Compliance Corner: Set up 'research insurer' to keep CT billings accurate and compliant
Set up 'research insurer' to keep CT billings accurate and compliant
Financial analyst reviews all charges
Research billing might continue to pose challenges for hospital research centers, but there are specific steps they can take to ensure accuracy and compliance with all regulations.
They key is to make certain there is correct interpretation of the rules, solid policies and procedures, thorough budget analysis, and continual checks and balances. Then, professionals representing all of these perspectives need to meet and discuss how to improve or establish a billing process that is as airtight as possible.
"Get all of the correct people in the room, including the process people who are in charge," says Patricia Bass, JD, MPH, an associate general counsel at the Boston Medical Center in Boston, MA.
"You need the frontline people because they know exactly what happens when someone comes in the door," Bass says. "You need people from legal and compliance to say, 'These are the official rules,' and you need research staff, faculty investigators, and the billing office."
Often, great solutions come out of this process of putting so many different people together.
For example, at Boston Medical Center, the billing staff suggested that they set up an insurance company model that could be used to hold all patient care charges that would be paid through the clinical trial agreement, Bass says.
Bass describes additional ways a clinical trial site can improve its billing process and ensure compliance:
• Provide a financial analysis of proposed study. Financial analysts can work from the moment when clinical trial protocol negotiation begins to see which charges would be related to the research intervention and which would be allocated to Medicare or insurance.
"What is and isn't paid for by the sponsor has implications for budget negotiation," Bass says.
The analysis relies on what the protocols say is routine care and what is not. Also, the analysis provides information about what expenses are associated with the trial, such as training for the research coordinator staff, Bass says.
The end result is a list of what cannot be billed to Medicare.
"Then we are able to say to sponsors, 'It's our best estimate that insurers won't pay for these things so if you want us to do the study this is how much money we need," Bass says.
• Form spreadsheet listing all costs. At BMC, the grants department sets up a spreadsheet, listing each procedure and where it will be billed, Bass says.
"This is before the insurance company is set up," Bass says.
"They rely on the financial analysis about what is covered under the cover decision," she says.
The spreadsheet should include costs that sometimes aren't directly reimbursed, include the IRB submission and review, a clinical trial office fee, records storage, and other indirect costs, Bass says.
Then the grants office uses the new information when completing negotiation with sponsors, Bass says.
• Set up billing entity for research costs. When a research insurance company is created, it's given a number and a starting and ending date, Bass says.
"They set it up as though it is an insurance company, and this makes it easy when the charges come through the system," Bass explains.
The fictional research insurance company then is the entity that receives all of the charges that cannot be billed to Medicare or an actual payer.
"When the research subject comes in to have a procedure done, he reports to the study coordinator and is registered using the fictional insurance company," Bass says. "Instead of listing Medicare or Blue Cross as the insurer, it lists the research insurance as a billing source."
• Checking for compliance and accuracy. "All of the research insurance charges are reviewed by a clinical trial financial analyst and the grant staff for anything that has been released for billing to a third party," Bass says. "The charges are reconciled to make sure that they were done correctly the first time."
One issue that makes it more complex is that since research participants often have already been seen as patients in the hospital, they will have an existing patient registration.
To avoid confusion, these patients, when they become research participants, have to be registered again, Bass says.
So all research participants are given a new registration number, and this is what's used for their billing during the research trial.
The clinical trial financial analyst then reviews all charges for research participants to make certain they're billed under the correct registration number and to the correct payers.
Sometimes a research participant will come into the hospital for a regular, non-research associated procedure, and this charge will accidentally be categorized as a research insurance charge, Bass notes.
When this happens, the financial analyst will undo the charge and make certain it's sent to the correct payer under the correct patient registration number, she adds.
The legal team provides oversight of the rules and regulations, to make certain everyone on the research team knows when changes take place, Bass says.
"My job is to look at the various Medicare rules and national coverage decision," she adds.
Research billing might continue to pose challenges for hospital research centers, but there are specific steps they can take to ensure accuracy and compliance with all regulations.Subscribe Now for Access
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