Legal Issues in Long Term Care

1
Legal Issues in Long Term Care
PMDA 15th AnnualEducational SymposiumOctober
26, 2007
2
Paula G. Sanders, Esquire Post Schell, P.C. 17
North 2nd Street, 12th Floor Harrisburg, Pa
17101 717-612-6027 PSanders_at_postschell.com
3
Trends in Survey Issues

• Increased emphasis on individualized and
  comprehensive care plans and outcomes
• Increased emphasis on citing PROCESS
  deficiencies (CMS SC 05-20)(March 2005)
• Heightened liability concerns, particularly
  regarding documentation

4
Trigger Points and Themes

• Greater emphasis on physician and facility
  collaboration
• Policies for significant change in condition and
  consult with physician
• Predictable staff supervision schedules
• Failure to immediately and thoroughly investigate
  allegations of abuse and neglect

5
Government Initiatives

• Quality of care and fraud and abuse are
  intertwined from the governments perspective
• New laws and interpretations are expanding
  enforcement actions in new and unexpected ways

6
OIG Work Plan 2008Quality of Care

• Quality of care and corporate compliance programs
  in homes with corporate integrity agreements
• Care plans addressing MDS and RAPs through
  provided services (new)
• Quality of care, patient abuse neglect
  investigations jointly with MFCUs
• Use DRA to train agents partners for claims
  for care not provided to nursing home residents

7
Amendment Of A Medical Record

• Documentation must be contemporaneous or as soon
  as practicable
• Information may be corrected or clarified on the
  chart only if the correction is clearly
  identified as a subsequent entry by date and
  time.
• Information may be added when it is not available
  at the time the record was first created only if
• Such additions are clearly dated as subsequent
  entries.
• The information is added within a reasonable
  time.
• 40 P.S. 1303.511

8
Effect of Improper Alteration or Destruction of
Medical Record from Litigation Perspective

• Significant blow to credibility as a fact witness
  at trial
• Could allow the judge to instruct the jury that
  it can come to an adverse inference about the
  medical records.

9
Effect of Improper Alteration or Destruction of
Medical Record from Licensing Perspective

• Licensure Sanction
• Alteration or destruction of records to eliminate
  evidence that might lead to a professional
  liability action will constitute a ground for
  suspension.
• Providers must report any suspected alteration or
  destruction of medical records to the appropriate
  licensure boards.

10
Focus on Care Documentation

• Subpoenas
• Search warrants
• Undercover agents
• Cameras

11
Undercover Agents

• Qui Tam relators (whistleblowers)
• Tucker House -- undercover CNAs
• Ruidoso Care Center (New Mexico) -- undercover
  ex-cop posing as resident
• Hidden cameras
• Wired for sound

12
Illustrative Cases

• Ronald Reagan Atrium I Nursing and Rehabilitation
  Center (Pennsylvania) (cover up of death)
• Oakland Grove Nursing Center (Rhode Island)
  (failure to report death)
• Melville Borne, Jr. (Louisiana) (federal criminal
  failure of care)

13
Falsification (U.S. v. Tabis)

• LPN at ManorCare Bethlehem 2
• Falsified order for coumadin reduction
• Forged co-worker signatures
• Federal Punishment
• 10 months plus 3 yrs supervised release
• 1,000 fine/15 year exclusion
• Physician group CIA

14
Smile, Youre On Candid Camera

• Past Surveys
• Repeat deficiencies - same resident?
• Actual harm?
• What is the level of care and where is care being
  rendered?

15
Authorization for Filming

• Consent from resident, if possible
• Consent from responsible party
• Court approval

16
State Prosecutions The Camera Cases

• Jennifer Matthew - Rochester
• Hidden Camera reveals widespread neglect and
  falsification of records
• 20 of staff falsified records
• Criminal cases v. 15 nurses and aides
• Civil prosecution of home

17
Health Care Fraud and Falsification of
Records

• State of Delaware criminal cases
• Multiple nurses charged and pled guilty
• State of Florida v. Bowen and Fralick
• Falsification of MARs when no medication was
  given

18
Busy Year For CMS

• Changes to Special Focus Facility program (5
  SNFs in PA/18 months or youre out)
• Increased federal survey activity
• More consistent sanctions
• Survey user/re-visit fees
• New Survey Certification letters

19
Busy Year for DOH

• ERS Alerts
• Act 169 Advance Directives/Health Care
  Decision-Making
• Health Care Associated Infections (HAI)
  Prevention and Control Act
• Recognition of CRNP expanded scope of practice

20
DOH 2006 Statistics 3,181 Visits

• 731 facilities/621 revisits
• 48.7 had 1 10 had 2 or more
• 212 G levels
• 11 IJs
• 2,247 complaints 1,982 surveys (82)
• 673 substantiated
• 9.1 G or above
• Source DOH Message Board, 9/19/2007

21
2006 Incident Reports 32,485

• Most frequently reported events
• Abuse 6,206
• Falls 4,789
• Transfer to Hospital 11,416
• Source DOH Message Board, 9/19/2007

22
(No Transcript)
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DOH ERS Alerts

• On April 20, 2007, you were notified via the
  Division of Nursing Care Facilities Message Board
  of a program to alert each facility when the
  submitted incident reports of Abuse, Falls or
  Resident Transfer to Hospitals have reached a
  level which requires facility intervention.
• This letter is to advise you that the numbers
  for events in the category of  FILL IN THE BLANK
  WITH ONE OF THE THREE CATEGORIES ABOVE have
  reached a critical level. As outlined in Chapter
  51, 28 Pa. Code, 51.3(e),(f) Notification, the
  response to this e-mail should outline the steps
  your facility will take to rectify this
  situation.
• Your written response should be sent to  . .

24
Revisit User Fee Program

• Offsite revisit survey 168
• Onsite revisit survey 2,072
• Payment due within 30 days of bill
• Nonpayment may result in termination
• Reconsideration requests due w/i 14 days (ltd
  challenges ie., clerical error, already paid, no
  revisit)
• Payment non-allowable cost

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• ACT 169 In A Nutshell

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What Does Act 169 Accomplish?

• Defines new terms and redefines old terms
• New format for the Living Will.
• Establishes Health Care POA option.
• Establishes Health Care Representative option.
• Establishes Default Health Care Representative.

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End-Stage Medical Condition Defined

• An incurable and irreversible medical condition
  in an advanced state caused by injury, disease or
  physical illness that will, in the opinion of the
  attending physician to a reasonable degree of
  medical certainty, result in death despite the
  introduction or continuation of medical
  treatment, except as specifically set forth in an
  advance health care directive.

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End-Stage Medical Condition

• Note
• No maximum life-expectancy in the definition of
  End-Stage Medical Condition.
• 6-month life-expectancyassociated with the term
  Terminal Illness.
• Hospice coverage unaffected by Act 169.
• Only 1 physician must certify.

29
Health Care Agent

• Individuals identified in Health Care POA.
• Individuals authorized to make medical treatment
  decisions for a resident.
• Health Care Agents direct health care whether or
  not the resident has an end-stage medical
  condition or is permanently unconscious.

30
Health Care Representative

• Individuals who are self-declared.
• Individuals who are appointed by a resident.
• Individuals who are appointed by default under
  the law.
• Health Care Representatives direct health care
  decisions necessary to preserve life ONLY when
  the resident has an end-stage medical condition
  or is permanently unconscious.

31
Incompetent

• Unable to understand, make, and communicate
  health care decisions, even when provided
  appropriate information and aids.
• A resident may be competent to make some simple
  health care decisions, but incompetent to make
  complex decisions.

32
Option for Health Care Agent (Health Care POA
Document)

• Health Care Agent has very broad power to make
  health care decisions.
• Health Care Agent can make medical treatment
  decisions before or after the resident is
  diagnosed with an end stage medical condition or
  permanent unconsciousness.

33
Option for Health Care Representative

• A resident of sound mind may appoint a Health
  Care Representative(s).
• The process is less formal.
• May be in writing or by verbal consent
• Health Care Representative may make decisions
  regarding life sustaining treatment only if the
  resident has an end stage medical condition or is
  permanently unconscious.

34
Option for DefaultHealth Care Representative

• An incompetent resident will have a Default
  Health Care Representative(s) automatically
  assigned to make medical treatment decisions.
• Health Care Representative may make life
  sustaining treatment decisions only if the
  principal has an end stage medical condition or
  is permanently unconscious.

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Health Care Agent vs.Health Care Representative

• Health Care Agent has broad power to make medical
  treatment decisions in all situations.
• Health Care Representative(s) may refuse life
  saving care only when principal has an end stage
  medical condition or is permanently unconscious.

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What Decision-Making Process Must Be Followed By
A Health Care Agent Or A Health Care
Representative?

• Collection of information concerning prognosis
  and medical alternatives regarding diagnosis,
  treatments, and supportive care.

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Health Care Representative Or Agent
Decision-Making Process

• The following considerations must be made in
  order of priority
• 1. Clearly expressed resident wishes
• 2. Resident preferences and values3. Best
  interest of the resident.

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The Default Health Care Representative Priority
Class

• Spouse and adult child (children) from prior
  marriage
• Adult child (children)
• Parent(s)
• Adult sibling(s)
• Adult grandchild (grandchildren)
• Close friend(s)

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How Are Health Care Representatives Assigned?

• Resident may assign or disqualify one or more
  Health Care Representatives to make treatment
  decisions.
• Resident may adjust or alter the order of
  priority.
• Someone from the priority list may step forward
  and state their intention to be the Health Care
  Representative.

40
What Factors Affect Who Serves As A Health Care
Representative?

• Divorce or filing for divorce.
• Any member of a default class petitions the court
  to disqualify one or more otherwise eligible
  individuals for serving.
• Court disqualify a higher priority individual in
  favor of a lower priority individual.

41
What Factors Affect Who Serves As A Health Care
Representative?

• Unless related by blood, marriage, or adoption,
  neither the residents physician nor an owner,
  operator, or employee of a health care provider
  in which the resident is receiving care may serve
  as Health Care Agent or Representative for the
  resident.

42
Dispute Resolution Among Health Care
Representatives

• Follow decisions of highest priority
  decision-maker.
• Decision-makers of equal priority must agree on
  the course of action.
• Majority decision determines course of action.

43
Dispute Resolution Among Health Care
Representatives

• If priority class is evenly split
• 1. No one else votes to break the tie.
• 2. Ethics Committee involvement.
• 3. Court hearing for appointment of
  Guardian of Person.

44
Dispute Resolution Among Health Care
Representatives

• Medical treatment according to acceptable
  standards of practice must be started or
  maintained until a dispute is resolved.

45
Countermanding Medical Treatment Decisions

• A resident who is of sound mind may countermand a
  medical treatment decision made by a Health Care
  Agent or Health Care Representative by stating
  their wishes verbally or in writing to the
  Attending Physician or other health care worker.
  

46
Countermanding Medical Treatment Decisions

• A resident who is deemed incompetent to make
  medical treatment decisions may countermand the
  decision of a Health Care Agent or Health Care
  Representative to withhold or withdraw a life
  sustaining treatment.

47
Countermanding Medical Treatment Decisions

• A resident who is deemed incompetent to make
  medical treatment decision may NOT countermand
  the decision of a surrogate decision-maker to
  institute a life-sustaining treatment.

48
Legal Guardians vs. Health Care Agents

• Health Care Agent appointed by a resident
  retains authority to make health care decisions
• Guardian of Person is granted authority to revoke
  or amend appointment of a Health Care Agent

49
Act 169 Key Points

• Four entities to direct health care
  decision-making
• 1. The resident
• 2. The Advanced Directive
• 3. The Health Care Agent
• 4. The Health Care Representative.

50
Act 169 Policy Considerations

• Encourage capable residents to make their own
  decisions pertinent to end-of-life care,
• Encourage capable residents to complete an
  Advanced Directive for Health Care, and
• Encourage capable residents to appoint a Health
  Care Agent in a POA document.

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Act 169 Policy Considerations

• If unsuccessful, encourage capable residents to
  appoint a Health Care Representative.
• For incompetent residents, encourage someone to
  step forward to function as a Health Care
  Representative.

52
Duty To Inform The Resident

• Attending physicians and health care providers
  have the duty to communicate health care
  decisions to the resident.
• Attending physicians and health care providers
  have the duty to communicate resident
  countermands to the surrogate.

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Implications For Facilities

• A key provision of the law requires facilities to
  adopt policies and procedures to reflect the
  intent of the statute.  DOH will enforce this
  through licensure surveys. 

54
Health Care Associated Infections (HAI) Act --
Deadlines

• 12/17/07 Develop and implement Internal Infection
  Control Plan
• 12/31/07 Submit Plan to Department of Health
• 12/31/07 Notify all health care workers, physical
  plan personnel and medical staff of Plan

55
HAI Act Deadlines

• 7/1/08 Department assessment of surcharge on
  nursing home license Total 1,000,000
• 1/1/09 Payment of quality improvement payments
  to qualified facilities by DPW
• 1/1/10 Facility measurements against benchmarks
  developed by Department

56
Minimum Elements of Infection Control Plan

• Multidisciplinary committee
• Effective measures for the detection, control and
  prevention of health care- associated infections
• Culture surveillance process and policies
• System to identify and designate residents known
  to be colonized or infected with MRSA or other
  MDRO

57
Minimum Elements of Infection Control Plan

• Procedures/protocols for staff potentially
  exposed to resident with MRSA and MDRO, including
  cultures and screenings, prophylaxis and
  follow-up care
• Outreach process for notifying a receiving
  facility or ASF of any resident known to be
  colonized prior to transfer within or between
  facilities
• Required infection-control intervention protocol
• Procedures to ensure that PSA advisories are
  distributed to and easily accessible by all staff
  and medical personnel

58
Who Must Be On Your Multidisciplinary Committee?

• Medical staff Medical Director
• Administration representatives CEO, CFO, or NHA
• Laboratory personnel
• Nursing staff DON or Supervisor
• Pharmacy staff, pharmacy consultant
• Physical plant personnel

59
Who Must Be On Your Multidisciplinary Committee?

• A Patient Safety Officer
• Members from the infection control team, which
  could include an epidemiologist
• The community, except that these representatives
  may not be an agent, employee or contractor of
  the health care facility

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What is the Required Infection-Control
Intervention Protocol?

• Infection control precautions, based on
  nationally recognized standards, for general
  surveillance of infected or colonized residents
• Intervention protocols based on evidence-based
  standards
• Isolation procedures
• Physical plant operations related to infection
  control
• Appropriate use of microbial agents
• Mandatory educational programs
• Fiscal and human resource requirements

61
CRNP Expanded Scope of Practice (Act 48)

• Order home health and hospice care
• Order durable medical equipment
• Issue oral orders to the extent permitted by the
  facilitys by-law, rules, regulations or
  administrative policies and guidelines
• Make PT and dietitian referrals
• Make respiratory and OT referrals

62
CRNP Expanded Scope of Practice (Act 48)

• Perform disability assessments for the TANF
  program
• Issue home-bound schooling certifications
• Perform and sign the initial assessment of
  methadone treatment evaluations, provided that
  any order for methadone treatment shall be made
  only by a physician

63
Additional Licensure Requirements for CRNPs

• Must still act within scope of written
  collaborative agreement with a physician
• Must act within scope of CRNP specialty
  certification
• Collaborative agreement more detailed if CRNP can
  prescribe drugs
• Physician may only supervise 4 CRNPs who
  prescribe/dispense drugs
• CRNP must maintain minimum PL coverage but cannot
  participate in MCARE Fund

64
DOH CRNP/Facility Requirements

• Policies must indicate manner in which PA/CRNPs
  will be used and responsibility of supervising
  physician
• Each nursing station must have a list posted with
  the supervising physicians and the names and
  titles of CRNP/PAs they supervise.

65
DOH CRNP/Facility Requirements

• Maintain copy of supervising physicians
  registration and PA/CRNP certificate in the
  facility
• Post notice plainly visible to residents in
  prominent areas explaining the meaning of the
  terms physician assistant and certified
  registered nurse practitioner
• Be alert to Medicare/MA billing nuances.

66
DOH CRNP/Documentation Requirements

• All documentation on residents record must be
  countersigned by supervising physician within 7
  days with an original signature and date by the
  physician
• Progress notes
• Physical examination reports
• Treatments
• Medications and any other notations made by
  PA/CRNP

67
DOH CRNP/Documentation Requirements

• Physicians must countersign and date verbal
  orders to PA/CRNPs within 7 days.

68
CMS FY 2007 F Tag Changes

• 07-39 F332 F333 Med Pass
• Clarification (9/28/07)
• 07-30 F373 (New) Paid Feed Assistants
• (8/10/07)
• 07-25 F323 Accidents Supervision
• (7/6/07)

69
CMS FY 2007 Survey Cert. Letters

• 07-38 PASRR and the Nursing Home
• Survey (9/28/07)
• 07-36 Canopy and Overhang Sprinkler
  Requirements and the Use of the
• Fire Safety Evaluation System
• (7/13/07)
• 07-26 Communication Between State Survey
• Agencies and State Long Term Care
• Ombudsman (7/6/07)

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CMS FY 2007 Survey Cert. Letters

• 07-26 Communication between State Survey
• Agencies and State Long-Term Care
• Ombudsman (7/6/07)
• 07-22 Clarification of a Physical Restraints as
• Applied to the Requirements for LTC
• Facilities (6/22/07)
• 07-18 Permitted Gaps in Corridor Doors
  Doors in Smoke Barriers
• (4/20/07)

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CMS FY 2007 Survey Cert. Letters

• 07-10 Medical Gas Storage Usage
• Considerations (1/12/07)
• 07-07 Nursing Home Culture Change
• Regulatory Compliance Questions
  Answers (12/21/06)

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CMS FY 2007 Survey Cert. Letters

• 07-05 Life Safety Code Exit Discharge
• Requirements and the Fire Safety
• Evaluation System (12/7/06)
• 07-01 New Fire Safety Requirements for
• the Use of (ABHRs) and Installation
• of Battery Powered Smoke Alarms
• (11/1/06)

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New F373 Paid Feeding Assistants (PFAs)

• PFAs must
• Complete 8 hour state-approved training program
• Be supervised by RN/LPN
• Identify clear chain of command
• Make sure PFA training records are maintained

74
New F373 Paid Feeding Assistants (PFAs)

• Assess residents for eligibility to use PFAs
• Document and care plan
• Residents who can benefit
• At risk for unplanned weight loss and dehydration
• No complicated problems associated with eating or
  drinking
• Cannot or do not eat independently due to
  physical or cognitive disabilities
• Need cueing or encouragement to eat

75
New F373 Paid Feeding Assistants (PFAs)

• Noncompliance for F-Tag where
• PFA has not completed a state-approved training
  program
• PFA isnt properly supervised
• Facility has not selected an appropriate resident
  to receive paid feed assistance
• Facility has not maintained records indicating
  all paid feeding assistant have completed a
  training class

76
New F323 Accidents and Supervision

• The facility must ensure that
• The resident environment remains as free of
  accident hazards as is possible and
• Each resident receives adequate supervision and
  assistance devices to prevent accidents.
• 42 CF.R. 483.25(h)(1) and (2)

77
Expectations of Facility (F323)

• Identify hazards and risks
• Evaluate and analyze hazards and risks
• Implement interventions to reduce hazards and
  risks and
• Monitor for effectiveness and modify
  interventions as indicated.

78
New Definition of Accident

• Unexpected or unintentional incident
• May result in injury or illness
• Not an adverse outcome directly related to
  treatment or care

79
Identify Hazards and Risks

• Quality assurance activities
• Environmental rounds
• MDS/RAPS data
• Medical history and physical exam
• Individual observation

80
Risk Areas Lack of Adequate Supervision

• Failure to accurately assess a resident and/or
  the resident environment to determine whether
  supervision to avoid an accident or injury was
  necessary and/or
• Determine supervision of the resident or resident
  environment is necessary, but fail to provide it.
  
• Liberty Commons Nursing Rehab (2006) IJ upheld
  for failure to implement plan to prevent exposure
  to latex

81
Other Specified Risk Areas (F323)

• Resident smoking
• Resident-to-Resident altercations
• Falls
• Unintentionally coming to rest on the ground,
  floor, or other lower level, but not as a result
  of an overwhelming external force.
• If a resident loses his/his balance and would
  have fallen, if not for staff intervention, still
  a fall.
• A fall without injury is still a fall.

82
Other Specified Risk Areas (F323)

• Wandering
• Physical plant hazards
• Assistive devices for mobility
• Assistive devices for transfer
• Devices associated with entrapment risks

83
Surveyor Interviews Under F323Resident/Family

• Was resident aware of his/her risk of an
  accident
• Was resident aware of hazards for other
  residents
• Did resident report a hazard to staff and
• How and when staff responded to a hazard once it
  was identified.

84
Surveyor Interviews Under F323Staff

• Are they aware of planned interventions to reduce
  a residents risk
• Did they report potential resident risks
• Did they take action to correct an immediate
  hazard and
• Did they receive training regarding facility
  procedures to remove or reduce hazards.

85
Resource List

• CMS Survey Cert Letters http//www.cms.hhs.gov/
  SurveyCertificationGenInfo/PMSR/
• CMS User Revisit Fees http//www.cms.hhs.gov/Sur
  veyCertificationGenInfo/06_RevisitUserFeeProgram.a
  spTopOfPage
• DOH Nursing Care Facility Message Board
• http//app2.health.state.pa.us/commonpoc/content/
  FacilityWeb/FacMsgBoard.asp?DistributionFSelecti
  onNCF
• DOH Nursing Care Facility Provider Bulletins
• http//www.dsf.health.state.pa.us/health/CWP/view
  .asp?A188QUESTION_ID243799
• OIG 2008 Work Plan
• http//oig.hhs.gov/08/Work_Plan_FY_2008.pdf
• OIG/AHLA Guidances for Health Care Boards of
  Directors
• (9/17/07) http//oig.hhs.gov/fraud/docs/complianc
  eguidance/CorporateResponsibilityFinal209-4-07.pd
  f
• (7/1/04) http//oig.hhs.gov/fraud/docs/complianc
  eguidance/Tab204E20Appendx-Final.pdf
• (4/2/03) http//oig.hhs.gov/fraud/docs/compliance
  guidance/040203CorpRespRsceGuide.pdf