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: September 18, 2019)
There are several important regulatory issues at the top of WSHA’s priority list:
- Balance Billing. We are actively engaged in the balance billing rulemaking following the Legislature passing HB 1065, The Balance Billing Protection Act. The Office of the Insurance Commissioner (OIC) has released two stakeholder drafts, available here and here. WSHA submitted comments on both the first and second stakeholder drafts. For more information on the rulemaking, visit the OIC’s Balance Billing rulemaking website. (Andrew Busz)
- Behavioral Health Agencies. We are also actively engaged in the Department of Health (DOH) rulemaking on WAC 246-341 governing Behavioral Health Agencies (BHA). The rulemaking is divided between 2019 legislative implementation work and a major rules re-write project relating to the behavioral health integration. Presently, DOH is working on the rules to implement HB 1394, which among other things requires reviewing the BHA rules that may require changes to facility community hospitals providing 90 and 180 day civil commitment services. The pre-proposal (CR101) is available here. WSHA is working closely with DOH and other stakeholders in the HB 1394 workgroup. We invite members to participate in this workgroup. Stakeholder meetings have been set for August 12, August 19 and August 26. Meeting details, including call-in information, are available on DOH’s BHA rulemaking website. Please contact Jaclyn Greenberg, Policy Director, Legal Affairs, for more information. Following the completion of the HB 1394 project, DOH will undertake a comprehensive review and rules re-write of WAC 246-341. In preparation, it has released a Behavioral Health Agencies Licensing and Certification Rules Survey to obtain feedback from stakeholders about the rules to inform how they intend to organize the project. The survey is open now until August 23. You can access the survey here. We encourage members to participate in the survey. Please also share your feedback with Jaclyn Greenberg, Policy Director, Legal Affairs. (Jaclyn Greenberg)
- EMS and Trauma Care. We are closely following the ongoing stakeholder meetings related to revising rules governing emergency medical services (EMS) and trauma care. So far, the stakeholder group has discussed updates to align training and certification requirements with current best practice. The next EMS rules workshop will be held on August 21. Further information, including meeting location and web conferencing information is available on the EMS rulemaking website. (Lauren McDonald)
- Hospital Licensing Fees Increase. We are getting the word out regarding Department of Health’s plans to increase licensing fees for acute care, psychiatric, and alcohol and chemical dependency hospitals by about sixty percent. According to DOH, the current fee level does not provide sufficient funds to cover DOH’s costs to license, inspect, investigate, and perform other regulatory work. Please see DOH’s hospital fee issue brief and the hospital fee cost drivers, and visit the hospital license fee rulemaking website. DOH has filed the formal proposal (CR102) available here. The public hearing was June 25, 2019. For more info, see WSHA Fiscal Watch – June 12, 2019. (Andrew Busz)
In addition to our ongoing Top Priority State Rules Track, we are including a running list of rulemaking completed in 2019 impacting hospitals and health systems. Each completed rules list contains our quick take of the result. Look for the thumbs up, thumbs down or neutral marker.
(Updated: August 8, 2019)
Department of Health and the State of Board Health release July rulemaking agenda
The Department of Health (DOH) and the State Board of Health (SBOH) have released a report detailing current and anticipated rulemaking activities. The report is available here.
The Health Care Authority releases its Semi-Annual Rulemaking Agenda
The Health Care Authority’s semi-annual rulemaking agenda was released on July 29 and is available here.
Rulemaking begins on establishing additional patient notification requirements when prescribing opioids
SSB 5380 requires the various Commissions and Boards of opioid prescribers to adopt by January 1, 2020 amendments to their rules to establish additional patient notification requirements when prescribing opioids. The Washington Medical Commission (WMC) and the Board of Osteopathy have each held preliminary rule workshops to discuss the required amendments. The Nursing Care Quality Assurance Commission (NQAC), the Pharmacy Quality Assurance Commission (PQAC), the Dental Quality Assurance Commission (DQAC) and the Podiatric Medical Board (PMB) will also be amending their rules governing patient notification, secure storage and disposal.
- The WMC’s first workshop was held July 10 to discuss WAC 246-918-815 and WAC 246-919-865. A workshop package including meeting notification and draft language are available here. The new requirements include notifying patients of their right to refuse an opioid prescription and documenting this refusal, and providing patients with information related to the risks of opioids and pain management alternatives to opioids. WSHA participated in this workshop and provided several comments that were adopted by the Commission. Comments may be sent to firstname.lastname@example.org. The Pre-proposal (CR101) is expected to be filed shortly.
- The Board of Osteopathy’s first workshop was held July 11 to discuss WAC 246-854-255and WAC 246-853-675. The Board also considered the rules at its July 19 meeting. The Pre-proposal (CR101) is expected to be filed shortly.
- The Podiatric Medical Board and Dental Quality Assurance Commission have also filed pre-proposals to address the same regulations for their associated professions.
Pharmacy Commission Seeks Input on Draft Rules
The Pharmacy Quality Assurance Commission is seeking comments, suggestions and input on draft rules under its Rule Rewrite Project. The goal of the rewrite project is to develop rules that are less prescriptive and focus on standard of care and patient safety. The draft rules need to be flexible to allow for the use of innovation in pharmaceutical care with the intent to improve patient outcomes. There are several draft rules, including draft operational standards, draft general licensing standards, draft professional standards, and draft general provisions. The Commission has prepared a crosswalk to help navigate the proposed changes, available here. The Commission scheduled two workshops in June and early August to review comments and the draft rules.
WSHA has provided general comments to Commission staff regarding current challenges for pharmacists that we see potential opportunities for addressing through this rulemaking project. Details of the workshops as well as other information is available on the Commission’s Rewrite Project website. Comments should be emailed to PharmacyRules@doh.wa.gov. (Lauren McDonald)
The Department of Health releases new handout for Naloxone
The Department of Health (DOH) has developed a new patient information handout for Naloxone. The handout is available here. Additional education materials and resources relating to opioid prescribing requirements are available on DOH’s Opioid Prescribing webpage, including toolkits and FAQs for providers. (Lauren McDonald)
Changes to the Medical Regulations by the U.S. Nuclear Regulatory Commission
The U.S. Nuclear Regulatory Commission has adopted some big changes to their medical regulations. The changes apply to medical, gamma knife and nuclear pharmacy licensees. The Washington State Department of Health (DOH) will be required to adopt the NRC’s changes, and DOH plans to prepare draft rules later in 2019. In the meantime, the Commission hosted an informational webinar to explain the changes on April 24, 2019. Presentation slides are available here. (Jaclyn Greenberg)
Hospital Construction Standards Rules Project
Members may also want to note that the Department of Health is reviewing certain rules governing hospital construction standards. DOH is in the early stages of that process, namely reviewing draft rules language and proposals at workshops. The workshops took place in October and early December 2018. Meeting notes from the second workshop are expected soon. The formal proposal (a filed CR-102) is expected to follow shortly thereafter (scheduled for Spring 2019). Full details, including the draft rules language, a link to a webinar on the 2018 Facility Guideline Institute (FGI) changes (on which the revised rules will be based), and a report on draft proposals are available here. Please contact DOH Construction Review Services Manager John Williams to receive free access to the 2018 FGI Guidelines. Find more general information on this rulemaking on the Construction Review Services website or by joining the Construction Review listserv.
Please contact us if there is a state rulemaking activity impacting your hospital or health system that you do not see listed here. (Jaclyn Greenberg)
Federal Regulatory Issues
Federal rulemaking and regulatory activity is also critically important to hospitals and health systems’ operations and their ability to deliver the best possible health care. WSHA tracks certain federal regulatory issues. Current highlights are listed below.
(Updated: August 8, 2019)
CMS Proposed Outpatient Rule Continues Cuts to Off-Campus Hospital Clinics and 340B Hospitals, Requires Posting of Negotiated Rates with Carriers
On July 29, The Centers for Medicare and Medicaid Services (CMS) released its proposed 2020 Outpatient Prospective Payment System (OPPS) rule. CMS proposes to continue its existing 30 percent cut to Medicare payments for drugs provided to 340B hospitals, despite a court ruling in favor of hospitals that CMS exceeded its regulatory authority and the cuts were unlawful. In the proposed rule, CMS is asking for comments on whether a smaller cut to 340B payments would be more acceptable. CMS is also continuing its phase-in of cuts to exempted, off-campus hospital clinics based on the rule finalized last year. For 2019, payments were reduced by 30 percent, to 70 percent of the regular OPPS. Under the proposed rule, 2020 clinic services would be reduced by an additional 30 percent, to 40 percent of the regular OPPS rate. The American Hospital Association and hospitals, including Olympic Medical Center, are challenging the cuts in court on the basis that Congress did not authorize CMS to apply site-neutral cuts to existing clinics, only new facilities opened after November 2015. The proposed rule also expands the 2019 requirement that hospitals post their standard charges to include their negotiated payments with payors for up to 300 “shoppable” sets of services. The proposal creates significant operational and technical challenges for hospitals, in addition to the contractual and legal issues involved. On a positive note, the proposed rule permanently applies a “general supervision” rather than a “direct supervision” standard for outpatient services, a change WSHA, AHA and hospitals have been seeking for several years. Adoption of the direct supervision standard averts a huge barrier for access to care, particularly in rural areas. Comments on the proposed rule are due September 27. WSHA will be commenting on these items, among other provisions. We will distribute a copy of our draft comments to members prior to the comment deadline. (Andrew Busz, email@example.com)
CMS Finalizes IPPS Rule, Wage Index Changes
On August 2, CMS released its final Inpatient Prospective Payment System rule for 2020. The proposed rule finalizes CMS’s proposal to raise payment for the quartile of hospitals with lowest wage index by reducing the wage index adjustment for the hospitals in the top quartile and applying an additional budget neutrality adjustment reduction to all PPS hospitals. Because Washington state is not in the lowest quartile, WSHA estimates all 48 of Washington’s PPS hospitals would experience some reduction in wage index payment as a result of the change. WSHA and AHA commented to CMS that increases to low wage index hospitals should not be funded by cuts to other hospitals, many of which also provide care in rural areas under difficult economic conditions. WSHA’s comment is available here. (Andrew Busz, firstname.lastname@example.org).
CMS seeks input on reducing administrative, regulatory burden
The Centers for Medicare & Medicaid Services (CMS) has issued a Request for Information (RFI) seeking new ideas from the public on how to ease administrative burden and improve healthcare delivery, building on its 2017 Patients over Paperwork initiative. As of January 2019, its estimated that that initiative, which streamlined regulations to cut down on “red tape”, has saved the healthcare system an estimated 40 million hours and 5.7 billion through 2021. The new RFI is an opportunity to share new ideas and continue to build on improvements to healthcare delivery. CMS is especially interested in ideas to relieve burden and ways to improve:
- Reporting and documentation requirements
- Coding and documentation requirements for Medicare or Medicaid payment
- Prior authorization procedures
- Policies and requirements for rural providers, clinicians, and beneficiaries
- Policies and requirements for dually enrolled (i.e., Medicare and Medicaid) beneficiaries
- Beneficiary enrollment and eligibility determination
- CMS processes for issuing regulations and policies
CMS seeks comments by August 12. WSHA encourages members to submit ideas. Please share any ideas submitted to CMS with Jaclyn Greenberg, Policy Director, Legal Affairs at email@example.com.
WSHA comments on Draft CMS guidance on hospital co-location
WSHA recently commented on draft guidance on hospital co-location and shared service arrangements by the Centers for Medicare & Medicaid Services (CMS). That draft guidance is available online. Co-location occurs where two hospitals or a hospital and another health care entity are located on the same campus or in the same building and share space, staff or services. WSHA supports co-location and flexible arrangements that increase coordinated, efficient and cost-effective health care, and commended CMS for its move towards explicitly allowing these arrangements. Our comments concentrated on recommendations for revising the draft guidance to provide increased clarity on how these arrangements may be structured and more nuanced direction around specific issues that would promote rather than hinder flexibility in co-location. Specifically, we recommended greater flexibility around “floating” staff, revisions to the guidance’s section on the provision of emergency services, providing explicit direction about the use of timeshare agreements and co-location arrangements with provider-based clinics, more flexible use of check-in areas, and recommendations for implementation including a grandfather clause for co-locations arrangements previously found to be compliant with Medicare Conditions of Participation. (Jaclyn Greenberg)