83 FR 48428 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 186 (September 25, 2018)

[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48428-48430]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20807]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-0891]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled World Trade Center Health Program Enrollment, 
Treatment, Appeals & Reimbursement to the Office of Management and 
Budget (OMB) for review and approval. CDC previously published a 
``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on May 11, 2018, to obtain comments from the 
public and affected agencies. CDC did not receive comments related to 
the previous notice. This notice serves to allow an additional 30 days 
for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) 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;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) 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 submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

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 
(NIOSH), 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 individuals affected by the terrorist 
attacks on September 11, 2001. Eligible individuals include 
firefighters and related personnel, law enforcement officers, and 
rescue, recovery, and cleanup workers who responded to the 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 information collection 
previously approved under the World Trade Center Health Program 
Petition for the Addition of a New WTC-Related Health Condition for 
Coverage under the World Trade Center (WTC) Health Program (OMB No. 
0920-0929, expiration date 7/31/2018), which has been discontinued. The 
revision of OMB No. 0920-0891 will provide a comprehensive summary of 
information collection needed to administer the World Trade Center 
Health Program.
    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

[[Page 48429]]

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. 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 (3) 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 2 hours (rounded).
    Section 42 CFR 88.21 establishes procedures for the appeal of WTC 
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 will 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 (5) 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 one hour per 
respondent. The annual burden estimate for decertification appeals is 8 
hours.
    We further estimate that Program members request certification for 
20,000 health conditions each year. Of those 20,000, we estimate that 
one percent (200) of certification requests are denied by the WTC 
Health Program. We also 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.
    In addition, 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 revision request also includes the addition of 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 8 hours.
    The total estimated annualized burden hours are 14,063, an increase 
of 469 hours from the previously approved estimate of 13,594 hours. The 
revised estimate includes forms that have not been modified; changes 
due to the appeals processes authorized by 42 CFR 88.21 and 42 CFR 
88.23; inclusion of the new HIPPA Release Form; incorporation of a form 
previously approved under OMB No. 0920-0929; and miscellaneous actions. 
The revision request provides a detailed summary of each change and its 
impact on the burden estimate.

                                        Background and Brief Description
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
         Type of respondent                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
FDNY Responder.....................  World Trade Center Health                45               1           30/60
                                      Program FDNY Responder
                                      Eligibility Application.
General Responder..................  World Trade Center Health             2,475               1           30/60
                                      Program Responder
                                      Eligibility Application
                                      (Other than FDNY).
Pentagon/Shanksville Responder.....  World Trade Center Health               630               1           30/60
                                      Program Pentagon/
                                      Shanksville Responder.
WTC Survivor.......................  World Trade Center Health             1,350               1           30/60
                                      Program Survivor
                                      Eligibility Application
                                      (all languages).
General responder..................  Clinic Selection Postcard             2,475               1           15/60
                                      for new general responders
                                      in NY/NJ to select a
                                      clinic.
Program Medical Provider...........  Physician Request for                20,000               1           30/60
                                      Certification (WTC-3).
Responder (FDNY and General          Denial Letter and Appeal                 45               1           30/60
 Responder)/Survivor.                 Notification--Enrollment.
Responder (FDNY and General          Disenrollment Letter and                  3               1           30/60
 Responder)/Survivor.                 Appeal Notification--
                                      Enrollment.

[[Page 48430]]

 
Responder (FDNY and General          Decertification Letter and                5               1             1.5
 Responder)/Survivor.                 Appeal Notification--
                                      Health Condition.
Responder (FDNY and General          Denial Letter and Appeal                 60               1             1.5
 Responder)/Survivor.                 Notification--Health
                                      Condition Certification.
Responder (FDNY and General          Denial Letter and Appeal                 26               1             1.5
 Responder)/Survivor.                 Notification--Treatment
                                      Authorization.
Responder (FDNY and General          WTC Health Program Medical               10               1           10/60
 Responder)/Survivor.                 Travel Refund Request.
Program Members....................  Designated Representative                30               1           15/60
                                      Form.
Program Member.....................  HIPAA Release Form to allow              30               1           15/60
                                      the sharing of member
                                      information with a third
                                      party.
Pharmacy...........................  Outpatient prescription                 150             261            1/60
                                      pharmaceuticals.
Program Medical Provider...........  Reimbursement Denial Letter             600               1           30/60
                                      and Appeal Notification--
                                      Providers.
Responder/Survivor/Advocate          Petition for the addition                60               1               1
 (physician).                         of health conditions.
----------------------------------------------------------------------------------------------------------------


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. 2018-20807 Filed 9-24-18; 8:45 am]
 BILLING CODE 4163-18-P