[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Proposed Rules]
[Pages 55086-55104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18679]



[[Page 55085]]

Vol. 81

Wednesday,

No. 159

August 17, 2016

Part V





Department of Health and Human Services





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42 CFR Part 88





World Trade Center Health Program; Amendments to Definitions, Appeals, 
and Other Requirements; Proposed Rule

  Federal Register / Vol. 81 , No. 159 / Wednesday, August 17, 2016 / 
Proposed Rules  

[[Page 55086]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[Docket No. CDC-2016-0072; NIOSH-291]
RIN 0920-AA56


World Trade Center Health Program; Amendments to Definitions, 
Appeals, and Other Requirements

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: In 2011 and 2012, the Secretary, Department of Health and 
Human Services (HHS), promulgated regulations designed to govern the 
World Trade Center (WTC) Health Program (Program), including the 
processes by which eligible responders and survivors may apply for 
enrollment in the Program, obtain health monitoring and treatment for 
WTC-related health conditions, and appeal enrollment and treatment 
decisions, as well as a process to add new conditions to the List of 
WTC-Related Health Conditions. After using the regulations for a number 
of years, the Administrator of the WTC Health Program has identified 
potential improvements to certain existing provisions, including, but 
not limited to, appeals of enrollment, certification, and treatment 
decisions, as well as the procedures for the addition of health 
conditions for WTC Health Program coverage. He has also identified the 
need to add new regulatory provisions, including, but not limited to, 
standards for the disenrollment of a WTC Health Program member and 
decertification of a certified WTC-related health condition.

DATES: The Administrator of the WTC Health Program invites comment on 
this proposed rule from interested parties. Comments must be received 
by September 16, 2016.

ADDRESSES: Interested parties may submit comments by any of the 
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, 
Cincinnati, OH 45226-1998.
    Instructions: All submissions received should include the agency 
name (Centers for Disease Control and Prevention, HHS) and docket 
number (CDC-2016-0072; NIOSH-291) or Regulation Identifier Number 
(0920-AA56) for this rulemaking. All relevant comments, including any 
personal information provided, will be posted without change to http://www.regulations.gov. For detailed instructions on submitting public 
comments, see the ``Public Participation'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents, go 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst; 1090 
Tusculum Ave, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629 
(this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION:  This preamble is organized as follows:

I. Executive Summary
    A. Purpose of Regulatory Action
    B. Summary of Major Provisions
    C. Costs
II. Public Participation
III. Background
    A. History and Scope of Rulemaking
    B. WTC Health Program Statutory Authority
IV. Summary of Proposed Rule
V. Regulatory Assessment Requirements
    A. Executive Order 12866 and Executive Order 13563
    B. Regulatory Flexibility Act
    C. Paperwork Reduction Act
    D. Small Business Regulatory Enforcement Fairness Act
    E. Unfunded Mandates Reform Act of 1995
    F. Executive Order 12988 (Civil Justice)
    G. Executive Order 13132 (Federalism)
    H. Executive Order 13045 (Protection of Children From 
Environmental Health Risks and Safety Risks)
    I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)
    J. Plain Writing Act of 2010

I. Executive Summary

A. Purpose of Regulatory Action

    The Secretary, HHS, promulgated regulations designed to implement 
the WTC Health Program in a 2011 interim final rule establishing Part 
88 in Title 42 of the Code of Federal Regulations,\1\ and in a 2012 
final rule adding procedures for the submission of petitions to add 
health conditions for Program coverage.\2\ These regulations in 42 CFR 
part 88 include the processes by which eligible responders and 
survivors may apply for enrollment in the WTC Health Program, obtain 
health monitoring and treatment for WTC-related health conditions, and 
appeal enrollment and treatment decisions. The Administrator of the WTC 
Health Program (Administrator) has determined that amending some 
provisions in Part 88 and adding others will benefit both the WTC 
Health Program and its members by clarifying requirements and improving 
administrative processes.
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    \1\ 76 FR 38914 (July 1, 2011).
    \2\ 77 FR 24628 (Apr. 25, 2012).
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B. Summary of Major Provisions

    Although the Administrator proposes to amend a number of existing 
sections in part 88, many of the changes would be non-substantive. Some 
existing language would be moved into new sections for clarity. 
Substantive amendments would be made to the following existing 
provisions:
     Sec.  88.11 Appeals regarding eligibility determinations--
responders and survivors--this section would be amended to clarify 
appeal procedures and to allow the Administrator to make a final 
decision on the appeal.
     Sec.  88.15 Appeals regarding treatment--this section 
would be significantly modified to clarify the appeal process, 
including allowing a WTC Health Program member or his/her designated 
representative to submit new evidence in support of the appeal and make 
an oral statement to the Federal Official reviewing the case, and allow 
the Administrator to make a final decision on the appeal.
     Sec.  88.17 Addition of health conditions to the list of 
WTC-related health conditions--this section would be amended to extend 
the deadline for the Administrator's response to a petition for the 
addition of a health condition from 60 to 90 calendar days, consistent 
with current law. Another amendment to this section would allow the 
Administrator to consider a petition to be invalid if it presents the 
same scientific evidence supporting the addition of the health 
condition that was previously considered by the Administrator in a 
response published in the Federal Register.
    New language on the following topics would be added to Part 88:
     Disenrollment--this new section would describe the WTC 
Health Program's procedures for disenrolling a Program member and the 
circumstances under which disenrollment would be applicable.
     Decertification--this new section would describe the WTC 
Health Program's ability to decertify a WTC-related health condition or 
health condition medically associated with a WTC-related health 
condition and the circumstances under which decertification would be 
applicable.
     Appeal of reimbursement denial--this new section would 
clarify the statutory appeal right for Program medical providers in 
cases in which the WTC Health Program has denied

[[Page 55087]]

reimbursement for treatment found not to be medically necessary.
     Coordination of benefits and recoupment--this new section 
would be added to reflect the statutory requirement that payment for 
treatment, including pharmaceuticals, must be reduced or recouped as 
appropriate when the WTC Health Program finds that payment has been 
made by workers' compensation, public, or private health insurance.

C. Costs

    This rulemaking is expected to result in approximately $42,742 in 
costs to the WTC Health Program associated with updating existing 
Program policies and developing new policies in accordance with 
amendments proposed in this action.

II. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, opinions, recommendations, 
and/or data. Comments are invited on any topic related to this proposed 
rule. Comments received, including attachments and other supporting 
materials, are part of the public record and subject to public 
disclosure. Any information in the comment or supporting materials 
considered confidential or inappropriate for public disclosure should 
not be included.
    Comments submitted electronically or by mail should be titled 
``Docket No. CDC-2016-0072'' and should identify the author(s) and 
contact information in case clarification is needed. Electronic and 
written comments can be submitted to the addresses provided in the 
ADDRESSES section, above. All communications received on or before the 
closing date for comments will be fully considered by the Administrator 
of the WTC Health Program.

III. Background

    This action proposes to amend certain regulatory provisions 
established in Part 88 of Title 42 of the Code of Federal Regulations 
and add new provisions to the part.

A. History and Scope of Rulemaking

    On July 1, 2011, HHS published an interim final rule (July 2011 
IFR) to establish Part 88 in Title 42 of the Code of Federal 
Regulations and implement the WTC Health Program as administered by the 
Director of the National Institute for Occupational Safety and Health 
(NIOSH) (76 FR 38914). Provisions established in Part 88 include the 
following: WTC Health Program definitions; general provisions; 
eligibility and application requirements for WTC responders and 
screening- and certified-eligible survivors; initial health evaluations 
for screening-eligible survivors; enrollment, certification, and 
treatment appeals; physician determinations; the process for certifying 
WTC-related health conditions; the medical necessity standard; and 
reimbursement for health care providers.
    A section describing the process for adding new health conditions 
to the List of WTC-Related Health Conditions (List) was finalized on 
April 25, 2012 (77 FR 24628).
    Regulations establishing the eligibility criteria for Shanksville, 
Pennsylvania and Pentagon responders were established in an interim 
final rule published on March 28, 2013 (78 FR 18855).
    Certain types of cancer, including rare cancers and childhood 
cancers, were added to the List in a September 12, 2012 final rule (77 
FR 56138). Another cancer rulemaking, adding prostate cancer to the 
List, was finalized on September 19, 2013 (78 FR 57505). An IFR was 
published on February 18, 2014 (February 2014 IFR) to clarify the 
definition of ``childhood cancers'' and revise the definition of ``rare 
cancers'' (79 FR 9100). As a result of this IFR, cancers of the brain, 
the pancreas, and the testes, and invasive cervical cancer are also 
considered covered conditions.
    Finally, on September 11, 2015, a notice of proposed rulemaking 
(NPRM) was published proposing the addition of new-onset chronic 
obstructive pulmonary disease (COPD) and WTC-related acute traumatic 
injury to the List (80 FR 54746). A final rule adding the two health 
conditions to the List was published on July 5, 2016 (81 FR 43510).
    Regulatory text promulgated through an IFR, such as Part 88, is 
effective prior to the consideration of public comments and may be 
amended just as if it had been promulgated by normal notice-and-comment 
rulemaking. In this proposed rule, the Administrator proposes 
amendments to certain sections of Part 88, responds to public comments 
on those sections received in response to the July 2011 IFR and the 
February 2014 IFR, and seeks public comment on the amendments proposed 
in this notice.
    This NPRM and all of the interim final rules described above,\3\ as 
well as any public comments to any of the interim final rules not 
addressed in this NPRM, will be addressed in a final rule.
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    \3\ These include the July 2011 IFR (establishing Part 88 and 
implementing the Program), the March 2013 IFR (establishing 
eligibility criteria for Shanksville and Pentagon responders), and 
the February 2014 IFR (clarifying the definition of ``childhood 
cancers'' and revising the definition of ``rare cancers'').
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B. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title 
XXXIII to the Public Health Service Act (PHS Act), establishing the WTC 
Health Program within HHS. The WTC Health Program provides medical 
monitoring and treatment benefits to eligible firefighters and related 
personnel, law enforcement officers, and rescue, recovery, and cleanup 
workers who responded to the September 11, 2001, terrorist 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).
    All references to the Administrator of the WTC Health Program 
(Administrator) in this notice mean the WTC Program Administrator, the 
Director of NIOSH, or his or her designee. Section 3301(j) of the PHS 
Act authorizes the Administrator to promulgate such regulations as are 
necessary to administer the WTC Health Program.

IV. Summary of Proposed Rule

    The Administrator finds it necessary to amend certain existing 
sections of 42 CFR part 88, to rearrange others, and to add new 
sections. The rationales for each proposed amendment are offered below, 
along with summaries of the proposed rule text. This action answers 
only those public comments relevant to the provisions that the 
Administrator is proposing to amend in this action.
    The Administrator proposes to amend the title of certain Part 88 
sections referenced below; the new titles used in the preamble 
correspond with the proposed regulatory text found at the end of this 
document.
    The table below matches the proposed reorganization of Part 88 with 
the originating sections in the existing regulation. No changes are 
proposed to Sec. Sec.  88.3 and 88.7; although they are included in the 
table for completeness, they are not referenced again in this notice. 
The regulatory text with

[[Page 55088]]

proposed amendments is found in the last section of this notice.

          Proposed Reorganization and Section Title Amendments
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            Proposed section                   Originating section
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88.1 Definitions.......................  88.1 Definitions.
88.2 General provisions................  88.2 General provisions.
88.3 Eligibility--currently-identified   88.3 Eligibility--currently-
 responders*.                             identified responders.
88.4 Eligibility criteria--WTC           88.4 Eligibility criteria--
 responders.                              status as a WTC responder.
88.5 Application process--WTC            88.5 Application process--
 responders.                              status as a WTC responder.
88.6 Enrollment decision--WTC            88.6 Enrollment determination--
 responders.                              status as a WTC responder.
88.7 Eligibility--currently-identified   88.7 Eligibility--currently-
 survivors *.                             identified survivors.
88.8 Eligibility criteria--WTC           88.8 Eligibility criteria--
 survivors.                               status as a WTC survivor.
88.9 Application process--WTC survivors  88.9 Application process--
                                          status as a WTC survivor.
88.10 Enrollment decision--screening-    88.10 Enrollment determination--
 eligible survivors.                      status as a WTC survivor.
88.11 Initial health evaluation for      88.10 Enrollment determination--
 screening-eligible survivors.            status as a WTC survivor.
88.12 Enrollment decision--certified-    88.10 Enrollment determination--
 eligible survivors.                      status as a WTC survivor.
88.13 Disenrollment....................  New.
88.14 Appeal of enrollment or            88.11 Appeals regarding
 disenrollment decision.                  eligibility determinations--
                                          responders and survivors.
88.15 List of WTC-Related Health         relocated from 88.1.
 Conditions.
88.16 Addition of health conditions to   88.17 Addition of health
 the List of WTC-Related Health           conditions to the list of WTC-
 Conditions.                              related health conditions.
88.17 Physician's determination of WTC-  88.12 Physician's
 related health conditions.               determinations of WTC-related
                                          health conditions.
88.18 Certification....................  88.13 WTC Program
                                          Administrator's certification
                                          of health conditions.
88.19 Decertification..................  New.
88.20 Authorization of treatment.......  88.14 Standard for determining
                                          medical necessity.
88.21 Appeal of certification,           88.15 Appeals regarding
 decertification, or treatment            treatment.
 authorization decision.
88.22 Reimbursement for medical          88.16 Reimbursement for
 treatment and services.                  medically necessary treatment,
                                          outpatient prescription
                                          pharmaceuticals, monitoring,
                                          and initial health
                                          evaluations, and travel
                                          expenses.
88.23 Appeal of reimbursement denial...  New.
88.24 Coordination of benefits and       New.
 recoupment.
88.25 Reopening of WTC Health Program    88.11 Appeals regarding
 final decisions.                         eligibility determinations--
                                          responders and survivors and
                                         88.15 Appeals regarding
                                          treatment.
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* No amendments are proposed for this section.

Section 88.1 Definitions

    The Administrator established definitions of the terms commonly 
used in the WTC Health Program in 42 CFR 88.1. For reasons discussed 
below, amendments are proposed to the definitions of the following 
terms: ``Act,'' ``Certification,'' ``Certified-eligible survivor,'' 
``Clinical Center of Excellence,'' ``List of World Trade Center (WTC)-
related health conditions,'' ``Medically necessary treatment,'' 
``Nationwide provider network,'' ``World Trade Center (WTC) Health 
Program,'' ``World Trade Center (WTC) Program Administrator,'' ``World 
Trade Center (WTC)-related health condition,'' and ``World Trade Center 
(WTC)-related musculoskeletal disorder.'' New definitions of ``World 
Trade Center (WTC) Health Program member'' and ``World Trade Center 
(WTC)-related acute traumatic injury,'' would also be added.
Act
    The Administrator proposes to amend the current definition of 
``Act'' to reference the 2016 reauthorization of the WTC Health Program 
in Public Law 114-113.
Certification
    The Administrator proposes to amend the current definition of 
``certification'' to better characterize the role of certification in 
the WTC Health Program. Certification would mean the WTC Health Program 
review and approval of a health condition as eligible for medically 
necessary treatment. A certified WTC-related health condition or a 
certified health condition medically associated with a certified WTC-
related health condition is eligible for medically necessary treatment 
in the WTC Health Program.
Certified-Eligible Survivor
    The current definition of ``certified-eligible survivor'' 
references enrollment of certified-eligible survivors under Sec.  
88.10(f). This reference is incorrect and, in any event, should be 
amended to reflect the reorganization of Part 88 in this action, 
placing the enrollment of certified-eligible survivors in Sec.  
88.12(b).
Clinical Center of Excellence (CCE)
    The Administrator proposes to amend the current definition of 
``Clinical Center of Excellence'' to add the acronym ``CCE.'' An 
amendment to paragraph (2) would strike reference to certified-eligible 
survivors and indicate that a CCE may include health care providers who 
have received WTC Health Program training, as described in the PHS 
Act.\4\ The term ``WTC Program Administrator'' is replaced with 
``Administrator of the WTC Health Program'' in paragraph (4) of this 
definition.
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    \4\ See PHS Act, sec. 3305(b)(1)(A)(ii).
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List of WTC-Related Health Conditions
    The Administrator proposes non-substantive amendments to the 
existing definition of ``List of World Trade Center (WTC)-related 
health conditions'' (List) to allow for easier reference to the health 
conditions covered by the WTC Health Program, to simplify future 
amendments to the List, and to give the List more prominence by moving 
it into its own section. The term ``List of WTC-

[[Page 55089]]

Related Health Conditions'' would be capitalized to reflect common 
usage by the Program. Furthermore, the Administrator proposes to move 
the List from the Sec.  88.1 Definitions section to a new Sec.  88.15. 
The definition of ``List of WTC-related health conditions'' would be 
replaced in the Sec.  88.1 Definitions section with a marker to point 
the reader to the new Sec.  88.15.
Medically Necessary Treatment
    The Administrator proposes to amend the existing definition of 
``medically necessary treatment'' to add the term ``WTC Health Program 
members'' to clarify that the standard applies to the provision of 
health care services to a particular member. The definition would also 
be amended to indicate that the medical treatment protocols are also 
developed with input from the CCEs. This language would be added to 
reflect the language in section 3305(a)(2)(A)(vi) of the PHS Act.
Nationwide Provider Network
    The existing definition of ``Nationwide provider network'' would be 
slightly amended to capitalize the name Nationwide Provider Network and 
include the acronym ``NPN.''
World Trade Center (WTC) Health Program
    The Administrator proposes to amend the existing definition of 
``World Trade Center (WTC) Health Program'' to update the reference to 
the authorizing statute, Title XXXIII of the Public Health Service Act 
as amended, 42 U.S.C. 300mm to 300mm-61 (codifying Title I of the James 
Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-347, as 
amended by Pub. L. 114-113).
World Trade Center (WTC) Health Program Member
    The Administrator proposes to add a new definition for the term 
``World Trade Center (WTC) Health Program member.'' This term is often 
used in Program publications and refers generally to any responder, 
screening-eligible survivor, or certified-eligible survivor enrolled in 
the WTC Health Program. The phrase ``responder, screening-eligible 
survivor, or certified-eligible survivor'' is replaced with ``WTC 
Health Program member'' as appropriate in this Part.
World Trade Center (WTC) Program Administrator
    The Administrator proposes to amend the existing definition of 
``WTC Program Administrator'' to clarify the title and to allow 
flexibility in how the Administrator is addressed in WTC Health Program 
documents. This non-substantive amendment to the existing definition 
would allow the use of the identical terms ``Administrator of the WTC 
Health Program'' and ``Administrator.''
World Trade Center (WTC)-Related Acute Traumatic Injury
    The Administrator proposes to add ``WTC-related acute traumatic 
injury'' to direct the reader to the List of WTC-Related Health 
Conditions in 42 CFR 88.15.
World Trade Center (WTC)-Related Health Condition
    ``World Trade Center (WTC)-related health condition'' would be 
amended to clarify that WTC-related health conditions are those that 
are found in the WTC Health Program regulations. The Administrator has 
added new health conditions to the statutory list, found in sections 
3312 and 3322 of the PHS Act, through rulemaking; \5\ the expanded List 
is currently codified in Sec.  88.1 of Part 88. Because the 
Administrator is proposing to move the List from Sec.  88.1 to Sec.  
88.15, amendments to this definition would direct the reader to its 
location.
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    \5\ See final rule, 77 FR 56138 (Sept. 12, 2012) (adding certain 
types of cancer); final rule, 78 FR 57505 (Sept. 19, 2013) (adding 
prostate cancer); interim final rule, 79 FR 9100 (Feb. 18, 2014) 
(clarifying the definition of ``childhood cancers'' and revising the 
definition of ``rare cancers''); and final rule, 81 FR 43510 (July 
5, 2016) (adding new-onset chronic obstructive pulmonary disease and 
WTC-related acute traumatic injury).
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World Trade Center (WTC)-Related Musculoskeletal Disorder
    The Administrator proposes to amend the existing definition of 
``WTC-related musculoskeletal disorder'' to direct the reader to the 
List of WTC-Related Health Conditions in 42 CFR 88.15.

Section 88.2 General Provisions

    This existing section establishes the appointment process for an 
applicant's or WTC Health Program member's designated representative 
and the parameters of the representative's authority. In response to 
public comments submitted to the July 2011 IFR docket regarding this 
section,\6\ the Administrator declines to amend this section to add 
``organization'' to the types of eligible representatives in paragraph 
(a) or to allow the designation of an alternate representative. Only 
one individual at a time is permitted to be the designated 
representative; if the applicant or member wishes to select a different 
representative, he or she may do so by notifying the WTC Health Program 
in writing, signed by the applicant or member and either submitted in 
hard copy or scanned and submitted electronically, of the intent to 
withdraw the previous representative and name a new one. Accordingly, 
the Administrator proposes to amend paragraph (a)(2) of this section to 
clarify that a designated representative must be withdrawn in writing. 
Paragraph (a)(3) would be amended to clarify that the designated 
representative may represent the WTC Health Program member on any other 
administrative matter, in addition to eligibility and certification 
matters. Paragraph (a)(4) would be amended to indicate that an 
applicant or Program member may designate a representative unless that 
individual's service is prohibited by law, WTC Health Program policies 
and procedures, or contract provisions.
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    \6\ NIOSH Docket 235, CDC-2011-0009.
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    Finally, because of proposed amendments to existing Sec.  88.16, 
the Administrator would move provisions regarding reimbursement for 
transportation and travel expenses into reserved paragraph (b).

Section 88.4 Eligibility Criteria--WTC Responders

    This section title would be amended from ``Eligibility criteria--
status as a WTC responder'' to the title above, for clarity.

Section 88.5 Application Process--WTC Responders

    This section title would be amended from ``Application process--
status as a WTC responder'' to the title above, for clarity.

Section 88.6 Enrollment Decision--WTC Responders

    This section title would be amended from ``Enrollment 
determination--status as a WTC responder'' to the title above, for 
clarity. The Administrator also finds that the term ``determination'' 
or ``determine'' should be replaced with ``decision'' or ``decide'' in 
this section and throughout Part 88 where the text refers to a WTC 
Health Program action. Although these terms were used interchangeably 
in the July 2011 IFR, the word ``determination'' is used in the Program 
to describe the finding made by a CCE or NPN physician that a member's 
diagnosed health condition meets the PHS Act standards to be considered 
a WTC-related health condition or a health condition medically-
associated with a WTC-related health condition; such determination is 
submitted to the Administrator for a certification decision (see Sec.  
88.18). Finally, language in existing paragraph (c)(2)(i) and

[[Page 55090]]

(c)(2)(i)(A) would be consolidated into one paragraph at (c)(2)(i).

Section 88.8 Eligibility Criteria--WTC Survivors

    This section title would be amended from ``Eligibility criteria--
status as a WTC survivor'' to the title above, for clarity.

Section 88.9 Application Process--WTC Survivors

    This section title would be amended from ``Application process--
status as a WTC survivor'' to the title above, for clarity.

Section 88.10 Enrollment Decision--Screening-Eligible Survivors

    The Administrator proposes to simplify the existing provisions in 
Sec.  88.10, titled ``Enrollment determination--status as a WTC 
survivor,'' by splitting the section into three separate sections: 
Enrollment decision--screening-eligible survivors; initial health 
evaluation for screening-eligible survivors; and enrollment decision--
certified-eligible survivors. The screening-eligible survivor status 
decision provisions would remain in Sec.  88.10; the initial health 
evaluation provisions would be moved into a new Sec.  88.11, and the 
certified-eligible survivor status provisions would be moved into a new 
Sec.  88.12.
    For the reasons discussed above, the Administrator proposes to 
amend the title of this existing section from ``Enrollment 
determination--status as a WTC survivor'' to ``Enrollment decision--
screening-eligible survivors.'' The new title would clarify that 
enrollment ``decisions'' are made by the WTC Health Program, to avoid 
confusion with ``determinations'' made by CCE and NPN physicians 
regarding a member's health condition. Amendments to this section would 
retain and combine the substance of existing paragraphs (a), (b), and 
(c) into new paragraphs (a) and (b). Proposed revisions to the language 
concerning the 60-day deadline for the WTC Health Program's decision 
would clarify that the date would be calculated in calendar days and 
extend the notification deadline to be no later than 60 days of receipt 
of the application, rather than the date of transmission of the 
application, which can be difficult to determine. The 60-day 
notification deadline would be tolled while the applicant is correcting 
deficiencies in the application or supporting documents. Existing 
paragraph (d), described below, would be removed to a new Sec.  88.11. 
Existing paragraphs (e), (f), and (g), described below, would be 
removed to a new Sec.  88.12.

Section 88.11 Initial Health Evaluation for Screening-Eligible 
Survivors

    A new Sec.  88.11 comprises language formerly found in Sec.  
88.10(d). Minor amendments to this new section would include replacing 
``diagnoses'' with ``determines'' to align the rule text with terms 
commonly used by the WTC Health Program.
    In response to public comments submitted to the July 2011 IFR 
docket regarding these provisions,\7\ the Administrator declines to 
allow a screening-eligible survivor to obtain an additional health 
evaluation at no cost or to specify that the cost of an additional 
evaluation would be the same as is paid by the WTC Health Program. The 
Administrator is constrained by section 3321(b)(3) of the PHS Act, 
which explicitly limits screening-eligible survivors to a single 
initial health evaluation at no cost. The member could request more 
than one health evaluation, but the Administrator has no legal 
obligation or authority to pay for subsequent health evaluations. The 
Administrator does not propose any substantive changes to this text.
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    \7\ NIOSH Docket 235, CDC-2011-0009.
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Section 88.12 Enrollment Decision--Certified-Eligible Survivors

    A new Sec.  88.12 would comprise the former Sec.  88.10(e), 
describing certification determinations; Sec.  88.10(f), describing 
denials of certification; and Sec.  88.10(g), describing notification 
of the certified-eligible survivor status decision. The new title would 
clarify that enrollment ``decisions'' are made by the WTC Health 
Program, to avoid confusion with ``determinations'' made by CCE or NPN 
physicians regarding a member's health condition. Proposed amendments 
to this new section would include removing redundant language and 
clarifying certification status language. Existing language in Sec.  
88.10(e) states that ``[i]f the individual's condition is certified as 
a WTC-related health condition, the individual will also be certified 
as a certified-eligible survivor.'' The use of ``also'' may incorrectly 
suggest the WTC Health Program member retains two statuses, as both a 
screening-eligible and a certified-eligible survivor, simultaneously. 
Amendments would clarify that if the Program member's condition is 
certified as a WTC-related health condition, the member's status will 
automatically change to that of a certified-eligible survivor. The 
Administrator does not propose any substantive changes to this text.

Section 88.13 Disenrollment

    The Administrator proposes to add a new section to Part 88 to 
clarify the process for disenrolling a member from the WTC Health 
Program. To date, only 12 enrolled members have been found to have been 
wrongly enrolled due to Program error or inaccurate eligibility 
information. Allowing individuals who do not meet WTC Health Program 
enrollment eligibility criteria to stay in the Program may result in 
those individuals improperly receiving medical benefits. Moreover, 
individuals who are erroneously enrolled may fill the statutory limits 
on the number of WTC responders and certified-eligible survivors 
enrolled in the WTC Health Program,\8\ thereby preventing qualified 
individuals from enrolling.
---------------------------------------------------------------------------

    \8\ See PHS Act, secs. 3311(a)(4) and 3321(a)(3).
---------------------------------------------------------------------------

    Pursuant to this section, a WTC Health Program member enrolled 
pursuant to Sec.  88.4 or Sec.  88.8 may be disenrolled if the member 
did not provide sufficient proof of eligibility and was mistakenly 
enrolled in the Program, or the member's location, activities, and/or 
duration are inconsistent with the eligibility criteria for newly 
enrolled WTC responders or screening-eligible survivors; additionally, 
a member may be disenrolled if his or her enrollment was based on 
inaccurate or fraudulent information. A member may be disenrolled 
following a periodic audit conducted by the Program to ensure that 
enrollment decisions are proper or when the Program is made aware of 
new information that would impact the enrollment decision. A member 
could also choose to disenroll from the Program at his or her own 
discretion.
    A member who has been disenrolled from the WTC Health Program would 
be notified in writing of the disenrollment decision and given the 
opportunity to appeal that decision, within 90 days of the date of the 
Administrator's notification letter, in accordance with Sec.  88.14. 
Finally, a member who is disenrolled may reapply for enrollment in the 
WTC Health Program if new information is available to support the 
application.

Section 88.14 Appeal of Enrollment or Disenrollment Decision

    This section establishes procedures for the appeal of a WTC Health 
Program decision to deny enrollment to an applicant or disenroll a 
Program member. The Administrator proposes to amend the section heading 
from

[[Page 55091]]

``Appeals regarding eligibility determinations--responders and 
survivors'' to ``Appeal of enrollment or disenrollment decision,'' to 
provide greater clarity.
    The Administrator has identified the need to make substantive 
amendments to this existing section due to other proposed revisions in 
this notice and in response to public comment on the July 2011 IFR.\9\ 
Commenters asserted that the existing 60-day deadline for filing an 
appeal of an enrollment denial is too short and requested that 
applicants be given from 180 days to a year to file an appeal. The 
Administrator agrees that the current requirement that an applicant 
file an appeal within 60 days of the date on the notification letter 
explaining the enrollment denial may not provide enough time for the 
applicant to gather necessary documentation or other information for 
the appeal. Therefore, the Administrator proposes amendments to this 
section to permit consideration of a denied applicant's appeal letter 
that is postmarked \10\ within 90 calendar days of the date of the 
Administrator's denial notification letter. The Administrator similarly 
finds that allowing 90 days for submission of an appeal request 
subsequent to a disenrollment of a Program member should allow ample 
time for a disenrolled Program member to gather any necessary 
information. However, the Administrator requests further public comment 
on the appropriateness of allowing 90 days for appeal of a 
disenrollment decision.
---------------------------------------------------------------------------

    \9\ NIOSH Docket 235, CDC-2011-0009.
    \10\ For appeal letters submitted electronically via fax or 
email, the date of the electronic transmission is understood to be 
the date the letter is `postmarked.'
---------------------------------------------------------------------------

    The Administrator also proposes to amend this section to recognize 
appeals of a WTC Health Program decision to disenroll a Program member, 
as described in the proposed new disenrollment provisions in Sec.  
88.13.
    Because of the reorganization of this part, the current number of 
this section, Sec.  88.11, would be changed to Sec.  88.14. Existing 
paragraph (b) would be redesignated paragraph (c). New language for 
paragraph (b) would establish the appeal request process and mirror the 
appeal process for certification, decertification, and treatment 
authorization decisions in Sec.  88.21. The new language would specify 
that an appeal request must be made in writing, identify the denied 
applicant or disenrolled Program member and the designated 
representative, if any, and state the reasons why the WTC Health 
Program's action was incorrect and should be reversed. As currently 
permitted, the appeal request may include relevant new information not 
previously considered by the Program. Existing paragraph (c), which 
allows the Administrator to reopen and reconsider an enrollment denial, 
would be removed from this section and placed in a new section, Sec.  
88.25 described below, regarding reopenings generally. A new paragraph 
(c) would describe the appeal process, which would consist of the 
appointment of a Federal Official, who will be an HHS employee 
independent of the WTC Health Program, to review the case and submit a 
recommendation to the Administrator.
    Finally, a new paragraph (d) would change the existing appeal 
process to result in the Federal Official making a recommendation to 
the Administrator, who would then make a final decision on the appeal. 
This paragraph would also clarify that the Administrator will share the 
results of the Federal Official's review and any administrative actions 
taken by the WTC Health Program with the denied applicant, disenrolled 
Program member, or designated representative who filed the appeal. The 
Administrator declines to offer a deadline for the final decision on an 
enrollment appeal, as requested by public comment on the July 2011 
IFR.\11\ Given the potentially complex nature of appeals decisions, the 
Administrator is concerned that limiting the amount of time available 
to the Federal Official and/or the Administrator to review the denied 
applicant's or disenrolled Program member's file (including any new 
information submitted) could result in undue burden on the Federal 
Official and/or Program staff and not allow for a thorough review of 
the appeal. In the Program's experience, final decisions on enrollment 
appeals typically occur within 45 days of receipt of the applicant's 
appeal request.
---------------------------------------------------------------------------

    \11\ NIOSH Docket 235, CDC-2011-0009.
---------------------------------------------------------------------------

Section 88.15 List of WTC-Related Health Conditions

    This new section contains the health conditions enumerated in the 
PHS Act at sections 3312(a)(3) and 3322(b) as well as those additional 
WTC-related health conditions promulgated through rulemaking by the 
Administrator.\12\ The Administrator proposes moving the List of WTC-
related health conditions from Sec.  88.1, the definitions section, to 
a new Sec.  88.15 in order to better clarify and emphasize for 
stakeholders the conditions that are covered by the WTC Health Program. 
The Administrator also proposes to capitalize the section title as well 
as the name ``List of WTC-Related Health Conditions,'' as it appears 
throughout Part 88, to reflect the terminology commonly used in most 
Program publications. The health conditions that would be included in 
this new section are the same health conditions named in the 
definition, ``List of WTC-related health conditions'' currently found 
in Sec.  88.1. The reference to ``interstitial lung disease'' in 
paragraph (a)(1) should be plural and would be corrected in this 
action, the reference to ``upper airway hyperreactivity'' in paragraph 
(a)(7) is misspelled in the current regulation and would be corrected 
in this action, and the acronym ``PTSD'' would be added to the existing 
WTC-related health condition, ``Posttraumatic stress disorder'' in 
(b)(1).
---------------------------------------------------------------------------

    \12\ See supra note 5.
---------------------------------------------------------------------------

    The definition of ``WTC-related musculoskeletal disorder,'' also 
currently found in Sec.  88.1, would be incorporated into paragraph (c) 
of the new Sec.  88.15. No other substantive changes to the rule text 
regarding the List are proposed.
    In response to the July 2011 IFR, one commenter requested that 
`musculoskeletal disorders' be available to survivors for 
certification.\13\ The PHS Act limits the coverage of musculoskeletal 
disorders to responders to the terrorist attacks in New York City. The 
same commenter requested the addition of ``developmental disorders and 
any disorder linked specifically to children's WTC exposures, including 
those that occurred in utero.'' Individuals who were children at the 
time of the terrorist attacks may be considered survivors if they meet 
the eligibility criteria for screening- or certified-eligible 
survivors. Health conditions cannot be added to the List without 
rulemaking, supported by scientific or medical evidence, pursuant to 
the PHS Act and procedures established under Part 88 for adding new 
WTC-related health conditions to the List.
---------------------------------------------------------------------------

    \13\ NIOSH Docket 235, CDC-2011-0009.
---------------------------------------------------------------------------

    Public comments submitted to the docket for the February 2014 IFR 
(clarifying the definition of ``childhood cancers'' and revising the 
definition of ``rare cancers'') relevant to this section \14\ are 
addressed here, including questions regarding the availability of a 
list of rare cancers identified by the Program, and requests that the 
WTC Health Program reach out to members who were denied certification 
of brain and pancreatic cancers prior to

[[Page 55092]]

publication of the February 2014 IFR.\15\ The WTC Health Program 
published a list of the cancers considered rare on the Policies & 
Procedures Web page; \16\ the full list of cancer types covered by the 
Program is found on the List of WTC-Related Health Conditions. Further, 
when a new health condition is added to the List or when WTC Health 
Program policy regarding a condition on the List changes, it is Program 
practice to communicate directly with members or their CCE or NPN 
regarding conditions previously denied certification, to determine if 
the condition should be re-evaluated for certification. No amendments 
to the List are proposed in response to public comment.
---------------------------------------------------------------------------

    \14\ NIOSH Docket 268, CDC-2014-0004.
    \15\ This interim final rule amended the List of WTC-Related 
Health Conditions to reverse the policy of considering cancers of 
the brain and the pancreas ineligible for Program coverage, 
clarified the definition of ``childhood cancers,'' and revised the 
definition of ``rare cancers'' (79 FR 9100). As a result of the IFR, 
cancer of the brain, the pancreas, the testes, and invasive cervical 
cancer are considered eligible for coverage in the Program.
    \16\ See John Howard, Administrator of the WTC Health Program, 
Rare Cancers, May 5, 2014, http://www.cdc.gov/wtc/pdfs/WTCHP_PP_RareCancers05052014.pdf.
---------------------------------------------------------------------------

Section 88.16 Addition of Health Conditions to the List of WTC-Related 
Health Conditions

    A new Sec.  88.16 would comprise language formerly found in Sec.  
88.17. This section establishes the process for adding a new health 
condition to the List of WTC-Related Health Conditions in Sec.  88.15. 
The Administrator has determined that these existing provisions should 
be revised to clarify the circumstances under which the Administrator 
is required to consider a new submission requesting the addition of a 
health condition that has been previously considered. Amending this 
section would promote administrative efficiency by not requiring WTC 
Health Program staff to devote time to reviewing and responding to a 
submission that, in substance, was already considered.
    The Administrator proposes to change the number of this existing 
section from Sec.  88.17 to Sec.  88.16. The Administrator further 
proposes minor amendments to clarify that the List would be moved to 
Sec.  88.15 and to replace ``determination'' with ``decision,'' as 
explained above. Paragraph (a) describes the criteria for a valid 
petition, including the following: An explicit statement of an intent 
to petition; the name, contact information, and signature of the 
petitioning party; the name and/or description of the condition(s) to 
be added; and the reasons for adding the condition(s), including the 
medical basis for the association between the September 11, 2001, 
terrorist attacks and the condition(s) to be added. The paragraph would 
be amended to clarify that the Administrator accepts all submissions 
from interested parties and then evaluates the submissions to decide 
whether they are valid petitions. Paragraph (a)(1) would be amended 
slightly to clarify in paragraph (a)(1)(i) that the petition must state 
an intent to petition the Administrator to add a health condition to 
the List. Paragraph (a)(1)(ii) would be amended to require that the 
petitioner provide a signature on the petition. Requiring a signature 
aligns the regulation with the petition form offered by the Program, 
which requires that the petitioner provide a signature. Paragraph 
(a)(1)(iii) would be amended to indicate that a petitioner may include 
either the name ``and/or'' a description of the petitioned health 
condition.
    Paragraph (a)(2) would be amended to state that the Administrator 
will take one of the available actions within 90 calendar days after 
receipt of a valid petition, including requesting a recommendation from 
the WTC Health Program Scientific/Technical Advisory Committee (STAC) 
or publishing a notice in the Federal Register. The window for 
administrative action following receipt of a petition was extended from 
60 to 90 days in the recent amendments to the PHS Act.\17\ Each 
petition and corresponding Federal Register notice is published on the 
WTC Health Program Web site.
---------------------------------------------------------------------------

    \17\ See Public Law 111-347, as amended by Public Law 114-113, 
PHS Act, sec. 3312(a)(6)(B)-(C).
---------------------------------------------------------------------------

    Existing paragraph (a)(3) would be redesignated (a)(4), and new 
text in paragraph (a)(3) would allow the 90-day deadline to be tolled 
while the Administrator seeks more information from the interested 
party regarding an unclear submission.
    Because of the preceding change, existing paragraph (a)(4) is 
redesignated (a)(5), and proposed amendments would clarify the handling 
of a submission that requests the addition of a health condition 
previously evaluated for addition to the List by the WTC Health 
Program. In such a case, if the submission does not include a new 
medical basis for an association between the health condition and 9/11 
exposures and is received after the publication of a response to an 
earlier petition in the Federal Register, then the submission would not 
be considered a valid petition and would not be answered in the Federal 
Register. The submitter would be provided an explanation of the 
Program's decision in writing.
    The Administrator proposes to amend paragraph (b) to identify the 
proposed new location of the List of WTC-Related Health Conditions as a 
separate section in Part 88. Other amendments to paragraph (b) would 
incorporate additional PHS Act amendments extending the respective 
deadlines for the submission of the STAC's recommendation, when 
requested, and the subsequent publication of the Administrator's 
decision from 60 to 90 calendar days.\18\ Paragraph (b)(1) would be 
amended to update those deadlines and clarify that all deadlines will 
be calculated in terms of calendar days. A new paragraph (b)(2) would 
reflect the recent amendments to the PHS Act requiring the 
Administrator to provide for an independent peer review of the 
scientific and technical evidence that would be the basis for adding a 
health condition to the List.\19\
---------------------------------------------------------------------------

    \18\ PHS Act, sec. 3312(a)(6)(C).
    \19\ PHS Act, sec. 3312(a)(6)(F).
---------------------------------------------------------------------------

Section 88.17 Physician's Determination of WTC-Related Health 
Conditions

    A new Sec.  88.17 would comprise language formerly found in Sec.  
88.12. This section establishes the basis for a CCE or NPN-affiliated 
physician's determination that a WTC Health Program member has a health 
condition that can be certified and covered by the WTC Health Program.
    The Administrator finds it important to clarify the statutory 
standard for a physician's determination that a health condition is 
WTC-related or medically associated with a WTC-related health 
condition. The language of this existing section requires simply that a 
physician communicate the ``basis for the diagnosis'' to the WTC Health 
Program; the Program then decides whether to certify the health 
condition for treatment. The Administrator proposes to amend this 
section to incorporate statutory language requiring that the basis for 
a physician's determination be a finding that 9/11 exposure is 
``substantially likely'' to be a ``significant factor in aggravating, 
contributing to, or causing the illness or health condition.'' Although 
the WTC Health Program has not documented any problems with 
interpretation of the existing rule text, the Administrator thinks that 
inclusion of the statutory standard would clarify for stakeholders what 
the physician is required to establish before requesting certification 
of a health condition or medically associated health condition. This

[[Page 55093]]

amendment would have no impact on the Program or its members.
    Because of proposed amendments to earlier sections, the original 
number of this section, Sec.  88.12, would be changed to Sec.  88.17. 
``Shall'' would be replaced with ``must.''
    Public comments submitted to the July 2011 IFR docket on this 
section \20\ included a request to specify that a physician's 
determination must be transmitted to the Administrator ``promptly, but 
in no case longer than 30 days from the initial clinical visit.'' The 
Administrator declines to establish such a deadline because doing so 
may unduly burden the physician. No amendments to this section are 
proposed in response to comments. Physician determinations and 
certification requests are typically submitted to the WTC Health 
Program within 60 days of the completion of the member's examination 
and/or record review.
---------------------------------------------------------------------------

    \20\ NIOSH Docket 235, CDC-2011-0009.
---------------------------------------------------------------------------

Section 88.18 Certification

    This section establishes that the WTC Health Program will promptly 
assess physician determinations submitted by a CCE or NPN-affiliated 
physician and, if the Program concurs with the determination and 
decides that a health condition is a WTC-related health condition or a 
health condition medically associated with a WTC-related health 
condition, will certify the condition as eligible for coverage under 
the WTC Health Program. The Administrator has identified the need to 
amend this section to make necessary clarifications and respond to 
public comment.
    The Administrator proposes to change the number of this existing 
section from Sec.  88.13 to Sec.  88.18, and to change the title from 
``WTC Program Administrator's certification of health conditions'' to 
``Certification.''
    The section would also be amended to include the statutory 60-day 
deadline for the Program's decision on whether to certify a health 
condition as medically associated with a WTC-related health 
condition,\21\ as requested by commenters. Specifically, the proposed 
amendment to paragraph (b) would specify that the Program will notify 
the WTC Health Program member in writing of the certification decision 
within 60 calendar days of the date the physician's determination is 
received.
---------------------------------------------------------------------------

    \21\ See PHS Act, sec. 3312(b)(2)(B)(ii).
---------------------------------------------------------------------------

    The language in existing paragraph (c) concerning authorization of 
treatment pending certification would be removed to a new Sec.  88.20. 
Language in existing paragraphs (a)(2) and (b)(2) concerning the right 
to appeal a denial of certification would be consolidated in paragraph 
(c).
    Public comments submitted to the July 2011 IFR docket on this 
section \22\ included concerns about the use of physician panels for 
the review of health conditions medically associated with WTC-related 
health conditions, as authorized in the PHS Act and included in 
paragraph (b). Commenters asserted that the use of the physician panel 
identified in the rule text is mandatory, that the empaneled physicians 
should be board certified, and that the Administrator should publicize 
the qualification criteria for such a panel as well as the names and 
credentials of empaneled physicians. Finally, commenters asserted that 
input on panel selection should be sought from the ``community,'' 
including recommendations from the CCEs, Data Centers, and Steering 
Committees.
---------------------------------------------------------------------------

    \22\ NIOSH Docket 235, CDC-2011-0009.
---------------------------------------------------------------------------

    The Administrator interprets the statutory language in section 
3312(b)(2)(B) of the PHS Act to require the establishment of procedures 
governing the use of such a panel. The Administrator finds that in many 
cases, certification of a medically associated health condition is 
clearly supported, making panel review unnecessary. The addition of 
unnecessary administrative layers may delay a decision; therefore, the 
Administrator declines to make panel review mandatory. Any physician 
panel members would be chosen for their medical or scientific expertise 
at the sole discretion of the Administrator.
    Commenters also suggested a deadline for certification decisions 
and recommended that decisions be made within 30 days of the 
Administrator's receipt of the physicians' determination and request 
for certification. Although the Administrator declines to set a 30-day 
deadline for WTC Health Program certification decisions, he is 
committed to rendering this decision in a timely manner. WTC Health 
Program members are typically notified of Program decisions within 
approximately a month of receipt of a physician's determination.
    One commenter expressed concern that on-going treatment for a 
certified condition should not require re-certification each time 
treatment is necessary. The Administrator agrees. WTC Health Program 
physicians are not required to request re-certification for on-going 
treatment of a certified WTC-related health condition.
    Finally, one commenter requested that notification regarding a 
certification decision by the Administrator should be made by certified 
mail, return receipt requested, and by email where such contact 
information is available. Although the Administrator generally agrees 
that notification of any certification decisions made pursuant to this 
section should be sent by certified mail, he declines to specify in the 
rule text the mode of transmission, finding the detail potentially 
detrimental to Program flexibility. He also declines to send 
notifications by email because receiving more than one notification may 
be confusing and email notifications do not ensure the protection of 
private health information.

Section 88.19 Decertification

    Similar to the issue of disenrollment, the Administrator has also 
identified a need for the WTC Health Program to clarify the process for 
decertification of a WTC-related health condition or health condition 
medically associated with a WTC-related health condition. Circumstances 
that would lead to decertification would be limited to those where the 
condition was certified in error, such as where the WTC Health Program 
member's 9/11 exposure is later found to be insufficient; the Program 
decides that the physician erroneously found that the member's 9/11 
exposures were substantially likely to be a significant factor in 
aggravating, contributing to, or causing the health condition; or the 
Program decides the health condition was erroneously certified as 
medically associated with a WTC-related health condition. Such concerns 
may be discovered during routine audit of enrollment decisions. 
Allowing a health condition to remain certified in error may result in 
WTC Health Program members receiving treatment for conditions that were 
not associated with their 9/11-related exposures, leading to 
inappropriate use of Program services and dollars. The WTC Health 
Program member would be notified of the decision to decertify the 
health condition and given an opportunity to appeal the Program's 
decertification decision.

Section 88.20 Authorization of Treatment

    Amendments to the existing section titled ``Standard for 
determining medical necessity'' would clarify the WTC Health Program's 
treatment authorization process. A new paragraph (a) would describe the 
provision of medically necessary treatment in accordance with 
applicable Program protocols and policies and procedures.
    Paragraph (b) would incorporate the existing standard for 
determining whether the treatment for a WTC-related

[[Page 55094]]

health condition or a health condition medically associated with a WTC-
related health condition is medically necessary. The Administrator 
finds it important to clarify that the medical treatment protocols \23\ 
are developed by the Data Centers, with input from the CCEs.
---------------------------------------------------------------------------

    \23\ See Policy and Procedure Manual for the WTC Health Program, 
Jan. 1, 2015, Chapter 4: Medical Benefits, Section 4: Covered 
Medical Services, Part B: Medically Necessary Treatment, http://www.cdc.gov/wtc/ppm.html#4d. Program communications sometimes also 
refer to medical treatment protocols as ``medical guidelines.''
---------------------------------------------------------------------------

    The Administrator proposes to amend the original number of this 
section, Sec.  88.14, to Sec.  88.20, and change the title to 
``Authorization of treatment.'' The Administrator further proposes to 
replace ``WTC Program Administrator'' with ``Administrator of the WTC 
Health Program.''
    Public comments submitted to the July 2011 IFR docket on this 
section \24\ included a request that the Administrator create a 
mechanism by which additional treatment modalities, including 
alternative therapies not presently part of the existing treatment 
protocols, would be considered for addition to those existing protocols 
deemed medically necessary. The Program routinely considers and 
discusses proposals for new treatment modalities with the CCEs and NPN 
and reviews available scientific evidence from authoritative bodies to 
support the inclusion of the proposed treatment modalities.
---------------------------------------------------------------------------

    \24\ NIOSH Docket 235, CDC-2011-0009.
---------------------------------------------------------------------------

    A new paragraph (c) would incorporate existing language in Sec.  
88.13(c) regarding treatment pending certification.

Section 88.21 Appeal of Certification, Decertification, or Treatment 
Authorization Decision

    This section establishes that a WTC Health Program member or the 
designated representative of such a member may appeal the Program's 
decision to deny certification of a health condition as WTC-related or 
medically associated with a WTC-related health condition, decertify a 
WTC-related health condition or medically associated health condition, 
or deny authorization of treatment for a certified health condition. 
Based on Program administrative experience and in response to public 
comments on the July 2011 IFR,\25\ the Administrator has found a need 
to revise the existing health condition certification and treatment 
appeals section. Providing more clarity regarding the appeal process 
will benefit WTC Health Program members and help address concerns 
raised by commenters asking that the appeal process be more member-
friendly. In particular, stakeholders requested that a member be 
allowed to submit new evidence in support of his or her appeal and 
interact with the Federal Official reviewing the case.
---------------------------------------------------------------------------

    \25\ NIOSH Docket 235, CDC-2011-0009.
---------------------------------------------------------------------------

    The Administrator proposes to change the number of this existing 
section from Sec.  88.15 to Sec.  88.21 and change the section name 
from ``Appeals regarding treatment'' to ``Appeal of certification, 
decertification, or treatment authorization decision.''
    The Administrator proposes to include in paragraph (a)(3) a right 
of appeal for a WTC Health Program member for whom the Program has 
decided to decertify a WTC-related health condition or health condition 
medically associated with a WTC-related health condition, pursuant to 
proposed language in Sec.  88.19. Members would still be allowed the 
right to appeal WTC Health Program decisions not to certify a health 
condition as WTC-related; not to certify a health condition as 
medically associated with a WTC-related health condition; or to deny 
treatment authorization for a certified WTC-related health condition or 
medically associated condition because the treatment is not deemed 
medically necessary.
    Public comments on the July 2011 IFR \26\ asked that the 
Administrator allow the member to appeal a decision made by a CCE or 
NPN-affiliated physician not to request certification of the member's 
health condition. Section 3312(b)(1)(A) of the PHS Act requires that a 
CCE [or NPN-affiliated] physician make a determination regarding the 
health condition before the WTC Health Program can decide whether to 
certify the health condition as WTC-related. In accordance with WTC 
Health Program policies and procedures, a Program member may request a 
secondary review of the physician's decision not to seek certification 
of a condition as a WTC-related or medically associated health 
condition.\27\
---------------------------------------------------------------------------

    \26\ NIOSH Docket 235, CDC-2011-0009.
    \27\ See Policy and Procedure Manual for the WTC Health Program, 
Jan. 1, 2015, Chapter 3: Certification of Health Conditions, Section 
5: CCE/NPN Physician Determination and Request for Certification of 
Health Conditions, Part B: Secondary Review of Negative Physician 
Determination, http://www.cdc.gov/wtc/ppm.html#3e.
---------------------------------------------------------------------------

    Commenters also asked the Administrator to allow the member's 
physician or CCE medical director to represent the responder or 
survivor in the appeal, or give the physician the right to appeal the 
Administrator's certification denial directly. The Administrator 
declines to allow a CCE or NPN medical director, provider, or staff to 
represent a member in an appeal because doing so may create a conflict 
of interest for the medical director, provider, or staff. The 
Administrator also declines to allow the physician to appeal the 
certification denial directly; if the physician believes that the 
Administrator has denied a certification in error, the physician may 
re-submit the request for certification and provide additional 
explanation or evidence supporting the physician's determination that 
the health condition is WTC-related.
    The Administrator proposes to amend paragraph (b)(1) to clarify 
that the appeal process begins when the member or member's designated 
representative sends a signed letter, either submitted in hard copy or 
scanned and submitted electronically, to the Administrator requesting 
the appeal. In response to public comment, the Administrator also 
proposes to extend the amount of time for filing an appeal from 60 to 
90 calendar days from the date of the letter to the member notifying 
them of the WTC Health Program's adverse decision.
    As in the current rule, the appeal request letter must describe the 
reasons the WTC Health Program's decision is incorrect and should be 
reversed. For example, the member could argue for reversal on the 
grounds that factual errors were contained in the scientific or medical 
information submitted to the Program by the CCE or NPN physician; the 
Program failed to correctly follow or apply relevant Program policies 
or procedures; or the Program's decision was unreasonable as applied to 
the facts of the case. Any basis provided in the appeal request must be 
sufficiently detailed and supported by information to permit review of 
the appeal. The Administrator agrees with commenters that the member 
may have additional relevant information that was not available to the 
member, the determining physician, or the Program at the time of the 
decision not to certify the health condition, decertify the condition, 
or not to authorize treatment. Accordingly, the Administrator now 
proposes to allow the member or designated representative to submit new 
information with the appeal request or at a later date, if requested by 
the Program.
    The Administrator proposes to amend portions of the section to 
clarify the appeal review process and incorporate procedures the WTC 
Health Program

[[Page 55095]]

has outlined elsewhere.\28\ As requested by commenters, the 
Administrator proposes new paragraph (b)(3) to codify the WTC Health 
Program's current process allowing the Program member or the member's 
designated representative the opportunity to make a 15-minute oral 
statement by telephone.\29\ A transcript of the oral statement is 
included in the record and provided to the Program member and/or the 
member's designated representative. The Administrator finds that more 
formal hearings would be administratively burdensome, divert Program 
resources away from patient care, and be of little benefit to the 
member.
---------------------------------------------------------------------------

    \28\ See WTC Health Program: Appeals Process, Overview of the 
Appeal Process For Denial of Health Condition Certification, http://www.cdc.gov/wtc/appeals_condition.html. The 15-minute oral statement 
allows the member to present his or her case to the Federal Official 
assigned to review the case; however, the member is not permitted to 
present witnesses and the Federal Official does not issue a ruling 
at the conclusion of the oral statement.
    \29\ See id.
---------------------------------------------------------------------------

    Finally, the Administrator proposes to amend paragraph (c) to 
clarify that after receipt of the appeal request, the Administrator 
assigns an independent Federal Official to review the case and the WTC 
Health Program's decision not to certify the health condition or 
medically associated condition, to decertify, or not to authorize 
treatment. The Federal Official decides whether to recommend granting 
the appeal by considering whether the WTC Health Program substantially 
complied with all relevant Program policies and procedures; whether the 
information supporting the Program's decision was factually accurate; 
and whether the Program's decision was reasonable as applied to the 
facts of the case.
    Proposed paragraph (c)(1) would clarify that the Federal Official 
will review the case record, including any oral statement made by the 
WTC Health Program member or the member's designated representative, as 
well as any additional relevant new information submitted with the 
appeal request or provided at the request of the WTC Health Program. As 
established in paragraph (b)(2) of the current rule, proposed paragraph 
(c)(2) would state that the Federal Official may consult one or more 
qualified experts; amendments to this paragraph would permit any 
experts consulted to review the WTC Health Program's adverse decision 
and the Program member's records as well as any new information 
provided by the member during the appeal. As described in proposed 
paragraph (c)(3), the Federal Official will submit his or her 
recommendation to the Administrator. The recommendation would include 
the Federal Official's recommendation and findings regarding the 
disposition of the appeal and any relevant supporting materials, 
including the transcript of any oral statement and the findings of any 
experts. One commenter asserted that some of the experts must be 
unaffiliated with the Federal government to prevent bias and that 
community input should be obtained for the selection of experts, 
including from the WTC Health Program survivor and responder steering 
committees and CCEs. The Administrator declines to adopt this 
suggestion and notes that relevant expertise is likely to be related to 
exposure assessments and medical findings. Further, the Federal 
Official may consult one or more expert reviewers when deemed 
necessary; the use of expert reviewers may not always be beneficial and 
could result in administrative burden and delay.
    The Administrator proposes to further revise the section by adding 
paragraph (d), which would recharacterize the outcome of the Federal 
Official's review of the appeal as a recommendation to be provided to 
the Administrator. In the final step of the appeal process, the 
Administrator would review the Federal Official's recommendation and 
supporting materials and make a final decision regarding the 
certification, decertification, or treatment authorization decision 
being appealed. The Administrator would notify the member and/or the 
member's designated representative of the Federal Official's findings 
and recommendation, the Administrator's final decision, and provide an 
explanation of the decision and any administrative actions taken by the 
WTC Health Program in response to the final decision. The Administrator 
declines to adopt a deadline for notification of a final appeal 
decision, as requested by public comment on the July 2011 IFR.\30\ 
Given the potentially complex nature of appeals decisions, the 
Administrator is concerned that limiting the amount of time available 
to the Federal Official and/or the Administrator to review the Program 
member's file (including any new information submitted) could result in 
undue burden and prevent a thorough review of the appeal.
---------------------------------------------------------------------------

    \30\ NIOSH Docket 235, CDC-2011-0009.
---------------------------------------------------------------------------

    Finally, for administrative clarity, the Administrator proposes 
striking existing paragraph (c), which allows the Administrator to 
reopen final decisions, and moving the text from this section to a new 
section Sec.  88.25.

Section 88.22 Reimbursement for Medical Treatment and Services

    A new Sec.  88.22 would comprise language formerly found in Sec.  
88.16. This section establishes how the WTC Health Program will 
reimburse or pay for the cost of monitoring, initial health 
evaluations, medical treatment, and outpatient prescription 
pharmaceuticals.
    The Administrator proposes to change the number of this existing 
section from Sec.  88.16 to Sec.  88.22, and to move provisions 
regarding travel expenses, unchanged, out of this section and into 
Sec.  88.2, General provisions (see above). The existing language would 
be rearranged slightly. Existing paragraph (c)(1) would be redesignated 
as paragraph (a) to clarify that each reimbursement or payment claim is 
reviewed by the WTC Health Program and that claims that cannot be 
validated will be further assessed by the Administrator. Paragraph 
(b)(1) would consolidate existing language about reimbursement for 
costs associated with initial health evaluations, medical monitoring, 
and medically necessary treatment, and also correct the reference to 
regulations implementing the Federal Employees Compensation Act (FECA), 
20 CFR part 10. New text in paragraph (b)(1)(ii) would clarify that 
treatment for which rates have not been established under either FECA 
or Medicare fee for service rate schedules, such as dental services, is 
reimbursed at rates set by the Administrator.\31\ Language would be 
added to paragraph (b)(2) to clarify that the Administrator may 
withhold reimbursement if the treatment is inconsistent with WTC Health 
Program protocols, pursuant to language in section 3312(c)(3) of the 
PHS Act.
---------------------------------------------------------------------------

    \31\ Rates for dental services are available in the Policy and 
Procedure Manual for the WTC Health Program, Jan. 1, 2015, Chapter 
4: Medical Benefits, Section 28: Medically Necessary Dental Care, 
http://www.cdc.gov/wtc/ppm.html.
---------------------------------------------------------------------------

    Paragraph (c) would include language from existing paragraph 
(a)(2). The term ``pharmaceutical providers'' would be replaced with 
``pharmaceutical benefit management services.''

Section 88.23 Appeal of Reimbursement Denial

    The Administrator has determined that the right of a CCE or NPN 
medical director or affiliated provider to appeal a WTC Health Program 
decision not to authorize reimbursement or payment for treatment should 
be included in Part 88 for clarity and completeness. This appeal right 
is established in section 3312(b)(3)(B) of the PHS Act, which calls on 
the Administrator to establish a

[[Page 55096]]

process for appeal of a determination under section 3312(c)(3). Section 
3312(c)(3) authorizes the WTC Health Program to withhold reimbursement 
or payment for treatment provided when it determines the treatment is 
not medically necessary or is not in accordance with medical treatment 
protocols.
    Accordingly, the Administrator proposes to establish an appeal 
process in Sec.  88.23 to allow the CCE or NPN medical director or 
affiliated provider to appeal such decisions where all contractual or 
procedural remedies have been exhausted. Appeals of WTC Health Program 
decisions to not authorize reimbursement or payment for treatment would 
be made in accordance with Program policies and procedures published on 
the Program Web site.

Section 88.24 Coordination of Benefits and Recoupment

    The Administrator proposes to add a new section to address the 
matter of coordination of benefits, including recoupment from workers' 
compensation settlements. Pursuant to section 3331 of the PHS Act, this 
section would explain that the WTC Health Program attempts to recover 
the costs associated with treatment, including pharmacy benefits, for a 
member's certified WTC-related health condition or medically associated 
health condition in certain situations. As directed by the Act, the WTC 
Health Program coordinates benefits with any workers' compensation 
insurance available \32\ for members' work-related \33\ conditions, and 
with any public or private health insurance available for members' non-
work-related conditions.
---------------------------------------------------------------------------

    \32\ To the extent that payment for treatment of the member's 
work-related condition has been made, or can reasonably be expected 
to be made, under any other work-related injury or illness benefit 
plan of the member's employer, the WTC Health Program will also 
attempt to recover the costs associated with treatment, including 
pharmacy benefits, for the member's certified WTC-related health 
condition or health condition medically associated with a WTC-
related health condition. See PHS Act, sec. 3331(b)(1). For purposes 
of this regulation, ``workers' compensation law or plan'' or 
``workers' compensation insurance'' includes any other work-related 
injury or illness benefit plan of the WTC Health Program member's 
employer.
    \33\ The term ``work-related'' is defined in sec. 3331(e) of the 
PHS Act to mean: ``(1) the condition is diagnosed in an enrolled WTC 
responder, or in an individual who qualifies as a certified-eligible 
WTC survivor on the basis of being a rescue, recovery, or cleanup 
worker; or (2) with respect to the condition the individual has 
filed and had [sic] established a claim under a workers' 
compensation law or plan of the United States or a State, or other 
work-related injury or illness benefit plan of the employer of such 
individual.''
---------------------------------------------------------------------------

    Proposed paragraph (a) would describe circumstances in which the 
WTC Health Program member is eligible for workers' compensation or 
another illness or injury benefit plan to which New York City is 
obligated to pay.
    Proposed paragraph (b) would describe circumstances in which the 
WTC Health Program member has filed a workers' compensation claim but 
the claim is still pending acceptance by the workers' compensation 
board.
    Proposed paragraph (c) would describe circumstances in which the 
WTC Health Program member has filed a workers' compensation claim but a 
final decision is issued denying coverage for medical treatment of the 
condition.
    Proposed paragraph (d) would describe circumstances in which the 
WTC Health Program member has filed a successful claim for a certified 
WTC-related health condition or medically associated health condition 
with a workers' compensation plan to which New York City is not 
obligated to pay. In this case, the WTC Health Program recoups costs 
for treatment from the workers' compensation insurer. As described in 
proposed paragraph (d)(1), if the WTC Health Program member settles the 
workers' compensation claim by entering into a settlement agreement 
that releases the employer or insurance carrier from paying for future 
medical care, the agreement must protect the WTC Health Program's 
interests regarding future medical expenses that might otherwise have 
been paid for by the workers' compensation insurance.\34\ If the WTC 
Health Program member has accepted a lump sum or other payment award 
for future medical care, the WTC Health Program may require the member 
to reimburse the Program for treatment services provided after receipt 
of the award. Proposed paragraph (d)(2) would also clarify that the WTC 
Health Program pays providers for treatment in accordance with the 
rates recognized under Sec.  88.22(b) of this part, but recoups at the 
worker's compensation rate, if lower than the WTC Health Program rates.
---------------------------------------------------------------------------

    \34\ Policy and Procedures for Recoupment: Lump-Sum Workers' 
Compensation Settlements, addressing the adequacy of settlement 
agreements to protect the WTC Health Program's interests, is found 
on the Program's Policies and Procedures Web page, at http://www.cdc.gov/wtc/policies.html.
---------------------------------------------------------------------------

    Proposed paragraph (e) would describe circumstances in which the 
WTC Health Program member's certified health condition is not work-
related and the member's public or private health insurance plan is the 
primary payer. In such cases, the WTC Health Program pays costs not 
reimbursed by the public or private health insurance plan due to the 
application of deductibles, co-payments, co-insurance, other cost 
sharing arrangements, or payment caps up to and in accordance with the 
rates described in Sec.  88.22(b) of this part.\35\
---------------------------------------------------------------------------

    \35\ PHS Act, sec. 3331(c)(1).
---------------------------------------------------------------------------

    Finally, proposed paragraph (f) would describe how the WTC Health 
Program handles situations that are not specifically covered by 
proposed paragraphs (a)-(e) described above and refers interested 
parties to the Program policies and procedures \36\ for further 
guidance.
---------------------------------------------------------------------------

    \36\ Policies and procedures describing recoupment and 
coordination of benefits are found on the WTC Health Program's Web 
site at http://www.cdc.gov/wtc/policies.html.
---------------------------------------------------------------------------

Section 88.25 Reopening of WTC Health Program Final Decisions

    As discussed above, the Administrator proposes the creation of a 
new section to clarify the Administrator's authority to reopen any 
final decisions made by the WTC Health Program, including those 
concerning enrollment, health condition certification, and appeals. At 
any time, and without regard to whether new evidence or information is 
provided or obtained, the Administrator may reopen a final decision and 
may affirm, vacate, or modify such decision, or take any other action 
he or she deems appropriate. Such reopenings may be necessary to 
address administrative errors or to incorporate or address changes in 
Program eligibility criteria, regulations, or policies and procedures. 
This authority is currently described in the two existing appeals 
sections, at Sec. Sec.  88.11(c) and 88.15(c); for clarity and to aid 
administrative decision-making, the Administrator intends to 
consolidate the authority into one section.

V. Regulatory Assessment Requirements

A. Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, and public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility.
    This proposed rule has been determined not to be a ``significant 
regulatory action'' under section 3(f) of Executive Order 12866. With 
this action, the Administrator is proposing

[[Page 55097]]

amendments to certain sections in 42 CFR part 88. Non-substantive 
amendments would include a reorganization of provisions from the 
existing Sec.  88.10 into new Sec. Sec.  88.11 and 88.12 and the 
addition of a new Sec.  88.15, List of WTC-Related Health Conditions. 
Reorganization of this part would necessitate the renumbering of 
existing Part 88 sections, which would be done throughout the 
regulatory text. The Administrator would also clarify throughout Part 
88 that deadlines are calculated in terms of calendar days. An 
amendment to the existing section regarding the physician's 
determination of WTC-related health conditions would clarify that the 
determination must be predicated upon the statutory requirements for a 
WTC-related health condition. Various other minor clarifications of WTC 
Health Program practice would be made throughout Part 88.
    New, substantive regulatory text would be added to Part 88 to 
define the term ``WTC Health Program member,'' codify an existing 
statutory appeal right for CCEs and NPN-affiliated providers, and 
codify existing WTC Health Program policies regarding the disenrollment 
of WTC Health Program members, decertification of certified WTC-related 
health conditions, and coordination of benefits.
    Amendments to the existing provision regarding the addition of 
health conditions to the List of WTC-Related Health Conditions would 
include the following: A valid petition must include the petitioner's 
signature; the statutory deadline for a response to a petition is 
extended from 60 to 90 calendar days and may be tolled while the 
Administrator seeks clarification from the interested party regarding 
the submission, if necessary; and the Administrator would not consider 
a submission to be a valid petition if it does not provide a new 
medical basis for the addition of the health condition and is received 
after the publication of a response in the Federal Register to a 
petition requesting the addition of the same health condition.
    Lastly, amendments to the existing certification and treatment 
authorization appeals section would codify existing WTC Health Program 
policy and also allow for an appeal of a Program decision to decertify 
a WTC-related health condition.
    This proposed rule does not result in substantial costs to the WTC 
Health Program, Program members, or stakeholders, nor does it raise any 
novel legal or policy issues. The Administrator finds that amendments 
to Sec.  88.14 and Sec.  88.21 (enrollment and medical appeals) and 
Sec.  88.16 (addition of health conditions) will result in necessary 
changes to several existing WTC Health Program policies; the proposed 
novel regulatory provisions in Sec.  88.13 (disenrollment), Sec.  88.19 
(decertification), and Sec.  88.23 (reimbursement appeals) will require 
the revision of existing policies or development of new policies.
    The Administrator estimates that amending the existing Policy and 
Procedures for Handling Submissions and Petitions to Add a Health 
Condition to the List of WTC-Related Health Conditions and the Web page 
containing frequently asked questions regarding appeals, and developing 
new disenrollment, decertification, and reimbursement appeal policies 
will require approximately 568 hours of staff time. Accordingly, this 
rulemaking is expected to cost the WTC Health Program approximately 
$42,742.
    This rule does not interfere with State, local, or Tribal 
governments in the exercise of their governmental functions.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
requires each agency to consider the potential impact of its 
regulations on small entities including small businesses, small 
governmental units, and small not-for-profit organizations. The 
Administrator certifies that this proposed rule has ``no significant 
economic impact upon a substantial number of small entities'' within 
the meaning of the RFA.

C. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an 
agency to invite public comment on, and to obtain OMB approval of, any 
regulation that requires 10 or more people to report information to the 
agency or to keep certain records. Data collection and recordkeeping 
requirements for the WTC Health Program are approved by OMB under 
``World Trade Center Health Program Enrollment, Appeals & 
Reimbursement'' (OMB Control No. 0920-0891, exp. September 30, 2018). 
HHS has determined that non-substantive changes may be needed to the 
information collection request already approved by OMB and that these 
revisions would not result in any change in respondent burden.

D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996, 5 U.S.C. 801 et seq., HHS will report 
the promulgation of this rule to Congress prior to its effective date.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 
et seq., directs agencies to assess the effects of Federal regulatory 
actions on State, local, and Tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this proposed rule does not include any 
Federal mandate that may result in increased annual expenditures in 
excess of $100 million in 1995 dollars by State, local, or Tribal 
governments in the aggregate, or by the private sector.

F. Executive Order 12988 (Civil Justice)

    This proposed rule has been drafted and reviewed in accordance with 
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly 
burden the Federal court system. This rule has been reviewed carefully 
to eliminate drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

    The Administrator has reviewed this proposed rule in accordance 
with Executive Order 13132 regarding Federalism, and has determined 
that it does not have ``Federalism implications.'' The rule does not 
``have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government.''

H. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, the Administrator has 
evaluated the environmental health and safety effects of this proposed 
rule on children. The Administrator has determined that the rule would 
have no environmental health and safety effect on children.

I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, the Administrator has 
evaluated the effects of this proposed rule on energy supply, 
distribution or use, and has determined that the rule will not have a 
significant adverse effect.

[[Page 55098]]

J. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to the public how to comply with a requirement the Federal 
government administers or enforces. The Administrator has attempted to 
use plain language in promulgating the proposed rule consistent with 
the Federal Plain Writing Act guidelines and requests public comment on 
this effort.

List of Subjects in 42 CFR Part 88

    Aerodigestive disorders, Appeal procedures, Health care, Mental 
health conditions, Musculoskeletal disorders, Respiratory and pulmonary 
diseases.

Proposed Rule

    For the reasons discussed in the preamble, the Administrator 
proposes to amend 42 CFR part 88 as follows:

PART 88--WORLD TRADE CENTER HEALTH PROGRAM

0
1. The authority citation for Part 88 is amended to read as follows:

    Authority: 42 U.S.C. 300mm to 300mm-61, Pub. L. 111-347, 124 
Stat. 3623, as amended by Pub. L. 114-113, 129 Stat. 2242.

0
2. In Sec.  88.1, revise the definitions ``Act'', ``Certification'', 
``Certified-eligible survivor'', ``Clinical Center of Excellence'', 
``List of World Trade Center (WTC)-related health conditions'', 
``Medically necessary treatment'', ``Nationwide provider network'', 
``World Trade Center (WTC) Health Program'', ``World Trade Center (WTC) 
Program Administrator'', ``World Trade Center (WTC)-related health 
condition'', and ``World Trade Center (WTC)-related musculoskeletal 
disorder'', and add ``World Trade Center (WTC) Health Program member'' 
and ``World Trade Center (WTC)-related acute traumatic injury'' to read 
as follows:


Sec.  88.1  Definitions.

    Act means Title XXXIII of the Public Health Service Act, as 
amended, 42 U.S.C. 300mm through 300mm-61 (codifying Title I of the 
James Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-
347, as amended by Pub. L. 114-113), which created the World Trade 
Center (WTC) Health Program.
* * * * *
    Certification means WTC Health Program review of a health condition 
in a particular WTC Health Program member for the purpose of 
identification and approval of a WTC-related health condition, as 
defined in this section and included on the List of WTC-Related Health 
Conditions in 42 CFR 88.15, or a health condition medically associated 
with a WTC-related health condition.
    Certified-eligible survivor means (1) an individual who has been 
identified as eligible for medical monitoring and treatment as of 
January 2, 2011; or (2) a screening-eligible survivor who is eligible 
for follow-up monitoring and treatment pursuant to Sec.  88.12(b).
    Clinical Center of Excellence (CCE) means a center or centers under 
contract with the WTC Health Program. A CCE:
    (1) Uses an integrated, centralized health care provider approach 
to create a comprehensive suite of health services that are accessible 
to enrolled WTC responders, screening-eligible survivors, or certified-
eligible survivors;
    (2) Has experience in caring for WTC responders and screening-
eligible survivors, or includes health care providers who have received 
WTC Health Program training;
    (3) Employs health care provider staff with expertise that 
includes, at a minimum, occupational medicine, environmental medicine, 
trauma-related psychiatry and psychology, and social services 
counseling; and
    (4) Meets such other requirements as specified by the Administrator 
of the WTC Health Program.
* * * * *
    List of WTC-Related Health Conditions means those conditions 
eligible for coverage in the WTC Health Program as identified in Sec.  
88.15 of this part.
* * * * *
    Medically necessary treatment means the provision of services to a 
WTC Health Program member by physicians and other health care 
providers, including diagnostic and laboratory tests, prescription 
drugs, inpatient and outpatient hospital services, and other care that 
is appropriate, to manage, ameliorate, or cure a WTC-related health 
condition or a health condition medically associated with a WTC-related 
health condition, and which conforms to medical treatment protocols 
developed by the Data Centers, with input from the Clinical Centers of 
Excellence, and approved by the Administrator of the WTC Health 
Program.
* * * * *
    Nationwide Provider Network (NPN) means a network of providers 
throughout the United States under contract with the WTC Health Program 
to provide an initial health evaluation, monitoring, and treatment to 
enrolled WTC responders, screening-eligible survivors, or certified-
eligible survivors who live outside the New York metropolitan area.
* * * * *
    World Trade Center (WTC) Health Program means the program 
established by Title XXXIII of the Public Health Service Act as 
amended, 42 U.S.C. 300mm to 300mm-61 (codifying Title I of the James 
Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-347, as 
amended by Pub. L. 114-113) to provide medical monitoring and treatment 
benefits for eligible responders to the September 11, 2001, terrorist 
attacks and initial health evaluation, monitoring, and treatment 
benefits for residents and other building occupants and area workers in 
New York City who were directly impacted and adversely affected by such 
attacks.
    World Trade Center (WTC) Health Program member means any responder, 
screening-eligible survivor, or certified-eligible survivor enrolled in 
the WTC Health Program.
    World Trade Center (WTC) Program Administrator (Administrator of 
the WTC Health Program, or Administrator) means, for the purposes of 
this part, the Director of the National Institute for Occupational 
Safety and Health, Centers for Disease Control and Prevention, 
Department of Health and Human Services, or his or her designee.
    World Trade Center (WTC)-related acute traumatic injury means the 
health condition eligible for coverage in the WTC Health Program as 
described in Sec.  88.15(e)(1) of this part.
    World Trade Center (WTC)-related health condition means an illness 
or health condition for which exposure to airborne toxins, any other 
hazard, or any other adverse condition resulting from the September 11, 
2001, terrorist attacks, based on an examination by a medical 
professional with expertise in treating or diagnosing the health 
conditions in the List of WTC-Related Health Conditions, is 
substantially likely to be a significant factor in aggravating, 
contributing to, or causing the illness or health condition, including 
a mental health condition. Only those conditions on the List of WTC-
Related Health Conditions codified in 42 CFR 88.15 may be considered 
WTC-related health conditions.
    World Trade Center (WTC)-related musculoskeletal disorder means the 
health condition eligible for coverage in the WTC Health Program as 
described in Sec.  88.15(c)(1) of this part.
* * * * *
0
3. Revise Sec.  88.2 to read as follows:

[[Page 55099]]

Sec.  88.2  General provisions.

    (a) Designated representative. (1) An applicant or WTC Health 
Program member may appoint one individual to represent his or her 
interests under the WTC Health Program. The appointment must be made in 
writing and consistent with all relevant Federal laws and regulations 
in order for the designated representative to receive personal health 
information.
    (2) There may be only one designated representative at any time. 
After one designated representative has been properly appointed, the 
WTC Health Program will not recognize another individual as the 
designated representative until the appointment of the previously 
designated representative is withdrawn in a signed writing.
    (3) A properly appointed designated representative who is 
recognized by the WTC Health Program may make a request or give 
direction to the WTC Health Program regarding the eligibility, 
certification, or any other administrative issue pertaining to the 
applicant or WTC Health Program member under the WTC Health Program, 
including appeals. Any notice requirement contained in this part or in 
the Act is fully satisfied if sent to the designated representative.
    (4) An applicant or WTC Health Program member may authorize any 
individual to represent him or her in regard to the WTC Health Program, 
unless that individual's service as a representative would violate any 
applicable provision of law (such as 18 U.S.C. 205 or 18 U.S.C. 208) or 
is otherwise prohibited by WTC Health Program policies and procedures 
or contract provisions.
    (5) A Federal employee may act as a representative only on behalf 
of the individuals specified in, and in the manner permitted by, 18 
U.S.C. 203 and 18 U.S.C. 205.
    (6) If a screening-eligible or certified-eligible survivor is a 
minor, a parent or guardian may act on his or her behalf.
    (b) Transportation and travel expenses. The Administrator of the 
WTC Health Program may provide for necessary and reasonable 
transportation and expenses incident to the securing of medically 
necessary treatment through the NPN, involving travel of more than 250 
miles.
0
4. Amend Sec.  88.4 to revise the section heading to read as follows:


Sec.  88.4   Eligibility criteria--WTC responders.

0
5. Amend Sec.  88.5 to revise the section heading to read as follows:


Sec.  88.5  Application process--WTC responders.

0
6. Revise Sec.  88.6 to read as follows:


Sec.  88.6   Enrollment decision--WTC responders.

    (a) The WTC Health Program will prioritize applications in the 
order in which they are received.
    (b) The WTC Health Program will decide if the applicant meets the 
eligibility criteria provided in Sec.  88.4 and notify the applicant in 
writing (or by email if an email address is provided by the applicant) 
of any deficiencies in the application or the supporting documentation.
    (c) Denial of enrollment. (1) The WTC Health Program will deny 
enrollment if the applicant fails to meet the applicable eligibility 
requirements.
    (2) The WTC Health Program may deny enrollment of a responder who 
is otherwise eligible and qualified if the Act's numerical limitations 
for newly enrolled responders have been met.
    (i) No more than 25,000 WTC responders, other than those enrolled 
pursuant to Sec. Sec.  88.3 and 88.4(a)(1)(ii), may be enrolled at any 
time. The Administrator of the WTC Health Program may decide, based on 
the best available evidence, that sufficient funds are available under 
the WTC Health Program Fund to provide treatment and monitoring only 
for individuals who are already enrolled as WTC responders at that 
time.
    (ii) [Reserved]
    (3) No individual who is determined to be a positive match to the 
terrorist watch list maintained by the Federal government may qualify 
to be enrolled or be determined to be eligible for the WTC Health 
Program.
    (d) Notification of enrollment decision. (1) Applicants who meet 
the current eligibility criteria for WTC responders in Sec.  88.4 and 
are qualified will be notified in writing by the WTC Health Program of 
the enrollment decision within 60 calendar days of the date of receipt 
of the application.
    (2) If the WTC Health Program decides that an applicant is denied 
enrollment, the applicant will be notified in writing and provided an 
explanation, as appropriate, for the decision to deny enrollment. The 
notification will inform the applicant of the right to appeal the 
initial denial of eligibility and provide instructions on how to file 
an appeal.
0
7. Amend Sec.  88.8 to revise the section heading to read as follows:


Sec.  88.8   Eligibility criteria--WTC survivors.

0
8. Amend Sec.  88.9 to revise the section heading to read as follows:


Sec.  88.9  Application process--WTC survivors.

0
9. Revise Sec. Sec.  88.10 through 88.18 to read as follows:


Sec.  88.10   Enrollment decision--screening-eligible survivors.

    (a) The WTC Health Program will decide if the applicant meets the 
screening-eligibility criteria pursuant to Sec.  88.8(a) and notify the 
applicant of the decision in writing within 60 calendar days of the 
date of receipt of the application. The applicant will be notified of 
any deficiencies in the application or the supporting documentation. 
The 60-day time period will not include any days during which the 
applicant is correcting deficiencies in the application or supporting 
documentation.
    (b) If the WTC Health Program decides that an applicant is denied 
enrollment, the applicant will be notified in writing and provided an 
explanation for the decision to deny enrollment. The notification will 
inform the applicant of the right to appeal the enrollment denial and 
provide instructions on how to file an appeal.
    (1) The WTC Health Program may deny screening-eligible survivor 
status if the applicant is ineligible under the criteria specified in 
Sec.  88.8(a).
    (2) The WTC Health Program may deny screening-eligible survivor 
status if the numerical limitation on certified-eligible survivors in 
Sec.  88.12(b)(3)(i) has been met.
    (3) No individual who is determined to be a positive match to the 
terrorist watch list maintained by the Federal government may qualify 
to be a screening-eligible survivor in the WTC Health Program.


Sec.  88.11  Initial health evaluation for screening-eligible 
survivors.

    (a) A CCE or NPN will provide the screening-eligible survivor an 
initial health evaluation to determine if the individual has a WTC-
related health condition.
    (b) The WTC Health Program will provide only one initial health 
evaluation per screening-eligible survivor. The individual may request 
additional health evaluations at his or her own expense.
    (c) If the physician determines that the screening-eligible 
survivor has a WTC-related health condition, the physician will 
promptly transmit to the WTC Health Program his or her determination, 
consistent with the requirements of Sec.  88.17(a).


Sec.  88.12  Enrollment decision--certified-eligible survivors.

    (a) The WTC Health Program will prioritize certification requests 
in the order in which they are received.
    (b) The WTC Health Program will review the physician's 
determination,

[[Page 55100]]

render a decision regarding certification of the individual's WTC-
related health condition, and notify the individual of the decision and 
the reason for the decision in writing, pursuant to Sec. Sec.  88.17 
and 88.18.
    (1) If the individual is a screening-eligible survivor and the 
individual's condition is certified as a WTC-related health condition, 
the individual will automatically receive the status of a certified-
eligible survivor.
    (2) If a screening-eligible survivor's condition is not certified 
as a WTC-related health condition pursuant to Sec. Sec.  88.17 and 
88.18, the WTC Health Program will deny certified-eligible status. The 
screening-eligible survivor may appeal the decision to deny 
certification, as provided under Sec.  88.21.
    (3) The WTC Health Program may deny certified-eligible survivor 
status of an otherwise eligible and qualified screening-eligible 
survivor if the Act's numerical limitations for certified-eligible 
survivors have been met.
    (i) No more than 25,000 individuals, other than those described in 
Sec.  88.7, may be determined to be certified-eligible survivors at any 
time. The Administrator of the WTC Health Program may decide, based on 
the best available evidence, that sufficient funds are available under 
the WTC Health Program Fund to provide treatment and monitoring only 
for individuals who have already been certified as certified-eligible 
survivors at that time.
    (ii) [Reserved]
    (4) No individual who is determined to be a positive match to the 
terrorist watch list maintained by the Federal government may qualify 
to be a certified-eligible survivor in the WTC Health Program.


Sec.  88.13  Disenrollment.

    (a) The disenrollment of a WTC Health Program member may be 
initiated by the WTC Health Program in the following circumstances:
    (1) The WTC Health Program mistakenly enrolled an individual under 
Sec.  88.4 (WTC responders) or Sec.  88.8 (screening-eligible 
survivors) who did not provide sufficient proof of eligibility 
consistent with the required eligibility criteria; or
    (2) The WTC Health Program member's enrollment was based on 
incorrect or fraudulent information.
    (b) The disenrollment of a WTC Health Program member may be 
initiated by the enrollee for any reason.
    (c) A disenrolled WTC Health Program member will be notified in 
writing by the WTC Health Program of a disenrollment decision, provided 
an explanation, as appropriate, for the decision, and provided 
information on how to appeal the decision. A disenrolled WTC Health 
Program member disenrolled pursuant to paragraph (a) may appeal the 
disenrollment decision in accordance with Sec.  88.14.
    (d) A disenrolled WTC Health Program member who has been 
disenrolled in accordance with paragraphs (a) or (b) of this section 
may seek to re-enroll in the WTC Health Program using the application 
and enrollment procedures, provided that the application is supported 
by new information.


Sec.  88.14  Appeal of enrollment or disenrollment decision.

    (a) An applicant denied WTC Health Program enrollment, a 
disenrolled WTC Health Program member, or the applicant's or member's 
designated representative (appointed pursuant to Sec.  88.2(a)) may 
appeal the enrollment denial or disenrollment decision.
    (b) Appeal request. (1) A letter requesting an appeal must be 
postmarked within 90 calendar days of the date of the letter from the 
Administrator notifying the denied applicant or disenrolled WTC Health 
Program member of the adverse decision. Electronic versions of a signed 
letter will be accepted if transmitted within 90 days of the date of 
the Administrator's notification letter.
    (2) A valid request for an appeal must:
    (i) Be made in writing and signed;
    (ii) Identify the denied applicant or disenrolled WTC Health 
Program member and designated representative (if applicable);
    (iii) Describe the decision being appealed and state the reasons 
why the denied applicant, disenrolled WTC Health Program member, or 
designated representative believes the enrollment denial or 
disenrollment was incorrect and should be reversed. The appeal request 
may include relevant new information not previously considered by the 
WTC Health Program; and
    (iv) Be sent to the WTC Health Program at the address specified in 
the notice of denial or disenrollment.
    (3) Where the denial or disenrollment is based on information from 
the terrorist watch list, the appeal will be forwarded to the 
appropriate Federal agency.
    (c) Appeal process. Upon receipt of a valid appeal, the 
Administrator will appoint a Federal Official independent of the WTC 
Health Program to review the case. The Federal Official will review all 
available records relevant to the WTC Health Program's decision not to 
enroll the applicant or to disenroll the WTC Health Program member, and 
assess whether the appeal should be granted. In conducting the review, 
the Federal Official's consideration will include the following: 
whether the WTC Health Program substantially complied with all relevant 
WTC Health Program policies and procedures; whether the information 
supporting the WTC Health Program's decision was factually accurate; 
and whether the WTC Health Program's decision was reasonable as applied 
to the facts of the case.
    (1) The Federal Official may consider additional relevant new 
information submitted by the denied applicant, disenrolled WTC Health 
Program member, or designated representative.
    (2) The Federal Official will provide his or her recommendation 
regarding the disposition of the appeal, including his or her findings 
and any supporting materials, to the Administrator.
    (d) Final decision and notification. The Administrator will review 
the Federal Official's recommendation and any relevant information and 
make a final decision on the appeal. The Administrator will notify the 
denied applicant or disenrolled WTC Health Program member and/or 
designated representative of the following in writing:
    (1) The recommendation and findings made by the Federal Official as 
a result of the review;
    (2) The Administrator's final decision on the appeal;
    (3) An explanation of the reason(s) for the Administrator's final 
decision on the appeal; and
    (4) Any administrative actions taken by the WTC Health Program in 
response to the Administrator's final decision.


Sec.  88.15  List of WTC-Related Health Conditions.

    WTC-related health conditions include the following disorders and 
conditions:
    (a) Aerodigestive disorders:
    (1) Interstitial lung diseases.
    (2) Chronic respiratory disorder--fumes/vapors.
    (3) Asthma.
    (4) Reactive airways dysfunction syndrome (RADS).
    (5) WTC-exacerbated and new-onset chronic obstructive pulmonary 
disease (COPD).
    (6) Chronic cough syndrome.
    (7) Upper airway hyperreactivity.
    (8) Chronic rhinosinusitis.
    (9) Chronic nasopharyngitis.
    (10) Chronic laryngitis.
    (11) Gastroesophageal reflux disorder (GERD).
    (12) Sleep apnea exacerbated by or related to a condition described 
in preceding paragraphs (1)-(11).

[[Page 55101]]

    (b) Mental health conditions.
    (1) Posttraumatic stress disorder (PTSD).
    (2) Major depressive disorder.
    (3) Panic disorder.
    (4) Generalized anxiety disorder.
    (5) Anxiety disorder (not otherwise specified).
    (6) Depression (not otherwise specified).
    (7) Acute stress disorder.
    (8) Dysthymic disorder.
    (9) Adjustment disorder.
    (10) Substance abuse.
    (c) Musculoskeletal disorders:
    (1) WTC-related musculoskeletal disorder is a chronic or recurrent 
disorder of the musculoskeletal system caused by heavy lifting or 
repetitive strain on the joints or musculoskeletal system occurring 
during rescue or recovery efforts in the New York City disaster area in 
the aftermath of the September 11, 2001, terrorist attacks. For a WTC 
responder who received any treatment for a WTC-related musculoskeletal 
disorder on or before September 11, 2003, such health condition 
includes:
    (i) Low back pain.
    (ii) Carpal tunnel syndrome (CTS).
    (iii) Other musculoskeletal disorders.
    (2) [Reserved].
    (d) Cancers:
    (1) Malignant neoplasms of the lip; tongue; salivary gland; floor 
of mouth; gum and other mouth; tonsil; oropharynx; hypopharynx; and 
other oral cavity and pharynx.
    (2) Malignant neoplasm of the nasopharynx.
    (3) Malignant neoplasms of the nose; nasal cavity; middle ear; and 
accessory sinuses.
    (4) Malignant neoplasm of the larynx.
    (5) Malignant neoplasm of the esophagus.
    (6) Malignant neoplasm of the stomach.
    (7) Malignant neoplasm of the colon and rectum.
    (8) Malignant neoplasm of the liver and intrahepatic bile duct.
    (9) Malignant neoplasms of the retroperitoneum and peritoneum; 
omentum; and mesentery.
    (10) Malignant neoplasms of the trachea; bronchus and lung; heart, 
mediastinum and pleura; and other ill-defined sites in the respiratory 
system and intrathoracic organs.
    (11) Mesothelioma.
    (12) Malignant neoplasms of the peripheral nerves and autonomic 
nervous system; and other connective and soft tissue.
    (13) Malignant neoplasms of the skin (melanoma and non-melanoma), 
including scrotal cancer.
    (14) Malignant neoplasm of the female breast.
    (15) Malignant neoplasm of the ovary.
    (16) Malignant neoplasm of the prostate.
    (17) Malignant neoplasm of the urinary bladder.
    (18) Malignant neoplasm of the kidney.
    (19) Malignant neoplasms of the renal pelvis, ureter, and other 
urinary organs.
    (20) Malignant neoplasms of the eye and orbit.
    (21) Malignant neoplasm of the thyroid.
    (22) Malignant neoplasms of the blood and lymphoid tissues 
(including, but not limited to, lymphoma, leukemia, and myeloma).
    (23) Childhood cancers: any type of cancer diagnosed in a person 
less than 20 years of age.
    (24) Rare cancers: any type of cancer \37\ that occurs in less than 
15 cases per 100,000 persons per year in the United States.
---------------------------------------------------------------------------

    \37\ Based on 2005-2009 average annual data age-adjusted to the 
2000 U.S. population. See Glenn Copeland, Andrew Lake, Rick Firth, 
et al. (eds), Cancer in North America: 2005-2009. Volume One: 
Combined Cancer Incidence for the United States, Canada and North 
America, Springfield, IL: North American Association of Central 
Cancer Registries, Inc., June 2012.
---------------------------------------------------------------------------

    (e) Acute traumatic injuries:
    (1) WTC-related acute traumatic injury is physical damage to the 
body caused by and occurring immediately after a one-time exposure to 
energy, such as heat, electricity, or impact from a crash or fall, 
resulting from a specific event or incident. For a WTC responder or 
screening-eligible or certified-eligible survivors who received any 
medical treatment for a WTC-related acute traumatic injury on or before 
September 11, 2003, such health condition includes:
    (i) Eye injury.
    (ii) Burn.
    (iii) Head trauma.
    (iv) Fracture.
    (v) Tendon tear.
    (vi) Complex sprain.
    (vii) Other similar acute traumatic injuries.
    (2) [Reserved]


Sec.  88.16   Addition of health conditions to the List of WTC-Related 
Health Conditions.

    (a) Any interested party may submit a request to the Administrator 
of the WTC Health Program to add a condition to the List of WTC-Related 
Health Conditions in Sec.  88.15. The Administrator will evaluate the 
submission to decide whether it is a valid petition.
    (1) Each valid petition must include the following:
    (i) An explicit statement of an intent to petition the 
Administrator to add a health condition to the List of WTC-Related 
Health Conditions;
    (ii) Name, contact information, and signature of the interested 
party petitioning for the addition;
    (iii) Name and/or description of the condition(s) to be added;
    (iv) Reasons for adding the condition(s), including the medical 
basis for the association between the September 11, 2001, terrorist 
attacks and the condition(s) to be added.
    (2) Not later than 90 calendar days after the receipt of a valid 
petition, the Administrator will take one of the following actions:
    (i) Request a recommendation of the WTC Health Program Scientific/
Technical Advisory Committee;
    (ii) Publish in the Federal Register a proposed rule to add such 
health condition;
    (iii) Publish in the Federal Register the Administrator's decision 
not to publish a proposed rule and the basis for that decision; or
    (iv) Publish in the Federal Register a decision that insufficient 
evidence exists to take action under paragraph (a)(2)(i) through (iii) 
of this section.
    (3) The 90-day time period will not include any days during which 
the Administrator is consulting with the interested party to clarify 
the submission.
    (4) The Administrator may consider more than one petition 
simultaneously when the petitions propose the addition of the same 
health condition. Scientific/Technical Advisory Committee 
recommendations and Federal Register notices initiated by the 
Administrator pursuant to paragraph (a)(2) of this section may respond 
to more than one petition.
    (5) The Administrator will be required to consider a submission for 
a health condition previously reviewed by the Administrator and found 
not to qualify for addition to the List of WTC-Related Health 
Conditions as a valid new petition only if the submission presents a 
new medical basis (i.e., a basis not previously reviewed) for the 
association between the September 11, 2001, terrorist attacks and the 
condition to be added. A submission that provides no new medical basis 
and is received after the publication of a response in the Federal 
Register to a petition requesting the addition of the same health 
condition will not be considered a valid petition and will not be 
answered in a Federal Register notice pursuant to paragraph (a)(2), 
above. The interested party will be informed of the WTC Health 
Program's decision in writing.

[[Page 55102]]

    (b) The Administrator may propose to add a condition to the List of 
WTC-Related Health Conditions in Sec.  88.15 of this part by publishing 
a proposed rule in the Federal Register and providing interested 
parties a period of 30 calendar days to submit written comments. The 
Administrator may extend the comment period for good cause.
    (1) If the Administrator requests a recommendation from the WTC 
Health Program Scientific/Technical Advisory Committee, the Advisory 
Committee will submit its recommendation to the Administrator no later 
than 90 calendar days after the date of the transmission of the request 
or no later than a date specified by the Administrator (but not more 
than 180 calendar days after the request). The Administrator will 
publish a proposed rule or a decision not to publish a proposed rule in 
the Federal Register no later than 90 calendar days after the date of 
transmission of the Advisory Committee recommendation.
    (2) Before issuing a final rule to add a health condition to the 
List of WTC-Related Health Conditions, the Administrator will provide 
for an independent peer review of the scientific and technical evidence 
that would be the basis for issuing such final rule.


Sec.  88.17   Physician's determination of WTC-related health 
conditions.

    (a) A physician affiliated with either a CCE or NPN will promptly 
transmit to the WTC Health Program a determination that a member's 
exposure to airborne toxins, any other hazard, or any other adverse 
condition resulting from the September 11, 2001, terrorist attacks is 
substantially likely to be a significant factor in aggravating, 
contributing to, or causing the illness or health condition, including 
a mental health condition. The transmission will also include the basis 
for such determination. The physician's determination will be made 
based on an assessment of the following:
    (1) The individual's exposure to airborne toxins, any other hazard, 
or any other adverse condition resulting from the September 11, 2001, 
terrorist attacks.
    (2) The type of symptoms experienced by the individual and the 
temporal sequence of those symptoms.
    (b) For a health condition medically associated with a WTC-related 
health condition, the physician's determination must contain 
information establishing how the health condition has resulted from 
treatment of a previously certified WTC-related health condition or how 
it has resulted from progression of the certified WTC-related health 
condition.


Sec.  88.18  Certification.

    (a) WTC-related health condition. The WTC Health Program will 
review each physician determination and render a decision regarding 
certification of the condition as a WTC-related health condition. The 
WTC Health Program will notify the WTC Health Program member of the 
decision and the reason for the decision in writing.
    (b) Health condition medically associated with a WTC-related health 
condition. The WTC Health Program will review each physician 
determination and render a decision regarding certification of the 
condition as a health condition medically associated with a WTC-related 
health condition. The WTC Health Program will notify the WTC Health 
Program member in writing of the decision and the reason for the 
decision within 60 calendar days after the date the physician's 
determination is received.
    (1) In the course of review, the WTC Health Program may seek a 
recommendation about certification from a physician panel with 
appropriate expertise for the condition.
    (2) [Reserved]
    (c) Appeal right. If certification of a condition as a WTC-related 
health condition or a health condition medically associated with a WTC-
related health condition is denied, the WTC Health Program member may 
appeal the WTC Health Program's decision to deny certification, as 
provided under Sec.  88.21.
0
10. Add Sec.  88.19 to read as follows:


Sec.  88.19  Decertification.

    (a) The decertification of a WTC Health Program member's certified 
WTC-related health condition or health condition medically associated 
with a WTC-related health condition may be initiated by the WTC Health 
Program in the following circumstances:
    (1) The WTC Health Program finds that the member's exposure is 
inadequate or is otherwise not covered;
    (2) The WTC Health Program finds that the member's certified WTC-
related health condition was certified in error or erroneously 
considered to have been aggravated, contributed to, or caused by 
exposure to airborne toxins, any other hazard, or any other adverse 
condition resulting from the September 11, 2001, terrorist attacks, 
pursuant to Sec.  88.17(a); or
    (3) The WTC Health Program finds that the member's health condition 
was erroneously determined to be medically associated with a WTC-
related health condition, pursuant to Sec.  88.17(b).
    (b) A WTC Health Program member will be notified in writing by the 
WTC Health Program of a decertification decision, provided an 
explanation, as appropriate, for the decision, and provided information 
on how to appeal the decision. A WTC Health Program member whose WTC-
related health condition or health condition medically associated with 
a WTC-related health condition is decertified may appeal the 
decertification decision in accordance with Sec.  88.21 of this part.
0
11. Add Sec.  88.20 to read as follows:


Sec.  88.20  Authorization of treatment.

    (a) Generally. Medically necessary treatment of certified WTC-
related health conditions and certified health conditions medically 
associated with WTC-related health conditions will be provided through 
the CCEs or the NPN as permitted under WTC Health Program treatment 
protocols and in accordance with all applicable WTC Health Program 
policies and procedures.
    (b) Standard for determining medical necessity. All treatment 
provided under the WTC Health Program will adhere to a standard which 
is reasonable and appropriate; based on scientific evidence, 
professional standards of care, expert opinion or any other relevant 
information; and which has been included in the medical treatment 
protocols developed by the Data Centers, with input from the CCEs, and 
approved by the Administrator of the WTC Health Program.
    (c) Treatment pending certification. While certification of a 
condition is pending, authorization for treatment of a WTC-related 
health condition or a health condition medically associated with a WTC-
related health condition must be obtained from the Administrator of the 
WTC Health Program before treatment is provided, except for the 
provision of treatment for a medical emergency.
0
12. Add Sec.  88.21 to read as follows:


Sec.  88.21   Appeal of certification, decertification, or treatment 
authorization decision.

    (a) A WTC Health Program member or the member's designated 
representative (appointed pursuant to Sec.  88.2(a)) may appeal the 
following four types of decisions made by the WTC Health Program:
    (1) To deny certification of a health condition as a WTC-related 
health condition;
    (2) To deny certification of a health condition as medically 
associated with a WTC-related health condition;

[[Page 55103]]

    (3) To decertify a WTC-related health condition or a health 
condition medically associated with a WTC-related health condition; or
    (4) To deny authorization of treatment for a certified health 
condition based on a finding that the treatment is not medically 
necessary.
    (b) Appeal request. (1) A letter requesting an appeal must be 
postmarked within 90 calendar days of the date of the letter from the 
Administrator of the WTC Health Program notifying the member of the 
adverse decision. Electronic versions of a signed letter will be 
accepted if transmitted within 90 days of the date of the 
Administrator's notification letter.
    (2) A valid request for an appeal must:
    (i) Be made in writing and signed;
    (ii) Identify the member and designated representative (if 
applicable);
    (iii) Describe the decision being appealed and the reason(s) why 
the member or designated representative believes the decision is 
incorrect and should be reversed. The description may include, but is 
not limited to, the following: scientific or medical information 
correcting factual errors that may have been submitted to the WTC 
Health Program by the CCE or NPN; information demonstrating that the 
WTC Health Program did not correctly follow or apply relevant WTC 
Health Program policies or procedures; or any information demonstrating 
that the WTC Health Program's decision was not reasonable given the 
facts of the case. The basis provided in the appeal request must be 
sufficiently detailed and supported by information to permit a review 
of the appeal. Any new information not previously considered by the WTC 
Health Program must be included with the appeal request, unless later 
requested by the WTC Health Program; and
    (iv) Be sent to the WTC Health Program at the address specified in 
the notice of denial.
    (3) The appeal request may also state an intent to make a 15-minute 
oral statement by telephone. The WTC Health Program member or 
designated representative will have a second opportunity to schedule an 
oral statement after being contacted by the WTC Health Program 
regarding the appeal.
    (c) Appeal process. Upon receipt of a valid appeal, the 
Administrator will appoint a Federal Official independent of the WTC 
Health Program to review the case. The Federal Official will review all 
available records relevant to the WTC Health Program's decision to deny 
certification of a health condition as a WTC-related health condition, 
deny certification of a health condition as medically associated with a 
WTC-related health condition, decertify the WTC-related health 
condition or health condition medically associated with a WTC-related 
health condition, or deny treatment authorization, and assess whether 
the appeal should be granted. The Federal Official's consideration will 
include the following: whether the WTC Health Program substantially 
complied with all relevant WTC Health Program policies and procedures; 
whether the information supporting the WTC Health Program's decision 
was factually accurate; and whether the WTC Health Program's decision 
was reasonable as applied to the facts of the case.
    (1) In conducting his or her review, the Federal Official will 
review the case record, including any oral statement made by the WTC 
Health Program member or the member's designated representative, as 
well as additional relevant new information submitted with the appeal 
request or provided by the WTC Health Program member or the member's 
designated representative at the request of the WTC Health Program.
    (2) The Federal Official may consult one or more qualified experts 
to review the WTC Health Program's decision and any additional 
information provided by the WTC Health Program member or the member's 
designated representative. The expert reviewer(s) will submit their 
findings to the Federal Official.
    (3) The Federal Official will provide his or her recommendation 
regarding the disposition of the appeal, including his or her findings 
and any supporting materials (including the transcript of any oral 
statement and any expert reviewers' findings), to the Administrator.
    (d) Final decision and notification. The Administrator will review 
the Federal Official's recommendation and any relevant information and 
make a final decision on the appeal. The Administrator will notify the 
WTC Health Program member and/or the member's designated representative 
of the following in writing:
    (1) The recommendation and findings made by the Federal Official as 
a result of the review;
    (2) The Administrator's final decision on the appeal;
    (3) An explanation of the reason(s) for the Administrator's final 
decision on the appeal; and
    (4) Any administrative actions taken by the WTC Health Program in 
response to the Administrator's final decision.
0
13. Add Sec.  88.22 to read as follows:


Sec.  88.22  Reimbursement for medical treatment and services.

    (a) Review of claims. Each claim for reimbursement for treatment 
will be reviewed by the WTC Health Program. Claims that cannot be 
validated by that process will be further assessed by the Administrator 
of the WTC Health Program.
    (b) Initial health evaluations, medical monitoring, and medically 
necessary treatment. (1) The costs incurred by a CCE or NPN-affiliated 
provider for providing a WTC Health Program member an initial health 
evaluation, medical monitoring, and/or medically necessary treatment or 
services for a WTC-related health condition or a health condition 
medically associated with a WTC-related health condition will be 
reimbursed according to the payment rates that apply to the provision 
of such treatment and services under the Federal Employees Compensation 
Act (FECA), 5 U.S.C. 8101 et seq., 20 CFR part 10.
    (i) The Administrator will reimburse a CCE or NPN-affiliated 
provider for treatment for which FECA rates have not been established 
pursuant to the applicable Medicare fee for service rate, as determined 
appropriate by the Administrator.
    (ii) The Administrator will reimburse a CCE or NPN-affiliated 
provider for treatment for which neither FECA nor Medicare fee for 
service rates have been established, at rates as determined appropriate 
by the Administrator.
    (2) If the treatment is determined not to be medically necessary or 
is inconsistent with WTC Health Program protocols, the Administrator 
will withhold reimbursement.
    (c) Outpatient prescription pharmaceuticals. Payment for costs of 
medically necessary outpatient prescription pharmaceuticals for a WTC-
related health condition or health condition medically associated with 
a WTC-related health condition will be reimbursed by the WTC Health 
Program under a contract with one or more pharmaceutical benefit 
management services.
0
14. Add Sec.  88.23 to read as follows:


Sec.  88.23  Appeal of reimbursement denial.

    Appeal of reimbursement denial. After exhausting procedural and/or 
contractual administrative remedies, a CCE or NPN medical director or 
affiliated provider may submit a written appeal of a WTC Health Program 
decision to withhold reimbursement or payment for treatment found to be 
not medically necessary or not in accordance with approved WTC Health 
Program medical treatment protocols

[[Page 55104]]

pursuant to Sec.  88.20 of this part. Appeal procedures are published 
on the WTC Health Program Web site.
0
15. Add Sec.  88.24 to read as follows:


Sec.  88.24  Coordination of benefits and recoupment.

    The WTC Health Program will attempt to recover the cost of payment 
for treatment, including pharmacy benefits, for a WTC Health Program 
member's certified WTC-related health condition or health condition 
medically associated with a WTC-related health condition by 
coordinating benefits with any workers' compensation insurance 
available \38\ for members' work-related health conditions, and with 
any public or private health insurance available \39\ for members' non-
work-related health conditions.
---------------------------------------------------------------------------

    \38\ As described in PHS Act, sec. 3331(b). To the extent that 
payment for treatment of the member's work-related condition has 
been made, or can reasonably be expected to be made, under any other 
work-related injury or illness benefit plan of the member's 
employer, the WTC Health Program will also attempt to recover the 
costs associated with treatment, including pharmacy benefits, for 
the member's certified WTC-related health condition or health 
condition medically associated with a WTC-related health condition. 
See PHS Act, sec. 3331(b)(1). For purposes of this regulation, 
``workers' compensation law or plan'' or ``workers' compensation 
insurance'' includes any other work-related injury or illness 
benefit plan of the WTC Health Program member's employer.
    \39\ As described in PHS Act, sec. 3331(c).
---------------------------------------------------------------------------

    (a) Where a WTC Health Program member's WTC-related health 
condition or health condition medically associated with a WTC-related 
health condition is eligible for workers' compensation or another 
illness or injury benefit plan to which New York City is obligated to 
pay, the WTC Health Program is the primary payer.
    (b) Where a WTC Health Program member has filed a workers' 
compensation claim for a WTC-related health condition or health 
condition medically associated with a WTC-related health condition and 
the claim is pending, the WTC Health Program is the primary payer; 
however, if the claim is ultimately accepted by the workers' 
compensation board, the workers' compensation insurer in question is 
responsible for reimbursing the WTC Health Program for any treatment 
provided and/or paid for during the pendency of the claim.
    (c) Where a WTC Health Program member has filed a workers' 
compensation claim for a WTC-related health condition or health 
condition medically associated with a WTC-related health condition, but 
a final decision is issued denying the compensation for the claim, the 
WTC Health Program is the primary payer.
    (d) Where a WTC Health Program member has filed a workers' 
compensation claim for a WTC-related health condition or health 
condition medically associated with a WTC-related health condition with 
a workers' compensation plan to which New York City is not obligated to 
pay, the workers' compensation insurer is the primary payer. The WTC 
Health Program is the secondary payer.
    (1) If a WTC Health Program member settles a workers' compensation 
claim by entering into a settlement agreement that releases the 
employer or insurance carrier from paying for future medical care, the 
settlement must protect the interests of the WTC Health Program. This 
may include setting aside adequate funds to pay for future medical 
expenses, as required by the WTC Health Program, which would otherwise 
have been paid by workers' compensation. In such situations, the WTC 
Health Program may require reimbursement for treatment services of a 
WTC-related health condition or health condition medically associated 
with a WTC-related health condition directly from the member.
    (2) The WTC Health Program will pay providers for treatment in 
accordance with Sec.  88.22(b); to the extent that the workers' 
compensation insurance pays for treatment at a lower rate, the WTC 
Health Program will recoup treatments costs at the workers' 
compensation insurance rate.
    (e) Where a WTC Health Program member's WTC-related health 
condition or health condition medically associated with a WTC-related 
health condition is not work-related, the WTC Health Program member's 
public or private health insurance plan is the primary payer. The WTC 
Health Program will pay costs not reimbursed by the public or private 
health insurance plan due to the application of deductibles, co-
payments, co-insurance, other cost sharing arrangements, or payment 
caps up to and in accordance with the rates described in Sec.  
88.22(b).
    (f) Any coordination of benefits or recoupment situation not 
described in paragraphs (a) through (e) of this section will be handled 
pursuant to WTC Health Program policies and procedures, as found on the 
WTC Health Program Web site.
0
16. Add Sec.  88.25 to read as follows:


Sec.  88.25  Reopening of WTC Health Program final decisions.

    At any time, and without regard to whether new evidence or 
information is provided or obtained, the Administrator of the WTC 
Health Program may reopen any final decision made by the WTC Health 
Program pursuant to the provisions of this part. The Administrator may 
affirm, vacate, or modify such decision, or take any other action he or 
she deems appropriate.

    Dated: July 27, 2016.
John Howard,
Administrator, World Trade Center Health Program and Director, National 
Institute for Occupational Safety and Health, Centers for Disease 
Control and Prevention, Department of Health and Human Services.

    Dated: July 27, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-18679 Filed 8-16-16; 8:45 am]
 BILLING CODE 4163-18-P