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HEALTHCARE: Operate Without Guidance At Your Own Risk

HEALTHCARE: Operate Without Guidance At Your Own Risk


APRIL 8, 2015

On March 16, 2015, New York State Attorney General Eric T. Schneiderman announced that New York State, along with 49 other states and the District of Columbia, hadreached a settlement with Daiichi Sankyo, Inc., a global pharmaceutical company, to resolve allegations of violations of the False Claims Act; the company agreed to pay the federal government and state Medicare programs a total of $39 million.

On March 19, 2015, the United States Department of Justice announced that BioTelemetry Inc., a heart monitoring company, had agreed to pay $6.4 million to resolve allegations of its own violations of the False Claims Act in connection with Medicare billings.

These announced settlements come on the heels of the February 2, 2015 testimony of the Acting Medicaid Inspector General before the New York State legislaturethat New York State’s enforcement efforts have resulted in recoveries of over $1.7 billion over the last three years; against the backdrop of that staggering statistic, the Inspector General highlighted the critical importance of companies having in place Medicaid compliance programs – as mandated by both New York State (NYS Mandatory Provider Compliance Program) and the federal government (the Federal Deficit Reduction Act of 2005).

While the healthcare field is not alone in requiring effective and up-to-date compliance programs, the attention it draws from a patchwork of federal and state authorities keeps it in the news. Under these circumstances, periodic risk assessments of compliance programs are advisable to ensure that appropriate policies and procedures are in place regarding such key areas as record keeping, billing and coding, and HIPPA record privacy and security.

In a complex regulatory environment like the healthcare field it is difficult for even licensed professionals to keep abreast of regulatory and reporting requirements. Increasingly therefore, healthcare practices and facilities (including, among others, medical practices, surgical centers, nursing facilities, pharmacies and medical suppliers) are turning to independent compliance professionals who are knowledgeable and current on issues specific to healthcare to ensure that their compliance programs are equal to the task of keeping them in compliance – and out of the news.

Such proactive risk assessments are not only a good way to ensure that regulatory obligations are being met – and will be viewed favorably if the regulators undertake an investigation based on an allegation of wrong-doing – they  also will have tangible operational benefits: A well designed and functioning compliance program, as enhanced through recommendations generated by a risk assessment, will  mean that employees will be less likely to make unintended errors; that, in and of itself, will make it less likely that allegations of wrong-doing will be made. Which is, of course, the idea.

About the author


Thomas A. McShane is the president of investigations and monitoring at Guidepost Solutions.  He plays a key supervisory role in many of the company’s complex and high-profile cases involving organizations in various industries and sectors.  Mr. McShane spearheaded the development of the company’s Independent Monitoring Program and works with numerous governmental and quasi-governmental authorities. He has served as Counsel to the New York State Commission on Government Integrity and Chief Counsel to a successor commission, the New York State Temporary Commission on Local Government Ethics. Thomas can be reached at


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