2011-22395. 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 [e-mail].

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 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

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Avg. burden per response (in hrs)	Total burden (in hrs)
Responder (FDNY and General Responder)/Survivor	Eligibility and Qualification for the WTC Health Program	290	1	10/60	48
FDNY Responder	World Trade Center Health Program FDNY Responder Eligibility Application	189	1	30/60	95
General Responder	World Trade Center Health Program Responder Eligibility Application (Other than FDNY)	2979	1	30/60	1490
WTC Survivor	World Trade Center Health Program Survivor Eligibility Application	1560	1	15/60	390
Responder (FDNY and General Responder)/Survivor	Denial Letter and Appeal Notification—Eligibility	47	1	30/60	24
Responder (FDNY and General Responder)/Survivor	Denial Letter and Appeal Notification—Health Conditions	30	1	30/60	15
Responder (FDNY and General Responder)/Survivor	Denial Letter and Appeal Notification—Treatment	588	1	30/60	294
Responder (FDNY and General Responder)/Survivor	WTC Health Program Medical Travel Refund Request	10	1	10/60	2
Physician	WTC Health Condition Certification Request	2,300	14	1	32,200
	Attestation for previously-enrolled	2,300	14	5/60	2,683
	Request for treatment pending authorization	6,000	1	30/60	3,000
Pharmacy	Outpatient prescription pharmaceuticals	150	261	1/60	653
Total					40,894

Dated:August 25, 2011.

Daniel Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.