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Washington Debrief: Senators Demand More Info on FDA's Health IT Regulatory Plans

March 24, 2014
by Gabriel Perna
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Jeff Smith, Senior Director of Federal Affairs

Top News

Senators ask for More Info on FDA’s Health IT Regulatory Plans

Key Takeaway: A bipartisan group of six Senators sent a letter to the Food and Drug Administration (FDA) asking for clarification on the agency’s plans to regulate health IT. The letter is notable because it includes the chair and ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee.

Why it Matters: This letter represents the latest attempt by healthcare stakeholders to better define how the FDA views its regulatory authority over health IT. An impending report will articulate the administration’s views, and it will signal to healthcare CIOs how much of their future plans must incorporate FDA regulation of their IT systems.

In a joint statement, Sens. Tom Harkin (D-IA), Lamar Alexander (R-TN), Michael Bennet (D-CO), Richard Burr (R-NC), Orrin Hatch (R-UT), and Mark Warner (D-VA) urged “FDA to provide further clarity and transparency in its policy regarding medical mobile apps… to promote innovation and keep consumers safe in light of changing technologies” The Senators ask FDA nine questions about agency processes to handle emerging functionalities; the possible effects of legislatively mandated definitions for medical software; and questions about how FDA will enable business to better navigate regulatory requirements. This bipartisan effort comes only days before a much-anticipated report from HHS agencies, including the FDA, ONC and Federal Communications Commission, and it joins two bills, the House-introduced SOFTWARE Act and the Senate’s PROTECT Act.

In a related news item, the FDA issued a class I (high-risk) recall notice about a McKesson-made clinical decision support system, called Anesthesia Care. The anesthesia information management system is designed to monitor patients under anesthesia and notify clinicians about possible dangerous medication reactions and contraindications. The FDA recalled the system because of a patient data mismatch incident initiated by a software error that could “cause serious adverse health consequences, including death.” This case is already being highlighted by opponents and proponents of introduced legislation. Opponents of the House and Senate bills believe that clinical decision support systems must remain under the purview of FDA; proponents of legislation believe the FDA has outmoded regulatory processes, which will hinder its ability to regulate software.

For a CHIME analysis of the two bills, click here.

Legislation & Politics

SGR Climate: What’s Happening and What’s Next?

Key Takeaway: As the March 31 deadline for a 24 percent decrease in Medicare reimbursement in physician payments approaches, Congress is trying to figure out how to pay for a permanent SGR fix.

Next Steps: In recent weeks, three main themes have emerged in the discussion on how to pay for a permanent solution – pass the bill with no “pay-fors,” delay the individual mandate or divert war savings to help offset SGR reform costs. It is likely that a three- or nine-month patch will emerge towards the end of the month to give Congress time to determine how to pay for a permanent fix.

As the deadline looms, partisan solutions have been proposed, and none are likely to gain bipartisan, bicameral support. Last week, the House passed H.R. 4015 and added a five-year delay of the Affordable Care Act individual mandate to pay for it – this inclusion is not likely to gain traction in the Senate because of its Democratic majority. Sen. Hatch (R-UT) has proposed S. 2122 to mirror this language, but the Senate has yet to vote on any proposed SGR bills. This version will cost $138.4 billion over 10 years.

On the other hand, Sen. Wyden (D-OR) introduced S. 2110, which will cost $180 billion over 10 years; it has the same language as H.R. 4015 and adds extensions to a few Medicare programs that are set to expire. He proposes paying for SGR repeal by using war savings funds from massive reductions in deployments in Afghanistan and Iraq. House and Senate Republicans are not likely to support this language and have called it a “gimmick.” The only other two options to consider are passing a bill without “pay-fors,” which neither party wants to do, or passing another short-term patch until the end of the year, which would put SGR reform in the hands of a new Congress after elections.

SGR reform focuses on moving from fee-for-service to fee-for-quality. Physician reimbursement would increase by 0.5% each year from 2014 to 2018, and then would focus on alternative payment models and the proposed Merit-Based Incentive Payment System for payment increases.