Transcript Managing the Impacts of the Changing Regulatory and

Managing The Impacts Of The
Changing Regulatory And Oversight
Environment In Which You Operate
Kimberli Poppe-Smart
Senior Attorney, Wroten & Associates
Roadmap
Overview of Change Concepts
Record Releases – Changing Landscape
Group Exercise
Governing Body & Compliance Role
Group Exercise
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.”
Moving Through Change
Stability
Comfort
and
Control
Learning,
Acceptance,
Commitment
Looking Back
Looking Forward
Fear,
Anger, and
Resistance
Inquiry,
Experimentation,
and
Discovery
Chaos
Elements Of Successful Change
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Realistic, achievable and measurable
Managers as champions
Create a thoughtful plan with a clear goal
Implement thoughtfully and strategically
Engage staff at all levels
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?
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
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
Overcoming Resistance To Change
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Education and Communication
Participation and Engagement
Facilitation and Support
Negotiation and Agreement
Manipulation and Co-optation
Explicit and Implicit Coercion
Moving Through Change
Stability
Comfort
and
Control
Looking Back
Fear,
Anger, and
Resistance
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Create a
palpable
need for
change
2
Introduce
the
change
4
Stabilize
and
Sustain the
Change
3
Revise and
Finalize the
Change
Plan
Chaos
Learning,
Acceptance,
Commitment
Looking Forward
Inquiry,
Experimentation,
and
Discovery
Storm To Norm Through Creativity
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
More On Brainstorming
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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
HIPAA Compliant Release
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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.
Plaintiff’s 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 Patient’s 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.”
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)
Plaintiff’s 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.”
Plaintiff’s 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, . . .
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).
Designated Record Set
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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.
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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 "burdens…of
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.
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.”
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.
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
Enjoy The View
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.
The Changing Landscape
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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
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.
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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
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 Guidelines—Oversight
compliance is a factor in assessing penalties.
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
“CMS’S Efforts To Support The Digital
Data Strategy”
http://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/ODF_SNFLTC.html
Governing Body – Fiduciary Duties
Core Fiduciary Duties now includes overseeing quality
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Series of questions and issues for Boards for self-assessment:
1. Set goals for quality and measures to assess those goals?
2. Accountability assigned to key management and clinical staff for outcomes?
3. Does Governing Body need additional training to be competent to oversee quality?
4. Do quality report flow to the Governing Body and do they provide an adequate picture
for oversight?
5. Is there communication between corporate compliance programs and patient safety?
6. Has the Governing Body assessed the resources allocated for quality and patient safety?
7. Does the Governing Body know the process to respond to adverse events--reports,
analysis, action plan?
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 body’s 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 facility’s reputation, can limit
liability, and improve position for alliances.
Governing Body Steps To Meet Quality
Oversight Role
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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.
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.
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.
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?