A new article published in Policy and Medicine highlights bipartisan efforts in Congress to pass a broad regulatory overhaul known as '21st Century Cures,' which includes an important provision that would exempt certain "transfers of value" related to CME from the Sunshine Act's reporting requirements. This bipartisan provision, based on legislation introduced by Reps. Michael Burgess (R-TX) and Peter DeFazio (D-OR), would encourage continued physician participation in CME events without concern for being publicly reported in a database for having received payments from commercial supporters. In response to the advancement of this bill, Andrew Rosenberg of the CME Coalition said that Congress "has demonstrated the commitment to CME as a bipartisan issue."
This morning, the House Energy and Commerce Committee voted 51-0 to approve the 21st Century Cures Act. With the way the bipartisan bill sailed through, it appears the 21st Century Cures train has left the station.
The Act was authored by full committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member DeGette, 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).
"This historic day marks a big bipartisan step forward on our path to cures,” said Upton. “We have all said too many early good-byes to people we love and treasure. Every single person has a common goal: we want more time with those we love. In this, the greatest country in the world, Americans deserve a system second to none. We can and must do better. The time for 21st Century Cures is now.”
"In the last century, American medicine leapt from medicine shows to the mapping of the human genome,” said DeGette.”With the 21st Century Cures Act, we seek to support the biomedical community in making a similar leap forward in this next century. With billions in support for our premier research and development institutions and comprehensive reform of our systems, 21st Century Cures will make a real difference in the lives of patients and their families."
Rep. Green added, “I’m proud of the final bill that was voted out of Committee, which will improve the innovation ecosystem for the development of life-saving medical breakthroughs, foster the development and the interoperability of health information technology, and better leverage critical resources to facilitate the discovery of new cures. After one year of deliberation, research, and stakeholder input we’re one step closer to delivering new cures and therapies, and hope to patients.”
After the voting, Congressman Joe Barton (R-TX) expressed his enthusiasm for the fact that the Cures bill was unanimous:
I’ve been on the Committee for 28 years, and I don’t think we’ve ever had a major bill that didn’t have somebody...that voted no. That is an amazing accomplishment Mr. Chairman, and I think the Committee should congratulate you, Mr. Pallone, Ms. DeGette, Mr. Pitts, and all the other members who worked in a leadership role.
This is a real achievement. This will change America. This will change the world for the better. This will last. This bill will become law and it will last for decades.
That is a real achievement.
The 21st Century Cures Act is full of important provisions, including a number of issues regularly covered on Policy and Medicine.
Encouraging Continuing Medical Education for Physicians
Section 3041 would exempt certain transfers of value to physicians from Sunshine reporting requirements that physicians have indicated hinder them from participation in important continuing medical education activities.
Section 2101: Facilitating Dissemination of Health Care Economic Information
This section would add clarity and facilitate dissemination of health care economic information, as defined in the section, to payers, formulary committees, or other similar entities.
Section 2102: Facilitating Responsible Communication of Scientific and Medical Developments
This section would require FDA to issue guidance on facilitating responsible, truthful, and nonmisleading scientific and medical information not included in the label of drugs.
John Kamp, the Executive Director of the Coalition for Healthcare Communication, called 21st Century Cures "a great step forward for American patients." Andrew Rosenberg of the CME Coalition notes that Congress "has demonstrated the commitment to CME as a bipartisan issue."
We will continue to provide updates to the 21st Century Cures Act progress as it moves through the House and Senate.