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Subchapter R. Diabetes

28 TAC §§21.2602 and 21.2604

The Commissioner of Insurance adopts amendments to §§21.2602 and 21.2604 concerning minimum standards for benefits provided to enrollees with diabetes in health benefit plans and coverage under health benefit plans for equipment and supplies and self-management training associated with the treatment of diabetes. The amendments are adopted without changes to the proposed text as published in the July 18, 2003 issue of the Texas Register (28 TexReg 5625), and will not be republished.

The amendments are intended to properly implement Insurance Code art. 21.53D, consistent with legislative intent. The amendments to §§21.2602 and 21.2604 are provided to clarify that all requirements of 28 TAC, Chapter 21, Subchapter R, (Diabetes) apply to health plans provided by risk pools created under Chapter 172, Local Government Code (risk pools). Subchapter R was adopted in 1999 pursuant to Insurance Code art. 21.53D, which directs the Commissioner of Insurance, in consultation with the Texas Diabetes Council (TDC), to adopt by rule minimum standards for benefits provided to enrollees with diabetes. Subchapter R, as originally adopted, excluded risk pools from the requirement that health plans that provide benefits for the treatment of diabetes and associated conditions must provide coverage for diabetes equipment, supplies and self-management training programs. Excluding risk pools from providing these coverages does not conform to the applicable statutory mandate and is inconsistent with legislative intent. Adoption of the amendments resolves that inconsistency.

The amendments include language changes that make clear that risk pools are subject to the requirements of §§21.2603, 21.2605, and 21.2606, so that risk pools must meet the same requirements as all other health plans to which Subchapter R applies.

The adoption also includes an amendment to §21.2602 to delete unnecessary language and an amendment to §21.2604 to correct a citation.

COMMENTS AND AGENCY RESPONSE TO COMMENTS.

§§21.2602 and 21.2604: One comment was received on the proposal. The same commenter submitted comments to an earlier proposal of the same nature, that was published in the January 10, 2003 issue of the Texas Register (28 TexReg 403). The comment to the current proposal was submitted as a "supplement" to the comment on the proposal published on January 10, 2003.

The commenter believes that requiring a risk pool created pursuant to Local Government Code Chapter 172 to provide coverage for diabetes equipment and supplies and for diabetes self-management training is beyond the department´s authority. The commenter notes that Chapter 172 risk pools are generally exempt from Texas Insurance Code provisions pursuant to the language found at Local Government Code §172.014, but acknowledges that art. 21.53D contains language that essentially nullifies the Chapter 172 exemption. The commenter contends that this nullification of the Chapter 172 exemption applies to mandated benefits under art. 21.53D, but not to coverage for supplies and services associated with diabetes under art. 21.53G. The standards set forth by the commissioner pursuant to art. 21.53D, the commenter argues, may not include requirements regarding coverage for supplies and services associated with the treatment of diabetes because the legislature enacted a separate statute, art. 21.53G, that applies to those supplies and services, and art. 21.53G does not include a nullification of the Chapter 172 exemption.

The commenter believes that the department unnecessarily attempts to construe an unambiguous statute. This comment is part of an analysis by the commenter that focuses entirely on art. 21.53G, and argues that the rule of statutory construction historically known as expressio unius est exclusio alterius (the express mention of one thing, consequence or class in a statute is tantamount to the exclusion of all others) prohibits the department from requiring risk pools to provide coverage for supplies and services associated with diabetes that are addressed under art. 21.53G.

The commenter reflects a clear understanding of the department´s stated position that in order to effect the will of the legislature, the minimum standards for the treatment of diabetes adopted pursuant to art. 21.53D must include a requirement that health plans provide coverage for diabetes supplies, equipment and training. But the commenter also argues that if this were the case, there would have been no need for the legislature to enact art. 21.53G, and it cannot be presumed that the legislature engaged in a useless or meaningless act.

The commenter also disagrees with the department´s position, stated in the July 18 proposal, that art. 21.53D is the controlling authority and determines the outcome because the legislature took final action on art. 21.53D after it took final action on art. 21.53G. The commenter´s position is that both articles were adopted in the same legislative session, with the same effective date, and there is no conflict between the two articles.

The commenter requests that the rule be revised to clarify that Chapter 172 risk pools are subject only to the requirements of art. 21.53D and not to art. 21.53G.

Agency Response:

The department respectfully disagrees, and declines to make the requested changes to the proposed rule.

Art. 21.53D does not incorporate art. 2153G by reference. Each article is independent with regard to the health plans to which it applies and with regard to the mandates it imposes for coverage of diabetes care. Art. 21.53G is cited along with art. 21.53D as authority for these amendments because art. 21.53G provides more specific guidance about minimum requirements for coverage for diabetes supplies, equipment and self-management training. The commenter seems to acknowledge that the mandates in art. 21.53D are broader in scope than those in art. 21.53G, and only seeks to have risk pools excluded from the parts of the art. 21.53D mandates that require coverage for diabetes supplies, equipment and self-management training. However, nothing in art. 21.53G affects in any way the applicability of all standards established pursuant to art. 21.53D to all of the health plans identified in art. 21.53D, §2.

The commenter´s reliance upon the cited rule of statutory construction would only be helpful if the applicability of art. 21.53G alone was being considered. But the real issue identified by the commenter is the need to correctly reconcile two statutes that are in conflict with regard to the applicability to risk pools of certain minimum standards for diabetes care coverage. Whereas art. 21.53G does not expressly include risk pools in its scope, art. 21.53D does. Thus, expressio unius est exclusio alterius does not control the question of the applicability of art. 21.53D to risk pools.

The department also disagrees with the commenter´s argument that if minimum standards established pursuant to art. 21.53D could require risk pools to provide coverage for diabetes equipment, supplies and self-management training, there would have been no need for the legislature to enact art. 21.53G. Art. 21.53G addresses standards for coverage for diabetes equipment, supplies and self-management training by many different kinds of health plans other than risk pools, including reciprocal exchanges operating pursuant to Chapter 942 of the Insurance Code. Art. 21.53D does not include reciprocal exchanges in its scope. Art. 21.53G is the only statute that mandates coverage for diabetes supplies, equipment and self-management training by reciprocal exchanges and it is therefore not rendered meaningless or useless by the department´s interpretation of art. 21.53D.

The department considers the fact that the legislature took final action on art. 21.53D after it took final action on art. 21.53G to be a very salient point. Government Code §311.025(a) stipulates that if statutes enacted in the same legislative session are irreconcilable, the statute latest in date of enactment prevails. As noted in the proposal, art. 21.53D was enacted after art. 21.53G.

The legislature also made a specific statement about the applicability of art. 21.53D to risk pools, while it made no specific statement on the inclusion of risk pools in the scope of art. 21.53G. Art. 21.53G did not address the issue of its applicability to risk pools at all. Art. 21.53G and its legislative history are actually silent on the question of the applicability of art. 21.53G to risk pools. It is only because of the language in Local Government Code §172.014 that the necessary interpretation of this silence is that art. 21.53G presumptively, when read in isolation, does not apply to risk pools.

Perhaps most important to note is that the legislature made its intent clear by including in its record an express statement regarding the applicability of art. 21.53D to risk pools. During the House floor debate on second reading of SB 162 (the bill enacting art. 21.53D) on May 23, 1997, Representative Madden offered Floor Amendment #2, which read as follows:

Amend SB 162 as follows:

On page 3, following line 25, add a new subsection " (3)" that incorporates this language, " Notwithstanding Section 172.014, Local Government Code, or any other law, this article applies to health and accident coverage provided by a risk pool created under Chapter 172, Local Government Code.", and renumber the lines of the subsequent text accordingly.

Representative Madden stated the amendment was the same one "offered last night" to allow coverage under the Local Government Code, Chapter 172. The House Journal for May 22, 1997 shows that CSSB 54 was debated by the House on that date. On p. 3329 of the 1997 House Journal is a Floor Amendment for CSSB 54 that is identical in wording to Floor Amendment #2 for SB 162. No other bill was discussed in the House on May 22, 1997 that had the same or similar wording. When Representative Gray laid out CSSB 54, she indicated that there was one amendment, to be offered by Representative Madden, that would make sure women working for cities and counties would also receive the benefits of CSSB 54. (CSSB 54 allowed women to go directly to their OB/GYN without first seeing their primary care physician.)

Thus, the legislature did see fit to enact legislation that is intended to require risk pools to provide coverage for diabetes supplies, equipment and self-management training. Rather than suggesting an intent to include risk pools in the scope of art. 21.53D for only limited purposes, the history gives the clear message that persons covered by risk pools (persons working for cities and counties) are to receive the same benefits as everyone else covered by art. 21.53D.

Art. 21.53D was enacted more recently than art. 21.53G, and addressed its applicability to risk pools more specifically than did art. 21.53G. These facts, combined with the legislative history cited above, compel the department to conclude that risk pools should be treated the same as all other benefit plans that are subject to these rules. This includes the requirement that the benefit plans provide coverage for diabetes equipment, supplies and self-management training in accordance with the standards in these rules.

NAMES OF THOSE COMMENTING FOR AND AGAINST THE SECTIONS.

Against:Texas Municipal League Intergovernmental Employee Benefits Pool (TMLIEBP).

The amendments are adopted under the Insurance Code Arts. 21.53G, 21.53D and §36.001. Art. 21.53G provides guidance about coverages required for diabetes supplies, equipment and self-management training. Art. 21.53D, §3 provides that the commissioner shall by rule adopt minimum standards for benefits to enrollees with diabetes and that each health care benefit plan shall provide benefits for the care required by the minimum standards. Section 36.001 provides that the Commissioner of Insurance may adopt any rules necessary and appropriate to implement the powers and duties of the Texas Department of Insurance under the Insurance Code and other laws of this state.

§21.2602.Required Benefits for Persons with Diabetes.

(a) Notwithstanding §172.014, Local Government Code, or any other law, health plans provided by a risk pool created under Chapter 172, Local Government Code, delivered, issued for delivery, or renewed on or after January 1, 1998, that provide benefits for the treatment of diabetes and associated conditions must provide coverage to an insured for diabetes equipment, diabetes supplies, and diabetes self-management training programs, in accordance with §21.2603 of this title (relating to Out of Pocket Expenses), §21.2605 of this title (relating to Diabetes Equipment and Supplies) and §21.2606 of this title (relating to Diabetes Self-Management Training).

(b) Health benefit plans (other than reciprocal exchanges operating under Chapter 942 of the Texas Insurance Code) delivered, issued for delivery, or renewed on or after January 1, 1999, must provide coverage to each insured in accordance with §21.2603 of this title and §21.2604 of this title (relating to Minimum Standards for Benefits for Persons with Diabetes).

(c) Health benefits plans delivered, issued for delivery, or renewed on or after January 1, 1998, by an entity other than an HMO, which provide coverage limited to hospitalization expenses, shall provide coverage to each insured for diabetes equipment, diabetes supplies, and diabetes self-management training programs, in accordance with §§21.2603, 21.2605 and 21.2606 of this title, during hospitalization of the insured.

(d) A determination of medical necessity may be applied to benefits required under this subchapter provided it complies with all applicable laws and regulations.

§21.2604. Minimum Standards for Benefits for Persons with Diabetes, Requirement for Periodic Assessment of Physician and Organizational Compliance.

(a) Health benefit plans provided by HMOs shall provide coverage for the services in paragraphs (1) through (7) of this subsection and shall contract with providers that agree to comply with the minimum practice standards outlined in subsection (b) of this section. Services to be covered include:

(1) office visits and consultations with physicians and practitioners for monitoring and treatment of diabetes, including office visits and consultations with appropriate specialists;

(2) immunizations required by Insurance Code Article 21.53F, Coverage for Childhood Immunizations;

(3) immunizations for influenza and pneumococcus;

(4) inpatient services, and physician and practitioner services when the insured is confined to:

(A) a hospital;

(B) a rehabilitation facility; or

(C) a skilled nursing facility;

(5) inpatient and outpatient laboratory and diagnostic imaging services;

(6) diabetes equipment and supplies in accordance with §21.2605 of this title (relating to Diabetes Equipment and Supplies); and

(7) diabetes self-management training, in accordance with subsection (b)(1)(A)(iii) of this section and §21.2606 of this title (relating to Diabetes Self-Management Training);

(b) HMOs shall contract with providers who, at a minimum, provide care that complies with subsection (a) of this section that includes:

(1) for all insureds:

(A) at initial visit by the insured:

(i) a complete history and physical including an assessment of immunization status;

(ii) development of a management plan addressing all of the following that are applicable to the insured:

(I) nutrition and weight evaluation;

(II) medications;

(III) an exercise regimen;

(IV) glucose and lipid control;

(V) high risk behaviors;

(VI) frequency of hypoglycemia and hyperglycemia;

(VII) compliance with applicable aspects of self care;

(VIII) assessment of complications;

(IX) follow up on any referrals;

(X) psychological and psychosocial adjustment;

(XI) general knowledge of diabetes; and

(XII) self-management skills;

(iii) diabetes self-management training given or referred by the physician or practitioner as required by §21.2606 of this title and §21.2607 of this title;

(iv) referral for a dilated funduscopic eye exam to be performed by an ophthalmologist or therapeutic optometrist for an insured with Type 2 Diabetes.

(B) at every visit the following:

(i) weight and blood pressure taken,

(ii) foot exam performed without shoes or socks, and

(iii) dental inspection.

(C) every six months the following:

(i) review of the management plan, and

(ii) glycosylated hemoglobin test.

(D) annually the following:

(i) lipid profile,

(ii) microalbuminuria;

(iii) influenza immunization;

(iv) referral for a dilated funduscopic eye exam performed by an ophthalmologist or therapeutic optometrist; and

(v) for insureds under eighteen years of age, a referral for a retinal camera examination to be performed by an ophthalmologist or therapeutic optometrist.

(2) For treatment of an insured sixty-five years of age and over or an insured with complications affecting two or more body systems:

(A) minimum practice standards as set forth in paragraph (1) of this subsection; and

(B) specific inquiries into and consideration of treatment goals for comorbidity and polypharmacy.

(3) For pregnant insureds with pre-existing or gestational diabetes:

(A) minimum practice standards as set forth in paragraph (1) of this subsection; and

(B) enhanced fetal monitoring based on the standards promulgated by the American College of Gynecologists and Obstetricians.

(4) For insureds with Type 1 Diabetes:

(A) minimum practice standards as set forth in paragraph (1) of this subsection;

(B) an initial diagnosis, consideration of hospitalization due to the insured's:

(i) age;

(ii) physical condition;

(iii) psychosocial circumstances; or

(iv) lack of access to outpatient diabetes self-management training as required in §21.2606 of this title or §21.2607 of this title; and

(C) on-going management which includes quarterly office visits at which evaluation includes:

(i) weight;

(ii) blood pressure;

(iii) ophthalmologic exam;

(iv) thyroid palpation;

(v) cardiac exam;

(vi) examination of pulses;

(vii) foot exam;

(viii) skin exam;

(ix) neurological exam;

(x) dental inspection;

(xi) results of home glucose self monitoring;

(xii) frequency and severity of hypoglycemia or hyperglycemia;

(xiii) medical nutrition plan;

(xiv) exercise regimen;

(xv) adherence problems;

(xvi) psychosocial adjustment;

(xvii) reevaluation of short and long term self-management goals;

(xviii) anticipatory guidance related to issues of Type 1 Diabetes;

(xix) glycosylated hemoglobin;

(xx) counseling for high risk behaviors; and

(xxi) for insureds under eighteen years of age, growth assessment.

(c) Health plans provided by HMOs shall periodically assess physician and organizational compliance with the minimum practice standards contained in subsection (b) of this section.

(d) Health benefit plans provided by entities other than HMOs shall provide coverage at a minimum for:

(1) office visits and consultations with physicians and practitioners for monitoring and treatment of diabetes, including office visits and consultations with appropriate specialists;

(2) immunizations required by Insurance Code Article 21.53F, Coverage for Childhood Immunizations;

(3) immunizations for influenza and pneumococcus;

(4) inpatient services, physician, and practitioner services when an insured is confined to:

(A) a hospital;

(B) a rehabilitation facility; or

(C) a skilled nursing facility;

(5) inpatient and outpatient laboratory and diagnostic imaging services;

(6) diabetes equipment and supplies in accordance with §21.2605 of this title;and

(7) diabetes self-management training in accordance with §21.2606 of this title.

For more information, contact: ChiefClerk@tdi.texas.gov