State Regulatory Issues

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.

Click here to see WSHA’s Top Priority State Rules Tracker

(Updated: June 5, 2019)

There are several important regulatory issues at the top of WSHA’s priority list:

  1. Hospital Licensing Fees Increase. We are also actively engaged in the Department of Health’s plans to increase licensing fees for acute care, psychiatric, and alcohol and chemical dependency hospitals. Current fees do not provide sufficient funds to license, inspect, investigate, and perform other regulatory work to protect patient safety. Please see DOH’s hospital fee issue brief and the hospital fee cost drivers, and visit the hospital license fee website. DOH has filed the formal proposal (CR102) available here. A public hearing is set for Tuesday, June 25 at 10 am at the Department of Health, Point Plaza East Room 152-153, 310 Israel Road, Tumwater, WA, 98501. For more info, see WSHA Fiscal Watch – April 17, 2018. (Andrew Busz)
  2. Charity Care. We are actively engaged in the Department of Health’s charity care rulemaking. We recently participated in a rules development meeting on May 30 and have scheduled a webinar -– “What You Don’t Do Can Hurt You: Charity Care and Medical Debt” – for WSHA members on Monday, July 1 at 9:30 am. You can register for the WSHA webinar here. Further details about the rulemaking are available at the Charity Care Rules website. (Zosia Stanley)
  3. EMS and Trauma Care. We are closely following the ongoing stakeholder meetings related to revising rules governing emergency medical services (EMS) and trauma care. The next EMS rules workshop will be held on Thursday, June 13 at 10:30 am. Further information, including meeting location and web conferencing information is available on the EMS rulemaking website. (Lauren McDonald)
  4. Overtime for Exempt Employees. We are also closely following the rulemaking process about overtime pay exemptions for Executive, Administrative and Professional (EAP) workers by the Department of Labor and Industries. The formal proposal and commencement of the official rulemaking process was announced on June 5, 2019. Details about the rulemaking are available on L&I’s overtime rules website. Public hearings are schedule across the state in July and August. Our analysis is forthcoming.  (Jaclyn Greenberg)

Click here to see WSHA’s Top Priority State Rules Tracker – **2019 Completed Rules**

Click here to see WSHA’s Top Priority State Rules Tracker – **2018 Completed Rules**

(Updated: June 5, 2019)

In addition to our 2018 year end list of completed rules impacting hospitals and health systems, we are including a running list of rulemaking completed in 2019. Each completed rules list contains our quick take of the result. Look for the thumbs up, thumbs down or neutral marker.

OIC seeks stakeholder feedback for surprise billing  law  rulemaking process

OIC is engaged in implementation planning for HB 1065, the surprise billing law that passed during the 2019 legislative session and is effective January 1, 2020. Prior to initiating formal rulemaking, OIC requests input from stakeholders regarding which provisions of the new law need further clarification or development through OIC rulemaking; and, whether rulemaking should be done through a single proceeding, or separately by subject. Stakeholders can provide input via a stakeholder meeting to be held on Friday, June 14, 2019 at 11:30 am, Room 120 – Office of the Insurance Commissioner, 5000 Capitol Blvd, Tumwater, WA, 98501. Stakeholders may submitt written comments to RulesC@oic.wa.govby by June 14, 2019.  For more information on HB 1065 see our New Law Implementation Guide page. (Andrew Busz)

Pharmacist to Pharmacy Technician Ratio Rule Hearing Continued until June 21, 2019

On April 26, 2019, the Pharmacy Quality Assurance Commission held a public rules hearing to consider proposed amendments to WAC 246-901-130, which would eliminate standardized pharmacist to pharmacy technician ratios across all practice settings. The proposed rule authorizes pharmacists to set ratios based on their practice needs and the ability provide appropriate supervision. The Commission has continued its deliberation and decision portion of the rules hearing until it’s next meeting on Friday, June 21, 2019. At that time, the Commission will consider and respond to the comments and testimony received, as well as take action on the proposed rule. No further comments or testimony will be taken. Questions can be sent to WSPQAC@doh.wa.gov. (Lauren McDonald)

Pharmacy Commission Seeks Input on Draft Rules – by email and in June and August workshops

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 standardsdraft general licensing standardsdraft professional standards, and draft general provisions. The Commission has prepared a crosswalk to help navigate the proposed changes, available here. The Commission has scheduled two workshops to review comments and the draft rules, on Thursday, June 20, 2019 and Thursday, August 1, 2019. People may attend in person or by webinar. 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)

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: June 11, 2019)

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 WSHA Policy Director for Legal Affairs, Jaclyn Greenberg at jaclyng@wsha.org.

The RFI is available here. For more information, visit the Patients over Paperwork webpage.

CMS Proposed Inpatient Rule Includes Wage Index Reductions for Washington Hospitals

Recently WSHA sent the Chief Financial Officer or designated Finance contact for each prospective payment system (PPS) hospital financial impact analyses of the Medicare Inpatient Prospective        Payment System (IPPS) hospital FFY 2020 proposed payment rule, which was released May 3, 2019. The proposed rule includes a proposal to increase payment for the quartile of prospective payment system hospitals with lowest wage index by reducing wage index for the PPS hospitals in the top quartile and applying an additional budget neutrality adjustment reduction to all PPS hospitals. Under the proposal, all 48 of Washington’s PPS hospitals would experience reduction in wage index payment. WSHA plans to comment on the proposed rule and will provide draft comment language in the next few weeks to affected hospitals that may wish to submit their own comments. Comments on the proposed rule are due CMS by June 24, 2019. (Andrew Busz, andrewb@wsha.org)

Draft CMS guidance on hospital co-location released, WSHA requests comments

The Centers for Medicare & Medicaid Services (CMS) recently released draft guidance on hospital co-location and shared service arrangements, available online. Prior to the draft guidance, hospital co-location was confusing at best, outright prohibited at worst. 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. All co-located hospitals must demonstrate separate and independent compliance with Medicare Conditions of Participation. With this draft guidance, CMS is clarifying how shared spaces, services and personnel and emergency services can be organized to allow each hospital to demonstrate independent compliance. CMS is seeking comments on the draft by July 2, 2019. WSHA is now seeking feedback on the draft guidance in anticipation of preparing its own comment letter by June 14, 2019. Hospitals are also encouraged to submit individual comments on the draft guidance. (Jaclyn Greenberg)

CMS seek comments on guidance on ligature risk, AHA release regulatory advisory summarize the guidance

The Centers for Medicare & Medicaid Services (CMS) released draft guidance in April to clarify its ligature risk policy, updating its 2017 Guidance on the topic. The guidance covers the environmental safeguard requirements for patients who at risk of harm to themselves or others. The draft guidance clarifies what constitutes a ligature risk and the agency’s expectation for psychiatric units, both locked and unlocked, around preventing them. Locked psychiatric units within a general acute care hospital, including locked emergency department psychiatric units, and psychiatric hospitals are required to achieve a ligature-resistant environment. Unlocked psychiatric units within psychiatric hospitals and acute care hospitals (e.g. ICU, medical inpatient unit, etc.) are not subject to the same expectation, but they must have a plan for identifying and protecting patients who may be at risk of harm to themselves or others. The draft guidance also includes a process requesting an extension to remedy identified ligature risks that cannot be fixed within 60 days. The American Hospital Association recently prepared a Regulatory Advisory including a summary and key takeaways, available hereCMS is accepting comments on the draft guidance through June 17, 2019. (Jaclyn Greenberg)


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