TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF MEDICINE

Fast-Track Regulation

Title of Regulation: 18VAC85-40. Regulations Governing the Practice of Respiratory Therapists (amending 18VAC85-40-10, 18VAC85-40-55, 18VAC85-40-66, 18VAC85-40-70, 18VAC85-40-86; repealing 18VAC85-40-20, 18VAC85-40-30, 18VAC85-40-89).

Statutory Authority: §§ 54.1-2400 and 54.1-2912.1 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: January 29, 2025.

Effective Date: February 13, 2025.

Agency Contact: Erin Barrett, Director of Legislative and Regulatory Affairs, Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 300, Henrico, VA 23233, telephone (804) 750-3912, FAX (804) 915-0382, or email erin.barrett@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Medicine the authority to promulgate regulations to administer the regulatory system. Section 54.1-2954.1 of the Code of Virginia provides specific authority for the board to regulate respiratory care practitioners.

Purpose: The rationale for the amendments includes (i) the reduction of regulatory requirements; (ii) the elimination of provisions redundant of statutory language; and (iii) the elimination of provisions that are no longer needed. The elimination of redundant provisions generally protects the health, safety, and welfare of citizens by ensuring a sufficient workforce of respiratory therapists with a reduction of redundant or outdated requirements.

Rationale for Using Fast-Track Rulemaking Process: The impetus for these amendments was the board's 2022 periodic review of this chapter. This regulatory change is expected to be noncontroversial and is appropriate for the fast-track rulemaking process because these amendments delete outdated or redundant provisions and clarify others, and there is not expected to be any pushback to these changes.

Substance: The amendments delete redundant statutory provisions or useless directions in regulation, including provisions related to (i) an unused definition, (ii) public participation regulations, (iii) violations of Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia, (iv) fees related to voluntary practice by out-of-state licensees, (v) board audits of continuing education, (vi) posting requirements for destruction of records, (vii) the closing or selling of a practice, and (viii) solicitation or remuneration in exchange for referral. The amendments also clarify portions of the scope of practice of respiratory therapists.

Issues: There are no primary advantages or disadvantages to the public. There are no primary advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget Economic Impact Analysis:

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 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. As the result of a periodic review,² the Board of Medicine (board) proposes to remove text from various portions of 18VAC85-40 Regulations Governing the Practice of Respiratory Therapists.

Background. The board relates that each portion of text proposed for removal qualifies as one of the following: (i) definition not used in the regulation, (ii) refers to another regulation that is not used in this regulation, (iii) redundant, (iv) imposes a $10 fee for an individual licensed out-of-state to register for voluntary practice in the Commonwealth, (v) requires the board to periodically conduct a random audit of its active licensees to determine compliance, (vi) limits licensees from performing actions that the board believes should be within their scope of practice, (vii) duplicative of Health Insurance Portability and Accountability Act (HIPAA) provisions, or (viii) duplicative of statute.

Estimated Benefits and Costs: According to DHP, the $10 fee for an individual licensed out-of-state to register for voluntary practice itself costs more administratively to collect than $10. Thus, eliminating the fee would be beneficial in that it would both reduce cost for respiratory therapists licensed out-of-state seeking to volunteer in Virginia and net costs for the board. In 18VAC85-40-66 D, the current regulation states that "The board shall periodically conduct a random audit of its active licensees to determine compliance. The practitioners selected for the audit shall provide all supporting documentation within 30 days of receiving notification of the audit." According to DHP, the board has only performed one or two of these audits in the last two decades, and only on two sets of its 18 types of licensees. DHP adds that the board does not have staff or the ability to conduct such audits and has not for years. Thus, the proposed repeal of the quoted sentence at the beginning of this paragraph would conform the regulation to practice. In setting forth the scope of practice for respiratory therapists, the current text 18VAC85-40-70 states that "This practice shall include, but not be limited to, ventilatory assistance and support; the insertion of artificial airways without cutting tissue and the maintenance of such airways; the administration of medical gases exclusive of general anesthesia; topical administration of pharmacological agents to the respiratory tract; humidification; and administration of aerosols." According to DHP, the board proposes to delete "without cutting tissue" and "exclusive of general anesthesia" to conform to current standard of care. The board notes that the amendments are needed because the regulation as currently written limits the scope of practice by not allowing respiratory therapists to perform, for example, emergency tracheotomies, which they are required to do at times. DHP believes that the limitation on the scope of practice caused by the current inclusion of "without cutting tissue" and "exclusive of general anesthesia" may have caused issues providing care. However, the agency has no direct information that this limitation occurred in actuality, but advisory board members had this concern. Thus, the proposed removal of these terms may be beneficial by increasing the scope of practice available to respiratory therapists. Removing the other instances of definitions that are not used in the regulation, text that refers to another regulation, or that is redundant or duplicative of HIPAA provisions or statute would have no impact on requirements for regulated entities or the public.

Businesses and Other Entities Affected. The proposed amendments affect the 4,724 respiratory therapists licensed in the Commonwealth,³ as well as their patients and employers. According to survey data from the most recently published Virginia Healthcare Workforce Data Center report on respiratory therapists,⁴ the primary type of employers of respiratory therapists in the Commonwealth are distributed as follows:

The Code of Virginia requires the DPB to assess whether an adverse impact may result from the proposed regulation.⁵ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. As no proposed amendment increases costs or reduces net revenue for any entity, no adverse impact is indicated.

Small Businesses⁶ Affected.⁷ The proposed amendments do not appear to adversely affect small businesses.

Localities⁸ Affected.⁹ The proposed amendments neither disproportionally affect any particular localities nor introduce costs for local governments.

Projected Impact on Employment. The proposed amendments do not appear to affect total employment.

Effects on the Use and Value of Private Property. To the extent that respiratory therapists who work for private entities may have refrained from performing emergency tracheotomies and other procedures due to the current text on the scope of practice in 18VAC85-40-70, the proposed amendments to this section as described above may lead to such respiratory therapists newly performing emergency tracheotomies and other procedures once the changes are in effect. This change could increase the value of those private entities; however, any such increase is expected to be minimal. The proposed amendments do not affect real estate development costs.

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¹ Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

² See https://townhall.virginia.gov/l/ViewPReview.cfm?PRid=2148.

³ Source: https://www.dhp.virginia.gov/about/stats/2023Q3/04CurrentLicenseCountQ3FY2023.pdf.

⁴ See https://www.dhp.virginia.gov/media/dhpweb/docs/hwdc/medicine/0117RT2021.pdf.

⁵ Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁶ Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁷ If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) 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, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) 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 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁸ "Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁹ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The Board of Medicine concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The amendments delete outdated or redundant provisions and clarify provisions to be consistent with current practice of respiratory therapists, including removing (i) an unused definition, public participation requirements, and a cross reference for a list of violations of Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia; (ii) a fee related to voluntary practice by out-of-state licensees; (iii) a requirement for periodic board audits of continuing education; (iv) posting requirements for destruction of records and for the closing or selling of a practice; and (v) prohibition of solicitation or remuneration in exchange for referral.

18VAC85-40-10. Definitions.

A. The following words and terms when used in this chapter shall have the meanings ascribed to them in § 54.1-2900 of the Code of Virginia:

Board

Qualified medical direction

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

"AARC" means the American Association for Respiratory Care.

"Accredited educational program" means a program accredited by the Commission on Accreditation for Respiratory Care or any other agency approved by the NBRC for its entry level certification examination.

"Active practice" means a minimum of 160 hours of professional practice as a respiratory therapist within the 24-month period immediately preceding renewal or application for licensure if previously licensed or certified in another jurisdiction. The active practice of respiratory care may include supervisory, administrative, educational, or consultative activities or responsibilities for the delivery of such services.

"Advisory board" means the Advisory Board on Respiratory Care to the Board of Medicine as specified in § 54.1-2956 of the Code of Virginia.

"NBRC" means the National Board for Respiratory Care, Inc.

"Respiratory therapist" means a person as specified in § 54.1-2954 of the Code of Virginia.

18VAC85-40-20. Public participation. (Repealed.)

A separate board regulation, 18VAC85-11, provides for involvement of the public in the development of all regulations of the Virginia Board of Medicine.

18VAC85-40-30. Violations. (Repealed.)

Any violation of Chapter 29 of Title 54.1 of the Code of Virginia shall be subject to the statutory sanctions as set forth in the Act.

18VAC85-40-55. Registration for voluntary practice by out-of-state licensees.

Any respiratory therapist who does not hold a license to practice in Virginia and who seeks registration to practice under subdivision 27 of § 54.1-2901 of the Code of Virginia on a voluntary basis under the auspices of a publicly supported, all volunteer, nonprofit organization that sponsors the provision of health care to populations of underserved people shall:

1. File a complete application for registration on a form provided by the board at least five business days prior to engaging in such practice. An incomplete application will not be considered;

2. Provide a complete record of professional licensure in each state in which he the respiratory therapist has held a license and a copy of any current license;

3. Provide the name of the nonprofit organization, the dates, and the location of the voluntary provision of services;

4. Pay a registration fee of $10; and

5. 4. Provide a notarized statement from a representative of the nonprofit organization attesting to its compliance with provisions of subdivision 27 of § 54.1-2901 of the Code of Virginia.

18VAC85-40-66. Continuing education requirements.

A. In order to renew an active license as a respiratory therapist, a licensee shall attest to having completed 20 hours of continuing education within the last biennium as follows:

1. Courses approved and documented by a sponsor recognized by the AARC;

2. Courses directly related to the practice of respiratory care as approved by the American Medical Association for Category 1 CME credit;

3. A credit course of post-licensure academic education relevant to respiratory care offered by a college or university accredited by an agency recognized by the U.S. Department of Education; or

4. Passage of a specialty examination of the National Board of Respiratory Care for 20 hours of credit in the biennium in which the examination was passed.

Up to two continuing education hours may be satisfied through delivery of respiratory therapy services, without compensation, to low-income individuals receiving services through a local health department or a free clinic organized in whole or primarily for the delivery of health services. One hour of continuing education may be credited for three hours of providing such volunteer services. For the purpose of continuing education credit for voluntary service, the hours shall be approved and documented by the health department or free clinic.

B. A practitioner shall be exempt from the continuing education requirements for the first biennial renewal following the date of initial licensure in Virginia.

C. The practitioner shall retain in his the practitioner's records the completed form with all supporting documentation for a period of four years following the renewal of an active license.

D. The board shall periodically conduct a random audit of its active licensees to determine compliance. The practitioners selected for the audit shall provide all supporting documentation within 30 days of receiving notification of the audit.

E. D. Failure to comply with these requirements may subject the licensee to disciplinary action by the board.

F. E. The board may grant an extension of the deadline for continuing competency requirements, for up to one year, for good cause shown upon a written request from the licensee prior to the renewal date.

G. F. The board may grant an exemption for all or part of the requirements for circumstances beyond the control of the licensee, such as temporary disability, mandatory military service, or officially declared disasters.

18VAC85-40-70. Individual responsibilities.

Practice as a licensed respiratory therapist means, upon receipt of written or verbal orders from a qualified practitioner and under qualified medical direction, the evaluation, care, and treatment of patients with deficiencies and abnormalities associated with the cardiopulmonary system. This practice shall include, but not be limited to, ventilatory assistance and support; the insertion of artificial airways without cutting tissue and the maintenance of such airways; the administration of medical gases exclusive of general anesthesia; topical administration of pharmacological agents to the respiratory tract; humidification; and administration of aerosols. The practice of respiratory care shall include such functions shared with other health professionals as cardiopulmonary resuscitation; bronchopulmonary hygiene; respiratory rehabilitation; specific testing techniques required to assist in diagnosis, therapy, and research; and invasive and noninvasive cardiopulmonary monitoring.

18VAC85-40-86. Patient records.

A. Practitioners shall comply with the provisions of § 32.1-127.1:03 of the Code of Virginia related to the confidentiality and disclosure of patient records.

B. Practitioners shall provide patient records to another practitioner or to the patient or his the patient's personal representative in a timely manner in accordance with provisions of § 32.1-127.1:03 of the Code of Virginia.

C. Practitioners shall properly manage and keep timely, accurate, legible, and complete patient records.

D. Practitioners who are employed by a health care institution or other entity in which the individual practitioner does not own or maintain his the practitioner's own records shall maintain patient records in accordance with the policies and procedures of the employing entity.

E. Practitioners who are self-employed or employed by an entity in which the individual practitioner owns and is responsible for patient records shall: 1. Maintain maintain a patient record for a minimum of six years following the last patient encounter with the following exceptions:

a. 1. Records of a minor child, including immunizations, shall be maintained until the child reaches the age of 18 years of age or becomes emancipated, with a minimum time for record retention of six years from the last patient encounter regardless of the age of the child;

b. 2. Records that have previously been transferred to another practitioner or health care provider or provided to the patient or his the patient's personal representative; or

c. 3. Records that are required by contractual obligation or federal law may need to be maintained for a longer period of time.

2. From October 19, 2005, post information or in some manner inform all patients concerning the time frame for record retention and destruction. Patient records shall only be destroyed in a manner that protects patient confidentiality, such as by incineration or shredding.

3. When closing, selling or relocating his practice, meet the requirements of § 54.1-2405 of the Code of Virginia for giving notice that copies of records can be sent to any like-regulated provider of the patient's choice or provided to the patient.

18VAC85-40-89. Solicitation or remuneration in exchange for referral. (Repealed.)

A practitioner shall not knowingly and willfully solicit or receive any remuneration, directly or indirectly, in return for referring an individual to a facility or institution as defined in § 37.2-100 of the Code of Virginia or hospital as defined in § 32.1-123 of the Code of Virginia.

Remuneration shall be defined as compensation, received in cash or in kind, but shall not include any payments, business arrangements, or payment practices allowed by 42 USC § 1320 a-7b(b), as amended, or any regulations promulgated thereto.