[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Pages 76733-76736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31562]



Centers for Disease Control and Prevention

[30 Day-12-12AZ]

Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an email to 
[email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this 

Proposed Project

    World Trade Center Health Program Enrollment, Appeals, 
Reimbursement and Certification--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

[[Page 76734]]

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 (Fire Department of New York City 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 
    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 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 (WTCHP). The 
EDI transmission conforms to ANSI standards developed by the National 
Council for Prescription Drug Programs. The information collection 
burden occurs as the WTCHP 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. The total estimated annual burden hours are 19,161.

[[Page 76735]]

Estimated Annualized Burden Hours

    Currently Identified Responders and Currently Identified Survivors: 
HHS estimates that approximately .5 percent of responders and survivors 
who had been enrolled in the prior MMTP or Community Program (currently 
identified responders and survivors), or 290, will be asked to provide 
the Program with additional information to ensure that the individual 
meets all criteria to be eligible for the program. There is no form 
associated with this request. Rather, the Program staff will collect 
the information provided and make a note of it in the patient files. We 
expect responding to this inquiry to take no more than 10 minutes.
    World Trade Center Health Program Eligibility Application: Three 
different eligibility forms were developed to address the different 
criteria for each group covered by the WTC Health Program: Fire 
Department of New York responders, general responders, and survivors. 
We expect that to receive approximately 4,728 applications per year. 
The burden table reflects the annualized total burden broken into the 
three separate applicant groups: we estimate that 189 Fire Department 
of New York (FDNY) responders (4% of applicants); 2,979 general 
responders (63%); and 1,560 survivors (33%) will submit written 
applications. The burden estimates for these three different forms are: 
FDNY responders = 95 hours; general responders = 1,490 hours; and 
survivors = 390 hours.
    Denial Letter and Appeal Notification--Eligibility: Of the 4,728 
applications we expect to receive per year, we expect that 10% will 
fail due to ineligibility. We further assume that 10% of those 
individuals, or 47 respondents, will appeal the decision. The burden 
estimate is 24 hours (Attachment F)
    Denial Letter and Appeal Notification--Health Condition: We expect 
that program participants (enrolled responders and survivors) will 
request certification for 32,361 health conditions each year. Of those 
32,361, we expect that .001% (32) of certification requests will be 
denied by the WTC Program Administrator. We further expect that 95% of 
denied certifications, or 30 individuals, will be appealed. The burden 
estimate is 15 hours (Attachment G).
    Denial Letter and Appeal Notification--Treatment: Of the projected 
19,596 enrollees who will receive medical care, it is estimated that 3 
percent (588) 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. The burden 
estimate is 294 hours (Attachment H).
    WTC Health Program Medical Travel Refund Request: WTC responders or 
certified eligible survivors who travel more than 250 miles to a 
nationwide network provider for medically necessary treatment may be 
provided necessary and reasonable transportation and other expenses. 
These individuals may submit a travel refund request form, which should 
take respondents 10 minutes to complete. HHS expects no more than 10 
claims per year. The burden estimate is 2 hours (Attachment I).
    WTC Health Condition Certification Request: Physicians will report 
this data electronically and on paper. HHS expects that 2,300 program 
physicians will spend approximately 30 minutes extracting the required 
elements from the patient records and transmitting them to NIOSH, and 
that approximately 32,361 diagnoses, or 14 per provider, will be 
reported to the WTC Health Program each year. The burden estimate is 
16,100 hours (Attachment J).
    Outpatient prescription pharmaceuticals: Pharmacies will 
electronically transmit reimbursement claims to the WTC Health Program. 
HHS estimates that 150 pharmacies will submit reimbursement claims for 
39,192 prescriptions per year, or 261 per pharmacy; we estimate that 
each submission will take 1 minute. The burden estimate is 653 hours.
    Standard Form 3881, for reimbursement for medically necessary 
treatment, monitoring, initial health evaluations: Standard U.S. 
Treasury form SF 3881 (OMB No. 1510-0056) will be used to gather 
necessary information from Program healthcare providers so that they 
can be reimbursed directly from the Treasury Department. HHS expects 
that approximately 200 providers and provider groups will submit SF 
3881, which is estimated to take 15 minutes to complete. Providers will 
submit only one SF 3881.

                                                                                             Number of        Number        burden per     Total burden
               Type of respondent                               Form name                   respondents    responses per   response (in        hours
                                                                                                            respondent        hours)
Currently Identified Responders and Currently    No Form................................             290               1           10/60              48
 Identified Survivors.
FDNY Responder.................................  World Trade Center Health Program FDNY              189               1           30/60              95
                                                  Responder Eligibility Application.
General Responder..............................  World Trade Center Health Program                  2979               1           30/60            1490
                                                  Responder Eligibility Application
                                                  (Other than FDNY).
WTC Survivor...................................  World Trade Center Health Program                  1560               1           15/60             390
                                                  Survivor Eligibility Application.
FDNY Responder, General Responder and WTC        Denial Letter and Appeal Notification--              47               1           30/60              24
 Survivor.                                        Eligibility.
FDNY Responder, General Responder and WTC        Denial Letter and Appeal Notification--              30               1           30/60              15
 Survivor.                                        Health Conditions.
FDNY Responder, General Responder and WTC        Denial Letter and Appeal Notification--             588               1           30/60             294
 Survivor.                                        Treatment.
FDNY Responder, General Responder and WTC        WTC Health Program Medical Travel                    10               1           10/60               2
 Survivor.                                        Refund Request.
Physician......................................  WTC Health Condition Certification                2,300              14           30/60          16,100
Pharmacy.......................................  Outpatient prescription pharmaceuticals             150             261            1/60             653

[[Page 76736]]

Physician......................................  Standard Form 3881, for reimbursement               200               1           15/60              50
                                                  for medically necessary treatment,
                                                  monitoring, initial health evaluations.

    Dated: December 2, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-31562 Filed 12-7-11; 8:45 am]