California’s Electronic Prescription Requirement Overview
The requirements for electronic prescriptions in California are more than just a recommendation, or even a guideline; they are now mandated by state law. Effective January 1, 2019, California practitioners must generate a patient’s prescription electronically unless a specific exemption applies. This requirement is a result of the passage of Assembly Bill 2760 ("AB 2760") and, while it is already in effect, the date by which all practitioners must comply with the mandate to issue electronic prescriptions is subject to a phased approach that varies based on the type of prescriber and the prescription(s) they issue.
California Business & Professions Code section 4160.2 is commonly referred to as California’s "e-prescribing" law. It requires virtually all licensed physicians, physician assistants, nurse practitioners, dentists, podiatrists, optometrists, veterinarians and pharmacists to issue prescriptions electronically with limited exceptions.
According to the state legislature, AB 2760 was intended to "prohibit the state Department of Justice from requiring a specific type of electronic prescription system that a prescriber must use," and to "permit the prescribing practitioner to determine what electronic prescribing technology to use, including an eversion that operates without any other electronic health record technology . " The law does not require providers to use their own electronic health record systems or otherwise streamline their practices.
The e-prescribing law applies to a prescription for a drug that is issued electronically and then dispensed in California, regardless of where the prescriber practices medicine. This law does not, however, apply to a practitioner who writes a prescription that is given to a patient to be filled outside California (unless the prescriber also routinely practices in California).
There are a number of exceptions to the electronic prescribing mandate for which there is no deadline by which the practitioner must comply. Prescribers do not have to issue electronic prescriptions if a patient has been issued a written or telephonic order for a drug in a licensed care facility on or within a certain number of days before the time when the practitioner issues an electronic prescription. There are also several clear exemptions from the electronic prescribing mandate for prescribers and veterinarians who are not subject to the law, and for any prescribes who obtain a waiver from the Department of Justice.
Who Must Comply: A List of Affected Entities
The California statute applies to prescribers, which include physicians and surgeons, podiatrists, dentist, optometrists, and naturopaths, as well as health care facilities, including clinics, hospitals, and skilled nursing. A "prescriber" is "any person who is authorized by law to issue a prescription and who is licensed by the appropriate licensing authority. . ." Prescribers may not show "good cause" for not complying with the mandate "unless medical reasons exist for not issuing electronic prescriptions." Cal. Bus. & Prof. Code § 4160(d)(2). Additionally, any prescriber or clinic that "fails to comply with this section" may be subject to a fine not to exceed $5,000 for each prescription not issued in compliance with the statute. Cal. Bus. & Prof. Code § 4170.
While whether a prescriber is a natural person will be self-evident in most cases, that question is not so easy when applied to a health care facility, such as a hospital, or a prescriber employed by a health care facility. In September 2018, the California Medical Association ("CMA") submitted a letter to the Medical Board of California and the Osteopathic Medical Board of California asking for clarification on the statute’s impact on multi-physician practices and hospital medical staffs. The CMA recommends that "the prescriber’s duty to electronically prescribe is separate and apart from the duty of the clinic, hospital or medical group" (hereinafter, "physician employer") to have an e-prescribing system available. Such a requirement, the CMA argues, places the onus for compliance on a single physician – the one who fails to comply – rather than on the physician employer’s practices and policies. Noting that establishing policy and procedures for the implementation of technology and training employees in its use, is a burden that is typically placed on the employer, the CMA is concerned that "the culture of this responsibility should not change simply because of the presence of an e-prescribing system." As such, the CMA contends:
"Neither California Business and Professions Code § 4160, nor the directives from the Medical Board of California, intend to place the burden on individual physicians who independently choose to work in a facility that has or has not adopted an e-prescribing system and made that system available in the course of their employment."
Given that the statute does not define "prescriber" and that there is no enforcement mechanism for physicians employed by entities other than clinics and hospitals, it is likely that, in practice, the statutory duties may only be enforced against prescribers who are natural persons. Accordingly, unless and until the Medical Board of California or the Osteopathic Medical Board of California determines otherwise, it is our recommendation that multi-physician practices and hospital medical staffs not be held to the e-prescribing mandate.
Basic Requirements for Electronic Prescribing
In addition to meeting the general requirements for prescriptions, electronic prescriptions must also be accompanied by a number of specific features to ensure the safety and security of the documents. For electronic prescriptions to be valid in California, among other things, the software must be capable of: An electronic signature associated with each prescription provides a means of electronically signing, sealing and authenticating a prescription electronically (signature/software requirements for the pharmacist are found in Business and Professions Code Section 4160.7, and the purported electronic signature is defined in Penal Code Section 631(k)). A strong authentication credential issued by a certification authority (or equivalent technology) such as a smart card, biometric, or one-time password must also be used with the software to ensure standards for protected health information (PHI) and tamper safeguard requirements are met. The pharmacy must be able to demonstrate appropriate security procedures when handling PHI. For evidence of proper security procedures, the Department of Justice, Health and Human Services, and certain other state agencies, as well as the vendor’s management, must be able to inspect the source code and the electronic signature key under exigent circumstances. The software must also include standards that are specifically designed for electronic prescribing and for the pharmacy receiving the prescription (including if a hard copy or fax copy is required). The system must ensure that the pharmacy can record and print a copy of the prescription upon dispensing. It must also require the prescriber to include alone or in combination with the prescriber’s name, office address and telephone number: The prescriber’s name and office address must be recorded by the system while the prescriber is present and enrolled in the system. The prescriber must also approve content, if possible, in the electronic system prior to making it available for use. Additionally, the pharmacist must record the following on the hard copy if permitted by the prescriber: The system must ensure that the pharmacy can record and print a copy of the prescription upon dispensing. It must also require the prescriber to include alone or in combination with the prescriber’s name, office address and telephone number: The prescriber’s name and office address must be recorded by the system while the prescriber is present and enrolled in the system. The prescriber must also approve content, if possible, in the electronic system prior to making it available for use. Additionally, the pharmacist must record the following on the hard copy if permitted by the prescriber: To prevent a user from gaining access through another medium, the signature credential must be: The system must encrypt electronic prescriptions using at least a 128-bit length key and must retain a copy of each prescription in its native electronic format. The system must also store all prescriptions for 180 days if they are transmitted to the pharmacy and associated with the pharmacy’s unique identifier unless the issuer of the software determines that it would not be appropriate for security and privacy reasons to do so.
Exemptions from Requiring Electronic Prescriptions
Exceptions to the requirement for prescription-only and over-the-counter medications to be done primarily via electronic means are the following:
(a) A healthcare practitioner may authorize another person to enter a manually written prescription into the computer system of the provider’s practice service in a situation where the practitioner is acting with good faith to remedy the failure in the provider’s electronic prescription system.
(b) Unforeseen technological or electrical failure of an electronic health record system prevents the prescription from being generated electronically and sent to the pharmacy for a period of time that the healthcare practitioner, exercising his or her best judgment, determines is beyond 24 hours. The unsuccessful attempt at electronic transmission of the prescription shall be documented in the patient’s paper or electronic record.
(c) In all situations or circumstances when a healthcare practitioner is reasonably unimpaired by an emergency situation, the healthcare practitioner shall generate the prescription in an electronic format with the exception of circumstances where the provider’s electronic health record system has known deficiencies as described in paragraph (2) of subdivision (A) (Section 1756.56) and override the default settings to allow for a manually written prescription. Emergency situations include, but are not limited to, situations where the:
- (1) Recipient of a controlled substance is in the emergency room, the surgeon’s office, or the hospital for surgery.
- (2) Prescriber is using an electronic pharmacy device that is not compatible with the electronic health record and the record cannot be modified.
- (3) Prescriber is performing a procedure in which the prescriber cannot use a device and the interoperability of the prescriber’s electronic health record system and the pharmacy’s electronic records would be compromised.
- (4) Prescriber does not have adequate coverage due to unforeseen circumstances and needs to write a prescription.
- (5) Prescriber does not have internet access and therefore cannot utilize a wireless prescription system.
- (6) Prescriber is obtaining prescriptions on behalf of patients in acute care hospitals and in other emergency situations.
Benefits of Having an Electronic Prescription
The move to electronic prescriptions (e-prescriptions) is another step forward in the growth of digital technology in healthcare. As more providers and patients embrace technological advances, the benefits of e-prescriptions have proven relevant at every stage of the prescribing process. As part of the push for more accessibility, electronic prescribing allows for immediate distribution of a prescription to the pharmacy of choice for the patient. Software pathways ensure that prescriptions are received and routed directly to pharmacies within minutes of receipt by the physician. Whether a patient is picking up a medication at a local pharmacy or filling a prescription through a mail-order provider, e-prescriptions provide immediate availability for pick-up or fulfillment. In addition to faster distribution to pharmacies, the information contained in a digital prescription is easier to access and track when held within an electronic health record (EHR). Rather than sifting through illegible, hand-written notes and faxed prescriptions, providers can quickly pull up a patient’s active medications and allergies when establishing new patients . For many providers, this is an integral step in preventing drug interactions and other adverse medical impacts. It also creates a more spot-on picture of a patient’s needs and history, which can assist with diagnosis and treatment. Tonight’s safety-first approach to patient care is encouraged by e-prescriptions that reduce the occurrence of human error and miscommunication. Over 120,000 Americans die each year due to medication errors, and e-prescriptions help to eliminate many of the common points of error associated with traditional methods. When a physician or NP prescribes medication in an EHR, the system automatically checks for potential interactions and flags those that may cause undesirable effects. E-prescribing also creates clear safeguards for the physician’s office staff when fulfilling prescriptions in an ever-dynamic medical environment. Confusion over faxed prescriptions is avoided and the time lost from phone calls, faxes and scanning is diminished. The result is a more streamlined workflow that maintains safety as priority number one.
Challenges of Switching to an Electronic Prescription
With this experience in mind, it is not surprising that many healthcare providers have found that the implementation of an electronic prescription system has been more difficult than they had expected. Common challenges have included the following:
- (1) Initial confusion over the requirements and whether their existing systems or medical software were compliant with the new and continuing regulations (this blog post is intended to help clarify these requirements).
- (2) Initial concerns over the need to change to a new or different data hosting and storage system and the costs associated with such change.
- (3) The cost of acquiring any new equipment or software necessary to implement the electronic prescribing and electing whether the business should lease or purchase such equipment or software.
Many physicians will find that their current electronic records systems are already compatible with the new requirements by virtue of the fact that they have been required to implement electronic prescriptions for controlled substances (the DEA required such systems to be in place by June 1, 2010). Those physicians who were not aware of the changes may wish to reach out to their software or hardware vendors for help in that regard. For those physicians who were not previously required to implement an electronic prescription program, their vendors will be instrumental in ensuring that their existing systems are compatible. However, issues may arise if the issue of whether or not a physician’s electronic record system was compliant with the prior requirements was not made clear to them by their vendor.
Most often, physicians will be able to incorporate any changes required within their existing infrastructure. There should be no need to invest additional money in acquiring new systems or equipment. If substantial changes are going to be required, physicians should be aware that they may be able to seek some funding from their local health policy commission in order to offset those costs.
How to Get Started with Electronic Prescribing
Electronic prescribing isn’t as simple as simply buying a program and installing it – you also need to consider the workflow for how prescriptions are written and refilled in your practice. You’ll also want to ensure that your hardware and software are HIPAA-compliant; many standalone prescription programs aren’t. Wireless mobile devices, if used for e-prescribing, also require secure passwords and an inability for messages to be forwarded to or from mobile devices like smartphones and tablets. Some steps you can take to start the transition to electronic prescribing include: 1) Determine your needs, so that you can pick software that fits those needs. Considerations might include whether you want the software to work with an existing practice management solution or be a standalone system; whether or not modules will work with your existing electronic medical records. Consider also what kind of prescribing you want it to do – drug interaction checking, prescription renewal requests, allergies monitoring, medication history. 2) Once you’ve decided on what features you want in an electronic prescribing module and what you need to make it work within your practice, determine how that will fit into your existing workflow. Will staff need to be trained in how to use the new system? Will doctors and NPs? Will the program be easy to use with your existing systems? 3) Once you’ve picked a solution, you’ll need to configure it, which may involve customizing some of the fields if it’s a standalone program, or ensuring that the program can integrate well with all the various solutions you probably have (more on that later). If you end up making lots of changes, you’ll want to have procedures in place for everyone to follow for every prescription, so there aren’t any gaps that end up compromising patient safety or security. 4) After you have your program configured, have everyone spend a week or two just using it without their usual information to see how well it works, and if there is anything that they find confusing or cumbersome. Our goal here is to try to find out if any problems you’ll run into with the standard configuration before you’re reliant on it day-to-day. 5) Once the program passes muster, ensure that doctors and NP’s are trained in the system. You could even interview patients as to whether they would be willing to let the doctors look/enter information about medications into their own devices. 6) Start counting down to the start date…
What is it: Future Outlook of Electronic Prescriptions
Future trends in electronic prescription technology will likely include increased adoption of mobile applications by patients for medication management, expanded pharmacy participation in electronic prescription networks, greater use of digital health tools that auto-generate prescriptions based on biometric data, and a continued push towards interoperability between EHR platforms and other health information technology. In addition, large prescription benefit managers (PBMs) are increasingly integrating into the electronic prescription process by enhancing their ability to manage drug formulary lists and incentivize the use of lower-cost alternative medications (e.g., through text alerts , desktop alerts) in real-time. There are also a number of "home delivery pharmacies" where medications can be delivered electronically directly to a patient’s home. These pharmacies, which include those operated by Cigna, Wellmark Blue Cross, and Evio Pharmacy, mean that pharmacies are becoming distributed patient-centered medical homes. As mentioned above, California law allows for an "e-prescribing network" by which pharmacies can connect across many of the barriers that have been used as a reason to avoid 100% adoption, including differences in EHR systems. As these new technologies are adopted, it will be important for the California legislature and regulators to clarify and streamline the law and regulations governing e-prescribing.