Legislative Activity

H.R. 5273, Helping Hospitals Improve Patient Care Act of 2016, scheduled for House Floor Vote

House Majority Leader, Kevin McCarthy, announced H.R. 5273, Helping Hospitals Improve Patient Care Act of 2016 (HIP-C), introduced by House Committee on Ways and Means Subcommittee on Health Chairman Pat Tiberi (R-OH) and Ranking Member Jim McDermott (D-WA), will be considered on the floor of the House of Representatives under suspension of the rules on Tuesday, June 7. The bipartisan bill was favorably reported by the House Committee on Ways and Means at the end of May by a unanimous vote. It is part of a continued effort to promote greater access, increased choice, and improved health care quality. The bill would ease payment restrictions for some outpatient services and adjust 30-day readmission penalties to account for socioeconomic disparities. H.R. 5273 has received the support of the Federation of American Hospitals, the American Hospital Association, the Association of American Medical Colleges, America’s Essential Hospitals, the Ambulatory Surgery Center Association, the National Coalition on Health Care, the Alliance of Dedicated Cancer Centers, and the Medicare Rights Center.

This Week’s Hearings:

• Tuesday, June 7: The Senate Committee on the Judiciary will hold a hearing titled “Deadly Synthetic Drugs: The Need to Stay Ahead of the Poison Peddlers.”

• Tuesday, June 7: The Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will hold a markup of the FY2017 Labor, Health and Human Services, and Education Appropriations Bill.

• Tuesday, June 7 and Wednesday, June 8: The House Committee on Energy and Commerce Subcommittee on Health will hold a markup of H.R. 3299, Strengthening Public Health Emergency Response Act of 2015 and H.R. 921, Sports Medicine Licensure Clarity Act of 2015.

• Wednesday, June 8: The House Committee on Ways and Means Subcommittee on Health will hold a hearing titled “Legislation to Improve and Sustain the Medicare Program.”

• Wednesday, June 8: The Senate Committee on Indian Affairs will hold a markup of S. 2417, Tribal Veterans Health Care Enhancement Act and S. 2916, A bill to provide that the pueblo of Santa Clara may lease for 99 years certain restricted land, and for other purposes.

• Friday, June 10: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “Advancing Patient Solutions for Lower Costs and Better Care.”

Regulatory Activity

FDA Releases Draft Guidance on Medicare Coverage of IDE Devices

On June 1, 2016, the Food and Drug Administration (FDA) released draft guidance on FDA categorization of Investigational Device Exemption (IDE) medical devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions. The draft guidance addresses how feasibility studies for modified approved devices which raise additional safety questions will be reimbursed by CMS. FDA also demonstrates a pathway for a device to go from the non-reimbursable Category A device to a Category B device covered by Medicare. In a 2013 final rule CMS modified its definitions for Category A and Category B devices. A Category A device is, “a device for which the ‘absolute risk’ of the device type has not been established and the FDA is unsure whether the device type can be safe and effective.” A Category B device is, “a device for which the incremental risk is the primary risk in question or it is known that the device type can be safe and effective because other manufacturers have obtained FDA premarket approval or clearance for that device type.”