New Requirements on Opioid and Controlled Substances Prescribing and New Allowance for Remote Dispensing Sites for Treatment of Opioid Use Disorder

Change of Law: Hospital Action Required

To:	Hospital Chief Executive Officers, Chief Medical Officers, Legal Counsel and Government Affairs Staff
From:	Jaclyn Greenberg, JD, LLM | Policy Director, Legal Affairs JaclynG@wsha.org | (206) 216-2506
Subject:	New Requirements on Opioid and Controlled Substances Prescribing and New Allowance for Remote Dispensing Sites for Treatment of Opioid Use Disorder

Purpose

The purpose of this bulletin is to inform hospitals about new deadlines for important changes related to the prescribing of opioids and controlled substances:

• The Prescription Monitoring Program (PMP) Electronic Health Records (EHR) integration mandate has been extended and is now effective September 30, 2021 (originally January 1, 2021).
• The electronic prescribing of controlled substances requirement has been extended and is now effective September 30, 2021 (originally January 1, 2021).
• The requirement for dispensers to submit information to the PMP “as soon as readily available, but no later than one business day from the date of distribution” is effective January 1, 2021.

While these changes do not go in effect until 2021, hospitals will need to plan ahead to comply with these mandates. Further waivers beyond September 30, 2021, for the PMP-EHR integration or electronic prescribing mandates will also be available if certain narrow conditions are met (discussed further below).

This bulletin also contains information on a new law allowing certain pharmacies to add remote dispensing sites to their existing pharmacy license where technology, such as automated drug dispensing devices, is used to dispense medications for the treatment of opioid use disorder. This law is in effect now.

Applicability/Scope

The new laws related to opioid prescribing include two requirements that directly impact opioid and controlled substance prescribing practices and processes at hospitals and one option specifically relating to pharmacies that dispense opioid use disorder medication. Specifically:

• PMP-EHR integration. The provisions governing the integration of the state’s Prescription Drug Monitoring Program (PMP) with electronic health records (EHR) systems apply to all facilities, entities, offices, and provider groups with 10 or more prescribers that use a federally certified EHR system. Critical Access Hospitals as defined in RCW 74.60.010 are exempt from these provisions.

• E-prescribing mandate. The electronic prescribing requirement applies to prescriptions for a controlled substance included in Schedules II through V, or refills for a controlled substance included in Schedules III through V, with certain exceptions (see more information below).

• Remote dispenses. The allowance for remote dispensing sites applies to pharmacies licensed under RCW 18.64.

Recommendation & Next Steps

1. Review this bulletin and the new laws.
2. If your hospital does not already have a method for complying with the requirements for electronic prescribing of controlled substances, determine next steps with your technology department. If necessary, plan to seek a waiver from DOH for this requirement.
3. Work with your hospital’s EHR system vendor to ensure that the system will meet requirements to integrate with the PMP. If necessary, plan to seek a waiver from DOH for this requirement.
4. Watch for more information coming from DOH regarding the rules governing the waiver process for both the integration and electronic prescribing requirements.
5. Watch for more information from the Pharmacy Quality Assurance Commission regarding standards for remote dispensing sites to increase access to medications used to treat opioid use disorder.

Overview

In 2019, the legislature passed SSB 5380, an omnibus bill aimed at addressing the opioid crisis through improved access to treatment and reduced stigmatization of medications used to treat opioid use disorder. Many of the bill’s provisions remove regulatory barriers to encourage treatment and ensure access. Among these changes are two requirements that directly impact opioid prescribing processes for hospitals: integration of PMP data in to EHR platforms (codified at RCW 70.225.090) and electronic prescribing for certain controlled substances (codified at RCW 69.50.312).

In 2020, the legislature passed SSB 6086, which allows pharmacies to extend their license to remote dispensing sites. This is to facilitate and improve access to medications used to treat opioid use disorder.

1. PMP-EHR Integration mandate

RCW 70.225.090 creates a mandate for all facilities, entities, offices, and provider groups[1] with 10 or more prescribers that use a federally certified EHR system to integrate with the state’s PMP. These entities must demonstrate that the EHR system is able to fully integrate data to and from the state’s PMP. This requirement was set to go into effect on January 1, 2021, however in recognition of the impact COVID-19 has had and continues to have on health care providers, the Department of Health (DOH) issued a temporary nine-month blanket waiver delaying the  requirement through September 30, 2021. Note: The integration mandate does not apply to critical access hospitals.

RCW 70.225.090(2)(b) also contemplates additional individual waivers. It directs DOH to develop a process for entities to seek an individual waiver due to economic hardship, technological limitations that are not reasonably in the control of the facility, or other exceptional circumstances. Rulemaking related to the waiver process is ongoing, but individual waivers are limited to a one-year timeframe. WSHA is actively engaged in this rulemaking and will provide updates as they are available.

RCW 70.225.090(3) places limits on EHR vendors in respect of pricing the integration, by prohibiting EHR vendors that are fully integrated with the PMP from charging an ongoing fee or a fee based on the number of transactions or providers. The law stipulates that the total cost of connection may not impose unreasonable costs on the facility or other entity and must be consistent with current industry pricing structures.

Effective January 1, 2021, under RCW 70.225.020, dispensers are required to submit information to the PMP “as soon as readily available, but no later than one business day from the date of distribution, in accordance with transmission methods established” by DOH.

Finally, RCW 70.225.090(1) requires DOH to collaborate with stakeholders including health professionals and facility associations, such as WSHA, to facilitate PMP-EHR integration. WSHA, together with the Washington State Medical Association (WSMA), advocated strongly for this provision with the intent of obtaining federal funds to assist with PMP-EHR integration efforts. The process has not resulted in funding to date but other resources to assist integration efforts are continuing to be developed. WSHA will share those resources as they become available.

2. Electronic prescribing for controlled substances

RCW 69.50.312 will require that prescriptions for Schedule II through V controlled substances, or refill authorizations for a controlled substance included in Schedules III through V controlled substances be electronically communicated to pharmacies. Violation is subject to a civil penalty of $250 per violation, up to $5,000 per calendar year.

This requirement was set to go into effect on January 1, 2021, however in recognition of the impact COVID-19 has had and continues to have on health care providers, the Department of Health (DOH) issued a temporary nine-month waiver through September 30, 2021.

The e-prescribing mandate is subject to several exemptions, including:

• Prescriptions issued for a patient in a long-term care facility, as defined in RCW 18.64.011, or a hospice program as defined in RCW 18.64.011;
• When the electronic system is unavailable due to a temporary technological or electronic failure;
• When the prescriber and pharmacist are employed by the same entity or entities under common ownership or control;
• Prescriptions that are intended to be dispensed out of state;
• Prescriptions issued for a drug that the FDA or DEA requires to contain certain elements that are not able to be accomplished electronically;
• Any controlled substance prescription that requires compounding as defined in RCW 18.64.011;
• Prescriptions issued for nonpatient specific prescription under a standing order, approved protocol for drug therapy, collaborative drug therapy agreement, in response to a public health emergency, or other circumstances allowed by statute or rule where a practitioner may issue a nonpatient specific prescription;
• Prescriptions issued under a drug research protocol;
• When the practitioner reasonably determines it is impractical for the patient to obtain the electronically communicated prescription in a timely manner, and such delay would adversely impact the patient’s medical condition; or
• Prescriptions issued by a prescriber who has received a waiver from the department.

A pharmacist that receives a written, oral, or faxed prescription is not required to verify that an exemption applies prior to filling the prescription. They may continue to dispense and deliver medications from otherwise valid written, oral or faxed prescriptions.

Like the PMP-EHR integration mandate, DOH may provide individual waivers for the electronic prescribing mandate due to economic hardship, technological limitations outside the practitioner’s control, or other exceptional circumstances. Rulemaking related to the waiver process is ongoing, but facilities may note that the law contemplates that such waivers are limited to a one-year timeframe.

Systems used for electronic communication of prescribing information must meet several standards including:

• Complying with applicable federal laws and rules;
• Maintaining adequate security and systems safeguards to prevent and detect unauthorized access;
• Modification or manipulation of these records;
• Allow an explicit opportunity for practitioners to indicate their preference regarding generic drugs; and
• Be able to input and track partial fills of a controlled substance.

3. Other changes under SB 5380 related to opioid treatment, prevention and services

In addition to the electronic prescribing and PMP-EHR integration mandate, SB 5380 contains several other important provisions to address the opioid epidemic. These other provisions include:

• A directive for the Secretary of Health to issue a standing order for naloxone.
• New provisions clarifying the confidentiality of PMP data, and the purpose of authorized disclosure of PMP data for quality improvement purposes. These provisions have subsequently helped WSHA in its quality improvement efforts with prescribers.
• Requirement that health plans to cover at least one FDA-approved product for the treatment of opioid use disorder without prior authorization.
• Direction to state agencies and Medicaid managed care organizations to promote access to medication assisted treatment in opioid treatment programs.

4. Authorization for remote dispensing sites to improve access to treatment for opioid use disorder

Under SB 6086, pharmacies are now authorized to extend their pharmacy license to a remote dispensing site, where technology (such as automated drug dispensing devices or ADDDs) may be used to dispense medications for the treatment of opioid use disorder (OUD). The provision applies only to FDA-approved medications for the treatment of OUD. To use these remote dispensing sites, a pharmacy must register each remote site separately with the Pharmacy Quality Assurance Commission (PQAC).

The law directs the PQAC to establish minimum standards for these remote dispensing sites, including who can retrieve medications for OUD stored in or at a remote dispensing site pursuant to a valid prescription or chart order. The pharmacy will be responsible for stocking and maintaining a perpetual inventory of the medications for OUD stored in or at the registered remote dispensing site.

There may be a fee charged with registering such sites, and the registration will be considered part of the pharmacy license issued under RCW 18.64.043.

Background

Responding to the opioid epidemic continues to be a high priority issue for legislators. Over the last several legislative sessions, legislation has been introduced to improve opioid prescribing practices, expand access to overdose reversal medication and treatment services, and reduce stigma associated with OUD. The PMP in particular has been an area of focus, with legislation enacted in 2017 to require the adoption of opioid prescribing rules, expand access to PMP data for quality improvement purposes, and require a report to the Legislature regarding the status of integration with electronic health records.

Throughout these debates, WSHA has advocated in support of improved access to treatment. WSHA has also supported solutions to help prescribers access data they need to identify and treat opioid use disorder, while balancing the need for guidelines that allow practitioners to continue to treat legitimate chronic pain.

WSHA is actively committed to improving opioid stewards and substance use disorder (SUD) treatment and recovery support services in Washington state through its safety and quality work. WSHA has collaborated with key partners to increase opioid stewardship, with a goal of improving opioid prescribing practices, preventing future opioid dependence, reducing overdoses and increasing access to treatment. For instance, in partnership with WSMA, WSHA has enrolled providers to receive opioid prescribing feedback reports, leveraging the PMP database to generate peer benchmarks on acute, chronic, high dose and co-prescribing sedatives. To date, WSHA and WSMA have recruited 87 hospitals and multiple clinics, reaching over 22,000 prescribers across the state.

Resources

RCW 70.225.090 – Integration with certified electronic health record technologies.

RCW 69.50.312 – Electronic communication of prescription information.

SSB 5380 – Concerning opioid use disorder treatment, prevention, and related services.

SSB 6086 – Increasing access to medications for opioid use disorder.

WSHA Opioid Stewardship

Prescription Monitoring Program (PMP) – Department of Health

WSHA’s 2020 New Law Implementation Guide

Please visit WSHA’s 2020 implementation guide online, where you will find a list of the high priority laws that WSHA is preparing resources and information on to help members implement the new laws, as well as links to resources such as this bulletin. In addition, you will find the Government Affairs team’s schedule for release of upcoming resources on other laws and additional resources for implementation.

 

[1] As identified in RCW 70.255.040