Alan E. Reider, JD, MPH

A recent advisory opinion issued by the Inspector General declined to approve a proposal for optometrists to participate as owners in three single specialty ophthalmology ASCs. The only question raised by the opinion is why the requestors asked the question.

The Office of Inspector General recently issued an Advisory Opinion that addressed a proposed arrangement between a hospital and a group of physicians relating to the sale of ownership interests in an ambulatory surgical center.

As readers of this column are aware, part of my responsibility is to identify enforcement and compliance trends in order to alert physicians to areas of risk so that you may take appropriate steps to protect yourselves.

On June 12, the Office of Inspector General of the United States Department of Health and Human Services issued an advisory opinion that addressed a proposed arrangement between a hospital and a group of physicians relating to the sale of ownership interests in an ASC. The OIG determined that the arrangement could potentially generate remuneration that is prohibited under the anti-kickback statute and declined to issue a favorable opinion.

This article, highlighting the top 10 legal and regulatory problems found in ophthalmology practices, is based on a presentation made at the Hawaiian Eye 2007 meeting and reflects conduct that, in some cases, resulted in serious consequences for the physician.

A Massachusetts physician has agreed to pay $150,000 to settle allegations that he submitted false claims to Medicare and Medicaid for office and nursing home visits performed by employed nurse practitioners and physician assistants without appropriate supervision. It is believed to be the first case of its kind to focus exclusively on violations of the “incident to” rules.

Each October the Office of the Inspector General issues its work plan for the new fiscal year, in which it identifies areas of focused review. In this era of heightened enforcement, all members of the health care community should use this as a guide to be certain that their activities are not the target of OIG scrutiny. For 2007, there are a number of issues that should be of interest to ophthalmologists. Here are the most significant.

In recent months, interest in presbyopia correction has increased considerably, and the trickle of inquiries on the noncovered charges related to presbyopia correction at cataract surgery has become a torrent. It is clear that some important issues need clarification. This article — an update to the original legal treatment of this issue by Mr. Reider and Ms. Shuren (See “Refractive ‘bracket creep’ makes billing for presbyopia services complex,” March 15, 2005) — will include consideration of the ruling by the Centers for Medicare and Medicaid Services that was published thereafter in May 2005.

For the past several years, there has been considerable focus on the relationship between physicians and the pharmaceutical industry. This focus has generated significant federal enforcement activity, and much of the concern has been directed at the promotion of drugs to physicians. In response, PhRMA, the national trade association of the pharmaceutical industry, has issued guidelines for the relationship between its members and the physician community.

An ophthalmologist in Vermont was recently acquitted of multiple counts of Medicare and health care fraud relating to the performance of unnecessary surgery. The acquittal confirms the ill-conceived decision to prosecute this ophthalmologist, whose biggest crime appears to have been the failure to maintain understandable medical records. But this is the first of several current investigations of ophthalmologists to be resolved, and it is not clear whether these multiple investigations reflect a coincidence or a disturbing trend.