Tuesday, Senator Lamar Alexander (R-Tenn.), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced  that he will pursue a “step by step” approach to crafting major biomedical innovation legislation.  This is a marked departure from both the House-passed 21st Century Cures bill and the previously announced Senate plan.

The HELP Committee strategy is now to split legislation into at least seven discrete pieces of legislation. According to the HELP Committee announcement, the first “step” is a markup of the following bills on February 9th:

• 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 (R-Ill.), Bennet (D-Colo.), Hatch (R-Utah), Murkowski (R-Alaska), Isakson (R-Ga.), and Collins (R-Maine); and
• Legislation regarding FDA regulation of duodenoscopes.

Following this session, the HELP Committee plans to hold subsequent markups on March 9th and April 6th.  Presently, the following bills are on the docket for the March 9th markup, which will be focused on “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”:

• 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.

This approach increases the risk for passing comprehensive legislation during this session of Congress.  HELP Committee democrats, including Ranking Member Patty Murray (D-Wash.), have stated that there is not bipartisan support for marking up smaller bills beyond those scheduled for consideration February 9th.  However, it is possible that following the April hearing, the Committee could decide to combine the pieces of legislation that have the most bipartisan support into a semi-comprehensive bill.  With slightly over 120 legislative calendar days before the election, Democratic consensus will be critical to move any piece of healthcare-related legislation.

Whichever path the HELP Committee chooses, House Energy and Commerce Committee Fred Upton (R-Mich.) and Representative Diana DeGette (D-Colo.), who led passage of 21st Century Cures, expressed optimism that movement in the Senate is a “positive milestone.”

As the legislative clock continues to run, we will be closely monitoring the words and actions of the HELP Committee.

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