State regulations have a big impact on hospitals, health systems and their patients. WSHA tracks rulemaking activity throughout the state and works closely with regulatory agencies, as well as other groups, to advocate for a reasonable regulatory environment. All statewide rulemaking activity is published in the Washington State Register.
(Updated: October 6, 2021)
There are several regulatory issues at the top of WSHA’s current priority list, including:
Hospital Data Reporting and Transparency – The Department of Health (DOH) issued a CR 101 pre-proposal to begin rulemaking to implement E2SHB 1272, which created new data reporting requirements for hospitals. According to the CR 101, E2SHB 1272 “requires hospitals to report patient discharge information related to race, ethnicity, gender identity, sexual orientation, preferred language, disability status, and zip code of residence. It also requires the department to develop a waiver and grant process to assist hospitals that are certified by the Centers for Medicare and Medicaid Services (CMS) as a critical access hospital, certified by CMS as a sole community hospital, or qualifies as a Medicare dependent hospital to comply with the requirements.” WSHA actively participated in the legislative debate over E2SHB 1272 and will be engaged in the rulemaking. WSHA will provide updates as the rulemaking process progresses. (Ashlen Strong)
Public Option Contracting– The Health Care Authority (HCA) issued a CR 101 preproposal announcing the rulemaking process to implement the public option contracting provisions passed in E2SSB 5377. According to the CR 101, “This bill provides that if a public option plan is not available in each county during plan year 2022 or later, hospitals licensed under chapter 70.41 RCW receiving payment from one of the agency’s benefit programs or its medical assistance program must contract with at least one public option plan to provide in-network services to that plan’s enrollees. The bill also provides that the agency may adopt rules including levying fines and taking other actions necessary to enforce compliance when a hospital must contract with a public option plan.” WSHA actively participated in the legislative discussion on E2SSB 5377 and this is rulemaking is a top priority. We will provide updates as this rulemaking progresses. Please see WSHA’s bulletin on E2SSB 5377 for additional information about hospitals’ participation in the public option program. (Ashlen Strong)
Whistleblower Complaints in Healthcare Settings – DOH has issued a CR 102 proposal that contains updates to protections provided to “whistleblowers” that report to DOH or who initiate, participate, or cooperate in investigations which raise quality of care concerns. The rules establish rights of whistleblowers and procedures for filing, investigation, and resolution of whistleblower complaints. WSHA has been actively engaged in the rulemaking process. This rulemaking is in response to the passage of SHB1049 in 2019. Please see WSHA’s bulletin on SHB1049 for more information on the law and WSHA’s participation in the legislative process. (Cara Helmer)
Behavioral Health Agencies – The Department of Health (DOH) has started Phase 2 of a multi-year, multi-phase rulemaking project to update and modernize the licensing regime for behavioral health services in Washington (Chapter 246-341 WAC). Weekly DOH rulemaking workshops for Phase 2 began on July 20, 2021 and will continue through September. The focus of Phase 2 rulemaking will largely be focused on streamlining and improving certifications. WSHA is an active participant in these workshops and has convened a workgroup of interested members to evaluate DOH’s rulemaking proposals and provide feedback throughout the process. Phase 1 took place in summer and fall 2020, over the course of five months and 17 workshops. The final rules –effective July 1, 2021, (compliance date January 1, 2022)—are a product of those workshops. This phase concentrated on updating language, refining inconsistencies across services, and addressing other obvious areas of improvement. You can find more information about the conclusion of Phase 1 and new final regulations in this WSHA Bulletin. Phase 3 of this project will take place in the summer of 2022. (Brooke Evans)
Audio-Only Telemedicine– The Office of the Insurance Commissioner (OIC) and the Washington State Telehealth Collaborative are currently working to implement HB 1196, which established audio-only telemedicine as a covered and reimbursable service in Washington State.
OIC recently issued a CR 102 proposal following engagement with stakeholders. The proposal adds definition and criteria to the patient consent requirements in HB 1196; defines the term “same amount of compensation” to provide clarity for providers and payers; and adds two additional scenarios into the “established relationship” definition. The additional scenarios are (1) the use of locum tenens and designated backups when the provider is unavailable and (2) audio-only encounters when the provider making a referral joins the call with the additional provider. OIC will be holding a public hearing on the proposal on October 28, 2021 at 11 AM via Zoom. WSHA’s Telemedicine Work Group is currently evaluating the proposal in advance of the hearing. Please share comments on the proposal with David Streeter.
HB 1196 requires the Washington State Telehealth Collaborative to “study the need for an established patient/provider relationship before providing audio-only telemedicine, including considering what types of services may be provided without an established relationship.” Additionally, the Collaborative “must submit a report to the legislature on its recommendations regarding the need for an established relationship for audio-only telemedicine.” To fulfill its mandate, the Collaborative voted in favor of four recommendations for the established relationship provision at its’ September 9, 2021 meeting. The recommendations are:
- Change the term “clinic” in the “established relationship” definition to “shared group practice.”
- Change the established relationship time period from 1 year to 3 years.
- Allow an audio-visual telemedicine visit to satisfy the in-person visit requirement that is part of the established relationship.
- Add “the provider providing audio-only telemedicine has direct access to the covered person’s real-time or electronic medical record” as an option for establishing the patient-provider relationship.
The next step for the Telehealth Collaborative is to finalize its recommendations for the legislature, which will likely result in legislation for the 2022 legislative session. WSHA remains engaged in the implementation of HB 1196 and will continue to provide updates. (David Streeter)
Prescription Monitoring Program (PMP)- HCA issued its final CR 103 rule to implement PMP checks for Medicaid patients mandated by the federal SUPPORT Act. The new rule applies to all prescribers and outpatient pharmacies. Under the rule, prescribers must check the PMP before prescribing a controlled substance to Medicaid patients and pharmacists must check the PMP before dispensing a controlled substance to Medicaid patients. According to HCA, the requirement applies if prescribing controlled substances to be filled upon discharge or leaving the emergency room or hospital. The new rule took effect October 1, 2021 and HCA issued additional information to prescribers and pharmacists through a Frequently Asked Questions document. According to the document, the PMP review is required for clients enrolled in an Apple Health Managed Care plan or Fee-for-Service program. This includes dual-eligible clients (those with Medicare and Medicaid) and clients with third-party-liability where Apple Health is the secondary payer. The PMP review is also not required for clients who are receiving hospice or palliative care; or treatment for cancer, a resident of a long-term care facility, or a resident of a facility for which frequently abused drugs are dispensed through a contract with a single pharmacy. WSHA published a bulletin on the new rule that is available here. (David Streeter)
New $55 OUD Remote Dispensing Site Fee– The Pharmacy Quality Assurance Commission (PQAC) finalized its’ new $55 annual registration fee for opioid use disorder (OUD) remote dispensing sites, effective December 1, 2021. According to PQAC’s fee narrative, the remote sites are an extension of the pharmacy’s license that “enables a pharmacy to extend its license of location to a remote dispensing site where technology is used to dispense FDA-approved medications” for OUD. The fee narrative specifies that pharmacies can complete the OUD remote dispensing site’s registration application at any time and that the site’s renewal cycle will track with the pharmacy’s renewal schedule. The remote site fee is part of PQAC’s implementation of SB 6086 (2020), which authorized PQAC to establish a licensure program for OUD remote dispensing sites. Additional information and background is available in PQAC’s fee narrative document here. (David Streeter)
Physician Assistant Practice Laws- In 2020 the Washington State Legislature passed legislation to modernize the state’s physician assistant (PA) laws. Currently, PA’s and physicians work together under delegation agreements approved by the Washington Medical Commission (WMC). Beginning July 1, 2021, the delegation agreement process will be replaced with the new practice agreement system outlined in HB 2378 (2020). Current delegation agreements will still be valid after July 1, 2021, unless the contents of a delegation agreement changes, or the PA changes jobs. WMC hosted a webinar explaining the changes, which can be viewed here. The webinar covers the components of a practice agreement, changes regarding remote sites, and supervision expectations. Additionally, WMC posted its’ new practice agreement form on its website alongside other PA practice resources. WSHA’s bulletin on the new PA laws is available here. (David Streeter)
Washington State Energy Code Updates– The Washington State Building Code Council (WSBCC) is preparing a CR 102 that contains two proposed energy code updates that would uniquely impact hospitals. One of WSBCC’s proposals would eliminate the use of fossil fuel power sources for primary water heating equipment in all commercial buildings. WSHA testified to WSBCC that this requirement poses a significant risk for patient safety and conflicts with federal backup power requirements for hospitals. Currently, hospitals’ backup power is provided through fossil fuel sources since battery storage technology is not feasible on a scale that meets hospitals’ needs. WSBCC’s proposal would make it more difficult to power their primary water heating sources in the event of a power outage. Because of this, WSHA is seeking the addition of a health care exception that would give hospitals the ability to work with Code Officers to ensure that federally required backup power requirements can be satisfied. WSBCC is also proposing to require new construction and renovation projects greater than 10,000 sq/ft to install a renewable energy system capable of generating .5 watt per sq/ft. This proposal could create additional costs and construction delays for hospitals implementing projects to expand needed services for their communities. This requirement may also be difficult for rural hospitals since there are currently few clean energy vendors serving rural areas. Because of this, WSHA is seeking a financial hardship exemption modeled after the language in the Clean Buildings regulations in chapter 194-50 WAC. WSHA will provide an update once the CR 102 is released. (David Streeter)
Semi-Annual Rulemaking Agendas– Several state agencies relevant to hospitals issued their semi-annual rulemaking agendas. The agendas show what rules are currently in progress and what rules are forthcoming this year. Click the agency below to view its agenda:
- Department of Health (Washington Medical Commission, State Board of Health, Pharmacy Quality Assurance Commission, and Nursing Care Quality Assurance Commission)
- Health Care Authority
- Department of Social and Health Services
- Office of the Insurance Commissioner
- Employment Security Department
- Department of Labor & Industries
- Employment Security Department