New York Proposes Antitrust Immunity Certificate to Improve the Delivery and Accessibility of Care

On September 18, 2013, the New York Department of Health (the “Department”) proposed regulations that would grant a certificate of public advantage to health care providers entering into arrangements with other providers or entities in order to provide limited protection from liability under state antitrust laws, and a defense against federal antitrust claims.[1]

The proposed rules originated from the state Medicaid Re-Design Team’s March 2011 support of immunity from state and federal antitrust liability through active state supervision to ensure public benefits outweighed any anticompetitive effects of the arrangement.  The New York Legislature also supported this recommendation as an avenue for encouraging collaborative arrangements among providers to enhance efficiency and access to care across the state.

The proposed rules would require health care providers seeking immunity to undergo an initial evaluation to ensure that the proposed transaction would provide enough benefits to receive immunity.  Those wishing to obtain the certificate of advantage would first submit a $5,000 application fee with a copy of the agreement, a description of the nature and scope of the activities, a description of any consideration exchanged between the parties, and any additional materials or information required by the Department. 

The Department would then evaluate the application based on a number of factors including, but are not limited to:

• The financial condition of the parties;
• The dynamics of the relevant market including the availability of health care services, the level of competition in the market, the likelihood of new providers entering the market, and any unique challenges of the market;
• The potential benefits of the arrangement to the provision of health care in the region;
• The potential disadvantages of the arrangement to the provision of health care in the region;
• The availability of alternative arrangements that are less restrictive on competition and achieve the same benefits; and
• The extent to which active supervision is likely to mitigate any disadvantages.

Under the proposed rules, the Department would have the ability to impose conditions on a certificate that are related to the activities and goals of the agreement.  For example, the Department may require quality benchmarks, certain services of access for under-served populations, clinical integration plans, investment in primary care, measures to prevent cost increases, and improvements in the recruitment and retention of health care providers.  The Department would also have discretion in determining the duration of each certificate with the minimum length being two years.

The Department would coordinate closely with the Public Health and Health Planning Council and the New York Attorney General’s Office in reviewing and approving any requests for certificates of advantage.  A report of activities pursuant to any cooperative agreements would be required to be filed periodically with the Department and the Attorney General.  During the first four years of the certificate, the parties would be reviewed annually. After the first four years, the Department would review the parties at its discretion.

The Department would also have authority to revoke the certificate of public advantage at any time if the parties do not comply with a condition of the certificate, the disadvantages of the collaboration outweigh the benefits, the Attorney General objects to the continuation of the certificate, the holder of the certificate fails to file a report required or fails to provide requested information pursuant to a review, or a change in state or federal law warrants a revocation.

The proposed rules are open for public comment until November 4, 2013.  Comments may be submitted to Katherine Ceroalo at:  New York State Department of Health, Bureau of House Counsel, Regulatory Affairs Unit, Corning Tower Building, Room 2438, Empire State Plaza, Albany, New York 12237, [email protected].