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CMS Program Audit Universe Preparation M. Juhanson

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Michelle Juhanson, CHC, CHPC

Michelle Juhanson discusses preparing data universes for submission to CMS, emphasizing the importance of accurate data for audits. The presentation highlights CMS's expectations, consequences of universe errors, and best practices for compliance. Key topics include universe requirements, common failures, and specific record layouts for standard coverage determinations.

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Prepare Data Universe for Appropriate Submission to CMS Michelle Juhanson, CHC, CHPC Director, Compliance & Quality Pharmacy Benefit Oversight and Compliance Conference – November 12-13, 2015
Speaker’s Disclaimer • Michelle Juhanson, CHC, CHPC does not have any financial conflicts to disclose. • This presentation was prepared or accomplished by Michelle Juhanson, CHC, CHPC in her personal capacity. The opinions expressed in this presentation are the speaker’s own and do not reflect the view of PerformRx. • The speaker is not promoting any service or product. 2
Speaker Introduction Michelle Juhanson, CHC, CHPC Director, Compliance and Quality • 10 years of Part D compliance experience in multiple settings: Part D IRE, plan sponsor, and PBM • Accountable for PBM responses to numerous CMS audits for clients in 12 states and the District of Columbia since 2007 – Program audits – 1/3 financial audits – PDE data validation – Transition monitoring – Formulary administration • Oversaw PBM responses to more than 250 external audits since 2007 • Compliance Officer at PerformRx • Directs integrity audit and rejected claims processes at PerformRx • Chair of the PerformRx Compliance, Quality, and Star Alliance Committees • Member of the Health Care Compliance Association and certified in Health Care Compliance (CHC) as well as Health Care Privacy Compliance (CHPC) • Speaks on issues of compliance and quality at industry conferences nationwide UPDATE- CMS Program Audit 2015- All CDAG and FA Universes passed CMS review. 0 CAR, 0 ICAR, 0 observation, no resubmission requests!!! 3
Presentation Goals • Understand purpose of a universe for any audit • Review CMS’ general universe collection/submission expectations • Identify typical universe problems • Understand consequences for universe failures • Learn CDAG and FA universe requirements • Review best practices and lessons learned • Q & A 4
WHY IS A UNIVERSE IMPORTANT FOR ANY AUDIT? What is a universe?
Why a universe is important • What the average person thinks Universe - (statistics) the entire aggregation of items from which samples can be drawn; it is an estimate of the mean of the population Synonyms: population • What an auditor means = 6
Why a universe is important “…from which samples can be drawn” • Samples give auditors a good idea of what is happening in the whole population • An accurate universe is necessary for audit integrity • Sample Selection • False Positives • False Negatives 7
CMS’ UNIVERSE COLLECTION & SUBMISSION EXPECTATIONS 3 strikes you’re out turns into foul ball
CMS’ universe expectations General Requirements • Provide accurate and timely universe within 15 business days of the engagement letter date. • Major changes to universe record layouts & submission timelines • CMS will hold a call with you to review the universe request and answer any questions- • Do - INVITE THE BUSINESS OWNERS WHO HAVE TO PULL THE UNIVERSE • Do - INVITE THE PBM • Don’t - Practice compliance hoarding 9
CMS’ universe expectations- What they said in June 2015 SUBMIT UNIVERSE 1 • 15 days to submit • If data issue identified…Strike 1 SUBMIT UNIVERSE 2 • If perfect, CMS will use this universe. • If there are still errors…Strike 2 SUBMIT UNIVERSE 3 • CMS will use this universe regardless. • No chance to revise universe • If you can’t get accurate data… Strike 3! 10
2015 -2016 Audit Protocols Calculation of Score Change • Invalid Data Submission (IDS) • IDS conditions will be cited when a sponsor is not able to produce an accurate universe within a maximum of 3 attempts. • IDS conditions will be worth one (1) point. CMS’ universe expectations- What they are saying now) 11
CONSEQUENCES FOR UNIVERSE FAILURES The thrill of victory and the agony of defeat
Consequences for universe failures • “Not having accurate universes can drastically affect your audit score” • “Poor audit results may lead to a referral for possible enforcement actions” • “…can adversely affect STAR ratings and past performance “ - Jennifer Smith CMS , Division of Analysis, Policy, & Strategy (DAPS) CMS Oversight & Enforcement Conference – June 16, 2015 13
Consequences for universe failures • After 2nd failed attempt – CMS will document “observation” in final audit report • After 3rd failed attempt – - Invalid Data Submission (IDS) “condition” in audit report for each element that cannot be tested grouped by the type of case. – UPDATE Automatic ICAR for every applicable condition/element and possible enforcement action • Example: if 11 audit conditions in Transition, CMS will issue 11 ICARs for Transition – If limited to one or two elements, ICAR cited per condition – Proof of ICAR correction not required on re-audit • Accurate universe(s) will be required on re-audit 14
Consequences for universe failures Why is this happening!? CMS Says: • Equity & consistency across audited sponsors • Efficiency and need to complete the audit • Plan sponsor accountability - collect and submit accurate data MJ Says: • Bad universes waste everyone’s time and resources • It’s your data. It’s 2015. Poor universes speak poorly of the organization. • An audit is only as good as the universe & they are time sensitive “An inability to pull a universe will adversely affect our ability to conduct the audit and your ability to complete the audit” - Jennifer Smith CMS , Division of Analysis, Policy, & Strategy (DAPS) 15
COMMON UNIVERSE PROBLEMS
Common universe problems CMS Pain Points Description of the Problem Examples Data in the wrong fields Date where time belongs Missing data Blank fields not cases of data N/A Inappropriate data Continuing members in the universe for new members Previously pointed out universe errors repeated despite CMS instruction Using the date a letter was written vs. the date the letter was sent in the mail 17
Self-inflicted injuries Common universe problems The FA universe did not contain rejection error codes in five separate cases The FA Universe showed beneficiary as new when they were not FA and Transition - In many instances, the primary return messaging was not provided, making it difficult to fully evaluate the claim. Producing universe for re-audit in incorrect template for the initial audit year (i.e., 2013 re-audit on 2014 universe format) Universe produced for the audit did not include the complete pharmacy messaging as required in the CMS audit templates. CMS template states “***Sponsor must provide ALL pharmacy messaging, not limited to the number of fields in this template. Please insert columns as necessary.” Universe error resulted in patient residence/pharmacy location errors 18
Self-inflicted injuries Common universe problems ADMINISTRATIVE ERRORS File format (MS Excel to .txt conversion problems (with headers, without headers) File transfer problems between companies (claims processor - to PBM - to plan) File naming convention errors Failure to produce FA universe timely (48hrs) 19
CDAG AND FA UNIVERSE REQUIREMENTS What’s New & What You Need to Know
CDAG universe key points 15 Individual Universe Templates – Delivered in tab delimited text (.txt) file format WITH A HEADER ROW – Include all contracts and PBPs identified in engagement letter in each universe – 15 record layouts for new requirements – Universe validation calls with CMS – to quickly check that the dates/times in universes are the same as what's in the system. – Include favorable, partially favorable, and unfavorable decisions in each universe – Correction: “was interest paid on the claim?” is an error and CMS will remove it from DMRCD and DMRRD universes 1. SCD 2. ECD 3. DMRRD 4. EIRE 5. EIAM 6. SCDER 7. ECDER 8. ERD 9. SIAM 10. SGD 11. DMRCD 12. SDR 13. SIRE 14. DMRRE 15. EGD 21
Formulary Administration (FA) key points 4 Individual Universe Templates – Delivered in tab delimited text (.txt) file format WITH A HEADER ROW – Include all contracts and PBPs identified in engagement letter in each universe – Excel may be accepted based on CMS Oversight and Enforcement conference and October 20 memo. • Please confirm with your CMS audit lead in all cases • Auditors still prefer .txt format 1. Rejected Claims Formulary Administration (RCFA) 2. Rejected Claims Transition (RCT) 3. Prescription Drug Event (PDE) 4. New Member (NM) 22
Standard Coverage Determination (SCD) Record Layout 29 Elements Field Name Field Type Field Length Description Beneficiary HICN CHAR Always Required 11 Health Insurance Claim Number assigned by the Social Security Administration to an individual for the purpose of identifying him/her as a Medicare beneficiary. The number is between seven and 11 digits long (e.g., 123456789A). Do not include any spaces, hyphens or other special characters. Beneficiary First Name CHAR Always Required 30 First name of the beneficiary. 23 If delegated, does the FDR have the HICN and is it easily retrievable?
Field Name Field Type Field Length Description Beneficiary Last Name CHAR Always Required 30 Last name of the beneficiary. Enrollment Effective Date CHAR Always Required 10 Effective date of enrollment for the beneficiary into their current PBP. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Cardholder ID CHAR Always Required 20 Cardholder identifier used to identify the beneficiary. This is assigned by the sponsor. 24 Standard Coverage Determination (SCD) Record Layout (cont'd) NOTE – if you delegate CDs, is this data available to your PBM, or is this in another source?
Field Name Field Type Field Length Description Contract ID CHAR Always Required 5 The contract number (e.g., H1234, S1234) of the organization. Plan ID CHAR Always Required 3 The plan number (e.g., 001, 002) of the organization. 25 Standard Coverage Determination (SCD) Record Layout (cont'd) Note field length requirements. A length of 5 means there can only be 5 spaces worth of data in that field. This is just one of many items to QA.
Field Name Field Type Field Length Description Patient Residence CHAR Always Required 2 Residence code for the beneficiary. Valid values are: 00 – Not specified, other patient residence not identified below 01 – Home 03 – Nursing Facility 04 – Assisted Living Facility 06 – Group Home 09 – Intermediate Care Facility/Mentally Retarded 11 – Hospice Note: When the patient residence code is not directly populated on the incoming coverage determination (CD) the sponsor can obtain the information from the rejected claim prompting the CD, other paid claims occurring within 3 days of the CD, or any medical information the plan may have at the initiation of a coverage request. If the sponsor still cannot determine the patient residence code, then enter 00- not specified in the universe field. 26 Standard Coverage Determination (SCD) Record Layout (cont'd) Note: A “00” response is acceptable if residence code cannot be determined. Pulling residence from claim data may be complicated if not stored in PA system. Note: CMS copy/paste error – Use NCPDP values for patient residence, not pharmacy values on pg. 21 v021015
Field Name Field Type Field Length Description Date the request was received CHAR Always Required 10 Date the request was received from the beneficiary, their authorized representative, or their prescriber. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Time the request was received CHAR Always Required 8 Time of day the request was received from the beneficiary, their authorized representative, or their prescriber. Time is in HH:MM:SS military time format (e.g., 23:59:59). 27 Standard Coverage Determination (SCD) Record Layout (cont'd) Note – characters are always required. As a QA look for any blank fields.
Field Name Field Type Field Length Description Was the case approved or denied? CHAR Always Required 16 Enter the final disposition of the case. Valid values are: approved, denied, IRE auto-forward, dismissed, withdrawn, re-opened. Enter NA if the request was never resolved/ processed. Description of the issue CHAR Always Required 2000 Description of the issue. For denials, also include an explanation of why the case was denied. 28 Standard Coverage Determination (SCD) Record Layout (cont'd) Partial approvals are technically denials. Consider using rationale from decision letter.
Field Name Field Type Field Length Description NDC_11 CHAR Always Required 11 11-Digit National Drug Code. When no NDC is available, enter the applicable Uniform Product Code (UPC) or Health Related Item Code (HRI). Do not include any spaces, hyphens or other special characters. Enter NA if not applicable. Drug Name, Strength & Dosage Form CHAR Always Required 150 Drug name, strength & dosage form. Was request made under the expedited timeframe but processed by the sponsor under the standard timeframe? CHAR Always Required 1 Yes/No indicator of whether request made under expedited timeframe was processed under the standard timeframe based on the sponsor deciding that expedited case was unnecessary. (Y/N) 29 Standard Coverage Determination (SCD) Record Layout (cont'd)
Field Name Field Type Field Length Description Clearly indicate exception type. CHAR Always Required 19 Type of exception request. Valid values are: tier, non-formulary, prior authorization, quantity limit, step therapy, or hospice. Please list expiration date of the approval. CHAR Always Required 10 Expiration date of the exception approval. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Enter NA if not applicable. Is this a protected class drug? CHAR Always Required 1 Protected class drug indicator. (Y/N) Date prescriber supporting statement received CHAR Always Required 10 Date the prescriber's supporting statement was received. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Enter NA if not applicable. 30 Standard Coverage Determination (SCD) Record Layout (cont'd)
Field Name Field Type Field Length Description Time prescriber supporting statement received CHAR Always Required 8 Time the prescriber's supporting statement was received. Submit in HH:MM:SS military time format (e.g., 23:59:59). Enter NA if not applicable. Disposition of the request CHAR Always Required 16 Status of the request. Valid values are: approved, denied, IRE auto- forward, dismissed, withdrawn, re- opened. Enter NA if the request was never resolved/ processed. Was request denied for lack of medical necessity? CHAR Always Required 2 Yes/No indicator of whether request denied for lack of medical necessity. (Y/N/NA) 31 Standard Coverage Determination (SCD) Record Layout (cont'd) Supporting statement in case of exceptions only for timeliness test
Field Name Field Type Field Length Description If denied for lack of medical necessity, was the review completed by a physician or other appropriate health care professional? CHAR Always Required 2 Yes/No indicator of review by physician or other appropriate health care professional if case was denied for lack of medical necessity. (Y/N/NA) Date of plan decision CHAR Always Required 10 Date of the plan decision (e.g., approved, denied, IRE auto-forward, dismissed, withdrawn, re-opened). Submit in CCYY/MM/DD format (e.g., 2015/01/01). Enter NA if not applicable. 32 Standard Coverage Determination (SCD) Record Layout (cont'd)
Field Name Field Type Field Length Description Time of plan decision CHAR Always Required 8 Time of the plan decision (e.g., approved, denied, IRE auto-forward, dismissed, withdrawn, re-opened). Submit in HH:MM:SS military time format (e.g., 23:59:59). Enter NA if not applicable. Date effectuated in the plan's system CHAR Always Required 10 Date effectuated in the plan's system. Submit in CCYY/MM/DD format (e.g., 2015/01/01). For denials and IRE auto- forwards indicate NA. Time effectuated in the plans' system CHAR Always Required 8 Time effectuated in the plan's system. Submit in HH:MM:SS military time format (e.g., 23:59:59). For denials and IRE auto-forwards indicate NA. 33 Standard Coverage Determination (SCD) Record Layout (cont'd)
Field Name Field Type Field Length Description Date oral notification provided to enrollee CHAR Always Required 10 Date oral notification (or documented good faith attempt) provided to enrollee (or their authorized representative). Submit in CCYY/MM/DD format (e.g., 2015/01/01). If no oral notification, indicate NA. Time oral notification provided to enrollee CHAR Always Required 8 Time oral notification provided to enrollee. Submit in HH:MM:SS military time format (e.g., 23:59:59). If no oral notification, indicate NA. 34 Standard Coverage Determination (SCD) Record Layout (cont'd) Note – if you did not connect with the enrollee you must enter “NA”- Also- CMS uses “N/A” and “NA” & confirmed that plans will not be “dinged” for either
Field Name Field Type Field Length Description Date written notification provided to enrollee CHAR Always Required 10 Date written notification provided to enrollee. The term “provided” means when the letter left the sponsor’s establishment by either US Mail, fax, or electronic communication. This field is not for when a letter is generated or printed within the sponsor’s organization. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Enter NA if not applicable. Time written notification provided to enrollee CHAR Always Required 8 Time written notification provided to enrollee. Submit in HH:MM:SS military time format (e.g., 23:59:59). Enter NA if not applicable. 35 Standard Coverage Determination (SCD) Record Layout (cont'd) NOTE THE INSTRUCTION – Not the date letter printed. It’s the date the letter is mailed or faxed.
Field Name Field Type Field Length Description If untimely, date forwarded to IRE CHAR Always Required 10 For untimely decisions, date the request was forwarded to the IRE. Submit in CCYY/MM/DD format (e.g., 2015/01/01). For timely decisions indicate NA. If untimely, time forwarded to IRE CHAR Always Required 8 For untimely decisions, time the request was forwarded to the IRE. Submit in HH:MM:SS military time format (e.g., 23:59:59). For timely decisions indicate NA. If untimely, date enrollee notified request has been forwarded to IRE CHAR Always Required 10 For untimely decisions, date the enrollee was notified of request forwarded to the IRE. Submit in CCYY/MM/DD format (e.g., 2015/01/01). For timely decisions indicate NA. 36 Standard Coverage Determination (SCD) Record Layout (cont'd)
BEST PRACTICES & LESSONS LEARNED If at first you don’t succeed, try, try again
Best Practices & Lessons Learned Document process for requesting, pulling, validating, submitting • Consider PBM / FDR timeframes and information flow • Confirm naming conventions • Determine what systems are compatible and “talk” to one another • Be prepared to combine data across platforms – Combine data from FDRs with the plan data or other FDRs • Have a plan for transferring and receiving the information – FTP/NDM/email/ portal? So many ways, so many pitfalls. • If PBM or claims processor is the source of the data, have clear documented agreement – Contracts, performance guarantees, or executive level agreement KNOW YOUR DATA SOURCES FOR EACH UNIVERSE/ELEMENT 38
Best Practices & Lessons Learned What we did that worked • QA universes until 100% complete - even after submission to CMS or plan • Always disclose errors to client. Provide: – Description of issue – New universe – Before/after pictures of correction – Methodology to find errors – How you know its fixed – Revised attestation of correctness • Be prepared to discuss with client/CMS Potential false positives – Example – Date decision letter mailed before date/time decision made – Your system, workflow may not match CMS expectations – Explain your process confidently Identified universe errors and CMS has the file – Explain # of lines any error exists General Recommendations 39
Best Practices & Lessons Learned What we did that worked • Analysts, managers, and executives accountable – Dedicated time & team – Dedicated (quiet) rooms – This is the priority • BO owns data and results regardless of informatics • Line item review • Review a sample of claims and CD/RD cases against the universe • MS Excel- pivot tables to find things that don’t make sense – Duplicates that may point to copy paste errors – Date mismatches- if you have “NA” in one field, but a date in another and vice versa – Blank fields where CMS says “CHAR Required” – Foundation vs. supporting field errors Business Owner (BO) Review 40
Field Label Field Name A If untimely, date forwarded to IRE B If untimely, time forwarded to IREC C If untimely, date enrollee notified request has been forwarded to IRE 41 Best Practices What we did that worked • In this example- • If you have data in “A” then you must have data in “B” and “C” • Know your foundation fields versus your supporting fields • Complete pivot table searches for blanks or ‘N//A” in any supporting field (B, C) where there is data in the foundational field (A) Foundation Field Supporting Field LOGIC 101 If P then Q If not P then not Q PIVOT TABLES
Best Practices What we did that worked • Open all files look for – Blank fields – Improperly labeled field names – Failure to apply any CMS- clarified elements • Require signed attestations from BO executives & vendors – Describes QA process – Affirms accuracy of universe – Confirms executive-level ownership of accuracy and any negative outcomes • Compliance should NEVER blindly forward audit documents to client/ CMS • Everyone is accountable for expertise in this process Compliance Review 42
Best Practices What we did that worked • Very short turn-around time • Immediate notice to business as issues identified • Final report/memo issued of all identified errors • Written response from BO required for documentation purposes • Universe audit – Blank fields – Improperly labeled field names – Failure to apply any CMS- clarified elements – Improper formats (dates/times) • 100% of CDAG samples…if possible for match of universe data – Blank fields – Discrepancies btw universe and case file Internal Audit Review 43
Best Practices & Lessons Learned • Get top-down support from executive leadership – Show them CMS enforcement letters. $$$ talks! • Make sure you have a “real” QA plan. – Compliance “looking at it“ wont cut it – Business owners must own the universe, results, and QA • Train your business owners on CMS universe requirements. Line- by-line, universe-by-universe • Encourage automation wherever possible • Conduct mock audits – announced/unannounced universe monitoring events…until you get it right – Make sure people take the mock audits as seriously as a CMS audit – Consider hiring a third party 44
Recap New universe requirements and consequences • 15 days – Complete & Accurate Universe • 3 strikes & you’re out-ish • CDAG – 15 templates • FA – 4 templatesPerfect Universes don’t Make Themselves • Learn from common mistakes • Have a plan • PBM/FDR engagement is key • Perfect practice makes perfect execution 45
Resources CMS Program Audits Web Page http://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D- Compliance-and-Audits/ProgramAudits.html 46
Questions ? Michelle Juhanson, CHC, CHPC mjuhanson@performrx.com Office: 215.937.4108 Mobile: 215.432.3002 LinkedIn 47
Copyright © PerformRx, LLC 2015 All Rights Reserved

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CMS Program Audit Universe Preparation M. Juhanson

  • 1. Prepare Data Universe for Appropriate Submission to CMS Michelle Juhanson, CHC, CHPC Director, Compliance & Quality Pharmacy Benefit Oversight and Compliance Conference – November 12-13, 2015
  • 2. Speaker’s Disclaimer • Michelle Juhanson, CHC, CHPC does not have any financial conflicts to disclose. • This presentation was prepared or accomplished by Michelle Juhanson, CHC, CHPC in her personal capacity. The opinions expressed in this presentation are the speaker’s own and do not reflect the view of PerformRx. • The speaker is not promoting any service or product. 2
  • 3. Speaker Introduction Michelle Juhanson, CHC, CHPC Director, Compliance and Quality • 10 years of Part D compliance experience in multiple settings: Part D IRE, plan sponsor, and PBM • Accountable for PBM responses to numerous CMS audits for clients in 12 states and the District of Columbia since 2007 – Program audits – 1/3 financial audits – PDE data validation – Transition monitoring – Formulary administration • Oversaw PBM responses to more than 250 external audits since 2007 • Compliance Officer at PerformRx • Directs integrity audit and rejected claims processes at PerformRx • Chair of the PerformRx Compliance, Quality, and Star Alliance Committees • Member of the Health Care Compliance Association and certified in Health Care Compliance (CHC) as well as Health Care Privacy Compliance (CHPC) • Speaks on issues of compliance and quality at industry conferences nationwide UPDATE- CMS Program Audit 2015- All CDAG and FA Universes passed CMS review. 0 CAR, 0 ICAR, 0 observation, no resubmission requests!!! 3
  • 4. Presentation Goals • Understand purpose of a universe for any audit • Review CMS’ general universe collection/submission expectations • Identify typical universe problems • Understand consequences for universe failures • Learn CDAG and FA universe requirements • Review best practices and lessons learned • Q & A 4
  • 5. WHY IS A UNIVERSE IMPORTANT FOR ANY AUDIT? What is a universe?
  • 6. Why a universe is important • What the average person thinks Universe - (statistics) the entire aggregation of items from which samples can be drawn; it is an estimate of the mean of the population Synonyms: population • What an auditor means = 6
  • 7. Why a universe is important “…from which samples can be drawn” • Samples give auditors a good idea of what is happening in the whole population • An accurate universe is necessary for audit integrity • Sample Selection • False Positives • False Negatives 7
  • 8. CMS’ UNIVERSE COLLECTION & SUBMISSION EXPECTATIONS 3 strikes you’re out turns into foul ball
  • 9. CMS’ universe expectations General Requirements • Provide accurate and timely universe within 15 business days of the engagement letter date. • Major changes to universe record layouts & submission timelines • CMS will hold a call with you to review the universe request and answer any questions- • Do - INVITE THE BUSINESS OWNERS WHO HAVE TO PULL THE UNIVERSE • Do - INVITE THE PBM • Don’t - Practice compliance hoarding 9
  • 10. CMS’ universe expectations- What they said in June 2015 SUBMIT UNIVERSE 1 • 15 days to submit • If data issue identified…Strike 1 SUBMIT UNIVERSE 2 • If perfect, CMS will use this universe. • If there are still errors…Strike 2 SUBMIT UNIVERSE 3 • CMS will use this universe regardless. • No chance to revise universe • If you can’t get accurate data… Strike 3! 10
  • 11. 2015 -2016 Audit Protocols Calculation of Score Change • Invalid Data Submission (IDS) • IDS conditions will be cited when a sponsor is not able to produce an accurate universe within a maximum of 3 attempts. • IDS conditions will be worth one (1) point. CMS’ universe expectations- What they are saying now) 11
  • 12. CONSEQUENCES FOR UNIVERSE FAILURES The thrill of victory and the agony of defeat
  • 13. Consequences for universe failures • “Not having accurate universes can drastically affect your audit score” • “Poor audit results may lead to a referral for possible enforcement actions” • “…can adversely affect STAR ratings and past performance “ - Jennifer Smith CMS , Division of Analysis, Policy, & Strategy (DAPS) CMS Oversight & Enforcement Conference – June 16, 2015 13
  • 14. Consequences for universe failures • After 2nd failed attempt – CMS will document “observation” in final audit report • After 3rd failed attempt – - Invalid Data Submission (IDS) “condition” in audit report for each element that cannot be tested grouped by the type of case. – UPDATE Automatic ICAR for every applicable condition/element and possible enforcement action • Example: if 11 audit conditions in Transition, CMS will issue 11 ICARs for Transition – If limited to one or two elements, ICAR cited per condition – Proof of ICAR correction not required on re-audit • Accurate universe(s) will be required on re-audit 14
  • 15. Consequences for universe failures Why is this happening!? CMS Says: • Equity & consistency across audited sponsors • Efficiency and need to complete the audit • Plan sponsor accountability - collect and submit accurate data MJ Says: • Bad universes waste everyone’s time and resources • It’s your data. It’s 2015. Poor universes speak poorly of the organization. • An audit is only as good as the universe & they are time sensitive “An inability to pull a universe will adversely affect our ability to conduct the audit and your ability to complete the audit” - Jennifer Smith CMS , Division of Analysis, Policy, & Strategy (DAPS) 15
  • 17. Common universe problems CMS Pain Points Description of the Problem Examples Data in the wrong fields Date where time belongs Missing data Blank fields not cases of data N/A Inappropriate data Continuing members in the universe for new members Previously pointed out universe errors repeated despite CMS instruction Using the date a letter was written vs. the date the letter was sent in the mail 17
  • 18. Self-inflicted injuries Common universe problems The FA universe did not contain rejection error codes in five separate cases The FA Universe showed beneficiary as new when they were not FA and Transition - In many instances, the primary return messaging was not provided, making it difficult to fully evaluate the claim. Producing universe for re-audit in incorrect template for the initial audit year (i.e., 2013 re-audit on 2014 universe format) Universe produced for the audit did not include the complete pharmacy messaging as required in the CMS audit templates. CMS template states “***Sponsor must provide ALL pharmacy messaging, not limited to the number of fields in this template. Please insert columns as necessary.” Universe error resulted in patient residence/pharmacy location errors 18
  • 19. Self-inflicted injuries Common universe problems ADMINISTRATIVE ERRORS File format (MS Excel to .txt conversion problems (with headers, without headers) File transfer problems between companies (claims processor - to PBM - to plan) File naming convention errors Failure to produce FA universe timely (48hrs) 19
  • 20. CDAG AND FA UNIVERSE REQUIREMENTS What’s New & What You Need to Know
  • 21. CDAG universe key points 15 Individual Universe Templates – Delivered in tab delimited text (.txt) file format WITH A HEADER ROW – Include all contracts and PBPs identified in engagement letter in each universe – 15 record layouts for new requirements – Universe validation calls with CMS – to quickly check that the dates/times in universes are the same as what's in the system. – Include favorable, partially favorable, and unfavorable decisions in each universe – Correction: “was interest paid on the claim?” is an error and CMS will remove it from DMRCD and DMRRD universes 1. SCD 2. ECD 3. DMRRD 4. EIRE 5. EIAM 6. SCDER 7. ECDER 8. ERD 9. SIAM 10. SGD 11. DMRCD 12. SDR 13. SIRE 14. DMRRE 15. EGD 21
  • 22. Formulary Administration (FA) key points 4 Individual Universe Templates – Delivered in tab delimited text (.txt) file format WITH A HEADER ROW – Include all contracts and PBPs identified in engagement letter in each universe – Excel may be accepted based on CMS Oversight and Enforcement conference and October 20 memo. • Please confirm with your CMS audit lead in all cases • Auditors still prefer .txt format 1. Rejected Claims Formulary Administration (RCFA) 2. Rejected Claims Transition (RCT) 3. Prescription Drug Event (PDE) 4. New Member (NM) 22
  • 23. Standard Coverage Determination (SCD) Record Layout 29 Elements Field Name Field Type Field Length Description Beneficiary HICN CHAR Always Required 11 Health Insurance Claim Number assigned by the Social Security Administration to an individual for the purpose of identifying him/her as a Medicare beneficiary. The number is between seven and 11 digits long (e.g., 123456789A). Do not include any spaces, hyphens or other special characters. Beneficiary First Name CHAR Always Required 30 First name of the beneficiary. 23 If delegated, does the FDR have the HICN and is it easily retrievable?
  • 24. Field Name Field Type Field Length Description Beneficiary Last Name CHAR Always Required 30 Last name of the beneficiary. Enrollment Effective Date CHAR Always Required 10 Effective date of enrollment for the beneficiary into their current PBP. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Cardholder ID CHAR Always Required 20 Cardholder identifier used to identify the beneficiary. This is assigned by the sponsor. 24 Standard Coverage Determination (SCD) Record Layout (cont'd) NOTE – if you delegate CDs, is this data available to your PBM, or is this in another source?
  • 25. Field Name Field Type Field Length Description Contract ID CHAR Always Required 5 The contract number (e.g., H1234, S1234) of the organization. Plan ID CHAR Always Required 3 The plan number (e.g., 001, 002) of the organization. 25 Standard Coverage Determination (SCD) Record Layout (cont'd) Note field length requirements. A length of 5 means there can only be 5 spaces worth of data in that field. This is just one of many items to QA.
  • 26. Field Name Field Type Field Length Description Patient Residence CHAR Always Required 2 Residence code for the beneficiary. Valid values are: 00 – Not specified, other patient residence not identified below 01 – Home 03 – Nursing Facility 04 – Assisted Living Facility 06 – Group Home 09 – Intermediate Care Facility/Mentally Retarded 11 – Hospice Note: When the patient residence code is not directly populated on the incoming coverage determination (CD) the sponsor can obtain the information from the rejected claim prompting the CD, other paid claims occurring within 3 days of the CD, or any medical information the plan may have at the initiation of a coverage request. If the sponsor still cannot determine the patient residence code, then enter 00- not specified in the universe field. 26 Standard Coverage Determination (SCD) Record Layout (cont'd) Note: A “00” response is acceptable if residence code cannot be determined. Pulling residence from claim data may be complicated if not stored in PA system. Note: CMS copy/paste error – Use NCPDP values for patient residence, not pharmacy values on pg. 21 v021015
  • 27. Field Name Field Type Field Length Description Date the request was received CHAR Always Required 10 Date the request was received from the beneficiary, their authorized representative, or their prescriber. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Time the request was received CHAR Always Required 8 Time of day the request was received from the beneficiary, their authorized representative, or their prescriber. Time is in HH:MM:SS military time format (e.g., 23:59:59). 27 Standard Coverage Determination (SCD) Record Layout (cont'd) Note – characters are always required. As a QA look for any blank fields.
  • 28. Field Name Field Type Field Length Description Was the case approved or denied? CHAR Always Required 16 Enter the final disposition of the case. Valid values are: approved, denied, IRE auto-forward, dismissed, withdrawn, re-opened. Enter NA if the request was never resolved/ processed. Description of the issue CHAR Always Required 2000 Description of the issue. For denials, also include an explanation of why the case was denied. 28 Standard Coverage Determination (SCD) Record Layout (cont'd) Partial approvals are technically denials. Consider using rationale from decision letter.
  • 29. Field Name Field Type Field Length Description NDC_11 CHAR Always Required 11 11-Digit National Drug Code. When no NDC is available, enter the applicable Uniform Product Code (UPC) or Health Related Item Code (HRI). Do not include any spaces, hyphens or other special characters. Enter NA if not applicable. Drug Name, Strength & Dosage Form CHAR Always Required 150 Drug name, strength & dosage form. Was request made under the expedited timeframe but processed by the sponsor under the standard timeframe? CHAR Always Required 1 Yes/No indicator of whether request made under expedited timeframe was processed under the standard timeframe based on the sponsor deciding that expedited case was unnecessary. (Y/N) 29 Standard Coverage Determination (SCD) Record Layout (cont'd)
  • 30. Field Name Field Type Field Length Description Clearly indicate exception type. CHAR Always Required 19 Type of exception request. Valid values are: tier, non-formulary, prior authorization, quantity limit, step therapy, or hospice. Please list expiration date of the approval. CHAR Always Required 10 Expiration date of the exception approval. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Enter NA if not applicable. Is this a protected class drug? CHAR Always Required 1 Protected class drug indicator. (Y/N) Date prescriber supporting statement received CHAR Always Required 10 Date the prescriber's supporting statement was received. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Enter NA if not applicable. 30 Standard Coverage Determination (SCD) Record Layout (cont'd)
  • 31. Field Name Field Type Field Length Description Time prescriber supporting statement received CHAR Always Required 8 Time the prescriber's supporting statement was received. Submit in HH:MM:SS military time format (e.g., 23:59:59). Enter NA if not applicable. Disposition of the request CHAR Always Required 16 Status of the request. Valid values are: approved, denied, IRE auto- forward, dismissed, withdrawn, re- opened. Enter NA if the request was never resolved/ processed. Was request denied for lack of medical necessity? CHAR Always Required 2 Yes/No indicator of whether request denied for lack of medical necessity. (Y/N/NA) 31 Standard Coverage Determination (SCD) Record Layout (cont'd) Supporting statement in case of exceptions only for timeliness test
  • 32. Field Name Field Type Field Length Description If denied for lack of medical necessity, was the review completed by a physician or other appropriate health care professional? CHAR Always Required 2 Yes/No indicator of review by physician or other appropriate health care professional if case was denied for lack of medical necessity. (Y/N/NA) Date of plan decision CHAR Always Required 10 Date of the plan decision (e.g., approved, denied, IRE auto-forward, dismissed, withdrawn, re-opened). Submit in CCYY/MM/DD format (e.g., 2015/01/01). Enter NA if not applicable. 32 Standard Coverage Determination (SCD) Record Layout (cont'd)
  • 33. Field Name Field Type Field Length Description Time of plan decision CHAR Always Required 8 Time of the plan decision (e.g., approved, denied, IRE auto-forward, dismissed, withdrawn, re-opened). Submit in HH:MM:SS military time format (e.g., 23:59:59). Enter NA if not applicable. Date effectuated in the plan's system CHAR Always Required 10 Date effectuated in the plan's system. Submit in CCYY/MM/DD format (e.g., 2015/01/01). For denials and IRE auto- forwards indicate NA. Time effectuated in the plans' system CHAR Always Required 8 Time effectuated in the plan's system. Submit in HH:MM:SS military time format (e.g., 23:59:59). For denials and IRE auto-forwards indicate NA. 33 Standard Coverage Determination (SCD) Record Layout (cont'd)
  • 34. Field Name Field Type Field Length Description Date oral notification provided to enrollee CHAR Always Required 10 Date oral notification (or documented good faith attempt) provided to enrollee (or their authorized representative). Submit in CCYY/MM/DD format (e.g., 2015/01/01). If no oral notification, indicate NA. Time oral notification provided to enrollee CHAR Always Required 8 Time oral notification provided to enrollee. Submit in HH:MM:SS military time format (e.g., 23:59:59). If no oral notification, indicate NA. 34 Standard Coverage Determination (SCD) Record Layout (cont'd) Note – if you did not connect with the enrollee you must enter “NA”- Also- CMS uses “N/A” and “NA” & confirmed that plans will not be “dinged” for either
  • 35. Field Name Field Type Field Length Description Date written notification provided to enrollee CHAR Always Required 10 Date written notification provided to enrollee. The term “provided” means when the letter left the sponsor’s establishment by either US Mail, fax, or electronic communication. This field is not for when a letter is generated or printed within the sponsor’s organization. Submit in CCYY/MM/DD format (e.g., 2015/01/01). Enter NA if not applicable. Time written notification provided to enrollee CHAR Always Required 8 Time written notification provided to enrollee. Submit in HH:MM:SS military time format (e.g., 23:59:59). Enter NA if not applicable. 35 Standard Coverage Determination (SCD) Record Layout (cont'd) NOTE THE INSTRUCTION – Not the date letter printed. It’s the date the letter is mailed or faxed.
  • 36. Field Name Field Type Field Length Description If untimely, date forwarded to IRE CHAR Always Required 10 For untimely decisions, date the request was forwarded to the IRE. Submit in CCYY/MM/DD format (e.g., 2015/01/01). For timely decisions indicate NA. If untimely, time forwarded to IRE CHAR Always Required 8 For untimely decisions, time the request was forwarded to the IRE. Submit in HH:MM:SS military time format (e.g., 23:59:59). For timely decisions indicate NA. If untimely, date enrollee notified request has been forwarded to IRE CHAR Always Required 10 For untimely decisions, date the enrollee was notified of request forwarded to the IRE. Submit in CCYY/MM/DD format (e.g., 2015/01/01). For timely decisions indicate NA. 36 Standard Coverage Determination (SCD) Record Layout (cont'd)
  • 37. BEST PRACTICES & LESSONS LEARNED If at first you don’t succeed, try, try again
  • 38. Best Practices & Lessons Learned Document process for requesting, pulling, validating, submitting • Consider PBM / FDR timeframes and information flow • Confirm naming conventions • Determine what systems are compatible and “talk” to one another • Be prepared to combine data across platforms – Combine data from FDRs with the plan data or other FDRs • Have a plan for transferring and receiving the information – FTP/NDM/email/ portal? So many ways, so many pitfalls. • If PBM or claims processor is the source of the data, have clear documented agreement – Contracts, performance guarantees, or executive level agreement KNOW YOUR DATA SOURCES FOR EACH UNIVERSE/ELEMENT 38
  • 39. Best Practices & Lessons Learned What we did that worked • QA universes until 100% complete - even after submission to CMS or plan • Always disclose errors to client. Provide: – Description of issue – New universe – Before/after pictures of correction – Methodology to find errors – How you know its fixed – Revised attestation of correctness • Be prepared to discuss with client/CMS Potential false positives – Example – Date decision letter mailed before date/time decision made – Your system, workflow may not match CMS expectations – Explain your process confidently Identified universe errors and CMS has the file – Explain # of lines any error exists General Recommendations 39
  • 40. Best Practices & Lessons Learned What we did that worked • Analysts, managers, and executives accountable – Dedicated time & team – Dedicated (quiet) rooms – This is the priority • BO owns data and results regardless of informatics • Line item review • Review a sample of claims and CD/RD cases against the universe • MS Excel- pivot tables to find things that don’t make sense – Duplicates that may point to copy paste errors – Date mismatches- if you have “NA” in one field, but a date in another and vice versa – Blank fields where CMS says “CHAR Required” – Foundation vs. supporting field errors Business Owner (BO) Review 40
  • 41. Field Label Field Name A If untimely, date forwarded to IRE B If untimely, time forwarded to IREC C If untimely, date enrollee notified request has been forwarded to IRE 41 Best Practices What we did that worked • In this example- • If you have data in “A” then you must have data in “B” and “C” • Know your foundation fields versus your supporting fields • Complete pivot table searches for blanks or ‘N//A” in any supporting field (B, C) where there is data in the foundational field (A) Foundation Field Supporting Field LOGIC 101 If P then Q If not P then not Q PIVOT TABLES
  • 42. Best Practices What we did that worked • Open all files look for – Blank fields – Improperly labeled field names – Failure to apply any CMS- clarified elements • Require signed attestations from BO executives & vendors – Describes QA process – Affirms accuracy of universe – Confirms executive-level ownership of accuracy and any negative outcomes • Compliance should NEVER blindly forward audit documents to client/ CMS • Everyone is accountable for expertise in this process Compliance Review 42
  • 43. Best Practices What we did that worked • Very short turn-around time • Immediate notice to business as issues identified • Final report/memo issued of all identified errors • Written response from BO required for documentation purposes • Universe audit – Blank fields – Improperly labeled field names – Failure to apply any CMS- clarified elements – Improper formats (dates/times) • 100% of CDAG samples…if possible for match of universe data – Blank fields – Discrepancies btw universe and case file Internal Audit Review 43
  • 44. Best Practices & Lessons Learned • Get top-down support from executive leadership – Show them CMS enforcement letters. $$$ talks! • Make sure you have a “real” QA plan. – Compliance “looking at it“ wont cut it – Business owners must own the universe, results, and QA • Train your business owners on CMS universe requirements. Line- by-line, universe-by-universe • Encourage automation wherever possible • Conduct mock audits – announced/unannounced universe monitoring events…until you get it right – Make sure people take the mock audits as seriously as a CMS audit – Consider hiring a third party 44
  • 45. Recap New universe requirements and consequences • 15 days – Complete & Accurate Universe • 3 strikes & you’re out-ish • CDAG – 15 templates • FA – 4 templatesPerfect Universes don’t Make Themselves • Learn from common mistakes • Have a plan • PBM/FDR engagement is key • Perfect practice makes perfect execution 45
  • 46. Resources CMS Program Audits Web Page http://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D- Compliance-and-Audits/ProgramAudits.html 46
  • 47. Questions ? Michelle Juhanson, CHC, CHPC mjuhanson@performrx.com Office: 215.937.4108 Mobile: 215.432.3002 LinkedIn 47
  • 48. Copyright © PerformRx, LLC 2015 All Rights Reserved

Editor's Notes

  • #4: Long in the tooth in the compliance world and want to share In a constant state of audit Passionate about the audit process Because auditors report to me I am sympathetic to their needs
  • #8: False positive is the idea of getting a result that incorrectly tells you the result is true or correct or positive. False negative is a result that incorrectly tells you the result is wrong or incorrect or negative. False positive: Test result that says you are doing drugs even though it was the sesame seed bagel you ate before the test that triggered the result. Concluding there is an error is a sample when the population is actually error-free. Impact? You do unneeded testing to reach a correct conclusion the population is okay. False negative: Test result that says you are sober even though you are falling-down drunk. Concluding a population is okay based on a sample even though there are multiple material errors. Impact? You issue a clean opinion on a materially incorrect financial statement.
  • #15: When the data is so incomplete or inaccurate that CMS cannot conduct their audit (cannot pull a sample)-