Legislative Activity

Zika Virus Priority Review Voucher Slated for House Floor Consideration

House Majority Leader Kevin McCarthy (R-CA) announced that S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act, will be considered on the floor on Monday, April 11. This bill, introduced by Al Franken (D-MN) in the Senate, amends the Federal Food, Drug, and Cosmetic Act to add Zika virus to the list of tropical diseases under the priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease. This bill was approved by the Senate on March 17, 2016.

House Energy and Commerce Committee to Hold Hearing on the Flint Water Crisis

On Wednesday, April 14, the House Committee on Energy and Commerce Subcommittee on Environment and the Economy and Subcommittee on Health will hold a hearing titled “Flint Water Crisis: Impacts and Lessons Learned.” The hearing will be an opportunity for the Committee to assess the drinking water crisis in Flint, Michigan and better understand the problems with the drinking water infrastructure and possible public health implications. The hearing builds upon previous action taken by the House of Representatives to support the people of Flint. In February, the House of Representatives passed H.R. 4470, the Safe Drinking Water Act Improved Compliance Awareness Act, sponsored by Rep. Dan Kildee (D-MI) and Energy and Commerce Committee Chairman Fred Upton (R-MI). H.R. 4470 would ensure that a community is immediately notified of excessive lead levels in drinking water by setting forth how and when states, the Environmental Protection Agency (EPA), and public utilities communicate their findings. The bill has yet to pass the Senate.

This Week’s Hearings:

  • Wednesday, April 13: The Senate Committee on Homeland Security and Governmental Affairs will hold a hearing titled “America’s Insatiable Demand for Drugs.”
  • Wednesday, April 13: The House Committee on Energy and Commerce Subcommittee on Environment and the Economy and Subcommittee on Health will hold a hearing titled “Flint Water Crisis: Impacts and Lessons Learned.”
  • Wednesday, April 13: The House Committee on Oversight and Government Reform will hold a hearing titled “Waste and Inefficiency in the Federal Government: GAO’s 2016 Duplication Report.”
  • Wednesday, April 13: The House Committee on Veterans’ Affairs Subcommittee on Disability Assistance and Memorial Affairs will hold a hearing on ten bills. The bills being discussed include R. 3936, the Veterans Engagement Team (VET) Act; H.R. 4087, the Fair Treatment for Families of Veterans Act; H.R. 4757, To expand the eligibility of headstones, markers, and medallions furnished by the Secretary of Veterans Affairs for deceased individuals who were awarded the Medal of Honor and are buried in private cemeteries; H.R. 4758, To amend title 38, United States Code, to authorize the award of the Presidential memorial Certificate to certain deceased members of the reserve components of the Armed Forces and certain deceased members of the Reserve Officers’ Training Corps; H.R. 4759, To amend title 38, United States Code, to authorize the Secretary of Veterans Affairs to pay costs relating to transportation of certain deceased veterans to veterans cemeteries owned by a state or tribal organization; H.R. 4782, the Veterans’ Compensation Cost-of-Living Adjustment Act of 2016; H.R. 3715, the Final Farewell Act of 2015; H.R. ___, the Medal of Honor Legacy Act; H.R.___, the Love Lives On Act of 2016; Legislation to amend title 38, United States Code, to improve the consideration of evidence by Board of Veterans’ Appeals; Legislation to amend title 38, United States Code, to pay special compensation to certain veterans with the loss or loss of use of creative organs.
  • Wednesday, April 13: The House Committee on Energy and Commerce Subcommittee on Communications and Technology will hold a hearing on seven communications bills. The bills being considered include H.R. 4111, the Rural Health Care Connectivity Act of 2015; H.R. 4167, the Kari’s Law Act of 2015; H.R. 4884, the Controlling Unchecked Reckless Ballooning (CURB) Lifeline Act of 2016; H.R. 3998, the Securing Access to Networks in Disasters (SANDY) Act; H.R. 2031, the Anti-Swatting Act of 2015; and H.R. 4889, the Kelsey Smith Act.
  • Wednesday, April 13: The Senate Committee on Indian Affairs will hold a hearing on S. 2205, the Tribal healing to Wellness Courts Act of 2015; S. 2421, To provide for the conveyance of certain property to the Tanana Tribal Council located in Tanana, Alaska, and to the Bristol Bay Area Health Corporation located in Dillingham, Alaska; S. 2564, the Dine College Act of 2016; S. 2643, the Pueblo de Cochiti Self-Governance Act; and S. 2717, the Dam Repairs and Improvements for Tribes (DRIFT) Act of 2016.
  • Wednesday, April 13: The House Committee on Ways and Means will hold a hearing titled “Tax Treatment of Health Care.”
  • Thursday, April 14: The House Committee on Veterans’ Affairs Subcommittee on Health and Subcommittee on Oversight and Investigations will hold a hearing titled “Evaluating VA IT: Scheduling Modernization Choice Consolidation.”
  • Thursday, April 14: The Senate Committee on Energy and Natural Resources will hold a hearing titled “Oversight on Options for Addressing the Continuing Lack of Reliable Emergency Medical Transportation for the Isolated Community of King Cove, Alaska.”
  • Thursday, April 14: The Senate Committee on Homeland Security and Governmental Affairs will hold a hearing titled “The Federal Perspective on the State of Our Nation’s Biodefense.”
  • Thursday, April 14: The House Committee on Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions will hold a hearing titled “Innovations in Health Care: Exploring Free-Market Solutions for a Healthy Workforce.”
  • Thursday, April 14: The House Committee on Oversight and Government Reform Subcommittee on National Security will hold a hearing titled “Connecting Veterans with PTSD with Service Dogs.”
  • Friday, April 15: The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled “Unlawful Reinsurance Payments: CMS Diverting $3.5 Billion from Taxpayers to Pay Insurance Companies.”
  • Friday, April 15: The Senate Committee on Homeland Security and Governmental Affairs will hold a field hearing titled “Border Security and America’s Heroin Epidemic: The Impact of the Trafficking and Abuse of Heroin and Prescription Opioids in Wisconsin.”

Regulatory Activity

FTC Issues Guidelines for Health App Developers

On Tuesday, April 5, the Federal Trade Commission (FTC) issued an online tool for app developers that clarifies the specific laws and regulations that apply to their software. The FTC guidance was developed in coordination with the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS). The guidance asks app developers questions about the apps’ functionality and data collection capability and uses the answers to provide them necessary information from the Health Insurance Portability and Accountability Act (HIPAA) as well as FDA and FTC laws and rules.

Request for Information Regarding the Medicare Access and CHIP Reauthorization Act of 2015

On Thursday, April 5, The Office of the National Coordinator for Health Information Technology (ONC) released a Request for Information (RFI) for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA detailed a national objective to achieve widespread exchange of health information through interoperable certified electronic health record (EHR) technology nationwide by December 31, 2018. ONC issued a RFI to solicit input on the following topics: (1) measurement population and key components of interoperability that should be measured; (2) current data sources and potential metrics that address section 106(b)(1) of MACRA; and (3) other data sources ONC should consider with respect to section 106(b)(1) of MACRA or interoperability measurement more broadly. Written or electronic comments must be received no later than 5 p.m. on Friday, June 3, 2016.