75R60221Q00029 Amend 0008.pdf

(x)

75R60221Q00029 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

Rockville MD 20857

OAMP

5600 Fishers Lane, Room 14W26B Management and Policy Office of Acquisition

HHS/HRSA/OO/OAMP

Rockville MD 20857

OAMP

5600 Fishers Lane, Rm 14W26B Management and Policy Office of Acquisition

HHS/HRSA/OO/OAMP

10/12/20220008

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

03/10/2021

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

TITLE: MEDICAL EXPERT SERVICES FOR THE VACCINE INJURY COMPENSATION PROGRAM (VICP) /

Countermeasures Injury Compensation Program (CICP) .

The purpose of this amendment is to answer questions received for Solicitation

75R60221Q00029.

Question 1. The VICP/CICP BPA solicitation was first released March 10, 2021, has been amended multiple times, and is now open on a rolling basis until March 9, 2023. Will the

BPA awards include both programs or will the BPA awards be program-specific?

Answer: the award of a BPA allows for work to be performed for both programs

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16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

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Question 2. How many BPA awards have been made to date? Please identify the BPA awardees and indicate if the awards are for both programs or are program-specific.

Answer: This needs to be requested via FOIA

Question 3. The purpose of the solicitation is to acquire medical-expert services and medical reviewer/case managers for the National Vaccine

Injury Compensation Program (VICP) and

Countermeasures Injury Compensation Program

(CICP) efforts in the litigation process in defense of the petitions and filed against the

HHS Secretary (emphasis added). The VICP and CICP tasks in the BPA are the same for both programs, but the program specific procedures are different. The VICP is a judicial process. To receive compensation through the VICP, the claimant must file a petition with the U.S. Court of Federal Claims. The CICP is an administrative process. To apply for CICP compensation, the claimant must file a request for benefits with

HRSA. The PREP Act precludes judicial review of

HHS eligibility and compensation decisions. Is the BPA limited to the litigation process? Please clarify the VICP-specific and CICP-specific BPA tasks separately.

Answer: Refer to Attachment A, Description of

Agreement, section IV (4) page 3

Question 4. What is the current process for assigning (awarding task orders) medical records to prime contract awardees?

Answer: Availability of funds and the needs of each program

Question 5. Does HRSA view any organization conflicts of interest through this BPA?

a. General: The Contractor shall have programs in place to identify, report, and mitigate actual and potential conflicts of interest for itself, its employees, subcontractors and consultants.

The existence of such programs and the disclosure of known actual or potential conflicts are material performance requirements of this BPA.

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Sponsored by GSA

FAR (48 CFR) 53.110

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b. Disclosure: The Contractor shall report all actual and potential conflicts of interest pertaining to this contract to the Contracting

Officer, including those that would be caused by a contemplated modification to this BPA or another contract. Such reports shall be in writing (including by email). Upon request, the

Contractor shall respond to a Contracting

Officer's request for an OCI mitigation plan.

c. Resolution: In the event the Contracting Officer determines that a conflict of interest exists, based on disclosure from the Contractor or from other sources, the Contracting Officer shall take action which may include, but is not limited to, requesting a mitigation plan from the

Contractor, terminating part or all of the contract, modifying the contract or obtaining a waiver in accordance with applicable law, including FAR 9.503 as applicable.

Question 6. Please describe the process flow once for a request for benefits from initial receipt by HRSA through a final determination and identify the responsible entity (HRSA or the contractor) for each major process step.

Answer: Details will be provided to BPA awardees at the time of assigning a case via a call order

Question 7. Is the BPA contractor required to access any HRSA systems to perform assigned work?

If so, what system(s) and for what purpose(s)?

Answer: Not at this time

Question 8. Is the BPA contractor required to use an internal tracking system or will the contractor use HRSA's tracking system?

Answer: HRSA tracks the cases, but the Contractor is expected to maintain the records of cases assigned to them as described in the Description of Agreement

Question 9. Will the BPA contractor interact with the claimant? If so, by what are the required communications method(s)?

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Answer: No

Question 10. The Deliverables Schedule specified submission timeliness requirements. Are there other performance metrics the contractor is expected to meet? If so, please include them in

BPA solicitation.

Answer: Details will be provided to BPA awardees at the time of assigning a case

Question 11. Has the Countermeasure Injury Table specific to COVID-related countermeasures been promulgated in final form? If not, when does HRSA expect the final regulations to be published that will allow for the majority of COVID-related countermeasure claims submitted to HRSA to move from pending status.

Answer: No, a COVID-19 Countermeasure Injury

Table has not been developed. An injury table is not needed for claims review to proceed.

COVID-19 claims are being reviewed.

Question 12. As of April 1, 2022, no COVID-related countermeasure claims had been compensated. Thirteen COVID-related claims have been denied compensation because the standard of proof for causation was not met and/or a covered injury was not sustained. One claim due to an anaphylactic reaction has been determined eligible for compensation but is still in review for eligible expenses. Over 7,600 COVD-related claims were pending as of April 1, 2022. Please provide the number of COVID-related benefit requests received by HRSA by month for calendar year 2021 and by month for calendar year 2022 to date.

Answer: Submit a FOIA request to obtain this information. CICP data is available at https://www.hrsa.gov/cicp/cicp-data.

Question 13. Please confirm our understanding that, without an applicable Countermeasure Injury

Table, the majority of COVID-related countermeasure claims submitted to HRSA will remain in a pending status.

Answer: An injury table is not needed for claims

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75R60221Q00029/0008 review to proceed. COVID-19 claims are being reviewed.

Question 14. For COVID-related injuries not on the Injury Table (when issued), the claimant must prove the injury was the direct result of the

COVID-related countermeasure based on

"compelling, reliable, valid and scientific evidence" beyond mere temporal association. With respect to COVID countermeasures, at this time there is a paucity of peer-reviewed, compelling, reliable, valid, and scientific evidence available. Will a BPA contract include an indemnification provision for contractor medical review of COVID-related countermeasure claims?

Answer: No

Question 15. If a claim for compensation is denied and the claimant requests a redetermination, does the BPA contractor have tasks related to redeterminations? If so, please describe the contractor's redetermination tasks.

Answer: No

Question 16. Is HRSA able to share the criteria for claims to be reviewed against? We would like to share with our clinical team prior to submitting a proposal, just to ensure comfortability and ability.

Answer: No

Question 17. What is the current timeline for claims to be reviewed, and final reports to be submitted back from the time of claims being issued to contractors?

Answer: It depends on the complexity of the case.

Question 18. Are there existing incumbents who have been awarded this BPA?

Answer: Yes

Question 19. Have any task orders been issued? If not, why not?

Answer: Yes

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Question 20. Can government tell us how long the contractor will have to complete the review, we understand each review may take 12 hours and the due date will be provided in the guidance memo.

Answer: VICP cases have deadlines issued by the court. CICP has internal deadlines that will be shared when a case is sent to the contractor

Question 21. Is there historical information available to understand how many days the contractor has to complete the review?

Answer: See answer to question # 20

Period of Performance: 01/27/2022 to 03/09/2023

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