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Kyruus Blog

And The Grades Are In!

Last week the American Medical School Association released it’s annual PharmFree Scorecard rating academic medical centers and medical schools. The scorecard provides a letter grade to 152 participating organizations by assessing 11 areas of potential conflict. This is the fifth year the scorecard has been released and uses a methodology developed in conjunction with the Pew Prescription Project.

Topics: Physicians Industry Interactions/Compliance 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

Jabs From Both Sides On Push For Transparency

The Sunshine Act has been getting a lot of attention lately with CMS’s comment period set to wind down on February 17. Last week the NY Times ran a front-page article titled, “U.S. to Force Drug Firms to Report Money Paid to Doctors” by Robert Pear. The article summarized the act, which mandates all life science companies with at least one product covered by Medicare and Medicaid to publicly disclose payments to doctors other than its own employees. The article quotes Senator Grassley, Republican of Iowa, who is obviously pleased to see movement on one of his initiatives as saying, “The goal is to let the sun shine in and make information available to foster accountability”.

Topics: Physicians Industry Interactions/Compliance Hospitals

Will Industry Disclosures Follow the IRB Path?

This is guest blog post by Ben Resner, Product Manager at Kyruus.

Much has been written here about the Physician Payment Sunshine Act (PPSA) currently making its way through congress. It is important to see this legislation as part of a larger trend of transparency and regulation in the healthcare industry. In the same way the PPSA mandates the creation of entities to gather and report financial conflict of interest, The National Research Act of 1974 initiated the creation of Institutional Review Boards (IRB) that now oversee research on human subjects and provide the public with protections in that arena . This legislation was in response to the outrage associated with the Tuskegee syphilis experiment, Milgram electrical shocks, Stanford prisoner experiment, and of course the unimaginable medical atrocities seen during WW2. Prior to this law, oversight of research on human subjects was dependent on the values of the principle investigators (P.I.’s). Researchers interested in controversial topics relied on informal peer networks to review research protocols and raise ethical questions regarding decisions to proceed. This, as became apparent, left subjects vulnerable to abuse and left well-intentioned investigators exposed if an otherwise properly-designed experiment caused harm.

IRBs have become a cornerstone of life-sciences research in part because they include a systematic process to provide review of a proposed protocol through lenses other than that of the P.I . This helps protect the subjects, the researcher, and institution against poor judgment and enables science to progress. It also ensures participants fully understand the risks and have the option to decline participation at any point in the research. Despite the significant time required to create, review and implement an IRB policy, there is no mainstream or even fringe movement to abolish them.

In the same way IRBs open the process by which researchers and human subjects interact to greater public scrutiny, the PPSA is an opportunity to open to public scrutiny the financial interactions between industry and physicians. This would allow physicians who genuinely believe in the therapeutic effect of a drug to both prescribe it to his or her patients as well as be compensated for time spent researching on behalf of the developer. The hope is a standardized disclosure policy means legitimate prescription patterns can be cleared and questionable prescription patterns detected. We hear anecdotes of physicians who are reluctant to attend industry-sponsored events now that cash and non-cash transfers of value are reported in states like Massachusetts and soon at the federal level. This is unfortunate because the physician is denying his or her curiosity about a therapy that might help patients. We hope the PPSA helps remove this stigma and engenders a dialogue about relationships just as the National Research Act has helped promote health-sciences research on human subjects.

Implementation of IRBs is an evolving process and not without controversy. The first IRBs were staffed by researchers at local institutions with domain knowledge of the experiment under review. More recently, private for-profit IRBs have appeared. These entities have the value-proposition that today’s research is too complex for volunteers to fully review and a professional class of dedicated IRB reviewers is necessary. While this premise merits further debate, IRBs have firmly established a meaningful role in protecting subjects while advancing medical science.

We should expect similar debates in how the PPSA is implemented. But we need to understand the era of hidden interactions between physicians and industry is and should be over.

Photo by fortherock

 

 

Topics: Industry Interactions/Compliance Hospitals

Three Reasons Why You Need To Know What's Out There

This is guest blog post by Joanna Brownstein, Director of Customer Operations at Kyruus.

Do you know what is in the public domain about the physicians at your institution? If not, you need to. Here’s why:

Other people know about it - Media outlets such as ProPublica are actively scouring the web for information about physicians’ interactions with industry. They make this information available to the public, and actively work with journalists to highlight stories about physicians who receive large payments from industry. No institution likes to be caught off guard and end up as front-page news. Armed with publicly available data, one compliance officer we know was able to successfully educate a reporter about her physicians’ interactions. As a result they were not included in the news story, the ideal outcome from her perspective. As David Hood commented in his recent blog post, industry collaboration is essential for continued innovation in health care. Interactions such as product development, participation in scientific advisory boards, and clinical trials show healthy knowledge transfer between physicians and the companies that make life saving products.

No matter what you think, you don’t have all of the information - Many hospitals and medical schools feel like they have a pretty good handle on what their physicians are doing. However, if you rely on self-reported processes you are likely not getting the full story. We recently did a pilot with a large academic medical center to compare the information they collected directly from physicians to the data that were publicly available about the same docs. We found over 50% more interactions in the public domain than the physicians had reported. This is not too far out of line with published research on the subject. Being armed with publicly available information will allow you to have meaningful conversations with physicians and to identify the cause of such discrepancies.

Some of the data in the public domain is incorrect - Some of the information reported by industry is incorrect, and you and your physicians should be armed with the information to get the errors fixed. I recently spoke with a compliance officer from a specialty hospital, who found an industry disclosure for one of her physicians was incorrect. Armed with that information, the physician was able to contact the company and rectify the error.

The amount of data in the public domain will increase exponentially as the Physician Payment Sunshine Act comes into effect. As a result, others will have access to information about your institution's physicians that you may not have access to with your current methods. Make sure to include searches of publicly available data in your toolbox, to ensure you are prepared to manage industry interactions and potential conflicts of interest effectively.

[box] Register for the upcoming webinar, Industry Interactions in the Age of Transparency - Making Public Data Work for You, on January 19. Former Chief Compliance Officer, Leon Goldman, MD will share his perspective on being proactive by mining public data.[/box]

Photo by dSeneste

Topics: 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