(a) Clinical initiative evaluation process. This process consists of the submission, preliminary review, analysis, and approval of a clinical initiative.
  (1) Authorized submitters may submit suggestions of clinical initiatives in written form sent via postal mail, in electronic form via email, or using the designated online form available via the HHSC Internet website required under this subchapter.
  (2) Each suggestion for a clinical initiative will be submitted to the state Medicaid director.
  (3) Designated HHSC staff will review each suggestion and determine if it warrants a full analysis. Suggestions selected for full analysis will be posted on HHSC Internet website for public comment within 30 days of receipt by the state Medicaid director.
  (4) HHSC will determine the number of selected suggestions to undergo full analysis depending on available staff resources. If sufficient staff resources are available, the full analysis will be completed within 180 days of receipt of the suggestion by the state Medicaid director.
  (5) HHSC staff will consult appropriate subject matter experts both internally and externally for determination of whether a clinical initiative suggestion warrants full analysis. Subject matter experts will also be consulted during full analysis and report development of the clinical initiative, if additional input is needed.
(b) Number of clinical initiatives selected for full analysis. HHSC is authorized by statute to determine the number of clinical initiatives that will receive full analysis. This determination will be based on staff resources and external contractor availability and whether a clinical initiative is already a Texas Medicaid benefit.
(c) Preliminary review of clinical initiatives suggestions. HHSC staff will consult with the appropriate advisory committees to determine whether a clinical initiative suggestion warrants full analysis. A suggestion of a clinical initiative will be reviewed and the determination as to whether it warrants a full analysis will be based on the following criteria:
  (1) Suggestion is not currently a benefit under the Medicaid program;
  (2) There is evidence that the suggestion will improve quality of care under Medicaid;
  (3) There is evidence that the suggestion will improve the cost-effectiveness of Medicaid;
  (4) Suggestion is not undergoing clinical trials; and
  (5) Suggestion will not expand a health care provider's scope of practice beyond the law governing the provider's practice.
(d) Analysis of clinical initiative.
  (1) HHSC staff will consult with the appropriate internal and external stakeholders and subject matter experts during the full analysis. These sources can include:
    (A) Advisory committees that advise HHSC on quality-related issues and policies;
    (B) Internal HHSC business and clinical units, including but not limited to, the Office of Medical Director and the Office of Medicaid/CHIP Policy; and
    (C) External contractors as designated by HHSC.
  (2) A full analysis of selected clinical initiatives is based on the following sources relating to the initiative (where applicable and if available):
    (A) Public comments and submitted research;
    (B) Available clinical research and historical utilization information;
    (C) Published medical literature;
    (D) Any adoption of the initiative by medical societies or other clinical groups;
    (E) Implementation by Medicare, another state Medicaid program or the Children's Health Insurance Program;
    (F) Results of reports, research, pilot programs, or clinical studies relating to the initiative conducted by institutions of higher education, governmental entities and agencies, private and nonprofit think tanks and research groups;
    (G) Impact the initiative would have on the Medicaid program if implemented in Texas, including an estimated number of recipients under Medicaid and potential cost savings to the state; and
    (H) Any statutory barriers to implement the approved clinical initiative.
(e) Final reports.
  (1) HHSC staff will consult with the appropriate internal and external clinical experts on developing the final reports, including:
    (A) Internal HHSC business and clinical units, such as the Office of Medical Director and the Office of Medicaid/CHIP Policy; and
    (B) External contractors as determined by HHSC.
  (2) A final report of an approved clinical initiative will include the following information:
    (A) The feasibility of implementing the initiative;
    (B) The likely impact on quality of care provided under the Medicaid program;
    (C) Any anticipated cost savings to the state;
    (D) A summary of public comments, including a description of any opposition to implementing the initiative;
    (E) The identification of any statutory barriers; and
    (F) If the initiative is not implemented, an explanation of why.

Source Note: The provisions of this §354.2503 adopted to be effective January 1, 2014, 38 TexReg 9467