As a leading House Republican opponent of the Affordable Care Act, Tennessee Congresswoman Marsha Blackburn has emerged as a darling of the tea party movement. During the ongoing federal government shutdown, Blackburn has appeared frequently on TV serving as a mouthpiece for the GOP trying to explain and justify their motives for political brinksmanship.
Late last month, on the eve of the government shutdown, the House passed a continuing resolution that included Blackburn's proposal to delay the Affordable Care Act for one year and to repeal its "unfair" medical device tax. Not surprisingly, Blackburn has joined other conservative Republicans in demanding changes to the Affordable Care Act in any deal to reopen the federal government.
In March congressional hearings, Blackburn and her Republican colleagues on the House Energy and Commerce Committee attempted to make political points by linking the 2.3 percent medical device tax to mobile devices and mHealth apps. Undeterred, she then drafted a proposed bill to amend Section 201 of the Federal Food, Drug, and Cosmetic Act. If a product is labeled, promoted or used in a manner that meets the definition in section 201 of the FD&C Act, it is regulated by the U.S. Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls and ostensibly is subject to the medical device excise tax.
Earlier this year, Blackburn sent the draft of her bill to the mHealth Regulatory Coalition (MRC) to get the organization's feedback on the proposed legislation. Bradley Merrill Thompson, the MRC's general counsel, reviewed the document raising "a number of questions and important concerns with the proposed approach and the use of new terminology" in Blackburn's draft.
"It would appear that the draft is attempting to shield health information technologies from the medical device tax by changing certain health information technology from the medical device category into the medical health technology category," wrote Thompson in a July 12 MRC letter to Blackburn in response to her draft bill. "Our concern is that this legislation adds ambiguity, thereby frustrating innovation. While we support any effort to repeal the tax, the approach of creating a whole new category would again be the wrong solution to the problem. The MRC believes that the tax is the problem and must go. Trying to avoid it through a new category that incidentally creates ambiguity only creates new problems."
Now, Blackburn, who is vice chair of the House Energy and Commerce Committee, is planning to introduce a bill to Congress regarding health-related mobile apps that encourages new technologies and creates jobs. The bill, which reportedly has been in draft form for about a month, "will provide the FDA with the tools it needs to effectively protect consumers from the high-risk technologies" without stifling innovation and subjecting lower-risk technologies to unnecessary oversight, Blackburn said last week at the Telecommunications Industry Association conference in Washington.
Thompson told FierceMobileHealthcare that he has not seen a proposal for revised legislation since providing a critique of Blackburn's draft bill this summer. However, he said that it was his understanding that the congresswoman's office was "changing it substantially." We'll just have to wait and see what Blackburn has up her sleeve, especially given the fact that the FDA on Sept. 23 issued its final guidance on mobile medical applications. - Greg (@Slabodkin)