When Alex Azar, the Secretary of the Department of Health and Human Services (“DHHS”), declared a national emergency on January 31, 2020 in response to the COVID-19 pandemic, he triggered an exception to the “in-person medical evaluation” requirement for online prescribing as set forth in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”). In short, the Haight Act prohibits physicians and other prescribers from issuing a valid prescription for a controlled substance by means of the internet (which includes telehealth technologies) without having first conducted at least one in-person medical evaluation, except in certain specified circumstances. A public health emergency is one such exception to the in-person medical examination requirement.
As noted in our prior posts about telehealth and the Haight Act in particular – See, the July 10, 2017 and July 13, 2017 posts on this blog – although the Haight Act’s in-person medical evaluation requirement applies nationally through federal legislation, there are state restrictions that must be waived/limited in order for the federal Haight Act public health emergency exception to have a real impact on prescribers and patients.
In this article, we review the key elements of the federal in-person medical examination waiver and highlight state actions that are enabling on-line prescribing and thus allowing telehealth to serve as a robust tool promoting healthcare access while maintaining social distancing.
EXCEPTION TO HAIGHT ACT’S IN-PERSON MEDICAL EXAMINATION REQUIREMENT
On March 16, 2020, Secretary Azar issued a statement regarding the Haight Act’s online prescribing requirements in which he noted that the public health emergency exception to the in-person medical examination requirement would apply to both non-scheduled controlled substances and all Schedule II-V controlled substances for the duration of the COVID-19 public health emergency so long as the following requirements were met:
- the prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice;
- the telemedicine communication occurs using an audio-visual, real-time, two-way interactive communication system; and
- the practitioner is acting in accordance with applicable Federal and State laws including, without limitation, the applicable Drug Enforcement Agency (“DEA”) regulations.
STATE ACTION – ONLINE PRESCRIBING
As noted in our prior online prescribing blog posts referenced above, for several years prior to the current public health emergency states have been moving towards loosening telemedicine prescribing restrictions. In response to Secretary Azar’s Haight Act statement, state action has escalated, with many states permitting some form of online prescribing or loosening prescribing requirements during the COVID-19 emergency. Such states include, but are not limited to, the following:
- Alabama. The Alabama State Board of Medical Examiners and the Alabama State Board of Pharmacy released a joint notice of enforcement discretion stating that coextensive with the DEA’s guidance, both entities will not impose penalties for noncompliance with state controlled substance-related regulatory requirements on health care providers who, in good faith, utilize telemedicine to care for their existing patients during the public health emergency.
As a result of the above action, the Boards will not enforce (i) the State requirement that a physical in-person examination precede the issuance of a prescription for a controlled substance for chronic pain; (ii) the State’s prohibition against telephonic prescription orders of Schedule II pharmaceuticals when the prescriber is unable to otherwise use electronic prescribing; and (iii) the DEA requirement that a prescriber send a hard copy of a prescription to a pharmacist within 7 days of the prescriber’s electronic submission of a prescription to the pharmacy. As an alternative to the DEA requirement, Alabama is following the DEA’s recommendation that a prescriber be required to provide a prescription (via mail, fax, photo or scan) to a pharmacist no later than 15 days after the drug is prescribed. Alabama intends to maintain these exceptions until the earlier of the end of the state’s emergency or at the direction of the DEA.
- Delaware. The Delaware Board of Health Professions released a Telehealth Letter to Pharmacists, expanding upon the Governor’s March 18, 2020 Emergency Declaration, which suspended any requirements that necessitated in-person contact before telemedicine services could be provided. With this expansion, if a practitioner is otherwise authorized to prescribe controlled substances (they have prescriptive authority, hold an active DEA number, etc.) they may prescribe controlled substances through telehealth during Delaware’s State of Emergency. This Letter suspends the Board of Medical Licensure & Discipline’s regulations prohibiting the prescribing of controlled substances by telehealth.
- Georgia. On March 19, 2020, Georgia’s Medical Board issued an Emergency Rule allowing DEA-registered practitioners to issue prescriptions for controlled substances via an audio/visual telemedicine platform without an in-person medical evaluation, so long as certain conditions enumerated in the Emergency Rule are met. In this way, the Emergency Rule suspends the prohibition against prescribing controlled substances for a patient based solely on a consultation via electronic means, and against providing treatment to a patient via electronic means without a physical examination by a Georgia licensee. This rule lasts for the duration of the public health state of emergency.
- Indiana. Pursuant to an Executive Order on March 30, 2020, Indiana’s governor authorized prescribers, who are also DEA-registered practitioners, to issue prescriptions for all Schedule II-V controlled substances to patients for whom they have not conducted an in-person medical consultation, provided that the DEA requirements have been met. This Executive Order came only four days after the governor had initially limited online prescribing of controlled substances to established patients using opioids for chronic conditions. Typically Indiana allows online prescribing without the initial in-person meeting for non-controlled substances, as long as certain conditions are met.
- Vermont. Vermont’s Board of Pharmacy set Emergency Guidance, most recently updated on April 10, 2020, clarifying Vermont’s policies, interpretations and recommendations to address the COVID-19 pandemic. As described by the Board of Pharmacy in the Emergency Guidance, Vermont generally prohibits a prescriber from writing a prescription for a patient unless the prescriber and the patient have an established relationship that is not based solely on an online consultation. Under the Emergency Guidance, remote consultation by a prescriber who has no previous relationship with a patient may be “legitimate” during a declared state of emergency so long as the pharmacist receiving the prescription is comfortable that: (1) the prescriber is lawfully authorized to prescribe; (2) the prescriber collected from the patient, whether in-person or otherwise, information adequate to assess the patient’s fitness for the pharmacotherapy ordered; (3) the prescriber appears to have exercised responsible professional discretion when prescribing the medication at issue; and (4) the prescription otherwise passes drug-utilization review.
STATE PHARMACY WAIVERS – BEYOND ONLINE PRESCRIBING
In addition to taking action to clear the path for online prescribing, many states have also been issuing pharmacy-related waivers and guidance favoring social distancing at bricks-and-mortar pharmacies. For example:
- Alabama. In guidance dated March 13, 2020, the Alabama Board of Pharmacy implemented remote order verification allowing pharmacists to use secure technology to process and verify prescriptions without having to be physically present at the pharmacy. As result, pharmacists in Alabama can now interpret prescription orders, perform drug utilization review, obtain refill and substitution authorizations, and provide clinical drug information about prescriptions without having to be in the pharmacy. The relevant Alabama regulations were officially amended effective March 20, 2020 to reflect the March 3, 2020 guidance.
In further guidance dated March 17, 2020, the Alabama Board of Pharmacy (i) waived the requirement that patients sign prescription receipts when picking up their medication; and (ii) encouraged pharmacies to practice social distancing, including through the use drive-through windows and curbside assistance when possible.
- Kansas. In guidance from April 14, 2020, which also discusses online prescribing of controlled substances, the Kansas Board of Pharmacy stated that it will temporarily allow pharmacy employees, licensed and registered with the Board, to work on discrete tasks remotely. However, the employees must meet certain requirements, such as possessing secure electronic access to the pharmacy processing software. The Board also set forth additional requirements depending on whether the employee at issue is a pharmacist, technician or intern. While technicians may perform certain tasks, such as data and order entry, refill and insurance processing, or contacting patients remotely, there are certain activities, such as contacting prescribers, that they may not perform while away from the pharmacy. Additionally, technicians must maintain communication capabilities with a supervising pharmacist who must be located at the pharmacy. The guidance also discusses best practices, such as curb-side pickup, distancing in line, and using a counter extension to increase the distance between the customer and cashier at the pharmacy.
- California. Effective April 1, 2020, the California Board of Pharmacy revised California’s oral consulting requirements, allowing the pharmacist in charge to make the determination as to whether oral consultation with a patient about his or her prescription would put the public or personnel at risk for exposure to COVID-19. Typically, a California pharmacist must ensure that his or her patient receives an oral consultation regarding the prescription being dispensed (a) upon request or when the pharmacist deems necessary, as well as (b) whenever the drug is being dispensed to the patient for the first time or in a new form (such as in a higher dosage). Until July 1, 2020, however, a pharmacist may decide to waive the oral consultation entirely as long as certain conditions are met. Most prominently, the pharmacist must provide the patient with verbal or written notice of his or her right to consultation, provide the hours and phone number the physician must be reached, and ensure a pharmacist is readily available to speak to the patient or patient’s agents during regular hours of operation.
In addition, effective March 18, 2020, the California Board of Pharmacy expanded the range of pharmacy activities available under remote processing to include such tasks as order and data entry, and insurance processing of prescriptions and medication orders under remote supervision. To be provide proper supervision, the supervising physician must be readily available to answer questions and verify the work performed by the pharmacy intern or technician. Pharmacists performing remote processing may also “receive, interpret, evaluate, clarify, and approve” medication orders and prescriptions, including those for Schedule II, III, IV, or V controlled substances. This portion of the waiver also newly allows pharmacists to interpret clinical data and authorize the release of medication for administration while away from the pharmacy.
- South Carolina. On March 23, 2020, South Carolina’s Board of Pharmacy released an Emergency Order providing temporary authorization for the use of automated pharmacy pick-up kiosks in order to reduce face-to-face contact during prescription pick-up. Those electing to use such kiosks must notify the Board Administrator, and may only use certain pre-approved kiosks. Those permitted to use the kiosks must also document any errors experienced and appear in front of the Board of Pharmacy within six (6) months after the state of emergency is completed.
Similar to other states, South Carolina also suspended its typical prohibition on remote order entry, i.e. the processing of prescriptions and medication orders from a non-permitted site, with certain conditions. Namely, pharmacy personnel engaging in such actions must be licensed in South Carolina. In addition, the pharmacy engaging in such remote order entry must develop policies and procedures delineating the responsibilities of personnel engaged in remote activities, provide such personnel with access to a common electronic file with sufficient patient information necessary for prospective drug use review and approval of medication orders, and develop mechanisms to ensure that such remote order entry is conducted in compliance with federal, state and local laws.
- West Virginia. In West Virginia, the Insurance Commissioner released an Emergency Declaration on March 27, 2020, permitting pharmacies to deliver prescribed medications, pharmacy supplies, and pharmacy products to patients via common carrier, mail delivery, or other home delivery methods if the pharmacy elects to do so. Importantly, the Commissioner stated that certain entities, including insurance companies and various payors, may not enforce contractual terms with pharmacies that prohibit such pharmacies from delivering medications. Additionally, the Emergency Declaration prohibits such insurance companies and payors from refusing to reimburse and from recouping for payments already made to pharmacies for medications or supplies delivered in this manner.
In considering the steps required to compliantly engage in online prescribing, providers may also reference a useful flow chart, created by the DEA, on methods of prescribing controlled substances to patients here. While the chart does not cover state-by-state requirements, many states have referenced this chart as useful guidance to follow during the emergency, and it offers a clear starting point for providers navigating new flexibilities. We are also available to discuss your specific questions about new and state-specific flexibilities and to help in developing processes and procedures that will best serve your organization and your patients.
This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand. This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.
*This alert is provided for information purposes only and does not constitute legal advice and is not intended to form an attorney client relationship. Please contact your Sheppard Mullin attorney contact for additional information.*