Healthcare organizations accused of violating a federal law often find themselves in the settlement agreement process with the Department of Health and Human Services’ Office of the Inspector General (OIG), leading the company to comply with rigorous terms of a corporate integrity agreement (CIA). Those involved in particularly egregious or consistent violations of federal law governing the manufacturing and marketing of pharmaceuticals may even be obligated to enter into a deferred prosecution agreement with the U.S. Department of Justice (DOJ).
Continue reading "Beyond Fines, Corporate Integrity Agreements Compound Compliance Costs"
In The Headlines
Scott Evans, PharmD, MHA, Senior Vice President and CEO | Sharp Grossmont Hospital
The struggle is real. As an executive in health care, I understand the impact regulation has on our business. No doubt, physicians and pharmaceutical companies feel it as well: especially given some very significant changes that have transpired over the past 20 months. The Physician Financial Transparency Reports, or Sunshine Act, requires increased reporting of financial relationships between health care providers and pharmaceutical manufacturers and sheds light on potential conflicts of interest. Ultimately, the Act surmises, patients would have a better opportunity to learn about potential conflicts and consider those in the context of their prescribed treatment. But like others, well-intentioned legislations, I sometimes wonder how the Act is working.
Continue reading "The New Relationship Dilemma: Evaluating Physician Payment Transparency Regulations"
Topic of Discussion
In the Age of Overwhelming Opinions, Who Is Your KOL and How Do You Assess Their Risks and Benefits in the Evolving Health Care Environment
Dr. Rocco Rotello | Cedarville University
As with most disciplines, including scientific and medical fields, clinical teams, marketing and business minds seek out a spokesperson — or Key Opinion Leader (KOL) — who will help launch a new product and with whom patients can identify. This was evident in the late 90s, which observed a new therapeutic class that entered the post-menopausal osteoporosis scene, bisphosphonates, mainly Fosamax, Actonel and Boniva. For example, Actonel from Procter & Gamble (P&G), the second drug to market bisphosphonate, had a once-a-day and then once-a-week therapy. A few years later, Actonel faced stiff competition from the launch of the once-a-month Boniva. P&G could not complete with the message of Sally Field, a well-known actress who became the face of for aging women and a key spokesperson for Boniva. Patients told their doctors they wanted what Sally was taking to protect their bones. With this as a backdrop, one can begin to see how a strong voice for an idea, product or trend can be important within the scientific and medical fields.
Continue reading "In the Age of Overwhelming Opinions, Who Is Your KOL and How Do You Assess Their Risks and Benefits in the Evolving Health Care Environment"
East Norriton, Penn. Feb. 4, 2016. TGaS® Advisors is expanding its roster of commercial solutions with the addition of Medical Regulatory Legal (MRL) Operations. The new solution reflects high client demand in this critical area. The benchmarking and advisory firm also named TGaS Management Advisor Karl Kraft to head the new practice. The MRL benchmark is in growing demand as companies seek to make this critical process shorter, more efficient, more strategic and less costly, according to ... [Continue Reading]