The Inflation Reduction Act—passed by the Senate on August 7 following a marathon weekend session—is currently being debated on the House floor, where it is expected to narrowly pass along party lines. It is then expected to quickly be signed into law by President Biden. After August 12, Congress will return to recess until after Labor Day. Meanwhile, the US Department of Health and Human Services (HHS) granted emergency use authorizations (EUAs) for monkeypox vaccines.
Senate Passes Inflation Reduction Act; House on Schedule to Follow Suit. On August 7, following almost a year of negotiations among congressional Democrats and the White House, the Senate approved the Inflation Reduction Act of 2022 (IRA) by a vote of 50-50, with Vice President Harris breaking the tie. The IRA is now being considered on the House floor, with final passage likely to occur late in the afternoon on August 12.
The initial iteration of the IRA was the Build Back Better Act, which passed the House in November 2021. After that, Democrats hit roadblocks in the Senate, where Senators Manchin (D-WV) and Sinema (D-AZ) expressed concerns regarding the size and costs of the package, especially considering rising inflation.
After months of private negotiations between Majority Leader Schumer (D-NY) and Senator Manchin, a deal was announced in late July to reduce the federal deficit, reform prescription drug pricing, cap out-of-pocket drug costs for Medicare beneficiaries, extend the American Rescue Plan’s (ARP’s) increased Affordable Care Act advanced premium tax credit (APTC) subsidies for three years, make several tax reforms, and invest in energy and climate change. Prior to floor consideration, the Manchin-Schumer deal was further modified to gain the support of Senator Sinema, but her changes did not impact the healthcare provisions.
While the original aspirations of the Build Back Better Act were significantly more robust, the IRA is still a substantial piece of legislation that achieves many of President Biden’s initiatives on climate, taxes, energy and healthcare. The drug pricing provision in the IRA is one of the most consequential pieces of healthcare legislation in the last 25 years. Presuming enactment, the process of implementing the prescription drug pricing provision will be long and potentially arduous. In addition, it is likely to be subject to legal challenges, as has been the case with most healthcare legislation in recent memory.
The additional APTC subsidies enacted in the ARP have led to significant increases in coverage, and the maintenance of these subsidies is important, given that millions of people will become ineligible for Medicaid once the COVID-19 public health emergency ends. These coverage gains will remain in jeopardy, however, because this IRA provision is only a three-year extension, rather than permanent policy.
Additional analysis of the IRA’s healthcare provisions can be found here.
HHS Takes Steps on EUAs for Monkeypox Vaccines. As part of the newly-declared monkeypox PHE, the HHS Secretary on August 9 issued a determination under Section 564 of the Federal Food, Drug and Cosmetic Act, to grant EUAs for monkeypox vaccines.
In a press release announcing these actions, HHS stated that, to date, it has “made more than 1.1 million doses of the JYNNEOS vaccine available to order and, so far, has shipped more than 620,000 doses. HHS also has made the smallpox ACAM2000 and smallpox treatment TPOXX available for states and other jurisdictions to order. Through partnerships with the country’s largest commercial laboratories, testing capacity has increased rapidly to more than 80,000 per week as HHS continues to communicate important public health messages and raise awareness with key stakeholders.”
With Congress in recess through Labor Day, our weekly Check Up will be taking a summer break. We will provide updates should notable developments occur during the month of August, and will otherwise return to our regular publication schedule on September 9.
For more information, contact Debra Curtis, Kristen O’Brien or Erica Stocker.
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