In September 2016, the Centers for Medicare and Medicaid Services (CMS) released the revised Requirements for Participation and Reform of Requirements for the Long-Term Care Facilities rule. The new regulations reflected advances in the theory and practice of long-term care service delivery and safety, and implemented sections of the Affordable Care Act. The overarching themes of the Final Rule were person-centered care and quality; utilizing a facility assessment competency-based approach; care planning from a person centered perspective; alignment with HHS initiatives; comprehensive review and modernization; and implementation of legislation. The rules were re-organized and updated, making them consistent with current health and safety knowledge.
In light of the implementation of these new regulations surveyors, facilities, practitioners, as well as those in the legal field involved in long-term care and skilled nursing care litigation have been eagerly awaiting the new Interpretive Guidelines for details. These guidelines are effective November 28, 2017, and CMS released the revised version of Appendix PP (interpretive guidelines for surveyors) in advance of the implementation date for Phase 2 of the CMS revisions. Research of these changes can be challenging and tedious, but ALN Consulting stays on top of all of the regulation changes and interpretive guidelines so that each review uses the most up-to-date information available. In Part 1 of this ALN Special News Bulletin, we will give you an overview of the new Interpretive Guidelines and revised F-Tags. In Part 2, we will delve deeper into the particulars of the changes and implementation.
Revised Interpretive Guidance – Appendix PP
The new changes are effective November 28, 2017, and until then providers and surveyors will continue to use the revised version of Appendix PP released March 8, 2017. The CMS Medicare Learning Network created an “F-Tag Crosswalk,” a tool for users to identify new tag numbers, cross referenced with old tags, and the regulation text that was moved to the new tag:
According to CMS, many standards have remained unchanged since the early 1990’s. CMS updated the existing guidelines where necessary, and added a section in some areas to the Interpretive Guidelines titled, “Key Elements of Noncompliance” intended to guide surveyors and LTC facilities about the key behaviors and practices identified in the regulation.
Quality of Care F-Tags
A revised list of the F-Tags under each regulatory group is now available for use. The regulations were re-structured: some tags combined, and some tags split into multiple subparts.
An example of an F-Tag which changed is F600 – Abuse and Neglect, which combined into a single tag. Additional guidance clarified what constitutes abuse and neglect; assessing consent; involuntary seclusion; physical and chemical restraints; policies to prohibit abuse and neglect; and reporting requirements.
The new F684 – Quality of Care Tag was formerly F309 – Hospice, palliative care, and other care issues. It now contains guidance on dialysis, respiratory care, fecal incontinence, position change alarms, and bed rails.
New guidance for Infection Control includes discussion of an “Antibiotic Stewardship Program,” to encourage minimum antibiotic use protocols and a system for monitoring antibiotic use based on CDC guidance.
Enforcement of New Regulations
CMS released a statement confirming they “heard concerns regarding the scope and timing of the new requirements for Phase 2. We believe that these standards (for example, development of an antibiotic stewardship program to combat multi-drug resistant organisms) represent important national health and safety standards. However, to address these concerns, CMS will provide a one-year restriction of enforcement remedies for specific Phase 2 requirements. Specifically, we will not utilize civil money penalties, denial of payment, and/or termination. Should a facility be found to be out of compliance with these new requirements beginning in November of 2017, CMS would use this year-long period to educate facilities…by requiring a directed plan of correction or additional directed in-service training. Enforcement of other existing standards (including Phase 1 requirements) would follow the standard process.”
CMS has not released the listing of specific Phase 2 requirements associated with enforcement delays. However, this will present a unique challenge to litigation focused on this period for both Plaintiff and Defense alike. The requirements will be implemented, but not all enforced equally. Review of records with allegations pertaining directly to the regulation changes should be handled with a keen eye toward the changes implemented by the facility, and also toward specific correction plans if applicable.
We’ve done the research, so you don’t have to! ALN Consulting will continue to stay on top of these and other developments. Contact ALN Consulting if you have questions about a case and would like an initial consultation.
Interpretive Guidelines, CMS Revision to SOM Appendix PP, effective 11/28/17
Interpretive Guidelines, CMS Revision to SOM Appendix PP, effective 03/08/17
Final Rule, Federal Register, October 4, 2016.
MLN Revised Interpretive Guidance for Nursing Homes and New Survey Process