Section 2706 of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 ("PPACA" or the "Act") authorizes physicians, hospitals and other health care providers to form Accountable Care Organizations ("ACOs") to work together to manage and coordinate care for Medicare beneficiaries for purposes of the Act's Medicare Shared Savings Program. Under that program, participating providers meeting certain criteria defined by the Centers for Medicare and Medicaid Services ("CMS") may qualify to share savings they create under the Medicare program. Given the time and resources required to form and operate ACOs, however, it is anticipated that participating providers will use the same ACOs for commercially insured patients as well.
The Federal Trade Commission ("FTC") and Department of Justice ("DOJ," collectively the "Agencies") recognize that ACOs may result in innovations and other benefits for both Medicare and commercially insured patients, but also that the increased provider consolidation resulting from the formation of ACOs may have anticompetitive effects. To balance these concerns, on October 20, 2011, the same date on which CMS issued final rules regarding the formation of ACOs, the Agencies issued their Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (the "Policy Statement" or "Statement"), "to ensure that health care providers have the antitrust clarity and guidance needed to form procompetitive ACOs that participate in both the Medicare and commercial markets."
The Policy Statement addresses the criteria ACOs qualifying for the Shared Savings Program must meet to be considered sufficiently integrated by the Agencies to engage in joint price negotiations with commercial health plans (referred to in the Statement as "private payers"), and other joint activity, without being liable for per se violations of the Sherman Act. In addition, the Statement sets out criteria for how ACOs representing various shares of services in participating providers' "primary services areas" will be evaluated by the Agencies "under the rule of reason". This includes defining a new safety zone for networks that do not represent more than 30 percent of any health care service, even if the network is exclusive as to physician services.
On the whole, the Policy Statement will give providers greater leeway than the 1996 FTC/DOJ Statements of Antitrust Enforcement Policy in Health Care ("1996 Health Care Statements" or "Health Care Statements"), to form consolidated networks with the potential to exercise market power in negotiating with health plans. Further, the Statement will require health plans to be proactive in alerting the Agencies to newly forming ACOs that are potentially anticompetitive as well as existing ACOs that are engaging in anticompetitive behavior.
The Policy Statement applies to ACOs that are eligible and intend to be, or have been, approved by CMS to participate in the Shared Savings Program. While the Statement applies to a variety of forms of collaboration between otherwise independent providers used to form an ACO (e.g., a joint venture), it does not apply to mergers, which will continue to be evaluated under the DOJ and FTC Horizontal Merger Guidelines ("Merger Guidelines"). In order to qualify for the Shared Savings Program, ACOs must sign up with CMS to participate for at least three years beginning in 2012.
Summary of Policy Statement Provisions
In general, joint pricing agreements among competitors are treated as per se illegal under Section 1 of the Sherman Act. However, a joint pricing agreement among competing health care providers is evaluated under the rule of reason—under which the potential procompetitive benefits of the agreement are weighed against its potential anticompetitive effects—if the providers are financially or clinically integrated, and the agreement is reasonably necessary to accomplish the procompetitive benefits of that integration.
Under the 1996 Health Care Statements, the Agencies defined specific types of financial integration, or risk sharing, such as entering into capitated contracts or withholding a substantial portion of provider compensation (e.g., 20 percent), that would be paid only if the participating providers as a group met certain cost containment goals; the Health Care Statements also acknowledged that other types of financial integration might be sufficient. In addition, the Health Care Statements described general criteria for sufficient clinical integration, including that the providers implement an ongoing program to evaluate and monitor practice patterns and to create a high degree of interdependence among the providers to control costs and quality, but the Health Care Statements did not provide specific criteria for clinical integration; rather, FTC staff advisory opinions discussed evidence sufficient to meet these requirements in specific circumstances. See FTC advisory opinions at http://www/ftc/gov/bc/healthcare/industryguide/advisory.htm#2010.
In the Policy Statement, the Agencies have taken a different approach by agreeing to accept CMS eligibility criteria for the Shared Savings Program as sufficient to demonstrate initially that ACOs are clinically integrated for purposes of qualifying for rule of reason treatment.1 PPACA Section 3022 provides that CMS may approve ACOs that meet certain eligibility criteria, including (1) a formal legal structure that allows the ACO to receive and distribute payments for shared savings; (2) a leadership and management structure that includes clinical and administrative processes; (3) processes to promote evidence-based medicine and patient engagement; (4) reporting on quality and cost measures; and (5) coordinated care for beneficiaries. The Statement also provides that if a CMS-approved ACO uses the same governance and leadership structure and the same clinical and administrative processes it uses in the Shared Savings Program in the commercial market, these integration criteria are sufficient to support rule of reason treatment for ACO agreements with commercial payers as well. Factors (1) and (2) do not have any apparent competitive characteristics of antitrust significance; factors (3)-(5), however, appear to be a proxy (albeit a regulatory one) for the more traditional antitrust analysis that would determine whether a joint venture is financially or clinically integrated.
B. Rule of Reason Treatment for ACOs Meeting CMS Eligibility Criteria
Under the Policy Statement, the FTC and DOJ have divided ACOs that meet CMS eligibility requirements for the Shared Savings Program, and therefore are treated as clinically integrated, into two categories for purposes of rule of reason treatment based on the share of services the ACO has in the primary service areas or "PSAs" of participating providers. These include (1) an antitrust safety zone for ACOs that do not exceed 30 percent of any PSA share threshold; and (2) additional guidance and voluntary Agency review for ACOs that exceed this 30 percent threshold or are otherwise outside of the safety zone.2
1. Antitrust Safety Zone
For an ACO to fall within the safety zone, participating providers that provide a "common service" must have a combined share of 30 percent or less of each common service in each participant's PSA.3 For physicians, this threshold applies regardless of whether they participate in the ACO on an exclusive or non-exclusive basis. (In contrast, in Statement No. 8 of the 1996 Health Care Statements (Physician Joint Ventures), the antitrust safety zone for physician networks applied a 20 percent threshold to exclusive networks, and a 30 percent threshold to non-exclusive networks; the Health Care Statements also limited the safety zone to networks meeting the requirements for financial integration.) In addition, any participating hospital or ambulatory surgery center ("ASC") must contract with the ACO on a non-exclusive basis, regardless of whether the PSA shares of competing hospitals or ASCs for any common service are 30 percent or below. There are two exceptions to these criteria:
2. ACOs Outside the Safety Zone
The Policy Statement acknowledges that an ACO that is outside the safety zone frequently may be procompetitive, but also has the potential to have anticompetitive effects. Therefore, it describes certain types of conduct such an ACO should avoid to reduce the likelihood that it will be investigated and found to be anticompetitive. The Statement also describes how an ACO can obtain additional guidance from the Agencies, as well as how the Agencies will monitor the competitive performance of ACOs in the Shared Savings Program.
a. Conduct to Avoid
i. Improper Sharing of Competitively Sensitive Information
Regardless of whether an ACO has a high market share or other indicia of market power,6 significant competitive concerns can arise if the ACO's operations lead to price fixing or other collusion among ACO participants in their sale of services outside the ACO. For example, sharing competitively sensitive data, including pricing information, among ACO participating providers could facilitate collusion on prices other terms for their non-ACO business. To avoid these concerns, the Policy Statement recommends that the ACO implement appropriate firewalls or other safeguards against such collusion.7
ii. Conduct by ACOs with High PSA Shares or Other Possible Indicia of Market Power That May Raise Competitive Concerns
For ACOs with high PSA shares or other indicia of market power, the Agencies identify four types of conduct that may raise competitive concerns. The Policy Statement notes that whether these activities actually raise concerns will depend on each ACO's circumstances, including whether the ACO has market power (i.e., concerns will be greater the fewer the number of competing ACOs and/or the number of physicians available to participate in competing ACOs). The four types of conduct are:
b. Availability of Expedited Voluntary Agency Review
A newly formed ACO (i.e., an ACO formed after March 23, 2010) that wants additional guidance can seek expedited 90-day review from the Agencies regarding whether the ACO's formation and planned operation is likely to harm competition. The ACO should submit its request for review to both Agencies prior to entering into the Shared Savings Program, after which the ACO will be told which of the Agencies will conduct the review. To start the 90-day review period, the reviewing Agency must receive certain documents and information.8 In addition, to the extent possible during the 90-day review period, the reviewing Agency will consider factors in the rule of reason analysis contained in the 2000 FTC and DOJ Antitrust Guidelines for Collaborations Among Competitors and the 1996 Health Care Statements (e.g., market share, market concentration, exclusivity, entry, etc.) Within 90 days of receiving the relevant information, the reviewing Agency will advise the ACO whether it (1) does not likely raise competitive concerns, (2) potentially raises competitive concerns, or (3) likely raises competitive concerns.9 Consistent with existing practice, if it appears the ACO's formation or conduct may be anticompetitive, the Agency may investigate the ACO and, if appropriate, take enforcement action at any time before or during the ACO's participation in the Shared Savings Program.
c. Agency Monitoring
The Agencies will monitor the competitive effects of ACOs based on data provided by CMS. Specifically, CMS will provide the Agencies with aggregate claims data regarding allowed charges and fee-for-service payments for all ACOs accepted into the Shared Savings Program, as well as copies of all applications to the program by ACOs formed after March 23, 2010. Further, the "Agencies will vigilantly monitor complaints about an ACO's formation or conduct and take whatever enforcement action is appropriate."
As noted above, the Policy Statement relaxes a number of key provisions of the 1996 Health Care Statements regarding safety zones, including not requiring financial integration for safety zone treatment, deferring to CMS on what constitutes sufficient clinical integration, permitting exclusive networks with up to 30 percent of the share of services in a geographic area, and permitting ACOs with providers with more than 50 percent of the services in one area to qualify for safety zone treatment. In addition, the Statement extends safety zone treatment for the first time to multi-provider networks that include hospitals.
On the other side of the ledger, Agency monitoring of ACOs in the Shared Savings Program may result in more active Agency enforcement or have the effect of discouraging anticompetitive behavior even by ACOs with market power. However, because the data for such monitoring will be limited to data from the Medicare program, in which the government sets prices and has greater control over the terms of service than a private payer, it may have limited impact on whether an ACO engages in anticompetitive behavior towards private payers.
Further, the use of PSAs as a surrogate for geographic markets is likely to result in ACOs being evaluated in narrower geographic areas than under the 1996 Health Care Statements. PSAs are based solely on the areas in which providers historically have obtained patients while geographic market analysis under the 1996 Health Care Statements employed the geographic market definition principles in the Merger Guidelines, which consider the alternatives in other geographic areas to which existing patients could turn in response to a price increase. (See 1996 Health Care Statement No. 8, Section B.2 (Applying the Rule of Reason)). In many cases, a PSA may result in a narrower geographic area, and higher shares, than would a geographic market as described by the Merger Guidelines. On the whole, however, there is a substantial likelihood that the Policy Statement will permit ACOs to form that represent a higher degree of market concentration, and less stringent integration requirements, than would have been permitted under the 1996 Health Care Statements.
The Policy Statement appears to allow additional provider consolidation while at the same time relaxing, to a certain extent, integration requirements. This may allow the formation of ACOs with a greater ability to exercise market power against health plans than ACOs formed under the 1996 Health Care Statements. Given the enforcement approach taken in the Policy Statement, it will be critical for ACOs to carefully consider whether their formation or operation raises competitive concerns and, if so, to take appropriate steps to ensure they operate in compliance with the antitrust laws, including seeking voluntary review where appropriate. In addition, health plans need to be vigilant about ACOs that they believe raise competitive concerns, or that may be operating in an anticompetitive manner. This may include being much more proactive in contract negotiations and, where appropriate, bringing those concerns to the attention of the Agencies.
1 See Policy Statement at 5 (CMS proposed eligibility criteria are "broadly consistent" with the indicia of clinical integration in the 1996 Health Care Statements and advisory opinions regarding specific proposed networks).
2 To calculate these shares, the ACO first must identify any service provided by two or more participating providers or groups of providers ("common service"). For each such service, the ACO then must calculate the share all ACO providers have in each PSA in which two or more ACO participating providers provide the service. "PSA" is defined as the lowest number of postal zip codes from which the provider obtains at least 75 percent of its patients. Services are defined for physicians based on Medicare Specialty Codes as defined by CMS, and shares are calculated based on total Medicare-allowed charges for claims billed; services are defined for inpatient services by Medical Diagnostic Categories and calculated based on patient discharge data; for outpatient services provided by hospitals or ambulatory surgery centers, shares are based on Medicare fee-for-service payment data for the common services categories. Similarly, for services rarely used by Medicare recipients (e.g., pediatrics, OB/GYN), the ACO should use fee-for-service payment data or, if such data are not available, for example, data on the number of active physicians within the specialty located within the PSA.
3 For example, if an ACO includes two cardiologist practice groups, A and B, cardiology would be a common service, and the ACO would need to calculate the combined share of cardiology services based on total Medicare-allowed charges for claims billed by the ACO's cardiologists in both A's and B's PSA. Unless the share for each common service in each PSA is 30 percent or below, the ACO cannot qualify for the safety zone.
4 The Policy Statement defines "rural area" as any county containing at least one zip code that has been classified as "isolated rural" or "other small rural" according to the WWAMI Rural Health Research Center of the University of Washington, http://depts.washington.edu/uwruca/ruca-maps.php.
5 A "Rural Hospital" is defined as a "Sole Community Hospital" or "Critical Access Hospital" as defined for purposes of the Social Security Act and Medicare regulations, or any other hospital located in a rural area that has no more than 50 acute care inpatient hospital beds and is located at least 35 miles from any other inpatient acute care hospital.
6 The Policy Statement does not define "high market share." It seems likely, however, that ACOs with a PSA share approaching or exceeding 50 percent for one or more common services will attract closer scrutiny.
7 The Policy Statement also notes that the 1996 Health Care Statement Nos. 4, 5 and 6 provide guidance for how pricing, cost and other data may be shared among competitors, including safety zones for fee and non-fee related data.
8 The required information includes: (1) the ACO's application and supporting materials that it has submitted or plans to submit to CMS for the Shared Savings Program; (2) documents regarding the ACO's plans to compete in the Medicare or commercial markets and the ACO's likely impact on prices, costs and quality; (3) the level and nature of competition among ACO participants and the competitive significance of the ACO and its participants in the markets in which they provide services; and (4) information sufficient to show the common services provided by ACO participants, the PSA for each ACO participant, the ACO's PSA shares for each common service, restrictions that prevent ACO participants from obtaining competitor price information, the identity of the five largest actual or projected private payers for the ACO's services, and the identity of existing or proposed ACOs that will operate in any PSA where the ACO will provide services. The ACO also may provide other information that may be useful to the review, including evidence the ACO does not have market power, substantial procompetitive justifications for the ACO's composition, and if relevant, why the ACO is engaging in any of the four types of conduct the Policy Statement says should be avoided.
9 Based on past experience with the 1996 Health Care Statements that promised a similar deadline for reviewing proposed conduct, this time frame is unrealistic given all of the information the Agencies are seeking and the follow up that will be required to analyze it. 90 to 180 days is more realistic, especially if the reviewing Agency is besieged with requests for the Agencies' enforcement intentions.
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