by James C. Sherlock

I have been asked an excellent question: What are the Virginia Health Commissioner’s responsibilities under federal and state law to regulate nursing homes? I will provide what I hope is a sufficiently complete answer.

The question is relevant because we need to ensure that episodes like the Canterbury Rehabilitation tragedy don’t happen. It did, and, as I have written, we need to know why. We will need an audit of the records of the Virginia Department of Health to see if it complied with the laws and regulations below.

First, I first refer readers to the CMS State Operations Manual^[1]. Second, I will provide relevant sections from the Code of Virginia.

CMS State Operations Manual

“Chapter 7 implements the nursing home survey, certification, and enforcement regulations at 42 CFR Part 488. No provisions contained in this chapter are intended to create any rights or remedies not otherwise provided in law or regulation.

“The nursing home reform regulation establishes several expectations. The first is that providers remain in substantial compliance with Medicare/Medicaid program requirements as well as state law. The regulation emphasizes the need for continued, rather than cyclical compliance. The enforcement process mandates that policies and procedures be established to remedy deficient practices and to ensure that correction is lasting; specifically, that facilities take the initiative and responsibility for continuously monitoring their own performance to sustain compliance. Measures such as the requirements for an acceptable plan of correction emphasize the ability to achieve and maintain compliance leading to improved quality of care. (See §7304.4 for plan of correction requirements.)

“The second expectation is that all deficiencies will be addressed promptly. The standard for program participation mandated by the regulation is substantial compliance. The State (for non-state-run facilities such as Canterbury) and the regional office (for state-run facilities) will take steps to bring about compliance quickly. In accordance with §7304, remedies such as civil money penalties, temporary managers, directed plans of correction, in-service training, denial of payment for new admissions, and State monitoring can be imposed before a facility has an opportunity to correct its deficiencies.

“The third expectation is that residents will receive the care and services they need to meet their highest practicable level of functioning. The process detailed in these sections provides incentives for the continued compliance needed to enable residents to reach these goals.

“It should be noted that references to the State would be applicable, as appropriate, to the regional office throughout this chapter when the regional office is the surveying entity. It should also be noted that in cases where the State is authorized by CMS and/or the State Medicaid Agency, the state may provide notice of imposition of certain remedies on their behalf, within applicable notice requirements.”

7304.4 – Acceptable Plan of Correction

“Except in cases of past noncompliance, facilities having deficiencies (other than those at scope and severity level A) must submit an acceptable plan of correction. The requirement for a plan of correction is in 42 CFR 488.402(d), and §7400.2 and §7400.5.3. An acceptable plan of correction must:

• “Address how corrective action will be accomplished for those residents found to have been affected by the deficient practice;
• “Address how the facility will identify other residents having the potential to be affected by the same deficient practice;
• “Address what measures will be put into place or systemic changes made to ensure that the deficient practice will not recur;
• “Indicate how the facility plans to monitor its performance to make sure that solutions are sustained; and
• “Include dates when corrective action will be completed. The corrective action completion dates must be acceptable to the State. If the plan of correction is unacceptable for any reason, the State will notify the facility in writing. If the plan of correction is acceptable, the State will notify the facility by phone, e-mail, etc.
• “Facilities should be cautioned that they are ultimately accountable for their own compliance, and that responsibility is not alleviated in cases where notification about the acceptability of their plan of correction is not made timely. The plan of correction will serve as the facility’s allegation of compliance.

“The plan of correction serves as the facility’s allegation of compliance and, without it, CMS and/or the State have no basis on which to verify compliance. A plan of correction must be submitted within 10 calendar days from the date the facility receives its Form CMS-2567. If an acceptable plan of correction is not received within this timeframe, the State notifies the facility that it is recommending to the RO and/or the State Medicaid Agency that remedies be imposed effective when notice requirements are met. The requirement for a plan of correction is in 42 CFR 488.402(d). Further, 42 CFR 488.456(b)(ii) requires CMS or the State to terminate the provider agreement of a facility that does not submit an acceptable plan of correction.”

7311 – Enforcement Action When Immediate Jeopardy Does Not Exist   

7311.1 – Actions to Be Taken

(Rev. 63, Issued: 09-10-10, Effective: 09-10-10, Implementation: 09-10-10)

7311.1 Actions to be taken.

“When the surveying entity finds that a facility’s deficiencies do not pose immediate jeopardy to resident health or safety but the facility is not in substantial compliance (as defined in 42 CFR 488.301), the surveying entity may recommend that the enforcing entity either terminate the facility’s provider agreement, or impose alternative remedies, or do both. The State may also provide formal notice of imposition and rescission of category 1 remedies and/or denial of payment for new admissions, as authorized by CMS and/or the State Medicaid Agency. (See also §7506.1 and §7314.) The action may be taken immediately or the facility may be given an opportunity to correct, as described in §7304. Also, the facility must submit a plan of correction, as described in §7304. (See also §7301 and §7305.1.)

42 CFR 488.402(d) Plan of correction requirement

(1) Except as specified in paragraph (d)(2) of this section, regardless of which remedy is applied, each facility that has deficiencies with respect to program requirements must submit a plan of correction for approval by CMS or the survey agency.

(2) Isolated deficiencies. A facility is not required to submit a plan of correction when it has deficiencies that are isolated and have a potential for minimal harm, but no actual harm has occurred.

42 CFR 488.301

“A State must establish, in addition to termination of the provider agreement, the following remedies or an approved alternative to the following remedies for imposition against a non-State operated NF:

(1) Temporary management.
(2) Denial of payment for new admissions.
(3) Civil money penalties.
(4) Transfer of residents.
(5) Closure of the facility and transfer of residents.
(6) State monitoring.

(e) Optional remedies for a non-State operated NF. A State may establish the following remedies for imposition against a non-State operated NF:

(1) Directed plan of correction.
(2) Directed in-service training.
(3) Alternative or additional State remedies.
(f) Alternative or additional State remedies.

If a State uses remedies that are in addition to those specified in paragraph (d) or (e) of this section, or alternative to those specified in paragraph (d) of this section (other than termination of participation), it must –

(1) Specify those remedies in the State plan^[2]; and

(2) Demonstrate to CMS’s satisfaction that those alternative remedies are as effective in deterring noncompliance and correcting deficiencies as the remedies listed in paragraphs (d) and (e) of this section.

The Code of Virginia. 

Virginia law references Enforcement Procedures set forth in 42 C.F.R. Part 488 quoted above

Ҥ 32.1-126. Commissioner to inspect and to issue licenses to or assure compliance with certification requirements for hospitals, nursing homes, and certified nursing facilities; notice of denial of license; consultative advice and assistance; notice to electric utilities.

32. Pursuant to this article, the Commissioner shall issue licenses to, and assure compliance with certification requirements for hospitals and nursing homes, and assure compliance with certification requirements for facilities owned or operated by agencies of the Commonwealth as defined in subdivision (vi) of § 32.1-124, which after inspection are found to be in compliance with the provisions of this article and with all applicable state and federal regulations. The Commissioner shall notify by certified mail or by overnight express mail any applicant denied a license of the reasons for such denial.
33. The Commissioner shall cause each and every hospital, nursing home, and certified nursing facility to be inspected periodically, but not less often than biennially, in accordance with the provisions of this article and regulations of the Board. However, except when performed in conjunction with an inspection required by the Centers for Medicare and Medicaid Services, no hospital, nursing home, or certified nursing facility shall receive additional inspections until all other hospitals, nursing homes, or certified nursing facilities in the Commonwealth, respectively, have also been inspected, unless the additional inspections are (i) necessary to follow up on a pre-operational inspection or one or more violations; (ii) required by a uniformly applied risk-based schedule established by the Department; (iii) necessary to investigate a complaint regarding the hospital, nursing home, or certified nursing facility; or (iv) otherwise deemed necessary by the Commissioner or his designee to protect the health and safety of the public.

 

Unless expressly prohibited by federal statute or regulation, the findings of the Commissioner, with respect to periodic surveys of nursing facilities conducted pursuant to the Survey, Certification, and Enforcement Procedures set forth in 42 C.F.R. Part 488, shall be considered case decisions pursuant to the Administrative Process Act (§ 2.2-4000 et seq.) and shall be subject to the Department’s informal dispute resolution procedures, or, at the option of the Department or the nursing facility, the formal fact-finding procedures under § 2.2-4020. The Commonwealth shall be deemed the proponent for purposes of § 2.2-4020. Further, notwithstanding the provisions of clause (iii) of subsection A of § 2.2-4025, such case decisions shall also be subject to the right to court review pursuant to Article 5 (§ 2.2-4025 et seq.) of Chapter 40 of Title 2.2.”

12VAC30-20-251. Termination of Provider Agreement.

Part VI

Nursing Facility Enforcement

488. Mandatory termination. As set forth by 42 CFR 488.408 (1995), the Commonwealth shall (i) impose temporary management on the nursing facility; (ii) terminate the nursing facility’s provider agreement; or (iii) impose both of these remedies when there are one or more deficiencies that constitute immediate jeopardy to resident health or safety. In addition, the Commonwealth shall terminate the nursing facility’s provider agreement when the nursing facility fails to relinquish control to the temporary manager, or in situations when a facility’s deficiencies do not pose immediate jeopardy, if the nursing facility does not meet the eligibility criteria for continuation of payment set forth in 42 CFR 488.412(a) (1995).
489. The Commonwealth shall have the authority to terminate a nursing facility’s provider agreement if such nursing facility:
490. Is not in substantial compliance with the requirements of participation, regardless of whether or not immediate jeopardy is present; or
491. Fails to submit an acceptable plan of correction within the timeframe specified by the Commonwealth. For purposes of this section, substantial compliance shall be defined as meaning a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

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^[1]

CMS State Operations Manual. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.

^[2] I have not been able to locate online the State Plan required by CMS