House Passes NDAA FDA Sidecar Bill

The House of Representatives unanimously passed a sidecar measure last week that will allow the Food and Drug Administration (FDA) to retain sole authority to approve drugs and medical devices while also ensuring the Department of Defense (DoD) more rapid access to lifesaving treatments for the battlefield. The National Defense Authorization Act (NDAA) included language that would have allowed DoD to approve some medical products for military personnel. The separate legislative fix (H.R. 4347) was a compromise to preserve the FDA’s review power. The bill allows DoD to request that the FDA expedite the approval process for medical treatments through emergency use authorization. The FDA and DoD will be required to meet on a semiannual basis to review the relevant products in the DoD’s portfolio and to meet quarterly to discuss high-priority products such as freeze-dried plasma. H.R. 4347 will now go to the Senate. The House will not officially send the NDAA to the upper chamber until the Senate passes the sidecar measure unamended.

Appropriations Outlook

Senate Appropriations Committee Chairman Thad Cochran (R-Miss.) issued a statement last week stressing the need for a budget deal between Congress and the Administration in order to complete work on fiscal year (FY) 2018 appropriations. Lawmakers have yet to reach an agreement on top-line funding levels for defense and non-defense programs. The current continuing resolution (CR) expires on December 8. Sen. Cochran has indicated that he plans to release a chairman’s mark next week for the four remaining appropriations bills that have not yet been taken up by the Committee. These include appropriations for Defense, Homeland Security, Financial Services, and Interior-Environment. Some sources say that Congressional leaders are currently discussing a two-year increase in the federal spending caps to raise defense and non-defense funding by a combined $200 billion. Sen. John Cornyn (R-Texas) has stated that the inclusion of cost-sharing reduction (CSR) payments in the end-of-year spending bill is also a possibility. It is becoming increasingly likely, however, that another short-term CR will be necessary to keep the government operating past December 8.

E&C Requests SBOMs to Increase Cybersecurity

Chairman of the House Energy and Commerce Committee Greg Walden (R-Ore.) is requesting that the U.S. Department of Health and Human Services (HHS) strengthen the supply chain of medical devices to improve cybersecurity. In a letter to the Acting HHS Secretary, he asks that the Department begin requiring manufacturers to account for third-party software components used in each of their products – known as software bills of materials (SBOM). The request aligns with a recommendation from HHS’ Health Care Industry Cybersecurity Task Force to better protect technologies relied upon by the health care industry from cyber threats. Rep. Walden requests that HHS develop a plan to coordinate a framework among medical device stakeholders to create, deploy, and leverage SBOMs for health care technologies by December 15.

Ways and Means Reaches Deal on Medicare Extenders

The House Ways and Means Committee announced that they have reached a bipartisan agreement relating to Medicare “extenders.” The legislative package will extend or make permanent a group of Medicare policies known as extenders, most of which are scheduled to expire by the end of the year without action from Congress. The polices were last extended in 2015 through the Medicare Access and CHIP Reauthorization Act (MACRA). The Ways and Means package includes a two-year extension of the Medicare geographic practice cost index (GPCI) for physician payments, a two-year extension of the Medicare Dependent Hospital Program and the Low-Volume Adjustment Program, a five-year extension of the Home Health rural add-on, a two-year extension of the State Health Insurance Assistance Programs (SHIP), and a twoyear extension of funding for consensus based entity work on quality measures. The Ways and Means Committee also offers a number of financial offsets for the extenders package, including extension of a policy to redistribute misvalued billing codes, a Medicare Improvement Fund rescission, and modifications to skilled nursing facility (SNF), home health agency, and critical access hospital payments. Last month, a bipartisan Medicare extenders discussion draft was released by the Senate Finance Committee. Unlike the House Ways and Means’ agreement, the draft released by Chairman Hatch (R-Utah) and Ranking Member Wyden (D-Ore.) does not include offset provisions.

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