[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Pages 76733-76736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31562]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
notice.
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
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 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.
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Average
Number of Number burden per Total burden
Type of respondent Form name respondents responses per response (in hours
respondent hours)
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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
Request.
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.
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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]
BILLING CODE 4163-18-P