Many health care entities took a “set it and forget it” approach to their CQIPs once the CQIPs were approved by DOH under regulations adopted in 2006. Beginning tomorrow, such entities will need to reconsider their approach. DOH has published significant changes to its regulations regarding approval of CQIPs that are operated by health care entities such as provider groups, health care facilities that are not hospitals, and health care plans. In light of the revisions to WAC Chapter 246-50, health care entities should review the contents of their CQIPs regularly and establish new mechanisms for managing CQIPs.
The new regulations as adopted are available at: https://app.leg.wa.gov/wac/default.aspx?cite=246-50.
The final rule that shows the regulatory changes can be found at: http://lawfilesext.leg.wa.gov/law/wsr/2021/09/21-09-077.htm.
Requirements for Obtaining and Maintaining Approval for a CQIP
The new rule becomes effective May 21, 2021, and requires health care entities to:
- Apply for renewed approval of their current CQIPs by December 31, 2021, and pay a $75 renewal fee;
- Request renewed DOH approval for their CQIPs every five years thereafter;
- Notify DOH within 30 days if there is a change in the entity’s “authorized representative” who submitted the application for new or renewed approval; and
- Modify their CQIPs within six months to comply with any future changes to CQIP requirements adopted by DOH or the Washington legislature and to seek DOH approval for the modifications.
If a health care entity does not apply for renewed approval on a timely basis, the existing approval for the CQIP lapses, and the entity must submit a new application for approval. This scenario may be a trap for unwary organizations that overlook the renewal date. Quality improvement and peer review records created during the interim period between the expiration of approval and a new application may not be considered privileged and confidential in the same way they would be while the CQIP approval is in effect. During that interim period, individuals who provide information or participate in peer review and quality improvement activities may not enjoy the immunity protections provided for under the statute that authorized the DOH approval process, RCW 43.70.510.
Health care entities should consider adopting measures to mitigate the effects of lapsed approvals such as participating in a patient safety organization (“PSO”), that offers additional protection under the Health Care Quality Improvement Act of 1986, and requiring contractors to represent that their CQIPs are in good standing with DOH.
Although all health care entities must apply for renewed approval for their CQIPs by the end of the year, they need not worry about the consequences of any delay caused by the volume of renewal requests. Current CQIP approval remains in place while a renewal application is under DOH review. However, a health care entity that intends to seek new approval for a CQIP should apply as soon as possible to avoid delays caused by a potential backlog of renewal applications.
Limited Eligibility Under the New Regulations
Some health care organizations may be surprised to discover that they are no longer eligible to request CQIP approval, or to rely on the related privileges and immunities. The regulations still provide that health care entities may apply for approval, but no longer include a detailed definition of health care entity with the itemized list of organizations eligible to seek CQIP approval. This change creates exposure for a number of the organizations that appeared on the list, such as public health departments, fire departments, Native American facilities, and veterans’ hospitals and homes, unless they can otherwise demonstrate they are entities eligible to seek CQIP approval under the new rule.
The deleted definition identified “health care institutions and medical facilities” as entities eligible to apply for CQIP approval. Now, such organizations may be eligible because the revised regulations apply to “health care institutions and medical facilities” but only if they are licensed by DOH. This change clearly has implications for any unlicensed organizations, e.g., small clinics. For other organizations, it creates ambiguity as to whether or how a CQIP pertains to operations not covered by a license, e.g., operations that are not covered by a limited license such as a medical testing license or facilities at sites other than the licensed location. Health care institutions and medical facilities should consider the breadth of their operations and any contemplated expansions in their CQIP plan and the application for DOH approval.
Groups of five or more providers remain eligible to apply for CQIP approval, but “provider” is now defined as a professional licensed by DOH. Employees of licensed providers no longer count in determining whether a group includes five providers, and the count may not include professionals practicing under a temporary permit or providers suspended by DOH pending investigation. The new regulations do not explain the consequences for a group that ceases to include at least five members after its CQIP is approved. Provider groups may wish to specify in their application or CQIP plan that such a change will not affect the CQIP. If a group’s size will be reduced indefinitely, the group should consider whether they are eligible for CQIP approval under another applicable provision or should look to alternatives for protecting quality improvement work (such as a PSO).
Contents of the CQIP and the Application for Approval
The new regulations do provide some flexibility as to the scope of a CQIP. Generally, a CQIP must contain certain components that are, and have been, enumerated in the regulations. The revised rule now provides DOH discretion to approve a CQIP with components that are modified to reflect the “structural organization” of a health care entity. It is not clear how organizations should address modifications when they apply for new or renewed approval or whether DOH may impose additional requirements related to the modifications. There is no detail in the rule regarding the allowable modifications or the extent of DOH’s discretion. The application for CQIP approval found on the DOH website has not been changed in light of the new regulations.
The additional discretion of DOH may be helpful to some organizations, but it may not be sufficient to meet the needs of contemporary and complex health care organizations, such as integrated delivery systems, accountable care organizations, multi-disciplinary provider groups or other organizations that perform peer review or quality improvement for a multitude of eligible entities. Again, health care entities should take care to describe the full scope of their operations in the application for DOH approval of the CQIP. The CQIP plan with modifications should adhere closely to the required components when possible, and the modifications should be justified so that the plan reflects alignment with the scope and purpose of the regulations and related statutes.
Change in Perspective
Finally, the purpose of the regulations is more narrowly described in the new rule. The regulations no longer speak to the discovery limitations available to documents prepared for a CQIP and no longer mention that they allow a broad range of health care entities to operate a CQIP for purposes of improving health care quality and reducing malpractice. Most health care entities appreciate the important role of a CQIP in quality improvement activities and recognize that the related discovery limitations and immunities encourage the development of documents necessary to quality improvement and individual participation in quality improvement work. The modifications to the purpose statement, taken with the other changes described above, seem to reflect a reduced emphasis on such considerations. Given this, health care entities may wish to evaluate options for conducting and protecting their quality work, such as participating in a PSO.
For questions and additional guidance related to CQIPs, and other peer review and quality improvement matters, please contact Terri Rambosek at email@example.com or Ronak Chokhani at firstname.lastname@example.org.