PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 37. MATERNAL AND INFANT HEALTH SERVICES
SUBCHAPTER P. SURVEILLANCE AND CONTROL OF BIRTH DEFECTS
The Executive Commissioner of the Health and Human Services Commission on behalf of the Department of State Health Services (department) proposes amendments to §§37.301 - 37.306, concerning the surveillance and control of birth defects.
BACKGROUND AND PURPOSE
The birth defects program was established by Health and Safety Code, Chapter 87, to monitor birth defects; to collect reports of and maintain a registry of birth defects; and to conduct "investigations to determine the nature and extent of the disease, or the known or suspected cause of the birth defect and to formulate and evaluate control measures to protect the public health."
Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 37.301 - 37.306 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.
SECTION-BY-SECTION SUMMARY
Amendments to §§37.301, 37.302, 37.304, and 37.306 clarify and improve the rule language in order to strengthen the requirements of the program. The amendment to §37.303(10)(I) adds "a clinical or medical laboratory" to the types of health facility definitions. Amendments to §37.303(14) and §37.305(d) add new language to provide guidance for remote electronic access active data collection.
FISCAL NOTE
Lucina Suarez, Ph.D., Director, Environmental Epidemiology and Disease Registries Section, has determined that for the first five-year period the sections are in effect, there will be no fiscal implications to state or local government as a result of enforcing or administering the sections as proposed, because there is no cost impact to state or local government.
ECONOMIC IMPACT STATEMENT AND REGULATORY FLEXIBILITY ANALYSIS FOR SMALL AND MICRO-BUSINESSES
Dr. Suarez has also determined that there will be no adverse economic impact on small businesses or micro-businesses required to comply with the sections as proposed. This was determined by interpretation of the rules that small businesses and micro-businesses will not be required to alter their business practices in order to comply with the sections. An economic impact statement and regulatory flexibility analysis are not required.
ECONOMIC IMPACT TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT
There are no anticipated economic costs to persons who are required to comply with the sections as proposed. There is no anticipated impact on local employment.
PUBLIC BENEFIT
In addition, Dr. Suarez has also determined that for each year of the first five years the sections are in effect, the public will benefit by added clarity to the definitions. The amendments allow the department to collect data in a more efficient and convenient manner. The amendments clarify the department's policies and procedures regarding access to data and the allowed research use of the data.
In adopting the rules which cover this program, the department has considered the known incidence and prevalence rates of birth defects in the state; the known incidence and prevalence rates of particular birth defects in specific population groups who live in the state or portions of the state; the morbidity and mortality resulting from these birth defects; and the existence, cost, and availability of a strategy to prevent and treat these birth defects.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "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 environment 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
The department has determined that the proposed amendments do 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, do not constitute a taking under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Mark Canfield, Ph.D., Department of State Health Services, MC 1964, P.O. Box 149347, 1100 West 49th Street, Austin, Texas 78714-9347, telephone (512) 458-7232, fax (512) 458-7330. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The amendments are authorized by Health and Safety Code, §87.001, which allows the department to specify which health facilities are required to report information on birth defects; §87.021(d), which requires the department to adopt rules to govern the operation of the program and carry out the intent of the statute; §87.022(b) and (c), which requires the department to adopt rules on how information is made available to the department; §87.063(a), which requires the department to adopt rules to establish criteria to be used in deciding if research which proposes to use birth defect data should be approved; and the Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rules implements Government Code, §2001.039.
The amendments affect Health and Safety Code, Chapters 87 and 1001; and Government Code, Chapter 531.
§37.301.Purpose.
These sections implement the provisions of
Health and Safety Code, Chapter 87, [
to the Health and Safety Code. Chapter 87] that provides [the
Texas Board of Health with] the authority to adopt rules relating
to the surveillance and control of birth defects. The legislation
directs the Texas Department of Health to develop a statewide surveillance
program. The Texas Department of Health and the Texas Board of Health
were abolished by Chapter 198, §§1.18 and 1.26, 78th Legislature,
Regular Session, 2003. Health and Safety Code, Chapter 1001, establishes
the Department of State Health Services (department), which now administers
these programs. Government Code, §531.0055, provides authority
to the Executive Commissioner of the Health and Human Services Commission
to adopt rules for the department.
§37.302.Policy.
(a) The department, recognizing the sensitive and confidential
nature of information collected regarding birth defects and their
possible causes, expects [shall expect] all
staff to carry out all duties in a professional, compassionate, and
culturally sensitive manner.
(b) The department shall [It is the
policy of the program to] limit medical researcher contact with
individuals and families identified by the central registry to only
those studies with high scientific merit with no feasible alternate
means of conducting the study.
(c) The department shall [It is also
the policy of the program to
] protect patient information from
disclosure through the legal process and Government Code, Chapter 552.
§37.303.Definitions.
The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.
(1) - (9) (No change.)
(10) Health facility--Any of the following types of facility:
(A) - (F) (No change.)
(G) a physician peer review organization; [or]
(H) a birthing center; or [.]
(I) a clinical or medical laboratory.
(11) - (13) (No change.)
(14) Surveillance--The systematic collection, analysis, interpretation, and dissemination of health data on an ongoing basis.
(A) Active surveillance--program staff regularly contact or visit data sources, or use remote electronic access, to find and collect data on cases.
(B) (No change.)
(15) (No change.)
§37.304.Confidentiality of Information Provided to the Department.
(a) (No change.)
(b) The department may release demographic, medical, epidemiological, or toxicological information:
(1) (No change.)
[(2) to the case management program
of the department for guidance in applying for financial or medical
assistance available through existing state and federal programs,
if appropriate;]
(2) [(3)] with the consent of
each person identified in the information or, if the person is unable
to consent or is a minor, the minor's parents, managing conservator,
guardian, or other person who is legally authorized to consent;
(3) [(4)] to medical personnel,
appropriate state agencies, health authorities, regional directors,
and public officers of counties and municipalities relating to the
identification, monitoring, and referral of children with birth defects;
(4) [(5)] to appropriate federal
agencies such as the Centers for Disease Control and Prevention of
the United States Public Health Service;
(5) [(6)] to medical personnel
to the extent necessary to protect the health or life of the child
identified in the information; or
(6) [(7)] to medical researchers
conducting bona fide medical research under the conditions described
in §37.306 of this title (relating to Access to Information in
the Central Registry), and Health and Safety Code, §87.063.
§37.305.Surveillance of Birth Defects: Central Registry.
(a) - (c) (No change.)
(d) Interaction between department staff and health
facility staff [at facilities] is detailed below:
(1) The chief operating officer, administrator, manager,
director, and/or person in charge of each facility or office or center
shall appoint one staff member as the contact person for the central
registry surveillance activities. That staff member will coordinate
scheduled visits and/or remote electronic access by central
registry staff to review logs, discharge indices and other case-finding
sources, and will be responsible for arranging visits and/or
remote electronic access for medical records review [
visits] and providing the needed records at the time [
of the] scheduled [visit].
(2) (No change.)
(3) Central registry staff and the contact individual
shall establish a general schedule of visits and/or remote electronic
access for case-finding and record review [visits].
This schedule shall take into account the capabilities of the health
care facility in responding to requests, as well as the expected needs
of the central registry workload.
(e) (No change.)
§37.306.Access to Information in the Central Registry.
(a) (No change.)
(b) After the program manager receives the completed request for information, the protocol will be reviewed by a program review panel. The panel shall consist of the program manager, the unit manager, and a departmental epidemiologist. Upon approval by the program panel, the protocol shall be evaluated and judged by the department's institutional review board. Final approval of the protocol shall require the approval of both the program panel and the institutional review board and shall be based on an evaluation of the criteria listed in subsection (c) of this section. The department's institutional review board shall evaluate the research based on federal regulations found in Title 45, Code of Federal Regulations, Chapter 46.
(c) - (i) (No change.)
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on July 30, 2009.
TRD-200903219
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 13, 2009
For further information, please call: (512) 458-7111 x6972
The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes the repeal of §§61.1 - 61.4, 61.6 - 61.9, 61.13, and 61.14, and new §§61.1 - 61.11 concerning Kidney Health Care (KHC).
BACKGROUND AND PURPOSE
The program for KHC serves Texas residents with end-stage renal disease (ERSD) diagnosis, who are not Medicaid eligible. The program contracts with providers to deliver covered services, including Medicare Part D premiums, deductibles, and co-insurance, travel reimbursement for ESRD related services, and allowable dialysis and access surgery benefits.
The proposed repeals and new rules strengthen eligibility requirements for benefits, reorganize and update information, delete and revise language, and make grammatical corrections to improve flow, accuracy, and clarity.
Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 61.1 - 61.4, 61.6 - 61.9, 61.13, and 61.14 have been reviewed, and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.
SECTION-BY-SECTION SUMMARY
New §61.1 groups the terms "purpose," "confidentiality of information," and "forms" together.
New §61.2 includes new definitions for terms used in this subchapter which include administrative review; client; date of service; denial; effective date; filing deadline; KHC formulary; low income subsidy; medical benefit; Medicare advantage plan; Medicare Part A; Medicare Part B; Medicare Part D; Medicare Prescription Drug Plan; Medigap plan; modification; program; qualified individual and Medicare beneficiary; reimbursement; specified low income Medicare beneficiary, and termination.
New §61.3 clarifies client eligibility requirements, financial criteria, and residency requirements.
New §61.4 clarifies the client application process and eligibility dates requirements.
New §61.5 clarifies existing language, includes new language regarding access to benefits by Veterans Administration clients, and sets out conditions for KHC benefits and limitations.
New §61.6 clarifies provider enrollment criteria and effective dates.
New §61.7 includes language regarding claims submission and payment rates.
New §61.8 includes language regarding claims filing deadlines.
New §61.9 includes language regarding rights and responsibilities for applicants, clients, and providers.
New §61.10 includes language regarding modifications, suspensions, denials, and terminations for applicants, clients, and providers.
New §61.11 restores language regarding the appeal process and describes the process for administrative reviews and fair hearing requests.
FISCAL NOTE
Jann Melton-Kissel, RN, MBA, Director, Specialized Health Services Section, has determined that for each year of the first five-year period that the sections will be in effect, there will be no fiscal impact to state or local governments as a result of enforcing and administering the sections as proposed. The repeals and new sections are intended to clarify, update, and strengthen the subchapter, and are not anticipated to be controversial or have significant fiscal impact to the department or local government.
ECONOMIC IMPACT STATEMENT AND REGULATORY FLEXIBILITY ANALYSIS FOR SMALL AND MICRO-BUSINESSES
Ms. Melton-Kissel has also determined that there will be no effect on small businesses or micro-businesses required to comply with the sections as proposed, because neither small businesses nor micro-businesses that are providers of the KHC program will be required to alter their business practices in order to comply with the sections, and an economic impact statement and regulatory flexibility analysis are not required.
ECONOMIC COST TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT
There are no anticipated economic costs to persons who are required to comply with the sections as proposed. There is no anticipated negative impact on local employment.
PUBLIC BENEFIT
Ms. Melton-Kissel has determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections is improved accuracy and consistency in the rules, and more accurate interpretation of their intent. In addition, the new rules will allow the program to function more efficiently and effectively.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "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
The department 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 Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted by mail to Kathleen Ford, Purchased Health Services Unit, MC 1938, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347; by telephone at (512) 458-7111, extension 6836; or by email to kathleen.ford@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.
SUBCHAPTER A. KIDNEY HEALTH CARE PROGRAM
25 TAC §§61.1 - 61.4, 61.6 - 61.9, 61.13, 61.14
(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Department of State Health Services or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin, Texas.)
STATUTORY AUTHORITY
The repeals are authorized by Health and Safety Code, §42.003(c), which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules necessary to carry out Chapter 42 and to provide adequate kidney care and treatment for the citizens of this state; and Government Code, §531.0055(e), and the Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the sections implements Government Code, §2001.039.
The repeals affect Government Code, Chapter 531; and Health and Safety Code, Chapters 42 and 1001.
§61.1.General.
§61.2.Recipient Requirements.
§61.3.Residency and Residency Documentation Requirements.
§61.4.Applications.
§61.6.Limitations and Benefits Provided.
§61.7.Claims Submission and Payment Rates.
§61.8.Claim Filing Deadlines.
§61.9.Participating Providers.
§61.13.Forms.
§61.14.Confidentiality of Information.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on July 30, 2009.
TRD-200903220
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 13, 2009
For further information, please call: (512) 458-7111 x6972
The new rules are authorized by Health and Safety Code, §42.003(c), which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules necessary to carry out Chapter 42 and to provide adequate kidney care and treatment for the citizens of this state; and Government Code, §531.0055(e), and the Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the sections implements Government Code, §2001.039.
The new rules affect Government Code, Chapter 531; and Health and Safety Code, Chapters 42 and 1001.
§61.1.General.
(a) Purpose. The purpose of this subchapter is to establish rules for the Kidney Health Care (KHC) program. The authority for these rules is granted in the Texas Health and Safety Code, Chapter 42.
(b) Confidentiality of Information.
(1) All information submitted, as required by this subchapter, may be verified at the discretion of the Department of State Health Services (department) with or without notice to applicants, clients, or providers of KHC benefits or services. This information is confidential to the extent authorized by law.
(2) Information may be disclosed in summary, statistical, or other forms that do not identify particular individuals.
(c) Forms. The program provides approved forms to applicants, clients, and providers.
§61.2.Definitions.
The following words and terms when used in this subchapter shall have the following meanings, unless the context clearly indicates otherwise.
(1) Access surgery--The surgical procedure which creates or maintains the access site necessary to perform dialysis.
(2) Action--A suspension, modification, denial, or termination of KHC eligibility, benefits, or participation.
(3) Administrative review--A process that allows applicants, clients, or providers the opportunity to request an informal review of any intended program action that would suspend, modify, deny, or terminate their eligibility, benefits or participation in the program.
(4) Allowable amount--The maximum amount that the program will pay or reimburse for a covered benefit or service.
(5) Applicant--An individual who has submitted an application for KHC benefits and has not received a final determination of eligibility.
(6) Claim--A request for payment or reimbursement of services.
(7) Client--A person who has applied for program services and who meets all KHC eligibility requirements and is determined to be eligible for program services.
(8) CMS--The Centers for Medicare and Medicaid Services.
(9) Co-insurance--A cost-sharing arrangement in which a covered person is responsible for paying a specified percentage of the charge for a covered service or product.
(10) Commissioner--The commissioner of the Department of State Health Services.
(11) Co-pay/Co-payment--A cost-sharing arrangement in which a covered person is responsible for paying a specified or fixed charge for a covered service or product.
(12) CRNA--Certified registered nurse anesthetist.
(13) Date of service (DOS)--The date a service is rendered.
(14) Denial--An action by the program that disallows program eligibility, benefits, or administrative review requests.
(15) Department--Department of State Health Services.
(16) Effective date--The initial date of eligibility for a KHC client or provider.
(17) End-Stage Renal Disease (ESRD)--The final stage of renal impairment that requires dialysis and/or kidney transplant to reduce uremic symptoms and/or prevent the death of the patient.
(18) EOB--A form, in paper or electronic format, which provides an explanation of benefits. It is used to explain a payment or denial of a claim.
(19) Fair hearing--The informal hearing process the department follows under §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).
(20) Filing deadline--The last date that a claim may be received by the program and still be considered eligible for benefit.
(21) Final decision--A decision that is made by a decision maker after conducting a fair hearing under §§1.51 - 1.55 of this title.
(22) Interim approval--The status given by the program to an outpatient dialysis facility, free-standing or hospital-based, which has applied for participation as a KHC provider but has not executed an agreement with the program.
(23) KHC--Kidney Health Care.
(24) KHC formulary--A list of general therapeutic categories of drugs, over-the-counter products, and limited diabetic supplies that are covered for reimbursement by the program.
(25) Low Income Subsidy (LIS)--The subsidy provided under the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003 for Medicare Part D plan premiums and related costs, at varying levels, for some low-income Medicare beneficiaries.
(26) Medical benefit--Any medical treatment or procedure approved by the program as a covered service.
(27) Medicare Advantage Plan--A Medicare health plan that is similar to a health maintenance organization, participating provider organization, or other Medicare health plan, and includes medical, drug coverage and other benefits.
(28) Medicare Part A--Hospital insurance for people age 65 or older, or under age 65 with certain disabilities, that helps cover inpatient hospital stays, care in a skilled nursing facility, hospice care, and some home health care.
(29) Medicare Part B--Health insurance for people age 65 or older, or under age 65 with certain disabilities, and any age with ESRD, that helps cover medically necessary services, such as doctors' services and outpatient care, and some preventive services.
(30) Medicare Part D--Established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), it provides members with prescription drug coverage, expanded health plan options, improved health care access for rural Americans, and preventive care services.
(31) Medicare Part D out-of-pocket expenses--Include premiums, deductibles, and co-insurance amounts.
(32) Medicare Part D Premium--The amount paid monthly under a Medicare Part D contract to insure coverage.
(33) Medicare Prescription Drug Plan (PDP)--A stand-alone drug plan offered by insurers and other private companies to individuals eligible for Medicare Part D.
(34) Medigap plan--A Medicare supplement insurance policy sold by private insurance companies to fill "gaps" in Medicare coverage.
(35) Modification--A change made to a client's record that affects a program benefit or eligibility status.
(36) Program--Kidney Health Care Program.
(37) Provider--Any individual or entity approved by the program to furnish covered services to KHC clients including:
(A) outpatient dialysis facilities;
(B) out-of-state outpatient dialysis facilities;
(C) hospitals and ambulatory surgical centers (ASCs) located in Texas and operating in compliance with applicable law;
(D) out-of-state hospitals and ASCs;
(E) military or Veterans Administration hospitals located in Texas which have a renal unit approved by the Joint Commission on Accreditation of Healthcare Organizations or the American Osteopathic Association;
(F) pharmacies approved as Texas Medicaid providers and licensed to operate within the United States and its territories, including mail order pharmacies;
(G) physicians and certified registered nurse anesthetists (CRNAs) licensed in Texas;
(H) out-of-state physicians and CRNAs; and
(I) Medicare Prescription Drug Plan (PDP) and Medicare Advantage Plan (MA-PD) providers.
(38) Qualified Individual (QI)--A Medicaid program for beneficiaries who need help in paying for Medicare Part B premiums. The beneficiary must have Medicare Part A and limited income and resources and not be otherwise eligible for Medicaid. For those who qualify, the Medicaid program pays full Medicare Part B premiums only.
(39) Qualified Medicare Beneficiary (QMB)--A Medicaid program for beneficiaries who need help in paying for Medicare services. The beneficiary must have Medicare Part A and limited income and resources. For those who qualify, the Medicaid program pays Medicare Part A premiums, Part B premiums, and Medicare deductibles and coinsurance amounts for Medicare services.
(40) Reimbursement--Payment of a claim for allowable services or transportation.
(41) Reimbursement rate--The KHC payment rate for allowable products, services, and transportation determined annually for the following fiscal year.
(42) Specified Low Income Medicare Beneficiary (SLMB)--A Medicaid program that pays for Medicare Part B premiums for individuals who have Medicare Part A, a low monthly income, and limited resources.
(43) Suspension--Eligibility for benefits which is held without final action pending satisfaction of a program request or requirement.
(44) Termination--A final action by the program, which ends client or provider participation in the KHC program.
§61.3.Client Eligibility Requirements.
(a) A person shall meet all of the following requirements to be eligible for KHC benefits:
(1) have a diagnosis of ESRD; and
(A) require a regular course of chronic renal dialysis treatments; or
(B) have received a kidney transplant;
(2) satisfy the Texas residency criteria as specified in subsection (b) of this section and not be:
(A) in the custody of or incarcerated by a city, county, state, or federal entity; or
(B) a ward of the state;
(3) not be eligible for drug, transportation, and medical benefits under the Texas Medicaid Program;
(4) submit a complete application for benefits; and
(5) satisfy the financial criteria as specified in subsection (c) of this section.
(b) Residency Requirements.
(1) The following conditions must be met by an applicant and maintained by a client to satisfy the residency requirements in this section:
(A) physically reside within the state; and
(B) maintain a home or dwelling within the state.
(2) If the applicant is residing with a person establishing residency on behalf of the applicant (such as a parent, legal guardian, managing conservator, sibling, adult child, or spouse), then that person must meet all of the requirements of paragraph (1) of this subsection.
(3) All documents acceptable to meet residency requirements, as specified by the program, must be in the applicant's name, or in the name of the person establishing residency for the applicant, provide some verification of a Texas address or domicile, and be in English or be accompanied by an accurate English translation.
(c) Financial Criteria. The applicant or the person(s) who has a legal obligation, as defined by state law, to support the applicant must have an annual gross income of less than $60,000. Income reported as "joint income" is considered as one income.
(d) Maintenance of Benefits Eligibility.
(1) A client must meet the following requirements within the first 3 months of KHC eligibility:
(A) apply for medical, drug, and transportation benefits and Medicare Savings Plans (QMB, SLMB and QI) under Title XIX, Social Security Act (Medicaid);
(B) apply for Medicare hospital and medical benefits under Title XVIII, Social Security Act (Medicare);
(C) enroll in Medicare Part D benefits and apply for Low Income Subsidy under the Medicare Prescription Drug Improvement and Modernization Act of 2003, if Medicare eligible;
(D) provide authorization for Medicare premium payments by the program as specified in §61.5 of this title (relating to Benefits and Limitations), if obligated to pay the Part A premium.
(2) A client must meet the following requirements to continue benefit eligibility:
(A) continue premium payments on health insurance plans under Medicare, individual or group health insurance plans, and prepaid medical plans, where enrollment was effective prior to KHC eligibility;
(B) re-apply for LIS annually;
(C) re-apply for Medicaid annually;
(D) re-apply for Medicare hospital and medical benefits as requested by the program if there are changes in the client's status that would make the client potentially eligible for Medicare benefits; and
(E) notify the program within 30 days of changes in the following:
(i) permanent home address;
(ii) treatment status;
(iii) insurance coverage; and
(iv) location of treatment.
§61.4.Applications.
Persons meeting the eligibility requirements set forth in §61.3(a) - (c) of this title (relating to Client Eligibility Requirements) must make a complete application for benefits.
(1) A complete application must include all of the following:
(A) a complete and notarized Application for Benefits, with the applicant's, or the applicant's representative's, original signature or "mark;"
(B) a copy of the completed, signed and dated Centers for Medicare and Medicaid Services (CMS) End-Stage Renal Disease Medical Evidence Report;
(C) documentation of Texas residency as required by §61.3 of this title;
(D) a copy of the applicant's social security card issued by the Social Security Administration (SSA), or an allowable substitute, as follows:
(i) a copy of a SSA document which verifies the social security number; or
(ii) a copy of a valid Medicare card, if the Medicare account is established in the applicant's own social security number and the social security number is printed on the Medicare card.
(E) applicant's financial data. The applicant or the person(s) legally obligated to support the applicant must verify income by providing one of the following:
(i) a copy of the first page of the federal individual income tax return for the most recent tax year; or
(ii) a statement of estimated or declared income for the current tax year, and supporting documentation, if requested.
(2) Incomplete application. An application which does not meet all of the requirements of paragraph (1) of this section is incomplete. Incomplete applications may be returned to the submitting person or entity for correction or completion.
(3) Eligibility date for KHC benefits. The KHC eligibility date is the date the program receives a complete application.
(4) If KHC benefits are terminated, the eligibility date for any subsequent benefit period is the date the program receives a subsequent complete application for KHC benefits.
(5) An applicant whose eligibility for benefits is denied may appeal under §61.11 of this title (relating to Rights of Appeal).
§61.5.Benefits and Limitations.
(a) Benefits.
(1) Outpatient drugs and drug products listed on the current KHC formulary.
(2) Transportation reimbursement for ESRD-related medical services.
(3) Medical benefits, including:
(A) access surgery-related services; and
(B) chronic maintenance dialysis.
(4) Medicare Part A and B premium payment. To qualify for this benefit, clients must:
(A) be 65 years of age or older;
(B) be accepted for Medicare hospital and medical insurance;
(C) be obligated to pay the Part A premium;
(D) not be eligible for the following types of Medicare savings programs:
(i) QMB;
(ii) SLMB; or
(iii) QI; and
(E) promptly submit all Medicare premium due notice statements to the program for payment.
(5) Medicare Part B immunosuppressive drug co-insurance amounts. To qualify for this benefit, clients must:
(A) be eligible for KHC drug benefits;
(B) be accepted for Medicare hospital and medical insurance;
(C) enroll in a Texas Medicare Part D Stand-Alone Plan;
(D) not be enrolled in a Medigap plan;
(E) not be enrolled in a Medicare Advantage Plan with drug coverage; and
(F) not be eligible for the following types of Medicare Savings Programs:
(i) QMB;
(ii) SLMB; or
(iii) QI.
(6) Limited Medicare Part D out-of-pocket expenses. To qualify for this benefit, clients must:
(A) be eligible for KHC drug benefits;
(B) be accepted for Medicare Part D benefits;
(C) enroll in a Texas Medicare Part D stand-alone plan;
(D) not be eligible for LIS from Medicare that covers full premium and deductible amounts; and
(E) not be enrolled in a Medicare Advantage Plan with drug coverage.
(7) Benefits are payable beyond the qualifying period for eligible clients who have applied for and have been denied Medicare coverage based on ESRD. Clients must submit a copy of the official Social Security Administration Medicare denial notification (based on chronic renal disease) to the department.
(b) Limitations.
(1) Only out-of-state providers approved by the program may provide covered services and KHC allowable drugs.
(2) Covered services are limited to a maximum allowable amount per client based upon:
(A) available funds;
(B) established limits for covered services by type or category;
(C) an agreement between the department and the client's provider;
(D) the reimbursement rates established by the department;
(E) any co-payment or co-insurance applied to client service benefits; and
(F) any third-party liability.
(3) Clients eligible for drug coverage under an individual or group health insurance plan are not eligible to receive KHC drug benefits. A client that has exhausted drug coverage under an individual or group health insurance plan may be eligible to receive drug benefits from the program.
(4) Access surgery benefits are payable only if the services are performed on or after the date Texas residency is established and not more than 180 days prior to the client's KHC eligibility effective date.
(5) KHC medical benefits are payable during the Medicare three-month qualifying period. Benefits are payable for services received on or after the client's KHC eligibility effective date. The three-month qualifying period is calculated from the first day of the month the client begins chronic maintenance dialysis. When a client becomes eligible for Medicare during the three-month period, KHC medical benefits are not payable from the date of Medicare eligibility.
(6) Transportation reimbursement is available from the first day of the month following the KHC eligibility effective date for in-center dialysis clients or from the KHC effective date for transplant and home peritoneal dialysis clients.
(7) Clients eligible for hospital and medical benefits from Medicare, or other government programs which cover the treatment of ESRD are not eligible to receive KHC medical benefits.
(8) Clients receiving services, including access surgery, dialysis, or drug benefits through the Veterans Administration (VA) or the military may not be eligible to receive these services through the program, depending on the client's access to VA or military services.
(9) Clients eligible for hospital and medical benefits from private/group health insurance which covers the treatment of ESRD are not eligible for KHC medical benefits.
(10) The program is the payor of last resort. All third parties must be billed prior to the program. The Commissioner may waive this requirement in individually considered cases where its enforcement will deny services to a class of ESRD patients because of conflicting state or federal laws or regulations, under the Texas Health and Safety Code, §42.009.
(11) If budgetary limitations exist, the department may:
(A) restrict or categorize covered services. Categories will be prioritized based upon medical necessity, other third party eligibility and projected third party payments for the different treatment modalities, caseloads, and demands for services. Caseloads and demands for services may be based on current and/or projected data. In the event covered services must be reduced, they will be reduced in a manner that takes into consideration medical necessity and other third party coverage. The department may change covered services by adding or deleting specific services, entire categories or by making changes proportionally across a category or categories, or by a combination of these methods; or
(B) establish a waiting list of eligible applicants. Information will be collected from each applicant who is placed on a waiting list to facilitate contacting the applicant when benefits become available and to allow efficient enrollment of the applicant for benefits.
§61.6.Provider Requirements and Effective Dates.
(a) Requirements.
(1) Outpatient dialysis facilities must:
(A) execute an agreement with the program;
(B) have Medicare certification and a Medicare ESRD provider number;
(C) be a current Texas Medicaid provider;
(D) be licensed by the department as an ESRD facility;
(E) reimburse the program for any overpayments upon request; and
(F) not be on suspension as a KHC provider, as a Texas Medicaid provider, as a Medicare certified ESRD facility, or as a licensed Texas ESRD facility.
(2) An out-of-state outpatient dialysis facility must:
(A) meet all the requirements in paragraph (1)(A) - (C) and (E) of this subsection;
(B) be licensed by its state, if applicable;
(C) be a Medicaid provider in its state; and
(D) not be on suspension as a KHC provider, as a Texas Medicaid provider, as a Medicaid provider in its state, as a Medicare-certified ESRD facility, or by the ESRD licensing authority of its state.
(3) Any outpatient dialysis facility may be given interim approval according to the following:
(A) client applications for KHC benefits may be submitted by the facility during the period of interim approval.
(B) interim approval extends no longer than six months from the date the program mails the agreement to the facility.
(C) if interim approval lapses, the unexecuted agreement is nullified and a new agreement with term dates and the period of interim approval may be initiated by the program.
(D) claims for outpatient dialysis services shall not be considered for payment by the program until the program has a fully executed agreement with the facility.
(E) claim filing deadlines apply, as contained in §61.8 of this title (relating to Claim Filing Deadlines).
(4) A pharmacy, including a mail order pharmacy, must execute an agreement as a KHC provider through the Health and Human Services Commission Pharmacy Contracts and Rebates unit or designated contractor.
(5) A physician or CRNA must:
(A) execute an agreement with the program;
(B) be licensed to practice medicine in the State of Texas, if a physician;
(C) be certified to practice within the scope of his or her certification in the State of Texas, if a CRNA;
(D) be a Texas Medicaid provider;
(E) not be on suspension as a KHC provider, as a physician licensed to practice medicine in the State of Texas, as a CRNA certified to practice within the scope of the certification in the State of Texas, or as a Texas Medicaid provider; and
(F) reimburse the program for any overpayments upon request.
(6) An out-of-state physician and a CRNA must:
(A) meet all the requirements in paragraph (5)(A), (D) and (F) of this subsection;
(B) be licensed to practice medicine in the state in which services are provided, if a physician; or
(C) be certified to practice within the scope of his or her certification in the state in which services are provided, if a CRNA; and
(D) not be on suspension as a KHC provider, as a Texas Medicaid provider, as a physician licensed to practice medicine in the state in which services are provided, as a CRNA certified to practice within the scope of the certification in the state in which services are provided.
(7) A hospital or ambulatory surgical center (ASC) must:
(A) execute an agreement with the program;
(B) be in compliance with all applicable laws to provide hospital or ASC services in the State of Texas;
(C) be a current Texas Medicaid provider;
(D) have Medicare certification;
(E) not be on suspension as a KHC provider, as a hospital authorized under applicable law to provide hospital services in the State of Texas, as an ASC licensed to provide ASC services in the State of Texas, as a Texas Medicaid provider, or as a Medicare certified hospital or ASC; and
(F) reimburse the program for any overpayments upon request.
(8) An out-of-state hospital or ASC must:
(A) meet all the requirements in paragraph (7)(A), (C), (D) and (F) of this subsection;
(B) be licensed to provide hospital or ASC services in the state in which services are provided;
(C) not be on suspension as a KHC provider, as a Texas Medicaid provider, as a Medicaid provider in its state, as a hospital licensed to provide hospital services in the state in which services are provided, as an ASC licensed to provide ASC services in the state in which services are to be provided, or as a Medicare certified hospital or ASC;
(9) A Medicare Prescription Drug Plan (PDP) must:
(A) execute an agreement with the program;
(B) be Medicare approved as a PDP and maintain approval;
(C) share and exchange data in an acceptable format with the program for the coordination of drug benefits under the Medicare PDP (Part D);
(D) accept a program payment for premiums; and
(E) reimburse the program for any overpayments upon request.
(b) Effective dates.
(1) The effective date of all outpatient dialysis facility agreements shall be on or after the Medicare ESRD certification date.
(2) The effective date of all pharmacy agreements shall be determined by the Health and Human Services Commission Pharmacy Contracts and Rebates unit or its designated contractor.
(3) The effective date of all other provider agreements, listed in subsection (a)(5) - (9) of this section, shall be the first day of the sixth month prior to the program's receipt of the completed and signed provider agreement.
§61.7.Claims Submission and Payment Rates.
(a) Drug benefit claims must be submitted electronically by the pharmacy to the designated claims processor for the program, except when paper submissions are allowed or required.
(b) Medical benefit claims must be submitted to the program by the provider who rendered the service(s) to the KHC client.
(c) Transportation benefit claims must be submitted to the program by the client or the provider performing outpatient dialysis services. Claims must be submitted electronically through the Automated System for Kidney Information Tracking (ASKIT), or any other designated claims payment system, except when the program allows or requires paper submissions.
(d) Payments are made using the rates in effect on the date the service is rendered, and not prospectively.
(e) Incomplete or incorrect claims will not be considered for payment. Claims which are not received by the program within the deadlines established in §61.8 of this title (relating to Claim Filing Deadlines) will be denied payment.
§61.8.Claim Filing Deadlines.
(a) The program must receive all claims for transportation reimbursement, hospital, out-patient dialysis, and access surgery services, within the claim filing deadlines established in this section.
(1) Claims must be received no later than 95 days from the last day of the month in which services were provided.
(2) Claims must be received no later than 60 days from the date on the program's notice of eligibility for newly approved clients.
(b) In addition to the requirements in subsection (a) of this section, the program must receive claims for out-patient dialysis and access surgery services within 60 days from the date on the agreement approval letter for newly approved providers, but no later than 180 days from the date of service.
(c) The program must receive all billing statements for Medicare Part D premium benefits from eligible PDPs within 95 days from the last day of each month for which the premium coverage applies.
(d) The program must receive resubmitted claims within the deadlines established under subsections (a) - (c) of this section, or within 30 days from the date of the program's return letter or the program's EOB, whichever is later. Resubmitted claims must:
(1) be resubmitted with a copy of the program's return letter or the program's EOB, if applicable;
(2) be resubmitted on the original claim form, if applicable; and
(3) contain no new or additional charges for service.
(e) Pharmacies must submit claims for drug charges to the designated claims processor for the program in accordance with claim filing deadlines contained in 1 Texas Administrative Code, §354.1901, (relating to Pharmacy Claims).
§61.9.Rights and Responsibilities.
(a) The applicant and client shall have the right to:
(1) apply for eligibility determination;
(2) choose providers subject to KHC limitations;
(3) be notified of the program's decisions relating to modifications, suspensions, denials, or terminations;
(4) appeal the program's decisions and receive a response within the deadline as described in §61.11 of this title (relating to Rights of Appeal); and
(5) assurance that all information concerning his or her status as an applicant or client shall be confidential in the manner and to the extent authorized by law.
(b) Providers shall have the right to:
(1) be notified of the program's decision relating to modifications, suspensions, denials, or terminations; and
(2) assurance that all information concerning the provider's program status shall be confidential in the manner and to the extent authorized by law.
(c) The applicant and client shall have the responsibility to:
(1) provide accurate medical information to providers and notify providers of KHC eligibility prior to delivery of services;
(2) abide by KHC rules and policies; and
(3) notify the program of any lawsuit(s) contemplated or filed concerning the cause of the medical condition for which the program has made payment.
(d) The provider shall have the responsibility to:
(1) enroll as a KHC provider and submit a completed application to the program, including all documents requested;
(2) abide by the program rules and policies;
(3) not discriminate against applicants or clients based on source of payment; and
(4) notify the program of any lawsuit(s) contemplated or filed concerning the cause of the medical condition for which the program has made payment.
§61.10.Modifications, Suspensions, Denials, and Terminations.
(a) An applicant's or client's eligibility for benefits may be modified, suspended, or denied for failing to comply with the applicant and client responsibilities listed in §61.3 of this title (relating to Client Eligibility Requirements) and §61.9(c) of this title (relating to Rights and Responsibilities).
(b) A provider's participation may be modified, suspended or denied for failing to comply with the provider responsibilities listed in §61.6(a) of this title (relating to Provider Requirements and Effective Dates) and §61.9(d) of this title.
(c) A client's eligibility may be terminated for any of the following reasons:
(1) failing to maintain Texas residency or to furnish evidence upon demand of residency using the criteria in §61.3 of this title;
(2) failing to continue to meet the income requirements for eligibility or to provide income data as requested by the department to determine continued KHC eligibility;
(3) failing to reimburse the department as requested for overpayments made to the client;
(4) failing to apply for medical, drug, and transportation benefits under Title XIX, Social Security Act (Medicaid);
(5) becoming eligible for drug, transportation, and medical benefits under the Medicaid Program;
(6) regaining native kidney function;
(7) voluntarily discontinuing treatment for ESRD;
(8) becoming incarcerated by or in the custody of a city, county, state, or federal entity;
(9) becoming a ward of the state;
(10) determination by the program that the client made a material misstatement or misrepresentation on their application or any document required to support their application;
(11) determination by the program that the client submitted false claim(s); or
(12) lack of a claim for benefits paid by the program on behalf of the client for a minimum period of 12 consecutive months.
(d) Any action taken under subsections (a) or (c) of this section does not relieve the client, or the person(s) with legal obligation to support the client, of any financial obligation owed to the program.
(e) An applicant must reapply for KHC benefits when eligibility for KHC benefits is terminated.
(f) A client who loses eligibility will not be reinstated until all outstanding debts owed to the program by the client are paid or arrangements acceptable to the program are made for payment.
(g) A client whose benefits are modified or suspended, or whose eligibility is terminated, may appeal the program's decision under §61.11 of this title (relating to Rights of Appeal).
(h) A provider's participation may be terminated or suspended for any of the following reasons:
(1) loss of approval or exclusion from participation in the Medicare program;
(2) exclusion from participation in the Medicaid program;
(3) providing false or misleading information regarding any participation criteria;
(4) material breach of any contract or agreement with the program;
(5) filing false or fraudulent information or claims for KHC benefits;
(6) failure to submit a payable claim to the program during a minimum period of 12 consecutive months; or
(7) failure to maintain the participation criteria contained in §61.6(a) of this title.
(i) Providers may appeal a termination or suspension under §61.11 of this title.
§61.11.Rights of Appeal.
(a) Administrative Review.
(1) When the program modifies, suspends, denies, or terminates eligibility or benefits, the program shall give written notice of and the reason for the action. Applicants, clients, and providers have the right to request an administrative review of the action within 30 days of the notice date.
(2) If the program does not receive a written request for administrative review within 30 days of the notice date, applicants, clients, and providers waive the right to the administrative review process.
(3) If a written request for administrative review is received within 30 days of the notice date, the program conducts an administrative review of the circumstances surrounding the action. The program must give written notice of the decision including the supporting reasons, within 30 days of receiving all information required to make a determination regarding the request for an administrative review.
(4) The department establishes the KHC reimbursement rates. Clients and providers may not request an administrative review of reimbursement amounts for claims that are paid in accordance with the reimbursement rates as described in §61.5 of this title (relating to Benefits and Limitations).
(b) Fair Hearing.
(1) Applicants, clients, and providers who disagree with a program administrative review decision may request a fair hearing in writing addressed to Kidney Health Care, Purchased Health Services Unit, MC 1938, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347, within 20 calendar days following the date of receipt of the administrative review decision notice.
(2) If the fair hearing request is not received within 20 calendar days following the date of the receipt of the administrative review decision notice, the program will presume the fair hearing process has been waived, and the program may take final action.
(3) A fair hearing shall be conducted in accordance with §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).
(4) The program may not terminate KHC participation until a final decision is rendered under the department's fair hearings process.
(5) The program may withhold claims payment pending final decision under the department's fair hearings process.
(6) The program must release any withheld payments and reinstate participation if the final determination is in favor of the provider.
(7) The program shall not enter into, extend, or renew an agreement with a provider until a final decision is rendered under the department's fair hearings process.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on July 30, 2009.
TRD-200903221
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 13, 2009
For further information, please call: (512) 458-7111 x6972
The Executive Commissioner of the Health and Human Services Commission on behalf of the Department of State Health Services (department) proposes the repeal of §229.172 and new §229.172 concerning the accreditation of certified food management programs, and the repeal of §229.176 and new §229.176 concerning the certification of food managers.
BACKGROUND AND PURPOSE
The purpose of the repeals and new §229.172 and §229.176 is to reflect the decision to remove the department as one of the approved certified food manager examination providers. Neither the statutes nor the repealed rules require the department to provide an examination. The department's decision not to provide examinations required changes to the rules. The repeal and new rules are also a result of the Certified Food Managers (CFM) Program utilizing the recommendations of the Sunset Occupational Licensing Model (model). Through its history of reviewing occupational licensing agencies dating back to 1977, the Sunset Commission has observed standard practices that guide such matters as agency structure, the oversight they receive, and their approach to licensing and enforcement. The compilation of these standard practices provides a model for evaluating occupational licensing agencies to see if they are efficient, effective, fair, and accountable in their mission to protect the public. The model states that for any written exam, an agency should use a national or regional testing service and not prepare its own test. A testing service eliminates bias and uses validated questions. It also promotes standardization of licensing requirements nationwide and helps simplify the movement of licensees from state to state.
The Conference for Food Protection (CFP) has developed the essential components of a nationally recognized food manager certification examination. The components outline the criteria for the development of food safety certification examinations, which includes psychometric standards, job analysis, internal security, periodic review and examination administration. The American National Standards Institute (ANSI) is the reviewing organization for companies that choose to achieve ANSI-CFP accreditation. At this time, the department licenses three companies that meet ANSI-CFP accreditation standards. The department also licenses two Internet certification examination providers that meet department rule requirements.
SECTION-BY-SECTION SUMMARY
The repeal and new §229.172 concern the accreditation of food management programs, to reflect the decision that the department will no longer be an examination provider in Texas. References in the new section have been updated throughout to reflect this change.
Concerning new §229.172(b), the following definitions are deleted as a result of the department not being one of the approved Certified Food Manager examination providers, so these terms are no longer necessary: "Examination administrator," "Proctor," "Psychometric," "Secure," and "Traceable means." The following definition is added for clarification, "On-site examination." Minor grammatical changes are made for clarification.
The repeal and new §229.176 concern the certification of food managers, to reflect the decision that the department will no longer be an examination provider in Texas, and adds new §229.176(g) concerning Internet examination development and additional reporting requirements for Internet examination providers. References in the new section reflect these changes.
Concerning new §229.176(b), the following definitions are deleted as a result of the department not being one of the approved Certified Food Manager examination providers, so these terms are no longer necessary: "Examination administrator," "Nonprofit organization," "Proctor," Psychometric," "Secure," and "Traceable means." The following definitions are added, "Internet examination," and "On-site examination." Minor grammatical changes are made for clarification.
FISCAL NOTE
Susan Tennyson, Section Director, Environmental and Consumer Safety Section, has determined that for the first five-year period that the rules are in effect, there will be no fiscal implications to the state or local governments as a result of implementing the sections as proposed.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Ms. Tennyson has also determined that there will not be adverse impacts to small businesses or micro-businesses that elect to voluntarily comply with the sections as proposed. This was determined by interpretation of the rules that small businesses and micro-businesses will not be required to alter their business practices in order to comply with the sections. The proposed rules address the licensing requirements for accredited training programs and examination sites. The repeals and new §229.172 and §229.176 remove obsolete rule provisions and clarify existing provisions without imposing new requirements. There are no anticipated economic costs to persons who are required to comply with the sections as proposed. There is no anticipated negative impact on local employment.
ECONOMIC IMPACT STATEMENT AND REGULATORY FLEXIBILITY ANALYSIS
The purpose of these rules is to provide the framework for accrediting food manager food safety programs in accordance with the Health and Safety Code, Chapter 438, Subchapters D and G. A uniform standard governing the accreditation of food safety programs enhances the recognition of reciprocity among regulatory agencies and reduces the expense of duplicate education incurred when food establishment managers work in multiple regulatory jurisdictions. New §229.172 and §229.176 establish the standards for the education or the demonstration of knowledge for food establishment managers. This provides more qualified personnel, thereby reducing the risk of foodborne illness outbreaks caused by improper food preparation and handling techniques. The state accreditation of a program or test site is voluntary.
Ms. Tennyson has determined that some small businesses and micro-businesses are subject to regulation under the proposed rules. However, no additional economic burden is associated with the proposed rules so no adverse economic impact to small businesses or micro-businesses is anticipated. Therefore, an economic impact statement and regulatory flexibility analysis for small businesses and micro-businesses are not required.
PUBLIC BENEFIT
In addition, Ms. Tennyson has also determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of these sections. The public benefit anticipated as a result of administering the sections as proposed is improved practices and increased knowledge of food safety within the food service industry, resulting in a lesser risk of contracting a foodborne illness due to training of food service workers in nationally recognized principles and standards.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "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
The department has determined that the proposed repeals and new rules do 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, do not constitute a taking under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Deborah Marlow, Food Establishments Group, Policy/Standards/Quality Assurance Unit, Division for Regulatory Services, Environmental and Consumer Safety Section, Department of State Health Services, Mail Code 1987, P.O. Box 149347, Austin, Texas 78714-9347 (512) 834-6753, extension 2023, or by email to ione.wenzel@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.
PUBLIC HEARING
A public hearing to receive comments on the proposal will be scheduled after publication in the Texas Register, and will be held at the Department of State Health Services, Exchange Building, 8407 Wall Street, Austin, Texas 78754. The meeting date will be posted on the Food Establishments Group website (www.dshs.state.tx.us/foodestablishments). Please contact Ione Wenzel at (512) 834-6753, extension 2138, or ione.wenzel@dshs.state.tx.us if you have questions.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.
SUBCHAPTER K. TEXAS FOOD ESTABLISHMENTS
(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Department of State Health Services or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin, Texas.)
STATUTORY AUTHORITY
The repeals are authorized by Health and Safety Code, Chapter 438, which provides the Executive Commissioner of the Health and Human Services Commission with authority to adopt rules and guidelines relating to §438.042, food service programs, §438.102, certification of food managers, §438.043, basic food safety accreditation, and §437.0076(b), certified food manager; and Government Code, §531.0055(e), and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.
The repeals affect the Health and Safety Code, Chapters 437, 438, and 1001; and Government Code, Chapter 531.
§229.172.Accreditation of Certified Food Management Programs.
§229.176.Certification of Food Managers.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on July 29, 2009.
TRD-200903210
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 13, 2009
For further information, please call: (512) 458-7111 x6972
STATUTORY AUTHORITY
The new rules are authorized by Health and Safety Code, Chapter 438, which provides the Executive Commissioner of the Health and Human Services Commission with authority to adopt rules and guidelines relating to §438.042, food service programs, §438.102, certification of food managers, §438.043, basic food safety accreditation, and §437.0076(b), certified food manager; and Government Code, §531.0055(e), and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.
The new rules affect the Health and Safety Code, Chapters 437, 438, and 1001; and Government Code, Chapter 531.
§229.172.Accreditation of Certified Food Management Programs.
(a) Purpose. This section is intended to provide the framework for accrediting manager level food safety training programs in accordance with the Health and Safety Code, Chapter 438, Subchapter D, Food Service Programs. A uniform standard governing the accreditation of food safety programs enhances the recognition of reciprocity among regulatory agencies and reduces the expense of duplicate education incurred when food establishment managers work in multiple regulatory jurisdictions. Education of the food establishment manager provides more qualified personnel, thereby reducing the risk of foodborne illness outbreaks caused by improper food preparation and handling techniques.
(b) Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise.
(1) Accredited certified food manager training program--A certified food manager training and testing program approved by the department that meets the standards set forth in this section.
(2) Alternative training methods--Training other than classroom, including but not limited to distance learning, computerized training programs, and correspondence courses.
(3) ANSI-CFP Program Accreditation--Accreditation by the American National Standard Institute (ANSI) and the Conference for Food Protection (CFP), which accredit programs as outlined in the CFP: Standards for Accreditation of Food Protection Manager Certification Programs.
(4) Certificate--The documentation issued by a department-approved ANSI-CFP Program examination licensee verifying that an individual has complied with the requirements of this section.
(5) Certification--The process whereby a certified food manager certificate is issued.
(6) Certified food manager--A person who has demonstrated that he or she has the knowledge, skills and abilities required to protect the public from foodborne illness by means of successfully completing a certified food manager examination and becoming certified as described in this section.
(7) Certified food manager examination--A department-approved ANSI-CFP Program accredited on-site examination for food manager certification.
(8) Certified food manager program; certified food management program--A training program accredited by the department that provides food safety education for food establishment managers and administers a certified food manager examination for certification or recertification purposes.
(A) Certification program--A certified food manager program whose course work consists of a minimum of 14 hours of instruction on food safety topics which may include traditional or alternative methods of training, including distance education, and at least a one-hour certified food manager examination.
(B) Recertification program--A certified food manager program whose course work consists of a minimum of six hours of instruction on food safety topics, which may include traditional or alternative methods of training, including distance education, and a certified food manager examination.
(9) Continuing education--Documented professional education or activities that provide for the continued proficiency of a certified food management program instructor.
(10) Department--Department of State Health Services.
(11) Food--A raw, cooked, or processed edible substance, ice, beverage or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.
(12) Food establishment--
(A) Food establishment means an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption:
(i) such as a restaurant; retail food store; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and
(ii) that relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.
(B) Food establishment includes:
(i) an element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; and
(ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location; where consumption is on or off the premises; and regardless of whether there is a charge for the food.
(C) Food establishment does not include:
(i) an establishment that offers only prepackaged foods that are not potentially hazardous;
(ii) a produce stand that only offers whole, uncut fresh fruits and vegetables;
(iii) a food processing plant;
(iv) a kitchen in a private home if only food that is not potentially hazardous is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law;
(v) an area where food that is prepared as specified in clause (iv) of this subparagraph is sold or offered for human consumption;
(vi) a Bed and Breakfast Limited facility as defined in these rules; or
(vii) a private home that receives catered or home-delivered food.
(13) Law--Applicable local, state and federal statutes, regulations and ordinances.
(14) Licensee--The individual, corporation or company that is licensed by the department to operate certified food management programs.
(15) On-site examination--An ANSI-CFP Program accredited paper and computer-based examination for food manager certification administered by a certified food manager program.
(16) Person--An association, corporation, partnership, individual, or other legal entity, government or governmental subdivision or agency.
(17) Qualified instructor--An individual whose educational background and work experience meet the requirements for approval as a qualified food management program instructor as described in this section.
(18) Reciprocity--Acceptance by state and local regulatory authorities of a department-approved certified food manager certificate.
(19) Regulatory authority--The local, state, or federal enforcement body or authorized representative having jurisdiction over the food establishment.
(20) Single entity--A corporation that educates only its own employees.
(21) Sponsor--An individual designated in writing to the department, by the licensee, as the person responsible for administrative management of the certified food manager program.
(22) Two-Year Renewal Certificate--The certificate issued by the department from May 6, 2004 to April 24, 2008, verifying that a certified food manager has completed the application and submission of fees for renewal of a department-issued certificate.
(c) Certified food manager.
(1) Certified food manager responsibilities. Responsibilities of a certified food manager include:
(A) identifying hazards in the day-to-day operation of a food establishment that provides food for human consumption;
(B) developing or implementing specific policies, procedures or standards aimed at preventing foodborne illness;
(C) coordinating, training, supervising or directing food preparation activities, and taking corrective action as needed to protect the health of the consumer;
(D) training the food establishment employees on the principles of food safety; and
(E) conducting in-house self-inspections of daily operations on a periodic basis to ensure that policies and procedures concerning food safety are being followed.
(2) Certification by training and food safety examination. To be certified, a food manager shall complete an accredited certified food management certification or recertification program and pass a certified food manager examination.
(3) Certificate reciprocity. Department-approved food manager certificates shall be recognized statewide by regulatory authorities as the only valid proof of successful completion of a department-accredited certified food management program.
(4) Certificate availability. The original certified food manager certificate shall be posted in a location in the food establishment that is conspicuous to consumers.
(d) Certification program course curriculum. A certification program shall include a minimum of 14 hours of food safety training utilizing the training and time requirements in Health and Safety Code, §438.043(a).
(e) Recertification program course curriculum. A recertification training program shall include a minimum of six hours of food safety training.
(f) Requirements for qualification of instructors. The instructors for all certified food management programs shall be department-qualified prior to teaching a class. The instructors for all certified food management programs shall meet the qualifications in these rules. Instructors meeting these qualifications shall be approved for the two-year permit term of the certified food management program licensee. The completed application form shall be submitted to the department through the accredited certified food management program licensee.
(1) New instructors. A completed application for new instructors shall be submitted by the program licensee to the department with the following documentation:
(A) the completed and signed application form;
(B) a copy of a valid food management certificate; and
(C) verification of education or experience in food safety documented by one of the following:
(i) an associate or higher college degree from an accredited institution in a major related to food safety or environmental health, evidenced by a copy of the candidate's diploma or transcript;
(ii) five years of food establishment work experience as a food manager verified in an attached resume; or
(iii) two years of regulatory food inspection experience verified in an attached resume.
(2) Nationally accredited program instructors. Nationally accredited program instructors who have met the minimum standards as set forth by this section shall be given reciprocity when instructing and administering an ANSI-CFP Program Accreditation examination.
(g) Responsibilities of qualified instructors.
(1) Compliance with certified food management program laws and rules. All qualified instructors are responsible for compliance with applicable certified food management program laws and rules.
(2) Training requirements. All qualified instructors are responsible for instructing the course content as specified in subsection (o)(3) of this section, and meeting the training time requirements as specified in subsection (n)(6) of this section.
(h) Requirements for the renewal of qualified instructors. In order to renew an instructor's qualification, the program licensee shall comply with the requirements of this subsection.
(1) Contact hours for continuing education. Certified food management programs shall submit a renewal application and documentation of five contact hours of continuing education for each instructor during the two-year certified food manager program license period to maintain qualification as a certified food manager program instructor.
(2) Accepted continuing education topics. Continuing education topics may include areas in food safety or instruction enhancement.
(3) Verification of continuing education. The following may be used for continuing education:
(A) a certificate of completion for a course or seminar with the participant's name, course name, date and number of contact hours earned;
(B) a college transcript with course description; or
(C) other documentation of attendance as approved by the department.
(i) On-site examination. ANSI-CFP Program accredited food safety certification examinations shall be the only department-approved paper and computer-based certified food manager examinations.
(j) Certified food manager certificates.
(1) General certificate issuance. Certificates shall be issued by the department-approved examination provider. Candidates whose certificates are issued after successful passage of a department-approved examination shall be deemed to meet the requirements for food manager certification.
(2) Certificate period. A certified food manager certificate issued by a department-approved examination provider under this section shall comply with the CFP Standards for Accreditation of Food Protection Manager Certification Programs, §7.3, Effective Date of Certificate, as amended, 2008, at http://www.foodprotect.org/managers-certification/.
(3) Recertification. Candidates may become recertified by taking a recertification class and passing a department-approved examination, or by passing an examination as described in §229.176(i)(3) of this title (relating to Certification of Food Managers).
(4) Certification through single entity corporations. Candidates from accredited single entity corporations may receive food manager certificates as described in this section, except that the food manager certificate shall:
(A) clearly indicate that the certificate is valid for food manager duties performed for the single entity only;
(B) be recognized by regulatory authorities for only that single entity; and
(C) not receive reciprocity or recertification.
(k) Department certificate.
(1) Two-year renewal certificate. Certified food manager certificates issued by the department from May 6, 2004 to April 24, 2008, shall be renewed every two years and may be renewed two times.
(2) Department certificate replacement. An individual requesting a certified food manager certificate replacement shall submit a completed written application to the department with the appropriate non-refundable fee. Replacement certificates will bear the same expiration date as the original certificate.
(l) Department certificate fees.
(1) Two-year renewal certificate fee. The fee for renewal of a two-year certificate issued shall be $10.
(2) Replacement certificate fee. A replacement certificate fee for the department examination shall be $15.
(3) Texas Online Authority fee. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.
(m) Licensing of single entity certified food management programs. In addition to the licensing requirements as specified in subsection (n) of this section, a corporation wishing to use a single entity option, which offers course length and topic requirements as specified in Health and Safety Code, §438.043(a), shall submit to the department:
(1) a copy of the course syllabus; and
(2) a copy of the course curriculum.
(n) Licensing of certified food management program licensee. The department shall issue a license of accreditation to each certified food management program licensee who has demonstrated compliance with this section. A license issued under these rules shall expire two years from the date of issuance. This license is not transferable on change of ownership, name, or site location.
(1) Application. A person wishing to apply for a certification or recertification certified food management program license shall submit a completed application to the department.
(2) Security agreement. The licensee shall submit a signed security agreement that individual examination items, examination item banks, certified food manager certification examinations, examination answer sheets, and candidate scores shall be secure at all times, and during administration that the examinations shall remain secure.
(3) Certified food management program license fee. The completed license application shall include the appropriate non-refundable fee as specified in subsection (p)(1) of this section.
(4) Sponsor. The licensee may designate a certified food manager program sponsor as the person responsible for the administrative management of the program.
(5) Qualified instructor. The licensee shall provide a list of all qualified food management program instructors who plan to teach an accredited certification or recertification course to the department. A completed instructor application, along with other necessary documentation shall be submitted for all non-qualified instructors.
(6) Course syllabus. The licensee shall provide a course syllabus to the department verifying the minimum of 14 hours of training for a certification program as specified in subsection (d) of this section and a minimum of six hours of training for a recertification program as specified in subsection (e) of this section. The training methods shall be designated on the application. A course curriculum shall be available for review to verify the course syllabus.
(7) Certification examination. Department-approved examination(s) utilized by the certified food management programs shall be designated on the completed application.
(o) Responsibilities of a licensee.
(1) Compliance with certified food management program laws and rules. The licensee is responsible for compliance with applicable certified food management program laws and rules.
(2) Payment of fees. All fees shall be non-refundable and paid as specified in subsection (p) of this section.
(3) Certified food management program course content. All certified food management programs shall be taught utilizing the training and time requirements in Health and Safety Code, §438.043(a).
(4) Change of sponsor. The licensee shall notify the department in writing of the name of the new program sponsor.
(5) Change of qualified instructor. The licensee shall ensure that only a department-qualified instructor serves as the instructor for the certified food management program. All new instructors shall complete the application for new instructors that shall be submitted by the licensee to the department with the applicable documentation. Licensees shall instruct all new instructors on the applicable laws and rules and administrative responsibilities.
(p) Required fees. All fees are payable to the Department of State Health Services and are non-refundable. Licensees shall submit fees with the appropriate form that relates to the fee category. A current license shall only be issued when all past due fees and late fees are paid for all years of operation in Texas. The fees shall be:
(1) Certified food manager program license fee for initial, renewal, or change of ownership. The certified food manger program license fee shall be $600 for a two-year license for each certification or recertification program.
(2) Certified food manager program amended license fee. Program amendment fees shall be $300 for each certification or recertification program.
(3) Late fee. Certified food manager licensees submitting a completed renewal application to the department after the expiration date shall pay an additional $100 as a late fee.
(4) Texas Online Authority fee. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.
(q) Certified food management program registry. The department shall maintain a program registry of all accredited certification and recertification programs. The registry shall be made available on the department website.
(r) Department audits. Audits of examination and classroom may be conducted to assess program compliance. Audits may be based on analysis of data compiled by the department. The licensee shall allow personnel authorized by the department access for the purposes of an audit.
(s) Denial, suspension and revocation of program accreditation. An accredited food manager program license may be denied, suspended or revoked for the following reasons:
(1) breach of the security agreement;
(2) delinquency in payment of fees as described in this section; or
(3) violation of the provisions of this section.
(t) Denial, suspension and revocation procedures. Denial, suspension and revocation procedures under this section shall be conducted in accordance with the Administrative Procedure Act, Government Code, Chapter 2001.
(u) Suspension of License Relating to Child Support and Child Custody.
(1) On receipt of a final court order or attorney general's order suspending a license due to failure to pay child support or for failure to comply with the terms of a court order providing for the possession of or access to a child, the department shall immediately determine if a license has been issued to the obligator named and:
(A) record the suspension of the license in the department's records;
(B) report the suspension as appropriate; and
(C) demand surrender of the suspended license.
(2) The department shall implement the terms of a final court or attorney general's order suspending a license without additional review or hearing. The board will provide notice as appropriate to the licensee or to others concerned with the license.
(3) The department may not modify, remand, reverse, vacate, or stay a court or attorney general's order suspending a license issued under the Family Code, Chapter 232, and may not review, vacate, or reconsider the terms of an order.
(4) A licensee who is the subject of a final court or attorney general's order suspending his or her license is not entitled to a refund for any fee paid to the department.
(5) If a suspension overlaps a license renewal period, an individual with a license suspended under this section shall comply with the normal renewal procedures in the Act and this chapter; however, the license will not be renewed until subsections (l) and (m) of this section are met.
§229.176.Certification of Food Managers.
(a) Purpose. This section is intended to provide the framework of certification requirements for food managers in accordance with Health and Safety Code, Chapter 438, Subchapter G, Certification of Food Managers, supports demonstration of food safety knowledge, thereby reducing the risk of foodborne illness outbreaks caused by improper food preparation and handling techniques.
(b) Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise.
(1) ANSI-CFP Program Accreditation--Accreditation by the American National Standards Institute (ANSI) and the Conference for Food Protection (CFP), which accredit programs as outlined in the CFP: Standards for Accreditation of Food Protection Manager Certification Programs.
(2) Certificate--The documentation issued by a department-approved Internet examination provider licensee or an ANSI-CFP Program examination licensee verifying that an individual has complied with the requirements of this section.
(3) Certification--The process whereby a certified food manager certificate is issued.
(4) Certified food manager--A person who has demonstrated that he or she has the knowledge, skills and abilities required to protect the public from foodborne illness by means of successfully completing a certified food manager examination and becoming certified as described in this section.
(5) Certified food manager examination--A department-approved Internet examination or an ANSI-CFP Program accredited on-site examination for food manager certification.
(6) Department--Department of State Health Services.
(7) Examination site--The physical location at which the department-approved examination is administered.
(8) Food--A raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.
(9) Food establishment--
(A) Food establishment means an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption:
(i) such as a restaurant; retail food store; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and
(ii) that relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.
(B) Food establishment includes:
(i) an element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; and
(ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location; where consumption is on or off the premises; and regardless of whether there is a charge for the food.
(C) Food establishment does not include:
(i) an establishment that offers only prepackaged foods that are not potentially hazardous;
(ii) a produce stand that only offers whole, uncut fresh fruits and vegetables;
(iii) a food processing plant;
(iv) a kitchen in a private home if only food that is not potentially hazardous is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law;
(v) an area where food that is prepared as specified in clause (iv) of this subparagraph is sold or offered for human consumption;
(vi) a Bed and Breakfast Limited facility as defined in these rules; or
(vii) a private home that receives catered or home-delivered food.
(10) Internet examination--A department-approved examination delivery system utilizing the Internet for food manager certification.
(11) Law--Applicable local, state and federal statutes, regulations and ordinances.
(12) Licensee--The individual, corporation, or company that is licensed by the department to administer a department-approved examination for food manager certification.
(13) On-site examination--An ANSI-CFP Program accredited paper and computer-based examination for food manager certification administered by a certified food manager program.
(14) Person--An association, corporation, partnership, individual or other legal entity, government or governmental subdivision or agency.
(15) Personal validation question--A question designed to establish the identity of the candidate taking a certified food manager examination by requiring an answer related to the candidate's personal information such as a driver's license number, address, date of birth, or other similar information that is unique to the candidate.
(16) Reciprocity--Acceptance by state and local regulatory authorities of a department-approved certified food manager certificate.
(17) Regulatory authority--The local, state, or federal enforcement body or authorized representative having jurisdiction over the food establishment.
(18) Two-Year Renewal Certificate--The certificate issued by the department from May 6, 2004 to April 24, 2008, verifying that a certified food manager has completed the application and submission of fees for renewal of a department-issued certificate.
(c) Certified food manager.
(1) Certified food manager responsibilities. Responsibilities of a certified food manager include:
(A) identifying hazards in the day-to-day operation of a food establishment that provides food for human consumption;
(B) developing or implementing specific policies, procedures or standards aimed at preventing foodborne illness;
(C) coordinating training, supervising or directing food preparation activities and taking corrective action as needed to protect the health of the consumer;
(D) training the food establishment employees on the principles of food safety; and
(E) conducting in-house self-inspection of daily operations on a periodic basis to ensure that policies and procedures concerning food safety are being followed.
(2) Certification by a food safety examination. To be certified, a food manager shall pass a department-approved Internet examination or an accredited ANSI-CFP Program on-site examination.
(3) Certificate reciprocity. A certificate issued to an individual who successfully completes a department-approved examination shall be accepted as meeting the training and examination requirements under Health and Safety Code, §438.046(b).
(4) Certificate availability. The original food manager certificate shall be posted in a location in the food establishment that is conspicuous to consumers.
(d) On-site examination. ANSI-CFP Program accredited food safety certification examinations shall be the only department-approved paper and computer-based examinations.
(e) Internet examinations. A department-approved examination utilizing the Internet for delivery shall meet the examination criteria outlined in this section.
(f) Responsibilities for Internet examination providers.
(1) Compliance with food manager laws and rules. Internet examination providers are responsible for compliance with food manager laws and rules applicable to Internet examinations in this section.
(2) Examination Security Agreement. Internet examination providers shall submit the department security agreement signed by the certified food manager Internet examination provider licensee.
(3) Examination security. Candidates taking Internet examinations shall be advised on the application that outside training materials or assistance shall not be used during administration of the examination and that appropriate measures shall be taken to assure that the examination is not compromised.
(g) Internet examination development. Internet examination development shall meet the criteria established by the CFP Standards for Accreditation of Food Manager Certification Programs, §4.0, Food Safety Certification Examination Development, as amended, 2008, at http://www.foodprotect.org/managers-certification/.
(1) Examination questions. Internet examinations shall consist of a minimum of 75 statistically valid questions that are administered at one time following any voluntary training that may precede the examination.
(2) Examination forms. Each candidate shall receive a unique form of the examination with regard to question sequence.
(3) Time allotment for non-proctored Internet examination providers. Time allotted for administration of non-proctored examinations shall not exceed 90 minutes.
(h) Internet examination administration.
(1) Registration requirements for Internet examinations. The licensee shall register the candidates and require the candidates to:
(A) verify their identity;
(B) provide responses to ten personal validation questions; and
(C) maintain examination security.
(2) Licensee examination disclosure information. The licensee shall inform the candidate that:
(A) reference materials shall not be used during the examination;
(B) the candidate shall not receive assistance from anyone during the examination; and
(C) examination questions shall not be replicated in any fashion.
(3) Personal validation questions. The licensee shall verify a candidate's identity throughout the examination. The personal validation process shall include the following elements:
(A) a minimum of five personal validation questions selected from the ten questions provided during registration shall be incorporated at various times during the examination;
(B) the personal validation questions shall be randomly generated with respect to time and order;
(C) the same personal validation questions shall not be asked more than once during the same examination; and
(D) the examination session shall cease and the candidate shall be automatically exited from the examination if a candidate answers a personal validation question incorrectly.
(4) System support. The Internet examination provider licensee shall include the following Internet examination system capabilities and security measures:
(A) capability to browse or review previously completed examination questions;
(B) capability to navigate logically and systematically through the examination;
(C) technical support personnel for Internet examination issues;
(D) security of personal candidate information in transit and at rest;
(E) a back-up and disaster recovery system capability; and
(F) assurance that examination data is maintained in a secure and safe environment and readily available to the department.
(5) Reporting requirements for non-proctored Internet examination administrators. Internet examination administrators who administer examinations in non-proctored locations shall submit a semi-annual report to enable the department to evaluate examination security and system performance for each language in which the examination is offered. The report shall include:
(A) statistical data to enable measurement of central tendency, ranges of examination scores, standard deviation, standard error of measurement, and examination cut score;
(B) number of examinations administered;
(C) number and percentage of candidates passing the examination;
(D) number of personal validation questions used;
(E) number of examinations discontinued due to incorrect responses to personal validation questions; and
(F) statistics describing the performance of each item used on the examinations administered during the six-month period.
(i) Certified food manager certificates.
(1) General certificate issuance. Certificates shall be issued by the department-approved examination provider. Candidates whose certificates are issued after successful passage of a department-approved examination shall be deemed to meet the requirements for food manager certification.
(2) Certificate period. A certified food manager certificate issued by a department-approved examination provider under this section shall comply with the CFP Standards for Accreditation of Food Protection Manager Certification Programs, §7.3, Effective Date of Certificate, as amended, 2008, at http://www.foodprotect.org/managers-certification/.
(3) Recertification. Candidates may become recertified by passing a department-approved examination.
(j) Department certificates.
(1) Two-year renewal certificate. Food manager certificates issued by the department from May 6, 2004 to April 24, 2008, shall be renewed every two years and may be renewed two times.
(2) Department certificate replacement. An individual requesting a certified food manager certificate replacement shall submit a completed written application to the department with the appropriate non-refundable fee. Replacement certificates will bear the same expiration date as the original certificate.
(k) Department certificate fees. All fees are payable to the Department of State Health Services and are non-refundable. Fees shall be submitted with the appropriate form that relates to the fee category. A current license shall only be issued when all past due fees and late fees are paid for all years of operation in Texas. Fees shall be:
(1) Two-year renewal certificate fee. The fee for a two-year renewal certificate shall be $10.
(2) Replacement certificate fee. A replacement certificate fee for the department examination shall be $15.
(3) Texas Online Authority fee. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.
(l) Licensing of certified food manager licensee. The department shall issue a license to a certified food manager licensee meeting the requirements of this section. A license issued under these rules shall expire two years from the date of issuance. A license is not transferable on change of ownership, name, or examination site location.
(1) Application. Persons wishing to apply for a certified food manager license shall submit a completed application to the department.
(2) Security agreement. The licensee shall submit a signed security agreement stating that individual examination items, examination item banks, certified food manager certification examinations, examination answer sheets, and candidate scores shall be secure at all times, and during administration the examinations shall remain secure.
(3) Certified food manager licensee fee. The completed license application shall include the appropriate non-refundable fee as specified in subsection (n)(1) of this section.
(4) Certification examination. Department-approved examination(s) utilized by the certified food manager licensee shall be designated on the application.
(5) Number of examination sites utilized. The license application shall indicate the number of examination sites to be utilized under the certified food manager license.
(m) Responsibilities of licensee.
(1) Compliance with food manager laws and rules. The licensee is responsible for compliance with applicable food manager laws and rules.
(2) Payment of fees. All fees shall be non-refundable and paid as specified in subsection (n) of this section.
(n) Required fees. All fees are payable to the Department of State Health Services and are non-refundable. Fees shall be submitted with the appropriate form that relates to the fee category. A current license shall only be issued when all past due fees and late fees are paid for all years of operation in Texas. Fees shall be:
(1) Certified food manager licensee fee. Certified food manager licenses shall be valid for a two-year period and fees shall be based on the number of examination sites at which the licensee administers the examinations based on the following scale:
(A) one site:
(i) the two-year license fee for initial, renewal, or change of ownership shall be $400; and
(ii) a license fee for a program amendment during the current licensure period shall be $200;
(B) two to ten sites:
(i) the two-year license fee for initial, renewal, or change of ownership shall be $1,000; and
(ii) a license fee for a program amendment during the current licensure period shall be $500;
(C) over ten sites:
(i) the two-year license fee for initial, renewal, or change of ownership shall be $2,000; and
(ii) a license fee for a program amendment during the current licensure period shall be $1,000.
(2) Late fee. A certified food manager licensee submitting a completed renewal application to the department after the expiration date shall pay an additional $100 as a late fee.
(3) Texas Online Authority fee. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.
(o) Certified food manager licensee registry. The department shall maintain a registry of all certified food manager licensees. The registry shall be made available on the department website.
(p) Department audits. Audits of certified food manager licensees may be conducted to assess compliance with these rules. Audits may be based on analysis of data compiled by the department. Licensees shall allow personnel authorized by the department access for the purposes of an audit.
(q) Denial, suspension and revocation of certified food manager license. A certified food manager license may be denied, suspended or revoked for the following reasons:
(1) breach of the security agreement;
(2) delinquency in payment of fees as described in this section; or
(3) violation of the provisions of this section.
(r) Denial, suspension and revocation procedures. Denial, suspension and revocation procedures under this section shall be conducted in accordance with the Administrative Procedure Act, Government Code, Chapter 2001.
(s) Suspension of License Relating to Child Support and Child Custody.
(1) On receipt of a final court order or attorney general's order suspending a license due to failure to pay child support or for failure to comply with the terms of a court order providing for the possession of or access to a child, the department shall immediately determine if a license has been issued to the obligator named and:
(A) record the suspension of the license in the department's records;
(B) report the suspension as appropriate; and
(C) demand surrender of the suspended license.
(2) The department shall implement the terms of a final court or attorney general's order suspending a license without additional review or hearing. The board will provide notice as appropriate to the licensee or to others concerned with the license.
(3) The department may not modify, remand, reverse, vacate, or stay a court or attorney general's order suspending a license issued under the Family Code, Chapter 232, and may not review, vacate, or reconsider the terms of an order.
(4) A licensee who is the subject of a final court or attorney general's order suspending his or her license is not entitled to a refund for any fee paid to the department.
(5) If a suspension overlaps a license renewal period, an individual with a license suspended under this section shall comply with the normal renewal procedures in the Act and this chapter; however, the license will not be renewed until subsections (j) and (k) of this section are met.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on July 29, 2009.
TRD-200903211
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 13, 2009
For further information, please call: (512) 458-7111 x6972