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Kyruus Blog

PPSA's Final Ruling is Here: Now What?

This interpretation was written by Leon Goldman, Kyruus' Chief Privacy Officer and former Chief Compliance Officer at Beth Israel Deaconess Medical Center

The final rule of the Physician Payment Sunshine Act, commonly called “PPSA”, has been published in the Federal Register as of today, February 8, 2013. Anxiously awaited by the healthcare industry and the public alike, the final ruling means applicable manufacturers and group purchasing organizations will be frantically reviewing it, trying to ensure their organization’s processes and systems are ready and able to report the data to CMS by the deadline of March 31, 2014.

While there is anxious activity among the manufactures and GPOs, it is certainly less clear to hospitals and physicians what the PPSA will mean to them, and what exactly they need to be doing to prepare. Aside from providing the opportunity to review the data posted about them, PPSA does not place any statutory obligations on hospitals or physicians - it will, however, reveal a great deal of information about them to the public.

The process by which hospitals have monitored financial relationships with industry has long relied on individual disclosure, either on an annual or transactional basis triggered by specific events, such as seeking permission to perform research studies. Proactive review of publicly available information has not been part of standard review for most institutions - often because the perceived benefit of implementing such a process has not outweighed the cost of review, in both dollars and time. PPSA mandates not only the collection of a vast amount of information about “covered recipients” but also the creation of a vast database that must be downloadable, easily searchable, and aggregated. How and to what extent this will actually change the playing field is yet to be known.

This database will provide (relatively) easy access to vast amounts of information to the public, regulators, or the media for the first time. While some information is already available today via select states reporting and approximately 50 companies currently disclosing, PPSA will significantly increase the amount of information available to the public. We project the following:

  • Over 3 million public industry payment disclosures amounting to over $4 billion
  • Over 700,000 healthcare professionals indicated with public industry payment disclosures
  • Over 1,500 companies disclosing payments

At Kyruus, we have little doubt that agencies, such as the National Institutes of Health, will use the information as a way to “verify” what they are told by their applicants. The media, too, will see the data as an interesting source of information for investigative reporting. Lastly, individual patients and families will likely use the data to become more informed about their physicians and the relationships those physicians have with industry. Given all who will likely use the data, it behooves hospitals and covered recipients to be aware of the data.

Nevertheless, the presence of such a database will not relieve institutions of the need to gather information on their own as they have been doing up to this point. Factors for consideration:

  1. The annual posting of the data may not provide adequate information for organizations to fulfill their transactional obligations for events such as accepting payment from PHS for funded research.
  2. The PPSA database will contain nothing about non-physicians receiving payments or transfers of value about which the organizational policies require disclosure.
  3. There may be payments to physicians that need to be disclosed under an organization's policies, but which are exempt from reporting under the PPSA and can only be discovered through an active disclosure process.
  4. Consolidation of reporting by manufactures may make the information that is reported less useful to the institution for their assessment need. Again - the institution will need to continue to monitor data internally to understand what PPSA will mean for them, and what they need to do.

Kyruus believes that best practices will move organizations to develop policies and procedures that actively collect disclosure information from affected individuals and actively monitor publicly available information. This allows organizations to be in control of the information, to reconcile discrepancies, identify and eliminate problem areas, and to respond quickly to both public and regulatory inquiries.

Topics: Life Sciences Physicians Big Data Hospitals

Administration Pledges $200 Million For Big Data

This is a guest blog by Katie Dixon, Market Solutions Associate at Kyruus

The Obama Administration is investing big time in big data. On Friday, March 30, the Administration’s Office of Science and Technology Policy (OSTP) launched a $200 million, multi-agency effort titled the “Big Data Research and Development Initiative.” Fundamentally, the initiative’s mission is to highlight and create public-private partnerships in big data. The Administration is inviting industry, research universities, and non-profits to join forces and make the most of the opportunities created by big data. To view the announcement, click here or you can view the streaming video webcast.

While the initiative launches six new agency efforts, numerous agencies are already involved in the big data revolution including the: Department of Defense (DOD), Department of Homeland Security (DHS), Department of Energy (DOE), Department of Veterans Administration (VA), Department of Health and Human Services (HHS) and National Security Agency (NSA), among others. These agencies administer some of the most fundamental aspects of the American public’s life. For more detail, check out the official Big Data Fact Sheet.

The Implications

What can we infer from the announcement? The initiative is an institutional precedent for big data as a discipline. In a sense, the federal government is legitimizing a practice that science and commercial companies have benefitted from for years. This is huge. One can extrapolate that big data is moving from an introductory/pioneering stage to a growth stage in its commercial life cycle. Big data is legit, it’s commercially viable and it can help the public live better.

A Call To Action

The announcement last week was designed to spur action. Now is the time for academia, corporations, NGOs, associations, foundations, governments and everything in between to step forward and make things happen. Collaboration is the key to identifying opportunities, inventing better products and systems, and reducing costs. The Administration knows that no one actor individually can address the biggest issues facing our citizenry. Together, however, possibilities are endless.

If you are interested in learning more about the announcement and big data initiatives, here are a few links.

Why Science Really Needs Big Data
Feds Launch Big Data Initiative to Advance Science
Why Big Data is a Magnet for Startups

Photo by James Vilija







Topics: Life Sciences Big Data Hospitals

Industry Group Calls for More Accuracy

As a group representing the pharmaceutical industry, the recent stance of PhRMA on the Physician Payment Sunshine Act is not what one might anticipate. In a recent article on the The Hill, president and CEO of PhRMA, John Castellani, called for more accuracy and context in the proposed disclosures. He eloquently makes the point that the current industry interaction disclosures as a result of Corporate Integrity Agreements and state laws have in some cases led to some confusion over the payments and inaccurately suggest bias.

Topics: Life Sciences Physicians Industry Interactions/Compliance Hospitals

Breaking Sunshine News

CMS announced today the proposed final rule for increasing transparency in health care. The Sunshine rule as stipulated in the Patient Protection and Affordable Care Act (PPACA) was initially to be finalized by Oct. 1st and we’ve seen a fair amount of hand wringing by sponsors of the original legislation and industry stakeholders gearing up to meet the Sunshine deadlines.

Topics: Life Sciences Physicians Industry Interactions/Compliance Hospitals

More Info Coming On Sunshine?

The fathers of the Sunshine Act, Herb Kohl (D-Wis.) and Chuck Grassley (R-Iowa), are holding a hearing on December 15, titled “Parting the Clouds: Implementing the Physician Payments Sunshine Act”. The hearing was scheduled by Senate Special Committee on Aging chairman Kohl with Senator Grassley expected to be in attendance.

Topics: Life Sciences Physicians Industry Interactions/Compliance Hospitals

Journals Need To Verify Disclosures

The Spine Journal recently published a letter (login required) by researchers embroiled in controversy over whether or not the doctors failed to disclose a significant cancer risk in papers published over a decade long period. The letter is in response to a Spine Journal analysis of the research that found there was evidence of increased malignancies. The editors of the journal said the authors used "poor reporting practices" and failed to communicate, “the concern of independent investigators and analysts regarding the risk of cancer with the BMP-2 products (the authors) promote".

Topics: Life Sciences Physicians Industry Interactions/Compliance Hospitals

My Takeaways From the Physician Payments Disclosure & Aggregate Spend Conference

I had the opportunity to recently attend the 3rd Annual Forum on Physician Payments Disclosure & Aggregate Spend Conference in New York City on October 17. The timing of the event should have been perfect, as the dates were likely selected based on the expected date of the finalization of the Sunshine Provision rules; however as we’ve documented on Transparent Innovations, that wasn’t the case. Despite the absence of final regulatory language, it was fascinating to get a better appreciation of the many viewpoints shared during the two days.

Topics: Life Sciences Industry Interactions/Compliance

Forecast Cloudy For Final Sunshine Provision

According to the Physician Payment Sunshine Provision, which was passed as part of the Patient Protection and Affordable Care Act (PPACA) of 2010, the Center for Medicare and Medicaid Services (CMS) had until October 1st, 2011 to finalize the rules and regulations for reporting and ultimately public disclosure of payments made to physicians by life science companies. The October 1st date has now come and gone with no word as to when the final rules will be available to those in the industry who will be responsible for collecting aggregate spend data beginning on January 1, 2012.

Topics: Life Sciences Physicians Industry Interactions/Compliance Hospitals

Shame on the Shame Campaign

Transparency in health care is a subject that has received a lot of attention in the last couple of years. State laws in Massachusetts, Vermont, Minnesota, California, West Virginia, Nevada and Washington DC require life science companies to disclose industry interactions with health care providers, and in a few cases, the data is then made publicly available on web sites. Additional data may be published by organizations under corporate integrity agreements (CIAs) that outline steps to ensure transparency. By most accounts, the number of public disclosures is expected to increase considerably with the finalization of the Sunshine Act that is set to take effect in January of 2012.

Topics: Life Sciences Physicians Industry Interactions/Compliance Hospitals

The Explosion Of Data

Few need to be convinced that we live in a world today that is increasingly tracking, measuring and monitoring a broad spectrum of activities. This point was illustrated in a McKinsey report I read recently titled, "Big data: The next frontier for innovation, competition, and productivity". The introduction summarizes nicely why the amount of data is growing exponentially and how that can be a good thing for capturing value.

Topics: Life Sciences Physicians Analytics Big Data Hospitals