A COMPLIANCE SOLUTION DESIGNED TO HELP PLANS MEET CMS REQUIREMENTS
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1 A COMPLIANCE SOLUTION DESIGNED TO HELP PLANS MEET CMS REQUIREMENTS Founded on the Common Conditions, Improvement Strategies, and Best Practices based on 2013 Program Audit Reviews HPMS memo, dated August 27, 2014 WRITTEN BY: Celia Girard, Director of Policy and Training, Gorman Health Group Jill Stillman, Associate Director of Compliance Products, Gorman Health Group yellowcollection WHITE PAPER January 11, 2015
2 THE ISSUES In a memo from the Director of the Medicare Parts C and D Oversight Enforcement Group, released on August 27, 2014, The Centers for Medicare & Medicaid Services (CMS) outlined areas where plans have been consistently non-compliant, and described best practices to address these failings. Some of the reoccurring conditions that CMS identified for Formulary Administration, Organization Determinations, Coverage Determinations and Appeals include: Sponsors failed to properly administer CMS-approved formulary and transition processes by applying unapproved quantity limits, unapproved utilization management practices, and failing to provide a continuing beneficiary a transition supply of a non-formulary medication. Sponsors misclassified coverage determinations or redetermination requests as a grievance and/or customer service inquiry. Sponsors improperly effectuated items. They did not process prior authorization or exception requests correctly, made inappropriate denials for coverage determinations, failed to notify beneficiaries and providers of decisions, and often did not meet processing timeframes for payment decisions. Sponsors did not demonstrate appropriate outreach for information to make clinical decisions. Further, beneficiaries and providers did not receive adequate and/or accurate rationale for the denials, nor were they always provided with a description of the appeals process. Sponsors did not review OIG and GSA exclusion lists for any new employee, temporary employee, volunteer, consultant, governing body member, and/or FDR prior to hiring or contracting; nor monthly thereafter. Sponsor did not provide evidence that it audits the effectiveness of the compliance program at least annually, and that the results are shared with the governing body of their organization. Further, Sponsor did not demonstrate distribution of the standards of conduct (SOC) and policies and procedures to employees who supported the Medicare line of business: 1) within 90 days of hire; 2) when there were updates to the policies and procedures; and 3) annually thereafter. Sponsor did not provide fraud, waste and abuse (FWA) training and/or general compliance information or training materials to its FDRs. (Note: Special Needs Plans (SNPs) had some specific issues as well, which are not included in this paper.) 2
3 WHAT S GOING WRONG? These failings and associated results point to a lack of tools and/or resources, as well as ineffective oversight of FDRs. To quickly identify these issues, and put CMS recommended practices in place, organizations must implement strong monitoring and auditing protocols, including case file and metric reviews, to familiarize themselves with current performance, trends and risks. In addition, results should be reported to department management, the Compliance Committee, and the Board of Directors (as appropriate) on a regular basis. For any items that are displaying a negative trend or appear to be at risk of non-compliance, the Organization must establish and implement procedures and a system for promptly responding to issues as they are raised, investigate potential compliance problems as identified in the course of self-evaluations and audits, and correct such problems promptly and thoroughly to reduce the potential for recurrence. This is usually accomplished by instituting a Corrective Action Plan (CAP) with continued monitoring and auditing once the solution is in place to ensure continued compliance. POTENTIAL CONSEQUENCES CMS can take a number of enforcement actions when they determine there is non-compliance present. These actions vary in severity from a Notice of Non-Compliance, which requires immediate remediation, to monetary penalties, suspension of new enrollments, and, if severe enough, termination of the Organization s contract with CMS. RECOMMENDATIONS To aid Organizations in avoiding or correcting the issues highlighted above, CMS has recommended a number of actions, as outlined in the August 27, 2014, HPMS Notice, including: At the beginning of each contract year, test the logic of programming for all drugs, including those that changed formulary status, ensure inappropriate edits do not cause rejections, complete routine, aggressive reviews of B vs. D processing, validate that claims for new beneficiaries will not reject for transition supplies, and complete a 100% review of rejected claims to identify and correct any formulary and transition errors. After the initial assessment, periodically perform quality checks by routinely comparing the formulary file submitted to CMS with the adjudication system file, to ensure there are no inconsistencies. Clearly provide and explain the reason for any denial in the free-text field of the standardized denial notice. Applicable Medicare coverage rule or plan policy must be described in the denial rationale and prescription drug coverage should align with the formulary. Ensure that systems clearly indicate time-stamped receipt of coverage determination, organization determination or appeal requests, and identify whether it is a standard or expedited request. Perform quality assurance tests on systems to ensure that processing and notification occurs within required timeframes. Validate the clinical accuracy of plan decision-making, including adherence to Medicare and plan coverage criteria. This includes ensuring all adverse coverage determinations involving medical necessity are reviewed by an appropriate clinician, all redeterminations involving medical necessity are made by an appropriate physician, and all prescriber supporting statements for exception requests are given appropriate consideration. 3
4 Process payments for Direct Member Reimbursement (DMR) requests on a daily basis. Ensure that beneficiaries and providers receive detailed, accurate and complete information about the appeals process, including information about how to file an appeal with the Independent Review Entity (IRE). Take steps to ensure staff understands CMS policy for using the 14-day extension to request additional information properly. Communicate compliance and FWA information to FDRs timely. Develop a process that monitors and tracks the distribution of standards of conduct (SOC) and policies and procedures to ensure sponsors are distributing: 1) within 90 days of hire; 2) when there are updates, and 3) annually thereafter. Develop automated monitoring and auditing systems to detect excluded providers, and retain source documentation or screen prints from OIG and GSA exclusion databases. Develop a process for distributing CMS guidance memos received via HPMS to appropriate personnel, and confirming the new programmatic requirements were implemented by the appropriate functional areas. Develop a tool to track and manage corrective action plans (CAP) developed from external and internal audits. EXCEL IS NOT A SOLUTION Addressing issues and monitoring performance presents a distinct challenge for many organizations. Much tracking and trending today is done using Excel spreadsheets, which work best for a single user handling limited data. Excel, while a powerful tool, is not a system and is not operationally efficient. It is not robust enough to track results, create charts demonstrating performance, and assess risk. When relying primarily on Excel, organizations find themselves falling short of CMS expectations. SOLUTIONS: A BETTER OPTION One solution available to help organizations meet the CMS requirements is the Online Monitoring Tool (OMT ) from Gorman Health Group, LLC (GHG). OMT is a highly flexible oversight tool and dashboarding software that brings together key metrics, documents, and tasks for ongoing monitoring and auditing, which results in the Organization being audit ready. This integrated solution also streamlines vital compliance activities, such as the implementation of new requirements and corrective actions. OMT is a web-based, hosted solution. The software is maintained by GHG, which minimizes the impact on an organization s IT resources. Users log in and have different permission and access levels. Automatic 4
5 notifications let users know when something is assigned to them and provide reminders of upcoming deadlines to help keep items on track. HOW DOES OMT DO IT? OMT uses several integrated modules to help organizations meet CMS requirements as described below. AUDITING AND MONITORING Both auditing and monitoring functions are required elements of an effective Compliance Program. Monitoring is regular reviews, performed as part of normal operations, to confirm ongoing compliance and to ensure that corrective actions are undertaken and effective. Monitoring allows organizations to quickly identify trends and address concerns before they escalate. First, robust monthly metric reporting can be completed through the Indicators module. This module can be used to track key performance metrics, such as the number of new enrollments, the number of enrollments processed timely, or the percentage of new staff members who received compliance training within 90 days of hire. OMT also provides self-calculating worksheets based on CMS requirements, which allow users to document the review and results of sample case file review. Worksheets can be completed on a recurring basis for monitoring in the Indicators module. This mechanism of sampling allows operational areas to validate compliance with many regulatory requirements, including organization and coverage determination processing, assessing timeliness, and reviewing the accuracy of letters and appropriateness of denials. Worksheets can also be completed for First Tier, Downstream and Related Entities (FDRs), to demonstrate oversight of actions they are performing for the organization. As metrics and worksheets are completed, the results display on charts on the dashboard. Worksheet results display with metrics on performance dashboards. Charts are color coded based on goals and help identify risk areas at a glance. This allows organizations to respond quickly when there is a need for intervention. Standardized operational reports can be set up to mirror and even enhance current reporting. In addition, Organizations may choose to complete an annual assessment of compliance with CMS requirements within the Elements module. This is accomplished by having an auditor annually review selected requirements and all associated information within OMT (metrics, worksheets, policies, etc.) to determine if the Organization is in compliance. Auditing is the formal review of compliance with a particular set of standards (e.g., policies and procedures, laws and regulations). This allows an organization to validate on-going reporting and monitoring through ad hoc or routine compliance audits in the Audits module. In-depth review by trained auditors can help identify process issues, system issues, or misreported data. Audits are set up as needed, and prioritized by the organization based on the current compliance landscape and the annual risk assessment. The OMT Audits module provides access to hundreds of GHG-maintained compliance and operational elements as well as the same self-calculating worksheets used for ongoing monitoring. 5
6 COMPLIANCE ACTIVITIES Finally, OMT can be used for documenting compliance activities. When deficiencies are identified during monthly monitoring or an audit, a CAP can be created in the CAPs/CIPs module. New guidance, such as HPMS Notices, can be stored and implementation activities tracked using the Notices module. Review of Marketing Materials by Compliance and submission to HPMS can be tracked in the Materials module. Within these modules, project managers can keep items on track with due dates and document the entire process from the initial distribution of information, to tasks assignment and completion, as well as any testing that is performed and the finished results. Detailed reporting is available for on-going monitoring of completion and targeted reports can be created as needed for compliance committee meetings, Board meetings and even serve as evidence during a CMS audit. CONCLUSION Compliance departments are subject to competing demands, and often adopt a risk-based approach to Compliance monitoring to help them to focus on the areas that present the highest perceived risk of non-compliance. OMT allows organizations to share information on the fly, at all levels, from the Board of Directors to the enrollment processor and enables the rapid identification of and response to these potential risks. The most significant benefits to using OMT for overall CMS compliance assessment are, therefore: An enhanced risk management framework, allowing for timely identification of risk areas; The ability to demonstrate oversight of the organization processes and procedures by all relevant staff, including end-users, senior management and the Board; Proactive identification of control failures and non-compliance with regulatory requirements; The ability to make informed decisions for necessary business improvements that will reduce the risk of CMS Compliance actions, material financial loss, or damage to the organization s reputation; and Having sufficient data to understand the organization s strengths, weaknesses and level of overall compliance, allowing for continued improvements. In this age of limited resources, IT that is spread too thin, error-laden spreadsheets, and over-worked staff, a tool like OMT is a breath of fresh air. During recent audits, CMS has cited this tool, when used properly, as a best practice. Let OMT support your compliance needs, and help your organization run an efficient Compliance department. 6
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