Fast-Track Regulation

Title of Regulation: 12VAC5-217. Regulations of the Patient Level Data System (amending 12VAC5-217-10, 12VAC5-217-20, 12VAC5-217-70; adding 12VAC5-217-15; repealing 12VAC5-217-30, 12VAC5-217-80, 12VAC5-217-90).

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: 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, or email debbie.condrey@vdh.virginia.gov.

Basis: The regulation is promulgated under the authority of § 32.1-12 and Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 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. Section 32.1-276.2 requires the board to administer the health care data reporting initiatives established by Chapter 7.2 of Title 32.1.

Purpose: To fulfill the statutory mandate to review regulations and to protect the citizens of the Commonwealth, the department conducted a periodic review of 12VAC5-217, Regulations of the Patient Level Data System, 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 The amendments are necessary to protect the health, safety, and welfare of citizens because they correct outdated citations and enhance the clarity of the regulations in order to achieve improvements that will be reasonable and prudent, and will not impose an unnecessary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 update the regulations to reflect current practice. The department does not expect that this regulatory action will be controversial.

Substance:

12VAC5-217-10. Definitions - Correct three definitions and remove an unnecessary definition.

12VAC5-217-15. Requirements of processed, verified data - Create a new section. The substance of this section comes from the previous definition of "processed verified data." The definition had numerous substantive requirements that were not appropriate to be located in the definitions section.

12VAC5-217-20. Reporting requirements for patient level data elements - Remove outdated citations; add language to ensure the section does not become outdated due to later publications from the National Uniform Billing Committee; and add language clarifying that reporting requirements require a complete filing submitted in electronic format.

12VAC5-217-30. Options for filing format - Repeal this section.

12VAC5217-70. Establishment of annual fee - Amend this section to reflect current practice.

12VAC5-217-80. Payment of fee to nonprofit organization - Repeal this section.

12VAC5-217-90. Waiver or reduction of fee - Repeal this section.

Issues: The purpose of the proposed regulatory action is to comply with the Code of Virginia and to remove outdated regulations that no longer reflect current practice. There are no known disadvantages to the public, the regulated entities, business entities, or the Commonwealth. The advantage is 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 for consistency with the Code of Virginia, 2) repeal obsolete language, 3) move text for improved organization, 4) amend language for clarity, and 5) place in the regulation the current policy that inpatient hospitals that submit data pursuant to this regulation are not assessed fees if the data is processed, verified, and timely in accordance with standards established by the Board.

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

Estimated Economic Impact. Updating definitions for consistency with the Code of Virginia, repealing obsolete language, improving organization of text, and amending language to improve clarity are all moderately beneficial in that they may reduce some potential confusion amongst the interested public.

Inpatient hospitals are required to submit specified patient level data for each hospital inpatient, including a separate record for each infant, if applicable. Inpatient hospitals are defined as 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 Article 2 (§ 32.2-403 et seq.) of Chapter 4 of Title 37.2 of the Code of Virginia, a hospital operated by the Department of Behavioral Health and Developmental Services for the care and treatment of individuals with mental illness, or a hospital operated by the University of Virginia or Virginia Commonwealth University Health System Authority.

It is current Board policy to not assess fees to inpatient hospitals who submit data that is processed, verified, and timely in accordance with standards established by the Board. 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 105 licensed hospitals in 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 will not 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 will not affect real estate development costs.

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

Summary:

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

12VAC5-217-10. Definitions.

The following words and terms, when used in this chapter, shall have the following meanings:

"Board" means the Virginia Board of Health.

"Complete filing" means that patient level data of at least 99% of a hospital's inpatient discharges for a calendar year quarter are submitted.

"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 Article 2 (§ 37.2-403 et seq.) of Chapter 4 of Title 37.2 of the Code of Virginia, a hospital operated by the Department of Behavioral Health and Developmental Services for the care and treatment of individuals with mental illness, 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 § 32.1-276.4 of the Code of Virginia.

"Processed, verified data" means data on inpatient records which have been subjected to edits that fulfill the requirements specified in 12VAC5-217-15. These edits shall be applied to data elements which are on the UB-92 Billing Form (or a successor Billing Form adopted by the Virginia Uniform Billing Committee for use by inpatient hospitals in Virginia). The edits shall have been agreed to by the board and the nonprofit organization. Inpatient records containing invalid UB-92 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 all records which are submitted by an inpatient hospital in aggregate per calendar year quarter and which are subjected to these edits must be free of error at a prescribed minimum rate. The prescribed minimum error rate shall be 95% overall, with patient identifier separately calculated at 95% or a minimum rate recommended by the board of directors of the nonprofit organization and approved by the Virginia Board of Health. The error rate shall be calculated on only those fields designated in 12VAC5-217-20 or as subsequently approved by the board through the process specified in 12VAC5-217-20.

"System" means the Virginia Patient Level Data System.

12VAC5-217-15. Requirements of processed, verified data.

Inpatient hospitals shall submit only processed, verified data from inpatient records. To be considered processed and verified, a complete filing of all records that are submitted by an inpatient hospital in aggregate per calendar year quarter must be free of error at a prescribed minimum rate. The prescribed minimum accuracy rate shall be 95% overall, with patient identifier separately calculated at 95%. The accuracy rate shall be calculated on only those fields designated in 12VAC5-217-20. Inpatient records containing invalid codes or blank fields for any of the data elements shall be designated as error records.

12VAC5-217-20. Reporting requirements for patient level data elements.

Every inpatient hospital shall submit a complete filing of each patient level data element listed below in the table in this section for each hospital inpatient, including a separate record for each infant, if applicable. Most of these data elements are currently collected from a UB-92 Uniform Billing Form located in the latest publication of the Uniform Billing Manual prepared by the National Uniform Billing Committee. The column for a "Form Locator" indicates where the data element is located on the UB-92. For elements collected on the UB-92, the column "Page Number" refers to the Uniform Billing Manual (UB-92), revised May, 1993. The Uniform Billing Form and the Uniform Billing Manual are located on the National Uniform Billing Committee's website at www.nubc.org. The Uniform Billing Manual UB-92, prepared for Virginia hospitals by the Virginia Uniform Billing Committee, provides a detailed field description and any special instructions instruction pertaining to that element. An asterisk (*) indicates when the required data element is either not on the UB-92 billing form or in the Uniform Billing Manual. The instructions provided under that particular data element should then be followed. If a successor billing form to the UB-92 form is adopted by the Virginia Uniform Billing Committee for use by inpatient hospitals in Virginia, information pertaining to the data elements listed below should be derived from that successor billing form. Inpatient hospitals that submit patient level data directly to the board or the nonprofit organization shall submit it in an electronic data format.

Data Element	Form Locator	Page Number
1. Hospital identifier.* Enter the six-digit Medicare provider number or a number assigned by the board or its designee.	*	*
2. Attending physician identifier. Enter the nationally assigned physician identification number, either the Uniform Physician Identification Number (UPIN) or National Provider Identifier (NPI) as approved by the board for the physician assigned as the attending physician for an inpatient.	82	82-1 and 82-2
3. Other physician identifier. Enter the nationally assigned physician identification number, either the Uniform Physician Identification Number (UPIN) or National Provider Identifier (NPI) as approved by the board for the physician identified as the operating physician for the principal procedure reported.	83 A & B	83-1 and 83-2
4. Payor identifier.	50 A, B, C	50-1 through 50-11
5. Employer name identifier.	65 A	65-1
6. Patient identifier.* Enter the nine-digit social security number of the patient. If a social security number has not been assigned, leave blank. The nine-digit social security number is not required for patients under four years of age.	*	*
7a. Patient sex.	15	15-1
7b. Race code.* If an inpatient hospital collects information regarding the choices listed below, the appropriate one-digit code reflecting the race of the patient should be entered. If a hospital only collects information for categories 0, 1, or 2, then the appropriate code should be entered from those three selections.	*	*
0 = White
1 = Black
2 = Other
3 = Asian
4 = American Indian
5 = White Hispanic
6 = Black Hispanic
7c. Date of birth.	14	14-1
7d. Zip Street address, city or county, and zip code.	13	13-1
7e. Patient relationship to insured.	59 A, B, C	59-1 through 59-3
7f. 7e. Employment status code.	64 A, B, C	64-1 and 64-2
7g. 7f. Patient status (i.e., discharge). Inpatient codes only.	22	22-1 and 22-2
7h. 7g. Birth weight (for infants)* Enter the birth weight of newborns in grams.	*	*
8a. Admission type.	19	19-1 and 19-2
8b. Admission source.	20	20-1 through 20-3
8c. Admission date.	17	17-1
8d. Admission hour.	18	18-1
8e. Admission diagnosis code.	76	76-1
9a. Discharge date. Only enter date of discharge.	*	*
10. Principal diagnosis code. Enter secondary diagnoses (up to eight). In addition, include diagnoses recorded in the comments section for DX6-DX9.	67 68-75	67-1 and 67-2 68-1
11. External cause of injury code (E-code). Record all external cause of injury codes in secondary diagnoses position after recording all treated secondary diagnoses.	77	77-1
12. Co-morbid conditions existing but not treated.
12. 13. Principal procedure code and date. Enter other procedures and dates (up to five). In addition, include procedures recorded in the comments section for PX4-PX6.	80 81 A-E	80-1 81-1
13. 14. Revenue code (up to 23). Units of service (up to 23). Units of service charges (up to 23).	42 46 47	42-1 through 42-56 46-1 47-1
14. 15. Total charges (by revenue code category or by HCPCS code). (R.C. Code 001 is for total charges. See page 47-1.)	47	47-1

12VAC5-217-30. Options for filing format. (Repealed.)

Inpatient hospitals of 100 beds or more that submit patient level data directly to the board or the nonprofit organization shall submit it in an electronic data format. Hospitals of less than 100 beds that submit patient level data directly to the board or the nonprofit organization may directly submit it in electronic data format or in hard copy. If hard copy is utilized the hospital shall submit, for each inpatient discharged, a copy of the UB-92 and an addendum sheet for those data elements not collected on the UB-92 or defined in the Uniform Billing Manual. These hospitals must submit all patient level data in electronic data format by January 1, 1995.

If a hospital submits processed, verified data directly to the nonprofit organization, it shall be in electronic format.

12VAC5-217-70. Establishment of annual fee.

The board shall not assess any fee against any health care provider that submits data under this chapter that is processed, verified, and timely in accordance with standards established by the board. The board shall prescribe a reasonable fee not to exceed $1.00 per discharge for each inpatient hospital submitting patient level data pursuant to this chapter that is not processed, verified, or timely to cover the cost of the reasonable expenses in processing and verifying such data. The fee shall be established and reviewed annually by the board. Payment of the fee by a hospital shall be at the time quarterly inpatient data is submitted.

12VAC5-217-80. Payment of fee to nonprofit organization. (Repealed.)

If an inpatient hospital chooses to submit its patient level data directly to the nonprofit organization, that hospital may pay the fee described in 12VAC5-217-70 to the nonprofit organization at the time it submits its quarterly data. If a hospital pays its fee directly to the nonprofit organization, the requirements of a fee to be paid to the board, as described in 12VAC5-217-70, shall be waived by the board.

12VAC5-217-90. Waiver or reduction of fee. (Repealed.)

If a hospital submits processed, verified patient level data to the nonprofit organization, the nonprofit organization may, in its discretion, grant a waiver or reduction of the fee if it determines that the hospital has submitted properly processed, verified data.