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.


Senate Passage of BIF Expected This Week

The Senate agreed to proceed to debate on the $550 billion bipartisan infrastructure framework by a vote of 66-28 on Friday. Sixteen Republicans, including Minority Leader Mitch McConnell (R-Ky.), joined Democrats in advancing the legislation. The bill, which contains traditional infrastructure- related provisions to fund roads, bridges, transit, and broadband build-out, is expected to pass with bipartisan support this week after weeks of back and forth, closed-door negotiations led by Sens. Kyrsten Sinema (D-Ariz.) and Rob Portman (R-Ohio). Agreement was recently reached on how to fully offset the bill. Pay-fors include re-purposing $200 billion in unspent COVID-19 relief funds – but leaving unspent money in the Provider Relief Fund (PRF) untouched - and further delaying the Trump-era rebate rule for $49 billion in savings. The bill also saves $3 billion through a provision requiring rebates from pharmaceutical manufacturers for certain physician-administered single-use medications, meant to discourage the packaging of single-use vials with more than the recommended amount of drug. An additional $9 billion of the bill’s cost will be covered by an extension of the Medicare sequester. After release and introduction of the final bill language on Sunday afternoon, Senate Majority Leader Chuck Schumer said the chamber could wrap up work on the bipartisan bill “in a matter of days.” Final congressional action, however, will not come until after the House returns from a recess in September.

Senate passage of the bipartisan infrastructure framework would facilitate Senate consideration of a fiscal year (FY) 2022 budget resolution, containing reconciliation instructions for passage of President Joe Biden’s broader economic agenda and Democratic party priorities, including climate change, taxes, and health care reform. Budget Committee Chairman Bernie Sanders (I-Vt.) has stated that he expects the chamber to cancel its first week of August recess, scheduled to begin August 9, to vote on the budget resolution, and Democrats have the 50 votes necessary to ensure passage. Sen. Sanders does not expect the reconciliation package to be voted on until September.

House Speaker Nancy Pelosi (D-Calif.) has said that her chamber will not vote on the bipartisan infrastructure legislation until the Senate passes the broader reconciliation bill. With the Senate evenly divided and the Democrats’ House majority lessened to three following the swearing in of Rep. Jake Ellzey (R-Texas) to replace the late Rep. Ron Wright on Friday, Democratic leadership in both chambers will have to balance the interests of the centrist and more progressive factions of the party in drafting the larger partisan package.

House Passes FY 2022 Labor-HHS Minibus

The House of Representatives passed a $600 billion fiscal year (FY) 2022 minibus spending bill last week by a party-line vote of 219-208. The seven-bill package used the Labor-Health and Human Services-Education legislation (H.R. 4502) as the vehicle while adding the Agriculture-Food and Drug Administration (FDA), Energy and Water, Financial Services, Interior- Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development (HUD) measures. Members voted to add a series of amendments to the package including the addition of $2.5 million for the Office of Management and Budget (OMB) to convene a conference on food, nutrition, hunger, and health; an increase of $3 million for Lyme disease research; an addition of $10 million to the Centers for Disease Control and Prevention’s (CDC) Autism Developmental Disability Monitoring Network; and the addition of language highlighting the need for the FDA to proceed with regulations on cannabidiol (CBD).

A continuing resolution (CR) is expected to be necessary to avoid a government shutdown at the end of the fiscal year on September 30, as the House bills contain provisions considered nonstarters amongst Republicans, including the elimination of a longstanding ban on federal funding for abortions (also known as the Hyde amendment). The Senate has not yet released any of its appropriations measures but is scheduled to mark up its Agriculture-FDA, Energy and Water, and Military Construction-VA bills this week.

Senate Judiciary Passes Bills to Increase Competition in Pharmaceutical Industry

The Senate Judiciary Committee advanced four bills by voice vote aimed at increasing competition and reducing prices in the prescription drug market last week. The bipartisan legislation approved by the committee includes:

  • The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act (S. 1425);
  • The Preserve Access to Affordable Generics and Biosimilars Act (S. 1428);
  • The Prescription Pricing for the People Act of 2021 (S. 1388); and
  • The Affordable Prescriptions for Patients Act of 2021 (S. 1435).

Lawmakers Urge HHS to Consider Canadian Drug Importation

Abipartisan group of senators have sent a letter to U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra calling on the department to allow Americans to import certain prescription drugs from Canada. “As the Administration considers options for lowering the cost of prescription drugs for patients, we urge your support for permanent solutions that will allow Americans to safely and personally import their medication,” the letter states. The lawmakers express support for the Safe and Affordable Drugs from Canada Act (S. 259), which would permit personal importation of certain safe and effective prescription drugs from approved pharmacies in Canada. The letter was signed by Sens. Amy Klobuchar (D-Minn.), Chuck Grassley (R-Iowa), Angus King (D-Maine), and Susan Collins (R-Maine).

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