No. 31980 (New Rule): R380-70. Standards for Electronic Exchange of Clinical Health Information

DAR File No.: 31980
Filed: 09/30/2008, 05:37
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this new rule is to adopt a clinical exchange standard for laboratory results.

Summary of the rule or change:

A provider that chooses to electronically exchange laboratory results with another provider will be required to use the standard adopted in this rule.

State statutory or constitutional authorization for this rule:

Sections 26-1-37 and 26-1-30

This rule or change incorporates by reference the following material:

Clinical Laboratory Results, Version 2.0

Anticipated cost or savings to:

the state budget:

Setting a statewide standard for exchanging information between the state public health laboratory with private providers and the state epidemiology program will impose front-end costs for those state entities that choose to participate. Costs are estimated to be from $5,000 to $50,000 per entity. Long-term savings due to standardization will be evaluated by those entities before they choose to proceed.

local governments:

Setting a statewide standard for exchanging information between the local public health laboratories with private providers and the state epidemiology program will impose front-end costs for those local entities that choose to participate. Costs are estimated to be from $5,000 to $50,000 per entity. Long-term savings due to standardization will be evaluated by those entities before they choose to proceed.

small businesses and persons other than businesses:

Patients will benefit from the statewide electronic clinical information exchange without additional costs to their service. Timely, accurate, and comprehensive medical information for a patient at the point of care will reduce medical errors and improve quality of care. Setting a statewide standard for exchanging information between the laboratories and other providers will impose front-end costs for those entities that choose to participate. Costs are estimated to be from $5,000 to $50,000 per entity. Long-term savings due to standardization will be evaluated by those entities before they choose to proceed.

Compliance costs for affected persons:

To comply with the standards adopted by this rule, the affected persons and organizations will need to incorporate the new standards into their current electronic communication programs. Many organizations in Utah have already used the proposed standard -- Clinical Laboratory Results Version 2.0. Therefore, the costs for the initial adoption will vary among organizations from $5,000 where the standard is in place to $50,000 or more where the standard is not used. However, to adopt a statewide standard for electronic exchanges of laboratory results will save the resources for participating organizations in the future to program proprietary communication applications.

Comments by the department head on the fiscal impact the rule may have on businesses:

The standard adopted by this rule for electronic exchange of laboratory results was developed over a period of three years with broad participation from the major laboratory systems, major hospital systems and other interested parties, including the Utah Health Information Network. This consensus process has sought to minimize fiscal impact. David N. Sundwall, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Administration
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY UT 84116-3231

Direct questions regarding this rule to:

Wu Xu at the above address, by phone at 801-538-7072, by FAX at 801-538-9346, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

11/17/2008

Interested persons may attend a public hearing regarding this rule:

11/06/2008 at 9:00 AM, Utah Department of Health, Cannon Health Building, Room 114, 288 N 1460 W, Salt Lake City, UT

This rule may become effective on:

01/05/2009

Authorized by:

David N. Sundwall, Executive Director

RULE TEXT

R380.Health, Administration.

R380-70.Standards for Electronic Exchange of Clinical Health Information.

R380-70-1.Purpose and Authority.

This rule governs electronic information exchanges between health care providers, laboratories, and third party payers.It is authorized by Sections 26-1-30 and26-1-37.

 

R380-70-2.Definitions.

The terms defined in Utah Code 26-1-37 apply to this rule and the standards adopted by this rule.In addition, the following terms apply to this rule and the standards adopted by this rule:

(1)"Clinical health information" means data gathered on patients regarding episodes of clinical health care.

(2)"Clinical laboratory" means a laboratory that performs laboratory testing on humans(except research) in the U.S.

(3)"Health care provider" has the same meaning as used in Utah Code Section 26-1-37 and includes an entity, such as a clinic, employer, or other business arrangement, where an individual licensed under Title 58, Occupations and Professions, provides health care.

 

R380-70-3.Terms Used in Standards.

Some terms used in this rule and the standards adopted by this rule are nationally recognized terms within the clinical data exchange community.The following are provided as an aid to the reader:

(1)Health care information codes

(a)"ASA Codes" are the codes contained in the ASA Relative Value Guide developed and maintained by the American Society of Anesthesiologists to describe anesthesia services and related modifiers.

(b)"CDT Codes" are the Current Dental Terminology prescribed by the American Dental Association.

(c)"CPT Codes" means the Current Procedural Terminology, published by the American Medical Association.

(d)"HCPCS" are CMS's Common Procedure Coding System, a coding system that describes products, supplies, procedures and health professional services and includes, the American Medical Association's Current Procedural Terminology codes, alphanumeric codes, and related modifiers.HCPCS codes are:

(i)"HCPCS Level I Codes" are the CPT codes and modifiers for professional services and procedures.

(ii)"HCPCS Level II Codes" are national alphanumeric codes and modifiers for health care products and supplies, and codes for professional services not included in the AMA's CPT codes.

(e)"ICD-CM Codes" are the diagnosis and procedure codes in the International Classification of Diseases, clinical modifications published by the U.S. Department of Health and Human Services.

(f)"LOINC" means Logical Observation Identifiers Names and Codes.It is a set of universal codes and names to identify laboratory and other clinical observations developed by the Regenstrief Institute.

(g)"NDC" means the National Drug Codes of the Food and Drug Administration.

(h)"SNOMED" means Systematized Nomenclature of Medicine maintained and distributed by the International Health Terminology Standards Development Organisation.It is a systematically organized computer processable collection of medical terminology.

(2)Electronic Data Interchange Standards

(a)"ASC X12N" are standard formats developed by the Accredited Standards Committee X12N Insurance Subcommittee of the American National Standards Institute and the ASC X12N implementation guides either as promulgated or as modified by another federally registered SDO;

(b)"HL7" are electronic data interchange standard formats developed by Health Level 7, which is a standards development organization accredited by the American National Standards Institute.The HL7 standard is usually modified into specific implementation guides by a separate standards development organization;

(c)"NCPDP" are standard formats for the transfer of data to and from the pharmacy services sector of the healthcare industry.It is developed by the National Council on Prescription Drug Program, which is a standards development organization accredited by the American National Standards Institute.

 

R380-70-4.Electronic Exchange Requirements.

(1)A health care provider or third party payer that exchanges information electronically with another health care provider or third party payer must comply with the provisions of this rule.

(2)A person required to report information to the Utah Department of Health and that submits its report electronically shall submit the report in accordance with the provisions of this rule.

(3)A health care provider or third party payer may reject electronically transmitted clinical information if it is not transmitted in accordance with this rule.

 

R380-70-5.Exemptions.

(1)This rule does not govern the exchange of information that is not conducted electronically or for which no standard has been established in this rule.

(2)This rule does not apply to the exchange of clinical health information among affiliates, as provided in 26-1-37, within a health care system.

(3)Nothing in this rule requires a health care provider or third party payer to use a specific telecommunications network for the exchange of clinical health information.

 

R380-70-6.Electronic Data Interchange Standards.

Standards incorporated by reference in this rule are available for public inspection at the department during normal business hours or at http://health.utah.gov/phi/rule/.

(1)A health care provider, a clinical laboratory, or third-party payer that electronically exchanges clinical laboratory results with another health care provider, a clinical laboratory, or third-party payer must comply with Clinical Laboratory Results v2.0, which is incorporated by reference.

 

R380-70-7.Standards Recommendations.

A party that recommends standards to the Department, shall seek guidance and work with national standard setting entities, such as the American National Standards Institute ASC X12, Health Level 7, and the National Council on Prescription Drug Program, that deal with the particular subject matter.

 

KEY:standards, clinical health information exchange

Date of Enactment or Last Substantive Amendment:2008

Authorizing, Implemented, or Interpreted Law: 26-1-30; 26-1-37