PART 1. DEPARTMENT OF STATE HEALTH SERVICES
SUBCHAPTER E. CHILDREN'S OUTREACH HEART PROGRAM
The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes the repeal of §§61.71 - 61.83, and new §§61.71 - 61.83 concerning the Children's Outreach Heart Program (COHP).
BACKGROUND AND PURPOSE
The COHP provides prediagnostic cardiac screening and follow-up services to individuals less than 21 years of age who may have heart disease or defects. The COHP contractor provides routine clinic services, including a comprehensive history and physical exam, as well as laboratory studies, electrocardiograms, chest x-rays, and an individual care plan for each client who is referred by the clinic to a secondary center.
The proposed repeals and new rules will 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 61.71 - 61.83 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
The proposed rules update references to the legacy agency, now part of the Health and Human Services Commission, reflect the department's name change from "Texas Department of Health" to "Department of State Health Services." References to the compliance document reflect the document's name change from "Quality Care: Client Services Standards for Public Health and Community Clinics" dated June 1997 to "Department of State Health Services Standards for Public Health Clinic Services" dated August 2004.
The proposed §61.71 includes the general purpose of the program and refers to confidentiality of information.
The proposed §61.72 includes new definitions that improve and clarify the rules.
The proposed §61.73 includes language necessary for clarification of the COHP client services eligibility requirements.
The proposed §61.74 includes language necessary for clarification of COHP contractor funding requirements.
The proposed §61.75 includes language necessary for clarification of the contractor's responsibility to maximize program income and establish client co-payment policy.
The proposed §61.76 includes language necessary for clarification of contractor staff responsibilities.
The proposed §61.77 includes language necessary for clarification of requirements of clinic facilities and equipment and compliance with the document "Department of State Health Services Standards for Public Health Clinic Services" dated August 2004.
The proposed §61.78 includes language necessary for clarification of required clinical services and contractor staff responsibilities.
The proposed §61.79 includes language necessary for clarification of the contractor and clinic staff responsibility for coordination of community services.
The proposed §61.80 includes language necessary for clarification of the clinic(s) and contractor responsibility to maintain client rights.
The proposed §61.81 includes language necessary for clarification of the responsibility of clinic(s) to maintain a tracking system that monitors each client's health status and use of health care services.
The proposed §61.82 includes language necessary for clarification of the responsibility of clinic(s) to comply with HIPAA records management requirements and the document "Department of State Health Services Standards for Public Health Clinic Services," dated August 2004.
The proposed §61.83 includes language necessary for clarification of the contractor's responsibility for internal review, evaluation of program services, and reporting in compliance with department policy and the document "Department of State Health Services Standards for Public Health Clinic Services" dated August 2004.
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 rules 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.
MICRO-BUSINESS AND SMALL BUSINESS IMPACT ANALYSIS
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 affected by the COHP rules will be required to alter their business practices in order to comply with the rules, and an economic impact statement and regulatory flexibility analysis are not required. 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 rules. The public benefit anticipated as a result of enforcing or administering the rules 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 Angela Carrasco, Purchased Health Services Unit, Mail Code 1938, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347, by telephone at (512) 458-7111, extension 3067, or by email at angela.carrasco@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.
(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.)
STATUTORY AUTHORITY
The proposed repeals are authorized by the Health and Safety Code, §39.003, which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules necessary to define the scope of the children's outreach heart program; Government Code, §531.0055(e), and the Health and Safety Code, §1001.075, which authorizes 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 proposed repeals affect Government Code, Chapter 531; and Health and Safety Code, Chapter 1001.
§61.71.Purpose.
§61.72.Definitions.
§61.73.Eligibility for Client Services.
§61.74.Contractor Staff.
§61.75.Clinic Facilities and Equipment.
§61.76.Services.
§61.77.Records Management.
§61.78.Patient Rights.
§61.79.Program Income and Patient Co-payment.
§61.80.Tracking/follow-up.
§61.81.Coordination of Community Services.
§61.82.Evaluation.
§61.83.Funding of Children's Outreach Heart Program Contractor.
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 January 16, 2009.
TRD-200900214
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: March 1, 2009
For further information, please call: (512) 458-7111 x6972
STATUTORY AUTHORITY
The proposed new rules are authorized by the Health and Safety Code, §39.003, which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules necessary to define the scope of the children's outreach heart program; Government Code, §531.0055(e), and the Health and Safety Code, §1001.075, which authorizes 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 proposed new rules affect Government Code, Chapter 531; and Health and Safety Code, Chapter 1001.
§61.71.General Information.
(a) Purpose. The purpose of this subchapter is to establish rules for the Children's Heart Outreach Program (COHP). By authority granted in Health and Safety Code, Chapter 39, COHP provides:
(1) prediagnostic cardiac screening and follow-up evaluation services to persons less than 21 years of age who are from low-income families and who may have heart disease and/or defects; and
(2) training to local physicians and public health nurses in screening and diagnostic procedures for heart disease and/or defects.
(b) Confidentiality of Information.
(1) All information submitted, as required by this chapter, may be verified at the discretion of the Department of State Health Services (department) with or without notice to the applicant, client, or contractor staff of COHP services. Information required by this chapter and received by the department is kept confidential to the extent authorized by law.
(2) Information may be disclosed in summary, statistical, or other forms that do not identify particular individuals.
§61.72.Definitions.
The following words and terms when used in this subchapter shall have the following meanings unless the context clearly indicates otherwise.
(1) Applicant--A person making an initial application for Children's Outreach Heart Program (COHP) services.
(2) Bona fide resident--A person who:
(A) is physically present within the geographic boundaries of the state;
(B) has an intent to remain within the state; and
(C) maintains an abode within the state (i.e., house or apartment, not merely a post office box).
(3) Cardiac--Of, relating to, situated near, or acting on the heart.
(4) Cardiac outreach clinic (clinic)--A primary or secondary level health care facility staffed by local and secondary or tertiary level outreach personnel and equipped to perform the following functions:
(A) screening and assessment of children for cardiac disease;
(B) identification and referral of children with cardiac disease to the closest appropriate tertiary center for definitive diagnostic procedures and, if needed, surgery; and
(C) management of children with heart disease to include development of an individual care plan, tracking, and periodic follow-up and coordination with local case management services providers, if available.
(5) CHIP--The Children's Health Insurance Program established under Title XXI of the federal Social Security Act (42 U.S.C. §§1397aa, et seq.)
(6) Client--A person who has applied for program services and who meets all COHP eligibility requirements and has been determined to be eligible for program services.
(7) Contractor--One or more individuals or entities selected by the department to provide Children's Outreach Heart Program services, including departments, agencies, boards, educational institutions, county governments, municipal governments, states, or the United States.
(8) Co-pay/co-payment--A cost-sharing arrangement in which a client pays a specified charge for a specified health care service, usually at the time the service is provided.
(9) CSHCN Services Program--The Children with Special Health Care Needs Services Program; Health and Safety Code, Chapter 35.
(10) Department--The Department of State Health Services.
(11) Federal Poverty Level (FPL)--The minimum income needed by a family for food, clothing, transportation, shelter, and other necessities in the United States, according to the United States Department of Health and Human Services, or its successor. The FPLs vary according to family size, and after adjustment for inflation, are published annually in the Federal Register.
(12) Heart disease or defect--An abnormality or disease of the heart or major blood vessel(s) near the heart.
(13) HIPAA--The Health Insurance Portability and Accountability Act of 1996; 42 U.S.C. §§1320d-2 et seq.
(14) Individual care plan--A comprehensive plan for the provision of needed care, support and services to an individual client by designated service providers and by members of the client's family and personal support system.
(15) Medical home--A respectful partnership between a client, the client's family as appropriate, and the client's primary health care setting. A medical home is family-centered health care that is accessible, continuous, comprehensive, coordinated, compassionate, and culturally competent. A medical home includes a licensed medical professional who accepts responsibility for the provision and/or coordination of primary, preventive, and/or specialty care for a client, and coordination of care with other community services providers.
(16) Outreach physician--A board-certified pediatric cardiologist responsible for supervising the clinic(s).
(17) Physician--A person licensed by the Texas Medical Board to practice medicine in the State of Texas.
(18) Program--The Children's Outreach Heart Program (COHP).
(19) Program income--All revenues received by a contractor as a result of providing services under this subchapter, including third party payments, such as Medicaid, CHIP, CSHCN Services Program, and private insurance; and client co-payments.
(20) Registered nurse (RN)--A person currently licensed by the Texas Board of Nursing to practice professional nursing in the State of Texas.
§61.73.Eligibility for Client Services.
(a) An applicant shall meet all of the following requirements to be eligible for benefits from the COHP:
(1) have a heart disease and/or defect;
(2) be under 21 years of age; and
(3) be a bona fide resident of the State of Texas.
(b) An applicant's family income shall meet one of the following financial requirements to be eligible for benefits from the COHP:
(1) the family's income level is at or below 200% of the FPL; or
(2) the family's income level exceeds 200% of the FPL, but the applicant is not eligible for public assistance with medical expenses.
(c) An applicant whose family income exceeds 200% of the FPL may be required to pay a co-payment based on family income and household size.
§61.74.Funding of the COHP Contractor.
(a) The department will provide COHP services through a contractor selected in compliance with the department's contracting and procurement procedures.
(b) An entity seeking funding as a contractor must demonstrate in its proposal that:
(1) provision of program services in the designated community(ies) and surrounding geographic area would meet a recognized need;
(2) services to be provided are not available to the identified population due to distance or a lack of access, resulting in a barrier to quality health care for the community(ies);
(3) the local community(ies), including the local or county medical society(ies), support(s) the need for the clinic(s); and
(4) proposed services can be integrated into the local health care system.
(c) The contractor may receive cost-based or fee-for-service reimbursement for the following:
(1) travel to the clinic(s) by the outreach physician and team members;
(2) the salaries of local and/or outreach staff necessary for administration of the clinic(s) or provision of clinic services;
(3) physician services;
(4) facility use fees; and
(5) laboratory, radiology, electrocardiography, and other procedures necessary for assessment and screening of clients.
§61.75.Program Income and Client Co-payment.
(a) The contractor shall maximize program income by billing third-party payers for the clients served, including CSHCN Services Program, Medicaid, CHIP, and private insurance. The contractor shall ensure that clients who may be eligible for Medicaid, CHIP, and/or CSHCN Services Program are referred for eligibility determination.
(b) The contractor shall develop a co-payment policy concerning program services provided to clients whose family incomes exceed 200% of the FPL, but who are not eligible for public assistance with medical expenses, including the following:
(1) co-payments shall be based on family income and household size; and
(2) any schedule of sliding scale co-payments shall be approved by the department prior to implementation.
(c) No client who meets age and medical eligibility criteria will be denied services on the basis of inability to pay.
§61.76.Contractor Staff.
(a) The contractor shall assure that clients have access to:
(1) a coordinator who communicates with clinic staff as frequently as necessary to:
(A) process referrals;
(B) schedule appointments;
(C) coordinate the activities of the clinics, if more than one exists; and
(D) track clients, if follow-up is necessary;
(2) an outreach physician who is a board-certified pediatric cardiologist responsible for:
(A) supervising the clinic(s);
(B) coordinating the screening and assessment process;
(C) developing an individual care plan for each client identified with heart disease and/or defect who is referred by the clinic to a secondary or tertiary center;
(D) making appropriate recommendations for referral, when necessary;
(E) sending follow-up letters to referral sources;
(F) maintaining appropriate medical records for clients; and
(G) assuming responsibility for provision of all services that would otherwise have been provided by an RN if no RN is on site.
(3) an RN with at least one year of clinical pediatric experience, preferably with pediatric cardiology experience, who shall be on site during clinic hours; and
(4) a social worker licensed by the department, or other clinic staff member, who identifies the need for and makes referrals to case management services as documented in clients' medical records.
§61.77.Clinic Facilities and Equipment.
(a) The clinic(s) shall assure that adequate supplies, space, and equipment are available to:
(1) measure vital signs for children of all ages;
(2) perform age-appropriate anthropometric testing on all clients; and
(3) obtain electrocardiograms and chest x-rays on all clients.
(b) All equipment and supplies used shall be appropriate for the client's age and level of development.
(c) The contractor shall obtain routine lab work. If unable to provide echocardiography or x-rays directly, the contractor will obtain these services through sub-contractual or other arrangements.
(d) The clinic(s) shall be conducted in compliance with the document "Department of State Health Services Standards for Public Health Clinic Services" dated August 2004, or its successor, specifically including the following requirements:
(1) the clinic(s) shall be accessible to the target population;
(2) clinic facilities shall be appropriate for pediatric care;
(3) clinic services shall be provided in settings designed to ensure client comfort, safety, and privacy, and to expedite the work of the staff; and
(4) the contractor or clinic site(s) shall meet any licensure or certifications required for clinic operations in the State of Texas.
§61.78.Services.
(a) Routine clinic services must include a comprehensive history and physical exam.
(b) Additional services, as determined necessary by the physician, may include:
(1) laboratory studies;
(2) electrocardiograms;
(3) chest x-rays; and
(4) echocardiography may be performed if the results are of acceptable quality for pediatric clients and reviewed and interpreted by the outreach physician responsible for the clinic.
(c) The outreach physician shall develop an individual care plan for each client identified with heart disease and/or defect who is referred by the clinic to a secondary or tertiary center.
(d) The clinic staff shall work as a team in conjunction with the client, family, the referral source, and the secondary or tertiary center to develop the individual care plan.
(e) Clinic staff shall track clients if the individual care plan requires follow-up.
(f) Clinic services shall be integrated into the overall service needs of each client through clinic staff cooperation and sharing of information with local case management services providers, if available.
(g) The clinic(s) shall ensure that translation and interpreter services are available to all clients who are unable to communicate effectively in English, and shall provide services in a culturally sensitive manner.
(h) The following clinical services shall not be approved or reimbursed by the program at cardiac outreach clinics:
(1) echocardiography for routine screening purposes;
(2) exercise testing;
(3) catheterization; and
(4) surgery.
§61.79.Coordination of Community Services.
(a) The contractor shall inform the local communities, including local physicians, community service groups, and the general public, of the clinic and its services within three months of a funding award.
(b) The contractor shall provide a report addressing the number of clients served, services provided, and diagnoses to the local or county medical society annually.
(c) The outreach physician shall communicate with the client's local or primary physician, medical home, or referral source concerning the client's history, physical exam, and diagnosis and must involve the local physician in the development of the client's individual care plan.
(d) The contractor shall encourage local physicians to participate in the clinic(s).
(e) The outreach physician and clinic staff should provide local physicians, and other community professionals involved with the clinic population, with continuing education in the areas of diagnosis, evaluation, and treatment of children with suspected and confirmed cardiovascular disease.
(f) The clinic(s) shall coordinate services with other community activities in an effort to facilitate the public's access to the clinic(s) and other community services, and to prevent duplication of services.
(g) If local pediatric cardiology expertise becomes available that meets the needs expressed in the clinic proposal and is community-supported, the contractor shall phase out services in coordination with the local providers.
§61.80.Client Rights.
(a) The clinic(s) shall provide services in a timely manner.
(b) The clinic(s) shall assure confidentiality of client information and provide information to clients and their families regarding its policies.
(c) Facilities within the clinic(s) shall be arranged or designed so that services are provided in a manner that protects the dignity and privacy of clients and their families.
(d) The clinic(s) shall provide services in a nondiscriminatory manner, complying with civil rights statutes, regulations, and the department's policies.
(e) The contractor or clinic staff shall not coerce individuals into services, nor may participation in one service or program be a requirement for eligibility for another service.
(f) The clinic(s) shall provide services in ways that can be understood by clients and their families including, but not limited to, addressing the needs of clients with limited English proficiency, as required by Title VI of the Civil Rights Act of 1964.
(g) The contractor shall either post or provide information in writing to clients and their families concerning procedures available to address concerns about care received or alleged violation of clients' and their families' rights.
§61.81.Tracking and Follow-up.
(a) The clinic(s) shall utilize a tracking system to monitor each client's health status and use of health care services. The tracking system shall:
(1) schedule contacts with the client and their family at regular intervals according to program guidelines and protocols, and coordinate with other services and opportunities as needed;
(2) monitor the status of the individual care plan, including compliance and the need for revisions;
(3) monitor broken appointments and establish a system for rescheduling appointments;
(4) alert staff for follow-up concerning conditions identified as priorities for care;
(5) track referrals made to other providers or agencies; and
(6) follow-up with the client and the client's family, as appropriate, to ensure that services were accessed.
(b) If a client moves out of the identified service area, clinic(s) shall attempt to maintain continuity of care by providing the client and the client's family with information on available services, including case management, in the area to which they are relocating.
(c) The clinic(s) shall evaluate the effectiveness of services provided on an ongoing basis and shall adjust the individual care plan when needed to maximize the client's health.
§61.82.Records Management.
(a) The clinic(s) shall utilize an organized client record system.
(b) The clinic(s) shall comply with laws and regulations regarding confidentiality of client records, including HIPAA. In addition:
(1) records shall be confidential and secure;
(2) records shall be available to the client, family, or guardian upon request with a signed release of information; and
(3) the clinic(s) shall implement a policy that delineates guidelines for the release of confidential information.
(c) The clinic(s) shall maintain a complete and accurate record for each client.
(d) The clinic(s) shall implement a written policy regarding retention and proper disposal of client records.
(e) The clinic(s) shall comply with records management requirements in the document "Department of State Health Services Standards for Public Health Clinic Services," dated August 2004, or its successor.
§61.83.Evaluation.
(a) The contractor shall have a plan for internal review and evaluation of program services to assure the provision of quality services in compliance with "Department of State Health Services Standards for Public Health Clinic Services," dated August 2004, or its successor and other department policies.
(b) The contractor shall submit reports to the department in a format and include content specified by the department. The reports will be used as a paper audit to assure that the contractor is performing in accordance with the contract. The department shall also conduct on-site visits when deemed necessary to evaluate the contractor's adherence to the department's guidelines and requirements. The contractor typically will receive a two-week notice and will be consulted for scheduling purposes.
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 January 16, 2009.
TRD-200900215
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: March 1, 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 new §61.91 concerning the establishment of a diabetes pilot project that will create an electronic registry to track glycosylated hemoglobin levels and to govern the format and method of collecting glycosylated hemoglobin data.
BACKGROUND AND PURPOSE
The new section is necessary to comply with Chapter 706, uncodified, (House Bill (HB) 2132) passed by the 80th Texas Legislature, 2007, that requires the department to establish a diabetes mellitus registry pilot program. The rule requires a clinical laboratory located in the participating public health district to submit to the district and the department the results of each glycosylated hemoglobin test that the laboratory performs. Not later than December 1, 2009, the department shall submit to the legislature a report concerning the effectiveness and recommendations for the program. This rule and the statute that supports it, expire in September 2010.
SECTION-BY-SECTION SUMMARY
New §61.91(a) describes the purpose of the Diabetes Mellitus Registry Pilot Program. New §61.91(b) defines the terms "Diabetes Mellitus" and "Glycosylated hemoglobin test." New §61.91(c) provides language stating that the pilot program will be conducted by the San Antonio Metropolitan Health District, and provides language informing the clinical laboratory staff where to report glycosylated hemoglobin test results. New §61.91(d) provides language stating what information shall be reported for each glycosylated hemoglobin test result and describes the protocol to ensure confidentiality. New §61.91(e) and §61.91(f) state when reporting of glycosylated hemoglobin test results shall begin and the date when reporting will end.
FISCAL NOTE
Casey Blass, Section Director, Disease Prevention and Intervention Section, has determined that for each year of the first five years that the section will be in effect, there will be no fiscal implications to state government as a result of enforcing or administering the section as proposed because the legislation states "the participating public health district is solely responsible for the costs of establishing and administering the pilot program." (Chapter 706, uncodified, 80th Texas Legislature, 2007, Section 1(f)). There are fiscal implications for the San Antonio Metropolitan Health District, who will administer this program. These implications apply only in the first two years of the program because the legislation expires in September 2010 (Chapter 706, uncodified, 80th Texas Legislature, 2007, Section 5). During this period the estimated cost to the district shall be approximately one full time staff person to administer and implement this program and a contractor to collect and analyze the data, an annual cost of approximately $200,000.
SMALL AND MICRO-BUSINESS ECONOMIC IMPACT STATEMENT
Mr. Blass has also determined that there will be no effect on small businesses or micro-businesses required to comply with the section as proposed. This was determined by interpretation of the rule that small businesses and micro-businesses will not be required to alter their business practices in order to comply with the section. 100% of the required glycosylated hemoglobin tests will be reported by clinical laboratories, which are not small businesses or micro-businesses.
Requiring reporting from clinical and hospital laboratories is the only way to accomplish the important public health purpose of Chapter 706, uncodified, 80th Legislature, 2007. The department chose the San Antonio Metropolitan Health District because it was the only district that met the requirements set in Section 1(c) of the Chapter.
PUBLIC BENEFIT
In addition, Mr. Blass has also determined that for each year of the first five years that the section is in effect the public will benefit from adoption of the section. The institutions and individuals responsible for reporting the glycosylated hemoglobin tests will have clear guidance on what is reportable; the public health community will be able to assess methods to promote the prevention and improve control of diabetes; and the general public will be better served by the department as it fulfills its responsibility to monitor, track, and assess the trends and economic costs related to the burden of diabetes.
ECONOMIC COSTS TO PERSONS
In addition, Mr. Blass has also determined that for each year of the first five years that the section is in effect, there is a cost per report for the clinical laboratory. A major laboratory informed the department that the anticipated economic cost to comply with the section as proposed is up to $25,000. This cost may be subsidized by the San Antonio Metropolitan Health District, which intends to provide reporting labs with software to facilitate reporting.
LOCAL EMPLOYMENT IMPACT
There is no anticipated affect on local employment.
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 rule 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 to Cassandra DeLeon, Director, Texas Diabetes Council/Program, Department of State Health Services, P. O. Box 149347, Austin, Texas 78714-9347, (512) 458-7111 extension 3549 or by email to Cassandra.Deleon@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 rule has been reviewed by legal counsel and found to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The proposed new section is authorized by Chapter 706, uncodified, (HB 2132) 80th Texas Legislature, 2007, Section 2, which requires the Executive Commissioner of the Health and Human Services Commission to adopt rules necessary to implement and govern the format and method of collecting glycosylated hemoglobin data; and 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 the health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.
The proposed new section affects Chapter 706, uncodified, (HB 2132) 80th Texas Legislature, 2007; Health and Safety Code, Chapter 1001; and Government Code, Chapter 531.
§61.91.Diabetes Mellitus Glycosylated Hemoglobin Test Registry Pilot.
(a) Purpose. The Diabetes Mellitus Registry Pilot Program, Statute Chapter 706, uncodified, (House Bill 2132) 80th Texas Legislature, 2007 requires the establishment of a pilot program for the reporting of glycosylated hemoglobin tests.
(b) Definitions. The following words and terms when used in this subchapter shall have the following meanings unless the context clearly states otherwise.
(1) Glycosylated hemoglobin test--A measurement of a form of hemoglobin used primarily to identify the average plasma glucose concentration over prolonged periods of time.
(2) Diabetes Mellitus--A syndrome characterized by disordered metabolism and abnormally high blood sugar (hyperglycemia) resulting from insufficient levels of the hormone insulin or reduced insulin sensitivity.
(c) Where to report. The pilot program is being conducted in the San Antonio Metropolitan Health District. This jurisdiction meets the requirements of the statute. A clinical laboratory located in the participating public health district shall submit to the district and the department the results of each glycosylated hemoglobin test that the laboratory performs.
(d) Reportable information requirements.
(1) The test result information that shall be reported for each glycosylated hemoglobin test performed within the San Antonio Metropolitan Health District service area is as follows: glycosylated hemoglobin value; patient name, address, telephone number, age, date of birth, sex, race and ethnicity; date of test, location of test site, diabetes diagnosis; and physician name, address, and telephone number.
(2) Additional information necessary to determine the trends and public health costs of diabetes control shall also be reported if requested.
(3) Reports, records, and information are confidential and are not subject to disclosure under Government Code, Chapter 552, are not subject to subpoena, and may not otherwise be released. The reports, records, and information obtained are for the confidential use of the department and the persons or public or private entities that the department determines are necessary to carry out the intent of this pilot program.
(e) When to report. Reporting shall begin on the effective date of this rule. Glycosylated Hemoglobin test results shall be reported within 5 calendar days.
(f) This rule expires September 1, 2010.
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 January 15, 2009.
TRD-200900195
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: March 1, 2009
For further information, please call: (512) 458-7111 x6972
SUBCHAPTER D. ADMINISTRATIVE HEARINGS OF THE DEPARTMENT IN CONTESTED CASES
25 TAC §§411.151 - 411.160, 411.162, 411.163
(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.)
The Executive Commissioner of the Health and Human Services Commission (HHSC) on behalf of the Department of State Health Services (department) proposes the repeal of §§411.151 - 411.160, 411.162, and 411.163, concerning the administrative hearings for contested cases.
BACKGROUND AND PURPOSE
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 411.151 - 411.160, 411.162, and 411.163 have been reviewed and the department has determined that reasons for adopting the sections no longer exist. Although these rules were needed at the time of adoption, when the Texas Department of Mental Health and Mental Retardation was in existence, HHSC has recently adopted new rules in 1 TAC Chapter 357, Subchapter I, which address the same subject matter and would supersede these rules.
SECTION-BY-SECTION SUMMARY
Sections 411.151 - 411.160, 411.162, and 411.163 are being repealed in their entirety. The rules are no longer necessary because they are superseded by HHSC rules in 1 TAC Chapter 357, Subchapter I, regarding hearings under the Administrative Procedure Act.
FISCAL NOTE
Mike Maples, Assistant Commissioner for Mental Health and Substance Abuse Services, has determined that for each year of the first five-year period that the sections will be in effect, there will be no fiscal implications to state or local governments as a result of enforcing and administering the sections as proposed.
SMALL AND MICRO-BUSINESS ECONOMIC IMPACT STATEMENT AND PERSONS AND LOCAL EMPLOYMENT
Mr. Maples 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. 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. Therefore, an economic impact statement and regulatory flexibility analysis for small and micro-businesses are not required.
PUBLIC BENEFIT
Mike Maples has determined that for each year of the first five years the repeal of the sections is in effect, the public will benefit. The public benefit anticipated as a result of repealing the sections is that the department will maintain a clear, concise set of rules and avoid the potential for confusion from retaining rules that have no effect.
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 repeals would 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 proposed repeal may be submitted in writing to Janet Fletcher, Department of State Health Services, Mail Code 2082, 909 West 45th Street, Austin, Texas 78751, or by email to janet.fletcher@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.
STATUTORY AUTHORITY
The proposed repeals are authorized by Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of 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 proposed repeals affect the Government Code, Chapter 531; and Health and Safety Code, Chapter 1001.
§411.151.Purpose.
§411.152.Applicability and Scope of Rules.
§411.153.Definitions.
§411.154.Administrative Law Judge.
§411.155.Hearing Guidelines.
§411.156.Conduct of Hearings--General Requirements.
§411.157.Prehearing Procedure.
§411.158.Evidence and Depositions.
§411.159.Deliberation.
§411.160.Decisions.
§411.162.References.
§411.163.Distribution.
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 January 14, 2009.
TRD-200900189
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: March 1, 2009
For further information, please call: (512) 458-7111 x6972
SUBCHAPTER G. MEDICAID FAIR HEARINGS
(Editor's note: The text of the following section proposed for repeal will not be published. The section 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.)
The Executive Commissioner of the Health and Human Services Commission (HHSC), on behalf of the Department State Health Services (department), proposes the repeal of §419.301, concerning Medicaid Fair Hearings.
BACKGROUND AND PURPOSE
This rule, §419.301, adopted by the former Texas Department of Mental Health and Mental Retardation, primarily incorporates by reference the HHSC rules relating to Medicaid Fair Hearings. This separate, independent rule is not necessary to retain and is being proposed for repeal.
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). Section 419.301 has been reviewed and the department has determined that there is no need to retain the rule and is proposing its repeal.
The department offers Medicaid mental health services and notifies eligible clients of their right to a fair hearing when benefits or services are denied, delayed, terminated, reduced, or suspended. In the event that a client requests a fair hearing, the hearing is provided by the Appeals Division of HHSC, and is subject to the HHSC rules in 1 TAC Chapter 357, Subchapter A. Section 419.301 is redundant and unnecessary because it incorporates HHSC rules that apply when HHSC conducts the fair hearings for Medicaid clients receiving mental health services from the department.
SECTION-BY-SECTION SUMMARY
Section 419.301 is proposed for repeal as unnecessary because HHSC rules apply to Medicaid fair hearings conducted by HHSC.
FISCAL NOTE
Mike Maples, Assistant Commissioner for Mental Health and Substance Abuse Services, has determined that for each year of the first five-year period that the section will be in effect, there will be no fiscal implications to state or local governments as a result of enforcing and administering the section as proposed.
SMALL AND MICRO-BUSINESS ECONOMIC IMPACT STATEMENT AND PERSONS AND LOCAL EMPLOYMENT
Mr. Maples has also determined that there will be no adverse economic impact on small businesses or micro-businesses required to comply with the section 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 section. There are no anticipated economic costs to persons who are required to comply with the section as proposed. There is no anticipated impact on local employment. Therefore, an economic impact statement and regulatory flexibility analysis for small and micro-businesses are not required.
PUBLIC BENEFIT
Mr. Mike Maples has determined that for each year of the first five years the repeal of the section is in effect, the public will benefit. The public benefit anticipated as a result of repealing the section is that the department will maintain a clear, concise set of rules and avoid the potential for confusion from retaining a rule that is unnecessary and has no effect.
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 repeal would 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 proposed repeal may be submitted in writing to Janet Fletcher, Department of State Health Services, Mail Code 2082, 909 West 45th Street, Austin, Texas 78751, or by email to janet.fletcher@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 rule has been reviewed by legal counsel and found to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The proposed repeal is authorized by 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. The review of the section implements Government Code, §2001.039.
The proposed repeal affects the Government Code, Chapter 531; and Health and Safety Code, Chapter 1001.
§419.301.Medicaid Fair Hearings.
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 January 14, 2009.
TRD-200900192
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: March 1, 2009
For further information, please call: (512) 458-7111 x6972