September 19, 2018

Over the weekend, the New York Times and ProPublica broke a jointly-reported story about a top breast cancer research doctor failing to disclose pharmaceutical company financial ties that stretched into millions of dollars over...

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Over the weekend, the New York Times and ProPublica broke a jointly-reported story about a top breast cancer research doctor failing to disclose pharmaceutical company financial ties that stretched into millions of dollars over the course of several years.

The Times reported that Dr. José Baselga, the chief medical officer at the renowned Memorial Sloan Kettering Cancer Center in New York City, had provided inadequate disclosures of some of the consulting fees he received and financial interests he held in cancer-research startups.

Although Baselga expressed regret for the oversights and pledged to go back and correct the omissions, the damage in the court of public perception has been done: The impartiality of Dr. Baselga’s valuable breast cancer clinical trial research he oversaw, papers he authored and progress made under leadership positions he held, such as during his tenure as president of the American Association for Cancer Research, are now clouded.

And to what end? The case of Dr. Baselga is a chilling cautionary tale for top-tier medical professionals whose skills are sought after by Life Sciences companies to design, interpret and educate fellow health care professionals about critical therapeutic innovations. Without their participation, their insights and expertise, lifesaving breakthrough innovations can go undiscovered. It is instances like these that bring into sharp relief the need for a comprehensive, compliance-centric reporting system.

According to the Times, a spokesperson for Memorial Sloan Kettering said the burden fell on Dr. Baselga to “disclose such relationships to entities like medical journals,” a response that is illustrative of how much of today’s growing regulatory burden entails shifting responsibility and putting the weight of compliance on the shoulders of busy and dedicated scientists and clinical professionals.

In the future, Life Sciences companies are likely to face growing demand from their clinical partners concerned about risk mitigation. They will request, if not require, access to easy-to-use, turnkey technology solutions that equip them with the tools to self-manage their interconnected roles and obligations.

Especially for healthcare professionals at the top of their fields, the value of having all of their commitments within a compliance-centered framework can hardly be overstated. Platforms which offer both web and mobile access to facilitate access from around the world empower them to use their scientific talents to the best of their abilities, whether that be through clinical trial design, research, consulting, speaking and all the other ways these leaders advance medical progress.

When these sought-after professionals consider with which Life Sciences companies to engage, the value-add of having such a robust suite of management tools at their fingertips is a powerful incentive.

 

Contributed by:

Susan Hill, SVP, Global Products & Solutions, AHM

Susan joined AHM in June of 2013 and is responsible for the oversight and management of AHM’s Global Business Development and Solutions and Marketing team. With over nineteen years of experience in the Life Science industry, Susan brings experience in business development, product marketing, and new technology investment and optimization.

June 18, 2018

Event and meeting planning involves countless details and managing an incredible array of logistics. But sometimes, in the quest to get everything “just right,” the attendee experience can fall out of focus. Embracing a...

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Event and meeting planning involves countless details and managing an incredible array of logistics. But sometimes, in the quest to get everything “just right,” the attendee experience can fall out of focus. Embracing a customer-service mindset doesn’t have to cost a lot and can pay dividends in terms of satisfaction, engagement and repeat attendance. All it takes to get started is the ability to think like an attendee: What are their concerns and needs? What questions would you have if you were in their shoes?

If your group is well-versed in technology, there are online and mobile tools that can facilitate these experiential improvements, but you can solve attendees’ problems before they even arise using low-tech methods, as well. Here are three common examples, along with the solutions you can implement.

Answering Questions: Attendees will have questions about everything from how to log into the venue’s Wi-Fi, to where and when they can get food and beverages. If you use a dedicated mobile app for each event, adding chatbot functionality puts those answers literally at their fingertips. This tool can field a wide array of questions and comments, and more complicated situations can be escalated to an on-site staff member in real time. Being able to query someone or lodge a complaint in real time will go a long way towards making your attendees feel like their voices are being heard.

No app? No problem: Some organizers — even ones for whom technology is at the forefront — staff large meetings with event ambassadors, easily identifiable volunteers located either at a central “help desk” or scattered throughout the area. These representatives have a broad base of knowledge and can answer questions for people, or quickly find the person who can help them out.

Agenda Items: If an attendee needs to check something on their schedule, even the most basic event apps will be able to help them out here. Loading program content onto the app will keep this information close at hand, and most apps also have the functionality for attendees to change their schedules, as well. The other perk for the organizer is that, if the printed schedule changes, they can alert attendees who have downloaded the app via push notifications.

In the absence of an app, scheduling switches will still have to be handled and publicized manually, but you can make it easier for attendees by printing a mini version of the agenda booklet right into the event name badges. Being able to look down and flip though to find out where they need to go next is far and away easier than having to dig out a paper program from within a bag or briefcase.

Wayfinding: Attendees will want to know not only where their meeting rooms are, but where concessions, bathrooms, shuttle stops and other amenities are located. Wayfinding or interactive map functionality built into an event app can show them the way. Sophisticated app platforms on the market today even offer beacon-based wayfinding that can provide turn-by-turn directions, giving attendees a GPS-like experience right within the venue.

But you don’t necessarily need an app to show your guests how to get around. Something as simple as floor decals labeled with arrows, or footpaths offer a simpler form of guidance. Depending on the nature of the event, it may be possible to get those decals sponsored — a truly unique opportunity for one of your partners to showcase their brand to your attendees.

Good customer service can be the element that gives your meeting the edge over the competition, and cultivate the kind of engagement that you can build on for the future.

 

Contributed by:


Grazia Mohren, Director or Marketing, AHM

Passionate about digital marketing, social media, and incorporating new technologies into marketing strategy, Grazia Mohren brings more than 12 years of experience in marketing and public relations, to her role as Director of Marketing at AHM. Prior to joining AHM in 2017, Mohren spearheaded campaigns for hundreds of events and conferences, including Oscar and Golden Globe events, film festivals, product launches, and more.

May 31, 2018

Among the many other logistical challenges of meeting planning, producers of pharmaceutical and life sciences conferences and related educational programming have to comply with per diems and meal caps. Although the hospitality industry and...

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Among the many other logistical challenges of meeting planning, producers of pharmaceutical and life sciences conferences and related educational programming have to comply with per diems and meal caps. Although the hospitality industry and the life sciences sector have a primarily symbiotic relationship, compliance with regulatory requirements like the “Sunshine” Act as well as internal mandates regarding transfers of value can create tension when it comes to negotiating with a hotel or conference facility, when spending on rooms and event-provided meals is tightly controlled.

A new research paper from iSeatz and Phocuswright finds that an increasing number of hotels are tracking many categories of the ancillary products and services business travelers purchase during their stays, and the data researchers uncovered has the potential to give both planners and their negotiating partners on the supplier side more visibility into the value-added component these meeting groups contribute to a hotel’s bottom line.

Phocuswright and iSeatz researchers found that more than 70% of business travelers were, in at least some cases, willing to spend more for ancillary goods and services. Nine out of 10 indicated that they would pay for speedier, upgraded Wi-Fi access and more than 80% said they would pay early check-in or late check-out. “Many also indicated their willingness to pay extra for non-food and beverage items such as business services, personal services, retail and in-room entertainment,” researchers say.

Another advantage for the life sciences sector is that the class of hotel in which travelers tended to be most willing to spend more of their own money on many of these categories aren’t upscale hotels or luxury resorts, but the type of mid-range properties that most often play host to this industry’s educational conferences and meetings. And life sciences educational planners who have an audience of HCPs on the younger end of the spectrum have an extra advantage, as this data reveals a greater willingness among younger travelers to pay out of their own pocket for ancillary services, perks or products.

As more hotels capture these categories of spending, planners should leverage their relationships with property-level and brand sales managers to obtain this data when possible; it also is worth considering incorporating questions about your HCPs’ ancillary out-of-pocket spending on post-event surveys.

Even though compliance regulations impose tight room rate and meal cap limits, if you can come to the bargaining table with empirical evidence that your HCPs are delivering value to host properties through out-of-pocket spending on amenities like faster Wi-Fi, in-room entertainment and dining, late check-outs and other “extras,” you will have demonstrated a much greater value proposition, one that still fits within a compliance-centric paradigm — a win-win for all parties involved.

 

Contributed by:


Matthew Derner, Global Director, Strategic Meetings Management, AHM

Matthew joined AHM in 2016 and has 18 years of Life Sciences experience. He leads AHM’s Stragetic Meetings Management (SMM) Department and is responsible for engaging current and prospective clients about our SMM compliant meeting solutions across their organizations. Matthew also leads a team of Event Managers & Coordinators that are responsible for the planning and execution of any meeting type outside of Speaker Bureau. Prior to joining AHM, Matthew has worked for Pharmaceutical Companies as well meeting planning agencies in various roles.

April 26, 2018

The clock is ticking down to May 25, when the European Union’s new General Data Protection Regulation goes into effect. The GDPR centers around the protection of personally identifiable data — a category that...

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The clock is ticking down to May 25, when the European Union’s new General Data Protection Regulation goes into effect. The GDPR centers around the protection of personally identifiable data — a category that is broader than many people outside the IT and data analytics fields realize — and this sweeping privacy law will reshape the way businesses collect, store and process data under their purview.

For life sciences companies working in a global marketplace, complying with this mandate will take an investment, but it also offers an unprecedented opportunity to consolidate data and develop new benchmarks for business operations involving that data.

The GDPR is important even for those life sciences companies based in the United States. As per the legislation, multinational companies — regardless of where they are based — that do business or have constituents in the E.U. will have to comply.

This new era of personal-data regulation is intended to give consumers more transparency into and control over how their personal data is stored and used. Companies that collect personal data on their constituents will be accountable for the accuracy and security of that data, and will be obligated to destroy it if consent is not obtained or is revoked.

The foundation of the GDPR is enhanced consent verification: Companies have to communicate clearly and receive affirmative confirmation of consent — commonly used methods such as pre-ticked check boxes are no longer sufficient. What’s more, consent must be obtained individually for specific functions; “bundling” consent will not be permitted.

For life sciences companies, one of the greatest challenges of GDPR compliance is the decentralized nature of the industry. Vendors, contractors and others may be granted access to HCP data, and according to the new legislation, life sciences companies can be held responsible for any missteps made by those third parties.

The stakes are high for companies, since running afoul of the GDPR can mean significant financial penalties. However, life sciences companies can be reassured by the following: Those of their partner companies that have already been operating under a compliance-centered paradigm are well-equipped to transition into this new era of oversight that makes personal data security paramount.

Historically, as the existing global online and cloud-based ecosystem for data management grew organically, companies collected personal data in many different ways — event registrations, surveys, social media activity, just to name a few — and for many different purposes. The E.U. has put the business community on notice that this traditional, often scattershot, approach to data management will no longer pass muster. Instead, companies must proactively take a comprehensive inventory of the personal data they keep, and centralize activity pertaining to that vast store of information.

For the life sciences industry, this means seeking out partners that offer a holistic solution to data collection, management and analysis. Rather than working piecemeal across corporate silos and geographical borders with an array of third parties, executives at life sciences companies will need to seek out firms that provide an entire suite of products and services encompassing technology, communication and analytics. More importantly, they will need to seek out firms that have demonstrated a commitment to customer satisfaction.

As with all change, the adoption of the GDPR is likely to cause some growing pains for companies that fail to plan for the significant adaptations compliance will require. The bright side, though, is that life sciences businesses that have seen the writing on the wall and taken steps to partner with firms that can execute 360-degree compliance will reap the benefit of accurate and detailed analytics-ready stakeholder information. Building this type of profile would never be possible if vital facts were spread among multiple partner companies.

What’s more, the opportunity presented by this legislation is likely to yield improvements in efficiencies and allow life sciences companies to leverage economies of scale to their financial benefit. They could reap long-term cost savings by doing away with piecemeal data management and replacing it with a consolidated, comprehensive platform.

As we look into the future, it is entirely possible that the next level of data analytics evolution will have the GDPR to thank.

Contributed by:

Frank C. Castora
Sr. Director, Global Solutions Management

Frank joined AHM in 2007 and has been delivering compliance solutions to the Life Science industry for over 10 years. He has delivered solutions for compliance-based Interactions Management and provided expertise on data integration and exchange needs for Aggregate Spend and Disclosure Reporting. Frank is currently responsible for the strategy and product management of AHM’s Global Compliance Solutions platform, CentrisDirect™, and new business intelligence and data analytics solution, CentrisIQ™.

February 8, 2018

On January 16, a New Jersey law titled “Limitations on and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers” went into effect. It sets a cap of $15 per prescriber, per...

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On January 16, a New Jersey law titled “Limitations on and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers” went into effect. It sets a cap of $15 per prescriber, per meal on breakfasts, lunches and dinners served at promotional events, and it bars physicians from earning more than $10,000 per year — in aggregate — from speaking fees, advisory board participation and consulting related to promotional activities, with the prescriber responsible for documentation and reporting.
The new law’s $15 meal cap is problematic as it effectively eliminates physician-led educational events hosted in off-site venues. Although considered promotional, these types of programs have a long track record of positive outcomes. They provide medical value and advance patient care. This kind of industry education has been widely adopted precisely because the medical industry recognizes the unique benefits it provides.
The stated intent of the law is to “minimize the potential for conflicts of interest between prescribers and pharmaceutical manufacturers.” As it is written, though, it upsets the formula — a compliance-centric practice, it should be noted — that has functioned well for many years, and creates an undue burden on medical professionals as they seek to further their and their peers’ education. The constraints are substantially below what has been nationally generally accepted as standards for reasonable meal costs and compensation caps.
The prevalence of such events, as well as increased participation, shows how much healthcare providers value them. These professionals readily travel to offsite venues — on their own time, no less — to confer with peers and acquire knowledge in an appropriate, distraction-free setting appointed with tools and technology conducive to educational instruction. Removing these attributes that allow them to be more productive and learn more, runs counter to both the spirit and practice of improving the health of ordinary Americans.
An even greater challenge is the reporting mechanism for the $10,000 annual cap — which mandates that prescribers themselves document their compliance. The New Jersey law imposes a de facto new regulatory requirement on healthcare professionals by shifting this administrative burden from Life Sciences firms, which are well-equipped to handle this function thanks to decades of observing compliance regulations, to these individuals.
As a result, it is not unlikely that many New Jersey-licensed prescribers who currently act as speakers, advisors, and consultants will limit their participation to a single pharmaceutical firm, or will opt to curtail their engagement with these programs altogether. This would be a great loss to medical progress. This dynamic industry absolutely needs to keep prescribers apprised of the latest discoveries and innovations in pharmaceutical development. The peer-to-peer dialogue that takes place at these well-regarded forums is invaluable in this regard.
By cracking down on “boondoggles” that don’t exist, we fear this new law will impact doctors’ ability and willingness to share their insights, doing a disservice not only to these medical professionals but to the patient populations who depend on them for care.


Written by:


Christine Croft, CEO, AHM

Christine is AHM’s CEO and is responsible for leading the strategic direction of the Company, sales and business development, organizational effectiveness and operational excellence. She was AHM’s SVP & CFO for three years prior to this and was responsible for financial management, human resources, information technology, facilities and contracts. She also has nineteen years of financial management experience within technology and service industries, including twelve years within Life Sciences.

March 1, 2017

Healthcare Professional (HCP) Perspectives As noted in Part 1 and Part 2 blogs in this series, successful compliance ultimately involves everyone in the organization and also includes engaging HCPs in the process. Everyone has...

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Healthcare Professional (HCP) Perspectives
As noted in Part 1 and Part 2 blogs in this series, successful compliance ultimately involves everyone in the organization and also includes engaging HCPs in the process. Everyone has the responsibility for doing the right thing, and organizational culture must support and strengthen this process. Operational checklists and audit practices are all important, along with a universal understanding of what is meant by compliance. Everyone that compliance touches should be ready to step up and do their part to ensure success.
Consider that the average length of time it takes to develop a new medicine or product ranges from 10 to 15 years. During this time, Life Sciences employees in many areas interact with HCPs. Throughout this interval, each organization needs to ensure that every action and interaction is compliant across state, federal, and even international regulations, as well as internal corporate guidelines and SOPs. The expectation that everyone is responsible for ethical practices and standards begs the question: How can HCPs contribute to increased success with compliance for an organization while simultaneously focusing on patient needs? At AHM’s Annual Industry Conference, our HCP panelists commented on this very question. Some of their suggestions included:

  • “Just make complying easier!”
  • “We need time with our patients, we need time in the office, we need time to keep abreast of cutting edge therapies—you need to make dealing with industry less cumbersome.”

We recommend that Life Science organizations start by communicating the compliance process to HCP in a clear, concise, and continuous manner. This should include providing any rules or policies around reporting or exceptions to the process. The feedback that AHM received implies that this is still not adequately addressed. When all parties are engaged and informed, a solid relationship is built between the parties, and the credibility of the organization is increased. HCPs long to be communicated to correctly and clearly. To make their experience less confusing and burdensome, they would like to have the same experiences regardless of what activity or who in the organization they are working with. Since the Open Payments Act was established, HCPs and their relationships with industry are reportable, thereby providing greater transparency into financial transfers of value in categories of honoraria, and travel and meal costs associated with speaking or consulting. HCPs contribute to compliance by understanding the policies of the organizations they interact with. Moreover, HCPs have welcomed the communication necessary to inform the public on their role in the drug/device development process and how it impacts patients and their care.
HCPs partner with industry to achieve their primary goal, patient care; however, the process can be further improved so that compliance obstacles do not stand in the way.
AHM has a suite of end-to-end single-platform solutions to meet the compliance needs of Life Sciences organizations and HCPs. These capabilities can smooth compliance for HCPs and help them become a valuable partner in the process. For more information, please visit: http://www.ahmdirect.com/.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

February 15, 2017

Introduction In the Life Sciences industry, many organizations utilize third parties and multiple vendors to assist with compliance. Results from the AHM and MeetingsNet Healthcare Professional Meetings and Engagements 2016 Industry Benchmarking Study* revealed...

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Disclaimer


Introduction
In the Life Sciences industry, many organizations utilize third parties and multiple vendors to assist with compliance. Results from the AHM and MeetingsNet Healthcare Professional Meetings and Engagements 2016 Industry Benchmarking Study* revealed that 56% of the respondent organizations use a hybrid model of some internal departments and some outsourced to other third party vendors.
The third party or vendor is a critical component in the success of the compliance process. This blog aims to help the Life Sciences industry not only understand the role of the third party but also to provide recommendations on ways to best work with third parties and vendors in assisting organizations with their compliance processes.
*The full study is available here.
What Unique Perspective Can the Third Party or Vendor Provide?
A third party or vendor brings a unique perspective regarding compliance to their clients due to the very nature of working with multiple clients, each with a different process, policy, and interpretation of various state, federal, and international guidelines. This unique perspective can provide valuable guidance, benchmarking, and business intelligence, which often increases trust and credibility in the third party. It allows the third party to position themselves as a trusted advisor and leader in the Life Sciences industry. Third parties and vendors can lead the discussion on compliance at industry educational events and serve as thought leaders and subject matter experts in compliance.
What Are the Challenges to the Third Party or Vendor?
There are challenges that the third party or vendor confronts as organizations outsource the various components of the compliance process. In Part 1 of this blog series we highlighted that:

  • 72% of respondents indicated multiple, disparate systems for the capture and reporting of data was their biggest problem. This, too, is a challenge for the third-party or vendor. Often they must navigate multiple systems for the approval process, including collection of healthcare professional (HCP) spending and for reporting purposes.
  • 48% of respondents indicated multiple vendors handling their tracking and reporting of HCP data was a challenge. Third parties are also challenged in working with different vendors in which the processes and knowledge of policy and client interpretation may be different.

Additional challenges may include:

  • An increase in the number of clients asking third parties or vendors to have a financial stake in the accuracy and timeliness of data being entered and reported. This may cause friction in the relationship if the expectation was not set initially or may add additional risk to the third party.
  • Condensed timeframes required to collect and report accurate data, which causes undue stress and pressure and can lead to errors and unforeseen budget increases.
  • Data provided by the various vendors may not be consistent in format or organized in a manner that is easily transcribed or uploaded into multiple systems. This may result in additional fees or increased staff hours that were not anticipated or allocated in the approved budget.
  • HCP dissatisfaction towards the third party or vendor due to lack in communication or clear process/policy from the client.

Mitigating the Risk to Their Client—How Can They Help?
As an organization is selecting a third party or vendor to assist with compliance, keep in mind that third parties and vendors often need to adjust quickly to meet or exceed client expectations. A successful working relationship between client and vendor includes honest, open feedback as well as expectation and goal setting at the beginning of a project. Success in assisting the client with compliance begins with identifying and understanding the key stakeholders and parties. As mentioned in Part 1 of this blog series, different organizations place the responsibility of compliance in various business units and parts of the organization. Each organization needs to determine what is best for it. The third party or vendor will have the most success when they have a firm grasp on the organization’s process, policy, and key players. Following are a few recommendations and qualities to look for when selecting the right third party or vendor for compliance needs.
The third part or vendor:

  • Keeps abreast on all industry regulations, including local and global compliance regulations, and cultivates on-staff subject matter experts in compliance process and policy.
  • Attends industry education, speaking engagements, business intelligence reporting, and benchmarking to continually provide innovative solutions and proactive ideas for Life Sciences organizations’ compliance reporting and analysis needs.
  • Participates in regular meetings with key stakeholders regarding compliance, and serves as a resource to internal staff and key stakeholders.
  • Provides multiple technology and service solutions to meet the organization’s end-to-end compliance needs including approvals, transfer of value data, and reporting capabilities.
  • Aligns their goals and objectives regarding compliance with the organization, understands the corporate culture, and customizes solutions to meet the organization’s needs.

AHM has a suite of end-to-end single-platform solutions to help ensure organizations are compliant in all HCP interactions. For more information, please visit: http://www.ahmdirect.com/.
Next Steps
Check back in at AHM Voice to read Part 3 in this series, which will look at the perspectives on compliance from the HCP (physician), and how HCPs can contribute to successful compliance for an organization while simultaneously focusing on patient needs.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

February 2, 2017

Introduction There are multiple departments, business units, vendors, and stakeholders involved in Life Sciences compliance and the Open Payments process. With the multitude of moving parts, it is common to experience challenges in reporting,...

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Disclaimer


Introduction
There are multiple departments, business units, vendors, and stakeholders involved in Life Sciences compliance and the Open Payments process. With the multitude of moving parts, it is common to experience challenges in reporting, timeliness, and accuracy of these data. Moreover, there are challenges with communication to healthcare professionals (HCPs) and the various players involved in this process. This blog series is intended to identify the various perspectives involved in defining challenges and issues and to provide potential discussion points and solutions for the reader.
What Are the Challenges to a Life Sciences Organization?
Results from the AHM and MeetingsNet Healthcare Professional Meetings and Engagements 2016 Industry Benchmarking Study* illuminated the following:

  • More than 40% of respondents said compliance was the greatest challenge at their organization; and
  • 82% of respondents said increasing compliance was the most important HCP engagement initiative.

Several key challenges to more successful compliance management surfaced, including:

  • 72% noted multiple, disparate systems for the capture and reporting of data was their biggest problem;
  • 48% indicated multiple vendors handling their tracking and reporting of HCP data was a challenge;
  • 43% of respondents reported HCP data accuracy was a challenge; and
  • 42% of respondents cited lack of internal and external resources to handle data tracking and reporting as a challenge.

*The full study is available here.
Compliance Within the Life Sciences Organization
Across the Life Sciences industry, the primary purpose of any organization is to deliver quality patient care and/or healthcare solutions for patients. Clinicians, scientists, and other employees strive to bring innovative products to market that will benefit patients across the age spectrum. Compliance drives many of the decisions in developing new products. There are a host of laws, best practices, and guidelines associated with drug/device development and commercialization, such as clinical regulatory compliance, legal compliance associated with anti-bribery, anti-kickback laws, and ethical accounting practice statutes, among many others. Employees across the Life Sciences organization may find themselves saying, “I am not a compliance officer; my job is ‘X’ or my responsibility is ‘Y’ and has nothing to do with a regulations or a compliance program.”
Yet the expectation is or should be that everyone has the responsibility for doing the right thing. Organizations must create a culture whereby each employee upholds the highest ethical and professional standard as general practice. Several industry leaders’ mantra is to have a thorough and robust compliance program addressing the myriad of risks associated with bringing new products to market. Yet it must also be one that promotes ease of adherence. Processes, operational checklists, and audit practices are all necessary but there needs to be a universal definition of compliance instead of a fragmented description. Leaders driving compliance are really seeking employees to create and embrace an ethical barometer. They must ask themselves not only, “Can I do it?” but “Should I do it?” Once that is answered, the how needs to be easy, trackable, and monitored.
What Can a Life Sciences Organization Do to Improve Compliance?
Any good compliance program at a Life Science organization starts with key stakeholder identification. Different organizations place the responsibility of compliance in various business units and parts of the organization. Each organization needs to determine what is best for it. Some organizations handle this internally whereas others outsource this task to a third party. It doesn’t matter who handles it as long as they have a firm understanding of the organization’s needs and a process for the accurate and timely capture and reporting of the data. Based on AHM’s experience, we recommend the following:

  1. As your organization begins to analyze its compliance process to ensure accurate and timely reporting, it is crucial to identify all the parties involved and their level of commitment and expectations. Various departments may include: legal, compliance, medical affairs, meeting management services, accounting, the compliance officer, and administration.
  2. Schedule regular meetings with all parties involved to discuss the objectives, process and timeline for adhering to SOPs and reporting requirements to ensure understanding and expectations.
  3. Ensure that each vendor understands your internal compliance, data collection, and reporting requirements so they adhere to processes and provide the data in a format you can understand and use.
  4. Continually communicate the process to the HCP in a clear and concise manner, including any rules or policies on interactions with your organization and reporting or exceptions to the data collection process. When all parties are engaged and informed, a better relationship is built between the parties and the credibility of the organization is increased.

Once the organization has identified the key players and compliance goals and objectives, the right vendors and external resources can be instituted to ensure data on compliant HCP interactions are collected and reported in an accurate and timely manner.
Next Steps
Check back in at AHM Voice to read Part 2 in this series, which will look at the perspective of the third party or vendor to identify challenges and recommend solutions for improving the compliance process.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

January 4, 2017

When the Sunshine Act (also known as The Physician Open Payments Program) was established in 2014, it was met with grave concern and negative perceptions of the fate of interactions between healthcare professionals (HCP)...

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When the Sunshine Act (also known as The Physician Open Payments Program) was established in 2014, it was met with grave concern and negative perceptions of the fate of interactions between healthcare professionals (HCP) and Life Sciences manufacturers. HCPs, industry, and industry partners were up in arms about the increased scrutiny and “public shaming” stemming from reporting of payments made by industry, and the deleterious outcomes this federal law would have in their respective professions, and consequently on patient care.
Fast forward approximately 2 years later. The Sunshine Act is now part of The Affordable Care Act. HCPs have access to the Open Payments website to monitor payments attributed to them. Life Sciences manufacturers are reporting in-kind compensation made to HCPs. And, despite transfer of value reporting, HCP participation in promotional and other programs as well as industry support remains consistent and robust, as evidenced in detailed research conducted and published in a white paper by AHM. Results from AHM’s research illuminate 3 stark realities of the “Sunshine Era.”
Reality #1: HCP Visits to the Open Payments Program Website Is Varied and the Website Requires Enhancements
Results from a market research survey showed that not all physicians have time to visit the Open Payments website. For those who visit the website out of mere curiosity or payment accuracy concerns, approximately 50% found inaccurate payment data and almost 15% reported missing payments. Panel proceedings from AHM’s Third Annual Industry Conference, Agile Solutions. Compliant Interactions, underscored that some physicians found that the website needed better organization and efficiency, and that promotional programs provided a first-rate forum for HCP education.
Reality #2: Despite Transfer of Value Reporting, HCP Participation and Industry Support Remain Strong
To identify trends, influences, and outcomes in promotional programming, AHM evaluated programs conducted across a substantial segment of its customer base, both during the Sunshine Act implementation after its implementation (2012 to 2015). Overall, the Sunshine Act has neither lessened HCP involvement in nor industry support for promotional programs. More specifically:

  • Despite the transfer of value reporting, speaker program volume increased nearly one-third from 2013 to 2014, and volume has remained constant through last year;
  • Live meetings comprised the greatest percentage of programs conducted by Life Sciences manufacturers in 2015, suggesting that HCPs prefer live interactions compared with teleconferences and web-based programs;
  • HCP attendance at promotional speaker programs has increased since 2012;
  • Since 2012, live meetings have appreciated a steady increase in average attendance by HCPs; and
  • Despite higher average attendance and more live meetings, the cost per meeting attendee has remained constant since the full inception of the Sunshine Act in 2014.

Reality #3: Compliance Controls Exist but Challenges Persist
AHM also evaluated customers’ compliance controls to contain promotional programming spend. Research showed that all of AHM customers instituted compliance controls. These include per-person costs and cost per-person thresholds, venue receipt acquisition, venue/caterer restrictions, and minimum attendance requirements. Yet results garnered from an industry-wide survey showed that when managing HCP meetings and interactions, compliance remains the greatest challenge for organizations. As such, Life Sciences manufacturers and their partners are working together to institute more controls, more thresholds, and common strategies to ensure compliance is met with success.
Even More Realities Will Be Realized in This Sunshine Era
New products will launch and existing products will go off patent, advancements in technology may modify promotional programming, participation, processes, and pave the way for greater efficiencies. Continued collaboration among HCPs, industry, and industry partners will be key to ensure program success, compliance with Open Payments, and HCP education that is sustainable, relevant, and conveys the latest innovations in patient care.
Review the full results of this research. Download the Promotional Programs Continue to Heat Up With or Without Sunshine! white paper here.
Source: Gallo T. Promotional Programs Continue to Heat Up With or Without Sunshine! September 2016.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

July 13, 2016

Anyone in the Life Sciences industry who’s been involved in customer management for promotional and non-promotional events recognizes the challenges associated with maintaining the integrity of a customer master and consistent reporting of unique...

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Disclaimer


Anyone in the Life Sciences industry who’s been involved in customer management for promotional and non-promotional events recognizes the challenges associated with maintaining the integrity of a customer master and consistent reporting of unique Health Care Practitioner (HCP) customers. Both can be impacted by the process by which a company decides to address the scenario where attendee sign-in is required for a given event and a qualified, unknown person attends the event. The host has one of two options, as directed by company policy, to formally close out the event. The host may either add a write-in profile and close out the event without having matched the attendee to an existing customer master record or first request to have the attendee mastered in the company database through a separate process and then match the attendee to the newly mastered record as a prerequisite for closeout. All AHM customers at some point have encountered the dilemma of identifying the best approach and some continue to question their established policies.
A company’s decision as to the selected approach is typically influenced by Legal & Compliance, Sales & Marketing and Information Technology (IT). Legal & Compliance want to ensure adherence to Physician Payment Sunshine Act (PPSA) and State reporting requirements and restrictions whereas Sales & Marketing have a primary focus on accurately capturing customer attendee reach with a desire to enhance the field-force “user experience”. IT’s attention tends to fall on data integrity maintenance with a penchant for fewer systems and standard processes. All these stakeholders play some part in company policy with respect to event closeout and the acceptance or prohibition of write-ins. There are pros and cons to both options which makes the decision challenging. Let’s take the case of companies that allow write-ins. In this scenario, the onus to match an unexpected, qualified attendee to a customer master is not placed on the hosting sales representative; the host may better concentrate on the quality execution of the event. The effort to add or match a write-in to the customer master lies with the back-end support process. Potential risks to this approach with varying likelihood include creating duplicate profiles if a profile merge process is not in place, incomplete write-in details from the event host which may lead to inability to match or add as a new profile and fragmented transparency spend information as it relates to the PPSA. Alternatively, companies can prohibit write-ins and require event hosts to match the attendee to a customer master record during closeout. In this situation, the administrative effort remains with the host since the process typically involves an initial request by the host to have the profile mastered through a separate company system. Possible risks include diminished host “user-experience”, the opportunity costs tied to the seemingly burdensome process, untimely closeout of events and potential delays in PPSA attendee reporting or speaker payments.
Irrespective of the selected approach, compliant HCP interactions are the unifying goal with which all stakeholder-desired outcomes may be achieved. AHM best practices lie with implementing sound processes to manage compliant HCP interactions and are not necessarily tied to the decision itself to allow or not allow write-ins. Each client’s preferred and sometimes unique approach can be accommodated by applying “best in class” approaches, and AHM’s CentrisDirect suite of solutions and corresponding services are vehicles to achieve key outcomes: Compliant Events, Improved Data Integrity, Increased Reporting Accuracy and Reduced Costs & Stress.

Contributed by:


Nelson Pinguelo, Sr. Acct Director, Account Management, AHM

Collaborating with Life Science companies for 16 years, Nelson has provided account management and service delivery excellence with improved customer satisfaction for Sales, Marketing, Clinical and Regulatory solutions. During his career, he received significant training on PDMA, cGMP and HIPAA regulations, and worked directly with the DEA and AMA. Nelson has been with AHM since 2010 in support of Speaker & Event Logistics and KOL Management solutions, and he currently is a Senior Account Director for a key account.