Title of Regulation: 12VAC5-407. Procedures for the Submission of Health Maintenance Organization Quality of Care Performance Information (amending 12VAC5-407-10, 12VAC5-407-50 through 12VAC5-407-100; repealing 12VAC5-407-30, 12VAC5-407-40, 12VAC5-407-120).

Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: January 13, 2016.

Effective Date: February 1, 2016.

Agency Contact: Debbie Condrey, Chief Information Officer, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7118, FAX (804) 864-7156, or email debbie.condrey@vdh.virginia.gov.

Basis: The regulation is promulgated under the authority of §§ 32.1-12 and 32.1-276.5 of the Code of Virginia. Section 32.1-12 grants the board the legal authority "to make, adopt, promulgate, and enforce such regulations necessary to carry out the provisions" of Title 32.1 of the Code of Virginia. Subsection B of § 32.1-276.5 requires health maintenance organizations (HMOs) to submit annually to the Commissioner of Health audited data consistent with the latest version of the Health Employer Data and Information Set (HEDIS) as collected by the National Committee for Quality Assurance (NCQA). Subsection B of § 32.1-276.5 requires that the board promulgate regulations to implement this requirement.

Purpose: To fulfill the statutory mandate to review regulations and to protect the citizens of the Commonwealth, the department conducted a periodic review of 12VAC5-407, "Procedures for the Submission of Health Maintenance Organization Quality of Care Performance Information" pursuant to Executive Order 14 (2010). As a result of this review, the department determined it was necessary to use the regulatory process to amend these regulations. The amendments are essential to protect the health, safety, and welfare of citizens because they enhance the clarity of the regulations in order to achieve improvements that will be reasonable and prudent and will not impose an unnecessary burden on the Virginia Department of Health or the public.

Rationale for Using Fast-Track Process: These amendments simply clarify confusing language, eliminate unnecessary sections within the existing regulations, and correct the statutory authority for the chapter. This regulatory action does not propose any substantive changes. These amendments have also been created with input from stakeholders. Therefore, the department does not expect that this regulatory action will be controversial.

Substance:

12VAC5-407-10. Definitions -- Remove the unnecessary definition of "Code." Correct the definitions of "HEDIS" and "Nonprofit Organization."

12VAC5-407-30 Reporting requirements for HMO -- Remove an unnecessary section.

12VAC5-407-40 Exceptions to HEDIS reporting -- Remove an unnecessary section.

12VAC5-407-50 Reporting methods and exemption from reporting -- Restructure the section for improved clarity.

12VAC5-407-60 Audited data required -- Change the section into active voice and remove unnecessary language from the section.

12VAC5-407-70 Process for data submission -- Clarify language.

12VAC-407-80 Fees -- Clarify language and update terminology.

12VAC5-407-90 Late charge -- Change terminology for consistency across the regulations.

12VAC5-407-100 Duties of the nonprofit organization -- Clarify language.

12VAC5-407-120 Other duties of the board -- Remove an unnecessary section.

Issues: The primary advantage to the agency, the Commonwealth, and the public of the proposed regulatory action will be clearer and less burdensome regulations. There are no known disadvantages to the agency, the Commonwealth, or the public.

Small Business Impact Review Report of Findings: This regulatory action serves as the report of the findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to: 1) update definitions, 2) amend language to improve clarity, and 3) remove obsolete language.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Code of Virginia § 32.1-276.5 (B) requires health maintenance organizations (HMOs) to annually submit audited data to the State Health Commissioner and the Board to promulgate regulation to implement this requirement. The Regulations for the Submission of Health Maintenance Organization Quality of Care Performance Information are such regulation.

None of the Board's proposed amendments change requirements in practice. Proposed language changes will enable readers of the regulation to more accurately understand requirements in practice. Thus the proposed amendments will likely produce a small net benefit.

Businesses and Entities Affected. The proposed amendments pertain to the 10 HMOs with active licenses to operate in the Commonwealth of Virginia. None of these firms are small businesses.¹

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments will not affect employment.

Effects on the Use and Value of Private Property. The proposed amendments will not significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments will not significantly affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments will not significantly affect small businesses.

Real Estate Development Costs. The proposed amendments will not affect real estate development costs.

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¹ Data source: Virginia Department of Health

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the findings of the economic impact analysis.

Summary:

The amendments clarify and simplify the regulation, update definitions and titles, and eliminate three unnecessary sections.

Part I
Definitions and General Information

12VAC5-407-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Board" means State Board of Health.

"Code" means the Code of Virginia.

"Commissioner" means the State Health Commissioner.

"Consumer" means any person (i) whose occupation is other than the administration of health activities or the provision of health services,; (ii) who has no fiduciary obligation to a health care institution or other health agency or to any organization, public or private, whose principal activity is an adjunct to the provision of health services,; or (iii) who has no material financial interest in the rendering of health services.

"Department" means the State Virginia Department of Health.

"Health maintenance organization" or "HMO" means any person who undertakes to provide or to arrange for one or more health care plans pursuant to Chapter 43 (§ 38.2-4300 et seq.) of Title 38.2 of the Code of Virginia.

"HEDIS" means the Health Plan Employer Data and Information Set, also known as the Healthcare Effectiveness Data and Information Set, a set of standardized performance measures sponsored, supported collected and maintained by the National Committee for Quality Assurance.

"NCQA" means the National Committee for Quality Assurance.

"Nonprofit organization" means a nonprofit, tax-exempt health data organization with the characteristics, expertise, and capacity to execute the powers and duties set forth for such entity in this chapter Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 of the Code of Virginia and that enters into a contract for the compilation, storage, analysis, and evaluation of data pursuant to Chapter 7.2 of Title 32.1.

Part II
Quality of Care Data Reporting

12VAC5-407-30. Reporting requirements for HMO data. (Repealed.)

A. Every HMO shall make available to the commissioner those HEDIS or any other quality of care or performance information set, or a subset thereof.

B. The board may contract directly with NCQA to purchase the selected HEDIS measures on behalf of the HMOs.

12VAC5-407-40. Exception to HEDIS reporting. (Repealed.)

A. The board may approve and require quality of care data other than the HEDIS measures provided that reasonable notice is given to the HMOs in writing.

12VAC5-407-50. Reporting methods and exemption from reporting.

A. Every HMO with an active license in the Commonwealth shall be required to submit the HEDIS or any other quality of care or performance information set approved by the board unless granted a written exemption by the commissioner.

B. The following methods shall be used for data submission:

1. If the HMO submits data to NCQA, the commissioner may purchase HEDIS data or any other quality of care or performance information set from NCQA.

2. If the HMO does not submit data to NCQA, or the commissioner elects not to purchase HEDIS data from the NCQA, then the HMO shall submit the performance information sets approved by the board to the nonprofit organization in accordance with the timeframes established in 12VAC5-407-70.

B. C. An HMO may, in writing, petition the commissioner for an exemption. The commissioner, at his discretion, may grant a waiver from reporting the HEDIS or any other approved quality of care or performance information set. In considering a petition for waiver, the commissioner may give due consideration to the HMO's (i) sample size; (ii) number of covered lives; (iii) length of operating experience in Virginia; (iv) accreditation status with respect to NCQA or other national accrediting organizations; or (v) any other relevant factors he deems appropriate.

C. D. An HMO that can demonstrate that it does not meet NCQA's minimum sample size requirements to collect statistically valid information on at least 50% of the HEDIS effectiveness of care measures or performance information sets approved by the board shall be exempt from reporting the HEDIS quality of care or performance sets during the reporting period. The HMO shall submit documentation to the commissioner each reporting period to demonstrate that it meets the criteria for obtaining an exemption from reporting.

D. Options for data submission.

1. The commissioner may purchase HEDIS data or any other quality of care or performance information set from NCQA that includes all HMOs operating in the Commonwealth that submit HEDIS data to NCQA.

2. HMOs that do not submit data directly to NCQA must submit the performance information sets approved by the board to the nonprofit organization in accordance with the timeframes established in 12VAC5-407-70.

3. If the budget pursuant to 12VAC5-407-100 E includes a cost benefit for direct submission of HEDIS data or any other quality of care or performance information set, the commissioner may thereafter require direct submission.

12VAC5-407-60. Audited data required.

A. Data submitted by HMOs is required to be shall submit HEDIS or other quality of care or performance information set approved by the board that has been verified by an independent auditing organization with no financial interest in or managerial association with the HMO. The HMO shall submit an audit report with the data.

B. HMOs whose performance information set is audited by an NCQA-certified HEDIS compliance auditor will have a notice to that effect published with their HEDIS data.

C. HMOs whose performance information set is not audited by NCQA-certified auditors will have a notice to that effect published with their HEDIS data.

12VAC5-407-70. Process for data submission.

A. Before January 1 of each year, the commissioner shall submit to each HMO in writing the process required for data submission, obtaining a waiver from reporting and the amount of the fee to be paid the fee associated with data submission, and the process for obtaining a waiver. HMOs providing HEDIS or any other quality of care or performance information set directly to the commissioner nonprofit organization shall submit the data by September 15 of each year.

B. The nonprofit organization board shall direct the nonprofit organization to publish annually the quality information data before December 31.

12VAC5-407-80. Fees.

A. For each HMO required to provide information pursuant to this chapter, the board shall prescribe a reasonable fee to cover the cost of collecting and making available such data. The commissioner may purchase HEDIS data or other quality of care or performance information set on behalf of all the actively licensed HMOs in the Commonwealth that are participating in HEDIS and divide the cost among the HMOs. Each HMO shall pay an equal share of the cost to the board for purchase of the HEDIS data directly from NCQA. The remainder of the cost associated with making the data available shall be divided among the participating HMOs in a tiered format based on the number of enrollees per HMO.

B. Fees described in subsection A of this section shall not exceed $3,000 per HMO per year.

C. The payment of such fees shall be on September 15 of each year or later if determined by an agreement between the board and the nonprofit organization. The nonprofit organization providing services pursuant to an agreement or contract as provided in § 32.1-276.4 of the Code of Virginia shall be authorized to charge and collect the fees prescribed by the board in subsection A of this section when the data are provided directly to the nonprofit organization. Such fees shall not exceed the amount authorized by the board.

D. The nonprofit organization providing services pursuant to an agreement or contract as provided in § 32.1-276.4 of the Code of Virginia shall be authorized to charge and collect reasonable fees approved by the board for making available to any individual or entity who requests the HEDIS data or other approved quality of care data; however, the commissioner, the State Corporation Commission, and the Commissioner of Mental Health, Mental Retardation and Substance Abuse Services Behavioral Health and Developmental Services shall be entitled to receive relevant and appropriate data from the nonprofit organization at no charge.

E. HMOs shall be entitled to receive relevant and appropriate HMO data as defined by and from the nonprofit organization, with input from the HMO industry at no charge. The board shall direct the nonprofit organization to solicit input from the HMO industry to determine relevant and appropriate data that the industry shall receive at no charge.

12VAC5-407-90. Late charge.

A. A late charge of $25 per working day shall be paid to the board by an HMO that has not received an exemption from the commissioner as provided for in 12VAC5-407-50 and that has not paid the assessed fees by September 15 or later if determined by an agreement between the board and the nonprofit. The late fee charge may not be assessed until completion of a 30-day grace period for submitting the data.

B. Late charges may be waived by the board, in its discretion, if an HMO can show that an extenuating circumstance exists. Examples of an extenuating circumstance may include, but are not limited to, the installation of a new computerized system, a bankruptcy proceeding, or change of ownership in the HMO.

Part III
Duties of the Board and the Nonprofit Organization

12VAC5-407-100. Contract with Duties of the nonprofit organization.

The contract entered into by the board and the nonprofit organization pursuant to Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 of the Code of Virginia shall provide:

A. The commissioner shall negotiate and contract with a nonprofit organization pursuant to § 32.1-276.4 of the Code of Virginia for compiling, storing, and making 1. The nonprofit organization shall compile, store, and make available to consumers the data submitted by HMOs pursuant to 12VAC5-407-30 and 12VAC5-407-40.

B. 2. The nonprofit organization shall assist the board in developing a summary plan and budget to collect and make available HMO HEDIS or any other quality of care performance information set results for consumers. The nonprofit organization shall present the summary plan and budget on a biennial basis to the board for approval. The commissioner, at his discretion, shall also review the summary plan on a periodic basis to determine its effectiveness.

C. 3. The nonprofit organization shall collect the HEDIS data in the most cost-effective manner available.

D. 4. The nonprofit organization will shall prepare a biennial summary plan in identifying the measures selected for reporting. The summary plan shall include:

1. a. The rationale for selecting each measure to be made available to consumers;

2. b. The goal of reporting each measure;

3. c. The cost and benefit of collecting the measures and making them available to consumers; and

4. d. The scope of dissemination of information in paper or electronic format and the target audience.

E. 5. The nonprofit organization shall prepare a biennial budget that includes a cost-benefit analysis of purchasing HEDIS data from NCQA or obtaining the information performance sets directly from the HMOs.

F. 6. The nonprofit organization will shall present the summary plan and budget to the board for review and approval on a biennial basis.

G. 7. The nonprofit organization shall organize, present, and make available to consumers all data required by the board to be reported to the commissioner. This data shall also be available on the nonprofit's website.

12VAC5-407-120. Other duties of the board. (Repealed.)

The board shall (i) maintain records of its activities relating to the dissemination of data reported by HMOs and (ii) collect and account for all fees, as described in this chapter, and deposit the moneys so collected into a special fund from which the expenses attributed to this chapter shall be paid.