Managing The Impacts Of The Changing Regulatory And Oversight Environment In Which You Operate

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Managing The Impacts Of The Changing Regulatory
And Oversight Environment In Which You Operate

• Kimberli Poppe-Smart
• Senior Attorney, Wroten Associates

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Roadmap

• Overview of Change Concepts
• Record Releases Changing Landscape
• Group Exercise
• Governing Body Compliance Role
• Group Exercise

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Change

• Change is good..you go first.
• The only person that likes change is a wet
  baby.
• The only thing that remains constant is change.

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Moving Through Change
Stability
Comfort and Control
Learning, Acceptance, Commitment
Looking Forward
Looking Back
Inquiry, Experimentation, and Discovery
Fear, Anger, and Resistance
Chaos
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Elements Of Successful Change

• Realistic, achievable and measurable
• Managers as champions
• Create a thoughtful plan with a clear goal
• Implement thoughtfully and strategically
• Engage staff at all levels

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Change Starts With These Questions

• What do we want to achieve from this change?
• How will we know we were successful?
• Who and what processes will be affected by this
  change?
• How will staff react to the change?
• How much can we do, where will we need help?

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Successful Change Management

• People will change when they see the need to
  change
• People will change when they know how to make the
  change
• People will change when they are actively
  involved in the change
• People will resist surprise

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Successful Change Management

• People will change when they feel secure in the
  change process
• People respond to acknowledgement of their
  contribution
• Attitude, feelings and status are as important as
  the change
• Attitudes can be slow to change

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Overcoming Resistance To Change

• Education and Communication
• Participation and Engagement
• Facilitation and Support
• Negotiation and Agreement
• Manipulation and Co-optation
• Explicit and Implicit Coercion

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Moving Through Change
Stability
Learning, Acceptance, Commitment
Comfort and Control
4 Stabilize and Sustain the Change
1 Create a palpable need for change
Looking Forward
Looking Back
3 Revise and Finalize the Change Plan
2 Introduce the change
Inquiry, Experimentation, and Discovery
Fear, Anger, and Resistance
Chaos
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Storm To Norm Through Creativity
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Brainstorm The Solutions

1. Agree on what the objective is
2. Set time limits for brainstorming and open the
   floodgates
3. Assess, analyze
4. Organize/Prioritize results
5. Agree on the Action and Timelines
6. Follow-up

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More On Brainstorming

• Do not judge ideas
• Encourage out of the box, wild ideas
• Synergize, build on ideas
• Stay focused on topic
• One conversation at a time
• Visual aids
• More is better

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HIPAA Compliant Release

• Information to be released is specified
• Who is to release the information
• Who is to receive the information
• Purpose of disclosing the information
• Statement of right to revoke the authorization,
  how to revoke and exceptions to the right to
  revoke.
• Statement that signature is not required to
  receive treatment.
• Statement that information disclosed may be
  redisclosed by the recipient and is no longer
  protected.
• Statement that the authorization will expire 1)
  on a specific date, 2) after a specific amount of
  time, and 3) any exceptions to the right to
  revoke.
• Signature of patient or agent and description of
  the agent's authority to act on behalf of the
  patient.

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Plaintiffs View Of Record Releases

• Records will be available in two days for our
  copy service.
• Should these records not be made available for
  copying within two days, you will be in violation
  of the Patients Bill of Rights, found at 42
  C.F.R. 483.10(b)(2)(i) and (ii), and we will
  have no alternative but to file a formal
  complaint with the Department of Public Health
  and your facility may be subject to legal action,
  including statutory damages and attorneys fees.

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• 45 CFR 483.10(b)(2)(i)-(ii), relating to a
  patients' access to records, states
• (2) The resident or his or her legal
  representative has the right
• (i) Upon an oral or written request, to access
  all records pertaining to himself or herself
  including current clinical records within 24
  hours (excluding weekends and holidays) and
• (ii) After receipt of his or her records for
  inspection, to purchase at a cost not to exceed
  the community standard photocopies of the records
  or any portions of them upon request and 2
  working days advance notice to the facility.
  (emphasis added)

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Plaintiffs View Of Record Production

• This records request includes not only the
  medical records, billing records, charts and
  writing relating to resident, but any and all
  admission agreements, reviews, utilization review
  committee records, photographs, and the like.

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Plaintiffs View Of Record Production

• 42 U.S.C. 1396r(b)(6)(C) mandates that skilled
  nursing facilities maintain clinical records on
  each resident.
• - plan of care
• - resident assessments
• - results of preadmission screenings.
• 42 C.F.R. 483.75(1) requires maintenance of
  clinical records on each resident in accordance
  with accepted professional standards and
  practices that are complete, accurately
  documented readily accessible, and systematically
  organized. The records are to be maintained for
  at least five years after the resident's
  discharge, and must safeguard the records from
  loss, destruction, and unauthorized use. The
  clinical record must contain sufficient
  information to identify the resident a record of
  the resident's assessments the plan of care and
  services provided the results of any
  preadmission screening conducted by the State
  and progress notes.
• Federal and state statutes and regulations -
  treatment, medication administration,
  notifications to physician's and resident family
  members and/or responsible parties, MDS
  assessments, intake and output of fluids, drug
  orders, reasons for the denial or limitation of a
  resident's rights, receipt of education regarding
  influenza vaccinations, refusal of an influenza
  vaccination, reasons for transfer or discharge,
  specific diagnoses requiring the administration
  of antipsychotic drugs, resident height and
  weight, behavior triggering the use of chemical
  restraints, data to be collected for the
  evaluation of effectiveness and adverse reactions
  to chemical restraints, food preferences and
  physician food orders, physical therapy orders,
  physical therapy procedures,. physical therapy
  assessments, physical therapy progress notes,
  occupational therapy orders, occupational
  therapy, . . .

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HIPAA Designated Record Set

• The Health and Human Service's Final Rule on 45
  CFR 164.501, which governs the definition of a
  "Designated Record Set," states
• In the final rule, we modify the definition of
  designated record set to specify certain records
  maintained by or for a covered entity that are
  always part of a covered entity's designated
  record sets and to include other records that are
  used to make decisions about individuals. We do
  not use the means of retrieval of a record as a
  defining criteria.
• The final rule further states
• We do not require a covered entity to provide
  access to all individually identifiable health
  information, because the benefits of access to
  information not used to make decisions about
  individuals is limited and is outweighed by the
  burdens on covered entities of locating,
  retrieving, and providing access to such
  information. Such information may be found in
  many types of records that include significant
  information not relevant to the individual as
  well as information about other persons. For
  example, a hospital's peer review files that
  include protected health information about many
  patients but are used only to improve patient
  care at the hospital, and not to make decisions
  about individuals, are not part of that
  hospital's designated record sets. 65 FR 82462,
  82606 (emphasis added).

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Designated Record Set

• The rule does not require a facility to disclose
  any and all records. Rather, the HHS specifies
  that a designated record set includes records
  commonly kept by a facility that are particularly
  relevant in making decisions about individual
  care. The rule additionally preempts an
  erroneously broad definition of a designated
  record set by noting that information pertaining
  to other persons and general patient care is
  significant but not relevant to what constitutes
  such a record.
• In addition, the final rule suggests that covered
  entities have some discretion in determining what
  constitutes a designated record set, given that
  it underscores the absence of a requirement for
  disclosing all individual identifiable health
  information and the "burdensof locating,
  retrieving, and providing access to such
  information." The example provided about hospital
  peer review files demonstrates that the rule
  anticipates overbroad requests for files that are
  easily mistaken as belonging to a designated
  record set. Because every medical record does not
  constitute a designated record set, an entity can
  be expected to make determinations about what
  information falls under the rule.

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Legal Advice To Facility From Plaintiff

• Resident refuses to release their records to
  any other person or entity other than to our
  office. This includes any of your attorneys,
  parent companies, subsidiaries, corporate
  headquarters, or to any person employed by,
  acting as the agent for, otherwise working on
  behalf of same.

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Permitted Use And Disclosure Includes Health Care
Operations

• 45 CFR 164.502
• Health care operations are any of the following
  activities (a) quality assessment and
  improvement activities, including case management
  and care coordination (b) competency assurance
  activities, including provider or health plan
  performance evaluation, credentialing, and
  accreditation (c) conducting or arranging for
  medical reviews, audits, or legal services,
  including fraud and abuse detection and
  compliance programs (d) specified insurance
  functions, such as underwriting, risk rating, and
  reinsuring risk (e) business planning,
  development, management, and administration and
  (f) business management and general
  administrative activities of the entity,
  including but not limited to de-identifying
  protected health information, creating a limited
  data set, and certain fundraising for the benefit
  of the covered entity.

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Brainstorming Process Change To Records Release

• Choose facilitator
• Choose scribe
• Issue Records are released without elements
  being verified
• Brainstorm ways to improve process
• 10 minutes
• More is better

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Enjoy The View
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SWITCHBACKS
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The Evolving Role Of The Governing Body

• 42 CFR 483.75 provides (d) Governing body.
• (1) The facility must have a governing body, or
  designated persons functioning as a governing
  body, that is legally responsible for
  establishing and implementing policies regarding
  the management and operation of the facility
  and (2) The governing body appoints the
  administrator who is-- (i) Licensed by the
  State where licensing is required and (ii)
  Responsible for management of the facility.

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The Changing Landscape

• Increased focus on transparency public
  reporting
• Pay for performance
• Non-payment for poor performance
• New care delivery models increased home care,
  decreased cost, increased quality and performance
• Increased investment and oversight of IT
• Heightened oversight of quality
• Increased accountability and expectations of
  leadership, including Governing Body

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Governing Body Oversight - Quality

• Section 6102 of the Affordable Care Act also
  requires HHS to establish and implement a quality
  assurance and performance improvement program
  (QAPI program) for skilled nursing facilities
• Governance and Leadership The governing body
  and/or administration of the nursing home
  develops and leads a QAPI program that involves
  leadership working with input from facility
  staff, as well as from residents and their
  families and/or representatives.
• adequately resourced to conduct its work
• establishing policies to sustain the QAPI program
  despite changes in personnel and turnover
• setting priorities for the QAPI program and
  building on the principles identified in the
  design and scope
• for setting expectations around safety, quality,
  rights, choice, and respect by balancing both a
  culture of safety and a culture of
  resident-centered rights and choice.
• ensures that while staff are held accountable,
  there exists an atmosphere in which staff are not
  punished for errors and do not fear retaliation

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Governing Body Oversight - Compliance

• OIG Compliance Guidance includes patient safety
  as a key compliance concern.
• Corporate Integrity Agreements covering health
  care quality mandate onerous requirements to
  oversee quality.
• 2012 Federal Sentencing GuidelinesOversight
  compliance is a factor in assessing penalties.

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Governing Body Oversight Public Reporting

• Governing Body is, or should be, on notice of
  quality concerns related to publicly available
  patient safety and quality measures.
• Serves as threshold for knowledge and measure of
  Governing Body and performance improvement
  efforts to assess penalties and corrective
  actions.

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Governing Body Oversight Heightened Quality
Enforcement

• False Claims Act quality counts!
• Services so poor as to be worthless or
  essentially not delivered
• Billing unnecessary services
• Focus areas of enforcement grounded in violation
  of patient safety/quality regulations,
  (restraints, psychotropics) can also serve as
  basis for False Claims Act violation

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CMSS Efforts To Support The Digital Data
Strategy
http//www.cms.gov/Outreach-and-Education/Outreach
/OpenDoorForums/ODF_SNFLTC.html
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Governing Body Fiduciary Duties

• Core Fiduciary Duties now includes overseeing
  quality
• Series of questions and issues for Boards for
  self-assessment
• Set goals for quality and measures to assess
  those goals?
• Accountability assigned to key management and
  clinical staff for outcomes?
• Does Governing Body need additional training to
  be competent to oversee quality?
• Do quality report flow to the Governing Body and
  do they provide an adequate picture for
  oversight?
• Is there communication between corporate
  compliance programs and patient safety?
• Has the Governing Body assessed the resources
  allocated for quality and patient safety?
• Does the Governing Body know the process to
  respond to adverse events--reports, analysis,
  action plan?

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Governing Body Oversight Setting Standards

• The Joint Commission The governing body is
  ultimately responsible for the safety and quality
  of care, treatment and services.
• This duty derives from the governing bodys legal
  responsibility for organizational performance.
  The governing body must provide for internal
  structures and resources that support quality and
  safety. (Standard LD 01.03.01)
• Governing body members, management, and medical
  staff leaders must address conflicts of interest
  that could affect the safety and quality of care.
  (Standard LD 02.02.01)
• The governing body, senior managers, and leaders
  of the organized medical staff regularly
  communicate with each other about issues of
  safety and quality. (Standard LD 02.03.01)

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Governing Body Managing New Obligations

• Are quality and compliance incorporated in your
  mission?
• Transparency is being required. Do you know what
  you are publically reporting? Know it before it
  is published.
• Weigh decisions with the notion that there are
  penalties for poor quality.
• Quality efforts speak to facilitys reputation,
  can limit liability, and improve position for
  alliances.

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Governing Body Steps To Meet Quality Oversight
Role

• Foster culture committed to quality
• Foster and recruit talent with quality passion
  and expertise
• Encourage active Quality Committee
• Expect strategic planning for resident safety,
  performance improvement, patient satisfaction,
  patient-centered care
• Require routine reporting to the Governing Body
  regarding public quality measure reporting,
  improvement activities, IT capacity for
  streamlining quality reporting and other
  opportunities to monitor and improve quality.

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Governing Body Tools

• Develop criteria for quality reporting to
  Governing Body. Publically reported measures are
  a great platform for dashboards. Look also for
  additional measures. Seek from medical leadership
  targeted measures on strengths and weaknesses.
• Set clear, realistic goals for improvement in
  relation to benchmarks.
• Require reports on serious adverse events and
  quality trends below established benchmarks, with
  analysis, action plan and follow up.
• Require coordination between compliance and
  patient safety.

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Annual Measures

• Governing Body Review and Approval of Annual
  Quality Plan
• Annual plan potential data sources public
  quality measures, state surveys, internal
  measures, serious care incidents, near misses,
  management quality committee reports, risk
  management reports, compliance input, and other
  available quality information.
• Set strategic goals and priorities for quality
  tied to applicable public reporting and financial
  incentives.
• Identify if corrective actions were completed if
  not, add to plan.
• Staff training on quality.

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Group Exercise

• What measures does Governing Body need/want?
• 1. Define data set (target audience, identify Key
  Performance Indicators, determine if the data is
  available, define work flow)
• 2. Build (get the data to the dashboard and
  provide analysis)
• 3. Test does it provide what GB needs? Is the
  data accurate and meaningful? Can we take action
  based on the data?

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