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

Kimberli Poppe-SmartSenior Attorney, Wroten & Associates

RoadmapOverview of Change ConceptsRecord Releases – Changing LandscapeGroup ExerciseGoverning Body & Compliance RoleGroup 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 ChangeStability

Chaos

Looking ForwardLooking Back

Comfortand

Control

Learning, Acceptance, Commitment

Inquiry, Experimentation,

and Discovery

Fear, Anger, and Resistance

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

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

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

Moving Through ChangeStability

Chaos

Looking ForwardLooking Back

Comfortand

Control

Learning, Acceptance, Commitment

Inquiry, Experimentation,

and Discovery

Fear, Anger, and Resistance

4Stabilizeand Sustain the Change

3Revise and Finalize the Change Plan

2Introduce

the change

1 Create a palpable need for change

Storm To Norm Through Creativity

Brainstorm The Solutions

1. Agree on what the objective is2. Set time limits for brainstorming and open the

floodgates3. Assess, analyze 4. Organize/Prioritize results5. Agree on the Action and Timelines6. Follow-up

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

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.

Plaintiff’s View Of Record ReleasesRecords 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 Production42 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 SetThe 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• 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 "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• 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 - QualitySection 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

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 DutiesCore Fiduciary Duties now includes overseeing quality • 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

• 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 MeasuresGoverning 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 ExerciseWhat 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?