Notice of Intended Action

Jurisdiction
Iowa
Publication
Issue 21
Volume XLIII
Published April 7, 2021
Rule Type
Proposed Rule
Issuing Body
Professional Licensure Division
Source
IA_20210407_5555C.pdf
IA_20210407_TOC.html
Pre-Rule Proposed Rule Final Rule

Notice Text

ARC 5555C PROFESSIONAL LICENSURE DIVISION[645] Notice of Intended Action Proposing rule making related to telemedicine and providing an opportunity for public comment The Board of Physician Assistants (Board) hereby proposes to amend Chapter 327, “Practice of Physician Assistants,” Iowa Administrative Code. Legal Authority for Rule Making This rule making is proposed under the authority provided in Iowa Code section 147.76. State or Federal Law Implemented This rule making implements, in whole or in part, Iowa Code chapters 147, 148C and 272C. Purpose and Summary This proposed rule making establishes standards of practice for physician assistants who provide patient care through telemedicine. The proposed rule establishes the standard of care and requires HIPAA-compliant technology, as well as imposing other requirements to ensure the patient’s confidential health information is secure. The rule aligns with the Board of Medicine rules governing telemedicine, which will ensure that physician assistants and their supervising physicians will operate under uniform standards and do not need to worry about any differing or potentially conflicting telemedicine standards when coordinating remote care. Fiscal Impact This rule making has no fiscal impact to the State of Iowa. Jobs Impact After analysis and review of this rule making, no impact on jobs has been found. Waivers Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 645—Chapter 18. Public Comment Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Board no later than 4:30 p.m. on April 27, 2021. Comments should be directed to: Susan Reynolds Professional Licensure Division Iowa Department of Public Health Lucas State Office Building 321 East 12th Street Des Moines, Iowa 50319 Email: susan.reynolds@idph.iowa.gov Public Hearing A public hearing at which persons may present their views orally or in writing will be held as follows:
April 27, 2021 Via Webex:
10:30 to 11 a.m. idph.webex.com/idph/j.php?MTID=mab53252486f2c
e8f8ff02111af8c22f5
Password: rfRyMJP4@42
Via telephone: 408.418.9388
Access code: 187 215 8512
Persons who wish to make oral comments at the public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rule making. In an effort to ensure accuracy in memorializing a person’s comments, a person may provide written comments in addition to or in lieu of oral comments at the hearing. Any persons who intend to attend the public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Board and advise of specific needs. Review by Administrative Rules Review Committee The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).
The following rule-making actions are proposed: ITEM 1. Adopt the following new rule 645—327.9(147,148C,272C): 645—327.9(147,148C,272C) Standards of practice—telemedicine. This rule establishes standards of practice for the delegated provision of telemedicine services. 327.9(1) Telemedicine, generally. a. Technological advances have made it possible for licensees in one location to provide medical care to patients in another location with or without an intervening health care provider. b. Telemedicine is a useful tool that, if applied appropriately, can provide important benefits to patients, including increased access to health care, expanded utilization of specialty expertise, rapid availability of patient records, and potential cost savings. c. Licensees using telemedicine will be held to the same standards of care and professional ethics as licensees using traditional in-person medical care. d. Failure to conform to the appropriate standards of care or professional ethics while using telemedicine may subject the licensee to potential discipline by the board. 327.9(2) Definitions. For the purposes of this rule: “Asynchronous store-and-forward transmission” means the collection of a patient’s relevant health information and the subsequent transmission of the data from an originating site to a health care provider at a distant site without the presence of the patient. “Board” means the Iowa board of physician assistants. “In-person encounter” means that the physician assistant and the patient are in the physical presence of each other and are in the same physical location during the physician assistant-patient encounter. “Licensee” means a physician assistant licensed by the board. “Telemedicine” means the practice of medicine using electronic audiovisual communications and information technologies or other means, including interactive audio with asynchronous store-and-forward transmission, between a licensee in one location and a patient in another location with or without an intervening health care provider. Telemedicine includes asynchronous store-and-forward technologies, remote monitoring, and real-time interactive services, including teleradiology and telepathology. Telemedicine shall not include the provision of medical services only through an audio-only telephone, email messages, facsimile transmissions, or U.S. mail or other parcel service, or any combination thereof. “Telemedicine technologies” means technologies and devices enabling secure electronic communications and information exchanges between a licensee in one location and a patient in another location with or without an intervening health care provider. 327.9(3) Practice guidelines. A licensee who uses telemedicine shall utilize evidence-based telemedicine practice guidelines and standards of practice, to the degree they are available, to ensure patient safety, quality of care, and positive outcomes. The board acknowledges that some nationally recognized medical specialty organizations have established comprehensive telemedicine practice guidelines that address the clinical and technological aspects of telemedicine for many medical specialties. 327.9(4) License required. A physician assistant who uses telemedicine in the diagnosis and treatment of a patient located in Iowa shall hold an active Iowa physician assistant license consistent with state and federal laws. Nothing in this rule shall be construed to supersede the exceptions to licensure contained in rule 645—326.17(148C). 327.9(5) Standards of care and professional ethics. A licensee who uses telemedicine shall be held to the same standards of care and professional ethics as a licensee using traditional in-person encounters with patients. Failure to conform to the appropriate standards of care or professional ethics while using telemedicine may be a violation of the laws and rules governing the practice of medicine and may subject the licensee to potential discipline by the board. 327.9(6) Scope of practice. A licensee who uses telemedicine shall ensure that the services provided are consistent with the licensee’s scope of practice, including the licensee’s education, training, experience, ability, licensure, and certification. 327.9(7) Identification of patient and physician assistant. A licensee who uses telemedicine shall verify the identity of the patient and ensure that the patient has the ability to verify the identity, licensure status, certification, and credentials of all health care providers who provide telemedicine services prior to the provision of care. 327.9(8) Physician assistant-patient relationship. a. A licensee who uses telemedicine shall establish a valid physician assistant-patient relationship with the person who receives telemedicine services. The physician assistant-patient relationship begins when: (1)The person with a health-related matter seeks assistance from a licensee; (2)The licensee agrees to undertake diagnosis and treatment of the person; and (3)The person agrees to be treated by the licensee whether or not there has been an in-person encounter between the physician assistant and the person. b. A valid physician assistant-patient relationship may be established by: (1)In-person encounter. Through an in-person medical interview and physical examination where the standard of care would require an in-person encounter; (2)Consultation with another licensee. Through consultation with another licensee (or other health care provider) who has an established relationship with the patient and who agrees to participate in, or supervise, the patient’s care; or (3)Telemedicine encounter. Through telemedicine, if the standard of care does not require an in-person encounter, and in accordance with evidence-based standards of practice and telemedicine practice guidelines that address the clinical and technological aspects of telemedicine. 327.9(9) Medical history and physical examination. Generally, a licensee shall perform an in-person medical interview and physical examination for each patient. However, the medical interview and physical examination may not be in person if the technology utilized in a telemedicine encounter is sufficient to establish an informed diagnosis as though the medical interview and physical examination had been performed in person. Prior to providing treatment, including issuing prescriptions, electronically or otherwise, a licensee who uses telemedicine shall interview the patient to collect the relevant medical history and perform a physical examination, when medically necessary, sufficient for the diagnosis and treatment of the patient. An Internet questionnaire that is a static set of questions provided to the patient, to which the patient responds with a static set of answers, in contrast to an adaptive, interactive and responsive online interview, does not constitute an acceptable medical interview and physical examination for the provision of treatment, including issuance of prescriptions, electronically or otherwise, by a licensee. 327.9(10) Non-physician assistant health care providers. If a licensee who uses telemedicine relies upon or delegates the provision of telemedicine services to a non-physician assistant health care provider, the licensee shall: a. Ensure that systems are in place to ensure that the non-physician assistant health care provider is qualified and trained to provide that service within the scope of the non-physician assistant health care provider’s practice; b. Ensure that the licensee is available in person or electronically to consult with the non-physician assistant health care provider, particularly in the case of injury or an emergency. 327.9(11) Informed consent. A licensee who uses telemedicine shall ensure that the patient provides appropriate informed consent for the medical services provided, including consent for the use of telemedicine to diagnose and treat the patient, and that such informed consent is timely documented in the patient’s medical record. 327.9(12) Coordination of care. A licensee who uses telemedicine shall, when medically appropriate, identify the medical home or treating clinician(s) for the patient, when available, where in-person services can be delivered in coordination with the telemedicine services. The licensee shall provide a copy of the medical record to the patient’s medical home or treating clinician(s). 327.9(13) Follow-up care. A licensee who uses telemedicine shall have access to, or adequate knowledge of, the nature and availability of local medical resources to provide appropriate follow-up care to the patient following a telemedicine encounter. 327.9(14) Emergency services. A licensee who uses telemedicine shall refer a patient to an acute care facility or an emergency department when referral is necessary for the safety of the patient or in the case of an emergency. 327.9(15) Medical records. A licensee who uses telemedicine shall ensure that complete, accurate and timely medical records are maintained for the patient when appropriate, including all patient-related electronic communications, records of past care, physician assistant-patient communications, laboratory and test results, evaluations and consultations, prescriptions, and instructions obtained or produced in connection with the use of telemedicine technologies. The licensee shall note in the patient’s record when telemedicine is used to provide diagnosis and treatment. The licensee shall ensure that the patient or another licensee designated by the patient has timely access to all information obtained during the telemedicine encounter. The licensee shall ensure that the patient receives, upon request, a summary of each telemedicine encounter in a timely manner. 327.9(16) Privacy and security. A licensee who uses telemedicine shall ensure that all telemedicine encounters comply with the privacy and security measures of the Health Insurance Portability and Accountability Act (HIPAA) to ensure that all patient communications and records are secure and remain confidential. a. Written protocols shall be established that address the following: (1)Privacy; (2)Health care personnel who will process messages; (3)Hours of operation; (4)Types of transactions that will be permitted electronically; (5)Required patient information to be included in the communication, including patient name, identification number and type of transaction; (6)Archiving and retrieval; and (7)Quality oversight mechanisms. b. The written protocols should be periodically evaluated for currency and should be maintained in an accessible and readily available manner for review. The written protocols shall include sufficient privacy and security measures to ensure the confidentiality and integrity of patient-identifiable information, including password protection, encryption or other reliable authentication techniques. 327.9(17) Technology and equipment. Broad categories of telemedicine technologies currently exist, including asynchronous store-and-forward technologies, remote monitoring, and real-time interactive services. While some telemedicine programs are multispecialty in nature, others are tailored to specific diseases and medical specialties. The technology and equipment utilized for telemedicine shall comply with the following requirements: a. The technology and equipment utilized in the provision of telemedicine services must comply with all relevant safety laws, rules, regulations, and codes for technology and technical safety for devices that interact with patients or are integral to diagnostic capabilities; b. The technology and equipment utilized in the provision of telemedicine services must be of sufficient quality, size, resolution and clarity such that the licensee can safely and effectively provide the telemedicine services; and c. The technology and equipment utilized in the provision of telemedicine services must be compliant with the HIPAA. 327.9(18) Disclosure and functionality of telemedicine services. A licensee who uses telemedicine shall ensure that the following information is clearly disclosed to the patient: a. Types of services provided; b. Contact information for the licensee; c. Identity, licensure, certification, credentials, and qualifications of all health care providers who are providing the telemedicine services; d. Limitations in the drugs and services that can be provided via telemedicine; e. Fees for services, cost-sharing responsibilities, and how payment is to be made, if these differ from an in-person encounter; f.Financial interests, other than fees charged, in any information, products, or services provided by the licensee(s); g. Appropriate uses and limitations of the technologies, including in emergency situations; h. Uses of and response times for emails, electronic messages and other communications transmitted via telemedicine technologies; i.To whom patient health information may be disclosed and for what purpose; j.Rights of patients with respect to patient health information; and k. Information collected and passive tracking mechanisms utilized. 327.9(19) Patient access and feedback. A licensee who uses telemedicine shall ensure that the patient has easy access to a mechanism for the following purposes: a. To access, supplement and amend patient-provided personal health information; b. To provide feedback regarding the quality of the telemedicine services provided; and c. To register complaints. The mechanism shall include information regarding the filing of complaints with the board. 327.9(20) Financial interests. Advertising or promotion of goods or products from which the licensee receives direct remuneration, benefit or incentives (other than the fees for the medical services) is prohibited to the extent that such activities are prohibited by state or federal law. Notwithstanding such prohibition, Internet services may provide links to general health information sites to enhance education; however, the licensee should not benefit financially from providing such links or from the services or products marketed by such links. When providing links to other sites, licensees should be aware of the implied endorsement of the information, services or products offered from such sites. The maintenance of a preferred relationship with any pharmacy is prohibited. Licensees shall not transmit prescriptions to a specific pharmacy, or recommend a pharmacy, in exchange for any type of consideration or benefit from the pharmacy. 327.9(21) Circumstances where the standard of care may not require a licensee to personally interview or examine a patient. Under the following circumstances, whether or not such circumstances involve the use of telemedicine, a licensee may treat a patient who has not been personally interviewed, examined and diagnosed by the licensee: a. Situations in which the licensee prescribes medications on a short-term basis for a new patient and has scheduled or is in the process of scheduling an appointment to personally examine the patient; b. For institutional settings, including writing initial admission orders for a newly hospitalized patient; c. Call situations in which a licensee is taking calls for another health care provider who has an established provider-patient relationship with the patient; d. Cross-coverage situations in which a licensee is taking calls for another health care provider who has an established provider-patient relationship with the patient; e. Emergency situations in which the life or health of the patient is in imminent danger; f.Emergency situations that constitute an immediate threat to the public health including, but not limited to, empiric treatment or prophylaxis to prevent or control an infectious disease outbreak; g. Situations in which the licensee has diagnosed a sexually transmitted disease in a patient and the licensee prescribes or dispenses antibiotics to the patient’s named sexual partner(s) for the treatment of the sexually transmitted disease as recommended by the U.S. Centers for Disease Control and Prevention; and h. For licensed or certified nursing facilities, residential care facilities, intermediate care facilities, assisted living facilities, hospice settings, and correctional facilities. 327.9(22) Prescribing based solely on an Internet request, Internet questionnaire or a telephonic evaluation—prohibited. Prescribing to a patient based solely on an Internet request or Internet questionnaire (i.e., a static questionnaire provided to a patient, to which the patient responds with a static set of answers, in contrast to an adaptive, interactive and responsive online interview) is prohibited. Absent a valid physician assistant-patient relationship, a licensee’s prescribing to a patient based solely on a telephonic evaluation is prohibited, with the exception of the circumstances described in subrule 327.9(21). ITEM 2. Amend 645—Chapter 327, implementation sentence, as follows: These rules are intended to implement Iowa Code section sections 147.10 and 147.107 and chapters 148C and 272C.