Paul Melmeyer, MPP

Earlier this summer the House passed the 21st Century Cures Act  by a 344-77 vote, and the bill was unanimously approved by the Energy and Commerce Committee, the committee of jurisdiction in the House of Representatives that oversees much of the U.S healthcare system. The bill includes policy reforms for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), as well as greater investment in furthering innovative Health IT practices.

For the NIH, the bill encourages investment in high-risk but high-reward, biomedical research, offers greater support for emerging scientists, alleviates several administrative burdens, increases coordination of pediatric research, and includes other reforms aimed at strengthening the world’s largest funder of biomedical research.

For the FDA, the bill establishes a biomarker and surrogate endpoint qualification process, encourages the use of “real-world” evidence in approving therapies, incentivizes orphan drug development, streamlines the medical device approval process, and tasks the agency with increasing the inclusion of “patient experience data” in the drug review process.

The bill contains several health care delivery-focused provisions that are aimed at the greater integration of Health IT innovations, such as the greater coordination of interoperability standards and telehealth services, and several tweaks to the laws governing continuing medical education and durable medical equipment.

The bill includes additional mandatory funding for the NIH and FDA – $8.5 billion and $550 million respectively – to be appropriated over the next five years.  Much of the bill’s funding will come from selling millions of barrels of oil from the Strategic Petroleum Reserve.  

Supporters of the 21st Century Cures Act have heralded the policy reforms as revolutionary; however, the bill’s detractors cite the general lack of substantive changes to the healthcare delivery system as a reason to not support its passage. After all, what good is developing a medical treatment research and development superhighway if the delivery system is a dirt road? The consensus opinion seems to be merely tepid support. The leading argument is that while the bill offers a little bit of something for everyone, it presents nothing particularly “game-changing” in accelerating the pace of medical and therapeutic innovation.

Within the next month the Senate  Health, Education, Labor, and Pensions (HELP) Committee is expected to release its widely anticipated legislative discussion draft of the Innovation for Healthier Americans Initiative, the Senate’s parallel effort to the House’s 21st Century Cures Act.

It is up to the Senate HELP Committee to decide what pieces of the 21st Century Cures Act make it into the October discussion draft, and what pieces are left on the cutting room floor. Senate HELP members also make it very clear that the Innovation for Healthier Americans Initiative is independent from the 21st Century Cures Act, implying  that there could be little to none of the 21st Century Cures Act included in the draft.

Health care policy observers are most interested in what will come of the 21st Century Cures Act mandatory funding for the NIH and FDA. Much of this funding (revenue from selling oil) does not fall within the Senate HELP Committee’s jurisdiction, leaving this funding source in question. In order to use this funding, the HELP Committee would have to go through the Energy and Natural Resources Committee, greatly complicating the enactment process.

Instead, the HELP Committee may choose to make the funding discretionary rather than mandatory, a move that will create a more public price-tag for the bill, thus possibly harming its chances with conservatives. Mandatory funding is attractive as it bypasses the appropriations process and guarantees the policy reforms are funded. The funding is also not subject to the discretionary spending budget caps.

Regardless, the health policy community eagerly awaits the discussion draft’s release in early October, and is once again preparing itself for a legislative battle over the cost of medical innovation.