On April 30, President Trump announced that he was withdrawing the nomination of Dr. Casey Means to serve as U.S. Surgeon General and instead nominating Dr. Nicole B. Saphier. Dr. Saphier is a radiologist and the director of breast imaging at Memorial Sloan Kettering in Monmouth, New Jersey. She is a Fox News contributor and the author of Panic Attack: Playing Politics with Science in the Fight Against COVID-19 and Make America Healthy Again: How Bad Behavior and Big Government Caused a Trillion-Dollar Crisis. 

Dr. Saphier also has a podcast called “Wellness Unmasked with Dr. Nicole Saphier,” where she has discussed several recent policy announcements from the Trump Administration related to health and wellness, including changes to the childhood immunization schedule made under Secretary Kennedy’s leadership. In a podcast episode discussing the changes, she stated that she does think the previous version of the schedule was “bloated,” but criticized the “mixed” and “confusing” messaging used to communicate the changes by HHS, including stating that the messaging may mislead Americans to believe that there was new evidence regarding the safety and efficacy of certain vaccines. In a later episode, she also criticized the decision to derive the schedule from other countries, stating that, with respect to comparing the U.S. and Denmark, “it’s like apples and oranges,” but overall said the changes are “okay.” 

In the post announcing her nomination, President Trump called Dr. Saphier a “STAR physician” and an “INCREDIBLE COMMUNICATOR, who makes complicated health issues more easily understood by all Americans.” However, President Trump simultaneously expressed frustration regarding the decision to withdraw the nomination of Dr. Means in several posts on Truth Social. In one post, President Trump called Senate HELP Committee Chair Bill Cassidy (R-LA) a “very disloyal person” that “stood in the way of Robert F. Kennedy’s Nominee, Casey Means, for the important position of U.S. Surgeon General,” noting that she “will continue to fight for MAHA.” 

 The posts surrounding the withdrawal of Casey Means’ nomination highlight escalated tension between President Trump and the chair of the committee that will consider the recently announced nominations for CDC Director, the Surgeon General, and the Assistant Secretary for Preparedness and Response (ASPR) roles. The recent nomination of Dr. Erica Schwartz by President Trump marks the third nominee for CDC Director, following the previous nominations of Dr. Dave Weldon and Dr. Susan Monarez, while Dr. Saphier is the third nominee for Surgeon General following Dr. Janette Nesheiwat and Dr. Casey Means. Sean Kaufman is the first nominee this term for the ASPR role. 

Committee hearings for the nominees have not been scheduled, and it is unclear whether the nominees will have a combined hearing or be considered separately. This could be impacted by the timing of nominees’ paperwork submissions to the committee and its review of the paperwork, as well as nominee meetings with Senators and staff. 

Last week, the White House formally sent the nomination of Sean Kaufman to serve as Assistant Secretary for Preparedness and Response (ASPR) to the Senate, a role that must also be reviewed and confirmed by the Senate HELP Committee. Mr. Kaufman’s nomination has been anticipated since January, but this marks his formal nomination for the role.

Mr. Kaufman has served as a Senior Advisor for Global Affairs at the CDC, and is the CEO and Founder of Safer Behaviors, a consulting firm “specializing in behavioral-based safety and public health preparedness.” According to LinkedIn, he has also served as an expert witness advocating for “for individuals in the United States who chose not to receive the COVID-19 vaccine and are still facing the consequences.” 

Finally, HHS also confirmed last week that Dr. Katherine Szarama will serve as the Acting Director of the FDA Center for Biologics Evaluation and Research, following the departure of Dr. Vinay Prasad, whose planned departure from the agency was announced by Commissioner Marty Makary in March. Dr. Szarama has been serving as Deputy Center Director of CBER since December and previously held roles at ARPA-H and CMS. 

 It does not appear that FDA intends for Dr. Szarama to serve as CBER Director permanently. 

On April 30, the White House issued an Executive Order (EO) on “Promoting Efficiency, Accountability, and Performance in Federal Contracting.” The EO directs that, consistent with law, agencies should utilize fixed-price contracts, as defined in Part 16 of the Federal Acquisition Regulation (FAR), Title 48 CFR, with performance-based considerations as the default and preferred method of procurement. It recognizes that for some circumstances a cost-reimbursement contracting approach is appropriate, such as for research and pre-production developmental phase of major systems acquisition, but this should be the exception and involve senior-level agency accountability. 

 The EO specifies that any non-fixed-price contracts must be accompanied with written justification by the contracting officer to the agency head and that non-fixed-price contracts or hybrid contracts that exceed certain amounts must receive written approval by agency heads. This includes: 

• Department of War contracts exceeding $100 million; 
• Department of Homeland Security contracts exceeding $25 million; and 
• Any contracts by other agencies exceeding $10 million. 

 Exceptions to this are provided for support of emergency responses, as defined under Part 2 of the FAR, or research and development or pre-production development for major systems acquisition under Parts 34 and 35 of the FAR. 

 The EO directs agency heads to review and if needed, to modify, restructure, or renegotiate the 10 largest non-fixed-price contracts in their purview within 90 days. The EO also requires agency heads to issue a semi-annual report to the Director of OMB on the number of, funding amount of, and written justifications for, any non-fixed price contracts approved, with the first due within 90 days. Finally, the EO notes that: 

• Within 45 days, the director of OMB will issue guidance to agencies; and 
• Within 120 days, the Administrator for Federal Procurement Policy shall:  
  • Propose amendments to the FAR consistent with EO policy; and 
  • Coordinate with the Defense Acquisition University and the Federal Acquisition Institute to develop a training program on developing, negotiating, and managing fixed-price contracts for contracting and program employees. 

 This EO comes about a year after President Trump issued an EO that seeks to overhaul procurement through changes to the FAR. 

On April 30, FDA published a notice proposing to exclude several active ingredients used in GLP-1 drugs, including semaglutide, tirzepatide, and liraglutide, from its 503B bulk drug substances list, which enumerates drugs that can be compounded using bulk ingredients. In the press release, FDA states that it has determined there is not a specific clinical need for these drugs to be compounded by outsourcing facilities, which is required for drugs that are not in shortage to appear on the 503B list. The notice is open for public comments through June 29, after which FDA will make a final determination regarding the listing of the drugs. FDA had previously indicated its intent to take such action against non-FDA approved compounded drugs, while also noting concern regarding the “mass-marketing” of these drugs in a manner that was misleading to consumers. 

On April 28, HHS OIG released a report titled, “CMS Could Strengthen Medicare Program Safeguards To Prevent and Detect Potentially Improper Payments for Virtual Check-in and E-visit Services,” finding that CMS made up to $2.3 million in potentially improper payments for communication technology-based services from 2019 through 2022. Specifically, OIG identified that within that time, CMS made: 

• $1,964,125 in potentially improper payments for 173,287 virtual check-in services that occurred within 7 days after, or 24 hours prior, to an evaluation and management (E/M) service with the same diagnosis code for the same enrollee; and 
• $298,200 in potentially improper payments for 10,237 e-visit services provided within 7 days of another e-visit with the same diagnosis code for the same enrollee. 

OIG attributed these payments to the absence of system edits within CMS’s Common Working File and the Medicare Administrative Contractors’ claim processing systems, as well as insufficient provider education on billing requirements for these newly established services. OIG made three recommendations to CMS: 

• Develop system edits to flag for review or reject claims in which virtual check-ins, e-visits, and E/M services overlap inappropriately; 
• Strengthen the HCPCS code descriptions for virtual check-ins in the Physician Fee Schedule to clarify the meaning of “related or same medical condition” and “soonest available appointment”; and 
• Further educate providers on proper billing requirements. 

CMS concurred with the first and third recommendations and described corrective actions, including system edits implemented since the audit period, but did not concur with the second recommendation, stating that the clarifications would be better achieved through subregulatory guidance than through changes to the code descriptions.