Transparency for FMV Rates: Finding a Balance Abroad

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

Sunshine Act and the States

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

Is Pharma Ready for the Sunshine Act?

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

Happy Holidays!

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


Physician Payment Disclosures and FMV Going Strong Despite Sunshine Act Delays

By Elio Evangelista,
Director of Research

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

Extended Sunshine Act deadline provides extra time to track and report physician payments

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:

  1. 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).
  2. 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.
  3. Establish a centralized location – Centrally located databases are more reliable for preventing duplicated efforts and data loss.
  4. 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.
  5. Create a built-in system to verify data – It is always easier to handle mistakes internally than to have external agencies point them out.
  6. 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.

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FMV Work and Travel Costs Take Center Stage in New Study

New study provides process for calculating compliant fair-market value payments

Although 100 percent of drug companies compensate key opinion leaders (KOLs) for their method of travel, only 60 percent do so for any preliminary work. And as mandatory public reporting of thought leader compensation approaches with the launch of the Sunshine Act, questions remain surrounding both travel and pre-work compensation. Continue reading

Drug and Device Companies Still Waiting For Sunshine Act Guidelines

By Elio Evangelista,
Director of Research

In about five weeks, pharmaceutical, biotechnology and medical device companies will have to start compiling and aggregating data on their physician expenditures to meet the requirements spelled out in the Physician Payments Sunshine Provision of the Patient Protection and Affordable Care Act. There’s a fairly significant problem, however – the U.S. government has yet to provide Continue reading

Physicians’ Conflict of Interest in Spotlight Again after BMJ Study Published

By Ryan McGuire,
Senior Research Analyst

Physicians’ conflict of interest is once again popping up as a hot topic. A study published in the British Medical Journal has received a lot of attention lately. It highlighted the prevalence of financial conflicts of interest (COI) for researchers sitting on 14 specific guideline-setting panels in the United States and Canada between the years 2000 and 2010. Our colleague Ed Silverman of Pharmalot discussed it. And both the Wall Street Journal and Continue reading

Sunshine Act Presents Uncertainty for Clinical Development

The sunshine provision of the landmark U.S. healthcare law passed in 2010 requires that drug and device manufacturers report all gifts and payments exceeding $10 in value. While the law seems clear for consulting fees, it becomes quite murky when discussing clinical investigator payments, which reimburse costs incurred during the clinical trial process. This is causing concern among pharmaceutical companies and CROs alike, and the Association of Clinical Research Organizations (ACRO) has recently expressed its frustrations with the law. Continue reading