TITLE 26. HEALTH AND HUMAN SERVICES

PART 1. HEALTH AND HUMAN SERVICES COMMISSION

CHAPTER 306. BEHAVIORAL HEALTH DELIVERY SYSTEM

SUBCHAPTER G. USE AND MAINTENANCE OF THE HEALTH AND HUMAN SERVICES COMMISSION PSYCHIATRIC DRUG FORMULARY

26 TAC §§306.351 - 306.360

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes new §306.351, concerning Purpose; §306.352, concerning Application; §303.353, concerning Definitions; §306.354, concerning General Requirements; §306.355, concerning Organization of HHSC Psychiatric Drug Formulary; §306.356, concerning Responsibilities of the Psychiatric Executive Formulary Committee; §306.357, concerning Adding a Drug to the HHSC Psychiatric Drug Formulary; §306.358, concerning Changing the HHSC Psychiatric Drug Formulary; §306.359, concerning Prescribing Non-formulary Drugs; and §306.360, concerning Adverse Drug Reactions.

BACKGROUND AND PURPOSE

The purpose of the proposed new rules is to move HHSC rules in Texas Administrative Code (TAC) Title 25, Chapter 415, Subchapter C and 40 TAC Chapter 5, Subchapter C to 26 TAC Chapter 306, Subchapter G as part of consolidating HHSC rules. The rules are repealed, updated, and reorganized, as they have not been reviewed since 2002, and are placed in 26 TAC Chapter 306. The rule project workgroup has updated the rules for clarity using plain language where possible and to provide a simpler description of the composition and operation of the agency's formulary committee. The repeal of those rules is proposed simultaneously elsewhere in this issue of the Texas Register.

SECTION-BY-SECTION SUMMARY

Proposed §306.351 states the purpose of the new subchapter.

Proposed §306.352 provides that the rules apply to the listed facilities.

Proposed §306.353 provides the definitions used in the subchapter.

Proposed §306.354 describes the general requirements for the HHSC Psychiatric Drug Formulary.

Proposed §306.355 describes how drugs will be listed in the HHSC Psychiatric Drug Formulary, recommended doses, limitations, and provides that the Interim Formulary Update confirms to the same form as the formulary.

Proposed §306.356 lists the responsibilities of the Psychiatric Executive Formulary Committee (PEFC), which includes recommending standards of drugs, periodically reviewing the drugs listed in the formulary, and considering applications submitted to have drugs added to the formulary.

Proposed §306.357 provides the procedures for applying to have a drug added to the formulary.

Proposed §306.358 provides that changes to the formulary is based on need, effectiveness, risk, and cost and the formulary is updated and published once a year, at a minimum.

Proposed §306.359 provides the procedure for prescribing a non-formulary drug.

Proposed §306.360 provides that each local authority develop written policies and procedures to report adverse drug reactions and HHSC will develop policies and procedures for HHSC facilities.

FISCAL NOTE

Trey Wood, Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of HHSC employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to HHSC;

(5) the proposed rules will create new rules in 26 TAC, which will replace rules being repealed contemporaneously from 25 TAC and 40 TAC;

(6) the proposed rules will expand existing rules;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities.

The proposed rules do not apply to small or micro-businesses, or rural communities.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas and do not impose a cost on regulated persons.

PUBLIC BENEFIT AND COSTS

Timothy E. Bray, Associate Commissioner of State Hospitals, and Scott Schalchlin, Associate Commission of State Supported Living Centers, have determined that for each year of the first five years the rules are in effect, the public benefit will be rules that reference the correct agency, HHSC.

Trey Wood has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules. The proposed rules codify and combine existing agency practices under 26 TAC. There is no requirement for providers to alter current business practices.

TAKINGS IMPACT ASSESSMENT

HHSC has determined that the 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 Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to HHSC, Health and Specialty Care System, Mail Code 619E, P.O. Box 13247, Austin, Texas 78711-3247, or by email to healthandspecialtycare@hhsc.state.tx.us.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rules 19R052 Drug Formulary" in the subject line.

STATUTORY AUTHORITY

The new sections are authorized by Texas Government Code §531.0055 which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Health and Safety Code §533.0356 which allows the Executive Commissioner of HHSC to adopt rules to govern the operations of local behavioral health authorities; §571.006 which provides the Executive Commissioner of HHSC with authority to adopt rules as necessary for the proper and efficient treatment of persons with mental illness; §534.052, which requires the adoption of rules necessary and appropriate to ensure the adequate provision of mental health services through a local authority; §591.004 which provides that the Executive Commissioner of HHSC shall adopt rules to implement the Persons with an Intellectual Disability Act; and §533A.0355 which provides that the Executive Commissioner of HHSC shall adopt rules establishing the roles and responsibilities of local intellectual and developmental disability authorities.

The new sections implement Texas Government Code §531.0055 and Texas Health and Safety Code §533.0356, §571.006, §534.052, §591.004, and §533A.0355.

§306.351.Purpose.

The purpose of this subchapter is to require the use and maintenance of the Texas Health and Human Services Commission (HHSC) Psychiatric Drug Formulary.

§306.352.Application.

(a) This subchapter applies to HHSC facilities, HHSC-funded community behavioral health centers (including substance use treatment providers), local authorities, and their respective contractors for medications and medication-related services funded by HHSC. The HHSC Psychiatric Drug Formulary in its entirety applies to all HHSC facilities in all circumstances except when HHSC transfers an individual to a general hospital to receive non-mental health acute care services.

(b) HHSC facilities and local authorities are responsible for drafting contracts with their contractors that provide HHSC-funded medications and medication-related services to ensure that contractors comply with this subchapter.

§306.353.Definitions.

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.

(1) Adverse drug reaction--Any response to a drug that is noxious and unintended and occurs at doses normally used in humans.

(2) Contractor--An entity that provides HHSC-funded mental health services pursuant to a contract with a service system component or HHSC.

(3) Drug entity--A specific chemical compound and all its pharmaceutically equivalent salt forms that are used in the diagnosis, cure, mitigation, treatment or prevention of disease.

(4) Emergency--A situation in which it is immediately necessary to administer medication to an individual to prevent:

(A) imminent probable death or substantial bodily harm to the individual because the individual:

(i) overtly or continually is threatening or attempting to commit suicide or serious bodily harm; or

(ii) is behaving in a manner that indicates that the individual is unable to satisfy the individual's need for nourishment, essential medical care, or self-protection; or

(B) imminent serious physical or emotional harm to others as indicated by threats, attempts, or other acts the individual overtly or continually makes or commits.

(5) HHSC--Texas Health and Human Services Commission.

(6) HHSC facility--A facility operated by HHSC, including state hospitals and state supported living centers.

(7) HHSC Psychiatric Drug Formulary--A listing by nonproprietary name of all drugs approved for use by service system components and their contractors that is updated annually, at a minimum.

(8) Individual--Any person receiving services from a service system component or contractor.

(9) Interim Formulary Update--An update to the HHSC Psychiatric Drug Formulary, which is incorporated into the HHSC Psychiatric Drug Formulary.

(10) Local authority--A local mental health authority designated in accordance with Texas Health and Safety Code, §533.035(a), a local behavioral health authority designated in accordance with Texas Health and Safety Code, §533.0356, and a local intellectual and developmental disability authority designated in accordance with Texas Health and Safety Code §533A.035(a).

(11) Mental health services--Any services concerned with the diagnosis, treatment, and care of individuals for a mental illness (known as serious emotional disturbance in reference to children and adolescents), which may be accompanied by a co-occurring diagnosis.

(12) PEFC--Psychiatric Executive Formulary Committee. A committee composed of representatives from the state hospitals, state supported living centers, community behavioral health entities, and others as selected by the state hospitals associate commissioner in consultation with the state supported living center associate commissioner, the behavioral health services associate commissioner, and the intellectual and developmental services associate commissioner. The committee is responsible for the formulation of broad professional policies regarding the evaluation, selection, handling, use, administration, and all other matters relating to the use of drugs and devices in an HHSC facility, local authority, and their respective contractors for medications and medication-related services funded by HHSC.

(13) Pharmacy and Therapeutics Committee--An HHSC facility committee composed of physicians, pharmacists, registered nurses, and others as selected by the facility head, or their designee, that assists in the formulation of broad professional policies regarding the evaluation, selection, distribution, handling, use, administration, and all other matters relating to the use of drugs and devices in the facility.

(14) Practitioner--A person who acts within the scope of a professional license to prescribe, distribute, administer, or dispense a prescription drug or device, (e.g. a physician, registered nurse, advanced practice registered nurse, physician assistant, licensed vocational nurse, pharmacist, or dentist).

(15) Reserve drug--A formulary drug with specific guidelines for use as described in the HHSC Psychiatric Drug Formulary.

(16) Service system component--HHSC, an HHSC facility, and a local authority.

§306.354.General Requirements.

(a) HHSC maintains a closed formulary (HHSC Psychiatric Drug Formulary) that lists drugs approved by the PEFC for use by service system components and their contractors.

(b) A drug is not available for general use by service system components or their contractors unless it is approved by the PEFC. Drugs not listed in the HHSC Psychiatric Drug Formulary or Interim Formulary Update may not be used except under the limited circumstances described in §306.359 of this subchapter (relating to Prescribing Non-formulary Drugs).

(c) The use of formulary drugs in unusual clinical situations or the use of unusual drug combinations must be accompanied by written justification in the individual's medical record. Additional clinical consultation in these situations should occur as deemed necessary by the prescribing physician.

(d) Reserve drugs may be prescribed for use outside the guidelines described in the formulary if the prescription is justified in the individual's medical record and reviewed in audits of reserve drug use conducted by the service system component as clinically indicated.

(e) Drug research conducted at an HHSC facility is governed by 25 TAC Chapter 414, Subchapter P (relating to Research in TDMHMR Facilities). Local authorities conducting drug research must comply with all applicable state and federal laws, rules, and regulations, including 45 CFR Part 46, as required by §301.325 of this title (relating to Rights and Protection).

§306.355.Organization of HHSC Psychiatric Drug Formulary.

(a) Drugs are listed in the HHSC Psychiatric Drug Formulary by their nonproprietary names. The list is based on a modified format of the American Hospital Formulary Service Drug Information and includes an alphabetical index. The use of proprietary names, which may follow in parentheses, is for information purposes only and is not meant to be an endorsement. Cost comparisons and prescribing information are provided as determined necessary by the PEFC. The HHSC Psychiatric Drug Formulary provides tables summarizing the recommended dosage ranges for the psychotropic drugs for clinician reference. These tables are intended as guidelines and are not intended to replace other references or the clinician's clinical judgment. Clinicians should consult the approved Food and Drug Administration product labeling or other clinical resources on the appropriate prescribing of psychoactive medications. The HHSC Psychiatric Drug Formulary notes limitations recommended by the PEFC regarding the use of a drug, including specific limitations or guidelines for the use of a reserve drug.

(b) The Interim Formulary Update conforms to the same format as the HHSC Psychiatric Drug Formulary and shall be incorporated into the annual HHSC Psychiatric Drug Formulary.

§306.356.Responsibilities of the Psychiatric Executive Formulary Committee.

(a) The PEFC maintains and updates the HHSC Psychiatric Drug Formulary by:

(1) recommending standards of drug use that discourage unnecessary duplication of therapeutic alternatives and encourage the highest standards of medical and pharmacy practice;

(2) periodically reviewing the drugs listed in the formulary to ensure consistency with need, effectiveness, risk, and cost;

(3) consulting with experts in clinical pharmacy, pharmacology, and other medical specialties as necessary to objectively assess drugs under consideration; and

(4) considering the applications submitted in accordance with §306.357 of this subchapter (relating to Adding a Drug to the HHSC Psychiatric Drug Formulary) or as:

(A) presented by committee members; or

(B) submitted by other qualified persons at the invitation of the PEFC chairperson.

(b) The PEFC may make other recommendations concerning drug use and policy.

(c) Approval of a drug entity for inclusion in the HHSC Psychiatric Drug Formulary does not imply approval of all formulations for that drug. The PEFC designates the formulations that are allowed for general use by service system components and their contractors.

(d) Approval of a drug formulation constitutes approval of all brands of the product that have been proven to be bioequivalent as listed in the then-current Approved Drug Products with Therapeutic Equivalence Evaluations, published by the United States Food and Drug Administration.

(e) For a drug entity that has known bioequivalency problems, the PEFC may limit its use to a specific brand based on objective clinical pharmacokinetic data.

§306.357.Adding a Drug to the HHSC Psychiatric Drug Formulary.

(a) Applying to have a drug added to the HHSC Psychiatric Drug Formulary.

(1) Any member of the PEFC, any service system component practitioner, or any contract practitioner may apply to have a drug added to the HHSC Psychiatric Drug Formulary by completing the New Drug Application form found in the HHSC Psychiatric Drug Formulary on the HHSC Psychiatric Formulary website.

(2) Include the following with the New Drug Application form:

(A) published articles in biomedical literature that substantiate the efficacy and safety of the proposed drug;

(B) information on the advantages of the proposed drug compared with similar formulary drugs;

(C) a list of formulary drugs that the proposed drug would replace or supplement; and

(D) cost effectiveness data.

(b) Submitting the application.

(1) An HHSC facility practitioner or HHSC facility contract practitioner shall submit the application to the facility's pharmacy and therapeutics committee for approval. If the committee approves the application, the committee forwards the application to the PEFC.

(2) A non-facility service system component practitioner or non-facility service system component contract practitioner shall submit the application to the component's clinical/medical director or designee who determines if the application is appropriate and complete, and if so, shall forward the application to the PEFC.

(3) A member of the PEFC shall submit the application directly to the PEFC.

(c) Considering the application. The PEFC considers the drug application and shall:

(1) approve the proposed drug's inclusion and, if appropriate, approve audit criteria and recommend dosage guidelines;

(2) approve the proposed drug on a trial basis for a specified period of time;

(3) approve the proposed drug as a reserve drug, with guidelines;

(4) postpone the decision until a later meeting; or

(5) deny the proposed drug's inclusion.

§306.358.Changing the HHSC Psychiatric Drug Formulary.

(a) Changes to the HHSC Psychiatric Drug Formulary are based on need, effectiveness, risk, and cost as contained in current and unbiased biomedical literature.

(b) The HHSC Psychiatric Drug Formulary is updated and published once a year, at a minimum. Quarterly updates to the HHSC Psychiatric Drug Formulary, if any, will be listed in an Interim Formulary Update.

§306.359.Prescribing Non-formulary Drugs.

(a) Non-formulary drugs may be prescribed:

(1) if no formulary drug exists that is as safe or effective in the specified situation;

(2) if a limited trial of the drug appears to be safer or more effective than any drug listed in the formulary and the prescribing practitioner anticipates applying to have the drug added to the formulary;

(3) if the course of therapy established prior to the individual's admission to the facility where he or she is being treated would be interrupted; or

(4) in an emergency.

(b) Each local authority shall develop and enforce written policies and procedures for monitoring and approving the prescribing of non-formulary drugs by its practitioners and contract practitioners.

(c) HHSC shall develop and enforce written policies and procedures for monitoring and approving the prescribing of non-formulary drugs by HHSC facility practitioners and facility contract practitioners.

§306.360.Adverse Drug Reactions.

(a) Each local authority shall develop written policies and procedures for reporting adverse drug reactions to the Food and Drug Administration.

(b) HHSC shall develop written policies and procedures for HHSC facilities for reporting adverse drug reactions to the Food and Drug Administration.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on October 6, 2020.

TRD-202004161

Karen Ray

Chief Counsel

Health and Human Services Commission

Earliest possible date of adoption: November 22, 2020

For further information, please call: (512) 206-5084