On February 17th, 2012 the Medical Device Manufacturing Association (MDMA) submitted a letter on behalf of the medical device industry to the Centers for Medicare and Medicaid Services in response to the proposed rule CMS-5060-P regarding "Transparency Reports and Reporting of Physician Ownership or Investment Interests. MDMA represents hundreds of medical device companies. The commentary submitted by MDMA focused on
- Timelines for implementation
- Expansion of the definition of covered recipients to include manufacturer payments to hospital GPOS
- Recognition of innovation in physician/manufacturer collaborations
Under the PPAC Act medical device companies were required to begin collecting payment recording data on January 1. 2012, yet since CMS did not provide adequate time for companies to provide this feedback MDMA requested that a delay be granted, by which CMS acquiesced. Under the proposed rule, CMS is considering to require companies to begin collecting payment data after 90 days upon publication of the final rule. At the time of this letter, MDMA did not believe that this was a sufficient matter of time to allow manufacturers to comply with the mandate. MDMA contends that the majority of medical device manufacturers in the U.S. are small to medium size companies, and that this would be a tremendous burden on those entities, stating that Section 6022 of the PPACA will place an administrative burden on these small companies as they need to develop the necessary information technology to track payments. The question that TSB must ask Mr. Novelli the signer of the letter, just how much time do any of these small companies really need? It is rather entertaining the Mr. Novelli writes that these companies need time to ensure compliance, since compliance has rarely been acknowledged in the spine industry. As for failing to report accurately, TSB highly doubts that the government is going to be running around checking for accuracy. If companies need 90 days to train someone to manage this mandate, is this a commentary on the quality of the people that work in our industry? Why would anyone entrust their compliance to an outside source? The reason that the MDMA has requested additional time is to buy the smaller to mid-size companies the time needed to clean up the many deals and side deals that exist considering that most small companies in today's environment have a slew of surgeons investors and so-called consultants. You know the surgeon that provides you with volume in exchange for his payola, while placing his imprimatur on another variation to your screwdriver. Since transparency is a word loosely defined in the industry, TSB believes that CMS should expand the criteria so that it will address the various business models that exists to circumvent the lack of transparency. As for hospital GPO's, its a no brainer that they too should be included since they have done their very best to constrain everyone's ability to compete in a free and open market where it comes down to the best price and implant.
TSB suggests that CMS should mandate that all companies have a link on their updated websites (hint, hint people) that includes all consultants, inventors, investors, and honorariums that have been paid out. This would alleviate much wasted time attempting to sell a surgeon that doesn't give a rats ass about your product because he is on another company's payroll. An example would be attempting to sell Andy Cappaccino your lateral device when he is the lead Lanx developer of their lateral device. Money talks, bullshit walks. TSB believes that rather than provide consumers with information on how a product is developed and commercialized, just let the public know how much money surgeons are paid for their services, and the public will understand why the delivery of healthcare is so expensive. Who do you think absorbs these costs? The request by MDMA to include how a medical device progresses from concept to commercialization and how the interactions between the manufacturer and physician/surgeons is smoke and mirrors. No one consumer is going to take the time to read or understand this process. In essence, MDMA is looking to hinder CMS' ability to effect this Act by suggesting unrealistic proposals. The funniest part of the letter is when it states the MDMA opposed any inappropriate relationship between a manufacturer and a covered recipient. SO WHAT? Who care what MDMA thinks? No need to worry about the publics perception based on the numerous stories that circulate on a weekly, monthly or quarterly basis in major publications.
If CMS caves in to MDMA's recommendation in enforcing a provision of how a medical technology is commercialized, CMS will have lost its battle in enacting this in a timely manner as everyone scurries to hide the bodies as quickly as possible, or find creative ways to circumvent the process. Don't believe it? Just look at some of the legal forums that are offered regarding compliance. So in closing, if its transparency that you want, then let CMS enact this mandate and let the device industry stop with their objections to finally putting everything on the table. Besides if the surgeons want the government to keep feeding the beast, then they along with their partners, the companies must make concessions. TSB wants to know what our readers think?