Editor’s Note: On March 27, 2018, the author partnered with Christine White, vice president of legal affairs at Northwell Health, Inc., to present a webinar for the Greater New York Hospital Association (GNYHA) entitled “DSRIP Antitrust Considerations: The Case for a COPA.” Highlights are summarized below.
Under New York State law, providers who might otherwise be viewed as competitors can apply for a Certificate of Public Advantage (COPA) for certain collaborative arrangements. If approved, a COPA can confer immunity under state and federal antitrust law. The webinar explained the COPA background and reasons why parties participating in a Delivery System Reform Incentive Payment (DSRIP) Performing Provider System (PPS) might consider applying for COPAs. The deadline for applying for a DSRIP COPA has been extended to December 31, 2020.
Background to COPA Laws: Healthcare and Antitrust Policy Issues
According to the federal antitrust agencies, the antitrust laws are consistent with healthcare reform’s triple aim of 1) improving quality, 2) enhancing patient experience and access to care, and 3) reducing costs. The antitrust agencies believe that mergers and collaborations consolidate market power, which can lead to adverse effects on competition, a position supported by economic research showing that consolidation leads to higher prices.
The agencies stress that regulation is not an effective substitute for competition and that COPA laws granting antitrust immunity are unnecessary to encourage procompetitive provider collaborations. While the agencies have consistently opposed COPA laws, they have also explained that competition is not a panacea for all of the problems with American healthcare.
COPA laws authorize “cooperative agreements” among competing providers where it is shown that the agreements can improve quality, moderate cost increases, improve rural access and help keep smaller hospitals open. These laws seek to balance competition with regulation and provide that competition is just one issue to take into account. Very few COPAs actually have been applied for or issued until recently, and there has been minimal research conducted on whether COPAs actually achieve their purported benefits.
Antitrust Laws and Provider Collaborations
The federal antitrust laws generally prohibit 1) agreements that restrain trade, 2) monopolization and 3) mergers that substantially lessen competition. Each state also has its own antitrust act which generally mirrors the federal statutes. Most often, the antitrust agencies will assess healthcare collaborations under the rule of reason, recognizing the fundamentally procompetitive reasons for entering into these arrangements.
In the DSRIP context, there are a number of issues that could give rise to antitrust liability:
- Joint contracting could be viewed as price-fixing;
- Value-based contracting may increase exposure to potential price fixing or boycott claims from payers who are not shy about suing or complaining to the Federal Trade Commission (FTC);
- A PPS agreement that particular providers will serve particular patient segments or that particular specialties will be located at particular facilities and that competing facilities would not offer certain services could be viewed as market allocation;
- PPS providers coming together to provide services to a group of patients could be viewed as taking away the opportunity for competitors to service that group of patients, which could be viewed as monopolization or group boycott activity;
- Exclusive agreements can also violate the antitrust laws if they harm competition by restricting distribution channels or access to particular services or patients; and
- Sharing of competitive information on which parties act can also be anticompetitive.
Lawsuits could be brought by local providers not participating in the PPS, or complaints could lead to government investigations. Excluded competitors may be incentivized to sue because if they are successful, they could be entitled to treble damages and attorneys’ fees.
The New York DSRIP Program
The DSRIP program is a state-sponsored pilot program arising from the Federal Social Security Act § 1115. A state’s ability to participate in this waiver program is subject to the Department of Health & Human Services’ (HHS) approval. Section 1115 waivers permit states significant flexibility in how they deliver their Medicaid programs and allow states to direct supplemental payments to providers that also invest in delivery reform.
New York’s DSRIP program is a regulatory solution to the problem of high Medicaid spending and subpar quality. New York had the second-highest spending in the nation and was concerned about its rising costs, as well as quality issues. For example, New York was rated last in the nation for its overutilization of hospitals. DSRIP seeks to achieve health system transformation and a 25% reduction in avoidable hospital use over five years.
To accomplish these goals, DSRIP involves extensive data collection and reporting and requires every PPS to satisfy milestones for the creation of infrastructure, as well as for process and outcomes metrics and milestones. As a result, DSRIP brings providers together to share significant data and information. New York State, concerned about potential antitrust liability discouraging providers, encouraged providers to seek COPAs providing antitrust immunity for PPS activities to drive participation.
The New York COPA Law and Regulations
The New York COPA law expressly states that “the intent of the state is to supplant competition ... and to provide state action immunity under the state and federal antitrust laws.” This language would almost certainly pass muster as a clear articulation of a state policy to displace competition.
The second requirement for state action immunity is active supervision. The New York COPA law itself stresses that active supervision is required. Whether there is sufficient active supervision, however, depends on what the state actually does. There needs to be continuous monitoring and interaction for a COPA to be valid. Any challenge to the validity of a COPA would likely target active supervision. The regulations include specific provisions requiring active supervision throughout the process and the COPA’s life cycle and include the ability to modify or revoke the COPA. Whether there is active supervision ultimately will be a factual question.
The COPA review process requires the New York State Department of Health (DOH) to assess the COPA’s primary service area, as a proxy for the relevant market, and try to anticipate the benefits or disadvantages that may occur within that area. The review process allows DOH to consider factors other than competition, including whether the PPS will help preserve services for needy populations or whether it facilitates the implementation of payment methodologies designed to control unnecessary costs or utilization.
The Staten Island PPS COPA
Following the submission of several COPA applications, the FTC sent a letter to DOH expressing its views that COPAs are unnecessary and based on inaccurate presumptions about the antitrust laws and the value of competition, including in a letter directed to New York on April 22, 2015. According to the FTC, because the antitrust laws permit procompetitive collaborations, COPAs only serve to protect anticompetitive collaborations. Nonetheless, DOH granted a COPA to Staten Island in December 2016 after receiving this letter. Another COPA application is still pending.
While Staten Island’s final COPA was never published, DOH published an executive summary in connection with the proposed COPA. The executive summary explains that the COPA is valid through March 31, 2020, or termination of the PPS’s participation in DSRIP and that the COPA has no bearing outside of the PPS’s Medicaid activities in connection with DSRIP. Additionally, the COPA was proposed to be subject to certain conditions, including:
- Acknowledgment by the PPS that it will not invoke COPA or antitrust immunity for any purpose outside of Medicaid activities under DSRIP;
- Acknowledgment by the PPS that material changes may result in additional conditions or the COPA’s revocation; and
- Continued compliance with the PPS’s reporting requirements.
The executive summary also set forth the considerations in granting the COPA. One factor was substantial coverage, which benefits DSRIP because accomplishing delivery system reform requires covering a large portion of the market. This, however, presents a conflict with the FTC’s concerns, which arise due to the participants’ high combined market shares. One key way to reduce antitrust exposure when bringing providers together is to ensure that participation is nonexclusive to the entity. In the PPS, the participating providers are permitted to provide services outside of the PPS, which reduces concerns.
DOH’s analysis also addressed the procompetitive benefits and efficiencies of the COPA, including increased access to local services, care coordination and disease management services, clinical integration, and performance-based financial incentives. The analysis also noted that there was a potential for anticompetitive effects through spillover into the commercial market, but those concerns were mitigated through nonexclusivity of the provider network, active supervision, an internal monitoring program, and an antitrust compliance policy and program.
COPA Filing Considerations
The webinar panelists discussed the advantages of the COPA’s grant of antitrust immunity from both private and government antitrust actions. The panelists explained that the additional time and expense, including the filing of the actual application and increased reporting obligations, are not burdensome, because the COPA is based on the DSRIP application. Finally, the panelists stressed the importance of compliance with COPA conditions and the need for active state supervision to ensure a good basis for state action immunity should the COPA ever be challenged.
Note: GNYHA members may access the webinar at https://www.gnyha.org/event/dsrip-antitrust-considerations-the-case-for-a-copa-webinar/.