Biden Signs More Executive Orders in Second Week

Last week, President Joe Biden signed several executive orders (E.O.s). One major E.O. contained the President’s plan for ‘Buy American.’ The order directs U.S. agencies to strengthen purchase requirements for acquiring goods and services from U.S. companies and workers, making it more difficult for the federal government to obtain waivers for the purchase of products overseas. It also establishes a new post in the Office of Management and Budget (OMB) to oversee the changes and provide transparency around agencies that do seek a waiver and revises the standards for American-made products with an aim of ensuring they are manufactured with a higher percentage of U.S. components and labor. The E.O. directs the provisions to be implemented within six months.

Another E.O. issued on January 21 directs the U.S. Department of Health and Human Services (HHS) to review the interoperability of public health data systems across the nation with the goal of better enabling COVID data sharing throughout the federal government, improving vaccine distribution, and increasing the understanding of the scope of the pandemic in communities throughout the country. OMB is directed to issue additional guidance on how to de-identify COVID-related data and make it available to the public.

President Biden also moved to reopen HealthCare.gov for a special enrollment period aimed at those individuals needing coverage during the ongoing pandemic. The administration plans to spend $50 million in advertising and outreach for the additional open enrollment period. The federal marketplace will be opened for three-months starting on February 15 under the E.O., which also directs a broad review of policies “that limit Americans’ access to health care.”

White House Delays, Withdraws Additional Health Rules

The Biden administration has acted to delay the effective date of several Trump-era regulations. The Organ Procurement Organizations Conditions for Coverage final rule, which altered the requirements related to organ procurement organizations (OPOs), was scheduled to take effect on February 1 but is now delayed until March 30 to provide the new administration time to review “issues of fact, law, and policy.” The White House also paused the Trump administration’s drug rebate rule, which would replace current rebates with fixed-fee arrangement, delaying the policy until March 22 from an original effective date of January 29. The Government Accountability Office (GAO) had flagged the rule for violating the Congressional Review Act, which requires major rules to take effect no sooner than 60 days after publication in the Federal Register. The HHS is also delaying the Secure Electronic Prior Authorization for Medicare Part D rule, originally slated to go into effect January 30, until March 30. The rule aims to streamline the prior authorization process for certain products in Part D.

The White House has also withdrawn three rules proposed by the Centers for Medicare and Medicaid Services (CMS) during the Trump administration: Conditions for Coverage for End-Stage Renal Disease Facilities—Third Party Payments; Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions; and Revisions to Medicare Part A Enrollments.

Administration Freezes Buprenorphine Guidance

The Biden administration is planning to freeze guidance drafted by the previous administration that would make it easier for physicians to prescribe Buprenorphine, according to a report from the Washington Post. A draft announcement from the White House cites their significant legal and clinical concerns with the guidance, but reiterates the President’s commitment to improving access to opioid use disorder treatment.

In related news, several Senators have raised concerns about the possible nomination of Janet Woodcock to lead the Food and Drug Administration (FDA). Senate Health, Education, Labor, and Pensions (HELP) Committee member Maggie Hassan (D-N.H.) and Sen. Ed Markey (D-Mass.) recently questioned Woodcock’s role leading the agency’s drug division during the opioid epidemic and warned that the FDA has still not accounted for the approval and labeling decisions that resulted in the availability of dozens of opioids on the market.

Biden Selects Nurse as Acting Surgeon General

President Joe Biden has selected Rear Admiral Susan Orsega, MSN, FNP_BC, FAANP, FAAN to serve as the Acting Surgeon General. Orsega is a nurse practitioner, infectious-disease specialist, and career-commissioned officer in the U.S. Public Health Service corps. Previously, she served as Director of Commissioned Corps Headquarters and was the principal advisor to the Surgeon General. She will serve as Acting Surgeon General pending the confirmation of Dr. Vivek H. Murthy by the U.S. Senate.

Senate Continues to Confirm Bidenís Cabinet

The Senate confirmed Janet Yellen as Treasury Secretary last week by a vote of 84-15. She will play a critical role in trying to shore up support for the administration’s $1.9 trillion COVID-19 stimulus plan. During her confirmation hearing she argued that the historically low interest rates makes it the right time for additional deficit spending. Antony Blinken was also confirmed by the Senate to be Secretary of State by a vote of 78-22. The Senate Finance Committee has received and is reviewing all of HHS secretary nominee Xavier Becerra’s required paperwork but has yet to set a date for his confirmation hearing.

Progress Made on Senate Power-Sharing Agreement

Senate Majority Leader Chuck Schumer (D-N.Y.) and Minority Leader Mitch McConnell (R-Ky.) have made progress on a power sharing agreement for the 117th Congress. Minority Leader Mitch McConnell (R-Ky.) dropped his demand for an assurance that the filibuster would be kept intact after Sens. Joe Manchin (D-W.V.) and Kyrsten Sinema (D-Ariz.) pledged that they would not vote to do away with the rule, which allows the minority to block legislation requiring 60 members to end debate on a bill and bring it for a vote. With the 50-50 partisan split in the Senate, the President will need the support of at least 10 Republicans in the Senate to pass legislation under regular order. In votes where only a majority is needed, Vice President Kamala Harris can break a tie. The Senate is expected to vote soon on an organizing resolution, which would help establish the committee structure.

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