Health Law Alert

2011: Issue 5 – Focus on Fraud and Abuse

OIG Ceases Exclusion Efforts Against Forrest Labs CEO – Not All Corporate Officers

By: Anthony J. Burba *

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services has ended its effort to exclude former Forrest Laboratories’ CEO Howard Solomon. The OIG informed Mr. Solomon by letter on Friday, August 5, 2011 that “Based on a review of information in our file, and consideration of the information your attorneys provided to us both in writing and in an in-person meeting, we have decided to close this case.” Mr. Solomon’s case had been the subject of considerable attention in the health care community as the OIG attempted to exercise its permissive exclusion authority under section 1128(b)(15) of the Social Security Act.

OIG Warns That Arrangements Between CPAP Suppliers and Sleep Labs Pose F&A Risks

By: Alan J. Arville

In Advisory Opinion 11-08, the OIG took an unfavorable view of both an existing and a proposed arrangement where the requestor, a durable medical equipment (DME) supplier of continuous positive airway pressure equipment and supplies (CPAP), would contract with sleep labs enrolled with Medicare as independent diagnostic testing facilities (IDTFs) to provide CPAP set-up and patient education services on behalf of the DME Supplier. In its July 14, 2011, ruling, the OIG expressed concern that payments to potential referral sources for such services could potentially generate prohibited remuneration under the federal anti-kickback statute.

Online Referral Service Proposes to Charge for Services, Raises OIG Concerns

By: Christopher P. Dean

The Office of Inspector General (OIG) recently issued a negative advisory opinion that raises concerns about fees charged by some online referral services. Specifically, Advisory Opinion 11-06 analyzed a proposal by an online referral service to charge a startup and monthly user fee to post-acute care providers in exchange for the use of an electronic referral service used by hospitals. The OIG expressed concern that payments to potential referral sources for such services could potentially generate prohibited remuneration and present more than a minimal risk of violating the antikickback statute.

Metadata Standards for EHRs: A Sneak Preview of Meaningful Use Stage 2?

By: Sarah E. Swank

The Office of National Coordinator for Health Information Technology (ONC) has announced that it is seeking comments on metadata standards related to patient access to summary care records from their health care providers. In short, metadata is the background data about data. The implementation of metadata standards would mean that background data from electronic health records could be used to create a summary about patient electronic records, which patients could access through exchanges. This is the first step in easy and safe patient access to health information, a goal of HITECH alongside exchange of information between health care providers and reporting to government agencies. Comments are due by September 23, 2011.

CMS Provides Guidance on the Elder Justice Act’s Reporting Requirements

By: Virginia B. Evans* and John S. Linehan

On June 17, 2011, CMS issued guidance [PDF] on the Elder Justice Act’s reporting requirements for long-term care facilities, promulgated over a year ago in section 6703(b)(3) of the Affordable Care Act (ACA). This serves as welcome news for the long-term care community, which has patiently struggled to comply with the law’s manifold vagaries while operating under the threat of its harsh penalties. On August 12, 2011, CMS’s guidance memorandum was supplemented to include a question and answer (Q&A) section.

Are Local IRBs Going the Way of the Dodo? Historic Proposed Changes to the Common Rule

By: Sarah E. Swank

The regulations governing research protections for human subjects across several federal agencies, known collectively as the Common Rule [PDF], have remained basically unchanged since their inception in the 1980s. The Department of Health and Human Services (HHS) is now revisiting the Common Rule, however, in an attempt to balance the need for additional protections for human subjects with calls for a more streamlined approval process for frustrated investigators. HHS announced its proposed changes to the Common Rule, entitled Human Subject Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators [PDF], on July 22, 2011. Along with the expansive changes proposed in its announcement, HHS posed a series of 75 questions for public comment on potential regulations.

The FTC’s Interpretation of the State-Action Exemption

By: John J. Miles

In a number of situations, the antitrust laws do not apply to certain parties or to certain activities—that is, the party or conduct is “exempt” or “immune” from antitrust liability. One of the more important antitrust exemption doctrines in analyzing many health care antitrust issues is the state-action exemption — an exemption based on congressional intent that the antitrust laws not apply to the activities of states and on federalism when they choose to replace competition with regulation.