you may be eligible for reimbursement of up to $1,000,000 for expenses related to that theft. If an enrolled individual’s identity is compromised, the policy provides coverage for up to $1,000,000, with no deductible, from an A.M. Best “A-rated” carrier. Covered expenses include:

1. Fees of specialists such as lawyers, accountants, and investigators necessary to restore credit rating to pre-theft level

2. Legal fees incurred by the impacted individual to defend a civil or criminal suit brought against them

3. Reimbursement of stolen funds

4. $7,500 lost wages per week, for a maximum of four (4) weeks

5. No deductibles

Definitions and Acronyms

Adverse Events: Untoward incidents, therapeutic misadventures, iatrogenic injuries, or other adverse occurrences directly associated with care or services provided within the jurisdiction of a medical facility, outpatient clinic, or other VHA facility

Adverse Drug Event (ADE): An injury resulting from the use of a drug. This includes harm caused by the drug as a result of adverse drug reactions, drug-drug interactions, product quality problems or drug overdoses (whether accidental or intentional)

CfCs: Conditions for Coverage

CMS: Centers for Medicare and Medicaid Services

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

CoPs: Conditions of Participation

COR: (Contracting Officer’s Representative) A person who takes necessary action, within delegated authority, to insure the Contractor performs in accordance with and adheres to the specifications contained in the contract, and to protect the interest of the Government. Any indication of non-compliance shall be promptly reported to the Contracting Officer so that appropriate action can be taken

Credentialing: The systematic process of screening and evaluating qualifications, including: licensure, required education, relevant training and experience, and current competence and health status

Critical Finding (or Critical Value, Critical Test Result): A critical finding or test result is defined as those values or interpretations that, if left untreated, could be life threatening or place the Veteran at serious risk. Critical values or results are those results from laboratory, cardiology, radiology departments and other diagnostic areas that upon analysis are determined to be “critical” regardless of the ordering priority. This conforms to Joint Commission National Patient Safety Goal NPSG.02.03.01. (Definition from “Critical Value or Result” in VHA Directive 2009-019)

DEA: Drug Enforcement Administration

EDI: Electronic Data Interchange

Emergent Care is defined as care considered essential to evaluate and stabilize conditions that may result in loss of life, limb or vision; or care that if not provided will likely result in unacceptable morbidity/pain when there is significant delay in evaluation or treatment.

Episode of Care: A set of clinically related health care services for a specific unique illness or medical condition (diagnosis and/or procedure) provided by an authorized provider during a defined authorized period of time not to exceed one year.

FDA: Food and Drug Administration

FIPS: The Federal Information Processing Standard (FIPS) Publication 140-2, (FIPS PUB 140-2), is a U.S. government computer security standard used to approve cryptographic modules. The title is Security Requirements for Cryptographic Modules.

HHS: Health and Human Services

HIPAA: Health Insurance Portability and Accountability Act

IVF/ART: In-Vitro Fertilization / Assisted Reproductive Technology

NIST: The National Institute of Standards and Technology (NIST) is a metrology laboratory, and a non-regulatory agency of the United States Department of Commerce. Its mission is to promote innovation and industrial competitiveness.

On Call Coverage: is defined as twenty-four (24) hour per day coverage.

Pharmacy Services: Provision of medicines, supplies and nutritional supplements

Privileging: Privileging (Clinical Privileging). The process by which a practitioner, licensed for independent practice (i.e., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.), is permitted by law and the facility to practice independently, to provide specific medical or other Veteran care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training, and licensure. Clinical privileges must be facility-specific and provider-specific

Provider: A hospital, clinic, health care institution, health care professional, or group of health care professionals who provide a service to Veterans

PWS: Performance Work Statement

QA: Quality Assurance

SAM: System of Award Management. Government Website for verification of any provider/contractor who has or had performed business with any government agency. It will report if the Contractor/Provider is in good standing with the Government in current or past business.

Sentinel Events: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. These include (but are not limited to): suicide of any Veteran receiving care, treatment, and services in a staffed around-the-clock care setting, or within 72 hours of discharge; unanticipated death of a full-term infant; abduction of any Veteran receiving care, treatment, and services; discharge of an infant to the wrong family; rape; hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities; surgery on the wrong Veteran or wrong body part; unintended retention of a foreign object in a Veteran after surgery or other procedure, and prolonged fluoroscopy with cumulative dose >1500 rads to a single field or any delivery of radiotherapy to the wrong body region or >25 percent above the planned radiotherapy dose.

Service Connection: As described in section 101 of title 38, United Stated Code, with respect to disability or death, that such disability was incurred or aggravated, or that the death resulted from a disability incurred or aggravated, in line of duty in the active military, naval, or air service. This includes adjunct conditions; when service connection is thus established for a secondary condition, the secondary condition shall be considered a part of the original condition

Urgent Care: Urgent care is defined as care considered essential to evaluate and stabilize conditions. Urgent care is care that if not provided will likely result in unacceptable morbidity/pain when there is a significant delay in evaluation or treatment. Urgent care is not the same as a medical emergency. Urgent medical care does not threaten life, limb or vision, but needs attention to prevent it from becoming a serious risk to health.

VA: Veterans Affairs

VAMC: VA Medical Center

VA Medical Facility: VA Medical Center or VA Community Based Outpatient Clinic

B.5 PRICE/COST SCHEDULE

Invitro Fertilization (IVF)/ ART Health Care Services as part of an authorized episode of care and irrespective to any applicable Medicare rate. Begin use of this pricing upon execution date of this contract. This pricing is to be used for all health care and providers associated with the IVF/ ART VA authorization type. VA will pay up to 100 percent of billed charges for the services performed on service-connected Veteran and/or legal spouse. Contractor must provide pricing for each CPT code in both male and female tabs of attached price/cost schedule. Pricing for additional commonly used CPT codes may be added if deemed appropriate.

Any award will result in a 5 year Blanket Purchase Agreement

ITEM INFORMATION

See attachment D.1 for detailed itemized schedule 36C24418Q9641

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SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an…