Iowa Admin. Code r. 653-13.11 - Standards of practice-experimental treatments for patients with a terminal illness
(1)
Exemption from discipline. To the extent consistent with state
law, the board will not revoke, fail to renew, suspend, or take any action
against a physician's license based solely on the physician's recommendations
to an eligible patient regarding access to or treatment with an investigational
drug, biological product, or device.
(2)
Eligible patient. A
physician shall ensure that a patient meets all of the following conditions
prior to the use of an investigational drug, biological product, or device
pursuant to this rule:
a. The patient has a
terminal illness, attested to by the patient's treating physician.
b. The patient has considered and rejected or
has tried and failed to respond to all other treatment options approved by the
U.S. Food and Drug Administration (FDA).
c. The patient has received a recommendation
from the patient's physician for an investigational drug, biological product,
or device.
d. The patient has given
written informed consent for the use of the investigational drug, biological
product, or device.
e. The patient
has documentation from the patient's physician that the patient meets the
requirements of this rule.
(3)
Investigational drug, biological
product, or device. A physician may recommend access to or treatment
with an investigational drug, biological product, or device that has
successfully completed phase 1 of an FDA-approved clinical trial but has not
yet been approved for general use by the FDA and remains under investigation in
an FDA-approved clinical trial.
(4)
Terminal illness. A physician shall ensure that a patient has
a terminal illness prior to the use of an investigational drug, biological
product, or device pursuant to this rule. A terminal illness is a progressive
disease or medical or surgical condition that entails significant functional
impairment and that is not considered by a treating physician to be reversible
even with administration of treatments approved by the FDA and that, without
life-sustaining procedures, will result in death.
(5)
Written informed
consent. A physician shall obtain written informed consent prior to
the use of an investigational drug, biological product, or device pursuant to
this rule. Written informed consent is a written document that is signed by a
patient, a parent of a minor patient, or a legal guardian or other legal
representative of the patient and attested to by the patient's treating
physician and a witness and that includes all of the following:
a. An explanation of the products and
treatments approved by the FDA for the disease or condition from which the
patient suffers.
b. An attestation
that the patient concurs with the patient's treating physician in believing
that all products and treatments approved by the FDA are unlikely to prolong
the patient's life.
c. Clear
identification of the specific proposed investigational drug, biological
product, or device that the patient is seeking to use.
d. A description of the best and worst
potential outcomes of using the investigational drug, biological product, or
device and a realistic description of the most likely outcome. The description
to include the possibility that new, unanticipated, different, or worse
symptoms might result and that death could be hastened by use of the proposed
investigational drug, biological product, or device. The description is based
on the treating physician's knowledge of the proposed investigational drug,
biological product, or device in conjunction with an awareness of the patient's
condition.
e. A statement that the
patient's health plan or third-party administrator and provider are not
obligated to pay for any care or treatments consequent to the use of the
investigational drug, biological product, or device, unless the patient's
health plan or third-party administrator and provider are specifically required
to do so by law or contract.
f. A
statement that the patient's eligibility for hospice care may be withdrawn if
the patient begins curative treatment with the investigational drug, biological
product, or device and that hospice care may be reinstated if treatment ends
and the patient meets hospice eligibility requirements.
g. A statement that the patient understands
that the patient is liable for all expenses consequent to the use of the
investigational drug, biological product, or device and that this liability
extends to the patient's estate unless a contract between the patient and the
manufacturer of the investigational drug, biological product, or device states
otherwise.
(6)
Assisting suicide. This rule is not to be construed to allow a
patient's treating physician to assist the patient in committing or attempting
to commit suicide as prohibited in Iowa Code section
707A.2.
(7)
Grounds for discipline.
A physician may be subject to disciplinary action for violation of this rule or
653-Chapter 23. Grounds for discipline include but are not limited to the
following:
a. The physician recommends access
to or treatment with an investigational drug, biological product, or device to
an individual who is not an eligible patient pursuant to this rule.
b. The physician fails to obtain appropriate
written informed consent prior to recommending access to or treatment with an
investigational drug, biological product, or device pursuant to this
rule.
c. The physician assists the
patient in committing or attempting to commit suicide as prohibited in Iowa
Code section 707A.2.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
This
1. The board recognizes that 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.
2. 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.
3. The board advises that licensees using telemedicine will be held to the same standards of care and professional ethics as licensees using traditional in-person medical care.
4. 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 .
(1) Definitions. As used in 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.
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"In-person encounter" means that the
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"Telemedicine" means the practice of medicine using electronic audio-visual communications and information technologies or other means, including interactive audio with asynchronous store-and-forward transmission, between a
"Telemedicine technologies" means technologies and devices enabling secure electronic communications and information exchanges between a
(2) 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.
(3) Iowa medical license required. A physician who uses telemedicine in the diagnosis and treatment of a patient located in Iowa shall hold an active Iowa medical license consistent with state and federal laws. Nothing in this rule shall be construed to supersede the exceptions to licensure contained in 653-subrule 9.2(2).
(4) 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 .
(5) 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.
(6) Identification of patient and physician . 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.
(7) Physician -patient relationship.
a. A licensee who uses telemedicine shall establish a valid physician -patient relationship with the person who receives telemedicine services. The physician -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 and the person.
b. A valid physician -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.
(8) 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 .
(9) Nonphysician health care providers. If a licensee who uses telemedicine relies upon or delegates the provision of telemedicine services to a nonphysician health care provider, the licensee shall:
a. Ensure that systems are in place to ensure that the nonphysician health care provider is qualified and trained to provide that service within the scope of the nonphysician health care provider's practice;
b. Ensure that the licensee is available in person or electronically to consult with the nonphysician health care provider, particularly in the case of injury or an emergency.
(10) 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.
(11) Coordination of care. A licensee who uses telemedicine shall, when medically appropriate, identify the medical home or treating physician (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 physician (s).
(12) 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.
(13) 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.
(14) 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 -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.
(15) 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 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.
(16) Technology and equipment. The board recognizes that three 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 Health Insurance Portability and Accountability Act.
(17) 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 e-mails, 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.
(18) 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 .
(19) Financial interests. Advertising or promotion of goods or products from which the licensee (s) 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 (s) 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.
(20) 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 call for another licensee who has an established physician -patient relationship with the patient;
d. Cross-coverage situations in which a licensee is taking call for another licensee who has an established physician -patient relationship with the patient;
e. Situations in which the patient has been examined in person by an advanced registered nurse practitioner or a physician assistant or other licensed practitioner with whom the licensee has a supervisory or collaborative relationship;
f. Emergency situations in which the life or health of the patient is in imminent danger;
g. 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;
h. 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
i. For licensed or certified nursing facilities, residential care facilities, intermediate care facilities, assisted living facilities and hospice settings.
(21) 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 -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 13.11(20).
(22) Medical abortion. Nothing in this rule shall be interpreted to contradict or supersede the requirements established in rule 653-13.10 (147,148,272C).
This