Although the revised Requirements of Participation published in October 2016[1] have not yet been fully implemented, the Centers for Medicare & Medicaid Services (CMS) published proposed rules on July 18, 2019 to revise them and also to make changes in survey and enforcement rules.[2] CMS contends that its proposals are intended to “promote efficiency and transparency” and “to become a better business partner,”[3] the 32-page document in the Federal Register uses the term “burden” or “burdensome” 102 times, all with reference to burdens on facilities. The Center for Medicare Advocacy’s preliminary review of the proposed regulations finds nothing that is either intended to, or will, improve quality of care or quality of life for residents. We will be more closely analyzing the proposed changes and drafting comments to share in the days ahead, but a few immediate observations are possible.
First, the proposed rules cut back on standards of care that facilities must meet to be eligible for Medicare and Medicaid reimbursement. For example,
- The 2016 rules created a new position of infection preventionist (IP), a person or persons who is responsible for overseeing the facility’s infection prevention and control program.[4] The provisions for IPs were scheduled to go into effect November 28, 2019. CMS proposes to replace the current requirement that the IP work at least part-time in the facility, with a vague requirement that the IP “have sufficient time at the facility.” The preamble to the proposed rules acknowledges “Between 1.6 and 3.8 million infections occur each year in these nursing homes, with almost 388,000 deaths attributed to these infections,” and with annual costs associated with infections in nursing facilities ranging from $673 million to $2 billion.[5] When infections do so much harm and cause the death of so many residents, cutting back infection prevention and control rules that have not yet fully taken effect will not improve resident care.
- CMS proposes to ease requirements for the administration of antipsychotic drugs PRN (as needed), responding to “feedback from the provider community concerning the burden resulting from the limitations on PRN orders for psychotropic drugs.”[6] Antipsychotic drugs may be medically appropriate for a small number of residents with certain mental illnesses, but they are dangerous and life-threatening (according to the Food and Drug Administration’s Black Box warnings) for the approximately 200,000 residents with dementia who now receive them.
- CMS proposes “to remove the specific duties required of the grievance official who is responsible for overseeing the grievance process.”[7] It distinguishes “grievances” from “general feedback or complaints,” writing, “[G]eneral feedback or complaints stem from general issues that can typically be resolved by staff present at the time a concern is voiced, while grievances are more serious and generally require investigations into allegations regarding the quality of care.”[8] CMS adds, “[W]e would expect that as a general practice, facilities would continue to make every effort to resolve resident concerns before the grievance process is initiated.”[9] Through these proposed changes, CMS is making “grievance” a highly formalized process that will be difficult to invoke.
- Discussing the requirement that facilities send the ombudsman notices of only “facility-initiated transfers,” CMS defines “facility-initiated” in the preamble, but not in regulatory language, as a transfer or discharge “that the resident objects to, did not originate through a resident’s verbal or written request, and/or is not in alignment with the resident’s stated goals for care and preferences.”[10] If a facility orally tells a resident that she should leave and she does not “object,” does CMS consider that discharge not to be “facility-initiated”? This loophole could swallow the requirement for ombudsman notification.
- Although the 2016 rules allow a physician to delegate to the dietician “the task of prescribing a resident’s diet to the extent allowed by state law,” CMS proposes to eliminate the enhanced professional credentials for dieticians that the 2016 rules also required.[11]
- The 2016 rules mandated that facilities conduct a facility-wide assessment, a process to determine the resources, including staffing, that are needed to provide care to the facility’s residents on a day-to-day basis and during emergencies. Responding to provider feedback that the process is “excessively burdensome,” CMS proposes to extend from one year to two years the timeframe for facilities to complete assessments.[12]
- Section 6102 of the Affordable Care Act required facilities to implement a Quality Assurance and Performance Improvement (QAPI) program by 2012. CMS proposes to delete 42 C.F.R. 483.75(c)(1)-(4), which provides details about program feedback, data systems, and monitoring, as well as 42 C.F.R. §483.75(d)(2), which requires facilities to develop and implement policies for systematic analysis and systemic action. The effects of these proposed changes is a QAPI program whose programmatic details are determined solely by facilities.
In contrast to loosening Requirements of Participation to relieve provider burden, CMS proposes to add more prescriptive and detailed requirements to survey, certification, and enforcement procedures that will both make these procedures more difficult for states and CMS to use, and reduce enforcement. Specifically, for example,
- CMS proposes new regulatory language to require “more specific requirements” for informal dispute resolution (IDR) and independent IDR (IIDR). New regulatory language requires that facilities receive written notification of the results of IDR or IIDR that includes the rationale for the recommendation about a deficiency and that CMS document its rationale for disagreeing with an IDR or IIDR recommendation.[13]
- CMS proposes a “constructive waiver process,” which presumes that a facility waives its appeal rights even if it does not appeal, but continues to allow the facility to benefit from an automatic 35% reduction in the civil money penalty (CMP).[14] The average per instance CMP, which is now the default type of CMP,[15] is less than $9000.[16]
One other CMS proposal warrants comment. In the portion of the preamble discussing Collection of Information Requirements, CMS writes that it is proposing to revise “the reporting requirements for abuse to provide flexibility around the timeframes for reporting [bold font provided].”[17] As confirmed by CMS in an email to the Center for Medicare Advocacy on July 24, the proposed changes are not discussed elsewhere in the preamble or in the proposed regulatory language. A new Government Accountability Office (GAO) report,[18] released on July 23, 2019 at the Senate Finance Committee hearing, was summarized by the GAO’s witness as finding more than a doubling of abuse deficiencies between 2017 and 2018, with the largest increase in actual harm and immediate jeopardy deficiencies, and continued underreporting of abuse.[19] In light of the GAO’s findings, CMS may have decided not to propose relaxing reporting requirements for abuse.
Comments on the proposed rules, CMS-3347-P, are due September 16, 2019.
July 25, 2019 – T. Edelman
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[1] 81 Fed. Reg. 68688 (Oct. 4, 2016), https://www.govinfo.gov/content/pkg/FR-2019-07-18/pdf/2019-14946.pdf.
[2] 84 Fed. Reg. 34737 (Jul. 18, 2019).
[3] 84 Fed. Reg. 34737 (Jul. 18, 2019).
[4] 42 C.F.R. §483.80(b).
[5] 84 Fed. Reg. 34737, 34746 (Jul. 18, 2019).
[6] 84 Fed. Reg. 34737, 34743 (Jul. 18, 2019), amending 42 C.F.R. §483.45(e)(5).
[7] 84 Fed. Reg. 34737, 34741 (Jul. 18, 2019).
[8] 84 Fed. Reg. 34737, 34741 (Jul. 18, 2019).
[9] 84 Fed. Reg. 34737, 34741 (Jul. 18, 2019).
[10] 84 Fed. Reg. 34737, 34742 (Jul. 18, 2019).
[11] 84 Fed. Reg. 34737, 34744 (Jul. 18, 2019).
[12] 84 Fed. Reg. 34737, 34745 (Jul. 18, 2019), amending 42 C.F.R. §483.70(e).
[13] 84 Fed. Reg. 34737, 34750 (Jul. 18, 2019), amending 42 C.F.R. §488.331.
[14] 84 Fed. Reg. 34737, 34751 (Jul. 18, 2019), amending 42 C.F.R. §488.436.
[15] CMS, “Final Revised Policies Regarding the Immediate Imposition of Federal Remedies,” QSO 18-18-NH (Jun. 15, 2018), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO18-18-NH.pdf (making final CMS, “Revised Policies regarding the Immediate Imposition of Federal Remedies – FOR Action,´ S&C: 18-01-NH (Oct. 27, 2017), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-18-01.pdf.
[16] Jordan Rau, Kaiser Health News, “Trump Administration Cuts The Size Of Fines For Health Violations In Nursing Homes,” National Public Radio (Mar. 15, 2019), https://www.npr.org/sections/health-shots/2019/03/15/702645465/trump-administration-cuts-the-size-of-fines-for-health-violations-in-nursing-hom.
[17] 84 Fed. Reg. 34737, 34754.
[18] GAO, Nursing Homes: Improved Oversight Needed to Better Protect Residents from Abuse, GAO-19-433 (Jun. 2019), https://www.gao.gov/assets/700/699721.pdf.
[19] GAO, Nursing Homes: Improved Oversight Needed to Better Protect Residents from Abuse, GAO-19-671T (Jul. 23, 2019), https://www.gao.gov/assets/710/700418.pdf.