Title of Regulation: 12VAC5-218. Rules and Regulations Governing Outpatient Health Data Reporting (amending 12VAC5-218-10, 12VAC5-218-20, 12VAC5-218-40, 12VAC5-218-50; adding 12VAC5-218-25; repealing 12VAC5-218-30).

Statutory Authority: §§ 32.1-12 and 32.1-276.6 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: July 31, 2015.

Effective Date: August 29, 2015.

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

Basis: The regulation is promulgated under the authority of §§ 32.1-12 and 32.17-276.6 of the Code of Virginia. Section 32.1-12 grants the board the legal authority to make, adopt, promulgate, and enforce regulations necessary to carry out the provisions of Title 32.1 of the Code of Virginia. Section 32.1-276.6 requires the board to promulgate regulations specifying the format for submission of the outpatient data elements that facilities are mandated to submit to the board.

Purpose: To fulfill the statutory mandate to review regulations and to protect the citizens of the Commonwealth, the Virginia Department of Health conducted a periodic review of Rules and Regulations Governing Outpatient Health Data Reporting (12VAC5-218) 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department determined it was necessary to use the regulatory process to amend these regulations to make corrections to outdated citations and to enhance the clarity of the regulations in order to achieve improvements that will be reasonable and prudent and will not impose an unnecessary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 agency or the public.

Rationale for Using Fast-Track Process: These amendments simply update the regulations to reflect current practice. The department does not expect that this regulatory action will be controversial.

Substance: The amendments:

1. Correct three definitions and remove two unnecessary definitions in 12VAC5-218-10.

2. Remove outdated citations, specify the format of reporting requirements, update the data elements that are required to be reported due to statutory changes, and update references to publications from the National Uniform Billing Committee and the Centers for Medicare and Medicaid Services in 12VAC5-218-20.

3. Add 12VAC5-218-25 to include the requirements previously listed in the definition of "outpatient processed verified data." The definition had numerous substantive requirements that were not appropriate to be located in the definitions section.

4. Repeal 12VAC5-218-30.

5. Update for clarity the language in 12VAC5-218-40 and 12VAC5-218-50.

Issues: The purpose of the proposed regulatory action is to comply with the Code of Virginia and to remove outdated citations and update language that no longer reflects current practice. There are no known disadvantages to the public, the regulated entities, business entities or the Commonwealth. The advantage will be greater clarity of the regulations.

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 Board of Health (Board) proposes to: 1) update definitions and references, 2) repeal obsolete language, 3) amend language for clarity, and 4) establish existing policy in this regulation.

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

Estimated Economic Impact. Updating definitions and references, repealing obsolete language, and amending language to improve clarity are all moderately beneficial in that they may reduce some potential confusion amongst the interested public. General hospitals, ordinary hospitals, outpatient surgical hospitals, and other facilities licensed or certified pursuant to Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia, are required to submit outpatient level data either to the Board or to the nonprofit organization Virginia Health Information on behalf of the Board. Physicians performing surgical procedures in their offices or oral and maxillofacial surgeon's office as defined by § 32.1-276.3 of the Code of Virginia are also required to submit outpatient level data. If the submitted data has not already been processed and verified, then fees may be charged. It is current Board policy that the fees not exceed $.75 per record and that no fees are charged to state agencies reporting data. The Board proposes to specify in this regulation that the fees shall not exceed $.75 per record and that no fees are charged to state agencies reporting data. Establishing this policy in regulation does not change what occurs in practice, but does provide a modest benefit in that it provides clarity for interested parties.

Businesses and Entities Affected. The proposed amendments concern approximately 150 licensed or certified facilities performing outpatient surgical procedures across the Commonwealth, as well as the nonprofit organization Virginia Health Information.

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

Projected Impact on Employment. The proposed amendments are unlikely to significantly 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 costs for small businesses.

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

Real Estate Development Costs. The proposed amendments are unlikely to affect real estate development costs.

Legal Mandate. General: The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order Number 17 (2014). Section 2.2-4007.04 requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the report should include but not be limited to:

• the projected number of businesses or other entities to whom the proposed regulatory

action would apply,

• the identity of any localities and types of businesses or other entities particularly affected,

• the projected number of persons and employment positions to be affected,

• the projected costs to affected businesses or entities to implement or comply with the

regulation, and

• the impact on the use and value of private property.

Small Businesses: If the proposed regulatory action will have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include:

• an identification and estimate of the number of small businesses subject to the proposed

regulation,

• the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents,

• a statement of the probable effect of the proposed regulation on affected small businesses, and

• a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation.

Additionally, pursuant to § 2.2-4007.1, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules is notified at the time the proposed regulation is submitted to the Virginia Register of Regulations for publication. This analysis shall represent DPB's best estimate for the purposes of public review and comment on the proposed regulation.

Agency's Response to Economic Impact Analysis: The Department of Health concurs with the results of the analysis performed by the Department of Planning and Budget, specifically, the benefits likely exceed the costs for all proposed changes.

Summary:

The amendments clarify provisions by (i) updating definitions and references, (ii) repealing obsolete language, (iii) separating requirements for outpatient processed verified data out of the definition for that term, and (iv) establishing existing policy regarding fees for reporting data in the regulation.

12VAC5-218-10. Definitions.

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

"Board" means the State Board of Health.

"Inpatient hospital" means a hospital providing inpatient care and licensed pursuant to Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia, a hospital licensed pursuant to Chapter 8 (§ 37.1-179 et seq.) of Title 37.1 of the Code of Virginia, a hospital operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services for the care and treatment of the mentally ill, or a hospital operated by the University of Virginia or Virginia Commonwealth University Health System Authority.

"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 Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 of the Code of Virginia and with which the Commissioner of Health has entered into a contract as required by the Code of Virginia.

"Outpatient processed, verified data" means data on outpatient records that have been subjected to edits fulfill the requirements specified in 12VAC5-218-25. These edits shall be applied to data elements that are on the UB-92 Billing Form, HCFA 1500 Billing Form or a nationally adopted successor billing form used by reporting entities. The edits shall have been agreed to by the board and the nonprofit organization. Outpatient records containing invalid UB-92 codes, HCFA 1500 codes, another nationally adopted billing form codes or all blank fields for any of the data elements subjected to edits shall be designated as error records. To be considered processed and verified, a complete filing of outpatient surgical procedures specified by the board submitted by a reporting entity in aggregate per calendar year quarter and that are subjected to these edits must be free of error at a prescribed rate. The overall error rate shall not exceed 5.0%. A separate error rate shall be calculated for patient identifier, and it shall not exceed 5.0%. The error rate shall be calculated on only those fields approved by the board through the process specified in 12VAC5-218-20.

"Outpatient surgery" surgical procedures" means all surgical procedures performed on an outpatient basis in a general hospital, ordinary hospital, outpatient surgical hospital or other facility licensed or certified pursuant to Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia or in a physician's office or oral and maxillofacial surgeon's office as defined by § 32.1-276.3 of the Code of Virginia. Outpatient surgery refers only to those surgical procedure groups on which data are collected by the nonprofit organization as a part of a pilot study.

"Physician" means a person licensed to practice medicine or osteopathy in the Commonwealth pursuant to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia.

"Physician's office" means a place (i) owned or operated by a licensed physician or group of physicians practicing in any legal form whatsoever or by a corporation, partnership, limited liability company or other entity that employs or engages physicians and (ii) designed and equipped solely for the provision of fundamental medical care, whether diagnostic, therapeutic, rehabilitative, preventive or palliative, to ambulatory patients.

"Reporting entity" means every general hospital, ordinary hospital, outpatient surgical hospital or other facility licensed or certified pursuant to Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia and every physician performing surgical procedures in his office or oral and maxillofacial surgeon's office as defined by § 32.1-276.3 of the Code of Virginia.

"Surgical procedure group" means at least five procedure groups, identified by the nonprofit organization designated pursuant to § 32.1-276.4 of the Code of Virginia in compliance with regulations adopted by the board, based on criteria that include, but are not limited to, the frequency with which the procedure is performed, the clinical severity or intensity, and the perception or probability of risk. The nonprofit organization shall form a technical advisory group consisting of members nominated by its board of directors' nominating organizations to assist in selecting surgical procedure groups to recommend to the board for adoption.

"System" means the Virginia Patient Level Data System.

12VAC5-218-20. Reporting requirements for outpatient data elements.

Every reporting entity performing outpatient surgical procedures shall submit each patient level data element listed below in the table in this section for each patient for which an outpatient surgical procedure is performed and for which the data element is collected on the standard claim form utilized by the reporting entity. Most of these data elements are currently collected from a UB-92 Billing Form or HCFA 1500 Form In the table below, the column for a field description indicates where the data element is located on the UB-92 and HCFA 1500 forms. An asterisk (*) indicates when the required data element is either not on the UB-92 or the HCFA 1500. The instructions provided under that particular data element should then be followed. If a successor billing form to the UB-92/HCFA 1500 form is adopted nationally, information pertaining to the data elements listed below should be derived from that successor billing form Uniform Billing Form (UB-04) located in the latest publication of the Uniform Billing Manual prepared by the National Uniform Billing Committee or from the Centers for Medicare and Medicaid (CMS) Health Insurance Claim Form (CMS 1500). The Uniform Billing Form and the Uniform Billing Manual are located on the National Uniform Billing Committee's website at www.nubc.org. The Centers for Medicare and Medicaid Health Insurance Claim Form is available on the CMS website at www.cms.gov. Every reporting entity performing outpatient surgical procedures shall submit in an electronic data format. The nonprofit organization will develop detailed record layouts for use by reporting entities in reporting outpatient surgical data. This detailed record layout will be based upon the type of base electronic or paper-billing form utilized by the reporting entity. Outpatient surgical procedures reported will shall be those adopted by the Board of Health board as referred by the nonprofit organization. The nonprofit organization may recommend changes to the list of procedures to be reported not more than annually.