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1 Legal and Regulatory ASHRM References Legend CPHRM Prep CPHRM Exam Preparation Guide ERMPB Enterprise Risk Management Playbook RFPB Health Care Risk Financing Playbook Fundamentals Health Care Risk Management Fundamentals OBPB Obstetrical Risk Management Playbook PSPB Patient Safety Risk Management Playbook POPB Physician Office Risk Management Playbook Handbook Risk Management Handbook, 6 th edition RCAPB Root Cause Analysis Playbook Examine the value of ethics as a cornerstone in the delivery of health care Describe the informed consent process and its impact on patient care Summarize key regulations and laws that govern patient care, data management, payment, employment, and workplace safety in the health care environment Discuss accreditation, licensure and surveying bodies and the value of participating 2 Objectives
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Page 1: Legal and Regulatory - StarChapter · •Appropriate medical and clinical staff should be included •There should be a clerical representative from the religious community •A layperson

1

Legal and Regulatory

ASHRM References LegendCPHRM Prep CPHRM Exam Preparation Guide

ERMPB Enterprise Risk Management Playbook

RFPB Health Care Risk Financing Playbook

Fundamentals Health Care Risk Management Fundamentals

OBPB Obstetrical Risk Management Playbook

PSPB Patient Safety Risk Management Playbook

POPB Physician Office Risk Management Playbook

Handbook Risk Management Handbook, 6th edition

RCAPB Root Cause Analysis Playbook

• Examine the value of ethics as a cornerstone in the

delivery of health care

• Describe the informed consent process and its impact on

patient care

• Summarize key regulations and laws that govern patient

care, data management, payment, employment, and

workplace safety in the health care environment

• Discuss accreditation, licensure and surveying bodies and

the value of participating

2

Objectives

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3

Statutes, Standards and

Regulations

Patient CareData

ManagementPayment Employment

Workplace safety

Fundamentals p. 171-217

4

Types of Law

Statutory law• Enacted by congress and approved by the

president.

Administrative law

• Regulations and rules developed and implemented by a federal or state agency to provide direction for carrying out the purposes of the Acts it oversees.

Case law• (Common law) Judicial interpretation of a statute or

established court precedent.

Fundamentals p. 179-181

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Patient Care

• Created by the collision of:

• Law

• Medicine

• Biotechnology

• Business

• Philosophy

• Religion

6

Ethical Issues

Fundamentals p. 210

Handbook v. 1 p. 27-31, 42-44, 439-456

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• Ethical principles and moral obligations

• Societal policy

• ASHRM Code of Professional Conduct: available at

www.ashrm.org

• AMA’s Principles of Medical Ethics: available at www.ama-

assn.org

7

Ethics Basics

Fundamentals p. 66

Handbook v. 1 p. 165-167, 440-441

• Ability to make decisions without undue influenceAutonomy

• To do good and protect from harmBeneficence

• To avoid causing harm or prohibition against cruel treatmentNon-maleficence

• Fairness and equal distribution of healthcare, non-discriminatory careJustice

8

Ethical Principles

Fundamentals p. 210

Handbook v. 1 p. 440

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• Respect patient’s privacy and protect confidentiality

• Communicate honestly about all aspects of the patient’s

diagnosis, treatment and prognosis

• Determine whether patient is capable of sharing in decision

making

• Conduct an ethically valid process of informed consent

9

Moral Obligations

Fundamentals p. 173-177, 206-209

Handbook v. 1 p. 440

10

Ethical Issues

Advance directives

Do-not-resuscitate orders

Research

Institutional review boards

Informed consent

Fundamentals p. 210

Handbook v. 1 p. 23-24, 42-44, 146, 410-417, 451-455; v. 2 p. 79-82, 113-125

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• Provide written information to all adult patients on

admission

• Comply with state law regarding patient rights

• Document appropriately in the medical record

• Do not condition the provision of care on the execution of

an advance directive

• Educate the staff and the community

11

Patient Self-Determination

Act

Handbook v. 1 p. 42, 451-453; v. 3 p. 15-16

• Governed at the state level

• No uniform document

• Preferably written, but also can be verbal

• Can specify what to include and exclude

• Patient can change mind at last minute

12

Advance Directives

Handbook v. 1 p. 42; v. 2 p. 496, 543; v. 3 p. 15-16

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• Governed at the state level

• Requires a physician order

• Documented in the medical record

• Requires clear policy and procedure

• Documented education of patient, family and staff

• Does not require an advance directive as a precondition

• May be rescinded for surgical interventions

13

Do Not Resuscitate

Handbook v. 1 p. 42-44, 453-455; v. 2 p. 395-396

Which of the following are examples of advance medical

directives?

1) Living will

2) Durable power of attorney for health care

3) Physician’s do not resuscitate (DNR) order

4) Legal guardianship papers

a) 1 only

b) 1 and 2 only

c) 1,2 and 3 only

d) All of the above

14

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• Life-sustaining treatment is any treatment that serves to

prolong life without reversing the medical condition

• Clear policy and procedure

• Examples of such treatment

• Intubation

• Mechanical ventilation

• Renal dialysis

• Artificial nutrition and hydration

• Antibiotics

• Blood and blood products

15

Withholding and

Withdrawing Treatment

Handbook v. 1 p. 42-44, 453-455

• Patients must be:

• Able to understand the nature of the situation and the

consequences of the decision

• Able to communicate the wishes to the caregiver

• Capacity:

• Normally determined by the physician

• Presumed unless there is a reason to question

• May come and go so act as close to the time of capacity as possible

• Normally not questioned as long as the health care providers and

the patient’s family agree

• Of age (varies greatly by state and circumstances)

16

Capacity

POPB p. 36

Handbook v. 2 p. 82-85, 92-97

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• Definition: the individual who is legally authorized to make

health care decisions on behalf of a patient who is unable

to make or communicate decisions

• Common law next-of-kin

• Durable power of attorney for health care

• State-specific

17

Surrogates of Patients

Handbook v. 1 p. 439-440, 457; v. 2 p. 79-85, 91

• Quality of life is defined by the patient’s values, not by the

surrogate or caregiver’s

• Physicians do not have an obligation to deliver care that, in

their best judgment, will not have a reasonable chance of

benefiting the patient

• Physicians are not required to violate their own ethical or

religious beliefs

• Clinical staff may decline only for reasons of “conscience”

18

Non-Beneficial Care

Handbook v. 1 p. 453-455, 459

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• Do not abandon the patient; arrange transfer

• Have appropriate policies

• Be sure decisions are based on medical issues, not age,

social status, or be financially driven

• Avoid court if at all possible

• Negotiate with the patient, surrogates, and health care

providers, if necessary

• Use the Ethics Committee

19

Non-Beneficial Care

Handbook v. 1 p. 453-455, 459

• The National Quality Forum

• Endorsed 45 best practices to deliver culturally appropriate and

patient-centered care.

• Issues addressed

• Communication

• Community engagement

• Workforce training

20

Culturally Appropriate Care

Handbook v. 1 p. 201, 406-409

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• The Joint Commission Requirements to Advance Effective Communication, Cultural Competence, and Patient-Centered Care

• Became effective January 1, 2011 with a grace period of 1 year

• Will be graded in TJC 2012 surveys

• Incorporates issues such as diversity, language, culture, health literacy into current standards or draft new requirements

• Some issues addressed

• Effective communication

• Equitable treatment

• Accommodation of patient’s cultural, religious, spiritual needs and beliefs

• Non-discrimination in care

• Staff training in cultural sensitivity

21

Culturally Appropriate Care

Handbook v. 1 p. 399-400

Ethical Decisions

• Based on what is best for the

common good and, generally,

exceed what is required by law

Legal Decisions

• Based on what is mandated by

statutes or case law

22

Ethics and the Law

Handbook v. 1 p. 439-440

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23

Karen Ann Quinlan 70 NJ 10

(1976)

Handbook v. 3 p. 45

Case Name Description Issues Outcomes

Karen Ann

Quinlan

70 NJ 10 (1976)

• 21 year old collapsed at party after

taking valium while drinking and

dieting.

• Doctors saved her.

• She remained in coma for 10 years

in New Jersey nursing home.

• Family battled to remove life support

equipment. Family won, equipment

was removed and she remained

alive for 10 years.

• Legal vs. common death

• Patient’s wishes

• Right to Privacy

• Established

Ethics

Committees

• Led to creation

of Advanced

Directives

Case Name Description Issues Outcomes

Cruzan v.

Director, Missouri

Dept. of Health

497 U.S. 261

(1990)

• 25 year old Missouri female involved

in car accident

• In persistent vegetative state in

skilled nursing facility (SNF)

• Years later, parents wanted to

withdraw nutrition & hydration

• Nursing home demanded court order

– case entered legal system

• Trial court support parents; SNF

appealed

• Missouri Supreme Court overturned

trial court- needed clear &

convincing evidence

• Went to Supreme Court- right to

refuse treatment

• Back to trial court

• Family prevailed (after 10 years)

• 14th Amendment to U.S

Constitution grants each

person the right to refuse

unwanted medical

treatment- the principle

of autonomy

• “Clear & convincing’

evidence (of wants/ don’t

wants) comes from the

patient.

Developed

Patient Self

Determination Act

(similar to

Schiavo case)

24

Cruzan v. Director, Missouri

Dept. of Health (1990)

Handbook v. 1 p. 452; v. 3 p. 45

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25

Stamford Hosp. v. Vega

(1995)

Case Name Description Issues Outcomes

Stamford

Hospital v.

Vega (1995)

236 Conn. 646

• Patient was Jehovah

Witness

• Began hemorrhaging

after delivering a baby

and needed blood

transfusion to save her

life

• She declined

blood/blood products

due to religious

preferences

• Court order was filed and

granted

• Was transfused against

wishes and survived

Question of Interests Over Patient Refusal

of Blood - 3 sets of interest:

1. Patient:

• Common law right to self-determination

• Federal right to self-determination

• Constitutional right to exercise religious

freedoms (federal and state)

2. Hospital:

• Preserving patient’s life

• Protecting ethical integrity of the

healthcare profession

3. State:

• Preservation of life

• Protection of an innocent third party

• Prevention of suicide

• Maintenance of the ethical integrity of

medical profession

Theory of

‘battery’

resulted

Schlinder v. Schiavo (2005)

Handbook v. 1 p. 455

Case Name Description Issues Outcomes

Schlinder v

Schiavo (2005)

FL

• Went into cardiac arrest secondary

to electrolyte imbalance related to

dieting strategy

• Never regained consciousness

• Remained on ventilator

• Husband knew patient would not

want to continue life sustaining

measures

• Husband entered a DNR order; SNF

convinced him to remove it

• Husband wanted to remove feeding

tube- was opposed by parents

• Parents desire to remove spouse as

guardian

• Life support was removed; expired

due to dehydration

• Case involved 14 appeals,

numerous petitions

• Conflicting interests:

• State

• Parents – desire to

remove spouse as

guardian

• Spouse – desire to

support patient

wishes

• Withdrawal of

life support

• Support of

patient’s wishes

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• Chairperson should be well educated or trained in ethical

issues

• Appropriate medical and clinical staff should be included

• There should be a clerical representative from the religious

community

• A layperson from the community should be a member

• Decisions are nonbinding – consultative only

27

Ethics Committee

Handbook v. 1 p. 455-456, 459, 591

• The risk manager should:

• Be a neutral party during the discussions

• Serve as a facilitator

• Act as a consultant on legal issues

• Develop an ethics consultation mechanism

28

Ethics Committee

CPHRM Prep p. 161

Handbook v. 1 p. 146, 160

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29

Topics for Ethics

Committees

Handbook v. 1 p. 591

Abortion and reproductive

rights

End-of-life or futile care

Quality of life

Surrogate decision-making

Advance directives

DNRs

Medical resources

Staff rights that conflict with

patient wishes

Ethics consultations and decision-making done

systematically will help to ensure that ethical principles are

met. This approach would include all of the following except:

a) Verification of the facts

b) Documentation of the rationale for the decision

c) Unanimous agreement among the participants

d) Identification for the potential legal and ethical problems that may

be involved

30

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• Introduction

• Consent is a communication process, not merely the completion of

a form

• Consent is influenced by:

• Federal law

• State law

• Case law

• Failing to obtain consent may result in punitive damages and

charges of unprofessional conduct

31

Informed Consent

Fundamentals p. 173

Handbook v. 2 p. 77-79

• Risk Management Approach to Consent or Treatment

• Policies and procedures

• Risk identifiers

• Education

• Must recognize state-specific exceptions

• “Family-focused” consent process is encouraged

• Documentation

32

Informed Consent

Fundamentals p. 178

POPB p. 32-33

Handbook v. 2 p. 102-107

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33

Informed Consent

6 basic elements

Disclosure of the nature and purpose of the test or treatment

Description of the probable risks and benefits

Explanation of risks and benefits of alternatives

Risks and benefits of foregoing the test or treatment

Opportunity for questions and understandable answers

Opportunity to make a decision free of coercion and undue influence

Fundamentals p. 174

OBPB p. 251-253

POPB p. 34-35

Handbook v. 2 p. 84-85

• Exceptions from the General Rules of Consent

• Emergency treatment exception

• Therapeutic privilege exception

• Compulsory treatment situation

34

Informed Consent

Fundamentals p. 175

POPB p. 36-37

Handbook v. 2 p. 85-88

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35

Informed Consent

• Patient or recognized decision-maker must have mental capacity

• Inform patient of consequences of refusal of proposed test or treatment

• Document discussion with patient or recognized decision-maker

• Patients and decision-makers have the right to withdraw consent

Importance of an Informed Refusal

of Care

Fundamentals p. 176-177

OBPB p. 253-254

POPB p. 37-38

Handbook v. 2 p. 90-91

• Needs of Specific Patients in the Informed Consent

Process

• Preliminary screening to identify special patients

• Patients who warrant special considerations

• Minors

• Mentally disabled or challenged persons

• Patients undergoing testing or treatment for certain diseases

such as HIV, blood transfusion, or breast cancer

• Research patients – have a specific process and form that must

be followed

36

Informed Consent

Fundamentals p. 176-177

OBPB p. 254

POPB p. 37

Handbook v. 2 p. 92-97

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• Results of a Breakdown in the Consent Process

• Battery

• Negligent consent

• Misrepresentation or deceit

• Breach of contract

• Corporate liability

37

Informed Consent

Handbook v. 2 p. 99-102

• AKA: CoP, CfC

• Purpose: provides the minimum health and safety

standards that providers and suppliers must meet for initial

and continued Medicare and Medicaid certification.

• Details: these rules apply to twenty different health care

settings and categories of providers including hospitals,

rural health facilities, outpatient service providers, nursing

facilities, home health, critical access providers, etc.

38

Medicare Conditions of

Participation

Conditions for Coverage

CPHRM Prep p. 126-127

Fundamentals p. 197-198

Handbook v. 3 p. 26-28

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• Quality assessment and

performance improvement

• Medical staff

• Nursing services*

• Physical environment

• Infection control*

• Surgical services

• Governing body

• Patient’s rights*

• Medical record services

• Pharmaceutical services

• Radiological services

• Laboratory services

• Food and dietetic services

• Long-term care (LTC) services

(swing beds)

• Psychiatric hospitals: special

medical record and staff

requirements

39

CoPs for Hospitals

Fundamentals p. 182-183, 194-195, 197-198

Handbook v. 3 p. 26-27

• Defines the operational elements of a nursing service that

includes the following mandates:

• Staffing and staff supervision,

• Developing and implementing nursing care plans,

• Staff competency assessment,

• Medication administration, and

• Reporting blood transfusion reactions, adverse drug reactions, and

medication errors.

40

CoP: Nursing Services

Handbook v. 3, p. 26

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• Requirements include:

• Designating an infection control officer and developing policies that

address identifying and controlling infections and diseases;

• Developing and maintaining a log system to track these conditions;

and

• Delegating responsibility and accountability onto the hospital CEO,

the medical staff, and director of nursing services for

• Ensuring that hospital-wide QI and training programs are

implemented to address issues identified by the infection control

officer

• Implementing corrective action plans in problem areas.

41

CoP: Infection Control

Handbook v. 3 p. 26-27

• Scope of the services

• Staffing

• Duties of staff

• Surgical privileges

• Delivery of service

• Medical history and physical examination.

• Informed consent form for the operation

• Post-operative care.

• Operating room register

• Operative report

42

CoP: Surgical Services

Handbook v. 3, p. 26

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• Notice of Rights

• Complaint and Grievance Process

• Exercise of Rights

• Privacy and Safety

• Confidentiality of Medical Records

• Restraint or seclusion

43

CoP: Patient’s Rights

POPB p. 235-236

Handbook v. 3, p. 26

• Standards set by CMS that hospitals must follow to

manage complaints & grievances

• Standards must ensure:

• Families are informed of their rights to present complaints and the

mechanism to do so; by issuing a complaint it does not compromise

patient’s future access to care

• Analysis of complaints and appropriate action is taken to correct the

issues

• A response is sent to each patient/family which addresses the

complaint

44

CoP: Complaint &

Grievances

Fundamentals p. 198-199

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• Purpose: for discharges occurring on or after Oct. 1, 2008, Medicare will no longer pay a hospital at a higher rate for an inpatient hospital stay if the sole reason for the enhanced payment is one of the selected HACs and the condition was acquired during the hospital stay.

• Enacted due to:

• High cost and high volume

• Assignment of higher MS-DRG payment (increased reimbursement)

• Could reasonably have been avoided through evidence based medicine

• Details: The government has compiled and published the list of HACs, which are…

45

CMS Hospital Acquired

Conditions (HACs, Serious

Safety Events)

Fundamentals p. 189

Handbook v. 3 p. 9-10

• Foreign Objects Retained After Surgery

• Air Embolism

• Blood Incompatibility

• Stage III and IV Pressure Ulcers

• Falls and Trauma

• Fractures

• Dislocations

• Intracranial Injuries

• Crushing Injuries

• Burns

• Electric Shock

• Iatrogenic Pneumothorax with venous catherization

46

CMS HACs

Handbook v. 3 p. 9-10

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• Manifestations of Poor Glycemic Control

• Catheter-Associated Urinary Tract Infection (UTI)

• Vascular Catheter-Associated Infection

• Surgical Site Infection Following:

• Coronary Artery Bypass Graft (CABG) – Mediastinitis

• Bariatric Surgery

• Orthopedic Procedures (spine, neck, shoulder, elbow)

• Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)

• Total Knee Replacement

• Hip Replacement

47

CMS HACs

Handbook v. 3 p. 10-11

• AKA: HCQIA

• Purpose: establish an infrastructure (NPDB) to identify

physicians and other providers who have been subject to

certain professional disciplinary actions or, on whose

behalf, payments were made to resolve professional

liability claims or legal actions.

48

Health Care Quality

Improvement Act of 1986

CPHRM Prep p. 115-117

Fundamentals p. 237

Handbook v. 3 p. 28 - 30

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• Details: provides conditional immunity from anti-trust suits

against healthcare facilities and their medical staff that

participate in peer review, provided that…..

• “Due-process” protections were made available to the physician

under review, and

• The reviewers acted in good faith “in furtherance of quality patient

care.”

49

HCQIA: National Practitioner

Data Bank (NPDB)

Fundamentals p. 356-357

Handbook v. 3 p. 28-30

• Reporting Requirements

• Payments of judgments or settlements made on behalf of specified

licensed practitioners, regardless of the amount in response to

written demand – report within 30 days of the date of payment to

NPDB

• Hospitals and other healthcare entities: Actions taken which

adversely affect privileges of physicians and dentists or membership

on the staff – report within 15 days of adverse action to board of

medical examiners

• Disciplinary actions taken by State medical and dental boards –

licensing board reports within 30 days

50

HCQIA: National Practitioner

Data Bank (NPDB)

Fundamentals p. 237-238

OBPB p. 245

Handbook v. 3 p. 28-30

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• Hospitals must request information from NPDB on a new

physician, dentist or other practitioner at the time of initial

application

• Information on current members must be requested at a

minimum of every 2 years

• Hospital may suspend or restrict privileges for 14 days

during which an investigation may be conducted to

determine the need for a professional review action

• Hospital may summarily suspend privileges, subject to

subsequent notice and hearing, if failure to take such action

would jeopardize the health of any individual

51

HCQIA: NPDB

Handbook v. 3 p. 28-30

• Failure to report indemnity payments…up to $11,000 fine

• Hospitals that do not request information from the NPDB

are presumed to know about the information they would

have obtained if they had asked.

• Failure to report a reportable adverse action waives the

hospital’s immunity protection from discovery for three

years.

52

HCQIA: NPDB

Handbook v. 3 p. 28-30

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• AKA: HIPDB

• Purpose: a clearinghouse for the reporting and disclosure of certain final “adverse actions” taken against health care practitioners, suppliers, and other providers in an effort to combat fraud and abuse.

• As of May 6, 2013, the National Practitioner Data Bank (NPDB) and the Healthcare Integrity and Protection Data Bank (HIPDB) are now one Data Bank: the NPDB.http://www.npdb.hrsa.gov

• Users will experience no disruption in Data Bank service, and essentially no change to their reporting workflow or requirement.

53

The Healthcare Integrity and

Protection Data Bank

CPHRM Prep, p. 135

Handbook v. 3 p. 30-31

• HIPDB contains information regarding:

• Civil judgments against health care providers, suppliers, or

practitioners related to the delivery of a health care item or service

• Federal or State criminal convictions against health care providers,

suppliers, or practitioners related to the delivery of a health care

item or service

• Actions by Federal or State agencies responsible for the licensing

and certification of health care providers, suppliers, or practitioners

• Exclusions of health care providers, suppliers, or practitioners from

participation in Federal or State health care programs

• Any other adjudicated actions against health care providers,

suppliers, or practitioners

54

HIPDB – Details

Handbook v. 3 p. 30-31

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• AKA: VBP

• Three domains: • Clinical Process of Care (13 measures)

• Patient Experience of Care (8 HCAHPS dimensions)

• Outcome (3 mortality measures)

• Quality incentive program built on the Hospital Inpatient Quality Reporting (IQR) measure reporting infrastructure

• Designed to promote higher quality care for Medicare beneficiaries

• Rewards facilities with better patient outcomes, processes and experiences instead of just volume of services

• Funded by a 1.25% reduction from participating hospitals’ base-operating Diagnosis-Related Group (DRG) payments in FY 2014

55

Hospital Value-Based

Purchasing Program

• AKA: FDA: a division of the Department of Health and Human Services

• Purpose: protect public health by regulating commerce that involves food, drugs (including biologics) and medical devices (including radiation devices).

• Details: a robust collection of laws that impact the day-to-day delivery of healthcare in a multitude of ways, such as

• Record keeping for dispensing narcotics

• Manufactures of drugs must show evidence of drug safety and provide evidence of drug effectiveness

• Initiated tracking of medical devices

• Required reporting of serious events related to medical devices

56

Food and Drug

Administration

CPHRM Prep p. 114, 117-119

Fundamentals p. 336-337

Handbook v. 3 p. 5, 35-36

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Center for Devices &

Radiological Health –

CDRH

Center for Drug Evaluation

and Research –

CDER

Center for Biologics

Evaluation & Research –

CBER

Responsible for regulating

companies that manufacture,

repackage, relabel, and/or

import medical devices.

Responsible for oversight of

the development, testing and

marketing of all

pharmaceuticals (except

vitamins and dietary

supplements)

Responsible for oversight of

the nation’s blood supply

Tracks reports of adverse

events including device

malfunctioning

Includes over the counter,

prescription, biological

therapeutics & generics

Ensures safety and

effectiveness of biological

products

Regulates all radiation-

emitting electronic devices

Other products such as

fluoride toothpaste,

antiperspirants, dandruff

shampoos & sunscreens

Includes vaccines, blood

and blood products, cells,

tissues, & gene therapies

57

FDA: 3 Healthcare Divisions

Fundamentals p. 81-82, 336-337

Handbook v. 3, p. 5, 6, 35-38

• AKA: SMDA, FDA device reporting law

• Purpose: gather information regarding safety of medical

devices, including reports about adverse incidents

associated with their use (including user error)

• Device: any item used for the diagnosis, treatment, or

prevention of a disease, injury, illness or other condition,

that is not a drug.

58

Safe Medical Device Act of

1990

Fundamentals p. 81-82

Handbook v. 3 p. 35-38

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Who Reports

• Hospitals

• Ambulatory surgical centers

• Outpatient diagnostic &

treatment facilities

• Nursing homes

• Home care agencies

• Ambulance providers

• Rehab & psych facilities

Who is Exempt

• Physicians’ offices

• Chiropractitioners

• Optometrists

• Nurse practitioners

• Employee health clinics

• Dentists

• Freestanding care units

59

SMDA

Handbook v. 3, p. 35

• If device has or may have caused or contributed to a death…

report to product manufacturer (if known) and FDA within 10

working days of notice (eMDR Electronic Medical Device

Reporting)

• If device has or may have caused or contributed to a serious

injury… report to product manufacturer only within 10 working

days of notice. If the manufacturer is unknown, report to the

FDA (eMDR Electronic Medical Device Reporting)

• If a facility submitted any eMDR Electronic Medical Device

Reporting reports to the manufacturer or the FDA, the facility

must submit a summary to the FDA no later than January 1st

60

SMDA:

What and When to Report

eMDR – electronic medical device reporting. Online data entry and processing of reportable medical

device events. Has a low volume (single report at a time) or high volume (batch submission).

Fundamentals p. 81-82

Handbook v. 3, p. 35

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The risk manager has been notified of a death associated

with an IV pump malfunction resulting in a fatal dose of a

narcotic. The risk manager must:

a) Call the Food and Drug Administration

b) File a controlled substance report

c) Complete a SMDA report

d) Have the device checked by manufacture

Fundamentals p. 81-82.

• Federal Agencies

• FDA

• OSHA

• Accreditation Requirements

• The Joint Commission

• Standard EC.02.01.01, EP 11

• Standard MM.05.01.17, EPs 1-4

• Manufacturing trends – outsourcing of products

• Product quality and safety outside full control of corporation

62

Recall Drivers

Handbook v. 2 p. 72-73

http://www.jointcommission.org

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• Develop standardized processes to receive and

disseminate information about product recalls, notifications,

and safety alerts to appropriate departments and

individuals

• Accountability – who is responsible?

• Communication plan

• Consider pharmaceuticals

• Alerts Tracking mechanism

• Timely management of recall and replacement efforts

• Establish a claims processing mechanism

63

Recall Challenges

Handbook v. 2 p. 72-73

• AKA: EMTALA

• Purpose: congressional mandate for hospitals and

providers to provide a “safety net” for persons seeking

assessment and care for a possible clinical emergency at a

Medicare-contracted hospital

• To eliminate “patient dumping” of uninsured patients for no reason

other than an inability to pay

64

Emergency Medical

Treatment and Labor Act

Fundamentals p. 201

CPHRM Prep p. 12-123; v. 3 p. 13-15

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• Details: requires hospitals to provide a medical screening

exam (MSE) and, if needed, clinical stabilization, to any

individual who comes to hospital seeking care

• If an individual is believed to have an emergency medical

condition (EMC), the hospital must provide a medical

examination and treatment within its capacity and capability

to stabilize the medical condition

• EMC includes psychiatric illness, including alcohol and drug

intoxication

65

EMTALA

Fundamentals p. 203

OBPB p. 282-284

Handbook v. 3 p. 13-15

• An unstable patient with an emergency medical condition

may not be discharged or transferred to another facility

unless:

• Patient refuses treatment or requests a transfer

• Hospital does not have capability

• Physician certifies that benefits of transfer outweigh the risks

66

EMTALA

Fundamentals p. 204

Handbook v. 3 p. 13

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• Mandatory reporting: hospitals are required to report

suspected improper transfers (e.g., no prior notice from

other hospital, financial “dumps,” etc.) within 72 hours. Not

doing so is, itself, a violation.

• Sanctions:

• Termination of the hospital’s Medicare provider agreement

• Civil monetary penalties of up to $50,000 per violation (includes

hospitals and physicians)

67

EMTALA

Fundamentals p. 205

Handbook v. 3 p. 15

EMTALA is triggered when:

a) The patient’s physician office accepts an emergency

patient

b) A patient is loaded into a hospital owned ambulance

c) The patient requests a county-wide ambulance for

transportation

d) A patient presents within 300 yards from the main

building

Fundamentals p. 202

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• AKA: LTC laws

• Purpose: requirements that an institution must meet in

order to qualify to participate as a SNF in the Medicare

program, and as a nursing facility in the Medicaid program.

• Details: emphasized residents’ rights, promoting the dignity

of residents; residents may file formal complaints about

infraction of any right

69

Medicare Regulations for

Long Term Care Facilities

CPHRM Prep p. 119-120

Handbook v. 1 p. 38-40

• Develop initiatives to continually improve and maintain

overall level of patient care (including a special focus on

restraint reduction)

• Reduce the incidence of pressure ulcers and malnutrition

• Imposes staffing obligations – nursing coverage, physician

examinations and follow-up visits

• Establish a formal training and certification for nursing

assistants

• Establish and enforce resident’s rights

70

LTC Requirements

Fundamentals p. 55

Handbook v. 1 p. 38-40

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• Child Abuse Prevention and Treatment Act (CAPTA) of

1974 defines what constitutes child abuse and neglect.

• States have adopted their own strict Child Protective

Services laws.

• Older Americans Act defines elder abuse and funds the

National Center for Elder Abuse and related programs.

• States have implemented Adult Protective Services

organizations to address this issue.

71

Child Abuse and Elder/

Dependent Abuse Reporting

CPHRM Prep p. 145-146

Handbook v. 3 p. 33-35

OBPB p. 267

• AKA: ADA – Title III – Nondiscrimination on the Basis of

Disability in Public Accommodations and Commercial

Facilities

• Purpose: prohibits private entities who provide public

accommodations and services from denying goods,

services and programs to people based on their disabilities.

• Includes the following:

• Structural accessibility requirements for private entities

• Programmatic access: reasonable modifications in policies and

procedures or practices when such are necessary to provide

same level of goods, services, etc. to disabled as non-disabled

72

The Americans with

Disabilities Act

Fundamentals p. 193-194

Handbook v. 3 p. 183

www.ada.gov/regs2010/titleIII_2010/titleIII_2010_regulations.htm#subparta

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• A public accommodation

• must not impose or apply eligibility criteria that screen out or tend to

screen out an individual with a disability or any class of individuals

with disabilities

• may impose legitimate safety requirements that are necessary for

safe operation.

• may not impose a surcharge on a particular individual with a

disability or any group of individuals with disabilities to cover the

costs of measures for accommodation

73

ADA: Title III

www.ada.gov/regs2010/titleIII_2010/titleIII_2010_regulations.htm#subparta

• What is the definition of a disability according to ADA?• A physical or mental impairment that substantially limits one or more of

the major life activities of such individual

• Examples of physical or mental impairment • Anatomical loss affecting one or more of the following body systems

• Any mental or psychological disorder such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities

• Includes, but is not limited to orthopedic, visual, speech, and hearing impairments, cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, cancer, heart disease, diabetes, mental retardation, emotional illness, specific learning disabilities, HIV disease, tuberculosis, drug addiction, and alcoholism

• What are major life activities?• Functions such as caring for one´s self, performing manual tasks,

walking, seeing, hearing, speaking, breathing, learning, and working.

74

ADA: Title III

Handbook v. 3 p. 181-183

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Data Management

• HIPAA Regulations

• Release of Personal Health Information

• Must adhere to HIPAA rules and state statutes

• New variations of old concerns introduced by new

information technologies

• Electronic Patient Records

• Confidentiality and security issues

• Accessibility and durability

• Accuracy and evidentiary concerns

• Social media

76

Data Management

Fundamentals p. 206-209, 303-304

Handbook v. 1 p. 347-348, 494-498; v. 3 p. 521-524, 527-539

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• Purpose of the Medical Record

• Primary communication medium for planning, coordinating, and

orchestrating patient care

• Primary basis for reimbursement

• Legal document

• Defense against negligence claims

• Basis for many other important activities

77

Data Management

Handbook v. 1 p. 331-332

78

Data Management

Documentation

• Federal and state statutes

• Professional practice standards

• Specific health care facility protocols

• Third party payers

• Accrediting organizations

Handbook v. 1 p. 340-343

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• Security

• Risk Manager’s Role

• Monitor to assess quality of documentation

• Communicate regularly with the Health Information Services/Health

Information Management Committee

• Educate the clinical staff

• Work closely with privacy officer

79

Data Management

Fundamentals p. 158-164

Handbook v. 1 p. 352-358

The rules that govern documentation come from which of the

following sources?

1) The Joint Commission

2) State and federal statutes

3) Professional practice standards

4) Insurance companies

a) 1 and 2 only

b) 2 and 3 only

c) 1, 2 and 3 only

d) All of the above

80

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• AKA: HIPAA

• Purpose: creates standards for the use and dissemination

of health care information

• Details: Privacy Rule regulates the use and disclosure of

certain information held by "covered entities“ and

establishes regulations for the use and disclosure of

Protected Health Information (PHI).

• PHI is any information held by a covered entity which concerns

health status, provision of health care, or payment for health care

that can be linked to an individual including any part of an

individual's medical record or payment history

81

The Health Insurance

Portability and Accountability

Act

CPHRM Prep p. 131-135

Fundamentals p. 206-209

Handbook v. 1 p. 517-60

Notify individuals of use of their PHI

Track PHI disclosures

Appoint Privacy Officer to receive

complaints, document policies & educate

staff

Provide PHI to individual within 30

days of request

Disclose PHI when mandated by law

Take reasonable steps to ensure confidentiality of communication

82

HIPAA Obligations of

Covered Entities

Fundamentals p. 206-209

Handbook v. 1 p. 517-60

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• A covered entity may disclose PHI without authorization for

4 purposes; to facilitate treatment, to obtain payment for

services, for purposes of an organizations internal health

care operations and as may be mandated by law.

• A covered entity may disclose PHI if such entity has

obtained authorization from the individual

• When a covered entity discloses any PHI, it must disclose

only the minimum necessary information required to

achieve its purpose.

• The Privacy Rule gives individuals the right to request that

a covered entity correct any inaccurate PHI.

83

HIPAA

Fundamentals p. 208, 342

Handbook v. 1 p. 517-60

• AKA: HITECH

• Purpose: promotes and advances the adoption of health

information technology (HIT).

• Details: HIT is intended to provide rapid, efficient and

secure coordination of care and sharing of information

among hospitals, physicians, long term care facilities, home

health agencies and all other authorized users.

84

Health Information Technology

for Economic and Clinical

Health Act

Handbook v. 3 p. 38-39

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• Creates the right of individuals to be notified by the

“covered entity” (CE) within sixty days if there us a breach

of their protected health information (PHI).

• A “breach” is defined as “the unauthorized acquisition,

access, use, or disclosure of [PHI] which compromises the

security or privacy of such information, except where an

unauthorized person to whom such information is disclosed

would reasonably have been able to retain such

information.”

85

HITECH – Breach

Notification Rule

Fundamentals p. 209, 342

Handbook v. 3 p. 38-39

86

Breach Notification –

Requirements for HIPAA and

HITECH

Notification requirements

Under special circumstances posting on the home page of the of covered entity – or notice in major print or broadcast media

If felt to be urgent due to the possibility of “imminent misuse” of the PHI, notice by telephone or other method

Written notice to the individual or their next of kin

If the breach is believed to affect more than 500 residents of a state or jurisdiction, notice must be provided to prominent media within that area, and posting on an HHS web site.

Fundamentals p. 208

Handbook v. 3 p. 38-39

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CMS Initiatives

Related to Payment

• AKA: Stark I, II, III – Anti self-referral law.

• Purpose: deters fraud by prohibiting a physician from

referring patients to an entity for a designated health

service (DHS) covered by Medicare, if the physician or a

member of his immediate family has a financial relationship

with the entity, unless an exception (“safe harbor”) exists.

88

Omnibus Budget

Reconciliation Act of 1989

CPHRM Prep p. 129-131

Handbook v. 3 p. 127-28

Fundamentals p. 363

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• Prohibits a physician from submitting a claim or a bill to any person for a service or item furnished pursuant to a prohibited referral

• Includes bribes, kickbacks, excessive or unreasonable discounts or rebates, and profit-sharing agreements

• Various healthcare services under scrutiny include:

• Labs

• PT/OT

• Radiology and radiation oncology

• DMEs

• Prosthetics

• HHC

89

Stark

Handbook v. 3 p. 127-28

• AKA: RAC (Recovery Audit Contractor)

• Purpose: to identify and correct Medicare improper payments through the detection and collection of overpayments and underpayments made on claims of health care services provided to Medicare beneficiaries

• Overview: Claims submitted to Medicare are screened prior to payment and are generally paid without requesting the supporting medical records. As a result, some claims may be paid inappropriately, resulting in improper payments. The most prevalent reasons for improper payment are:

• Items or services that do not meet Medicare's coverage and medical necessity criteria

• Items that are incorrectly coded

• Services where the supporting documentation submitted does not support the ordered service.

90

Recovery Audit Program

Fundamentals p. 33

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• AKA: MMSEA

• Purpose: requires that liability insurers (including self-

insurers), no-fault insurers, and workers’ compensation

plans report specific information about Medicare

beneficiaries.

• What Must Be Reported: the identity of a Medicare

beneficiary whose illness, injury, incident, or accident was

at issue to enable an appropriate determination concerning

coordination of benefits, including any applicable recovery

claim.

91

Medicare, Medicaid, and

SCHIP Extension Act of 2007

Employment

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• Fair Labor Standards Act (FLSA)

• Title VII of the Civil Rights Act of 1964

• Title I Americans with Disabilities Act (ADA)

• Age Discrimination in Employment Act (ADEA)

• Sections 1981 and 1983 of the Reconstruction Civil Rights Acts

• Family and Medical Leave Act of 1993 (FMLA)

• Equal Pay Act of 1963

• Uniformed Services Employment and Reemployment Rights Act

• “Whistle-blower” protection

93

Federal Statutes Regarding

Employment

Fundamentals p. 191-195, 359

Handbook v. 3 p. 172-187

• AKA: anti-discrimination law

• Purpose: prohibits not only intentional discrimination, but

also practices that have the effect of discriminating against

individuals because of their race, color, national origin,

religion or sex.

• Details: for example, the law makes illegal…

94

Title VII of Civil Rights Act of

1964

CPHRM Prep p. 127-128

Fundamentals p. 191-192

Handbook v. 3 p. 172-77

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• Sexual harassment: any act that creates a “hostile work environment” is prohibited.

• A hostile work environment is a work environment made intolerable to a reasonable person by the frequency, severity or pervasiveness of objectionable words, actions or other materials of a sexual nature, or materials that direct hostility at people because of their ethnicity, race or age. Employees who experience sexual or nonsexual harassment can claim the discrimination created a hostile work environment.

• Pregnancy-based discrimination: pregnancy, childbirth and related medical conditions must be treated as are other illnesses and temporary conditions and may not be used to deny employment opportunities.

95

Title VII:

Anti-discrimination Law

Fundamentals p. 191-195

Handbook v. 3 p. 172-77

• AKA: ADA for employees

• Purpose: prohibits discrimination in recruitment, hiring,

promotions, training, pay, social activities, and other

privileges of employment on the basis of disability in all

employment practices.

• Details: to be protected by the ADA, an individual must

have a disability or have a relationship or association with

an individual with a disability.

• A disability is defined as a person who has a physical or mental

impairment that substantially limits one or more major life activities;

a person who has a history or record of such an impairment; or a

person who is perceived by others as having such an impairment.

96

Title I, Americans with

Disabilities Act of 1990

CPHRM Prep p. 128-129

Fundamentals p. 193-194, 349, 354

Handbook v. 3 p. 181-183

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• Title I requires employers with 15 or more employees to

provide qualified individuals with disabilities an equal

opportunity to benefit from the full range of employment-

related opportunities available to others.

• The law restricts questions that can be asked about an

applicant's disability before a job offer is made.

• Employers are required to make reasonable

accommodation to the physical or mental limitations of

otherwise qualified individuals with disabilities, unless it

results in undue hardship.

97

More Details…

Fundamentals p. 349, 354

Handbook v. 3 p. 181-183

• Federal agency within the Department of Labor

• Responsible for receiving and investigating charges of

discrimination filed by former, current or prospective

employees under Title VII, ADA, and ADEA

• EEOC claim must be filed w/in 180 days of alleged action

• If negative findings – employee can bring civil action

• If positive findings – EEOC brings charges against organization

98

Equal Employment Opportunity

Commission (EEOC)

Fundamentals p. 41, 192

Handbook v. 1 p. 3-19, 104-105; v. 3 p. 172-174, 194

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Workplace Safety

• Occupational Safety and Health Administration

• The primary regulatory agency in the field of occupational safety

and health is OSHA, a federal agency within the U.S. Department of

Labor

• 20 different categories listed in textbook that address the principal

health concerns for which OSHA has developed safety standards

• Numerous other injuries and illnesses not directly addressed by

OSHA

100

Occupational and

Environmental Risk Exposures

for Health Care Facilities

Fundamentals p. 41

Handbook v. 3 p. 425-455

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• Environmental Issues

• Underground storage tanks

• Aboveground storage tanks

• Asbestos removal

• Disposal of hazardous waste

• On-site medical waste incinerators

• Clean Air Act

• Clean Water Act

• Toxic Substance Control Act

• Environmental Issues in Acquisitions

• Inspection of the property

• Records review

101

Occupational and

Environmental Risk Exposures

for Health Care Facilities

POPB p. 118-127

Handbook v. 1 p. 544-548; v. 3 p. 459-468

Underground and above ground storage tanks to store fuel

oil are regulated by which Federal agency?

a) EPA

b) NFPA

c) OSHA

d) FDA

Fundamentals p. 106 102

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52

• AKA: OSH Act

• Purpose: to create workplace safety rules.

• Details: establishes a federal requirement that employers

provide a place of employment that is free from recognized

hazards to personal safety and health, such as exposure to

toxic chemicals, excessive noise levels, mechanical

dangers, unsanitary conditions, heat or cold stress, etc.

103

Occupational Safety and

Health Act of 1970

Fundamentals p. 353

Handbook v. 3 p. 145-46

Covers…

• Asbestos abatement

• Blood-borne pathogen control

• Hepatitis B immunizations

• Infectious waste handling

• Sharps injury prevention

programs

• Radiation exposure safety

• Ergonomics in work place

And…

• Hazard Communication

Standards/Material Safety Data

Sheets (MSDS)

• Hazardous Waste Operations

and Emergency Response

Standards (HAZWOPER):

applies to workers who clean up

hazardous spills or hazardous

material

104

OSHA

Fundamentals p. 354

Handbook v. 3 p. 145-46

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Accreditation

CPHRM Prep p. 136-140

A reflection of compliance with established norms or standards

A reflection or snapshot in time

Viewed by the public and payer as a “Seal of Approval”

For some payers a threshold for contracting

106

What is Accreditation?

Handbook v. 3 p. 153-55

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• And there are others…

107

Accreditation:

Voluntary Organizations

The Joint Commission – TJC

Det Norske Veritas – DNV

National Committee for Quality

Assurance – NCHQ

Healthcare Facilities

Accreditation Program – HFAP

College of American Pathologists – CAP

Handbook v. 3 p. 60-77

• Value of Participating

108

Accreditation

Public demands it

Participation makes good business sense

Leads to improved patient care and safer environment

Promotes good discipline

Supports transparency

Fundamentals p. 150-151, 195-197

Handbook v. 3 p. 55-56

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55

• Liability exposure: We are talking “standards of care”.

• Non-compliance = Loss of certification for

Medicare/Medicaid and private payer contracts

• If the CMS uncovers any evidence of non-compliance,

other state and federal agencies may be notified

• Loss of status = Reputational loss

109

Accreditation: Risk

Management Implications

Handbook v. 3 p. 54-56

Corporate Compliance

CPHRM Prep p. 129-131

Fundamentals p. 34

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56

• Supports legal/regulatory/accreditation obligations

• Improve the quality and safety of care

• Demonstrates a commitment to honesty and integrity in

work practices

• Provide a more accurate view of employee and contractor

behavior

• Identify and prevent criminal and unethical conduct

• Implement a means for immediate and appropriate

corrective action

111

Why Have a Corporate

Compliance Program?

Fundamentals p. 57, 99

Handbook v. 3 p. 123-33

112

Corporate Compliance

Program Elements

Program elements

Develop and distribute written standards of conduct and P&Ps that demonstrate the organization’s commitment to compliance

Designate a chief compliance officer and an appropriate oversight committee

Develop and implement regular and effective employee education programs

Implement and maintain an appropriate confidential complaint process

Develop a process to respond to allegations

Use audits to monitor compliance

Investigate and resolve identified problems

Handbook v. 3 p. 135-44

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57

• Department of Health & Human Services

• Oversight of programs funded through the American

Recovery and reinvestment Act of 2009 (Recovery Act)

• Develops annual work plans focused on gaps within

healthcare systems

• Focused investigations:

• Individuals & organizations who knowingly and willfully execute

schemes to defraud any HHS program, grant, or contract involving

Recovery Act funds; and

• Facilitate ongoing communications with Federal, State, and

local law enforcement and other agencies regarding the

use and distribution of HHS Recovery Act funds.

113

Corporate Compliance: Office of

Inspector General (OIG)

Responsibility

Fundamentals p. 242

114

Questions


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