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.


Presidentís Fiscal Year (FY) 2023 Budget

The White House released President Joe Biden’s $5.8 trillion fiscal year (FY) 2023 budget request last week. The President’s budget request is a non-binding document used by congressional appropriators to consider the administration’s priorities as they craft government funding legislation for the coming year. The President’s budget calls for $1.598 trillion in discretionary spending, a 5.7% increase over the FY 2022 omnibus spending bill signed into law earlier this year – with $813 billion for defense-related programs and $769 billion for domestic spending. The budget increases funding for nearly every federal agency, while also emphasizing deficit reduction - reducing deficit spending by $1 trillion over the next decade. It includes a minimum 20% tax on households worth more than $100 million that would target both standard taxable income as well as unrealized capital gains. It also includes a corporate tax rate hike from 21% to 28%. The budget proposes $81.7 billion in mandatory funding over the next five years for health agencies to prepare for future pandemics.

The U.S. Department of Health and Human Services (HHS) would receive $127.3 billion in discretionary funding, a nearly 27% increase over FY 2021. The President requests $5 billion in discretionary funds for the creation of the Advanced Research Projects Agency for Health (ARPA-H). During a hearing before the House Appropriations Committee on the President’s budget request last week, HHS Secretary Xavier Becerra confirmed that ARPA-H would be established within the National Institutes of Health (NIH), though the ARPA-H Director would report directly to the HHS Secretary. This decision has drawn concerns from several lawmakers, including Appropriations Chair Rosa DeLauro (D-Conn.) and Energy and Commerce Health Subcommittee Chair Anna Eshoo (D-Calif.), who have argued that tethering ARPA-H to the NIH bureaucracy will not allow the new agency to nimbly achieve the breakthrough research and development it was established to accomplish. The President proposes to grow the budget of the NIH by $20 billion for a total of $62 billion in FY2023. However, $12 billion of those funds are designated for the larger pandemic preparedness effort and $5 billion for ARPA-H. The Food and Drug Administration (FDA) would receive a total budget of $8.4 billion, a 34% increase over FY 2022. This includes $1.6 billion to strengthen the agency’s IT and laboratory system as a part of the broader pandemic preparedness portion of the President’s budget. The FDA also seeks new authority over the design of post-approval studies conducted by pharmaceutical manufacturers for products approved via the accelerated approval pathway as a part of the budget request, and to revise the FDA’s procedures for withdrawing an accelerated approval. The budget would give federal regulators the authority to fine insurers that violate mental health parity law, with $275 million provided to the Department of Labor to audit health plans for compliance, and states would be provided with $125 million for mental health parity enforcement. The budget would also allow HHS to apply parity law to all plans and insurers, including Medicare plans. The budget does not detail any of the measures contained in the President’s now stalled Build Back Better agenda, but instead includes a deficit-neutral reserve fund as a placeholder for a future agreement between congressional Democrats and the administration on the reconciliation package.

House Passes Insulin Pricing, Marijuana Legalization Bills

The House of Representatives passed the Affordable Insulin Now Act (H.R. 6833) last week to cap out-of-pocket costs for insulin by a vote of 232-193. Twelve Republicans joined every House Democrat in support of the measure. The legislation would limit out-of-pocket costs for selected insulin products under private insurance and Medicare to the lesser of $35 a month or 25% of a plan’s negotiated price. The bill’s chances remain unclear in the Senate, where Sen. Raphael Warnock (D-Ga.) is working on a slightly broader drug pricing measure containing the insulin cost cap with Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine). Shaheen recently stated that an agreement has been reached in principle on the bipartisan proposal, but that details of the bill are not yet finalized.

The House also passed the Marijuana Opportunity Reinvestment and Expungement (MORE) Act (H.R. 3617) last week, which would end the federal prohibition of marijuana and eliminate criminal penalties for its distribution or possession. The bill passed largely along party lines in a 220-204 vote, with three Republicans joining all but two Democrats in support of the measure. It remains unclear whether the bill could garner the 60 votes necessary to pass the Senate. Majority Leader Chuck Schumer (D-N.Y.) plans to introduce a separate marijuana legalization proposal later this month.

Lawmakers Near Agreement on $10 Billion in New COVID Aid

Lawmakers have reached an agreement in principle on an additional $10 billion in COVID-19 emergency aid that will be fully offset. The Senate could vote on the measure as early as this week, though Democrats are reportedly still working to ensure the proposal includes funds to support global vaccine response. According to Sen. Mitt Romney (R-Utah), who has been negotiating the package on behalf of the GOP, Republicans are still awaiting an analysis of the package from the Congressional Budget Office (CBO). Romney has stated that the bill will be offset in part by the rescission of unspent funds previously appropriated in response to the pandemic. The $10 billion figure is significantly smaller than the $22.5 billion initially requested by the White House to continue the administration of vaccines, care for the uninsured, provide global coronavirus aid, and maintain supplies of COVID-19 tests and treatments – increasing the likelihood that Congress will need to return to the issue of COVID funding shortly. Senate Majority Leader Chuck Schumer has already teed up a House-passed bill (H.R. 4373) to serve as a vehicle for the next COVID-19 funding measure. Lawmakers had hoped to send a bill to the President for his signature before departing for a two-week recess at the end of this week.

Finance Committee Releases Bipartisan Report on U.S. Mental Health Care

The Senate Finance Committee released a bipartisan report last week detailing potential solutions to address mental health care access problems in the U.S. The report describes the mental health workforce’s issues, including a shortage of providers, an uneven geographic distribution of mental health professionals across the nation, and provider burnout following the drastic increase in requests for care since the start of the coronavirus pandemic. The report states that Americans wait for an average of 11 years between the onset of mental health symptoms and first receiving treatment. Finance Committee leadership is currently working to negotiate a package of mental health related legislation they hope to advance later this year.

In related news, the Centers for Disease Control and Prevention (CDC) has released a survey regarding the toll of the COVID-19 pandemic on the mental health of teenagers. The survey found that more than one in three U.S. high school students characterized their mental health as poor during the pandemic. More than half experienced emotional abuse by a parent or other adult in the home.

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