10112023 - (04) Insufficient Documentation - Initial 60-day Letter - CLEAN

Health Systems Bureau

5600 Fishers Lane

Rockville, MD 20857

Date

Name

Address

Address

Case Number: CICPNumerical Case Number

Dear Salutation. Last Name:

This letter is to inform you that there is insufficient documentation in the Request for Benefits Package (Request Package) that you filed with the U.S. Department of Health and Human Services’ (HHS) Countermeasures Injury Compensation Program (CICP or the Program) for the Program to make a determination concerning your eligibility for CICP benefits. See 42 C.F.R. §110.71. You must submit the necessary documentation, identified below, to the CICP within 60 calendar days from the date of this letter. If insufficient documentation is submitted in response to this letter, the CICP may disapprove the Request for Benefits. 42 C.F.R. § 110.71.

Documentation Received

The CICP has received the following documents pertaining to your claim for CICP benefits:

• Medical Records ReceivedDate To - From

Documentation Required But Not Yet Received

COMMENTS: [ADD CASE SPECIFIC INFORMATION CONCERNING THE MISSING RECORDS]

The CICP prefers that medical records are sent directly to the program by your health care provider(s). The indicated required documentation should be sent directly to the CICP online at injurycompensation.hrsa.gov (preferred). If unable to submit electronically, please send them to the following address:

Health Resources and Services Administration

Countermeasures Injury Compensation Program

5600 Fishers Lane, 8W-25A

Rockville, MD 20857

If you are unable to provide the required additional documentation, you may provide a written explanation of the reason(s) that the requested documentation is unavailable and the efforts you have made to obtain the documentation. 42 C.F.R. §§110.50(c);110.71. The CICP may accept such a statement in place of the required documentation or disapprove the Request for Benefits due to insufficient documentation.

Other Documentation

In addition to the required documentation that you must submit, identified above, you also may submit additional documentation that you believe will support your Request Package. This may include additional medical documentation or scientific evidence in order to establish that an injury was caused by a covered countermeasure.¹ Letters from treating physicians may be submitted as additional evidence but may not substitute for the required medical documentation. 42 C.F.R. §110.50(b).

Please note that if you disagree with the CICP’s eligibility determination and you request a reconsideration of the determination by an independent panel, the panel cannot review any new documentation that was not previously submitted to the Program. 42 C.F.R. §110.90(a).

If you have questions, please call 1-855-266-2427, email CICP@HRSA.gov, or mail them to the address above.

Sincerely,

CDR George Reed Grimes, MD, MPH

Director, Division of Injury Compensation Programs

Response Form (Optional)

Please return by mail to the following address:

Health Resources and Services Administration

Countermeasures Injury Compensation Program

5600 Fishers Lane, 8W-25A

Rockville, MD 20857

Please check the box of the statement that applies to you. Select only one option below.

I will not submit any more documentation. Please review my file for medical eligibility based on what has already been submitted, and do not wait the 60 days outlined in CICP’s letter. The CICP will determine medical eligibility after receipt of this form and inform the requester of the result and next steps.

I plan to submit the following additional documentation:

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

____________________________ _______________________

Name of Requester (Please print) CICP Case Number

____________________________

Signature

1 To establish causation, a requester must demonstrate that the covered injury occurred as a direct result of the administration or use of a covered countermeasure based on compelling, reliable, valid, medical and scientific evidence. 42 C.F.R. §110.20(c).

Health Resources and Services Administration

www.hrsa.gov