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.

To read more go to www.nhhsHealthcare.com

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.

Tools for Managing the High Ground: Putting Trust and Analytics into Medical Conflict of Interest

Managing medical conflicts of interest with accepted standards and practices is the direction we are headed in but the path is not well marked. "Physician Conflict Of Interest" may be defined as any possible compromising of a physician's professional judgment for the purpose of financial reward. It is also presumed to be a conflict if ownership is present, even if the judgment is not compromised and there is no financial gain in the process. In either case operating within acceptable boundaries with full disclosure offers the best opportunity for medical excellence and public trust.


In April 2009 the Institute of Medicine (IOM) completed its report on collaboration between industry and HCPs.  The IOM report stressed the need to prevent bias and mistrust which undermines the value of work being done by the medical community and the industry. The report focused specifically on financial conflicts of interest involving pharmaceutical, medical device, and biotechnology companies.


IOM’s conclusion states; “Society traditionally has placed great trust in physicians and researchers, grant­ing them the considerable leeway to regulate themselves. However, there is growing concern among lawmakers, government agencies, and the public that extensive con­flicts of interest in medicine require stronger measures. Responsible and reasonable conflict of interest policies and procedures will reduce the risk of bias and the loss of trust while avoiding undue burdens or harms and without damaging constructive collaborations with industry. Decisions about biomedical research, medical education, and patient care directly affect the public’s health. The public needs to be able to trust that physicians’ decisions are not inappropriately influenced by their financial rela­tionships with industry.”

While the committee recommended the implementation of policies and procedures to reduce the risk of conflicts, change has been gradual. Currently, much to the dismay of many, the wheels are in motion for the Physician Payments Sunshine Act (PPSA) to confront the controversy.  This corrective action may be a bitter pill to swallow in the coming months but in the long term, management of the process will disclose more than just the originally intended payments to HCPs. The release of payments made to the medical community is the high ground for the industry that can help recapture public trust. In addition the emerging data is revealing previously unknown new perspectives on industry spending patterns, priorities and budgets providing competitive information on contracted services.

In past weeks additional installments of manufacturer disclosure information were released for public consumption.  This latest release has again sparked media attention and increased concern about physicians, hospitals, ancillary health facilities and industry conflicts of interest. As information trickles out in advance of the PPSA deadline, shock and criticism are the story lines as reaction to the sums being paid for contracted services get reviewed. But also emerging from the scattered data sources is a new set of data offering the opportunity for competitive analytics on a segment of industry where investments are likely to exceed one billion dollars a year. 


Efforts to aggregate posted company payments to physicians have led to the creation of Physician Contracting Analysis (PCA); a database and analytics tool. Using the latest in business intelligence software along with skilled data management techniques, PCA has created new levels of analytics around the reported payment data. The new data and analytics capabilities have opened up unexpected amounts of information that savvy professionals can use for strategic and tactical advantage.


As PPSA continues to be unpopular to many, including providers, the industry should seize the opportunity to recapture the high ground on public trust by actively participating in PPSA and exploring the competitive environment that is HCP contracted services. A look at how the industry collaborates with the medical community cannot only have positive impact on the public; it can also be a good way to more effectively manage the business.

To read more about PCA go to www.nhhsHealthcare.com

Ethics, HCPs and Industry: Learning from Transparency

In April 2009 PhRMA attempted to draw internal support around the PhRMA Code in an effort to establish guidelines for dealing with Health Care Professionals (HCPs). These voluntary guidelines were written to define boundaries for ethical interactions with HCPs. But PhRMA’s well intended efforts were eclipsed by federal and state legislators. The Physician Payments Sunshine Act was included in the Patient Protection and Affordable Care Act of 2009 (H.R. 3590, section 6002), which was signed into law on March 23, 2010. The new law requires full transparency and mandatory reporting by drug and medical device manufacturers regarding gifts and payments made to physicians and teaching hospitals.  A number of state legislative bodies also have passed legislation that mandates financial disclosure between HCPs and industry members.

How far has industry progressed on this issue? Have medical and device manufacturers closed the gap on the Sunshine Act and state requirements?   The eight companies that report online information on HCP contracted services gives us a window into the compliance complexities associated with the Sunshine Act.  While these companies may seem to be ahead of their peers, their current postings are mostly the result of a Corporate Integrity Agreement (CIA) rather than direct Sunshine Act compliance.  The posted data do, however, give us a glimpse into the future.

Sunshine Act information is scheduled to be posted to a public website in September 2013. The closest thing we have today to what the CMS site could look like is the ProPublica website (http://projects.propublica.org/docdollars/ ).  From this small slice of reported data we can see the challenges that lie ahead as systems, procedures and standards are put in place to manage the HCP contracting and reporting process under Sunshine Act requirements. Managing the process, collecting the data and reporting the information will be no simple task. 

Today, as a result of this legislation, numerous back-end industry solutions are being developed to meet Sunshine requirements. It is not clear whether the industry as a whole will stand ready to meet the Sunshine Act timelines. It is fair to say that current manufacturer efforts toward systems development is widely varied with a major focus on enterprise data management.  But what can be learned from the broader landscape? Will companies move beyond their internal preoccupation with data to find ways to gain insight into best practices that help improve industry interactions with HCPs?