Digital Ties That Bind: Hospital-Physician

Relationships InvolvingEHRs and HIERobert A. Gerberry, J.D.

Associate Counsel

2

Who Is Summa?

� Summa is…

� An Integrated Delivery System

� Tertiary, Community and Physician-Owned Hospitals, Multi-Specialty Physician Group, Research Division, Health Plan and Foundation

� Located in a 5-County Area in Northeast Ohio

� Working to…

• Enhance the patient and member experience

• Create value through a collaborative focus

• Provide high quality care at low costs

• Serve the community as the largest employer in our service area

3

The Integrated Delivery System

Hospitals

Inpatient Facilities• Tertiary/Academic Campus• 3 Community Hospitals• 1 Affiliate Community Hospital• 2 JV Hospitals with Physicians

Outpatient Facilities• Multiple ambulatory sites• Locations in 3 Counties

Service Lines• Cardiac, Oncology,

Neurology, Ortho, Surgery, Behavioral Health, Women’s, Emergency, Seniors

Key Statistics• 2,000+ Licensed Beds• 62,000 IP Admissions• 45,000 Surgeries• 660,000 OP Visits• 229,000 ED Visits• 5,000 Births• Over 220 Residents

MultipleAlignment Options• Employment• Joint Ventures• EMR• Clinical Integration• Health Plan

Summa Physicians, Inc.• 265 Employed Physician

Multi-Specialty Group

Summa Health Network• PHO with over 1,000

physician members• EMR/Clinical Integration

Program

Geographic Reach• 17 Counties for

Commercial• 18 Counties for Medicare• 55-hospital Commercial

provider network • 41-hospital Medicare

provider network• National Accounts in 2

States

155,000Total Members• Commercial Self Insured• Commercial Fully Insured• Group BPO/PSN• Medicare Advantage• Individual PPO

Physicians Health Plan Foundation

System FoundationFocused On:• Development• Education• Research• Innovation• Community Benefit• Diversity• Government Relations• Advocacy

Net Revenues: Over $1.6 BillionTotal Employees: Nearly 11,000

Summa Akron City Hospital St. Thomas Hospital

Summa Wadsworth-Rittman Hospital

Summa Western Reserve Hospital Robinson Memorial Hospital

Summa Barberton Hospital

4

5

Summa’s Service Area

6

SummaCare

� Health Insurance Company

� Provider Owned

� Four Product Lines

� Total Membership – 150,000 +

� 18 County Northern Ohio Service Area

� Multi-State, National Accounts

� Annual Revenue $400 million

� 300+ Employees

� Large Provider Network

Physician AlignmentStrategy

8

Physician Alignment Options

� First plank – Develop primary care network

� Second plank – Offer Fully-employed and Physician-Managed employment models

� Third plank – Joint ventures

� Fourth plank – Clinical and financial integration through SHN

� Fifth plank – Managed Services Organization

A Multi-Pronged Approach

9

PHO EMR Grant Process

� Summa Health Network utilized a P4P payer grant to fund EMR project for PHO physicians

� All the physicians in the PHO were offered the opportunity to participate

� Purpose was to assist members with the purchase and implementation of EMR in their offices

� SHN hoped to achieve greater clinical and financial integration and better quality of care for patients in the community

� Funds were distributed in 3 installments-

• 50%--when office signs contract with EMR Vendor

• 25%--when office goes live on EMR

• 25%--when office submits clinical data back to SHN

Summa Physicians, Inc. (“SPI”)

11

SPI Overview

� SPI employs 265 physicians in 33 specialties

� 1/3: fully-employed model

� 2/3: physician-managed lease model

� SPI sets goal of implementing EMR across all practices by January 2012

� Projected to create incentive payments of approximately $11 million and will avoid potential Medicare penalties in 2015

� Capital cost for implementing EMR across SPI is approximately $2 million

SPI Overview (cont.)

� Move from independent silos to group culture by evolving to full connectivity on common IT platform

� Majority of Physicians implementing eClinical Works as EMR platform, but certain specialists permitted to remain on their prior EMR platform based on needs of specialists (e.g. cardiologists and surgeons)

12

13

SPI Overview (con’t)

Summa Physicians, Inc.(265 physicians)

Internal Medicine(38)

Family Medicine(41)

OB/Gyn(21)

Geriatrics(11)

Cardiology(28)

Surgery(35)

Ortho/Sports(8)

Oncology(7)

Behavioral Health(25)

Infectious Disease(7)

Endocrinology(4)

Critical Care(11)

Palliative Care(6)

Others(19)

Gastroenterology(4)

Physician-Hospital Joint Ventures

15

Summa/Physician Current Joint Ventures

Joint Venture

% Summa/

% Physicians Description

SummaCare 98/2 Provides insurance and TPA services throughout nation

Summa Western Reserve Hospital

40/60 Acute Care Hospital located in Northern market. Partnership between Summa Health System and 220 physicians

Crystal Clinic Orthopaedic Center

50/50 JV Hospital includes inpatient orthopedic surgery at St. Thomas Hospital, ASC in suburban location and 8 hospital based clinics located throughout 3 counties

Medina ASC 20/80 ASC Surgery Center with 2 ORs and 1 procedure room

Select Hospital 5/10

(5 AGMC/80 Select)

60-bed LTACH for patients needing additional care after their acute care hospital stay

Aris Teleradiology 52/48 Teleradiology company provides final reads of radiology exams tohospitals/diagnostic centers across the country

Digestive Health 5/44

(51 AmSurg)

Outpatient Endoscopy Center

16

Physician-Hospital Joint Ventures

� Summa Western Reserve Hospital (“SWRH”)� Joint venture started in June 2009 between Summa

Health System and Western Reserve Hospital Partners (a local group of approximately 220 physicians)

� Commenced operations in June 2009 at the prior Summa Cuyahoga Falls General Hospital location

� Crystal Clinic Orthopedic Center (“CCOC”)� Orthopaedic Hospital Joint Venture between Summa

Health System and Crystal Clinic (a local group of approximately 30 orthopedic surgeons)

� Commenced operations in May 2009 on the Summa St. Thomas Hospital Campus

Combining Parts into an ACO

18

How Summa Views Accountable Care

� The concept of Accountable Care creates a burning platform for hospitals, physicians and other providers along the care continuum to work collaboratively to deliver high-quality, coordinated and cost-effective care

� Paradigm Shift from fee-for-service medicine to comply with Dr. Berwick’s Triple Aim-Better Care, Better Population Health and Lower Costs

19

How Summa Views Accountable Care (cont.)

� Accountable Care continues the following transitions:

� Moving away from the current fee-for-service payment system that rewards doing more to a new payment system that incentivizes a focus on primary care, wellness and population health

� Providers that are clinically and fiscally accountable for the populations they serve (consistent with our Joint Ventures)

� Patients that are actively engaged to take responsibility for their health

� Hospitals and physicians building upon their relationships with each other and partnering in a deeper way with patients, populations and payers

� Improving the health of our communities while, at the same time,reducing costs by anticipating health needs and proactively managing chronic care

SpecialtyCare

Why Change How We Provide Care?

Everyone is working in their own silos…, which impedes coordinated care

PrimaryCare

AmbulatoryHospitaland ED

SkilledNursing

NursingHome

HomeHealth

21

ACO as the Integrator

SpecialtyCare

PrimaryCare

AmbulatoryHospitaland ED

SkilledNursing

NursingHome

HomeHealth

ACO

22

22

Summa’s ACO Planning Process

� The Summa ACO planning process began in December 2009

� Summa is part of the Premier Implementation Collaborative

� Summa convened 4 ACO Work Groups to guide the process

� Care Model

� Delivery Network

� Finance

� Informatics and Technology

� Inclusive, not exclusive

� View the ACO as a community collaboration

� Engage both employed and independent providers

� Expand to all segments along the care continuum

� Inclusive of all physicians that want to participate as long as they meet ACO quality and utilization standards as defined in Conditions of Participation in Membership Agreement

� Initial partners include about 200 PCPs, more than 200 specialists and 6 hospitals

� 4 large independent primary care groups

� 2 employed multi-specialty groups

� All Summa hospitals

� SummaCare as the payer partner 23

Delivery Network Workgroup

ACO Conditions of Participation

� Sample of Conditions of Participation in Summa Membership Agreement:

� Comply with Credentialing Requirements

� Participate in ACO Education Initiatives to assist in development of ACO Care Models and Quality Improvement Strategies

� Open practice to new ACO enrollees

� Participate under Single Tax ID

� Provide Timely Care consistent with best practices

� Comply with ACO Policies and Procedures

� Adhere to ACO protocols to promote improvement in patient outcomes and patient satisfaction

� Make Referrals to other ACO providers when medically necessary and consistent with patient choice

24

ACO Conditions of Participation (cont.)

� Sample provisions (cont.):

� Implement and utilize ACO approved EMR consistent with CMS meaningful use guidelines

� Have capacity to exchange clinical and demographic information through secure transaction sets

� Provide patient data to develop care plans consistent with patient choice

� Protect privacy of patient PHI as required under HIPAA

25

26

Care Model Workgroup

� Care Model Concept

� Review high-cost and high-utilization clinical conditions

� Start with transitions of care as a way to approach all care models-Better Hand-Off of Patients

� Initial Care Model – Heart Failure

� Identified as a leading cost and utilization driver for the pilot population

� Will serve as an example for how to develop additional care models

� Create evidenced-based protocols which are followed by all providers

� Target preventable readmissions through better follow-up and monitoring of the patient

27

New HF Transitional Process

� New process will attempt to:

� Improve notification of PCP at the point of patient admission and discharge from the Hospital

� Improve communication of discharge plan to PCP

� Expand transitional care management to include all ACO patients admitted for Heart Failure

� Identify patients who would benefit from different care strategies

� Enhance patient engagement and activation materials

� These changes all require a sophisticated IT platform to achieve these goals

28

Informatics and Technology Workgroup

� In the Conditions of Participation in Summa’s Membership Agreement, ACO participants required to have certified EMR and “to have achieved meaningful use or be actively working towards that goal”

� 2 main goals of IT Workgroup:

� Develop a Call Center that will create an environment for ACO providers to have after-hours coverage, nurse clinical triage protocols, scheduling capability, and ability to track and make inpatient discharge follow-up calls

� Develop a Clinical Data Repository (to be discussed later-”Summa Harmony Project”)

29

What is the Summa ACO?

“New Health Collaborative” is a clinician-ledorganization that partners with communities to compassionately care for and serve in an accountable, value- and evidence-based manner

Organizational Facts

� Start Date – Began operations January 1, 2011

� Initial Pilot Population – Approximately 10,000 SummaCare Medicare Advantage members that currently see a participating primary care physician

� Legal Entity – Non-profit taxable structure allows for physician majority on the Board

� Board Composition – 4 community primary care physicians, 1 medical specialist, 1 surgical specialist, 3 Summa representatives

30

Core ACO Functions

� Manage clinical integration

� Develop new care models

� Capture and report data across the continuum of care

� Measure and monitor costs and quality

� Coordinate network development and financial relationships

� Provide infrastructure and tools to providers

31

What ACOs Mean for Patients?

� For Patients and Caregivers:

� High-quality, coordinated care convenient and close to home

� Access to an integrated system of hospitals and physicians and the latest technologies

� Active engagement in their care plans

What ACOs Mean for Physicians?

� For Physicians:

� An opportunity to play a leadership role in advancing clinical care delivery, research and innovation

� Easy access to the right clinical information when and where it is needed

� A new payment system that rewards value-based care

� Involvement in planning for the future of healthcare in the region

� Feeling valued and supported in providing the right care for thepatient in the right setting at the right time

� New tools, processes and infrastructure to help streamline care delivery

32

What ACOs Mean for Employers?

� For Employers and Communities:

� A partnership to help meet employees healthcare needs

� Improved health status for the community and reduced health disparities

� A healthier, more productive workforce and stable, predictable healthcare costs

33

IT Strategy for ACO and Integrated Delivery System

Office Practice EHR Adoption

35

Health Reform Drives IT Strategy

� HITECH Act makes available incentive payments totaling up to $27 billion over 10 years

� As much as $44,000 (through Medicare) and $63,750 (through Medicaid) per clinician (although Eligible Professionals may notparticipate in both programs, Hospitals are permitted to access both programs (75 Fed. Reg. 1844, 1938)

� In 2015, a 1% reduction in Medicare reimbursement will affect non-participants, 2% in 2016, and 3% in 2017

� New Payment Models highlight need for IT systems to measure data upon which future payments will be based

� IT projects can be self-sustaining through improvement of revenue cycle, risk management, and clinical process improvement 36

SPI Meaningful Use Implementation

� Summa hires dedicated Meaningful Use Coordinator to ensure practices meet guidelines

� Creates educational programs to ensure that providers understand core and menu set objectives/measures

� Works collaboratively with EMR Implementation team and Physician Office staff to facilitate compliance with CMS guidelines

37

Timing of MU Stages

38

HIE

� As connectivity among the various components of the health care delivery system expands, providers can “push” data to central portal

� As HIE exchanges evolve, providers will be able to “pull”data back out of clinical data repository (“CDR”)

� HIE may provide additional services such as quality reporting and disease management functionality

� Example: ED Physician sees unknown patient and queries HIE for information about patient. HIE allows ED Physician to pull patient history and then push ED visit to PCP. PCP automatically receives notification via clinical messaging agent of patient’s ED visit

39

HIE and Quality Reporting

40

AHIN/RHIOAkron Health Info Network

POST ACUTE

Community Physician EMR

IE

JVs and Affiliates

Robin

son

West

ern

Rese

rve

Cry

stal C

linic

Akron City/St. Thomas

Revenue Cycle

BarbertonWadsworth

Rittman

Revenue Cycle Revenue Cycle Revenue Cycle

Summa Physicians, Inc.

Financials Financials Financials Financials

HR/Payroll HR/Payroll HR/Payroll HR/Payroll

Infrastructure Infrastructure Infrastructure Infrastructure

Basic EMR Basic EMR Basic EMR

CPOE

Nursing Doc

Community

Reporting

Clinical Info Viewer SummaWeb

Clinical Portal

Clinical &

Business Data

Repositories

Basic EMR

CPOE CPOE CPOE

DocumentationNursing Doc Nursing Doc

Medication Mgmt Medication Mgmt Medication Mgmt Medication Mgmt

Patient / Member Portal

EHR

The Summa Harmony Project

� Goal: To promote accountable care through the development of a system-wide information exchange, information repository and reporting environment

� Need to make enterprise technology investment decisions to facilitate integration and standardization post-acquisitions which will optimize entities current IT systems and create flexible IT infrastructure going forward

� This environment requires the movement and analysis of patient specific patient data (clinical and non-clinical) from multiple hospital systems, participating physician EMR systems and other healthcare providers including post-acute (Skilled Nursing & Homecare) and pharmacies

41

The Summa Harmony Project (cont.)

� Goal is to move data between unique systems and normalize data to create enterprise master patient index-Function as 1 system even if using different systems

� Strategy does not look to single vendor solution, but embraces diversity of IT systems

� The Harmony Project has 3 objectives:

� Aggregate, normalize and store patient business (e.g. demographics, insurance and utilization information) and clinical data (e.g. lab and radiology reports)

� Facilitate electronic sharing of clinical data to allow active communication between entities

� Create business intelligence framework to facilitate secondary uses of normalized, aggregated data 42

Data Flow Legend

Revenue Cycle Transaction (ADT, Demographics, Charge

Detail, Provider, DRG, etc.)

Insurance Related Transaction (Claim,

Insurance Verification, etc.)

Clinical Information Transaction (Clinical Results –

Laboratory, Radiology, Dictated/Transcribed Results, etc.)

43

Integration – The Summa Harmony Project

Akron City & St.

ThomasSMS

Eclipsys

MedinaSMS

Eclipsys

GreenSMS

Eclipsys

BarbertonQuadramed

WadsworthCPSI

IMCeCW

FMCeCW

Oncology

?OB/GYN

OBTV

LabCare

Home

Grown

Crystal ClinicHMS

Western ReserveMcKesson

RobinsonMcKesson Eclipsys

SPIeCW

GEMMS

UnityeCW

Business

Data

Repository

Siemens DSS

NormalizePt. Identity

& Data

SummaCare

Portals & Tools

Call Center

TR

IGG

ER

EV

EN

T

ME

D E

CO

N D

AT

A

CARE MODEL

Claims

Repository

Crimson

Premier

Cost Flex

eCW eHealth

Exchange

CCR

BI

To

ols

44

Akron City

Hospital

St. Thomas

Hospital

Barberton

Hospital

Wadsworth

Hospital

Western

Reserve

Hospital

Robinson

Hospital

eCW

eHx

Summa

Physicians, Inc.

Interface Engine

Clinical Data

Repository (Harmony System)

Normalize Pt. ID & Data

45

HIE & CDR Benefits

� Integrate disparate IT systems across IDS and surrounding community

� Create system to trend lab values across separate facilities and the assignment of EMPI to identify patients

� System will allow providers to view EHR and communicate with other providers

� Provide platform for collaboration of data and functions across Service Oriented Architecture (“SOA”)

� Exchange information with industry and governmental data stores

� Provide physicians with actionable data for PI 46

HIE & CDR Challenges

� Sharing of sensitive information among participants on HIE & CDR platforms

� State law privacy debate around sharing of treatment information on HIE without consent of patient

� Opt-In: HIE must obtain patient consent to share their data with providers on HIE

� Opt-Out: The patient must elect to share no clinical data with providers on HIE

� Other alternative: Patient elects to opt-out except for emergency access to their clinical information

47

HIE & CDR Challenges (cont.)

� May require adding language to patient consent form and Notice of Privacy Practices such as the following:

� Potential Language: “Hospitals and physician offices shall make electronic medical record information available through an electronic health exchange to Hospital’s related and affiliated providers as well as unrelated providers who agree to access the information solely for the purpose of patient care and treatment”

48

ACO Regulations

Proposed ACO Regulations

� CMS released proposed rule on March 31, 2011 for Medicare Shared Savings Program under authority set forth in Section 3022 of Affordable Care Act

� The Proposed Shared Savings rule published on April 7, 2011 at 76 Fed. Reg. 19,528 with 60 day comment period

� In addition, the following agencies also published guidance on the Shared Savings Program in coordinated response with CMS on March 31:

� CMS/OIG: 76 Fed. Reg. 19655

� FTC/DOJ Policy Statement: www.ftc.gov/opp/aco

� IRS Notice (2011-22): www.irs.gov/pub/irs-drop/n-11-20.pdf

� Comments to CMS/OIG are due by June 6, 2011 and comments to FTC, DOJ, and IRS are due on May 31, 2011

50

Reaction to ACO Regulations

� Based on proposed regulations, many providers believe only large Integrated Delivery Systems will be able to comply with the proposed rule

� ACOs will require sophisticated IT platform in order to evaluate data and provide feedback to physicians, payers and patients

� CMS estimates only 75-150 ACOs will be included in 2012 demonstration project

51

Major Areas of Proposed Regulations

� Type of Entity/Eligible Providers

� Legal Structure/Governance

� Participation Requirements

� Beneficiary Assignment/Attribution

� Leadership/Management Systems

� Shared Savings

� Quality Measures

� Data Access

� Application Process 52

Highlighted Areas

� Significant reporting requirements on 65 different measures require integrated IT platform

� Beneficiary Retrospective Attribution to ACO-Plurality of Services

� Approval of All Marketing Materials prior to use

� One/Two Sided Models of Shared Savings

� 25% withhold of shared savings to ensure ACO can repay potential losses

� Achievement of Minimum Savings Rate

� Shared Savings Benchmarks include teaching and disproportionate share adjustments (not treated as add-on payments) 53

Highlighted Areas (cont.)

� Risk of inadequate payment/bonus for effort

� Governance structure comprised of 75% Medicare providers and a Beneficiary representative

� Clinical Oversight by Board-Certified Medical Director

� PCPs exclusivity to ACO, while Hospitals and Specialists may participate in multiple ACOs

� ACO Antitrust Review of Provider’s market share

� 3-year participation requirement

� Requirement to adopt a compliance plan that includes a compliance officer who is not legal counsel

54

Leadership/Management Systems

� Proposed ACO regulations require that ACO demonstrate that 50% of its PCP providers will meet meaningful use criteria by 2nd performance year to

continue participation in Program (§ 425.11(b)(1))

� If a ACO provider does not meet this test, then CMS may terminate the provider’s ACO Agreement

(§ 425.11(b)(2))

� CMS seeks comment on whether percentage-based requirement to adopt EMR should apply by 2nd year to Hospitals and whether requirement should apply where an ACO includes only 1 Hospital or No Hospital (76 Fed. Reg. 19,600)

55

Shared Savings

� In establishing benchmark for attributed beneficiaries, CMS exempts expenditures for incentive payments under Section 1848 value-based purchasing initiatives

including PQRS, HITECH, eRx incentives (§425.7(b)(7))

� CMS seeks comment on the impact of excluding CMS expenditures for incentive payments under value-based initiatives such as HITECH from calculation of shared savings benchmark (76 Fed. Reg. 19,609)

� CMS believes that excluding EHR incentives from the benchmark will continue to reward ACO providers for participation in other important initiatives

56

Patient-Centeredness

� Guidelines highlight need for informatics capacity to identify high-risk beneficiaries and develop care plans

for targeted populations (§425.5(15)(ii)(4))

� ACOs must have infrastructure, such as IT, to enable it to collect and evaluate data and provide feedback to ACO providers, including at the point of care

(§425.5(9)(viii))

� For providers enrolled in the electronic exchange of information, the process must be consistent with MU requirements under Medicare EHR Incentive Program

(§425.5(15)(ii)(5(iii)) 57

Quality Measures

� 65 different quality measures around 5 domains

(§425.10(a)):

� Patient/Caregiver Experience (7 measures)

� Care Coordination (16 measures, including transitions of care, HIT)

� Patient Safety (2 measures)

� Preventive Health (9 measures)

� At-Risk Population/Elderly Health (31 measures)

� In Year 1, ACOs will only report quality data. Beginning in Year 2, ACOs must report and achieve

performance standards (§425.10(b))

� ACOs that do not meet quality performance thresholds on all measures will not be eligible for shared savings.

58

Quality Measures (cont.)

� The first year’s performance measures will be reported through:

� Claims Data

� Group Practice Reporting Option (“GPRO”)

� Survey Instruments

� In subsequent years, the quality measures will be reported via EMR

� 5 HIT measures will be assessed through self-attestation and provider use of EHR systems (submitted through GPRO)

59

HIT Performance Measures

60

Domain Measure Title CMS Program Method Submission Measure Type

Care Coordination/

Information Systems

(#19)

% of Physicians

Meeting Stage 1

HITECH Meaningful

Use Requirements

CMS EHR Incentive

Program/Group

Practice Reporting

Option (“GRPO”)

Process

Care Coordination/

Information Systems

(#20)

% of PCPs Meeting

Stage 1 HITECH

Meaningful Use

Requirements

CMS EHR Incentive

Program/Group

Practice Reporting

Option (“GRPO”)

Process

Care Coordination/

Information Systems

(#21)

% of PCPs using

Clinical Decision

Support

CMS

EHR Incentive

Program Core

Measure

EHR Incentive

Program/Group

Practice Reporting

Option (“GRPO”)

Process

Care Coordination/

Information Systems

(#22)

% of PCPs who are

Successful

Electronic

Prescribers under

the eRx Incentive

Program

CMS

EHR Incentive

Program Core

Measure

EHR Incentive

Program/Group

Practice Reporting

Option (“GRPO”)

Process

Care Coordination/

Information Systems

(#23)

Patient Registry Use CMS

EHR Incentive

Program Core

Measure

EHR Incentive

Program/Group

Practice Reporting

Option (“GRPO”)

Process

Aggregate Data

� CMS will share de-identified data (as defined under HIPAA) with an ACO at the beginning of their agreement period based on the historical beneficiaries utilized to calculate its spending benchmark and quarterly

thereafter (§425.19(b)(1)(i),(ii))

� The aggregate reports should include the following

(§425.19(b)(2)):

� Financial Performance Information

� Quality Performance Scores

� Aggregated Metrics on assigned beneficiaries

� Utilization Data based on historical beneficiaries assigned to ACO 61

Aggregate Data (cont.)

� In order to identify the historically assigned beneficiaries used to calculate the spending benchmark, CMS will, upon an ACO’s request, share the

following information (§425.19(c)(1)):

� Beneficiary Names

� Date of Birth

� HICN (“Health Insurance Claim Number”)

� In its request, an ACO must certify that it is seeking information as either a HIPAA covered entity, or as the business associate of the ACO participants, and that the request is for minimum data necessary to conduct

health operations (§425.19(c)(2)(i),(ii)) 62

Aggregate Data (cont.)

� By sharing aggregated data, an ACO will be able to monitor its assigned or potentially assigned beneficiaries and mange and develop programs around utilization and quality improvement

� In the proposed rule, CMS cites as examples:

� If Data shows high rate of hospital readmissions, then ACO couldimprove its discharge coordination

� If Part D data shows beneficiaries are not filling their prescriptions, then ACO could develop strategy to ensure patient’s are filling their scripts

� CMS requests comments on the kinds of aggregate data and the frequency of data reports necessary to allow ACO’s to achieve their goals

63

Identifiable Data

� Subject to a beneficiary’s right to Opt-out, CMS will, upon an ACO’s request for data for purposes of evaluation provider/ supplier performance, conducting quality assessment and population-based activities, provide the ACO with monthly claims data for

potentially assigned beneficiaries (§425.19(d))

� The ACO must certify that it is requesting the information for either of the following:

� Its own Patients

� As the Business Associate of their covered entity ACO participants

64

Identifiable Data (cont.)

� To ensure a beneficiary has a meaningful opportunity to Opt-out, the ACO may only request claims data about a

beneficiary if (§425.19(d)(4)(i)(ii),(iii)):

� Beneficiary has been seen in offices of PCP during performance year

� Beneficiary is informed how ACO intends to use data to improve quality of care furnished to beneficiary

� Beneficiary did not elect to Opt-out

� An ACO must supply beneficiaries with a form allowing

them to Opt-out (§425.19(g)(2))-if not, may be

terminated from Shared Savings Program

(§425.14((a)(13))

� However, an ACO will still receive 4 data points for individuals in 3-year base set: Name, DOB, Gender, and HICN)

65

Identifiable Data (cont.)

� In the proposed rule comments, CMS states that it believes more complete identifiable data will enable ACOs to target individual beneficiaries who may be assigned to them

� CMS uses the example of a beneficiary with frequent emergency room visits-By providing identifiable data, the ACO can develop a process to ensure the individual beneficiary has timely access to a physician for ambulatory care

� CMS also agrees that beneficiary information subject to 42 CFR 290dd-2 (alcohol, drug abuse) must have patient consent to be shared with an ACO

66

Data Use Agreement

� Prior to receiving any beneficiary identifiable data, an ACO must enter into a Data Use Agreement with CMS

(§425.19(f)):

� By entering into a Data Use Agreement, the ACO will

agree to (§425.19(f)(1),(2),(3)):

� Comply with the HIPAA Privacy Rule for covered entities

� Not utilize identifiable health information for any prohibited purpose

� No longer receive data if it misuses or improperly discloses data

� Not share data with anyone outside ACO

� Potentially be terminated from Shared Savings Program for these violations

67

Transparency

� ACOs will be required to post signs in their offices and provide written notification to beneficiaries about their

participation in Shared Savings Program (§425.6(c)):

� ACO beneficiaries free to obtain services from providers and suppliers outside their assigned ACO

� ACO must annually report to CMS each ACO’s

participant tax ID number and NPI (§425.5(14)):

68

Data Submission

� ACOs will use Group Practice Reporting Option (“GRPO”) data collection tool from PQRS system to allow ACOs to submit clinical information from EHRs, registries and administrative data sources

(§425.17(a),(b))

� CMS will perform random sampling of 30 beneficiaries for each GPRO-submitted quality measures

� CMS will audit first 8 records, and only audit other 22 records if it finds an issue during the review of first 8 records

69

Stark Law/Antikickback

� Under the proposed ACO regulations, Stark/AKS waiver for distribution of shared savings payments

� CMS/OIG requests comments on whether current Exception/Safe Harbor for EHR donation by Hospital to Physicians should sunset on January 1, 2014 or be extended through a new waiver (76 Fed. Reg. 19,659)

� CMS also seeks comment on whether waivers should be implemented related to costs to form an ACO and build the technological capacity to achieve the cost and quality targets (76 Fed. Reg. 19,659)

70

Antitrust

� If independent ACO participants have market share for a common service in each participant’s primary

service area (§425.5(d)(2)):

� Below 30%, then the ACO will be in safety zone

� Between 30% and 50%, then the ACO will not subject to review if it engages in pro-competitive activities and does not impede function of market (sufficient providers to form competiting ACOs)

� Greater than 50%, then the ACO must obtain expedited review by FTC/DOJ

� ACOs accepted into CMS demonstration program will be deemed clinically integrated for antitrust purposes

71

Tax-Exempt Organizations

� A tax-exempt organization must ensure that its ACO activities will not inure private benefit to insiders

� Shared savings payments will generally not result in unrelated business income tax (“UBIT”) if substantially related to tax-exempt’s organization charitable purpose

� Comments requested regarding participation by tax-exempt organization in commercial ACO arrangements

72

Application Process

� Shared Savings Program begins in January 2012 (start date may be moved based on responses during comment period and development of final rule)

� Potential for July 1, 2012 start date with agreement period of 3.5 years (76 Fed. Reg. 19,533) due to short implementation period

� Applications must describe how ACO plans to:

� Promote evidenced-based medicine

� Report on cost and quality metrics

� Electronically exchange information during care transitions

� Engage Patients in their care 73

Questions?