POLICY BRIEFINGS


Zika Update


Members of the congressional conference committee to resolve the differences between the House and Senate funding packages to combat the Zika virus convened for the first time last week. A compromise must be reached not only on a funding level – the House has proposed $622 million, compared to the Senate’s $1.1 billion – but also on whether and how to offset the spending. House Appropriations Chairman Hal Rogers (R-Ky.) has said that the deal must be fully offset. While both Democratic and Republican appropriators seem hopeful that they will reach an agreement quickly, there is little time left for negotiations if a final package is to be complete before their target date of July 1. The House is scheduled to adjourn on Friday and won’t return until July 5. Following its third emergency meeting on the Zika outbreak, the World Health Organization (WHO) has concluded that the Olympic games being held in Brazil this summer pose “a very low risk of further international spread” of the virus. WHO believes attendees’ exposure to Zika will be minimal as a result of the Brazilian winter and precautionary measures being taken to reduce the chance of transmission. The Centers for Disease Control and Prevention (CDC) announced last week that three babies have been born in the United States with microcephaly as a result of the Zika virus. In three other cases, women have had miscarriages or terminated pregnancies due to the birth defect. All of the cases of Zika were contracted abroad.


Generics Bill introduced in the Senate


Chairman and Ranking Member of the Senate Judiciary Committee Chuck Grassley (R-Iowa) and Patrick Leahy (D-Vt.) have introduced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. The legislation creates a cause of action in federal court for generic manufacturers who are facing issues obtaining access to reference products subject to a Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use (REMS with ETASU) or a restricted distribution system self-imposed by the reference product manufacturer. The legislation creates some liability protection for a reference product manufacturer who makes product available to generic manufacturers. The Congressional Budget Office (CBO) estimates that the bill would save $2 billion over 10 years. The Senate Judiciary Committee will hold a hearing on this legislation on Tuesday.


Republican ACA Replacement Coming This Week


Republicans in the House will release their white paper outlining an alternative to the Affordable Care Act (ACA) this week. Because the plan is not a complete piece of legislation, it has not been scored by the Congressional Budget Office (CBO). The white paper is expected to include the use of high-risk pools and health plans for small business collectives, Health Savings Accounts (HSAs), and tax benefits for purchasing health insurance coverage. It will also cap the tax benefits that employers get for providing health care coverage to their employees.


Senate Goes to Conference on Opioid Legislation


The Senate voted to go to conference with the House regarding opioid legislation last week. The conferees are the chairmen and ranking members of the Judiciary Committee; the Health, Education, Labor and Pensions (HELP) Committee; and the Finance Committee, as well as Sen. Jeff Sessions (R-Ala.). The chamber agreed to instruct the conferees that the final conference report should include an unspecified amount of funding for state and local efforts to prevent and treat opioid abuse. Conferees will also be instructed to include authorizations for prescription drug monitoring programs (PDMPs), consider the needs of rural communities, and raise the federal limit on the number of patients to whom a doctor can prescribe buprenorphine from 100 to 500.



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