OIG Releases New Fraud and Abuse Advisory Opinion Involving EHR Data Exchange

On December 7, 2011, the Office of the Inspector General (OIG) released an Advisory Opinion regarding a proposed coordination service to facilitate the electronic exchange of data for patient referral purposes.  A health IT company requested the opinion to determine whether its proposed services would be subject to OIG sanctions or civil monetary penalties (CMP) under the Anti-kickback Statute (AKS). The AKS makes it a criminal offense to knowingly and willfully offer, pay, solicit or receive any remuneration to induce or reward referrals of items or services which are reimburseable by a Federal health care program.  

Three types of services were offered by the health IT company: billing services, electronic health record (EHR) management services, and automated messaging services for communicating with patients.  These services could be purchased as a package deal or on a monthly basis for a subscription fee.  The Proposed Arrangement, however, would provide a new service that would provide coordination services for referrals and managing patients receiving services from other health care professionals (the "Coordination Service"). 

Through the Coordination Service, a trading partner could send referrals as well as all necessary medical records in addition to insurance and billing information.  The patient information would be accessed and exchanged through an electronic database network.  Although purchase of the EHR services offered by the health IT company was required in purchasing the Coordination Services because of the need for all patient medical, demographic and other information contained within to be available for referral purposes, the Proposed Arrangement would offer a discount on a monthly EHR subscription fee of approximately 25-35%. Other transmission, functionality and service fees would be assessed, depending upon the complexity of the services performed and per referral.

Although the Proposed Arrangement did not fit into an AKS Safe Harbor, the OIG determined it would not impose administrative sanctions upon the health IT company if it proceeded with offering the Coordination Services.  Although health care professionals were paying fees in connection with the receipt and transmission of referrals, these did not result in enhanced access to a referral stream.  Health care professionals also were not required to enter into an agreement with the health IT company or purchase the Coordination Service in order to receive a referral through the network.

In addition, the fees reflected the fair market value of the services provided and were based upon the level of services that were provided, as well as assessed regardless of whether a patient followed through on a referral and actually received the referred services, therefore distinguished from traditional per-click success fees. The Opinion stated that the independent value provided by the services which were actually paid for was unrelated to inducing referrals, and fees charged,

would not vary based on the value of the items or services that a receiving health professional might ultimately provide to Federal health care program beneficiaries.

OIG Advisory Opinions may only be legally relied upon by the party requesting the opinion but can prove useful guidance to other entities in structuring arrangements to comply with the Anti-kickback Statute. You can read the full Advisory Opinion here.  CMS also issues Advisory Opinions pursuant to its authority under the Stark physician self-referral laws.   

 

The IRS/DOJ/FTC Weigh-in on ACOs

Following the release of the CMS proposed ACO rule, the IRS has released a notice requesting comment whether existing guidance for tax-exempt organizations seeking to participate in the Medicare Shared Savings Program as ACOs is sufficient and whether additional, and what, guidance may be needed. 

Released along with the CMS Proposed ACO Rule, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) joint Proposed Antitrust Policy Statement is available regarding antitrust enforcement for ACOs.  The proposed statement sets forth and requests public comment on a proposed "safety zone" for certain ACOs as well as an expedited review process.  It coordinates antitrust competition analysis with CMS's review of ACO applications to ensure necessary guidance is available for the formation of procompetitive ACOs.

For some "light" weekend reading, check out all the documents related to the coordinated efforts of the agencies:

CMS Proposed ACO Rule

CMS/OIG Joint Notice of Potential Fraud and Abuse Waivers

DOJ/FTC Proposed Antitrust Policy Statement

IRS Solicitation of Comments

 

"Soon" becomes Now - CMS releases long-awaited ACO Rules

The long wait is finally over.  The Centers for Medicare and Medicaid Services finally released the much anticipated Accountable Care Organization (ACO) proposed rules today after lengthy delays and promises that the rules would be out "soon."  The proposed rules set forth the requirements for the Medicare Shared Savings Program and are expected to clarify many questions about how ACOs will operate and receive incentive payments under the Shared Savings Program. 

The HHS Office of the Inspector General (OIG) has also released a notice and request for public comment on proposed fraud and abuse waivers for application of Stark, the Anti-kickback Statute and certain civil monetary penatlies (CMP) law provisions to ACOs. The Secretary is authorized to waive these laws as necessary to implement the Shared Savings Program.  The Federal Trade Commission (FTC) and the Department of Justice (DOJ) are also expected to weigh in on the antitrust implications for ACOs.