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How do I obtain an IDTF (independent diagnostic testing facility)

Resolved Question:

How do I obtain an IDTF (independent diagnostic testing facility) license from the state of Massachusetts?
Submitted: 5 years ago.
Category: Legal
Expert:  LawHelpNow replied 5 years ago.

Hello and thanks so much for choosing this forum to pose your important legal question. I will do my best to give you some honest and accurate guidance as I answer your question.


  1. I am a licensed attorney and registered nurse with administrative and regulatory law experience. I will be glad to try and answer your question. I hope that the following information will be helpful to you, but please just write back if you have any follow-up questions or need clarification on anything after reviewing the following information.
  2. The application form is available (be sure to check "Independent" in the third block) online in pdf format: Clinical Laboratory License Application Form. In addition, I would definitely encourage you to carefully study the online guide to operating such facilities: Independent Diagnostic Testing Facility Manual. This is not technically a license per se in the strictest sense of the word. Rather, it is recognition as a provider afforded by MassHealth.
  3. I hope that makes sense, but please do not hesitate to write back if needed. I shall be signing off soon to attend to some other professional obligations. Please rest assured, however, that I will be sure to check for any updated posts from you when I return to this online forum.


I hope that this information has been helpful to you. If we can be of any further assistance please free to use our service again. Best wishes for a successful outcome.


If my answer has been helpful to you, please click "ACCEPT" so that I may be paid. This is the only way that I will receive compensation for the work performed. Please consider clicking "BONUS" as a nice way of saying "thanks" for a job well done. Clicking "FEEDBACK" to leave your positive comments is always greatly appreciated.


The information provided is general in nature only and should not be construed as legal advice. By using this forum, you acknowledge that no attorney-client relationship has been created between you and Benjamin M. Burt, Jr., Esq. You should always consult with a lawyer in your state.

Customer: replied 5 years ago.
Thank you for your link, however that form is for a Clinical Laboratory and I am trying to license as an Independent Diagnostic Testing Facility. I don't think they are the same thing. We want to offer home sleep study testing services and the IDTF seems the closest match of institution on the Medicare application. However, I believe we need a license with the state before we can apply to Medicare. Is there a more specific application with the state? The reason I don't think we need to register as a lab is because we do not need to be CLIA certified.
Expert:  LawHelpNow replied 5 years ago.

Hello again,


Thanks for writing back -- good to hear from you.


I will be glad to comment further. I do ask that you kindly press "Accept" to process my answer.


My sincere apologies for not fully understanding your circumstances. Many thanks for the further explanation, which was indeed helpful to my analysis of your inquiry. 42 CFR §410.33(g) primarily governs such situations. You would need to enroll by completing CMS-855B. Please just click on the link to access the fillable pdf format document.


Take care and thanks again for choosing JustAnswer®!


Customer: replied 5 years ago.

I have CMS 855b, but it states that an IDTF must "operate its business in compliance with all applicable Federal and State licensure and regulatory requirements for the health and safety of patients." But I can't seem to find what the state requirements are in Massachusetts. On the Medicare application there are separate check boxes for clinical laboratory and IDTF, which makes me think that we do not need to apply for a license as a laboratory, but as an IDTF. is it possible we don't need a license with the state?

thank you for such prompt answers,


Expert:  LawHelpNow replied 5 years ago.

Hi there,


Yes, that is entirely correct, and unfortunately I did not succeed at stating that principle on my first attempt. That is what I was referencing when I mentioned it being more of a recognition than a license per se. In other words, you are indeed correct -- there is no state license issued to operate as such an entity.


It might help to think in terms of this rough analogy. One can form a corporation at the state level and operate as a sub-chapter S entity at the federal level for taxation and other purposes. However, the federal government does not actually grant the corporate charter. That is the role of the state, and the sub-chapter S recognition at the federal level follows the actual licensing at the state level.


I hope that makes sense and is of some additional help. Again, my apologies for any confusion. It has been a pleasure interacting with you. Thanks for your patience!


Take care and thanks again for choosing JustAnswer®!


LawHelpNow, Attorney/Lawyer
Category: Legal
Satisfied Customers: 7639
Experience: Relax. Let's work together. Practical solutions.
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