The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule (the “Proposed Rule”) with the stated intention to relieve the administrative burden placed on nursing facilities that participate in Medicare or Medicaid through the Requirements of Participation (“ROPs”) found at 42 C.F.R. §483. Comprehensively overhauled in 2016, the ROPs are in the process of being implemented in three phases. Phase 1 (November 2016) and Phase 2 (November of 2017) have already been implemented, with Phase 3 currently scheduled to take effect November 2019.
The Proposed Rule would change those sections of the ROPs that have already been implemented to relieve nursing facilities of “obsolete, excessively burdensome, and duplicative requirements.” The Proposed Rule would also delay the implementation of Phase 3 until one year after the publishing of a Final Rule.  If finalized, the Proposed Rule will require nursing facilities to make adjustments in how they implement the existing ROPs as well as their preparations for implementation of Phase 3. CMS anticipates significant cost savings to nursing facilities if the Proposed Rule is finalized in its current form. A comment period on the Proposed Rule is open until September 16, 2019. Below is a summary of the proposed changes that will affect nursing home ROPs.
CMS Proposed Changes
CMS is proposing to delay implementation of Phase 3 sections amended by the proposed rule. CMS is proposing to delay the implementation of Sections 483.75(a)(1) and (4), 483.75 (b)(1)-(4), 483.75(c)(1)-(4), 483.75(d)(1)-(2), 483.75(e)(1)-(3), 483.75(f)(1)-(6), 483.75(g)(2)(iii), 483.85(a)-(e), 483.95(d), and 483.95(f)(1)(2) until one year after the effective date of the final rule. As for the Infection Preventionist, CMS believes that the amended provisions concerning the Infection Preventionist constitute enough of a relief of burden that delay is unnecessary. The proposed rule also amends the following sections and provisions:
Current rules require nursing facilities to inform residents of the name and specialties of the physician and other primary care professionals responsible for his or her care. To relieve the burden of maintaining an exhaustive list of the healthcare professionals responsible for each resident, CMS proposes amending the language to require nursing facilities to provide residents only with their primary care professional’s name and contact information upon admission, with any change, and upon request.
CMS also proposes to soften the regulations requiring a grievance process by attempting to clarify the difference between a grievance and “general feedback” that does not require a grievance procedure. Under the Proposed Rule, “general feedback” typically concerns general issues that can be resolved quickly, while “grievances” relate to more serious issues that require investigation, although no specific definitions are provided. Absent further definition, it is the responsibility of the nursing facility to make the determination whether a complaint constituted a grievance or feedback and inform the resident of that decision.
CMS also proposes to remove the specific duties required of a grievance official and the specific requirements of grievance decisions, giving facilities more flexibility in how they handle grievances and feedback. Under the proposed rule, a grievance decision should contain pertinent information including summary of findings, conclusions, and corrective action taken. The time required to retain written evidence of grievance results would be shortened from 3 years to 18 months.
Nursing facilities are currently required to send copies of discharge notices to the State Long-Term Care Ombudsman for any “facility-initiated discharge.” CMS proposes to limit that requirement to “facility-initiated involuntary transfers or discharges.” In this provision, “facility-initiated involuntary transfers or discharges” would mean a “transfer or discharge 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.” Notably, the Proposed Rule would eliminate the requirement to provide notice to the Ombudsman for residents who are transferred to an acute care facility when return is expected.
CMS proposes to revise §483.25(n) to replace references to “installation” of bed rails to “use” of bed rails. This revision accounts for beds purchased by nursing facilities that have bed rails installed.
CMS proposes to reduce the time that a nursing facility must retain posted nursing staff data from 18 months to the greater of 15 months or as required by state law.
CMS proposes to remove language in Sections §483.40(a) and (c) that it feels is duplicative of language in Sections §483.35 and 483.65(a) respectively.
In what would be a significant departure in how anti-psychotic medications are treated under current rules, CMS proposes to eliminate the distinction between anti-psychotics and other psychotropic medications. Instead of requiring in-person examinations to extend anti-psychotic medications past 14 days, prescriptions of both types of medicines could be extended beyond 14 days if the attending physician or prescribing practitioner believes the extension to be appropriate and documents their rationale for this belief and the duration of the order in the patients’ medical record.
CMS proposes to amend the requirements for a Director of Food and Nutrition Services to one who has at least two years’ experience in that position or “has completed a minimum course of study in food safety that includes topics integral to managing dietary operations such as, but not limited to, foodborne illness, sanitation procedures, and food purchasing/receiving.” The Director would still be required to have the appropriate competencies and skills to perform the job and to regularly consult with a qualified dietician or clinically qualified nutrition professional.
CMS proposes to remove the requirement of §483.70(e)(3) that the facility assessment include a facility and community-based risk assessment, as CMS believes this is covered by the requirement in §483.73(a). This is accompanied by a clarification that data collected during the facility assessment can be used to inform other policy and procedures required by these regulations. Additionally, CMS proposes to permit facilities to conduct a biennial assessment, rather than being required to make annual updates.
The Proposed Rule would significantly pare back many of the specific elements of QAPI programs as required by existing rules that are currently scheduled to be implemented as part of Phase 2. These changes eliminate some of the specific requirements of the QAPI program to allow facilities greater authority in their QAPI implementation.
CMS proposes to eliminate the requirement that the Infection Preventionist work part-time at the facility or have frequent contact with the infection prevention and control program. Instead, the Proposed Rule would require that the Infection Preventionist have sufficient time at the facility to meet the objectives of the infection prevention and control program.
CMS proposes to eliminate many of the specific compliance and ethics provisions not required by statute as unnecessary to ensure quality and safety standards. CMS would eliminate the requirement for each facility to have a compliance officer and for each organization with five or more facilities to have a compliance liaison. Instead, organizations would need a compliance and ethics program appropriate for the organization and its facilities. CMS would also replace the annual assessment requirement with a “periodic” assessment requirement.
CMS also proposes that the operating organization for each facility develop, implement, and maintain a compliance and ethics program with established, written “standards, policies, and procedures that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations. . .” A high level person in the operating organization must be assigned to oversee this. The compliance and ethics program must be effectively communicated to the entire staff of the operating organization, and reasonable steps must be taken to ensure compliance. Organizations with five or more facilities must have a more formal program that is appropriate for its organizational complexity.
CMS proposes to allow nursing facilities that were Medicare or Medicaid certified before July 5, 2016 to continue to use the 2001 Fire Safety Equivalency System mandatory values when determining compliance for containment, extinguishment and people movement requirements. Additionally, CMS proposes to apply the following regulations only to newly constructed or certified facilities: (1) the requirement for a bathroom with a sink and toilet in each resident bedroom and (2) the requirement prohibiting no more than two residents to a bedroom. Both these changes are proposed to relieve the financial burden that would have been inflicted upon older facility owners who would be forced to undertake substantial construction to comply with the new regulations.
Two types of informal dispute resolution will remain in place for providers seeking to dispute survey findings or sanctions. CMS proposes to add language to the regulations that require IDR at the state level to be completed within 60 days of the facility’s IDR request. Furthermore, CMS proposes to add language that survey results will not be added to the Certification and Survey Provider Enhanced Reports (CASPER) System until after the conclusion of an IDR or IIDR. CMS proposes to add language that requires “a component of an umbrella state agency [to have] a specific understanding of Medicare and Medicaid programs requirements” in order to be approved to conduct an IIDR.
Currently, when an outside entity conducts an IIDR based on a survey, the results only serve as a recommendation to the State or CMS. The State or CMS still have the ability and independent judgment to disagree with the recommendation from the IIDR entity. CMS proposes to add language that requires the facility be provided with the written record that describes the rationale for the result of an IIDR.
Currently, facilities who receive a notice of imposition of civil money penalties can waive a right to a hearing to challenge the sanction and receive a 35% discount. CMS proposes to apply the 35% discount to any nursing facility that does not file an appeal without requiring an affirmative waiver.
CMS estimates that this proposed regulation will result in annual cost savings over each of the next five years of $616 million for nursing facilities due to the relief of burdensome administrative requirements and costly construction requirements. Comments on the proposed rule are due by 5 p.m. on September 16, 2019. Should you have any questions concerning these proposed regulations or if you wish to consider filing a comment, please contact Peter Mellette, Nathan Mortier, Harrison Gibbs, Elizabeth Dahl, or Scott Daisley at Mellette PC.
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.
 84 Fed. Reg. 34751-34752 (Sept. 16, 2019).
 Id. at 34740.
 Id. at 34741.
 Id. Note that CMS has previously clarified the timing of required notices by guidance document S&C 17-27-NH (May 12, 2017), available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-17-27.pdf.
 Id. at 34742.
 Id. at 34742-34743.
 Id. at 34743.
 Id. at 34744.
 Id. at 34745.
 Id. at 34745-34746.
 Id. at 34746-34747.
 Id. at 34747.
 Id. at 34748.
 Id. at 34749.
 Id. at 34750.
 Id. at 34751.