PPSA Transparency but Shadows Remain

The deadline for public comment on the Sunshine Act has past and there was no shortage of responses from industry and the medical community. Over 100 organizations asked CMS to scrap the current dispute resolution process and many providers and industry thought leaders believe that transaction disclosures will mislead the public resulting in limited medical research and innovation.

These concerns are not ill founded as a long as the nature and value of these relationships are not well understood. Public education will be essential but is complicated by press coverage that has focused on sensationalizing the topic; casting industry in an unfavorable light by implying that money paid to providers for services has influence on objective medical judgment.

As CMS pours through its collection of comments; it is safe to say that the controversy regarding the Sunshine Act is will continue.  The pros and cons of the Sunshine Act will go on but it is important that both sides of this discussion keep a fair and balanced approach to the facts. Each of the current stakeholders has their own perspectives but articles that are bias and provide false and misleading information such as those that portray past industry tactics as current policy belie the truth. Depicting industry in this way casts a pall over the ethics at play with the current system undermining the value of these relationships. This kind of information speaks to the concerns of both the industry and providers who share the negative impact of false and misleading information on innovation and health outcomes.

Crafting the Sunshine Act “final” rules CMS would be wise to follow the medical dictum of “first do no harm, then do good” taking care not to jeopardize all the positive interactions between industry and the medical community. Shedding light on industry transactions with providers must not be done at the expense of public trust.

When this transaction data is eventually posted it will, if not done with care, leave open a broad interpretation for implied kickback.  Patients, providers and the industry will depend on a fair and balanced approach to the facts. Without steps to educate the public, transaction postings will likely breed even deeper skepticism of the industry and provider paranoia when the overwhelming majority are ethical and result in improved patient health and outcomes.

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PPSA Data: How will the industry adapt?

As the healthcare industry waits for CMS to issue final rules for the Physician Payments Sunshine Act (PPSA) many questions remain. Building systems and processes are still the primary focus for many pharmaceutical, biotechnology and medical device companies as they set out to monitor spending as never before. But as the rules and systems are put in place the impact on industry relationships and the health care community is not clear. With just over one year remaining before 2012 aggregate-spend reports are due the question remains; how will the data be viewed and used?   

Soon thousands of records will be passed from manufacturers and covered entities into publicly available CMS and state web sites exposing previously unseen transactions to the light of day. As these transactions are disclosed the information will inevitably spark questions as to the nature and amounts of the payments. It is important that this information be reported accurately and also understood so that perceived conflicts of interests are not associated with each transaction made to a health care professional (HCP). The information must be managed in ways that give meaning to the purpose and value of these relationships.

As scrutiny intensifies, BioPharma, device and specialty companies must make smart investments in information technology, business processes, and compliance policies. Companies will need to employ comprehensive analytics across sales, marketing and R&D to develop systems and strategies to minimize exposure to compliance risk. They must also work to ensure that the collaboration between industry and the medical community is understood by the public.

These new challenges mean companies must commit to operational excellence in managing their data and communications by pushing the right analytic tools deeper into the organization. These tools will allow companies to effectively manage enterprise data and look out across a competitive landscape to support strategic and tactical planning while maintaining safe harbors under the watchful eye of the public.   

The new transparency environment will also generate new types of competitive intelligence capable of providing value across organizations. As data and reporting requirements continue to increase the role of business intelligence as a management tool will become increasingly important within the changing regulatory environment from 2012 and beyond. Companies will find that advanced analytic tools and data management will be an increasing and necessary component to business success.

After systems are in place, a lot will rest on how companies view their data and use the aggregate-spend information in combination with other industry related data. Business intelligence tools will provide new insights on macro and micro levels of business, helping companies manage and shape the nature of HCP relationships and the budgets that support them.