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 3, 2022)
There are several regulatory issues at the top of WSHA’s current priority list, including:
Modifications to the Balance Billing Protection Act – WSHA submitted comments and engaged in discussion with staff in the Office of the Insurance Commissioner (OIC) regarding the second prepublication draft of rulemaking to implement E2SHB 1688. WSHA has concerns regarding the definition of “outpatient hospital department” in the second prepublication draft, which we believe is overly expansive. WSHA is hopeful that these concerns will be addressed in the CR-102 rulemaking. (Andrew Busz)
Audio-Only Telemedicine – The Health Care Authority (HCA) issued a CR 102 proposal as part of the rulemaking process related to audio-only telemedicine under ESSB 1196. ESSB 1196 builds upon Washington state’s telemedicine payment parity laws by requiring that reimbursement for audio-only telemedicine be paid at the same rate that would be paid to the provider if the health care services were provided in person. ESSB 1196 increases access to remote care for patients who are currently unable to connect to audio-visual telemedicine visits, while ensuring that audio-only telemedicine is used as a supplemental tool for care. WSHA commented on HCA’s preproposal draft rule with suggested changes to ensure alignment with the authorizing law and with generally accepted health care practices and standards. We were successful in aligning the proposal with statute regarding an associated visit for behavioral health services conducted through store and forward technology. We are also successful in clarifying some of the recordkeeping requirements. However, we will continue to advocate for the rules to align with the statute regarding HCA’s authority to determine which services may be provided safely and effectively through telemedicine or store and forward technology.
Please see WSHA’s comment letter to read more about WSHA’s position on the proposed rules.
Prescription Drug Locker Guidance- The Pharmacy Quality Assurance Commission (PQAC) issued a guidance document regarding prescription drug pick up lockers. According to the document, PQAC “interprets its laws and rules to permit pharmacies to use pharmacy-owned lockers to deliver filled prescriptions for noncontrolled drugs, without the lockers being included as part of the pharmacy’s license. Pharmacies should be aware of specific laws and rules that apply to the delivery of filled prescriptions for non-controlled drugs, including WAC 246-945-415(1) which requires pharmacies to take appropriate measures when delivering filled prescriptions to ensure product integrity and receipt by the patient or patient’s agent.” Click here to access the full guidance document. (David Streeter)
New DEA Guidance on Schedule II Prescriptions- The Pharmacy Quality Assurance Commission (PQAC) issued a bulletin that contains the latest guidance from the Drug Enforcement Administration (DEA) regarding modifications to a schedule II prescription. DEA’s new guidance states, “Schedule II controlled substance prescriptions must contain all the information required in 21 CFR § 1306.05(a), and licensed pharmacists may add or modify Schedule II prescription information if consistent with state regulations or policy after oral consultation with a prescriber.” PQAC “interprets its laws and rules, and DEA’s laws, rules, and guidance, to permit a pharmacist to adapt a prescription for a controlled substance in Schedule II in accordance with WAC 246-945-335 after oral consultation with the prescriber. WAC 246-945-335 permits a pharmacist to: change the quantity (WAC 246-945-335(1)), change the dosage form (WAC 246-945-335(2)), or complete missing information (WAC 246-945-335(3)) if certain criteria are met. DEA guidance requires that any adaptation of a prescription for a controlled substance in Schedule II be in compliance with the commission’s laws and rules and after the pharmacist has had an oral consultation with the prescriber. If a pharmacist wants to adapt a prescription for a controlled substance in Schedule II in a manner that does not meet the criteria in WAC 246-945-335, then the pharmacist is required to obtain a new prescription from the prescriber that complies with WAC 246-945-010, WAC 246-945-011 and 21 C.F.R. § 1306.05(a).” Click here to read PQAC’s full bulletin regarding DEA’s new guidance. (David Streeter)
Hospital Data Reporting and Transparency – The Department of Health (DOH) has issued a final rulemaking, CR-103, to implement aspects of E2SHB 1272, related to patient demographic data required to be reported to the Department of Health (DOH) via the Comprehensive Hospital Abstract Reporting System (CHARS). The new demographic data reporting requirements apply to acute care hospitals licensed under chapter 70.41 RCW and behavioral health hospitals licensed under chapter 71.12 RCW.
Beginning on January 1, 2023, hospitals must report patient demographic information to the department via CHARS. This rulemaking requires hospitals to ask patients how they identify their race, ethnicity, gender identity, sexual orientation, preferred language, and disability status and report their responses via CHARS While hospitals are required to ask for the information, patient responses are voluntary. Hospitals must notify patients that their responses are voluntary.
The department is also required 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 qualify as a Medicare dependent hospital to comply with the requirements. The department recently sent communications to eligible hospitals indicating that the application form for grants and waivers will be available on October 1, 2022 and will be due by October 15, 2022.
Please see WSHA’s bulletin on the rulemaking for more information. WSHA actively participated in the legislative debate over E2SHB 1272 as well as participated in and commented on the rulemaking process. (Ashlen Strong)
Certificate of Need– The Washington State Department of Health has started to engage in rulemaking for the Certificate of Need (CN) program. The department is taking two tracks in this current rulemaking. Track 1 involves targeted changes to the Hospice methodology and the Percutaneous Coronary Intervention Volume Standards (PCI) methodology. DOH is currently hosting workshops on these targeted changes, however the PCI rulemaking is “on hold pending review of feedback received.” WSHA is neutral on these proposed changes but is monitoring to ensure that the processes used by DOH allow for active hospital engagement. Track 2 involves broader changes to the CN program “to clarify, streamline, and modernize language including need methodologies.”
Track 2 is the continuation of the CR 101 that was issued in December 2019, but sidelined due to the COVID-19 pandemic. DOH announced a series of facility-specific listening sessions to be held between September 2022 and January 2023. Hospital-specific listening sessions will be held on:
- 10/14/22 (10:30am-12:00pm)
- 11/9/22 (5:00pm-6:30pm)
- 1/11/23 (4:30pm-6:00pm)
General sessions along with sessions for hospice, PCI, home health, ESRD, nursing homes, ambulatory surgical facilities, and tertiary services are also scheduled. Click here to download the schedule from DOH’s listening session announcement. All of the latest information about the CN rulemaking can be found on DOH’s CN website. (David Streeter)
Charity Care– The Washington State Department of Health (DOH) intends to begin rulemaking this summer to amend the state’s charity care regulations (WAC 246-453) following updates to state charity care law made by the legislature in 2022 by HB 1616 and in 2018 in SB 6273. While rulemaking was previously started for the 2018 law change, no rulemaking was ever completed. For more information on HB 1616 please see our recent bulletin. You can find WSHA’s 2018 bulletin on SB 6273 here. The DOH plans to hold workgroups with stakeholders in order to develop the draft language, and WSHA will actively participate in order to represent the interests of hospitals. If you are a member and are interested in joining our workgroup to participate in or be kept up to date on this rulemaking, please contact Cara Helmer. (Cara Helmer)
Prescription Label Translation– The Pharmacy Quality Assurance Commission (PQAC) issued a CR 101 in April to commence rulemaking for prescription label standards that will cover both language and disability accessibility standards. PQAC is currently in the first stages of stakeholder engagement in this rulemaking and has not specified a completion deadline. Current engagement steps are:
- WSHA has asked the PQAC to consider hosting a hospital-specific stakeholder meeting to address our unique concerns and considerations.
- PQAC is likely to keep this topic as a standing agenda item for future Commission meetings. The next PQAC meetings are scheduled for November 17-18.
- PQAC’s prescription label accessibility survey is open for responses. Survey results will be used to inform PQAC’s rulemaking on prescription label accessibility. Please ensure that your pharmacy leaders respond to the survey by Sunday, October 16, 2022 at 11:59 pm. Click here to access the survey. The survey’s purpose “is to assess current pharmacy practices pertaining to accessible labeling for both patients with visual and/or print disabilities and patients who require that prescription information be translated into another language besides English.” The survey will help PQAC identify “what technological, financial, or resource-based obstacles prevent such options from being offered.
- Specific questions or feedback about this rulemaking can be sent to firstname.lastname@example.org.
This rulemaking will occur in place of HB 1852, which died at the end of the 2022 legislative session. HB 1852 would have created a statutory requirement for prescription label translations and contained specific requirements for pharmacies and PQAC. The bill was laudable in that it sought to offer prescription labels in additional languages, but unfortunately it created operational challenges for hospitals and health systems as written. WSHA will work to ensure that rules adopted by PQAC reflect the amendments and address other concerns raised by hospitals during the legislative session. In preparation for the rulemaking, WSHA will convene a Hospital Pharmacy Workgroup to participate in the regulatory process. Hospitals that would like to participate in the workgroup should email David Streeter for additional information. (David Streeter)
Acute Care Hospital Fines- The Department of Health has issued a CR 102 proposal as part of the rulemaking process to implement HB1148. HB1148 increased DOH’s oversight and enforcement abilities over acute care hospitals licensed under 70.41 RCW. The rulemaking, once complete, will create a fine matrix to establish fines that DOH will have the option to assess against hospitals based on the severity and scope of violation.
Please see WSHA’s bulletin for more information about HB1148.
DOH has previously released CR101 draft language which can be previewed here. WSHA worked closely with DOH on editing the CR101 draft language, though a series of workshops with stakeholders. The CR 102 language reflects the work that went into that process. WSHA will continue to work with members and the DOH to support hospital interests through this rulemaking process. (Cara Helmer)
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)
L&I Employment Law Webinars- Washington State’s Department of Labor & Industries announced a series of educational webinars about key state employment laws. According to L&I, “The sessions cover worker’s rights, white-collar overtime rules, isolated worker protections and the Equal Pay and Opportunities Act.” Each session will last approximately 45 minutes and includes time for Q&A. L&I’s announcement is available here and interested participants can register for the webinars through L&I’s webpage. (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
- Office of the Insurance Commissioner
- Health Care Authority
- Department of Social and Health Services
- Department of Children, Youth, and Families
- Department of Labor & Industries
- Employment Security Department
Note: the DOH agenda includes rules for the Washington Medical Commission, State Board of Health, Pharmacy Quality Assurance Commission, and Nursing Care Quality Assurance Commission. (David Streeter)