On January 23, 2015, BPC organized an event on Capitol Hill to assess and share the outlook for health information technology (IT) in the coming year. The audience of more than 250 people listened as professional staff serving key congressional committees shared their perspectives on both the challenges and the opportunities associated with HIT, as well as what might be expected in 2015. A question and answer period followed the presentations.
The director of BPC’s Health Innovation Initiative, Janet Marchibroda, moderated the panel discussion, which featured staff from the offices of five Republican and four Democrat legislators in the House and Senate who serve on one or more of three health-related committees.
Key takeaways from the discussion are highlighted below.
Expect more bipartisan action on the regulation of health software technologies
Panelists from both sides of the aisle reported support for greater clarity regarding regulation of health IT. The question is not if health IT will be regulated, said one panelist, but how it will be regulated, and how regulation will balance patient safety concerns.
Specific related issues discussed by the panel included key elements of the Medical Electronic Data Technology Enhancement for Consumers’ Health, or MEDTECH, Act, introduced by Senators Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) in December 2014. The bill aims to improve clarity and transparency of regulation of patient records and certain decision-support software by removing this type of software from the “medical device” category which is under Food and Drug Administration (FDA) jurisdiction.
In addition, the panel discussed Rep. Marsha Blackburn’s (R-TN) and Rep. Gene Green’s (D-TX) plans to reintroduce the Sensible Oversight for Technology which Advances Regulatory Efficiency, or SOFTWARE, Act. This bill was introduced in the 113th Congress as a marker and has involved an open and collaborative process for stakeholder input all along the way. Panelists shared that the most recent revised discussion draft was circulated again to stakeholders for feedback in January and is part of the 21st Century Cures Initiative. [following this panel, the 21st Century Cures discussion draft was released and contained the latest SOFTWARE language within Title II, subtitle E]. Staff from Rep. Blackburn’s and Green’s offices discussed key elements of the draft bill that seeks to divide health IT into two categories: medical software to be regulated by FDA, and health software that won’t be regulated by FDA. The language of the bill also calls for the HHS Secretary to promulgate final regulations associated with standards, policies, and procedures for medical software.
Interoperability is a big priority on both sides of the aisle
Across the board, panelists agreed that getting to greater levels of interoperability and information sharing is critical to efforts related to new models of delivery and payment. One panelist also noted that interoperability is essential to support clinical trials and comparative effectiveness studies. Several panelists said they are awaiting with interest the release of the proposed rule on Stage 3 Meaningful Use, which is expected to address interoperability in a significant way.
Release of 21st Century Cures draft legislation is an important step, along with focus on modernizing the FDA
Panelists were anticipating with great interest release of the 21st Century Cures initiative — discussion draft focused on improving the process of developing life-saving medical products and technologies (the discussion draft was released January 27). The draft includes initiatives designed to clarify the FDA’s role in getting medicines to market and cures to patients. Health IT plays a critical role in these endeavors, and staff indicated there is bipartisan interest in Congress for moving this initiative forward. (Note: since the Jan. 23 panel, Sen. Alexander and Sen. Burr released, Innovation for Healthier Americans).
Bipartisan, bicameral support for SGR replacement legislation continues
Panelists indicated continued interest on the Hill in moving SGR replacement legislation introduced in the 113th Congress forward. This legislation, introduced by the House Energy and Commerce Committee, House Ways and Means Committee, and Senate Finance Committee, already enjoys bicameral, bipartisan support and would replace the SGR with payment incentives that promote the delivery of high-quality, cost-effective care. The legislation is also backed by numerous patient, provider, health plan and business groups. Panelists said that finding ways to offset the cost of the bill would continue to be a challenge.
Panelists also expressed interest in other issues including advancing telehealth and addressing cybersecurity and privacy issues.
The panel discussion confirmed that congressional interest and likely action this year aligns considerably with BPC’s Health Innovation Priorities for Congress in 2015 (below), also shared at the event.
- Improve regulatory clarity associated with the oversight of health IT and advance an oversight framework for health IT that promotes innovation and protects patient safety.
- Encourage further interoperability across health IT systems and electronic information sharing among those who deliver care and services to patients to improve the cost, quality, and patient experience of care. Replacing the SGR and reforming Medicare payment to support the transition from fee-for-service payment to new payment models that reward value, improve health outcomes, improve patient experience, and reduce costs will serve as a significant incentive for interoperability and information sharing.
- Remove barriers to and provide incentives for telehealth services that improve access, improve the quality and patient experience of care, and reduce costs.
- Advance policies that promote innovation and reduce the time and cost associated with bringing innovative and safe drugs and devices to market.
BPC is grateful to congressional staff members for sharing their insights with stakeholders at this event, and looks forward to continuing to promote practical solutions to health care’s pressing problems that can garner widespread bipartisan support.
KEYWORDS: 21ST CENTURY CURES, FOOD AND DRUG ADMINISTRATION, GENE GREEN, HOUSE ENERGY AND COMMERCE COMMITTEE, HOUSE WAYS AND MEANS COMMITTEE, MARSHA BLACKBURN, MEDTECH ACT, MICHAEL BENNET, ORRIN HATCH, SENATE FINANCE COMMITTEE, SOFTWARE ACT OF 2013