immediate jeopardy? now what? successful strategies for protecting your ... jeopardy_bello...

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Immediate Jeopardy? Now What?

Successful Strategies forProtecting Your Facility

Jane Bello Burke, [email protected]

LeadingAge New YorkDirectors of Nursing Services/Directors of Social Work

2014 Annual Conference & Exposition

Accidents: Resident environments must remain as free of accident hazards as possible.

Abuse Investigation and Reporting: Facilities must ensure immediate reporting of all alleged violations

involving mistreatment, neglect or abuse, including injuries of unknown source and misappropriation of resident property;

thoroughly investigate alleged violation and prevent further potential abuse while the investigation is in progress; and

report the results of all investigations to the Administrator or his designated representative within five working days

2©2014 Hodgson Russ LLP

Perennial Hot Topics

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Quality of Care: Residents must be provided the necessary care and services to enable them to achieve their highest levels of physical, mental, and psychosocial well-being.

Care Planning Requirements: Facilities must develop individualized comprehensive care plans to help ensure that each resident receives necessary care and services.

Professional Standards: Facilities must ensure that the services they provide meet professional standards of quality.


More Perennial Hot Topics

Administration (F490): a facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain each resident’s highest practical physical, mental and psychosocial well being.

Governing Body (F493): the governing body is legally responsible for establishing and implementing policies and for appointing the licensed administrator, who is responsible for the management of the facility.

Medical Direction (F501): the medical director is responsible for the implementation of resident care policies and the coordination of medical care in the facility.

Quality Assurance (F520): a facility must have a QAA committee consisting of the DON, a physician and at least three other staff members, meeting at least quarterly to identify issues and develop and implement plans of action to correct identified quality deficiencies.


Tag-Along Tags

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Remedies/SanctionsCMP -- Civil Money Penalty

Per Day Per Instance

DoPNA -- Denial of Payment for New Medicare and Medicaid Admissions

Loss of NATCEP Approval -- Nurse Aide Training and Competency Evaluation Program

Termination from Medicare and Medicaid Program


Consequences ofAdverse Survey Determinations

CMP$4,500/day for 17 days = $76,500Reduced to $250/day for an additional 20 days

until substantial compliance = $5,000Total = $81,500

Loss of NATCEP Approval If CMP ≥ $5,000

Other “Contingent” Consequences


Sample: CMS’s “Determination”

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http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Downloads/usersguide.pdf

©2014 Hodgson Russ LLP

Impact of Deficiencies on Five-Star Ratings

• Other Potential Effects:• Collateral Use in Civil/Criminal Actions

• Attorney General/ Inspector General Investigations

• “Worthless Services” Claims

• Reputational Loss• Special Focus Facility Status

• NH Quality Pool Reimbursement

• Adverse CON Determinations

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Collateral Consequences

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Points assigned based on scope and severity (more for higher-level deficiencies)

More points for substandard quality of care deficiencies If status is “past non-compliance” and severity is IJ (J, K or

L), then the points for “G” level deficiency apply Life safety surveys not included in rating calculations Deficiencies from federal comparative surveys not

reported on NH Compare or included in rating calculations

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http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Downloads/usersguide.pdf


Five‐Star Calculation Rules

Correct the Record Hold Surveyors Accountable:

for exaggerating or misstating the facts, or for misapplying the regulations

Reduce a Huge Penalty Mitigate Other Adverse Consequences Challenge the Duration of “Per Diem” CMPs Support Staff (who sometimes simply need

someone to hear their side of the story)


Why Challenge Adverse Survey Determinations?

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Independent Dispute ResolutionStandard IDR

Independent IDR

Alternatively or in Addition:Appeal to HHS Departmental Appeals Board


How to ChallengeAdverse Survey Determinations

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IDR and Independent IDR

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What is IDR?• IDR is an informal process to dispute regulatory

deficiencies• Where to IDR?

• At G level or higher review at Central Office level• Below G level at Regional Office

• How to IDR?• On written submissions• Face-to-face IDR no longer available in New York


Informal Dispute Resolution

What is Independent IDR? The Affordable Care Act provides for: collection and escrow of CMPs prior to the

completion of appeal, and opportunity to request Independent IDR, if CMS

imposes a CMP which is subject to collection and placement in escrow before completion of the appeal

CMS may collect CMP and place it in escrow on earlier of: the date of completion of Independent IDR, or 90 calendar days after the date of the notice of

imposition of the CMP14©2014 Hodgson Russ LLP

Independent IDR

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Why I/IDR? Develop the facts and

test the validity of a possible appeal

Better recall during initial 10-day period

Ability to challenge lower-level deficiencies

No waiver of 35% discount

Why Not I/IDR? Expense

Limited time and resources (during 10-day POC period)

Possible development of additional evidence/ statements

IDR is not binding on CMS


To IDR or Not to IDR?

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Standard IDR Independent IDR

Timing 10 days after receipt of DOH SOD

10 days followingreceipt of CMS Letter

Panel NY LNHAs and LTC Ombudsman, with NY surveyor advice

New Jersey surveyors

Format Written submissionsNo face-to-face

Written submissionsNo face-to-face

Facility must select one(cannot pursue both IDR and Independent IDR)


Standard vs. Independent IDR

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Facility cannot challenge:• Scope or severity, except substandard

quality of care and immediate jeopardy• Choice of remedy• Alleged failure to comply with survey

process• Alleged inconsistency of the survey team• Alleged inadequacies or inaccuracy of the

IDR process


Limitations on I/IDR

Ask:Are the allegations in the SOD accurate and

complete?Did a regulatory violation occur? Is there a causal connection between the alleged

regulatory citation and the harm/potential harm? Decide: If yes, consider opportunities for improvement If no, start writing the challenge


The Investigation Process

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Understand the Regulatory Requirement Refer to the SOM App. PP interpretive guidelines:

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf

Independently Investigate Each Allegation Interview all witnesses (and have a witness!) Ask: Are these facts accurate?

Did you say this? Review the Resident’s Chart (including portions not cited)


Investigation Tips

Factual Challenge The Facility disputes the allegation that … Explain factual basis and provide evidentiary support

Regulatory Challenge The Facility challenges the conclusion that this condition

violated the regulations, because … The regulations require … According to the SOM, Guidance to Surveyors, … Explain how the facts reflect substantial compliance

Explain Immaterial/Irrelevant Allegations: The allegation that … does not establish a deficient condition, because …

Identify and Provide Relevant Documents


I/IDR Statement: Outline of Issues

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CMS/DOH must show causal connection between alleged regulatory violation and the harm or potential for harm.

The standard is substantial compliance, not perfection.


Keep In Mind:

IJ is where noncompliance “has caused, or is likely to cause, serious injury, harm, impairment, or death” Severity: Three components of IJ:

Harm – there was no actual or potential serious injury, harm, impairment, or death, because …

Immediacy – there was no immediacy, because … Culpability – there was no capability, because …

Ask: Do the three elements exist?Refer to SOM App. Q Guidelines for IJ:

Scope: Was the condition isolated/pattern/widespread?

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https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_q_immedjeopardy.pdf


I/IDR Statement: Outline of Issues

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Accidents: Facility not responsible for unavoidable outcomes that are not reasonably foreseeable

Care Planning Requirements: Facility not responsible for unavoidable outcomes based on resident’s condition

Significant Medication Errors: Facility not responsible unless error causes resident discomfort or jeopardizes health and safety, with determination of significance based on: (i) resident’s condition; (ii) drug category; (iii) frequency of error

Professional Standards: based upon accepted standards of clinical practice as reflected in professional organization, licensing board, or accreditation body publication or other regulatory agency, or in clinical literature.


Remember:

As you peel away the layers, ask:

How did this factor contribute to the problem, or the perceived problem?

Have we fixed it? If so, how? If not, what do we need to do?

What oversight measures should we put in place to make sure this issues stays fixed?


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ADMINISTRATIVEAPPEAL PROCESS


Two Levels

CRD -- Civil Remedies Division (single ALJ)

DAB -- Departmental Appeals Board (panel)

Appeal to Federal Court


DAB Basics

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While the statute appears to allow challenges to any enforcement determination or decision by the HHS Secretary, in practice:

the DAB may review only certain “initial determinations,” including

a finding of noncompliance that results in the imposition of any enforcement remedy

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Limits on Appeals


A facility has no right to appeal: a determination of noncompliance (a deficiency citation),

but instead, only the remedy imposed as a result of that determination

the State’s recommendation that CMS impose a remedy an adverse IDR or Independent IDR decision

Facilities may appeal only those remedies that persist through the appeal so, if CMS imposes, then withdraws, a remedy (because it

fears it might lose), the ALJ will dismiss the appeal the DAB consistently holds that the withdrawal of the

remedy eliminates the facility’s right to appeal


Limits on Appeals

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Per Instance CMPs -- if the only remedy is a “per instance” CMP, the facility may not appeal the “severity” of a citation, because a “per instance” CMP may be imposed

without regard to the level of “severity” Loss of NATCEP

42 C.F.R. § 489.3 provides for review of loss of NATCEP approval, but

the facility needs to be operating such a program at the time of the survey and appeal to base its appeal on this ground


Other Limitations

The 60-Day Rule

“Request for Hearing” is due within 60 days after receipt of the CMS determination letter imposing the federal remedy

A request for I/IDR does not toll or extend the deadline for filing the appeal


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The Request for Hearing must:identify the specific issues, and the findings offact and conclusions of law with which the[facility] disagrees, [and must] specify the basisfor contending that the findings and conclusions are incorrect.

The Request for Hearing must set forth in considerable detail: the precise basis for the facility’s case the facility’s factual disagreement with each cited

deficiency that supports the remedy


Content of the Request for Hearing

Noncompliance is a mixed question of fact and law: Are the agency’s allegations accurate and complete? (What

are the facts?) Does the regulatory provision reach the act or omission?

(What is the law and does it apply?)

CMS bears the initial burden of proceeding: CMS must establish a “prima facie case” of noncompliance, by Offering evidence regarding each element of each disputed

allegation of noncompliance (i.e., by applying the facts to the law and demonstrating a violation)


Burdens of Proceeding and Proof

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Pros ConsThe Facts are

Incorrect/IncompleteThe Facts are

Substantially Correct

The Surveyors Misconstrued the

Regulations

The Surveyors Correctly Interpreted

the Regulations

There was Little or No Impact on Resident

Condition

There was an Adverse Impact on Resident

Condition


Analysis: Mixed Questions of Fact and Law

The Facility was in Substantial Compliance CMS did not make a prima facie showing of any

deficient practice, because … To the extent it did, the preponderance of the

evidence at the hearing will demonstrate that the Facility was in substantial compliance, because …

Alternatively, the assertion of an immediate jeopardy was clearly erroneous, because …

The penalty was excessive (and/or continued in effect for too long), because …


Appeal Statement: Outline of Issues

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SOM App. PP (Interpretive Guidelines),App. Q (Guidelines for IJ)

ALJ Opinions http://www.hhs.gov/dab/decisions/civildecisions/index.html

DAB Decisions http://www.hhs.gov/dab/decisions/dabdecisions/index.html

Federal District Court Decisions


What are the Sources of Law?

Citations with a factual or legal error or excessive scope and severity

Citations that affect the CMP or denial of payment (e.g., immediate jeopardy)

Derivative deficiencies based on the same facts under different tags (e.g., F490, F493, F501, F520)

Start/end date of the deficiency, if it affects CMP Only those deficiencies with a reasonable

likelihood of success


Choosing Your Battles

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Early Preparation is Key!

Use the initial 10-day period following the receipt of the SOD to prepare: I/IDR request; or alternatively

Immediate CMS appeal

with the direction to be determined on a case-by-case basis

Use the results of the case preparation to bolster QA activities

Jane Bello Burke, Esq.Hodgson Russ, LLP

[email protected]

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Questions?