HSR Portal Updates

In an effort to make continuous improvements to the HSR portal, a few updates have been made:

• To help add clarification to certain fields in the HSR portal application, you may see purple “Learn More” text. When you see this, hover your cursor over “Learn More,” and a description of the field will appear as alternative text (see screenshot below).
• A guidance document has been created to clarify the differences between “Research Team Performed” and “Hospital Team Performed” procedures (see screenshot below).

• For amendment submissions the “Hospital Services” option has been updated for clarity. This option now reads:

Hospital services (check if adding new services or adding procedures to existing services (eg. Adding additional scan type (CT vs MRI) or body region); do not check if ONLY the frequency of items/services that are already approved are being modified).

• UCHealth Device Studies: For device studies, the hospital research specialists need to know if IDE studies have received approval from CMS or if the Sponsor will not be seeking CMS approval prior to completing the Medicare coverage analysis and billing plan for the study. To streamline communication, if a study with an IDE is submitted to the HSR Portal, the following questions will be asked:

1.Has the Sponsor received CMS approval for the study?

a.If yes, an upload field requires CMS approval letter

b.If the answer is no, then we will ask: Does the Sponsor intent on seeking CMS approval prior to the study opening to accrual?

HSR Portal Updates

In an effort to make continuous improvements to the HSR portal, a few updates have been made:

• To help add clarification to certain fields in the HSR portal application, you may see purple “Learn More” text. When you see this, hover your cursor over “Learn More,” and a description of the field will appear as alternative text (see screenshot below).
• A guidance document has been created to clarify the differences between “Research Team Performed” and “Hospital Team Performed” procedures (see screenshot below).

• For amendment submissions the “Hospital Services” option has been updated for clarity. This option now reads:

Hospital services (check if adding new services or adding procedures to existing services (eg. Adding additional scan type (CT vs MRI) or body region); do not check if ONLY the frequency of items/services that are already approved are being modified).

• UCHealth Device Studies: For device studies, the hospital research specialists need to know if IDE studies have received approval from CMS or if the Sponsor will not be seeking CMS approval prior to completing the Medicare coverage analysis and billing plan for the study. To streamline communication, if a study with an IDE is submitted to the HSR Portal, the following questions will be asked:

1.Has the Sponsor received CMS approval for the study?

a.If yes, an upload field requires CMS approval letter

b.If the answer is no, then we will ask: Does the Sponsor intent on seeking CMS approval prior to the study opening to accrual?