Budget

The Senate passed a fiscal 2019 Labor-HHS spending bill late Thursday (Aug. 23) that didn't include two controversial amendments -- one defunding Planned Parenthood and another allowing the Senate to intervene in the Texas v. HHS case should the court rule to eliminate the mandate for coverage of preexisting conditions.

Senate Appropriations HHS subcommittee on Tuesday (June 26) unanimously passed the fiscal 2019 funding bill, sending it to the full committee which plans to consider it on Thursday (June 28).

The Senate Appropriations Committee on Thursday (May 24) voted to send to the Senate floor a fiscal 2019 FDA funding bill that appears to give the agency $163 million more than its current level but still less than requested by the administration, coming after House appropriators also agreed to hike FDA spending.

House Appropriations agriculture subcommittee chair Robert Aderholt (R-AL) called FDA's request for a 13 percent increase in funding over fiscal 2018 levels “the largest and boldest funding request in recent memory and maybe ever” and signaled it might have to be cut back, but Democrats argued the budget lacks enough funding for food safety and opioids.

Democrats and seniors’ advocates worry an official estimate of annual government deficits topping $1 trillion by 2020 will spur Republicans to cut Medicare and Medicaid.

HHS Secretary Alex Azar told senators at a hearing Thursday (Feb. 15) that his agency's proposed cuts to federal spending on graduate medical education would add flexibility to GME programs and allow the agency to focus on training doctors in under-served medical specialties and geographic regions.

Neither the House Energy & Commerce Committee nor House appropriators have received FDA's formal budget justification, despite the fact that HHS Secretary Alex Azar will testify before E&C about the budget Thursday (Feb. 15).

Should the president's budget hike for FDA get ratified, the agency would spend the extra $400 million dollars on: creating Centers of Excellence for compounding and digital health, researching continuous manufacturing, standing up third-party certification of medical device quality, advancing near-real-time evaluation of real-world evidence, expanding the digital health precertification program, conducting natural history studies for rare disease, and creating new internal agency systems for knowledge management and generic drug submission, according to FDA Commissioner Scott Gottlieb.

The president's budget request includes drug-price chopping policies that CMS could accomplish administratively, including proposals to let groups of states negotiate prices using closed formularies and to change the reimbursement of doctors who administer drugs.