Medicare Part C UM Audits

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Overview

Instructions
Services Selected by CMS
Internal Coverage Criteria

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Sheet 1: Instructions

Instructions for Populating the Analysis of Internal Coverage Criteria

General

• Enter information for each policy or document containing internal coverage criteria into a new worksheet.

o This includes criteria used by the organization (parent), by all FDRs, and criteria used by both the organization and FDRs.

• Enter all internal coverage criteria applicable to the services selected by CMS. For the purposes of the Analysis of Internal Coverage Criteria, “service” is meant to include all Medicare services, items and Part B drugs.

• If multiple iterations of the same internal coverage policies or documents were used in the applicable calendar year (because the policies/documents were revised), organizations must enter all of the criteria, from all of the policies and documents that were in use in the calendar year.

Services Selected by CMS Tab

The services selected by CMS for this audit will be identified in the ‘Targeted Services Selected by CMS’ tab of the workbook.

Standardized Formatting Tab (List of Internal Coverage Criteria)

Part 1: Coverage Criteria for Medicare Advantage

Organizations must enter all information as requested in the following fields.

Service Name:

• The services selected by CMS for this audit will be identified in the ‘Services Selected by CMS’ tab of the workbook.

• Organizations must enter the name of the service that corresponds to the criteria entered into the applicable tab.

Criteria Policy/Document Name or Identifier:

• Organizations must enter the unique name, number, and/or other identifier assigned to the internal criteria policy or document developed for the Medicare service.

• The criteria name or identifier submitted on the standardized form should match the name, number, and/or identifier of the publicly available version, if applicable.

• Organizations must create a copy of the ‘Internal Coverage Criteria’ tab and enter each unique policy or document containing internal coverage criteria into a new tab.

MA Organization and/or FDR Name(s):

• Organizations must enter the name(s) of the MA Organization and/or all FDRs that utilize the internal coverage criteria identified in the applicable policy or document.

• If the organization (the parent organization) does not utilize the internal coverage criteria in the applicable policy or document, but one or more FDRs does utilize the internal coverage criteria, only enter the names of the FDRs that utilize the internal coverage criteria. Likewise, if the internal coverage criteria are only utilized by the organization and not the FDRs, only enter the name of the organization.

Applicable MAC Jurisdiction(s):

• Organizations must enter the Medicare Administrative Contractor (MAC) jurisdiction(s) where the internal coverage criteria is applicable.

• Enter the applicable jurisdiction code(s). For example, if the criteria is for a Medicare Part A or B service in Kansas, enter J-5. MAC jurisdiction codes can be found at: https://www.cms.gov/medicare/coding-billing/medicare-administrative-contractors-macs/who-are-macs

• Organizations may enter “All” if the criteria is applicable in all MAC jurisdictions.

Date Coverage Criteria Last Updated

• Enter the MM/DD/YYYY that the coverage criteria were last revised for any reason.

• If the coverage criteria have never been revised since implementation, enter the date the coverage criteria were first implemented by your organization.

Part 2: Analysis for Internal Coverage Criteria

The organization must enter the internal coverage criteria contained in the policy or document identified in Part 1. As a reminder, each policy or document containing criteria must be entered in a new worksheet.

If a policy contains criteria applicable to both Medicare members and other types of members (e.g. commercial), only enter internal coverage criteria applicable to your Medicare members.

• Do not enter criteria applicable to commercial members or other lines of business unless that criteria is utilized to render medical necessity decisions for Medicare members.

If your internal coverage criteria policies also contain CMS requirements (e.g., from sources such as statutes, regulations, NCDs, LCDs) do not enter those requirements.

Columns A through E must be completed by the MAO for each service selected by CMS.

Column F will be complete by CMS, once columns A through E are completed by the organization and the workbook is returned to CMS.

Column G must be completed by the MAO if the criteria is selected by CMS (in column F).

Column A:

• The column is pre-populated with unique identifiers, from 1 through 100. If there are more than 100 internal coverage criteria in a particular policy or document, organizations must enter additional unique and sequential numeric identifiers for each criterion after 100.

• Organizations must add as many rows as needed based on the internal criteria for the service.

• Each internal coverage criterion must have its own unique identifier.

Column B:

• Enter the language for each unique internal coverage criterion.

• All unique internal coverage criterion must be entered in a new row in column B.

Column C:

• For each internal coverage criterion, organizations must identify whether the criterion was created pursuant to § 422.101(b)(6)(i)(A), (B) or (C).

• Organizations must enter A, B, or C.

o Organizations are not required to enter § 422.101(b)(6)(i) in each row.

Column D:

Organizations should only complete Column D when internal coverage criteria is interpreting or supplementing Medicare coverage rules (when the response in column C is ‘A’).

• For each unique internal coverage criterion entered in Column B (that is either interpreting or supplementing a Medicare rule), enter the specific language from the Medicare rule (statute, regulation, NCD, LCD) that is being interpreted or supplemented.

• Language in Column D must be the verbatim text in the Medicare source (statute, regulation, manual, NCD or LCD)

• Do not enter all of the Medicare language related to the service. Only enter the language the internal coverage criterion is interpreting or supplementing.

• If internal coverage criterion is not interpreting or supplementing Medicare criteria pursuant to § 422.101(b)(6)(i)(A), enter NA.

Example:

• An NCD indicates that Medicare will cover a service when an individual is experiencing, “severe chronic pain.”

• The organization created an internal coverage criterion to define (interpret) severe pain as being greater than 6 on the Numeric Rating Scale (NRS) pain scale.

• In column B the organization must enter, “Greater than 6 on the NRS pain scale.”

• In column C the organization must enter, “A.”

• In column D the organization must enter, “severe chronic pain.”

Column E:

Organizations should complete Column E when internal coverage criteria is interpreting or supplementing Medicare coverage rules OR when internal coverage criteria is created because NCDs or LCDs include flexibility that explicitly allows for coverage in circumstances beyond the specific indications that are listed in an NCD or LCD (when the response in column C is ‘A’ or ‘B’).

• For each unique internal coverage criterion entered in Column B that was created pursuant to the authority in § 422.101(b)(6)(i)(A), enter the Medicare rule (statute, regulation, NCD, LCD) that is being interpreted or supplemented.

• For each unique internal coverage criterion entered in Column B that was created pursuant to the authority in § 422.101(b)(6)(i)(B), enter the NCD or LCD that explicitly allows flexibility.

• The source should be as specific as possible when appropriate. For example, a direct regulatory citation (42 C.F.R. § 412.3(d)) or an LCD number (L33797) is preferrable to a general citation.

• If the internal coverage criterion was created pursuant to the authority in § 422.101(b)(6)(i)(C), enter "NA."

Column F:

Organizations may not complete column F.

• Column F will be completed by CMS, once the workbook is returned with columns A-E completed by the organization.

• CMS will enter 'X' if the criterion in is selected.

Column G:

Important - Organizations should only complete column G if requested by CMS in column F.

• Do not complete column G before returning the workbook to CMS with columns A-E completed.

• Once CMS receives the workbook we will review columns A-E and determine which internal coverage criterion will be selected for additional review.

o CMS may select all of the criteria for additional review or narrow the scope of the review at our discretion.

• CMS will return the workbook to the organization with column F completed.

• Once the organization receives the workbook with column F completed, they must complete column G for the selected internal coverage criterion.

• When completing column G:

o For each internal coverage criterion, enter ALL evidentiary sources that support the creation of the internal coverage criterion.

o If there are multiple sources for a single internal coverage criterion, list all sources for the applicable criterion in a single cell.

o Each citation must be clear and specific and include information that leads directly to the portion of the evidence that supports the applicable criterion (page number, paragraph number, etc.).

o Organizations may use AMA style citations, but any format is acceptable as long as it leads directly to the applicable evidence.

o If the citation does not lead directly to the supporting evidence OR if CMS cannot access the applicable evidence, CMS may require submission of the supporting evidence and/or submission of the applicable text from the supporting evidence.

• Once column G is completed, the organization will return the workbook to CMS.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is OMB 0938-New. This information collection will allow CMS to conduct a comprehensive review of Sponsoring organizations’ compliance with Medicare Part C utilization management (UM) requirements. The time required to complete this information collection is estimated at 410 hours per response, including the time to review instructions, search existing data resources, gather the data needed, to review and complete the information collection. This information collection is mandatory per CMS’s authority under Section 1857(d) of the Social Security Act and implementing regulations at 42 CFR § 422.503 and § 422.504, which state that CMS must oversee a Medicare Advantage (MA) organization’s continued compliance with the requirements for a MA organization. Additionally, per § 422.516(a), MA organizations are required to compile and report to CMS information related to the utilization of services, and other matters as CMS may require. If you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

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Sheet 2: Services Selected by CMS

List of Targeted Services Selected by CMS
Applicable Calendar Year:	{CMS will enter the applicable calendar year}
Number	Name of Service	Brief Description of Service (if applicable)
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Sheet 3: Internal Coverage Criteria

General Instructions
Enter information for each policy or document containing internal coverage criteria into a new worksheet.
• This includes criteria used by the organization (parent), by all FDRs, and criteria used by both the organization and FDRs.
For the purposes of the Analysis of Internal Coverage Criteria, “service” is meant to include all Medicare services, items and Part B drugs.
Part 1: Coverage Criteria for Medicare Advantage
Service Name:	{Insert Name of Medicare Service}
Criteria Policy/Document Name or Identifier:	{Insert the unique name, number, and/or other identifier assigned to the internal criteria policy or document developed for the Medicare service}
MA Organization and/or FDR Name(s):	{Enter the name(s) of the MA Organization and/or all FDRs that utilize the internal coverage criteria}
Applicable MAC Jurisdiction(s):	{Enter the applicable MAC jurisdictions or enter All if criteria is applicable nationally}	Link to MAC Jurisdiction Information: https://www.cms.gov/medicare/coding-billing/medicare-administrative-contractors-macs/who-are-macs
Date Coverage Criteria Last Updated	{Insert in MM/DD/YYYY format the date the coverage criteria were last revised for any reason}
Part 2: Analysis for Internal Coverage Criteria
In Part 2, the Medicare Advantage Organization (MAO) must enter the internal coverage criteria contained in the policy or document identified in Part 1. As a reminder, each policy or document containing criteria must be entered in a new worksheet.
If your policy contains criteria applicable to both Medicare members and other types of members (e.g. commercial), only enter internal coverage criteria applicable to your Medicare members.
If your internal coverage criteria policies also contain CMS requirements (e.g., from sources such as statutes, regulations, NCDs, LCDs) do not enter those requirements.
Columns A through E: These columns must be completed by the MAO. See each column for guidance.
Column F: This column will be complete by CMS, once columns A through E are completed by the Medicare Advantage Organization and the workbook is returned to CMS.
Column G: This column must be completed by the MAO if the criteria is selected by CMS (in column F).
Column A	Column B	Column C	Column D	Column E	Column F	Column G
To be completed by the MAO (if necessary)	To be completed by the MAO	To be completed by the MAO	To be completed by the MAO	To be completed by the MAO	To be completed by CMS	To be completed by the MAO upon CMS request.
Unique Identifier The first 100 unique identifiers are pre-populated. Enter additional unique and sequential numeric identifiers for each criterion if there are more than 100 criterion.	Internal Coverage Criterion Language Enter the language for each unique internal coverage criterion. Enter each unique internal coverage criterion in a new row.	Identify if the internal coverage criterion was created pursuant to the authority in § 422.101(b)(6)(i)(A), (B) or (C). Enter A, B, or C. Example: A	For internal coverage criterion that is interpreting or supplementing Medicare criteria pursuant to § 422.101(b)(6)(i)(A): Insert the specific language from the Medicare rule (e.g., NCD or LCD) that is being interpreted or supplemented. If internal coverage criterion is not interpreting or supplementing Medicare criteria pursuant to § 422.101(b)(6)(i)(A), enter NA. Example (from NCD 210.2): There is evidence (on the basis of her medical history or other findings) that she is at high risk of developing cervical cancer	If the internal coverage criterion was created pursuant to the authority in § 422.101(b)(6)(i)(A) or § 422.101(b)(6)(i)(B), identify the applicable Medicare rule (i.e., statute, regulation, NCD, LCD, etc.). If the internal coverage criterion was created pursuant to the authority in § 422.101(b)(6)(i)(C), enter "NA." Example: NCD 210.2	Internal Coverage Criterion Selected for Review by CMS CMS will enter 'X' if the criterion in is selected.	In each row, enter ALL evidentiary sources that were relied upon to create the internal coverage criterion. If there are multiple sources for a single internal coverage criterion, list all sources for the applicable criterion in a single cell. Each citation must be clear and specific and include information that leads directly to the portion of the evidence that supports the applicable criterion (page number, paragraph number, etc.) such as (Smith, 2022, para. 3). Organizations may use AMA style citations, but any format is acceptable as long as it leads directly to the applicable evidence. If the citation does not lead directly to the supporting evidence OR if CMS cannot access the applicable evidence, CMS may require submission of the supporting evidence and/or submission of the applicable text from the supporting evidence. Enter NA if there is no direct source that supports this criterion.
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