CONTINUUM OF CARECONTINUUM OF CARE

CONTINUUM OF CARECONTINUUM OF CARECONTINUUM OF CARECONTINUUM OF CARE

OFFICEOFFICE ASCASC

CONTINUUM OF CARECONTINUUM OF CARECONTINUUM OF CARECONTINUUM OF CARE

Radiology

OFFICEOFFICE ASCASC

Laboratory

H it lHospital

Letters

Pathology

CONTINUUM OF CARECONTINUUM OF CARECONTINUUM OF CARECONTINUUM OF CARE

OFFICEOFFICE ASCASC

PATHOLOGYPATHOLOGY

CONTINUUM OF CARECONTINUUM OF CAREbLab

OFFICEOFFICE OFFICE

PATHOLOGY

OFFICE

PATHOLOGY

PATHOLOGY LAB

PATHOLOGY LAB

PATHOLOGY LAB

PATHOLOGY LAB

CONTINUUM OF CARECONTINUUM OF CAREh l iPathologist

OFFICEOFFICEOFFICEOFFICE

PATHOLOGISTPATHOLOGIST

PATHOLOGISTPATHOLOGIST

LAB DATALAB DATALAB DATALAB DATA

106,000 CLIA registered Physician Office Labs (POLs)(Half only do CLIA waived labs)(Half only do CLIA waived labs)

5,200 CLIA registered Independent Labs

8,600 CLIA registered Hospital Labs

C L IA  Reg is tered L abs Phys ician Labs :g Phys ician Labs  :C L IA waivedtests  only

P hys ician Labs

5,2008,600

Phys ician abs

Independent53,0053,000

Labs

Hospital Labs

Pathology precedentPathology precedentPathology precedentPathology precedent

Dermatologygy

Urology

Gastroenterology

Integration of care : reduced costsIntegration of care : reduced costs

PathPath

ASCASC

OfficeOffice

OFFICEOFFICE

PATIENTPATIENT ASCASCPrimary Care

Primary Care

LABLABLABLAB

disclaimerdisclaimer

This is a untrained gastroenterologist’s attempt to de-code Byzantine legal permutations within CMS. y g p

Retain a knowledgeable lawyer before proceeding.

State LawsState LawsP h l S iP h l S iPathology ServicesPathology Services

Direct Billing

ArizonaCalifornia

Anti-Markup

CaliforniaFlorida

Disclosure

ArizonaConnecticut

MassachusettsNevadaNew JerseyNew York

MichiganUtahOregonWashington

DelawareLouisianaMaineMarylandNew York

Rhode IslandLouisianaOhio

Washington MarylandNorth CarolinaOhioPennsylvania

South CarolinaTennesseeIowaMaryland

TexasVermontNew JerseyTennesseeMaryland

MontanaKansas

TennesseeUtah

Stark LawsStark LawsStark LawsStark Laws

Prevents referrals of designated health services by physicians to entities in which they have a physicians to entities in which they have a financial interest

Exception: “in-office ancillary services”

Stark LawStark LawStark LawStark Law

Designated Health Services (DHS)ExclusionExclusion

In-Office Ancillary Services (IOAS)

CMS 2008: Pod labs rulingOn-site vs. Off-site

StarkStarkStarkStark

Lab must be wholly owned by practice

Lab can serve needs of the practice’s patients only

Lab needs to be on premises

Pathologists must do the work in the lab where the specimen is prepared.

AMA Code of EthicsAMA Code of EthicsAMA Code of EthicsAMA Code of EthicsSection 8.09Section 8.09

Physicians focus is on quality and not economics

No mark-up for services by othersp y

Medicare and anti mark upMedicare and anti-mark-up

Pathologist must do “substantially all” (75%) professional services for that group.p g p

OR

Site-of-service option:TC must be performed and supervised and PC performed in the billing gastroenterologist’s officeperformed in the billing gastroenterologist s office

IOASIOASInIn--Office Ancillary ServicesOffice Ancillary Services

Performed in “Centralized Building”

Who bills for services? Who is the “service group”?1. Service group must be a group practice, “super group”

or consortium.

2 Person providing pathology specimens2. Person providing pathology specimensReferring physician (i.e. gastroenterologists)

Member of the group (i.e. pathologist who is employee or owner)

Individual supervised by a member of the group (generally does not apply)

IOASIOASInIn Office Ancillary ServicesOffice Ancillary ServicesInIn--Office Ancillary ServicesOffice Ancillary Services

(continued)(continued)

Follow Medicare Billing and Reassignment RulesReassignment: Physician may bill for services performed by an employed or contracted physician.

PathologistPathologistPathologistPathologist

Independent contractor

Employment agreementMust be “bona fide”

Fair market compensationFair market compensation

Written agreement (generally a year or more)

Compensation not reflective on referral

Malpractice & LiabilityMalpractice & LiabilityMalpractice & LiabilityMalpractice & Liability

Review current policy

There is increased exposureErrors & omissions by pathologist

Inadequate supervisionInadequate supervision

Negligent hiring

Billing errors: CMS fraud and abuseBilling errors: CMS fraud and abuse

Pod or Condo LabsPod or Condo LabsPod or Condo LabsPod or Condo Labs

Largely eliminated for Medicare patients by CMS in 2008.

Finalized in March 2009 after court challenge

Lab DevelopmentLab Development

PathologistPathologist

Physician Physician

Pathology Consultant•Construction•Equipment

Pathology Consultant•Construction•Equipment Physician

PracticePhysician Practice

Equipment•Personnel•Contracts•Certification•Insurance

Equipment•Personnel•Contracts•Certification•Insurance

PayorPayor

Insurance Insurance

Pathology LabPathology Lab

PC Professional Component

TC Technical Component

PC / TC BundledPC / TC Bundled

Traditional and historical model was for a hospital toown the lab (or partner with pathology group) and bill the TC.

Pathology group would then bill PC

ScenariosScenariosScenariosScenarios

PC TC PC/TC

1 32

IN-OFFICE

1 IN OFFICE PC1. IN OFFICE PC2. IN OFFICE TC3. IN OFFICE PC / TC

Scenario 1Scenario 1IN OFFICE PC

PC

IN-OFFICE

• Pathologist does bulk (75%) work with group.g ( ) g p

• No TC mark-up. TC bill submitted by out-sourced lab

• Un bundled bill (PC only) submitted• Un-bundled bill (PC only) submitted

Scenario 2Scenario 2IN OFFICE TC

TC

IN-OFFICEN O C

• Practice can bill TC (unbundled)

• Pathologist (not in-house): Pathologist bills for PC• Pathologist (not in-house): Pathologist bills for PC

• Practice can share ownership of on-site lab with other practices in building.

Scenario 3Scenario 3IN OFFICE PC / TC

PC / TC

IN-OFFICEN O C

• Practice can bill PC/TC bundled.

Scenario 3.1Scenario 3.1IN OFFICE PC / TC but multiple satellite

locationsoc o s

PC / TC

IN-OFFICE

• Practice can only bill Medicare TC at the main office and is subject to anti mark up at satellite officesand is subject to anti-mark-up at satellite offices

•Practice can bill PC if the pathologist reads at the p gsatellite office

System savingsSystem savingsSystem savingsSystem savings

Reduced administrative costElectronic interface with office EMRElectronic interface with office EMR

Charge pass to billing department / PM

Data transfer from pathology to ASC

No courier

No sales representative

Where’s the path???Where’s the path???

System savingsSystem savingsSystem savingsSystem savings

Move specimen processing out of hospital settingsg

Ultimate optimizationNarrow scope of operationNarrow scope of operation

Prompt turn around

On-site review

QualityQualityQualityQuality

Improved dialogue between endoscopist, nursing and pathologist: “vertical” integration of patient data

Pathologist has access to clinical information

Pathologist can tailor report to specific clinical questiong p p q

Expands team approach to patient care

Data mining and query functions (Pay For Performance) Data mining and query functions (Pay For Performance) as pathology results become integrated and linked to endoscopic findings, diagnosis, and clinical outcomes.

Expectations if you build your own labExpectations if you build your own labp y yp y y

Report program: expect high quality pathology report including photos and language that is p g p g gclinically applicable

Fast turn around

Easy access to second opinion

Transparency between the gastroenterologists and pathologists when a second opinion is sought

Expectations if you build your own labExpectations if you build your own labp y yp y y

Board certified pathologists

CLIA approved lab with adequate space

Pathologists must have easy access to relevant clinical information

100% accuracy matching specimen to patient (ideally no data re-entry).

SuggestionsSuggestions

Work with a knowledgeable consultantCan also helps keep legal fees minimizedCan also helps keep legal fees minimized

300 square feet + pathology reading office

Dialogue with your local pathology group

P l ’ iProcess only your group’s specimens

ObservationsObservationsObservationsObservations

Consolidated (TC / PC) billing is less confusing to the patientp

Pathology trendsPathology trends??

Movement of pathologists towards employees and subcontractors

Diminishing of hospital centered pathology with growth of ASCsg

Improved partnering between clinicians at point-of-care and pathologistsp g

Future trendsFuture trendsFuture trendsFuture trends

CMS may regulate PC from Independent Contractors

Pathology lobby advocating their interests

Molecular pathology:

Expanding partnerships betweenPathology and radiologyPathology and radiology

Further sub-specialization of pathology

In house liver biopsy

Non-endoscopic specimen collection

NPPs role expansion to endoscopy

Data sharing and integration

OfficeOffice

Data sharing and integration

O ceO ce

PMSPMSLabLab

ASCASCASCASC

PathologyProgram ASC

?

?

Patient EMR

?

Patient EMR record

Hospital data

Capsule endoscopy

Radiology

Pharmacy

O t id h i i

PracticeManagement

Outside physicians

Patient communications

OthSystem Other

Insurance

AP Lab Arrangements

PC TC PC/TC

ab a ge e ts

PC TC PC/TC

E Mi Mi MiExpenses Microscope

Software

Microscope

Software

Microscope

Software

Camera Camera

Technician

Camera

TechnicianTechnician

Consultant

Technician

Consultant

Space Space

EconomicsEconomicsEconomicsEconomics

Average 1.8 specimens per endoscopy

Medicare reimbursement: $90 - 100 / specimen (global fee)$ p (g )

TC : 60% / PC : 40%

P h l C lPathology Consultants

GI Pathology Partners

Lakewood Pathology

Path Lab Solutions

Path Options

Physicians Right PathPhysicians Right Path

Twin Crest Group

Data accessionData accession

specimens specimens

tissue grossingtissue grossing

Tissue prepTissue prep

Tissue embeddingTissue embedding

Wax embed prepWax embed prep

Wax coolingWax cooling

Thin sectioningThin sectioning

StainingStaining

Slide prepSlide prep

Final readFinal read

OFFICEOFFICEGI

PATIENTPATIENT ASCASCPrimary Care

Primary Care

LABLABLABLAB

questions

??