Although the government has varying motivations for requiring drug and device companies to disclose the payments they make to physicians, one consequence — intended or otherwise — is that drug company research payments have begun to exceed payments to physicians for promotional speeches. They’re also paying less money to doctors as a whole.
ProPublica’s Dollars for Doctors database houses the physician compensation data for 15 pharmaceutical companies that have been publishing information about the payments they make to doctors as far back as 2009. The cumulative amounts paid since then by 13 of these 15 companies total more than $2 billion. (Allergan and Valeant have disclosed payment ranges and not fixed numbers, so they’re more difficult to include in the cumulative total.) Continue reading
Advisory boards have been part of the pharmaceutical landscape for a long time, providing companies with valuable expert opinions on topics ranging from ensuring thorough regulatory submissions to clinical trial protocols. This role does not look to fade anytime soon, as regulatory requirements get tougher and payers look for ever more clinical data and health outcomes to prove the value of products on the market. Many companies are working to create a cohesive advisory board strategy – and set of advisory board functions – that encompasses which groups are best suited to handle the responsibility of coordinating advisory boards and how to achieve a useful deliverable out of a board meeting. Continue reading
The pharmaceutical industry has begun to dabble in online business communication, especially around speaker programs aimed at informing healthcare providers of new research and medicines. Of course, pharmaceutical speaker programs have existed for a while in the form of presentations, dinners and round-table discussions. New technology has recently expanded speaker programs into the online world, allowing one-way and interactive webcasts. Even some web-based teaching programs using principles of self-driven learning have been emerging as well. Continue reading
The future of speaker programs has looked murky for the past few years for several reasons: tightened budgets, increased regulatory scrutiny and heightened media attention to speaker fees — as seen in the Dollars for Docs platform and potential CME Sunshine Act reporting. This uncertainty thrived, especially before CMS published the final rules for the Sunshine Act in early February. However, even before the final ruling stipulated that fees for speakers for CME events will not be tracked as long as they fulfill certain requirements (such as accreditation or certification requirements), educational speaker programs were stabilizing. The final ruling is an added boon to medical educational speaker programs, and the overall trend for speaker programs has already begun improving. Continue reading
When France first released its 2011 draft of the Bertrand Act — which included a provision similar to the Sunshine Act here in the US – the legislation promised to be more stringent than US guidelines. The draft required companies to post its payments on its website within 15 days of the activity — complete with the recipient’s name and the amount he or she received. It also required companies to deliver a report detailing their outside spending to six professional organizations — even if payments were under the US equivalent of $95. Continue reading
There has been much buzz about the Sunshine Act since the Centers for Medicare and Medicaid Services (CMS) released its final draft of guidelines. Comparatively, there has been little mention as to how the Sunshine Act affects states. According to Section H of the guidelines, the law will take precedence over existing state laws in situations where the national and state reporting requirements overlap. Continue reading
At last. Cue the Etta James music because the Centers for Medicare and Medicaid Services (CMS) released the final version of the Sunshine Act. Is pharma ready for the Sunshine Act? As of February 8, the Sunshine Act will be included in the Federal Register and will go into effect shortly thereafter. Finally, pharma and the rest of the healthcare industry can breathe a little easier as they shift away from eagerly — or perhaps reluctantly— awaiting further legislative updates to focusing on adhering to these now-finalized guidelines. Continue reading
As the year comes to a close, we would like to thank our readers, clients, and partners for their contributions toward helping Cutting Edge Information create benchmarking reports for the life sciences industry.
With Sunshine Act responsibilities and continued patent cliff challenges in front of us in 2013, CEI is ready, willing and able to rise to the difficulties facing the Pharma industry. Check out our Annual Forecasting Guide to see what other trends will be impacting life sciences companies in 2013.
We look forward to serving you in 2013.
Here’s wishing everyone a safe and happy holiday season.
-The Team at Cutting Edge Information
The United States is still waiting for the Centers for Medicare and Medicaid Services (CMS) to issue its final ruling on how it will implement the physician payment disclosures rules outlined in the Sunshine Act. However, this has not deterred companies from continuing to make public disclosures or caused them to lose focus on determining fair-market value (FMV) physician fee schedules.
Initially, CMS was scheduled to give a ruling to drug and device manufacturers in October 2011. But the agency Continue reading
Six Tips to Help Build the Ideal Thought Leader Database
As the industry awaits the release of the delayed Sunshine Act guidelines, pharmaceutical and medical device companies are benefiting from the extra time by reviewing current physician payment reporting structures and tightening their documentation procedures. “Every company, no matter how large or small, needs a tracking and reporting system capable of handling all of the Sunshine Act’s requirements now,” said Elio Evangelista, director of research at Cutting Edge Information. “The largest companiesare ahead of the pack. Most already have sophisticated databases in place, as well as the IT infrastructure and personnel to support the documentation requirements.”
Cutting Edge Information’s report, “KOL Fair-Market Value and Aggregate Spend,” serves as a guidebook to companies working to comply with the reporting requirements of the Physician Payment Sunshine Act while meeting the needs of physicians and internal stakeholders. Based on interviews conducted with medical affairs executives across the industry, Cutting Edge Information recommends the following fundamentals when constructing a KOL database:
- Include fields for all information required by the Sunshine Act – Each entry must have fields to enter name, company, Medicare billing number, service provided, physician compensation and other reimbursed expenses (including travel, hotel, and food).
- Design strong report-building capabilities – The more sophisticated the database’s query building and report-generating capabilities are, the less work companies will have to do on the back end.
- Establish a centralized location – Centrally located databases are more reliable for preventing duplicated efforts and data loss.
- Create multiple access points with differing levels of clearance – Some employees may need the ability to enter new information into the database, but not everyone needs to alter information.
- Create a built-in system to verify data – It is always easier to handle mistakes internally than to have external agencies point them out.
- Include links to, or archive, thought leader deliverables – An easily traceable copy of the thought leader’s deliverable provides undisputable proof that a service has been rendered.