{"id":903,"date":"2023-06-09T07:59:12","date_gmt":"2023-06-09T07:59:12","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/device-study-procedure-flow\/"},"modified":"2024-10-29T18:07:39","modified_gmt":"2024-10-29T18:07:39","slug":"device-study-procedure-flow","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/informational\/device-study-procedure-flow\/","title":{"rendered":"Device Study Procedure Flow"},"template":"","categories":[68],"tags":[69],"content-type":[5],"topic":[70,40],"update-type":[],"class_list":["post-903","document","type-document","status-publish","hentry","category-calendar-review-analysis-office","tag-crao","content-type-informational","topic-billing","topic-clinical-research"],"acf":{"use_legacy_editor":true,"updated_date":"2023-06-09 10:45:00","update_notice":true,"author":"Calendar Review & Analysis Office","summary":"<p>The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 allowed Medicare payment of the routine costs of care furnished to Medicare beneficiaries in certain categories of <a href=\"https:\/\/www.cms.gov\/medicare\/coverage\/ide\">Investigational Device Exemption (IDE) studies<\/a>.<\/p>","button_links":null,"related_content":"","legacy_path":"device-study-procedure-flow","legacy_node_id":1673,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Further Information","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<p>As of January 1, 2015, the Center for Medicare & Medicaid Services (CMS) made changes to the process of obtaining coverage approval for standard-of-care items and services in a device trial. Previously handled by local Medicare Administrative Contractors (MACs), this process is now managed centrally by CMS.<\/p>\n\n<p>Investigators should note the following changes as a result of this new process:<\/p>\n\n<ul>\n\t<li>Study teams submitting IDE studies for approval AFTER January 1, 2015, must now go through the central CMS office to obtain CMS Approval Letters. Detailed submission requirements are available <a href=\"http:\/\/www.cms.gov\/Medicare\/Coverage\/IDE\/index.html\">here<\/a>.<\/li>\n\t<li>IDE studies approved by MACs PRIOR to January 1, 2015, will continue to be&nbsp;administered by the MAC. Study sponsors should continue to follow the process&nbsp;established by the MAC for any site additions or protocol changes.<\/li>\n\t<li>Study sponsors do NOT have to submit their protocol to CMS if the participating&nbsp;study investigator sites have already received approval from their&nbsp;MAC.<\/li>\n\t<li>CMS will post information on its website each week for IDE studies approved&nbsp;after January 1, 2015. Study teams are encouraged to check the&nbsp;<a href=\"http:\/\/www.cms.gov\/Medicare\/Coverage\/IDE\/Approved-IDE-Studies.html\">CMS website<\/a> to see if their site has already been approved prior to submitting&nbsp;a new application.<\/li>\n<\/ul>\n\n<p>To speed up the submission process, CMS has released a Checklist and Sample Crosswalk. Submitters are encouraged to submit the crosswalk along with the request packet to facilitate CMS&#8217; review. CMS will review each complete submission within approximately 30 days, and e-submissions (emails and\/or electronic documents) are preferred over hard copies.<\/p>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[],"update_notice_start":"2023-06-09 07:45:00","update_notice_end":"2023-06-09 07:45:00","update_notice_text_blocks":null,"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"<p>Contact us at <a href=\"mailto:CR2-AO@med.umich.edu\">CR2-AO@med.umich.edu<\/a>&nbsp;<br \/>\n2800 Plymouth Road, Building 520, Ann Arbor, MI 48109-2800<\/p>\n\n<p>Edited By: <a href=\"mailto:dagi@umich.edu\">dagi@umich.edu<\/a><br \/>\nLast Updated: June 9, 2023 11:00&nbsp;AM<\/p>","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/903","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":0,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/903\/revisions"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=903"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=903"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=903"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=903"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=903"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=903"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}