Distributing opioid overdose reversal medication in EDs and behavioral health settings – effective January 1, 2022

Change of Law: Hospital Action Required

To:	Hospital Chief Executive Officers, Chief Medical Officers, Emergency Department Directors, Psychiatric Hospital and Inpatient Behavioral Health Executives and Administrators, Legal Counsel and Government Affairs Staff
From:	Ryan Robertson, Director, Behavioral Health RyanR@wsha.org, (206) 216-2536 Cara Helmer, JD, RN, Policy Director, Legal Affairs CaraH@wsha.org, (206) 577-1827
Subject:	Distributing opioid overdose reversal medication in EDs and behavioral health settings – effective January 1, 2022

Purpose
This bulletin provides hospitals information about 2SSB 5195, a new law requiring hospital emergency departments (EDs) and many behavioral health settings (defined below), such as inpatient psychiatric units and psychiatric hospitals, to dispense or distribute opioid overdose reversal medication to patients at risk of an opioid overdose for individual use after discharge. The purpose of the new law is to have individuals at-risk of an opioid overdose leave hospitals and behavioral health settings with opioid overdose reversal medication. Hospitals will also have to provide patients at risk of an opioid overdose with information about medications for opioid use disorder and harm reduction strategies.[i]  The requirements for hospital EDs and behavioral health settings are effective January 1, 2022.

WSHA provided significant input into this law during the 2021 legislative session. While WSHA supported the underlying policy to provide more individuals with opioid overdose reversal medication, as introduced the law was contemplated without a reimbursement mechanism. Due to WSHA’s advocacy, the law now includes a process for hospitals to bill and be reimbursed for providing opioid overdose reversal medication.

Applicability/Scope
2SSB 5195 contains requirements for hospitals to provide opioid overdose reversal medication to certain patients presenting in the hospital emergency department (Section 3 of the bill) and behavioral health agencies (Section 4 of the bill) to provide or assist certain clients to access opioid overdose reversal medication.

Hospital emergency departments (EDs). Section 3 of 2SSB 5195 applies to all acute care hospitals licensed under chapter 70.41 RCW.

Behavioral health hospitals, clinics, and units (collectively referred to as “BHAs”). Section 4 of 2SSB 5195 applies to “all licensed or certified behavioral health agencies,” which means any entity licensed or certified according to chapters 71.24 RCW or 71.05 RCW that provide mental health, substance use, or co-occurring disorder services, among others.[1] This licensure-based definition captures freestanding psychiatric hospitals, inpatient psychiatric units, inpatient substance use disorder programs, and outpatient behavioral health clinics.

Recommendation

1. 1. 1. Review the law. Review this bulletin and the new requirements created by 2SSB 5195 with legal counsel and risk managers to determine the impact on your hospital and any resulting changes that may be required to processes, policies, and procedures.
      2. Create an implementation plan.  The main changes in the law in sections 3 and 4 are effective January 1, 2022.  However, WSHA encourages hospitals to begin implementation planning now.  WSHA will host a webinar for hospitals in November to support planning and implementation efforts.  Webinar details will be shared with hospitals in the coming month.  Hospital planning steps may include the following:
         • Working with pharmacies on distributing opioid overdose reversal medication.  As discussed below, there are no regulatory barriers to distributing opioid overdose reversal medication from an inpatient pharmacy for take-home purposes. Nevertheless, hospitals are likely to need to develop processes for obtaining the medication from their pharmacy, or if none is present onsite, working with outpatient pharmacies to develop a process for obtaining the medication.
         • Working with payors on billing requirements. As discussed below, in the near term there will be new billing codes for seeking reimbursement for take-home opioid overdose reversal medication for Medicaid enrollees and uninsured individuals. The Washington State Health Care Authority (HCA) is required to reimburse the medication for these individuals. The law does not create similar requirements on commercial plans, but WSHA believes they will use the same billing codes and will cover the medication in most instances. While WSHA will be working with the large commercial plans, hospitals are also encouraged to begin discussions with payors about billing processes and requirements.
         • Working with clinical staff on processes related to determining when a person is at-risk and subject to the new requirement. The new law contemplates circumstances when providing an at-risk individual opioid overdose reversal medication is not appropriate or needed. The new law also provides broad language for who is considered “at-risk” for purposes of providing the medication. WSHA encourages hospital administrators and clinicians to work together to develop policies and protocols for determining the patient populations who meet criteria for receiving take-home opioid overdose reversal medication and when that person may not need to receive it.
         • Training staff on distributing the medication, providing directions for use, and offering information on medications for opioid use disorder and harm-reduction strategies. In addition to providing the medication, hospital EDs and BHAs must also ensure individuals qualifying to receive opioid overdose reversal medication also receive directions for medication use and information and resources to help people manage substance use. These materials will be developed by the HCA, translated into all relevant languages, and provided for distribution by January 1, 2022. WSHA encourages hospitals to train a wide array of patient-facing staff about distributing the medication and ancillary materials.
      3. Continue to provide opioid overdose reversal medication to people at risk of an opioid overdose. Many hospitals already distribute opioid overdose reversal medication kits to people at risk of overdose. Most often this means people presenting in hospital EDs for an opioid overdose or other clear indicators of substance misuse. All hospitals should continue this practice regardless of the January 1, 2022, effective date. It is best practice to ensure that an at-risk individual has this life-saving medication in hand.  As discussed below, there are no regulatory barriers inhibiting distribution, including to family members and others with relationships to the at-risk individual. WSHA supports and agrees with 2SSB 5195’s purpose to make it easier for at-risk individuals to receive opioid overdose reversal medication.

      Overview and Requirements of the Law
      In response to Washington State’s high number of opioid overdose-related deaths, the legislature passed 2SSB 5195, which requires hospital EDs and most BHAs to ensure people at risk of an opioid overdose have an opioid overdose reversal medication on hand when they leave their point of care.

      Many hospitals already provide the medication to at-risk patients for individual use after discharge and there is good reason for it.  Even though Washington state has a standing order for the opioid overdose reversal medication, naloxone, which allows people to obtain the drug without a prescription, evidence suggests that many individuals do not take advantage of that option and the number of overdose-related deaths remains high and continues to grow. Providing the medication at the point of care is considered best practice for preventing overdose-related deaths.

      WSHA worked extensively on 2SSB 5195 with legislators and other stakeholders, including the Washington State Medical Association (WSMA), the Washington Chapter of the American College of Emergency Physicians (WA-ACEP), and the Washington Council for Behavioral Health. Through our advocacy, the bill contains important protections, flexibilities, and supports for hospitals and other behavioral health providers to help facilitate individuals at risk of an opioid overdose to receive opioid overdose reversal medication.  Here are important elements to be aware of:

      1. Effective date is January 1, 2022. Sections 3 and 4, the two sections that require action by hospitals and behavioral health providers, are effective January 1, 2022. WSHA was a strong advocate for this timing and was pleased it made it into law. This recognizes the time needed to develop processes and procedures for complying with 2SSB 5195, and for the HCA and other payors to update their billing processes to support the provision of medication outside of the traditional pharmacy setting.
      2. Opioid overdose reversal medication. The law refers to “opioid overdose reversal medication,” which is defined by RCW 69.41.095 to mean “any drug used to reverse an opioid overdose that binds to opioid receptors and blocks or inhibits the effects of opioids acting on those receptors. It does not include intentional administrations via the intravenous route.” This includes naloxone (often referred to by its brand name, Narcan).
      3. Basic Requirements. 2SSB 5195 sets out two similar but separate sets of requirements for providing opioid overdose reversal medication to people at risk of an opioid overdose. The requirements depend on the type of healthcare setting, as follows:

Setting	Requirements	Patient
Sec. 3 Acute Care Hospitals Chapter 70.41 RCW	An acute care hospital shall provide a person who presents at a hospital emergency department with: Opioid overdose reversal medication upon discharge unless there is professional determination that it is not appropriate, or the person already has it; Directions for use; and Information and resources about medications for opioid use disorder and harm reduction strategies and services. These materials should be available in all languages relevant to the communities that the hospital serves. Note: Materials will be developed by HCA and distributed to hospitals by January 1, 2022. This will include translated versions into all relevant languages.	Person presents to ED with symptoms of: an opioid overdose; opioid use disorder; or other adverse event related to opioid use.
Sec. 4 Licensed or certified behavioral health agencies (BHAs) that provide behavioral health treatment**Chapter 71.24 RCW	A BHA must during the person’s intake, discharge, or treatment plan review, as appropriate: Inform the client about opioid overdose reversal medication and ask whether the client has it; Unless the behavioral health provider determines that it is not appropriate, if the person does not have opioid overdose reversal medication, the provider must assist the person in directly obtaining the medication using the statewide standing order or a prescription as soon as practical by one of the following means: Directly dispensing the medication; Partnering with a pharmacy to obtain the medication on the person’s behalf and distributing it directly; Assisting the person in using a mail order pharmacy or pharmacy that mails prescription directly to the BHA and distributing the medication directly, if necessary; Obtaining and distributing the medication through the state bulk purchasing program; or Any other resources or means authorized by state law; Directions for use; and Information and resources about medications for opioid use disorder and harm reduction strategies. These materials should be available in all languages relevant to the communities that the BHA serves. **Definition of Behavioral Health Agencies (BHAs). Section 4 applies to the categories of facilities known in law as “licensed or certified behavioral health agencies,” which includes psychiatric hospitals, and acute care hospitals with inpatient units and outpatient clinics/services that provide behavioral health services licensed by the Department of Health (DOH). Note: Materials will be developed by HCA and distributed by January 1, 2022. This will include translated versions into all relevant languages.	Person who presents with symptoms of an opioid use disorder or who reports recent use of opioids outside legal authority.

2SSB 5195 applies to all BHAs that provide people treatment for mental health, substance use disorder, withdrawal management, secure withdrawal management, evaluation and treatment, or opioid treatment programs. WSHA’s interpretation is that all hospital units, clinics, and settings that provide licensed behavioral health services are subject to Section 4 of the new law. Hospital settings that accept Single Bed Certification under RCW 71.05.745 are not subject to Section 4.

1. 1. 4. Professional discretion for not providing opioid overdose reversal medication. Both Section 3 (for hospital EDs) and Section 4 (for BHAs) contemplate circumstances where providing someone with the medication is not appropriate or needed. For instance, if a person is being transferred from one facility to another (such as for involuntary treatment) or the person reports they already have opioid overdose reversal medication in their possession. This language is important to maintain prescriber decision-making autonomy.  WSHA was a strong supporter of the language and is pleased the language is included in the law.
   2. 1. • For hospital EDs, the treating practitioner must determine “in their clinical and professional judgment that dispensing or distributing opioid overdose reversal medication is not appropriate or the practitioner has confirmed that the patient already has opioid overdose reversal medication.” RCW 18.64.011 defines practitioner to mean a physician, nurse, or other person duly authorized by law or rule in the state of Washington to prescribe drugs.
         • For BHAs, the behavioral health provider must determine “using clinical and professional judgment that opioid overdose reversal medication is not appropriate.” RCW 71.24.025 defines behavioral health provider to mean osteopaths, physicians, physician assistants, osteopaths and osteopath physician assistants, psychologists, substance use disorder professionals, mental health counselors, marriage and family therapists, social workers, and registered nurses and advanced registered nurse practitioners.
   3. 5. Liability and regulatory protections. Thanks to strong advocacy from WSHA and its partners, both Sections 3 and 4 contain broad language protecting facilities, providers, and staff from legal risk associated with following the new law, specifically:
   4. 1. • For hospital EDs, “A hospital, its employees, and its practitioners are immune from suit in any action, civil or criminal, or from professional or other disciplinary action, for action or inaction in compliance” with Section 3.
         • For BHAs, “A behavioral health agency, its employees, and providers are immune from suit in any action, civil or criminal, or from professional or other disciplinary action, for action or inaction in compliance” with Section 4.In addition, there is also language for BHAs providing mental health treatment only that “actions taken in compliance” with the mandate “may not be construed as the entity holding itself out as providing or in fact providing substance use disorder diagnosis, treatment, or referral for treatment for purposes of state or federal law”.
   5. 6. Billing and reimbursement.  Reimbursement is a key component to the requirement to provide certain patients who present at the hospital ED or during an encounter with a behavioral health provider with opioid overdose reversal medication for potential use after the visit.  Typically, medications are obtained by the patient after a visit through an outpatient or retail pharmacy, and hospitals and BHAs do not normally seek reimbursement for “take-home” medications.  However, new reimbursement mechanisms were needed in 2SSB 5195 to account for providing the medication separate from the traditional visit.2SSB 5195 contains two reimbursement mechanisms: 1) a long-term, global bulk purchasing and distribution program that will be operated by the HCA and funded by commercial and public plans alike; and 2) until the HCA program is operational, a short-term reimbursement requirement for the HCA for Medicaid managed care and fee-for-service as well as uninsured individuals, as follows:
         • The HCA is directed to establish a bulk purchasing and distribution program for opioid overdose reversal medication “as soon as reasonably practicable.” This program will involve HCA purchasing the medication en masse and distributing it to hospitals and BHAs for distribution to individuals at-risk.  It will involve the HCA billing, charging, and receiving payment from health carriers, managed health care systems, and self-insured plans that choose to participate.  The law contains mandates on managed care plans, private plans, and plans for public employees to contribute as of January 1, 2023.
         • From January 1, 2022, until the HCA’s bulk purchasing and distribution program is operational, managed care organizations and the HCA must reimburse hospitals and BHAs for dispensing or distributing opioid overdose reversal medication to a covered person under Sections 3 or 4, as applicable. WSHA is working with the HCA to gather specific billing codes and instructions and will share this information with hospitals when available.
   6. 1. 1. Under section 3, the billing structure is as follows:
            1. • For Medicaid enrollees, hospitals must bill the cost of the medication to the patient’s Medicaid benefit using specific billing codes (will be shared with hospitals when available).  The billing must be separate from and in addition to the payment from the other services provided during the visit.
               • For people with insurance, hospitals must bill the patient’s health plan.
               • For people without insurance, hospitals must bill the HCA for the cost of the medication.

               Under section 4, BHAs are subject to the same billing structure to the extent they are the billing entity. Otherwise, pharmacies billing for distribution of the medication under Section 4 are subject to the same billing structure.

            WSHA advocated strongly for coverage requirements to align with the broad requirement to provide the medication to those at-risk, regardless of a person’s insurance coverage.  While we were disappointed that the legislature declined to extend the coverage requirement for people with commercial insurance in the short-term, we were pleased to see the legislature move forward with a bulk purchase and distribution program and sense of urgency attached to make this operational as soon as practicable. Even though there is no requirement in law for commercial payors to reimburse for take home opioid overdose reversal medication, WSHA believes commercial payors cover it already in many instances. WSHA will continue its advocacy to align reimbursement requirements with the medication distribution requirements.

   7. 7. Distributing existing supply of naloxone kits. WSHA is aware many hospitals have purchased and/or received naloxone kits through one-time grant funds and other sources. 2SSB 5195 explicitly permits hospitals and BHAs to distribute these kits so long as it is at no cost to the patient.
2. 1. 8. Pharmacy-related considerations. WSHA worked with the Department of Health (DOH), the Pharmacy Quality Assurance Commission (PQAC), and the Washington State Pharmacy Association (WSPA) to confirm that the existing regulatory structure permits providing people naloxone for take-home purposes under the state’s standing order for naloxone.For hospital EDs in particular, PQAC previously released a policy statement on the topic of distributing naloxone under the authority RCW 69.41.095 – Opioid overdose medication, which authorizes a hospital ED to distribute the medication to people at risk of opioid overdose and/or to first responders, family members, or other persons or entities in a position to assist such at-risk people pursuant to a practitioner’s prescription, standing order, or protocol. The policy statement states, in relevant part:
3. 1. 1. 1. 1. “The Commission believes that state law—RCW 69.41.095—authorizes the distribution of opioid overdose medication from emergency departments. No change to current state law is required to provide such authority.”
   2. 1. 2SSB 5195 waives the labeling requirements of RCW 69.41.050 and RCW 18.64.246 related to opioid overdose reversal medication dispensed or delivered in accordance with the new law. Furthermore, 2SSB 5195 contemplates that the medication may be dispensed “with technology used to dispense medications,” such as an automated drug dispensing device (ADDDs). These ADDDs may store and dispense medications for the treatment of opioid use disorder.  In 2020, the legislature passed SSB 6086, which authorized pharmacies to extend their license to remote dispensing sites.  For WSHA’s bulletin on that law and other opioid-related law changes, see here.
   3. 9. Technical assistance, training, and materials for distribution. 2SSB 5195 directs state agencies and other parties to provide hospitals and BHAs support and assistance in implementing the requirements above, including:
      1. • HCA is tasked with developing written materials (translated into all relevant languages) for each hospital and BHA to comply with the requirement to provide people education and information about medications for opioid use disorder and harm reduction strategies, including directions for use. These must be provided by January 1, 2022.
         • HCA, DOH, the Office of the Insurance Commissioner, and the University of Washington Addictions, Drug, and Alcohol Institute (ADAI) are tasked with providing technical assistance to hospitals and BHAs to assist these entities, practitioners, and providers in complying with the new law. For BHAs, this assistance includes:
           • Training nonmedical providers on distributing and providing client education and directions for use of opioid overdose reversal medication;
           • Guidance for billing for opioid overdose reversal medication; and
           • Analyzing the cost of staff time to carry out their activities, including guidance no later than January 1, 2022, for funding and billing direct service activities related to assisting clients to obtain opioid overdose reversal medication.
   4. References
      2SSB 5195 – AN ACT Relating to opioid overdose reversal medication
      Chapter 70.41 RCW – Acute care hospital licensing and regulation
      RCW 71.24.025 – Subsection 27 – Definition of Licensed or Certified Behavioral Health Agency
      RCW 70.41.480 – Authority to prescribe prepackaged emergency medications
      Pharmacy Quality Assurance Commission (PQAC) Policy Statement – Distributing Naloxone
      Department of Health News Release – Overdose deaths show alarming trend in 2020; fentanyl party to blame
      Department of Health News Release – Overdose rates on pace to break another record in 2021WSHA’s 2021 New Law Implementation Guide
      Please visit WSHA’s new law implementation guide online. The Government Affairs team is hard at work preparing resources and information on the high priority bills that passed in 2021 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] Under RCW 71.24.025, (27) “Licensed or certified behavioral health agency” means:
      (a) An entity licensed or certified according to this chapter or chapter 71.05 RCW;
      (b) An entity deemed to meet state minimum standards as a result of accreditation by a recognized behavioral health accrediting body recognized and having a current agreement with the department; or
      (c) An entity with a tribal attestation that it meets state minimum standards for a licensed or certified behavioral health agency.[i] The Health Care Authority (HCA) will prepare these materials and provide them to hospitals and behavioral health facilities by January 1, 2022.