Feb. 9 meeting will be 1st of 3 to produce companion legislation to 21st Century Cures Act already passed by House

 

 “The House has completed its work on the 21st Century Cures Act. The president has announced his support for a precision medicine initiative and a cancer ‘moonshot.’ It is urgent that the Senate finish its work and turn into law these ideas that will help virtually every American.”

Chairman Lamar Alexander (R-Tenn.) yesterday announced the Senate health committee will hold its first executive session considering bills on biomedical innovation on Tuesday, Feb. 9. At that committee meeting, the committee will consider at least seven bipartisan bills.

The committee’s February meeting will be the first of three. The two meetings held in March and April will consider additional bipartisan bills.

“Senators and staff on our committee have been working together throughout 2015 to produce a number of bipartisan pieces of legislation that are ready for the full committee to consider,” said Alexander. “The House has completed its work on the 21st Century Cures Act. The president has announced his support for a precision medicine initiative and a cancer ‘moonshot.’ It is urgent that the Senate finish its work and turn into law these ideas that will help virtually every American.”

Alexander continued, “The committee has also been working for months on legislation to help achieve interoperability of electronic health records for doctors, hospitals and their patients—and the committee will be releasing a bipartisan staff draft of that legislation later this week for public comment.”

The bills slated for consideration at the Feb. 9 committee meeting include:

Bipartisan HELP Committee legislation to improve electronic health records.

The FDA Device Accountability Act of 2015 (S.1622), sponsored by Sens. Burr (R-N.C.) and Franken (D-Minn.);

The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S.2030), sponsored by Sens. Bennet (D-Colo.), Burr (R-N.C.), Warren (D-Mass.), and Hatch (R-Utah);

The Advancing Research for Neurological Diseases Act of 2015 (S.849), sponsored by Sens. Isakson (R-Ga.) and Murphy (D-Conn.);

The Next Generation Researchers Act (S.2014), sponsored by Sens. Baldwin (D-Wisc.) and Collins (R-Maine);

The Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act (S. 800), sponsored by Sens. Kirk (D-Ill.), Bennet (D-Colo.), Hatch (R-Utah), Murkowski (R-Alaska), Isakson (R-Ga.), and Collins (R-Maine); and

Legislation regarding FDA regulation of duodenoscopes.

Alexander said the goals of the draft electronic health records bill to be released this week are:

Decreasing unnecessary physician documentation;

Enabling patients to have easier access to their own health records;

Making electronic health records more accessible to the entire health care team, such as nurses;

And these next areas are especially critical to developing systems that achieve interoperability:

Stopping information blocking—or intentional interference with access to personal health information;

Ensuring the government’s certification of a records system means what it says it does; and

Improving standards.

Alexander said there would be a second executive session on the innovation agenda on March 9. At that session, the committee will continue to consider bipartisan legislation to modernize the Food and Drug Administration and the National Institutes of Health and provide congressional support for the president’s Precision Medicine Initiative, including:

The Advancing Hope Act of 2015 (S. 1878), sponsored by Sens. Casey (D-Pa.), Isakson (R-Ga.), Brown (D-Ohio) and Kirk (R-Ill.);

The Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S. 1101), sponsored by Sens. Bennet (D-Colo.) and Hatch (R-Utah);

The Medical Countermeasures Innovation Act of 2015 (S. 2055), sponsored by Sens. Burr (R-N.C.), Casey (D-Pa.), Isakson (R-Ga.), and Roberts (R-Kan.);

The Combination Products Innovation Act of 2015 (S.1767), sponsored by Sens. Isakson (R-Ga.), Casey (D-Pa.), Roberts (R-Kan.) and Donnelly (D-Ind.);

The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077), sponsored by Sens. Burr (R-N.C.), Bennet (D-Colo.), Hatch (R-Utah), and Donnelly (D-Ind.); and

Legislation to support the president’s Precision Medicine Initiative and ensure that the NIH has the tools it needs to research treatments that are individualized for patients.

A third and final markup is planned for April 6 to complete committee action on the committee’s innovation agenda.