Closing the Loop

Proactively Resolving Open Payment Disputes and Inquiries

Closing the Loop

Proactively Resolving Open Payment Disputes and Inquiries

In January 2013, the Regulatory Law Group conducted a survey of more than 1,000 physicians to gain a baseline understanding of physician attitudes and awareness of the Open Payments reporting requirements. According to the survey: 63 percent of physicians are concerned that payments they have received in excess of $10 will be made available in a publicly searchable database. 94 percent of physicians feel it is important to review and dispute payment data prior to publication in the public domain, if necessary. 81 percent of physicians prefer to review payment data more than once a year. 21 percent of physicians would consider severing their relationship with a manufacturer that reports inaccurate information related to payments disclosed in the public domain.

Four Key Takeaways A well-defined dispute-management process involving the Compliance, Finance, Sales and IT teams is crucial to maintaining adherence to laws and avoiding significant penalties. The Centers for Medicare & Medicaid Services (CMS) will monitor the rate of disputes and resolutions, and explicitly recommend that companies provide Covered Recipients the ability to pre-review transactions before publishing to CMS. The current reactive process of resolving disputes will become functionally obsolete. There would be as few as ten business days to resolve a dispute, correct it in the source system, correct it in the spend capture tool, certify the new data and resubmit to CMS. A thorough analysis of possible dispute resolution scenarios must be performed to establish efficient, compliant methods to correct inaccurate expenditure reports.

1-866-377-0040 | huronconsultinggroup.com/lifesciences

Closing the Loop

In addition to managing healthcare provider (HCP) concerns for notification and reporting accuracy, manufacturers need to consider that the Centers for Medicare & Medicaid Services (CMS) has signaled that it intends to monitor the volume of disputes and resolutions between HCPs and manufacturers. In order to maintain legal compliance, and sustain key relationships with Healthcare Providers and Key Opinion Leaders (KOLs), it is important that manufacturers implement a well-defined Aggregate Spend dispute and inquiry process. This process should be comprehensive enough to address HCP as well as regulatory issues and provide the capability to: assign research/ resolution requirements throughout the organization, review/retrieve transactional data that may support the resolution, validate the resolution for the dispute within the organization, communicate resolution to the HCP, or healthcare organization (HCO), and provide feedback that the HCP/HCO concurs. This paper will identify challenges a manufacturer encounters when designing a dispute resolution process, emphasizing a proactive approach to ensure disputed transactions are handled in a timely and compliant manner. Additionally, this paper will provide a checklist of tasks needed to successfully establish a disputeresolution process. Requiring a Resolution Process In accordance with the Open Payments final rule, manufacturers, physicians, teaching hospitals and relevant Group Purchasing Organizations (GPOs) will have the opportunity to review their submitted data for 45 days before it is made public. During this period physicians and teaching hospitals can dispute information reported about them or their institutions. CMS has specifically stated that it will not mediate any of the reported disputes, so manufacturers will be required to implement a methodology and procedure to resolve possible disputes.

The Data Collection and Reporting Timeline

After the 45-day period, CMS will provide a 15-day window to resolve any disputes. During this 15-day window, manufacturers will be required to not only update spend tracking tools (and potentially source systems), but also approve and attest to the updated data in the revised report provided to CMS addressing any corrections. This short window for reviewing the data before publication creates the following challenges: Lack of distinction between the dispute phase and the resolution phase. If a dispute is made towards the end of the 45-day period, manufacturers are left with a diminutive timeframe to determine a proper resolution. Working ad hoc to reply within the 45-60 day resolution window may not provide sufficient time to review, approve and attest the resolution result. Of the 1,000 HCPs surveyed by the Regulatory Law Group, 59 percent stated they prefer to review payment information either quarterly or monthly. Trying to resolve disputes within the 45-60 day period may not provide sufficient time to manage the relationship with valued HCPs and KOLs.

Spend transaction disputes may result in necessary updates to payment source systems as well as Spend capture software, which for many manufacturers is used to generate the CMS report.

Approach For Implementing A Dispute Resolution Process And Solution When implementing an HCP dispute resolution the solution team should consider the following: 1. Should I proactively communicate with HCPs and provide data prior to submitting reports to CMS on March 31, 2014? 2. What protocol should I establish to communicate with HCPs and KOLs? 3. Can I access transaction data at the appropriate level of detail? 4. Can I establish an audit trail with key controls for all communications with HCPs during the dispute resolution process? Over the past year Huron Life Sciences has helped pharmaceutical and medical device manufacturers create dispute resolution solutions using the Five Phase approach illustrated below.

A Structured Approach To Help Pharmaceutical And Medical Device Manufacturers Create Dispute Resolution Solutions

Closing the Loop

Open Payments Reporting: A Five Phase Checklist For Manufacturers Phase I: Define cross-divisional procedures to manage inquiries and disputes Tasks and Considerations: Establish a baseline by documenting the current environment Identify all functional processes, regulatory requirements, work flow requirements and interdepartmental dependencies Develop policies that: Establish a cross divisional process that formalizes inquiry and dispute management Identify individuals within each business area that will support the inquiries and disputes process Develop Service Level Agreements (SLAs) appropriate for organizational commitment

Phase II: Develop inquiry and dispute support model Tasks and Considerations: Develop a functional vision for the future operational process Identify gaps that exist between the existing process and the desired process Identify opportunities to implement automatic system controls that can flag spend outliers to prevent disputes from occurring Determine ability/desirability to increase capability or infrastructure of existing call centers to support not only HCP inquiries and disputes, but potential requests from government agencies, media and the public at large HCPs disputing reports are customers that may expect a certain level of service or attention Call center representatives may not be qualified or the best resources to work directly with HCPs External facing points of contact need to provide information accurately and in a fashion which is in compliance with all applicable rules, regulations and internal policies Create work center design for managing HCP inquiries and disputes

Phase III: Determine inquiry and dispute resolution process Tasks and Considerations: Develop detailed scenario based process flows Approach for capturing, classifying, analyzing, and resolving disputes must be predetermined Roles and responsibilities must be clearly defined Determine level of critical disputes Organization must collect and have access to the appropriate supporting data elements Identify possible scenarios for legitimate disputes requiring correction of transaction data Determine where corrections will be made and how systems will be synchronized once these changes are made Develop a script for call center employees that details how to respond to inquiries and disputes Develop procedures to analyze and resolve disputes Identify required data elements to satisfy process, regulatory, work flow and interdepartmental requirements Develop criteria for approving or rejecting disputes Develop process to update transactions when errors are found

Phase IV: Establish communication plan and strategy Tasks and Considerations: Develop a methodology for communicating spend information to an HCP/HCO Determine a proactive or reactive communication approach 45-60 day dispute time frame may not provide enough time to adequately resolve issues and communicate with HCPs/HCOs HCPs require different levels of support depending on: Classification as Key Opinion Leader/Subject Matter Expert Type of dispute Relationships/Expectations Not all communications will originate from HCPs

Determine frequency for communicating with HCPs Develop escalation procedures to ensure that inquiries from the press, government agencies, watchdog groups, and consumers are escalated to the corporate communications department Develop standard responses for common inquiries that dont require analysis

Phase V: Determine options to leverage technology to streamline business process Tasks and Considerations: Determine the following: Communication method with HCPs Business/Functional requirements Work flow requirements Process flows and diagrams Data integration requirements Scenario data and system requirements Response time requirements Organizations are looking for vendors that can supply an off-the-shelf Dispute Management System HCPs desire a one stop shop communication solution

Determine solution systems architecture

Identify opportunities to use existing systems Develop implementation project plan based on best practice methodologies and not an arbitrary or forced milestone date

How Much Would It Be Worth If Your Organization Could Close The Loop? Most pharmaceutical and medical device manufacturers have spent considerable time and resources establishing processes and systems to capture and report transfers of value as required by Open Payments regulations. Now that the bulk of these efforts are nearing completion, the next phase is to consider how to address the dispute resolution requirements. CMS has indicated that it will provide the reporting portal for HCPs to review spend reports from manufacturers prior to publishing the information to the public website but will not mediate any reported disputes and expects manufacturers to manage the resolution/resubmission process. Since relationships with HCPs can be affected by the accuracy of the values displayed to the public on the CMS website, it is important that manufacturers provide HCPs opportunities to review spend data on a regular basis prior to it being submitted, and implement a customer service oriented resolution process that will address any disputes or issues.

For more information on how we can help you comply with the dispute resolution requirements and enhance your relationships with HCPs, contact: Mark Linver Managing Director 646.520.0054 mlinver@huronconsultinggroup.com

Suj Patel Director 312.833.2635 sujpatel@huronconsultinggroup.com

Juan Tessi Associate 646.520.0067 jtessi@huronconsultinggroup.com

YOUR MISSION | OUR SOLUTIONS

Huron Consulting Group helps clients in diverse industries improve performance, comply with complex regulations, reduce costs, recover from distress, leverage technology, and stimulate growth. The Company teams with its clients to deliver sustainable and measurable results. Huron provides services to a wide variety of both financially sound and distressed organizations, including healthcare organizations, Fortune 500 companies, leading academic institutions, medium-sized businesses, and the law firms that represent these various organizations. Learn more at www.huronconsultinggroup.com.

1-866-377-0040

www.huronconsultinggroup.com

2013 Huron Consulting Group Inc. All Rights Reserved. Huron is a management consulting firm and not a CPA firm, and does not provide attest services, audits, or other engagements in accordance with standards established by the AICPA or auditing standards promulgated by the Public Company Accounting Oversight Board (PCAOB).