Formulary and Benefit Administration (FA) protocols help to evaluate performance in the Centers for Medicare and Medicaid Services (CMS) Program Audit Protocol and Data Request related to Medicare Part D FA. The CMS performs its program audit activities in accordance with the FA Program Audit Data Request and applies compliance standards outlined in this Program Audit Protocol and the Program Audit Process Overview document. At a minimum, CMS will evaluate cases against the criteria listed below. CMS may review factors not specifically addressed below if it is determined that there are other related FA requirements not being met.
Audit Elements Tested
- Formulary Administration
- Transition
Inovaare compiled these tables from information contained within the CMS website and displayed the 2022 audit protocol changes in an easy-to-follow format. The red font indicates critical areas health plans need to address and the blue font indicates the actual data required. This table is available for download through the link at the bottom of the page.
Table 1: RCFA
| COLUMN ID | FIELD NAME | FIELD LENGTH | DESCRIPTION |
| A | Enrollee ID | 11 CHAR | Enter the Medicare Beneficiary Identifier (MBI) of the enrollee. An MBI is the non-intelligent unique identifier that replaced the HICN on Medicare cards as a result of The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. The MBI contains uppercase alphabetic and numeric characters throughout the 11-digit identifier and is unique to each Medicare enrollee. This number must be submitted excluding hyphens or dashes. |
| B | Enrollee First Name | 50 CHAR | Enter the first name of the enrollee. |
| C | Enrollee Last Name | 50 CHAR | Enter the last name of the enrollee. |
| D | Date of Birth | 10 CHAR | Enter the date of birth of the enrollee. Submit in CCYY/MM/DD format (e.g., 1940/01/01). |
| E | Enrollment Effective Date | 10 CHAR | Enter effective date of enrollment for the enrollee (PBP level). Enter the enrollment date relevant to the contract and plan ID of the enrollee at the time of the claim. Submit in CCYY/MM/DD format (e.g., 2020/01/01). |
| F | Effective Disenrollment Date | 10 CHAR | Enter effective date of disenrollment for the enrollee (PBP level). Enter the disenrollment date
relevant to the contract and plan ID of the enrollee at the time of the
claim. Submit in CCYY/MM/DD format (e.g., 2020/02/01). Enter NA if the enrollee was not disenrolled. |
| G | Cardholder ID | 20 CHAR | Enter cardholder identifier used to identify the enrollee. This is assigned by the sponsoring organization. |
| H | Contract ID | 5 CHAR | Enter the contract number (e.g., H1234) of the sponsoring organization. |
| I | Plan Benefit Package (PBP) | 3 CHAR | Enter the PBP (e.g., 001). |
| J | NDC | 11 CHAR | Enter the 11-Digit National Drug Code
using the NDC 11 format. Remove special characters separating the labeler, product, and trade package size. When less than 11 characters or a blank field is submitted by the pharmacy or delegate, populate the field as submitted. If the pharmacy submits a value greater than 11 characters, enter “valueXeeded” in the field. For multi-ingredient compound claims populate the field with the NDC as would be submitted on a paid claim’s PDE. |
| K | Date of Service | 10 CHAR | Enter the date of fill for the rejected claim. Submit in CCYY/MM/DD format (e.g., 2020/01/01). |
| L | Date of Rejection | 10 CHAR | Enter the date of rejection for the drug claim. Submit in CCYY/MM/DD format (e.g., 2020/01/01). |
| M | Claim Quantity | 11 CHAR | Enter the number of drug dosage units entered in the claim (e.g., 30 [tablets], 0.42 [milliliters of liquid]), including decimal values, when applicable. Units of measurement should not to be reported. |
| N | Claim Days Supply | 3 NUM | Enter the days’ supply of the drug entered on the claim (e.g., 30 [days]). Units of measurement should not to be reported. |
| O | Patient Residence | 5 CHAR | Enter the patient residence code for the enrollee as submitted by the pharmacy on the claim. While this may typically be an NCPDP value, other values submitted on the claim would be accepted. |
| P | Pharmacy Service Type | 5 CHAR | Enter the Pharmacy service type as submitted by the pharmacy on the rejected claim. While this may typically be an NCPDP value, other values submitted on the claim would be accepted. |
| Q | Compound Code | 1 CHAR | Enter code indicating whether or not the drug claim was for a
compounded product. Valid values are: 0 = Not specified 1 = Not a Compound 2 = Compound |
| R | Reject Reason Code | 7 CHAR | Enter the reason code associated with the rejected claim. This field should
always be followed by the pharmacy message field. All reject codes associated
with a claim must be included. Repeat the Reject Reason Code field as many times as needed to capture each individual reject reason code, followed by the corresponding pharmacy messaging related to the rejected claim. When a pharmacy message is generated without a reject reason code, enter NA in the reject reason code field. |
| S | Pharmacy Message | 1000 CHAR | All pharmacy messages associated with the rejected claim must be included. If
there are multiple messages associated with a single reject code, Sponsoring
organizations must include all applicable messaging in the same message field
(e.g., reject code 1: list all pharmacy messages, reject code 2: list all
pharmacy messages, reject code 3: list all pharmacy messages). Repeat the Pharmacy Message field as needed after each reject reason code submitted. For pharmacy messages generated in the absence of a reject reason code, enter NA in the reject reason code field preceding the pharmacy message field. Likewise, when a reject reason code is generated without a related pharmacy message, enter NA in the pharmacy message field. NOTE: In limited circumstances, when the messaging cannot be separated for purposes of populating the universe, Sponsoring organizations may choose to include all pharmacy messaging in the first pharmacy message field only. For subsequent reject codes, please enter NA in the associated pharmacy message fields. |
Table 2: RCT
| COLUMN ID | FIELD NAME | FIELD LENGTH | DESCRIPTION |
| A | Enrollee ID | 11 CHAR | Enter the Medicare Beneficiary Identifier (MBI) of the enrollee. An MBI is the non-intelligent unique identifier that replaced the HICN on Medicare cards as a result of The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. The MBI contains uppercase alphabetic and numeric characters throughout the 11-digit identifier and is unique to each Medicare enrollee. This number must be submitted excluding hyphens or dashes. |
| B | Enrollee First Name | 50 CHAR | Enter the first name of the enrollee. |
| C | Enrollee Last Name | 50 CHAR | Enter the last name of the enrollee. |
| D | Date of Birth | 10 CHAR | Enter the date of birth of the enrollee. Submit in CCYY/MM/DD format (e.g., 1940/01/01). |
| E | Enrollment Effective Date | 10 CHAR | Enter effective date of enrollment for the enrollee (PBP level). Enter the enrollment date relevant to the contract and plan ID of the enrollee at the time of the claim. Submit in CCYY/MM/DD format (e.g., 2020/01/01). |
| F | Effective Disenrollment Date | 10 CHAR | Enter effective date of disenrollment for the enrollee (PBP level). Enter the disenrollment date
relevant to the contract and plan ID of the enrollee at the time of the
claim. Submit in CCYY/MM/DD format (e.g., 2020/02/01). Enter NA if the enrollee was not disenrolled. |
| G | Cardholder ID | 20 CHAR | Enter cardholder identifier used to identify the enrollee. This is assigned by the sponsoring organization. |
| H | Contract ID | 5 CHAR | Enter the contract number (e.g., H1234) of the sponsoring organization. |
| I | Plan Benefit Package (PBP) | 3 CHAR | Enter the PBP (e.g., 001). |
| J | NDC | 11 CHAR | Enter the 11-Digit National Drug Code using the NDC 11 format. Remove special characters separating the labeler, product, and trade package
size. When less than 11 characters or a blank field is submitted by the pharmacy or delegate, populate the field as submitted. If the pharmacy submits a value greater than 11 characters, enter “valueXeeded” in the field. For multi-ingredient compound claims populate the field with the NDC aswould be submitted on a paid claim’sPDE. |
| K | Date of Service | 10 CHAR | Enter the date of fill for the rejected claim. Submit in CCYY/MM/DD format (e.g., 2020/01/01). |
| L | Date of Rejection | 10 CHAR | Enter the date of rejection for the drug claim. Submit in CCYY/MM/DD format (e.g., 2020/01/01). |
| M | Claim Quantity | 11 CHAR | Enter the number of drug dosage units entered in the claim (e.g., 30 [tablets], 0.42 [milliliters of liquid]), including decimal values, when applicable. Units of measurement should not to be reported. |
| N | Claim Days Supply | 3 NUM | Enter the days’ supply of the drug entered on the claim (e.g., 30 [days]). Units of measurement should not to be reported. |
| O | Patient Residence | 5 CHAR | Enter the patient residence code for the enrollee as submitted by the pharmacy on the claim. While this may typically be an NCPDP value, other values submitted on the claim would be accepted. |
| P | Pharmacy Service Type | 5 CHAR | Enter the Pharmacy service type as submitted by the pharmacy on the rejected claim. While this may typically be an NCPDP value, other values submitted on the claim would be accepted. |
| Q | Compound Code | 1 CHAR | Enter code indicating whether or not the drug claim was for a
compounded product. Valid values are: 0 = Not specified 1 = Not a Compound 2 = Compound |
| R | Reject Reason Code | 7 CHAR | Enter the reason code associated with the rejected claim. This field should
always be followed by the pharmacy message field. All reject codes associated
with a claim must be included. Repeat the Reject Reason Code field as many times as needed to capture each individual reject reason code, followed by the corresponding pharmacy messaging related to the rejected claim. When a pharmacy message is generated without a reject reason code, enter NA in the reject reason code field. |
| S | Pharmacy Message | 1000 CHAR | All pharmacy messages associated with the rejected claim must be included. If
there are multiple messages associated with a single reject code, Sponsoring
organizations must include all applicable messaging in the same message field
(e.g., reject code 1: list all pharmacy messages, reject code 2: list all
pharmacy messages, reject code 3: list all pharmacy messages). Repeat the Pharmacy Message field as needed after each reject reason code submitted. For pharmacy messages generated in the absence of a reject reason code, enter NA in the reject reason code field preceding the pharmacy message field. Likewise, when a reject reason code is generated without a related pharmacy message, enter NA in the pharmacy message field. NOTE: In limited circumstances, when the messaging cannot be separated for purposes of populating the universe, Sponsoring organizations may choose to include all pharmacy messaging in the first pharmacy message field only. For subsequent reject codes, please enter NA in the associated pharmacy message fields. |
Table 3: PDE
| COLUMN ID | FIELD NAME | FIELD LENGTH | DESCRIPTION |
| A | Enrollee ID | 11 CHAR | Enter the Medicare Beneficiary Identifier (MBI) of the enrollee. An MBI is the non-intelligent unique identifier that replaced the HICN on Medicare cards as a result of The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. The MBI contains uppercase alphabetic and numeric characters throughout the 11-digit identifier and is unique to each Medicare enrollee. This number must be submitted excluding hyphens or dashes. |
| B | Enrollee First Name | 50 CHAR | Enter the first name of the enrollee. |
| C | Enrollee Last Name | 50 CHAR | Enter the last name of the enrollee. |
| D | Date of Birth | 10 CHAR | Enter the date of birth of the enrollee. Submit in CCYY/MM/DD format (e.g., 1940/01/01). |
| E | Cardholder ID | 20 CHAR | Enter cardholder identifier used to identify the enrollee. This is assigned by the sponsoring organization. |
| F | Contract ID | 5 CHAR | Enter the contract number (e.g., H1234) of the sponsoring organization. |
| G | Plan Benefit Package (PBP) | 3 CHAR | Enter the PBP (e.g., 001). |
| H | NDC | 11 CHAR | Enter the 11-Digit National Drug Code using the NDC 11 format. Remove special characters
separating the labeler, product, and trade package size. When less than 11 characters or a blank field is submitted by the pharmacy or delegate, populate the field as submitted. If the pharmacy submits a value greater than 11 characters, enter “valueXeeded” in the field. For multi-ingredient compound claims populate the field with the NDC as would be submitted on a paid claim’s PDE. |
| I | Date of Service | 10 CHAR | This field contains the date on which the prescription was filled. Submit in CCYY/MM/DD format (e.g., 2020/01/01). |
| J | Claim Quantity | 11 CHAR | Enter the number of drug dosage units entered in the claim (e.g., 30 [tablets], 0.42 [milliliters of liquid]), including decimal values, when applicable. Units of measurement should not to be reported. |
| K | Claim Days Supply | 3 NUM | Enter the days’ supply of the drug entered on the claim (e.g., 30 [days]). Units of measurement should not to be reported. |
| L | Compound Code | 1 CHAR | Enter code indicating whether or not the drug claim was for a
compounded product. Valid values are: 0 = Not specified 1 = Not a Compound 2 = Compound |
Table 4: NE
| COLUMN ID | FIELD NAME | FIELD LENGTH | DESCRIPTION |
| A | Enrollee ID | 11 CHAR | Enter the Medicare Beneficiary Identifier (MBI) of the enrollee. An MBI is the non-intelligent unique identifier that replaced the HICN on Medicare cards as a result of The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. The MBI contains uppercase alphabetic and numeric characters throughout the 11-digit identifier and is unique to each Medicare enrollee. This number must be submitted excluding hyphens or dashes. |
| B | Enrollee First Name | 50 CHAR | Enter the first name of the enrollee. |
| C | Enrollee Last Name | 50 CHAR | Enter the last name of the enrollee. |
| D | Date of Birth | 10 CHAR | Enter the date of birth of the enrollee. Submit in CCYY/MM/DD format (e.g., 1940/01/01). |
| E | Enrollment Effective Date | 10 CHAR | Enter the effective date of enrollment for the enrollee (PBP level). Submit in CCYY/MM/DD format (e.g., 2020/01/01). In this table only, a separate record should be entered each time an enrollee is enrolled and considered a new enrollee. |
| F | Effective Disenrollment Date | 10 CHAR | Enter the effective date of
disenrollment for the enrollee (PBP level). Submit in CCYY/MM/DD format (e.g., 2020/02/01). Enter NA if the enrollee was not disenrolled |
| G | Cardholder ID | 20 CHAR | Enter cardholder identifier used to identify the enrollee. This is assigned by the sponsoring organization. |
| H | Contract ID | 5 CHAR | Enter the contract number (e.g., H1234) of the sponsoring organization. |
| I | Plan Benefit Package (PBP) | 3 CHAR | Enter the PBP (e.g., 001). |
- Yellow: Audit Review Period
- Blue: valid values
Disclaimer: The data included in these tables are transposed directly from the CMS website and have not been edited for grammar and format consistency. Inovaare distilled the content for your convenience and educational purposes; it should not be used as a substitute for health plan compliance team authorization. Due to the unique needs of health plans, the reader should consult her or his compliance officer to determine the appropriateness of the information contained herein.