Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


House Passes U.S.-Competitiveness Package

The House of Representatives passed the America COMPETES Act (H.R. 4521) last week by a vote of 222-210, largely along party lines. The expansive U.S. competitiveness package aims to strengthen U.S. manufacturing and research. The legislation includes $45 billion over six years for a new Supply Chains for Critical Manufacturing Industries Fund. It authorizes $10 billion to address climate change and deploy clean energy technologies. It also includes the Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce Act (H.R. 5374) to protect consumers against the online sale of counterfeit products. There are significant differences between the House legislation and the Senate-passed U.S. Innovation and Competition Act (S. 1260), and it remains unclear if or when conferees to reconcile the two bills will be named. The White House has stated that President Joe Biden is eager to sign the China competition bill into law.

Manchin Looks to Start from Scratch on BBB

While Democrats had hoped to secure Sen. Joe Manchin’s (D-W.Va.) support of a pared-back Build Back Better package to pass a deal by the end of the month, Manchin has characterized the administration’s economic agenda as “dead” and stated that future negotiations should start from scratch. Manchin has repeatedly cited concerns about deficit spending and the reconciliation package’s potential to worsen soaring inflation. He has, however, signaled that a deal could be reached on lowering prescription drug costs and addressing climate change. Sen. Manchin expressed his wish to shift his colleague’s focus to fiscal year (FY) 2022 appropriations bills and legislation to increase U.S. competitiveness with China.

Lujan Expected to Make Full Recovery After Stroke

Carlos Sanchez, chief of staff for Sen. Ben Ray Luján (D-N.M.), announced last week that the senator had recently suffered a stroke. As a part of the Senator’s treatment plan, he subsequently underwent decompressive surgery to ease swelling. He is currently recovering in the hospital. Luján is expected to make a full recovery and return to the Capitol in four to six weeks barring any complications. His absence in the evenly divided Senate has already delayed votes on some of President Joe Biden’s nominees, including nominations to the Federal Communications Commission (FCC) and the Federal Trade Commission (FTC).

Path Forward for Califf Nomination Unclear

Dr. Robert Califf ’s nomination to serve as commissioner of the Food and Drug Administration (FDA) remains in limbo, with Sen. Ben Ray Lujan’s (D-N.M.) absence following a stroke contributing greater uncertainty to his confirmation status. As a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Lujan voted in favor of Califf ’s nomination. Five Democrats have announced their opposition to Califf ’s confirmation, citing concerns about his ties to the private sector and ability to address the opioid crisis, while four HELP Committee Republicans voted in support of Califf– leaving him one vote short for full Senate confirmation in Lujan’s absence. Sen. Roy Blunt (R-Mo.), a potential supporter of Califf on the Senate floor, told reporters that he has not made a final decision, questioning whether the White House is standing fully behind their nominee. Sens. Rob Portman (R-Ohio) and Pat Toomey (R-Pa.) – two other potential GOP yes votes – said last week that they also remain undecided. Califf recently agreed to not seek employment or compensation from any pharmaceutical or medical device company for four years following his time in government, as well as to recuse himself from FDA matters involving Duke University, to secure the support of Sen. Elizabeth Warren (D-Mass.).

Biden Meets with Judiciary Leadership on Supreme Court Pick

President Joe Biden consulted with key members of the Senate last week, including Senate Judiciary Committee Chair Dick Durbin (D-Ill.) and Ranking Member Chuck Grassley (R-Iowa) on considerations around his choice to replace retiring Justice Stephen Breyer on the Supreme Court. The President is expected to announce his nominee by the end of the month and has pledged to nominate a Black woman. He has indicated that he will seek Republican support for his candidate. Durbin has said that he expects Senate confirmation of the nominee to take place approximately 40 days after the nomination is announced. Sen. Ben Ray Lujan (D-N.M.), who is currently recovering from a stroke, is expected to return to the Senate by that point; Majority Leader Chuck Schumer’s (D-N.Y.) office has said that Lujan’s medical situation is not expected to impact the Supreme Court nomination process. Former Sen. Doug Jones (D-Ala.) has been tapped to guide the eventual nominee through the Senate confirmation process.

President, Lawmakers at Odds on Placement of ARPA-H

President Joe Biden pressured Congress to fund the Advanced Research Projects Agency for Health (ARPA-H) during his relaunch of the Cancer Moonshot initiative last week. The President also pushed for housing ARPA-H within the National Institutes of Health (NIH). The House Energy and Commerce Committee has scheduled a hearing on ARPA-H for this Tuesday. Two measures have been introduced in the House of Representatives to authorize the agency -- one placing ARPA-H within the NIH and the other placing it more generally within the U.S. Department of Health and Human Services (HHS). Energy and Commerce Health Subcommittee Chair Anna Eshoo (D-Calif.), however, has said that ARPA-H will not be made a part of NIH, stating that Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) have backed away from their previous proposal. It remains unclear whether the Senate would follow Rep. Eshoo’s lead and create ARPA-H as a standalone entity.

President to Release FY23 Budget in Coming Weeks

Acting Office of Management and Budget (OMB) Director Shalanda Young stated last week that the President will release his fiscal year (FY) 2023 budget around the time of his State of the Union address, scheduled for March 1. Congress has yet to reach a deal on how to fund the government for the remainder of the current fiscal year. Lawmakers continue to negotiate another short-term continuing resolution (CR), potentially extending through only March 11, with the current February 18 government funding deadline fast approaching.

The Washington Post reported last week that the White House may have to ask Congress for additional aid to support coronavirus testing, therapeutics, and vaccines. While supplemental coronavirus resources have been discussed among lawmakers on Capitol Hill, Senate Majority Leader Chuck Schumer (D-N.Y.) has said that they are still awaiting a formal request from the administration. Senate Minority Leader Mitch McConnell (R-Ky.) has questioned whether more spending is really necessary and wishes to first account for unallocated pandemic relief funds.

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