One of the major changes in California pharmacy law in 2018 is the introduction of a new pharmacy type – “a remote dispensing site pharmacy.” Such pharmacies must use telepharmacy system (internet and teleconferencing) to reach critical population in medically underserved areas and dispense less than 225 prescriptions per day. The new law authorizes the California State Board of Pharmacy to issue specific permits for these dispensing sites-pharmacies. As of the date of this writing, however, the Board has not made the application process available on its website.

The main feature of a remote dispensing site is the ability to operate without a pharmacist being present. A registered technician may order dangerous drugs/devices – even controlled substances – and sign for the delivery. A caveat: any controlled substances signed for by a pharmacy technician must be stored separately from the existing inventory until they are reviewed and countersigned by a pharmacist.

What is a remote dispensing site pharmacy?

A remote dispensing site pharmacy is a dispensing location without a pharmacist, but which has a pharmacist available through telepharmacy technologies to supervise dispensing and to counsel patients.

A registered pharmacy technician may work at a remote site and to perform order entry, packaging, manipulating, repetitive, and other nondiscretionary tasks. A pharmacist at a supervising pharmacy must supervise the technician through telepharmacy system – such as videoconferencing – by visually monitoring the technician’s work to ensure that the right medications have been filled and dispensed. At the end of the process, the supervising pharmacist provides a two-way video consultation for the patient to ensure that they understand the intended medication use and administration. The supervising pharmacist may supervise up to 2 pharmacy technicians at each remote dispensing site in addition to any technicians being supervised at the originating pharmacy.

TelePharmacy in Other States

TelePharmacy in retail settings has primarily occurred in rural states with pharmacist shortages.

For example, in response to an increasing number of rural community pharmacies going out of business, North Dakota became the first state to allow retail pharmacies to operate without requiring a pharmacist to be present. As a result of these new rules, more than 56 remote sites enabled delivery of pharmacy services to 80,000 rural residents who lost access to pharmacy due to a massive pharmacy shut down. According to a North Dakota State University study, telepharmacy project “has restored access to health care in remote, medically underserved areas and added approximately $26.5 million in economic development to the local rural economy.”

What is TelePharmacy?

The National Association of Boards of Pharmacy defines “telepharmacy” as “the provision of pharmaceutical care through the use of telecommunications and information technologies to patients at a distance.” In a nutshell, telepharmacy delivers clinical pharmacy services and the dispensing of a prescription at a remote location without the physical presence of a pharmacist.

You might be performing TelePharmacy services, if you perform the following:

• Mail Order (home delivery and central fill)

• Telephonic patient counseling

• Compliance and collaborative Drug Management

• Central processing & remote order entry

• Remote supervision of technician dispensing

• Automated dispensing systems

• Medication kiosks with 24/7 counseling

• Texting to patients: refill reminders, auto-deliveries, medication tracking

• Online chats & counseling.

Potential issues with TelePharmacy

While TelePharmacy may sound as a tremendous opportunity to expand pharmacy business into rural areas and solve some of the access to care issues, TelePharmacy – as any TeleHealth –  is prone to an array of legal issues. Below I discuss just a few of them.

Privacy and Security:  

TelePharmacy involves the transmission of personal and health-related information over the Internet. Security of information becomes a concern because it is essential to keep this huge transfer of data under control. Prior to engaging in telepharmacy, providers must ensure that they have secure communication channels, implement business associate and other confidentiality and privacy agreements, educate administrators and users regarding the appropriate use of telemedicine technologies, and analyze whether they are fully compliant with HIPAA and state medical confidentiality laws.

Informed consent:

A remote dispensing site pharmacy must obtain an informed consent from a patient using its services. Such consents must be carefully drafted and include consent to the risks of TelePharmacy, including delays, equipment failures, and possible security breaches.

Malpractice Insurance:

There is a widespread assumption that TelePharmacy (or any telehealth provider) – may potentially be exposed to increased malpractice risks, particularly in matters of procedure and duty of care concerns. Pharmacies involved in a telepharmacy arrangement should ensure that a professional liability insurance policy is in place and actually affords coverage for telemedicine services. If your policy is silent on telepharmacy or telemedicine, seek a written confirmation.

Reimbursements:

Some third-party payors may be unfamiliar with regulations and business aspects of TelePharmacy and may deny certain claims coming from dispensing sites-pharmacies. There is no solid industry guidance on whether a remote dispensing site pharmacy should apply for a new contract or may bill under the same NCPDP as the supervising pharmacy.

In addition, TelePharmacy arrangements are not immune from Anti-Kickback and False Claims enforcement. Anti-kickback laws provide that it is a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce referrals of items or services reimbursable by any federal health care program. In the context of TelePharmacy, such issues may arise in discounted or free equipment or technologies, as well as offering kickbacks to a referring site. The False Claims Act prohibits knowingly submitting or causing to be submitted false or fraudulent claims for payment or false statements or certifications to the government. In the TelePharmacy context, if a pharmacy is not complying with all state regulations on proper operation of a remote dispensing site, it may subject itself to false claims enforcement. It’s beyond the scope of this post to delve into anti-kickback laws and false claims act enforcement in the context of TelePharmacy – it should be a subject of a completely new (and a lengthy) post.

While Telepharmacy may positively impact access to care in California, providers should scrutinize legal and business sides of the arrangement and take extreme care when applying for a permit for a remote dispensing site. During the operation of a remote dispensing site, pharmacists should prioritize record-keeping for both sites (dispensing and supervising), assuring compliance with state and federal laws for both locations.