Preparing Clinical Laboratories for Invasive Federal Enforcement of Fraud and Abuse Laws, Increased Scrutiny by Private Payers, New Education Audits, and More

Medical laboratory leaders need to take opportunities to stay abreast of government and payer activity, particularly as payer audits become tougher, say legal experts Even compliant clinical laboratories and anatomic pathology groups are reporting tougher audits and closer scrutiny of the medical lab test claims they submit for payment. This is an unwelcome development at a time when falling lab test prices, narrowing networks, and more prior-authorization requirements are already making it...

Federal Investigations into Alleged Kickback Schemes between Hospitals and Physicians Increase in Number and Scope

Hospitals and other organizations are finding ways to pay physicians for referrals in ways that don’t always look like kickbacks Hospitals nationwide are being scrutinized by the federal Office of the Inspector General (OIG) for allegedly violating federal anti-kickback statutes. This will be of interest to clinical pathology laboratories that have been under a similar spotlight for various referral-kickback schemes and arrangements in the last few years, which Dark Daily repeatedly...

Study of Urologists Who Refer Patients for Imaging to Facilities They Own is Published by the New England Journal of Medicine

Radiology and pathology associations are supporting a new bill in Congress to address self-referrals made by urologists Criticism is mounting against urologists who refer their patients to radiation providers in which they have an ownership relationship. This criticism is strikingly similar to concerns that pathologists and others have expressed about situations where urologists refer their patients to anatomic pathology laboratories in which they have an ownership relationship. Study about...

IRS Memorandum Clarifies How Hospitals and Hospital Labs May Provide EHRs to Medical Staff

To hasten the day when all Americans have an electronic health record (EHR), last year, on August 8, 2006, the U.S. Department of Health and Human Services (“HHS”) issued regulations that would allow hospitals to provide certain software and technical support services to physicians without violating federal antikickback law. Because many physicians have been slow to invest in electronic health record systems, this new regulation is designed to encourage hospitals and health systems to step...

Labs Should Be Wary of OIG’s New Safe Harbors for Electronic Health Information Technology and Services

On August 8 of 2006, the Office of the Inspector General (OIG) created new exceptions and safe harbors to two key federal fraud and abuse laws for arrangements involving the donation of certain electronic health information technology and services. Publication of this guidance triggered positive and negative changes in the competitive marketplace and Dark Daily has insights on this issue from a well-known attorney in this field. The first law affected by the OIG’s new exceptions and safe...
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