Establishing the physician-patient relationship is often a requirement of state telemedicine law, but what does it mean that the physician has in fact “established” the physician-patient relationship?
This seems like odd language, given that “establishing the physician-patient relationship” can range from a physical, in-person visit to an audiovisual conference. One thing is sure: treating a patient without having “established” the physician-patient relationship can be a violation. Physicians need to understand whether the “establishment” is a legal requirement under their state law, and what that means.
Internet Prescribing Particularly Thorny
Although there is definitely a growing trend, among states, toward emphasizing establishment of the physician-patient relationship in telemedicine, the question of whether this must be in person of “face to face” yet online (or through mobile devices) is not always addressed.
Sometimes the state telemedicine statute will actually define what is sufficient. (Often, for example, an audio-visual meeting between physician and patient will be sufficient but an audio only visit is not).
Some states will allow prescribing remotely—where the patient does not see the physician in person—provided the prescription practice is within the standard of care.
Others require that the “good faith” or “appropriate prior” examination be in-person.
The term “face to face” is, of course, ambiguous, as one can be face to face through Facetime, Skype, and other services.
In California, the Medical Board of California (“MBC”) has expressed its ambivalence (or perhaps antipathy) toward “Internet prescribing.”
This term “Internet prescribing” harks back to earlier days of telemedicine, which were rife with unlicensed pharmacies promoting easy access to Rx drugs online.
The old posture (well, only part of a decade or so old) is at odds today with trends around the nation toward more liberal policies with respect to prescribing without an in-person exam, so long as standard of care is met. Indeed, there is some inconsistency in MBC’s position, given MBC’s own statement in its page on Telehealth, that:
Physicians are held to the same standard of care, and retain the same responsibilities of providing informed consent, ensuring the privacy of medical information, and any other duties associated with practicing medicine regardless of whether they are practicing via telehealth or face-to-face, in-person visits.
California’s Less Than Liberal Policy
The California Medical Board’s warnings resound. In Internet Prescribing – Information for Physicians, MBC says the following:
The short answer: it’s illegal to prescribe without an appropriate examination. This requirement (Business and Professions Code section 2242) existed long before the Internet was created and is the cornerstone of why Internet prescribing is illegal when a legitimate physician-patient relationship does not exist.
MBC goes on to emphasize:
Some physicians have attempted to legitimize their Internet prescribing by engaging in the review of questionnaires, which Internet users will complete, although there is no way to confirm the patient is reporting accurate or truthful information.
In-person examinations not only enhance the opportunity to confirm if a patient needs the identified medication or to rule out other medical conditions, but ensures the patient is advised of alternative treatment options and is aware of potential side effects. For some patients, certain drugs are contraindicated and serious injury, including death, can follow.
Senator Jackie Speier authored Business and Professions Code section 2242.1 which became effective in January 2001. It specifically states no person may prescribe, dispense or furnish dangerous drugs or devices via the Internet without an appropriate prior examination and medical indication therefor. A violation of this section may result in the issuance of a citation or civil penalty with a $25,000 fine per occurrence.
Internet prescribing has flourished because there is such a financial gain for the involved participants including the site operator, the physician and the pharmacist (or wholesale drug supplier). Violations occur in the state where the patient is located.
The Board has taken action against California physicians and licensees from other states for prescribing over the Internet without an appropriate prior exam, and continues to investigate cases as it becomes aware of the practice.
In Frequently Asked Questions—Internet Prescribing and Practicing, MBC reiterates that:
Business and Professions Code section 2242 states that, with very limited exceptions, prescription drugs must be prescribed by a physician after an appropriate examination has been performed and a medical indication for the prescription has been determined. Ordering drugs without a relationship with a physician is potentially dangerous.
MBC uses the term “physician,” and does not address the role of mid-levels here.
In Internet Prescribing—Information for Consumers, MBC repeats its warnings, with admonitions to the consumer to not avoid the doctor’s office:
While it’s human nature, the avoidance of the doctor’s office, in some instances, can be dangerous and even life threatening…
Many of the conditions which you may be attempting to treat have underlying medical causes that should be evaluated by your physician during an actual examination. If contemplating obtaining prescriptions through the Internet, consumers should consider the following:
- Ordering drugs without a relationship with a physician is potentially dangerous. By law, with very limited exceptions, prescription drugs must be prescribed by a physician after a good faith examination has been performed and a medical indication for the prescription has been determined. There is good reason for this, as drugs should only be prescribed after an examination is performed and the cause of the problem or condition is diagnosed. Online “consultations” cannot, with any certainty, provide enough information to make a verifiable diagnosis….
- Self-diagnosing can be dangerous, and treating a symptom without determining the underlying cause may mask symptoms that will prevent appropriate treatment of a serious, and maybe life-threatening, disease or condition.
- All drugs, particularly prescription drugs, have the potential for dangerous side effects. After the prescription is sold, it is likely that the prescribing online physician will not be available to help you. Patients need a physician with whom they have a relationship to monitor and treat their conditions for a number of very good reasons. In the event of side effects, if the condition worsens, or if there is an interaction with other drugs, each patient needs a physician who is aware of his or her condition and the medications.
Once again, MBC’s posts are full of warnings and emphasize the need for a physician exam. Although MBC’s posts are not law and only represent MBC’s summary of relevant law, they do suggest MBC’s basic enforcement posture, and should be read seriously as a warning about MBC’s scrutiny in this area.
Supporting California Law
Below are some relevant statutory cites.
California Business & Professions Code, Section 4067 provides:
(a) No person or entity shall dispense or furnish, or cause to be dispensed or furnished, dangerous drugs or dangerous devices, as defined in Section 4022, on the Internet for delivery to any person in this state without a prescription issued pursuant to a good faith prior examination of a human or animal for whom the prescription is meant if the person or entity either knew or reasonably should have known that the prescription was not issued pursuant to a good faith prior examination of a human or animal…
(b) Notwithstanding any other provision of law, a violation of this section may subject the person or entity that has committed the violation to either a fine of up to twenty-five thousand dollars ($25,000) per occurrence pursuant to a citation issued by the board or a civil penalty of twenty-five thousand dollars ($25,000) per occurrence….
(f) For the purposes of this section, “good faith prior examination” includes the requirements for a physician and surgeon in Section 2242….
Section 2242 provides:
(a) Prescribing, dispensing, or furnishing dangerous drugs as defined in Section 4022 without an appropriate prior examination and a medical indication, constitutes unprofessional conduct.
(Subsection (b)(1) provides an allowance for a 72-hour supply, and subsection (b)(2) deals with transmission of order in an inpatient facility.)
Section 2242.1 continues:
(a) No person or entity may prescribe, dispense, or furnish, or cause to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices, as defined in Section 4022, on the Internet for delivery to any person in this state, without an appropriate prior examination and medical indication, except as authorized by Section 2242.
(b) Notwithstanding any other provision of law, a violation of this section may subject the person or entity that has committed the violation to either a fine of up to twenty-five thousand dollars ($25,000) per occurrence pursuant to a citation issued by the board or a civil penalty of twenty-five thousand dollars ($25,000) per occurrence.
(c) The Attorney General may bring an action to enforce this section and to collect the fines or civil penalties authorized by subdivision (b)….
Section 5.12 (Internet Prescribing) of MBC’s publication, Guide to the Laws Governing the Practice of Medicine by Physicians and Surgeons, emphasizes these points:
Computer-related violations of California state law regarding health care are occurring on the Internet. Business and Professions Code §2242.1 (Prescribing, dispensing, or furnishing dangerous drugs or devices on Internet), requires that a physician provide a patient with an appropriate prior examination and that there exist a medical indication before prescribing, dispensing or furnishing a dangerous drug. Violation of this law may result in a fine of up to $25,000 for each occurrence. Essential components of proper prescribing include performing and documenting a physical examination that includes obtaining a legitimate medical history, engaging in sufficient dialogue to form a treatment opinion, determining the risks and benefits of the drug or treatment regimen, scheduling follow-up appointments to assess therapeutic outcome and maintaining an adequate and accurate medical record before prescribing any medication for the first time. Telephone interviews, Internet questionnaires or online consultations are not appropriate or acceptable by law, and fail to meet the minimum components of an appropriate prior examination since they cannot, with any certainty, provide enough information to make a verifiable diagnosis.
Even if MBC is not currently active in enforcement in this area, the seriousness of the Board’s online statements bears noting.
On its webpage describing telemedicine, the California Medical Board (CMB) appears to default to the standard of care as the test as to whether telemedicine is permissible; however, on its webpage concerning Internet prescribing, CMB states that the law prohibits prescribing, without an “appropriate prior examination,” notwithstanding that standard of care may be satisfied or that it might be considered within the range of acceptable professional practice by peers not to have an in person exam (for example, in some tele-dermatology). On this page, CMB cites California Business & Professions Code, Section 2242.
Notably, as of October 11, 2019, the California legislature amended and liberalized Section 2242 via AB 1264, to provide that an appropriate prior examination does not require a synchronous interaction between the patient and the licensee and can be achieved through the use of telehealth, as specified, provided that the licensee complies with the appropriate standard of care. Thus, 2242 now provides:
“Prescribing, dispensing, or furnishing dangerous drugs as defined in Section 4022 without an appropriate prior examination and a medical indication, constitutes unprofessional conduct. An appropriate prior examination does not require a synchronous interaction between the patient and the licensee and can be achieved through the use of telehealth, including, but not limited to, a self-screening tool or a questionnaire, provided that the licensee complies with the appropriate standard of care.”
Cal. Bus. And Professions Code § 2242.
Yet even so, there are also standard of care concerns, as noted in a 2019 disciplinary action by the Medical Board of California entitled, In re Richard J. Holmes, M.D
Other States Have Varying Telemedicine Prescribing Rules
We’ve written before about evolving law in this area. See for example:
Telemedicine laws continue to push forward to keep pace with telehealth market practices.
The bottom line is to understand that even though state laws are increasingly turning a tolerant and even benevolent eye toward telemedicine, prescribing—and particularly, prescribing controlled substances—can raise regulatory red flags. Some states only require that the physician-patient relationship be “established;” some require that this be in person while others allow an audiovisual consult to suffice. Other states prohibit prescribing without an in-person prior examination; some states allow this exam to be done by a Nurse Practitioner or Physician Assistant (under appropriate supervision and standardized procedures or a delegation of services agreement, respectively).