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

§ 88.16 Reimbursement for medically necessary treatment, outpatient prescription pharmaceuticals, monitoring, initial health evaluations, and travel expenses.

(a) Medically necessary treatment and outpatient prescription pharmaceuticals.

(1) The costs of providing medically necessary treatment or services for a WTC-related health condition or a health condition medically associated with a WTC-related health condition by a Clinical Center of Excellence or by a member of the nationwide provider network will be reimbursed according to the payment rates that apply to the provision of such treatment and services by the facility under the Federal Employees Compensation Act (5 U.S.C. 8101 et seq., 20 CFR Part 20).

(i) The WTC Program Administrator will reimburse a Clinical Center of Excellence or a member of the nationwide provider network for treatment not covered under the Federal Employees Compensation Act pursuant to the applicable Medicare fee for service rate, as determined appropriate by the WTC Program Administrator.

(ii) [Reserved]

(2) Payment for costs of medically necessary outpatient prescription pharmaceuticals for a WTC-related health condition or health condition medically associated with a WTC-related health condition will be reimbursed by the WTC Program Administrator under a contract with one or more pharmaceutical providers.

(b) Monitoring and initial health evaluations.

(1) Payment for the costs of providing monitoring and initial health evaluations to a WTC responder, screening-eligible survivor, or certified-eligible survivor by a Clinical Center of Excellence or a member of the nationwide provider network will be reimbursed according to the payment rates that would apply to the provision of such treatment and services under the Federal Employees Compensation Act (5 U.S.C. 8101 et seq., 20 CFR Part 20).

(c) Review of claims for reimbursement for medically necessary treatment.

(1) Each claim for reimbursement for treatment will be reviewed by the WTC Program Administrator.

(2) If the WTC Program Administrator determines that the treatment is not medically necessary, reimbursement will be withheld by the WTC Program Administrator.

(d) Transportation and travel expenses. The WTC Program Administrator may provide for necessary and reasonable transportation and expenses incident to the securing of medically necessary treatment through the nationwide provider network, involving travel of more than 250 miles

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

(a) Any interested party may submit a request to the Administrator of the WTC Health Program to add a condition to the List of WTC-Related Health Conditions in § 88.15. The Administrator will evaluate the submission to decide whether it is a valid petition.

(1) Each valid petition must include the following:

(i) An explicit statement of an intent to petition the Administrator to add a health condition to the List of WTC-Related Health Conditions;

(ii) Name, contact information, and signature of the interested party petitioning for the addition;

(iii) Name and/or description of the condition(s) to be added;

(iv) Reasons for adding the condition(s), including the medical basis for the association between the September 11, 2001, terrorist attacks and the condition(s) to be added.

(2) Not later than 90 calendar days after the receipt of a valid petition, the Administrator will take one of the following actions:

(i) Request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee;

(ii) Publish in the Federal Register a proposed rule to add such health condition;

(iii) Publish in the Federal Register the Administrator's decision not to publish a proposed rule and the basis for that decision; or

(iv) Publish in the Federal Register a decision that insufficient evidence exists to take action under paragraph (a)(2)(i) through (iii) of this section.

(3) The 90-day time period will not include any days during which the Administrator is consulting with the interested party to clarify the submission.

(4) The Administrator may consider more than one petition simultaneously when the petitions propose the addition of the same health condition. Scientific/Technical Advisory Committee recommendations and Federal Register notices initiated by the Administrator pursuant to paragraph (a)(2) of this section may respond to more than one petition.

(5) The Administrator will be required to consider a submission for a health condition previously reviewed by the Administrator and found not to qualify for addition to the List of WTC-Related Health Conditions as a valid new petition only if the submission presents a new medical basis (i.e., a basis not previously reviewed) for the association between the September 11, 2001, terrorist attacks and the condition to be added. A submission that provides no new medical basis and is received after the publication of a response in the Federal Register to a petition requesting the addition of the same health condition will not be considered a valid petition and will not be answered in a Federal Register notice pursuant to paragraph (a)(2), above. The interested party will be informed of the WTC Health Program's decision in writing.

(b) The Administrator may propose to add a condition to the List of WTC-Related Health Conditions in § 88.15 of this part by publishing a proposed rule in the Federal Register and providing interested parties a period of 30 calendar days to submit written comments. The Administrator may extend the comment period for good cause.

(1) If the Administrator requests a recommendation from the WTC Health Program Scientific/Technical Advisory Committee, the Advisory Committee will submit its recommendation to the Administrator no later than 90 calendar days after the date of the transmission of the request or no later than a date specified by the Administrator (but not more than 180 calendar days after the request). The Administrator will publish a proposed rule or a decision not to publish a proposed rule in the Federal Register no later than 90 calendar days after the date of transmission of the Advisory Committee recommendation.

(2) Before issuing a final rule to add a health condition to the List of WTC-Related Health Conditions, the Administrator will provide for an independent peer review of the scientific and technical evidence that would be the basis for issuing such final rule.