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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.
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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,
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!