Miscellaneous Tasks: Applicant Follows-Up, Applicant Gives Further Clarification of Data or Gives Further Application Information to CMS

PRA for the Add-On Payments for New Medical Services and Technologies Policy(CMS-10638)

FY_2018_New_Technology_Cost_Spreadsheet Example.xlsx

Miscellaneous Tasks: Applicant Follows-Up, Applicant Gives Further Clarification of Data or Gives Further Application Information to CMS

OMB: 0938-1347

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Example of How to Submit and Case Weight Data for Cost Criterion

As explained in the application applicants must meet a “cost threshold”. The applicant submits data to CMS verifying that the average charge per case exceeds the MS-DRG threshold published in Table 10 of the IPPS final rule. If the technology is across multiple MS-DRGs then the case-weighted average standardized charge per case must exceed the case-weighted threshold by MS-DRG. Applicants can submit a sample of data demonstrating they meet the cost criteria using multiple source(s) such as: MedPAR, Clinical Trial Claims Data, External (non MedPAR) data; Premier, other non Medicare claims databases, actual claims the manufacturer collects from hospitals.
MS-DRG Cases Case Weighted Amount (Take the Cases for Each DRG in Column B and Divide by the Total Amount of Cases in Column B) Table 10 Threshold Table 10 Case Weighted Threshold (Column C * D) Average Charge Per Case (Unstandardized with No Case Weight) 1Remove Charges for the Prior Technology or the Technology Being Replaced 2Remove Charges Related to the Prior Technology or the Technology Being Replaced Adjusted Average Charge Per Case (Unstandardized with No Case Weight) (Column F+G+H) Average Standardized Charge Per Case (Standardize the Claims Used to Compute the Amount in Column I) 3Inflation Factor Inflated Average Standardized Charges Per Case (Column J * (1+Column K)) 4Add Charges for the New Technology (Inflate if Appropriate) 5Add Charges Related to the Case or Technology (Inflate if Appropriate) Final Average Inflated Standardized Charge Per Case (Column L+M+N) Final Inflated Case Weighted Standardized Charge Per Case (Column C * O)
220 20 40.00% $75,000 $30,000 $75,000 ($2,000) ($1,000) $72,000 $68,000 10.00% $74,800 $1,000 $500 $76,300 $30,520
221 30 60.00% $65,000 $39,000 $65,000 ($2,000) ($1,000) $62,000 $58,000 10.00% $63,800 $1,000 $500 $65,300 $39,180
Total 50 100%
$69,000









$69,700
Note: Since the total amount in column P exceeds the total amount in column E, the technology meets the cost criteria.














Example of Form CMS-10638 Expires XX/XX/2020












Footnotes














1Remove Charges for the (Actual) Prior Technology (for example, if the technology is replacing the implanatation of a different device, remove charges for the previous device; Do not remove other related charges such as operating room (OR) and/or intensive care unil (ICU) charges in this column). Some applications may not need to do this.





2Remove Charges Related to the Prior Technology (for example, if the technology is replacing the implantation of a different device and requires less or more OR time and ICU days, remove all OR and ICU charges). Some applications may not need to do this (for example, If the new technology uses the same resources and charges as the previous technology then no removal is necessary).





3For example, applicants can use the charge inflation from the annual final rule that is used in the outlier threshold determination. Alternative factors are also acceptable with explanation.





4Add Charges for the New Technology (only those charges for the new technology such as the drug or device; Do Not Include Other Charges Such As OR or ICU Charges in This Column)





5Add Charges Related to the New Technology (For Example, Add Related Charges Such As OR and ICU).





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