Antitrust Issues in the Managed Care World Matthew Roberts Tim Hewson

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Antitrust Issues in the Managed Care World Matthew Roberts Tim Hewson MRoberts@NexsenPruet.com THewson@NexsenPruet.com July 15, 2010 Society of Managed Care Professionals

Trends in Health Care Industry Integration / Consolidation of Hospital Systems Physician / Hospital Integration Consolidation / Integration of Payors

Impact of Health Care Reform Hospitals, physicians and other health care providers being encouraged and incentivized to work more closely together More Government and public focus on cost of health care What does it cost? Who is paid what? Who makes what?

Why Talk About Antitrust? Health Care Reform Encourages Provider Collaboration 1. Accountable Care Organizations 2. EHR Incentives 3. Market Reaction to Reform: Greater Integration Among Providers KEY: Anytime competitors combine or agree (that is, cooperate and integrate), antitrust laws must be considered.

Basics of Antitrust Purpose Protect competition Promote low prices, high output, high quality and efficiency Antitrust laws protect competition not competitors Challenged conduct must adversely affect market-wide competition and consumers Increased effect on market power increases chances of anti-competitive effect

Basics of Antitrust Types of Antitrust Problems Collusion: Consumers are direct target e.g. price fixing arrangements Exclusion Direct targets are competitors and consumers are indirect targets e.g., refusal to deal

Antitrust Statutes Sherman Antitrust Act (enacted 1890) Section 1 Prohibits agreements unreasonably restraining competition every contact, combination in the form of trust or otherwise, or conspiracy in restraint of trade or commerce among the several states.is hereby declared illegal. Practices that are per se illegal» Price fixing» Market allocation» Boycotts» Civil and Criminal Statute - Penalties Section 2 Prohibits monopolization, attempted monopolization, and conspiracies to monopolize.

Antitrust Statutes Clayton Act Section 7: Prohibits all types of acquisitions that may substantially lessen competition. The Robinson Patman Act: Prohibits certain discriminations in pricing and services. Section 5 of the Federal Trade Commission Act: Prohibits unfair methods of competition and applies to persons, partnerships, or corporations organized to carry on business for their own profit or that of their members.

Antitrust Enforcement Antitrust laws are enforced by: The antitrust division of the United States Department of Justice The Federal Trade Commission State attorneys general Private parties injured by antitrust violations

Current Issues in Antitrust Government Enforcement Obama Administration: During his campaign President Obama promised increased focus on antitrust enforcement. He has fulfilled that promise. Introduced pro-enforcement leadership at DOJ Antitrust Division

Current Issues in Antitrust Christine Varney head of DOJ Antitrust Division: Former FTC commissioner Condemned passive antitrust enforcement under Bush Administration As FTC commissioner, opposed legislation that would grant physicians immunity to collectively set fees and receive immunity for boycotts or price-fixing as long as it promotes quality Health care will be a focus

Current Issues in Antitrust Recent DOJ Activities Repudiated lenient monopolization enforcement policy from the Bush Administration and promised vigorous healthcare antitrust enforcement Collected $1 billion in criminal fines FY 09; in addition convicted an antitrust violator to an unprecedented 48 month sentence Recent FTC Activities Brought price-fixing charges against Alta Bates Medical Group, Inc., a 600-physician independent practice association for fixing prices charged to health care insurers and unlawful concerted refusal to deal, defendants settled Brought price-fixing charges against Roaring Fork Valley Physicians IPA for price fixing against health insurers. Roaring Fork agreed to halt is alleged anticompetitive activities

Current Issues in Antitrust Congressional Activities Amendment of False Claims Act expands liability to third parties who do not deal directly with the government. Many antitrust claims involving sales to the government also include FCA allegations. Members of U.S. Senate Judiciary have threatened a repeal of the McCarran- Ferguson Act (insurers exemption from certain antitrust laws).

Current Issues in Antitrust Government tolerates certain behavior ordinarily viewed as anti-competitive, but only to effectuate legitimate purposes of a Joint Venture Where purported efforts to integrate are principally a vehicle for obtaining and exploiting market power or simply a subterfuge for price fixing, then FTC and DOJ will take action to protect competition and consumers. - Christie A. Varney, May 24, 2010 Speech to ABA/AHLA Antitrust in Healthcare Conference (emphasis added)

Two Types of Integration for Healthcare JVs Financial Integration Clinical Integration

Financial Integration KEY: Sharing of Substantial Financial Risk Capitated payment by JV Provision of services by JV for percentage of premiums or revenues for a plan Use by JV of significant financial incentives for GROUP to achieve specific cost containment goals. Incentives include: Withholds administered by JV Financial rewards or penalties administered by plan Agencies: New type of risk sharing arrangements may develop. Use expedited business review/advisory opinion process if uncertain if your venture has sufficient financial risk sharing.

Clinical Integration Active and ongoing program to evaluate and modify practice patterns by the network s physician participants and create a high degree of interdependence and cooperation among the physicians to control costs and ensure quality. 1996 FTC/DOJ Statements on Healthcare Antitrust Enforcement Policy FTC has approved 4 clinically integrated physician networks: TriState Health Partners, Inc. (2009) Greater Rochester Independent Prac. Assoc. (2007) MedSouth, Inc. (2002, 2006) Suburban Health Organization (2002)

Current Issues in Antitrust Electronic Health Records (EHR) provide an ideal platform to develop a clinical integration plan.» Stimulus bill includes substantial financial incentives for providers to implement EHR. - $2 mill + enhanced Medicare reimbursement for hospitals - $44,000 for physicians» EHR will help meet the guidelines for Clinical Integration Legislative Assistance Federal: Congress has considered bills that would permit physicians and other providers to bargain collectively with payers. States: Texas has enacted a similar provision to allow providers to bargain collectively. Other states including NJ, Washington and NY have considered similar provisions.

Current Issues in Antitrust Conflicting Messages Two Dynamics: Quality vs. Price-fixing Quality: Health Reform and Stimulus bills both put an emphasis on providers working together to improve the quality of care for patients. Price-fixing: Government is also keenly focused on prosecuting and eradicating pricefixing and other anti-competitive behavior amongst providers. This enforcement focus limits providers ability to work together. Which policy position will ultimately win the day?

Methods for Providers to reduce antitrust risks Qualify for an Antitrust Safety Zone 1996 Statements of Antitrust Enforcement Policy in Health Care Issued jointly by DOJ and FTC: provides guidance to providers in 9 statements. Statements 4-6, 8 & 9 are applicable to managed care. Qualify for Rule of Reason Analysis Obtain Advisory Opinion Business Review Letter SC Certificate of Public Advantage (COPA) Be careful about statements of purpose and all forms of communications

Antitrust Safety Zones Statement 4: Provider s Collective Provision of Non-Fee Related Information to Purchasers of Health Care Services (MCOs) Medical Data provided collectively by Providers to MCOs to help resolve issues related to mode, quality, or efficiency of treatment: Example: State medical society collects from its members outcome data about a particular procedure that they believe should be covered and provides information to MCOs. Medical Data intended to assist providers with clinical decision making (Clinical Protocols).

Antitrust Safety Zones Statement 5: Providers collective provision of fee info to MCO Allows providers to collectively provide MCOs factual information concerning Current or historical fees Reimbursement Methods Accepted 3 Standards: 3d Party manages collection No sharing of current or future fees among competing providers If collective data is made available to providers furnishing individual data then:» At least 5 Providers» No Single Provider s data is more than 25% of Collective Data» The way the Collective Data is presented cannot allow an individual provider to determine current prices of its competitors

Antitrust Safety Zones Statement 6: Providers exchange of price and cost info Competing providers participate in surveys of prices for healthcare services or surveys on compensation Can be procompetitive by enabling providers to price services competitively and to pay competitive compensation Safety Zone standards same as Statement 5

Antitrust Safety Zones Statement 8: Physician Network Joint Ventures (PNJV) Exclusive or Non-exclusive: Exclusive PNVJ won t be challenged if:» Physicians share substantial financial risk» the network constitutes 20% or less of the physicians in each physician specialty with active hospital staff privileges who practice in the relevant local geographic market Non-exclusive won t be challenged if:» Physicians share substantial financial risk» the network constitutes 30% or less of the physicians in each physician specialty with active hospital staff privileges who practice in the relevant local geographic market

Rule of Reason Analysis Rule of Reason: will the network have substantial anticompetitive effect, and, if so, will that potential effect be outweighed by any procompetitive efficiencies resulting from the joint venture? Analysis takes into account: Define the relevant market Evaluate the competitive effects of the joint venture Evaluate the impact of the procompetitive efficiencies Evaluate any collateral agreements Financial and Clinical Integration efforts should trigger RoR analysis

Advisory Opinions / Business Review Letters Advisory Opinion Requests are submitted to FTC (16 C.F.R. 1.1-1.4) Requests should be submitted in writing (one original and two copies to the Secretary of the Commission) State the question clearly Cite the provision of law under which the question arises Hypothetical questions will not be answered Business Review Letter requests are submitted to the DOJ (28 C.F.R. 50.6) Requests must be submitted in writing to the Assistant Attorney General, Antitrust Division, Dept. of Justice, Washington, DC 20530 Requesting party must make a full and true disclosure of the business conduct Request must be accompanied by all relevant data DOJ will also conduct any independent investigation it deems appropriate Obtaining Advisory Opinions can be a lengthy and costly process Process typically entails at least a 90-day review period prior to agency issuing its guidance

In South Carolina obtain Certificate of Public Advantage (COPA) DHEC may grant approval to agreements that may be prohibited by federal and state antitrust laws where it determines that such agreements are beneficial to South Carolinians Currently Palmetto Health and Regional Health Plus have COPAs DHEC monitors COPA projects

Antitrust Enforcement Trends Possible areas of activity Review most favored nation concepts Use of Civil Investigative Demands (CID s) against trade associations