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SUBCHAPTER A. GENERAL PROVISIONS 28 TAC §11.2 SUBCHAPTER Q. OTHER REQUIREMENTS 28 TAC §11.1607 SUBCHAPTER T. QUALITY OF CARE 28 TAC §§11.1901-11.1902

The Commissioner of Insurance adopts amendments to §11.2 concerning definitions relating to health maintenance organization (HMO) telehealth services and telemedicine medical services and physician and provider credentialing; §11.1607 concerning accessibility and availability requirements for HMOs providing telemedicine medical services and telehealth services; and §§11.1901-11.1902 concerning quality improvement programs operated by HMOs, including credentialing and recredentialing of physicians and providers. Section 11.1902 is adopted with changes to the proposed text as published in the April 26, 2002, issue of the Texas Register (27 TexReg 3436). Sections 11.2, 11.1607 and 11.1901 are adopted without changes and will not be republished.

The amendments to §11.2 provide definitions necessary to implement Senate Bill 544, which enacted Insurance Code Article 20A.39 relating to credentialing of physicians and providers and Senate Bill 789 which amended the Insurance Code Article 21.53F relating to telemedicine and telehealth services. The amendments to §11.1607 are necessary to clarify the applicability of both telehealth services and telemedicine medical services as a result of the enactment of Senate Bill 789. The amendments to §§11.1901 and 11.1902 are necessary to reorganize, clarify, and eliminate redundancy in the current requirements and procedures in these sections, for quality improvement programs operated by HMOs. Additionally, the amendments to §11.1902(4) and (5) are necessary to implement Senate Bill 544 which specifies the standards for rules adopted under the Insurance Code Article 20A.39 that regulate implementation and maintenance of HMO credentialing, the process for selecting and retaining affiliated physicians and providers. Senate Bill 544 requires that the standards used for credentialing and recredentialing physicians and providers comply with the standards of the National Committee for Quality Assurance (NCQA), to the extent that the NCQA standards do not conflict with other laws of this state. The NCQA is an independent nonprofit organization that uses performance measures to assess and accredit managed care organizations, including HMOs. Article 20A.37 requires each HMO to have an ongoing internal quality assurance program to monitor and evaluate its health care services in all institutional and noninstitutional contexts and authorizes the Commissioner to establish, by rule, minimum standards and requirements for these programs, including, but not limited to, standards for assuring availability, accessibility, quality and continuity of care.

The amendments to §11.2 clarify that credentialing is the process of collecting, assessing, and validating qualifications and other relevant information pertaining to a physician or provider to determine eligibility to deliver health care services. They also delete the reference to "dentist" in the definition of credentialing and clarify, in the definition of dentist, that a dentist is an individual provider. These clarifying amendments are consistent with §§11.1901-11.1902 which include dentists as individual providers in the rules. The amendments also add definitions for individual provider, institutional provider, recredentialing, telehealth service and telemedicine medical services.

The amendments to §11.1607(i)-(k) clarify that the current requirements and criteria that apply to an HMO´s provision of telemedicine also apply to telehealth services, including that each evidence of coverage delivered or issued for delivery by an HMO may provide enrollees the option to access covered health care services through a telehealth service or a telemedicine medical service. The amendments also change the term "telemedicine" to "telemedicine medical services" for consistency with the Insurance Code Article 21.53F as enacted by Senate Bill 789.

The amendments to §§11.1901-11.1902 are adopted for clarification, simplification, and elimination of redundancy. The amendments to §11.1901 relate to the responsibilities of the HMO governing body to receive and review reports on the quality improvement program, including the delegation of quality improvement activities and the use of multidisciplinary teams by the quality improvement committee.

The amendments to §11.1902 clarify that the HMO shall dedicate adequate resources to the quality improvement program and clarify that the HMO shall continuously update and monitor the quality improvement program. The amendments to §11.1902(2) clarify that an annual quality improvement work plan shall include a schedule of activities designed to reflect the population served by the HMO in terms of age groups, disease categories, and special risk status. Further, the amendments clarify that the annual quality improvement work plan shall include goals, objectives, and planned projects or activities identified from the previous year and the current year; time frames for implementation; individuals responsible; and coordination of functions. In addition, the HMO must include in the annual quality improvement work plan the manner in which it will monitor quality improvement, including objective and measurable quality indicators, process or outcome performance measurements, and data appropriate to the goals and objectives of the activity.

The amendments to §11.1902(2)(C) clarify that the annual quality improvement work plan shall include ongoing or periodic assessment of both quality of care and quality of service in planned projects and specifies what is to be assessed, including network adequacy; continuity of health care and related services; clinical studies; the adoption and annual updating of clinical practice guidelines or clinical care standards; enrollee, physician, and individual provider satisfaction; the complaint and appeal process and complaint data and identification and removal of communication barriers which may impede the making of complaints against the HMO; preventive health care through promotion and outreach activities; the claims payment processes; contract monitoring, and utilization review processes. The amendments to §11.1902(2)(D) clarify that the annual quality improvement work plan shall include ongoing or periodic analysis and evaluation of both quality of clinical care and quality of service in planned projects specified in §11.1902(2)(C).

The amendments to §11.1902(3) clarify that there shall be an annual written evaluation report on the quality improvement program that includes completed activities, trending of clinical and service indicators, analysis of program performance, conclusions, and demonstrated improvements in care and services.

Most of the amendments to §11.1902(4) bring current physician and provider HMO credentialing standards into compliance with the standards in the Insurance Code Article 20A.39 and with NCQA standards, to the extent that the NCQA standards do not conflict with other laws of this state. In compliance with NCQA standard CR 1.8, adopted §11.1902(4)(A) requires that HMO policies and procedures clearly indicate the physician or provider responsible for the credentialing program. The amendments to §11.1902(4)(B) are for clarification and readability purposes and, consistent with NCQA standard CR 1, require written criteria for credentialing of physicians and providers and written procedures for verification.

Under the Insurance Code Article 20A.39(a), rules adopted by the Commissioner that relate to an HMO´s credentialing of physicians and providers are not required to comply with NCQA standards if those standards conflict with other laws of this state. Section 11.1902(4)(B)(ii) and (iii) clarify who is required and not required to be credentialed. In accordance with NCQA standard CR 1.1, pharmacists have been added to those who are not required to be credentialed. The rule also requires all dentists to be credentialed, including those who provide dental care only under a dental plan or rider. Insurance Code Articles 20A.03(c) and 20A.37 authorize the Department to regulate dental HMOs, including credentialing of contracted dentists, and the NCQA standards in this instance conflict with the other laws of this state. The NCQA standards do not specifically include or exclude advanced practice nurses (APNs) and physicians´ assistants (PAs) from credentialing requirements. The rule requires APNs and PAs to be credentialed if listed in the provider directory and if they fall within the NCQA definition of practitioners which means they have an independent relationship with the managed care organization. The Insurance Code Article 20A.14(j) provides that if an APN or PA is statutorily authorized to provide care by a physician participating in an HMO´s provider network, the HMO may not refuse to contract with an APN or PA to be included in the HMO´s provider network, refuse to reimburse the APN or PA for covered services, or otherwise discriminate against the APN or PA solely because the APN or PA is not identified as a practitioner under the Insurance Code Article 21.52, §3.

Section 11.1902(4)(B)(vi), consistent with NCQA standard CR 10, specifies procedures for monitoring physician and provider performance between periods of recredentialing. Section 11.1902(4)(B)(vii) complies with NCQA standard CR 13 on delegation of credentialing, including required annual audits and exceptions and the requirement that the HMO maintain the right to approve credentialing, suspension, and termination of physicians and providers. The amendments to §11.1902(5)(B)(vii) also clarify that credentialing files maintained by other entities to whom the HMO has delegated credentialing functions be made available to the Department for examination upon request, which is in accordance with the Insurance Code Article 20A.17(b)(4).

Section 11.1902(4)(B)(ix) clarifies and complies with NCQA standard CR 11 on HMO procedures for notifying appropriate authorities when a physician´s or provider´s affiliation is suspended or terminated due to quality of care concerns.

Subparagraph (C)(i) requires that physicians complete the standardized credentialing application adopted in §21.3201, which is published elsewhere in this issue of the Texas Register. Amendments to subparagraph (C)(i) also provide that HMOs are not precluded from using the standardized credentialing application form specified in §21.3201 for individual providers and require, in compliance with NCQA standard CR 4, that the completion date on the credentialing application shall be within 180 calendar days prior to the date the credentialing committee deems a physician or individual provider eligible for initial credentialing.

Subparagraph (C)(ii)(I) provides that, in compliance with NCQA standard CR 3.1, the license and sanctions must be verified within 180 calendar days prior to the date the credentialing committee deems a physician or individual provider eligible for initial credentialing and the license must be in effect at the time of the credentialing decision.

Subparagraph (C)(ii)(II) provides, consistent with NCQA standard CR 3.3, that if a specialty board verifies education and training, evidence of board certification shall also serve as a primary source verification of education and training. Section 11.1902(4)(C)(ii)(III) provides, in compliance with NCQA standard CR 3.4, that the source used must be the most recent available. Subparagraph (C)(ii)(IV) complies with NCQA standard CR 3.2.

In accordance with NCQA standard CR 3.6, amendments to §11.1902(4)(C)(iii)(I) require professional liability claims history to be verified within 180 days prior to the date of the credentialing decision and to be obtained from the professional liability carrier or the National Practitioner Data Bank. In accordance with NCQA standard CR 5.3, amendments to §11.1902(4)(C)(iii)(II) require information on previous sanction activity by Medicare and Medicaid to be verified within 180 days prior to the date of the credentialing decision and to specify seven possible sources, including the National Practitioner Data Bank.

Section 11.1902(4)(C)(iv), in accordance with NCQA standard CR 6, requires initial credentialing site visits to each obstetrician-gynecologist and high-volume individual behavioral health provider and allows one site visit in specified instances of group practice situations. Section 11.1902(4)(C)(v), in accordance with the Insurance Code Article 20A.39(c), requires that site visit evaluations consist of appointment availability. Amendments to §11.1902(4)(C)(v) also provide that if a physician or individual provider offers services, such as radiology or laboratory services, that require certification or licensure in accordance with the Insurance Code Article 20A.39(b), the current certification or licensure must be available for review at the initial credentialing site visit. In accordance with NCQA standard CR 6, §11.1902(4)(C)(v) requires corrective action plans and follow-up site visits every six months until the site meets the HMO´s standards.

Amended §11.1902(4)(D), in accordance with the Insurance Code Article 20A.39(d)(1), requires HMOs to recredential physicians and individual providers at least once every three years. Amended §11.1902(4)(D), in accordance with NCQA standard CR 9, requires HMOs to consider performance indicators for primary care and high-volume individual behavioral health care providers in recredentialing decision making. Amended §11.1902(5)(D)(i)-(ii), in accordance with NCQA standard CR 7, requires reverification from specified primary sources.

Section 11.1902(4)(E), in accordance with NCQA standard CR 12, specifies the credentialing process for institutional providers, including on-site evaluation of the institutional provider against the HMO´s written standards if the provider is not accredited by the HMO-required national accrediting body. Recredentialing of institutional providers at least every three years, is addressed in §11.1902(4)(F). Adopted §11.1902(4)(F) also provides, in accordance with NCQA standard CR 12.5, that the recredentialing process shall update information obtained for initial credentialing.

Section §11.1902(4)(G), in accordance with the Insurance Code Article 20A.39(a), provides that if the NCQA standards change and there is a difference between the Department´s promulgated standards and the NCQA standards, that the NCQA standards shall prevail to the extent those standards do not conflict with the other laws of this state.

Section 11.1902(5)(A), in accordance with NCQA standard CR 6.7, requires the HMO to have procedures for detecting deficiencies subsequent to the initial site visit and to reevaluate the site and institute actions for improvement when the HMO identifies new deficiencies. Section 11.1902(5)(B), in accordance with the Insurance Code Article 20A.39(e), specifies the requirements and guidelines for HMOs conducting site visits for cause.

These amendments are adopted to be effective August 1, 2002, with the standardized credentialing application form for physicians required in §11.1902(4)(C)(i) to be used for initial credentialing or recredentialing that occurs on or after August 1, 2002.

General: A commenter states that the additional quality requirements of the rules are too prescriptive, will increase administrative costs to health plans, and place unfair competition on products between HMOs and PPOs, thus making it difficult to provide competitive rates in the market. The commenter recommends that the additional requirements be deleted.

Response: The Department disagrees. This part of the rule merely reorganized and clarified existing requirements; no additional improvement requirements were added.

§11.1902(2): A commenter states that requiring a schedule of activities designed to reflect the populations served in terms of age groups, disease categories, and special risk status is onerous and recommends deletion of the provision.

Response: The Department disagrees, as these requirements are existing and were combined for simplification and better organization of the rule. The statute requires the quality improvement plan to be consistent with prevailing recognized professional standards and these requirements are consistent with those standards.

§11.1902(2)(C)(i): A commenter requests clarification regarding the term "open/closed" as it relates to provider panels.

Response: The term "open/closed" panels refers to whether a provider is accepting new patients.

§11.1902(2)(C)(ii): A commenter requests clarification of the phrase "continuity of health care and related services" with regards to network adequacy.

Response: This phrase "continuity of health care and related services" with regards to adequacy within the network refers to the continuation of specific care and services. When read as a whole, the section requires an HMO to develop a quality improvement work plan that includes assessments of clinical care and quality of service as well as assessment of the continuation of care and services and the adequacy of the network to ensure continuity of care.

§11.1902(2)(C)(vi): A commenter suggests deleting the reference to "removal of communication barriers" as it is vague and a new provision.

Response: The Department disagrees. This is an existing requirement that was in the prior rule and the provision is sufficiently clear to give the HMO the latitude to address this particular issue.

§11.1902(2)(C)(vii): A commenter suggests changing the wording of this provision to more closely track the existing rule which makes it clear that health promotion and outreach is to the HMO's members and not the public at large.

Response: The Department disagrees that a change is necessary. Subclause (i) of this paragraph clearly states that the health management and outreach programs are for the enrollees assigned to the physicians and providers.

§11.1902(2)(D)(I): A commenter notes that a health plan cannot guarantee that evaluation results will always indicate improvement in clinical care and services.

Response: The Department recognizes the commenter´s concern, but believes that health plans can ensure improvement in care and services by utilization of evaluation criteria. In the Department´s experience, utilization of analysis and evaluation of services results in improvement of services.

§11.1902(4)(A): A commenter believes that the person directly responsible for the credentialing program should not have to be a physician or individual provider, even though that may be desirable.

Response: The Department disagrees. This is an NCQA requirement, which also recognizes the importance that the person responsible for credentialing be qualified to perform those functions.

§11.1902(4)(B)(i): A commenter requests clarification regarding whether advanced practice nurses and physicians´ assistants must be credentialed only if listed in the provider directory.

Response: The Department agrees that the rule as written may be ambiguous. The Department has revised this clause, as well as clause (ii), to clarify when credentialing of these providers is necessary.

§11.1902(4)(C)(v): A commenter questions the appropriateness of a site visit to check appointment availability.

Response: The Department believes that site visits are an appropriate means to assess the availability of appointments. The rule does not preclude the use of additional methods, such as mystery shopper calls, to assess appointment availability at the HMO´s option.

Comment: A commenter does not believe that a follow-up site visit is necessary or appropriate for all corrective action plans. Follow-up site visits should be at the HMO´s discretion.

Response: The Department disagrees with the deletion of the provision, as NCQA requires HMOs to perform follow-up site visits every 6 months until the non-complying site becomes compliant.

For with changes: Scott & White Health Plan and Texas Association of Health Plans.

Against: None.

The amendments are adopted pursuant to the Insurance Code Articles 20A.39, 20A.37, 21.58D, and §36.001. Article 20A.39(a) requires the rules adopted under Article 20A.37 that relate to implementation and maintenance by an HMO of a process for selecting and retaining affiliated physicians and providers to comply with the provisions of new Article 20A.39 and the standards promulgated by the National Committee for Quality Assurance, to the extent that those standards do not conflict with other laws of this state. Article 20A.37(b) requires each HMO to have an ongoing internal quality assurance program to monitor and evaluate its health care services in all institutional and noninstitutional contexts and authorizes the Commissioner to establish, by rule, minimum standards and requirements for these programs, including, but not limited to, standards for assuring availability, accessibility, quality and continuity of care. Article 21.58D requires the Commissioner by rule to adopt a standardized form for the verification of the credentials of a physician and to require HMOs operating under the Insurance Code Chapter 20A to use the form. Section 36.001 provides that the Commissioner of Insurance may adopt rules to execute the duties and functions of the Texas Department of Insurance only as authorized by statute.

§11.2. Definitions.

(a) The definitions found in the Texas Health Maintenance Organization Act §2, as amended, codified in Texas Insurance Code Article 20A.02, are hereby incorporated into this chapter.

(b) The following words and terms, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise.

(1) Act--The Texas Health Maintenance Organization Act, Senate Bill 180, enacted by Acts 1975, 64th Legislature, Chapter 214, pages 514-530, first effective December 1, 1975, as amended, codified as the Texas Insurance Code Chapter 20A.

(2) Admitted assets--All assets as defined by statutory accounting principles, as permitted and valued in accordance with §11.803 of this title (relating to Investments, Loans, and Other Assets).

(3) Adverse determination--A determination upon utilization review that the health care services furnished or adopted to be furnished to a patient are not medically necessary or not appropriate.

(4) Affiliate--A person that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, the person specified.

(5) Agent--As defined in the Insurance Code Articles 20A.15 and 20A.15A, unless the context of the rule clearly indicates applicability to any agents licensed under one specific article.

(6) ANHC or approved nonprofit health corporation--A nonprofit health corporation certified under Medical Practice Act §5.01(a) (Texas Civil Statutes, Article 4495b).

(7) Basic health care service--Health care services which an enrolled population might reasonably require to maintain good health, including, without limitations as to time and cost, those benefits as prescribed in §§11.508 and 11.509 of this title (relating to Mandatory Benefit Standards: Group, Individual and Conversion Agreements, and Additional Mandatory Benefit Standards - Group Agreement Only), other than those limitations specifically prescribed in this title.

(8) Code--The Texas Insurance Code, 1951, as amended.

(9) Contract holder--An individual, association, employer, trust or organization to which an individual or group contract for health care services has been issued.

(10) Control--As defined in the Insurance Code Article 21.49-1.

(11) Controlled HMO--An HMO controlled directly or indirectly by a holding company.

(12) Controlled person--Any person, other than an HMO, who is controlled directly or indirectly by a holding company.

(13) Copayment--A charge in addition to premium to an enrollee for a service which is not fully prepaid.

(14) Credentialing--The process of collecting, assessing, and validating qualifications and other relevant information pertaining to a physician or provider to determine eligibility to deliver health care services.

(15) Dentist--An individual provider licensed to practice dentistry by the Texas State Board of Dental Examiners.

(16) General hospital--A licensed establishment that:

(A) offers services, facilities, and beds for use for more than 24 hours for two or more unrelated individuals requiring diagnosis, treatment, or care for illness, injury, deformity, abnormality, or pregnancy; and

(B) regularly maintains, at a minimum, clinical laboratory services, diagnostic X-ray services, treatment facilities including surgery or obstetrical care or both, and other definitive medical or surgical treatment of similar extent.

(17) HMO--A health maintenance organization as defined in Insurance Code Article 20A.02(n).

(18) Health status related factor--Any of the following in relation to an individual:

(A) health status;

(B) medical condition (including both physical and mental illnesses);

(C) claims experience;

(D) receipt of health care;

(E) medical history;

(F) genetic information;

(G) evidence of insurability (including conditions arising out of acts of domestic violence, including family violence as defined by the Insurance Code Article 21.21-5); or

(H) disability.

(19) Individual provider--Any person, other than a physician or institutional provider, who is licensed or otherwise authorized to provide a health care service. Includes, but is not limited to, licensed doctor of chiropractic, dentist, registered nurse, advanced practice nurse, physician assistant, pharmacist, optometrist, registered optician, and acupuncturist.

(20) Institutional provider--A provider that is not an individual. Includes any medical or health related service facility caring for the sick or injured or providing care or supplies for other coverage which may be provided by the HMO. Includes but is not limited to:

(A) General hospitals,

(B) Psychiatric hospitals,

(C) Special hospitals,

(D) Nursing homes,

(E) Skilled nursing facilities,

(F) Home health agencies,

(G) Rehabilitation facilities,

(H) Dialysis centers,

(I) Free-standing surgical centers,

(J) Diagnostic imaging centers,

(K) Laboratories,

(L) Hospice facilities,

(M) Infusion services centers,

(N) Residential treatment centers,

(O) Community mental health centers,

(P) Urgent care centers, and

(Q) Pharmacies.

(21) Limited provider network--A subnetwork within an HMO delivery network in which contractual relationships exist between physicians, certain providers, independent physician associations and/or physician groups which limit the enrollees´ access to only the physicians and providers in the subnetwork.

(22) Limited service HMO--An HMO which has been issued a certificate of authority to issue a limited service health care plan as defined in the Insurance Code Article 20A.02(l).

(23) Out of area benefits--Benefits that the HMO covers when its enrollees are outside the geographical limits of the HMO service area.

(24) Pathology services--Services provided by a licensed laboratory which has the capability of evaluating tissue specimens for diagnoses in histopathology, oral pathology, or cytology.

(25) Pharmaceutical services--Services, including dispensing prescription drugs, as defined in the Pharmacy Act, Texas Civil Statutes, Article 4542a-1, §5 that are ordinarily and customarily rendered by a pharmacy or pharmacist.

(26) Pharmacist--An individual provider licensed to practice pharmacy under the Pharmacy Act, Texas Civil Statutes, Article 4542a-1.

(27) Pharmacy--A facility licensed under the Pharmacy Act, Texas Civil Statutes, Article 4542a-1 §29.

(28) Premium--The prospectively determined rate that is paid by or on behalf of an enrollee for specified health services.

(29) Primary care physician or primary care provider--A physician or individual provider who is responsible for providing initial and primary care to patients, maintaining the continuity of patient care, and initiating referral for care.

(30) Primary HMO--An HMO that contracts directly with, and issues an evidence of coverage to, individuals or organizations to arrange for or provide a basic, limited, or single health care service plan to enrollees on a prepaid basis.

(31) Provider HMO--An HMO that contracts directly with a primary HMO to provide or arrange to provide health care services on behalf of the primary HMO within the primary HMO´s defined service area.

(32) Psychiatric hospital--A licensed hospital which offers inpatient services, including treatment, facilities and beds for use beyond 24 hours, for the primary purpose of providing psychiatric assessment and diagnostic services and psychiatric inpatient care and treatment for mental illness. Such services must be more intensive than room, board, personal services, and general medical and nursing care. Although substance abuse services may be offered, a majority of beds must be dedicated to the treatment of mental illness in adults and/or children.

(33) Qualified HMO--An HMO which has been federally approved under Title XIII of the Public Health Service Act, Public Law 93-222, as amended.

(34) Quality improvement--A system to continuously examine, monitor and revise processes and systems that support and improve administrative and clinical functions.

(35) Recredentialing--The periodic process by which:

(A) qualifications of physicians and providers are reassessed;

(B) performance indicators, including utilization and quality indicators, are evaluated; and

(C) continued eligibility to provide services is determined.

(36) Reference laboratory--A licensed laboratory that accepts specimens for testing from outside sources and depends on referrals from other laboratories or entities. HMOs may contract with a reference laboratory to provide clinical diagnostic services to their enrollees.

(37) Reference laboratory specimen procurement services--The operation utilized by the reference laboratory to pick up the lab specimens from the client offices or referring labs, etc. for delivery to the reference laboratory for testing and reporting.

(38) Referral specialists (other than primary care)--Physicians or individual providers who set themselves apart from the primary care physician or primary care provider through specialized training and education in a health care discipline.

(39) Schedule of charges--Specific rates or premiums to be charged for enrollee and dependent coverages.

(40) Service area--A geographic area within which direct service benefits are available and accessible to HMO enrollees who live, reside or work within that geographic area and which complies with §11.1606 of this title (relating to Organization of an HMO).

(41) Single service HMO--An HMO which has been issued a certificate of authority to issue a single health care service plan as defined in the Insurance Code Article 20A.02(y).

(42) Special hospital--A licensed establishment that:

(A) offers services, facilities and beds for use for more than 24 hours for two or more unrelated individuals who are regularly admitted, treated and discharged and who require services more intensive than room, board, personal services, and general nursing care;

(B) has clinical laboratory facilities, diagnostic X-ray facilities, treatment facilities or other definitive medical treatment;

(C) has a medical staff in regular attendance; and

(D) maintains records of the clinical work performed for each patient.

(43) Statutory surplus--Admitted assets minus accrued uncovered liabilities.

(44) Subscriber--If conversion or individual coverage, the individual who is the contract holder and is responsible for payment of premiums to the HMO; or if group coverage, the individual who is the certificate holder and whose employment or other membership status, except for family dependency, is the basis for eligibility for enrollment in the HMO.

(45) Subsidiary--An affiliate controlled by a specified person directly or indirectly through one or more intermediaries.

(46) Telehealth service--As defined in Section 57.042, Utilities Code.

(47) Telemedicine medical service--As defined in Section 57.042, Utilities Code.

(48) Urgent care--Health care services provided in a situation other than an emergency which are typically provided in a setting such as a physician or individual provider´s office or urgent care center, as a result of an acute injury or illness that is severe or painful enough to lead a prudent layperson, possessing an average knowledge of medicine and health, to believe that his or her condition, illness, or injury is of such a nature that failure to obtain treatment within a reasonable period of time would result in serious deterioration of the condition of his or her health.

(49) Utilization review--A system for prospective or concurrent review of the medical necessity and appropriateness of health care services being provided or adopted to be provided to an individual within this state. Utilization review shall not include elective requests for clarification of coverage.

(50) Voting security--As defined in the Insurance Code Article 21.49-1, including any security convertible into or evidencing a right to acquire such security.

(51) NAIC--National Association of Insurance Commissioners.

(52) Annual financial statement--The annual statement to be used by HMOs, as promulgated by the NAIC and as adopted by the commissioner under Insurance Code Articles 1.11 and 20A.10.

(53) RBC--Risk-based capital.

(54) RBC formula--NAIC risk-based capital formula.

(55) Authorized control level--The number determined under the RBC formula in accordance with the RBC instructions.

(56) RBC Report--1999 NAIC Managed Care Organizations Risk-Based Capital Report including Overview and Instructions for Companies published by the NAIC.

(57) Total adjusted capital--An HMO's statutory capital and surplus/total net worth as determined in accordance with the statutory accounting applicable to the annual financial statements required to be filed pursuant to the Insurance Code, and such other items, if any, as the RBC instructions provide.

§11.1607. Accessibility and Availability Requirements.

(a) An enrollee shall not be required to:

(1) travel in excess of 30 miles from the site of eligibility to reach a primary care physician and general hospital care except as provided in subsections (b) and (c) of this section;

(2) travel in excess of 75 miles from the site of eligibility to secure contact with referral specialists, specialty hospitals, psychiatric hospitals, diagnostic and therapeutic services, and single or limited service health care physicians or providers except as provided in subsections (b) and (c) of this section;

(3) for purposes of this subsection, "site of eligibility" refers to the location which makes the subscriber eligible for coverage.

(b) If any covered health care service or a participating physician and provider is not available to an enrollee within the mileage radii specified in subsection (a)(1) and (2) of this section because physicians and providers are not located within such mileage radii, or if the HMO is unable to obtain contracts after good faith attempts, or physicians and providers meeting the minimum quality of care and credentialing requirements of the HMO are not located within the mileage radii, the HMO shall submit a plan to the department for approval, at least 30 days before implementation. The plan shall include the following:

(1) the geographic area identified by county, city, ZIP code, mileage, or other identifying data in which services and/or physicians and providers are not available;

(2) for each geographic area identified as not having covered health care services and/or physicians or providers available, the reason or reasons that covered health care services and/or physicians and providers cannot be made available;

(3) a map, with key and scale, which identifies the areas in which such covered health care services and/or physicians and providers are not available;

(4) the HMO's general plan for making covered health care services and/or physicians and providers available to enrollees in each geographic area identified;

(5) the names and addresses of the participating physicians and providers and a listing of the covered health care services to be provided through the HMO delivery network to meet the medical needs of the enrollees covered under the HMO's general plan required under paragraph (4) of this subsection;

(6) the names and address of other physicians and providers and a listing of the specialties for any other health care services or physicians and providers to be made available in the geographic area in addition to those physicians and providers participating in the HMO delivery network listed under paragraph (5) of this subsection;

(7) a general description of the day to day procedures to be followed by the HMO to assure that primary care physicians, general hospitals, referral specialists, special hospitals, psychiatric hospitals, diagnostic and therapeutic services, or single or limited health care service providers and all other mandated health care services are made available and accessible to enrollees in the geographic areas identified as being areas in which such covered health care services and/or physicians and providers are not available and accessible, and any plans of the HMO for attempting to develop an HMO delivery network through which covered health care services are available and accessible to enrollees in these geographic areas in the future; and

(8) any other information which is necessary to assess the HMO's plan.

(c) The HMO is not precluded from making arrangements with physicians or providers outside the service area for enrollees to receive a higher level of skill or specialty than the level which is available within the HMO service area such as, but not limited to, treatment of cancer, burns, and cardiac diseases.

(d) The HMO shall require the HMO physicians and other providers of care who employ physician assistants, advanced practice nurses, dental hygienists and individuals other than physicians to assess the health care needs of HMO enrollees to have written policies which are implemented and enforced and describe the duties of all such providers in accordance with statutory requirements for licensure, delegation, collaboration, and supervision as appropriate.

(e) The HMO shall systematically and regularly verify that health care services furnished by physicians and providers of care such as dentists and physical therapists are available and accessible to enrollees without unreasonable periods of delay.

(f) The HMO shall develop and maintain a statistical reporting system which allows for compiling, developing, evaluating, and reporting statistics relating to the cost of operation, the pattern of utilization of its services, and the availability and accessibility of it services.

(g) Each health benefit plan delivered or issued for delivery by an HMO must include an HMO delivery network which is adequate and complies with the Insurance Code Article 20A.05(a)(1).

(h) The HMO shall not be required to expand services outside its service area to accommodate enrollees who live outside the service area, but work within the service area.

(i) Each evidence of coverage or certificate delivered or issued for delivery by an HMO may provide enrollees the option to access covered health care services through a telehealth service or a telemedicine medical service.

(j) Before providing telehealth services or telemedicine medical services to an enrollee, an HMO shall provide the enrollee with the option to select a physician or provider within the HMO delivery network to provide the covered health care services, or to elect to receive telehealth services or telemedicine medical services.

(k) In order to provide covered health care services to any enrollee by a telehealth service or a telemedicine medical service, an HMO shall satisfy the criteria specified under subsection (a) of this section.

§11.1901. Quality Improvement Structure.

(a) The HMO shall develop and maintain an ongoing quality improvement program designed to objectively and systematically monitor and evaluate the quality and appropriateness of care and services and to pursue opportunities for improvement.

(b) The HMO governing body is ultimately responsible for the overall quality improvement program. The HMO governing body shall:

(1) appoint a quality improvement committee that shall include practicing physicians, individual providers and at least one enrollee from throughout the HMO's service area. For purposes of this section, the enrollee appointed to the committee may not be an employee of the HMO;

(2) approve the quality improvement program;

(3) approve an annual quality improvement plan;

(4) meet no less than annually to receive and review reports of the quality improvement committee or group of committees and take action when appropriate; and

(5) review the annual written report on the quality improvement program.

(c) The quality improvement committee shall develop and evaluate the overall effectiveness of the quality improvement program.

(1) The quality improvement committee may delegate quality improvement activities to other committees that may, if applicable, include practicing physicians, individual providers, and enrollees from throughout the service area.

(A) All committees shall collaborate and coordinate efforts to improve the quality, availability, and accessibility of health care services to be furnished by the HMO to its enrollees.

(B) All committees shall meet and regularly report findings, recommendations, and resolutions in writing through the qualify improvement committee for the HMO governing body.

(C) If the quality improvement committee delegates any quality improvement activity to any subcommittee, then the quality improvement committee must establish a method of oversight of each subcommittee.

(2) The quality improvement committee shall use multidisciplinary teams, when indicated, to accomplish quality improvement program goals.

§11.1902. Quality Improvement Program. The quality improvement program shall be continuous and comprehensive, including both the quality of clinical care and the quality of service. The HMO shall dedicate adequate resources such as personnel, analytic capabilities, and data resources to the quality improvement program. The HMO shall continuously update and monitor the quality improvement program.

(1) Written description. There shall be a written description of the quality improvement program that outlines program organizational structure, functional responsibility and design.

(2) Work plan. There shall be an annual quality improvement work plan that includes a schedule of activities designed to reflect the population served by the HMO in terms of age groups, disease categories, and special risk status. The work plan shall include but not be limited to the following:

(A) Goals, objectives, and planned projects or activities identified from the previous year, as well as for the current year; time frames for implementation; responsible individuals; and coordination of functions.

(B) Use of quality indicators, performance measurements, and quality improvement data collection to monitor quality improvement.

(i) Quality indicators must be objective, measurable, and include performance goals for each indicator.

(ii) Performance measures must be process or outcome measures.

(iii) Data collected must be appropriate to the goals and objectives of the activity.

(C) Ongoing or periodic assessment of both quality of clinical care and quality of service in planned projects, specifically:

(i) Network adequacy, which includes availability and accessibility of care, including assessment of open/closed physician and individual provider panels;

(ii) Continuity of health care and related services;

(iii) Clinical studies, which shall specify methodologies to be used to accomplish them;

(iv) The adoption and annual updating of clinical practice guidelines or clinical care standards, compatible with current principles of health care; the quality improvement program shall assure the practice guidelines:

(I) are approved by participating physicians and individual providers;

(II) are included in physician and provider manuals; and

(III) include preventive health services.

(v) Enrollee, physician, and individual provider satisfaction;

(vi) The complaint and appeal process, complaint data, and identification and removal of communication barriers which may impede enrollees, physicians, and providers from effectively making complaints against the HMO;

(vii) Preventive health care through health promotion and outreach activities:

(I) The HMO shall inform and educate physicians and providers about using the health management and outreach programs for the enrollees assigned to them.

(II) Outreach may be accomplished through, but not limited to, written educational materials, community-based programs and presentations, health promotion fairs, and monetary contributions to community-based organizations and health related initiatives of other programs.

(viii) Claims payment processes;

(ix) Contract monitoring, including delegation oversight and compliance with filing requirements; and

(x) Utilization review processes.

(D) Ongoing or periodic analysis and evaluation of both quality of clinical care and quality of service planned projects specified in subparagraph (C) of this paragraph, which shall include:

(i) Evidence that results of evaluation are used to improve clinical care and services; and

(ii) A systematic method of tracking areas identified for improvement to assure that appropriate action is taken to effect the needed improvement.

(3) Evaluation. There shall be an annual written report on the quality improvement program, which includes completed activities, trending of clinical and service indicators, analysis of program performance, conclusions, and demonstrated improvements in care and services.

(4) Credentialing. An HMO shall implement a documented process for selection and retention of contracted physicians and providers, which includes the following elements, as applicable:

(A) The HMO´s policies and procedures shall clearly indicate the physician or individual provider directly responsible for the credentialing program and shall include a description of his or her participation.

(B) HMOs shall develop written criteria for credentialing of physicians and providers and written procedures for verifications.

(i) Credentialing is required for all physicians and providers, including advanced practice nurses, and physicians´ assistants. Physicians or providers who are members of a contracting group, such as an independent physician association or medical group, shall be credentialed individually.

(ii) Credentialing is not required for:

(I) hospital-based physicians or individual providers, including advanced practice nurses and physicians´ assistants unless listed in the provider directory;

(II) individual providers who furnish services only under the direct supervision of a physician or another individual provider except as specified in clause (i) of this subparagraph

(III) students, residents, or fellows; or

(IV) pharmacists.

(iii) The initial credentialing process, including application, verification of information, and a site visit (if applicable), must be completed before the effective date of the initial contract with the physician or provider.

(iv) An HMO shall have written policies and procedures for suspending or terminating affiliation with a contracting physician or provider, including an appeals process, pursuant to the Insurance Code Article 20A.18A(b).

(v) The HMO shall have a procedure for the ongoing monitoring of physician and provider performance between periods of recredentialing and shall take appropriate action when occurrences of poor quality are identified. Monitoring shall include, but not be limited to:

(I) Medicare and Medicaid sanctions;

(II) Information from state licensing boards regarding sanctions or licensure limitations; and

(III) Complaints.

(vi) If the HMO delegates credentialing functions to other entities, it shall have a process for developing delegation criteria and for performing pre-delegation and annual audits, a delegation agreement, a monitoring plan, and a procedure for termination of the delegation agreement for non-performance. If the HMO delegates credentialing functions to an entity accredited by the National Committee for Quality Assurance, the annual audit of that entity is not required ; however, evidence of this accreditation shall be made available to the department for review. The HMO shall maintain documentation of pre-delegation and annual audits, executed delegation agreements, reports received from the delegated entities, current rosters or copies of signed contracts with physicians and providers who are affected by the delegation agreement, and ongoing monitoring and shall make this documentation available to the department for review. Credentialing files maintained by the other entities to whom the HMO has delegated credentialing functions shall be made available to the department for examination upon request. In all cases, the HMO shall maintain the right to approve credentialing, suspension, and termination of physicians and providers.

(vii) The HMO´s procedures shall ensure that selection and retention criteria do not discriminate against physicians or providers who serve high-risk populations or who specialize in the treatment of costly conditions.

(viii) The HMO shall have a procedure for notifying licensing or other appropriate authorities when a physician´s or provider´s affiliation is suspended or terminated due to quality of care concerns.

(C) Initial credentialing process for physicians and individual providers shall include, but not be limited to, the following:

(i) Physicians shall complete the standardized credentialing application adopted in §21.3201 of this title (relating to the Texas Standardized Credentialing Application for Physicians) and individual providers shall complete an application which includes a work history covering at least five years, a statement by the applicant regarding any limitations in ability to perform the functions of the position, history of loss of license and/or felony convictions; and history of loss or limitation of privileges, sanctions or other disciplinary activity, current professional liability insurance coverage information, and information on whether the individual provider will accept new patients from the HMO. This does not preclude an HMO from using the standardized credentialing application form specified in §21.3201 of this title for credentialing of individual providers. The completion date on the application shall be within 180 calendar days prior to the date the credentialing committee deems a physician or individual provider eligible for initial credentialing.

(ii) The following shall be verified from primary sources and evidence of verification shall be included in the credentialing files:

(I) A current license to practice in the State of Texas and information on sanctions or limitations on licensure. The primary source for verification shall be the state licensing agency or board for Texas, and the license and sanctions must be verified within 180 calendar days prior to the date the credentialing committee deems a physician or individual provider eligible for initial credentialing. The license must be in effect at the time of the credentialing decision.

(II) Education and training, including evidence of graduation from the appropriate professional school and completion of a residency or specialty training, if applicable. Primary source verification shall be sought from the appropriate schools and training facilities or the American Medical Association´s MasterFile. If the state licensing board, agency, or specialty board verifies education and training with the physician´s or individual provider´s schools and facilities, evidence of current state licensure or board certification shall also serve as primary source verification of education and training.

(III) Board certification, if the physician or individual provider indicates that he/she is board certified on the application. Primary source verification may be obtained from the American Board of Medical Specialties Compendium, the American Osteopathic Association, the American Medical Association MasterFile, or from the specialty boards, and the source used must be the most recent available.

(IV) Valid Drug Enforcement Agency (DEA) or Department of Public Safety (DPS) Controlled Substances Registration Certificate, if applicable. These must be in effect at the time of the credentialing decision and may be verified by any one of the following means:

(-a-) copy of the DEA or DPS certificate;

(-b-) visual inspection of the original certificate;

(-c-) confirmation with DEA or DPS;

(-d-) entry in the National Technical Information Service database; or

(-e-) entry in the American Medical Association Physician Master File.

(iii) The following shall be verified within 180 calendar days prior to the date of the credentialing decision and shall also be included in the physician´s or individual provider´s credentialing file:

(I) Past five years of history of professional liability claims that resulted in settlements or judgments paid by or on behalf of the physician or individual provider, which may be obtained from the professional liability carrier or the National Practitioner Data Bank;

(II) Information on previous sanction activity by Medicare and Medicaid which may be obtained from one of the following:

(-a-) National Practitioner Data Bank;

(-b-) Cumulative Sanctions Report available over the internet;

(-c-) Medicare and Medicaid Sanctions and Reinstatement Report distributed to federally contracting HMOs;

(-d-) state Medicaid agency or intermediary and the Medicare intermediary;

(-e-) Federation of State Medical Boards;

(-f-) Federal Employees Health Benefits Program department record published by the Office of Personnel Management, Office of the Inspector General;

(-g-) entry in the American Medical Association Physician Master File.

(iv) The HMO shall perform a site visit to the offices of each primary care physician, obstetrician-gynecologist, primary care dentist, and high-volume individual behavioral health provider as part of the initial credentialing process. In addition, the HMO shall have written procedures for determining high-volume individual behavioral health providers. If physicians or individual providers are part of a group practice which shares the same office, one visit to the site may be used for all physicians or individual providers in the group practice, as well as for new physicians or individual providers who subsequently join the group practice. The site visit assessment shall be made available to the department for review.

(v) Site visits shall consist of an evaluation of the site´s accessibility, appearance, appointment availability, and space, using standards approved by the HMO. If a physician or individual provider offers services that require certification or licensure, such as laboratory or radiology services, the physician or individual provider shall have the current certification or licensure available for review at the site visit. In addition, as a result of the site visits, it shall be determined whether the site conforms to the HMO´s standards for record organization, documentation, and confidentiality practices. Should the site not conform to the HMO´s standards, the HMO shall require a corrective action plan and perform a follow-up site visit every six months until the site complies with the standards.

(D) The HMO shall have written procedures for recredentialing physicians and individual providers at least every three years through a process that updates information obtained in initial credentialing, including professional liability coverage. The process shall also consider performance indicators for primary care and high-volume individual behavioral health care providers, including enrollee complaints and information from quality improvement activities. Recredentialing procedures shall include, but not be limited to, the following processes:

(i) Reverification of the following from the primary sources and in accordance with the same verification time limit as for the initial credentialing process specified in subparagraph (C) of this paragraph:

(I) Licensure and information on sanctions or limitations on licensure;

(II) Board certification:

(-a-) if the physician or individual provider was due to be recertified; or

(-b-) if the physician or individual provider indicates that he or she has become board certified since the last time he or she was credentialed or recredentialed; and

(III) Drug Enforcement Agency (DEA) or Department of Public Safety (DPS) Controlled Substances Registration Certificate, if applicable. These may be reverified by any one of the following means:

(-a-) copy of the DEA or DPS certificate;

(-b-) visual inspection of the original certificate;

(-c-) confirmation with DEA or DPS;

(-d-) entry in the National Technical Information Service database; or

(-e-) entry in the American Medical Association Physician Master File.

(ii) Updated history of professional liability claims, and sanction and restriction information from Medicare and Medicaid in accordance with the verification sources and time limits specified in subparagraph (C)(iii) of this paragraph.

(E) The credentialing process for institutional providers shall include the following:

(i) Evidence of state licensure;

(ii) Evidence of Medicare certification;

(iii) Evidence of other applicable state or federal requirements, e.g., Bureau of Radiation Control certification for diagnostic imaging centers, Texas Mental Health and Mental Retardation certification for community mental health centers, CLIA (Clinical Laboratory Improvement Amendments of 1988) certification for laboratories;

(iv) Evidence of accreditation by a national accrediting body, as applicable; the HMO shall determine which national accrediting bodies are appropriate for different types of institutional providers. The HMO´s written policy and procedures must state which national accrediting bodies it accepts;

(v) Evidence of on-site evaluation of the institutional provider against the HMO´s written standards for participation if the provider is not accredited by the national accrediting body required by the HMO.

(F) The HMO procedures shall provide for recredentialing of institutional providers at least every three years through a process that updates information obtained for initial credentialing as set forth in subparagraph (E)(i)-(v) of this paragraph.

(G) Under Insurance Code Article 20A.39, the standards adopted in this paragraph must comply with the standards promulgated by the National Committee for Quality Assurance (NCQA) to the extent that those standards do not conflict with other laws of the state. Therefore, if the NCQA standards change and there is a difference between the standards specified in this paragraph and the NCQA standards, the NCQA standards shall prevail to the extent that those standards do not conflict with the other laws of this state.

(5) Site visits for cause.

(A) The HMO shall have procedures for detecting deficiencies subsequent to the initial site visit. When the HMO identifies new deficiencies, the HMO shall reevaluate the site and institute actions for improvement.

(B) An HMO may conduct a site visit to the office of any physician or provider at any time for cause. The site visit to evaluate the complaint or other precipitating event shall be conducted by appropriate personnel and may include, but not be limited to, an evaluation of any facilities or services relating to the complaint or event and an evaluation of medical records, equipment, space, accessibility, appointment availability, or confidentiality practices, as appropriate.

(6) Peer Review. The quality improvement program shall provide for an effective peer review procedure for physicians and individual providers.



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