Senate HELP Committee Begins Consideration of Companion Legislation to the House 21st Century Cures Act

Senator Lamar Alexander (R-TN), Chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, recently announced that the committee will hold the first of three executive sessions to consider legislation to address biomedical innovation. The legislation affects the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The bills would serve as the companion legislation to the 21^st Century Cures Act passed by the House last summer (see Update, July 14, 2015). The executive sessions are planned for February 9, March 9, and April 6. Alexander stressed that the Committee worked throughout 2015 to produce the bills that are now ready for the full committee to consider, emphasizing the urgency required by the Senate to “finish its work and turn into law these ideas.”

Alexander specifically highlighted the committee’s work on legislation “to achieve interoperability of electronic health records” (EHRs). The Committee recently released a discussion draft of legislation along with a summary addressing health information technology (HIT), including EHRs, and is seeking comments. The discussion draft includes provisions to assist doctors and hospitals in improving quality of care for patients, establish Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT), provide the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing, foster a “network of networks” including establishing “an initial set of common data elements,” ensure that registries are certified to transmit and receive from certified HIT, provide “certification and development of patient-centered health record technology so that patients can access their health information through secure and user-friendly software, which may update automatically,” secure EHRs, and direct the Governmental Accountability Office (GAO) “to review methods for securely matching patient records to the correct patient.”

According to the Chairman, at least seven “bipartisan bills” are expected to be considered at the February session:

• Bipartisan HELP Committee legislation to improve Electronic Health Records;
• The FDA Device Accountability Act of 2015 (S. 1622): Senators Richard Burr (R-NC) and Al Franken (D-MN);
• The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S. 2030): Senators Michael Bennet (D-CO), Richard Burr (R-NC), Elizabeth Warren (D-MA), and Orin Hatch (R-UT);
• The Advancing Research for Neurological Diseases Act of 2015 (S. 849): Senators Johnny Isakson (R-GA), and Christopher Murphy (D-CT);
• The Next Generation Researchers Act (S. 2014): Senators Tammy Baldwin (D-WI) and Susan Collins (R-ME);
• The Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act (S. 800): Senators Mark Kirk (R-IL), Michael Bennet (D-CO), Orin Hatch (R-UT), Lisa Murkowski (R-AK), Johnny Isakson (R-GA), and Susan Collins (R-ME); and
• Legislation regarding FDA regulation of duodenoscopes

The March and April sessions will continue to address issues pertaining to NIH and FDA and would “provide congressional support” for President Obama’s Precision Medicine Initiative (PMI).

• The Advancing Hope Act of 2015 (S. 1878): Senators Robert Casey (D-PA), Johnny Isakson (R-GA), Sherrod Brown (D-OH), and Mark Kirk (R-IL);
• The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act (S. 1101): Senators Michael Bennet (D-CO), and Orin Hatch (R-UT);
• The Medical Countermeasures Innovation Act of 2015 (S. 2055): Senators Richard Burr (R-NC), Robert Casey (D-PA), Johnny Isakson (R-GA), and Pat Roberts (R-KS);
• The Combination Products Innovation Act of 2015 (S. 1767): Senators Johnny Isakson (R-GA), Robert Casey (D-PA), Pat Roberts (R-KS), and Joe Donnelly (D-IN);
• The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077): Senators Richard Burr (R-NC), Michael Bennet (D-CO), Orin Hatch (R-UT), and Joe Donnelly (D-IN); and
• Yet-to-be released legislation to support PMI to “ensure that the NIH has the tools it needs to research treatments that are individualized for patients.”

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