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 Advances COVID Stimulus Plan via Reconciliation: Could Trigger Sequestration Cuts

The House of Representatives passed the American Rescue Plan Act (H.R. 1319) in the early hours of Saturday morning by a vote of 219 to 212. No Republicans voted in support of the bill, and two Democrats – Reps. Jared Golden (Maine) and Kurt Schrader (Ore.) – voted against it. The bill, which totals approximately $1.9 trillion, includes $1,400 stimulus checks for individuals, enhanced unemployment benefits, $350 billion in state and local aid, $160 billion in funding for vaccines, testing, and tracing, $.7.25 billion for the Paycheck Protection Program (PPP), and money for temporary health care premium subsidies. The fast-track reconciliation process will allow the legislation to be enacted with simple majorities in both chambers of Congress, bypassing the 60-vote threshold typically required for Senate passage through regular order.

The legislation will now be sent to the Senate, and may be further amended to address the minimum wage issue, other items subject to the ‘Byrd Rule’ (which may include health insurance premiums), the PAYGO waiver, and the need to trim some of the funding for the legislation to comply with the $1.9 trillion limit as prescribed in the budget resolution. Last week, Senate parliamentarian Elizabeth MacDonough ruled the increase to minimum wage to be out of order. McDonough found that the provision to phase in a $15 minimum wage does not have sufficient fiscal impact in relation to its effect on the economy and therefore does not qualify for action under the Senate’s Byrd rule for the budget reconciliation process. Some Democrats are pushing leadership to attempt to overturn the Senate’s Byrd rule, while others are in favor of revising the measure to meet the qualifications of the budget reconciliation process. The ruling on the application of the Byrd rule could be overturned with 51 votes. Sens. Joe Manchin (D-W.Va.) and Kyrsten Sinema (D-Ariz.), however, have stated that they do not support the minimum wage increase as it is currently drafted, and the White House has said that it does not support overruling the parliamentarian. Other items may also face Byrd rule issues, including the bill’s funding for health insurance premium subsidies.

The Congressional Budget Office (CBO) reported on Thursday that the stimulus bill would trigger $36 billion in Medicare cuts in fiscal year 2022 (FY22), unless there is bipartisan support for waiving the requirements of the Statutory Pay-As- You-Go-Act of 2010 (PAYGO). Because the cost of the stimulus bill is not offset by revenue increases or spending cuts, PAYGO would require the Office of Management and Budget (OMB) to issue a sequestration order within 15 days of the end of the Congressional session to reduce spending in FY22 by $381 billion. The PAYGO law limits reductions to Medicare spending to four percentage points – an estimated $36 billion. Waiving the requirement would require 60 votes in the Senate. In the past, lawmakers have attached PAYGO waivers to must-pass spending bills.

Democrats aim to send the measure to the President’s desk ahead of the March 14 expiration of supplemental jobless benefits. The bill is not expected to garner any GOP support in the Senate, as Republicans remain opposed to the total size of the package and continue to argue in favor of more targeted pandemic relief. All Senate Democrats will need to vote in favor of the bill in order to secure passage. And, once the Senate passes the amended bill, the House will need to act again before the President could sign.

Lawmakers Push for WTO Vaccine Patent Waiver

Agroup of Democratic lawmakers are urging President Joe Biden to support a temporary waiver of patent protections for COVID-19 vaccines. This waiver would allow global manufacturers to replicate vaccine formulas to increase vaccine production across the world. The waiver, which was proposed by India and South Africa through the World Trade Organization (WTO) last year, was opposed by the Trump administration. House Ways and Means Trade Subcommittee Chair Earl Blumenauer (D-Ore.) has argued in support of the waiver request, stating that it is “literally a matter of life and death” for poorer nations. Energy and Commerce Committee member Rep. Jan Schakowsky (D-Ill.) has also previewed a letter that approximately 30 members of Congress plan to send to the President. The letter states that any loss of profit by pharmaceutical companies resulting from the waiver would be offset by the global economic gains that result from pandemic recovery across the rest of the world. Opponents of the waiver believe that strong intellectual property protections are necessary to incentivize continued innovation. A spokesperson for the Biden administration stated that they are “exploring every avenue to coordinate with our global partners” and are evaluating the efficacy of this specific waiver proposal.

FDA Issues EUA to J&J for Third COVID Vaccine

The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third COVID-19 vaccine to Johnson & Johnson (J&J). The EUA allows the vaccine to be distributed in the U.S. for use in individuals age 18 and older. The Janssen vaccine, manufactured using adenovirus type 265, is administered as a single dose. Data indicates that the vaccine is approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. The vaccine is approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination. J&J has said that it is prepared to immediately ship nearly four million doses, which the Centers for Disease Control and Prevention (CDC) expects will be distributed to states, retail pharmacies, community vaccine centers, and federally qualified health centers (FQHCs). The company is on track to supply 20 million doses to the U.S. by the end of this month and 100 million by the end of June. Globally, J&J expects to produce one billion doses this year.

White House to Give Small Businesses Exclusive PPP Access

The Biden administration will provide small firms exclusive access to the Paycheck Protection Program (PPP) for a 14- day window. From Feb. 24 through March 9, only small businesses with fewer than 20 employees will be able to apply for relief through the program. In addition to this relief for small business, the White House has also announced that it will recalculate a formula to make more funding available to sole proprietors, independent contractors, and the self-employed and will act to remove restrictions preventing non-U.S. citizens and convicted felons from accessing the program.

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