Prescribing through Telemedicine Raises Legal Challenges: Learn the Regulatory Terrain

Our telemedicine lawyers get a fair number of calls from telehealth startups that include online prescription practices.  The healthcare startups often question the legal rules around prescribing and wonder to what extent their medical doctors can prescribe:

• Across state lines—i.e., for patients who live in states where the physicians are not licensed; and
• Without the MD physically examining the patient in person.

These two questions—medical practice across state line, and, whether and when a “good faith exam” or “appropriate prior exam” is required—are part of the legal questions most telemedicine startups ask our telehealth legal team.  These telemedicine law questions are particularly acute where the business model concerns the practice of:

• Integrative medicine
• Functional medicine
• Holistic health
• Anti-aging medicine
• Regenerative medicine
• Or the use of hormones such as testosterone

We’ve written extensively on this healthcare and FDA law blog on the ins and outs of telemedicine law.  Let’s refresh the conversation with a focus on the laws governing telemedicine prescribing practices.

What’s Wrong with Internet Prescribing?

The Medical Board of California (the Medical Board of California) makes its position clear that it disfavors “Internet prescribing.”

The contours of what constitutes Internet prescribing may have been clear enough when the Medical Board of California issued its posts during earlier days of the Internet but may appear somewhat blurred today when telemedicine is very common.

Nonetheless, the Medical Board of California’s warnings resound.

In Internet Prescribing – Information for Physicians, the Medical Board of California 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.

The Medical Board of California 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, the Medical Board of California 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.

the Medical Board of California uses the term “physician,” and does not address the role of mid-levels here.

In Internet Prescribing—Information for Consumers, the Medical Board of California 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, the Medical Board of California’s posts are full of warnings and emphasize the need for a physician exam.

In Practicing Medicine Through Telehealth Technology, the Medical Board of California states that the standard of care is the same for physicians, whether in-person or online.  Certainly, standard of care should be considered in any business model that uses mid-levels and/or involves prescription of controlled substances.

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

Can an NP Conduct a Good Faith Exam?

In California, and many other states, the Nurse Practitioner can be the one who provides the “good faith exam” or “appropriate exam.”  However, this has to be under physician supervision.

Collaborative protocols are recommended between the Nurse Practitioner and the Medical Doctor.

As well, the MD should be immediately available for supervision, if necessary.

When thinking through the NP’s role, it’s useful to take a look at some statutory definition that control different aspects of what the various practitioners can do with respect to Rx medications.  These include (in California):

• “Dangerous drug” means “any drug … unsafe for self-use in humans …” and includes Rx and/or prescription drugs. (Business & Professions Code, Section 4022)
• Per Section 4021, “Controlled substance” means “any substance listed in Chapter 2 (commencing with Section 11053) of Division 10 of the Health and Safety Code.”
• “Dispense” means: (1) “the furnishing of drugs or devices upon a prescription from a physician … or upon an order to furnish drugs or transmit a prescription from a … nurse practitioner … acting within the scope of his or her practice;” or (2) the furnishing of drugs or devices directly to a patient by a physician … [or] nurse practitioner … acting within the scope of his or her practice.” (Section 4024)
• “Furnish” means “to supply by any means, by sale or otherwise” (Section 4026).
• Section 4040 defines “prescription.” Note that: “A person may not furnish any dangerous drug, except upon the prescription” of a physician and certain other designated licensees (NPs are not included).  There are some exceptions and exemptions.
• Section 4060 deals with possession of a controlled substance and authorizes possession furnished pursuant to a physician prescription or a “drug order issued by … a nurse practitioner pursuant to Section 2836.1.”
• Section 4067 talks about the good faith prior examination.

(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, or if the person or entity did not act in accordance with Section 1761 of Title 16 of the California Code of Regulations.

(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 the Medical Board of California’s publication, Guide to the Laws Governing the Practice of Medicine by Physicians and Surgeons, states:

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.

In other words, while California law allows a mid-level, such as a Nurse Practitioner, to fulfill the good faith, prior examination, the medical board continues to emphasize the dangers of online prescription.

What about Physician Supervision, Again?

In delineating the NP’s role in the good faith exam, the Medical Board of California has focused largely on the NPs in cosmetic treatments in medical spas.  Key resources include: FAQs – Cosmetic Treatments, and The Bottom Line: The Business of Medicine—Medical Spas

Within these documents, the Medical Board of California emphasizes that the physician must supervise the NP, under standardized procedures:

Standardized procedures for nurses allow nurses to perform procedures while the physician is not on-site; however, they do not absolve physicians of their supervision responsibilities.  Nor does the law allow nurses to set up a practice in a salon, hire a physician supervisor, or perform medical procedures independently.  The law does not contain a legal definition of supervision, and therefore, absent a legal definition, the plain English definition applies. “Supervision” is defined as the act of supervising, which is to oversee, to direct, to have charge, to inspect, to provide guidance and evaluation…

As an example, the regulations for “standardized procedures guidelines” require physicians to be responsible for ensuring the experience, training, and education requirements for performance of the delegated function – and this must be documented.  The regulations require that a method of initial and continuing evaluation of the nurses’ competence be established.

As to whether the physician must present, the Medical Board of California states:

When functioning under “standardized procedures,” physicians need not be present in the facility when the procedures are being performed.

The Medical Board of California goes on to note that:

The facility, however, must be a medical setting.  Regulations require that the location be an “organized healthcare system,” which is not a salon, spa, or other facility not under the control of the physician.” What we discussed here is that if you are in a setting other than your own office, you should rent at fair market value and have exclusive control of the medical space during the time you are using it….

In other words, the medical board still takes physician supervision seriously and does not simply abdicate responsibility to the NP.

While telemedicine laws continue to grow more liberal across the U.S., regulatory attitudes toward prescribing via telehealth remain stringent in many states.  This makes it challenging to predict medical board enforcement.  Models of online health and telehealth platforms that facilitate online prescription must be carefully crafted, as otherwise they leave physicians who provide telemedicine and the healthcare startups that support these physician practices, vulnerable to enforcement action.  Contact an experienced telemedicine lawyer for healthcare law advice relevant to your telehealth venture.