Administrative Rules of the State of Montana

BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES

OF THE STATE OF MONTANA

In the matter of the amendment of ARM 37.108.507 pertaining to HEDIS components of quality assessment activities

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NOTICE OF PROPOSED AMENDMENT

NO PUBLIC HEARING CONTEMPLATED

TO: All Concerned Persons

1. On January 13, 2014, the Department of Public Health and Human Services proposes to amend the above-stated rule.

2. The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. If you require an accommodation, contact Department of Public Health and Human Services no later than 5:00 p.m. on January 2, 2014, to advise us of the nature of the accommodation that you need. Please contact Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena MT 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail [email protected].

3. The rule as proposed to be amended provides as follows, new matter underlined, deleted matter interlined:

37.108.507 COMPONENTS OF QUALITY ASSESSMENT ACTIVITIES

(1) Annually, the health carrier shall evaluate its quality assessment activities by using the following HEDIS ~~year 2013~~ 2014 measures:

(a) through (3) remain the same.

(4) The department adopts and incorporates by reference the HEDIS ~~year 2013~~ 2014 measures for the categories listed in (1)(a) through (e). The HEDIS ~~year~~ ~~2013~~ 2014 measures are developed by the National Committee for Quality Assurance and provide a standardized mechanism for measuring and comparing the quality of services offered by managed care health plans. Copies of HEDIS ~~2013~~ 2014 measures are available from the National Committee for Quality Assurance, 1100 13th St. NW, Suite 1000, Washington, D.C. 20005 or on the Internet at www.ncqa.org.

AUTH: 33-36-105, MCA

IMP: 33-36-105, 33-36-302, MCA

4. STATEMENT OF REASONABLE NECESSITY

The Department of Public Health and Human Services (department) is proposing to amend ARM 37.108.507 to update the healthcare effectiveness data and information set (HEDIS).

The Managed Care Plan Network Adequacy and Quality Assurance Act (Title 33, Chapter 36, MCA) establishes standards for health carriers offering managed care plans and the implementation of quality assurance standards in administrative rules. ARM 37.108.501 through 521 were adopted in 2001 to establish mechanisms for the department to evaluate quality assurance activities of health carriers providing managed care plans in Montana. ARM 37.108.507 requires health carriers to report their quality assessment activities to the department using HEDIS measures, nationally utilized measures that are updated annually. Since the HEDIS standards change somewhat every year, the rule must also be updated annually to reflect the current year's measures and ensure that national comparisons are possible, since the other states will also be using the same updated measures.

The department is proposing to delete the word "year" from (1) and (4) to be consistent with the National Committee for Quality Assurance usage when referring to their performance measure tool known as HEDIS.

The option of not updating the HEDIS measure was considered and rejected because these are national quality measures which allow comparison among health plans. If the measures are not kept current, this function is lost.

The changes from adopted 2013 measures to the proposed 2014 measures are indicated below:

Changes to HEDIS 2014

(1) Childhood Immunization Status

(a) Removed coding tables and replaced all coding table references with value set references.

(2) Breast Cancer Screening

(a) Removed coding tables and replaced all coding table references with value set references.

(b) Revised the continuous enrollment time frame.

(d) Revised the numerator time frame.

(3) Cervical Cancer Screening

(a) Removed coding tables and replaced all coding table references with value set references.

(b) Added the hybrid reporting method for commercial plans.

(c) Added steps to allow for two appropriate screening methods of cervical cancer screening: cervical cytology performed every three years in women 21–64 years of age and cervical cytology/HPV co-testing performed every five years in women 30–64 years of age.

(4) Comprehensive Diabetes Care

(a) Removed coding tables and replaced all coding table references with value set references.

(b) Added canagliflozin to the description of "Sodium glucose cotransporter 2 (SGLT2) inhibitor" in Table CDC-A.

(d) Clarified hybrid requirements for the HbA1c Control indicators.

(e) Clarified medical record documentation requirements for a negative retinal or dilated eye exam.

(f) Clarified that a finding (e.g., normal, within normal limits) is acceptable for the LDL-C Screening indicator.

(g) Clarified hybrid requirements for the LDL-C Control (<100 mg/dL) indicator.

(h) Clarified step 2 of the numerator for BP Control indicators in the Hybrid Specifications to state when a BP reading is not compliant.

(i) Clarified in the "Note" section that organizations must use the most recent result for indicators that require it, regardless of data source.

(5) HEDIS/Consumer Assessment of Health Plan Survey (CAHPS) Health Plan Survey 5.0H, Adult Version

(a) This measure is collected using survey methodology. Detailed specifications and summary of changes are contained in HEDIS 2014, Volume 3: Specifications for Survey Measures.

Corrections, policy changes and clarifications to HEDIS 2014, Volume 2, Technical Specifications

Updated Random Number Table for Measures using the Hybrid Method

(1) Childhood Immunization Status

(a) Administrative Specification—Exclusion (optional): Any particular vaccine

(i) Replace the two bullets with the following text:

Anaphylactic reaction to the vaccine or its components (Anaphylactic Reaction Due To Vaccination Value Set).

Anaphylactic reaction to the vaccine or its components (Anaphylactic Reaction Due To Serum Value Set), with a date of service prior to October 1, 2011.

(2) Breast Cancer Screening

(a) Eligible Population—Allowable gap

(i) Replace the text in this section with the following text:

No more than one gap in enrollment of up to 45 days for each full calendar year of continuous enrollment (i.e., the measurement year and the year prior to the measurement year). To determine continuous enrollment for a Medicaid beneficiary for whom enrollment is verified monthly, the member may not have more than a 1-month gap in coverage during each full calendar year of continuous enrollment (i.e., the measurement year and the year prior to the measurement year).

No gaps in enrollment are allowed from October 1 two years prior to the measurement year through December 31 two years prior to the measurement year.

(3) Cervical Cancer Screening

(a) Administrative Specification—Numerator

(i) Replace the text in step 2 with the following text:

From the women who did not meet step 1 criteria, identify women 30–64 years of age as of December 31 of the measurement year who had cervical cytology (Cervical Cytology Value Set) and a human papillomavirus (HPV) test (HPV Tests Value Set) with service dates four or less days apart during the measurement year or the four years prior to the measurement year and who were 30 years or older on the date of both tests.

(b) Hybrid Specification—Denominator

(i) Replace the first sentence with the following text:

A systematic sample drawn from the eligible population.

(i) Replace the first paragraph in step 2 with the following text:

From the women who did not meet step 1 criteria, identify the number of women 30–64 years of age as of December 31 of the measurement year who had cervical cytology and an HPV test on the same date of service during the measurement year or the four years prior to the measurement year and who were 30 years or older as of the date of testing. Documentation in the medical record must include both of the following:

(A) A note indicating the date when the cervical cytology and the HPV test were performed. The cervical cytology and HPV test must be from the same data source.

(B) The results or findings.

(4) Comprehensive Diabetes Care

(a) Administrative Specification—Required exclusions for HbA1c Control <7% for a Selected Population indicator

(i) Replace the second bullet with the following text:

CABG. Members discharged for CABG (CABG Value Set) during the measurement year or the year prior to the measurement year. Use both facility and professional claims to identify CABG and include inpatient claims only.

(b) Administrative Specification—Medical Attention for Nephropathy

(i) In the eighth bullet, replace the reference to "microalbumin" with "macroalbumin."

(i) In the first paragraph, replace "Outpatient Visit Value Set" with "Outpatient Value Set."

(d) Monitoring for Diabetic Nephropathy—Step 1

(i) Replace text in the diagram with the following text:

Is there documentation of ESRD, chronic or acute renal failure, renal insufficiency, diabetic nephropathy, dialysis or renal transplant?

5. The department intends to apply these rules retroactively to January 1, 2014. A retroactive application of the proposed rules does not result in a negative impact to any affected party.

6. Concerned persons may submit their data, views, or arguments concerning the proposed action in writing to: Kenneth Mordan, Office of Legal Affairs, Department of Public Health and Human Services, P.O. Box 4210, Helena MT 59604-4210, no later than 5:00 p.m. on January 9, 2014. Comments may also be faxed to (406) 444-9744 or e-mailed to [email protected].

7. If persons who are directly affected by the proposed action wish to express their data, views, or arguments orally or in writing at a public hearing, they must make written request for a hearing and submit this request along with any written comments to Kenneth Mordan at the above address no later than 5:00 p.m., January 9, 2014.

8. If the agency receives requests for a public hearing on the proposed action from either 10% or 25, whichever is less, of the persons directly affected by the proposed action; from the appropriate administrative rule review committee of the Legislature; from a governmental subdivision or agency; or from an association having not less than 25 members who will be directly affected, a hearing will be held at a later date. Notice of the hearing will be published in the Montana Administrative Register. Ten percent of those directly affected has been determined to be one based on the two health insurance providers affected by this rule change.

9. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency. Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices. Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to the contact person in 6 above or may be made by completing a request form at any rules hearing held by the department.

10. An electronic copy of this proposal notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register. The Secretary of State strives to make the electronic copy of this notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered. In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

11. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

12. With regard to the requirements of 2-4-111, MCA, the department has determined that the amendment of the above-referenced rule will not significantly and directly impact small businesses.

/s/ Francis X. Clinch /s/ Richard H. Opper

Francis X. Clinch Richard H. Opper, Director

Rule Reviewer Public Health and Human Services

Certified to the Secretary of State December 2, 2013.