Crosswalk

Revisions to Form CMS-10518: IVIG Demonstration Application

Issue #		Page #		Section	Action to be performed	Changes to the Application	Reason for the Change
	1		Introduction		Add additional introductory information	Introduction section added to application	Commenter suggestion
	1 - 2		2		Questions 9-13 reorganized	Original question 9 becomes question 10. Original questions 10 and 10a become questions 11 and 11a. Original question 11 becomes question 9. Original question 12 becomes question 13. Original questions 13, 13a & 13b become 12, 12a & 12b.	Reorganization of questions provides better flow and clarity of questions and will reduce potential for confusion as well as likelihood that beneficiary accurately and completely fills out form. Reorganization responds to commenters suggestions.
	1		2		Wording on questions 12 and 13 revised	Wording revised to more clearly ask about how patient currently receives medication vs. how they might receive it under the demonstration	Commenter suggestion.
	1		2		Wording revised	New question 10 (formerly question 9) has additional wording “I receive (or intend to start receiving)…” as some applicants may be newly diagnosed and not yet receiving the immunoglobulin medication.	Commenter suggestion.
	2		2		Typographical error corrected	Corrected typographical error in two of the response options for Q. 14 (from “intravenously administration” to “intravenous administration”)	Typographical error
	2		2		Additional response options added to question	Response options related to time savings combined into one option; added response options related to reducing exposure to risk and risk of impaired driving due to medication reaction	Commenter suggestion
	1 & 2		2, 3		Provide additional space for other	Additional space provided on paper application for filling in “Other” responses.	Commenter suggestion
	3		2		Clarify question 15	Add sentence to question 15 to clarify that question applies to beneficiaries who are not yet taking the medication but plan to (e.g. newly diagnosed). The sentence added is: “If you are currently not taking this medication but plan to, who do you expect will pay for these expenses if you do not participate in the demonstration.”	Commenter suggestion
	3		2		Clarify question 16	Add sentence to question 16 to clarify that question applies to beneficiaries who are not yet taking the medication but plan to (e.g. newly diagnosed). The sentence added is: “If you are currently not taking this medication but plan to, check the other health insurance that will cover the nursing and supplies associated with this drug you do not participate in the demonstration.”	Commenter suggestion
	3		End of application		Provide application submission information	Information on how to submit application and get additional information provided directly on application. Previously this information was only available on a separate “Enrollment Application Guide”. This avoids applicant having to reference another document.	Commenter suggestion.

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