Over the past decade, the Centers for Medicare and Medicaid Services (CMS) has implemented numerous initiatives to expand oversight of the use of antipsychotic medications in nursing facilities (NFs). CMS takes credit for a 38.9% reduction in the use of antipsychotic medications in NFs since 2011. The updated Requirements of Participation for NFs, effective November 28, 2017, incorporated many regulatory changes for NFs, including an expanded definition of psychotropic medications and new limitations on the use of such medications. Following years of efforts to reduce psychotropic medication use through education, outreach, and regulatory changes, CMS’s approach to spur continued improvement is now shifting towards enhanced enforcement of regulations and penalties for facilities deemed to be “late adopters” of current standards for psychotropic medication use.
In March of 2019, CMS announced that certain nursing facilities identified as “late adopters” will be subject to enhanced oversight and enforcement penalties. This advisory provides a brief summary about the implications of the newly defined groups of late adopters, the enforcement actions that will be taken against them, and the steps facilities identified as “late adopters” can take moving forward. The full memorandum can be located at this link: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO-19-07-Enhanced-Oversight-and-Enforcement-of-Non-Improving-Late-Adopters.pdf.
In 2017, the National Partnership to Improve Dementia Care in Nursing Homes identified 1500 NFs across the country as late adopters for failing to improve their rates of antipsychotic medication use for residents of long-stay NFs since the fourth quarter of 2011 and for continued high rates of antipsychotic medication use. The late adopters were distinguished based on the total number of CMS certification survey deficiency citations for inappropriate use of psychotropic or unnecessary medications the NFs received since January 1, 2016. CMS has since set a goal of a 15% reduction in antipsychotic medication use for long-stay residents in late adopter NFs by the close of this year.
CMS identified two distinct groups of late adopters: Group One and Group Two. Group One late adopters have had at least three prior survey deficiency citations for inappropriate use of psychotropic or unnecessary medications since January 1, 2016. Group Two late adopters have had two prior survey deficiency citations for inappropriate use of psychotropic or unnecessary medications since January 1, 2016. Out of the 1500 NFs identified as late adopters nationally, CMS has identified 41 within Group One, and 194 within Group Two, for focused improvement.
Group One and Group Two NFs are subject to considerable sanctions if a NF is not in substantial compliance during any type of survey, including a revisit, recertification, focused dementia/schizophrenia, or complaint survey for chemical restraints (F605), dementia care (F744), or psychotropic medications (F758) tags for only scope and severity levels above C.
For both groups, CMS Regional Offices will enact a discretionary Denial of Payment for New Admissions (DPNA). In addition, solely for Group One late adopters, CMS will impose a per-day Civil Monetary Penalty (CMP) beginning on the first day of the survey in which tags F605, F744, or F758 are cited, as determined by the CMP Analytic Tool.
Any late adopter NF that has a cited deficiency must submit a plan of correction to be approved by either the surveying agency or CMS, with the exception of those NFs that only have one isolated deficiency of minimal harm but no actual harm. In addition, there will be a mandatory DPNA if the facility has not gained compliance after three months of the deficiency citation and termination for unremedied noncompliance.
Preventing Deficiency Citations Regarding Psychotropic Medications
While all NFs need to remain vigilant to ensure that psychotropic medication use remains within the parameters of the applicable regulations, NFs identified as Group One or Group Two need to be especially mindful to avoid receiving additional deficiency citations related to unnecessary use of psychotropic medications.
In general, applicable regulations require clear documentation of the diagnosis and indications for placing or continuing residents on psychotropic medication therapy. CMS guidelines also instruct that residents currently on psychotropic medications should be placed on both gradual dose reduction and on behavioral interventions to discontinue their use. The duration of PRN psychotropic medications should not exceed 14 days unless the resident’s physician documents the rationale for a longer duration on the resident’s medical chart. Additionally, a PRN order can only be renewed if the attending or prescribing health care provider evaluates the resident to determine if continued use of the psychotropic drug is appropriate.
Drug regimen reviews for each resident are also required to identify potentially unnecessary drugs. Such reviews should evaluate and include the following elements to address potential unnecessary psychotropic medication use:
Disputing Deficiency Citations
Due to the imposition of a DPNA and potential CMPs even for level D (isolated, potential harm) deficiencies, Group One and Group Two NFs should dispute any psychotropic medication deficiency citation that is not well-supported by the facts. In addition to informal discussions with a survey supervisor, each NF has the option to dispute the deficiency via an informal dispute resolution (IDR) process after it receives a CMS-2567 form. A Virginia NF must file an IDR request within the same 10-day calendar period given to submit an acceptable plan of correction to the Office of Licensure and Certification. Guidance for IDRs is available on OLC’s website: http://www.vdh.virginia.gov/content/uploads/sites/96/2018/08/Informal-Dispute-Resolution-Process.pdf
The IDR process can lead to a deletion or a change in severity of the cited deficiency, which can lead to a modified or rescinded enforcement action. If a CMP is imposed, such as for Group One late adopters, the NF will also have the opportunity to conduct an independent IDR before CMS, if it requests the independent IDR within 10 days of the CMS offer and completes the process within 60 days of making the request.
While Group One and Group Two NFs will face stiff sanctions for future deficiencies related to psychotropic medications, all NFs should be mindful of the potential for increased survey scrutiny and penalties related to what CMS views as inappropriate psychotropic medication use. NF resident records must contain thorough documentation on all psychotropic and other classes of medications to comply with the updated CMS participation requirements. NFs facing potential survey deficiencies should also be prepared to reach out to legal counsel in any case where survey findings are in dispute. Should you have questions concerning survey results or potential sanctions, please contact Peter Mellette, Nathan Mortier, Harrison Gibbs, Elizabeth Dahl, or Scott Daisley at Mellette PC.
Mellette PC acknowledges with appreciation the assistance of Albana Zherka, PharmD (William & Mary Law School ’20) in the preparation of this client advisory.
This client advisory is for general educational purposes only. It is not intended to provide legal advice specific to any situation you may have. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice.
 Id. If the deficiency for either Group is for psychotropic medications (F758) related only to PRN medication limitations, which occurred on or before May 28, 2019, then the remedy imposed would be a directed plan of correction or directed in-service training because of the 18-month moratorium period.
 42 C.F.R. § 483.402(d)(1)-(2).
 S&C: 18-04-NH.
 42 C.F.R. § 483.45(e)(1).
 42 C.F.R. § 483.45(e)(2).
 42 C.F.R. § 483.45(e)(4).
 42 C.F.R. § 483.45(e)(5).
 42 C.F.R. § 483.45(d)(1)-(6).am
 S.O.M. 7212.1.
 S.O.M. 7212.3.