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July 15, 2015 Dale Cooke0

For years, pharmaceutical marketers have tried to convince themselves that the FDA accepted a standard under which risk information could be presented separately from benefit information via a hyperlink in online communications (the so-called one click rule). And for just as long, the Food and Drug Administration kept taking enforcement actions making clear that it did not accept that position.

Indeed, some people began to referring to one click as the rule that isn’t. But that didn’t stop marketers from dreaming of a world in which they could use social media and other online platforms to communicate benefit information while limiting the presentation of risks to a destination in a link.

Hand Cursor With Reflection

Apparently, some members of Congress agree. For the past year and a half, the House of Representatives has been engaged in a bipartisan effort to radically transform healthcare and the approval process for new drugs. That effort is known as the 21st Century Cures Act. The first draft legislation released in January of this year included a provision about social media that would essentially have written into a law a version of the one click rule.

Just last week, on Friday, July 10, the House of Representatives passed the 21st Century Cures in an overwhelming vote (344-77). 21st Century Cures now moves to the Senate, where its future is far from certain. Unfortunately for advocates of the one click rule, that provision wasn’t in the version of the legislation that received the vote; however, that isn’t the end of the road for this item.

The one click provision is now a standalone bill that Representative Billy Long from Missouri is sponsoring. That legislation could either be part of a revised version of 21st Century Cures (for example as part of the Senate bill), or it could pass as a separate item.

In addition, the Prescription Drug User Fee Act (PDUFA), which comes up for renewal every five years, is again being updated. The last time PDUFA was updated in 2012, the bill was called the Food and Drug Administration Safety and Innovation Act (FDASIA). Pharmaceutical marketers might recall that FDASIA mandated FDA release social media guidance by July of 2014. Some people credit that legislation for the three draft guidances on social media that FDA released last year.

So there is extremely recent precedent for Congress to use this vital must-pass legislation to prod the agency about its direction on advertising and promotion of prescription drugs, specifically regarding new and emerging platforms and technologies.

And of course, FDA is itself reviewing the comments received on those draft guidances, and several comments endorsed some version of a one click rule and encouraged the FDA to accept such a provision.

Marketers of pharmaceutical products will need to pay attention in the next few months as all of these pieces fall into place. For now, one click remains the rule that isn’t, but marketers are born dreamers, and this is a dream that clearly won’t die easily.



July 15, 2015 admin0

Health care coverage was expanded automatically to 32 million Americans in March 2010 when President Barack Obama signed into law the Patient Portability and Affordable Care Act (ACA). President Obama stated, “My job is to set forward a vision – point people in the right direction.” Since the ACA eliminated pre-existing conditions, developmentally, intellectually and physically disabled patients become a separate target audience for pharmaceutical marketers currently faced with a new direction. The ACA impacts prescription marketing for the disabled both narrowly and broadly through fee-for-value and patient lifestyle autonomy, respectively, setting forth opportunities for pharmaceutical marketers to grow innovative business.

DiPersio-Julyartwork1Narrow Impact: Fee-for-Value
Overall value moves to the forefront of ACA’s goal to deliver more effective care at a lower cost to the disabled population while the platform of efficacy and safety shifts to the background. Pharmaceutical marketers engage in positioning and messaging to the influencers and stakeholders of the disabled, including family, friends, physicians, others who have disabilities and community groups. They market their products based on both clinical and economic outcomes. Expressing outcomes through emotional drivers, such as quality of life, evokes a deeper feeling among medical staff and patients. At the Mayo Clinic and Dartmouth Hitchcock Medical Center, shared decision making centers attract doctors and health coaches to assist the disabled in weighing options and making informed decisions about elective procedures. Due to some disabled patient mobility issues, marketing teams are gravitating toward business-to-business strategies instead of relying on frequent visits. Similarly, marketing channels include an integrated approach that reaches more remote locations of the target audience.

DiPersio-Julyartwork2Broad Impact: Patient & Lifestyle Autonomy
Many disabled have numerous, multi-faceted health problems and require more and different types of prescriptions with pharmaceutical marketers focusing on the promotion of patient and lifestyle autonomy. The statistics are overwhelming. On average, the disabled need 40% more prescriptions. They spend 50% more money on prescriptions drugs. Also, they are three times more likely to have high total drug spending. The ACA extends certain prescription drug coverage for Medicaid recipients. Coverage of anti-seizure and anti-spasm medications is also mandated under the health reform law. Thirty percent of disabled Americans confront challenges in travelling to pharmacies because they either live in rural areas or have disabilities which hinder their mobility. Under ACA, physicians can prescribe a variety of medically beneficial drugs without restrictions on how these medications are delivered to patients in a timely manner and without any major inconvenience to the disabled or their caregivers.

ACA is changing the lifestyle of disabled Americans and prescription marketing is geared toward their new living standards. Our country now has an educational system which is much more centered on preparing all students, regardless of any type of disability, for a university degree and/or a career. Under ACA, federal contractors must meet a quota for employing the disabled which creates jobs for this target audience. Opportunity Works provides community and center-based employment services and support to individuals allowing for more independent lifestyles including salaries. This agency allows for vocational assessment, career exploration, on-the-job training, placement, and supervision while teaching a variety of skills.

With steady employment, disabled Americans are afforded the opportunity to earn money to pay for their prescription benefits with private health carriers. They have a choice of carrying public or private coverage. Many special needs attorneys believe that the vast majority of Special Needs Trusts (SNT) patients will select private health insurance over Medicaid. The families of the disabled who are covered under the SNT are required to repay their benefits upon death which produces an excessive financial burden. Pharmaceutical marketers develop strategies now that aim its attention at a gainfully employed disabled population being assimilated into the general public as equal citizens living with dignity and garnering respect.

In summary, Harvard Professor Philip Kotler, author of the classic 1967 textbook “Marketing Management” developed the concept that marketing is the exchange of value between two parties. He maintains that marketing is the art of creating genuine customer value and helping customers become better off. Without a doubt, the ACA provides unparalleled opportunities for pharmaceutical manufacturers to market prescriptions to a large disabled population with narrow and broad ACA impacts of fee-for-service and patient lifestyle autonomy. Pharmaceutical companies change their thinking about beliefs and basic assumptions, beginning with identifying the disabled as a new target audience and understanding their needs, with the desire to increase business.



July 15, 2015 Mike Spitz0

We’ve all heard about “Meaningful Use,” but where did it come from, what does it mean, and how might healthcare consumers ultimately benefit? Let’s find out!

Back in 2008 the National Quality Forum (NQF) issued a report identifying opportunities for improving public health, efficiency, safety, privacy, and patient engagement, among other areas. The recommendations became the foundation for the “Meaningful Use” of electronic medical and health records (EMR/EHRs), which gained momentum a year later when the American Recovery and Reinvestment Act (ARRA) formalized the need for preserving and improving healthcare affordability.

hand touching medical interface

The HITECH Act soon followed, designed to help meet those goals through Health Information Technology (HIT). Monetary incentives through Medicaid and Medicare were offered to eligible healthcare professionals and hospitals to adopt certified EMR/EHR technology and use it “meaningfully” to improve healthcare. The goal is to ultimately create better clinical outcomes, increased transparency and efficiency, boost individual empowerment, and produce more robust research data.

In July 2010, the Centers of Medicare & Medicaid Services (CMS) established three phases of the EHR Incentive Program applicable over five years, whereby eligible physicians and hospitals would meet meaningful use criteria and gain incentives by adopting certified EHR technology, and use it to achieve specific objectives:

  • Stage 1: Data Capture and Sharing (2011-2012)
    The nuts and bolts of EHR integration, including capture and standardization, tracking, internal communication, reporting of quality measures, engaging patients and their families through data.
  • Stage 2: Advance Clinical Processes (2014)
    Integration with the Health Information Exchange (HIE) of e-prescriptions and lab results, electronic transmission of patient care summaries, and increasingly utilized patient-controlled data.
  • Stage 3: Improved Outcomes (2016)
    Achieving top line benefits, including improved quality, safety, and efficiency, and healthcare outcomes; decision-support; patient access to self-management tools; HIE-based access to patient data.

Implications & Opportunities

Up to now, the integration and adoption of health information technology, especially EHRs, have often been problematic. Whereas most professionals and even patients agree that technology can improve outcomes, the disruptive nature of digital often precludes utilization, and typically spawns fragmentation and interoperability nightmares. Meaningful Use combats these obstacles with genuine incentives, physicians qualifying for as much as $63,750, and hospitals for $2 million or more.

  • 88% of providers report that their EHR produces clinical benefits for the practice
  • 75% of providers report that their EHR allows them to deliver better patient care

Such an unprecedented synergy between government, healthcare providers, and technology has already created powerful opportunities, especially in EHRs and digital health. Focused on realizing the looming goals of Meaningful Use, technologists are getting closer to the Holy Grail of platform agnosticism, device interoperability, and data universality. The central tenet of patient empowerment – making the healthcare system less paternalistic – is a core objective of Stage 2.

As such, the ACA and Meaningful Use hold tremendous promise for patients and patient-centric communications. Despite many challenges and the ongoing need for caution, unique and compelling opportunities abound for closing the loop between patient data and their physicians through EHRs at the point of care. Additional opportunities for integrating patient data into decision-making tools such as @Point of Care powered by IBM Watson are taking hold, further expanding the vision.

Summary & Key Takeaways

The future of health information technology, especially EHRs, points to a “Coke vs Pepsi” future competitive landscape, where thousands of fragmented vendors eventually coalesce into three, most likely just two, main platforms. Until the inevitable happens Meaningful Use has helped drive adoption, utilization, and innovation. The benefit to the patient is realized not only in terms of reduced costs and heightened efficiencies, but in exciting new opportunities for engagement:

  • Patients will gain ever-increasing control of their own data
  • Patients will communicate more directly and transparently with their physicians beyond the point of care
  • Patients will integrate their EMR/EHR platform with wearables and other biosensors to make biometric data input and sharing seamless
  • Patients will share biometric data between appointments, giving their physicians an unprecedented view into their overall health
  • Patients will make their data responsive, with alerts and other feedback loops to help heighten adherence and other forms of behavioral modification

So pay close attention to the evolving digital health landscape, where science, communications, and technology merge – sometimes even with helpful impetus from the government – for the benefit of patients and the healthcare systems that serve them.