SUBJECT:
TO:
Health and Human Services Commission Council
DATE:
November 22, 2013
FROM:
Matthew Ferrara, Director
Agenda Item 4.b.-Medicaid Quality Improvement Process for Clinical Initiatives
BACKGROUND: Federal Requirement
Legislative Requirement
Other
The Health and Human Services Commission (HHSC) proposes to add new Subchapter L,
Medicaid Quality Improvement Process for Clinical Initiatives under Title 1, Part 15, Chapter
354. Senate Bill 1542, 83rd Legislature, Regular Session, 2013 adds Chapter 538 to the
Government Code requiring the HHSC to develop and implement a quality improvement process
to receive clinical suggestions that improve the quality of care and cost-effectiveness under the
Medicaid program, conduct a preliminary review of each suggestion, and conduct an analysis of
clinical initiative suggestions that are selected for analysis. The new rules will define terms, add
the clinical initiative review process and add information related to submitting clinical initiatives
via a website for review.
ISSUES AND ALTERNATIVES:
N/A
STAKEHOLDER INVOLVEMENT:
HHSC solicited external stakeholder input from the following organizations on September 20,
2013:
1.
Texas Medical Association
2.
Texas Association of Family Practitioners
3.
Texas Association of Obstetricians and Gynecologists
4.
Texas Osteopathic Medical Association
5.
Texas Pediatric Society
6.
Coalition for Nurses in Advanced Practice
7.
Texas Hospital Association
8.
Texas Allergy, Asthma and Immunology Society
9.
Texas Health Care Association
10.
Texas Association for Home Care and Hospice
11.
Texas Organization of Rural and Community Hospitals
12.
Texas Association of Community Health Centers
13.
Medical Equipment Suppliers Association
14.
Greater Texas Rehab Providers' Council
15.
Texas Dental Association
16.
Texas Academy of Pediatric Dentistry
17.
Texas Academy of General Dentistry
18.
Texas Society Psychiatric Physicians
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19.
20.
21.
22.
23.
24.
25.
Texas Society Child and Adolescent Psychiatrist
Texas Psychological Association
Texas Chapter of National Social Worker
Association of Substance Abuse Programs
Texas Ophthalmological Association
Texas Optometric Association
Texas Anesthesiology Association/Society
Comments received from external stakeholders will be reviewed by HHSC staff and taken into
consideration.
FISCAL IMPACT:
None
Yes
SERVICES IMPACT STATEMENT:
The proposed rules do not have a negative impact on the HHSC client population. If the
commission chooses to implement the initiative after conducting a full analysis, the client
population may experience a positive impact as a result of the implementation.
RULE DEVELOPMENT SCHEDULE:
November 8, 2013
November 22, 2013
October 18, 2013
December 20, 2013
January 1, 2014
Present to Medical Care Advisory Committee
Present to HHSC Council
Publish proposed rule in the Texas Register
Publish adopted rule in the Texas Register
Effective date
REQUESTED ACTION:
Information Only
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TITLE 1
PART 15
CHAPTER 354
SUBCHAPTER L
RULE §354.2501
RULE §354.2503
RULE §354.2505
RULE §354.2507
ADMINISTRATION
TEXAS HEALTH AND HUMAN SERVICES COMMISSION
MEDICAID HEALTH SERVICES
QUALITY IMPROVEMENT PROCESS FOR CLINICAL
INITIATIVES
Definitions
Clinical Initiative Evaluation Process
Action on Approved Clinical Initiatives
Internet Website
PROPOSED PREAMBLE
The Health and Human Services Commission (HHSC) proposes to add new Subchapter L,
concerning the Medicaid Quality Improvement Process for Clinical Initiatives.
Background and Justification
Senate Bill (S.B.) 1542, 83rd Legislature, Regular Session, 2013 adds Chapter 538 to the
Government Code requiring the commission to develop and implement a quality improvement
process to receive clinical suggestions that improve the quality of care and cost-effectiveness
under the Medicaid program, conduct a preliminary review of each suggestion, and conduct an
analysis of clinical initiative suggestions that are selected for analysis, prepare a final report on
each clinical initiative that has received a full analysis, and implement clinical initiatives that are
cost-effective and improve quality of care under Medicaid.
Section-by-Section Summary
Proposed new §354.2501 adds definitions for terms used.in new Subchapter L.
Proposed new§354.2503 describes the process by which clinical initiatives will be evaluated
including the preliminary review criteria, number of clinical initiatives that receive full analysis,
analysis of the clinical initiative (if applicable) and the final report.
Proposed new§354.2505 describes the action taken on the suggested clinical initiative (if
applicable) determined by the Executive Commissioner.
Proposed new§354.2507 adds information related to the website that will be used to receive
comments or information related to a specific initiative.
Fiscal Note
Greta Rymal, Deputy Executive Commissioner for Financial Services, has determined that for
the first five years the proposed rules are in effect, there is no anticipated fiscal impact to state or
local governments. There is no anticipated negative impact on local employment. There are no
anticipated economic costs to persons who are required to comply with the proposed rule as they
are not required to alter their current business practices to comply.
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Small and Micro-business Impact Analysis
Ms. Rymal has also determined that there will be no adverse economic impact to small
businesses or micro businesses to comply with the proposed new rules as they will not be
required to alter their business practices as a result of the new rules. There are no anticipated
economic costs to persons who are required to comply with the proposed rule.
Public Benefit
Chris Traylor, Chief Deputy Commissioner for Medicaid and CHIP, has determined that for each
year of the first five years the new rules are in effect, the public will benefit from the adoption of
the rules. The anticipated public benefit of enforcing the proposed new rules will be improved
quality of care and cost-effectiveness of services provided under the Medicaid program.
Regulatory Analysis
HHSC has determined that this proposal is not a “major environmental rule” as defined by
§2001.0225 of the Texas Government Code. A “major environmental rule” is defined to mean a
rule the specific intent of which is to protect the environment or reduce risk to human health
from environmental exposure and that may adversely affect, in a material way, the economy, a
sector of the economy, productivity, competition, jobs, the environment, or the public health and
safety of a state or a sector of the state. This proposal is not specifically intended to protect the
environment or reduce risks to human health from environmental exposure.
Takings Impact Assessment
HHSC has determined that this proposal does not restrict or limit an owner’s right to his or her
property that would otherwise exist in the absence of government action and, therefore, does not
constitute a taking under §2007.043 of the Government Code.
Public Comment
Written comments on the proposal may be submitted to Janna Doan, Program Specialist,
Healthcare Quality Analytics, Research, Coordination, and Support, Health Policy and Clinical
Services, Health and Human Services Commission at 6330 Highway 290 East, Suite 100, Austin,
Texas 78723; by fax to (512) 380-4380; or by e-mail to
SB1542_Clinical_Initiatives@hhsc.state.tx.us within 30 days of publication of this proposal in
the Texas Register.
Public Hearing
A public hearing is scheduled for (Date) from (Start Time) to (End Time) (central time) in the
(Location and Address). Persons requiring further information, special assistance, or
accommodations should contact (Contact Name) at (Phone Number).
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Statutory Authority
These new rules are proposed under Texas Government Code §531.033, which provides the
Executive Commissioner of HHSC with broad rulemaking authority; and Texas Human
Resources Code Chapter §32.021 and Texas Government Code §531.021(a), which provide
HHSC with the authority to administer the federal medical assistance (Medicaid) program in
Texas).
The proposed new rules affect Texas Human Resources Code Chapter 32, and Texas
Government Code Chapter 531. No other statutes, articles, or codes are affected by this
proposal.
This agency hereby certifies that this proposal has been reviewed and approved by legal counsel
and found to be within the agency’s legal authority to adopt.
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Legend:
Underlined text - an addition to proposed rule language
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Regular print - rule language as it was proposed
TITLE 1
PART 15
CHAPTER 354
SUBCHAPTER L
ADMINISTRATION
TEXAS HEALTH AND HUMAN SERVICES COMMISSION
MEDICAID HEALTH SERVICES
QUALITY IMPROVEMENT PROCESS FOR CLINICAL INITIATIVES
RULE § 354.2501
Definitions
The following words and terms, when used in this subchapter, shall have the following
meanings, unless the context clearly indicates otherwise.
(1) Advisory committee--In this subchapter, refers to an existing advisory committee that
provides guidance to the HHSC executive commissioner and the agency on matters related to
the Medicaid program and any quality-related issue and policy.
(2) Authorized submitter--A member of the state legislature; the executive commissioner of
HHSC; commissioners of DADS, DARS, DFPS, and DSHS; and chairs of the Medical Care
Advisory Committee, the Physician Payment Advisory Committee, and the Electronic Health
Information Exchange System Advisory Committee may submit suggestions of clinical
initiatives.
(3) Children’s Health Insurance Program (CHIP)--The Texas State CHIP that is established
under Title XXI of the federal Social Security Act (42 U.S.C. §§1397aa, et seq.) and Chapter
62 of the Health and Safety Code.
(4) Clinical initiative--Any effort, project, intervention, or best practice currently being explored,
tested, or examined to improve the quality of care for recipients of health care services
provided by public or private insurers that can potentially be implemented under the
Medicaid program.
(5) Approved clinical initiative--Suggested clinical initiative that has met preliminary review
criteria and been determined to warrant further analysis.
(6) Clinical trial--A clinical trial is a type of research study conducted in the clinical setting that
follows a pre-determined plan or protocol that compares one treatment against another. The
treatment can be a new drug, a new invasive medical device, or care protocol on human
subjects.
(7) Department of Aging and Disability Services (DADS)--The HHS agency that administers
long-term services and supports for people who are aging and for people with intellectual
and physical disabilities. DADS also licenses and regulates providers of these services and
administers the state's Guardianship program.
(8) Department of Assistive and Rehabilitation Services (DARS)--The HHS agency that
administers programs for people with disabilities and children who have developmental
delays.
(9) Department of Family Protective Services (DFPS)--The HHS agency that works with
communities to protect children, the elderly, and people with disabilities from abuse, neglect,
and exploitation. It also works to protect the health and safety of children in daycare, as well
6
as foster care and other types of 24-hour care. The agency conducts investigations, provides
services and referrals, enforces regulation, and provides prevention programs.
(10) Department of State Health Services (DSHS)--The HHS agency that is the state's
designated public health agency.
(11) Electronic Health Information Exchange System Advisory Committee--The committee
established under Section 531.904, Human Resources Code.
(12) Full analysis--A complete analysis of a suggestion for a clinical initiative that has met all
preliminary review criteria. The analysis is conducted to determine whether the clinical
initiative will improve quality of care under Medicaid and is cost-effective to the state. The
analysis includes all elements described under Analysis of Clinical Initiative.
(13) Texas Health and Human Services Commission (HHSC)--The single state agency that
administers and oversees the Texas Medicaid program. HHSC is established by and its
authority is described in Chapter 531 of the Texas Government Code.
(14) Institution of higher education--As defined by Section 61.003, Education Code, is any
public technical institute, public junior college, public senior college or university, medical
or dental unit, public state college, or other agency of higher education as defined in this
section.
(15) Internet website--HHSC designated website related to the quality improvement process
required under this subchapter.
(16) Medicaid--The medical assistance program authorized and funded pursuant to Title XIX
of the Social Security Act (42 U.S.C. §1396 et seq) and administered by HHSC.
(17) Medical Care Advisory Committee--The committee established under the authority of
Title XIX of the Social Security Act, 42 CFR §431.12, and Section 32.022, Human Resource
Code.
(18) Medicare--A federal system of health insurance for people over 65 years of age and for
certain people younger than 65 years of age who have disabilities.
(19) Physician Payment Advisory Committee--The committee created under Section
32.022(d), Human Resources Code.
(20) Preliminary review--An administrative process that determines whether a suggestion for a
clinical initiative warrants a full analysis.
(21) Quality improvement--A system to continuously examine, monitor, and revise processes
and systems that support and improve administrative and clinical functions.
(22) State-operated health care programs--In this subchapter, refers to programs that are
funded solely through state general funds and operated and administered under state laws and
rules.
(23) Suggestions--Proposed clinical initiatives submitted by authorized individuals either in
written or electronic form.
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TITLE 1
PART 15
CHAPTER 354
SUBCHAPTER L
ADMINISTRATION
TEXAS HEALTH AND HUMAN SERVICES COMMISSION
MEDICAID HEALTH SERVICES
QUALITY IMPROVEMENT PROCESS FOR CLINICAL INITIATIVES
RULE § 354.2503
Clinical Initiative Evaluation Process
(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)
(2)
(3)
(4)
Suggestion is not currently a benefit under the Medicaid program;
There is evidence that the suggestion will improve quality of care under Medicaid;
There is evidence that the suggestion will improve the cost-effectiveness of Medicaid;
Suggestion is not undergoing clinical trials; and
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(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;
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(E) The identification of any statutory barriers; and
(F) If the initiative is not implemented, an explanation of why.
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Legend:
Underlined text - an addition to proposed rule language
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Regular print - rule language as it was proposed
TITLE 1
PART 15
CHAPTER 354
SUBCHAPTER L
ADMINISTRATION
TEXAS HEALTH AND HUMAN SERVICES COMMISSION
MEDICAID HEALTH SERVICES
QUALITY IMPROVEMENT PROCESS FOR CLINICAL INITIATIVES
RULE §354.2505
Action on Approved Clinical Initiatives
Action on approved clinical initiatives. After HHSC conducts an analysis of a clinical initiative:
(1) If the commission determines that the initiative is cost-effective and will improve the
quality of care under the Medicaid program, HHSC may:
(A) Implement the initiative if implementation of the initiative is
not otherwise prohibited by law; or
(B) If implementation requires a change in law, submit a copy of
the final report together with recommendations relating to the
initiative's implementation to the standing committees of the
Senate and House of Representatives having jurisdiction over
the Medicaid program; and
(2) If the commission determines that the initiative is not cost-effective or will not
improve quality of care under the Medicaid program, the commission may not
implement the initiative.
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Legend:
Underlined text - an addition to proposed rule language
Strikethrough - a deletion of proposed rule language
Regular print - rule language as it was proposed
TITLE 1
PART 15
CHAPTER 354
SUBCHAPTER L
ADMINISTRATION
TEXAS HEALTH AND HUMAN SERVICES COMMISSION
MEDICAID HEALTH SERVICES
QUALITY IMPROVEMENT PROCESS FOR CLINICAL INITIATIVES
RULE § 354.2507
Internet Website
Internet website. The content of this website required under this subchapter will include:
(1) An explanation of the clinical initiative evaluation process;
(2) An explanation of how members of the public may submit comments or research related
to an initiative;
(3) A copy of each initiative selected for further analysis;
(4) The status of each initiative in the approval process; and
(5) A copy of the final report for each approved clinical initiative.
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