For Medtech Insight readers, as in previous years, coverage of FDA inspection and compliance issues were the most popular, and very prominent among our top 25 US regulatory and policy stories in 2017. (See table below.) On the one hand, this reflects an ever-present fear of the unknown and, particularly, of negative outcomes that could result from the agency's scrutiny of firms' quality systems. The first two stories on our list, emphasizing inspection "horror stories" (the second in an annual series, and the second year in a row it was the top hit-getter) and things you should never say to an FDA investigator, underscore this fear.
But interest was also driven to the topic by some important changes that became reality in 2017. In particular, "program alignment," a complete reorganization of FDA's field staff that was hatched years ago during the Obama administration, but was finally rolled out in May. The change will have a big impact on the types of people who will be visiting device facilities to inspect and how inspections are conducted.
In addition, Congress included more reforms to FDA's inspection procedures in the Reauthorization Act, and the agency is pushing forward with multiple pilot programs experimenting with new philosophies of inspections and quality. Meanwhile, the global environment in which device companies and FDA investigators are operating is changing even more significantly, with the new international quality standard (ISO 13485) taking effect and the Medical Device Single Audit Program getting off the ground. The long-term implication of all of these reforms remains to be seen, but its likely 2017 will be viewed as an important pivot point for the agency's approach to inspections and regulatory compliance.
Congress: Catalyst And Frustrater
While the issue of compliance and inspections loomed large for our readers, there was much else to keep people's attention.
2017 was so laden with big catalysts for change that it is difficult to sort the impacts. New appointments by the Trump administration to FDA and the Centers for Medicare and Medicaid Services (CMS), among other agencies, obviously played an important role. But there was two pieces of major FDA legislation passed by Congress within seven months of each other that enacted an array of reforms developed well before the current White House administration took power – the 21st Century Cures Act, enacted in the closing days of 2016, followed by the FDA Reauthorization Act, signed into law this summer.
The highest profile US health-care policy events in 2017 were Congress' repeated failed attempts to repeal the Affordable Care Act (and ultimate success in repealing the individual mandate associated with that legislation as part of December's sweeping tax reform). The challenges associated with those efforts were certainly one key factor in the device industry's failure on its signature legislative goal – to repeal the 2.3% device excise tax. Once the ACA "repeal-and-replace" measures fell through as viable legislation, the industry was never able find a workable alternative, despite repeated attempts. Companies are hoping the Internal Revenue Service will go easy on them until Congress finally does come through – if it does at all.
With regards to overall FDA medtech policy development, the year started slow – very slow. From Trump's inauguration on Jan. 20 through June, the agency did not issue one medical device- or IVD-related guidance document. But once new FDA Commissioner Scott Gottlieb was settled in, the dynamic changed dramatically. From the summer till now, CDRH has issued 44 new draft and final guidance documents – just about the same number that the center produced in all 12 months of 2016.
While the focus of the guidelines and other policy documents issued in the Gottlieb era have varied, there has been an emphasis on new, sometimes experimental approaches to streamlining product development or oversight. In many cases, the documents are implementing provisions of the Cures or Reauthorization Acts, but the agency has also made a point of saying that it is using the new congressional authorities as a foundation to build out more expansive frameworks to support innovation.
New regulatory ideas or approaches that were developed internally during the prior administration in parallel to congressional processes appear to be rolling out at a rapid, but structured, pace by Gottlieb's agency. Digital health has been a major topic of focus in this regard. FDA unveiled an overarching action plan for the sector that incorporates deregulatory elements enacted in the Cures Act, but goes beyond what Congress mandated and envisions a completely new regulatory paradigm for health software tools that would apply the concept of "precertification."
Reimbursement And More For 2018
Overall, the FDA regulatory environment is in a good state and getting better from industry's perspective. More programs designed to give quicker options to market are anticipated for rollout in 2018, including a novel 510(k) pathway that the agency says won't involve predicate comparisons.
The bigger challenge for the coming year is likely to be in the realm of market access and reimbursement. As approval processes refine, Medicare and other payer policies that would help provide a market on-ramp for breakthrough technologies have not kept pace. Although finally wresting victory on permanent device-tax repeal will be industry's biggest US policy goal in 2018, engaging CMS and Congress to improve coverage, coding and payment pathways for new technologies will also be high on the list.
Device firms will also be watching closely on policies impacting value-based purchasing models in health care. The Trump administration has taken clear steps to roll back or slow down Obama-era mandatory alternative-payment models, including bundled payment programs in orthopedic and cardiac device-dependent procedures. Many firms look at the moves as an opportunity to design payment models that will better reward the value that medtech tools bring to the system, but the coming year could be an important one in better determining the government's role in this health-care evolution.
But, on a macro-level, 2018 could be another year of political chaos. With mid-term congressional elections coming in November and investigations of the White House over election collusion with Russia heating up, the environment for policymaking that will shake out is hard to predict.
Check out the top 25 Medtech Insight US regulatory and policy stories of 2017, based on Web hits, in the table below.