With the midterm elections now over, the attention of the health policy community has shifted to the Affordable Care Act’s open enrollment period, which began on November 15. Due to last year’s bungled rollout, as well as recently disclosed statements made by economist and White House consultant Jonathan Gruber, a renewed focus on the effectiveness of the Affordable Care Act is sure to dominate conversations in Washington in the coming weeks.
On Capitol Hill, lawmakers continue to probe the government’s response to Ebola and other public health threats. Hearings on this topic are planned in the House Committee on Foreign Affairs, the House Committee on Energy and Commerce, and the Senate Committee on Homeland Security and Governmental Affairs. On Wednesday, November 19, the Senate Committee on Health, Education, Labor, and Pensions will meet in executive session to consider, among other agenda items, S. 2917, Adding Ebola to the FDA Priority Review Voucher Program Act, and H.R. 669, Sudden Unexpected Death Data Enhancement and Awareness Act.
This Week’s Hearings:
- Tuesday, November 18: The House Committee on Foreign Affairs, Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations will hold a hearing titled “Fighting Ebola: A Ground-Level View.” The House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations will hold a hearing titled “Update on the U.S. Public Health Response to the Ebola Outbreak.”
- Wednesday, November 19: The House Committee on Energy and Commerce, Subcommittee on Health will hold a hearing titled “Examining Medical Product Development in the Wake of the Ebola Epidemic.” The Senate Committee on Homeland Security and Governmental Affairs will hold a hearing titled “Preparedness and Response to Public Health Threats: How Ready Are We?” The Senate Committee on Veterans’ Affairs will hold a hearing titled “Mental Health and Suicide Among Veterans.” The Senate Committee on Indian Affairs will hold an oversight hearing titled “Protecting Our Children’s Mental Health: Preventing and Addressing Childhood Trauma in Indian Country.”
- Thursday, November 20: The Senate Committee on Health, Education, Labor, and Pensions, Subcommittee on Primary Health and Aging will hold a hearing titled “Why Are Some Generic Drugs Skyrocketing in Price?”
HRSA Withdraws Proposed 340B “Mega Rule”
The Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) withdrew its plans to publish a 340B “mega rule” last week, stating on its website, “In 2015, HRSA plans to issue a proposed guidance for notice and comment that will address key policy issues raised by various stakeholders committed to the integrity of the 340B program. HRSA is also planning to issue proposed rules pertaining to civil monetary penalties for manufacturers, calculation of the 340B ceiling price, and administration dispute resolution.” This past July, HRSA released an interpretive rule, which required pharmaceutical manufacturers to discount orphan drugs when hospitals utilize them for conditions other than their specified condition. Previously, in May, the U.S. District Court for the District of Columbia invalidated an HHS regulation of the same nature