Ensuring Compliance for Academic Medical Centers 

Advancements in medical diagnosis and treatments often begin with clinical research and services performed at academic medical centers. Yet most compliance pros don’t realize there are unique compliance issues involved with research and services in academic settings.   

Here are three of the issues, and some tips for navigating them.  

Issue 1: Teaching Physician Billing Rules 

Academic medical centers usually offer graduate medical education (GME) where recent graduates can train in a specialty as part of a residency. Medicare makes GME payments to support these new physicians’ residencies and training – but does not allow additional payment to attending or supervising physicians unless they are involved in direct patient care and meet certain requirements. These requirements are often known as teaching physician billing rules. 

One medical school in Texas and its partners recently agreed to pay the government $15 million to settle allegations that teaching physician rules were not met. The specific allegations involved supervising physician attendance at concurrent heart surgeries. 

If your organization bills for teaching physicians, ensure the compliance program has integrated the rules into its training and monitoring efforts.   

Issue #2: Clinical Trial Billing 

Academic medical centers are frequently involved in clinical research through participation in clinical trials. When medical services are provided in conjunction with these clinical trials, some may be reimbursable by Medicare (for example) and other services might not.  

These coverage rules are explained in a Medicare National Coverage Determination (NCD) titled “Routine Costs in Clinical Trials (310.1).” By not following these rules, and billing Medicare for services that should have been billed to other entities such as a clinical trial sponsor, organizations can get themselves into compliance trouble. 

For example, a cancer and research hospital in Florida agreed to pay $19.5 million to settle allegations of False Claims Act violations related to the billing of routine costs of clinical trials.  Specifically, it was alleged that the organization billed federal healthcare programs for items and services provided as part of clinical trial research that should have been billed to non-government trial sponsors. After learning of these issues, the organization initiated an independent investigation and compliance review and voluntarily provided the government with a written disclosure of its findings. It also cooperated fully with the government’s investigation of the conduct and implemented prompt and substantial remedial measures. Because they took full responsibility in this manner, the government agreed to reduce monetary penalties against the organization. 

Issue #3: Conflict of Interest Disclosures 

Many recipients of grants awarded by the National Institutes of Health (NIH) are researchers at universities and academic medical centers. These federal dollars come with many requirements, including accurate and truthful conflict of interest disclosures – especially as they may relate to any influence or collaboration with foreign actors or organizations. 

The U.S. government has recently increased its focus on foreign influence in academic research – which some call “academic espionage.” Most recent cases with publicly announced enforcement actions are connected to China, and other cases relate to Russia, Iran, and North Korea. 

For example, a former chair of the chemistry and chemical biology departments at Harvard University was charged with making false statements regarding his participation in a program from China. He was later convicted by a federal jury of two counts of making false statements to federal authorities. He was sentenced to time served (two days) in prison, two years of supervised release with six months of home confinement, a fine of $50,000, and $33,600 in restitution to the IRS. 

If you work in or partner with an academic medical center, these three unique scenarios are likely to come into play. Be sure you have a plan for ensuring compliance with them or create and implement one at your earliest opportunity.  

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