Healthcare Leadership Council Releases Statement on “21st Century Cures” Draft Legislation

WASHINGTON – The Healthcare Leadership Committee released the following statement today in conjunction with the House Energy and Commerce health subcommittee hearing on “21st Century Cures.”

The Healthcare Leadership Council (HLC), a coalition of chief executives of the nation’s leading healthcare companies and organizations, appreciates your efforts and the bipartisan work toward the release of the second draft of the “21st Century Cures Act’’ by the House Energy and Commerce Committee.

HLC strongly supports the effort to modernize the discovery, development and delivery of innovative treatments and cures to patients nationwide and is pleased to see this effort led on a bipartisan basis by Energy and Commerce Committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), full committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX). HLC and its members have actively worked to support many sections of this draft legislation.

For example, HLC is pleased by the inclusion of provisions designed to speed the clinical trial process and reduce unnecessary administrative burdens. While the provisions on expanding the sharing of data generated through NIH-funded research are important, HLC strongly believes that any effort to accelerate treatments and cures must include robust data sharing from the Centers for Medicare and Medicaid Services (CMS), as well.

In testimony before the House Energy and Commerce health subcommittee last summer, on existing barriers to developing and communicating medical evidence, HLC testified that in order to advance health system improvements and medical research, health data held by the federal government should be shared more freely with organizations working to treat patients and develop new treatments and cures. Any standard that restricts access to critical federally-held data is detrimental to our shared goals for medical and human progress. We hope future drafts include provisions encouraging greater data sharing with the private sector by federal agencies.

HLC is pleased to see the Energy and Commerce Committee address modernization of research restrictions related to the Health Insurance Portability and Accountability Act (HIPAA). We believe that medical privacy laws are serving the public well, but minor updates are necessary to enabling optimal use of today’s health databases. HLC’s testimony to Congress encouraged members to keep in mind that HIPAA was created at a time in which policymakers weren’t thinking about the knowledge that could be gained by accessing data residing in large databases and the technological ability to process that data very rapidly. It is appropriate to adjust the authorization components of HIPAA to ensure that data can be used effectively for research.

Throughout the 21st Century Cures Initiative process, HLC has emphasized the importance of telehealth and electronic health record interoperability for inclusion in the draft legislation. We strongly support the Energy and Commerce Committee’s continued work on these sections for inclusion in the final legislation.

HLC CEO members, who are leaders in every healthcare field, have agreed on the need for an interoperable health IT infrastructure constructed in a way that is both beneficial to consumers and realistic and sustainable for industry. In a September 2014 statement, all HLC members endorsed a role for policymakers in encouraging the exchange of material and meaningful health data and in decertifying electronic health record products that knowingly block information. We will continue to work with Congress to finalize draft language addressing these critical issues in the 21st Century Cures Act.

We look forward to seeing the provisions on telehealth, and are pleased that work continues on a bipartisan basis. Telemedicine legislation is essential to equip healthcare providers with the tools needed to ensure they can meet the demands of an innovative healthcare system, dramatically changing patient demographics, and engaging patients in the prevention and management of their chronic diseases. HLC’s multisector, consensus principles on workforce identify telehealth as a top priority, and stress the importance of significantly addressing the current restrictive reimbursement, licensure, and other regulatory barriers that make it challenging to employ telehealth effectively.

Thank you for your continued leadership on issues critical to millions of Americans. We appreciate the opportunity to work with you as you continue to develop this legislation.
The opportunity to accelerate cures and treatments for those most in need is one we all must embrace and advance.