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Medicare Consul Services

The First and Best MMSEA Reporting Solution since 2009

 

Top Four Clinical Trial MMSEA Reporting Agent FAQs

The four things you need to consider when choosing a reporting agent

 Does the MMSEA Reporting Agent know how to report Clinical Trials?

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

 Does the MMSEA Reporting Agent really understand Clinical Trials?

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?

 

Medicare Compliance Medicare Consul Services

 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

  •  Implementation guides
  •  Document templates
  •  Advice on study binders

On an ongoing basis, we will provide you:

  •  Change of PI / Address updates
  •  Custom reports
  •  Piece of mind knowing you’ve engaged the premier clinical trials reporting  company

 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) ?

 

  • The vast majority of MMSEA Reporting Services started out as MSA firms that only offered reporting so they could mine your data for potential MSAs.

 

  • If fact, most of these companies will provide free reporting IF you can promise you will buy so many MSAs per year.

 

  • But MSAs are NOT REQUIRED in this situation.

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