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By MICHAEL R. LOWE and BRIAN C. EVANDER

At its core, a Clinically Integrative Network (CIN) is a collective of health care organizations in a local or geographic region in which providers share access to electronic health record systems. It is a health network working together, using proven protocols and measures, to improve patient care, decrease cost and demonstrate value to the market. This network of systems allows practices to track shared patient populations in order to improve patient engagement and deliver the best care at the lowest cost. The main goals of a CIN are to increase efficiency and provide better care. The Department of Justice (DOJ) and the Federal Trade Commission (FTC) define clinical integration as an active and ongoing program to evaluate and modify practice patterns by CIN participants to create a high degree of interdependence and cooperation among physicians to control costs and ensure quality patient care.

In its article, The 7 Components of a Clinical Integration Network, Becker's Hospital Review defines CINs as individual providers and health systems that are collaborating strategically to do three things: 1) improve patient care, 2) decrease the cost of care and 3) demonstrate their value to the rapidly changing market.

As care delivery methods and compensation evolve, clinical integration and CINs are being leveraged to deal with market changes, both anticipated and realized. And while changes in the market are one big reason for the uptick in CINs in recent years - there are now around 500 CINs in existence in the United States according to Becker's Hospital Review - many CIN members have joined networks because they believe the ultimate goals of CINs will improve the health of their patients.

Clinically integrated networks provide a legal way for independent practices to bargain with insurers for better payment rates, make IT improvements that would otherwise prove difficult to implement on their own and help patients receive the best care possible. CINs are a legal structure with benefits that extend beyond the bottom line.

"The legal structure allows them to provide more integrated and coordinated care and do some more bargaining with payers, which would not be allowed from independent providers," Senior Associate of the American College of Physicians Neil Kirschner told the ModernMedicine Network.

CINs create mutual accountability that encourage health systems and community-based providers to deliver high-quality care efficiently and effectively. Clinically integrated networks also allow practices to remain independent while leveraging a broader community of experts. The CIN can contract with payors, employers or health systems. These contracts can range from a specific procedure to a population of patients. Many hospital systems have reported that payors are not requiring that CIN contracts include downside risk for the network. Some hospitals have also contracted with their own CIN to realize cost saving opportunities and to more effectively manage cost within their own health plan.

CINs are a win-win for Independent Practices and for their patients. The benefits independent practices receive from joining a CIN would include a practical and financial advantage without giving up or relinquishing control over their practice. Not every patient wants their care to be provided by a large institution. They may be looking for that customized, personalized high-quality care that an independent practice can give. The patients will benefit from staying with their doctors whom they know and trust while receiving higher-quality care at lower costs. The basic idea behind CINs is that patients are best served when doctors of all specialties are working in a single integrated network to cohesively optimize care. Doctors also benefit from quality-optimization standards, as well as from the resources and support from the health care system. By maintaining control through such physician-driven clinical networks, doctors are able to instill change in both patient care and health care reform.

According to the U.S. Department of Justice, CINs all share four defining characteristics. In order to operate legally as a CIN, a network must:

• Have physicians play a key leadership role. Whether a CIN is a joint venture between a health system and providers (called a Joint Venture Physician-Hospital Organization or PHO), a collaboration between provider partners only (called an Independent Practice Association) or a subsidiary of a health system (called a Health System Subsidiary), physicians must be part of the CIN's governance structure. Physician leadership and buy-in is not only essential from a legal perspective, it's also critical to the success of a CIN.
• Commit to comply with clinical guidelines. Members of a CIN commit to working on certain performance improvement activities, including improving care outcomes, increasing efficiency of delivered care and increasing patient satisfaction.
• Strategically use data and technology. In a value-based care model, data and analytics are essential. CINs need to strategically use data to shape their care strategies and to prove how they are improving outcomes, increasing efficiency and reducing costs. CINs should be continuously setting metrics and then using data to assess those metrics and make improvements.
• Demonstrate its value. CINs must show how they are delivering better care at lower costs. Essentially, a CIN must be able to speak to and deliver on its value proposition.

Without each of these four components, a CIN runs the risk of becoming an organization that has the power to negotiate better rates for its members based on its size, not because of the value it provides to patients and payers.

There can be some antitrust concerns when structuring your CIN. The CIN must be structured such that it avoids a per se violation of the antitrust laws and avoids overriding anticompetitive effects. The network must be "integrated" - either financially integrated or clinically integrated. CIN requires a structure such that the network of competing providers will result in a high degree of provider interdependence and cooperation to control health care costs and ensure quality health care through the CIN. Properly structured, the CIN will avoid a per se violation of price fixing, market allocation or agreement not to compete.

Some key provisions to reduce Antitrust Risks are: 1) Providers should enter into non-exclusive contracts with the network such that the providers can engage in contracting independently or through participation in a competing network; 2) The providers agree to participate in all payer contracts entered into by the CIN. This increases the likelihood that the providers will actively participate to achieve the quality and efficiency goals; and 3) The CIN provides a mechanism to avoid competing providers engaging in discussions and possible anticompetitive agreements outside of the legitimate business activities of the CIN, such as regular provider antitrust counseling.

Key takeaways for distributions of funds: 1) Payments to physicians must not violate the Stark law or anti-kickback statute and similar state laws; 2) Ensure overall purpose is not to induce physician referrals; 3) Document appropriate business case; and 4) Ensure payments are reasonable and are within fair market value for physician's participation.

The rapid evolution of the health care market requires providers to consider a range of options to best meet patient and financial imperatives. The antitrust laws recognize that there are patient and efficiency benefits created when providers work together, but different forms of collaboration create different levels of opportunity and risk, which are all highly fact-specific. Those risks should be carefully assessed before moving forward.

Michael R. Lowe, Esquire is a Florida board-certified health law attorney at Lowe & Evander, P.A. Brian C. Evander, Esquire and Mr. Lowe regularly represent providers, physicians and other licensed health care professionals, and facilities in a wide variety of health care law matters.

For more information regarding those health care law and such matters please visit our website https://www.lowehealthlaw.com or call our office at (407) 332-6353.