Successful Strategies to Challenge Survey Enforcement Action

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SUCCESSFUL STRATEGIES TO CHALLENGE SURVEY
ENFORCEMENT ACTION Kenneth L. Burgess, JD
Poyner Spruill, LLP Raleigh, North
Carolina Julie Bowman-Mitchell, JD, LLM Health
Law Copeland, Cook, Taylor Bush, PA Ridgeland,
Mississippi
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• Successfully
• Navigating the IDR
• Process
• Lessons from the DAB

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You had a bad survey now what?

• CMS has certain expectations when it comes to
  nursing homes and their residents.
• Providers must remain in substantial compliance
  with the Medicare/Medicaid program requirements
  as well as state law.
• All deficiencies will be addressed promptly.
• Residents will receive the care and services they
  need to meet their highest practicable level of
  functioning.

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You had a bad survey now what?

• 2567 will trigger your appeal rights
• Focus on your POC but remember your POC can be
  used for and against you.
• Use a disclaimer
• Be careful of false statements

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Focus on Your POC

• In order for your POC to be acceptable, it must
• Contain elements detailing how the facility will
  correct the deficiency as it relates to the
  individual
• Show how the facility will act to protect
  residents in similar situations
• Include measures the facility will take or the
  systems it will alter to ensure that the problem
  does not recur.
• Indicate how it plans to monitor its performance
  to make sure that solutions are sustained and
• Provide dates when corrective action will be
  complete. SOM 7304D

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Successfully Navigating IDR

• What is IDR?
• Informal Dispute Resolution (IDR) is the
  process by which facilities can informally
  dispute regulatory deficiencies cited by the
  State Survey Agency. It is your one-shot freebie.

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Successfully Navigating IDR

• States are to notify facilities of their right to
  IDR in the letter transmitting the Official 2567.
  This notice should inform the facility of its
  rights and duties in IDR.

NOTICE
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Successfully Navigating IDR

• To appeal or not to appeal?
• You have a right to appeal.
• IDR 42 CFR 488.331
• DAB 42 CFR 498, et. seq.

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Successfully Navigating IDR

• IDR Notice from the State should include
• Right to IDR
• Name, address and telephone number of the person
  the facility must contact to request the IDR
• How IDR may be accomplished in that state, e.g.,
  telephone, in writing, or in a face-to-face
  meeting.
• Name and/or position title of the person who will
  be conducting the IDR, if known.

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Successfully Navigating IDR

• IDR (continued)
• A facility may request IDR for each survey that
  cites a deficiency. Facilities cannot use IDR to
  challenge any other aspect of the Survey process,
  including the
• Scope and Severity of the deficiencies, with the
  exception of SQC and IJ
• Remedy(ies) imposed by the enforcing agency
• Alleged failure of the survey team to comply with
  the survey process
• Alleged inconsistency of the survey team
• Alleged inadequacies or inaccuracy of the IDR
  process

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Successfully Navigating IDR

• A facility may request IDR based upon the results
  of a revisit or the previous IDR outcome if
• It is a continuation of the same deficiency or
  revisit
• There is a new deficiency (new or changed facts,
  new tag) at revisit or IDR
• It is a new example of a deficiency (new facts,
  same tag)
• At revisit or IDR if there is a different tag but
  same facts at revisit or IDR that constitutes
  substandard quality of care

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Successfully Navigating IDR

• Why IDR?
• Nothing to lose
• No waiver of discount
• Practice
• Memory recall
• Deficiencies will not be uploaded to Nursing Home
  Compare until IDR is complete
• IJ
• Pending or threatened litigation

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Successfully Navigating IDR

• Why not IDR?
• Limited time and resources
• Can raise new tags
• Can create suspect with regard to evidence
• IDR is not binding on CMS

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Successfully Navigating IDR

• If you choose IDR
• Request must be in writing.
• Request must include an explanation of the
  specific deficiencies that are being disputed.
• Request must be made within the same 10 calendar
  day period the facility has for submitting an
  acceptable POC.

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Successfully Navigating IDR

• You win! Now what?
• The deficiency is deleted, enforcement action
  resulting from that deficiency should be
  rescinded, and the s/s should be adjusted.
• To get a clean 2567 you must submit a clean POC.

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Successfully Navigating IDR

• When a facility is unsuccessful at IDR, the
  State must provide written notice of the results
  to the facility.

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Successfully Navigating IDR

• Things to note
• Failure to complete IDR will not delay
  enforcement, nor will it toll your time for an
  ALJ hearing.
• Imposition of remedies will not be tolled by a
  pending IDR process

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Successfully Navigating IDR

• When IDR is done with the state rather than CMS,
  CMS is not bound by the result.
• CMSs findings of noncompliance take precedence
  over state agencys findings of compliance.

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Successfully Navigating IDR

• Mistaken reliance on possibly misleading
  information from state agency is not good cause
  for failing to file a formal ALJ hearing request
  while IDR is ongoing.

OOPS!
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Successfully Navigating IDR

• Federal IDR
• Same as states
• Disclaimer is given to facility that IDR is
  informal and in no way to be construed as a
  formal evidentiary hearing.
• Counsel may accompany facility at a face-to-face
  meeting.
• CMS will verbally relay decision with written
  decision to follow.

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Successfully Navigating IDR

• All states must offer IDR in compliance with 7212
  of the SOM.
• CMS Memorandum June 12, 2003
• CMS Memorandum December 16, 2004

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LESSONS FROM THE DAB
Departmental Appeals Board
Departmental Appeals Board
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Lessons from the DAB

• Petition/Complaint
• Plead everything in your formal appeal in detail
• Each citation and Tag number challenged
• Challenge to overall finding of noncompliance
• Each remedy challenged
• Duration of remedies if can be legitimately
  argued
• Any findings of substandard quality of care
• Level of CMPs

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Lessons from the DAB

• Petition/Complaint
• Unchallenged deficiencies are deemed final
• Substantial noncompliance with only one
  participation requirement can support the
  imposition of a penalty

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Lessons from the DAB

• Petition/Complaint
• Summary disposition may be issued even without
  holding an in-person hearing where the facility
  fails to provide facts to dispute those facts
  offered by CMS in its 2567

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Lessons from the DAB

• Right to a Hearing
• You have 60 days from receipt of notice from CMS
  to timely file your request for an ALJ hearing.
• Failure to timely file your request will bar your
  right to appeal except where you can make a
  showing of good cause.
• Human error is NOT good cause
• Filing a plan of correction does not toll your 60
  days
• IDR does not toll your 60 days

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Lessons from the DAB

• Right to a Hearing
• If you feel the facility is in substantial
  compliance with participation requirements, you
  must come forward with something to show this
  compliance.
• CMS has no burden of producing facts showing a
  continuing state of noncompliance after an
  initial finding of same a presumption of
  noncompliance is established.

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Lessons from the DAB

• Right to a Hearing
• If you have no right to a hearing, the ALJ may
  dismiss the hearing request.
• CMS must actually impose a proposed remedy to
  grant a right to a hearing mere citation of a
  deficiency is not enough.
• You may withdraw your hearing request at any time
  prior to the hearing.

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Lessons from the DAB

• Burden of Proof and Evidence in Appeals
• CMS has the initial burden of making a prima
  facie case of a regulatory violation.

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Lessons from the DAB

• Burden of Proof and Evidence in Appeals
• CMS must show causal connection between alleged
  regulatory violation and the harm or potential
  for harm upon which it relies to support a
  deficiency.
• Once CMS establishes the presence of a
  deficiency, they have no additional burden to
  prove scope and severity.

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Lessons from the DAB

• Allegations of New Deficiencies by CMS During
  Appeals
• CMS may add a new deficiency during an appeal,
  under a different regulatory provision and tag
  number, to the deficiencies identified in the CMS
  2567 survey report
• The new alleged deficiency must be based upon
  facts relied upon by CMS which you have ample
  notice of via the 2567

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Lessons from the DAB

• CMSs Right to Impose CMPs for Any Noncompliance
• CMS has the discretion to impose CMPs for any
  instance of noncompliance, defined as any
  deficiency which poses the potential for more
  than minimal harm.
• Regulations direct CMS to impose CMPs to remedy
  level "F" or higher level deficiencies, but CMS
  may also impose CMPs for substantial
  deficiencies, level D" or higher

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Lessons from the DAB

• CMSs Right to Impose CMPs for Any Noncompliance
• You must focus on disproving the existence of the
  deficiency, the level of the deficiency or the
  duration of the deficiency and cannot simply
  challenge the right of CMS to impose a CMP
  because the deficiency did not involve the
  existence or allegation of actual harm.

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Lessons from the DAB

• CMSs Right to Impose CMPs for Any Noncompliance
• Substantial noncompliance with only one
  participation requirement can support the
  imposition of a penalty, i.e. challenge all
  deficiencies that may result in CMPs in the
  initial request for hearing.

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Lessons from the DAB

• Appealing the Amount of CMPs
• ALJs may find CMP levels to be excessive and
  reduce them, particularly where one or more
  deficiencies are overturned by the ALJ, or are
  found to be at a lower level than cited by CMS
• ALJs do not, however, have authority to overturn
  CMSs decision to select a CMP as the remedy of
  choice if a deficiency is upheld

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Lessons from the DAB

• Appealing the Amount of CMPs
• CMS is not required, as part of its case in
  chief, to present evidence on any or all of the
  factors or to explain its reasoning process in
  determining the amount of CMP to impose.

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Lessons from the DAB

• Appealing the Amount of CMPs
• If you want to challenge the amount of CMPs, you
  must actually make that specific challenge up
  front.
• Merely disputing the basis for CMPs, and failing
  to challenge whether or not the amount is
  reasonable based on the factors that CMS and the
  ALJ must consider, is not enough.

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Lessons from the DAB

• Appealing the Duration of CMPs
• You may challenge duration of noncompliance or
  deficiency
• However, if you do not offer an argument or
  evidence to challenge the alleged duration of
  noncompliance, CMSs determination is deemed
  administratively final

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Lessons from the DAB

• Competence of Surveyors as Clinical Witnesses
• Facilities attacking the competence of surveyors
  to assess a clinical issue must show specific
  evidence of a lack of knowledge, training or
  other basis for clinical expertise to
  successfully rebut CMSs clinical witnesses
• You cannot rebut CMSs prima facie case by
  showing that a surveyor has been off the floor
  for a period of time

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Lessons from the DAB

• Standard of Care
• The standard of care is substantial compliance,
  NOT strict liability.
• You must provide care and services to maintain
  highest practicable well-being of facility
  residents
• You will not be punished for unavoidable outcomes
  or untoward events that could not be reasonably
  foreseen.

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Lessons from the DAB

• Immediate Jeopardy (IJ)
• IJ exists if a facilitys noncompliance has
  caused or is likely to cause serious injury,
  harm, impairment, or death to a resident
• Actual harm is not required
• Key is whether a resident in that condition could
  have been injured

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Lessons from the DAB

• Immediate Jeopardy
• CMS may determine whether IJ existed even if
  state survey agency did not make that
  determination or impose remedies
• ALJ is permitted to rely on past events to
  determine whether noncompliance existed at the
  time of a survey

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Lessons from the DAB

• Comprehensive Assessments
• Comprehensive assessments are part of the care
  and services necessary to maintain highest
  practicable well-being of residents
• Residents right to refuse treatment does not
  excuse you from performing comprehensive
  assessments or offering appropriate services

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Lessons from the DAB

• Plan of Correction (POC) Must Actually Be
  Implemented
• You cannot overcome CMSs prima facie case simply
  by referring to a POC submitted to the state
  agency.
• A POC is merely a representation of what you
  intend to do to correct a deficiency it is the
  implementation of the POC that actually corrects
  deficiencies.

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Lessons from the DAB

• Hydration
• The regulations and the SOM do not specify what
  assessments and care plans are to look like or
  how detailed they are to be
• A survey is a result-oriented process if alleged
  dehydration is observed, presumption arises that
  inaction or deficient action by the facility was
  the cause, and CMS has made its prima facie case

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Lessons from the DAB

• Elopement/Wandering
• There is an unstated presumption that all
  elopements are preventable
• While you are only required to have in place
  procedures and policies to prevent wandering,
  when wandering occurs, the ALJs and the DAB
  virtually always find the facility had
  ineffective procedures in place to prevent
  resident wandering

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Lessons from the DAB

• Elopement/Wandering
• Actual harm is unnecessary for a residents
  elopement to constitute immediate jeopardy
• Based more on whether a resident in that
  condition could have been injured likelihood of
  potential for more than minimal harm
• The duty to protect goes beyond the walls of the
  facility

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Lessons from the DAB

• Elopement/Wandering
• Care-planning alone is not enough to constitute
  having effective procedures in place
• You must do all the facility reasonably can to
  protect residents from foreseeable risks of harm
  due to elopement
• However, you can sometimes prevail in
  wandering/elopement cases where the facility has
  taken a full range of preventive measures and
  documented them

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Lessons from the DAB

• Elopement/Wandering
• CMS is increasingly citing providers in
  wandering/elopement cases under both the accident
  prevention tag and for failing to administer the
  facility in a manner that enables residents to
  attain or maintain the highest practicable
  well-being of each resident

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Lessons from the DAB

• Accidents
• You are only required to have in place procedures
  and policies to prevent accidents
• Policies and procedures and subsequent
  interventions must be effective in the particular
  circumstances to prevent resident accidents
• Potential interventions must be implemented in a
  systematic, reliable manner

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Lessons from the DAB

• Accidents
• Your duty to provide adequate supervision and
  assistance devices to prevent accidents does not
  require a facility to be free of all accidents
• It does not impose strict liability on a facility
  for accidental injuries
• It does require a facility to take all reasonable
  measures within its power to prevent accidents

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Lessons from the DAB

• Accidents
• It is not necessary for CMS to show actual harm,
  only that the situation created a potential for
  more than minimal harm
• However, where a staff member assisting a
  resident failed to visually observe the resident
  momentarily, this did not establish that the
  resident would be placed at risk and thus did not
  support a deficiency based on inadequate
  supervision to prevent accidents

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Lessons from the DAB

• Accidents
• A facilitys duty to ensure that a resident
  receives adequate supervision and assistive
  devices to prevent accidents extends to
  situations where the resident is under temporary
  care of spouse/relative

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Lessons from the DAB

• Accidents
• Human error by a staff member is not a defense
• However, a facility may win an appeal of an
  isolated instance of staff malfeasance if the
  staff member was properly trained and supervised
  and the facilitys policies and care planning are
  in order
• But the incident must truly be an isolated
  instance and an isolated mistake that occurred in
  spite of, not because of, the facility policy,
  training and oversight

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Lessons from the DAB

• Accidents
• You must
• develop policies which implement protocols and
  procedures that are designed to minimize
  potential risks
• plan and implement care for individuals to
  minimize their risk of sustaining accidents
• train and supervise your staff so as to minimize
  the possibility of accidents resulting from staff
  errors

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Lessons from the DAB

• Abuse
• Does not require an intent to inflict harm, only
  that the incident was intentional and otherwise
  meets the abuse definition.
• Federal law governing abuse reporting trumps
  state law provisions and requires reports of
  allegations of abuse, whether or not they are
  substantiated.

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Lessons from the DAB

• Abuse
• Where your facilitys own policy defines an act
  or an omission as either abuse or neglect, a
  violation of that policy is sufficient to
  establish a finding of abuse or neglect by the
  facility
• Thus, your policy can become Exhibit A in CMSs
  case

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Lessons from the DAB

• Getting Proactive
• Upon discovery of potential violation, ask
  yourself
• what have I done, how and when to fix the
  problem?
• what have I done, how and when to decide if other
  residents are at risk from same issue?
• what system have I put in place and which staff
  are implementing that system to ensure the fix
  continues to work?
• have I documented all of this?

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Lessons from the DAB

• Provider Appeals to the Federal Court
• Final decision by DAB may be appealed to federal
  district courts, and ultimately to U.S. Ct. of
  Appeals
• However, federal courts tend to defer to the
  expertise, judgment and decisions of the DAB in
  these cases, absent clear evidence that the DAB
  has acted arbitrarily and capriciously in
  reviewing the case

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Lessons from the DAB

• Termination of Provider Agreements upheld where
• Facility contests validity of CMS regulations
  rather than survey facts and findings
• Facility failed to appeal in timely manner
• Facility failed to identify specific issues in
  CMS initial determination which it disagrees with
  
• Facility failed to prove it actually implemented
  a plan of correction designed to assure that no
  future incident occurs

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Lessons from the DAB

• Termination of Provider Agreements enjoined by
  federal courts where
• Facility shows not only irreparable harm to
  itself or to residents that is not outweighed by
  harm to the agency being enjoined, but a
  likelihood of success on the merits
• In recent injunction cases, federal courts have
  focused primarily on the irreparable harm to the
  provider and residents, the lack of opportunity
  for providers to have their day in court on the
  substance of the deficiencies alleged, and the
  lack of any lasting harm to CMS

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SUCCESSFUL STRATEGIES TO CHALLENGE SURVEY
ENFORCEMENT ACTION Kenneth L. Burgess, JD
Phone [phone] Poyner
Spruill, LLP Fax [phone]
Glenwood Ave. (27612) Email
kburgess_at_poynerspruill.com P.O. Box
10096 Raleigh, NC 27605-0096 Julie
Bowman-Mitchell, JD, LLM Health Law Phone
601-427-1226 Copeland, Cook, Taylor Bush, PA
Fax [phone] Concourse Email
jbmitchell_at_cctb.com 1076 Highland Colony Parkway
(39157) P.O. Box 6020 Ridgeland, Mississippi
39158