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 to Consider CR, NDAA, and Debt Limit This Week

The Rules Committee in the House of Representatives will meet today to take up a stop gap funding bill and the National Defense Authorization Act (NDAA), setting up a House vote on the bills this week. The funding measure to avoid a government shutdown on October 1 is expected to run through December 3. It will include emergency relief in response to recent natural disasters and funding to support the processing of Afghan refugees. Majority Leader Steny Hoyer (D-Md.) stated that along with the continuing resolution (CR), the House would also take action on the debt limit this week. It remains unclear whether the CR will include a measure to raise or suspend the debt limit, with Democrats insisting that they will not address the debt limit via reconciliation and nearly all Senate Republicans in opposition to a clean debt limit increase or suspension. The House also plans to vote on both the bipartisan infrastructure framework and the Build Back Better reconciliation package during its current work period, which ends on October 1. Democrats still plan to move the two pieces of legislation in tandem, though House Budget Committee Chair John Yarmuth (D-Ky.) has suggested that House Speaker Nancy Pelosi (D-Calif.) could hold the infrastructure bill for a period of time prior to sending it to the President for his signature as the Senate begins its work on the reconciliation package.

Reconciliation Content, Scope Under Debate as House Committees Complete Markups

Committees of jurisdiction in the House of Representatives have wrapped up work on the $3.5 trillion Build Back Better reconciliation package, but significant differences remain to be negotiated both within the House Democratic caucus and between the House and Senate on the content and scope of the bill.

During the Energy and Commerce Committee’s three-day markup, the panel agreed to the proposal to add vision, dental, and hearing benefits to the Medicare program. Rep. Kurt Schrader (D-Ore.) was the only Democrat to vote against the provision. Under the new benefit, vision coverage would begin in 2022, hearing coverage would begin in 2023, and dental coverage would begin starting in 2028. Energy and Commerce also cleared a proposal to expand Medicaid in states that have not yet done so prior to the creation of a federally-run Medicaid program in 2025. The measure would extend Affordable Care Act (ACA) insurance subsidies to Americans making less than 138% of the poverty level and would be coupled with a $10 billion annual reinsurance program.

Democrats’ signature drug pricing proposal, however, failed to advance in a tied committee vote. Reps. Kurt Schrader (D-Ore.), Scott Peters (D-Calif.), and Kathleen Rice (D-N.Y.) joined Republicans in voting against a measure that would have capped price increases for certain medications and created an international reference pricing mechanism. The proposal would have also placed a cap on out-of-pocket costs for Medicare beneficiaries. Rep. Peters is opposed to the bill’s 95% penalty on manufacturers that do not agree to the government’s price and has stated that he is working with congressional leadership on his own drug pricing proposal for inclusion in the reconciliation package. Democrats had planned to use the savings stemming from the drug pricing provisions to help pay for the reconciliation package overall.

Identical drug pricing language was advanced separately by the Ways and Means Committee last week. The only Democrat to oppose the Ways and Means reconciliation package was Rep. Stephanie Murphy (D-Fla.) who had announced her opposition in advance of the committee’s consideration. The panel also approved legislation to make permanent the ACA’s enhanced premium tax credits and to allow individuals receiving unemployment benefits to access premium-free insurance plans through 2025. In addition to the health care provisions, Ways and Means considered tax provisions that would raise more than $2 trillion in revenue to pay for the social spending provisions. The tax portion of the Democrats’ plan, which was advanced by a vote of 24-19, would raise the top corporate tax rate from 21% to 26.5% and increase the top rate on capital gains from 20% to 25%. Ways and Means adopted a proposal that would double the current rate of excise taxes on cigarettes and other tobacco products, while also imposing taxes on e-cigarettes. The Committee estimates that these provisions would generate $96 billion in revenue.

President Joe Biden hosted Sens. Joe Manchin (D-W.Va.) and Kyrsten Sinema (D-Ariz.) for separate meetings at the White House last week to discuss the reconciliation bill. Both members have stated that they wish to pare back the total size of the package, with Manchin recently asserting that he would support a package totaling between $1 and $1.5 trillion. Democrats will have to be unified in their support for the reconciliation bill in the evenly divided Senate, and House Speaker Nancy Pelosi (D-Calif.) can only afford to lose three votes from her caucus when the bill comes to the House floor.

Lawmakers Encourage USPTO to Reform IPR Process

A bipartisan, bicameral group of lawmakers have sent a letter to the U.S. Patent and Trademark Office (USPTO) urging the agency to reassert its role in reviewing drug manufacturer’s anticompetitive practices, specifically by ending the policies that have caused an increase in discretionary denials of patent challenges. The lawmakers assert that the inter partes review (IPR) process has been weakened by administrative changes that are not based in statute, and that USPTO’s increasingly frequent denials for IPR for reasons not based on merits has made it more difficult to curb anticompetitive practices by prescription drug companies. “Without a sufficiently strong IPR system to serve as a check against questionable patents, brand manufacturers will continue to wield patent thickets that are nearly impossible to challenge and engage in product hopping, further burdening the American people with needlessly high drug prices,” the letter states.

September 20, 2021: | Page 1 Page 2 Page 3



 -  2023

 +  2022

 +  2021

 +  2020

 +  2019

 +  2018