Lawmakers Unveil Discussion Draft for Medical Innovation Package
January 28, 2015 in News
On Tuesday, lawmakers on the House Energy and Commerce Committee unveiled a discussion draft for a bipartisan package of proposals aimed at increasing medical innovation, in part by expanding health IT, The Hill reports (Ferris, The Hill, 1/27).
In November 2014, Committee Chair Rep. Fred Upton (R-Mich.) and committee member Rep. Diana DeGette (D-Colo.) released a framework for the “21st Century Cures” legislative package, outlining its focus on six priority areas:
- Cultivating the future of science, including by encouraging young scientists;
- Further incorporating the patients’ perspectives into the regulatory process;
- Investing in advancing research;
- Modernizing clinical trials;
- Providing incentives for developing new devices and drugs to treat unmet medical needs; and
- Supporting health IT by furthering the use of new medical technologies and data sharing (iHealthBeat, 12/1/14).
Draft Proposal Details
While the discussion draft focuses largely on FDA and safeguarding medical device innovations, it contained several health IT-related proposals (The Hill, 1/27).
Specifically, the draft included:
- A proposal from Health Subcommittee Chair Joe Pitts (R-Pa.) that would require NIH grant recipients to share their data (Dvorak, FierceHealthIT, 1/27);
- Language from an Energy and Commerce workgroup that seeks to expand Medicare beneficiaries’ access to telehealth services; and
- The SOFTWARE Act, which would develop a regulatory framework for FDA’s oversight of health IT.
The discussion draft also included several proposals targeting health data sharing, such as:
- Language from a bill by Rep. Michael Burgess (R-Texas) that would encourage the sharing of electronic health record data;
- Revising the 2009 HITECH Act to increase access to data stored in health care facilities; and
- Streamlining informed consent rules and other types of ethical review of research (Pittman, Politico Pro, 1/27).
In addition, a proposal Rep. Tim Murphy (R-Pa.) would seek increased funding for brain research (The Hill, 1/27).
The lawmakers are looking to collect feedback on the proposals in an effort to create a bill that could be approved and sent to President Obama by the end of 2015 (Dvorak, FierceHealthIT, 1/28).
The discussion draft received praise from several health care industry groups (Tahir, Modern Healthcare, 1/28).
In a statement, United for Medical Research President Carrie Wolinetz said the discussion draft would help “ensure the U.S. keeps its title of world leader in medical innovation” (The Hill, 1/27).
Similarly, the Health IT Now Coalition in a statement said it was “encouraged” by the legislative package, particularly by “solutions related to how health IT is regulated, interoperability, telehealth and electronic matching of patients to clinical trials” (Health IT Now release, 1/27).
Dan Haley, vice president of government affairs at athenahealth, also said that he was “pleased” with the draft discussion.
The Advanced Medical Technology Association noted that “[p]olicy improvements are essential” to improve the innovation ecosystem that supports the health care industry, while the National Venture Capital Association said legislative action is needed to improve regulations and reimbursements for medical startups (Modern Healthcare, 1/28).
However, some Democratic lawmakers said they were disappointed with the discussion draft. For example, Rep. Frank Pallone (D-N.J.) said the draft “does not reflect true bipartisan collaboration.” He added, “In its current form, I am concerned that the nearly 400-page draft could create more problems for our health care system than it solves” (Attias, CQ Roll Call, 1/27).
Meanwhile, Jeff Smith, vice president of public policy at the College of Healthcare Information Management Executives, questioned why the draft discussion failed to include some of the top issues facing the health care industry. He said, “We have a bill here that’s supposed to bring the health care system into the 21st century that doesn’t mention meaningful use” (Modern Healthcare, 1/28).