Budget

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.

The Trump administration, in a reversal of previous GOP priorities, appears to call for legislation that would fully fund the Affordable Care Act's risk corridor program that ended in 2016.

The Trump administration's fiscal 2019 budget allocates $20 million to FDA's Oncology Center of Excellence, a pleasant surprise for Friends of Cancer Research (Friends), the organization that has been involved with OCE from its inception.

Advocates for robust funding of FDA were pleased the president's fiscal 2019 budget released Monday (Feb. 12) calls for a 13 percent increase over fiscal 2018 continuing resolution levels.

A newly released Council of Economic Advisors report on drug pricing, which is expected to inform HHS' fiscal 2019 budget request, is angering both public health advocates and those favoring sweeping drug pricing reforms, given it suggests FDA can lower drug prices by speeding FDA approvals of brand drugs and making FDA's approval standards easy to comply with, all while making no mention of brand industry-opposed reforms, including those that have been floated by FDA Commissioner Scott Gottlieb, such as cracking down on abuses of FDA-mandated safety programs.

The Senate and House included in their government-funding bills doctor-backed changes to the new Medicare physician pay system, such as excluding the cost of Part B drugs from the calculation of doctor pay, delaying the use of cost measures in doctor performance scores, giving CMS three more years to transition to the performance threshold, and letting the Physician-Focused Payment Model Technical Advisory Committee (PTAC) weigh in earlier on pay models that providers design.

The bipartisan budget deal announced by Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Charles Schumer (D-NY) on Wednesday (Feb. 7) includes four additional years of funding for the Children's Health Insurance Program; funding for community health centers, teaching health centers and the National Health Service Corps; repeal of the therapy caps; a delay of the Medicaid Disproportionate Share Hospital pay cuts and funding for other so-called Medicare extenders, according to a Democratic overview of the deal and draft bill language obtained by Inside Health Policy.