[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22067-22069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10067]



[[Page 22067]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0891; Docket No. CDC-2018-0045]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled World Trade Center Health Program 
Enrollment, Treatment, Appeals & Reimbursement.

DATES: CDC must receive written comments on or before July 10, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0045 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note:  Submit all Federal comments through the Federal 
eRulemaking portal (regulations.gov) or by U.S. mail to the address 
listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    World Trade Center Health Program Enrollment, Treatment, Appeals & 
Reimbursement (OMB Control No. 0920-0891, Expires 09/30/2018)--
Revision--National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    NIOSH seeks to request OMB approval to revise the currently 
approved information collection activities that support the World Trade 
Center (WTC) Health Program. The James Zadroga 9/11 Health and 
Compensation Act of 2010 (Pub. L. 111-347, as amended by Pub. L. 114-
113) created the WTC Health Program to provide medical monitoring and 
treatment benefits to eligible firefighters and related personnel, law 
enforcement officers, and rescue, recovery, and cleanup workers who 
responded to the September 11, 2001, terrorist attacks in New York 
City, at the Pentagon, and in Shanksville, Pennsylvania (responders), 
and to eligible persons who were present in the dust or dust cloud on 
September 11, 2001, or who worked, resided, or attended school, 
childcare, or adult daycare in the New York City disaster area 
(survivors).
    This request also seeks to incorporate the World Trade Center 
Health Program Petition for the addition of a New WTC-Related Health 
Condition for Coverage under the WTC Health Program package (0920-0929) 
into the existing approval, World Trade Center Health Program 
Enrollment, Appeals, Reimbursement, & Petitions (OMB Control No. 0920-
0891). Upon approval, OMB Control number 0920-0929 will be 
discontinued.
    Since its inception in 2011, the WTC Health Program has been 
approved to collect information from applicants and Program members 
(enrolled WTC responders and survivors) concerning eligibility and 
enrollment, appointment of a designated representative, medical care, 
travel reimbursement, and appeal of adverse Program decisions. The WTC 
Health Program is also currently approved to collect information from 
Program medical providers, including health condition certification 
requests and pharmaceutical claims. Currently approved total estimated 
burden is 13,594 hours annually (see OMB Control No. 0920-0891, exp. 
September 30, 2018).
    The WTC Health Program has determined that some existing forms need 
to be updated, and new information collections related to a recent 
rulemaking should be added. Changes to WTC Health Program regulations 
in 42 CFR part 88 will require the extension of existing information 
collections. Specifically, 42 CFR 88.13 establishes procedures for the 
appeal of Program decisions to disenroll Program members and deny 
enrollment to applicants. Appeals of enrollment denial decisions, which 
include the submission of appeal request letters, are currently 
approved; the Program proposes to extend this information collection to 
account for the burden of requests for appeal of disenrollment 
decisions. Of the over 70,000 Program members, we expect that 0.014 
percent (10) will be subsequently disenrolled from the Program. Of 
those, we expect that 30 percent (three) will appeal the disenrollment 
decisions. We estimate that the disenrollment appeal requests will take 
no more than 0.5 hours per respondent. The annual burden estimate is 
1.5 hours.
    Section 42 CFR 88.21 establishes procedures for the appeal of WTC

[[Page 22068]]

Health Program decisions to decertify a WTC-related health condition, 
deny certification, and deny treatment authorization. Appeals of health 
condition certification denials and treatment authorization denials, 
which include the submission of appeal request letters, are currently 
approved; the Program proposes to extend this information collection to 
account for the burden of requests for appeal of decertification 
decisions. The information collection would also be expanded to allow 
Program members to provide additional information and/or an oral 
statement. Of the estimated 51,472 Program members who have at least 
one health condition certification, we estimate that 0.02 percent (10) 
will be decertified, and 50 percent (five) of those will appeal a 
decertification. We estimate that the appeal request letter will take 
no more than 0.5 hours per respondent. Providing additional information 
and/or an oral statement will take no more than 1 hour per respondent. 
The annual burden estimate for decertification appeals is 7.5 hours.
    We estimate that Program members request certification for 20,000 
health conditions each year. Of those 20,000, we estimate that 1 
percent (200) of certification requests are denied by the WTC Health 
Program. We further expect that 30 percent of denied certifications, or 
60 individuals, will be appealed. We estimate that the appeals letter 
takes no more than 30 minutes and providing additional information and/
or an oral statement will take no more than one hour. The burden 
estimate for certification denial appeals is 90 hours.
    Of the projected 51,472 Program members who receive medical care, 
we estimate that 0.05 percent (26) will appeal a determination by the 
WTC Health Program that the treatment being sought is not medically 
necessary. We estimate that the appeals letter will take no more than 
30 minutes and providing additional information and/or an oral 
statement will take no more than one hour. The burden estimate for 
treatment authorization denial appeals is 39 hours.
    Finally, 42 CFR 88.23 establishes procedures for the appeal of a 
WTC Health Program decision to deny reimbursement to a Program medical 
provider for treatment determined not to be medically necessary. 
Accordingly, the Program proposes the addition of information collected 
in the appeal request. We estimate that of the nearly 52,000 Program 
providers, we estimate that 1.15 percent (600) annually will be denied 
reimbursement for treatment found to be not medically necessary or in 
accordance with treatment protocols, and will appeal the decision. We 
estimate that the appeal letter will take no more than 0.5 hours to 
compile. The burden estimate for treatment reimbursement denial appeals 
is 300 hours.
    The Program also finds it necessary to add a new form to allow 
applicants and Program members to grant permission to share information 
with a third person about an individual's application or case. We 
estimate that 30 applicants and members will submit a Health Insurance 
Portability and Accountability Act (HIPAA) Release Form annually. The 
form will to take no longer than 0.25 hours to complete. The burden 
estimate for the HIPAA Release form is 7.5 hours.
    In addition to describing those burden estimates revised by this 
action, the estimated annualized burden hours for those collection 
instruments not subject to revision in this action are included in the 
table below.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
FDNY Responder................  World Trade                   45               1           30/60              23
                                 Center Health
                                 Program FDNY
                                 Responder
                                 Eligibility
                                 Application.
General Responder.............  World Trade                2,475               1           30/60           1,238
                                 Center Health
                                 Program
                                 Responder
                                 Eligibility
                                 Application
                                 (Other than
                                 FDNY).
Pentagon/Shanksville Responder  World Trade                  630               1           30/60             315
                                 Center Health
                                 Program
                                 Pentagon/
                                 Shanksville
                                 Responder.
WTC Survivor..................  World Trade                1,350               1           30/60             675
                                 Center Health
                                 Program
                                 Survivor
                                 Eligibility
                                 Application
                                 (all languages).
General responder.............  Postcard for new           2,475               1           15/60             619
                                 general
                                 responders in
                                 NY/NJ to select
                                 a clinic.
Program Medical Provider......  Physician                 20,000               1           30/60          10,000
                                 Request for
                                 Certification.
Responder (FDNY and General     Denial Letter                 45               1           30/60              23
 Responder)/Survivor.            and Appeal
                                 Notification--E
                                 nrollment.
Responder (FDNY and General     Disenrollment                  3               1           30/60             1.5
 Responder)/Survivor.            Letter and
                                 Appeal
                                 Notification.
Responder (FDNY and General     Denial Letter                 60               1           90/60              90
 Responder)/Survivor.            and Appeal
                                 Notification--H
                                 ealth Condition
                                 Certification.
Responder (FDNY and General     Decertification                5               1           90/60             7.5
 Responder)/Survivor.            Letter and
                                 Appeal
                                 Notification.
Responder (FDNY and General     Denial Letter                 26               1           90/60              39
 Responder)/Survivor.            and Appeal
                                 Notification--T
                                 reatment
                                 Authorization.
Responder (FDNY and General     WTC Health                    10               1           10/60               2
 Responder)/Survivor.            Program Medical
                                 Travel Refund
                                 Request.
Designated Rep Form...........  Form to                       30               1           15/60             7.5
                                 designate a
                                 representative.
HIPAA Release.................  Form to share                 30               1           15/60             7.5
                                 member
                                 information.
Pharmacy......................  Outpatient                   150             261            1/60             653
                                 prescription
                                 pharmaceuticals.
Program Medical Provider......  Reimbursement                600               1           30/60             300
                                 Denial Letter
                                 and Appeal
                                 Notification.

[[Page 22069]]

 
Responder/Survivor/Advocate     Petition for the              60               1           60/60              60
 (physician).                    addition of
                                 health
                                 conditions.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          14,061
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Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-10067 Filed 5-10-18; 8:45 am]
 BILLING CODE 4163-18-P