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How to Establish Effective Global Transparency Reporting

  
  
  
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When it comes to exchanges of value with health care professionals and organizations, life science companies are faced with a myriad of transparency laws and industry codes. This complicated regulatory environment is predicted to become more extensive in 2014 and beyond, making it important for these companies to understand their reporting requirements and optimize their systems. Many life science companies are taking a global approach to compliance, which is prompting them to improve the efficiency of their data management systems.

An Analysis on Effectiveness Evidence in FDA's Approval of Orphan Drugs

  
  
  
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The FDA has a commitment to getting products to treat orphan diseases on the market as quickly as possible. Some of the people who have these diseases have no other options for treatment, and a new drug could offer them their only hope of survival.

Requirements for Open Payments Reporting for Clinical Research

  
  
  
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According to the Centers for Medicare and Medicaid Services, there has been a final ruling on the National Physician Payment Transparency Program: Open Payments, better known as the Sunshine Act. Under the Open Payments program, data collection of medical device and drug manufacturers who send gifts and payments to physicians and teaching hospitals is now mandatory. This applies to any manufacturer who receives government reimbursement, and collection data will be posted on a public website as of September 30, 2014.

eCoupons Offer Adherence and Patient Engagement Opportunities

  
  
  
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McKesson Patient Relationship Solutions (MPRS) is pleased to have been named a finalist in the 9th Annual Strategic Patient Adherence Awards, dedicated to recognizing excellence and advances in patient adherence. In advance of the Patient Adherence and Access Summit (PAAS), we wanted to preview the “Coupon Integration and Tracking within e-Prescribing Workflow” program, which was designed to provide brands with co-pay offset programs delivered through physicians’ e-Prescribing/EHR systems to patients at the point of prescribing.

How to Prepare for Public Disclosure of Sunshine Data

  
  
  
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The March 31, 2014 deadline for submitting reports reflecting the financial relationships between biotech companies, group-purchasing organizations (GPOs), pharmaceutical companies and medical device manufacturers passed. Physicians now have 45-days to review the reports for errors before the Centers for the Medicare and Medicaid Services (CMS) database goes online.

How to Standardize IRT Implementation and Management

  
  
  
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Standardizing IRT implementation and management is important to moving forward with clinical trials. IRT, or interactive response technologies, is also very important in increasing the efficiency and decreasing the cost of clinical trials and applications. While there is no perfect, foolproof method of standardizing IRT, there are options that are more likely to be successful for the majority of applications.

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Tips on mHealth & Healthy Habits

  
  
  
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Sad but true, there are thousands of great health apps that are never fully utilized. Seemingly great technologies too often fail due to lack of engagement. Research shows that many apps see a rapid drop off in users within the first three months after downloaded. So, how do we encourage patients to incorporate mobile technology into their daily lives so it becomes a routine habit, rather than a spur-of-the-moment download that falls by the wayside?

Why Attend Medicaid 2014? The Reasons Are Endless...

  
  
  
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The Medicaid and Government Pricing Congress is one of the industry’s largest gatherings of managers and executives responsible for Contracts, Pricing, Finance, Accounting and Government Program Compliance. Over the past 15 years, almost 3,000 attendees have benefited from this valuable conference, which brings real world topics — including Healthcare Reform, Medicaid Expansion, Exchanges, Gross-to-Net, VA/DoD, 340B and Compliance — all into one forum. The session content and quality of presenters are always outstanding, and the opportunities to network with industry peers are invaluable. 

Harnessing Digital Platforms for HCP Engagement in Emerging Markets

  
  
  
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The Need for Adaptability

Marketing in the healthcare field today is anything but a static environment. Every pharmaceutical brand is daily forced to deal with a constantly changing environment in the areas of technology, regulatory issues, and client expectations. In addition to flexibility, efforts to engage healthcare professionals require high levels of creativity and constant adaption.

Are Grey Areas In The Sunshine Act Leaving Manufacturers in a Fog?

  
  
  
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While some areas of the U.S. Sunshine law are “clear as daylight," after a glance, and then a nice, long, hard stare, other areas of the law may leave manufacturers wandering in the dark. Through organizing teleconferences and issuing FAQs and updates, Centers for Medicare & Medicaid Services (CMS) has attempted to narrow the gaps between the law and real-life practices, but even with the combination of the statute, final regulation and its preamble, and CMS guidance (collectively, what we can term the “solid ground”), significant areas of vagueness remain, including the identification of teaching hospitals and whether to report certain indirect payments. These outstanding gaps seem hardly fair as manufacturers face significant monetary penalties for failure to report accurately. So, what are some methods for how manufacturers can leverage “solid ground” resources to develop a reasoned approach in addressing such gap areas?

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