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1 2013 Annual Conference ICE Appeals & Grievances Team Medicare Part C & Part D Training Breakout Session Presented by: Staci Newton, Supervisor, Medicare Compliance & Reporting Sonja Banks-Butler, Appeals & Grievances Manager 2013 Annual Conference Medicare Part C & Part D Member A&G 101 Medicare Part C & Part D Training Breakout Session 2 2013 Annual Conference Definitions Medicare Part C & Part D Training Breakout Session 3

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Page 1: Medicare Part C & Part D Member A&G 101 · 12/26/2013  · Medicare Part C & Part D Member A&G 101 Medicare Part C & Part D Training Breakout Session 2 2013 Annual Conference Definitions

1

2013 Annual Conference

ICE Appeals & Grievances Team

Medicare Part C & Part D Training Breakout Session

Presented by: • Staci Newton, Supervisor,

Medicare Compliance & Reporting

• Sonja Banks-Butler, Appeals & Grievances Manager

2013 Annual

Conference

Medicare Part C & Part D

Member A&G 101

Medicare Part C & Part D Training Breakout Session

2

2013 Annual

Conference

Definitions

Medicare Part C & Part D Training Breakout Session

3

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2013 Annual

Conference

Part C Definitions:

Complaints

Grievances

Appeals

Reconsiderations

Medicare Part C & Part D Training Breakout Session

4

2013 Annual

Conference

Part D Definitions:

Complaints

Grievances

Appeals

Redeterminations

Medicare Part C & Part D Training Breakout Session

5

2013 Annual

Conference

Requirements, Classifications

& Member rights

Medicare Part C & Part D Training Breakout Session

6

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Part C Requirements: The Centers for Medicare and Medicaid Services (CMS) requires that Part C plan sponsors must provide written information to members about the appeal procedures, including the right to an expedited review - at initial enrollment, upon notification of an adverse organization determination, upon notification of a service or coverage termination and annually thereafter.

Grievance procedures must meet all CMS requirements and be separate and distinct from organization determinations and appeal procedures.

Medicare Part C & Part D Training Breakout Session

7

2013 Annual

Conference

Part D Requirements: CMS requires that Part D plan sponsors must provide written information to members about the appeal procedures that are available to them through the Part D plan sponsor at initial enrollment, upon notification of an adverse coverage determination or denial, and annually thereafter.

If a plan changes its formulary or the cost-sharing status of a drug that has been prescribed for a member, the plan must provide written information about the grievance and appeal procedures to members who are affected by the change.

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Part D Requirements (cont’d): Grievance procedures must meet all CMS requirements and be separate and distinct from organization determinations and appeal procedures.

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Classifications & Member Rights

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Classifications & Member Rights – Part C

Standard Part C Appeals

Expedited Part C Appeals

Fast Track Part C Appeals

Expedited Part C Grievances

Quality of Service (QOS) Part C Grievances

Quality of Care (QOC) Part C Grievances

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Classifications & Member Rights – Part D

Standard Part D Appeals

Expedited Part D Appeals

Expedited Part D Grievances

Quality of Service (QOS) Part D Grievances

Quality of Care (QOC) Part D Grievances

Medicare Part C & Part D Training Breakout Session

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Conference

Appointment of Representative (AOR)

Medicare Part C & Part D Training Breakout Session

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Conference

Part C Authorized Representative: An authorized representative is an individual appointed by the member or other party, or authorized by State law, to act on the behalf of an member or other party involved in an appeal or grievance.

Part D Authorized Representative: An authorized representative is an individual either appointed by the member or authorized under State or other applicable law to act on behalf of the member in filing a grievance, requesting a coverage determination, or in dealing with any of the levels of the appeals process.

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Processing Time Frames

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Part C appeal time frames:

60 calendar days for claim appeals.

30 calendar days plus an extension of 14 days if justified for standard service appeals.

72 hours plus an extension of 14 days if justified for expedited requests.

48 hours for fast track appeals.

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Part D appeal time frames:

7 calendar days for claim appeals (payment must be made by 30th calendar day).

7 calendar days for standard service appeals.

72 hours for expedited appeals.

Medicare Part C & Part D Training Breakout Session

17

2013 Annual

Conference

Part C grievance time frames:

30 calendar days plus an extension of 14 days if justified for quality of service grievances.

Medicare health plan’s are required to have a 24 hour expedited grievance process for issues that meet the CMS expedited grievance criteria.

Medicare Part C & Part D Training Breakout Session

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Conference

Part D grievance time frames:

30 calendar days plus an extension of 14 days if justified for quality of service grievances.

Medicare health plan’s are required to have a 24 hour expedited grievance process for issues that meet the CMS expedited grievance criteria.

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Good cause

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Part C Appeals Good Cause: If a party shows good cause, the Medicare health plan may extend the time frame for filing a request for reconsideration.

Part C Grievances Good Cause: The Medicare health plan must include the following requirements in its grievance procedures:

Ability to accept any information or evidence concerning the grievance orally or in writing not later than 60 calendar days after the event;

Medicare Part C & Part D Training Breakout Session

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Part D Appeals Good Cause: If a party shows good cause, the Part D plan sponsor may extend the time frame for filing a request for redetermination.

Part D Grievances Good Cause: An enrollee may file a grievance with the Part D plan sponsor either orally or in writing no later than 60 days after the event or incident that precipitates the grievance.

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Part D Grievances Good Cause (cont’d): Although the regulations at 42 CFR 423.564(d)(2) do not require a Part D plan sponsor to consider a grievance that is filed after the 60-day deadline, nothing in the regulations prevents a plan sponsor from doing so on a case-by-case basis. If a plan intends to accept grievances that are not filed timely, it is responsible for developing the criteria it will use to evaluate such requests.

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Education

and

Quality

Medicare Part C & Part D Training Breakout Session

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Conference

Addressing all issues (making the member "whole")

Conducting due diligence through thorough research

Member and provider outreach (make the call)

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Template letters & understandable language

Educating members

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Educating plan associates/staff

Medicare Part C & Part D Training Breakout Session

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Conference

The importance of:

Reporting

Conducting internal audits

Conducting mock audits

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Risks

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

References:

Medicare Managed Care Manual Chapter 13 (Rev. 105, Issued: 04/20/12)

Prescription Drug Benefit Manual Chapter 18 (Last Updated - Rev. 9, 2/22/13)

Medicare Part C & Part D Training Breakout Session

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References cont’d:

Best Practices and Common Findings from 2012 Program Audits, September 10, 2012

Best Practices and Common Findings Memo #2 from 2012 Program Audits, July 30, 2013

Medicare Part C & Part D Training Breakout Session

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2013 Annual

Conference

Medicare Part C & Part D Training Breakout Session

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

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Date: July 30, 2013 To: All Medicare Advantage Organizations and Prescription Drug Plans From: Gerard Mulcahy, Director Medicare Parts C and D Oversight and Enforcement Group Subject: Best Practices and Common Findings Memo #2 from 2012 Program Audits In the course of conducting audits and best practices reviews, the Centers for Medicare & Medicaid Services (CMS), Medicare Parts C and D Oversight and Enforcement Group (MOEG), formerly the Program Compliance and Oversight Group (PCOG), has observed Medicare Advantage (MA) organizations and Part D Sponsors demonstrate excellence in operations and achieve strong results. CMS also identified program areas where numerous Sponsors are non-compliant with Medicare regulations and guidance. This memo seeks to share the best practices and common findings identified through the course of conducting audits and best practice reviews during 2012. In addition, this memo provides CMS’ recommendations within each program area, as well as feedback and advice from previously audited Sponsors on how to best prepare for an audit. On September 10, 2012, MOEG issued a Health Plan Management System (HPMS) memo entitled, ‘Best Practices and Common Findings from 2012 Program Audits’ that included the best practices and common findings identified as of the date of its release. This document supplements the earlier memo. The “*” (asterisk) next to a finding indicates that it is a new common finding not identified in our earlier memo. A finding is considered common when it occurs in at least 4 of the conducted audits. Our audits in 2012 reviewed Part D formulary and benefits administration; Part D coverage determinations and appeals, and grievances; Part C organization determinations and appeals, and grievances; Part C access to care; Part C and D compliance program effectiveness; Part C and D agent and broker oversight; Part C and D enrollment and disenrollment; and Part D late enrollment penalty (LEP). Attachment A shares best practices and common findings for each of these areas. We hope that sharing this information will help all Sponsors focus their internal monitoring and auditing efforts to help ensure these deficiencies are prevented before they occur or corrected if they exist. CMS expects all Sponsors to carefully and routinely assess risks to their organization and monitor and audit their operations to ensure compliance with CMS requirements. Sponsors should review this memo with their compliance staff, compliance committee, and other affected stakeholders and take appropriate action. Additionally, CMS Account Managers (AM) will be discussing this memo with their Sponsors shortly.

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If you have any questions regarding the audit findings or best practices, please submit your inquiry to [email protected]. CMS will also be available to address questions during the Part C and Part D User Call scheduled for September 11, 2013.

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Attachment A

Best Practices and Common Findings from CMS Program Audits

PRESCRIPTION DRUG FORMULARY ADMINISTRATION

Best Practices 1. Pharmacy Messaging

Clear communication between the Part D sponsor and dispensing pharmacy is critical in ensuring beneficiary access to Part D-eligible prescribed medications. These processes allow the pharmacies to assist beneficiaries in resolving claim rejections, and can prevent delays in medication therapy. We observed the following:

• Clear pharmacy messaging for step therapy rejections, which allows for more efficient processing of claims.

• Utilization of detailed secondary reject messaging to provide dispensing pharmacies with detailed instructions on the steps required for resolving applicable claims rejections. For example, override codes are needed to process claims once the pharmacist verifies the submitted prescription.

2. Cost Edits CMS has noted that some sponsors set maximum cost edits that are based on usual and customary pricing for standard dosing regimens which results in beneficiaries receiving prescribed medications in a timelier manner. For example, drug X is normally dosed as one tablet daily and the usual and customary price for 30 tablets is $1500. The sponsor would set the maximum cost edit for drug X above $1500 to avoid claim rejections for a standard dose. As noted in the October 22, 2010 HPMS memo titled “CMS Part D Utilization Management Policies and Requirements” CMS expects that maximum cost edits can be overridden by the pharmacist once the correct quantity or dosage is confirmed with the prescriber and Part D sponsor.

Common Findings In the area of Formulary Administration, Sponsors must ensure that beneficiaries receive the Part D drugs they are entitled to consistent with CMS guidance. Several Sponsors were unable to properly administer their CMS approved formulary and comply with transition requirements. CMS reminds Sponsors that it is their responsibility to understand CMS requirements, oversee the pharmacy benefit manager (PBM) and ensure that the PMB is operating consistent with CMS requirements. During the audits, CMS documented the following findings:

1. Unapproved system edits. Some Sponsors continue to fail to properly administer their CMS-approved formularies through the inappropriate use of unapproved edits. The specific edits that Sponsors must ensure are not in place include, but are not limited to:

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• Unapproved quantity limits. • Unapproved step therapy edits and/or criteria.* • Inappropriate high cost edits that hinder beneficiary access. • Improper effectuation of approved prior authorizations. • Rejection of formulary medications as non-formulary.*

2. Part B versus Part D coverage determinations

Failure to aggressively determine coverage under Part B versus Part D, causing an interruption in beneficiary access to medically necessary drugs, including drugs within the protected classes.*

3. Part D Transition fills Sponsors continue to inappropriately reject transition fills for non-formulary drugs, protected class drugs, and drugs subject to utilization management restrictions during beneficiaries’ transition period for new and continuing enrollees. Sponsors must ensure beneficiaries have access to transition supplies. The following examples are errors in transition fill processing that were observed during the audits:

• Failure to provide a required transition supply of medications that were removed from the formulary from one contract year to the next.*

• Failure to provide a new beneficiary a transition supply of a medication with a CMS-approved prior authorization requirement.*

• Failure to provide a new beneficiary a transition supply of a medication with a CMS-approved quantity limit.*

• Failure to provide a new beneficiary a transition supply of a non-formulary medication.*

• Failure to extend transition timelines for long term care beneficiaries.*

CMS Recommendations: In addition to the above stated best practices, CMS recommends that Sponsors implement the following processes to ensure beneficiary access to care and compliance with CMS regulations:

• Ensure that the PBM does not administer the Part D benefit based on either Medicaid or commercial program requirements. CMS has observed that this practice leads to program non-compliance (e.g., inappropriate mandatory generic drug requirements).

• Perform regular review of rejected point of sale (POS) pharmacy claims. Reviewing a comprehensive set of claims on a daily basis is more likely to identify processing errors early and reduce beneficiary impact.

• Perform regular oversight of delegated PBM functions. • Perform comprehensive testing of formulary file and system edits prior to going

“live” in the adjudication system (e.g., compare the CMS approved formulary file to the adjudication file to ensure all drugs, tier information, and utilization management edits are consistent).

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• Ensure that transition look-back logic accurately identifies transition beneficiaries and drugs that are eligible for transition fills.

• Disclose known issues to their CMS account manager in a timely manner. • Provide outreach in a timely manner to all pharmacies experiencing rejections for

non-matched National Provider Identifiers (NPIs).

PART D COVERAGE DETERMINATIONS, APPEALS, AND GRIEVANCES

Best Practices

1. Ease of Beneficiary Access Beneficiary access is easily impacted, in both positive and negative situations. CMS observed policies and systems that provide a sense of clarity, ease, and/or care to the beneficiaries at a level above the required or expected. In all instances, the beneficiary was able to continue care or drug use with little to no disruption. We observed the following:

• A defined process for evaluation and effectuation of Part B versus Part D determinations allowed for seamless transitions for the beneficiary to receive necessary medications at point of sale with minimal disruptions.

• Requests approved for 12 months, as CMS requirements permit, rather than through the end of the plan year even though it was not a requirement. This process helps beneficiaries avoid coverage determination requests during the busiest time of the plan year.

• Prescriber confirmation on non-FDA approved dosages. • Referral to a social worker for beneficiaries experiencing financial hardship.

2. Timeliness

Time stamping incoming faxes in the coverage determination system with the date and time received helps ensure that timeliness standards are tracked from the time the request was received rather than when entered into the system. The processing of all requests in a timely fashion allows for the highest level of beneficiary access.

3. Effective Communication Clear communication is critical to beneficiary access. CMS discovered that some Sponsors went above and beyond the expected level of communication to be sure that beneficiaries were well informed regarding all care concerns. We observed the following:

• Providing oral notification, in addition to written notice, by calling all beneficiaries for all coverage determination approvals.

• Member files are sent via Certified Mail requiring signature. • Expiration reminders on prior authorization forms.

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Common Findings In the area of Part D Coverage Determinations, Appeals, and Grievances, several Sponsors lacked adequate systems and processes for timely and accurate communication with beneficiaries about coverage determinations, appeals, and grievances. Several Sponsors also lacked adequate processes for effective and accurate classification of coverage determinations, appeals, and grievances. Sponsors must ensure coverage determinations, appeals, and grievances are handled in a meaningful and timely manner. During the audits, CMS documented the following findings:

1. Noncompliance with Adjudication Timeframes and Processing Sponsors continue to be untimely in effectuating determinations. Timeliness is imperative in ensuring beneficiaries receive access to necessary medications. We observed the following:

• Failure to effectuate determinations within 24 hours of receipt of the expedited coverage determination requests.

• Failure to effectuate determinations within 72 hours of receipt of the standard coverage determination requests.

• Failure to effectuate determinations within 72 hours of receipt of the expedited redetermination request.

• Failure to effectuate exception approvals through the end of the Sponsor year.*

2. Noncompliance with Notification Requirements Sponsors continue to inadequately communicate with beneficiaries. Beneficiaries must receive clear communications from Sponsors. We observed the following:

• Failure to notify the beneficiaries or their prescribers of their decisions within 24 hours of receipt of an expedited coverage determination request.

• Failure to notify the beneficiaries or their prescriber of their decisions within 72 hours of receipt of a standard coverage determination request.

• Failure to notify the beneficiaries of their decisions within 7 days of receipt of a standard determination request.

• Failure to effectuate its determination within 7 days of receipt of the standard redetermination request.

• Denial letters did not include adequate rationale or contained incorrect information regarding the denial.

3. Improper Classification and Processing of Requests Sponsors continue to misclassify coverage determinations and redeterminations. Sponsors must appropriately classify and take appropriate action when processing requests. CMS observed the following findings:

• Redeterminations were inappropriately classified as coverage determinations and vice versa.

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• Insufficient outreach to the prescriber or beneficiary to obtain additional information necessary to make an appropriate clinical decision.

• Insufficient research to make an appropriate determination of coverage under Part B versus Part D.*

• Failure to appropriately auto-forward coverage determinations exceeding the CMS required timeframe to the IRE for review and disposition.

• Failure to adhere to HPMS approved utilization management criteria in its coverage determination.*

• Failure to honor the request for an expedited review or the requirements for notifying the beneficiary of their decision.

• Requests for coverage determinations were inappropriately denied.*

5. Grievances Sponsors continue to be noncompliant in their handling of Part D grievances. Sponsors must thoroughly process grievances to ensure resolution of all issues. The findings observed included:

• Complaints were improperly classified as grievances when they should have been processed as coverage determinations or redeterminations and vice versa.

• Failure to fully investigate or appropriately address all issues raised in the grievances.

• Inaccurate or incomplete information provided in the grievance resolution letters. • Failure to resolve and notify the beneficiaries of the resolution of the grievances

within CMS required timeframes or as expeditiously as the enrollees’ cases required.

CMS Recommendations: In addition to the above stated best practices, CMS recommends that Sponsors implement the items below to ensure beneficiary access to care and compliance with CMS regulations:

• Having an automated system to track requests to ensure decision-making, notification and effectuation timeliness.

• Having processes in place to ensure that approved exceptions requests are properly entered into your claims processing system (i.e., through the end of the plan year or for a period of 12 months).

• Having fully trained staff that understand the difference between an inquiry, grievance, coverage determination, redetermination, reconsideration and are able to classify them appropriately, as well as processes in place to review a certain number of cases daily to ensure compliance.

• Having processes in place to review decision letters/notices to ensure that decision rationale is clear and detailed and that appropriate appeal rights are included.

• Ensuring review staff understand their responsibility to conduct appropriate outreach to providers to obtain needed information to process a request (e.g., at a

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minimum 2 attempts to contact a provider’s office during the provider’s business hours on 2 different days and at different times of the day).

• Having systems in place to identify cases that are not decided timely, so they are auto-forwarded to the Independent Review Entity (IRE).

• Having processes in place to review grievances and ensure issues identified reached a proper resolution and were communicated accurately.

PART C ORGANIZATION DETERMINATIONS, APPEALS, AND GRIEVANCES

Best Practices

1. Beneficiary Satisfaction Continued beneficiary care and assurance of beneficiary satisfaction was found in several audits. We observed the following:

• Following up with beneficiaries to confirm their issue was resolved and they were satisfied with the outcome.

• Offering a second level grievance if the beneficiary is not satisfied with the outcome of the original grievance. Clear and specific instructions are provided on how to file the second level grievance.

2. Communication Clear communication is critical to beneficiary access. CMS discovered that some Sponsors were going above and beyond the expected level of communication to be sure that beneficiaries were well informed regarding all care concerns. Included in the observations were acknowledgement letters sent to the beneficiaries for every beneficiary appeal received.

3. Processing Accuracy Development and implementation of a tracking system for Waiver of Liability forms from providers allows for a more thorough level of accuracy in processing of requests and claims.

Common Findings In the area of Part C Organization Determinations, Appeals, and Grievances, organizations often continue to be noncompliant, predominantly in the areas of clinical decision making, timely processing and notification of decisions, and in classification and processing of grievances. Organizations must ensure coverage decisions, appeals, and grievances are handled appropriately in order to avoid beneficiary harm due to delayed or incorrectly denied access to services. During the audits, CMS documented the following findings:

1. Making Clinical Decisions Sponsors continue to be inaccurate and unclear in the communication of their coverage decisions. It is critical that Sponsors clearly and accurately communicate their decisions. We observed the following:

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• Upon receiving a request for reconsideration of a denied claim from a non-contract provider without the waiver of liability (WoL), there was a failure to make, and document, reasonable efforts to secure the necessary form.

• When Sponsors denied services or payments, in whole or in part, or discontinued/reduced a previously authorized ongoing course of treatment, it did not give the enrollee a written notice of its determination using the approved notice language.*

• Sponsors failed to gather all necessary information before reaching a coverage decision (i.e., failed to conduct appropriate outreach to obtain needed medical documentation).

2. Noncompliance with Adjudication Timeframes and Processing Sponsors continue to be untimely and/or improperly processing organization determinations, reconsiderations, and payments. Timeliness is imperative in ensuring beneficiaries receive access to care. We observed the following:

• Sponsors did not notify the enrollee of its determination within 14 calendar days after the date the organization received the request for a standard organization determination.*

• When Sponsors received a request for an expedited organization determination, they did not make the determination and notify the enrollee (and the physician involved, as appropriate) within 72 hours after receiving the request.*

• When Sponsors received a request for an expedited reconsideration, it did not complete the expedited reconsideration and give the enrollee notice (and the physician involved, as appropriate) of its decision within 72 hours after receiving the request.*

• Sponsors did not prepare a written explanation and send the case file to the IRE in a timely manner upon affirming its adverse organization determination.*

• Sponsors did not process a payment organization determination in a timely manner.

• Sponsors did not issue a decision for a standard payment reconsideration request timely.

• Sponsors did not issue a decision for a standard pre-service reconsideration request timely.

3. Denials Sponsors inappropriately denied services to beneficiaries, including:

• Sponsors denied payment for services that were either ordered or provided by their contract providers.*

• Sponsors did not provide enough information for the enrollee to understand the reason their request was denied; the denial rationale was not specific to the individual's case and was not written in a manner that an enrollee could understand.*

• Sponsors denied a request for payment from a non-contracted provider. The notice did not contain the required information, including provider appeal rights.*

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4. Grievances and Dismissals

Sponsors continue to misclassify organization determinations, appeals, and grievances. Proper classification is imperative in ensuring issues are appropriately addressed. We observed the following:

• Sponsors did not take prompt, appropriate action, including a full investigation, in response to grievances.*

• Sponsors’ quality of care grievance resolution letters failed to provide the beneficiary with written notice of their right to file with, and the contact information for, the QIO.

• Sponsors failed to correctly determine whether the issues in the enrollee’s complaint met the definition of a grievance, an appeal, or both and, therefore, did not resolve the complaints or disputes through the appropriate procedure.

• Sponsors failed to process and respond to grievances within 30 days of receiving the oral or written request.*

• Sponsors submitted dismissal cases to the IRE prior to the conclusion of the appeal time frame.*

CMS Recommendations: In addition to the above stated best practices, CMS recommends that Sponsors implement the items below to ensure beneficiary access to care and compliance with CMS regulations:

• Having an automated system to track incoming requests to ensure decision-making, notification and effectuation timeliness.

• Having fully trained staff that understands the difference between an inquiry, grievance, organization determination, or request for appeal and can classify them appropriately; and, processes in place to review a certain number of cases daily to ensure compliance.

• Having processes in place to review decision letters/notices to ensure that decision rationale is clear and detailed and that appropriate appeal rights are included.

• Ensuring review staff understand their responsibility to conduct appropriate outreach to providers to obtain needed information to process a request (e.g., at a minimum 2 attempts to contact a provider’s office during the provider’s business hours on 2 different days and at different times of the day).

• Having systems in place to ensure auto-forwarding of adverse plan reconsiderations to the Independent Review Entity (IRE).

• Having processes in place to review grievances and ensure issues identified reached a proper resolution and were communicated accurately.

• Ensuring that your claims processing systems and any automated enrollee notices that are issued as a result of claims determinations accurately reflect enrollee liability (e.g., no enrollee liability if a claim is denied but was provided, ordered or referred by a network provider).

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• Having processes in place to review requests for urgently needed care, to ensure that they are being processed in accordance with 42 CFR, §422.113(b)(iii).

• Ensuring that if an EOB is used in place of a standardized denial notice, that all of the language from the denial notice is placed, verbatim and in its entirety, in the EOB document.

COMPLIANCE PROGRAM EFFECTIVENESS

Best Practices

1. Communication Clear communication is critical to ensure that all individuals associated with the Sponsor are exposed to and well informed of the compliance expectations. We observed the following:

• CMS-required compliance provisions were added to all first-tier, downstream, and related entity (FDR) contracts.

• The Compliance Department created a series of communication vehicles including posters, newsletters, intranet links, videos, quizzes, contests, town hall meetings and employee essays. These methods work cohesively to serve as reminders to employees that a compliant culture is of utmost importance at the Sponsor.

2. Monitoring and Auditing

Sponsors are required by CMS to appropriately monitor and assess all dealings of the company. CMS discovered that Sponsors did in fact have procedures in place to ensure that the CMS requirements were met and often exceeded. We observed the following:

• Compliance committee activities and corrective actions independently monitored by the parent company.

• Rationale behind prescriptions being denied or unfilled is investigated. • 100% prepayment review of home infusion therapy claims to ensure that the

Sponsor is correctly billed, and therefore correctly paying, all claims. • Sponsors’ Internal Audit and Corporate Compliance Divisions that are staffed

with a highly-qualified, professional auditing staff including Certified Public Accountants, Certified Internal Auditors, and employees highly skilled in the operational requirements for Medicare Parts C and D program.

• Quarterly risk assessment analyses to address changes in law, regulations, CMS requirements and operational matters

3. Fraud, Waste, and Abuse (FWA) The avoidance of FWA events greatly enhances a Sponsor’s ability to provide quality care to all beneficiaries. We observed the following:

• Comprehensive monitoring of claims for identification of potential FWA.

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• OIG/GSA exclusions checked prior to every payment.

4. Governing Body CMS requires that a Sponsor’s governing body exercise reasonable oversight with respect to the implementation and effectiveness of said Sponsor’s compliance program. We observed the following:

• The Board of Directors is the only entity that can terminate the Director of Internal Audit and Chief Compliance Officer.

• The Sponsor’s Board of Directors held executive sessions with the Compliance Officer to discuss the effectiveness of the Sponsor’s compliance program and measures taken to resolve operational non-compliance and timely reporting to CMS.

• The Board of Directors includes board member(s) with healthcare, audit, and compliance backgrounds. This expertise on the Board can sensitize and assist governing body members with understanding the severe impact of regulatory noncompliance or fraudulent activities facing the organization.

Common Findings In the area of Part C and D compliance program effectiveness, CMS identified areas of concern with respect to some of the Sponsors’ compliance programs. During the audits, CMS documented the following findings:

1. Compliance Officer, Compliance Committee, and High Level Oversight Sponsors did not provide evidence that the Board had knowledge about the content and operation of the compliance program and exercises reasonable oversight with respect to the implementation and effectiveness of the compliance program.*

2. Training and Education Sponsors continue to fail to meet the requirements for training and education, including:

• Sponsors did not provide training and education addressing compliance, to the organizations’ employees, the organizations’ chief executive or other senior administrators, managers, and governing body members, upon hire and annually thereafter.

• Sponsors did not provide training and education addressing FWA, to the organizations’ employees, the organizations’ chief executive or other senior administrators, managers, and governing body members, upon hire and annually thereafter.

3. Routine Monitoring, Auditing, and Identification of Compliance Risks Sponsors continue to have ineffective systems for monitoring, auditing and identifying compliance risks, including:

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• Sponsors have not established and implemented a system for monitoring and auditing compliance program effectiveness.*

• Sponsors have not established and implemented an effective system for the identification of compliance risks within the organization.

4. Prompt Response to Compliance Issues Sponsors failed to meet the requirements for promptly responding to, investigating, and correcting issues of non-compliance and/or FWA. Observed deficiencies included:

• Sponsors have not established and implemented a system for responding to, investigating, and correcting potential and identified compliance issues.

• Sponsors have not established and implemented a system for responding to, investigating, and correcting potential FWA issues.

5. Effectiveness Measure Sample cases reviewed during the audits did not provide support that Sponsors have effective compliance programs.*

6. Sponsor Accountability and Oversight of FDRs Sponsors failed to appropriately monitor and manage their FDRs. Observed deficiencies included:

• Sponsors did not establish and implement effective systems for monitoring and auditing their FDRs’ performance and compliance with CMS requirements.

• Sponsors did not provide accessible lines of communication to their FDRs to allow compliance and potential FWA issues to be reported to Sponsors’ compliance officer/departments, including a method for anonymous and confidential good faith reporting of such issues.*

• Sponsors continue to not ensure that FDRs received and completed FWA training at orientation and annually thereafter.

CMS Recommendations: In addition to the above stated best practices, CMS recommends that Sponsors implement the items below to ensure beneficiary access to care and compliance with CMS regulations:

• Sponsor conducts monthly checks of the OIG and GSA exclusion lists to ensure all levels of employees, board members and FDRs are not excluded from participating in federal programs.

• Thoroughly review the Annual Call Letter (risks and changes to the MA and Part D programs), CMS Readiness Checklist (summarizes key operational requirements), enforcement and compliance actions and other CMS advisory materials to assist with creating the formal risk assessment.

• Establish a centralized unit dedicated exclusively to delegated entity (FDR) oversight. • Develop a comprehensive monitoring and auditing system to frequently validate the

performance of FDRs’ compliance with CMS operational requirements and detect

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unusual trends (e.g. formulary administration, Parts C and D determinations, appeals and grievances, Part C access to care, compliance program, etc.).

• Compliance of operational areas should be regularly tracked by management and any issues of noncompliance or FWA shared with staff and reported to senior management.

• Take timely and appropriate actions based on CMS fraud alerts distributed via HPMS memos.

• Ensure significant operational compliance challenges are reported to the CEO and governing body and are addressed in the compliance committee. Meeting minutes or other documentation should reflect organizational oversight of the Medicare operations,

• Ensure that the compliance department, as well as impacted business/operations managers, are aware of any operational areas with significant noncompliance, and ensure corrective action is implemented and effective.

• Implement a continuous process improvement program. Use current or past operational issues, track your responses and corrective actions to identified or reported issues, and trace all activities through each of the seven elements of an effective compliance program. This process will test internal and external controls with detecting and correcting program noncompliance and FWA.

AGENT/BROKER OVERSIGHT

Best Practices

1. Plan Effectiveness and Evaluation It was observed that some Sponsors were meticulous in their marketing oversight procedures and effectiveness. Through diligent monitoring and reaction, Sponsors were able to ensure the highest quality of service was provided to beneficiaries. We observed the following:

• Regularly performing secret shopper audits and open audits during which all agents are fully aware that management is performing audits for agents who have multiple complaints.

• Routinely hiring new and bilingual Secret Shoppers to secret shop its agents. The Secret Shoppers are rotated regularly to avoid the possibility of an agent recognizing an individual from a prior event.

• Management conducts sales complaint counseling with agent/brokers who have allegations brought against them. Each complaint against an agent had documented support of a sales complaint counseling session.

2. Communication CMS discovered that some Sponsors maintained above average procedures to ensure the clearest communication with beneficiaries. We observed the following:

• System generated outbound enrollment verification (OEV) letters. • Implementing new email and task procedures to ensure adequate communication

with beneficiaries during enrollment.

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• Implementing a new phone system to leave a message on unanswered OEV calls and receive a call back from the beneficiary.

Common Findings

In the area of Part C and D agent/broker oversight, the most common areas of deficiency include the appointment and training of agents, the requirements for outbound enrollment verification (OEV) calls, and the complaints process. During the audits, CMS documented the following findings:

1. Appointment and Training* Sponsors failed to meet the requirements for agent appointment and training, including:

• Agents sold a Sponsor’s product to beneficiaries prior to appointment in the state. • Agents did not complete CMS required annual training specific to the Sponsor

products they intend to sell. • Sponsors did not provide the appropriate Medicare or plan specific training to its

agent/brokers prior to selling Medicare Advantage and Part D Sponsor products.

2. OEV Calls Sponsors continue to fail to meet the requirements for OEV calls. It is critical that Sponsors ensure beneficiaries receive the appropriate communication following enrollment. We observed the following:

• Sponsors could not produce evidence that at least three OEV calls were made and/or that a follow-up enrollment verification letter was sent to the beneficiary.

• Sponsors did not comply with CMS regulations for completing OEV calls and supplying its beneficiaries with accurate information during the calls.

• Sponsors did not provide the beneficiary with the correct cancellation date either verbally during the phone call or in the OEV letter.

3. Complaints Sponsors continue to conduct incomplete investigations of beneficiary complaints, as not all allegations against the agent/broker were reviewed and followed up on by the Sponsor. Sponsors must conduct thorough investigations and take appropriate action against agent brokers who fail to follow procedures.

CMS Recommendations: In addition to the above stated best practices, CMS recommends that Sponsors implement the items below to ensure beneficiary access to care and compliance with CMS regulations:

• Sponsors should implement standardized procedures to ensure that new agents are properly appointed and licensed prior to selling products if required by the State. Additionally, Sponsors should enact a system or process which periodically checks agents to ensure they are licensed and appointed.

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• Sponsors should enhance internal controls over agent/broker training verification to ensure their agents/brokers are properly trained and tested on all updates pertaining to Medicare Parts A, B, C, and D. Sponsors should also ensure that the training and testing aligns with the annual CMS agent/broker Training Guidelines. Additionally, Sponsors must maintain evidence supporting completion of required training.

• Sponsors should establish an effective process and internal controls to ensure that all OEV staff members are trained properly on the OEV call process and plan benefits and services offered. Additionally, Sponsors should conduct internal monitoring to ensure all OEV staff are following requirements.

• Sponsors should have effective processes and internal controls in place to ensure accurate and timely OEV calls and verification letters are conducted in accordance with CMS requirements.

• Sponsors should implement procedures to ensure they follow CMS guidance regarding cancellation dates and must conduct quality assurance reviews to ensure that all beneficiaries are informed of the correct cancellation period.

• Sponsors should develop and implement internal controls and procedures to ensure that all beneficiaries’ complaints are fully investigated and followed up on in a timely manner. Additionally, Sponsors must ensure that the staff is appropriately trained on how to conduct an investigation on a beneficiary’s complaint.

• Sponsors must take action against agent/brokers who receive substantiated complaints against them.

PART C AND PART D ENROLLMENT AND DISENROLLMENT

Best Practices Beneficiary communication Clear communication is critical to ensure beneficiaries are aware of all details regarding their enrollment and disenrollment. CMS discovered that some Sponsors were going above and beyond the expected level of communication to be sure that beneficiaries were well informed. We observed the following:

• Sponsors send multiple delinquency notices for non-payment of premiums, to

provide several opportunities to inform the beneficiary of the repercussions of non-payment of premiums.

• For all cases that require member outreach, such as incomplete enrollment requests, there are three attempts to contact the beneficiary via telephone, in addition to sending a written notice.

• Following the receipt of an incomplete enrollment request, the Sponsor follows up with the beneficiary, as well as the agent/broker, in order to ensure the required additional information is received timely.

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Common Findings In the area of Part C and D enrollment and disenrollment, a significant number of Sponsors continue to be noncompliant with CMS requirements for processing enrollments and disenrollments. Sponsors must ensure enrollments and disenrollments are processed timely, thoroughly and in accordance with requirements. During the audits, CMS documented the following findings:

1. Processing of enrollment or disenrollment requests Sponsors incorrectly processed enrollment/disenrollment requests and denials, as follows:

• Sponsors failed to send the beneficiaries complete and accurate acknowledgement notices for enrollments and/or voluntary disenrollments.

• Sponsors did not determine and submit the correct enrollment or disenrollment effective dates.*

• Sponsors inappropriately denied enrollment and/or disenrollment requests. • Special Needs Plans incorrectly determined the start and/or end dates of the

period of deemed continued eligibility.* • Sponsors failed to send the beneficiary a complete and accurate notice of loss of

special needs status.*

2. Processing of incomplete requests Sponsors incorrectly processed incomplete enrollment requests, as follows:

• Sponsors inappropriately determined enrollment requests incomplete for various reasons; including, when the missing item was the Sponsor’s determination of a valid election period or by simply overlooking provided information.

• Sponsors failed to send the beneficiaries complete, accurate, and timely requests for additional information.*

• Sponsors did not provide the full required timeframe to the beneficiaries to supply missing information before enrollment or disenrollment denials.*

3. Timely Processing Sponsors were not timely in the processing of enrollment and disenrollment requests, as follows:

• Sponsors failed to process enrollment and voluntary disenrollment transactions timely.

• Sponsors failed to send the beneficiaries acknowledgement and /or denial notices in a timely manner.*

4. Non-Payment of Premium Sponsors failed to apply their grace period for payment of premiums correctly and consistently to all beneficiaries.*

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CMS Recommendations: In addition to the above stated best practices, CMS recommends that Sponsors implement the items below to ensure beneficiary access to care and compliance with CMS regulations:

• Conduct root cause analysis to identify aspects of current enrollment and disenrollment processes that contribute to unnecessary delays.

• Maximize the use of telephonic outreach for resolving incomplete enrollment and disenrollment requests.

• Utilize telephonic outreach for determining if the individual has a valid election period in which to request enrollment or disenrollment.

• Identify the elements most frequently missing from enrollment and disenrollment requests and enhance instructions in enrollment kits accordingly.

• Ensure adequate training regarding the relationship between enrollment and disenrollment request receipt dates, election periods and enrollment and disenrollment effective dates.

PART D LATE ENROLLMENT PENALTY

Best Practices No new Best Practices were identified related to this area.

Common Findings In the area of Part D Late Enrollment Penalty (LEP), a significant number of Sponsors continue to be noncompliant with regard to complete and effective communication with beneficiaries and CMS about Late Enrollment Penalty concerns. During the audits, CMS documented the following findings:

• Sponsors failed to send beneficiaries the initial attestation documents and notices of LEP timely.*

• Sponsors failed to send beneficiaries complete and accurate notice of LEP. • Sponsors did not abide by CMS stipulated guidance when calculating beneficiaries’

numbers of uncovered months.* • Sponsors failed to update CMS’ enrollment systems with the beneficiaries’ Number of

Uncovered Months (NUNCMO) timely.* • Sponsors failed to effectuate the IRE’s decision in their internal system timely.*

CMS Recommendations: CMS recommends that Sponsors implement the items below to ensure beneficiary access to care and compliance with CMS regulations:

• Ensure that staff understand and are providing the appropriate communication to beneficiaries regarding the LEP initial attestation documentation and timeframes for

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notification of the Part D LEP. This is critical to ensuring that the beneficiary can respond timely to the attestation of creditable coverage and, if necessary, file for a reconsideration of the penalty.

• Utilize the NUNCMO Tool to test accuracy in calculating the Number of Uncovered Months.

• Train staff regarding timeframes for updating the CMS systems with the NUNCMO. • Train staff regarding timeliness in effectuating the IRE’s decisions. • Establish internal processes for effectuating IRE decisions within 2 months of receipt.

SPONSOR RECOMMENDATIONS CMS conducted several listening sessions with previously audited sponsors to obtain their feedback on the audit process and their recommendations to fellow sponsors on how best to prepare for an audit. Below is a listing of their recommendations:

• Ensure your organization is audit ready.

o Assemble your audit team, so individuals who will be responsible for various portions of the audit are aware of their responsibilities and familiarize themselves with the protocols.

o Prepare your IT staff and talk with them about Webex technology and impacts to IT resources.

o Practice using Webex technology (sharing screens, pulling up systems). o Practice compiling universe requests. o Ensure your delegated entities are audit ready. o Utilize the protocols to conduct practice audits. o Don’t wait until receipt of the audit start notice to ask CMS your audit related

questions.

• Review your outbound communications to ensure they are written in a manner that can be understood by the member and/or provider.

• Ensure all of your internal processes and meeting minutes are well documented. • During the audit, keep executive leadership well informed of the progress of the audit. • During the audit, keep audit teams in close proximity for improved oversight.

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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) 2013.

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

Office of Medicare Hearings and Appeals ALJ Hearing

Standard Decision AIC ≥ $140***

90 day time limit

Medicare Appeals Council

Standard Decision 90 day time limit

Federal District Court AIC ≥ $1,400***

Office of Medicare Hearings and Appeals ALJ Hearing

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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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850 MEDICARE ENROLLMENT & APPEALS GROUP

DATE: September 10, 2013 TO: Medicare Advantage Organizations, Medicare Health Care Prepayment Plans, and

Medicare Cost Plans FROM: Arrah Tabe-Bedward Director, Medicare Enrollment & Appeals Group SUBJECT: Change in Part C Reconsideration Dismissal Procedures CMS is revising the current process requiring Medicare Advantage (MA) organizations and other Medicare health plans (collectively referred to as “plans”) to automatically forward all reconsideration requests that the plans believe should be dismissed to the Part C independent review entity (IRE). Effective January 1, 2014, in addition to being responsible for dismissing reconsideration requests when appropriate and providing timely notification of dismissals to enrollees or another party, plans will also be responsible for informing enrollees and other parties about the right to request IRE review of the dismissal. Plans will no longer automatically forward such reconsideration cases to the IRE for review. CMS will issue revised manual provisions that correspond to the process changes outlined in this memo and will develop a model Notice of Dismissal for plans to use when notifying appellants that their reconsideration request is being dismissed. Until Chapter 13 of the Medicare Managed Care Manual is updated, effective January 1, 2014, the revised procedures in this memorandum supersede the current guidance regarding Part C dismissals. Under the existing manual procedures related to dismissal of a reconsideration request, a dismissal is considered an adverse decision that must be forwarded to the IRE. However, in the case of a dismissal, the plan never performs a substantive review regarding coverage, because the procedural requirements for a valid request for plan reconsideration were not met. Therefore, we believe that a more appropriate interpretation and application of 42 CFR § 422.592 is that adverse decisions subject to auto-forwarding to the IRE should be limited to substantive decisions made on the merits of the case (a denial of coverage) and not include procedural actions such as dismissals. Thus, under the revised procedure described below, a dismissal of a reconsideration request by the plan does not constitute an adverse decision for purposes of applying 42 CFR § 422.592. We believe this process improvement will be a more efficient use of both plan and IRE resources, while preserving an enrollee’s or other party’s right to have a dismissal of a reconsideration request reviewed by the IRE. We also believe the improved efficiencies of this revised process will result in reduced costs and operational burden for plans. Currently, the IRE affirms plans’ determinations that a case should be dismissed in approximately 98 percent of the

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dismissals forwarded by plans. The most common reasons for upholding the plans’ dismissals are:

• Failure of the enrollee or other party to file a timely appeal request; • No waiver of liability submitted with an appeal filed by a non-contract provider; • Lack of proper appointment of representative documentation; or • Failure to exhaust the prior level of adjudication.

Our expectation is that plans will redirect the resources currently used to automatically forward dismissals to other critical areas in the processing of plan level appeals, such as conducting timely outreach to providers to obtain clinical documentation necessary to approve coverage and ensuring that enrollees receive timely decision notices. Revised Dismissal Procedures Reasons for Dismissing a Request. Plans shall dismiss reconsideration requests under any of the following circumstances:

(1) An individual requests a reconsideration on behalf of an enrollee, but a properly executed appointment of representative form has not been filed and there is no other documentation to show that the individual is legally authorized to act on the enrollee’s behalf per the guidance set forth in section 10.4.1 of Chapter 13. This does not relieve the plan of its obligation to make attempts to secure the missing documentation per section 10.4.1 prior to dismissal.

(2) A non-contract provider requests a reconsideration of a denied claim but fails to provide

a waiver of liability statement indicating that the non-contract provider will not bill the enrollee regardless of the outcome of the appeal. See section 60.1.1 of Chapter 13. This does not relieve the plan of its obligation to make attempts to secure the missing documentation per section 60.1.1 prior to dismissal.

(3) The enrollee or other party fails to file the reconsideration request within the established

timeframes and good cause for late filing has not been established. See section 70.2 and 70.3 of Chapter 13.

(4) A request for a standard pre-service reconsideration is made but the plan becomes aware that the enrollee has obtained the service before the plan completes its determination. See section 70.7.5 of Chapter 13. (5) Any other circumstance where the plan lacks jurisdiction to review the case. Notice of dismissal. If a plan dismisses a reconsideration request, the plan must send a written notice of the dismissal to the parties at their last known addresses within the applicable adjudication timeframe pursuant to the requirements of 42 CFR Part 422, Subpart M. The dismissal notice must state the reason for the dismissal and explain the right to request IRE review of the dismissal within 60 calendar days after receipt of the written notice of the plan’s dismissal. Requests for IRE review of a plan’s dismissal will be filed with the IRE. The

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dismissal notice must explain that the request for review of the plan’s dismissal should be filed with the IRE at the following address: MAXIMUS Federal Services, Inc. Medicare Managed Care & PACE Reconsideration Project 3750 Monroe Avenue, Suite 702 Pittsford, NY 14534-1302 Fax: 585-425-5292 Upon receipt of such request, the IRE will contact the appropriate plan to obtain the case file. Plans must assemble and forward the case file to the IRE within 24 hours of receiving the IRE’s case file request. Effect of Dismissal. The dismissal of a request for reconsideration is binding unless the enrollee or other party requests IRE review.

IRE review of MA organization dismissal. An enrollee or other party has a right to have a plan’s dismissal of a reconsideration request reviewed by the IRE if the enrollee or other party files a request for an IRE review within 60 calendar days after receipt of the written notice of the plan’s dismissal. If the IRE determines that the plan’s dismissal was in error, the IRE vacates the dismissal and remands the case to the plan for reconsideration. The IRE’s decision regarding a plan’s dismissal is binding and not subject to further review. The changes set forth in this memorandum must be implemented beginning January 1, 2014. The changes set forth in this memorandum apply exclusively to appeals processed in accordance with 42 CFR Part 422, Subpart M. Please send questions regarding this memorandum to [email protected].

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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) 2013.

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

Payment: 60 day time limit

Health Plan Reconsideration 72 hour time limit

Payment requests cannot be expedited

IRE Reconsideration Pre-Service: 30 day time limit

Payment: 60 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 ≥ $1,400**

Organization Determination

First Appeal Level

Second Appeal Level

Third Appeal Level

Fourth Appeal Level

Judicial Review

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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850 MEDICARE ENROLLMENT & APPEALS GROUP

DATE: October 30, 2013 TO: Medicare Advantage Organizations, Medicare Health Care Prepayment Plans, and

Medicare Cost Plans FROM: Arrah Tabe-Bedward Director, Medicare Enrollment & Appeals Group SUBJECT: Part C Reconsideration Dismissal Procedures – Model Dismissal Notice As announced in our September 10, 2013, HPMS memorandum, CMS is revising the current process requiring Medicare Advantage (MA) organizations and other Medicare health plans (collectively referred to as “plans”) to automatically forward all reconsideration requests that plans believe should be dismissed to the Part C independent review entity (IRE). Effective January 1, 2014, plans will be responsible for dismissing reconsideration requests when appropriate. Also, plans are responsible for providing timely notification of dismissals informing enrollees and other parties about their right to request IRE review of the plan’s dismissal. Please refer to the September 10, 2013, HPMS memorandum entitled “Change in Part C Reconsideration Dismissal Procedures” for further details. To facilitate proper notice of a plan’s decision to dismiss a reconsideration request, CMS has developed a model Notice of Dismissal of Appeal Request. A copy of the Notice of Dismissal of Appeal Request is attached to this memorandum and is also available at: http://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/Notices.html Plans must populate all identifying elements, including the date, the enrollee’s name and ID number, the plan’s name and contract identification number and fax number (see text box at the top of the Notice). In cases where a non-contract provider’s reconsideration request is dismissed, the plan must also include the non-contract provider’s name. (See specific instructions provided in brackets for the remaining free text fields.) Please send questions regarding this memorandum to [email protected].

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Ø

Notice of Dismissal of Appeal Request Date: Enrollee’s Name: Enrollee ID Number: (Insert Non-contract Provider Name, if applicable:) Health Plan Name/Medicare Contract Number: Health Plan Contact Fax Number:

We dismissed the appeal request you filed on (Insert date request received by the plan.)

Ø We can’t process your appeal request because: (Instructions: Use the space below to explain the specific reason for dismissal and what is missing fromthe request (e.g., lack of an appointment of representation (AOR) form, lack of waiver of liability (WOL) fora request filed by a non-contract provider). See Chapter 13 of the Medicare Managed Care Manual for guidance on when it may be appropriate to dismiss a reconsideration request.)

Do You Have Questions? If you have questions about this notice, please contact

(Insert Health Plan Name) __________________________________at

the following:

Toll Free Phone: Days & hours of operation: TTY Users Phone: Days & hours of operation:

If you disagree with our decision to dismiss your appeal request, you have the right to ask anindependent reviewer contracted with Medicare to review our decision. You must mail or fax your written request within 60 calendar days of receipt of this Notice of Dismissal of Appeal Request to:

MAXIMUS Federal Services, Inc. Medicare Managed Care & PACE Reconsideration Project3750 Monroe Avenue, Suite 702 Pittsford, NY 14534-1302

Phone: 585-348-3300Fax: 585-425-5292

Include a copy of this Notice of Dismissal of Appeal Request along with any supporting information with your request for review. The independent reviewer will send you a notice of its decision. If the independent reviewer agrees that your appeal should not have been dismissed, your appeal requestwill be returned to

(Insert Health P lan N ame) ______________________________________ for processing.

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Important: This notice explains your right to appeal our decision. Read this notice carefully. If you need help,

you can call one of the numbers listed on the last page under “Get help & more information.”

Notice of Denial of Medical Coverage

{Replace Denial of Medical Coverage with Denial of Payment, if applicable}

Date: Member number:

Name:

[Insert other identifying information, as necessary (e.g., provider name, enrollee’s Medicaid number, service

subject to notice, date of

service)]

Your request was denied We’ve {Insert appropriate term: denied, stopped, reduced, suspended} the {payment of} medical services/items

listed below requested by you or your doctor [provider]:

Why did we deny your request? We {Insert appropriate term: denied, stopped, reduced, suspended} the {payment of} medical services/items listed

above because {Provide specific rationale for decision and include State or Federal law and/or Evidence of

Coverage provisions to support decision}:

You have the right to appeal our decision You have the right to ask {health plan name} to review our decision by asking us for an appeal [Insert Medicaid

information, if applicable: and/or you can request a State Fair Hearing. You can ask for both types of review at

the same time, as long as you meet the deadlines. If you ask us for an appeal first, you may miss the deadline for

requesting a State Fair Hearing.]:

Appeal: Ask {health plan name} for an appeal within 60 days [Insert State Medicaid timeframe, if different] of

the date of this notice. We can give you more time if you have a good reason for missing the deadline.

State Fair Hearing: Ask for a State Fair Hearing within ( ) days of the date of this notice. You have up

to ( ) days if you have a good reason for being late.

If we’re stopping or reducing a service, you can keep getting the service while your case is being

reviewed. If you want the service to continue, you must ask for an appeal (Insert, if applicable:

or a State Fair Hearing) within 10 days of the date of this notice or before the service is stopped

or reduced, whichever is later. Your provider must agree that you should continue getting the

service. If you lose your State Fair Hearing appeal, you may have to pay for these services.

Form CMS 10003-NDMCP (Iss. 06/2013) OMB Approval 0938-0829

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If you want someone else to act for you

You can name a relative, friend, attorney, doctor, or someone else to act as your representative. If you want

someone else to act for you, call us at: {number(s)} to learn how to name your representative. TTY users call

{number}. Both you and the person you want to act for you must sign and date a statement confirming this is what

you want. You’ll need to mail or fax this statement to us.

Important Information About Your Appeal Rights

There are 2 kinds of appeals

Standard Appeal – We’ll give you a written decision on a standard appeal within 30 days [Insert timeframe for

standard Medicaid appeals, if different] after we get your appeal. Our decision might take longer if you ask for an

extension, or if we need more information about your case. We’ll tell you if we’re taking extra time and will

explain why more time is needed. If your appeal is for payment of a service you’ve already received, we’ll give

you a written decision within 60 days.

Fast Appeal – We’ll give you a decision on a fast appeal within 72 hours after we get your appeal. You can ask

for a fast appeal if you or your doctor believe your health could be seriously harmed by waiting up to 30 days for a

decision.

We’ll automatically give you a fast appeal if a doctor asks for one for you or supports your request. If you

ask for a fast appeal without support from a doctor, we’ll decide if your request requires a fast appeal. If we don’t

give you a fast appeal, we’ll give you a decision within 30 days.

How to ask for an appeal with {health plan name}

Step 1: You, your representative, or your doctor [provider] must ask us for an appeal [or State Fair Hearing].

Your {written} request must include:

Your name

Address

Member number

Reasons for appealing

Any evidence you want us to review, such as medical records, doctors’ letters, or other information that

explains why you need the item or service. Call your doctor if you need this information.

[Insert, if applicable: You can ask to see the medical records and other documents we used to make our decision

before or during the appeal. At no cost to you, you can also ask for a copy of the guidelines we used to make our

decision.]

Step 2: Mail, fax, or deliver your appeal {or call us}.

For a Standard Appeal: Address:

{Phone:} Fax:

{Insert, if applicable: If you ask for a standard appeal by phone, we will send you a letter confirming what you

told us.} For a Fast Appeal: Phone: Fax:

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Form CMS 10003-NDMCP (Iss. 06/2013) OMB Approval 0938-0829

What happens next?

If you ask for an appeal and we continue to deny your request for {payment of} a service, we’ll send you a written

decision and automatically send your case to an independent reviewer. If the independent reviewer denies your

request, the written decision will explain if you have additional appeal rights.

[Insert additional State-specific Medicaid rules, as applicable.]

How to ask for a Medicaid State Fair Hearing

[You have the right to ask for a State Fair Hearing without asking us (health plan) to review our

decision first.]

Step 1: You or your representative must ask for a State Fair Hearing (in writing) within ( ) days

of the date of this notice. You have up to ( ) days if you have a good reason for your request being

late.

Your {written} request must include:

Your name

Address

Member number

Reasons for appealing

Any evidence you want us to review, such as medical records, doctors’ letters, or other

information that explains why you need the item or service. Call your doctor if you need this

information.

Step 2: Send your request to: Address:

Phone: Fax:

What happens next? The State will hold a hearing. You may attend the hearing in person or by phone. You’ll be asked to

tell the State why you disagree with our decision. You can ask a friend, relative, advocate, provider,

or lawyer to help you. You’ll get a written decision within ( ) days. The written decision will

explain if you have additional appeal rights.

[A copy of this notice has been sent to:]

Get help & more information

{Health Plan Name} Toll Free: TTY users call:

{Insert plan hours of operation}

1-800-MEDICARE (1-800-633-4227), 24 hours, 7 days a week. TTY users call: 1-877-486-2048

Medicare Rights Center: 1-888-HMO-9050

Elder Care Locator: 1-800-677-1116

[Medicaid/State contact information]

Form CMS 10003-NDMCP (Iss. 06/2013) OMB Approval 0938-0829

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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850 MEDICARE ENROLLMENT & APPEALS GROUP

DATE: August 13, 2013 TO: All Medicare Advantage Organizations, Cost-Based Contractors, Health Care

Prepayment Plans, and Medicare-Medicaid Fully Integrated Dual Eligible Plans FROM: Arrah Tabe-Bedward Director, Medicare Enrollment & Appeals Group SUBJECT: Issuance of New Integrated Denial Notice (Form CMS 10003-NDMCP) As part of our continuing efforts to streamline appeal notice requirements, CMS is issuing a new OMB-approved standardized notice of denial and appeal rights. The new notice, referred to as the Integrated Denial Notice (IDN), consolidates Medicare Advantage coverage and payment denial notices and integrates, where applicable, Medicaid appeal rights information.

The IDN combines and replaces the standardized Medicare Part C denial notices entitled “Notice of Denial of Payment” and “Notice of Denial of Medical Coverage” (Form CMS-10003-NDP and Form CMS-10003-NDMC, respectively). In addition to combining the NDP and NDMC, the IDN integrates Medicaid appeal rights information for Medicare health plan enrollees receiving full benefits under a State Medical Assistance (Medicaid) program. Plans administering Medicaid benefits in addition to Medicare benefits are responsible for including applicable Medicaid information in the notice.

Medicare health plans and Fully Integrated Dual Eligible (FIDE) plans will issue the IDN to inform enrollees of their appeal rights, as applicable, for payment or service denials, and for discontinuation or reduction of a previously authorized course of treatment. Medicare-Medicaid Plans (MMPs) within the Financial Alignment Demonstrations also will use the IDN. All plans should begin using the IDN as soon as possible, but no later than November 1, 2013. Medicare Health Plans: The IDN and instructions are posted on the CMS website’s Beneficiary Notices Initiative (BNI) webpages (under the “MA Denial Notices” link): http://www.cms.gov/Medicare/Medicare-General-Information/BNI/MADenialNotices.html For questions regarding the IDN or Medicare health plan appeals, send an email to the following address and copy your CMS Account Manager: [email protected]

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Medicare-Medicaid Plans:

More information about the Financial Alignment Demonstrations can be found on the CMS website under “Medicare Medicaid Coordination” at:

http://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-MedicaidCoordination.html

For questions regarding Medicaid benefit appeals, contact your State Medicaid Agency. State-specific program and contact information can be found at: http://www.medicaid.gov/medicaid-chip-program-information/by-state/by-state.html

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Department of Health and Human Services Form Approved OMB Centers for Medicare & Medicaid Services No. 0938-0950

Appointment of Representative

Name of Party Medicare or National Provider Identifier Number

Section 1: Appointment of Representative To be completed by the party seeking representation (i.e., the Medicare beneficiary, the provider or the supplier): I appoint this individual, to act as my representative in connection with my claim or asserted right under title XVIII of the Social Security Act (the “Act”) and related provisions of title XI of the Act. I authorize this individual to make any request; to present or to elicit evidence; to obtain appeals information; and to receive any notice in connection with my appeal, wholly in my stead. I understand that personal medical information related to my appeal may be disclosed to the representative indicated below. Signature of Party Seeking Representation Street Address Phone Number (with Area Code) City State Zip Code

Date

Section 2: Acceptance of Appointment To be completed by the representative: I, , hereby accept the above appointment. I certify that I have not been disqualified, suspended, or prohibited from practice before the department of Health and Human Services; that I am not, as a current or former employee of the United States, disqualified from acting as the party’s representative; and that I recognize that any fee may be subject to review and approval by the Secretary. I am a / an

(Professional status or relationship to the party, e.g. attorney, relative, etc.) Signature of Representative Date Street Address Phone Number (with Area Code) City State Zip Code Section 3: Waiver of Fee for Representation Instructions: This section must be completed if the representative is required to, or chooses to waive their fee for representation. (Note that providers or suppliers that are representing a beneficiary and furnished the items or services may not charge a fee for representation and must complete this section.) I waive my right to charge and collect a fee for representing before the Secretary of the Department of Health and Human Services. Signature Date Section 4: Waiver of Payment for Items or Services at Issue Instructions: Providers or suppliers serving as a representative for a beneficiary to whom they provided items or services must complete this section if the appeal involves a question of liability under section 1879(a)(2) of the Act. (Section 1879(a)(2) generally addresses whether a provider/supplier or beneficiary did not know, or could not reasonably be expected to know, that the items or services at issue would not be covered by Medicare.) I waive my right to collect payment from the beneficiary for the items or services at issue in this appeal if a determination of liability under §1879(a)(2) of the Act is at issue. Signature Date Form CMS-1696 (Rev 06/12)

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Charging of Fees for Representing Beneficiaries Before the Secretary of the Department of Health and Human Services An attorney, or other representative for a beneficiary, who wishes to charge a fee for services rendered in connection with an appeal before the Secretary of the Department of Health and Human Services (DHHS) (i.e., an Administrative Law Judge (ALJ) hearing, Medicare Appeals Council review, or a proceeding before an ALJ or the Medicare Appeals Council as a result of a remand from federal district court) is required to obtain approval of the fee in accordance with 42 CFR §405.910(f). The form, “Petition to Obtain Representative Fee” elicits the information required for a fee petition. It should be completed by the representative and filed with the request for ALJ hearing or request for Medicare Appeals Council review. Approval of a representative’s fee is not required if: (1) the appellant being represented is a provider or supplier; (2) the fee is for services rendered in an official capacity such as that of legal guardian, committee, or similar court appointed representative and the court has approved the fee in question; (3) the fee is for representation of a beneficiary in a proceeding in federal district court; or (4) the fee is for representation of a beneficiary in a redetermination or reconsideration. If the representative wishes to waive a fee, he or she may do so. Section III on the front of this form can be used for that purpose. In some instances, as indicated on the form, the fee must be waived for representation Authorization of Fee The requirement for the approval of fees ensures that a representative will receive fair value for the services performed before DHHS on behalf of a beneficiary, and provides the beneficiary with a measure of security that the fees are determined to be reasonable. In approving a requested fee, the ALJ or Medicare Appeals Council will consider the nature and type of services rendered, the complexity of the case, the level of skill and competence required in rendition of the services, the amount of time spent on the case, the results achieved, the level of administrative review to which the representative carried the appeal and the amount of the fee requested by the representative. Conflict of Interest Sections 203, 205 and 207 of title XVIII of the United States Code make it a criminal offense for certain officers, employees and former officers and employees of the United States to render certain services in matters affecting the Government or to aid or assist in the prosecution of claims against the United States. Individuals with a conflict of interest are excluded from being representatives of beneficiaries before DHHS. Where to Send This Form Send this form to the same location where you are sending (or have already sent): (1) your appeal if you are filing an appeal, (2) grievance if you are filing a grievance, or (3) initial determination or decision if you are requesting an initial determination or decision. If additional help is needed, contact your Medicare plan or 1-800-MEDICARE (1-800-633-4227).

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0950. The time required to prepare and distribute this collection is 15 minutes per notice, including the time to select the preprinted form, complete it and deliver it to the beneficiary. If you have comments concerning the accuracy of the time estimates or suggestions for improving this form, please write to CMS, PRA Clearance Officer, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Form CMS-1696 (Rev 06/12)

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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

November, 14th , 2013

ICE ‐ Annual Conference

San Francisco, California

Lessons Learned and Best Practicesfrom Program Audits

OverviewOverview

• CDAG Recent Updates

• CDAG Lessons Learned & Best Practices

• CDAG Resources

2

Part D CDAG UpdatesPart D CDAG Updates

• Most recent version of Chapter 18 of the Part D Manual released February 2013 

• Part D standardized denial notice currently in process for OMB

• Final revised notice will be announced through HPMS

3

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CDAG Lessons Learned & Best PracticesCDAG Lessons Learned & Best Practices

Exceptions vs. Prior Authorization Request:

• Non‐compliance with adjudication timeframes

• Failure to effectuate exception approvals through end of the plan year

CDAG Lessons Learned & Best PracticesCDAG Lessons Learned & Best Practices

Program Requirement(s):

• Plans must have a process in place for reviewing all requests to determine if they involve an exception (tiering or formulary)

• Tolling is only permitted when ALL of the following are true:  – Exception request– No prescriber’s statement received– Coverage Determination level

• Requests that do not involve an exception (e.g.,enrollee is attempting to demonstrate that they meet the PA or other UM criteria) must be processed within required timeframes

• Approved exception requests must be through the end of the plan year

CDAG Lessons Learned & Best PracticesCDAG Lessons Learned & Best Practices

Dismissals:

Inappropriate dismissals of (including failure to process) coverage determination and appeal requests

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CDAG Lessons Learned & Best PracticesCDAG Lessons Learned & Best Practices

Program Requirement(s):• Generally, we expect plans to adjudicate all coverage requests 

on the merits and to do so within the requested timeframes and with an appropriate denial or approval notice

• If an enrollee or prescriber asks for a coverage determination for a formulary drug without UM criteria, the plan should process as a favorable CD rather than dismiss or fail to process the request

• If an enrollee or prescriber asks for coverage subsequent to an adverse coverage determination but the 60‐day appeal timeframe has passed and there is not cause for untimely filing, the plan should process the request as a new coverage determination rather than dismiss

CDAG Lessons Learned & Best PracticesCDAG Lessons Learned & Best Practices

Part B vs. Part D Coverage Determinations:• Failure to appropriately determine coverage under Part B 

vs. Part D

CDAG Lessons Learned & Best PracticesCDAG Lessons Learned & Best Practices

Part B vs. Part D Coverage Determinations (cont.):• While the application of Prior Authorizations criteria may be 

appropriate for these drugs, CMS expects sponsors to use available resources (e.g., plan help desk working with network pharmacies) to resolve Part B vs. Part D payment questions at the pharmacy counter to minimize delays in new therapy starts or interruptions of current therapy

• For Part B vs. Part D Prior Authorizations that go through the CD process, CMS also expect plans to aggressively solicit clinical information necessary to determine coverage for these drugs

• All coverage decisions must be made as expeditiously as the enrollee’s health condition requires

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CDAG Lessons Learned & Best PracticesCDAG Lessons Learned & Best Practices

Part B vs. Part D Coverage Determinations (cont.):• MA‐PD plans are strongly encouraged to establish processes to 

coordinate Part B and Part D benefits

• MA‐PD plans that deny requests for drug coverage under Part D because they have determined that coverage is available under Part B should establish processes to ensure authorization under the Part B benefit and notify enrollees

• MA‐PD plans may use the free text field in the Part D denial notice to include notification that the requested drug is approved and authorized under Part B

CDAG Lessons Learned & Best PracticesCDAG Lessons Learned & Best Practices

Misclassification:• Complaints improperly classified as grievances or inquiries 

when they should have been processed as coverage determinations or redeterminations

Program Requirement(s):• Plans must determine whether an enrollee or prescriber’s 

request is a request for coverage, a grievance , or both• Complaints must be categorized on a case‐by‐case basis as 

determined by the facts and circumstances of each request• Plans are required to accept verbal and written coverage 

determination requests from enrollees and prescribers• Enrollees are not required to use “magic words” or specific 

forms to request an initial coverage determination or redetermination

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” 

• Best Practices and Common Findings Memo #2 from 2012 Program Audits (July 30, 2013 HPMS)

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

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Questions? Questions? 

Part C Appeals & Grievances Mailbox: 

[email protected] 

Part D Appeals & Grievances Mailbox: 

[email protected] 

Part C & D AcronymsPart C & D Acronyms

AOR—Appointment of RepresentativeCCI—Coordinated Care InitiativeCD—Coverage DeterminationCDAG—Coverage Determinations, Appeals and GrievancesIDN—Integrated Denial NoticeIRE—Independent Review EntityMAPD—Medicare Advantage Prescription PlanMAO—Medicare Advantage OrganizationMMP—Medicare‐Medicaid PlanODAG—Organization Determinations, Appeals and GrievancesOMB—Office of Management and Budget PA—Prior AuthorizationUM—Utilization ManagementWOL—Waiver of Liability