[Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)]
[Notices]
[Pages 54470-54472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-11-0891]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 
and send comments to Daniel Holcomb, CDC Reports Clearance Officer, 
1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to 
[email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    World Trade Center Health Program Enrollment, Appeals & 
Reimbursement--New--National Institute for Occupational Safety and 
Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga 
Act), promulgated on December 22, 2010, establishes a Federal program 
to support health monitoring and treatment for emergency responders; 
recovery and cleanup workers; and residents, building occupants, and 
area workers in New York City who were directly impacted and adversely 
affected by the terrorist attacks of September 11, 2001. In order to 
provide medical monitoring and treatment to eligible individuals, the 
World Trade Center (WTC) Health Program will collect eligibility and 
appeals data as well as information from medical and prescription 
pharmaceutical providers.
    All responders to the New York City attack who will be newly 
seeking medical monitoring and treatment and survivors of the attack 
who were not covered by the Medical Monitoring and Treatment Program 
(MMTP) (for responders) or the Community Program (for survivors) prior 
to January 2, 2011, may apply to obtain coverage under the new WTC 
Health Program. In order to begin the determination eligibility 
process, an enrollment form must be completed. After an eligibility 
application is submitted to the Program, an unsuccessful applicant has 
an opportunity to appeal the decision; enrolled participants have 
further appeal rights. Health care and prescription pharmaceutical 
providers will be required to submit medical determinations to the WTC 
Program Administrator and request reimbursement.
    Data are being collected in order to determine the eligibility of 
applicants. If an applicant is denied enrollment based on the 
information provided, the applicant will receive a letter that gives 
the reason for the denial and the opportunity to appeal the decision. 
Once someone is enrolled, he or she may request approval for 
reimbursement of travel if the individual must travel more than 250 
miles to receive healthcare services.
    Healthcare providers and pharmacies will file claims electronically 
or by paper form to be paid for their services.
    There are three separate enrollment forms for each population of 
responders (FDNY responders, general responders, and survivors). The 
following information includes the definition of each population: 
``FDNY responder'' is defined as a member of the Fire Department of New 
York City (whether fire or emergency personnel, active, or retired) who 
participated at least one day in the rescue and recovery effort at any 
of the former World Trade Center sites. ``General Responder'' is a 
worker or volunteer who provided Rescue, Recovery, Demolition, Debris, 
Removal and related support services in the aftermath of the September 
11, 2001 attacks on the World Trade Center but was not affiliated with 
the Fire Department of New York. ``Survivor'' is a person who was 
present in the disaster area in the aftermath of the September 11, 2001 
attacks on the World Trade Center as a result of his or her work, 
residence, or attendance at school, childcare, or adult daycare.
    The eligibility application form will collect general contact 
information as well as information regarding the WTC disaster area 
experience. Some of the information provided will be shared with the 
Federal Bureau of Investigation in order to screen an individual 
against the terrorist watch list maintained by the Federal government. 
This information will also be shared with the WTC Program Administrator 
and will be kept in a secure manner.
    WTC Health Program applicants and enrolled participants have 
opportunities to appeal adverse decisions made by the WTC Program 
Administrator. The first opportunity to appeal arises after a 
determination that an applicant does not meet the eligibility 
requirements. Once enrolled in the Program, participants will also have 
the opportunity to appeal a decision not to certify a WTC-related 
health condition or a determination that treatment will not be 
authorized as medically necessary. In the notification letter 
explaining the adverse determination, the applicant will be advised 
that an appeal can be requested by submitting in writing his or her 
name, contact information, and an explanation for the basis of the 
appeal.
    Certain enrolled participants may be reimbursed for necessary and 
reasonable transportation and expenses incident to the securing of 
medically necessary treatment through the nationwide network if the 
care involves travel of more than 250 miles. Individuals requesting 
reimbursement must fill out a 1-page written form requesting such 
information as date of travel, distance, and total expense.
    Pharmacies will transmit reimbursement claims to the WTC Health 
Program. The following data

[[Page 54471]]

elements will be collected for pharmacy reimbursement: Pharmacy name, 
pharmacy address, drug name, prescription number, patient name, patient 
ID number, and cost. Pharmacies utilize Electronic Data Interchange 
(EDI) processing at the point-of-sale to transmit claims to the World 
Trade Center Health Program (WTC-HP). The EDI transmission conforms to 
ANSI standards developed by the National Council for Prescription Drug 
Programs. The information collection burden occurs as the WTC-HP member 
information is copied from the membership card at the point-of-sale. 
The EDI transmission occurs in real-time as the prescription 
transaction is made.
    The Zadroga Act of 2010 requires that all qualifying WTC-related 
health conditions or health conditions medically associated with a WTC-
related health condition be certified by member to enable reimbursement 
of treatment services for care rendered to that member for a given 
qualifying condition(s). To meet the requirement for certification and 
maintain continuity of care for an individual who had been enrolled in 
the prior MMTP or Community Program, the WTC Health Program physician 
shall attest that a prior determination was rendered in the previous 
federally sponsored program. The attestation will include the 
physician's name and signature, the name of the patient, and the name 
of the health condition and its diagnostic (ICD-9) code.
    An individual who is new to the WTC Health Program must have a 
certified WTC-related health condition or health condition medically 
associated with WTC-related health condition to receive reimbursement 
for treatment and other services. If a new medical determination is 
being made, the Program clinician must provide to the WTC Health 
Program the patient's name and program identification number, the name 
and diagnostic code of the health condition, and a brief narrative 
explaining the key exposure findings. The narrative will include 
information such as the time and duration of the individual's presence 
in defined geographic areas (of exposure), whether the individual was 
caught in the dust cloud on September 11, 2001, whether the individual 
conducted strenuous activity while in the exposure zone(s), the 
individual's symptom time course relative to September 11, 2001, and 
the reasons a person might be more likely to get sick from given 
exposures (family history or coexisting medical problems).
    A Program physician will also submit a form to the WTC Health 
Program when a member needs medical treatment for a condition that has 
not yet been certified. In that case, the physician will request 
authorization to treat the condition because of the urgency of the 
medical scenario. The physician will sign a form attesting that a 
determination was made, and indicate the patient's name and the name of 
the health condition and its diagnostic code.
    Physicians will be compensated through administrative expenses 
invoiced by their respective Clinical Center of Excellence that is 
under contract with the Federal government.
    There are no costs to respondents other than their time.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of      Avg. burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs)        (in hrs)
----------------------------------------------------------------------------------------------------------------
Responder (FDNY and General     Eligibility and              290               1           10/60              48
 Responder)/Survivor.            Qualification
                                 for the WTC
                                 Health Program.
FDNY Responder................  World Trade                  189               1           30/60              95
                                 Center Health
                                 Program FDNY
                                 Responder
                                 Eligibility
                                 Application.
General Responder.............  World Trade                 2979               1           30/60            1490
                                 Center Health
                                 Program
                                 Responder
                                 Eligibility
                                 Application
                                 (Other than
                                 FDNY).
WTC Survivor..................  World Trade                 1560               1           15/60             390
                                 Center Health
                                 Program
                                 Survivor
                                 Eligibility
                                 Application.
Responder (FDNY and General     Denial Letter                 47               1           30/60              24
 Responder)/Survivor.            and Appeal
                                 Notification--E
                                 ligibility.
Responder (FDNY and General     Denial Letter                 30               1           30/60              15
 Responder)/Survivor.            and Appeal
                                 Notification--H
                                 ealth
                                 Conditions.
Responder (FDNY and General     Denial Letter                588               1           30/60             294
 Responder)/Survivor.            and Appeal
                                 Notification--T
                                 reatment.
Responder (FDNY and General     WTC Health                    10               1           10/60               2
 Responder)/Survivor.            Program Medical
                                 Travel Refund
                                 Request.
Physician.....................  WTC Health                 2,300              14               1          32,200
                                 Condition
                                 Certification
                                 Request.
                                Attestation for            2,300              14            5/60           2,683
                                 previously-
                                 enrolled.
                                Request for                6,000               1           30/60           3,000
                                 treatment
                                 pending
                                 authorization.
Pharmacy......................  Outpatient                   150             261            1/60             653
                                 prescription
                                 pharmaceuticals.
                                                 ---------------------------------------------------------------

[[Page 54472]]

 
    Total.....................  ................  ..............  ..............  ..............          40,894
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    Dated:August 25, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-22395 Filed 8-31-11; 8:45 am]
BILLING CODE 4163-18-P