Certified Healthcare Constructor Exam Study Guide Questions 2022/2023 | Consisting Of 348 Questions With Verified Answers From Experts

What two types of med gas are required in a typical med/surg patient room?
vacuum and oxygen according to Guidelines for Design and Construction of Health Care Facilities.

When should medical equipment modality selections ideally be made during the planning, design, and construction process?
Before the end of SDs

When should medical equipment manufacturer selections ideally be made for each modality during the planning, design, and construction process?
Before the end of DDs

What is a medical equipment modality?
Refers to different types of imaging equipment

What are some examples of medical imaging modalities?
Conventional radiography
Fluoroscopy
Angiography
Mammography
Computed Tomography
Ultrasound and Ultrasound/Doppler
Magnetic resonance Imaging
Nuclear Medicine

NFPA 101-2000 details that “primary level of exit discharge of a building shall be the lowest story whose floor is level with or above finished grade on the exterior wall line for XX% or more of its perimeter.”
50%

Does an MRI machine use radiation to produce its images?
No, it uses magnetic and radio frequencies

Does an ultrasound use radiation to produce its images?
No, it uses sound waves

What does a CT scan machine use to produce its images?
Ionizing radiation

When should ICRA planning be complete when a new construction project is being built next to an existing building if the two will eventually connect?
Before construction starts

Before an employee enters a permit-required confined space, the internal atmosphere shall be tested with a calibrated direct-reading instrument for oxygen content and which of the following?
potential toxic air contaminants, and flammable gases and vapors

What are the 3 main components of the exterior wall system that keeps moisture out of the building?
weather barrier, air gap, exterior finish

What is the best contract type for an owner if a project is only 50% designed?
cost plus GMP

Is a facility in bad shape if it has a high FCI number?
Yes

Is self latching hardware required at doors within openings that are part of the smoke barrier?
No

How often should fire extinguishers be inspected at an HCF?
Monthly

How often should alternate exits caused by an ILSM plan be inspected during construction?
Daily

What wall type should separate renovation space from occupied space in a non-sprinklered?
1-hour

What is a sentinel event?
Any event that causes unanticipated harm to a patient not related to the natural course of the patient’s illness (according to TJC)

Acute is to ambulatory as…
inpatient is to outpatient

What is the most important ICRA requirement during a roof replacement?
Keeping the building dry to prevent mold growth

How many smoke compartments must a floor have if it is somewhere that patients sleep or patients are treated?
2 according to NFPA 101-2000

Does a general hospital or an ACC have a higher patient acuity? Why?
General hospital because it has an ER and an ICU. Ambulatory hospitals are outpatient hospitals.

When should an ILSM plan be implemented?
Anytime construction occurs, but also anytime a life safety issue is identified and cannon be immediately mitigated.

What is the most important patient safety feature in an inpatient behavioral health unit?
Suicide prevention

Is lead shielding required when constructing an MRI room?
No, no radiation is involved in the imaging process

What is the general procedure for when a hospitals fire alarm system is down during construction for an extended amount of time?
A hot work permit should be obtained, a fire watch implemented, and the system restored after closing out the hot work permit

How long does fire watch need to be implemented during hot work?
Fire watch must be implemented until the hot work permit is closed out

What specifies the duration of a fire watch during hot work?
The hot work permit

What type of radiation does a positron emission tomography (PET) Scan use for imaging?
intravenous radioactive materials

What does an electroencephalography (EEG) machine monitor?
Brainwaves

What is polysomnography (PSG) used for?
PSG monitors physiological data during sleep studies.

What is the Green Guide for Healthcare used for?
The Green Guide for Health Care is an agency that awards certification for buildings constructed to meet their standards.

Is temporary signage a required component in maintaining patient safety during construction?
No

What are some examples of patient safety requirements during construction?
back-up power, method of infection control, and fire/life safety

What typical cryogenic material is used to cool an MRI device?
Liquid helium

What is the danger to the patient if cryogenic material leaks?
it can displace air (starting at floor level because it is heavier than air) and cause asphyxiation

What is it called when cryogenic material is suddenly released?
Quenching

What is a risk associated with quenching a cryogen?
the liquid cryogen may rapidly turn to gas and release large amounts of energy resulting in an explosion.

Which of the following considerations is MOST important when selecting a construction delivery method for a project
Goals

What is the order of load shedding that should occur if a power outage occurs?
Equipment then critical then life safety

What is the purpose of having segregated branches of electrical systems?
load shedding that should occur if a power outage occurs

Place the following building envelope materials from the LEAST to MOST
expensive per square foot.

1. masonry
2. precast (tilt slab)
3. curtain wall
   precast, masonry, curtain wall

Is tilt wall construction more expensive than masonry type construction?
No

What are the 2 dangers of storing new IT equipment on a construction site?
Theft and dust

How many people die a year from hospital
acquired infections (HAI’s)
99,000

What percent of those that die from HAI’s can
be attributed to construction
5% to 7%

What are 4 main components of an ante room?
Hepa with magnehelic gauge, Sticky and walk off mats, Dedicated power, Signs with precaution levels

What class of construction requires an anteroom?
Class IV and whenever the ICRA plan specifies

What are some examples of construction activities that require a fire watch?
Cutting, torching, welding, Soldering, All open flame work, Fire alarm is inoperable for more than 4hrs in a 24 hour period, Using a chop saw

During an ILSM the Hospital Safety department
is required to conduct additional fire drills how
often?
Once per shift per quarter

How often are exits checked during an ILSM condition?
Daily

What should partitions be made out of in an ILSM condition?
non-combustible materials

What does the acronym ILSM stand for?
Interim life safety measurement

The ILSM will be established, implemented, documented and monitored during construction by:
The Director of Facilities & The Construction Manager

What are some examples of construction related educational concepts that a hospital might promote?
a) Building deficiencies
b) Construction hazards
c) Temporary measures are implemented
e) Maintaining fire safety

What are the two purposes of a fire watch?
-Supplement the existing fire detection
and response system
-To confirm all hot work has “cooled”
down and the safety of patients, staff and
visitors is not jeopardized

Corridor doors in a one hour smoke barrier must meet the following minimum requirements?
20 minute label, self-closing with non-latching hardware

According to the Life Safety Code, which of the following is correct in regard to corridor walls in a sprinklered occupancy?
The walls must limit transfer of smoke

In an Existing Facility, that is sprinklered, corridor doors must be able to resist X pounds of pressure from the latch side of the door?
5 pounds

Tubing for positive pressure medical gas systems delivered from the manufacturer shall have these 3 requirements:
Plugged or capped, Hard-drawn seamless, Identified as “oxy” or “med”

In positive pressure systems, area alarm sensors for vital life support and critical care areas shall be located on which 3 sides side of the
zone valve box assemblies?
patient room, outlet/inlet, and downstream

Where shall pressure indicators be provided for medical gas systems? (3 part answer)
On the main supply line, At the area alarm, Outlet/inlet side of zone valve

A level 1 dedicated WAGD source shall consist of ______or more producers, each shall be sufficient to serve the peak calculated
demand.
two

Level 1 medical-surgical vacuum sources shall consist of an automatic means to prevent __ through any off-cycle vacuum pump.
Backflow

Where medical air piping systems at different operation pressures are required, the piping shall separate after the __.
Filters

What is the required time that life safety equipment must be restored to power?
10 seconds

When using a metal clad cable for branch wiring in a Healthcare facility what type of cable is to be used?
HCF MC cable

What are the 4 basic test requirements associated with patient care area receptacles and what NFPA Code addresses the issue?
Physical integrity, continuity of grounding, correct polarity and retention force “NFPA 99”

How many receptacles are required at a patient bed location (headwall) in a General Care area? Critical Care area?
8 & 14

According to NFPA 99-1999, to which branch of the essential electrical system are the medical gas alarm panels connected:
Life Safety

Does a laundry room belong on the Critical Branch of the Essential Electrical System in a Patient Care area ?
No

The Joint Commission dates as far back as 1910 with Dr. Ernest Codman with
End Result System of Hospital Standardization

The premise on which TJC inspects is called
The Environment of Care

The three basic elements that make up the environment of Care are
Building, Equipment & Staff Support Services

When TJC is on site for an inspection they expect to see documentation for these 4 things:
-Signs and training for altered egress
-Fire & Smoke Barrier Management System
-Additional Fire Fighting Equipment in
Impaired Areas
-Continuous Debris Removal

What is 3 things are key to minimizing risk to the patient population
Planning, implementing & evaluating changes

When you in your accreditation cycle you can be inspected with in _ of your last inspection.
1.5 to 3 years

For the DOH book, certified subcontractor completion letters should have all of the following 4 attributes
a) Typed on subs company letterhead
c) Notarized, signed and dated
d) File number
e) Index number

If you fail the inspection how long must you typically wait before DOH will come back out?
4 weeks

What must you include in the follow up email after the inspection?
Corrective action with backup and photos

What NFPA code is required to be shown on the Fire Suppression Compliance Letter?
b) NFPA 13 and NFPA 25

What is NFPA 13?
Standard for the Installation of Sprinkler Systems

What is NFPA 25?
Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems

What 3 requirements must be met for Imaging equipment rooms to be permitted to open into a hybrid operating room?
a) It is physically separated from it with walls
and a door
b) Large enough to contain transformers and
power distribution equipment
c) Large enough to contain computers,
associated electronics, electrical gear, and
their associated clear floor areas

When replacing a CT system within an existing suite, which 2 parties must be coordinated with before tie-in of utilities and use of newly completed machine?
Coordinate with owner and appropriate facility personnel

What are the 3 main procedures of planning the utility interruption itself
a) owner notification / UIR form
b) ILS plan
e) EOP

MGPHO definition
Med gas professional healthcare organization

What 3 organizations address the qualification of med gas piping inspectors
a) NFPA
b) ASSE
c) MGPHO

Does the NITC address the qualification of med gas piping inspectors?
No

What kind of plan do you always need?
A back up plan

Which ASSE Standard outlines medical gas installer requirements
6010

Most Fires from Hot Work occur:
Within 5 minutes of the work

Who is responsible for confirming area conditions prior to issue of Hot Work Permit:
PAI

NPV=
CF0 + CF1/(1+DR) + CF2/(1+DR)^2 +…+ CFn/(1+DR)^n where DR is discount rate

ROI=
(Net Profit / Cost of Investment) x 100

Which project delivery method combines architectural and engineering services with construction performance under one contract (with the CM)?
Design-build

9) ___ is a tool used to reduce large scale projects into small, easy to manage parts.
PDC process

Name 3 things that are examples of a non-construction activity that should be included in the front end of a hospital renovation project?
ATP received, decant, EH&S Dept sign off

What does CHC stand for?
Certified Health Care Constructor

What are the 4 types of Exam Questions?
Health Care Industry Fundamentals, PDC Process, Health Care Facility Safety, Financial Stewardship

Name 5 Trends in Health Care
Changing Regulations;
Services offered;
Construction;
Length of stay;
Finance;
Patient flow and efficiency;

Name the 5 types of Health Care Facilities
Hospital;
Outpatient facilities;
Medical office building;
Elder care;
Skilled nursing facilities

Explain the Departmental Relationships
Emergency Department=
ED = Gateway to the hospital

Explain the Departmental Relationships
Surgery (surgery suite, operating rooms) (3)=
Pre-op, PACU (post anesthesia care unit / some call it recovery), Post-op (might combine recovery and discharge in ambulatory surgery)”

OR Classification
OR = Class A, B & C

Cath Lab”
Cath Lab = Cardiac Catheterization Lab
Often treated as surgery

Definition: MOB
Medical Office Building

Definition: PACU
Post Anesthesia Care Unit

Definition: CATH LAB
Cardiac Catheterization Lab

Definition: OB
Obstetrics

Definition: LDR
Labor Delivery Recovery

Definition: LDRP
Labor Delivery Recovery Post Partum

Definition: C-SECTION
Caesarian Section

Definition: ICU
Intensive Care Unit

Definition: NICU
Neonatal Intensive Care Unit

Definition: PICU
Pediatric Intensive Care Unit

Definition: SICU
Surgical Intensive Care Unit

Definition: CICU
Cardiac Intensive Care Unit

Definition: CCU
Coronary Care Unit

Definition: BMT
Bone Marrow Transplant

Definition: SDs
Schematic Design

Definition: DDs
Design Development

Definition: CDs
Construction Drawings

Definition: POE
Post Occupancy Evaluiation

Definition: IBC
International Building Code

Definition: UBC
Unified Building Code

Definition: NFPA
National Fire Protection Association

Definition: AHJ
Authority Having Jurisdiction

Definition: TJC
The Joint Commission

Definition: HFAP
Healthcare Facilities Accreditation Program

Definition: DNV
Det Norske Veritas

Definition: OSHA
Occupational Safety and Health Administration

Definition: EPA
Environmental Protection Agency

Definition: HIPAA
Health Insurance Portability and Accountability Act

Definition: ADA
Americans with Disabilities Act

Definition: CDC
Centers for Disease Control and Prevention

Definition: USP
United States Pharmacopeia

Definition: NRC
Nuclear Regulatory Commission

Definition: LEED
Leadership in Energy and Environmental Design

Definition: UL
Underwriter Laboratories

What does it Govern: NFPA 99
It’s the “healthcare code” and it covers several things including medical gas. We are using 2012 now

What does it Govern: ANSI/ASSE Standard 6010″
Med Gas Installer Qualifications

What does it Govern: ANSI/ASSE 6030
Med Gas System Verifier Qualifications

What does it Govern: NFPA99-2012 Chapter 6
Essential Electrical Systems

What does it Govern: NFPA 101
Life Safety Code

Definition: FGI
Facilities Guidelines Institute

List 3 Items shutting down the Medical Air System affects
NICU, Ability to calibrate respiratory therapy equipment, critical care and coronary care

Max amount of compressed gas allowed in a storage rm
300 cuft

How frequently do you have to test Fire Alarm Systems
Monthly (unless self-diagnostic in which case it follows the quarterly, semi, and annual schedule).

Definition: EOP
Emergency Operations Plan

Definition: HVA
Hazard Vulnerability Analysis

What type of space needs lead lining
Spaces that use ionizing radiation (X-Ray, CT)

How to calculate ACH: how to find CFM
CFM = room volume in cuft/60

To determine CFM required:
(Room cubic feet x number of ACH per ASHRAE 170)/60

AIIR
airborne infection isolation room

MERV
Minimum Efficiency Reporting Value

EXPLAIN OR CLASSES: CLASS A
Class A – local anesthesia / procedures, 15 ACH. 2 outdoor ACH.

EXPLAIN OR CLASSES: CLASS B
Class B – general anesthesia, CYSTO, 20 ACH. 4 outdoor ACH.

EXPLAIN OR CLASSES: CLASS C
Class C – Highest, Neuro/heart/other open body surgery, 20 ACH. 4 outdoor ACH

When is 2 stage filtering required?
In all clinical areas. Admin Office areas don’t require this.

What does it Govern: ASHRAE 188
Legionella in Hot Water Standard

What determines Capital Expense Vs. Operational Expense
Cost, life expectancy, and whether it is repair or replacement

Explain MRI Zones
1- when you first enter to check in
2- patient screening area and prep
3- already screened patients and personnel
4- screened MRI patients under direct supervision of trained MRI personnel only (inside room with magnet)”

What is Emergency Planning and Mitigation based on?
HVA (Hazard Vulnerability Analysis)

List 5 places for heightened safety and security needs / issues in the hospital
Pharmacy
Behavioral / psychiatric care areas
Emergency department
Infant / pediatric security
Patient dementia related security needs”

When to implement ILSM?
When construction alters any required life safety code elements

4 things required when FA out of service more than 4 hours in 24 or when Sprinkler out of service more than 10 hrs in 24 hr period
Fire watch
Notify the fire department
Document (esp if ILSM is necessary)
Possible other measures”

Explain: Vertical exits
-Exit stairways with walls constructed as a fire barrier and direct exit to exterior without having to renter compartments
-(fire resistance rating) 1hr where exit connects 3stories or less, 2hr for 4 and up (and all new healthcare)
-cannot be supported by structure

Explain: Horizontal Exit Passageways
-Similar to vertical exits – must equal rating of stairwell it serves
-Doors must be rated same as exit enclosure, be self closing and latching

Explain: Horizontal Exit
-2hr Fire rated barrier min
-All spaces must have at least one exit that isn’t a horizontal exit

What does it Govern: NFPA 241
Fire Protection During Construction

Exit enclosures cannot be used for (4 things)
utility chase
storage
an office
construction staging area

What utilities can run through an exit enclosure (both vertical and horizontal)
only utilities serving the egress path…
exit doors, lighting, ductwork / equipment for independent pressurization, sprinklers, heating and cooling the enclosure

What rating is required for separation of occupancies?
2hr FRR (Fire Resistance Rating)

Typical Rating to protect from Hazards
1hr FRR. (Does not include severe hazard.)

Maximum compartment size of smoke compartments
22,500 sf. Every story used by inpatients for sleeping or treatment into 2 or more compartments every story with occupant load >50 regardless of use”

Basic premise used to develop the Life Safety Code Health Care Chapters
Defend in place (evacuation is the last option)
Unit Concept (series of compartments)
Total Concept (from NFPA 101; minimize possibility of evacuation due to fire) design and construction of compartments; detection, alarm and extinguishment; planning, training and drilling”

Maximum travel distance of smoke compartments
200′

How many types of construction are on the Risk Classification Matrix?
4
A, B, C, D (A is just inspection through D being full demo / build)

How many Risk Groups are in the Risk Classification Matrix?
4
Low, Medium, High, Highest (low = office, Highest = open body surgery)

Definition: ICRMR
Infection Control Risk Mitigation Requirements

Where does it come from: PCRA requirement
TJC (The Joint Commission)

Define PCRA
Pre-Construction Risk Assessment

Where does it come from: ICRA during early planning phase
FGI Guidelines

Definition: Code Red
Fire Response

Definition: Code Pink
Pediatric / Neonatal Emergency

Definition: Code Blue
Cardiac Arrest / Medical Emergency

Definition: HCF
Health Care Facility

Definition: EMR
Electronic medical record

Definition: EHR
electronic health record

Definition: PACS
picture archive and control system

To recharge Plumbing Systems (4 options)
-flush lines
-retest water quality
-potential hyper-chlorination
-potential super heating to 180 deg F”

Definition: RO
Reverse osmosis

Definition: DI
De-Ionization

List 3 types of water treatment system used in a Dialysis system
-Carbon Filters (used to remove gases and chlorine)
-RO (Reverse Osmosis)
-DI (De-Ionization)”

What does it Govern: FGI 2018/ASHRAE 170
HVAC Systems Ventilation, Filtration, and pressure relationships

Pressure Relationship: Aii
-.01w.c. for airborne infection isolation rooms”

Pressure Relationship: construction sites at Risk Class 3 or 4
-.03w.c.; should flow less clean to clean or be evacuated from the facility with clean make-up air supplied

What are risk factors for Legionella
-amoeba in water (aid growth)
-dead legs in system piping
-aerosolization of water
-stagnant water
-thrives in 77-108 deg f”

Door requirements of egress corridors
-Solid core
-self latching
-self closing
-doors must be double egress in egress path (I.e. no cane pin or slide bolts)

What is a hyperbaric facility
Place used to force oxygen into wounds such as significant burns, etc.. High pressure and high oxygen.

FCI calculation
Facility Condition Index = Deferred Maintenance/replacement cost

2 main parts we use in FGI
Facilities Guidelines Institute – Part 2 Hospitals; Part 3 ASHRAE 170

Pressure Relationship: Surgery Class B and C / Cysto

• pressure; 4 outdoor ach; 20ach

Pressure Relationship: Critical and intensive care

• pressure; 2 outdoor ach; 6 ach

Pressure Relationship: Aii

• pressure; 2 outdoor ach; 12 ach

Pressure Relationship: PE

• pressure; 2 outdoor ach; 12 ach

What is an Aii room?
Airborne Infection Isolation

What is a PE room?
Protective environment

Pressure Relationship: Patient Room
N/A pressure; 2 outdoor ach; 6 ach

Filtration Required: Surgery Class B & C/Cysto Room, Radiology, Inpatient Delivery and recovery
Filter Bank 1 MERV7; Filter Bank 2 MERV14

Filtration Required: Inpatient care, treatment and diagnosis, Clean supply and clean processing, Aii
Filter Bank 1 MERV7; Filter Bank 2 MERV14

Filtration Required: PE Room
Filter Bank 1 MERV7; Filter Bank 2 MERV17 (HEPA)

Filtration Required: Skilled nursing facilities
Filter Bank 1 MERV13; Filter Bank 2 N/A

Filtration Required: Admin, bulk storage, soiled holding, laundry, food prep, other outpatient spaces
Filter Bank 1 MERV7; Filter Bank 2 N/A

Filtration Required: Laboratories and Class A surgery
Filter Bank 1 MERV13; Filter Bank 2 N/A

What electrical branch should serve: auto doors used for building egress, elevator cab lighting / control / communication / signaling, generator lighting, battery charger for emergency power battery lighting?
Life safety branch

What electrical branch should serve: task illumination / fixes equipment / for patient care of critical care areas, psych bed areas, medication prep areas, pharmacy dispensing areas
Critical Branch

What electrical branch should serve: egress lighting, exit signs, fire alarms, med gas and med vac alarms, hospital communications systems
Life safety branch

What electrical branch should serve: isolated power systems in special environments, nurses’ stations, nurse call systems, blood / bone / and tissue banks, telephone equipment rooms and closets
Critical Branch

What electrical branch should serve: Non-delayed automatic connection – generator accessories essential for generator operation (must auto transfer)
Equipment Branch

What electrical branch should serve: Delayed – auto connection – vacuum, compressed air, medical and controls air, smoke control stair pressurization, heating, select elevators
Equipment Branch

What electrical branch should serve: HVAC surgery, (OB, ICU, CCU, Nursery, Emergency Procedure areas) and critical areas (AII, PE,…), controls for emergency system equipment
Equipment Branch

Explain Med Gas System Levels
Level 1 – imminent danger of morbidity or mortality
Level 2 – manageable risk of morbidity or mortality Level 3 – Not place patients at risk of morbidity or mortality”

What are the 5 types of valves in a Med Gas System?
Source, main, service, riser, zone (and future)

What material is to be used on med gas Levels 1&2 and how to join?
Hard-drawn seamless copper to ASTM B819; brazed

What material is to be used on med gas Level 3 and how to join?
Hard-drawn seamless copper to ASTM B819; soldering may be used, brazing acceptable

How do you purge a med gas system?
continuous, oil-free, dry nitrogen purge is required during all work on med gas systems

What tests are required for med gas systems?
-Initial blow down (oil free, medical grade Nitrogen)
-initial pressure test (150% working pressure)
-cross connection test
-piping purge test
-standing pressure test (24hrs @ 120% working pressure)

What tests are required for med gas system certification?
-Cross connection (individual pressurization, pressure differential)
-Piping particulate test
-Medical air purity test
-Alarm tests

What general type of scope does the FGI cover?
Generally covers design of healthcare type facilities

What are the 3 parts of the FGI 2018?
1- General, 2-Hospitals, 3-ASHRAE 170

What general type of scope does the NFPA 101-2012 cover?
Fire protection code, focused on the preservation of life. (CMS, TJD, HFAP & DNV all reference the 2012 edition)

List 6 chapters of NFPA 101-2000 and what they cover.
CH7 – means of egress, CH 8 – Features of fire protection, CH 18 – New Health Care, CH 19 – Existing Health Care, CH 20 – New ACH, CH 21 – Existing AHC

What general type of scope does NFPA 99-1999 cover?
Focused on special systems in healthcare (we mainly reference essential electrical systems)

List 5 chapters NFPA 99-1999 covers
CH 3 – Electrical Systems, CH 4 – Med Gas Systems, CH 7 – Materials, CH 8 – Electrical equipment, CH 20 – Hyperbaric Facilities

What general type of scope does the CDC cover?
Guidelines for Environmental Infection Control in Health Care Facilities (Part1 = background research, Part2 = Recommendations)

What general type of scope does USP cover?
ISO Clean Room Standards to compounding areas (pharmacy type environments for mixing drugs, etc.)

Explain the ISO number
The lower the ISO number, the cleaner the space.
ISO 5 – laminar flow workbench or isolator
ISO 7 – buffer area
ISO 8 – ante room”

What general type of scope does the NRC cover?
Nuclear Regulatory Commission handles all things nuclear – diagnostic, therapeutic, research

What general type of scope does LEED cover?
Sustainability and energy efficiency is the main focus

What are the LEED Categories
Certified (40-49 points)
Silver (50-59 points)
Gold (60-69 points)
Platinum (70 and up points)”

What general type of scope does UL cover?
They evaluate components, products and systems to meet standards. They do not approve products.

Explain the impact of design on life-costs in the PDC Process
Cost of planning=.05
Cost of design=.1
Cost of building=1
Cost of maintenance=5
Cost in use to client=50-200
Lesson Learned (POE)=.05″

List the 5 items of the Project Process (planning based)
initial assessment
role of the facility
master program
master plan
functional program

List the 6 items of the Project Process (construction based)
SDs (schematic design)
DDs (design development)
CDs (construction drawings)
Construction
Occupancy
POE (post occupancy evaluation)

What does it Govern: NFPA 10
Portable fire extinguishers

What does it Govern: NFPA 13
Installation of sprinkler systems

What does it Govern: NFPA 25
Inspection, testing and maintenance of water-based fire protection systems

What does it Govern: NFPA 70
National Electric Code (NEC)

What does it Govern: NFPA 70E
Electrical safety in the workplace

What does it Govern: NFPA 72
National Fire Alarm Code

What does it Govern: NFPA 80
Fire doors and other opening protectives

What does it Govern: NFPA 90A
installation of air conditioning and ventilation systems

What does it Govern: NFPA 96
Ventilation and fire protection of commercial cooking operations

What does it Govern: NFPA 99
Healthcare facilities

What does it Govern: NFPA 99B
Hypobaric facilities

What does it Govern: NFPA 101
Life safety code

What does it Govern: NFPA 105
installation of smoke door assemblies and other opening protectives

What does it Govern: NFPA 110
Emergency and standby power systems

What does it Govern: NFPA 111
Stored energy emergency and standy power systems

What does it Govern: NFPA 241
Safeguarding construction, alteration and demolition operations

What does it Govern: NFPA 1600
Disaster / emergency management and business continuity

What does it Govern: NFPA 54
National Fuel Gas Code

What does it Govern: NFPA 220
Standard on Types of Building Construction

What is the maximum travel distance to a fire extinguisher
75 feet

What are the fire extinguisher mounting height requirements?
No more than 5′ to the top of the extinguisher and no closer than 4″ from the floor for the bottom of the extinguisher

A reason for having all normal non-emergency branch circuits fed from a single distribution panel at a particular patient bed location is to minimize
possible differences between out let grounds

Which 2 medical gas systems are REQUIRED to be in a typical med/surg patient room?
Vacuum and Oxygen

The owner of an outpatient diagnostic center is planning an expansion and considers adding several new imaging modalities. The owner asks for the construction manager’s input on when the medical imaging equipment selections should be made. When is the BEST time for those selections to be made
Prior to starting schematic design

A new hospital is being developed on a steep sloping site. Several levels will have doors exiting to grade from different levels of the building. According to NFPA 101, how do we determine the “primary level of exit discharge?”
The lowest floor level with the exterior grade for 50% or more of its perimeter

When discussing MRI, electromyography (EMG), computerized tomography (CT), and ultrasound examination, which of these uses lead as its primary shielding material?
Computerized Tomography (CT)

Of the following, which BEST describes an ILSM measures set?
-Temporary exits should be designated and inspected daily, at least two fire drills should be performed per quarter per shift
-Temporary exits should be designated and clearly marked, staff should be trained, and at least two fire drills should be performed per quarter per shift
-Have the local authority having jurisdiction approve temporary exits
-provide additional firefighting equipment and train staff on usage
-Temporary exits should be designated and clearly marked, staff should be trained, and at least two fire drills should be performed per quarter per shift

In the event of a failure of the medical air compressors, what would be directly affected?
NICU, Coronary Care, Critical Care, and the ability to calibrate respiratory equipment

Under which of the following delivery methods does a design team NOT have a contract with an owner?
-Construction manager at risk
-design/build
-design/bid/build
-integrated project delivery
Design/Build

Before an employee enters a permit-required confined space, the internal atmosphere shall be tested for oxygen content and what else?
Potential toxic air contaminants and flammable gases/vapors

A hospital plans to build a 125,000 sq ft ambulatory care center on a green field site. The project schedule requires occupancy within 12 months and a target budget is fixed. The design will be approximately 50% complete at the scheduled time of construction start. To achieve the given schedule and target budget, which of the following is the LEAST practical delivery model for this project?
-lump sum
-integrated project delivery
-cost plus stipulated fee
-cost plus GMP at design completion
-lump sum
(a lump sum delivery methodology cannot practically respond to a partial design)

An outpatient unit with a separate CMS provider number is being constructed as an addition to a hospital. How should the addition be separated from the hospital?
By a two-hour fire barrier when both buildings have the same construction type

What is the most effective way of testing the integrity of temporary construction barriers according to the CDC?
airborne particle counting of occupied areas

A fire alarm system is being taken out of service for three months and a temporary fire alarm system will be put into place. According to the interim life safety measures, is testing required of this system?
Yes, testing must be completed monthly

What component of interim life safety measures is/are required to be inspected daily?
alternate exits in the affected areas

Thinking from the standpoint of a contractor, when doing a construction project in a NICU, work will include minor demo, electrical work, and reconstruction of the nursing stations. When selecting demolition equipment, permission must be attained from ______ and the work should be performed as _____ as possible
Facility Manager / Quietly

The CDC recommends that microbiologic sampling of air, water, and inanimate surfaces occur only in which of the following situations?
A) Outbreak investigation, research, microbial abatement validation, and infection control procedure evaluation
B) outbreak investigation, research, verification of construction barrier effectiveness, and infection control practice evaluation
C) outbreak investigation, periodic air quality assessments, verification of construction barrier effectiveness, and microbial abatement evaluation
D) research, microbial abatement validation, periodic air quality assessments, and infection control practice evaluation
A) Outbreak investigation, research, microbial abatement validation, and infection control procedure evaluation

A contractor is working in an area that uses the Guidelines for the Design and Construction of Health Care Facilities as code. The contractor should use the version:
A) that is most current
B) used by the design team
C) that was used for permitting
D) currently enforced by the federal AHJ
C) that was used for permitting

During what phase of construction is the cost of changing desing features the lowest?
A) Schematic Design
B) Design Development
C) construction Delivery
D) Construction Documents
A) Schematic Design

According to the Guidelines for the Design and Construction of Hospitals and Outpatient Facilities (2014) the owner shall be provided with which of the following upon occupancy of the building or portion thereof?
A) lien release
B) set of record documents
C) clean, operational facility
D) certificate of occupancy
B) Set of record documents

A hospital is preparing to replace an existing roof. Leadership has voiced concerns on how to proceed based on past failed installations. Samples from the existing roof show moisture in the installation and possible decking deterioration. What is best practice?
Hire a consultant to design a new roof, inspect installation, and install in phases to keep it sealed at the end of each day.

A construction manager is constructing a comprehensive cancer center. Which of the following is MOST likely to have an effect on the construction sequencing?
A) first patient day
B) building commissioning
C) installation of equipment
D) imaging equipment testing
C) installation of equipment

Which of the following is the newest methodology for project construction?
A) design/build
B) design/bid/build
C) integrated project delivery
D) construction manager at risk
C) integrated project delivery

Which of the following is the MOST effective method for reducing infant abductions from a hospital?
A) Install a closed-circuit monitoring system
B) Conduct infant abduction drills for hospital staff
C) install an electronic infant abduction security system
D) educate mothers to release their infants only to authorized personnel
D) educate mothers to release their infants only to authorized personnel

Sustainability is important for healthcare institutions for which of the following 2 reasons?
A) marketing and community pressure
B) lowers operational costs
C) required by the Joint Commission
D) required by the Green Guide for Health Care
A) marketing and community pressure
B) lowers operational costs

What should the contractor do after closing the Hot Work Permit?
Continue fire watch in the area of the work for one hour after permit is closed and alarm system is restored

The primary patient safety hazard for computerized tomography (CT Scan) imaging is
ionizing radiation

Which of the following are recognized certification agencies for sustainable design and construction?
A) CMS
B) Green Guide for Health Care
C) Whole Building Design Guide
D) Green Globes
B) Green Guide for Health Care
D) Green Globes

A hospital is under construction and currently occupied. Which of the following are required to maintain patient safety?
A) ILSM, contractor parking, backup power
B) temporary signage, ILSM, contractor parking
C) backup power, infection control, fire/life safety
D) infection control, fire/life safety, temporary signage
C) backup power, infection control, fire/life safety

What is the maximum number of beds a critical access hospital may have?
25

Which of the following considerations is MOST important when selecting a construction delivery method for a project?
A) goals
B) quality
C) schedule
D) first cost
A) goals

Which if the following statements is correct regarding (inpatient) healthcare occupancies and ambulatory healthcare occupancies?
A) NFPA 101-2012 assumes that both types of occupancy will have patient sleeping rooms for overnight occupancy
B) Both types of occupancy must meet the requirements of NFPA 101-2012 chapter 19 if they are existing occupancies
C) Since defend-in-place strategies are used in both types of occupancies, the requirements are the same
D) The requirements of NFPA 101-2012 are based on the assumption that both types of occupancy will have patients who are incapable of self-preservation
D) The requirements of NFPA 101-2012 are based on the assumption that both types of occupancy will have patients who are incapable of self-preservation

Affordable Care Act
Allowed more hospital construction bc it allowed hospitals to more confidently predict their finances. More infrastructure, tech and finance influence construction also.

FGI: Guidelines (2014 Edition 2)
FACILITY GUIDELINES INSTITUTE: Guidelines for the design and construction of hospitals and outpatient care facilities.

Used to be published by the Federal Government
Was required to be followed to get a grant under the Hill-Burton Act of 1946.
Now not Fed Gov, now created by volunteers: Architects, facility managers, AHJ (Authorities Having Jurisdiction), people from ASHE, APIC (Association of Professionals in Infection Control)
40 states use this minimum standard
Determines: Room size, # of air exchanges, required medical gases, and infection control plans
4 year cycle of review.

HILL-BURTON ACT of 1946

“The Hospital Survey and Construction Act”
In 1975 it became the “Public Health Service Act”
Created first rush of hospital growth
Provided Federal grants and loans
Goal: to create 4.5 beds per 1,000 citizens
to get funds, hospitals could NOT discriminate (even though that was still legal), they had to provide some free care
Most funds went to middle class areas

2012 NFPA Life Safety Codes

July 5, 2016 the CMS ruled that everyone has to use it.
All accreditation programs use it (CMS, JC, DNV)
Published by the National Fire Protection Association
First time compliance was standardized

Options for Accreditation (to get Medicare/Medicaid Reimbursements)

The JC of HFAP (Joint Commission of Healthcare Facilities Accreditation Program)
CMS (Center for Medicare and Medicaid Services) which is a department of the Federal Government, which operates under the HHS (Department of Health and Human Resources)
DNV (Det Norske Veritas)

BRAC
The Defense Base Closure & Realignment Commission

military healthcare construction
most military hospitals are repurposed

CDC: Center For Disease Control

Publishes: Guidelines for Environmental Infection Control in Healthcare Facilities.
Uses a mix of CDC documents, as well as ASHRAE (American Society for Heating, Refrigeration & Air Conditioner Engineers)
Goal: to reduce HAI’s in hospitals, CDC has a proactive risk assessment for construction

Building Codes: BOCA and IBC and ICC International codes
Building Officials and Code Administrators

ICC (International Code Council) is a group resulting from BOCA working to establish global compliance
IBC is International Building Codes

NFPA 101: the Life Safety Code

This is widely adopted in the US.
It is administered, trademarked, copyrighted, and published by the National Fire Protection Association
Revised on 3 year cycle

NFPA 25
Standard for Inspection, Testing & Maintenance of Water-Based Fire Protection Systems (H20 Sprinklers)

NFPA 70
National Electric Code

NFPA 70 E
Standard for Electrical Safety in the Workplace

NFPA 72
National Fire Alarm Signaling Code

NFPA 13
Standard for Installation of Sprinkler Systems

NFPA 70 E
Standard for Electrical Safety in the Workplace

NFPA 72
National Fire Alarm Signaling Code

NFPA 99
Healthcare Facility Code (requirements for medical gas installers)

NFPA 101
Life Safety Code: standard widely adopted in the US. Revised on a 3 year cycle.

NFPA 110
Standard for Emergency & Standby Power Systems

ASHRAE
American Society for Heating, Refrigeration & Air Conditioning Engineers

ASHRAE/ASHE Standard Ventilation of Healthcare Facilities
This is in the 2014 FGI Guidelines

ASHRAE 188P
Prevention of Legionellosis Associated with Building Water Systems (approved standard)

USP
United States Pharmocepeia

USP 797

Refers to chapter 797 called “Pharmaceutical Compounding- Sterile Preparations” in the USP NATIONAL FORMULARY.
First set of enforceable sterile compounding standards issued by the USP.

NFPA 10
Standard for Portable Fire Extinguishers

NFPA 1600
Standard for Disaster/Emergency Management and Business/ Operations Continuity

Types of Capital Assets:

NFPA 10

Federal Sentencing Guidelines – Culpability Score Aggravating Factors

1. upper-level employee participates, condones, or ignores offense
2. repeat offense
3. hinder investigation
4. awareness and tolerance of violation is pervasive

Federal Sentencing Guidelines – Culpability Score Mitigating Factors

1. effective compliance program
2. reported promptly
3. cooperation with investigation
4. accept responsibility

Federal Sentencing Guidelines – Seven Elements of an Effective Compliance Program

1. written standards of conduct
2. Chief Compliance Officer
3. effective education and training
4. audits and evaluations to monitor compliance
5. reporting processes and procedures for complaints
6. appropriate disciplinary mechanisms
7. investigation and remediation of systematic problems

The only thing worse than not having a policy is…
…having a policy and not following it.

Medicare reimbursement – hospital inpatient codes
International Classification of Diseases (ICD)

Medicare reimbursement – physician codes
Current Procedural Technology (CPT)

Questions to guide the scope of an internal investigation.

1. What is the origin of the issue?
2. When did the issue originate?
3. How far back should the investigation go?
4. Can extrapolation of a statistical sample be used?

It is in the best interest of the organization to have the board _.
…take an active rather than a passive role in compliance.

Six tips for saving on future costs of compliance.

1. embed quality into existing processes
2. centralize common processes and controls
3. improve human resources infrastructures
4. improve information systems processes
5. emphasize training
6. monitor marketing and compensation

Baseline Audit Process

1. outline the current operational standards
2. identify real and potential weaknesses
3. offer recommendations

Compliance Program – Measures of Effectiveness

1. staff knowledge
2. all 7 elements included
3. comparing issues year to year
4. tracking and trending complaints
5. tracking corrective actions
6. reviewing current audits
7. educational session pre and post tests
8. tracking bill denials
9. organizational survey results
10. audit results
11. compliance topics on department/organization agendas

Modifier
a two digit alpha/numeric code used in conjunction with CPT or HCPCS codes that may increase or decrease reimbursement

gives new meaning to the code

International Classification of Diseases (ICD)
a statistical classification system that arranges diseases and injuries into groups according to established criteria (signs and symptoms)

Current Procedural Terminology (CPT)
American Medical Association publishes and maintains this coding system

Organized Health Care Arrangements (OHCA)
HIPAA arrangement between clinically integrated setting (ex: hospitals and medical staff)

Diagnosis Related Group (DRG)
an inpatient classification system based on: principal diagnosis, secondary diagnosis, surgical factors, age, sex, and discharge status

Healthcare Common Procedure Coding System (HCPCS)
for medication, maintained by CMS

CMS contracts with American Medical Association to use CPT coding for the Medicare program using this expanded version

Upcoding
providers use a billing code that reflects a higher payment rate for a device or service provided than the actual device or service furnished to the patient

Unbundling
submitting bills by piecemeal or in fragmented fashion to maximize reimbursement

Outlier
additional payment for patients with long hospital length of stay

Billing and Coding Concerns (*)

1. coding advice (if not in book – get in writing)
2. significant increases in volume (*) (find out why increase)
3. hiring external consultants (need BAA, if provide patient care – check OIG sanction list)
4. number of auditors for Part B audits
5. teaching physicians (*) (physician must be physically present and involved in managing care)
6. co-pay waivers (cannot routinely waive)
7. record does not support code
8. research payments (cannot bill Medicare for costs covered by sponsor)
9. disagreements (get 3rd party opinion)
10. DOCUMENTATION

“Incident To” services
services commonly furnished in a physician’s office by a nurse practitioner in which there is direct physician personal supervision and are billed under the physician’s provider number (does not apply in hospital setting)

physician must be present to bill (*)

Two-Midnight Rule
CMS will consider a claim as inpatient if the patient in hospital bed over two midnights

72 Hour Rule/3 Day Window Project (*)
all diagnostic outpatient charges and other related outpatient charges within 72 hours prior to an inpatient admission are bundled into inpatient stay reimbursement

False Cost Reports (*)
submission of charges to Medicare which are unrelated to medical care, such as administrative overhead

Credit Balances – Failure to Refund () provider has 60 days to refund credit balances ()

PPS Transfer Project
PPS transfer of patient (rather than discharge) and receiving payment

Advance Beneficiary Notice (ABN)
a written form that a provider gives to a Medicare beneficiary that informs the beneficiary that Medicare may not pay for an item or service

must be provided and signed by patient before services are provided (or provider cannot bill patient if Medicare denies)

Medicare Secondary Payer Questionnaire
used to identify the correct insurance company that must pay health care bills first when Medicare pays second

Hospital Outpatient Cardiac Rehabilitation
physician must be present during treatment

DRG Utilization (*)
DRG utilization should be reviewed when the number of uses of a particular DRG is outside of the norm or average

The three components of Evaluation and Management (E&M) services (*)

1. History
2. Examination
3. Medical Decision Making

Evaluation & Management Codes

1. subset of CPT codes
2. privileged providers
3. describe complexity of care, place of services, and type of service

Types of History or Examination

1. Problem Focused (CC & brief history)
2. Expanded Problem Focus
3. Detailed
4. Comprehensive

Complexities of Medical Decision Making

1. Straight-forward (simple, 1 problem)
2. Low complexity
3. Moderate complexity (may have some complications)
4. High complexity

Initial patient visit (*)
3 out of 3 key elements of E&M services must be met or exceeded in order to bill for this type of visit

Established patient visit (*)
2 out of 3 key elements of E&M services must be met or exceeded in order to bill for this type of visit

Inpatient Documentation Requirements

1. sufficient documentation to demonstrate signs/symptoms were sever enough to warrant inpatient care
2. preexisting medical problems or extenuating circumstances

Factors to Consider When Making the Decision to Admit as Inpatient

1. severity of signs and symptoms
2. medical predictability of something adverse happening to the patient
3. need for diagnostic studies
4. availability of diagnostic procedures at the time and location where patient presents

Medicare Part A
Part of Medicare that reimburses primarily for inpatient services provided by institutions such as hospitals and skilled nursing facilities

Medicare Part B
Part of the Medicare program that reimburses covered physician and supplier services

Medicare Part C (Medicare Advantage)
Formerly known as Medicare + Choice, government managed care program, must have Part B

Medicare Part D
part of Medicare that reimburses for outpatient prescription drugs

Medicare Administrative Contractor (MAC)
Processes Part A and Part B claims

Focused Medical Review (FMR)

1. determine if documentation supports claim
2. reviews guidelines

Medicaid
state health insurance that helps many people who can’t afford medical care and pays for some or all of their medical bills

1500 Form
Non-institutional providers must use this form to bill Medicare, Medicaid, CHAMPUS, and most private insurance companies

used to bill Part B claims

CMS 1450 or UB-04
institutional providers use this form to bill Medicare, Medicaid, CHAMPUS, and most private insurance companies

used to bill Part A claims

Fiscal Intermediary (FI)
an insurance company that contracts with CMS to process Medicare Part A claims – replaced by MACs in 2003

a Carrier
an insurance company that contracts with CMS to process Medicare Part B claims – replaced by MACs in 2003

Centers for Medicare and Medicaid Services (CMS)
HHS agency that establishes payment policies for providers, conducts research, and evaluates the quality of care provided to beneficiaries

Conditions of Participation (COP)
must be in compliance in order to be reimbursed by CMS

CMS Allowable
how much CMS will reimburse for a particular service or procedure

Third Party Carrier
entity that processes the claims on behalf of CMS

Disproportionate Share Hospital (DSH)
hospital that provides larger amount of care to indigent population

CMS provides increased reimbursement for these hospitals to cover cost of uninsured patients

Common Working File (CWF)
information about beneficiaries

Return to Provider (RTP) Report
indication of error in the claim submitted to CMS – must be corrected to receive reimbursement

Health Professional Shortage Area
geographic areas that have been designated as primary medical care shortage areas where physician who furnish medical care are entitled to a Medicare incentive payment

Participating Provider/Supplier
accepts CMS allowable as payment in full for services

Certificate of Medical Necessity (*)
physician statement that services are medically necessary

Assignment
agreement to accept payment in full – 20% copay, 80% Medicare

Reassignment
physician is paid a salary and entity receives payment from Medicare

Coordination of Benefits
decides primary, secondary, and tertiary payor

Local Coverage Determination (LCD)
determination of what is a covered service within a region,
used when there is no national coverage determination

National Coverage Determination (NCD)
determination of what is a covered service across the country, overrides local coverage determinations

Medicare Code Editor
halts the claims process but does not correct errors in claims

Grouper
uses all information about the claim (including complications and comorbidities) to determine the primary DRG

Pricer
amount paid by CMS for each DRG

Remittance Advice
details/describes the payment

Why develop a Compliance Program?

1. promotes culture of ethical behavior and commitment to compliance
2. prevents and detects wrong-doing
3. provides “safe” mechanisms for reporting and seeking help
4. raises awareness
5. positive impact to corporate reputation/culture and public image

How is the Compliance Program Addressing Significant Risks?

1. ensure that we get it right the first time (proactive)
2. new business ventures are evaluated for potential risk
3. timely response is made to newly developed rules and regulations

Why Does the Healthcare Industry Need Compliance Programs?

1. risks associated with non-compliance have grown dramatically
2. board compliance program oversight responsibility is on-going element of the duty of care
3. compliance programs are designed to mitigate risks to healthcare organizations in heavily regulated industry

Accountable Care Act Compliance Program Requirements (*)
by end of law everyone that bills federal money must have a compliance program

Federal Sentencing Guidelines – General Information

1. 1991
2. chapter 8 – seven elements
3. guidelines to help develop compliance program
4. give credit if have evidence of the 7 elements

Sarbanes/Oxely Act (SOX)

1. 2000’s
2. due to Enron
3. related to accounting (financial) fraud
4. for publicly traded companies
5. governance accountability

Federal Sentencing Guidelines – 2004 Amendment Compliance Program Recommendations

1. culture of ethics and compliance
2. defining ethics and compliance standards and procedures
3. spelling out compliance obligations
4. adequate resources
5. clarifying employee screening practices
6. training as an essential element
7. means for anonymous reporting
8. ongoing risk assessments (emphasized)

Governing Authority (relationship to compliance program)

1. Board of Directors
2. knowledgeable about compliance program with reasonable oversight
3. understand program background
4. fully engaged in oversight of the compliance program
5. adopt a resolution (outline duties, commitment to compliance, reporting requirement)
6. responsibility for the plan

Developing a Compliance Plan (resources)

1. OIG Work Plan(*), Advisory Opinions, Fraud Alerts, Settlements
2. State Attorney General Actions
3. AUSA Settlements/Convictions
4. Medicaid Fraud Units (Communications/Investigations)
5. Department of Managed Health Care
6. Department of Insurance
7. Senate Committee

Risk Assessment (definition)

1. identification of risks
2. determination of the quantitative or qualitative value of risk related to a concrete situation and a recognized threat (*)
3. basis for other elements of the compliance program
4. goal is the identification, measurement, and prioritization of likely relevant events or risks that may have a material consequence on ability to meet objectives

Why conduct a risk assessment?

1. Critical activity for the compliance program development and/or ongoing evolution
2. provides knowledge about culture
3. helps to further define risk intelligence/risk tolerance of an organization
4. increased government scrutiny
5. proactive vs. reactive
6. identify and prioritize risk
7. allocate resources
8. implement corrective action plan
9. reduce compliance violations
10. decrease potential fines and expenses
11. meet Federal Sentencing Guidelines

Risk Assessment process
identify risk -> analyze/measure risk -> prioritize risk

What is risk?

1. risk = things that might prevent an organization from meeting an objective
2. the possibility the organization will have lower than anticipated profits or will experience loss
3. strategic, operational, objective

Risk Management (definition)
identification, assessment and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events or maximize realization of opportunities

A risk assessment review will…

1. reduce the settlement if investigated
2. demonstrate to prosecutors that treble damages are unnecessary (*)
3. demonstrate to the OIG that a corporate integrity agreement is unnecessary or should be reduced
4. clarify necessary budgeting expenses for compliance
5. prioritize existing compliance resources
6. fulfill your board’s compliance oversight responsibility (*)
7. determine whether education has been adequate and whether staff understand policies and procedures
8. establish whether employees trust and use the anonymous reporting mechanism
9. ensure that reported incidence are resolved

Things that affect risk

1. organizational ethics
2. financial demands
3. technology
4. competition
5. mergers/joint ventures/acquisitions/alliances (*)
6. laws/rules/regulations
7. unknown (things happening in the organization)

Risk Identification

1. interviews (management/staff)
2. document review
3. employee surveys
4. others?

Management Responsibility Related to Risk

1. identify risk (*)
2. implement controls (*) – avoid risk, transfer risk, accept risk, reduce/mitigate risk

It is incumbent upon a health system’s __ to provide ethical leadership to the organization and assure that adequate systems are in place to facilitate ethical and legal conduct.
corporate officers and managers

adequate systems = internal controls (*)

Code of Conduct (elements)

1. keep it real; values based; avoid legalese
2. tailor to organization’s culture, ethical attitude, business, and corporate identity (*)
3. get input from focus groups, senior executives, etc. (*)
4. guidance on seeking help and reporting concerns (non retaliation)
5. high-level concepts and key policies
6. scenarios and FAQs
7. clearly stated expectations
8. primary language (watch translations)
9. periodically reviewed
10. emphasis on compliance with all applicable laws and regulations
11. applies to all employees and all representatives
12. plain, concise, and relatively short
13. signed by employees annually
14. training on code provided
15. consistently enforced
16. outlines discipline for noncompliance

Code of Conduct (definition)
define how to behave

Standards and Procedures

1. Structural (risk assessment methodology, anonymous mechanism and reporting, etc.)
2. Substantive (conflict of interest, privacy, etc.)
3. integrate and compliment other departmental policies and procedures
4. avoid repetition/duplication

Training and Communication

1. mandatory
2. needs to be consistent
3. effectiveness is seen in behavior

Monitoring and Auditing Plan

1. essential for effectiveness
2. based on risk assessment
3. scalable to the organization’s risks and resources

OIG Questions on Audit Plan – Assessing Effectiveness of Compliance Program

1. is audit plan re-evaluated annually
2. does audit plan address the proper areas of concern
3. does audit plan include an assessment of billing systems
4. does audit plan clearly establish role of auditors
5. is audit department available to conduct unscheduled reviews
6. does mechanism exist to allow compliance to request additional audits/monitoring should the need arise
7. has hospital evaluated error rates
8. if error rates not decreasing, has hospital conducted further investigation to determine weakness/deficiencies (* – need to know determine reason for increasing or maintained high error rate)
9. does audit include review of all billing documentation (including clinical) in support of claim

Auditing (*)

1. independent/objective (no vested interest) – more independent = better
2. formalized methodology
3. design established before beginning
4. error rate – 5% threshold

Monitoring (*)

1. management tool usually (compliance usually not part of monitoring)
2. can be objective but not always
3. easy day to day tool (ex. checklist)
4. not necessarily independent of business unit
5. part of doing business
6. approach may be informal

When to Audit (*)

1. when objective results are needed and integrity is critical (more objective = more integrity)
2. for cause reviews
3. not-for-cause reviews to assess risk
4. effectiveness of corrective actions

When to Monitor (*)

1. when watching compliance becomes part of daily operations
2. implementing new rules (*)
3. implementing corrective actions
4. high risk areas between audits

What is Needed for An Effective Compliance Auditing and Monitoring Plan?

1. understanding of current and applicable business risks and strategies (*) – areas of focus; include audit/monitor plan for each substantive area
2. appropriate, credible resources – subject matter experts, limited focus, understand protocols
3. ownership and accountability for resolution at appropriate level
4. follow-up to assure resolutions in place

Creating/Updating Annual Compliance Audit and Monitoring Plan

1. conduct a risk assessment
2. prioritize risks identified
3. identify resources that will be needed for implementing the plan
4. obtain buy-in
5. document process of developing your plan
6. evaluation (did meet goals, use resources appropriately, effectiveness, value added, client satisfaction)
7. proceed with finalizing the plan

Conducting a Compliance Audit – OIG Probe Audit Approach

1. sample of 20-40 units that is not statistically significant (may be less in some cases) (*)
2. if error greater than 5%, conduct statistically significant sample
3. think through error rate (what is denominator?)
4. used first in for-cause audits to determine if a problem exists (*)

Conducting a Compliance Audit – Statistical Approach (*)

1. involves randomly selecting claims in a sample where every member has equal probability of being selected
2. sample must be selected at random (no bias)
3. results can be extrapolated to make assumptions about the population universe
4. precision and confidence indicates an acceptable level of sampling error

Corporate Integrity Agreements – Discovery Samples (auditing)

1. discover sample – usually 50 claims (*)
2. error rate less than 5% – no additional sampling required
3. 5% or greater error rate – full sample required (size determined by discovery sample)
4. full sample must estimate overpayment in population with 90% confidence level and maximum relative precision of 25% to the point of estimate (*)

Consider Attorney Advice/Privilege – Retrospective Approach to Obtaining Audit Sample (*)

1. need a milestone to go back (ex: change in system, new people, new system, new rule, etc.)
2. worst way to change behavior
3. easy to access information
4. statistical model easier to develop (know sample unit)

Consider Attorney Advice/Privilege – Concurrent Approach to Obtaining Audit Sample

1. any time up to the final , usually “real time”
2. best way to change behavior
3. access to information is difficult due to “current” nature of documents
4. statistical model more difficult to determine

Monitor and Audit Process (*)

1. define review scope and assumptions (interviews, review policies/procedures/education/training, document)
2. develop review criteria (test review criteria, inter-rater reliability testing [give auditors same charts and see if get same results], enter criteria in database)
3. conduct review (review documents, enter findings)
4. document findings and observations (query for exceptional findings, summarize observations, develop recommendations)
5. obtain management response ( share findings, obtain reactions, draft corrective action plan)
6. remediate
7. finalize report and corrective action plan
8. re-audit

Internal Audit & Compliance
Internal Audit must be independent of Compliance

Reporting – Hotline/Helpline

1. essential program resource for reporting wrong-doing and/or seeking help and guidance
2. anonymous and confidential to extent allowed by law
3. policy on non-retaliation/non-retribution is important (*)
4. fear of retaliation and perceived inaction are main reasons people don’t call back
5. 80% for HR

Reporting – Investigations

1. address matters in a timely (as defined in policy) and consistent way
2. must participate in investigation, not obstruct
3. employees should know process

Exit Interviews
helpful reporting mechanism

Incentives

1. assists with prevention and deterrence of criminal conduct
2. should be aligned with being compliant
3. performance reviews and compensation should have compliance metrics identified

Enforcement

1. assists with prevention and deterrence of criminal conduct
2. must be consistent
3. support from senior management and the Board (*)
4. understanding by all members of the organization as to disciplinary measures, fairness, and consistency

Response

1. triage investigations – defined in policy at high level
2. decision tree for how matters are handled
3. matters assigned to other departments should be tracked to ensure resolution
4. investigations conducted by trained investigators

Prior to Beginning Investigation
Determine:

1. who will make the decision on findings
2. what is investigative process
3. format of reports
4. document retention/destruction defined
5. consider attorney-client privilege

Preventative Measures

1. resolution of issues is the goal (find root cause)
2. analysis of issues and identification of patterns/trends can prevent reoccurrence
3. monitor remediation efforts to ensure timeliness and adequacy addressing primary issue

Common Remediation Areas

1. Education (due to lack of knowledge)
2. Policies and Procedures (due to unclear expectations and/or not in a written policy)

Evaluating Effectiveness

1. Program metrics (hotline calls, incidents, etc.)
2. surveys
3. focus groups
4. testing
5. self-assessments
6. exit interviews
7. periodic risk assessment, internal audit reports, etc.

Enforcement Environment
Heightened scrutiny

Enforcement Activity
Recoveries are paying for the investigations

Enforcement Weapons
Forensic data mining, tracking/trending, etc.

Compliance should serve as catalyst to…

1. build capacity throughout the institution (make people aware)
2. identify vulnerabilities (weaknesses)
3. lead the design of systems to respond to needs (ongoing; make things happen)

Compliance cannot implement control processes because…
it takes away independence.

A compliance program is never _, it should always be .
finished; a work in progress.

Establish a , be assured that , then focus on .
framework; elements are working; effectiveness (outcomes based)

Policies and Procedures

1. makes clear to employees how they should act
2. may improve efficiency and workflow
3. brings consistency and clarity

can have a policy without procedure but not procedure without policy

Policy (definition)

1. statement of an approach to an issue
2. guidance on governing principle
3. rules that govern the organization

Procedure

1. defines implementation of the policy
2. outlines steps to be taken

Components of Policy

1. easy to understand
2. title
3. policy number
4. program area
5. purpose statement
6. definitions
7. responsible party
8. effective date
9. review date
10. related policies and procedures
11. applicability to whom
12. effect of non-compliance

Compliance Work Plan

1. develop an annual road map
2. work with management (*)
3. communicate your plan
4. don’t hesitate to make changes
5. include areas of concern and corrective action plans (*)

What is Infrastructure?
basic framework of the organization (*)
organizational chart; strong foundation
buy in and commitment makes the program strong and effective

Compliance Program’s Infrastructure (members)

1. Board of Directors
2. Oversight Committee
3. Management
4. Physicians
5. Compliance Officer
6. Staff

What Impacts Infrastructure? (*)

1. size
2. financial resources (compliance budget, people, training) – must match size
3. scope of program (what are you responsible for?)

for most – compliance is voluntary
no one size fits all program

Physicians At Teaching Hospitals (PATH)

1. 1990’s
2. started putting compliance programs in place for Medicare billing

The Compliance Function
prevention, detection, and resolution of actions

The Legal Function
advises the organization on legal and regulatory risks, defends the organization

The Internal Audit Function
provides an objective evaluation of the existing risk and internal controls and framework

The HR Function
manages recruiting, screening, and hiring, provides training and development

Quality Improvement
promotes consistent, safe, and high quality practices

Compliance Oversight Committee

1. Recommended by OIG (*)
2. goals and objectives set by chair
3. oversee implementation and operation of the program
4. review reports, statistical trends, and recommendations from the compliance officer
5. annual review and evaluation of the program
6. includes chair (not compliance officer), physician, compliance officer, coding/billing expert, senior management/administrator, and legal counsel
7. established rotation
8. mandatory attendance
9. process for member removal

Compliance Officer

1. direct board access
2. high level individual (authority to make decisions)
3. communicator (strong, strict, adheres to policies)
4. operational responsibility (leader, management of daily compliance operations, implementation of each compliance element*)
5. trust and respect
6. confidentiality
7. stamina and self-confidence
8. leadership and organizational skills
9. spend time with management – get buy-in (*)
10. should not report to or be counsel for an organization (*)

Physicians (relationship to compliance)

1. buy-in is key to success (responsible for patient care)
2. understand compliance as a necessity
3. documentation and coding responsibility

Compliance Staff

1. knowledgeable, courteous, and responsive
2. compliance officer
3. compliance analyst
4. educators/trainers
5. employment contracts

Buy-In (*)

1. compliance needs to be part of infrastructure
2. need buy-in from all chiefs
3. required for survival and effectiveness of the program

Key Buy-In Techniques

1. motivation (key)
2. education
3. participation
4. cooperation

Building Trust

1. communicate both good and bad news
2. keep commitments
3. honor confidentiality
4. allow frustrations to ventilate
5. take responsibility for mistakes

Strategic Planning

1. strategic risks
2. mission, vision, and values
3. resource allocation
4. organization direction
5. goal achievement

Commission of Sponsoring Organizations (COSO)
provides a sounds basis for establishing internal control systems and determining their effectiveness

Internal Control (definition) (*)
a process effected by an entity’s board of directors, management, and other personnel designed to provide reasonable assurance regarding the achievement of objectives

Primary Objective of Internal Controls

1. reliability and integrity of information
2. compliance with policies, plans, procedures, laws, regulations, and contracts
3. safeguarding of assets
4. economical and efficient use of resources
5. accomplishment of objectives and goals (avoid adverse outcomes)

COSO Components of Internal Control

1. Control Environment (BOT, Senior Management)
2. Risk Assessment
3. Control Activities (internal controls)
4. Information and Communication (appropriate information to people who need it)
5. Monitoring

Types of Internal Controls

1. Preventative (ex: passwords)
2. Detective (ex: audit trails)
3. Directive (ex: policies, procedures, guidelines, etc.)

Benefits of Controlled Self-Assessment

1. increases scope
2. targets audit work
3. frees internal audit resources
4. increases awareness
5. motivates personnel

Who Manages Risk?

1. Administration
2. Legal
3. Quality
4. Risk Management (Patient Complaints)
5. Internal Audit
6. Compliance

Preparation of Audit Plan

1. Identification of audit areas
2. classify audits of these units as operational, financial, compliance, or performance
3. identify the type of audit

Risk Mitigation Plan (development)

1. identify top high-risk areas
2. develop risk mitigation plan
3. discuss draft plan with management
4. issue final risk mitigation plan

Adult Education Principles

1. voluntary – learn based on their perceived need
2. trainers must capitalize on the experiences of participants (*)
3. should be characterized by mutual respect among participants
4. collaborative activity

Curriculum Design for Adult Learners

1. single concept – focus on application (*)
2. understand whether the concept/ideas will be in concert or in conflict with the learner
3. prefer self-directed and self-designed projects
4. more than one medium
5. control of pace
6. start and stop times

Classroom Design for Adult Learners

1. capitalize on first session
2. physically and psychologically comfortable
3. self-esteem and ego are on the line
4. clarify and articulate all expectations
5. concentrate on open-ended questions
6. present thought-provoking situations

Four Critical Elements of Learning

1. Motivation (*) – key to learning
2. Reinforcement
3. Retention
4. Transference (ability to teach)

Desirable Teaching Characteristics

1. develop an adult-to-adult working relationship
2. develop understanding of and responsibility for instruction (no fooling adults)
3. communicate your expectations – goals, objectives, future education
4. guard the contract – respect your audience

Understanding the Organization’s Culture to Provide Education

1. understand business and clinical side
2. understand training profile for the organization (training overlaps and saturation)
3. review operational policies and procedures
4. survey employees for understanding of compliance-related issues
5. conduct focus group – keep to less than 20 people (*)

Compliance Marketing and Themes

1. creative with color schemes/logos/slogans
2. emphasis on important issues
3. celebrate compliance week

Education – Audiences and Scheduling

1. mandatory vs. voluntary
2. training delivery schedule
3. number of participants
4. length of sessions
5. participants (employees, physicians, contractors, vendors, etc.)

Training Scope/Matrix
1 = broad principles, simple examples
2 = level 1, more detail and complex examples
3 = level 2 plus history, projected implications

1. ethics – 3 for all (board, sr. management, med staff, billing/coding, residents, care staff)
2. general compliance fraud and abuse – 2 for most, 3 for senior management (*)
3. coding and documentation – 1 for board, sr. managment, care staff; 2 for med staff and residents; 3 for billing and coding

Challenges When Training Physicians

1. time commitment
2. hesitant to open discussions
3. issues differ from employees
4. peer instruction is great
5. prefer lectures
6. get a physician champion for compliance

General Training Components (*)
everyone needs to know

1. ethics
2. documentation and coding
3. confidentiality issues
4. privacy
5. compliance program overview
6. HR issues (sexual harassment, etc.)
7. reporting system and how it works
8. conflicts of interest
9. gifts and gratuities

Focused Training Components (*)
only certain people need to know

1. Medicare’s Final Rule for teaching physicians
2. specific billing issues
3. joint ventures
4. stark self-referral law
5. cost reporting
6. environmental health and safety
7. radiation safety
8. EMTALA

OIG Recommended Training Topics

1. government emphasis on compliance and reason for emphasis
2. laws and regulations
3. why organization needs a compliance program
4. what does the organization’s compliance program include
5. guidance on what is expected of the employee
6. responsibility to report and understanding of reporting process

Training Approaches

1. cascading (train the trainer)
2. lectures
3. videos
4. case study and role play
5. computer based
6. combination

Lectures (*)

1. delivery style for clarifying information to a large group in a short period of time
2. need support from visual aides
3. instructor-centered

Computer Based Training
Pros

1. ability to choose time and location
2. ability to work alone and at own pace
3. ease of training large organization

Cons

1. no ability to assess comprehension
2. no ability to monitor time spent

Training Certification and Tracking (*)

1. know who has been trained by topic
2. keep information accessible
3. attestation (attendance, received code of conduct, understanding, intend to comply)

Why Evaluate Training?

1. identify areas of improvement
2. should training be repeated as is?
3. is training changing behavior?

Levels of Training Evaluation

1. reaction
2. learning
3. behavior
4. results

Training Evaluation Methods

1. pre and post testing
2. case study
3. evaluation forms

Training Evaluation – Pre and Post Testing
ensure effectiveness by…

1. creating guiding objectives
2. developing a focused testing instrument
3. providing continuous follow-up based on the results of the test

Training Evaluation – Case Study

1. presentation
2. interaction
3. discussion
4. effectiveness based on outcome

Training Evaluation Forms

1. balance questions
2. easy yes/no and open-ended questions
3. value feedback
4. use to enhance programs and increase effectiveness

Follow-Up Training (*)

1. one hour
2. new issues
3. changes in laws and regulations
4. overview of previous compliance issues

Training for New Hires (*)

1. 30 min to 1 hour
2. orientation
3. direct delivery
4. immediately

Compliance Training Requirements

1. engaging
2. through provoking
3. positive call for action

Health Insurance Portability and Accountability Act (HIPAA)

1. 1996
2. standardization – establishes a common “language” for transmission of electronic claims, payment, and administrative information
3. attempts to improve security in the age of ever-changing electronic data interchange
4. uniformity of the law – minimum standard for privacy laws nationwide

HIPAA Enforcement

1. Office of Civil Rights (OCR) – privacy and security civil complaints
2. CMS – transactions and code sets
3. Department of Justice (DOJ) – privacy criminal complaints (*)

Federal HIPAA law overrides state law unless…
…state law provides more protection/access.

HIPAA General Rule (*)
a covered entity may not use or disclose protected health information, except as permitted or required

HIPAA Covered Entities (*)

1. Health Plans
2. Providers
3. Clearinghouses

HIPAA Affiliated Covered Entity (ACE)
HIPAA designation – legally separate entities with the same owner(s)

HIPAA Hybrid Covered Entities
HIPAA designation – only some components of the business are a covered entity

An individual can request accounting of PHI disclosures, to include:

1. date disclosure was made
2. brief description of disclosure
3. purpose of disclosure
4. who received the information

An individual can request account of PHI disclosures up to a __ period.
6 year

Notice of _ Practices is required to be provided to patients.
Privacy

HIPAA – Definition of Use
with respect to individually identifiable health informant, the sharing, employment, application, utilization, examination, or analysis of such information within an entity that maintains such information

HIPAA – Definition of Disclosure
the release, transfer, provision of, access to, or divulging in any other manner of information outside the entity holding the information

Protected Health Information (PHI)

1. health information collected from an individual, created or received by a covered entity
2. relates to the past, present, or future physical or mental health/condition/provision of health care/payment for healthcare of an individual
3. identifies the individual (reasonably could be used to identify them)
4. maintained by electronic or any other form other than educational/employment records

De-Identified Information (*)

1. all identifiers listed in the regulations are stripped out
2. not PHI
3. not protected under HIPAA

Limited Data Sets (*)

1. contain some information and may be shared under a Data Use Agreement
2. listed as what may not be included

HIPAA Exceptions (*)

1. uses and disclosures for payment, treatment, and health care operations
2. required disclosures
3. uses and disclosures with authorization (*)
4. uses and disclosures with an opportunity to object
5. uses and disclosures for which an authorization or an opportunity to object is not required

HIPAA Exceptions – Payment, Treatment, and Healthcare Operations

1. audits
2. peer reviews
3. quality improvement
4. physician consults

HIPAA Exceptions – Required Disclosures

1. to the patient with some exceptions
2. Office of Civil Rights requests
3. to DHH to investigate alleged privacy violation

HIPAA Exceptions – Authorizations

1. authorization required if use/disclosure is not explicitly required or allowed under regulation
2. ensure all requirements are satisfied (including state)
3. often trump card – use when possible

HIPAA Exceptions – Opportunity to Object (*)

1. made for the hospital setting
2. facility directories
3. family, friends, and clergy involved in patient’s care or payment
4. notification (general condition)
5. can assume no objection with unconscious patient (*)

HIPAA Exceptions – Other Exceptions (*)

1. permitted by law
2. public health activities
3. report abuse and neglect
4. health oversight activities
5. legal proceedings
6. law enforcement
7. information about decedents (*)
8. organ and tissue donation
9. research (*)
10. avert serious threat
11. specialized government functions
12. worker’s compensation (*)

Patient Rights Under HIPAA

1. receive a copy of Notice of Privacy Practices
2. request restriction of use for treatment payment options
3. request confidential communication
4. access and copy information
5. requests for amendments
6. an accounting of disclosures
7. right to notification of a breach

Reportable Breach (*)

1. a privacy breach or unsecured PHI (*)
2. presumptive reportable breach unless there is a low probability of compromise

Privacy Breach

1. not permitted under privacy rule
2. unauthorized acquisition, access, use, or disclosure of PHI

Unsecured PHI

1. PHI not secured through technology or a method specified by the secretary through guidance
2. secured = encryption or destruction

Presumption of a Reportable Breach

1. unless there is a low probability of compromise of privacy and security of PHI
2. requires risk assessment (content, person, access, mitigation)
3. assess each factor on a scale to determine overall risk

HIPAA Breach Notification Requirements (*)

1. covered entity or business associate on notice on first day anyone (other than employee committing breach) in the organization knows of the breach or should have known
2. covered entity or business associate must notify the individual, next of kin, or representative without unreasonable delay – no later than 60 days after discovered
3. all breaches require written notification (1st class mail)
4. more than 500 individuals – must notify local media
5. substitute notification if undeliverable (less than 10 – fax, email, etc.; more than 10 – post on home page)
6. must be reported to DHHS 60 days after year end (500 or more requires immediate notification)

HIPAA – Minimum Necessary (*)
in all uses and disclosures, only provide the minimum necessary to get the job done

HIPAA – Business Associates
must have BAA in place outlining access/protection/destruction of information, actions in event of breach, and termination of agreement

HIPAA Privacy Rule

1. identifies what is to be protected
2. outlines individual’s rights to control access to their PHI

HIPAA Security Rule (*)

1. defines how to protect PHI in electronic form
2. only applies to PHI maintained or transmitted in electronic form (ePHI) (*)
3. three safeguards (Administrative, Physical, Technical)
4. 42 implementation specifications – 20 required, 22 addressable (optional based on environment of covered entity)
5. implement policies and safeguards
6. intended to be technology neutral
7. intended to be scalable
8. intended to protect the confidentiality, integrity (can be retrieved), and availability (when and to whom needed) of ePHI

Conflict of Interest – Definition (*)
when an individual’s private interest interferes in any way – or even appears to interfere- with the interests of the corporation as a whole

personal considerations may compromise or have appearance of compromising one’s professional judgment

Conflict of Interest – General Information

1. conflicts are inevitable
2. does not imply guilt
3. disclosure does not equal conflict
4. conflict is manageable
5. education, guidance, and awareness are essential

Scientific Conflict of Interest (*)

1. participation in review panels/groups that make decisions regarding the allocation of resources or the publication of papers
2. scientific testimony as an expert witness

Conflict of Interest in Clinical Care (*)
a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influences by a secondary interest

Conflict of Commitment
situation when one’s obligations to their employer or other entity are at odds with the commitments the individual has made in other areas (primary and secondary jobs)

Types of Conflicts (*)

1. physician/patient
2. researcher/research subject
3. researcher/institution
4. physician/other provider
5. executive/organization
6. employee/organization

Common Conflicts of Interest

1. use of company information for personal gain (i.e. insider trading)
2. general financial interests (hidden ownership, bid-rigging, etc.)
3. moonlighting (employment and future job offers)
4. service on board of directors
5. relationships – nepotism
6. relatives/partners as suppliers, vendors, customers, etc.
7. pressure to use manager’s relative
8. kickbacks and rebates
9. gifts from vendors, customers, etc.
10. improper use of company assets

Addressing Conflicts

1. federal legislation
2. PhRMA Code on interactions with healthcare professionals
3. guidance for pharmaceutical manufacturers
4. OIG special advisory bulletin – Aug 20, 2002
5. AdvaMed Code of Ethics – 1/1/2004

Physician Payment Sunshine Act (*)

1. drug and device manufacturers must disclose to government on a quarterly basis anything of value provided to physicians or teaching hospitals
2. report must describe the form of payment (cash, in-kind items/services, stock, etc.)
3. must describe the nature of the payment/transfer of value (consulting fees, compensation for services, honoraria, gift, entertainment, food, travel, education, research, charitable contribution, royalty, etc.) (*)
4. report not to include payments less than $10 (or less than $100/year), product samples, patient education materials, loan of device for less than 90 days, warranty replacements, items for use as a patient, discounts/rebates, items used in charity care, dividends from publically traded company

Internal Revenue Services (IRS) 501(c)(3) and Conflict of Interest
the purpose of the conflict of interest policy is to protect this tax-exempt organization’s interest when it is contemplating entering into a transaction or arrangement that might benefit the private interest of an officer or director of the organization or might result in a possible excess benefit transaction

Conflict of Interest Policy (*)
consists of a set of procedures to follow to avoid the possibility that those in positions of authority over an organization may receive an inappropriate benefit

IRS – Determining Conflict of Interest (*)

1. interested person
2. financial interest (ownership or investment, compensation, negotiating agreement, business, investment, family)
3. duty to disclose

PhRMA Code (*)

1. voluntary code
2. ethical relationships with health care professionals
3. basic interactions (intended to benefit patients)
4. promotional materials must be accurate (not misleading), make only substantiated claims, reflect the balance between risks and benefits, and be consistent with all FDA requirements
5. informational presentations, professional workday, and occasional meals all OK
6. entertainment and recreation items not appropriate
7. OK to provide continuing medical education, scholarships and educational funds, and educational/practice related items (*)
8. OK – compensation, venue, consultants
9. NOT OK – inducements, token arrangements

OIG Special Advisory Bulletin (*)

1. providers can offer Medicare beneficiaries inexpensive gifts ($10 each, not greater than $50 annually)
2. can offer more expensive items if it meets a statutory exception

AdvaMed Code of Ethics

1. for device manufacturers
2. voluntary
3. company training and education
4. third party training/education – depend on venue
5. sales/promotional meeting – depend on venue
6. consulting arrangements
7. gifts – only that they can use themselves – less than $100
8. reimbursement OK at market value
9. education grants – can’t decide recipient

National Science Foundation (NSF) Conflict of Interest (*)

1. first to require
2. requires investigator to disclose to a responsible representative of the institution a significant financial interest which is anything of monetary value

NSF Significant Financial Interest (*)
the institution is responsible for ensuring that the investigator reports all significant financial interest prior to submitting the proposal to NSF

FDA Guidance: Financial Disclosure by Clinical Investigators (*)
FDA will evaluate the disclosed conflict and may take various actions, including requiring further testing with non-conflicted investigators before approving drug/device

Conflicts of Interest – Organizations Conducting Research (*)

1. endanger human subjects’ safety
2. jeopardize public’s faith
3. reduce the public’s willingness to participate
4. inhibit future discoveries
5. focus area in OIG work plan

Sarbanes-Oxley Act of 2002 (*)

1. for publically traded (for profit) companies
2. conflict avoidance
3. auditors hired by audit committee (independent)
4. no consulting by audit company
5. limit partner rotations (must rotate every 5 years) (*)
6. hiring of audit company employees – can’t use company for at least one year after

Public Health Service Regulations

1. affects public health service governed agencies such as National Institutes of Health
2. 42 CFR Part 50, Subpart F
3. investigator must disclose any significant financial interest

Public Health Service – Significant Financial Interest (*)

1. income (salary, royalties, etc.) which aggregated for investor/spouse/dependent children exceeds $5,000 in 12 months OR
2. equity interest in excess of $10,000 or 5% ownership

Discipline (*)

1. personnel must comply with the law, policies and guidelines, code of conduct and compliance program
2. personnel have a duty to report suspected violations (subject to disciplinary action)
3. disciplinary actions reflect severity of noncompliance (up to and including termination)
4. part of job performance evaluation criteria
5. work with HR on written disciplinary standards
6. disciplinary actions are documented
7. discipline enforced consistently across organization

Stark Law Overview (*)

1. prohibits a physician from referring patients to an entity with which the physician has a financial relationship for certain designated health services that are reimbursable by Medicare unless an exception applies
2. prohibits entity from billing Medicare or any other person/payor for services performed as a result of prohibited referral
3. prevent over-utilization and unfair competition
4. preserve federal health care program funds
5. civil law only
6. Medicare only
7. strict liability – doesn’t require intent
8. must be physician and an entity in the mix
9. exceptions
10. CMS advisory options (need written contract)

Anti-Kickback Statute (*)
prohibits anyone from purposefully offering, soliciting, or receiving anything of value (remuneration) to generate referrals

1. criminal and civil
2. any federal healthcare program (Medicare, Tricare, etc.)
3. requires proof of improper intent
4. applies to any referral source (hospitals, nursing homes, etc.)
5. safe harbors
6. OIG advisory options (20-25/year; automatic exclusion from program)

Stark Law – Disallowance Period (*)

1. non-compliance period = disallowance period
2. can’t bill for services during disallowance period
3. begins when financial relationship fails to satisfy applicable exception
4. ends when brought into compliance and excess compensation is returned

Stark Law – Physician definition
a medical doctor, osteopathic doctor, doctor of dental surgery or dental medicine, a doctor of podiatry, a doctor of optometry or a chiropractor

Stark Law – Physician Immediate Family Member definition
spouse, natural or adoptive parents/children/siblings, step-siblings, in-laws, grandparents/grandchildren

Stark Law – Entity definition

1. organizations (sole proprietorship, corporation, etc.) that provide designated health services
2. physician practice (unless bills Medicare for purchased diagnostic test)

Stark Law – Referrals definition

1. broadly defined
2. excludes designated health services personally performed or provided by referring physician

Stark Law – Designated Health Services

1. clinical lab services
2. PT/OT/ST services
3. radiology services
4. radiation therapy services and supplies
5. DME and supplies
6. parenteral and enteral nutrients, equipment, and supplies
7. prosthetics/orthotics devices and supplies
8. home health services
9. outpatient prescription drugs
10. inpatient/outpatient hospital services (not lithotripsy)

Stark Law – Financial Relationship definition

1. may be ownership/investment interest or compensation arrangement
2. may be direct or indirect

Stark Law Exceptions

1. all exceptions have detailed criteria
2. all criteria in an exception must be met to use exception
3. if any criterion is not met – does not meet exception
4. some exceptions have special definitions

Stark Law Exceptions – Office Space and Equipment Leases

1. must be in writing
2. must be reasonable and necessary
3. term must be at least one year
4. terms set in advance and consistent with fair market value
5. charges cannot take into account referrals or other business generated
6. must be otherwise commercially reasonable
7. may terminate with or without cause at any time – but may not enter into another lease for the same space/equipment for at least one year
8. month-to-month holdovers allowed for up to 6 months
9. exclusive use includes subleases
10. per-click and percentage-based payments prohibited as of October 1, 2009 (no grandfathering)

Stark Law Exceptions – Bona Fide Employment Relationships

1. must be for identifiable services
2. remuneration must be consistent with fair market value and not take into account volume
3. agreements must be commercially reasonable
4. protects physicians who are employees under usual common law and IRS definitions
5. productivity bonus not prohibited if based on services personally performed by physician
6. may not receive payment for generating referrals of DHS performed by others

Stark Law Exceptions – Personal Service Arrangements

1. must be in writing, signed by parties, and specify services covered
2. must cover all services to be provided by physician to entity
3. aggregate services contracted for may not exceed those reasonable and necessary for legitimate business purposes
4. term must be at least one year (if terminated earlier, must wait one year before entering same arrangement)
5. compensation must be set in advance and not based on referrals or volume
6. service may not involve counseling of unlawful business arrangement
7. month-to-month holdovers allowed for up to 6 months

Stark Law – Medical Staff Incidental Benefits

1. applies only to hospitals and entities that have bona fide medical staffs
2. items/services less than $32/occurrence – no limit if reasonably related to provision of medical services
3. may not be cash or cash equivalents
4. compensation must be offered to all medical staff – not necessary accepted
5. must be offered without regard to volume or referrals (*)
6. compensation must be provided only while physician is making rounds or engaged in other services/activities that benefit the hospital or its patients
7. compensation is used by the physician only on hospital campus
8. may not violate anti-kickback statute or any law or regulation

Stark Law – Non-Monetary Compensation

1. compensation from entity in the form of items or services
2. no cash or cash equivalents
3. not determined based on volume or referrals
4. may not be solicited by physician
5. does not violate anti-kickback statute or any law or regulation
6. should be tracked
7. exceeding the limit and not meeting exception triggers disallowance period (*)

Stark Law Violations – Sanctions

1. denial – CMS will not pay claims for improperly referred DHS
2. refund – entity has duty to refund
3. civil monetary penalties – $15,000/claim; $100,000 if scheme to circumvent
4. potential for exclusion
5. potential FCA liability

Increased Scrutiny Due To:

1. rising cost of care
2. healthcare errors/poor quality and resultant publicity
3. questionable board oversight in high visibility corporate scandals
4. increase in amount and complexity of regulatory requirements

Addressing Concerns

1. more regulations/oversight
2. additional enforcement
3. increased fines and penalties
4. criminal prosecutions
5. holding boards and leadership personally accountable

General Expectations of Boards

1. understand member role and responsibilities
2. awareness of complexity of health care laws and regulations
3. provide advisory oversight and direction (*)

What is the Basis for Board’s Need to Know?

1. why does the government focus on board involvement?
2. what federal written agreement specifically details board oversight? – Conditions of Participation
3. How are boards educated about regulatory issues? – compliance
4. what specific regulations should the board be aware of? – services provided and billed by entity

Obligations of the Board of Directors (*)

1. decision-making function – applying duty of care principles to a specific decision or board action
2. oversight function – applying duty of care principles with respect to the general activity in overseeing the day-to-day business activities of the corporation

Duty of Care (*)

1. fiduciary duty of care = determination of whether the board has acted in good faith, with prudent level of care, in manner reasonably believe is the best interest of organization
2. reasonable inquiry – asking questions

Board of Directors – Compliance Program Focus Areas

1. Structural – understanding scope of program
2. Operational – understanding operation of program

Board of Directors – Oversight Structure (*)
determine if compliance oversight will be full board or sub-committee

role of subcommittee

1. ensure appropriate policies and procedures in place
2. ensure proper ethical and legal standards are present
3. monitor compliance with applicable laws/rules/regulations

Board of Directors – Compliance Program Oversight

1. understand organization’s internal reporting system
2. determine if the structure of the organization’s compliance program is appropriate to size/complexity of operations
3. determine if resources available to compliance function are adequate to address risk
4. does compliance officer have authority to act?
5. how often does board receive reports from compliance officer? – at least once/year
6. are there periodic risk assessments?
7. is there compliance audit and monitoring plan?
8. are there appropriate policies, procedures, or other internal controls?
9. is there open communication (no fear of retaliation)?

Board Agenda – Compliance Program Reports

1. education (current events, regulatory changes)
2. compliance program reports (special project report, active compliance projects, newly identified risk areas)
3. action items (policies and procedures, resource allocation

How Investigations are Initiated

1. competitor complaints
2. consumer complaints
3. current or former employee (whistleblower) complaints
4. insurance company complaints

Investigative Techniques

1. informal interviews and requests for documents
2. insider informants and whistleblowers
3. search warrants
4. subpoenas
5. electronic surveillance

When the Government Knocks to Obtain Documents…(*)

1. subpoena or search warrant or request by government agent
2. employees notify executives immediately
3. executives refer agent to company’s counsel

Search Warrants (*)

1. only time the government can take something and immediate response required
2. agents can seize original documents
3. corporations do not have 5th amendment privilege
4. if agent demands copy of personal records – respectfully decline and refer to counsel
5. important to label and segregate documents
6. request copy of warrant and affidavit and immediately fax to counsel
7. send all non-essential employees away from where search is taking place
8. do not interfere with agents and avoid confrontation
9. review warrant carefully – can technically only seize what is listed on warrant
10. no requirement to speak to agents or respond to questions (respectfully decline and refer to counsel)
11. attempt to identify attorney/client privileged documents (*)
12. identify and determine agency of each investigator and the agent in charge
13. agents will request signature on a vague inventory of items seized – avoid execution of the document
14. keep your own inventory of areas searched, documents/items seized, and questions asked by the agents (*)

Post Government Search (*)

1. counsel typically requests debriefing from investigators and/or government attorneys
2. consider public relations
3. debrief employees and response coordinator/team – prepare statement with counsel
4. attempt to obtain copies of documents seized through counsel
5. notice of investigation, instructions regarding interaction with government agents, and litigation hold/suspension of document destruction to employees (*)

Subpoenas

1. served by mail or personally by agent
2. does not require immediate response
3. typically has future return date
4. for documents and/or testimony
5. turn over to counsel for appropriate response
6. prepare to assist counsel with response
7. different types of subpoenas (civil investigation demand, HIPAA, OIG)
8. complete and timely response is important
9. may negotiate scope and timing of response
10. custodian of records for response

Government Interviews – Employee Rights (*)

1. may decline to speak with agents (5th amendment right)
2. may voluntarily speak to agents (not obligated)
3. ask agent to contact company counsel
4. joint defense agreement – share information between parties (still privileged)
5. company can advance cost of employee counsel
6. right to be represented by counsel at interview (usually not company’s counsel)
7. company should not forbid employee to speak to agents (would be obstruction of justice)

Post Government Investigation – Conducting an Internal Investigation (*)

1. important for an organization’s resolution of an external enforcement investigative matter
2. also important for compliance strategy/program and resolution of internal matters
3. no substitute for the facts regarding a resolution of external and internal matters (must learn the facts)

Duties and Rights of Employers and Employees Related to Internal Investigations

1. duty to maintain a safe workplace
2. negligent hiring and retention of employees
3. duty of loyalty and fair dealing
4. duty of employee to cooperate with organization investigation
5. employee right to privacy and work free from unreasonable interference and harassment
6. right to have reputation protected

Legal Standards in Investigations (*)

1. reasonable, fair, thorough, and prompt investigation which reasonable conclusions usually protects employers against claims
2. investigation process should be consistent throughout organization
3. investigation can only be sustained if there is probably cause and/or reliable and credible evidence of non-compliant conduct
4. ultimate factual conclusion must be based on preponderance of evidence
5. right of employee to generally know results of investigation and best practice (not privileged)
6. attorney-client privilege does not necessarily apply to factual findings of internal investigation but does apply to advise of lawyer based on findings

Legal Standards in Interviews (*)

1. employees cannot refuse to cooperate and/or be interviewed by organization representatives without risking continued employment
2. employees – no Miranda rights
3. employees have basic right to due process
4. employees right to confronted with proof and opportunity to respond
5. prohibition against retaliation
6. confidentiality of the interview, subject to waiver of privilege
7. right to counsel
8. proper instructions protect the evidence

Evidence Collection in Investigations
must prove each element of allegation using appropriate evidence

evidence must be…

1. relevant
2. material
3. competent
4. authentic

can be direct or circumstantial

Legal Claims When Things Go Wrong

1. report of non-compliant activity
2. defamation of an employee
3. retaliation for cooperating with investigation
4. false imprisonment in interviews
5. intentional infliction of emotional distress
6. assault and battery
7. invasion of privacy
8. malicious prosecution

What Must Be Investigated? (*)

1. report of non-compliant activity
2. allegation of a violation of law
3. report of improper conduct
4. potential for a government overpayment
5. potential for an overpayment by any other third-party payer
6. potential for whistleblower activity

Investigative Process – Validate and Planning

1. validation of original compliance report is essential and reason for internal investigation
2. avoid rush to judgment – measured investigative response, avoid siege mentality, don’t rely on unverified information
3. rarely end up where you thought you would upon initiation
4. don’t ignore privileges and protections
5. do the work and find out the facts

Duty to Investigate (*)

1. board of directors and compliance officers have fiduciary duty to protect company against unreasonable risk
2. monitoring and have current knowledge of risks
3. provide senior management and the board with timely, accurate information sufficient to reach informed decisions concerning organization’s compliance with law
4. investigations part of effective compliance and ethics program
5. detection and prevention of non-compliant activity is one of program’s key goals
6. employees have duty to cooperate with investigation

Key Purposes of Investigations (*)

1. must determine true story and back story
2. determine root causes of non-compliant activity
3. findings must establish accountability
4. findings must maximize the decision-making process for business people
5. findings must help bigger needs of business – avoid and mitigate damages
6. investigation must be done timely (practical reasons and prove no cover-up of improper conduct)

Investigations – Practical Initial Questions

1. differing agendas in integrated settings?
2. conflicts of interest?
3. time period at issue?
4. collateral issues?
5. point people internally?
6. who is/isn’t on investigative team?
7. how to preserve privilege?
8. how much to reserve in escrow?

Scope of Internal Investigation

1. subject matter to be addressed
2. who law firm and investigative team will be accountable to within organization
3. scope of internal investigation and proffer of fact and/or legal conclusions

Stakeholders Removed from Investigative Process

1. independence
2. objectivity
3. candor
4. credibility
5. fairness
6. effective compliance program
7. anti-retaliation

How Much to Investigate? (*)

1. depends on facts
2. enough to gauge credibility – gather evidence
3. dollar amount of potential exposure impacts scope, depth, and personnel

Who Should Investigate? (*)

1. HR – sexual harassment, discrimination, etc.
2. In-House – non-criminal general issues
3. Counsel (in-house or outside) – if attorney-client privilege needed
4. legal counsel and investigative team – criminal issues or likely significant civil liability (*)

Getting Counsel Involved (*)

1. expertise in white collar and healthcare compliance
2. familiarity with government enforcement and regulatory personnel
3. conflicts of interest
4. government perception and credibility of organization
5. familiarity with organization and industry segment
6. cost
7. independence
8. objectivity
9. disruption to ordinary business activities
10. availability

Investigation Roadmap (*)

1. identify potential issues
2. identify individuals likely to have information
3. identify potentially relevant documents and institute document “holds”
4. identify individuals best suited to conduct investigation
5. prepare investigation plan – more serious -> more detailed

Identifying Issues

1. what wrongdoing already identified?
2. what other wrongdoing might be uncovered by investigation?
3. always uncover additional facts and situations having ramifications
4. constant revision and modification of investigation work plan
5. risk of costs and disruptions to ordinary course of business
6. risk/benefit of potentially uncovering unknown additional issues
7. benefit of potential early disclosure
8. no substitute for knowing the facts

Identify Relevant Documents

1. obvious relevant documents
2. other communications (emails)
3. notes and records of meetings

Preserve Relevant Documents (*)

1. do not destroy documents
2. suspend routine document destruction (destroying relevant info could be viewed as criminal obstruction)
3. issue litigation hold memo (all persons likely to have relevant documents)

Identify Investigative Personnel

1. serious issues – investigated by counsel
2. counsel should be directed by senior management, board of directors, audit or other independent committee

In-House or Outside Counsel?

1. outside – bolster attorney/client privilege, preserve independence of investigation , likely more familiar with process/government enforcement/laws and regs
2. in house – more familiar with internal policies, may have more credibility within organization

Attorney-Client Privilege (*)
protects communications

1. intended to be confidential
2. made for the purpose of obtaining legal (not business) advice
3. confidentiality has not been waived by disclosures to third parties or otherwise
4. including with agents retained by attorney to assist in providing legal advice (secretaries, clerks, investigators, etc.) as if between attorney and client

more difficult if in-house counsel (benefit of outside counsel)

Prepare Investigation Plan

1. in consultation with client attorney should prepare investigation plan (potential issues, individuals with information, documents)
2. revise as needed

Making Investigation Plan

1. based on allegation – what precisely need to know
2. who has information?
3. order to conduct interviews
4. what info company needs for post-investigation
5. inform managers

Conducting Investigation – Document Reviews (*)

1. authorized personnel should gather and deliver documents
2. track where documents came from
3. keep confidential if necessary
4. identify “hot” documents (suggest wrongdoing, exculpatory, raise questions, etc.)
5. don’t need every document – only specific to investigation topic
6. emails generally snippets of larger story
7. personnel files are helpful but not whole picture
8. no reasonable expectation of privacy in company systems, desks, or other company property

Conducting Investigation – Interviews (*)

1. should be conducted in private (if possible have witnesses to take notes and corroborate understanding)
2. keep notes (do not record or transcribe)
3. management should only be present if necessary
4. employees must be advised that legal counsel represents the company not the individual (depending on allegation – may advise them of right to personal legal counsel)
5. employees must be encouraged to report if they have been threatened or asked to change story

Interviewing the Reporter

1. reporter is initial source of information
2. understand substance of their report
3. don’t adopt their characterization of the facts
4. be alert to confidentiality and retaliation concerns
5. manage reporter’s expectations
6. consider “back story”

Interview Process

1. start with skeleton and fill in landscape
2. gather intelligence on your witnesses before interview
3. make list of topics, not questions (don’t limit yourself)
4. interviewer must maintain control
5. keep your opinions to yourself
6. never ignore contradictions
7. always look for leads regarding other relevant areas of inquiry
8. maintain confidentiality during interview
9. review notes with witness – don’t ask them to sign
10. don’t allow recording
11. phone interviews have limited value
12. interview questionnaires for discrete questions – may not need interview

Interviewing the Implicated Person

1. interview vs. interrogation (implicated not usually interviewed)
2. looking for a confession
3. confront with information but limit amount shared
4. person should respond and offer mitigating circumstances
5. be aware of pitfalls of confrontation
6. prepare an interview memorandum upon completion

Evaluating the Evidence

1. complete quickly
2. determine if information gathered matches scope
3. burden of proof is the preponderance of evidence
4. be sure no implication of deeper problem
5. determine credibility of witnesses
6. get a second opinion if needed

External Investigation – Report

1. discovered facts
2. remaining unknowns
3. all (potentially) implicated laws
4. counsel’s analysis of facts in light of laws
5. maintain confidentiality – limit circulation

Internal Investigation – Report (*)

1. distributed on a limited basis (consider if should be written or oral – discoverable)
2. include summary of facts
3. allegations and how reported
4. potential cause(s)
5. financial impact
6. any health and safety matters
7. time period
8. individuals interviewed
9. documents reviewed
10. individuals who should have detected non-compliance
11. estimate of magnitude of issue
12. recommendations for corrective/remedial actions

Investigations – Fix the Problem (*)

1. use report to identify corrective action needed
2. assess compliance process and policies – identify deficiencies
3. discipline responsible employees as appropriate
4. add policies, procedures, reporting layers as necessary to promote future compliance

Investigations – Self Disclosure

1. need to discuss with client
2. DOJ, OIG, MAC, AG

Legal and Organizational Risks

1. retaliation (*) – employees and contractors/vendors
2. discovery in litigation (audits, compliance investigations, compliance committee records, processes, work products, etc.)

Wrongful Discharge

1. be fair in investigation and disciplinary process
2. even bad guys can raise legitimate issues
3. even bad guys can/do sue
4. HR and compliance involved in any termination

Protecting Against Legal Risks

1. respond to all credible reports of non-compliant activity
2. fix any problems found
3. document compliance and remediation processes
4. get professionals involved as appropriate
5. establish privilege
6. don’t ask questions if you’re not prepared for answer
7. no substitute for the facts

Obstruction of Justice

1. makes a bad situation worse
2. destroying/altering of evidence (*)
3. take care in internal investigations/treatment of witness statements
4. amateurs should not conduct investigations

False Claims Act (*)
Prohibits

1. knowingly presenting (or causing to be presented) to government false/fraudulent claim for payment
2. knowingly make/use/cause to be used a false record/statement to get false/fraudulent claim paid
3. conspiring to commit violation of False Claims Act
4. knowingly making/using/causing to be used false record/statement to an obligation to pay/transmit money/property to government

Offense requires

1. submit a claim
2. to the government
3. that is false/fraudulent
4. knowing of its falsity
5. seeking payment
6. damages (maybe)

Knowing and Knowingly (*)

1. no proof or specific intent to defraud is required
2. a person had knowledge of the information OR
3. a person acted in deliberate ignorance OR
4. a person acted in reckless disregard

False Claims Act – Penalties

1. civil – $5,500 to $11,000 per false claim
2. treble damages

False Claims Act – Qui Tam Actions & Government Intervention

1. private person (realtor) may bring FCA action (whistleblower)
2. government may intervene in suit
3. whistleblower and government become collaborators in recovery of money

Types of False Claims Act Cases (*)

1. unbundling
2. services not rendered or not rendered as billed
3. upcoding
4. billing for items/services not covered
5. duplicate billing
6. submitting false/inflated cost reports
7. quality of care
8. research grant/clinical trials
9. actions under Food, Drug, Cosmetic Act (mislabeling)
10. violation of Stark or Anti-Kickback (Tainted Claims) (*)

False Claims Act – Administrative Sanctions (*)

1. sanction = represents full range of administrative remedies and actions available to government to deal with improper actions by providers
2. does not include private contractor actions (pre-payment/post-payment audits)

Suspension of Payment
withholding of payment by intermediary or carrier of approved payment amount before final determination of overpayment amount

Offset
recovery by Medicare of a non-Medicare debt (ex: Medicaid) by reducing present or future Medicare payments and applying to debt

Recoupment
recovery by Medicare of any outstanding Medicare debt by reducing present or future payments and applying to debt

Exclusion (*)
no payment is made to anyone for any item or service furnished/ordered/prescribed by an excluded party under Medicare/Medicaid/Federal Health Program – cannot submit a claim

must request reinstatement at end of exclusion period to begin submitting claims again

check OIG sanction list

Mandatory Exclusion
individuals or entities convicted of

1. criminal offense related to delivery of item/services under Medicare/Medicaid
2. criminal offense related to neglect or abuse of patients in delivery of healthcare
3. criminal offense consisting of a felony related to fraud, theft, embezzlement, breach of fiduciary responsibility, other financial misconduct
4. criminal offense consisting of a felony relating to unlawful manufacture, distribution, prescription, or dispensing of controlled substances

at lease 5 years, 2x – 10 years, 3x – permanent

Permissive Exclusion
secretary may exclude individual/entity if numerous instances of non-compliant activity that is not criminal

Corporate Integrity Agreements (CIAs) (*)

1. OIG imposes compliance obligations on health care providers as part of settlement of federal enforcement actions
2. option of provider to agree to obligations in return for OIG agreement not to seek exclusion
3. part of global criminal/civil settlements
4. may represent OIG’s opinion on effectiveness of compliance program
5. adhere to essential elements in Federal Sentencing Guidelines

Civil Money Penalty Law

1. HHS has authority to levy administrative penalties as punishment for submitting false/improper claims
2. treble damages and penalties
3. submission of false/fraudulent claims
4. payments to induce reduction/limitation of medically necessary services
5. illegal remuneration under Stark or Anti-Kickback

Responsible Corporate Officer Doctrine

1. strict liability – corporate misconduct and violations of law can result in conviction of executives without individual involvement in wrongdoing or knowledge (holds executives responsible regardless of involvement or knowledge of organizational misconduct)

What Does the Government Expect from Business Organizations? (*)

1. partnership with government in detecting/preventing misconduct and promoting ethical corporate culture
2. fail to ferret out wrongful conduct – consequences
3. cooperation in investigating wrongdoing and identifying individual wrongdoers

Cooperation (*)

1. taken into consideration in charging decisions by DOJ
2. ability to make witnesses available
3. disclosure of internal investigation
4. timely and complete disclosure of facts
5. evaluated on case-by-case basis
6. full disclosure of key facts
7. previously could require waiver of attorney-client privilege and work product protections (requests by DOJ attorneys for waiver is now prohibited by DOJ policy/instruction) (*)

Deferred Prosecution Agreements (DPA)

1. creature of DOJ
2. consequence of enforcement of corporate culpability
3. organization commits to “best practices” for effective governance and promotion of ethical culture
4. CCO report directly to board
5. extensive training and education programs
6. hotline reporting of non-compliant conduct
7. appointment of monitor to oversee obligations under DPA

Self-Disclosure Process

1. investigation and evaluation
2. consider benefits and risks
3. consider which entity to disclose to
4. submit a timely, complete, and transparent disclosure
5. anticipate government validation
6. resolution – strategies and options

Self-Disclosure – Is It Voluntary? (*)

1. not really
2. Misprision of a Felony (active concealment = fine and/or imprisonment)
3. Medicare Statue (felony to conceal or not disclose facts affecting right to payment)
4. False Claims Act (illegal to conceal)

Self-Disclosure Considerations

1. decision to disclose should be made in conjunction with counsel
2. business decision
3. useful for substantial violations and whistleblower risk
4. minor disclosure may be too costly

Potential Advantages of Self-Disclosure

1. goodwill with government
2. limiting possibility of external investigation
3. expediting process of resolution
4. reduce criminal/civil liability
5. neutralizing whistleblower threat
6. lessen overall damages and penalties

Potential Disadvantages of Self-Disclosure

1. financial loss
2. increased government scrutiny (validation process)
3. no immunity from liability or prior commitments
4. possible penalties for conduct that may have remained undiscovered

Self-Disclosure – Choosing a Government Entity

1. billing errors – entity processing claims and payment
2. civil liability under Civil False Claims Act – DOJ or OIG
3. criminal liability – DOJ or OIG

OIG Self-Disclosure Protocol

1. full cooperation and complete disclosure
2. submission violates law (don’t submit mistake to OIG)
3. minimum settlement $50,000
4. submit within 60 days of discovery (30 days to limit damage)
5. ongoing fraud scheme = more immediate report
6. follow protocol

CMS Stark Self-Referral Disclosure Protocol

1. report and return overpayment within 60 days of identification of issue (or cost report)
2. follow CMS protocol
3. open access to financial records
4. intended to resolve physician self-referral matters without extraordinary financial liability
5. OIG or CMS (not both)
6. will consider nature, timeliness of disclosure, cooperation, litigation risk, and financial position in settlement

Self-Disclosure to DOJ

1. law enforcement agency
2. no formal protocol

Possible Settlement Factors

1. effectiveness of pre-existing compliance program
2. nature of conduct and financial impact
3. ability to repay
4. first-time offender, isolated and distinct incident
5. low-level bad actors
6. efforts to correct problem
7. successor liability under former management
8. period of conduct
9. how discovered
10. level of cooperation, candor, flexibility
11. relationships

Compliance Program Maturity Determination

1. no corporate-wide compliance processes and systems
2. Emerging – putting out fires, minimum level of compliance, inflexible
3. Evolving – planning mentality, more open approach with regulators, flexible enough to learn, more integrated
4. Mature – technical and business tools used to increase competitive advantage, maximize budget resources, max flexibility (anticipatory), participates with government regulators setting standards and policies

Effectiveness definition

1. producing a decided, decisive, or desired effect
2. capable of producing a result
3. the extent to which the outcomes of an activity achieve its stated objective

Indicator definition

1. measure to quantify achievement of a goal or objective
2. performance-based

Core Elements in Building an Effective Compliance Program

1. Structure – designed to meet 7 elements
2. Process – risk assessments identify risks, enforcement occurs
3. Outcomes – third party relationships appropriate, quality indicators improve

Structure Indicators

1. foundational elements
2. policies and procedure
3. committees
4. reporting structure
5. hotline

Process Indicators

1. achievement of individual objectives
2. survey completed
3. LEIE screening being done
4. education plan developed and implemented

Outcomes Indicators

1. behavioral
2. impact that compliance efforts have on organization’s level of compliance

Measuring Compliance Program Effectiveness – Tools for Measuring Effectiveness

1. FSG 7 elements
2. OIG model guidance
3. industry benchmarks (national and regional)
4. organization performance comparison year to year (*)
5. related outcomes (repayment costs for inaccurate billing/coding, denial rate)

Measuring Compliance Program Effectiveness – Determine Appropriate Outcomes/Thresholds

1. identify and prioritize risks
2. differentiate between mandatory and voluntary risks (licensing-mandatory; COP-mandatory; reputation-voluntary)

OIG Settlement Letter – Key Elements (*)

1. code of conduct and standards of behavior
2. budget for compliance department
3. policies and procedures related to CMS billing/coding/fraud and abuse laws
4. policies and procedures controlling discipline
5. description of process to identify excluded/convicted individuals
6. training programs – content, frequency, attendance
7. internal reporting mechanisms (methods for making employees aware, procedures to track, summaries of reports)

DOJ’s Effectiveness Determination Factors

1. comprehensiveness of compliance program
2. extent and pervasiveness of misconduct
3. number and level of employees involved in misconduct
4. seriousness/duration/frequency of misconduct
5. remedial actions by entity
6. promptness of self-disclosure
7. mechanisms for informing board of misconduct
8. whether board exercised independent judgment on issue
9. independence and sufficiency of internal audit mechanisms
10. paper program only or active
11. sufficient resources
12. employees informed about program and convinced of entity’s commitment

Developing Effectiveness Measures

1. outcome and process measures appropriate
2. depends on maturity of program and specific elements of program
3. ability to quantify and show leadership value of program

Measuring Compliance Program Effectiveness Provides…

1. valuable insight to move program from one level to the next (focus limited resources on high risk areas)
2. quantifies value of program within organization and demonstrates commitment
3. documents good faith efforts to government