• After 15 temporary patches since 2003, at a cost that some have put at $150 billion, may our Congressional leaders finally do away with the mess they created in 1997 with the Sustainable Growth Rate formula for Medicare reimbursement. As always, the legislative situation is fluid and last-minute, with the House approving a three-month delay in the anticipated 20-plus percent cut scheduled for 2014, and the Senate expected to take up the patch this week.
But many in Washington are pointing to more substantive efforts undertaken late this year that culminated on Dec. 12 with both the Senate Finance Committee and the House Ways and Means Committee approving legislation that would permanently repeal the SGR. Another can kicked down the road would not surprise anyone, but many seem confident that the “Value-based Payment Program” that would replace the PQRI and meaningful use programs may finally be the death knell of SGR.
• May this be the year that U.S. surgeons can finally have access to corneal crosslinking. In late November, the FDA granted priority review to Avedro of the new drug application for its crosslinking system. The priority review status establishes a PDUFA date of March 15, 2014. The proposed indications of treatment of keratoconus and corneal ectasia following refractive surgery are both orphan indications, prompting the priority review. With thousand of successful treatments and years of data collected internationally, crosslinking has become the poster boy for what’s wrong with the FDA trial system.
• May GSK’s announcement regarding changes in its financial relationship with doctor/spokespersons, and in the way it compensates its sales reps, be an inspiration for other pharmaceutical and medical device companies. The company will end the practice of direct payments to health-care professionals for speaking engagements and for attendance at medical conferences. In addition, the company will eliminate individual sales targets for reps. Instead, GSK’s sales reps who work directly with prescribing health-care professionals will be “evaluated and rewarded for their technical knowledge, the quality of the service they deliver to support improved patient care and the overall performance of GSK’s business,” the company said.
Some aspects of the new program are already in practice at other companies. But the overall trend toward transparency of relationships between industry and physicians, and quality, evidence-based education on medical products is to be applauded.