Legislative Activity

Lawmakers To Vie For House Ways And Means Gavel

With Rep. Paul Ryan (R-WI) expected to succeed Rep. John Boehner (R-OH) as Speaker of the House, some Republican lawmakers are eyeing the opening Rep. Ryan would leave behind at the helm of the House Committee on Ways and Means. Several congressmen are expected to vie for the chairmanship, including Reps. Kevin Brady (R-TX), Pat Tiberi (R-OH), and Devin Nunes (R-CA). Of note, Rep. Brady is Chairman of the Committee’s Subcommittee on Health, and he took a lead role in successfully shepherding H.R. 2, the Medicare Access and CHIP Reauthorization Act, through the House earlier this year. Also known as the Sustainable Growth Rate (SGR) package or the “permanent doc fix,” the bill permanently repealed Medicare’s often-criticized physician payment system. Rep. Brady is more senior than Rep. Tiberi, who is Chairman of the Committee’s Subcommittee on Trade. Rep. Nunes is Chairman of the House Permanent Select Committee on Intelligence.

This Week’s Hearings:

• Tuesday, October 27: The House Committee on Veterans’ Affairs Subcommittee on Oversight and Investigations and the House Committee on Oversight and Government Reform will hold a joint hearing titled “VA and DoD IT: Electronic Health Records Interoperability.”

• Wednesday, October 28: The Senate Committee on Veterans’ Affairs will hold a hearing titled “VA Mental Health: Ensuring Access to Care.”

• Thursday, October 29: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “Examining the Regulation of Diagnostic Tests and Laboratory Operations.”

• Thursday, October 29: The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a hearing titled “Mental Health and Substance Use Disorders in America: Priorities, Challenges, and Opportunities.”

Regulatory Activity

FDA Names Medical Device Security As A Priority

On Tuesday, October 20, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released its FY 2016 “Regulatory Science Priorities.” This document summarizes CDRH’s top ten regulatory science needs and priorities for FY 2016 and provides an overview of the process that the agency used to generate its priorities.

Of note, this report names “enhancing performance of Digital Health and medical device cybersecurity” as a top priority. As medical devices are increasingly used in networked environments, CDRH notes that research is needed to “enhance the performance and security of medical devices and interoperability,” as well as to “understand the impact of software modifications on device performance.”

CMS Releases Proposed Notice On Basic Health Program Funding

On Thursday, October 22, the Centers for Medicare and Medicaid Services (CMS) issued a proposed notice titled “Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018.” This document proposes methodology for determining federal payments to states that elect to establish a Basic Health Program (BHP) during the 2017 and 2018 program years. Under section 1331 of the Affordable Care Act, states have the option to create a BHP, which would provide coverage for residents who do not qualify for Medicaid, the Children’s Health Insurance Program (CHIP), or other minimum essential coverage, and have income between 133 percent and 200 percent of the federal poverty level.

This notice proposes to use the same funding methodology as established for the 2016 program year and offers updated values for several factors, including an adjustment for members of federally-recognized tribes who are enrolled in the program. The 30-day comment period runs until November 23. The agency plans to finalize the methodology by February 2016, which it anticipates would give states sufficient time to make program adjustments or begin implementing a BHP.