cms 2015 program audit protocol

CMS 2015 Program Audit Protocol

Do your protocols meet CMS’ standards?

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Introducing our Speaker

• 31 Years experience in Operations In the Healthcare Industry

• Government Programs (MEDICAID, MAPD, PDP)

• Commercial Large Accounts

• Small Group and Individual plans

• Past 12 years focused in Medicare • Enrollments, Claims, Customer Service, Delegated

Oversight, Appeals and Grievances, and Compliance

• Key Recent Accomplishments • Moved from 3 to 4-Star rating and maintenance of the 4-

Star rating for 3 years. • Achieved a 100% score in the CMS Validation Audit for

ODAG and CDAG in 2014

• Achieved the highest Audit Rating from CMS on the OEV process for 2014

Gabriel Viola

Discussion Topics

• CMS 2015 Program Audit Protocol changes General discussion

• The importance of a correct universe Pass or Fail, if you don’t submit a correct Universe you Fail

• “Monitoring” is not good enough

New audit protocols requiring proof of action taken on identified trends or issues across all contracts

• Beneficiary Investigation Analysis (BIA)

Are you prepared?

CMS 2015 Program Audit

Program Audit Changes

• Modifications have been made to the universe timeliness test and universe submissions

• Compliance Program Effectiveness (CPE) The 7 elements will be tested with five tracer samples

• Two new test elements will be piloted starting mid-year • Medication Therapy Management (MTM) • Provider Network Adequacy

• Timing has been modified for the program audit

• CMS expects correct universes submitted in a timely manner

• Beneficiary impact analysis

Enforcement Actions 101

• We all know that the penalties can: • Include Civil Money Penalties (CMPs),

• Intermediate Sanctions (suspension of enrollment, marketing, payment), or

• CMS can determine that the infraction may cause termination from the program

• Imposed at the contract level on Medicare Advantage, Prescription Drug, PACE, or Cost Plan contracts


• Levied $8,806,000 in CMPs for: • Violations found during program audits/validation

audits (38)

• Issuance of Late Annual Notice of Change/Evidence of Coverage documents (2)

• Inaccurate Network Pharmacy Directories (1)

• Enrollment processing (1)

• Average CMP amount - $209,667 • Highest: $1,000,000

• Lowest: $20,700

Sanctions, 6, 12%

CMPs, 42, 88%

48 Disciplinary Actions in 2014

Statistics provided by CMS at the June 16th Conference


Sanctions (6)

• Imposed intermediate sanctions for: • Violations found during program audits (4)

• Violating enrollment requirements due to State-imposed suspensions of enrollment (2)

• Average duration of intermediate sanctions related to program audits since 2014 – 292 days

Sanctions, 6, 12%

CMPs, 42, 88%

48 Disciplinary Actions in 2014

The limited marketing and enrollment period will end when the validation audit is concluded and CMS has determined that the sponsor has corrected the deficiencies that were the basis of the intermediate sanctions.


Information Confirmed at the CMS June 16th Conference

CMS’s final rule effective March 16, 2015, amended the MA & Part D program regulations. They added provisions CFR 42 §§ 422.503(d)(2) and 423.504(d)(2) to the program audit and inspection authority to allow CMS to require an SO to hire an independent auditor to conduct a review and attest that deficiencies found during a program audit were corrected.

• If you receive a CMP or sanction you will be required to obtain an independent auditor to validate the corrective action has been taken and prove remediation was successful.

The importance of a correct universe

Universe Preparation

Background

• CMS has created new record layouts for submitting universes and new requirements around universe submission.

• Record layout changes are mainly in ODAG and CDAG.

• There is now a limit on the number of resubmissions that will be allowed.

• Not having accurate universes can drastically affect your audit score.

• Can adversely affect STAR ratings and past performance.

Universe Preparation (cont.)

What is the new submission requirement? Sponsors will have a maximum of 3 attempts to provide complete and accurate universes.

If multiple attempts are made and the sponsor fails to provide an accurate and timely universe

CMS will document this as an observation in the sponsor’s program audit report after the first 2 attempts.

After the 3rd failed attempt the sponsor will be cited ICARs for the conditions related to the inaccurate universes.

Universe Preparation (cont.)

When will the new submission requirement be applied?

• When the data is so incomplete or inaccurate that the Auditor cannot conduct the audit; or

• For timeliness (CDAG and ODAG), when the Auditor is unable to confirm the accuracy of the dates and times applicable to the timeframe being tested

Specific areas of concern :

Failure to timely resolve grievances and notify the beneficiary of the disposition of the grievance.

In fact most egregious of all many sponsors failed simply because they couldn’t produce the required samples!

“Monitoring” is not good enough


New audit protocols requiring proof of action taken on identified trends or issues across all contracts


Part C and Part D Compliance Programs had to show that it effectively Monitored

• Effective Training and Education

• Systems for Monitoring and Auditing

• Promptly Responding to Compliance Issues

• FDR oversight

• Etc. etc. etc

Previous Standard CAP Responses showed


So you Identified that your H1234 contract is charging the wrong Co-Pay for Generics

• What about your S2468 or your H9876 contract

• What about Plan 01 or Plan 03

You will now need to show that your other plans or contracts do not have the same issue.

Beneficiary Investigation Analysis (BIA)


Pre-Audit Issue Summary

• The 2015 protocols requires Plans to identify their own issues.

• Plans are required to report the disclosed issues and submit to CMS on an on-going basis

• The format for reporting these issues is more detailed, and includes resolved and unresolved problems.

• There is a time limit for submission of this report and consequences if the time frame is missed – or if a Plan misses issues.

Beneficiary Impact Analysis

• A Beneficiary Impact Analysis (BIA), in the CMS format, must be submitted for each of the issues on the Pre-Audit Issue Summary and for certain issues discovered during an audit.

• The challenges for Plans include: • Developing the BIA queries, • Having adequate staff resources to carry out the analyses, and • Submitting adequately developed and accurate BIAs on time.

• CMS limits the number of attempts to provide an accurate BIA, with a range of consequences for failed or untimely submissions.


• Issue number

• Description of the issue (explain what happened)

• Root cause analysis of the issue (explain why it happened)

• # of members impacted

• Date issue identified (MM/DD/YY)

• Was the issue previously disclosed to CMS (e.g., account manager disclosure)?

• Date issue disclosed (if applicable, MM/DD/YY)

• To whom the issue was disclosed (first and last name)

• Was the issue fully remediated in the sponsor's system and for beneficiaries? Y/N

• Description of system/operational remediation

• Date system/operational remediation initiated (MM/DD/YY)

• Date system/operational remediation completed (MM/DD/YY)

• Description of remediation for negatively impacted beneficiaries

• Date beneficiary outreach and remediation initiated (MM/DD/YY)

• Date beneficiary outreach and remediation completed (MM/DD/YY)

Pre-Audit Issue Summary


CDAG Grievance BIA

1. Issue Number

2. HICN

3. Cardholder ID

4. Contract ID

5. Plan ID

6. "Effective Date of Enrollment (MM/DD/YY)"

7. "Is beneficiary currently enrolled? (Y/N)"

8. "Date grievance/ complaint was received (MM/DD/YY) "

9. "Time grievance/ complaint was received (HHMMSS- Military time) "

10. "How was the grievance/ complaint received (Oral or Written)"

11. Category of the grievance/complaint; at a minimum, categories must include each of the following:

Enrollment/Disenrollment; Plan Benefits; Coverage Determinations, Appeals Process; Marketing; Confidentiality/

Privacy; Quality of Care, Expedited cases; Fraud & Abuse; Other Description of the grievance

12. "Was the grievance/ complaint processed under the expedited timeframe? (Y/N)"

13. "Was a timeframe extension taken? (Y/N)"

14. "If an extension was taken, did the plan notify the member of the reason(s) for the delay and of their right to file

an expedited grievance? (Y/N/NA)"

15. "Date oral notification provided to enrollee (if no oral notification, please indicate N/A) (MM/DD/YY)"

16. "Time oral notification provided to enrollee (if no oral notification, please indicate N/A) (HHMMSS- Military time) "

17. "Date written notification of resolution provided to enrollee (MM/DD/YY)"

18. "Time written notification of resolution provided to enrollee (HHMMSS- Military time) "

19. "Brief summary of issue resolution (e.g. new grievance letter and reason, prescriber contact and outcome,

coverage determination initiated)"

20. If appeal or coverage determination request was included with the grievance,

21. Date of member outreach.

22. "If sponsor offered member the opportunity to file an appeal, did the member accept

(Y/N/NA= Sponsor did not offer an appeal)"

23. "Date of appeal (N/A Sponsor did not offer the opportunity to file an appeal or member declined opportunity)

(MM/DD/YY)"

24. Description of the appeal disposition (request approved/denied on redetermination)

25. "Date of appeal disposition (MM/DD/YY)"

To Be Completed By The Part D Sponsor

Pre-Audit Issue Summary Number

(From Attachment VIII)

Methodology - Describe the process that was undertaken to determine the # of

members impacted

Audit Timeline

Pre Audit and BIA due Webinar Start

Universes Due

CMS Issues Audit Engagement Notice

Pre audit Issue summary and BIA are due by day 5

Universe Due Due Day 15

Final Audit Report 60-90 days

Webinar

On Site

Week 8 Week 7 Week 6 Week 5 Week 1 Week 4 Week 3 Week 2

Start of On Site Audit

Audit Notice Will Arrive 6 weeks before audit start date, it will contain the audit scope, and the list of universes to be submitted

TIPS to a successful Audit

2015 chances of being audited is more

• Sponsors audited in the previous audit cycle (2010-2014) will be re-audited in the new cycle

• Sponsors of high star and low star will be audited

• Sponsor has never been audited previously

• Sponsor is new to the program

• Sponsor represents a large percentage of MA or Part D enrollment


• Make sure you are familiar with • HPMS Memos

• CMS Fraud Alerts

• Best practices from CMS audits

• High Risk Pharmacy and High Risk Prescriber Assessments

• Incorporate these notices into your work plans

• Make sure your policies and procedures are reviewed and updated with current audit requirements.


• Ensure Universes can be pulled quickly, and do it often - don’t wait!

• Provide samples for internal audits and practice webinars

• Review frequently by Department and Medicare Compliance

• Base your internal Audits on the CMS Audit Protocols • Another tool to confirm universe data is correct • Practice for the Departmental Audit teams

• Internal audits should be more rigid than CMS • Set the goal to exceed requirements – not just meet requirements

• Do not forget those areas that are not specifically in the audit protocols because all areas are connected

• Develop your BIA queries early - don’t procrastinate!

• If you use multiple systems, FDR, be sure you pull data from each of these systems for the universe.

So the Best way to Ensure a Good Audit

• Having monthly universes has proven to be very helpful • Much more stressful for teams who were not able to pull and review

universes monthly

• Regardless of how you practice and prepare for the audit • If you are doing it correctly now, it will show

• If not, it will show

Questions and Answers

Thank You

If you would like to obtain additional information or are interested in discussing how Inovaare can help please feel free to contact us.

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cms 2015 program audit protocol

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