No. 43188 (Amendment): Rule R156-1. General Rule of the Division of Occupational and Professional Licensing

(Amendment)

DAR File No.: 43188
Filed: 09/13/2018 08:47:04 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Telehealth Act (Title 26, Chapter 60) enacted by H.B. 154, passed in the 2017 General Session, established the scope of telehealth practice and described the responsibilities of a provider offering telehealth services. Section 26-60-104 of the Telehealth Act authorizes the Division of Occupational and Professional Licensing (Division) to enforce the Act's provisions as they relate to providers licensed under Title 58, Occupations and Professions. In collaboration with the Physicians Licensing Board, the Division proposes these amendments to clarify the standards required from a provider offering telehealth services under Title 58.

Summary of the rule or change:

Section R156-1-601 is a new section which: 1) incorporates certain definitions regarding telehealth from the Telehealth Act; 2) defines "patient encounter"; and 3) defines "provider" to include, in addition to an individual licensed under Title 58 to provide health care: a) an individual providing health care services under Title 58 but exempted from licensure pursuant to Subsection 58-1-307, and b) multiple providers providing care as a team consistent with standards of practice in traditional health care settings. Section R156-1-602 is a new section which clarifies the scope of practice for telehealth services pursuant to Section 26-60-103 and Subsection 26-60-104(1). Subsection R156-1-602(1) emphasizes that this section does not alter or amend the standard of practice for any healthcare field or profession. Subsection R156-1-602(2)(a) requires a provider to verify the patient's identity and originating site, and Subsection R156-1-602(2)(b) details how a provider shall obtain informed consent to the use of telehealth services. Subsection R156-1-602(2)(c) requires that the telehealth patient be allowed to select their provider to the extent possible, and Subsection R156-1-602(2)(d) requires the provider to ensure that the online site from which the provider offers telehealth services does not restrict the patient's choice to select a specific pharmacy. Subsection R156-1-602(3) clarifies that it is not an acceptable standard of care for a provider offering telehealth services to establish a diagnosis and identify underlying conditions and contraindications to a recommended treatment based solely on an online questionnaire, except as specifically provided in Title 58, Chapter 83, the Online Prescribing, Dispensing, and Facilitation Licensing Act. Subsection R156-1-602(4) clarifies and establishes how a provider offering telehealth services may carry out the mandate of Subsection 26-60-103(c) of the Telehealth Act to "be available" to the patient "for subsequent care related to the initial telemedicine services". Subsection R156-1-602(5) restates for clarity the mandate of Subsection 26-30-103(1)(d) that the provider must be familiar with available medical resources, including emergency resources near the originating site. Subsection R156-1-602(6) clarifies that if an established provider-patient relationship is not present, the provider shall establish a provider-patient relationship during the patient encounter in a manner consistent with standards of practice. Subsection R156-1-602(7) clarifies that nothing in this section prohibits electronic communications consistent with standards of practice in traditional health care settings, and identifies certain of these existing practices such as in on-call or cross-coverage situations or in an emergency.

Statutory or constitutional authorization for this rule:

Subsection 58-1-501(2)
Subsection 58-1-106(1)(a)
Section 58-1-308

Anticipated cost or savings to:

the state budget:

These proposed sections will clarify the standards for health care providers offering telehealth care under Title 58, Occupations and Professions, and will therefore indirectly affect those who employ such health care providers to provide telehealth services. This will include certain state government entities acting as businesses. However, because these proposed amendments only clarify the mandates of the Telehealth Act (Title 26, Chapter 60) as enacted by H.B. 154 (2017), the Division estimates that these proposed amendments will have no impact on state agencies over and above that already included in the fiscal note for H.B. 154 (2017), available online at: https://le.utah.gov/~2017/bills/static/HB0154.html. No other fiscal impact to the state is expected, beyond a minimal cost to the Division of approximately $75 to print and distribute this rule once these proposed amendments are made effective.

local governments:

These proposed sections will clarify the standards for health care providers offering telehealth care under Title 58, Occupations and Professions, and will therefore indirectly affect those who employ such health care providers to provide telehealth services. This will include certain local government entities acting as businesses. However, because these proposed amendments only clarify the mandates of the Telehealth Act (Title 26, Chapter 60) as enacted by H.B. 154 (2017), the Division estimates that these proposed amendments will have no impact on local governments over and above that already included in the fiscal note for H.B. 154 (2017), available online at: https://le.utah.gov/~2017/bills/static/HB0154.html.

small businesses:

These proposed sections will clarify the standards for health care providers offering telehealth care under Title 58, Occupations and Professions. Accordingly, these proposed sections will affect any Utah small businesses that employ health care providers to provide telehealth services. The Division estimates that there are approximately 9,421 small business employers in the health care industry in Utah who could potentially be affected. Broadly, these small businesses could include most small businesses categorized under NAICS 62; for a complete listing of NAICS Codes used in this analysis, please contact the Division. However, because these proposed amendments only clarify the mandates of the Telehealth Act (Title 26, Chapter 60), as enacted by H.B. 154 (2017), the Division estimates that these proposed amendments will have no impact on small businesses over and above that already included in the fiscal note for H.B. 154 (2017), available online at: https://le.utah.gov/~2017/bills/static/HB0154.html.

persons other than small businesses, businesses, or local governmental entities:

These proposed sections will affect health care providers offering telehealth care under Title 58, Occupations and Professions. However, because these proposed amendments only clarify the mandates of the Telehealth Act (Title 26, Chapter 60), as enacted by H.B. 154 (2017), the Division estimates that these proposed amendments will have no impact on other persons over and above that already included in the fiscal note for H.B. 154 (2017), available online at: https://le.utah.gov/~2017/bills/static/HB0154.html.

Compliance costs for affected persons:

These proposed sections will affect a health care provider who offers telehealth care under Title 58, Occupations and Professions. However, because these proposed amendments only clarify the mandates of the Telehealth Act (Title 26, Chapter 60), as enacted by H.B. 154 (2017), the Division estimates that these proposed amendments will have no compliance cost on any affected persons over and above that already included in the fiscal note for H.B. 154 (2017), available online at: https://le.utah.gov/~2017/bills/static/HB0154.html.

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

Section R156-1-601 is a new section which: 1) incorporates certain definitions regarding telehealth from the Telehealth Act; 2) defines "patient encounter"; and 3) defines "provider". Section R156-1-602 is a new section which clarifies the scope of practice for telehealth services pursuant to Section 26-60-103 and Subsection 26-60-104(1). These proposed sections will clarify the standards for health care providers offering telehealth care under Title 58, Occupations and Professions. Accordingly, these proposed sections will affect any Utah small businesses that employ health care providers to provide telehealth services. The Division estimates that there are approximately 9,421 small business employers in the health care industry in Utah who could potentially be affected. Broadly, these small businesses could include most small businesses categorized under NAICS 62. Because these proposed sections only clarify the mandates of the Telehealth Act (Title 26, Chapter 60), as enacted by H.B. 154 (2017), the Division estimates that these proposed sections will have no impact on small businesses over and above that already included in the fiscal note for H.B. 154 (2017), available online at: https://le.utah.gov/~2017/bills/static/HB0154.html.

Francine A. Giani, Executive Director

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

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY, UT 84111-2316

Direct questions regarding this rule to:

Larry Marx at the above address, by phone at 801-530-6254, by FAX at 801-530-6511, or by Internet E-mail at lmarx@utah.gov

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:

10/31/2018

Interested persons may attend a public hearing regarding this rule:

10/15/2018 09:30 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 474 (fourth floor), Salt Lake City, UT

This rule may become effective on:

11/07/2018

Authorized by:

Mark Steinagel, Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs

FY 2019

FY 2020

FY 2021

State Government

Local Government

Small Businesses

Non-Small Businesses

Other Person

Total Fiscal Costs:

Fiscal Benefits

State Government

Local Government

Small Businesses

Non-Small Businesses

Other Persons

Total Fiscal Benefits:

Net Fiscal Benefits:

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described above. Inestimable impacts for Non - Small Businesses are described below.

Appendix 2: Regulatory Impact to Non - Small Businesses (50 or more employees)

These proposed sections will clarify the standards for health care providers offering telehealth care under Title 58, Occupations and Professions. Accordingly, these proposed sections will affect any Utah non-small businesses that employ health care providers to provide telehealth services. The Division estimates that there are approximately 488 non-small business employers in the health care industry in Utah who could potentially be affected. Broadly, these non-small businesses could include most non-small businesses categorized under NAICS 62; for a complete listing of NAICS Codes used in this analysis, please contact the Division. However, because these proposed amendments only clarify the mandates of the Telehealth Act (Title 26, Chapter 60), as enacted by H.B. 154 (2017), the Division estimates that these proposed amendments will have no impact on non-small business over and above that already included in the fiscal note for H.B. 154 (2017), available online at: https://le.utah.gov/~2017/bills/static/HB0154.html.

The head of the Department of Commerce, Francine A. Giani, has reviewed and approved this fiscal analysis.

R156. Commerce, Occupational and Professional Licensing.

R156-1. General Rule of the Division of Occupational and Professional Licensing.

R156-1-601. Telehealth - Definitions.

In accordance with Section 26-60-103 and Subsection 26-60-104(1), in addition to the definitions in Title 58 and Rule R156, as used in this section:

(1) "Asynchronous store and forward transfer" means the same as defined in Subsection 26-60-102(1).

(2) "Standards of Practice" means those standards of practice applicable in a traditional health care setting, as provided in Subsection 26-60-103(1)(a)(ii).

(3) "Distant site" means the same as defined in Subsection 26-60-102(2).

(4) "Originating site" means the same as defined in Subsection 26-60-102(3).

(5) "Patient" means the same as defined in Subsection 26-60-102(4).

(6) "Patient Encounter" means any encounter where medical treatment and/or evaluation and management services are provided. For purposes of this rule, the entire course of an inpatient stay in a healthcare facility or treatment in an emergency department is considered a single patient encounter.

(7) "Provider" means the same as defined in Subsection 26-60-102(5)(b), an individual licensed under Title 58 to provide health care services, and:

(a) shall include an individual exempt from licensure as defined in Section 58-1-307 who provides health care services within the individual's scope of practice under Title 58; and

(b) for purposes of this section, "provider" may include multiple providers obtaining informed consent and providing care as a team, consistent with the standards of practice applicable to a broader practice model found in traditional health care settings.

(8) "Synchronous interaction" means the same as defined in Subsection 26-60-102(6).

(9) "Telehealth services" means the same as defined in Subsection 26-60-102(7).

(10) "Telemedicine services" means the same as defined in Subsection 26-60-102(8).

R156-1-602. Telehealth - Scope of Telehealth Practice.

(1) This rule is not intended to alter or amend the applicable standard of practice for any healthcare field or profession. The provider shall be held to the same standards of practice including maintaining patient confidentiality and recordkeeping that would apply to the provision of the same health care services in an in-person setting.

(2) In accordance with Section 26-60-103 and Subsection 26-60-104(1), a provider offering telehealth services shall, prior to each patient encounter:

(a) verify the patient's identity and originating site;

(b) obtain informed consent to the use of telehealth services by clear disclosure of:

(i) additional fees for telehealth services, if any, and how payment is to be made for those additional fees if they are charged separately from any fees for face-to-face services provided to the patient in combination with the telehealth services;

(ii) to whom patient health information may be disclosed and for what purpose, including clear reference to any patient consent governing release of patient-identifiable information to a third-party;

(iii) the rights of patients with respect to patient health information;

(iv) appropriate uses and limitations of the site, including emergency health situations;

(v) information:

(A) affirming that the telehealth services meet industry security and privacy standards, and comply with all laws referenced in Subsection 26-60-102(8)(b)(ii);

(B) warning of potential risks to privacy notwithstanding the security measures;

(C) warning that information may be lost due to technical failures, and clearly referencing any patient consent to hold the provider harmless for such loss; and

(D) disclosing the website owner/operator, location, and contact information; and

(c) allow the patient an opportunity to select their provider rather than being assigned a provider at random, to the extent possible;

(d) ensure that the online site from which the provider offers telehealth services does not restrict a patient's choice to select a specific pharmacy for pharmacy services.

(3) In accordance with Subsection 26-60-103(1)(b), it is not an acceptable standard of care for a provider offering telehealth services to establish a diagnosis and identify underlying conditions and contraindications to a recommended treatment based solely on an online questionnaire, except as specifically provided in Title 58, Chapter 83, the Online Prescribing, Dispensing and Facilitation Licensing Act.

(4) In accordance with Subsection 26-60-103(1)(c), a provider offering telehealth services shall be available to the patient for subsequent care related to the initial telemedicine services, by:

(a) providing the patient with a clear mechanism to:

(i) access, supplement, and amend patient-provided personal health information;

(ii) contact the provider for subsequent care;

(iii) obtain upon request an electronic or hard copy of the patient's medical record documenting the telemedicine services, including the informed consent provided; and

(iv) request a transfer to another provider of the patient's medical record documenting the telemedicine services;

(b) if the provider recommends that the patient needs to be seen in person, such as where diagnosis requires a physical examination, lab work, or imaging studies:

(i) arranging to see the patient in person, or directing the patient to the patient's regular provider, or if none, to an appropriate provider; and

(ii) documenting the recommendation in the patient's medical record; and

(c) upon patient request, electronically transferring to another provider the patient's medical record documenting the telemedicine services, within a reasonable time frame allowing for timely care of the patient by that provider.

(5) In accordance with Subsection 26-60-103(1)(d), a provider offering telehealth services shall be familiar with available medical resources, including emergency resources near the originating site.

(6) In settings and circumstances where an established provider-patient relationship is not present, a provider offering telehealth services shall establish a provider-patient relationship during the patient encounter, in a manner consistent with standards of practice including providing the provider's licensure and credentials.

(7) Nothing in this section shall prohibit electronic communications consistent with standards of practice applicable in traditional health care settings, including those:

(a) between a provider and a patient with a preexisting provider-patient relationship;

(b) between a provider and another provider concerning a patient with whom the other provider has a provider-patient relationship;

(d) in broader practice models where multiple providers provide care as a team, including, for example:

(i) within an existing organization; or

(ii) within an emergency department; or

(e) in an emergency, which as used in this section means a situation in which there is an occurrence posing an imminent threat of a life-threatening condition or severe bodily harm.

KEY: diversion programs, licensing, supervision, evidentiary restrictions

Date of Enactment or Last Substantive Amendment: [ ~~April 9,~~ ]2018

Notice of Continuation: December 6, 2016

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-1-308; 58-1-501(2)