February 12, 2016

Senate Committee Reviews Biomedical Innovations Bills

The Senate Health, Education, Labor, and Pensions (HELP) Committee held the first in a potential series of legislative markups on Feb. 9 pertaining to bills focusing on health information technology (HIT), the regulation and approval process for medical devices and pharmaceuticals, as well as disease and public health research. HELP Committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-WA) preferred to review a collection of individual, non-controversial biomedical “innovations” bills rather than H.R. 6, the 21st Century Cures Act.

Passed by the House of Representatives in July 2015, the 21st Century Cures Act is comprehensive legislation to modernize and streamline the federal government’s approval process for pharmaceuticals and medical devices. Senate Republican opposition to the creation of a mandatory funding stream for the National Institutes of Health (NIH) and a strong sense among Senate Democrats that H.R. 6 unnecessarily relaxed needed government regulation at the behest of lobbying from the drug and device industries prevented the HELP Committee from considering H.R. 6 in its entirety.

The HELP Committee reviewed and passed 7 total bills during the markup including:

  • S. 2511, the Improving Health Information Technology Act
  • S. 2503, the Preventing Superbugs and Protecting Patients Act
  • S. 849, the Advancing Research for Neurological Diseases Act of 2015
  • S. 800, the Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act
  • S. 1622, the FDA Device Accountability Act of 2015
  • S. 2030, the Advancing Targeted Therapies for Rare Diseases Act of 2015
  • S. 2014, the Next Generation Researchers Act
The American College of Radiology (ACR) is closely monitoring S. 2511, legislation that seeks to improve physician and consumer protections by implementing a development council-administered, three star ratings scale for certified HIT products in the areas of usability, interoperability and security. 

The U.S. Department of Health and Human Services (HHS) and the development council would work with specialty physicians, among other stakeholders, to develop reporting criteria to guide the ratings.

Although appreciative of the efforts to promote physician and consumer protection concepts within HIT, the ACR is following the Improving Health Information Technology Act primarily due to provisions designed to curb information blocking activities by both electronic health record vendors and health care providers. Many of the information-blocking concepts included in S. 2511 are slightly weaker than provisions initially included in the ACR-supported S. 2141, the Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015. 

The ACR submitted formal comments in late January and met with key HELP Committee staffers in mid-February urging the use of language in the Improving Health Information Technology Act that is more consistent with terms that appear in the TRUST IT Act. Ultimately, S. 2511 revised the TRUST IT Act’s definition of information blocking to create two distinct categories based on entity type – one for developers/vendors/Health Information Exchange networks, versus one for providers (e.g. hospitals and health systems).

Developers would be held accountable for essentially the same behaviors covered by the TRUST IT ACT, including blocking via ignorance or disregard, and providers would be held accountable for only “knowingly and unreasonably restricting” information exchange. Through a formal rulemaking process, HHS would identify reasonable and necessary actions by developers that are not information blocking, as well as a set of specified actions that are information-blocking by providers. 

S. 2511 also mandates different penalties based on entity type. Developers, vendors and exchange networks that engage in information-blocking would be assessed civil monetary penalties that are determined in forthcoming regulations by the Secretary of HHS. Providers, however, would only be subject to “appropriate incentives and disincentives under applicable federal law.” In contrast, the TRUST IT Act utilized more explicit language which permitted HIT vendors, as well as hospitals and health systems, to be fined for each incident of information blocking with financial penalties not to exceed $10,000.

Although the College submitted comments stressing improvements to the information-blocking section, the ACR is pleased that the HELP Committee ultimately passed S. 2511 unanimously. ACR views the Improving Health Information Technology Act as an important step in a larger process to improve health IT interoperability and information exchange.

Disagreement between Republicans and Democrats surrounding the need for mandatory versus discretionary funding for the NIH, however, was not solved in the Feb. 9 mark-up. As a result, full enactment of S. 2511 within the Senate and House remains murky. ACR members are encouraged to closely monitor the Advocacy in Action newsletter for additional information on the latest developments surrounding the HELP Committee’s biomedical innovations effort.