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What is Coverage Analysis in Clinical Research?

April 30, 2021

Billing compliance in clinical research is critical to a successful trial. The consequences of not following compliance standards are severe, potentially costing institutions millions of dollars, as well as affecting their reputations. Almost every area of a study is negatively impacted when an institution fails to build a compliant billing process.

Performing a coverage analysis is key to ensure correct billing. Coverage analysis is a review to determine if a research study is eligible to receive Medicare coverage, outlining what items and services performed as part of the research study should be billed to Medicare. The coverage analysis is a vital component of the study activation process and can save sites time, money, and their reputation in the future.

This infographic breaks down consequences to non-compliance, as well as offers solutions to avoid non-compliance in the future.

Infographic for What is Coverage Analysis in Clinical Research? (full text below)

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What is billing compliance in clinical research?

Billing compliance ensures all services in a trial are paid for, working to reduce double billing and preventing billing services not covered by the trial or are not medically necessary for the participant.

How does non-compliance happen?

It is largely due to a lack of understanding1. The clinical billing requirements that must be met include:

Areas of clinical research affected by non-compliance:

Non-compliance can also be costly to an organization. From the False Claims Act Cases, the Justice Department recovered in settlements:

Additionally, some sites have filed settlements, and the fines show just how much organizations are affected. Sites have settled for improper billing or overbilling for fines up to $3.39 million. In addition to the fines sites faced, a site’s reputation can face severe backlash following the settlements1.

The punishment for violating the False Claims act is hefty – it is up to 3 times the amount of the initial violation and an additional penalty of up to $21,916 per violation5.

In 2016, US hospitals submitted $3 trillion worth of medical claims; $262 billion of the charges were initially denied6.

What is coverage analysis?

Coverage analysis is a review to determine if a research study is eligible to receive Medicare coverage and outlines what items and services performed as part of the research study should be billed to Medicare.

Questions coverage analysts answer:

What to look for in your coverage analysis team:

Sources

  1. https://acrpnet.org/2016/03/04/clinical-trial-billing-errors-generate-multi-million-dollar-fines/
  2. https://www.justice.gov/opa/pr/justice-department-recovers-over-3-billion-false-claims-act-cases-fiscal-year-2019
  3. https://www.justice.gov/opa/pr/justice-department-recovers-over-28-billion-false-claims-act-cases-fiscal-year-2018
  4. https://www.justice.gov/opa/pr/justice-department-recovers-over-37-billion-false-claims-act-cases-fiscal-year-2017
  5. http://www.bumc.bu.edu/crro/files/2017/12/Samet-CRRO-Seminar-12-13-2017.pdf
  6. https://www.healthcarefinancenews.com/news/change-healthcare-analysis-shows-262-million-medical-claims-initially-denied-meaning-billions

 

Streamline your study activation and ensure compliance by utilizing our team of expert coverage analysts. 

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