Will You Get Rx Drugs from a Shopping Mall Kiosk? Telemedicine and Internet Prescribing:

fsmblogoInternet prescribing has been the bad boy of telemedicine, lagging behind telemedicine rules for medical practices generally; is this about to change?

 

 

 

North Carolina’s medical board has recently softened its position on Internet prescribing, stating:

Prescribing for a patient whom the licensee has not personally examined may be suitable under certain circumstances. These may include admission orders for a newly hospitalized patient, medication orders or prescriptions, including pain management, from a hospice physician for a patient admitted to a certified hospice program, prescribing for a patient of another licensee for whom the prescriber is taking call, continuing medication on a short-term basis for a new patient prior to the patient’s first appointment, an appropriate prescription in a telemedicine encounter where the threshold information to make an accurate diagnosis has been obtained, or prescribing an opiate antagonist to someone in a position to assist a person at risk of an opiate-related overdose.

In other states, such as California, the rules remain as they were pre-2014.

Typically, several issues arise with practicing across state lines via the Internet:

  • States require that the physician providing medical care be licensed in the state in which the patient is located. Thus, for example, if a physician licensed in California wishes to diagnose and treat a patient via the Internet in Georgia, the physician must be licensed in Georgia as well (unless that state allows a limited, telemedicine license). This will probably change with the new, Federation of State Medical Boards compact on telemedicine licensure.
  • An “appropriate” or “good faith” prior exam is generally required. There is not much additional law to flesh out this requirement, except that enforcement authorities can and will intervene if they suspect the arrangement as a whole.
  • Higher standards apply to prescription via the Internet. In California, “no person 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.” Cal. B&P 2242.1(a). Section 2242(b) provides limited occasions on which the physician may prescribe without first conducting an appropriate examination.

Physicians using telehealth technologies to provide care to patients located in California must be licensed in California and must provide an appropriate prior exam to diagnose and/or treat the patient. Physicians practicing via telehealth 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.

  • California law also regulates prescription and dispensing of controlled substances. These issues are beyond the scope of this already lengthy memo, although they should certainly be further explored in connection with the Business Structure. See, as a start, CMB, Controlled Substance Prescription Form Requirements, and our further discussion under Compounding & Pharmacy Issues.

In general, if it’s good for marketing and makes easy money, it’s probably good to slow down and ask about consequences on the regulatory and enforcement side. Many legal rules are archaic – even if that means they are pre-20th century, or from the early days of the Internet, 2000-2005-ish.

A bit more background:

Telemedicine Legal Issues

The term “telemedicine” (or “telehealth”) can be used in different ways, and is often subject to different statutory or administrative definitions.

At the broadest level, telemedicine refers to any encounter between clinical personnel and a consumer of healthcare services that does not take place physically, in a face-to-face, in-person encounter. In a narrower sense, telemedicine can be used to refer to distant consultations in-state via the Internet (for example, to deliver medical services to rural populations).

Licensure

Typically, when a physician provides clinical services to a patient online or via a mobile app to a patient who is located in another state (the “Remote State”), that physician must be licensed both in his or her “Home State,” and, in the Remote State where the patient is located.

A physician who is not licensed in the Remote State could be charged with unlicensed medical practice in that state. A company that provides telemedicine services where physicians are deemed to be practicing in states where they are not licensed, could be charged with corporate practice of medicine, and/or, with aiding and abetting unlicensed medical practice; and, individual physicians could be at risk of practicing medicine without a license in the remote states.

Definitions of “medicine” vary by state, but generally involve such activities as diagnosing, treating, prescribing, or operating, for any human disease or condition. Statutory definitions tend to be broad. For example, California law provides that an individual practices “medicine” when he or she:

practices or attempts to practice, or … advertises or holds himself or herself out as practicing, any system or mode of treating the sick or afflicted in this state, or … diagnoses, treats, operates for, or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury, or other physical or mental condition of any person.

California law also explains:

Whenever the words “diagnose” or “diagnosis” are used in this chapter, they include any undertaking by any method, device, or procedure whatsoever, and whether gratuitous or not, to ascertain or establish whether a person is suffering from any physical or mental disorder. Such terms shall also include the taking of a person’s blood pressure and the use of mechanical devices or machines for the purpose of making a diagnosis and representing to such person any conclusion regarding his or her physical or mental condition.

Generally, providing information and education online does not constitute practicing “medicine,” but as the information becomes less generic and more personalized, it is a slippery slope—one where regulators can call a practice “medical” even if styled as “informational only.”

Disclaimers to which a user or patient agrees (either by signing or accepting an online agreement) regarding the nature of the information might possibly be effective as a defense against a negligence action by a patient, but will not necessarily serve as a defense to a medical board investigation or a district attorney prosecution for unlicensed medical practice.

Generally, many telemedicine services try to rely on such disclaimers in an effort to limit both forms of liability.

Telemedicine exceptions to the licensing requirement laws vary by state.

Typically, in broad terms, there are three variations:

  1. Home State Physician may not offer any medical services to Remote State Patient, unless Home State Physician is licensed in Remote State.
  1. Home State Physician may consult with Remote State Physician, but may not consult directly with Remote State Patient.
  1. Home State Physician may consult with Remote State Patient, provided Home State Physician obtains a “special purpose” or telemedicine license in Remote State.

There are additional variations, but as noted, we have not done a state-by-state analysis.

Exam

Even if licensure requirements are satisfied, in many cases state law is ambiguous about what kind of exam is required prior to: (a) treating a patient, or (b) prescribing medication for a patient.

Open questions often include:

  • What constitutes an “appropriate” or “good faith” exam for purposes of treatment, and, for purposes of prescribing?
  • What type of exam is appropriate or necessary for a given kind of telemedicine encounter? For example, is a history and physical exam required; must there be laboratory work; and how long should the visit be, at minimum? Does the answer depend on the type of medicine or patient condition (for example, easier for acute, dermatological conditions that can be diagnosed via photograph than for complex chronic conditions)?
  • Is asynchronous, store-and-forward review by appropriate medical personnel of patients’ digital photos, together with answers to pre-set online questions, sufficient, or is an in-person exam required?
  • Who can perform the initial exam? A Nurse Practitioner?
  • How often must the exam be conducted, if there is no significant change in the patient’s condition?

These questions are not always resolved by legal research, as they are too new and unresolved; although some states do distinguish prescribing over the Internet (also known as “e-prescribing”) from diagnosing and treating over the Internet. For example, in Arizona, “a physician cannot rely on a questionnaire submitted over the Internet” but rather must perform “an adequate work-up” including taking a reliable medical history, conducting an appropriate physical examination, and establishing a proper diagnosis for the medication being prescribed.

In California, “no person 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.” The California Medical Board (CMB) has a webpage on Internet Prescribing—Information for Physicians, expressing “concern about the legitimacy of prescribing drugs via the Internet.” CMB also has a webpage on Practicing Medicine Through Telehealth Technology, which states:

Physicians using telehealth technologies to provide care to patients located in California must be licensed in California and must provide an appropriate prior exam to diagnose and/or treat the patient. Physicians practicing via telehealth 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.

California law also regulates prescription and dispensing of controlled substances. These issues are beyond the scope of this already lengthy memo, although they should certainly be further explored in connection with Phase II and IIII. See, as a start, CMB, Controlled Substance Prescription Form Requirements.

In addition, one must consider the possibility of federal enforcement, particularly if the prescription of controlled substances is involved.

Under federal law, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 regulates online pharmacies, but specifically excludes the “delivery, distribution or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine.” However, certain definitions in the Ryan Haight Act reference obligations under state law.

A savvy telemedicine lawyer understands the many different areas of law that can apply to telemedicine companies and projects. The right telemedicine attorney also knows how to advise client on risk management, so both can assess liabilities without giving the business structure an automatic “no” (as many lawyers tend to do), but without giving an unambiguous green light either.

It may be a while before Rx drugs appear in your shopping mall kiosk. There are pharmacy laws to consider too, for example. One thing is sure, though: the market moves faster than regulators.

Contact our telemedicine, mobile medical app, wearable health tech, and FDA legal team for compliance counsel and strategic advice if you have a telemedicine venture, particularly if it involves prescribing online.

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Michael H Cohen Healthcare & FDA Lawyers

Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.

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