Controlling Healthcare Costs through Accountable Care ......“The Cost of Confusion: Healthcare...

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1 ©HEALTH CAPITAL CONSULTANTS Controlling Healthcare Costs through Accountable Care Organizations September 25, 2012 Anne P. Sharamitaro, Esq. Senior Vice President, Health Capital Consultants

Transcript of Controlling Healthcare Costs through Accountable Care ......“The Cost of Confusion: Healthcare...

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Controlling Healthcare Costs through Accountable Care Organizations

September 25, 2012

Anne P. Sharamitaro, Esq. Senior Vice President, Health Capital Consultants

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About the Presenter

Anne P. Sharamitaro, Esq., is a Senior Vice President of HEALTH CAPITAL CONSULTANTS (HCC), where she focuses on the areas of Certificate of Need (CON); regulatory compliance, managed care, and antitrust consulting. Ms. Sharamitaro is a member of the Missouri Bar and holds a J.D. and Health Law Certificate from Saint Louis University School of Law, where she served as an editor for the Journal of Health Law, published by the American Health Lawyers Association, and has been admitted to the Missouri Bar. She has presented healthcare industry related research papers before Physician Hospitals of America (f/k/a American Surgical Hospital Association) and the National Association of Certified Valuation Analysts and co-authored chapters in Healthcare Organizations: Financial Management Strategies, published in 2008.

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INTRODUCTION TO ACOs

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What is an Accountable Care Organization?

• Provider mix dependent on type of structure: federal or commercial ACO structure

Healthcare organization with a coordinated set of providers…

• Clinical accountability – Quality of care

• Financial responsibility – Cost of Care

Who share responsibility and accountability for the continuum of care…

• Increase quality

• Decrease costs

By providing the highest possible value of care…

• Value-based payments

• Reimbursement for achieving cost and quality goals

For financial incentives or “shared savings”…

• Public Payors (e.g., Medicare, Medicaid)

• Commercial Payors (e.g., BCBS of MA)

From participating payors.

“The Promise of ACOs” Accountable Care Organization Learning Network, http://www.acolearningnetwork.org/why-we-exist/the-promise-of-acos; “Essential Guide to Accountable Care Organizations: Challenges, Risks, and Opportunities of the ACO Model,” The Healthcare Intelligence Network, 2011.

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Key Principles and Elements of ACOs

• Able to provide and manage across the continuum of care • Responsible and accountable for quality and cost of care • Incentivize providers for quality – not quantity

Local Accountability

• Legal entity and governance structure that allows receiving/distributing shared savings payments • Invest shared savings in delivery system improvements • Capable of financial and resource planning

Shared Savings

• Ongoing metrics to obtain evidence of meaningful outcome improvements and cost impacts • Measurements must be transparent and accessible • Essential cost savings are the result of meaningful improvements

Performance Measurement

“AC0 Model Principles,” The Accountable Care Organization Learning Network, http://www.acolearningnetwork.org/why-we-exist/aco-model-principles (Accessed 09/16/2011)

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National Health Expenditures per Capita, 1960-2010

Source: Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics Group, http://www.cms.hhs.gov/NationalHealthExpendData/(see Historical; NHE summary including share of GDP, CY 1960-2010; file nhegdp10.zip).

Why Accountable Care?

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Hospital Care 30.5%

Physician/Clinical Services 20.3%

Rx Drugs 10.1%

Other Health Spending

15.9%

Other Personal

Health Care 14.9%

Home Health 8.2%

*Note: Other Personal Health Care includes, for example, dental and other professional health services, durable medical equipment, etc. Other Health Spending includes, for example, administration and net cost of private health insurance, public health activity, research, and structures and equipment, etc. Source: Kaiser Family Foundation calculations using NHE data from Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics Group, at http://www.cms.hhs.gov/NationalHealthExpendData/ (see Historical; National Health Expenditures by type of service and source of funds, CY 1960-2009; file nhe2009.zip).

Why Accountable Care?

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Why Accountable Care?

1. Includes Research (2%) and Structures and Equipment (4%)

2. Includes expenditures for residential care facilities, ambulance providers, medical care delivered in non-traditional settings (such as community centers, senior citizens centers, schools, and military field stations, and expenditures for Home and Community programs under Medicaid

3. Includes Durable (1%) and Non-durable (2%) goods

Hospital Care 31 %

Physicians & Clinics 20%

Dental Services and Other Professionals

7%

Government Administration & Net Cost of Health Insurance

7% Nursing Care Facilities & Continuing

Care Retirement Communities 6% Rx Drugs

10%

Other 14%

Note: Sum of pieces may not equal 100% due to rounding.

Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group.

Other – 14%

Other Health, Residential, and Personal Care2 5%

Home Health Care 3%

Government Public Health Activities

3%

Other Medical Products3 3%

Investment1

6%

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THE PATH TO ACCOUNTABLE CARE

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The Path to Accountable Care

"Plain Speaking: An Oral Biography of Harry S. Truman" By Merle Miller, New York, NY: Berkley Publishing Company, 1974, p. 26.

“The only thing new in the world is the history you don’t know.”

- Harry S. Truman

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The Path to Accountable Care Managed Care

• Managed care plans integrate the financing and provision of

health services

o Administered by one managed care organization (MCO) in an effort to contain costs

• Hold providers accountable for providing care to a

population through:

o Clinical practice standardization

o Selective contracting

o Low-cost settings

o Reduced discretionary hospital admissions

o Effective staff use

“A Guide to Consulting Services for Emerging Healthcare Organizations,” By Robert James Cimasi, John Wiley & Sons, Inc., 1999 , p. 12.

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The Path to Accountable Care The Four Phases of Managed Competition

1st Generation 2nd Generation 3rd Generation 4th Generation

Managed Access Managed Benefits Managed Care Managed Outcomes

• Emphasis on managing/restricting patient access

• Administrative burdens (e.g., pre-certification, significant co-pays)

• Reliance primarily on non-clinical reviewers

• Physician totally outside system

• Emphasis on managing benefits

• Pre-certification primary and treatment planning secondary

• Cost containment emphasized over clinical management

• Traditional treatment models employed

• Physicians “included”, but their care delivery “inspected”

• Greater emphasis on treatment planning and quality management

• Focus on most appropriate care in most appropriate setting

• Patients managed through continuum of care

• Clinical management of network; provider-care manager collegiality

• Shift toward improving access and benefits to reduce costs

• Operational, clinical, and financial integration

• Locally responsive delivery systems and services based on national standards and capabilities

• Mutually beneficial partnerships with physician community

• Effective use of technology to measure, report, and enhance quality and outcomes

• Proof of value for patients

• Full accountability for costs and quality

ACO

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The Path to Accountable Care Accountable Care is Not a New Concept

• Accountable care was linked to better healthcare in 1932 when the Committee on the Costs of Medical Care suggested, among other things, that the focus of medical care should be on coordination of care to help lower costs

“The Final Report of the Committee on the Costs of Medical Care” California and Western Medicine, 1932, p.397

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The Path to Accountable Care

•Health Maintenance Act of 1973

oDesigned HMOs to contain healthcare costs and integrate health systems

•Significant consumer backlash during the 1990’s

“Timeline” Managed Care Museum: Modesto, CA, February 2011, http://www. Managedcaremuseum.com/timeline.htm (Accessed 4/10/12); "Total HMO Enrollment, July 2010" Kaiser Family Foundation, , July 2010, http://www.statehealthfacts.org/comparetable.jsp?ind=348&cat=7&sub=85&yr=208&typ=1&sort=a&o=a&sortc=1 (Accessed 4/10/12).

Main Predecessor – Managed Care

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The Path to Accountable Care

• Dominant theory of 1990’s healthcare reform

• Formalized by Alain Enthoven of Stanford University in 1993

• Blends competitive and regulatory strategies

• Aims to achieve maximum value for both consumers and providers

“The History and Principals of Managed Competition” By Alain C. Enthoven, Health Affairs, Vol. 12, No. Supp. 1, 1993, p. 24.

An Evolved Form of Managed Competition

Enthoven’s Definition of Managed Competition

Competing healthcare entities, mainly payors, are monitored by a supervisory structure that establishes:

equitable rules; creates price-elastic demand; and, avoids

uncompensated risk selection

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The Path to Accountable Care

• Medicare Physician Group Practice (PGP) Demonstration

o Examined incentive-based payment methods

o Initiated in 2005

o Took place over a 5 year period

o Main Foundation for Medicare Shared Savings Program (MSSP), a/k/a, Federal ACOS

• Term ACO was coined in 2006

o Elliott Fisher, a physician and professor of medicine at Dartmouth Medical School

o Glenn Hackbarth, the chairman of the Medicare Payment Advisory Commission (MedPAC)

The Birth of a Term

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The Path to Accountable Care

•March 23, 2010

•The Patient Protection and Affordable Care Act (ACA) was signed into law

•A mere four pages introduced the next big movement in healthcare… ACOs

Enter Healthcare Reform

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The Path to Accountable Care The 2010 Affordable Care Act and ACOs

Better Individual

Care

Lower Growth in

Expenditures

Triple Aim- ACA & ACOs

Better Population

Health

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations and Medicare Program: Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center; Proposed Rule and Notice” Federal Register, Vol. 76, No. 67 (April 7, 2011), pg. 19531; “Patient Protection and Affordable Care Act” Public Law 111-148, Section 3022, 124 STAT 395 (March 23, 2010).

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Related ACA Provisions Value Based Purchasing (VBP)

• VBP refers to any concept that links payments to quality of care

o Rewards providers for providing high quality, efficient clinical care

• The ACA establishes several VBP demonstration programs

o Hospitals (§3001)

o Home health agencies (§ 3006)

o Ambulatory surgery centers (§ 10301)

• The MSSP is one form of value-based purchasing linking provider payments to efficient coordinated care of Medicare beneficiaries that meets standards set within CMS’s proposed rules

“Patient Protection and Affordable Care Act” Public Law 111-148, Section 3021, 124 STAT 353, 372, 936 (March 23, 2010).

“The Cost of Confusion: Healthcare Reform and Value Based Purchasing” By Trent Haywood, Healthcare Financial Management, Vol. 64, No. 10, October 2010.

“CMS Releases Proposed Regulations Regarding Formation of Accountable Care Organizations” By Emily J. Cook and David L. Klatsky, McDermott Will & Emery, April 8, 2011, http://www.mwe.com/index.cfm/fuseaction/publications.nldetail/object_id/3bf8ec04-7a4d-4a4e-8ffe-b4281889b282.cfm (Accessed 4/17/2011)

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Related ACA Provisions Other Payment Reforms

• Medical Home Model

o Promotes team-based approach to care of a patient through a spectrum of disease states and across the various stages of life

• Bundling Demonstration Projects

o A voluntary national pilot program on bundling payments to healthcare providers

o Aims to provide incentives for providers to coordinate patient care across the continuum and to be jointly accountable for an entire episode of care

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations and Medicare Program: Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center; Proposed Rule and Notice” Federal Register, Vol. 76, No. 67 (April 7, 2011) , p. 19602. Affordable Care Act, Pub. L. No. 111-148, Section 3023 (March 23, 2011)

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Related ACA Provisions Other Payment Reforms

• Community Health Teams

o ACA Section 3502 directs the Secretary to establish a program to provide grants to enter into contracts with eligible entities

o Establish community based interdisciplinary, inter-professional teams (referred to in the statute as ‘‘health teams’’) to support primary care practices (including OB-GYN practices, within the hospital service areas served by the eligible entities

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MEDICARE SHARED SAVINGS PROGRAM

CMS Final Rule For ACOs

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Medicare Shared Savings Program Overview and Intent

Encourage ACO development for Medicare populations through a program that:

“[P]romotes accountability for a patient population and coordinates items and services under parts A and B, and encourages investment in infrastructure and

redesigned care processes for high quality and efficient service delivery.”

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No. 212 (November 2, 2011), pg. 67804; “Patient Protection and Affordable Care Act” Public Law 111-148, Section 3022, 124 STAT 395 (March 23, 2010). “Patient Protection and Affordable Care Act” Public Law 111-148, Section 3022, 124 STAT 395 (March 23, 2010).

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Medicare Shared Savings Program ACO Requirements

• Formal legal structure established • To receive and distribute any shared savings • Proposed rule modified to allow participation of entities organized

under Federal or Tribal law

Legal Entity

• Sufficient number of primary care physicians to provide care for at least 5,000 beneficiaries

Sufficient Size

• Must commit to participate in the program for at least three years • Must provide CMS with 60 days advance notice if terminating

agreement • Participating ACO will not share in any savings in the performance

year for which it notifies CMS of termination

3-Year Commitment

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No. 212 (November 2, 2011), p. 67807-08, 67814-16, 67821-22, 67825, 67827, 67829, 67891, 67980.

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Medicare Shared Savings Program ACO Requirements

•Must have a mechanism for shared governance and responsibility •Management structure must include both clinical and administrative systems •ACO participants must hold at least 75% control of the ACO’s governing body •Where ACO comprises multiple, otherwise independent entities not under common control, governing body must be separate and unique to the ACO

•Must provide for beneficiary representation on governing body •If governing body does not meet requirements, ACO must describe why it seeks to differ from requirements and how it will involve ACO participants in governance in innovative ways and/or provide for meaningful governance participation by Medicare beneficiaries

•ACO’s operations must be managed by an executive, officer, manager, or general partner, whose appointment and removal are under the control of the governing body

•Clinical management and oversight must be managed by a senior-level medical director who: is one of the ACO’s physicians; is physically present in an established ACO location on a regular basis; and, is board-certified and licensed in one of the states in which the ACO operates

Leadership & Governance

•Must define, establish, implement, and periodically update processes to promote evidence-based medicine

•Guidelines must cover those diagnoses with significant potential for achieving quality improvements, while taking into account individual beneficiaries’ circumstances

•Must define, establish, implement, and periodically update processes and infrastructure for ACO participants and providers/suppliers to internally report on quality and cost measures

•Must report data on 33 quality measures for each year of performance agreement

Performance Measurement

•Must adopt a focus on patient-centered care that is promoted by the governing body and integrated into practice by leadership and management

Patient-Centered

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No. 212 (November 2, 2011), p. 67807-08, 67814-16, 67821-22, 67825, 67827, 67829, 67891, 67980.

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Medicare Shared Savings Program Eligible Entities

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No . 212 (November 2, 2011), p. 67812; “Accountable Care Organizations: A Roadmap for Success: Guidance on First Steps” By Bruce Flareau and Joe Bohn, 1st ed., Virginia Beach, VA: Convergent Publishing, LLC, 2911, p. 45.

Final Rule Designation Potential Provider Organizations

• ACO professionals in group practices • Primary Care Physician Practices

• Networks of individual practices of ACO professionals

• Independent Practice Associations (IPA)

• Multispecialty Physician Groups (MSPG)

• Partnerships or joint venture arrangements between hospitals and ACO professionals

• Integrated Delivery Networks (IDN)

• Clinical Integrated Networks (CIN)

• Hospitals employing ACO professionals

• Hospital Medical Staff Organizations (MSO)

• Physician Hospital Organizations (PHO)

• Extended Hospital Medical Staff

• Critical Access Hospitals (CAHs)

Such other groups of providers of services and suppliers as the Secretary determines

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Medicare Shared Savings Program Becoming an ACO

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No . 212 (November 2, 2011), p. 67978.

Application Must Include Documents Outlining:

• Agreements describing ACO participants’ rights and obligations in the ACO

• Organizational and management structure

• Information regarding all of the ACO participants

• Methods the ACO will use to achieve “patient centeredness,” including a description of the remedial processes and penalties for failure to comply

• Ways the ACO’s governing body will adhere to structural requirements, or a description of why the ACO seeks to differ from requirements

• Any other documents as requested

Potential ACOs Must Apply and Provide Documentation of Ability to Manage Population Health

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Medicare Shared Savings Program Legal Structure and Governance

• May be structured through any state-permitted contract,

such as:

o Corporation

o Partnership

o Foundation

• Must be defined by its own unique Taxpayer Identification

Number (TIN)

• Must be recognized and authorized to conduct business

under applicable state, Federal, or Tribal law

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No . 212 (November 2, 2011), p. 67816.

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Medicare Shared Savings Program Legal Structure and Governance

For purposes of:

• Repaying shared losses

• Establishing, reporting, and ensuring ACO

participant and ACO provider/supplier

compliance with program requirements,

including the quality performance

standards

• Performing other ACO functions identified

in the statute “Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No. 212 (November 2, 2011), p. 67975.

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Medicare Shared Savings Program Leadership and Governance

• An “ACO shall have in place leadership and management structure that includes both clinical and administrative systems”

• “Mechanism for shared governance”

o Organization must “maintain an identifiable governing body with authority to execute the functions of the ACO”

o Governing body must be transparent and act in accordance with fiduciary duty to ACO

o Responsible for strategic direction and oversight

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No . 212 (November 2, 2011), p. 67975.

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Medicare Shared Savings Program Leadership and Governance

• Does not require a specific formation for the governing body

• Each individual ACO participant required to have “meaningful participation” in the governing body

• Must have Medicare beneficiary representation in the ACO governing body, with flexibility for “innovative” inclusion

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No. 212 (November 2, 2011), p. 67818-67821.

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Medicare Shared Savings Program Leadership and Governance

• ACO operations

o Managed by an executive, officer, manager, or general partner

o Appointment and removal are under control of the organization’s governing body

o Leadership team demonstrated ability to influence or direct clinical practice to improve efficiency processes and outcomes

• Clinical management and oversight

• Managed by a senior-level medical director who is one of the ACO’s physicians

o Board-certified physician

o Licensed in one of the states in which the ACO operates

o Present at “any clinic, office, or other location participating in the ACO.”

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No . 212 (November 2, 2011), p. 67823-67825.

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Medicare Shared Savings Program

Primary Care Services Restrictions

• The role of an ACO participant is defined in the MSSP: “Each ACO participant [physician provider working in an ACO] TIN upon which beneficiary assignment is dependent is required to commit to a 3-year agreement with CMS and will be exclusive to one ACO.”

• Participants in the ACO, must follow “required exclusivity,” meaning these participants may only be involved in a single ACO for a specific TIN

• However, providers may participate in multiple ACOs if they have multiple TINs

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations” Federal Register Vol. 76 No. 212, (November 2, 2011), p. 67811.

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Medicare Shared Savings Program The ACO Agreement

• “ACO shall enter into an agreement with the Secretary to participate in the [Shared Savings Program] for not less than a 3-year period…”

• CMS will review applications and approve application from eligible organizations prior to end of calendar year

• ACO’s performance periods will begin on Jan. 1 of each respective year

• Extended agreement periods for ACOs beginning April 1, 2012 and July 1, 2012, of 21 and 18 months

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No . 212 (November 2, 2011), p. 67835-67837.

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Medicare Shared Savings Program Assignment of Medicare Beneficiaries

• Based on utilization of primary care services provided by an “ACO professional”, which includes both physicians and non-physician practitioners

• Prospectively assigned to the ACO o Final updated assignment will be determined

retrospectively based on where beneficiaries receive a plurality of their primary care

• ACOs are responsible for any care received by the beneficiary, even if not received through the ACO o e.g., “Snowbirds” example

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No . 212 (November 2, 2011), p. 67851, 67861-67870.

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Medicare Shared Savings Program Quality Reporting Requirements

• Must determine appropriate measures to assess the quality of care furnished by the ACO, including:

o Measures of clinical processes and outcomes

o Patient and caregiver experience of care

o Utilization rates (e.g., admission for ambulatory sensitive conditions)

• Requires ACO participants to collect clinical and quality data and submit this information to CMS

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No . 212 (November 2, 2011), p. 67870, 67891-67895.

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Medicare Shared Savings Program Quality Reporting Requirements

33 quality reporting criteria across 4 domains include:

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No . 212 (November 2, 2011), p. 67889-67890, 67897.

Domain CMS Criteria Measures

1. Patient/Caregiver Experience 1-7

2. Care coordination/Patient Safety 8-13

3. Preventive Health 14-21

4. At-Risk Population 22-33

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Medicare Shared Savings Program Payment Mechanism – Shared Savings

• ACOs to receive payment for shared Medicare savings provided it

o Meets the quality performance requirements

o Demonstrates that it has achieved savings against benchmark of expected average per capita Medicare FFS expenditures

• An ACO shall be eligible for payment of shared savings

“[O]nly if the estimated average per capita Medicare expenditures under the ACO for Medicare FFS beneficiaries for Parts A and B services… is at least the percent specified by the Secretary below the applicable benchmark.”

• ACOs receive bonuses for achieving resource use and quality targets over the course of a year

• ACOs face penalties for failing to meet these requirements

• The final rule sets out two risk models with various incentives for ACOs to receive shared savings payments

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” Federal Register, Vol. 76, No. 212 (November 2, 2011), p. 67910, 67927-67930.

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Medicare Shared Savings Program Changes from CMS Proposed Rule to Final Rule

"Proposed Rule Versus Final Rule for Accountable Care Organizations (ACOs) In the Medicare Shared Savings Program: Major Changes" Centers for Medicare & Medicaid Services. https://www.cms.gov/ACO/Downloads/Appendix-ACO-Table.pdf (Accessed 12/28/11); "Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations" Vol 76 No 67 Reg. (April 7, 2011).

Provision/ Topic

Proposed Rule Final Rule

Quality Measures

Five categories with 65 measures of quality. Payment for acceptable reporting the first year, with a transition to pay-for-performance in later years. Proposed measures would eventually reflect quality goals currently utilized on the healthcare market .

Reduced to four categories with 33 quality measures, and a lax transition period for the ACO; full reimbursement in the initial year for reporting, with a mix of reporting and performance in the next two years for reimbursement.

ACO Reports Information provided for the ACOs at start of all performance years that contains the following assigned Medicare beneficiaries’ information: name; date of birth; sex; and, health insurance claim number.

The assignment process will occur over two steps: (1) "use plurality of allowed charges for primary care services rendered by primary care physicians" for those "beneficiaries who have received at least one primary care service from a physician," and (2) for those who have not received primary care services, "use plurality of allowed charges for primary care services rendered by any other ACO professional."

Beneficiary Assignment

In the one-step assignment process, beneficiaries will be "assigned on the basis of a plurality of allowed charges for primary care services rendered by primary care physicians."

The assignment process will occur over two steps: (1) "use plurality of allowed charges for primary care services rendered by primary care physicians" for those "beneficiaries who have received at least one primary care service from a physician," and (2) for those who have not received primary care services, "use plurality of allowed charges for primary care services rendered by any other ACO professional."

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Medicare Shared Savings Program Changes from CMS Proposed Rule to Final Rule

"Proposed Rule Versus Final Rule for Accountable Care Organizations (ACOs) In the Medicare Shared Savings Program: Major Changes" Centers for Medicare & Medicaid Services. https://www.cms.gov/ACO/Downloads/Appendix-ACO-Table.pdf (Accessed 12/28/11); "Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations" Vol 76 No 67 Reg. (April 7, 2011).

Provision/ Topic

Proposed Rule Final Rule

Utilization of Electronic Health Records (EHRs)

Fifty percent of primary care physicians must be "meaningful users" by the second performance year.

EHRs/"meaningful users" is no longer a requirement, but is still utilized for quality measures, and carries significant weight.

Potential ACO Participation Start Date

Three year agreements with same annual start date; Performance year same as calendar year.

According to CMS, "[p]rogram established by January 1, 2012"; first round of applications are due in early 2012. First ACO agreements start 4/1/2012 and 7/1/2012. ACOs will have agreements with a first performance "year" of 18 or 21 months. ACOs starting 4/1/2012 and 7/1/2012 have option for an interim payment if they report quality measures for CY 2013 to quality for first-performance-year shared savings.”

Beneficiary ACO Assignment

Primary care services utilization would determine which patients are retrospectively assigned to the ACO. Furthermore, a prospective identification of a benchmark population would determine which of the ACO patients are counted toward shared savings.

Initially, prospective-assignment will identify participating Medicare patients each quarter. Lastly, "final reconciliation after each performance year based on patients served by the ACO."

Beneficiary Claims Data

Beneficiaries can decline to participate at initial visit. During the first performance year, patients seen by the primary care physician of the ACO are the only ones subjected to shared claims data.

Participating beneficiaries will be offered an opportunity to decline after the ACO contacts them to detail the potential impact.

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Medicare Shared Savings Program Changes from CMS Proposed Rule to Final Rule

"Proposed Rule Versus Final Rule for Accountable Care Organizations (ACOs) In the Medicare Shared Savings Program: Major Changes" Centers for Medicare & Medicaid Services. https://www.cms.gov/ACO/Downloads/Appendix-ACO-Table.pdf (Accessed 12/28/11); "Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations" Vol 76 No 67 Reg. (April 7, 2011).

Provision/ Topic

Proposed Rule Final Rule

One-side and Two-sided and Conversion to Risk

ACOs can choose from either one-sided or two-sided models One sided comprises two years of shared savings with a required change in the third year. Two-sided would consist of three years performing in regards to the two-sided model. Three year agreement for both tracks.

Two-sided risk eliminated, but two tracks are still available for ACOs depending on where they fall on the spectrum of preparedness. The second model allows for greater reward and greater risk.

Marketing Guidelines for ACOs

The Centers for Medicare & Medicaid Services must acknowledge and approve all ACO marketing materials.

CMS will provide feedback on acceptable and "approved language," and the ACO can utilize marketing materials five days after they file materials with CMS, and "after certifying compliance with marketing guidelines."

Eligible ACO Entities or Participants

(1) ACO professionals in group practice arrangements, (2) networks of individual practices of ACO professionals, (3) partnerships or joint venture arrangements between hospitals and ACO professionals, and (4) hospitals employing ACO professionals. Lastly, other eligible entities detailed by the Secretary of HHS.

Aside from those detailed in the ACA, eligibility is extended to "Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs)." The only stipulation is FQHCs and RHCs need to detail primary care providers in their facilities who provide services to beneficiaries.

ACO Shared Savings

One-sided risk model: 2% savings triggers sharing amongst ACO, (small, physician-only and rural ACOs will have some exceptions compared to normal ACOs). Two-Sided risk model: shared savings from the beginning with no 2% savings required to trigger savings.

When the minimum savings rate is achieved, participating ACOs will have shared savings from the "first dollar."

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COST FOR PROVIDERS: DEVELOPMENT AND OPERATION OF ACOs

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Potential ACO Structure Federal ACOs

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Potential ACO Structure Federal ACOs Key

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Potential ACO Structure Commercial ACOs

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Potential ACO Structure Commercial ACOs Key

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Cost of Care

Fee For Service (i.e.,

RVS, RBRVS -Medicare)

Pay for Performan

ce (P4P)

Episodic Bundled

Payments

Population Bundled

Payments

Partial Capitation

Capitation

Commercial ACOs Models

Federal ACO

Model

More Risk Borne by Providers More Risk Borne by Payors

Potential Reimbursement Structures

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Cost for Providers Capital and Operating Requirements

• ACOs will require significant up-front costs

o Personnel and Intellectual Technology (IT) to satisfy the extensive quality reporting obligations

o Establish the required governance and management structure

o Ensure that the majority of the participating providers qualify as “meaningful users” or certified EHR technology by the end of ACO’s first year

• ACOs will require continuing expenses related to reporting

o Personnel

o IT Maintenance

o Continual coordination costs amount the different ACO members

“ACO Bound? Consider the Financials First” By David Lips, Health Leaders Media, December 30, 2010.

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Cost for Providers Capital Requirements for ACO Development

• ACOs are required to establish a self-executing method for repaying losses to the Medicare program by indicating that:

o Funds may be recouped from Medicare payments to the ACO’s participants

o ACOs must obtain reinsurance

o Place funds in escrow

o Obtain surety bonds

o Establish a line of credit that Medicare can draw upon, or

o Establish another appropriate repayment mechanism in order to ensure repayment to the Medicare Program

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations and Medicare Program: Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center; Proposed Rule and Notice” Federal Register, Vol. 76, No. 67 (April 7, 2011), p. 19643.

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Cost for Providers Financial Commitments

• The financial commitment will be quite large, even for more sophisticated ACO participants

• First year start-up and operation costs for all ACOs is anticipated as being between $132 million to $263 million

• The Government Accountability Office (GAO) reported that in 2008 that the participants in the CMS PGP Demonstration invested $1.7 million to meet the requirements of that program through the first year

• Many believe that these investments will not be recouped under the MSSP

“Managing the Risks of Accountable Care,” By Max Reynolds, Healthcare Financial Management Association, http://www.hfma.org/Templates/Print.aspx?id=27518 (Accessed 9/14/11).

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-3 -2 -1 0 1 2 3

Expe

ndin

g

Year

Projected Spending

Actual Spending

Shared Savings Target Spending

ACO Launched

“AC0 Model Principles,” The Accountable Care Organization Learning Network, http://www.acolearningnetwork.org/why-we-exist/aco-model-principles (Accessed 09/16/2011); ACO Toolkit, Accountable Care Organization Learning Network ; “How to Create Accountable Care Organizations,” Howard D. Miller, Center for Healthcare Quality and Payment Reform, 2009.

Reimbursement Considerations Potential Value from Shared Savings

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Cost for Providers Start-up Costs: Examples From PGP

Note: these cost are low estimates considering that the provider systems in the demonstration project had already absorbed other integration costs before the project got under way

“ACO Bound? Consider the Financials First,” By David Lips, Health Leaders Media, December 30, 2010.

Average up-front payment was

$489,000, plus $1.26 million in operating costs for first year

None of the 10 participants received any shared savings

from Medicare in the first year

Therefore, healthcare executives should

anticipate losses prior to gains in the

implementation of the ACO model

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Cost for Providers Capital Requirements

Estimates Based on Risk Based Capital Model

Required capital is lower if all ACO services are capitated

because the capitated providers are assuming the risk

“The Two Medicare ACO Programs: Medicare Shared Savings and Pioneer – Risk Actuarial Differences” Milliman, Inc, July 8, 2011

ACO Payment Method

Expected Costs Levels

Other Assumed

Capital

2 x Company Action Level

RBC

100% of ACO services are

paid FFS

90% of benchmark

None $27 million

100% of ACO services are

sub-capitated

95% of benchmark

None $11 million

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Cost for Providers AHA’s Hypothetical Models

• Start up costs and operational costs far exceed CMS estimate of $1.7 million

• Factors that determine start-up and ongoing costs:

o Size and composition of the patient population served

o Geographic area being served

o Characteristics of the organization that is undertaking the ACO development

o Extent to which some of the needed infrastructure is already in place

“From Volume to Value: The Transition to Accountable Care Organizations,” By Keith D. Moore and Dean C. Coddington, American Hospital Association, April 2011.

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Cost for Providers AHA Hypothetical Models: Two Prototype Options

“From Volume to Value: The Transition to Accountable Care Organizations,” American Hospital Association, April 2011.

Prototype A (200 bed, 1-hospital system, 80 PCPs, 150

specialist)

Total Start-Up Cost

$5,315,000

Total Annual Costs

$6,300,000

Prototype B (1,200 bed, 5-hospital system, 250 PCPs, 500

Specialists)

Total Start-up Costs

$12,000,000

Total Annual Costs

$14,090,000

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“The Work Ahead: Activities and Costs to Develop an Accountable Care Organization,” American Hospital Association, April 2011.

Prototype A: (200 bed, 1-hospital system,

80 PCPs, 150 specialists)

Prototype B: (1,200 bed, 5-hospital system,

250 PCPs, 500 specialists)

Activity Start Up

Costs Ongoing

(Annual) Costs Start Up

Costs Ongoing

(Annual) Costs

Group I. Network Development and Management

1. Providing ACO management and staff $550,000 $1,450,000 $600,000 $3,200,000

2. Leveraging the health system management resources $250,000 $200,000 $300,000 $250,000

3. Engaging legal and consulting support $350,000 $125,000 $500,000 $125,000

4. Developing financial and management information support systems $500,000 $80,000 $500,000 $160,000

5. Recruiting/acquiring primary care professionals, right-sizing practices $400,000 $800,000 $800,000 $1,600,000

6. Developing and managing relationships with specialists * * * *

7. Developing and managing an effective post-acute care network * * * *

8. Developing contracting capabilities $150,000 $150,000 $150,000 $150,000

9. Compensating physician leaders $75,000 $75,000 $190,000 $190,000

Group II. Care Coordination, Quality Improvement and Utilization Management

10. Disease registries $75,000 $10,000 $150,000 $20,000

11. Care coordination and discharge follow-up $150,000 $1,000,000 $300,000 $3,000,000

12. Specialty-specific disease management - $150,000 $300,000

13. Hospitalists $80,000 $160,000 $160,000 $320,000

14. Integration of inpatient and ambulatory approaches in service lines * * * *

15. Patient education and support - $100,000 - $100,000

16. Medication management - $100,000 - $100,000

17. Achieving designation as a patient-centered medical home $100,000 $15,000 $150,000 $25,000

Group III. Clinical Information Systems

18. Electronic health record (EHR) $2,000,000 $1,200,000 $7,050,000 $3,500,000

19. Intra-system EHR interoperability (hospitals, medical practices, other) $200,000 $200,000 $400,000 $200,000

20. Linking to a health information exchange (HIE) $150,000 $100,000 $200,000 $200,000

Group IV. Data Analytics

21. Analysis of care patterns $210,000 $210,000 $450,000 $450,000

22. Quality reporting costs $75,000 $75,000 $100,000 $100,000

23. Other activities and costs - $100,000 - $100,000

TOTAL $5,315,000 $6,300,000 $12,000,000 $14,090,000

*Costs are primarily management and staff and are included in previous elements (1, 2, and 3).

Financial Considerations Cost / Benefit Analysis

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Federal ACO Shared Savings Requirements

Financial Considerations Cost/Benefit Analysis

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations” Fed. Reg. Vol. 76 No. 212, Section 425.602-6, November 2, 2011, pg. 67986.

Small ACOS Medium ACOs Large ACOs

Number of Medicare Beneficiaries 5,000 20,000 80,000

Average Per Beneficiary Capital Cost $8,400

$8,400

$8,400

CMS Benchmark (i.e., Predicted Beneficiary Expenditures)

$42,000,000 $168,000,000

$672,000,000

One-Sided Model

Minimum Savings Rate (MSR) 3.9% 2.5% 2.0%

Minimum Amount of Cost Reduction Required to Experience Shared Savings

$1,638,000 $4,200,000

$13,440,000

Two-Sided Model

Minimum Savings Rate (MSR) 2.0% 2.0% 2.0%

Minimum Amount of Cost Reduction Required to Experience Shared Savings

$840,000 $3,360,000 $13,440,000

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Feasibility Analysis Cost / Benefit Analysis: Best Case Scenario

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations” Fed. Reg. Vol. 76 No. 212, Section 425.602-6, November 2, 2011, pg. 67986.

•There is a cap on the amount of shared savings an ACO can achieve

oOne-Sided – 10% of Benchmark

oTwo-Sided – 15% of Benchmark

•Reaching this cap is the best-case scenario for ACO benefits

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Feasibility Analysis Cost / Benefit Analysis: Best Case Scenario

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations” Fed. Reg. Vol. 76 No. 212, Section 425.602-6, November 2, 2011, pg. 67986.

Small ACOS Medium ACOs Large ACOs

10% for One-Sided ACO $4,200,000 $16,800,000 $67,200,000

15% for Two-Sided ACO $6,300,000 $25,200,000 $100,800,000

One-Sided Model Two-Sided Model

Small Medium Large Small Medium Large

Percentage of Shared Savings Given to ACO

50.0% 50.0% 50.0% 60.0% 60.0% 60.0%

Cost Reduction Required

$8,400,000 $33,600,000 $134,400,000 $10,500,000 $42,000,000 $168,000,000

Actual Expenditures $33,600,000 $134,400,000 $537,600,000 $31,500,000 $126,000,000 $504,000,000

Percentage Cost Reduction

20% 20% 20% 25% 25% 25%

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Feasibility Analysis

“The Dictionary of Health Economics” By Anthony J. Culyer, Second Edition, Edward Elgar Publishing Limited, 2010, p. 347; “Dictionary of Health Economics and Finance” By David E. Marcinko and Hope R. Hetico, New York, NY: Spring Publishing Company, LLC, p. 251.

• NPV analysis may determine at what size a healthcare enterprise should pursue ACO status

• Shared savings justify initial capital investments

o Incorporates cash flow over three year contract

NPV Analysis

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Feasibility Analysis NPV Analysis

“The Dictionary of Health Economics” By Anthony J. Culyer, Second Edition, Edward Elgar Publishing Limited, 2010, p. 347; “Dictionary of Health Economics and Finance” By David E. Marcinko and Hope R. Hetico, New York, NY: Spring Publishing Company, LLC, p. 251.

• Net Present Value (NPV) is …

“the difference in amount between initial payment and related future cash inflows

after cost of capital adjustments (interest rate), as of a specific date.”

• Positive NPV … ACO will be able to generate sufficient cash flows to offset initial investment cost as well as capital costs

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Feasibility Analysis NPV Analysis

"The Work Ahead: Activities and Costs to Develop an Accountable Care Organization" By Keith D. Moore and Dean C. Coddington, American Hospital Association, April 2011, p. 2; “Ibbotson SBBI: Cost of Capital” Morningstar, Chicago, IL: Morningstar, Inc., 2012; Please note that the weighted average cost of capital used is an industry average as reported in Ibbotson – this value will vary for each specific ACO investor; “Selected Interest Rates (Weekly) – H.15” Federal Reserve, April 9, 2012, http://federalreserve,gov/releases/H15/20120409/ (Accessed 4/18/2012).

Number of Beneficiaries

Required for an ACO

to be Profitable

NET PRESENT VALUE OF ACO INVESTMENT – ONE-SIDED MODEL

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Feasibility Analysis NPV Analysis

"The Work Ahead: Activities and Costs to Develop an Accountable Care Organization" By Keith D. Moore and Dean C. Coddington, American Hospital Association, April 2011, p. 2; “Ibbotson SBBI: Cost of Capital” Morningstar, Chicago, IL: Morningstar, Inc., 2012; Please note that the weighted average cost of capital used is an industry average as reported in Ibbotson – this value will vary for each specific ACO investor; “Selected Interest Rates (Weekly) – H.15” Federal Reserve, April 9, 2012, http://federalreserve,gov/releases/H15/20120409/ (Accessed 4/18/2012).

Number of Beneficiaries

Required for an ACO

to be Profitable

NET PRESENT VALUE OF ACO INVESTMENT – TWO-SIDED MODEL

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“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations” Fed. Reg. Vol. 76 No. 212, Section 425.602-6, November 2, 2011, pg. 67986.

• Positive NPV requires…

• One-Sided – 39,000 Beneficiaries

• Two-Sided – 16,000 Beneficiaries

• There is a greater opportunity to have

increased shared savings under the

two-sided model

• In exchange, it also exposes ACOs to risk

(i.e., potential shared losses)

Feasibility Analysis NPV Analysis

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BREAK EVEN ANALYSIS FOR ACOS OF VARIOUS SIZES

Feasibility Analysis NPV Analysis

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• One-sided

o Small and Medium (5,000-20,000 beneficiaries)

o Not feasible

• Two-sided

o Small (5,000 – 10,000 beneficiaries)

o Not feasible

Feasibility Analysis NPV Analysis

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• Large ACOs most likely to succeed

o 4% reduction in expenditures vs. 22%

o Added consideration – more likely to have previous integration (i.e., specialties, primary care, healthcare information technology)

o More likely to meet quality goals and reporting requirements

Poor quality can lower shared savings

Feasibility Analysis NPV Conclusions

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COST FOR PATIENTS: CONTROLLING HEALTHCARE COSTS

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Cost for Patients Will this Translate to Lower Healthcare Costs for Patients?

“Health Cost Containment and Efficiencies: Accountable Care Organizations,” National Conference of State Legislatures, NCSL Briefs for State Legislatures, No. 5, May 2010; “Monopolies Threaten Health Care Cost Controls” By Merrill Goozner, The Fiscal Times (February 3, 2011), http://www.thefiscaltimes.com/Articles/2011/02/03/Monopolies-Threaten-Health-Care-Cost-Controls.aspx, (Accessed 3/2/11).

- Lower Patient Costs -

Incentives that encourage quality over quantity may theoretically

eliminate unnecessary volume by lowering the amount of care

needed.

-Higher Patient Costs-

Integration may lead to greater market power for ACOs, leading to provider

savings.

Market Power has historically translated to higher consumer prices.

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Cost for Patients Controlling Healthcare Costs

ACOs may provide framework to control costs

“Health care providers sign an agreement to participate with the ACO. Spending targets are set based on past years’ data. If total spending

comes in under target, providers share the savings. Savings come from better chronic care management, compliance with preventive care

guidelines and better care coordination among ACO providers.”

- Health Policy Expert, Steven Shortell

“Health Cost Containment and Efficiencies: Accountable Care Organizations,” National Conference of State Legislatures, NCSL Briefs for State Legislatures, No. 5, May 2010.

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• Congressional Budget Office estimates potential savings from ACOs could reach approximately $5.3 billion between 2010-2019

• Net savings will not be realized until 2013

Despite These Estimates…

• Demonstration program outcomes: “It is questionable whether the PGP [Physician Group Practice Demonstration] has saved money.”

“Health Cost Containment and Efficiencies: Accountable Care Organizations,” National Conference of State Legislatures, NCSL Briefs for State Legislatures, No. 5, May 2010.

Cost for Patients Controlling Healthcare Costs

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Cost for Patients Value Metrics for Accountable Care

• Value is the expectation of future economic benefit

• In healthcare value has two components:

o Value to Society: future benefit to the population as a whole

o Value to Providers: emphasizes economic returns to individual enterprises, assets, and services

“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations and Medicare Program: Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center; Proposed Rule and Notice” Federal Register, Vol. 76, No. 67 (April 7, 2011), pg. 19531

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“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations and Medicare Program: Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center; Proposed Rule and Notice” Federal Register, Vol. 76, No. 67 (April 7, 2011), pg. 19531; “Investors Not Likely to Provide ACO Funding Under Proposed Rule, Venture Capitalist Says” By Sara Hansard, Bureau of National Affairs, Health Law Reporter, Vol. 20, No. 1026, 2011.

Value to Society

Better outcomes for individuals and populations accompanied by lower

growth in expenditures

Quality of care can be measured through patient outcomes metrics (i.e. average

length of stay; number of readmissions; and, patient satisfaction surveys.)

Value to Providers

Shared Savings Payments; Better Medicare Reimbursement; Greater

Market Power

Measured through provider expectations regarding financial returns; practice value;

lower practice expenditures (achieved through administrative efficiency, coordinating patient

care, and better patient outcomes.)

Cost for Patients Value Metrics for Accountable Care

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Providers vs. Patients Costs

An ACO’s value, either to society or to providers, must be weighed against the prospective costs

“Rising Healthcare costs may be Impervious to Courts, Regulators” By Philip Betbeze, HealthLeaders Media, July 1, 2011, http://www.healthleadersmedia.com/print/LED-268129/Rising-Healthcare-Costs-May-be-Impervious-to-Courts-Regulators (Accessed 7/1/2011).

Provider Positives

• Possible lower practice costs from increased efficiency

• Greater market (negotiating) power

• Possible shared savings payments

Patient Positives

• Better quality care

• More convenient care

• Possibly fewer physician visits

Provider Negatives

• Lower patient volumes equals lower FFS payments

• High IT costs

• High capital costs

Patient Negatives

• Greater power of providers tends to lead to larger costs for patients

• Confusing beneficiary assignment

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IMPACT OF ACOs

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The Four Pillars of the Healthcare Industry

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SCOTUS Decision

• June, 28, 2012, the Supreme Court of the United States (SCOTUS) handed down its decision which upheld most of the 2010 healthcare reform act, the Patient Protection and Affordable Care Act (ACA)

• This opinion held that the individual mandate was constitutional, relying on a narrow interpretation of Federal taxing authority

• One ACA provision was modified by the ruling; this modification stipulates that Medicaid expansion in the states is no longer mandatory and that states can decide not to receive the expansion with no Federal penalty

• The Court’s 5 to 4 ruling to uphold the Law will allow ACOs and most of the provisions of the reform law to continue implementation as was planned

"National Federation of Independent Business v. Sebelius" Nos. 11-393, 11-398 and, 11-400, 2012 BL 160004 (U.S. June 28, 2012).

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Distinguishing Between Federal and Commercial Markets

Four Pillars Federal ACO Commercial ACOs

Regulatory

Regulated by the MSSP Must be compliant with the same rules as non-ACO

providers

Waivers for Stark Law, Anti-kickback, and CMP As of yet, not eligible for CMS, DOJ, FTC waivers.

Guidelines and policies available for antitrust

Accredited by NCQA Standards Accredited by NCQA Standards

Reimbursements

Reimbursed through FFS Reimbursements range from FFS to single capitation

models

Shared Savings under two disbursement options. Any number of value-based purchasing agreements

(to be negotiated between ACO and payor)

Shared risk based on whether benchmarks are met

(only for two sided option) leading to possible

shared losses

Shared risk located within overall reimbursement (i.e.,

capitated payment) or as shared losses (less common

for commercial)

Shared savings only for Medicare population Shared savings for negotiated population

Competition

Medicare beneficiaries not required to stay within

the ACO, leading to competition

Population may or may not go outside of the ACO

depending on the payor contract.

Technology Doesn't require EHR, but requires sophisticated

data gathering

Doesn't require EHR, but requires sophisticated data

gathering

Some payors help implement telecommunications

within the ACO

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Regulatory Considerations

• Federal Anti-Kickback Statute (AKS)

• Federal Physician Self-Referral Law (Stark Law)

• Federal Civil Monetary Penalty (CMP)

• Federal Antitrust Law

• Federal Tax Law

• State Regulations o Antitrust

o Fraud and Abuse

o False Claims

o Corporate Practice of Medicine

o Insurance Law

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“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations and Medicare Program: Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center; Proposed Rule and Notice” Federal Register, Vol. 76, No. 67 (April 7, 2011).

Definition

Prohibition against soliciting, receiving, or paying remuneration in exchange for the referral healthcare service billed to Medicare, Medicaid,

or any other federal healthcare program

ACO Implication

Current safe harbors to potentially shield ACOs from possible violations

include:

(1) Direct employment;

(2) Co-management arrangements; and,

(3) Gainsharing

Regulatory Considerations Federal AKS

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“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations and Medicare Program: Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center; Proposed Rule and Notice” Federal Register, Vol. 76, No. 67 (April 7, 2011).

Definition

Prohibition against physician referrals to providers of

Designated Health Services (DHS) with whom the referring physician

has a financial relationship

ACO Implication

Compliance with the AKS and Stark may be waived, “as may be necessary,”

to conduct:

(1) Any payment model for ACOs that the Secretary determines will

improve the quality and efficiency of items and services furnished under

the Medicare program

(2) The bundled payment/episode of care pilot

Regulatory Considerations Federal Stark Law

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“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations and Medicare Program: Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center; Proposed Rule and Notice” Federal Register, Vol. 76, No. 67 (April 7, 2011).

Definition

Civil penalties against hospital payments to physicians for:

(1) Reducing length of stay;

(2) Reducing readmission rates; and,

(3) Other forms of fraud and abuse

ACO Implication

HHS has provided a waiver similar to those given for Stark Law and the AKS

Regulatory Considerations Federal Civil Monetary Penalties

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Definition

Integration between providers coordinating care may cause

nonprofit, tax exempt providers and for profit,

taxable entities, to merge

ACO Implication

Tax-exempt participants in ACOs should be able to remain that way as long as ACO furthers

charitable purposes

Regulatory Considerations Federal Tax Law

“Accountable Care Organizations: Promise of Better Outcomes at Restrained Costs; Can They Meet Their Challenges?” By C. Frederick Geilfuss and Renate M. Gray, BNA’s Health Law Reporter, Vol. 19, no. 956 (July 8, 2010); “Herding Cats? What Health Care Reform Means for Hospital-Physician Alignment and Clinical Integration,” By Daniel H. Melvin and Chris Jedrey, McDermott, Will & Emery (October 13, 2010), p.38.

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Definition

Sherman Act, Section 1 prohibits contracts, combinations and conspiracies that

unreasonably restrain trade

Applies to independent, competing providers

Does not apply to:

(1) Physicians all within the same group

(2) A hospital and its full-time, employed physician

(3) A hospital and its controlled subsidiaries

ACO Implication

FTC and DOJ released proposed rules governing mandatory antitrust

monitoring, based on the percentage of market share an ACO has for any

specific service line

Regulatory Considerations Federal Antitrust

“Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Saving Program” 76 FR 75 (April 19, 2011), p. 21895.

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“Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program" 76 FR 209 (October 28, 2011), p. 67028-67030.

No Risk – “Safety Zone”

1. ACO participants provide 30 percent or less of a specific service within a single ACOs PSA 2. No participating hospitals of ASCs work exclusively with a single ACO

3. Dominant Provider Limitation – A “dominant provider” (any ACO including a participant with more than 50 percent share of a specific service in a PSA) within the ACO must be in a non-exclusive relationship, where the ACO does not restrict their ability to contract/deal with other ACOs or provider networks. Will not lose “safety zone” status solely because it attracts more patients.

Optional Risk

• ACOs that are outside the safety zone, but are not defined as high risk, may obtain an optional review.

• ACO does not impede the functioning of a competitive market will not raise competitive concerns.

• If they are found in violation of antitrust guidelines, they will be prohibited from entering the MSSP program.

High Risk – Mandatory

Review

• ACO has greater than 50 percent share of a specific service within a single provider’s PSA (Note: If threshold is met due to a rural facilities, the Rural Exception is triggered and ACO may be in no-risk “safe zone”.)

• Must obtain permission to participate in MSSP

Regulatory Considerations Federal Antitrust

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Regulatory Considerations State Laws

• State “Corporate Practice of Medicine” (CPOM) laws prohibit the practice of medicine or the employment of physicians by business corporations

• A variety of care models and structures for hospital-physician relationships have been developed to comply with state statutes, which may not fit easily with the structure or goals of an ACO

• CPOM laws could prevent some ACOs from hiring physicians to work directly with provider participants in managing and better coordinating the provision of health services

“AAMC Statement on Legal Issues Related to Accountable Care Organizations (ACOs) and Healthcare Innovation Zones (HIZs),” Association of American Medical Colleges, October 5, 2010, https://www.aamc.org/download/151426/data/aamc_comment_on_legal_issues_related_to_accountable_care_organi.pdf (Accessed 09/14/2011); “Toolkit”, Accountable Care Organization Learning Network, The Brookings Institute;2010,http://www.nachc.com/client/documents/ACOToolkitJanuary2011.pdf#page=6 (Accessed 9/14/2011); “Accountable Care Organizations in California: Programmatic and Legal Considerations” By: William S. Bernstein et al., California HealthCare Foundation, July 2011, http://www.chcf.org/~/media/MEDIA%20LIBRARY%20Files/PDF/A/PDF%20ACOProgrammaticLegalConsiderations.pdf (Accessed 09/14/2011)

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Regulatory Considerations State Regulation

• Physician-self referral, anti-kickback, or related fraud and abuse laws

• Private Inurement/Private Benefit Issues

o 501(c)(3) organizations cannot be organized or operated for the benefit of private interests

• State Insurance Laws

o Some states require that health care providers assume financial risks, and that employer groups be regulated as health insurers

Can entail risk-based capital reserve requirements and other state law obligations, making it difficult for provider organizations (and ACO components) to enter into risk-sharing agreements

“AAMC Statement on Legal Issues Related to Accountable Care Organizations (ACOs) and Healthcare Innovation Zones (HIZs),” Association of American Medical Colleges, October 5, 2010, https://www.aamc.org/download/151426/data/aamc_comment_on_legal_issues_related_to_accountable_care_organi.pdf (Accessed 9/14/2011); “Toolkit”, Accountable Care Organization Learning Network, The Brookings Institute, 2010, http://www.nachc.com/client/documents/ACOToolkitJanuary20111.pdf#page=6 (Accessed 9/14/2011).

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Regulatory Considerations Fair Market Value and Commercial Reasonableness

• ACOs involve coordinated care covering a variable and wide range of services

o Quantifying opportunity cost and other marginal costs incurred by physicians during a transition to an ACO

o Determining the Fair Market Value attributable to the savings that accrue from this new system (which may result in compensation to physicians) may be difficult

• Proposed Stark Law waiver: shared savings earned by ACOs is not subject to FMV and commercially reasonable scrutiny

AAMC Statement on Legal Issues Related to Accountable Care Organizations (ACOs) and Healthcare Innovation Zones (HIZs),” Association of American Medical Colleges, October 5, 2010, https://www.aamc.org/download/151426/data/aamc_comment_on_legal_issues_related_to_accountable_care_organi.pdf (accessed 09/14/2011); “The Proposed Waivers of the Fraud & Abuse Laws for ACOs: Have OIG and CMS Gone Far Enough?, By Daniel Melvin and Webb Millsaps, McDermott Will & Emery, http://www.mwe.com/info/news/wp0511b.pdf (Accessed 09/14/2011).

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Reimbursement Considerations Medicare Reimbursement vs. Operating Costs

-10%

0%

10%

20%

30%

40%

2001 2002 2003 2004 2005 2006 2007 2008 2009

Operating Cost

per FTE Physician

for Multispecialty

Practices1

Annual Consumer

Price Index (CPI)2

Medicare

Reimbursement3

1. “Cost Survey for Multispecialty Practices”, 2010 Report Based on 2009 Data, Medical Group Management Association;“ Cost Survey for Multispecialty Practices”, 2009 Report Based on 2008 Data, Medical Group Management Association.

2. “Consumer Price Index” U.S. Department of Labor, Bureau of Labor Statistics, Washington D.C., ftp://ftp.bls.gov/pub/special.requests/cpi/cpiai.txt, (Accessed 8/9/2011). 3. “History of Medicare Conversion Factors” American Medical Association, http://www.ama-assn.org/ama1/pub/upload/mm/380/cfhistory.pdf (Accessed 8/9/2011).

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Reimbursement Considerations Hospitals

• Large health systems may be in best position to form ACOs

o Attract more PCPs

o Vertical Integration will likely aid in transition to ACO

o May easily meet quality requirements

o Greater access to capital and IT requirements

• Potential Hurdles: o May need to lower cost or increase private insurers’

cost to generate shared savings “Investors Not Likely to Provide ACO Funding Under Proposed Rule, Venture Capitalist Says” By Sara Hansard, Bureau of National Affairs, Health Law Reporter, Vol. 20, No. 1026, 2011; “Quality over Quantity” By Bryn Nelson, The Hospitalist (December 2009), www.the-hospitalist.org/details/article/477391/quality_over_quantity.html, (Accessed 2/28/11).; “Will Mayo Clinic save money as an ACO?” By Christopher Snowbeck and Don McCanne, Physicians for a National Health Program (February 8, 2011), www.pnhp.org/print/news/2011/february/will-mayo-clinic-save-money-as-an-aco, (Accessed 2/28/11).

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Reimbursement Considerations Physician Practices

Increasing hospital - physician alignment

“ACOs can work with physicians in charge” By Victoria Stagg Elliott, American Medical News (January 31, 2011), www.ama-assn.org/amednews/2011/01/31/bisa0131.htm, (Accessed 2/7/11).

Good for Physician • High Overhead and decreasing reimbursements

make practices expensive • Steady Salary and Benefits • Regulatory Buffer • Work-Life Balance • Less financial risk

Good for Hospital • More market power / market share • Clinical integration • ACO participation

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Reimbursement Considerations ASCs & Outpatient Providers

• Requires linking clinical and cost systems to the ACO’s information on the patient population through the implementation of electronic health record (EHR) system (Note: expensive proposition as there are no “meaningful use” subsidies for ASCs)

• Volume of services for ASCs may actually increase as providers look for ways to decrease hospital costs, depending on how ACOs react to the incentive to decrease costs

“Surgery Centers Play an Important Role in ACOs” By Andrew Hayek, Surgical Care Affiliates (January 3, 2011), www.beckersasc.com(Accessed 1/21/11). “4 Ways ACOS Could Affect ASCs” By Leigh Page, Becker’s ASC Review (December 20, 2010); “Accountable Care Organizations: Implications for Ambulatory Surgery Centers” By Healthcents (January 25, 2011), p. 26, 29.

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Reimbursement Considerations Medical Homes

• ACA does not include section specific to Patient-Centered Medical Homes (PCMH), but PCMH’s are promoted throughout health reform legislation

• PCMHs may likely be stepping stone to the formation of an ACO infrastructure

• PCMH structure: team-based model that is run by primary care physicians who are in charge of providing a continuum of care for all aspects of healthcare throughout a patient’s life.

o Requires streamlined infrastructure

• PCMH primary goal: coordinate the care of a patient while reducing unnecessary duplication of services and therefore increasing cost of care

“New Payment and Delivery Models Under Health Reform Require New Relationships Between Physicians and Hospitals” By Janice A. Anderson and Heidi R. Shaw, BNA’s Health Law Reporter, Vol. 19, no. 1612 (November 18, 2010).

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Reimbursement Considerations Ancillary Providers and Allied Health Practices

• ACA restricts qualified ACO participants to mid-level providers and practitioners, leaving ancillary providers and allied health practices out

• Push for ACO inclusion:

o Physical Therapists: CMS should designate PTs as “ACO Professional” in ACA

o Chiropractors: Using chiropractors in regular patient care cut down on hospitalizations dramatically

o Pharmacists: Including pharmacists in patient-care teams improve health care quality through direct care from pharmacists

o Radiologists: May share too much of the risk associated with shared savings and not enough of the savings

“APTA Response to CMS’ Request for Information Regarding ACOs” By R. Scott Ward, American Physical Therapy Association (December 3, 2010). “ACA Response to CMS’ Request for Information Regarding ACOs” By Rick McMichael, American Chiropractic Association (November 29, 2010). “Integrating Pharmacists into Accountable Care Organizations and Coordinated Care” By National Community Pharmacists Association (December 7, 2010). “Special Report: ACOs and imaging” By Brendon Nafziger, DotMed.com (October 21, 2010), www.dotmed.com’legal/print/story.html?nid+14573, (Accessed 1/31/11).

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Reimbursement Considerations Impact on Payers

Private Insurance

• Primary Concerns: o Increased market power by providers leading to increased

charges to private insurers o Insufficient accountable care progress for ACOs contracting

with health systems • Contracts move away from FFS reimbursement models

hoping to achieve cost and clinical efficiencies

Government • Goal to reduce Medicare spending • Congressional Budget Office CBO estimates ACOs will save

Medicare $4.9 billion through 2019, (1% of spending)

“Insurers, Healthcare Providers Spar Over ACO Regulations” By Lindsey Dunn, Beckers Hospitals Review (January 10, 2011). “Monopolies Threaten Health Care Cost Controls” By Merrill Goozner, The Fiscal Times (February 3, 2011), http://www.thefiscaltimes.com/Articles/2011/02/03/Monopolies-Threaten-Health-Care-Cost-Controls.aspx, (Accessed 3/2/11). “Insurers Work With Providers On Crucial ACO Components” ACO Business News, Vol. 1, No. 1, November 2010, p. 5.

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Competition Considerations Porter’s Five Forces

Competitive Rivalry

within an Industry

Bargaining Power of Providers

Bargaining Power of Patients

Threat of New

Entrants

Threat of Substitutes

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Technology Considerations

• Electronic Medical Records

o Significant cost

o Help eliminate silos and increase continuity of care

o Meaningful use standards

• The technological impacts on providers choosing to participate in an ACO are rooted in the primary issue of purchasing or updating an EHR system

o Costly

o Must meet meaningful use standards to be eligible for savings

• EHR integration and alignment among ACO participants is critical to ensure benefits of HIT utilization are obtained

“Technology Fundamentals for Realizing ACO Success”, Medicity, September 2010, http://www.himss.org/content/files/Medicity_ACO_Whitepaper.pdf, (Accessed June 30, 2011).

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Federal ACO Timeline

“Improving Incentives in the Medicare Program” Medicare Payment Advisory Commission, June 2009, pg. 39-57; “Proposed Rule Versus Final Rule for Accountable Care Organizations (ACOs) In the Medicare Shared Savings Program” Centers for Medicare & Medicaid Services. https://www.cms.gov/ACO/Downloads/Appendix-ACO-Table.pdf (Accessed 12/28/11); “Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations” Federal Register Vol. 76 No. 67 (April 7, 2011); “Medicare Program: Medicare Shared Savings Program: Accountable Care Organizations” Federal Register Vol. 76 No. 212, (November 2, 2011); “Patient Protection and Affordable Care Act” 124 Stat. 119, March 23, 2010; “Pioneer Accountable Care Organization Model: General Fact Sheet,” Center for Medicare and Medicaid Services, December 19, 2011; “Fact Sheet: CMS Names 89 New Medicare Shared Savings Accountable Care Organizations”, CMS Office of Public Affairs, July 9, 2012, http://www.cms.gov/apps/media/press/factsheet. (Accessed on 7/12/12).

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CONCLUDING REMARKS

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Concluding Remarks

• Even with 89 Federal ACOs, the MSSP still projects theoretical savings, and very real costs. Providers looking to transition to an ACO are more prevalent in the commercial market

o Some insurers negotiating ACO-like contracts include: BCBS MA (the alternative quality contract), Aetna, Human, and Wellpoint

• To succeed, ACOs will need what managed care lacked: public understanding, payor support, partnerships between physicians and hospitals, up-front financial resources, and time for integration

“Accountable Care Organizations: Whatever Its Growing Pains, The Concept is Too Vitally Important to Fail” By Francis J. Crosson, Health Affairs, Vol. 30, No. 7, July 2011, p. 1250-1255.

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Concluding Remarks

“Love everyone, trust no one, and paddle your own canoe.”