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.


White House Releases Part One of Infrastructure Proposal

The White House released the first portion of its infrastructure and jobs plan last week. Dubbed the “American Jobs Plan,” the $2.25 trillion proposal focused on broad infrastructure projects but contained a few, targeted health care provisions, including expanding access to long-term care (LTC) services by investing $400 billion over the next eight years in Medicaid home- and community-based care (HCBC). The plan also calls for addressing the issue of low wages across the LTC industry. It would extend the Money Follows the Person demonstration project, and expand the ability of home care workers to collectively bargain. The plan calls for approximately $18 billion to upgrade VA hospitals. Another $30 billion would be spent over the next four years on preventing the next pandemic, through investments in the Strategic National Stockpile (SNS), development of tests, treatments, and prototype vaccines for emerging diseases, improving vaccine production technology, strengthening the public health infrastructure, and pandemic response workforce training. The plan would be offset by a variety of tax changes, including increasing the corporate tax rate to 28 percent as well as a new global minimum tax to attempt to curtail the ability of multinational corporations to greatly reduce what they owe the U.S. government.

The second half of the economic recovery plan, which will be unveiled in the coming weeks, is expected to contain additional health care-related spending. Democratic lawmakers are pushing the administration to include a variety of health care reforms, including mandatory spending on public health, the creation of a public health insurance option, a reduction in the Medicare eligibility age, an expansion of Medicare benefits, and measures to reduce drug pricing. It remains unclear whether the White House will decide to pursue such major reforms through this package, which is expected to be moved via the budget reconciliation process. House Speaker Nancy Pelosi (D-Calif.) has said that her goal is to pass the infrastructure legislation by July 4.

Biden “Skinny” Budget May Be Released This Week

The much-anticipated fiscal year 2022 Biden budget may be released this week. Previously, the White House announced that it would be released last Thursday, but several reports noted that the Pentagon and the White House budget office have been at odds over the first defense budget under Biden. The disagreement may be at least partly to blame for delays in releasing the budget outline that was widely expected last week.

Lawmakers Look to Undo Sunset Rule

Reps. Raja Krishnamoorthi (D-Ill.) and Anna Eshoo (D-Calif.) have introduced H.J.Res.37, a resolution of disapproval of a Trump-era regulation at the U.S. Department of Health and Human Services (HHS) known as the SUNSET Rule. The regulation would cause existing health regulations to expire if they are not reviewed by HHS every 10 years. The resolution of disapproval currently has no Senate companion. The effective date of the rule was recently delayed by the Biden administration until 2022 to allow a lawsuit against the regulation to proceed.

Democrats Comment on NIST Bayh-Dole Regulation

Agroup of Democratic lawmakers led by House Ways and Means Health Subcommittee Chair Lloyd Doggett (D-Texas) has submitted a public comment on a Trump-era proposed rule from the National Institute of Standards and Technologies (NIST) to revoke the federal government’s authority under the Bayh-Dole Act to protect the public from unreasonable prices on taxpayer-funded inventions. The comments argue that the regulation would reverse the federal government’s ability to prevent price-gouging on prescription drugs. “The NIST proposal is a grave misjudgment and would likely exacerbate the already exorbitant cost of prescription medicines,” the lawmakers state. They encourage NIST to instead “pursue measures to support access to medicines and fiscal responsibility, such as a requirement of reasonable pricing clauses in all federal funding contracts.”

GAO Releases New Report on Remdesivir Development and Pricing

The Government Accountability Office (GAO) has released a report finding that the federal government spent at least $162 million between 2013 and 2020 on preclinical studies and clinical trials for antiviral drug Remdesivir, the first Food and Drug Administration (FDA)-approved treatment for COVID-19. The contributions did not result in government patent rights, however, because the research did not generate new inventions, the GAO concludes. The report was requested by House Oversight Committee Chairwoman Carolyn Maloney (D-N.Y.) and Sen. Debbie Stabenow (D-Mich.) to increase the understanding of how taxpayer funded research is being used to develop new drugs and vaccines. Following the report’s release, the lawmakers criticized manufacturer Gilead Sciences Inc. for “charging an unconscionable price for a drug developed with millions in taxpayer-funded research.” Remdesivir costs $3,120 for a five-day course. The two lawmakers called for more transparency around federal spending supporting drug development.

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