POLICY BRIEFINGS


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.


THIS WEEK'S BRIEFING - MAY 10, 2021


Pallone Previews Path for H.R. 3


House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) told reporters last week that Democrats’ signature drug pricing legislation (H.R. 3) could be added to the President’s infrastructure package, indicating that he is “going to use whatever vehicle I can to get this done.” He said that House committee leaders plan to mark up and pass H.R. 3 this year, without providing a more specific timeframe. Lawmakers have also yet to determine the number, size, and scope of bills through which to move the President’s infrastructure proposals.


House to Move FY22 Spending Bills in June and July


House Appropriations Committee Chair Rosa DeLauro (D-Conn.) announced that her panel will mark up the 12 annual spending bills for fiscal year (FY) 2022 in June, ahead of July floor votes. Lawmakers in the House of Representatives had until April 30 to submit earmark requests, which are now listed on the committee’s website. Congress has until the end of the fiscal year on September 30 to pass appropriations legislation or to rely on a stopgap spending measure to avoid a shutdown of the federal government. Neither Budget Committee chairs Rep. John Yarmuth (D-Ky.) nor Sen. Bernie Sanders (I-Vt.) have released FY22 budget resolutions, which would set top-line spending levels and could also set up the reconciliation process for the President’s infrastructure proposals. Yarmuth has previously stated plans to send a full budget proposal by Memorial Day.


Debt Limit Projection Revised


Last week, U.S. Treasury Secretary Janet Yellen indicated that the “extraordinary measures” for addressing the debt ceiling could run out “this summer.” While the debt ceiling is due to be re-instated as of July 31st, traditionally, the Department of Treasury has certain tools it can deploy to give Congress more time – up to several months -- to address the situation. Democrats are expected to use the budget reconciliation process to raise the ceiling, possibly tying it to the President’s recently proposed infrastructure packages.


White House Announces Support for Vaccine Trade Waiver


The Biden administration announced support of a proposed waiver of patent protections for COVID-19 vaccines. This so-called “TRIPS waiver” would allow global manufacturers to replicate vaccine formulas to potentially increase vaccine production across the world. The waiver, which was first proposed by India and South Africa through the World Trade Organization (WTO) last year and is supported by 55 other countries, was opposed by the Trump administration. Proponents of the waiver argue 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. The Biden administration’s move was praised by many Democratic lawmakers who had lobbied the White House in favor of the waiver and pointed to the U.S. government’s investment in each COVID-19 vaccine. Industry continues to assert that strong intellectual property protections are necessary to incentivize continued innovation, and that the waiver could create such a demand for vaccine supplies and raw materials amongst entities with little manufacturing experience that will impede global production while putting the safety and security of the supply chain at risk. The WTO operates by consensus, meaning all 164 members would have to agree to support the waiver to take effect. The United States’ change of position has already prompted Canada to say that it is willing to engage in talks on the subject matter, although the reversal was criticized by Germany, which stated “the limiting factor in vaccine manufacturing is production capacity and high quality standards, not patents.” It remains unclear whether other European Union countries will come out in support of the waiver. India and South Africa have stated that they could revise their waiver request, which originally covered COVID-19 vaccines, therapeutics, and diagnostics, to be more narrow. The issue may next be examined at a WTO intellectual property council meeting later this month.


House Lawmakers Push for E-Labeling Flexibility


Agroup of 20 bipartisan members of the House of Representatives are asking that appropriators allow for drug prescribing information to be sent to providers and pharmacists digitally. The letter, which was spearheaded by Reps. Mikie Sherrill (D-N.J.) and Adam Kinzinger (R-Ill.), argues that e-labeling would reduce the environmental footprint of paper prescribing and could be readily adopted by those already using electronic health records (EHRs). They urge appropriations leadership to not include any language in the FY 2022 appropriations bill that would prohibit the Food and Drug Administration (FDA) from allowing pharmaceutical prescribing information (PI) to be delivered in digital form instead of paper.


MA Prior Authorization Bill to be Reintroduced


In preparation for the reintroduction of the Improving Seniors’ Timely Access to Care Act this week, Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Ami Bera (D-Calif.), and Larry Buchson (R-Ind.) sent a Dear Colleague letter seeking original cosponsors for the bill. The legislation aims to increase accountability and bring transparency to the Medicare Advantage (MA) program by establishing an electronic prior authorization process and a process for “real-time decisions” for items and services that are routinely approved under prior authorization. It would also require MA plans to report on their use of prior authorization and the rate of approvals and denials. The bipartisan bill was previously cosponsored by 208 lawmakers during the 116th Congress.



May 10, 2021: | Page 1 Page 2

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