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Medicare Consul Services
The four things you need to consider when choosing a reporting agent
Clinical Trials reporting of Ongoing Responsibility for Medicals (ORM) is radically different from reporting liability settlements and requires unique reporting methods.
Don’t create a healthcare and financial nightmare for the test subject, the trial site and your company.
We developed the de-facto standard for Clinical Trials reporting
They should know HIPAA, but do they understand the challenges of double blind testing?
Do they understand the meaning Adverse and Serious Adverse Event and how to report without over-reporting.
Do they understand the difference between MMSEA and billable protocols?
Do they know a Study manager from a site coordinator?
The majority of our clients came to us through recommendations from pharma attorneys and industry insiders
Are they going to help you or are you going to have to help them?
We have worked with CROs and 1000’s of clinical trial sites on the behalf of our Pharma 15 clients. We stand alone among our competitors in our knowledge of clinical trials (see our articles in the Compliance Monitor and Compliance Weekly)
Will the MMSEA Reporting Agent help you get organized and stay informed?
Finding patients that need for your drug or device trial is your paramount concern, so your trial sites tend to be many and varied -- it’s complicated and not your everyday cup of tea for vendors more interested in selling you an Medicare Set Aside or some other unrelated service.
For Study Startup or for Ongoing Trials
On an ongoing basis, we will provide you:
Come on or loss leader? Is reporting the MMSEA Reporting Agent main business?
Are they focused on reporting or using it as foot in the door for their other, more profitable, services?
Are they providing reporting only in order to sell Medicare Set Asides (MSAs) ?
If their main business is not reporting and they are not familiar with clinical trials, it's fair to question their dedication to your reporting requirements.
David Piatt helped write the MMSEA (Title 42 U.S.C. 1395y(b)(8)) reporting rules, consults with leading law firms, writes for clinical trials publications, speaks at clinical trials conferences and is an expert in Medicare Secondary Payer (MSP) law