Billy Wynne

Final Rule Issued to Amend Definition of Biological Product; Aids Transition for Insulin as a Biologic The Food and Drug Administration (FDA) issued a final rule to amend the definition of “biological product” to incorporate statutory changes and to provide an interpretation for the definition of  a “protein.” In the accompanying press release, the FDA…

ONDCP, CDC Announce FY 2020 Drug-Free Communities Support Program Grant Opportunity; Due April 3 The White House Office of National Drug Control Policy (ONDCP), in partnership with the Centers for Disease Control and Prevention (CDC), recently issued a Notice of Funding Opportunity Announcement (FOA) for the fiscal year 2020 Drug-Free Communities (DFC) Support Program. The…

Agency Solicits Comments on Potential New Poverty Measures; Comments Due. April 14 The Office of Management and Budget (OMB) recently released a solicitation for comments on questions posed by the Interagency Technical Working Group on Evaluating Alternative Measures of Poverty (Working Group). In brief, the Working Group is considering the development of additional measures for…

WHG Side-By-Side Summarizes 5 Key Federal Telehealth Bills It can be hard to keep track of federal telehealth legislation in a sea of legislative and regulatory health care priorities, so the team at Wynne Health Group has made it easy for you. We created a side-by-side (SBS) summarizing five key telehealth bills introduced in the…

Request for Information on Vaping Products Associated with Lung Injuries Due April 15 The Food and Drug Administration (FDA) issued a request for information (RFI) related to the use of vaping products that are associated with lung injuries (press release). The FDA has issued this request in response to a Congressional directive to gather information…

Committee Leaders Request Extensive Information from UNOS Regarding Oversight of OPTN, Network of OPOs Senate Finance Chairman Chuck Grassley (R-IA), Ranking Member Ron Wyden (D-OR) and Sens. Todd Young (R-IN) and Ben Cardin (D-MD) cosigned a letter (press release) this week to Brian Shepard, CEO of the United Network for Organ Sharing (UNOS), regarding oversight…

In RFI, Agency Seeks Input on Ways to Improve Maternity and Infant Health; Responses Due April 12 The Centers for Medicare & Medicaid Services (CMS) released a request for information (RFI) seeking input on ways to improve access, quality, and outcomes for rural maternal and infant health. This RFI comes as congressional deliberations on the…

Members Advance Surprise Medical Billing Legislation; Plus Bills on Private Equity Firm Transparency and Hospice Oversight The House Ways and Means Committee convened a markup to consider the following bills: H.R. 5826, the Consumer Protections Against Surprise Medical Bills Act (WHG summary) H.R. 5825, the Transparency in Health Investments Act of 2020 H.R. 5821, the…

AINS to H.R. 5800, the Ban Surprise Billing Act, Favorably Reported The House Education & Labor Committee convened a markup to consider H.R. 5800, the Ban Surprise Billing Act (fact sheet, section-by-section). Chairman Bobby Scott (D-VA) offered an Amendment in the Nature of a Substitute (AINS) and it was favorably reported as amended by a…

Budget in Brief Details Key Health Proposals for FY 2021; Medicaid Block Grants, Work Requirements, and Site-Neutral Payments Discussed Monday, Feb. 10, 2020, the Trump Administration released its fiscal year (FY) 2021 Budget Request, “A Budget for America’s Future,” seeking $4.4 trillion in spending cuts over the next decade. The proposal includes $1.6 trillion in net…