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Transparency should bring clarity, not confusion

By John Castellani, president and CEO, Pharmaceutical Research and Manufacturers of America - 02/17/12 05:05 PM ET

Transparency is a word that often gets casually bandied about in Washington, especially when it comes to regulatory rulemakings. When done right, it can be a very good thing. But transparency without appropriate context runs the risk of actually muddying the waters and causing more confusion than clarity.

The ongoing implementation of the aptly named Physician Payment Sunshine provision of the Affordable Care Act offers a good example. This is a law that is intended to provide the public with transparency in interactions between biopharmaceutical companies and health care providers – and last Friday, PhRMA submitted comments to the Centers for Medicare and Medicaid Services on the related proposed rule.

Just as we supported the legislation that led to the law, PhRMA and its member companies continue to work as constructive partners to CMS during implementation. But we want to ensure that the ultimate outcome is not confusion or misrepresentation of information – rather, the goal should be a useful tool for patients to fully comprehend the role that their physicians play in clinical research and in the dissemination of scientific information among their peers.


We believe in the value of these relationships to the improvement of patient care. Without working together, the discovery and development of new medicines would suffer, as our ability to conduct clinical trials would be stymied. Patient access to new medicines would be limited, as physicians would have one less resource to learn about those new medicines, which may address unmet medical need. And emerging benefit and risk information would not find its way to healthcare providers as quickly as it must in order to protect and best care for America’s patients. The work that physicians do toward these goals takes time and effort, and is worthy of reasonable compensation.


If the information made available to the public does not include sufficient context to convey the nature of the relationships between companies and healthcare providers, that information could be useless or, worse, incorrect and confusing to patients.

Our comments to CMS are long and complicated, reflecting the complexities of the issue. They make use of examples, hypotheticals and incredibly long descriptions. And, ultimately, they themselves are an example of our overarching point: that information, without that important context, is of diminished value.

We have already seen examples of physician payment disclosure without context: a name and a dollar figure do not convey the information learned, the expertise provided, or the resources that went into particular research work.

In fact, some see such limited information as inaccurately suggesting a physician’s bias, despite research that has shown this could not be further from the truth. A 2011 survey of physicians by KRC Research found that physicians take into account many considerations when making their treatment decisions, particularly their own clinical experience and each individual patient’s unique needs.

As part of the open rulemaking process, our comments to CMS are public. In them, we ask for more-accurate interpretation of statutory definitions, improved clarification of information, better attribution of payments to physicians, and more – all in the interests of more useful transparency for patients once the law is fully implemented.

We’re proud of the way that we collaborate with physicians, and they with us, in the interests of medical progress. Our goal is to continue working with CMS to create a tool with the appropriate resources for patients to appreciate this, as well.

John Castellani, is the president and CEO of the Pharmaceutical Research and Manufacturers of America


Source:
http://thehill.com/blogs/congress-blog/healthcare/211497-john-castellani-president-and-ceo-pharmaceutical-research-and-manufacturers-of-america
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