55086 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Proposed Rules

DEPARTMENT OF HEALTH AND without change to http:// amending some provisions in Part 88 HUMAN SERVICES www.regulations.gov. For detailed and adding others will benefit both the instructions on submitting public WTC Health Program and its members 42 CFR Part 88 comments, see the ‘‘Public by clarifying requirements and [Docket No. CDC–2016–0072; NIOSH–291] Participation’’ heading of the improving administrative processes. SUPPLEMENTARY INFORMATION section of B. Summary of Major Provisions RIN 0920–AA56 this document. Docket: For access to the docket to Although the Administrator proposes World Trade Center Health Program; read background documents, go to to amend a number of existing sections Amendments to Definitions, Appeals, http://www.regulations.gov. in part 88, many of the changes would and Other Requirements be non-substantive. Some existing FOR FURTHER INFORMATION CONTACT: language would be moved into new AGENCY: Centers for Disease Control and Rachel Weiss, Program Analyst; 1090 Prevention, HHS. Tusculum Ave, MS: C–46, Cincinnati, sections for clarity. Substantive amendments would be made to the ACTION: Notice of proposed rulemaking. OH 45226; telephone (855) 818–1629 (this is a toll-free number); email following existing provisions: • § 88.11 Appeals regarding SUMMARY: In 2011 and 2012, the [email protected]. Secretary, Department of Health and eligibility determinations—responders SUPPLEMENTARY INFORMATION: This and survivors—this section would be Human Services (HHS), promulgated preamble is organized as follows: regulations designed to govern the amended to clarify appeal procedures World Trade Center (WTC) Health I. Executive Summary and to allow the Administrator to make Program (Program), including the A. Purpose of Regulatory Action a final decision on the appeal. B. Summary of Major Provisions • processes by which eligible responders § 88.15 Appeals regarding C. Costs treatment—this section would be and survivors may apply for enrollment II. Public Participation in the Program, obtain health significantly modified to clarify the III. Background appeal process, including allowing a monitoring and treatment for WTC- A. History and Scope of Rulemaking related health conditions, and appeal B. WTC Health Program Statutory WTC Health Program member or his/her enrollment and treatment decisions, as Authority designated representative to submit new well as a process to add new conditions IV. Summary of Proposed Rule evidence in support of the appeal and to the List of WTC-Related Health V. Regulatory Assessment Requirements make an oral statement to the Federal Conditions. After using the regulations A. Executive Order 12866 and Executive Official reviewing the case, and allow Order 13563 the Administrator to make a final for a number of years, the Administrator B. Regulatory Flexibility Act of the WTC Health Program has decision on the appeal. C. Paperwork Reduction Act • § 88.17 Addition of health identified potential improvements to D. Small Business Regulatory Enforcement conditions to the list of WTC-related certain existing provisions, including, Fairness Act health conditions—this section would but not limited to, appeals of E. Unfunded Mandates Reform Act of 1995 be amended to extend the deadline for enrollment, certification, and treatment F. Executive Order 12988 (Civil Justice) the Administrator’s response to a decisions, as well as the procedures for G. Executive Order 13132 (Federalism) petition for the addition of a health the addition of health conditions for H. Executive Order 13045 (Protection of condition from 60 to 90 calendar days, WTC Health Program coverage. He has Children From Environmental Health Risks and Safety Risks) consistent with current law. Another also identified the need to add new I. Executive Order 13211 (Actions amendment to this section would allow regulatory provisions, including, but not Concerning Regulations That the Administrator to consider a petition limited to, standards for the Significantly Affect Energy Supply, to be invalid if it presents the same disenrollment of a WTC Health Program Distribution, or Use) scientific evidence supporting the member and decertification of a J. Plain Writing Act of 2010 addition of the health condition that certified WTC-related health condition. I. Executive Summary was previously considered by the DATES: The Administrator of the WTC Administrator in a response published A. Purpose of Regulatory Action Health Program invites comment on this in the Federal Register. proposed rule from interested parties. The Secretary, HHS, promulgated New language on the following topics Comments must be received by regulations designed to implement the would be added to Part 88: September 16, 2016. WTC Health Program in a 2011 interim • Disenrollment—this new section ADDRESSES: Interested parties may final rule establishing Part 88 in Title 42 would describe the WTC Health submit comments by any of the of the Code of Federal Regulations,1 and Program’s procedures for disenrolling a following methods: in a 2012 final rule adding procedures Program member and the circumstances • Federal eRulemaking Portal: http:// for the submission of petitions to add under which disenrollment would be www.regulations.gov. Follow the health conditions for Program applicable. instructions for submitting comments. coverage.2 These regulations in 42 CFR • Decertification—this new section • Mail: NIOSH Docket Office, 1090 part 88 include the processes by which would describe the WTC Health Tusculum Avenue, MS C–34, eligible responders and survivors may Program’s ability to decertify a WTC- Cincinnati, OH 45226–1998. apply for enrollment in the WTC Health related health condition or health Instructions: All submissions received Program, obtain health monitoring and condition medically associated with a should include the agency name treatment for WTC-related health WTC-related health condition and the (Centers for Disease Control and conditions, and appeal enrollment and circumstances under which Prevention, HHS) and docket number treatment decisions. The Administrator decertification would be applicable. (CDC–2016–0072; NIOSH–291) or of the WTC Health Program • Appeal of reimbursement denial— Regulation Identifier Number (0920– (Administrator) has determined that this new section would clarify the AA56) for this rulemaking. All relevant statutory appeal right for Program comments, including any personal 1 76 FR 38914 (July 1, 2011). medical providers in cases in which the information provided, will be posted 2 77 FR 24628 (Apr. 25, 2012). WTC Health Program has denied

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reimbursement for treatment found not 38914). Provisions established in Part 88 This NPRM and all of the interim to be medically necessary. include the following: WTC Health final rules described above,3 as well as • Coordination of benefits and Program definitions; general provisions; any public comments to any of the recoupment—this new section would be eligibility and application requirements interim final rules not addressed in this added to reflect the statutory for WTC responders and screening- and NPRM, will be addressed in a final rule. requirement that payment for treatment, certified-eligible survivors; initial health B. WTC Health Program Statutory including pharmaceuticals, must be evaluations for screening-eligible Authority reduced or recouped as appropriate survivors; enrollment, certification, and when the WTC Health Program finds treatment appeals; physician Title I of the James Zadroga 9/11 that payment has been made by determinations; the process for Health and Compensation Act of 2010 workers’ compensation, public, or certifying WTC-related health (Pub. L. 111–347, as amended by Pub. private health insurance. conditions; the medical necessity L. 114–113), added Title XXXIII to the C. Costs standard; and reimbursement for health Public Health Service Act (PHS Act), care providers. establishing the WTC Health Program This rulemaking is expected to result A section describing the process for within HHS. The WTC Health Program in approximately $42,742 in costs to the adding new health conditions to the List provides medical monitoring and WTC Health Program associated with of WTC-Related Health Conditions (List) treatment benefits to eligible firefighters updating existing Program policies and and related personnel, law enforcement developing new policies in accordance was finalized on April 25, 2012 (77 FR 24628). officers, and rescue, recovery, and with amendments proposed in this cleanup workers who responded to the action. Regulations establishing the eligibility criteria for Shanksville, Pennsylvania September 11, 2001, terrorist attacks in II. Public Participation and Pentagon responders were New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), Interested persons or organizations established in an interim final rule and to eligible persons who were are invited to participate in this published on March 28, 2013 (78 FR present in the dust or dust cloud on rulemaking by submitting written views, 18855). September 11, 2001, or who worked, opinions, recommendations, and/or Certain types of cancer, including rare resided, or attended school, childcare, data. Comments are invited on any topic cancers and childhood cancers, were related to this proposed rule. Comments or adult daycare in the New York City added to the List in a September 12, disaster area (survivors). received, including attachments and 2012 final rule (77 FR 56138). Another other supporting materials, are part of All references to the Administrator of cancer rulemaking, adding prostate the WTC Health Program the public record and subject to public cancer to the List, was finalized on disclosure. Any information in the (Administrator) in this notice mean the September 19, 2013 (78 FR 57505). An WTC Program Administrator, the comment or supporting materials IFR was published on February 18, 2014 considered confidential or inappropriate Director of NIOSH, or his or her (February 2014 IFR) to clarify the designee. Section 3301(j) of the PHS Act for public disclosure should not be definition of ‘‘childhood cancers’’ and included. authorizes the Administrator to revise the definition of ‘‘rare cancers’’ promulgate such regulations as are Comments submitted electronically or (79 FR 9100). As a result of this IFR, by mail should be titled ‘‘Docket No. necessary to administer the WTC Health cancers of the brain, the pancreas, and Program. CDC–2016–0072’’ and should identify the testes, and invasive cervical cancer the author(s) and contact information in are also considered covered conditions. IV. Summary of Proposed Rule case clarification is needed. Electronic Finally, on September 11, 2015, a and written comments can be submitted The Administrator finds it necessary notice of proposed rulemaking (NPRM) to the addresses provided in the to amend certain existing sections of 42 was published proposing the addition of ADDRESSES section, above. All CFR part 88, to rearrange others, and to new-onset chronic obstructive communications received on or before add new sections. The rationales for pulmonary disease (COPD) and WTC- the closing date for comments will be each proposed amendment are offered related acute traumatic injury to the List fully considered by the Administrator of below, along with summaries of the (80 FR 54746). A final rule adding the the WTC Health Program. proposed rule text. This action answers two health conditions to the List was only those public comments relevant to III. Background published on July 5, 2016 (81 FR the provisions that the Administrator is This action proposes to amend certain 43510). proposing to amend in this action. regulatory provisions established in Part Regulatory text promulgated through The Administrator proposes to amend 88 of Title 42 of the Code of Federal an IFR, such as Part 88, is effective prior the title of certain Part 88 sections Regulations and add new provisions to to the consideration of public comments referenced below; the new titles used in the part. and may be amended just as if it had the preamble correspond with the been promulgated by normal notice- proposed regulatory text found at the A. History and Scope of Rulemaking and-comment rulemaking. In this end of this document. On July 1, 2011, HHS published an proposed rule, the Administrator The table below matches the proposed interim final rule (July 2011 IFR) to proposes amendments to certain reorganization of Part 88 with the establish Part 88 in Title 42 of the Code sections of Part 88, responds to public originating sections in the existing of Federal Regulations and implement comments on those sections received in regulation. No changes are proposed to the WTC Health Program as response to the July 2011 IFR and the §§ 88.3 and 88.7; although they are administered by the Director of the February 2014 IFR, and seeks public included in the table for completeness, National Institute for Occupational comment on the amendments proposed they are not referenced again in this Safety and Health (NIOSH) (76 FR in this notice. notice. The regulatory text with

3 These include the July 2011 IFR (establishing Shanksville and Pentagon responders), and the ‘‘childhood cancers’’ and revising the definition of Part 88 and implementing the Program), the March February 2014 IFR (clarifying the definition of ‘‘rare cancers’’). 2013 IFR (establishing eligibility criteria for

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

PROPOSED REORGANIZATION AND SECTION TITLE AMENDMENTS

Proposed section Originating section

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

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

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Related Health Conditions’’ would be Health Program documents. This non- Program in writing, signed by the capitalized to reflect common usage by substantive amendment to the existing applicant or member and either the Program. Furthermore, the definition would allow the use of the submitted in hard copy or scanned and Administrator proposes to move the List identical terms ‘‘Administrator of the submitted electronically, of the intent to from the § 88.1 Definitions section to a WTC Health Program’’ and withdraw the previous representative new § 88.15. The definition of ‘‘List of ‘‘Administrator.’’ and name a new one. Accordingly, the Administrator proposes to amend WTC-related health conditions’’ would World Trade Center (WTC)-Related paragraph (a)(2) of this section to clarify be replaced in the § 88.1 Definitions Acute Traumatic Injury section with a marker to point the that a designated representative must be reader to the new § 88.15. The Administrator proposes to add withdrawn in writing. Paragraph (a)(3) ‘‘WTC-related acute traumatic injury’’ to would be amended to clarify that the Medically Necessary Treatment direct the reader to the List of WTC- designated representative may represent The Administrator proposes to amend Related Health Conditions in 42 CFR the WTC Health Program member on the existing definition of ‘‘medically 88.15. any other administrative matter, in necessary treatment’’ to add the term World Trade Center (WTC)-Related addition to eligibility and certification ‘‘WTC Health Program members’’ to Health Condition matters. Paragraph (a)(4) would be clarify that the standard applies to the amended to indicate that an applicant or provision of health care services to a ‘‘World Trade Center (WTC)-related Program member may designate a particular member. The definition health condition’’ would be amended to representative unless that individual’s would also be amended to indicate that clarify that WTC-related health service is prohibited by law, WTC the medical treatment protocols are also conditions are those that are found in Health Program policies and developed with input from the CCEs. the WTC Health Program regulations. procedures, or contract provisions. This language would be added to reflect The Administrator has added new Finally, because of proposed the language in section 3305(a)(2)(A)(vi) health conditions to the statutory list, amendments to existing § 88.16, the found in sections 3312 and 3322 of the Administrator would move provisions of the PHS Act. 5 PHS Act, through rulemaking; the regarding reimbursement for Nationwide Provider Network expanded List is currently codified in transportation and travel expenses into The existing definition of § 88.1 of Part 88. Because the reserved paragraph (b). ‘‘Nationwide provider network’’ would Administrator is proposing to move the be slightly amended to capitalize the List from § 88.1 to § 88.15, amendments Section 88.4 Eligibility Criteria—WTC name Nationwide Provider Network and to this definition would direct the Responders include the acronym ‘‘NPN.’’ reader to its location. This section title would be amended from ‘‘Eligibility criteria—status as a World Trade Center (WTC) Health World Trade Center (WTC)-Related Musculoskeletal Disorder WTC responder’’ to the title above, for Program clarity. The Administrator proposes to amend The Administrator proposes to amend the existing definition of ‘‘World Trade the existing definition of ‘‘WTC-related Section 88.5 Application Process— Center (WTC) Health Program’’ to musculoskeletal disorder’’ to direct the WTC Responders update the reference to the authorizing reader to the List of WTC-Related Health This section title would be amended statute, Title XXXIII of the Public Health Conditions in 42 CFR 88.15. from ‘‘Application process—status as a Service Act as amended, 42 U.S.C. Section 88.2 General Provisions WTC responder’’ to the title above, for clarity. 300mm to 300mm-61 (codifying Title I This existing section establishes the of the James Zadroga 9/11 Health and appointment process for an applicant’s Section 88.6 Enrollment Decision— Compensation Act of 2010, Pub. L. 111– or WTC Health Program member’s WTC Responders 347, as amended by Pub. L. 114–113). designated representative and the This section title would be amended World Trade Center (WTC) Health parameters of the representative’s from ‘‘Enrollment determination—status Program Member authority. In response to public as a WTC responder’’ to the title above, comments submitted to the July 2011 for clarity. The Administrator also finds The Administrator proposes to add a 6 new definition for the term ‘‘World IFR docket regarding this section, the that the term ‘‘determination’’ or Trade Center (WTC) Health Program Administrator declines to amend this ‘‘determine’’ should be replaced with member.’’ This term is often used in section to add ‘‘organization’’ to the ‘‘decision’’ or ‘‘decide’’ in this section Program publications and refers types of eligible representatives in and throughout Part 88 where the text generally to any responder, screening- paragraph (a) or to allow the designation refers to a WTC Health Program action. eligible survivor, or certified-eligible of an alternate representative. Only one Although these terms were used survivor enrolled in the WTC Health individual at a time is permitted to be interchangeably in the July 2011 IFR, Program. The phrase ‘‘responder, the designated representative; if the the word ‘‘determination’’ is used in the screening-eligible survivor, or certified- applicant or member wishes to select a Program to describe the finding made by eligible survivor’’ is replaced with different representative, he or she may a CCE or NPN physician that a ‘‘WTC Health Program member’’ as do so by notifying the WTC Health member’s diagnosed health condition appropriate in this Part. meets the PHS Act standards to be 5 See final rule, 77 FR 56138 (Sept. 12, 2012) considered a WTC-related health (adding certain types of cancer); final rule, 78 FR World Trade Center (WTC) Program condition or a health condition Administrator 57505 (Sept. 19, 2013) (adding prostate cancer); interim final rule, 79 FR 9100 (Feb. 18, 2014) medically-associated with a WTC- The Administrator proposes to amend (clarifying the definition of ‘‘childhood cancers’’ related health condition; such the existing definition of ‘‘WTC Program and revising the definition of ‘‘rare cancers’’); and determination is submitted to the final rule, 81 FR 43510 (July 5, 2016) (adding new- Administrator’’ to clarify the title and to onset chronic obstructive pulmonary disease and Administrator for a certification allow flexibility in how the WTC-related acute traumatic injury). decision (see § 88.18). Finally, language Administrator is addressed in WTC 6 NIOSH Docket 235, CDC–2011–0009. in existing paragraph (c)(2)(i) and

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(c)(2)(i)(A) would be consolidated into (f), and (g), described below, would be propose any substantive changes to this one paragraph at (c)(2)(i). removed to a new § 88.12. text. Section 88.8 Eligibility Criteria—WTC Section 88.11 Initial Health Evaluation Section 88.13 Disenrollment Survivors for Screening-Eligible Survivors The Administrator proposes to add a This section title would be amended A new § 88.11 comprises language new section to Part 88 to clarify the from ‘‘Eligibility criteria—status as a formerly found in § 88.10(d). Minor process for disenrolling a member from WTC survivor’’ to the title above, for amendments to this new section would the WTC Health Program. To date, only clarity. include replacing ‘‘diagnoses’’ with 12 enrolled members have been found ‘‘determines’’ to align the rule text with to have been wrongly enrolled due to Section 88.9 Application Process— terms commonly used by the WTC Program error or inaccurate eligibility WTC Survivors Health Program. information. Allowing individuals who This section title would be amended In response to public comments do not meet WTC Health Program from ‘‘Application process—status as a submitted to the July 2011 IFR docket enrollment eligibility criteria to stay in WTC survivor’’ to the title above, for regarding these provisions,7 the the Program may result in those clarity. Administrator declines to allow a individuals improperly receiving screening-eligible survivor to obtain an medical benefits. Moreover, individuals Section 88.10 Enrollment Decision— additional health evaluation at no cost who are erroneously enrolled may fill Screening-Eligible Survivors the statutory limits on the number of or to specify that the cost of an WTC responders and certified-eligible The Administrator proposes to additional evaluation would be the survivors enrolled in the WTC Health simplify the existing provisions in same as is paid by the WTC Health Program,8 thereby preventing qualified § 88.10, titled ‘‘Enrollment Program. The Administrator is individuals from enrolling. determination—status as a WTC constrained by section 3321(b)(3) of the Pursuant to this section, a WTC survivor,’’ by splitting the section into PHS Act, which explicitly limits Health Program member enrolled three separate sections: Enrollment screening-eligible survivors to a single pursuant to § 88.4 or § 88.8 may be decision—screening-eligible survivors; initial health evaluation at no cost. The disenrolled if the member did not initial health evaluation for screening- member could request more than one provide sufficient proof of eligibility eligible survivors; and enrollment health evaluation, but the Administrator and was mistakenly enrolled in the decision—certified-eligible survivors. has no legal obligation or authority to Program, or the member’s location, The screening-eligible survivor status pay for subsequent health evaluations. activities, and/or duration are decision provisions would remain in The Administrator does not propose any inconsistent with the eligibility criteria § 88.10; the initial health evaluation substantive changes to this text. for newly enrolled WTC responders or provisions would be moved into a new Section 88.12 Enrollment Decision— screening-eligible survivors; § 88.11, and the certified-eligible Certified-Eligible Survivors additionally, a member may be survivor status provisions would be disenrolled if his or her enrollment was moved into a new § 88.12. A new § 88.12 would comprise the based on inaccurate or fraudulent For the reasons discussed above, the former § 88.10(e), describing information. A member may be Administrator proposes to amend the certification determinations; § 88.10(f), disenrolled following a periodic audit title of this existing section from describing denials of certification; and conducted by the Program to ensure that ‘‘Enrollment determination—status as a § 88.10(g), describing notification of the enrollment decisions are proper or WTC survivor’’ to ‘‘Enrollment certified-eligible survivor status when the Program is made aware of new decision—screening-eligible survivors.’’ decision. The new title would clarify information that would impact the The new title would clarify that that enrollment ‘‘decisions’’ are made by enrollment decision. A member could enrollment ‘‘decisions’’ are made by the the WTC Health Program, to avoid also choose to disenroll from the WTC Health Program, to avoid confusion with ‘‘determinations’’ made Program at his or her own discretion. confusion with ‘‘determinations’’ made by CCE or NPN physicians regarding a A member who has been disenrolled by CCE and NPN physicians regarding member’s health condition. Proposed from the WTC Health Program would be a member’s health condition. amendments to this new section would notified in writing of the disenrollment Amendments to this section would include removing redundant language decision and given the opportunity to retain and combine the substance of and clarifying certification status appeal that decision, within 90 days of existing paragraphs (a), (b), and (c) into language. Existing language in § 88.10(e) the date of the Administrator’s new paragraphs (a) and (b). Proposed states that ‘‘[i]f the individual’s notification letter, in accordance with revisions to the language concerning the condition is certified as a WTC-related § 88.14. Finally, a member who is 60-day deadline for the WTC Health health condition, the individual will disenrolled may reapply for enrollment Program’s decision would clarify that also be certified as a certified-eligible in the WTC Health Program if new the date would be calculated in calendar survivor.’’ The use of ‘‘also’’ may information is available to support the days and extend the notification incorrectly suggest the WTC Health application. deadline to be no later than 60 days of Program member retains two statuses, as receipt of the application, rather than both a screening-eligible and a certified- Section 88.14 Appeal of Enrollment or the date of transmission of the eligible survivor, simultaneously. Disenrollment Decision application, which can be difficult to Amendments would clarify that if the This section establishes procedures determine. The 60-day notification Program member’s condition is certified for the appeal of a WTC Health Program deadline would be tolled while the as a WTC-related health condition, the decision to deny enrollment to an applicant is correcting deficiencies in member’s status will automatically applicant or disenroll a Program the application or supporting change to that of a certified-eligible member. The Administrator proposes to documents. Existing paragraph (d), survivor. The Administrator does not amend the section heading from described below, would be removed to a new § 88.11. Existing paragraphs (e), 7 NIOSH Docket 235, CDC–2011–0009. 8 See PHS Act, secs. 3311(a)(4) and 3321(a)(3).

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‘‘Appeals regarding eligibility action was incorrect and should be proposes to capitalize the section title as determinations—responders and reversed. As currently permitted, the well as the name ‘‘List of WTC-Related survivors’’ to ‘‘Appeal of enrollment or appeal request may include relevant Health Conditions,’’ as it appears disenrollment decision,’’ to provide new information not previously throughout Part 88, to reflect the greater clarity. considered by the Program. Existing terminology commonly used in most The Administrator has identified the paragraph (c), which allows the Program publications. The health need to make substantive amendments Administrator to reopen and reconsider conditions that would be included in to this existing section due to other an enrollment denial, would be this new section are the same health proposed revisions in this notice and in removed from this section and placed in conditions named in the definition, response to public comment on the July a new section, § 88.25 described below, ‘‘List of WTC-related health conditions’’ 2011 IFR.9 Commenters asserted that the regarding reopenings generally. A new currently found in § 88.1. The reference existing 60-day deadline for filing an paragraph (c) would describe the appeal to ‘‘interstitial lung disease’’ in appeal of an enrollment denial is too process, which would consist of the paragraph (a)(1) should be plural and short and requested that applicants be appointment of a Federal Official, who would be corrected in this action, the given from 180 days to a year to file an will be an HHS employee independent reference to ‘‘upper airway appeal. The Administrator agrees that of the WTC Health Program, to review hyperreactivity’’ in paragraph (a)(7) is the current requirement that an the case and submit a recommendation misspelled in the current regulation and applicant file an appeal within 60 days to the Administrator. would be corrected in this action, and of the date on the notification letter Finally, a new paragraph (d) would the acronym ‘‘PTSD’’ would be added to explaining the enrollment denial may change the existing appeal process to the existing WTC-related health not provide enough time for the result in the Federal Official making a condition, ‘‘Posttraumatic stress applicant to gather necessary recommendation to the Administrator, disorder’’ in (b)(1). documentation or other information for who would then make a final decision The definition of ‘‘WTC-related the appeal. Therefore, the Administrator on the appeal. This paragraph would musculoskeletal disorder,’’ also proposes amendments to this section to also clarify that the Administrator will currently found in § 88.1, would be permit consideration of a denied share the results of the Federal Official’s incorporated into paragraph (c) of the applicant’s appeal letter that is review and any administrative actions new § 88.15. No other substantive postmarked 10 within 90 calendar days taken by the WTC Health Program with changes to the rule text regarding the of the date of the Administrator’s denial the denied applicant, disenrolled List are proposed. Program member, or designated notification letter. The Administrator In response to the July 2011 IFR, one representative who filed the appeal. The similarly finds that allowing 90 days for commenter requested that Administrator declines to offer a submission of an appeal request ‘musculoskeletal disorders’ be available deadline for the final decision on an subsequent to a disenrollment of a to survivors for certification.13 The PHS enrollment appeal, as requested by Program member should allow ample 11 Act limits the coverage of time for a disenrolled Program member public comment on the July 2011 IFR. Given the potentially complex nature of musculoskeletal disorders to responders to gather any necessary information. to the terrorist attacks in New York City. However, the Administrator requests appeals decisions, the Administrator is concerned that limiting the amount of The same commenter requested the further public comment on the addition of ‘‘developmental disorders appropriateness of allowing 90 days for time available to the Federal Official and/or the Administrator to review the and any disorder linked specifically to appeal of a disenrollment decision. children’s WTC exposures, including The Administrator also proposes to denied applicant’s or disenrolled Program member’s file (including any those that occurred in utero.’’ amend this section to recognize appeals Individuals who were children at the of a WTC Health Program decision to new information submitted) could result in undue burden on the Federal Official time of the terrorist attacks may be disenroll a Program member, as considered survivors if they meet the described in the proposed new and/or Program staff and not allow for a thorough review of the appeal. In the eligibility criteria for screening- or disenrollment provisions in § 88.13. certified-eligible survivors. Health Because of the reorganization of this Program’s experience, final decisions on enrollment appeals typically occur conditions cannot be added to the List part, the current number of this section, without rulemaking, supported by § 88.11, would be changed to § 88.14. within 45 days of receipt of the applicant’s appeal request. scientific or medical evidence, pursuant Existing paragraph (b) would be to the PHS Act and procedures redesignated paragraph (c). New Section 88.15 List of WTC-Related established under Part 88 for adding language for paragraph (b) would Health Conditions new WTC-related health conditions to establish the appeal request process and This new section contains the health the List. mirror the appeal process for conditions enumerated in the PHS Act Public comments submitted to the certification, decertification, and at sections 3312(a)(3) and 3322(b) as docket for the February 2014 IFR treatment authorization decisions in well as those additional WTC-related (clarifying the definition of ‘‘childhood § 88.21. The new language would health conditions promulgated through cancers’’ and revising the definition of specify that an appeal request must be rulemaking by the Administrator.12 The ‘‘rare cancers’’) relevant to this made in writing, identify the denied Administrator proposes moving the List section 14 are addressed here, including applicant or disenrolled Program of WTC-related health conditions from questions regarding the availability of a member and the designated § 88.1, the definitions section, to a new list of rare cancers identified by the representative, if any, and state the § 88.15 in order to better clarify and Program, and requests that the WTC reasons why the WTC Health Program’s emphasize for stakeholders the Health Program reach out to members conditions that are covered by the WTC who were denied certification of brain 9 NIOSH Docket 235, CDC–2011–0009. Health Program. The Administrator also and pancreatic cancers prior to 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 11 NIOSH Docket 235, CDC–2011–0009. 13 NIOSH Docket 235, CDC–2011–0009. ‘postmarked.’ 12 See supra note 5. 14 NIOSH Docket 268, CDC–2014–0004.

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publication of the February 2014 IFR.15 including the medical basis for the be provided an explanation of the The WTC Health Program published a association between the September 11, Program’s decision in writing. list of the cancers considered rare on the 2001, terrorist attacks and the The Administrator proposes to amend Policies & Procedures Web page; 16 the condition(s) to be added. The paragraph paragraph (b) to identify the proposed full list of cancer types covered by the would be amended to clarify that the new location of the List of WTC-Related Program is found on the List of WTC- Administrator accepts all submissions Health Conditions as a separate section Related Health Conditions. Further, from interested parties and then in Part 88. Other amendments to when a new health condition is added evaluates the submissions to decide paragraph (b) would incorporate to the List or when WTC Health whether they are valid petitions. additional PHS Act amendments Program policy regarding a condition on Paragraph (a)(1) would be amended extending the respective deadlines for the List changes, it is Program practice slightly to clarify in paragraph (a)(1)(i) the submission of the STAC’s to communicate directly with members that the petition must state an intent to recommendation, when requested, and or their CCE or NPN regarding petition the Administrator to add a the subsequent publication of the conditions previously denied health condition to the List. Paragraph Administrator’s decision from 60 to 90 certification, to determine if the (a)(1)(ii) would be amended to require calendar days.18 Paragraph (b)(1) would condition should be re-evaluated for that the petitioner provide a signature be amended to update those deadlines certification. No amendments to the List on the petition. Requiring a signature and clarify that all deadlines will be are proposed in response to public aligns the regulation with the petition calculated in terms of calendar days. A comment. form offered by the Program, which new paragraph (b)(2) would reflect the recent amendments to the PHS Act Section 88.16 Addition of Health requires that the petitioner provide a signature. Paragraph (a)(1)(iii) would be requiring the Administrator to provide Conditions to the List of WTC-Related for an independent peer review of the Health Conditions amended to indicate that a petitioner may include either the name ‘‘and/or’’ scientific and technical evidence that A new § 88.16 would comprise a description of the petitioned health would be the basis for adding a health 19 language formerly found in § 88.17. This condition. condition to the List. section establishes the process for Paragraph (a)(2) would be amended to Section 88.17 Physician’s adding a new health condition to the state that the Administrator will take Determination of WTC-Related Health List of WTC-Related Health Conditions one of the available actions within 90 Conditions in § 88.15. The Administrator has calendar days after receipt of a valid determined that these existing A new § 88.17 would comprise petition, including requesting a provisions should be revised to clarify language formerly found in § 88.12. This recommendation from the WTC Health the circumstances under which the section establishes the basis for a CCE Program Scientific/Technical Advisory Administrator is required to consider a or NPN-affiliated physician’s Committee (STAC) or publishing a new submission requesting the addition determination that a WTC Health notice in the Federal Register. The of a health condition that has been Program member has a health condition window for administrative action previously considered. Amending this that can be certified and covered by the following receipt of a petition was section would promote administrative WTC Health Program. extended from 60 to 90 days in the efficiency by not requiring WTC Health The Administrator finds it important recent amendments to the PHS Act.17 Program staff to devote time to to clarify the statutory standard for a Each petition and corresponding reviewing and responding to a physician’s determination that a health Federal Register notice is published on submission that, in substance, was condition is WTC-related or medically the WTC Health Program Web site. already considered. associated with a WTC-related health The Administrator proposes to change Existing paragraph (a)(3) would be condition. The language of this existing the number of this existing section from redesignated (a)(4), and new text in section requires simply that a physician § 88.17 to § 88.16. The Administrator paragraph (a)(3) would allow the 90-day communicate the ‘‘basis for the further proposes minor amendments to deadline to be tolled while the diagnosis’’ to the WTC Health Program; clarify that the List would be moved to Administrator seeks more information the Program then decides whether to § 88.15 and to replace ‘‘determination’’ from the interested party regarding an certify the health condition for with ‘‘decision,’’ as explained above. unclear submission. treatment. The Administrator proposes Paragraph (a) describes the criteria for a Because of the preceding change, to amend this section to incorporate valid petition, including the following: existing paragraph (a)(4) is redesignated statutory language requiring that the An explicit statement of an intent to (a)(5), and proposed amendments would basis for a physician’s determination be petition; the name, contact information, clarify the handling of a submission that a finding that 9/11 exposure is and signature of the petitioning party; requests the addition of a health ‘‘substantially likely’’ to be a the name and/or description of the condition previously evaluated for ‘‘significant factor in aggravating, condition(s) to be added; and the addition to the List by the WTC Health contributing to, or causing the illness or reasons for adding the condition(s), Program. In such a case, if the health condition.’’ Although the WTC submission does not include a new Health Program has not documented 15 This interim final rule amended the List of medical basis for an association between any problems with interpretation of the WTC-Related Health Conditions to reverse the the health condition and 9/11 exposures existing rule text, the Administrator policy of considering cancers of the brain and the and is received after the publication of thinks that inclusion of the statutory pancreas ineligible for Program coverage, clarified the definition of ‘‘childhood cancers,’’ and revised a response to an earlier petition in the standard would clarify for stakeholders the definition of ‘‘rare cancers’’ (79 FR 9100). As a Federal Register, then the submission what the physician is required to result of the IFR, cancer of the brain, the pancreas, would not be considered a valid petition establish before requesting certification the testes, and invasive cervical cancer are and would not be answered in the of a health condition or medically considered eligible for coverage in the Program. Federal Register. The submitter would associated health condition. This 16 See John Howard, Administrator of the WTC Health Program, Rare Cancers, May 5, 2014, http:// www.cdc.gov/wtc/pdfs/WTCHP_PP_ 17 See Public Law 111–347, as amended by Public 18 PHS Act, sec. 3312(a)(6)(C). RareCancers05052014.pdf. Law 114–113, PHS Act, sec. 3312(a)(6)(B)–(C). 19 PHS Act, sec. 3312(a)(6)(F).

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amendment would have no impact on the right to appeal a denial of made by certified mail, return receipt the Program or its members. certification would be consolidated in requested, and by email where such Because of proposed amendments to paragraph (c). contact information is available. earlier sections, the original number of Public comments submitted to the Although the Administrator generally this section, § 88.12, would be changed July 2011 IFR docket on this section 22 agrees that notification of any to § 88.17. ‘‘Shall’’ would be replaced included concerns about the use of certification decisions made pursuant to with ‘‘must.’’ physician panels for the review of this section should be sent by certified Public comments submitted to the health conditions medically associated mail, he declines to specify in the rule July 2011 IFR docket on this section 20 with WTC-related health conditions, as text the mode of transmission, finding included a request to specify that a authorized in the PHS Act and included the detail potentially detrimental to physician’s determination must be in paragraph (b). Commenters asserted Program flexibility. He also declines to transmitted to the Administrator that the use of the physician panel send notifications by email because ‘‘promptly, but in no case longer than 30 identified in the rule text is mandatory, receiving more than one notification days from the initial clinical visit.’’ The that the empaneled physicians should may be confusing and email Administrator declines to establish such be board certified, and that the notifications do not ensure the a deadline because doing so may unduly Administrator should publicize the protection of private health information. burden the physician. No amendments qualification criteria for such a panel as Section 88.19 Decertification to this section are proposed in response well as the names and credentials of to comments. Physician determinations empaneled physicians. Finally, Similar to the issue of disenrollment, and certification requests are typically commenters asserted that input on the Administrator has also identified a submitted to the WTC Health Program panel selection should be sought from need for the WTC Health Program to within 60 days of the completion of the the ‘‘community,’’ including clarify the process for decertification of member’s examination and/or record recommendations from the CCEs, Data a WTC-related health condition or review. Centers, and Steering Committees. health condition medically associated The Administrator interprets the with a WTC-related health condition. Section 88.18 Certification statutory language in section Circumstances that would lead to This section establishes that the WTC 3312(b)(2)(B) of the PHS Act to require decertification would be limited to Health Program will promptly assess the establishment of procedures those where the condition was certified physician determinations submitted by governing the use of such a panel. The in error, such as where the WTC Health a CCE or NPN-affiliated physician and, Administrator finds that in many cases, Program member’s 9/11 exposure is if the Program concurs with the certification of a medically associated later found to be insufficient; the determination and decides that a health health condition is clearly supported, Program decides that the physician condition is a WTC-related health making panel review unnecessary. The erroneously found that the member’s condition or a health condition addition of unnecessary administrative 9/11 exposures were substantially likely medically associated with a WTC- layers may delay a decision; therefore, to be a significant factor in aggravating, related health condition, will certify the the Administrator declines to make contributing to, or causing the health condition as eligible for coverage under panel review mandatory. Any physician condition; or the Program decides the the WTC Health Program. The panel members would be chosen for health condition was erroneously Administrator has identified the need to their medical or scientific expertise at certified as medically associated with a amend this section to make necessary the sole discretion of the Administrator. WTC-related health condition. Such clarifications and respond to public Commenters also suggested a deadline concerns may be discovered during comment. for certification decisions and routine audit of enrollment decisions. The Administrator proposes to change recommended that decisions be made Allowing a health condition to remain the number of this existing section from within 30 days of the Administrator’s certified in error may result in WTC § 88.13 to § 88.18, and to change the title receipt of the physicians’ determination Health Program members receiving from ‘‘WTC Program Administrator’s and request for certification. Although treatment for conditions that were not certification of health conditions’’ to the Administrator declines to set a 30- associated with their 9/11-related ‘‘Certification.’’ day deadline for WTC Health Program exposures, leading to inappropriate use The section would also be amended to certification decisions, he is committed of Program services and dollars. The include the statutory 60-day deadline to rendering this decision in a timely WTC Health Program member would be for the Program’s decision on whether to manner. WTC Health Program members notified of the decision to decertify the certify a health condition as medically are typically notified of Program health condition and given an associated with a WTC-related health decisions within approximately a month opportunity to appeal the Program’s condition,21 as requested by of receipt of a physician’s decertification decision. commenters. Specifically, the proposed determination. Section 88.20 Authorization of amendment to paragraph (b) would One commenter expressed concern Treatment specify that the Program will notify the that on-going treatment for a certified WTC Health Program member in writing condition should not require re- Amendments to the existing section of the certification decision within 60 certification each time treatment is titled ‘‘Standard for determining calendar days of the date the physician’s necessary. The Administrator agrees. medical necessity’’ would clarify the determination is received. WTC Health Program physicians are not WTC Health Program’s treatment The language in existing paragraph (c) required to request re-certification for authorization process. A new paragraph concerning authorization of treatment on-going treatment of a certified WTC- (a) would describe the provision of pending certification would be removed related health condition. medically necessary treatment in to a new § 88.20. Language in existing Finally, one commenter requested accordance with applicable Program paragraphs (a)(2) and (b)(2) concerning that notification regarding a certification protocols and policies and procedures. decision by the Administrator should be Paragraph (b) would incorporate the 20 NIOSH Docket 235, CDC–2011–0009. existing standard for determining 21 See PHS Act, sec. 3312(b)(2)(B)(ii). 22 NIOSH Docket 235, CDC–2011–0009. whether the treatment for a WTC-related

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health condition or a health condition process will benefit WTC Health the appeal, or give the physician the medically associated with a WTC- Program members and help address right to appeal the Administrator’s related health condition is medically concerns raised by commenters asking certification denial directly. The necessary. The Administrator finds it that the appeal process be more Administrator declines to allow a CCE important to clarify that the medical member-friendly. In particular, or NPN medical director, provider, or treatment protocols 23 are developed by stakeholders requested that a member be staff to represent a member in an appeal the Data Centers, with input from the allowed to submit new evidence in because doing so may create a conflict CCEs. support of his or her appeal and interact of interest for the medical director, The Administrator proposes to amend with the Federal Official reviewing the provider, or staff. The Administrator the original number of this section, case. also declines to allow the physician to § 88.14, to § 88.20, and change the title The Administrator proposes to change appeal the certification denial directly; to ‘‘Authorization of treatment.’’ The the number of this existing section from if the physician believes that the Administrator further proposes to § 88.15 to § 88.21 and change the section Administrator has denied a certification replace ‘‘WTC Program Administrator’’ name from ‘‘Appeals regarding in error, the physician may re-submit with ‘‘Administrator of the WTC Health treatment’’ to ‘‘Appeal of certification, the request for certification and provide Program.’’ decertification, or treatment additional explanation or evidence Public comments submitted to the authorization decision.’’ supporting the physician’s July 2011 IFR docket on this section 24 The Administrator proposes to determination that the health condition included a request that the include in paragraph (a)(3) a right of is WTC-related. Administrator create a mechanism by appeal for a WTC Health Program The Administrator proposes to amend which additional treatment modalities, member for whom the Program has paragraph (b)(1) to clarify that the including alternative therapies not decided to decertify a WTC-related appeal process begins when the member presently part of the existing treatment health condition or health condition or member’s designated representative protocols, would be considered for medically associated with a WTC- sends a signed letter, either submitted in addition to those existing protocols related health condition, pursuant to hard copy or scanned and submitted deemed medically necessary. The proposed language in § 88.19. Members electronically, to the Administrator Program routinely considers and would still be allowed the right to requesting the appeal. In response to discusses proposals for new treatment appeal WTC Health Program decisions public comment, the Administrator also modalities with the CCEs and NPN and not to certify a health condition as proposes to extend the amount of time reviews available scientific evidence WTC-related; not to certify a health for filing an appeal from 60 to 90 from authoritative bodies to support the condition as medically associated with calendar days from the date of the letter inclusion of the proposed treatment a WTC-related health condition; or to to the member notifying them of the modalities. deny treatment authorization for a WTC Health Program’s adverse A new paragraph (c) would certified WTC-related health condition decision. incorporate existing language in or medically associated condition As in the current rule, the appeal § 88.13(c) regarding treatment pending because the treatment is not deemed request letter must describe the reasons certification. medically necessary. the WTC Health Program’s decision is Public comments on the July 2011 incorrect and should be reversed. For Section 88.21 Appeal of Certification, IFR 26 asked that the Administrator example, the member could argue for Decertification, or Treatment allow the member to appeal a decision reversal on the grounds that factual Authorization Decision made by a CCE or NPN-affiliated errors were contained in the scientific or This section establishes that a WTC physician not to request certification of medical information submitted to the Health Program member or the the member’s health condition. Section Program by the CCE or NPN physician; designated representative of such a 3312(b)(1)(A) of the PHS Act requires the Program failed to correctly follow or member may appeal the Program’s that a CCE [or NPN-affiliated] physician apply relevant Program policies or decision to deny certification of a health make a determination regarding the procedures; or the Program’s decision condition as WTC-related or medically health condition before the WTC Health was unreasonable as applied to the facts associated with a WTC-related health Program can decide whether to certify of the case. Any basis provided in the condition, decertify a WTC-related the health condition as WTC-related. In appeal request must be sufficiently health condition or medically associated accordance with WTC Health Program detailed and supported by information to permit review of the appeal. The health condition, or deny authorization policies and procedures, a Program Administrator agrees with commenters of treatment for a certified health member may request a secondary review that the member may have additional condition. Based on Program of the physician’s decision not to seek relevant information that was not administrative experience and in certification of a condition as a WTC- available to the member, the response to public comments on the related or medically associated health determining physician, or the Program July 2011 IFR,25 the Administrator has condition.27 at the time of the decision not to certify found a need to revise the existing Commenters also asked the the health condition, decertify the health condition certification and Administrator to allow the member’s condition, or not to authorize treatment. treatment appeals section. Providing physician or CCE medical director to Accordingly, the Administrator now more clarity regarding the appeal represent the responder or survivor in proposes to allow the member or designated representative to submit new 23 See Policy and Procedure Manual for the WTC 26 NIOSH Docket 235, CDC–2011–0009. Health Program, Jan. 1, 2015, Chapter 4: Medical 27 See Policy and Procedure Manual for the WTC information with the appeal request or Benefits, Section 4: Covered Medical Services, Part Health Program, Jan. 1, 2015, Chapter 3: at a later date, if requested by the B: Medically Necessary Treatment, http:// Certification of Health Conditions, Section 5: CCE/ Program. www.cdc.gov/wtc/ppm.html#4d. Program NPN Physician Determination and Request for The Administrator proposes to amend communications sometimes also refer to medical Certification of Health Conditions, Part B: treatment protocols as ‘‘medical guidelines.’’ Secondary Review of Negative Physician portions of the section to clarify the 24 NIOSH Docket 235, CDC–2011–0009. Determination, http://www.cdc.gov/wtc/ appeal review process and incorporate 25 NIOSH Docket 235, CDC–2011–0009. ppm.html#3e. procedures the WTC Health Program

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has outlined elsewhere.28 As requested will submit his or her recommendation Section 88.22 Reimbursement for by commenters, the Administrator to the Administrator. The Medical Treatment and Services proposes new paragraph (b)(3) to codify recommendation would include the A new § 88.22 would comprise the WTC Health Program’s current Federal Official’s recommendation and language formerly found in § 88.16. This process allowing the Program member findings regarding the disposition of the section establishes how the WTC Health or the member’s designated appeal and any relevant supporting Program will reimburse or pay for the representative the opportunity to make materials, including the transcript of cost of monitoring, initial health a 15-minute oral statement by any oral statement and the findings of 29 evaluations, medical treatment, and telephone. A transcript of the oral any experts. One commenter asserted outpatient prescription statement is included in the record and that some of the experts must be pharmaceuticals. provided to the Program member and/or unaffiliated with the Federal The Administrator proposes to change the member’s designated representative. government to prevent bias and that the number of this existing section from The Administrator finds that more community input should be obtained for § 88.16 to § 88.22, and to move formal hearings would be the selection of experts, including from provisions regarding travel expenses, administratively burdensome, divert the WTC Health Program survivor and unchanged, out of this section and into Program resources away from patient responder steering committees and § 88.2, General provisions (see above). care, and be of little benefit to the CCEs. The Administrator declines to The existing language would be member. adopt this suggestion and notes that rearranged slightly. Existing paragraph Finally, the Administrator proposes to relevant expertise is likely to be related (c)(1) would be redesignated as amend paragraph (c) to clarify that after to exposure assessments and medical paragraph (a) to clarify that each receipt of the appeal request, the findings. Further, the Federal Official reimbursement or payment claim is Administrator assigns an independent may consult one or more expert reviewed by the WTC Health Program Federal Official to review the case and reviewers when deemed necessary; the and that claims that cannot be validated the WTC Health Program’s decision not use of expert reviewers may not always will be further assessed by the to certify the health condition or be beneficial and could result in Administrator. Paragraph (b)(1) would medically associated condition, to administrative burden and delay. decertify, or not to authorize treatment. The Administrator proposes to further consolidate existing language about The Federal Official decides whether to revise the section by adding paragraph reimbursement for costs associated with recommend granting the appeal by (d), which would recharacterize the initial health evaluations, medical considering whether the WTC Health outcome of the Federal Official’s review monitoring, and medically necessary Program substantially complied with all of the appeal as a recommendation to be treatment, and also correct the reference relevant Program policies and provided to the Administrator. In the to regulations implementing the Federal procedures; whether the information final step of the appeal process, the Employees Compensation Act (FECA), supporting the Program’s decision was Administrator would review the Federal 20 CFR part 10. New text in paragraph factually accurate; and whether the Official’s recommendation and (b)(1)(ii) would clarify that treatment for Program’s decision was reasonable as supporting materials and make a final which rates have not been established applied to the facts of the case. decision regarding the certification, under either FECA or Medicare fee for Proposed paragraph (c)(1) would decertification, or treatment service rate schedules, such as dental clarify that the Federal Official will authorization decision being appealed. services, is reimbursed at rates set by review the case record, including any The Administrator would notify the the Administrator.31 Language would be oral statement made by the WTC Health member and/or the member’s added to paragraph (b)(2) to clarify that Program member or the member’s designated representative of the Federal the Administrator may withhold designated representative, as well as any Official’s findings and recommendation, reimbursement if the treatment is additional relevant new information the Administrator’s final decision, and inconsistent with WTC Health Program submitted with the appeal request or provide an explanation of the decision protocols, pursuant to language in provided at the request of the WTC and any administrative actions taken by section 3312(c)(3) of the PHS Act. Health Program. As established in the WTC Health Program in response to Paragraph (c) would include language paragraph (b)(2) of the current rule, the final decision. The Administrator from existing paragraph (a)(2). The term proposed paragraph (c)(2) would state declines to adopt a deadline for ‘‘pharmaceutical providers’’ would be that the Federal Official may consult notification of a final appeal decision, as replaced with ‘‘pharmaceutical benefit one or more qualified experts; requested by public comment on the management services.’’ amendments to this paragraph would July 2011 IFR.30 Given the potentially Section 88.23 Appeal of permit any experts consulted to review complex nature of appeals decisions, Reimbursement Denial the WTC Health Program’s adverse the Administrator is concerned that decision and the Program member’s limiting the amount of time available to The Administrator has determined records as well as any new information the Federal Official and/or the that the right of a CCE or NPN medical provided by the member during the Administrator to review the Program director or affiliated provider to appeal appeal. As described in proposed member’s file (including any new a WTC Health Program decision not to paragraph (c)(3), the Federal Official information submitted) could result in authorize reimbursement or payment for undue burden and prevent a thorough treatment should be included in Part 88 28 See WTC Health Program: Appeals Process, review of the appeal. for clarity and completeness. This Overview of the Appeal Process For Denial of Finally, for administrative clarity, the appeal right is established in section Health Condition Certification, http://www.cdc.gov/ 3312(b)(3)(B) of the PHS Act, which wtc/appeals_condition.html. The 15-minute oral Administrator proposes striking existing statement allows the member to present his or her paragraph (c), which allows the calls on the Administrator to establish a case to the Federal Official assigned to review the Administrator to reopen final decisions, case; however, the member is not permitted to and moving the text from this section to 31 Rates for dental services are available in the present witnesses and the Federal Official does not Policy and Procedure Manual for the WTC Health issue a ruling at the conclusion of the oral a new section § 88.25. Program, Jan. 1, 2015, Chapter 4: Medical Benefits, statement. Section 28: Medically Necessary Dental Care, http:// 29 See id. 30 NIOSH Docket 235, CDC–2011–0009. www.cdc.gov/wtc/ppm.html.

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process for appeal of a determination for workers’ compensation or another sharing arrangements, or payment caps under section 3312(c)(3). Section illness or injury benefit plan to which up to and in accordance with the rates 3312(c)(3) authorizes the WTC Health New York City is obligated to pay. described in § 88.22(b) of this part.35 Program to withhold reimbursement or Proposed paragraph (b) would Finally, proposed paragraph (f) would payment for treatment provided when it describe circumstances in which the describe how the WTC Health Program determines the treatment is not WTC Health Program member has filed handles situations that are not medically necessary or is not in a workers’ compensation claim but the specifically covered by proposed accordance with medical treatment claim is still pending acceptance by the paragraphs (a)–(e) described above and protocols. workers’ compensation board. refers interested parties to the Program Accordingly, the Administrator Proposed paragraph (c) would policies and procedures 36 for further proposes to establish an appeal process describe circumstances in which the guidance. in § 88.23 to allow the CCE or NPN WTC Health Program member has filed medical director or affiliated provider to a workers’ compensation claim but a Section 88.25 Reopening of WTC appeal such decisions where all final decision is issued denying Health Program Final Decisions contractual or procedural remedies have coverage for medical treatment of the As discussed above, the been exhausted. Appeals of WTC Health condition. Administrator proposes the creation of a Program decisions to not authorize Proposed paragraph (d) would new section to clarify the reimbursement or payment for treatment describe circumstances in which the Administrator’s authority to reopen any would be made in accordance with WTC Health Program member has filed final decisions made by the WTC Health Program policies and procedures a successful claim for a certified WTC- Program, including those concerning published on the Program Web site. related health condition or medically enrollment, health condition associated health condition with a certification, and appeals. At any time, Section 88.24 Coordination of Benefits workers’ compensation plan to which and without regard to whether new and Recoupment New York City is not obligated to pay. evidence or information is provided or The Administrator proposes to add a In this case, the WTC Health Program obtained, the Administrator may reopen new section to address the matter of recoups costs for treatment from the a final decision and may affirm, vacate, coordination of benefits, including workers’ compensation insurer. As or modify such decision, or take any recoupment from workers’ described in proposed paragraph (d)(1), other action he or she deems compensation settlements. Pursuant to if the WTC Health Program member appropriate. Such reopenings may be section 3331 of the PHS Act, this section settles the workers’ compensation claim necessary to address administrative would explain that the WTC Health by entering into a settlement agreement errors or to incorporate or address Program attempts to recover the costs that releases the employer or insurance changes in Program eligibility criteria, associated with treatment, including carrier from paying for future medical regulations, or policies and procedures. pharmacy benefits, for a member’s care, the agreement must protect the This authority is currently described in certified WTC-related health condition WTC Health Program’s interests the two existing appeals sections, at or medically associated health condition regarding future medical expenses that §§ 88.11(c) and 88.15(c); for clarity and in certain situations. As directed by the might otherwise have been paid for by to aid administrative decision-making, 34 Act, the WTC Health Program the workers’ compensation insurance. the Administrator intends to consolidate coordinates benefits with any workers’ If the WTC Health Program member has the authority into one section. compensation insurance available 32 for accepted a lump sum or other payment members’ work-related 33 conditions, award for future medical care, the WTC V. Regulatory Assessment and with any public or private health Health Program may require the member Requirements insurance available for members’ non- to reimburse the Program for treatment A. Executive Order 12866 and Executive work-related conditions. services provided after receipt of the Order 13563 Proposed paragraph (a) would award. Proposed paragraph (d)(2) would describe circumstances in which the also clarify that the WTC Health Executive Orders 12866 and 13563 WTC Health Program member is eligible Program pays providers for treatment in direct agencies to assess all costs and accordance with the rates recognized benefits of available regulatory 32 To the extent that payment for treatment of the under § 88.22(b) of this part, but recoups alternatives and, if regulation is member’s work-related condition has been made, or at the worker’s compensation rate, if necessary, to select regulatory can reasonably be expected to be made, under any approaches that maximize net benefits other work-related injury or illness benefit plan of lower than the WTC Health Program the member’s employer, the WTC Health Program rates. (including potential economic, will also attempt to recover the costs associated Proposed paragraph (e) would environmental, and public health and with treatment, including pharmacy benefits, for describe circumstances in which the safety effects, distributive impacts, and the member’s certified WTC-related health equity). Executive Order 13563 condition or health condition medically associated WTC Health Program member’s certified with a WTC-related health condition. See PHS Act, health condition is not work-related and emphasizes the importance of sec. 3331(b)(1). For purposes of this regulation, the member’s public or private health quantifying both costs and benefits, ‘‘workers’ compensation law or plan’’ or ‘‘workers’ insurance plan is the primary payer. In reducing costs, harmonizing rules, and compensation insurance’’ includes any other work- promoting flexibility. related injury or illness benefit plan of the WTC such cases, the WTC Health Program Health Program member’s employer. pays costs not reimbursed by the public This proposed rule has been 33 The term ‘‘work-related’’ is defined in sec. or private health insurance plan due to determined not to be a ‘‘significant 3331(e) of the PHS Act to mean: ‘‘(1) the condition the application of deductibles, co- regulatory action’’ under section 3(f) of is diagnosed in an enrolled WTC responder, or in payments, co-insurance, other cost Executive Order 12866. With this an individual who qualifies as a certified-eligible action, the Administrator is proposing WTC survivor on the basis of being a rescue, recovery, or cleanup worker; or (2) with respect to 34 Policy and Procedures for Recoupment: Lump- the condition the individual has filed and had [sic] Sum Workers’ Compensation Settlements, 35 PHS Act, sec. 3331(c)(1). established a claim under a workers’ compensation addressing the adequacy of settlement agreements 36 Policies and procedures describing recoupment law or plan of the United States or a State, or other to protect the WTC Health Program’s interests, is and coordination of benefits are found on the WTC work-related injury or illness benefit plan of the found on the Program’s Policies and Procedures Health Program’s Web site at http://www.cdc.gov/ employer of such individual.’’ Web page, at http://www.cdc.gov/wtc/policies.html. wtc/policies.html.

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amendments to certain sections in 42 medical appeals) and § 88.16 (addition of this rule to Congress prior to its CFR part 88. Non-substantive of health conditions) will result in effective date. amendments would include a necessary changes to several existing reorganization of provisions from the WTC Health Program policies; the E. Unfunded Mandates Reform Act of existing § 88.10 into new §§ 88.11 and proposed novel regulatory provisions in 1995 88.12 and the addition of a new § 88.15, § 88.13 (disenrollment), § 88.19 Title II of the Unfunded Mandates List of WTC-Related Health Conditions. (decertification), and § 88.23 Reform Act of 1995, 2 U.S.C. 1531 et Reorganization of this part would (reimbursement appeals) will require seq., directs agencies to assess the necessitate the renumbering of existing the revision of existing policies or effects of Federal regulatory actions on Part 88 sections, which would be done development of new policies. State, local, and Tribal governments, throughout the regulatory text. The The Administrator estimates that and the private sector ‘‘other than to the Administrator would also clarify amending the existing Policy and throughout Part 88 that deadlines are Procedures for Handling Submissions extent that such regulations incorporate calculated in terms of calendar days. An and Petitions to Add a Health Condition requirements specifically set forth in amendment to the existing section to the List of WTC-Related Health law.’’ For purposes of the Unfunded regarding the physician’s determination Conditions and the Web page containing Mandates Reform Act, this proposed of WTC-related health conditions would frequently asked questions regarding rule does not include any Federal clarify that the determination must be appeals, and developing new mandate that may result in increased predicated upon the statutory disenrollment, decertification, and annual expenditures in excess of $100 requirements for a WTC-related health reimbursement appeal policies will million in 1995 dollars by State, local, condition. Various other minor require approximately 568 hours of staff or Tribal governments in the aggregate, clarifications of WTC Health Program time. Accordingly, this rulemaking is or by the private sector. practice would be made throughout Part expected to cost the WTC Health F. Executive Order 12988 (Civil Justice) 88. Program approximately $42,742. New, substantive regulatory text This rule does not interfere with This proposed rule has been drafted would be added to Part 88 to define the State, local, or Tribal governments in and reviewed in accordance with term ‘‘WTC Health Program member,’’ the exercise of their governmental Executive Order 12988, ‘‘Civil Justice codify an existing statutory appeal right functions. Reform,’’ and will not unduly burden for CCEs and NPN-affiliated providers, B. Regulatory Flexibility Act the Federal court system. This rule has and codify existing WTC Health been reviewed carefully to eliminate Program policies regarding the The Regulatory Flexibility Act (RFA), drafting errors and ambiguities. disenrollment of WTC Health Program 5 U.S.C. 601 et seq., requires each members, decertification of certified agency to consider the potential impact G. Executive Order 13132 (Federalism) WTC-related health conditions, and of its regulations on small entities coordination of benefits. including small businesses, small The Administrator has reviewed this Amendments to the existing provision governmental units, and small not-for- proposed rule in accordance with regarding the addition of health profit organizations. The Administrator Executive Order 13132 regarding conditions to the List of WTC-Related certifies that this proposed rule has ‘‘no Federalism, and has determined that it Health Conditions would include the significant economic impact upon a does not have ‘‘Federalism following: A valid petition must include substantial number of small entities’’ implications.’’ The rule does not ‘‘have the petitioner’s signature; the statutory within the meaning of the RFA. substantial direct effects on the States, deadline for a response to a petition is on the relationship between the national extended from 60 to 90 calendar days C. Paperwork Reduction Act government and the States, or on the and may be tolled while the The Paperwork Reduction Act, 44 distribution of power and Administrator seeks clarification from U.S.C. 3501 et seq., requires an agency responsibilities among the various the interested party regarding the to invite public comment on, and to levels of government.’’ submission, if necessary; and the obtain OMB approval of, any regulation Administrator would not consider a that requires 10 or more people to report H. Executive Order 13045 (Protection of submission to be a valid petition if it information to the agency or to keep Children From Environmental Health does not provide a new medical basis certain records. Data collection and Risks and Safety Risks) for the addition of the health condition recordkeeping requirements for the In accordance with Executive Order and is received after the publication of WTC Health Program are approved by 13045, the Administrator has evaluated a response in the Federal Register to a OMB under ‘‘World Trade Center Health the environmental health and safety petition requesting the addition of the Program Enrollment, Appeals & effects of this proposed rule on children. same health condition. Reimbursement’’ (OMB Control No. The Administrator has determined that Lastly, amendments to the existing 0920–0891, exp. September 30, 2018). the rule would have no environmental certification and treatment authorization HHS has determined that non- health and safety effect on children. appeals section would codify existing substantive changes may be needed to WTC Health Program policy and also the information collection request I. Executive Order 13211 (Actions allow for an appeal of a Program already approved by OMB and that Concerning Regulations That decision to decertify a WTC-related these revisions would not result in any Significantly Affect Energy Supply, health condition. change in respondent burden. Distribution, or Use) This proposed rule does not result in substantial costs to the WTC Health D. Small Business Regulatory In accordance with Executive Order Program, Program members, or Enforcement Fairness Act 13211, the Administrator has evaluated stakeholders, nor does it raise any novel As required by Congress under the the effects of this proposed rule on legal or policy issues. The Small Business Regulatory Enforcement energy supply, distribution or use, and Administrator finds that amendments to Fairness Act of 1996, 5 U.S.C. 801 et has determined that the rule will not § 88.14 and § 88.21 (enrollment and seq., HHS will report the promulgation have a significant adverse effect.

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J. Plain Writing Act of 2010 and approval of a WTC-related health WTC responders, screening-eligible Under Public Law 111–274 (October condition, as defined in this section and survivors, or certified-eligible survivors 13, 2010), executive Departments and included on the List of WTC-Related who live outside the New York Agencies are required to use plain Health Conditions in 42 CFR 88.15, or metropolitan area. language in documents that explain to a health condition medically associated * * * * * the public how to comply with a with a WTC-related health condition. World Trade Center (WTC) Health requirement the Federal government Certified-eligible survivor means (1) Program means the program established administers or enforces. The an individual who has been identified by Title XXXIII of the Public Health Administrator has attempted to use as eligible for medical monitoring and Service Act as amended, 42 U.S.C. plain language in promulgating the treatment as of January 2, 2011; or (2) 300mm to 300mm–61 (codifying Title I proposed rule consistent with the a screening-eligible survivor who is of the James Zadroga 9/11 Health and Federal Plain Writing Act guidelines eligible for follow-up monitoring and Compensation Act of 2010, Pub. L. 111– and requests public comment on this treatment pursuant to § 88.12(b). 347, as amended by Pub. L. 114–113) to Clinical Center of Excellence (CCE) effort. provide medical monitoring and means a center or centers under contract treatment benefits for eligible List of Subjects in 42 CFR Part 88 with the WTC Health Program. A CCE: responders to the September 11, 2001, Aerodigestive disorders, Appeal (1) Uses an integrated, centralized terrorist attacks and initial health procedures, Health care, Mental health health care provider approach to create evaluation, monitoring, and treatment conditions, Musculoskeletal disorders, a comprehensive suite of health services benefits for residents and other building Respiratory and pulmonary diseases. that are accessible to enrolled WTC occupants and area workers in New responders, screening-eligible survivors, York City who were directly impacted Proposed Rule or certified-eligible survivors; and adversely affected by such attacks. For the reasons discussed in the (2) Has experience in caring for WTC World Trade Center (WTC) Health preamble, the Administrator proposes to responders and screening-eligible Program member means any responder, amend 42 CFR part 88 as follows: survivors, or includes health care screening-eligible survivor, or certified- providers who have received WTC eligible survivor enrolled in the WTC PART 88—WORLD TRADE CENTER Health Program training; Health Program. HEALTH PROGRAM (3) Employs health care provider staff World Trade Center (WTC) Program with expertise that includes, at a Administrator (Administrator of the ■ 1. The authority citation for Part 88 is minimum, occupational medicine, WTC Health Program, or Administrator) amended to read as follows: environmental medicine, trauma-related means, for the purposes of this part, the Authority: 42 U.S.C. 300mm to 300mm-61, psychiatry and psychology, and social Director of the National Institute for Pub. L. 111–347, 124 Stat. 3623, as amended services counseling; and Occupational Safety and Health, Centers by Pub. L. 114–113, 129 Stat. 2242. (4) Meets such other requirements as for Disease Control and Prevention, specified by the Administrator of the ■ 2. In § 88.1, revise the definitions Department of Health and Human WTC Health Program. ‘‘Act’’, ‘‘Certification’’, ‘‘Certified- Services, or his or her designee. eligible survivor’’, ‘‘Clinical Center of * * * * * World Trade Center (WTC)-related Excellence’’, ‘‘List of World Trade List of WTC-Related Health acute traumatic injury means the health Center (WTC)-related health Conditions means those conditions condition eligible for coverage in the conditions’’, ‘‘Medically necessary eligible for coverage in the WTC Health WTC Health Program as described in treatment’’, ‘‘Nationwide provider Program as identified in § 88.15 of this § 88.15(e)(1) of this part. network’’, ‘‘World Trade Center (WTC) part. World Trade Center (WTC)-related Health Program’’, ‘‘World Trade Center * * * * * health condition means an illness or (WTC) Program Administrator’’, ‘‘World Medically necessary treatment means health condition for which exposure to Trade Center (WTC)-related health the provision of services to a WTC airborne toxins, any other hazard, or any condition’’, and ‘‘World Trade Center Health Program member by physicians other adverse condition resulting from (WTC)-related musculoskeletal and other health care providers, the September 11, 2001, terrorist disorder’’, and add ‘‘World Trade Center including diagnostic and laboratory attacks, based on an examination by a (WTC) Health Program member’’ and tests, prescription drugs, inpatient and medical professional with expertise in ‘‘World Trade Center (WTC)-related outpatient hospital services, and other treating or diagnosing the health acute traumatic injury’’ to read as care that is appropriate, to manage, conditions in the List of WTC-Related follows: ameliorate, or cure a WTC-related health Health Conditions, is substantially condition or a health condition likely to be a significant factor in § 88.1 Definitions. medically associated with a WTC- aggravating, contributing to, or causing Act means Title XXXIII of the Public related health condition, and which the illness or health condition, Health Service Act, as amended, 42 conforms to medical treatment protocols including a mental health condition. U.S.C. 300mm through 300mm–61 developed by the Data Centers, with Only those conditions on the List of (codifying Title I of the James Zadroga input from the Clinical Centers of WTC-Related Health Conditions 9/11 Health and Compensation Act of Excellence, and approved by the codified in 42 CFR 88.15 may be 2010, Pub. L. 111–347, as amended by Administrator of the WTC Health considered WTC-related health Pub. L. 114–113), which created the Program. conditions. World Trade Center (WTC) Health * * * * * World Trade Center (WTC)-related Program. Nationwide Provider Network (NPN) musculoskeletal disorder means the * * * * * means a network of providers health condition eligible for coverage in Certification means WTC Health throughout the United States under the WTC Health Program as described in Program review of a health condition in contract with the WTC Health Program § 88.15(c)(1) of this part. a particular WTC Health Program to provide an initial health evaluation, * * * * * member for the purpose of identification monitoring, and treatment to enrolled ■ 3. Revise § 88.2 to read as follows:

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§ 88.2 General provisions. § 88.6 Enrollment decision—WTC § 88.10 Enrollment decision—screening- (a) Designated representative. (1) An responders. eligible survivors. applicant or WTC Health Program (a) The WTC Health Program will (a) The WTC Health Program will member may appoint one individual to prioritize applications in the order in decide if the applicant meets the represent his or her interests under the which they are received. screening-eligibility criteria pursuant to WTC Health Program. The appointment (b) The WTC Health Program will § 88.8(a) and notify the applicant of the must be made in writing and consistent decide if the applicant meets the decision in writing within 60 calendar with all relevant Federal laws and eligibility criteria provided in § 88.4 and days of the date of receipt of the regulations in order for the designated notify the applicant in writing (or by application. The applicant will be representative to receive personal health email if an email address is provided by notified of any deficiencies in the information. the applicant) of any deficiencies in the application or the supporting (2) There may be only one designated application or the supporting documentation. The 60-day time period representative at any time. After one documentation. will not include any days during which designated representative has been (c) Denial of enrollment. (1) The WTC the applicant is correcting deficiencies properly appointed, the WTC Health Health Program will deny enrollment if in the application or supporting Program will not recognize another the applicant fails to meet the documentation. individual as the designated applicable eligibility requirements. (b) If the WTC Health Program (2) The WTC Health Program may representative until the appointment of decides that an applicant is denied deny enrollment of a responder who is the previously designated representative enrollment, the applicant will be otherwise eligible and qualified if the is withdrawn in a signed writing. notified in writing and provided an Act’s numerical limitations for newly (3) A properly appointed designated explanation for the decision to deny enrolled responders have been met. representative who is recognized by the enrollment. The notification will inform (i) No more than 25,000 WTC the applicant of the right to appeal the WTC Health Program may make a responders, other than those enrolled enrollment denial and provide request or give direction to the WTC pursuant to §§ 88.3 and 88.4(a)(1)(ii), Health Program regarding the eligibility, may be enrolled at any time. The instructions on how to file an appeal. (1) The WTC Health Program may certification, or any other administrative Administrator of the WTC Health issue pertaining to the applicant or WTC Program may decide, based on the best deny screening-eligible survivor status if Health Program member under the WTC available evidence, that sufficient funds the applicant is ineligible under the Health Program, including appeals. Any are available under the WTC Health criteria specified in § 88.8(a). notice requirement contained in this Program Fund to provide treatment and (2) The WTC Health Program may part or in the Act is fully satisfied if sent monitoring only for individuals who are deny screening-eligible survivor status if to the designated representative. already enrolled as WTC responders at the numerical limitation on certified- (4) An applicant or WTC Health that time. eligible survivors in § 88.12(b)(3)(i) has Program member may authorize any (ii) [Reserved] been met. individual to represent him or her in (3) No individual who is determined (3) No individual who is determined regard to the WTC Health Program, to be a positive match to the terrorist to be a positive match to the terrorist unless that individual’s service as a watch list maintained by the Federal watch list maintained by the Federal representative would violate any government may qualify to be enrolled government may qualify to be a applicable provision of law (such as 18 or be determined to be eligible for the screening-eligible survivor in the WTC U.S.C. 205 or 18 U.S.C. 208) or is WTC Health Program. Health Program. otherwise prohibited by WTC Health (d) Notification of enrollment Program policies and procedures or § 88.11 Initial health evaluation for decision. (1) Applicants who meet the screening-eligible survivors. contract provisions. current eligibility criteria for WTC (a) A CCE or NPN will provide the (5) A Federal employee may act as a responders in § 88.4 and are qualified screening-eligible survivor an initial representative only on behalf of the will be notified in writing by the WTC health evaluation to determine if the individuals specified in, and in the Health Program of the enrollment individual has a WTC-related health manner permitted by, 18 U.S.C. 203 and decision within 60 calendar days of the condition. 18 U.S.C. 205. date of receipt of the application. (6) If a screening-eligible or certified- (2) If the WTC Health Program (b) The WTC Health Program will eligible survivor is a minor, a parent or decides that an applicant is denied provide only one initial health guardian may act on his or her behalf. enrollment, the applicant will be evaluation per screening-eligible (b) Transportation and travel notified in writing and provided an survivor. The individual may request expenses. The Administrator of the explanation, as appropriate, for the additional health evaluations at his or WTC Health Program may provide for decision to deny enrollment. The her own expense. necessary and reasonable transportation notification will inform the applicant of (c) If the physician determines that and expenses incident to the securing of the right to appeal the initial denial of the screening-eligible survivor has a medically necessary treatment through eligibility and provide instructions on WTC-related health condition, the the NPN, involving travel of more than how to file an appeal. physician will promptly transmit to the 250 miles. ■ 7. Amend § 88.8 to revise the section WTC Health Program his or her ■ 4. Amend § 88.4 to revise the section heading to read as follows: determination, consistent with the heading to read as follows: requirements of § 88.17(a). § 88.8 Eligibility criteria—WTC survivors. § 88.4 Eligibility criteria—WTC responders. ■ § 88.12 Enrollment decision—certified- 8. Amend § 88.9 to revise the section eligible survivors. ■ 5. Amend § 88.5 to revise the section heading to read as follows: heading to read as follows: (a) The WTC Health Program will § 88.9 Application process—WTC prioritize certification requests in the § 88.5 Application process—WTC survivors. order in which they are received. responders. ■ 9. Revise §§ 88.10 through 88.18 to (b) The WTC Health Program will ■ 6. Revise § 88.6 to read as follows: read as follows: review the physician’s determination,

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render a decision regarding certification decision, and provided information on the WTC Health Program member, and of the individual’s WTC-related health how to appeal the decision. A assess whether the appeal should be condition, and notify the individual of disenrolled WTC Health Program granted. In conducting the review, the the decision and the reason for the member disenrolled pursuant to Federal Official’s consideration will decision in writing, pursuant to §§ 88.17 paragraph (a) may appeal the include the following: whether the WTC and 88.18. disenrollment decision in accordance Health Program substantially complied (1) If the individual is a screening- with § 88.14. with all relevant WTC Health Program eligible survivor and the individual’s (d) A disenrolled WTC Health policies and procedures; whether the condition is certified as a WTC-related Program member who has been information supporting the WTC Health health condition, the individual will disenrolled in accordance with Program’s decision was factually automatically receive the status of a paragraphs (a) or (b) of this section may accurate; and whether the WTC Health certified-eligible survivor. seek to re-enroll in the WTC Health Program’s decision was reasonable as (2) If a screening-eligible survivor’s Program using the application and applied to the facts of the case. condition is not certified as a WTC- enrollment procedures, provided that (1) The Federal Official may consider related health condition pursuant to the application is supported by new additional relevant new information §§ 88.17 and 88.18, the WTC Health information. submitted by the denied applicant, Program will deny certified-eligible disenrolled WTC Health Program status. The screening-eligible survivor § 88.14 Appeal of enrollment or member, or designated representative. may appeal the decision to deny disenrollment decision. (2) The Federal Official will provide certification, as provided under § 88.21. (a) An applicant denied WTC Health his or her recommendation regarding (3) The WTC Health Program may Program enrollment, a disenrolled WTC the disposition of the appeal, including deny certified-eligible survivor status of Health Program member, or the his or her findings and any supporting an otherwise eligible and qualified applicant’s or member’s designated materials, to the Administrator. screening-eligible survivor if the Act’s representative (appointed pursuant to (d) Final decision and notification. numerical limitations for certified- § 88.2(a)) may appeal the enrollment The Administrator will review the eligible survivors have been met. denial or disenrollment decision. Federal Official’s recommendation and (i) No more than 25,000 individuals, (b) Appeal request. (1) A letter any relevant information and make a other than those described in § 88.7, requesting an appeal must be final decision on the appeal. The may be determined to be certified- postmarked within 90 calendar days of Administrator will notify the denied eligible survivors at any time. The the date of the letter from the applicant or disenrolled WTC Health Administrator of the WTC Health Administrator notifying the denied Program member and/or designated Program may decide, based on the best applicant or disenrolled WTC Health representative of the following in available evidence, that sufficient funds Program member of the adverse writing: are available under the WTC Health decision. Electronic versions of a signed (1) The recommendation and findings Program Fund to provide treatment and letter will be accepted if transmitted made by the Federal Official as a result monitoring only for individuals who within 90 days of the date of the of the review; have already been certified as certified- Administrator’s notification letter. (2) The Administrator’s final decision eligible survivors at that time. (2) A valid request for an appeal must: on the appeal; (ii) [Reserved] (i) Be made in writing and signed; (3) An explanation of the reason(s) for (4) No individual who is determined (ii) Identify the denied applicant or the Administrator’s final decision on the to be a positive match to the terrorist disenrolled WTC Health Program appeal; and watch list maintained by the Federal member and designated representative (4) Any administrative actions taken government may qualify to be a (if applicable); by the WTC Health Program in response certified-eligible survivor in the WTC (iii) Describe the decision being to the Administrator’s final decision. Health Program. appealed and state the reasons why the denied applicant, disenrolled WTC § 88.15 List of WTC-Related Health § 88.13 Disenrollment. Health Program member, or designated Conditions. (a) The disenrollment of a WTC representative believes the enrollment WTC-related health conditions Health Program member may be denial or disenrollment was incorrect include the following disorders and initiated by the WTC Health Program in and should be reversed. The appeal conditions: the following circumstances: request may include relevant new (a) Aerodigestive disorders: (1) The WTC Health Program information not previously considered (1) Interstitial lung diseases. (2) Chronic respiratory disorder— mistakenly enrolled an individual under by the WTC Health Program; and fumes/vapors. § 88.4 (WTC responders) or § 88.8 (iv) Be sent to the WTC Health (3) Asthma. Program at the address specified in the (screening-eligible survivors) who did (4) Reactive airways dysfunction notice of denial or disenrollment. not provide sufficient proof of eligibility syndrome (RADS). consistent with the required eligibility (3) Where the denial or disenrollment (5) WTC-exacerbated and new-onset criteria; or is based on information from the chronic obstructive pulmonary disease (2) The WTC Health Program terrorist watch list, the appeal will be (COPD). member’s enrollment was based on forwarded to the appropriate Federal (6) Chronic cough syndrome. incorrect or fraudulent information. agency. (7) Upper airway hyperreactivity. (b) The disenrollment of a WTC (c) Appeal process. Upon receipt of a (8) Chronic rhinosinusitis. Health Program member may be valid appeal, the Administrator will (9) Chronic nasopharyngitis. initiated by the enrollee for any reason. appoint a Federal Official independent (10) Chronic laryngitis. (c) A disenrolled WTC Health of the WTC Health Program to review (11) Gastroesophageal reflux disorder Program member will be notified in the case. The Federal Official will (GERD). writing by the WTC Health Program of review all available records relevant to (12) Sleep apnea exacerbated by or a disenrollment decision, provided an the WTC Health Program’s decision not related to a condition described in explanation, as appropriate, for the to enroll the applicant or to disenroll preceding paragraphs (1)–(11).

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(b) Mental health conditions. (14) Malignant neoplasm of the female (i) An explicit statement of an intent (1) Posttraumatic stress disorder breast. to petition the Administrator to add a (PTSD). (15) Malignant neoplasm of the ovary. health condition to the List of WTC- (2) Major depressive disorder. (16) Malignant neoplasm of the Related Health Conditions; (3) Panic disorder. prostate. (ii) Name, contact information, and (4) Generalized anxiety disorder. (17) Malignant neoplasm of the signature of the interested party (5) Anxiety disorder (not otherwise urinary bladder. petitioning for the addition; specified). (18) Malignant neoplasm of the (iii) Name and/or description of the (6) Depression (not otherwise kidney. condition(s) to be added; specified). (19) Malignant neoplasms of the renal (iv) Reasons for adding the (7) Acute stress disorder. pelvis, ureter, and other urinary organs. condition(s), including the medical (8) Dysthymic disorder. (20) Malignant neoplasms of the eye basis for the association between the (9) Adjustment disorder. and orbit. September 11, 2001, terrorist attacks (10) Substance abuse. (21) Malignant neoplasm of the and the condition(s) to be added. (c) Musculoskeletal disorders: thyroid. (2) Not later than 90 calendar days (1) WTC-related musculoskeletal (22) Malignant neoplasms of the blood after the receipt of a valid petition, the disorder is a chronic or recurrent and lymphoid tissues (including, but Administrator will take one of the disorder of the musculoskeletal system not limited to, lymphoma, leukemia, following actions: caused by heavy lifting or repetitive and myeloma). (i) Request a recommendation of the strain on the joints or musculoskeletal (23) Childhood cancers: any type of WTC Health Program Scientific/ system occurring during rescue or cancer diagnosed in a person less than Technical Advisory Committee; recovery efforts in the New York City 20 years of age. (ii) Publish in the Federal Register a disaster area in the aftermath of the (24) Rare cancers: any type of proposed rule to add such health September 11, 2001, terrorist attacks. cancer 37 that occurs in less than 15 condition; For a WTC responder who received any cases per 100,000 persons per year in (iii) Publish in the Federal Register treatment for a WTC-related the United States. the Administrator’s decision not to musculoskeletal disorder on or before (e) Acute traumatic injuries: publish a proposed rule and the basis September 11, 2003, such health (1) WTC-related acute traumatic for that decision; or condition includes: injury is physical damage to the body (iv) Publish in the Federal Register a (i) Low back pain. caused by and occurring immediately decision that insufficient evidence (ii) Carpal tunnel syndrome (CTS). after a one-time exposure to energy, exists to take action under paragraph (iii) Other musculoskeletal disorders. such as heat, electricity, or impact from (a)(2)(i) through (iii) of this section. (2) [Reserved]. a crash or fall, resulting from a specific (3) The 90-day time period will not (d) Cancers: event or incident. For a WTC responder include any days during which the (1) Malignant neoplasms of the lip; or screening-eligible or certified-eligible Administrator is consulting with the tongue; salivary gland; floor of mouth; survivors who received any medical interested party to clarify the gum and other mouth; tonsil; treatment for a WTC-related acute submission. oropharynx; hypopharynx; and other traumatic injury on or before September (4) The Administrator may consider oral cavity and pharynx. 11, 2003, such health condition more than one petition simultaneously (2) Malignant neoplasm of the includes: when the petitions propose the addition nasopharynx. (i) Eye injury. of the same health condition. Scientific/ (3) Malignant neoplasms of the nose; (ii) Burn. Technical Advisory Committee nasal cavity; middle ear; and accessory (iii) Head trauma. recommendations and Federal Register sinuses. (iv) Fracture. notices initiated by the Administrator (4) Malignant neoplasm of the larynx. (v) Tendon tear. pursuant to paragraph (a)(2) of this (5) Malignant neoplasm of the (vi) Complex sprain. section may respond to more than one esophagus. (vii) Other similar acute traumatic petition. (6) Malignant neoplasm of the injuries. (5) The Administrator will be required stomach. (2) [Reserved] to consider a submission for a health (7) Malignant neoplasm of the colon § 88.16 Addition of health conditions to condition previously reviewed by the and rectum. the List of WTC-Related Health Conditions. Administrator and found not to qualify for addition to the List of WTC-Related (8) Malignant neoplasm of the liver (a) Any interested party may submit a Health Conditions as a valid new and intrahepatic bile duct. request to the Administrator of the WTC petition only if the submission presents (9) Malignant neoplasms of the Health Program to add a condition to a new medical basis (i.e., a basis not retroperitoneum and peritoneum; the List of WTC-Related Health previously reviewed) for the association omentum; and mesentery. Conditions in § 88.15. The between the September 11, 2001, (10) Malignant neoplasms of the Administrator will evaluate the terrorist attacks and the condition to be trachea; bronchus and lung; heart, submission to decide whether it is a added. A submission that provides no mediastinum and pleura; and other ill- valid petition. new medical basis and is received after defined sites in the respiratory system (1) Each valid petition must include the publication of a response in the and intrathoracic organs. the following: (11) Mesothelioma. Federal Register to a petition requesting (12) Malignant neoplasms of the 37 Based on 2005–2009 average annual data age- the addition of the same health peripheral nerves and autonomic adjusted to the 2000 U.S. population. See Glenn condition will not be considered a valid nervous system; and other connective Copeland, Andrew Lake, Rick Firth, et al. (eds), petition and will not be answered in a and soft tissue. Cancer in North America: 2005–2009. Volume One: Federal Register notice pursuant to Combined Cancer Incidence for the United States, (13) Malignant neoplasms of the skin Canada and North America, Springfield, IL: North paragraph (a)(2), above. The interested (melanoma and non-melanoma), American Association of Central Cancer Registries, party will be informed of the WTC including scrotal cancer. Inc., June 2012. Health Program’s decision in writing.

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(b) The Administrator may propose to progression of the certified WTC-related associated with a WTC-related health add a condition to the List of WTC- health condition. condition, pursuant to § 88.17(b). Related Health Conditions in § 88.15 of (b) A WTC Health Program member this part by publishing a proposed rule § 88.18 Certification. will be notified in writing by the WTC in the Federal Register and providing (a) WTC-related health condition. The Health Program of a decertification interested parties a period of 30 WTC Health Program will review each decision, provided an explanation, as calendar days to submit written physician determination and render a appropriate, for the decision, and comments. The Administrator may decision regarding certification of the provided information on how to appeal extend the comment period for good condition as a WTC-related health the decision. A WTC Health Program cause. condition. The WTC Health Program member whose WTC-related health (1) If the Administrator requests a will notify the WTC Health Program condition or health condition medically recommendation from the WTC Health member of the decision and the reason associated with a WTC-related health Program Scientific/Technical Advisory for the decision in writing. condition is decertified may appeal the Committee, the Advisory Committee (b) Health condition medically decertification decision in accordance will submit its recommendation to the associated with a WTC-related health with § 88.21 of this part. Administrator no later than 90 calendar condition. The WTC Health Program ■ 11. Add § 88.20 to read as follows: days after the date of the transmission will review each physician § 88.20 Authorization of treatment. of the request or no later than a date determination and render a decision (a) Generally. Medically necessary specified by the Administrator (but not regarding certification of the condition treatment of certified WTC-related more than 180 calendar days after the as a health condition medically health conditions and certified health request). The Administrator will publish associated with a WTC-related health conditions medically associated with a proposed rule or a decision not to condition. The WTC Health Program WTC-related health conditions will be publish a proposed rule in the Federal will notify the WTC Health Program provided through the CCEs or the NPN Register no later than 90 calendar days member in writing of the decision and as permitted under WTC Health after the date of transmission of the the reason for the decision within 60 Program treatment protocols and in Advisory Committee recommendation. calendar days after the date the accordance with all applicable WTC (2) Before issuing a final rule to add physician’s determination is received. Health Program policies and a health condition to the List of WTC- (1) In the course of review, the WTC procedures. Related Health Conditions, the Health Program may seek a (b) Standard for determining medical Administrator will provide for an recommendation about certification necessity. All treatment provided under independent peer review of the from a physician panel with appropriate the WTC Health Program will adhere to scientific and technical evidence that expertise for the condition. a standard which is reasonable and would be the basis for issuing such final (2) [Reserved] appropriate; based on scientific rule. (c) Appeal right. If certification of a evidence, professional standards of care, § 88.17 Physician’s determination of WTC- condition as a WTC-related health expert opinion or any other relevant related health conditions. condition or a health condition information; and which has been (a) A physician affiliated with either medically associated with a WTC- included in the medical treatment a CCE or NPN will promptly transmit to related health condition is denied, the protocols developed by the Data the WTC Health Program a WTC Health Program member may Centers, with input from the CCEs, and determination that a member’s exposure appeal the WTC Health Program’s approved by the Administrator of the to airborne toxins, any other hazard, or decision to deny certification, as WTC Health Program. any other adverse condition resulting provided under § 88.21. (c) Treatment pending certification. from the September 11, 2001, terrorist ■ 10. Add § 88.19 to read as follows: While certification of a condition is pending, authorization for treatment of attacks is substantially likely to be a § 88.19 Decertification. significant factor in aggravating, a WTC-related health condition or a contributing to, or causing the illness or (a) The decertification of a WTC health condition medically associated with a WTC-related health condition health condition, including a mental Health Program member’s certified must be obtained from the health condition. The transmission will WTC-related health condition or health Administrator of the WTC Health also include the basis for such condition medically associated with a Program before treatment is provided, determination. The physician’s WTC-related health condition may be except for the provision of treatment for determination will be made based on an initiated by the WTC Health Program in the following circumstances: a medical emergency. assessment of the following: ■ 12. Add § 88.21 to read as follows: (1) The individual’s exposure to (1) The WTC Health Program finds airborne toxins, any other hazard, or any that the member’s exposure is § 88.21 Appeal of certification, other adverse condition resulting from inadequate or is otherwise not covered; decertification, or treatment authorization the September 11, 2001, terrorist (2) The WTC Health Program finds decision. attacks. that the member’s certified WTC-related (a) A WTC Health Program member or (2) The type of symptoms experienced health condition was certified in error the member’s designated representative by the individual and the temporal or erroneously considered to have been (appointed pursuant to § 88.2(a)) may sequence of those symptoms. aggravated, contributed to, or caused by appeal the following four types of (b) For a health condition medically exposure to airborne toxins, any other decisions made by the WTC Health associated with a WTC-related health hazard, or any other adverse condition Program: condition, the physician’s resulting from the September 11, 2001, (1) To deny certification of a health determination must contain information terrorist attacks, pursuant to § 88.17(a); condition as a WTC-related health establishing how the health condition or condition; has resulted from treatment of a (3) The WTC Health Program finds (2) To deny certification of a health previously certified WTC-related health that the member’s health condition was condition as medically associated with condition or how it has resulted from erroneously determined to be medically a WTC-related health condition;

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(3) To decertify a WTC-related health certification of a health condition as § 88.22 Reimbursement for medical condition or a health condition medically associated with a WTC- treatment and services. medically associated with a WTC- related health condition, decertify the (a) Review of claims. Each claim for related health condition; or WTC-related health condition or health reimbursement for treatment will be (4) To deny authorization of treatment condition medically associated with a reviewed by the WTC Health Program. for a certified health condition based on WTC-related health condition, or deny Claims that cannot be validated by that a finding that the treatment is not treatment authorization, and assess process will be further assessed by the medically necessary. whether the appeal should be granted. Administrator of the WTC Health (b) Appeal request. (1) A letter The Federal Official’s consideration will Program. requesting an appeal must be include the following: whether the WTC (b) Initial health evaluations, medical postmarked within 90 calendar days of Health Program substantially complied monitoring, and medically necessary the date of the letter from the with all relevant WTC Health Program treatment. (1) The costs incurred by a Administrator of the WTC Health policies and procedures; whether the CCE or NPN-affiliated provider for Program notifying the member of the information supporting the WTC Health providing a WTC Health Program adverse decision. Electronic versions of Program’s decision was factually member an initial health evaluation, a signed letter will be accepted if accurate; and whether the WTC Health medical monitoring, and/or medically transmitted within 90 days of the date Program’s decision was reasonable as necessary treatment or services for a of the Administrator’s notification letter. applied to the facts of the case. WTC-related health condition or a (2) A valid request for an appeal must: health condition medically associated (i) Be made in writing and signed; (1) In conducting his or her review, the Federal Official will review the case with a WTC-related health condition (ii) Identify the member and will be reimbursed according to the designated representative (if applicable); record, including any oral statement made by the WTC Health Program payment rates that apply to the (iii) Describe the decision being provision of such treatment and services appealed and the reason(s) why the member or the member’s designated representative, as well as additional under the Federal Employees member or designated representative Compensation Act (FECA), 5 U.S.C. believes the decision is incorrect and relevant new information submitted with the appeal request or provided by 8101 et seq., 20 CFR part 10. should be reversed. The description (i) The Administrator will reimburse the WTC Health Program member or the may include, but is not limited to, the a CCE or NPN-affiliated provider for member’s designated representative at following: scientific or medical treatment for which FECA rates have the request of the WTC Health Program. information correcting factual errors not been established pursuant to the that may have been submitted to the (2) The Federal Official may consult applicable Medicare fee for service rate, WTC Health Program by the CCE or one or more qualified experts to review as determined appropriate by the NPN; information demonstrating that the WTC Health Program’s decision and Administrator. the WTC Health Program did not any additional information provided by (ii) The Administrator will reimburse correctly follow or apply relevant WTC the WTC Health Program member or the a CCE or NPN-affiliated provider for Health Program policies or procedures; member’s designated representative. treatment for which neither FECA nor or any information demonstrating that The expert reviewer(s) will submit their Medicare fee for service rates have been the WTC Health Program’s decision was findings to the Federal Official. established, at rates as determined not reasonable given the facts of the (3) The Federal Official will provide appropriate by the Administrator. case. The basis provided in the appeal his or her recommendation regarding (2) If the treatment is determined not request must be sufficiently detailed the disposition of the appeal, including to be medically necessary or is and supported by information to permit his or her findings and any supporting inconsistent with WTC Health Program a review of the appeal. Any new materials (including the transcript of protocols, the Administrator will information not previously considered any oral statement and any expert withhold reimbursement. by the WTC Health Program must be reviewers’ findings), to the (c) Outpatient prescription included with the appeal request, unless Administrator. pharmaceuticals. Payment for costs of later requested by the WTC Health medically necessary outpatient (d) Final decision and notification. Program; and prescription pharmaceuticals for a The Administrator will review the (iv) Be sent to the WTC Health WTC-related health condition or health Federal Official’s recommendation and Program at the address specified in the condition medically associated with a any relevant information and make a notice of denial. WTC-related health condition will be final decision on the appeal. The (3) The appeal request may also state reimbursed by the WTC Health Program Administrator will notify the WTC an intent to make a 15-minute oral under a contract with one or more Health Program member and/or the statement by telephone. The WTC pharmaceutical benefit management member’s designated representative of Health Program member or designated services. the following in writing: representative will have a second ■ 14. Add § 88.23 to read as follows: opportunity to schedule an oral (1) The recommendation and findings statement after being contacted by the made by the Federal Official as a result § 88.23 Appeal of reimbursement denial. WTC Health Program regarding the of the review; Appeal of reimbursement denial. appeal. (2) The Administrator’s final decision After exhausting procedural and/or (c) Appeal process. Upon receipt of a on the appeal; contractual administrative remedies, a valid appeal, the Administrator will CCE or NPN medical director or (3) An explanation of the reason(s) for appoint a Federal Official independent affiliated provider may submit a written the Administrator’s final decision on the of the WTC Health Program to review appeal of a WTC Health Program appeal; and the case. The Federal Official will decision to withhold reimbursement or review all available records relevant to (4) Any administrative actions taken payment for treatment found to be not the WTC Health Program’s decision to by the WTC Health Program in response medically necessary or not in deny certification of a health condition to the Administrator’s final decision. accordance with approved WTC Health as a WTC-related health condition, deny ■ 13. Add § 88.22 to read as follows: Program medical treatment protocols

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pursuant to § 88.20 of this part. Appeal is ultimately accepted by the workers’ costs at the workers’ compensation procedures are published on the WTC compensation board, the workers’ insurance rate. Health Program Web site. compensation insurer in question is (e) Where a WTC Health Program ■ 15. Add § 88.24 to read as follows: responsible for reimbursing the WTC member’s WTC-related health condition Health Program for any treatment § 88.24 Coordination of benefits and or health condition medically associated recoupment. provided and/or paid for during the with a WTC-related health condition is pendency of the claim. The WTC Health Program will not work-related, the WTC Health (c) Where a WTC Health Program attempt to recover the cost of payment Program member’s public or private member has filed a workers’ for treatment, including pharmacy health insurance plan is the primary compensation claim for a WTC-related benefits, for a WTC Health Program payer. The WTC Health Program will health condition or health condition member’s certified WTC-related health pay costs not reimbursed by the public medically associated with a WTC- condition or health condition medically or private health insurance plan due to associated with a WTC-related health related health condition, but a final the application of deductibles, co- condition by coordinating benefits with decision is issued denying the payments, co-insurance, other cost any workers’ compensation insurance compensation for the claim, the WTC sharing arrangements, or payment caps available 38 for members’ work-related Health Program is the primary payer. up to and in accordance with the rates health conditions, and with any public (d) Where a WTC Health Program described in § 88.22(b). or private health insurance available 39 member has filed a workers’ (f) Any coordination of benefits or for members’ non-work-related health compensation claim for a WTC-related recoupment situation not described in conditions. health condition or health condition paragraphs (a) through (e) of this section (a) Where a WTC Health Program medically associated with a WTC- will be handled pursuant to WTC member’s WTC-related health condition related health condition with a workers’ Health Program policies and or health condition medically associated compensation plan to which New York procedures, as found on the WTC with a WTC-related health condition is City is not obligated to pay, the workers’ Health Program Web site. eligible for workers’ compensation or compensation insurer is the primary ■ 16. Add § 88.25 to read as follows: another illness or injury benefit plan to payer. The WTC Health Program is the which New York City is obligated to secondary payer. § 88.25 Reopening of WTC Health Program pay, the WTC Health Program is the (1) If a WTC Health Program member final decisions. primary payer. settles a workers’ compensation claim At any time, and without regard to (b) Where a WTC Health Program by entering into a settlement agreement whether new evidence or information is member has filed a workers’ that releases the employer or insurance provided or obtained, the Administrator compensation claim for a WTC-related carrier from paying for future medical of the WTC Health Program may reopen health condition or health condition care, the settlement must protect the any final decision made by the WTC medically associated with a WTC- interests of the WTC Health Program. Health Program pursuant to the related health condition and the claim This may include setting aside adequate provisions of this part. The is pending, the WTC Health Program is funds to pay for future medical Administrator may affirm, vacate, or the primary payer; however, if the claim expenses, as required by the WTC modify such decision, or take any other Health Program, which would otherwise action he or she deems appropriate. 38 As described in PHS Act, sec. 3331(b). To the have been paid by workers’ extent that payment for treatment of the member’s compensation. In such situations, the Dated: July 27, 2016. work-related condition has been made, or can WTC Health Program may require John Howard, reasonably be expected to be made, under any other reimbursement for treatment services of Administrator, World Trade Center Health work-related injury or illness benefit plan of the Program and Director, National Institute for member’s employer, the WTC Health Program will a WTC-related health condition or also attempt to recover the costs associated with health condition medically associated Occupational Safety and Health, Centers for Disease Control and Prevention, Department treatment, including pharmacy benefits, for the with a WTC-related health condition member’s certified WTC-related health condition or of Health and Human Services. directly from the member. health condition medically associated with a WTC- Dated: July 27, 2016. related health condition. See PHS Act, sec. (2) The WTC Health Program will pay 3331(b)(1). For purposes of this regulation, providers for treatment in accordance Sylvia M. Burwell, ‘‘workers’ compensation law or plan’’ or ‘‘workers’ with § 88.22(b); to the extent that the Secretary, Department of Health and Human compensation insurance’’ includes any other work- Services. related injury or illness benefit plan of the WTC workers’ compensation insurance pays Health Program member’s employer. for treatment at a lower rate, the WTC [FR Doc. 2016–18679 Filed 8–16–16; 8:45 am] 39 As described in PHS Act, sec. 3331(c). Health Program will recoup treatments BILLING CODE 4163–18–P

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