A new congress was sworn in on January 3, 2015, and with it a new opportunity for advancing legislation. Although the Republican party now controls both houses, it still lacks a supermajority in the Senate, which may make legislation more difficult to pass. Although few pieces of legislation have actually been introduced in the few weeks this Congress has been in session, according to a recent analysis by Politico, several themes from the last congressional session (2013–2014) are likely to reemerge in this Congress.
At the top of the legislative agenda, Congress is expected to address FDA's role in regulating medical devices that are also health IT. Although FDA has indicated it will exercise enforcement discretion as a means of excluding the lowest risk health IT from the Agency's medical device regulatory scheme, industry and members of Congress from both parties believe that legislation is required to "clarify" FDA's role in regulating these technologies, particularly with regard to clinical-decision support software, which still lingers in a gray area of regulation. It is likely that either the SOFTWARE Act or MEDTECH Act, both introduced last session, will serve as a template for whatever legislation is introduced this session to address this issue.
Expanding telehealth coverage is also likely to be a priority in this Congress. The 21st Century Cures initiative, which seeks to create a comprehensive piece of legislation with the goal of "getting more cures and treatments to patients more quickly," was begun last year by Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO). The initiative intends to produce a discussion draft within the month and "move quickly." Politico reports that the 21st Century Cures package will almost certainly seek to expand Medicare coverage of telehealth services through one or more potential vehicles, including waiving restrictions on certain services (such as home health and hospice care), or expanding coverage to certain entities (such as federally qualified health clinics). Cost is likely to be a key factor in determining the manner in and extent to which Congress extends telehealth services to more patients.
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