Certifier User Guide (Crosswalk)

#	Form	Change	Current Location	Reason
1	Certifier User Guide	Revised date from "08" to "29"	Page 1	Updated date
2	Certifier User Guide	Revised date from "08" to "29"	Pages ii - 57 - Footnote	Updated date
3	Certifier User Guide	replaced "Create Assumption" with "Reasonable Assumptions	Page ii - 3.3.1	Formatting
4	Certifier User Guide	replaced "Upload Assumption File" with Other Assumptions (Optional)	Page ii - 3.3.2	Formatting
5	Certifier User Guide	replaced "3.4.1" with "3.5.1"	Page ii - 3.3.2	Formatting
6	Certifier User Guide	replaced "3.4.2" with "3.5.2"	Page ii - 3.3.2	Formatting
7	Certifier User Guide	replaced "3.4.3" with "3.5.3"	Page ii - 3.3.2	Formatting
8	Certifier User Guide	replaced "3.4.4" with "3.5.4"	Page ii - 3.3.2	Formatting
9	Certifier User Guide	replaced "Drug manufacturers can submit comments regarding their certifications to CMS. Manufacturers may submit these comments for either the current or prior reporting periods" with "Drug manufacturers can submit comments regarding their certifications to CMS via the Assumptions tab. Each quarter, manufacturers will submit these comments for the current reporting period, or they may submit assumptions for any previous quarters they are restating and resubmitting."	Page 21 - first paragraph under 3.3	New policy and guidelines
10	Certifier User Guide	deleted "Follow these steps to submit certification assumptions to CMS: 1. From the Medicare Part B Average Sales Price homepage, click the Assumptions tab. The Assumptions page opens, and defaults to the current quarter and year. Refer to Figure 23."	Page 21 - last paragraph	New policy and guidelines
11	Certifier User Guide	deleted figure 23 and text under figure "Figure 23: Assumptions" and "Note: Click the Reporting Period (required) tab in the top left to scroll through previous quarters. Use the drop-down menu to navigate to a previous quarter starting with the most recent quarter. Note: Click the Export to Excel box to download all products under the Assumptions tab."	Page 22	New policy and guidelines
12	Certifier User Guide	replaced "Create Assumption" with "Reasonable Assumptions"	Page 23 - top of page	New policy and guidelines
13	Certifier User Guide	added "Note: Certifiers cannot finalize the certification process until the Reasonable Assumptions Form is complete. If a drug manufacturer does not have additional information for the required response fields, please enter “N/A”." and "1. From the Medicare Part B Average Sales Price homepage, click the Assumptions tab. The Assumptions page opens, and defaults to the current quarter and year. Select the appropriate reporting period before clicking the Reasonable Assumptions (Required) tab . Refer to Figure 23."	Page 23 - under 3.3.1 header	New policy and guidelines
14	Certifier User Guide	added Figure 23 and text under figure "Figure 23: Assumptions" and "Note: Click the Reporting Period (Rrequired) tab in the top left to scroll through previous quarters."	Page 23 - header 1. From the Medicare Part B Average Sales Price homepage, click the Assumptions tab	New policy and guidelines
15	Certifier User Guide	replaced "1. Click the Create Assumption or Upload Assumption File button. The Create Assumption or Upload Assumption File window displays. The Module automatically defaults to the Reporting Period selected on the Assumptions default page with a Manufacturer Name (required) drop-down menu and empty Short Description and Text for Assumption file fields. Refer to Figure 24." to "2. Click the Reasonable Create Assumptions Form button. The Reasonable Assumption Form window displays. The Module automatically defaults to the Reporting Period selected on the Assumptions default page with a Manufacturer Name (required) drop-down menu and empty required response fields . Refer to Figure 24."	Page 23 - bottom of page to top of page 24	New policy and guidelines
16	Certifier User Guide	replaced figure 24 with a new figure 24 and replaced text "Figure 24: Assumptions - Create Assumption or Upload Assumption File" with "Figure 24: Reasonable Assumptions Form"	Pages 25 - 26	New policy and guidelines
17	Certifier User Guide	added text "4. Click “View All” to view all the required response fields. Refer to Figure 25. • Bona Fide Service Fees • Bundled Sales • Price Concessions and Discounts • Reporting of Products with Zero, Negative, or False Positive ASPs • Sales Excluded from Best Price • Sales to U.S. Territories • Time Value of Money • Free Goods Not Contingent on a Purchase Requirement • Value-Based Purchasing Agreements • Sales to 340B Covered Entities • Returned Goods • Billing Corrections"	Page 26 - bottom of page	New policy and guidelines
18	Certifier User Guide	added figure 25, text under figure 25 "Figure 25: “View All” Required Response Fields", and a note under the figure "Note: For drug manufacturers with contractual agreements, please enter comments in the Reasonable Assumptions form and complete the Bona Fide Service Fee Certification. Refer to Section 3.4 for instructions."	page 27 - top of page	New policy and guidelines
19	Certifier User Guide	added text "5. Complete all the required fields. Enter NA if reasonable assumptions are not available for a particular field. Note: Each required field allows for 1,000 characters of text to provide a summary of the assumption. If a response exceeds the character limit, submit or upload the additional verbiage on the Other Assumptions tab. Refer to Section 3.3.2 - Other Assumptions (Optional) for instructions."	page 27 - middle of page	New policy and guidelines
20	Certifier User Guide	added text "6. Click the Save Form button located at the bottom of the form. Refer to Figure 26."		New policy and guidelines
21	Certifier User Guide	added figure 26 and text "Figure 26: Save Reasonable Assumptions Form" under figure"	page 27 - last figure on page	New policy and guidelines
22	Certifier User Guide	added text under figure 26 "A message displays confirming you have successfully created your Reasonable Assumptions. The Module lists saved forms under Added Forms. Refer to Figure 27"	page 27 - bottom of page	New policy and guidelines
23	Certifier User Guide	replaced figure 25 with figure 27 and updated text under figure "Figure 27: New Assuption Successfully Saved"	page 28	New policy and guidelines
24	Certifier User Guide	added text "7.To make any necessary revisions before submitting, click the Edit button." and "8. If the submission does not require additional revisions, click the Submit button. A message displays confirming you have successfully submitted your Reasonable Assumptions. Refer to Figure 28."	page 28 - bottom of page	New policy and guidelines
25	Certifier User Guide	added figure 28 and text under figure "Figure 28: Reasonable Assumptions Successfully Submitted"	page 29 - top of page	New policy and guidelines
26	Certifier User Guide	added new text "3.3.2 Other Assumptions (Optional) This section provides instructions on how drug manufacturers can submit comments regarding their certifications to CMS via Create Assumptions or Upload Assumptions. 3.3.2.1 Create Assumptions Follow these steps to submit certification assumptions CMS: From the Medicare Part B Average Sales Price homepage, click the Assumptions tab. The Module automatically defaults to the Reasonable Assumptions (Required) Tab. Click the Other Assumptions (Optional) tab. Refer to Figure 29."	page 29 - under figure 28	New policy and guidelines
27	Certifier User Guide	added figure 29 and text under figure "Figure 29: Create Other Assumptions"	page 30 - top of page	New policy and guidelines
28	Certifier User Guide	added text "Note: Click the Reporting Period (required) tab in the top left to view previous quarters. Use the drop-down menu to navigate to select the appropriate quarter. 2. The Module automatically defaults to the Create Assumption radio button with a Manufacturer Name (required) drop-down menu and empty Short Description and Text for Assumption file (required) fields. Refer to Figure 29. 3. From the Manufacturer Name (required) drop-down menu, click the -Select- drop-down menu to expand the list and select the manufacturer name. 4. Complete the Short Description and Text for Assumption file fields. Note: The Short Description field is optional and allows 500 characters of text to provide a summary of the complete assumption you are submitting to CMS. The Text for Assumption file field is required and allows for 1,000 characters to provide as much detail as possible related to the selected period’s financial submission. 5. Click the Save Form button. A message displays confirming you have successfully created your Assumption. Refer to Figure 30."	page 30 - under figure 29	New policy and guidelines
29	Certifier User Guide	added figure 30 and text under figure "Figure 30: Other Assumptions Saved Successfully"	page 31 - top of page	New policy and guidelines
30	Certifier User Guide	replaced "3.3.2" with "3.3.2.2"	page 31 - under figure 30	Formatting
31	Certifier User Guide	replaced "1. Click the Create Assumption or Upload Assumption File tab." with "1. Click the Other Assumptions (Optional) file tab."	page 31 - under 3.3.2.2 header	New policy and guidelines
32	Certifier User Guide	replaced "A Manufacturer Name (required) drop-down menu and empty File Description field display. Refer to Figure 26." with ""A Manufacturer Name (required) drop-down menu and empty File Description (required) field display. Refer to Figure 31."	page 31 - right above figure 31	New policy and guidelines
33	Certifier User Guide	replaced figure 31 with a new figure and revised text under 31 to say "Figure 31: Upload Assumptions"	pages 31 - 32	New policy and guidelines
34	Certifier User Guide	deleted text "As you select your manufacturer name, additional fields display on the screen. Refer to Figure 27."	page 32	New policy and guidelines
35	Certifier User Guide	deleted figure 27 and text under figure	page 33	New policy and guidelines
36	Certifier User Guide	deleted text "Note: Click the Show More tab to display all Supported File Formats available in the Module for you to use in your Assumption File upload."	page 33	New policy and guidelines
37	Certifier User Guide	deleted text "refer to Figure 28"	page 33	New policy and guidelines
38	Certifier User Guide	deleted figure 28 and text under figure "Figure 28: Upload Assumption File - Uploading Files From Desktop	page 34	New policy and guidelines
39	Certifier User Guide	deleted text "A download bar displays as your file uploads"	page 34	New policy and guidelines
40	Certifier User Guide	replaced "Figure 29" with Figure 34"	page 34	New policy and guidelines
41	Certifier User Guide	added two figures	page 35	New policy and guidelines
42	Certifier User Guide	replaced text "29" with "34"	page 35	New policy and guidelines
43	Certifier User Guide	added text "3.4 Bona Fide Service Fee Certification Follow these steps to submit a Bona Fide Service Fee Certification to CMS: 1. From the Medicare Part B Average Sales Price homepage, click the Bona Fide Service Fee Certification tab. The Bona Fide Service Fee Certification page opens and defaults to the current quarter and year. Refer to Figure 35. 2. The Module automatically defaults to the current reporting period. Select the accurate reporting period before proceeding. 3. Select the Manufacturer Name in the drop-down menu. 4. Download, complete, and sign the Bona Fide Service Fee Certification Form. The fields to complete are as follows: Section 1: Enter all drug and manufacturer information associated with the bona fide service fee • Drug Name(s): • HCPCS code(s): • Manufacturer name: • Manufacturer address: Section 2: Recipient of BFSF information • Name and title of certifying individual: • Organization or entity name: • Organization or entity address: • Bona fide service: • Bona fide service fee amount (if the fee varies based on certain metrics, describe the conditions of the fee and how it is determined): Section 3.: Certification Statement • I certify that the fee is not passed on in whole or in part to an affiliate, client, or customer of an entity. • Manufacturer Signature: • Fee Recipient Signature: 5. Save the completed form to your computer. Upload the form once completed.	pages 35-36	New policy and guidelines
44	Certifier User Guide	added figure 35 and text under figure "Figure 35: Bona Fide Service Fee Certification Submission	page 36	New policy and guidelines
45	Certifier User Guide	replaced "3.4" with "3.5"	page 37	Formatting
46	Certifier User Guide	replaced "30" with "36"	page 37	Formatting
47	Certifier User Guide	replaced "31" with" "37"	page 37	Formatting
48	Certifier User Guide	replaced "32" with "38"	page 38	Formatting
49	Certifier User Guide	replaced "33" with "39"	page 38	Formatting
50	Certifier User Guide	replaced "3.4.1" with "3.5.1"	page 39	Formatting
51	Certifier User Guide	replaced "34" with "40"	page 40	Formatting
52	Certifier User Guide	replaced "35" with "41"	page 41	Formatting
53	Certifier User Guide	replaced "3.4.2" with "3.5.2"	page 41	Formatting
54	Certifier User Guide	replaced "36" with 42"	page 42	Formatting
55	Certifier User Guide	replaced "37" with "figure 43"	page 43	Formatting
56	Certifier User Guide	replaced "3.4.3" with "3.5.3"	page 43	Formatting
57	Certifier User Guide	replaced "38" with "44"	page 44	Formatting
58	Certifier User Guide	replaced "39" with "45"	page 45	Formatting
59	Certifier User Guide	replaced "40" with "46"	page 46	Formatting
60	Certifier User Guide	replaced "3.4.4" with "3.5.4"	page 46	Formatting
61	Certifier User Guide	replaced "41" with 47"	page 47	Formatting