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MedHOK Compliance Insights March 2015 – Important Reminders and 2015 Program Audit Protocols and Process Updates

 Important Reminders

  • Registration is now open for this year’s Medicare Advantage & Prescription Drug Plan Spring Conference & Webcast which will be held Wednesday, May 6, 2015 from 9:30am – 4:30pm. To learn more about this event, please visit the Compliance Training Education and Outreach (CTEO) section of CMS.gov.
    • Advance Notice of Changes for CY 2016 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter was released on February 20, 2015. CMS will announce the MA capitation rates and final payment policies on Monday, April 6, 2015. Click here to access the notice on cms.gov.
    • Preparation for Star Ratings Quality Assurance Reviews on Part D Coverage (Determinations and Redeterminations): CMS announced they have begun analyzing contract year (CY) 2014 Part D appeals auto-forward data for use in the 2016 Star Ratings. In March 2015, CMS will notify select Part D sponsors that they have been identified as a potential appeals auto-forward outlier. By the end of April 2015, selected sponsors will submit documentation following CMS specifications. Please see the HPMS memo dated February 13, 2015 for more information.
    • Medicare Part D Overutilization Monitoring System (OMS) Update:
      • Opioid Product List Change – Based on input from the Centers for Disease Control and Prevention (CDC), combination products containing buprenorphine and naloxone (e.g., Bunavail™, Suboxone®, Zubsolv®) will be removed from the OMS opioid list effective April 2015.
      • New Processing Logic for OMS Point-of-Sale (POS) Response Codes
      • New Part D Overutilization Management Mailbox (PartD_OM@cms.hhs.gov) is available for submission to CMS of any questions or suggestions related to overutilization management in Part D, the OMS, or POS edit information in MARx. Sponsors should also send copies of non-opioid, beneficiary-specific POS edit notices to this new mailbox rather than the CMS Part D Policy mailbox, in addition to sending copies to their CMS account manager.
      • Please see the HPMS memo dated March 6, 2015 for more information.
  • Updated Patient-level HEDIS 2015 information available. Summary and patient-level HEDIS data are due concurrently, on June 15, 2015. Please use the 2015 documents for the creation of the MY 2014 patient-level files. Be sure to deliver the updated versions of these documents to your NCQA-Certified HEDIS Compliance Auditor and any third-party vendor submitting data on your behalf.
    • CMS recently placed updated versions of the following documents on cms.gov under the downloads section:
      • 2015 Patient-level file specifications, File 1 of 2 (2014 Measurement Year) (dated January 14, 2015
      • 2015 Patient-level file specifications, File 2 of 2 (2014 Measurement Year) (dated January 15, 2015)
      • 2015 Patient-level data submission instructions (2014 Measurement Year) (dated January 14, 2015)
      • Crosswalk document showing changes from 2014 to 2015 patient-level file specifications
    • For more information or a demonstration of the MedHOK HEDIS Module, please click here or call us at 888-963-3465.

New HPMS-specific section on cms.gov

On February 18, 2015 CMS announced the release of a new HPMS-specific section on the cms.gov. For the initial release, the informational website includes the following materials:

  • Instructions for requesting a new CMS user ID
  • Instructions for requesting consultant and electronic signature access in HPMS
  • Detailed steps for recertifying a CMS user ID
  • Guidance on maintaining and updating your CMS password
  • HPMS logon instructions
  • HPMS system requirements (e.g., supported web browsers)
  • Contact information for various CMS help desks
  • Most frequently asked questions related to HPMS access
  • Instructions for requesting access to the HPMS listserv

Complaints Tracking Module (CTM) Enhancements

On February 6, 2015 CMS issued a comprehensive memo on the Complaints Tracking Module (CTM) covering the following items:

  • System Enhancements: On February 13, 2015 CMS implemented some important enhancements to the Health Plan Management System (HPMS) CTM, including an updated CTM user manual and adding additional fields to the Plan Download File for 1) Plan Request statuses, 2) the response to the question ‘Did the complainant contact the plan before the complaint was entered’, and 3) Pending Plan Requests.
  • Updated Standard Operating Procedures (SOP): The SOP supersedes all prior versions and replaces the memorandum issued June 28, 2013.
  • Casework Tips and Reminders
  • CTM Exclusion Criteria and Performance Standards
  • Suggested Examples of Plan CTM Resolution Notes
  • Common Acronyms/Casework Terms
  • Home Region Complaint Mailboxes

For more information or a demonstration of the MedHOK CTM Module, please click here or call us at 888-963-3465.

2015 Program Audit Protocols and Process Updates 

On February 13, 2015 CMS issued a memo to provide updates related to the 2015 Program Audit Cycle, including the start of a new audit cycle, changes to the scope of audits, new audit program areas, 2015 protocols, and modifications to the 2015 audit process.

START OF A NEW AUDIT CYCLE

In 2015, CMS will begin a new audit cycle. This means that all sponsors, even those audited in the previous cycle (2010-2014), will be considered for audit selection. For the new cycle, they will continue to utilize a risk-based approach to selecting sponsors for audit (both high and low risk), while also taking into account other key factors like: the sponsor has never previously been audited; the sponsor is new to the program (i.e., is in their first 2 years of operation and has no previous affiliation with the Medicare program); or the sponsor represents a large percentage of MA or Part D enrollment. Organizations are audited at the parent organization level. Therefore, if an MA or Part D sponsor also operates a Medicare-Medicaid Plan (MMP), CMS will audit the MMP contract as part of the larger parent organization audit.

MODIFICATIONS TO PROGRAM AUDIT SCOPE

Discontinued for 2015:
Formulary & Benefit Administration: The review of the P&T Committee was removed.

Program Areas/Elements Modified for 2015:
ODAG and CDAG Timeliness for universe tests and submission of universes will again be measured at the universe level for standard and expedited organization determinations (ODs), appeals and grievances and for standard and expedited coverage determinations (CDs), appeals and grievances. Previous universe request templates consolidated various types of requests into one spreadsheet, but it was difficult to conduct a timeliness test this way, as the various types of requests in one spreadsheet had different processing timeframes associated with them. In 2015, the same data are being requested as in past years, but now each separate request will have its own universe template.

Compliance Program Effectiveness – The Compliance Protocol has been redesigned to be more outcomes focused and less burdensome. For example, the content review, which required the sponsor to submit a large number of documents (32 pre-audit), has been eliminated. Instead, the seven elements will be tested by conducting 5 “tracer” samples, which means that an issue will be selected and the team will “trace” the issue as it moves through the organization’s compliance program. CMS will continue to conduct interviews, but the interview guides have been streamlined.

New Program Areas/Elements Added for 2015:
Medication Therapy Management (PILOT) – The objectives of this program audit area will be to assess a Medicare Part D sponsor’s performance with their CMS-approved MTM Program, educate sponsors and correct area(s) of deficiency, and initiate enforcement actions and/or identify possible performance measures for Sponsors to implement.

Provider Network Adequacy (PILOT) – The objectives of this program audit area will be to examine the adequacy of a sponsor’s provider network and the standards for accessibility and ensure that the providers in networks are open to treat enrollees.

These pilot audits will not start until mid-2015. As with other piloted protocols, sponsors who receive an MTM or Network Adequacy audit in 2015 will not have the score count against their total program audit score. A score will not be provided in the final audit report, nor will the pilot area scores be posted to CMS’ website. We encourage sponsors subject to these pilot audits to provide as much feedback as possible about the new protocols. These new protocols will then be incorporated into the 2016 audit scope and these scores will count in the total audit score.

RELEASE OF 2015 AUDIT PROTOCOLS

2015 audit process documents and protocols were released that will be utilized to measure outcomes in the following areas:

  • Part D Formulary and Benefit Administration
  • Part D Coverage Determinations, Appeals, and Grievances
  • Part C Organization Determinations, Appeals, and Grievances
  • Special Need Plans- Model of Care (SNP-MOC)
  • Part C and Part D Compliance Program Effectiveness

Audits will continue to be conducted over a two week period. Specifically, the first week of an audit will start with an entrance conference and the audit of all applicable operational areas (Part D Formulary Administration; Part D Coverage Determinations, Appeals, and Grievances; Part C Organization Determinations, Appeals, and Grievances; and SNP-MOC) virtually via webinar. The Compliance Program Effectiveness portion of the audit will occur during the second week and will be on-site. This will allow the sponsor’s compliance officer to be actively engaged during the audit of all operational areas in the first week and fully engage in the compliance program audit the second week.

The protocols and other associated audit documents can be found in the Downloads section of the CMS Program Audit website, located at: http://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D-Compliance-and-Audits/ProgramAudits.html

The two pilot protocols for Network Adequacy and Medication Therapy Management will not be posted until mid-2015. We will inform sponsors of the release of these two pilot protocols via a separate HPMS email.

MODIFICATIONS TO THE PROGRAM AUDIT PROCESS

Timing for receipt of audit start notice and universe submission (Beginning in 2015):

If a sponsor has been selected for an audit, an engagement letter will be sent 6 weeks prior to the audit start date, notifying them of the date the audit will begin, the scope of the audit, the contact information for the MOEG Auditor-In-Charge, and information being requested from the sponsor (e.g., universes). Sponsors will be expected to submit universes 3 weeks prior to the start date of the audit. To ensure we receive accurate universes, we are giving two additional weeks of notice before the audit start date including one additional week to submit universes. This will allow more time for sponsors to pull and quality check their universes and will give us additional time to validate the accuracy of the universes prior to selecting samples and beginning the audit.

Universe Submission Accuracy

In 2015, sponsors will have a maximum of 3 attempts to provide each universe requested, whether these attempts all occur prior to the entrance conference or both before and during the audit. If the sponsor fails to provide accurate and timely universe submissions twice, CMS will document this as an observation in the plan’s program audit report. After the third failed attempt the sponsor will be cited Immediate Corrective Action Required (ICARs) for every condition that cannot be tested due to the inaccurate universe (i.e., if there are 11 audit conditions that could have been tested in a given universe, we will automatically cite 11 ICARs, one for each possible condition that could have been tested). Although these will be referred to as ICARs in 2015, they will not require proof of correction within 72 hours, as typical ICARs currently require. However, CMS will include these areas in their validation exercises and sponsors will be expected to be able to produce a universe for that effort.

Sponsors are expected to abide by the universe submission deadlines and sponsors who fail to produce accurate universes or documentation required by audit could face possible enforcement action. In 2016, the audit scoring methodology will be updated to reflect that inaccurate data submissions (IDS) will be counted similar to ICARS (2 x number of conditions), but will differ in that they will not require validation in 72 hours, as typical ICARS require. In addition, an IDS condition will be created that sponsors will be cited for based on the inaccurate data provided.

Previously Disclosed versus Self-Identified Issues

CMS clarified the difference between disclosed and self-identified issues. A disclosed issue is one that has been reported to CMS prior to the date of the audit start notice. A self-identified issue is one that has been discovered by the sponsor but notification was not made to CMS until after the date of the audit start notice. Sponsors will be asked to provide a list of all previously disclosed and self-identified issues of non-compliance, from January 1, 2015 through the date of the audit start notice, which CMS may find in data universes.

  • Sponsors must provide a description of each issue as well as the remediation status using the Pre-Audit Issue Summary template. The sponsor’s Account Manager will review the summary for accuracy and completeness.
  • In addition, for each disclosed and self-identified issue the sponsor will be required to complete a Beneficiary Impact Analysis (BIA). BIA templates are provided to sponsors when noncompliant conditions are found .The BIA should include every impacted beneficiary across all of the sponsor’s contracts for the time period January 1, 2015 through the date of the audit start notice.
  • Both the issue summary and the associated BIA(s) are due within 5 business days after receipt of the engagement letter. These documents will be reviewed by the sponsor’s Account Manager.
  • Sponsors will have a maximum of 3 attempts to provide the Pre-Audit Issue Summary and the associated BIAs. If multiple attempts are made, CMS will only use the last Pre-Audit Issue Summary and BIAs submitted.
  • If the sponsor fails to provide accurate and timely data twice, CMS will document this as an observation in the program audit report.
  • If a sponsor fails to provide accurate data for the Pre-Audit Issue Summary and every associated BIA by the universe submission deadline (regardless of the number of attempts), the sponsor will not receive credit for any disclosed or self-identified issue during the course of the audit.

Account Managers (AMs) will review the pre-audit issue summary submitted to validate that issues identified as “disclosed” were known to CMS prior to the date of the audit start notice and determine if any issues listed as “self-identified” should instead be classified as “disclosed”. The AMs will validate the “disclosed” issue status of “corrected” and may also be asked to validate that issues have not been omitted from the “disclosed” summary.

Corrected Issue: CMS will consider an issue corrected if there is evidence of appropriate and adequate remediation, both in the sponsor’s systems and for the sponsor’s enrollees. The correction can occur prior to or during the “audit review period”, but must occur before receipt of the audit start notice. The “audit review period” refers to the period covered by the related universe request. No distinction will be made between disclosed and self-identified issues with respect to sample selection and timeliness tests for corrected issues.

Uncorrected issue: CMS will consider an issue uncorrected when appropriate and adequate remediation to the sponsor’s systems and its beneficiaries has not been completed prior to receipt of the engagement letter. Therefore, any issue included in the Pre-Audit Issue Summary that is detected and/or corrected after the date of the audit start notice will be treated as uncorrected.

If you have questions about any of the information provided in the memo, please send an email to part_c_part_d_audit@cms.hhs.gov.

Marc Ryan

Marc S. Ryan serves as MedHOK’s Chief Strategy and Compliance Officer. During his career, Marc has served a number of health plans in executive-level regulatory, compliance, business development, and operations roles. He has launched and operated plans with Medicare, Medicaid, Commercial and Exchange lines of business. Marc was the Secretary of Policy and Management and State Budget Director of Connecticut, where he oversaw all aspects of state budgeting and management. In this role, Marc created the state’s Medicaid and SCHIP managed care programs and oversaw its state employee and retiree health plans. He also created the state’s long-term care continuum program. Marc was nominated by then HHS Secretary Tommy Thompson to serve on a panel of state program experts to advise CMS on aspects of Medicare Part D implementation. He also was nominated by Florida’s Medicaid Secretary to serve on the state’s Medicaid Reform advisory panel.

Marc graduated cum laude from the Edmund A. Walsh School of Foreign Service at Georgetown University with a Bachelor of Science in Foreign Service. He received a Master of Public Administration, specializing in local government management and managed healthcare, from the University of New Haven. He was inducted into Sigma Beta Delta, a national honor society for business, management, and administration.

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