This rule establishes standards of practice for the delegated
provision of telemedicine services.
(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.
(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, for the purposes of this rule establishing
standards of practice, does 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.
(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.
(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).
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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).
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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).