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On July 13, 2015, the Centers for Medicare & Medicaid Services (CMS) posted proposed regulations to revise the Requirements of Participation for nursing homes (called Skilled Nursing Facilities under Medicare and Nursing Facilities under Medicaid).  The proposed rules were published in the Federal Register on July 16,[1] with a 60-day comment period. 

The public announcement stressed that the proposed rules will “modernize” the Requirements, which have not been comprehensively revised since 1991.  Although the rules use new language (e.g., behavioral health, instead of mental health; intellectual disability, instead of mental retardation), refer to new technology (e-mail, internet), reflect changes made by the Affordable Care Act,[2] and substantially revise the internal order of the regulatory standards, they do not address the single most significant cause of poor care in nursing homes – the absence of sufficient numbers of competent, well-trained, well-supervised, and well-compensated professional and paraprofessional nursing staff. 

CMS rejects requests to promulgate explicit staffing ratios, which, it says, would conflict with state law and limit flexibility and innovation.[3]  Instead, it suggests a “competency-based approach,” which requires facilities, at least annually, to determine their residents’ needs and meet them.[4]  CMS’s report that most facilities already use such an approach belies any serious expectation that this approach will be effective in improving nurse staffing levels going forward.  This approach has clearly failed for decades, as the overwhelming majority of facilities have been, and continue to be, seriously understaffed.

A second overriding concern is that the proposed rules dilute the quality of care regulations.[5]  For most of the specific care categories identified under quality of care, the current regulations use a similar approach.  They say that if a resident is admitted to a facility without the problem, the resident should not develop the problem unless it was medically unavoidable for that individual.  The facility must then take steps to correct the problem and to prevent its recurrence, if possible.  For example, if a resident did not have pressure sores at admission, the resident should “not develop pressure sores unless the individual’s clinical condition demonstrates that they were unavoidable.”[6]  If a resident has pressure sores, the resident must receive “necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.”[7]  This regulatory language brilliantly implements two key provisions of the 1987 Nursing Home Reform Law: the focus on each resident’s entitlement to care and the requirement that facilities “must provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.”[8]  The current quality of care regulation gives full and enforceable meaning to the statutory directives.

The proposed rules combine the current quality of life requirements[9] with the current quality of care requirements into a single regulatory standard, called quality of life and quality of care.[10]  The proposed rules revise the pattern and structure of the subsections; move specific quality of care subsections elsewhere (e.g., the section on unnecessary drugs is moved to proposed rules for pharmaceutical services[11]), making it impossible to find the requirements for care in a single regulatory section; appear to delete some current quality of care provisions (e.g., range of motion); and are difficult to read. 

A third concern is that creating a new set of Requirements inevitably involves long delay.  CMS needs to draft the final standards in response to public comments, give facilities time to understand and implement the new Requirements, create a new survey protocol, and train state and federal surveyors in the new protocol, at the very least.  As these multiple changes are made, effective enforcement of Requirements of Participation, already weak,[12] will be further postponed.

If the proposed changes made sufficiently meaningful and substantive changes to benefit residents, the delay could be worthwhile.  However, our preliminary review indicates that the proposed rules have too few positive benefits (although there certainly are some[13]) and too many regressions,[14] causing concerns for residents, their families, and their advocates. The Center for Medicare Advocacy will discuss the proposed rules and our concerns in more detail in a future CMA Alert.

Comments are due September 14, 2015.


[1] 80 Fed. Reg. 41267 (July 16, 2015), http://www.gpo.gov/fdsys/pkg/FR-2015-07-16/pdf/2015-17207.pdf.
[2] For example, the proposed rules address Quality Assessment and Performance Improvement as well as Compliance and Ethics Committee requirements.
[3] 80 Fed. Reg., 42175, 42210.
[4] Id., proposed 42 C.F.R. §483.70(e)
[5] Current 42 C.F.R. §483.25.
[6] Current 42 C.F.R. §483.25(c)(1).
[7] Current 42 C.F.R. §483.25(c)(2).
[8] 42 U.S.C. §§1395i-3(b)(2), 1396r(b)(2), Medicare and Medicaid, respectively.
[9] Current 42 C.F.R. §483.15.
[10] Proposed 42 C.F.R. §483.25.
[11] Unnecessary drugs is moved from current §483.25(l) to proposed §483.45(d).
[12] See, for example, Center for Medicare Advocacy, “Staffing Deficiencies in Nursing Facilities: Rarely Cited, Seldom Sanctioned” (CMA Alert, March 7, 2014), http://www.medicareadvocacy.org/staffing-deficiencies-in-nursing-facilities-rarely-cited-seldom-sanctioned/; Center, “The Worst-Performing Nursing Facilities Are Seldom Sanctioned; Self-Reporting Is Not an Accurate Quality Measurement” (CMA Alert, Jan. 24, 2013), http://www.medicareadvocacy.org/the-worst-performing-nursing-facilities-are-seldom-sanctioned-self-reporting-is-not-an-accurate-quality-measurement/.
[13] One example is the requirement for a baseline care plan, to be developed within 48 hours of a resident’s admission.  Proposed §483.21(a).  Current rules require that an assessment be developed within 14 calendar days after admission.  Current §483.20(b)(2)(i).  Residents can suffer adverse events in the first two weeks following admission.  Office of Inspector General, Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare Beneficiaries, OEI-06-11-00370 (Feb. 2014) (finding nearly one-third of Medicare residents experienced an adverse event or other harm within, on average, 15.5 days following admission to their skilled nursing facility), http://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf, discussed in Center for Medicare Advocacy, “”OIG Report: Care in Skilled Nursing Facilities Harmed Nearly One-Third of Medicare Residents in August 2011” (CMA Alert, March 19, 2014), http://www.medicareadvocacy.org/oig-report-care-in-skilled-nursing-facilities-harmed-nearly-one-third-of-medicare-residents-in-august-2011/.
[14] One example is the authorization, for the first time, of binding arbitration agreements.  Proposed §483.70(n).  This proposal seems inconsistent with the position of the Consumer Financial Protection Bureau (CFPB), which will soon begin rulemaking on arbitration agreements.  In March 2015, CFPB issued a Congressionally-mandated report, which found that arbitration agreements limit consumer relief in disputes.   CFPB, “CFPB Study Finds that Arbitration Agreements Limit Relief for Consumers” (Press Release, March 10, 2015), http://www.consumerfinance.gov/newsroom/cfpb-study-finds-that-arbitration-agreements-limit-relief-for-consumers/.

 

 

 

 

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