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West Lafayette
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West Lafayette, IN 47906
(765) 464-3200
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Current News and Issues

OIG Joint Venture Guidance Applies To Physician Investment In Device Companies

OIG Industry Guidance Branch Chief Vicki L. Robinson sent a letter to AdvaMed President Stephen Ubl confirming that the agency’s 1989 Special Fraud Alert on Joint Ventures represents current guidance applicable to the “apparent proliferation of physician investments in medical device and distribution entities.” The letter also confirmed that safe harbor provisions, like those applicable to small entity investments, are relevant to an analysis of physician and other joint ventures under federal fraud and abuse laws.
(http://oig.hhs.gov/fraud/docs/alertsandbulletins/GuidanceMedicalDevice%20(2).pdf)

FDA Report Recommends Strengthening Postmarket Program For Medical Devices

The FDA Center for Devices and Radiologic Health (CDRH) released a report that calls for a transformation of postmarket surveillance and enforcement activities. The report cited the need for improving communication within CDRH, improving the Center’s ability to collect and analyze postmarket data concerning device problems, maximizing the Center’s ability to provide timely information to practitioners and consumers, and revising and enhancing enforcement strategies.
(http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html)

OIG To Discontinue Publishing Exclusion List In Federal Register

OIG announced that exclusion actions will no longer be published in the Federal Register. The monthly exclusion actions known as the List of Excluded Individuals/Entities (LEIE) will instead be published on the OIG website at http://oig.hhs.gov.
(71 F.R. 65117-65120)

Eleventh Circuit Finds HHS May Require More Than CMN To Support Medical Necessity Determination

In a case of first impression among the Circuit Courts of Appeal, the 11th Circuit held that the Department of Health and Human Services may require more information than is contained in the certificate of medical necessity (CMN) form from a durable medical equipment supplier to obtain reimbursement. The court rejected the DME supplier’s argument that the statute precluded the government’s use of the discretion finding that no such intent could be found in the statutory language. Further, because of the complexity of the Medicare laws, the agency was entitled to significant deference in its interpretations of those laws.

Gulf Coast Medical Supply, Inc. v. HHS (11th Cir. No. 05-16935, Nov. 3, 2006) (www.ca11.uscourts.gov/opinions)

Indiana Medicaid Recipients And Providers Lack Right To Sue State For Inadequate Funding

The Indiana Court of Appeals held that Medicaid transportation services providers and Medicaid recipients were not entitled to sue the state for cuts in funding that reduced reimbursement below providers’ costs under a federal statute. The federal statute known as Section 1983 allows a private right of action against anyone who under color of law deprives a person of any rights secured by the Constitution and laws of the United States. The Indiana court held that Congress did not evidence an intent to create a specific entitlement right for either Medicaid providers or recipients under the “equal access” provisions of the Federal Medicaid Act, an essential requirement in a Section 1983 case.

Roob v. Fisher (No. 49A02-0602-CV-103, Nov. 8, 2006) (www.in.gov/judiciary/opinions/archapp.html)