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Health Policy Updates for the Week of May 6, 2019

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The Headlines

  1. The House Appropriations Committee approved its FY2020 subcommittee allocations, which includes the Labor-HHS-Education funding bill. 
  2. The Department of Health and Human Services (HHS) released a final rule that requires drug makers to disclose prices in consumer-directed television ads.
  3. The House passed two drug-pricing bills aimed at making it easier for generic and biosimilar companies to access information on drug patents and marketing exclusivity
  4. A federal court judge ruled the 2019 cuts to Medicare payments for 340B hospitals is unlawful and the HHS has until August 5 to submit a proposal with “appropriate remedial measures.
  5. Hearing highlights from this week below.

The Details

1. House Appropriations Committee
On Wednesday, the House Appropriations Committee held a mark up on the full FY 2020 subcommittee allocations, approving the plan which totals over $1.295 trillion in discretionary funding

The Committee also amended and approved its version of the FY 2020 Labor-HHS spending bill along party lines; it now awaits action by the House. More information about the bill and its accompanying report is available here. The House is planning to consider all 12 spending bills by the end of June.
 
2. Drug Pricing Rule
On Wednesday, HHS released a finalized rule that requires drug makers to disclose prices in consumer-directed television ads, if the product’s wholesale price or typical course of treatment is greater than $35 for 30 days. The proposal will likely be challenged by the drug industry. 
 
3. House Drug Pricing Bills
On Wednesday, the House passed two drug-pricing bills aimed at making it easier for generic and biosimilar companies to access information on drug patents and marketing exclusivity. H.R. 1503 would make changes to FDA's "orange" book to provide better information on brand drug and patent exclusivity. H.R. 1520 would update FDA's "purple" book on patents and exclusivity for biologic medicines. The measures could make it easier for generic and biosimilar companies to carve out pathways for cheaper versions to come to market. The House is expected to consider additional drug pricing bills this month.

4. Judge Ruling on 340B Cuts
On Monday, a federal court judge ruled that HHS has until August 5 to report back to him with “appropriate remedial measures” to the cuts to Medicare payments for hospitals participating in the 340B Drug Pricing Program. The judge also ruled that the 2019 cuts to the hospitals were unlawful. Here is the AHA, Association of American Medical Colleges and America’s Essential Hospital statement on the ruling. The government is likely to appeal the decision.
 
5. Committee Hearings


On Captiol Hill

Here is a snapshot of a few of our colleagues on Capitol Hill this week! Dr. Dani Zipkin and a group of Duke internal medicine doctors took a break from their Society of General Internal Medicine conference to meet with some of the NC delegation about generic drug protections for their patients. Dr. John Wiener and members of the Duke Children's Spina Bifida team also participated in a Hill Day, where they advocated for Spina Bifida research and patient care.

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