PMDA 15 th Annual Educational Symposium October 26, 2007

Legal Issues in Long Term Care

Paula G. Sanders, Esquire Post & Schell, P.C.

17 North 2 nd Street, 12 th Floor Harrisburg, Pa 17101 717-612-6027 [email protected]

Trends in Survey Issues

• • Increased emphasis on

individualized and comprehensive

care plans and outcomes • Increased emphasis on citing “PROCESS” deficiencies (CMS S&C 05-20)( March 2005) Heightened liability concerns, particularly regarding documentation

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

Government Initiatives

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

OIG Work Plan 2008: Quality 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

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

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.

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.

Focus on Care & Documentation

• • • • Subpoenas Search warrants Undercover agents Cameras

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

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)

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

“Smile, You’re On Candid Camera”

• • • • Past Surveys Repeat deficiencies - same resident?

Actual harm?

What is the level of care and where is care being rendered?

Authorization for Filming

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

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

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

Busy Year For CMS

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

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

DOH 2006 Statistics – 3,181 Visits

• • • • 731 facilities/621 revisits – 48.7% had 1 10% had 2 or more 212 “G” levels 11 IJ’s 2,247 complaints 1,982 surveys (82%) – 673 substantiated – 9.1% ≥ G or above Source: DOH Message Board, 9/19/2007

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

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 . .

Revisit User Fee Program

• • • • • Offsite revisit survey Onsite revisit survey $ 168 $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

ACT 169 – In A Nutshell

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.

End-Stage Medical Condition Defined

An incurable and irreversible medical condition

in an advanced state c

aused 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.

End-Stage Medical Condition

• • • •

Note

No maximum life-expectancy in the definition of

End-Stage Medical Condition

.

6-month life-expectancy associated with the term

Terminal Illness.

Hospice coverage unaffected by Act 169.

Only 1 physician must certify.

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.

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

unconscious.

direct health care decisions necessary to preserve life ONLY when the resident has an end-stage medical condition or is permanently

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.

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.

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.

Option for Default Health 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.

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.

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.

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 values; 3. Best interest of the resident.

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);

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.

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.

What Factors Affect Who Serves As A Health Care Representative?

• Unless related by blood, marriage, or adoption, neither the resident’s 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.

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.

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.

Dispute Resolution Among Health Care Representatives

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

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.

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.

Countermanding Medical Treatment Decisions

•

A resident who is deemed incompetent

treatment.

to make medical treatment decision may NOT countermand the decision of a surrogate decision-maker to institute a life-sustaining

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

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.

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.

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.

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.

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.

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

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

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

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

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

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

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

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 facility’s by-law, rules, regulations or administrative policies and guidelines • • Make PT and dietitian referrals Make respiratory and OT referrals

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

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

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.

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.

DOH CRNP/ Documentation Requirements

• – – – – All documentation on resident’s 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

DOH CRNP/ Documentation Requirements

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

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)

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)

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)

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)

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)

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

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

New F373 – Paid Feeding Assistants (PFAs)

• Noncompliance for F-Tag where: – – – PFA has not completed a state-approved training program PFA isn’t 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

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)

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.

New Definition of Accident

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

Identify Hazards and Risks

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

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

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.

Other Specified Risk Areas (F323)

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

Surveyor Interviews Under F323: Resident/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.

Surveyor Interviews Under F323: Staff

• • • • Are they aware of planned interventions to reduce a resident’s 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.

Resource List

CMS Survey & Cert Letters: http://www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/ CMS User Revisit Fees: http://www.cms.hhs.gov/SurveyCertificationGenInfo/06_RevisitUserFeeProgram.asp#TopOfPage DOH Nursing Care Facility Message Board: http://app2.health.state.pa.us/commonpoc/content/FacilityWeb/FacMsgBoard.asp?Distribution=F&Sele ction=NCF DOH Nursing Care Facility Provider Bulletins: http://www.dsf.health.state.pa.us/health/CWP/view.asp?A=188&QUESTION_ID=243799 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/complianceguidance/CorporateResponsibilityFinal%209-4-07.pdf

(7/1/04): http://oig.hhs.gov/fraud/docs/complianceguidance/Tab%204E%20Appendx-Final.pdf

(4/2/03): http://oig.hhs.gov/fraud/docs/complianceguidance/040203CorpRespRsceGuide.pdf