Manny Tzavlakis, Joe Morrell

For the past several years, ProPublica’s “Dollars for Docs” database has compiled publicly available data from 15 pharmaceutical and medical device companies that disclose certain transfers of value to physicians and teaching hospitals. This database has allowed consumers to easily search for payments to individual doctors and to review total payment amounts from each included company. Media outlets have repeatedly drawn on this information to highlight physicians who have received, in some cases, hundreds of thousands of dollars per year from industry.

		Recent articles in the media have continued to call attention to financial relationships between industry and physicians at both the macro and individual levels. For example, NPR and ProPublica [1] recently examined speaker-program payments to physicians—declining partly due to changing business conditions, but likely also due to increased public scrutiny of speaker relationships. Similarly, The Boston Globe [2] identified individual physicians who had both commercial and clinical relationships with individual manufacturers and raised the issue of real or perceived conflicts of interest.

		Separately, The New York Times [3], The Washington Post [4], and other organizations have brought searchable Medicare payment data to the public’s attention, with relatively little context to guide their interpretation. These data have led to many analyses, some potentially misinformed or taken out of context, of physician compensation.

		The pharmaceutical and medical device industries can expect Open Payments data to be similarly scrutinized when it is made available later this year. Building on existing institutional access restrictions, state legislation, and public perception, this will continue to challenge the relationship between industry and physicians. This article will consider how to maintain positive relationships with physicians, how to utilize Open Payments data for business purposes, and how to use aggregated data to enhance compliance with government regulations, industry guidance, and internal policies.

		At press time, the Centers for Medicare and Medicaid Services (CMS) planned to make draft Open Payments data available to physicians and teaching hospitals beginning in July; recipients will then have 45 days to review this data and potentially dispute its accuracy. A recent Huron Life Sciences survey [5] indicated that 45% of companies are still establishing policies and procedures to manage these disputes, and nearly 90% of companies are still working to implement systems to manage these disputes.

		As incorrectly posted data and/or mishandled disputes may damage customer relationships, companies must consider how they can facilitate inquiries from covered recipients while maintaining the integrity of the review process. In particular, companies should consider addressing the following basic areas prior to the projected August 1 opening of the dispute window.

		First, companies must ensure that their sales representatives and other field employees are prepared to receive disputes or inquiries directly from healthcare professionals. In Huron’s recent disclosure survey, 3% of respondents planned to directly involve sales representatives in routine disputes; most respondents planned to rely on sales representatives only to provide supporting information when necessary, or occasionally to assist in more difficult disputes.

		Generally, companies are planning to equip field employees with tearsheets providing a brief background on that company’s Open Payments policy along with instructions on how data can be reviewed and an inquiry may be opened—whether through the CMS or through a company’s own portal.

		Many companies are discouraging sales representatives from directly accepting inquiries since reps may not be able to gather all necessary information from a physician and may not be familiar with Open Payments regulations in detail. Instead, physicians are typically redirected to a centralized dispute email/number/portal by information in the tearsheet outlined above. However, manufacturers that are allowing reps to receive inquiries should ensure that reps have: a form to capture all information necessary for the disclosure team to research the inquiry; a dedicated e-mail address or phone number for this information to be transferred to the disclosure team; and clear expectations around how and by whom the dispute will be resolved.

		In addition to field employees, companies must identify all other touch points for physicians and teaching hospitals—customer support, medical information, and adverse event reporting lines, among others&mdash;and ensure that all employees are trained on basic Open Payments policy information as well as the correct method for re-routing a dispute.

		Many company compliance and disclosure teams are also establishing standards for resolving difficult disputes—for example, how to manage a physician who disputes a quarter or more of all in-office meals, or a key opinion leader who disputes a transaction for which no backup information is available. Beginning these discussions now and establishing standards will help companies respond to disputes in a timely manner. Handling disputes in the allotted timeframe (45 days to initial inquiries, plus an additional 15 days to continue to resolve inquiries) will be important for companies since any updates made after that time may not be updated by CMS in a timely manner on their website.

		Aside from establishing standards with compliance, disclosure teams should consider developing standard, approved form letter responses to typical disputes; establish a system to track, manage, and respond to these disputes; and identify the location of supporting documentation like sign-in sheets, payment vouchers, and contracts.

Leveraging Open Payments data for business purposes

		A potential silver lining of Open Payments is the ability to capture all spend data in one operational data store for business and compliance purposes. For years, pharmaceutical companies have been trying to create a strong customer master and single view of the customer that often eluded IT teams because of the complexity, however due to the Open Payments regulations, a number of companies have developed extremely effective master data management (MDM) initiatives to be able to aggregate and accurately report data.

		One director of transparency reporting at a specialty pharmaceutical company believes that established transparency programs can begin to deliver value back to the business now that reporting has begun. Using only internal data compiled for reporting purposes, the company has begun to identify cost-saving measures.

		For example, before gathering all transaction data for Open Payments reporting, this company “never examined the amount that it was spending on lunch-and-learns, travel, and other activities across the entire enterprise” with certain vendors, according to this director. By reviewing the information that has already been gathered, the company has begun to negotiate preferred rates with certain vendors and expects to realize direct cost savings as a result.

		However, the ability to compare the company’s data against its peers—which will be possible once Open Payments data is made public by CMS&mdash;offers many greater possibilities. “We’ll be able to see what we’re spending on meals as a percentage of revenue compared to what our peers are spending,” said the transparency reporting director. Outside of promotional activities, the company plans to establish benchmarks in clinical spending such as combining Open Payments and clinicaltrails.gov data. The company will also be able to approximate ballpark per-center and per-subject spending for Phase III trials in relevant therapeutic areas.

		Companies should anticipate that Open Payments data will be analyzed in detail by not only the press but also by other companies. At the same time, companies should consider how they can conduct their own analyses to gain insight into benchmarks, physician engagement by peers, and other best practices. For example, by observing which physicians peer companies are engaging with, companies may be able to identify additional key opinion leaders who may bring fresh insight to their company.

Using Open Payments data to enhance compliance internally

		Another use of Open Payments data that many companies are now considering is how to use disclosure data to monitor compliance with internal policies, industry standards and government regulations. Pharmaceutical and medical device companies can be proactive when it comes to uncovering potential suspicious activity across departments and divisional areas utilizing the rich data set developed by the Open Payments requirements coupled with other internal data sets across the organization (prescription data, sales representative activity, managed care) as well as external data sets (clinicaltrials.gov, publications, social media). The traditional method in helping to ensure compliance has been a very manual process, but with a data-driven approach an organization can help ensure that integrity is upheld across the organization.

		Typically, a disclosure data store includes data from a company’s expense reporting system, accounts payable tool, sales force automation system, customer master, and other databases.

		Even without incorporating outside data, disclosure teams can quickly identify areas of risk like meals outside of established meal limits, out-of-office meals outside of established parameters, fee-for-service payments exceeding established caps, and field activity outside of typical ranges. But by incorporating additional company data sources, more powerful analyses can be completed to target areas of government scrutiny. By incorporating additional data, like medical information requests, prescription volume data, contracting information, and fair market value rates, companies may be able to identify areas of compliance risk. These risk areas can include off label promotion, anti-kickback risk, and the timely and complete posting of clinical trials data.

		For example, including data from your company’s contracting or engagement management system may allow you to identify cases where physicians did not go through the proper contracting process prior to performing and being paid for a given service. Comparing speaker program attendees included in your aggregate spend system against physician data from your customer master may allow you to identify inappropriate attendees at certain programs. Combining call plan and prescription information with data from a company’s disclosure system and medical information requests may help to identify off-label promotion risk.

		Like data from Corporate Integrity Agreement disclosures and Medicare payments, companies should expect Open Payments data to be analyzed in detail by the press and the government. By reviewing their own data proactively, companies may be able to mitigate potential future or existing compliance risks. Additionally, companies may be able to use this data to answer compliance questions that are commonly asked by the Board of Directors and other leadership regarding activities with physicians and teaching hospitals.

		Pharmaceutical and medical device companies should look to develop dashboard visualizations that draw off of disclosure and other internal data to highlight areas of compliance risk. Consider how your company can leverage the power of this enterprise-wide data to identify and address potential risk areas and increase senior management comfort with business operations.

		Companies are anticipating the potential reactions from the industry, physician, teaching hospitals, the press and the government to this data being publically disclosed. The many unknowns about this reaction have caused some companies to waver or wait on decisions regarding how to address their data collection, communication to physicians, or data analysis regarding Open Payments. However, with all of these unknowns, many companies are still preparing their next steps for reporting in 2014 and beyond.

		At this time, many companies are already beginning to consider next year’s disclosure report. After the current review and dispute period ends, many companies are planning to conduct a “pre-disclosure” of transparency data from the first half of 2014. Companies may choose to provide a preview of aggregate spend data either to a random sample of physicians, physicians with the highest transaction or dollar volume, or other recipients identified by the business. Additionally, some teaching hospitals are now mandating pre-disclosure of transactions to physicians associated with that teaching hospital.

		Pre-disclosure allows companies to resolve potential disputes prior to remediation via the CMS framework, and may help to preserve relationships with physicians. Companies are initiating the pre-disclosure process both via e-mail addresses purchased from master data vendors and via traditional mail. Many commercial aggregate spend systems now include a pre-disclosure functionality to facilitate this review period.

		Additionally, many companies are conducting internal reviews of initial 2014 aggregate spend data at this time—Huron’s recent disclosure survey indicated that 73% of respondents are conducting periodic formal internal data reviews with commercial and clinical functional areas in order to increase comfort with the accuracy of data submissions. Comparing internal data to peer benchmarking ranges can help increase executive comfort with the completeness of disclosure data.

		Manny Tzavlakis (left) is a managing director in Huron Life Sciences (Chicago). He has more than 18 years of life sciences (pharmaceutical, medical device, biotechnology and diagnostics) industry and management consulting experience, specializing in aggregate spend/compliance strategy and analysis, predictive modeling/advanced analytics, off-label detection, sales force/marketing effectiveness and information technology.

		Joe Morrell is a manager in Huron Life Sciences. He has more than 10 years of experience working with global life sciences companies.

		Marci Juneau is a director for Huron Consulting Group’s Life Sciences practice.  She has over ten years of experience assisting pharmaceutical, biologic and medical device companies.

http://www.npr.org/blogs/health/2014/03/04/285298999/drugmakers-slash-spending-on-doctors-sales-talks

http://www.bostonglobe.com/metro/2014/03/24/drug-companies-extra-payments-researchers-raise-conflict-interest-concerns/N2xZV00WnLGhaHGH3c07OK/story.html

http://www.nytimes.com/interactive/2014/04/09/health/medicare-doctor-database.html?_r=0

http://www.washingtonpost.com/wp-srv/special/national/medicare-doctors-database/

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