42 C.F.R. § 431.416 : Public Health — CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES — MEDICAL ASSISTANCE PROGRAMS — STATE ORGANIZATION AND GENERAL ADMINISTRATION — SECTION 1115 DEMONSTRATIONS — Federal public notice and approval process

(a) General. Within 15 days of receipt of a complete application from the State for a new demonstration project or an extension of a previously approved demonstration project, CMS will:
(1) Send the State a written notice informing the State of receipt of the demonstration application, the date in which the Secretary received the State's demonstration application, the start dates of the 30-day Federal public notice process, and the end date of the 45-day minimum Federal decision-making period.
(2) Publish the written notice acknowledging receipt of the State's completed application on its Web site within the same 15-day timeframe.
(b) Public comment period. Upon notifying a State of a completed application, CMS will solicit public comment regarding such demonstration application for 30 days by doing the following:
(1) Publishing the following on the CMS Web site:
(i) The written notice of CMS receipt of the State's complete demonstration application.
(ii) Demonstration applications, including supporting information submitted by the State as part of the complete application, and associated concept papers, as applicable.
(iii) The proposed effective date of the demonstration.
(iv) Addresses to which inquiries and comments from the public may be directed to CMS by mail or email.
(2) Notifying interested parties through a mechanism, such an electronic mailing list, that CMS will create for this purpose.
(c) Public disclosure. CMS will publish on its Web site, at regular intervals, appropriate information, which may include, but is not limited to the following:
(1) Relevant status update(s);
(2) A listing of the issues raised through the public notice process.
(d) Publishing of comments.
(1) CMS will publish written comments electronically through its Web site or an alternative Web site.
(2) CMS will review and consider all comments received by the deadline, but will not provide written responses to public comments. While comments may be submitted after the deadline, CMS cannot assure that these comments will be considered.
(e) Approval of a demonstration application.
(1) CMS will not render a final decision on a demonstration application until at least 45 days after notice of receipt of a completed application, to receive and consider public comments.
(2) CMS may expedite this process under the exception to the normal public notice process provisions in §431.416(g) of this subpart.
(f) Administrative record.
(1) CMS will maintain, and publish on its public Web site, an administrative record that may include, but is not limited to the following:
(i) The demonstration application from the State.
(ii) The State's disaster exemption request and CMS' response, if applicable.
(iii) Written public comments sent to the CMS and any CMS responses.
(iv) If an application is approved, the final special terms and conditions, waivers, expenditure authorities, and award letter sent to the State.
(v) If an application is denied, the disapproval letter sent to the State.
(vi) The State acceptance letter, as applicable.
(vii) Specific requirements related to the approved and agreed upon terms and conditions, such as implementation reviews, evaluation design, quarterly progress reports, annual reports, and interim and/or final evaluation reports.
(viii) Notice of the demonstration's suspension or termination, if applicable.
(2) To ensure that the public has access to all documentation related to the demonstration project, including the aforementioned items, we will also provide a link to the State's public Web site.
(g) Exemption from the normal public notice process.
(1) CMS may waive, in whole or in part, the Federal and State public notice procedures to expedite a decision on a proposed demonstration or demonstration extension request that addresses a natural disaster, public health emergency, or other sudden emergency threats to human lives.
(2) The Secretary may exempt a State from the normal public notice process or the required time constraints imposed in this section or §431.408(a) of this subpart when the State demonstrates to CMS the existence of unforeseen circumstances resulting from a natural disaster, public health emergency, or other sudden emergency that directly threatens human lives that warrant an exception to the normal public notice process.
(i) The State is expected to discharge its basic responsibilities in submitting demonstration applications to the Secretary as required in §431.412 of this subpart.
(ii) Such applications will be posted on the CMS Web site.
(3) A State must establish (or meet) all of the following criteria to obtain such an exemption from the normal public notice process requirements:
(i) The State acted in good faith, and in a diligent, timely, and prudent manner.
(ii) The circumstances constitute an emergency and could not have been reasonably foreseen.
(iii) Delay would undermine or compromise the purpose of the demonstration and be contrary to the interests of beneficiaries.
(4) CMS will publish on its Web site any disaster exemption determinations within 15 days of approval, as well as the revised timeline for public comment or post-award processes, if applicable.

42 C.F.R. §431.416