01 part c a&g presentation k sugarman - iceforhealth.org · 3 odag common findings and how to...

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Medicare Part C: Organization Determinations, Appeals & Grievances (ODAG)

Medicare Part C: Organization Determinations, Appeals & Grievances (ODAG)

Kristi Sugarman‐CoatsAccount Manager

Division of Medicare Health Plans Operations

Centers for Medicare & Medicaid Services

December 11, 2014

ICE 2014 Annual Conference

San Francisco, CA

ODAG Improvement Strategies

OverviewOverview

• ODAG Recommendations

• ODAG Common Findings and How to Improve

• ODAG Recent Updates– Quality Improvement Organization (QIO)

– Non‐Contracted Provider Disputes

• ODAG Resources– Medicare Managed Care Manual, HPMS memos, MAXIMUS manual, Part C mailbox

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ODAG RecommendationsODAG Recommendations

• Review the August 27, 2014 HPMS memo titled Common Conditions, Improvement Strategies, and Best Practices based on 2013 Program Audits

– Similar findings last three years

– Findings in these areas may be elevated in future audits

– Account Managers reached out to plans to discuss the memo

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ODAG RecommendationsODAG Recommendations

Universe Submission

• Pay close attention to the directions for pulling the universe

• Ask ODAG team lead questions prior to submitting universe

• Oversight of delegated entity universes

– Ensuring an accurate and complete universe

ODAG Common Findings and How to ImproveODAG Common Findings and How to Improve

Notification Timeliness: Organization Determinations

• Expedited cases: Notify enrollee orally within 72 hours and follow up with written notice within 3 calendar days of oral notification

• Standard cases: Notify enrollee within 14 calendar days

• Payment cases: Notify enrollee within 60 calendar days


Notification Types

• Approvals

– For fully favorable decisions, the enrollee must be notified, however, the manner of notification may be either orally or in writing

• Denials

– For denials or partial denials, enrollee must be notified in writing

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Notice Content

• Denial rationale inadequate or inaccurate

– Denial reason needs to be written so that enrollee understands what is denied and why

• Non‐contracted provider denials lacked appeal rights

– EOB/remittance notice to non‐contracted provider must include appeal rights


Inappropriate Denials

• Outreach needed to provider and/or enrollee in order to obtain information needed to make decision

– Contracted providers must respond within timeframe requested by plan/delegated entity

• Inappropriate denials following referral from contracted provider

• Plans using incorrect guidelines to make decision


• Conduct internal audits and include your delegated entities

• Management oversight of processing appeals and grievances

• Perform quality assurance tests monthly and select a sampling of cases to validate accuracy

• Record customer service calls to ensure that enrollee calls are handled appropriately

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ODAG Recent UpdatesODAG Recent Updates

• Quality Improvement Organization (QIO) changes as of August 1, 2014

– Livanta is the new QIO in California, Arizona, Nevada, and Hawaii (plus other states)

– KEPRO is also a new QIO contractor in states not administered by Livanta

– Primarily responsible for quality of care reviews, discharge, and termination of service appeals


• Quality Improvement Organization (cont.)

– Update marketing materials to correct QIO information including (but not limited to):

• Evidence of Coverage (EOC)

• Grievance notices

• Detailed Explanation of Non‐Coverage

• Detailed Notice of Discharge

• Notice of Medicare Non‐Coverage

• Important Message from Medicare


• Non‐Contracted Provider Disputes

– CMS no longer contracts with C2C (as of January 31, 2014)

– Provider has to address disputes directly with the plan

– Plans need to make sure they include appeal rights on EOBs/remittances for non‐contracted providers

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ODAG ResourcesODAG Resources

• Medicare Managed Care Manual, Chapter 13• HPMS Memos

– 2013 Common Conditions & Best Practices memo (8/27/2014)

– QIO Program Changes (7/24/2014)

• MAXIMUS Reconsideration Process Manual http://www.medicareappeals.com/Portals/3/PDF/Recon%20Manual%2012‐19‐12.pdf

• 42 CFR Part 422, Subpart M• Part C Appeals & Grievances Mailbox:[email protected]

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Part D Coverage Determinations, Appeals & Grievances (CDAG)

Part D Coverage Determinations, Appeals & Grievances (CDAG)

Lucy Saldaña, Pharm.D.

Region IX Pharmacist Consultant

Division of Medicare Health Plan Operations

Centers for Medicare and Medicaid Services

December, 11th , 2014


San Francisco, CA

CDAG Improvement Strategies

OverviewOverview

• CDAG Recent Updates

• CDAG Common Findings, Improve Strategies and Best Practices

• CDAG Resources

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Part D CDAG UpdatesPart D CDAG Updates

Most recent version of Chapter 18 of the Part D Manual released May 12, 2014

• Requiring plans to employ a medical director who is responsible for ensuring the clinical accuracy

• Plan sponsor must make reasonable and diligent efforts to obtain the necessary information

• Eliminate the previous requirement that tieringexceptions be limited to brand‐to‐brand or generic‐to‐generic substitutions

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Part D CDAG Updates (con’t)Part D CDAG Updates (con’t)

• Clarifies that supporting statements for exception requests may be submitted orally or in writing

• Adds language clarifying that plan sponsors must make reasonable and diligent outreach efforts

• Clarify CMS’ expectations on plan sponsors’ limited use of the reopening process

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CDAG Common Findings andHow to Improve


Adequate and/or Accurate Rational for the Denial

• Letter did not contain specific reasons for the denial

• Letter did not state which requirements needed to be met to allow for coverage

• Denial rational did not comport with the CMS approved formulary and/or coverage criteria

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Improvement Strategies:

Clearly provide and explain the reason for denial in the free‐text field of the standardized denial notice

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Sufficient outreach to the prescriber or beneficiary was not demonstrated

• No formal outreach policy in place • Existing outreach policy was not followed nor were there proper internal controls to detect the sponsor’s non‐compliance

• No additional outreach attempts were made by the sponsor after the initial attempt

• Sponsor lacked effective internal controls to ensure sufficient supporting documentation was obtained from the prescriber

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Improvement Strategies:• Chapter 18 Sections 10.2. Responsibilities of the Part D Plan Sponsor

• Policy and Procedure that makes sense to your Plan

– Phone, Fax or email

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Misclassified a coverage determination or redetermination request as a grievance and/or

customer service inquiry

• Lack of effective controls to monitor the classifying

• Process, and resolve the beneficiary inquiries to ensure Part D requirements were followed

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• Continuous/ on going training of employees on the process

• Quality Improve checks to ensure compliance

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72 hours notification timeframe from receipt of a standard coverage determination request

was missed• Lack of adequate processes and internal controls to ensure beneficiaries were notified of standard coverage determination decisions

• Inappropriately tolled all coverage determination and appeal requests instead of adhering to required regulatory timeframes

• Coverage on weekends/holidays was not sufficient to ensure cases were worked within the required timeframes

• Notifications were not sent to beneficiaries after decisions were made 11




• The system should indicate when the beneficiary/provider notice was mailed, not just when the notice was created

• Ensure that the staff processing coverage determination requests understand and follow CMS’ policy for tolling adjudication timeframes for exception requests

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• Ensure that systems clearly indicate time of receipt of a coverage determination or redetermination request

• System should provide reminders of impending deadlines that are accessible to multiple staff members, and allow for tracking of elapsed time and daily management reports of pending workload

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Inappropriate denials when processing coverage

determinations

• Failure to comply with CMS and plan coverage rules, including CMS‐approved utilization management criteria

• Failure to ensure the clinical accuracy of medical necessity denials

• Clinical staff was not adequately trained or monitored to ensure proper clinical review of prescriber documentation

• Clinical reviewers did not consider all available clinical information prior to making a coverage determination

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Sponsor and their medical directors must ensure the clinical accuracy of plan decision‐making

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Best Practices:

• Payments for Direct Member Reimbursement (DMR) requests were issued on a daily basis

• Sponsor initiated an internal review process to aggressively resolve Part B vs. Part D rejections from the previous day

• Sponsor had systems that were able to provide an automated claim look‐back

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CDAG Resources CDAG Resources

Part D• 42 CFR Part 423, Subpart M

• Medicare Prescription Drug Benefit Manual, Chapter 18 “Part D Enrollee Grievances, Coverage Determinations and Appeals”

• HPMS Memos August 27, 2014 HPMS “Common Conditions, Improvement Strategies, and Best Practices based on 2013 Program Audits “

• Part D Appeals & Grievance Mailbox: [email protected]

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AcronymsAcronyms

MAPD‐Medicare Advantage Prescription Plan

MAO‐Medicare Advantage Organization

OMB‐ Office of Management and Budget

UM‐ Utilization Management

CD‐ Coverage Determination

PA‐ Prior Authorization

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Questions? Questions?

Part C Appeals & Grievances Mailbox:

[email protected]

Part D Appeals & Grievances Mailbox:

[email protected]

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Questions & AnswersQuestions & Answers

Jullin Kwok

Account Manager

Division of Medicare Health Plans Operations

Centers for Medicare & Medicaid Services

December 11, 2014


San Francisco, CA

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C4-21-26 Baltimore, Maryland 21244-1850

CENTER FOR M EDICARE DATE: July 24, 2014 TO: All Medicare Advantage Organizations and Prescription Drug Plans FROM: Kathryn A. Coleman, Acting Director

Medicare Drug & Health Plan Contract Administration Group Amy K. Larrick, Acting Director Medicare Drug and Part C & D Data Group Arrah Tabe-Bedward, Director Medicare Enrollment & Appeals Group

SUBJECT: Restructuring of the Quality Improvement Organization Program and the Impact

to Medicare Advantage Organizations and Prescription Drug Plans The purpose of this memorandum is to notify Medicare Advantage Organizations (MAOs) and Prescription Drug Plans (PDPs) that CMS is restructuring the Quality Improvement Organization (QIO) program to improve both patient care and health outcomes, and save taxpayer resources. The overall restructuring of the QIO program will allow for the creation of Beneficiary and Family-Centered Care Quality Improvement Organizations (BFCC-QIOs) contractors to support the program in five service areas. Effective August 1, 2014, the existing QIO contractors will be replaced by two BFCC-QIOs contractors that will be responsible for conducting quality of care reviews, discharge and termination of service appeals, and other areas of required review in the various provider settings. The two new BFCC-QIOs contractors are: LIVANTA Area Address Toll-free Number Fax Number

1 (CT, ME, MA, NH, NJ, NY, PA, PR, RI,

VT, VI)

Livanta BFCC-QIO Program 9090 Junction Drive, Suite 10 Annapolis Junction, MD 20701

866-815-5440 TTY: 1-866-868-2289

Appeals: 855-236-2423 All other reviews: 844-420-6671

5 (AK, AZ, CA, HI, ID, NV, OR, WA)

Livanta BFCC-QIO Program 9090 Junction Drive, Suite 10 Annapolis Junction, MD 20701

877-588-1123 TTY: 1-855-887-6668

Appeals: 855-694-2929 All other reviews: 844-420-6672

2

KEPRO Area Address Toll-free Number Fax Number

2 (DC, DE, FL, GA, MD, NC, SC, VA,

WV)

KEPRO 5201 W. Kennedy Blvd., Suite 900 Tampa, FL 33609

844-455-8708 844-834-7129

3 (AL, AR, CO, KY, LA, MS MT, ND, NM, OK, SD, TN,

TX, UT, WY)

KEPRO 5700 Lombardo Center Dr., Suite 100 Seven Hills, OH 44131

844-430-9504 844-878-7921

4 (IA, IL, IN, KS, MI, MN, MO, NE, OH,

WI)

KEPRO 5201 W. Kennedy Blvd., Suite 900 Tampa, FL 33609

855-408-8557 844-834-7130

Please note that MAOs and PDPs may be contacted by their current QIOs to discuss relevant transition activities and provide the new BFCC-QIO point of contact information. MAOs and PDPs must ensure the updated QIO contact information is included in all internal materials, as well as applicable communications sent to enrollees. This would include, but is not limited to, the following:

• The Evidence of Coverage (EOC); • MAO and PDP grievance notices related to quality of care complaints; • The Detailed Explanation of Non-Coverage (Form CMS-10124-DENC); and • The Detailed Notice of Discharge (Form CMS-10066).

To the extent possible, MAOs should ensure that their contracted providers have updated the notices listed below with the new BFCC-QIO contact information. MAOs should also be prepared to respond to enrollee questions regarding BFCC-QIO contact information contained in these notices:

• The Notice of Medicare Non-Coverage (Form CMS 10123-NOMNC); and • Important Message from Medicare (IM) (Form CMS-R-193).

More information about the QIO restructuring is detailed in the CMS press release at: http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2014-Press-releases-items/2014-05-09.html. If you have any questions about the QIO program, contact the QIO Program mailbox at [email protected]. For questions related to the notices of Non-Coverage contact [email protected]. For all other questions, contact your CMS Regional Account Manager.

http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2014-Press-releases-items/2014-05-09.html

http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2014-Press-releases-items/2014-05-09.html

mailto:[email protected]


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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C1-22-06 Baltimore, Maryland 21244-1850

CENTER FOR MEDICARE

Date: August 27, 2014

To: All Medicare Advantage Organizations and Prescription Drug Plans

From: Gerard Mulcahy, Director

Medicare Parts C and D Oversight and Enforcement Group

Subject: Common Conditions, Improvement Strategies, and Best Practices based on 2013

Program Audit Reviews

In the course of conducting audits and best practice reviews, the Centers for Medicare & Medicaid

Services (CMS), Medicare Parts C and D Oversight and Enforcement Group (MOEG), has observed

program areas where multiple sponsors were non-compliant with Medicare regulations and guidance, in

addition to areas in which Medicare Advantage (MA) organizations and Part D sponsors demonstrated

excellence in operations and achieved strong results.

This memo seeks to share the top five common conditions (i.e., audit findings) for each audit area, the

causes of these conditions, ideas for improving performance in these areas, and best practices identified

through the course of the 29 program audits conducted during 2013. The audit or program areas include:

Part D Formulary and Benefit Administration (FA); Part D Coverage Determinations, Appeals, and

Grievances (CDAG); Part C Organization Determinations, Appeals, and Grievances (ODAG);

Compliance Program Effectiveness (CPE); and Special Needs Plan Model of Care (SNP MOC). Note,

not all 29 sponsors were audited in all of these program areas (see attachments A-E for details). In

addition, although Parts C and D Outbound Enrollment Verification (OEV) was a 2013 program audit

area, the OEV results are not included in this memo due to the issuance of CMS-4159-F on May 23,

2014 (79 FR 29844), which significantly simplified agent broker requirements.

We want to remind sponsors that 3 prior Best Practice/Common Findings memos1 have been issued.

These memos are intended to provide sponsors with actionable information to enhance their compliance

with CMS regulations and policy and improve audit outcomes. The number of recurrent conditions

highlighted in this memo and the frequency with which they have been cited in past memos suggests this

information, as well as other internal monitoring recommendations and tools, are not being utilized as

expected. Sponsors should be aware that conditions noted in one or more Best Practice/Common

Findings memos will be considered an aggravating circumstance during the course of future program

audits, which can adversely affect a sponsor’s overall audit score. For example, an observation might be

elevated to a corrective action required (CAR) or a CAR might be elevated to an immediate corrective

action required (ICAR) if the condition cited had been addressed in a prior Best Practice memo.

CMS expects all sponsors to carefully and routinely assess risks to their organization, as well as

1 January 20, 2012, “2011 Program Audit Findings and Best Practices”; September 10, 2012, “Best

Practices and Common Findings from 2012 Program Audits”; July 30, 2013, “Best Practices and

Common Findings Memo #2 from 2012 Program Audits”.

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monitor and audit their operations to ensure compliance with CMS requirements. Sponsors should

review this memo with their compliance staff, compliance committee, senior leadership and other

affected stakeholders and take appropriate action. CMS Account Managers (AM) will also be

discussing this memo with their sponsors. We believe sponsors that implement the best practices

described in this memo should expect to achieve even greater success. In addition, we hope that

sharing the common conditions and their related causes will help all sponsors focus their internal

monitoring efforts and ensure any problems are corrected.

If you have any questions regarding the audit findings or best practices, please submit your inquiry to

[email protected].


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Attachment A: Part D Formulary and Benefit Administration (FA) Sponsors audited for FA: 28

Condition and Cause Summary (FA) Sponsors

Affected

Memo

Recurrence

Condition:

Sponsor failed to properly administer its CMS-approved formulary by applying

unapproved quantity limits.

17 (61%) 4/4

Cause Summary:

Inappropriately rejected claims based on the following:

o Utilized maximum daily dose limits that were more restrictive than the CMS-approved quantity

limits and/or Food and Drug Administration (FDA) maximum recommended daily doses.

o Applied a CMS-approved quantity limit specific for brand drugs only to generic versions of the

drugs.

o Failed to appropriately test and/or implement coding of quantity limits in the adjudication system,

resulting in inappropriate rejections.

o Applied quantity limits to non-formulary medications.

Condition:

Sponsor failed to properly administer its CMS-approved formulary by applying

unapproved utilization management practices. 14 (50%) 4/4

Cause Summary:

Implemented system edits that were not supported by FDA labeling and not part of the CMS-approved

formulary, such as:

o High dose

o Age

o Gender

Failed to allow claims for formulary drugs dispensed in the smallest commercially available package size

when the day supply, based on the prescribed dose, exceeded the plan’s day supply benefit.

Failed to allow claims for extended day supplies on initial prescriptions.

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Condition and Cause Summary (FA) Sponsors

Affected

Memo

Recurrence

Condition:

Sponsor failed to properly administer the CMS transition policy. 12 (43%) 4/4

Cause Summary:

Inappropriately rejected claims based on the following:

o Applied prior authorization edits on claims for beneficiaries with a utilization history of protected

class drugs.

o Failed to document that a transition notice was mailed to a beneficiary (or his/her representative).

o Failed to afford long term care beneficiaries multiple transition fills as necessary during the entire

length of the transition period.

o Failed to correctly identify drugs with a negative cross-year formulary change.

Imposed utilization management edits that were not appropriate during transition (e.g., the inappropriate edits

were not related to: Part B vs. Part D determination; FDA maximum daily dose; early refill, etc.).

Failed to generate and/or mail transition notices in a timely manner due to a manual file transfer process.

System was coded to reject transition-eligible claims for drugs in their smallest available package size when

the calculated days’ supply exceeded the transition day supply limits.

Transition policy did not afford a transition fill for drugs with a negative cross-year formulary change.

Transition policy classified emergency fills for long term care beneficiaries as transition fills which did not

allow the system to recognize the medications as existing treatment/therapy.

Condition:

Sponsor improperly effectuated a prior authorization or exception request. 11 (39%) 4/4

Cause Summary:

Failed to appropriately process a manual claim for reimbursement.

Issued one-time authorizations instead of making coverage determination requests, which, if approved, would

need to be effective for the remainder of the plan year.

System overrides were not properly coded as a result of favorable PA or exception requests (i.e., overrides of

step therapy or refill too soon edits).

Improperly effectuated prior authorization and exception requests at too granular a level (i.e., dose-specific),

which resulted in beneficiaries having to request additional coverage determinations with any change in dose. Effectuated authorizations for less than the period of time required by CMS. Specifically, less than the end of

the plan year for formulary exceptions, and/or less than the CMS-approved prior authorization coverage

duration.

Condition:

Sponsor failed to provide a continuing beneficiary a transition supply of a non-

formulary medication.

9 (32%) 4/4

Cause Summary:

Continuing beneficiaries were not identified as eligible for a transition supply for various reasons such as:

o Unsuccessful look-back logic.

o Incorrect identification of drugs with a cross-year negative formulary change (e.g., deletion, PA/ST

addition).

o Incorrect enrollment date and/or plan information.

o Sponsor lacked the ability to programmatically remove utilization management restrictions,

previously in place, from drugs that changed to non-formulary status in the next contract year.

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Improvement Strategies (FA)

Test the logic of the programming for all drugs that changed formulary status from one year to the next to ensure

they adjudicate properly.

Test claims for formulary drugs to ensure that inappropriate edits do not cause rejections.

Test transition logic prior to the start of the new plan year to ensure that claims for new beneficiaries will not

reject for transition supplies.

Perform quality checks by routinely comparing the formulary file submitted to CMS and the adjudication system

file to ensure that there are not inconsistencies that could create discrepancies and inappropriate rejections (e.g.,

unapproved UM, drug deletion, etc.).

Complete a review of 100% of rejected claims to identify and correct any formulary and transition errors and then

periodically review rejected claims to ensure no new errors develop.

Best Practices (FA)

Concurrent drug utilization review (DUR) logic was used to alert pharmacists to potential therapeutic duplications

and overutilization. Pharmacists were alerted when beneficiaries had claims from 4 or more prescribers or 4 or

more pharmacies for drugs in the same therapeutic class.

When claims were adjudicated for oral corticosteroids that had Part B vs. Part D prior authorizations (PA Type 3),

a claims look-back process for immunosuppressant therapy was used before rejecting claims. In the absence of

immunosuppressant therapy, the corticosteroid claim automatically paid at point-of-sale under Part D to avoid

unnecessary delays in accessing therapy.

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Attachment B: Part D Coverage Determinations, Appeals, and Grievances (CDAG) Sponsors audited for CDAG: 27

Condition and Cause Summary (CDAG) Sponsors

Affected

Memo

Recurrence

Condition:

Beneficiaries and prescribers did not receive an adequate and/or accurate

rationale for the denial.

24 (89%) 4/4

Cause Summary:

Denial language was not clearly understandable to the beneficiary and prescriber and did not contain the

specific reasons for the denial and any requirements that needed to be met to allow coverage.

Sponsor’s software did not permit the user to modify or customize the denial reasons to comply with the

requirement that the denial rationale is specific to each case.

Denial rationale did not comport with the CMS-approved formulary and/or coverage criteria for the

requested medication.

Condition:

Sponsor did not demonstrate sufficient outreach to the prescriber or beneficiary

to obtain information necessary to make an appropriate clinical decision.

21 (78%) 4/4

Cause Summary:

Sufficient outreach was not performed for the following reasons:

o No formal outreach policy in place.

o Existing outreach policy was not followed nor were there proper internal controls to detect the

sponsor’s non-compliance.

o No additional outreach attempts were made by the sponsor after the initial attempt.

Sponsor lacked effective internal controls to ensure sufficient supporting documentation was obtained from

the prescriber.

Condition:

Sponsor misclassified a coverage determination or redetermination request as a

grievance and/or customer service inquiry.

16 (59%) 3/4

Cause Summary:

Sponsor lacked effective controls to monitor the processing, classifying and resolution of beneficiary

inquiries to ensure Part D requirements were followed (e.g., grievance coordinators, Customer Service

Representatives, etc.).

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Condition and Cause Summary (CDAG) Sponsors

Affected

Memo

Recurrence

Condition:

Sponsor did not notify the beneficiary or their prescriber, as appropriate, of its

decision within 72 hours of receipt of a standard coverage determination request

or, for an exceptions request, the physician's or other prescriber's supporting

statement.

15 (56%) 3/4

Cause Summary:

Sponsor lacked adequate processes and internal controls to ensure beneficiaries were notified of standard

coverage determination decisions within the CMS required timelines.

Sponsor inappropriately tolled all coverage determination and appeal requests instead of adhering to required

regulatory timeframes.

Coverage on weekends/holidays was not sufficient to ensure cases were worked within the required

timeframes if they were received close to or over the weekend/holiday.

Notifications were not sent to beneficiaries after decisions were made.

Condition:

The Sponsor made inappropriate denials when processing coverage

determinations.

15 (56%) 4/4

Cause Summary:

Sponsor failed to comply with CMS and plan coverage rules, including CMS-approved utilization

management criteria.

Sponsor failed to ensure the clinical accuracy of medical necessity denials.

Clinical staff was not adequately trained or monitored to ensure proper clinical review of prescriber

documentation. Clinical reviewers did not consider all available clinical information prior to making a

coverage determination (e.g., failure to utilize physician supplied information and previous prescription

claims history).

Improvement Strategies (CDAG)

Clearly provide and explain the reason for denial in the free-text field of the standardized denial notice (e.g. non-

formulary, Part B vs. D determination, prior authorization, step therapy, safety edits, etc.). If there is a formulary

requirement that must be met, it must be specifically stated and must comport with the CMS-approved formulary.

Any applicable Medicare coverage rule or plan policy must be described in the denial rationale (e.g., a B v. D

denial for an immunosuppressant drug must describe Medicare coverage rules for these drugs).

Ensure that systems clearly indicate time of receipt of a coverage determination or redetermination request (via a

time stamp) and identify whether it is a standard or expedited request. The system should provide reminders of

impending deadlines that are accessible to multiple staff members, and allow for tracking of elapsed time and

daily management reports of pending workload. Additionally, the system should indicate when the

beneficiary/provider notice was mailed, not just when the notice was created.

Ensure that the staff processing coverage determination requests understand and follow CMS’ policy for tolling

adjudication timeframes for exception requests (i.e., tolling only at the coverage determination level and only

when a prescriber’s supporting statement is needed for adjudication).

Improvement Strategies (CDAG)

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Sponsor and their medical directors must ensure the clinical accuracy of plan decision-making, including

adherence to Medicare and plan coverage criteria (e.g., clinical reviewers are trained and can access all applicable

rules, formularies and compendia). This includes ensuring all adverse coverage determinations involving medical

necessity are reviewed by an appropriate clinician, all redeterminations involving medical necessity are made by

an appropriate physician, and all prescriber supporting statements for exception requests are given appropriate

consideration.

Best Practices (CDAG)

Payments for Direct Member Reimbursement (DMR) requests were issued on a daily basis. By making prompt

and timely payments for reimbursement requests beneficiaries did not experience financial hardships or delays

in access to care.

Sponsor initiated an internal review process to aggressively resolve Part B vs. Part D rejections from the

previous day by reviewing all rejections and proactively beginning a coverage determination if one had not

already begun. The process included researching information, such as call logs and claims history, and

performing outreach to pharmacies and prescribers to determine the appropriate coverage in each case. This

proactive approach ensured that beneficiaries did not experience more than a one day delay in access to

medication as a result of Part B vs. Part D system rejections.

Sponsor had systems that were able to provide an automated claim look-back for medications requiring prior

authorization for new starts only (PA Type 2), for a period of 180 days, to allow effectuation without requiring

another coverage determination.

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Attachment C: Part C Organization Determinations, Appeals, and Grievances (ODAG) Sponsors audited for ODAG: 24

Condition and Cause Summary (ODAG) Sponsors

Affected

Memo

Recurrence

Condition:

Sponsor did not make payment decisions within the required 30 or 60 day

claims processing timeframes.

18 (75%) 2/4

Cause Summary:

Paper claims were converted into electronic data interchange (EDI) files prior to uploading them into the

claim processing system, which caused a delay.

Sponsor lacked effective processes and internal controls to ensure that needed documentation was gathered

and reviewed on backlogged cases, so that a decision could be made within the required timeframes.

Sponsor held claims and requested information before sending it to their delegated entity to issue a decision,

which resulted in late determinations being issued by the delegated entity.

Sponsor lacked adequate processes and/or internal controls to detect the absence of an internal or external (if

completed by a delegated entity) comprehensive and timely review process.

The claims department lacked sufficient staffing to ensure payment requests were adjudicated timely.

Claims were incorrectly determined to be unclean when received and thus were not processed within required

timeframes.

The claims system payment code was not properly programmed for immediate payment release.

Condition:

Sponsor did not notify the beneficiary or the provider of its decision within 14

calendar days of receipt of a standard, pre-service organization determination

request.

14 (58%) 3/4

Cause Summary:

Inappropriate use of timeframe extensions when a provider was not prompt in returning information.

Inadequate processes and internal controls to ensure pre-service organization determination requests were

adjudicated timely.

Systems or processes lacked the ability to alert a sponsor that the timeframe to issue a decision was about to

expire.

Inappropriate staffing levels (i.e., being understaffed).

Condition:

Beneficiaries and providers did not receive an adequate and/or accurate rationale

for the denial.

13 (54%) 3/4

Cause Summary:

The system which generated the Explanation of Benefits (EOBs) did not have the capability to incorporate a

clear and detailed rationale for the denial.

Sponsor lacked effective internal controls to ensure the Integrated Denial Notice (IDN) was written in a

manner the beneficiary could understand, or that the IDNs contained accurate information about the denied

services and a clear and detailed rationale for the denial.

Condition:

When the sponsor denied a request for payment from a non-contracted provider,

the remittance advice/denial notice did not state the specific reason for the denial

nor did it provide a description of the appeals process.

12 (50%) 3/4

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Condition and Cause Summary (ODAG) Sponsors

Affected

Memo

Recurrence

Cause Summary:

Sponsor did not have policies and procedures to provide appeal rights to non-contracted providers with the

denial notice.

Sponsor lacked adequate internal controls to ensure the Explanation of Payment (EOP) notices or remittance

advice sent to non-contracted providers contained the standard appeal language.

Condition:

Sponsor did not demonstrate sufficient outreach to the provider or beneficiary to

obtain the information necessary to make an appropriate clinical decision.

12 (50%) 3/4

Cause Summary:

Sponsor lacked adequate processes and internal controls to ensure clinical information was obtained prior to

making a decision.

Improvement Strategies (ODAG)

Ensure that beneficiaries and providers receive accurate, clear and detailed information related to the specific

reason(s) for denial (e.g. not a covered benefit, not medically necessary, did not meet clinical/medical criteria,

etc.) The applicable Medicare coverage rule or plan policy (e.g., EOC provision) must be described in the denial

rationale. If a requirement must be met to obtain the service, the sponsor should include that information in the

denial notice.

Ensure that beneficiaries and providers receive detailed, accurate and complete information about the appeals

process, including information about how to file an appeal with the Independent Review Entity (IRE).

Perform quality assurance tests on systems to ensure that processing and notification of standard and expedited

organization determination requests occurs within required timeframes. Sponsor should ensure its systems clearly

indicate the date and time (for expedited requests) of receipt of an organization determination or reconsideration

request and identify whether it is a standard or expedited request. The system should provide reminders or alerts

of impending deadlines not only to the staff assigned to process these requests but provide management reports of

pending workload.

Provide training and adequate support to staff responsible for processing organization determinations and

reconsiderations to ensure its staff understands CMS’ policy for using the 14 day extension to requests additional

information.

Best Practices (ODAG)

A health care manager was assigned to beneficiaries to guide them through the organization determination and

reconsideration processes, namely, requesting prior authorization for items and services.

The Explanation of Benefits (EOBs) denoted a zero dollar balance, which helped ensure the beneficiary

understood that they did not have any financial liability.

11 | P a g e

All calls received by customer service representatives were recorded. This allowed for a comprehensive review

of all beneficiary grievances or coverage requests, and for the opportunity to improve performance associated

with call classification issues.

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Attachment D: Compliance Program Effectiveness (CPE) Sponsors audited for CPE: 28

Condition and Cause Summary (CPE) Sponsors

Affected

Memo

Recurrence

Condition:

Sponsor did not review OIG and GSA exclusion lists for any new employee,

temporary employee, volunteer, consultant, governing body member and/or FDR

prior to hiring or contracting; nor monthly thereafter.

18 (64%) 2/4

Cause Summary:

Sufficient resources were not deployed to review the OIG and GSA exclusion lists in accordance with CMS

requirements.

Sponsor failed to review employees of delegated entities against the exclusion lists.

Sponsor was unaware of the CMS requirements for FDR oversight.

Condition:

Sponsor did not provide evidence that it audits the effectiveness of the

compliance program at least annually and that the results are shared with the

governing body of their organization.

10 (36%) 2/4

Cause Summary:

Sponsor did not provide sufficient resources to conduct an independent audit of the compliance program.

During periods of management transitions the need for an annual audit of the effectiveness of the

compliance program was not communicated internally.

The FWA regulatory requirements were excluded from the scope of the compliance program audit.

When an external audit firm was hired to perform a compliance program audit, the audit did not address

many of the elements of an effective compliance program as required by Chapters 9 and 21.

Condition:

Sponsor did not provide fraud, waste and abuse (FWA) training or training

materials to its FDRs.

8 (29%) 3/4

Cause Summary:

Sponsor lacked adequate processes to ensure that FDRs were identified to receive FWA training both upon

contracting and annually thereafter.

Sponsor lacked sufficient resources to implement a compliance program in accordance with CMS

requirements, particularly related to FDR oversight.

Sponsor lacked awareness that FWA training materials needed to be provided to FDRs or that FWA training

be provided directly to its FDRs.

Condition:

Sponsor did not provide evidence that general compliance information was

communicated to its FDRs.

7 (25%) 1/4

Cause Summary:

Sponsor lacked awareness that the distribution of general compliance information to first tier entities was a

CMS requirement.

Sponsor lacked adequate processes to ensure compliance program requirements were met and well

documented.

Signed attestations from FDRs during the audit period were not received and no follow-up was conducted to

obtain the attestations.

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Condition and Cause Summary (CPE) Sponsors

Affected

Memo

Recurrence

Condition:

The Sponsor did not distribute its standards of conduct (SOC) and policies and

procedures to employees who supported the Medicare line of business: (1)

Within 90 days of hire; (2) when there were updates to the policies and

procedures, and, (3) annually thereafter.

7 (25%) 3/4

Cause Summary:

Sponsor lacked adequate internal controls or formalized processes to ensure that all FDRs either received its

SOC and compliance policies and procedures.

Adequate documentation was not maintained to verify that all employees received SOCs upon hire.

Improvement Strategies (CPE)

Ensure that internal processes for communicating compliance information to FDRs are implemented timely and

followed appropriately. Annual FWA training can be met through use of the web-based training module available

through the Medicare Learning Network (MLN).

Develop a process that monitors and tracks the distribution of standards of conduct (SOC) and policies and

procedures to ensure sponsors are distributing: (1) within 90 days of hire, (2) when there are updates, and, (3)

annually thereafter.

Develop automated monitoring and auditing systems to detect excluded providers and retain source

documentation or screen prints from OIG and GSA exclusion databases. A robust monitoring system is needed to

detect excluded providers, employees, temporary employees, volunteers, consultants, governing body members

and/or FDRs prior to hiring or contracting, and monthly thereafter.

Develop effective working relationships and frequent communication between the compliance department and

business function areas and FDRs (e.g. PBM, providers, pharmacies, hospitals, suppliers, contractors, etc.)

Streamline compliance and FWA training and education efforts with the use of CMS’ web-based Compliance and

FWA Training module on the Medicare Learning Network (MLN).

Best Practices (CPE)

Sponsor placed their compliance/fraud, waste and abuse (FWA) reporting hotline contact information on the

back of all employees’ security access badges.

Sponsor developed a process for distributing CMS guidance memos received via HPMS to appropriate

personnel and confirming the new programmatic requirements were implemented by the appropriate functional

areas. The Compliance Officer notified appropriate parties on the distribution list within hours of receiving

HPMS memos. In addition, a Vice President with executive responsibility for the Medicare program ensured

that other appropriate personnel (including first-tier, downstream and related entities (FDRs)) received

information about the memos within 24 hours. When HPMS memos were received by operational owners

responsible for implementing the new guidance, the operational owners were required to confirm review of the

memo and provide an action plan if steps were needed to update procedures and processes.

14 | P a g e

Best Practices (CPE)

Sponsor checked the Office of Inspector General (OIG) and General Services Administration (GSA) Excluded

Parties List System (EPLS) exclusion lists on a monthly basis which was automated for all employees, providers

and first-tier, downstream and related entities (FDRs) involved in providing healthcare services to Medicare

beneficiaries. In return, the workload for the compliance and human resources departments was reduced and

documentation could easily be tracked and obtained for auditing purposes.

Sponsor provided detailed training to the governing body regarding roles and responsibilities, as well as the

complexity of the Medicare Parts C and D requirements. These included specific questions the members of the

governing body should be asking the compliance officer, in relation to the risks and compliance activity specific

to the Medicare line of business, and to the effectiveness of the compliance program with detecting, responding

to, and preventing noncompliance and fraudulent activities. The training encouraged the governing body

members to become active and engaged in the discussions regarding oversight of the compliance program.

Sponsor developed an online monitoring tool to track and manage corrective action plans (CAP) developed from

external and internal audits. The tool was used to track Medicare key performance indicators across operational

areas, manage annual reviews of all Medicare policies and procedures, and served as an audit module for

operational audits conducted by the Compliance Department. The tool included links to all Medicare guidance

and audit protocols.

Sponsor developed an internal Medicare FWA prevention program. Various materials were developed including

creative posters and puzzle cubes to get employees as well as delegated entities engaged in FWA detection and

prevention. Following the official launch of the campaign, an increase in employees reporting

potential/suspected FWA issues for its Medicare plans was observed.

Personnel within the Compliance Department had background and technical experience specific to the Medicare

Parts C and/or Part D areas they oversaw. For example, a compliance officer with experience in a

clinical/pharmacy setting worked closely with the formulary, PBM and CDAG departments to develop training,

provide technical guidance on regulatory requirements, and perform auditing and monitoring activities.

Sponsor added common conditions from the CMS program audit Best Practice/Common Finding memos to an

internal risk assessment to drive internal audit processes to identify and correct areas of non-compliance.

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Attachment E: Special Needs Plans Model of Care (SNP MOC) Sponsors audited for SNP MOC: 12

Condition and Cause Summary (SNP MOC) Sponsors

Affected

Memo

Recurrence

Condition:

Sponsor administered the initial health risk assessment (HRA) to a beneficiary

more than 90 days after their enrollment.

9 (75%) 1/4

Cause Summary:

Inadequate processes and controls to ensure initial assessments were consistently performed within 90 days

of enrollment.

Documentation from the sponsor’s vendor was not available to prove the HRA was conducted.

Initial HRAs were missed due to incomplete data.

Resources were not sufficient to manage all elements of the model of care.

Condition:

Sponsor did not administer the comprehensive annual reassessment within 12

months of the last risk assessment.

9 (75%) 1/4

Cause Summary:

Inadequate internal controls to ensure annual reassessments were consistently performed within 12 months of

the last risk assessment.

Sponsor did not make multiple attempts to contact beneficiaries.

Condition:

Sponsor did not provide evidence that it had an individualized care plan (ICP)

for the beneficiary.

7 (58%) 1/4

Cause Summary:

Sponsor lacked sufficient internal controls to ensure that beneficiaries were consistently assessed, especially

those that required care coordination or other related case management services, or to ensure that

beneficiaries’ ICPs were implemented.

Inappropriately relied on a nursing home facility to develop a beneficiary's ICP.

Evidence was not provided that an ICP was initiated or completed.

Care coordinators did not follow the model of care (MOC) for clinical services.

The HRA process relied only on phone call attempts with little or no follow-up efforts.

Condition:

The ICP did not address issues identified in the HRA. 7 (58%) 1/4

Cause Summary:

Sponsor lacked sufficient internal controls to ensure chronic conditions, especially those that have become

exacerbated and/or problematic, were addressed in the ICP. Delegated entities did not receive the HRA;

therefore, the delegated entity was not able to develop the ICP based on the needs disclosed in the HRA.

Case management staff did not have the requisite knowledge or experience to identify and prioritize health

risks and include these needs in the development and implementation of the ICP.

There were no checks to ensure the ICP addressed issues identified in the HRA.

Care coordinators did not follow the MOC for clinical services.

Condition:

Sponsor did not provide evidence of individualized care plan (ICP)

implementation through care or case management notes.

5 (42%) 1/4

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Condition and Cause Summary (SNP MOC) Sponsors

Affected

Memo

Recurrence

Cause Summary:

Inadequate staffing to manage required functions (e.g., documentation); existing staff required to carry a

heavy caseload.

Sponsor lacked effective internal controls, or evidence of such, to ensure the implementation of the ICPs is

properly documented.

Improvement Strategies (SNP MOC)

Implement processes to fully complete the initial and annual HRA in a timely manner.

Ensure staff has appropriate training and tools to implement and document the ICP, and include how the ICP was

developed using the HRA.

Implement processes within the ICT to establish roles and responsibilities to ensure appropriate ICP

implementation and documentation.

Implement processes to ensure staff is fully trained and understands all components of the SNP MOC.

Document evidence that the SNP makes available and offers training to network providers and explain the

challenges associated with the completion of the MOC training for network providers.

Periodically review organization policies/procedures as well as desktop procedures for staff and ensure they are in

accordance with the SNP’s most recent MOC.

Perform regular internal monitoring of procedures that support the MOC implementation (i.e., HRA contact

attempts, documentation of member issues and/or updates, completion of HRAs and ICPs in accordance with

CMS timeframes, outreach completed regarding training of providers in the network, and documentation of

completed staff training in the MOC). Track and include these activities as part of the MA organization’s

compliance plan.

Ensure that electronic record systems are documenting notes/updates for members and outreach attempts. MA

organizations could develop or configure a tracking mechanism/process to alert staff when an HRA is due to be

completed for a member.

Develop outreach processes with primary care, specialists, hospitals, and/or long term care facilities to build

relationships and further develop methods in care coordination, especially in contacting “hard-to-reach” members.

Best Practices (SNP MOC)

Sponsor’s Model of Care established a standard of performing the initial health risk assessment within 30 days of

enrollment.

Sponsor established an “Embedded Nurse” program, which included a nurse as part of the interdisciplinary care

team to aid in individualized care plan implementation, member assessment and care coordination.

Medicare Managed Care (Part C - Medicare Advantage)

60 days to file

Automatic forwarding to IRE if plan reconsideration upholds denial

60 days to file 60 days to file

60 days to file AIC = Amount In Controversy / ALJ = Administrative Law Judge / IRE = Independent Review Entity *Plans must process 95% of all clean claims from out of network providers within 30 days. All other claims must be processed within 60 days. **The AIC requirement for an ALJ hearing and Federal District Court is adjusted annually in accordance with the medical care component of the consumer price index. The chart reflects the amounts for calendar year (CY) 2014.

Organization Determination/Appeals Process

STANDARD PROCESS* Pre-Service: 14 day time limit

Payment: 60 day time limit

EXPEDITED PROCESS Pre-Service: 72 hour time limit Payment requests cannot be

expedited

Health Plan Reconsideration Pre-Service: 30 day time limit


Health Plan Reconsideration 72 hour time limit

Payment requests cannot be expedited

IRE Reconsideration Pre-Service: 30 day time limit


IRE Reconsideration 72 hour time limit

Payment requests cannot be expedited

Office of Medicare Hearings and Appeals ALJ Hearing

AIC ≥ $140** No statutory time limit for processing

Medicare Appeals Council No statutory time limit for processing

Federal District Court AIC ≥ $1,430**

Organization Determination

First Appeal Level

Second Appeal Level

Third Appeal Level

Fourth Appeal Level

Judicial Review

Medicare Prescription Drug (Part D)

60 days to file 60 days to file 60 days to file 60 days to file 60 days to file AIC = Amount In Controversy ALJ = Administrative Law Judge IRE = Independent Review Entity MA-PD = Medicare Advantage plan that offers Part D benefits PDP = Prescription Drug Plan *A request for a coverage determination includes a request for a tiering exception or a formulary exception. A request for a coverage determination may be filed by the enrollee, by the enrollee’s appointed representative or by the enrollee’s physician or other prescriber. **The adjudication timeframes generally begin when the request is received by the plan sponsor. However, if the request involves an exception request, the adjudication timeframe begins when the plan sponsor receives the physician’s supporting statement. ***The AIC requirement for an ALJ hearing and Federal District Court is adjusted annually in accordance with the medical care component of the consumer price index. The chart reflects the amounts for calendar year (CY) 2014.

Coverage Determination*/Appeals Process

STANDARD PROCESS 72 hour time limit**

EXPEDITED PROCESS 24 hour time limit**

PDP/MA-PD Standard Redetermination

7 day time limit

PDP/MA-PD Expedited Redetermination

72 hour time limit

Part D IRE Standard Reconsideration

7 day time limit

Part D IRE Expedited Reconsideration

72 hour time limit


Standard Decision AIC ≥ $140***

90 day time limit

Medicare Appeals Council

Standard Decision 90 day time limit

Federal District Court AIC ≥ $1,430***


Expedited Decision AIC ≥ $140***

10 day time limit

Medicare Appeals Council Expedited Decision 10 day time limit

Coverage Determination

Second Appeal Level

First Appeal Level

Third Appeal Level

Fourth Appeal Level

Judicial Review

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