CMS logo
2012 Fall Conference
Program Audits
Tawanda Holmes, Director
&
Jonathan Blanar, Deputy
Director
Division of Compliance and
Policy Operations
Program Compliance and
Oversight Group
Center For Medicare
Image of smiling family of 6
September 5, 2012
Objectives
1. High Level Walk Through of Audit Process
2. Immediate Corrective Action Required
Process – New Since Spring Conference
3. Preparation Tips for Audit
4. 2012 Best Practices and Common Findings
5. 2013 Audit Planning
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Audit Process
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Immediate Corrective Action Required
(ICAR)
• Definition of ICAR:
– Deficiencies identified that have the potential to
cause significant beneficiary harm (whether
medical or financial) in the areas of:
• Part D coverage determinations, appeals, and
grievances (CDAG);
• Part D prescription drug formulary administration (FA);
• Part C organization determinations, appeals,
grievances; or
• Part C access to care (ODAG)
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Immediate Corrective Action Required
(ICAR)
(continued)
– Significant beneficiary harm exists if the identified
deficiency resulted in the plan’s failure to provide
medical services or prescription drugs, causing
financial distress, or posing a threat to enrollee
health and safety due to non-existent or
inadequate policies & procedures, systems,
operations or staffing
– Problems identified as needing immediate
corrective actions are not issues that have already
been resolved, but are current vulnerabilities 5
Examples of Deficiencies Requiring
ICAR
Part D Prescription Drug Formulary Administration
• Disruption of care for beneficiaries with drugs in the protected
classes or other critical medications
• Beneficiary access problems related to the use of clinically
inappropriate and unapproved utilization management criteria
• Transition issues that prohibit beneficiaries from receiving a
temporary supply of prescribed Part D drugs when they are eligible
for a transition benefit
Part D Coverage Determinations, Appeals, and Grievances
• Misclassifying coverage determinations or appeals as grievances or
failure to effectuate overturns or approvals
• Failure to auto-forward cases to the IRE as required
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Examples of Deficiencies Requiring
ICAR
Part C Organization Determinations, Appeals. and Grievances
and Part C Access to Care
• Failure to follow National Coverage Determinations (NCDs)/Local
Coverage Determinations (LCDs) or other CMS coverage policy
when making coverage decisions on any medical or other health
service that is covered by Medicare
• Misclassifying organization determinations or appeals as grievances
or failure to effectuate overturns or approvals
• Failure to auto-forward adverse reconsideration cases (including
cases that are not adjudicated within the required timeframe) to
the IRE as required
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ICAR Onsite/Webinar Process
Onsite/Webinar Audit
• TLs must identify and document access issues and/or systemic
issues that have the potential to cause significant beneficiary harm
• Audit team will immediately inform CMS management and
communicate verbally to the sponsor when identified
• The PCOG AL will send an email to the plan’s compliance officer the
same day, detailing the immediate corrective action issue and
requesting the plan fix it immediately
• The sponsor will be made aware of the seriousness of the issue(s)
and our expectations for immediate resolution (i.e. immediately
stop inappropriate action(s) and/or initiate manual intervention)
• The TL will reiterate immediate corrective action issues at the exit
conference
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ICAR Post Audit Process
Post Audit
• Within a few days of the exit conference, the AL
will send the immediate corrective action request
via email to the plan’s compliance officer
• The AL will have a call with the plan after sending
the email to describe CMS’ expectations
• The corrective action plan and confirmation must
be received by the AL, from the Sponsor, within 72
hours of receipt of the immediate corrective action
request
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ICAR Post Audit Process
Post Audit (continued)
• Once the response is received from the plan, it will
either be accepted or denied by PCOG
– Accepted: It is reasonable as long as the plan had
measurable responses describing actions taken to
immediately ensure the potential for significant beneficiary
harm has been eliminated
– Denied: If the responses are not reasonable or complete,
PCOG will reject the submission and have the plan resubmit
within 1 business day
• The AL will let the plan know whether or not the
submission is accepted via email
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Validation of ICAR by CMS
• For Formulary Administration – The sponsor will submit a 3
day universe of rejected claims starting the day after all
corrections are implemented by the sponsor
• For ODAG and CDAG - The sponsor will submit a 30 day
universe for both CDAG/ODAG starting the day after all
corrections are implemented by the sponsor
• The validation for the remainder of the areas audited and
findings that were not immediate needs will be handled
through the normal audit report process (90 days)
• Once validation is complete, the DCPO representative will
communicate to the sponsor via email the results of the
validation within 3 days of finalizing the results (Pass or Fail
and why)
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Preparation Tips for Audit
Pre-Audit
• BEFORE receiving an audit start notice, review the
HPMS memo (date), discuss the requirements
internally, and conduct mock audits
• AFTER receiving an audit start notice, discuss
requirements internally and forward questions to
CMS before the audit start notice follow-up call
• Notify your PBMs and other delegated entities who
would be needed to assist with pulling universes
• During the follow-up call, ask questions about the
universe templates, inform CMS of other audit
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efforts, etc
Preparation Tips for Audit
Pre-Audit (continued)
• Since CMS will audit all areas simultaneously, plan
staffing requirements and discuss scheduling needs
with audit lead
• Provide CMS with a contact for access to SFTP and test
the access upon receiving username and password
• Contact the audit lead if universes would be delayed
and for any other clarification or concerns
• For Enrollment/Disenrollment, LEP and Agent/Broker
areas, clearly label documents to support samples.
Highlight areas that prove you are compliant. Ensure
cases are complete and available for review after the
entrance conference
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Preparation Tips for Audit
Audit
• Samples are provided during the entrance conference. Be
ready to show supporting documentation for samples in your
systems live via webinar
• Be prepared to discuss how samples are compliant
• Feel free to ask questions if you are unclear on why a sample
is considered “failed”
• Provide screenshots of documents as requested by the CMS
team lead and upload to the SFTP daily
• Provide audit team with items requested within the deadlines
provided. If unable to meet a deadline, please notify the CMS
team members as soon as you can to propose a new deadline
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Preparation Tips for Audit
Audit
• Immediate issues should be addressed as directed by CMS.
Track other failed samples to assist in planning for corrective
action
• During the exit conference, ask questions
• Begin developing corrective action plans in anticipation of final
audit report
Post Audit
• Review the draft report and provide comments timely
• Upon receiving the final report, prepare your corrective action
plan for submission to CMS
• Respond to the audit questionnaire to assist CMS in improving
the audit process
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2012 Best Practices and Common
Findings
• Refer to HPMS memo
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2013 Audit Planning
• Finalize the 2013 audit strategy – October 2012
• Release 2012 audit lessons learned – December
2012
• Release 2013 protocols via HPMS – January 2013
• New audit module in HPMS will go live – January
2013
• 2013 Audits will begin – late January/early
February 2013
• Developing PCOG Webpage
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Q&A
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Contact Information
Jonathan.Blanar@cms.hhs.gov
Tawanda.Holmes@cms.hhs.gov
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