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October 4, 2021

This Week in Health Policy for October 4

This Week (October 4 - 8)

The House is expected to be out of session in Washington, D.C., but in Committee Work Weeks the next two weeks.

Last Week (September 27 - October 1)

Health Care Highlights

Bipartisan infrastructure bill stalled over disagreement on reconciliation package, with health care items on the chopping block. The House has still not voted on the Senate-passed bipartisan infrastructure framework (BIF) as the White House and House and Senate Democratic Leaders try to forge a deal on reconciliation between progressives and moderate Senators Joe Manchin (D-WV) and Krysten Sinema (D-AZ). House House Speaker Nancy Pelosi (D-CA) met with members throughout the day on Thursday (Sept. 30) after indicating she planned to move forward with a vote but recognized the longstanding position of progressives that some type of agreement on reconciliation be in hand before voting for the BIF. An outline of what Sen. Manchin would support from late July published by Politico suggested he could support a $1.5 trillion bill with certain stipulations. More of a mystery is Senator Kyrsten Sinema (D-AZ), who made three visits to the White House September 28 and later said she had made her reconciliation objections known.

As congressional Democrats look for ways to trim the price tag of their package, moderates have suggested limiting the expansion of some health care benefits to lower-income Americans. Sen. Manchin said he wants to means-test "everything we can" while other centrists have said new vision, dental, and hearing benefits for Medicare beneficiaries specifically need to be limited by income. Rep. Kurt Schrader (D-OR), a moderate who voted against the Energy and Commerce Committee's provision to expand Medicare benefits, said he wants dental coverage — the most expensive part of the coverage expansion — to be means-tested. Also on the chopping block is a proposal to create a federal Medicaid program to cover Americans in states that haven't expanded the program, potentially limiting the availability of the program to as few as three years. Sen. Tammy Baldwin (D-WI) said that "it's pretty clear it won't be made permanent." The Energy and Commerce Committee approved legislation earlier this month that would immediately give no-cost insurance through the Affordable Care Act (ACA) marketplaces to people in non-Medicaid expansion states under a certain income level, then transition them starting in 2025 to a new, federal Medicaid-like program. Rep. Lloyd Doggett (D-TX) indicated there is stronger support for the provision in the House, but also said there are "no shortage of potential revenue sources for Medicaid or any other policy we are seeking to enact in Build Back Better, only a question of the political will to move forward."

CR includes fentanyl measure, not debt limit suspension. On Thursday (Sept. 30), Congress approved a short-term government funding bill, or continuing resolution (CR), to keep the government funded through December 3 after Democrats delinked the measure from a debt limit suspension; that issue is now on hold with a must-act date a few weeks away (Oct. 18). Included in the CR was an extension of the government's power to automatically restrict fentanyl-like substances, which was set to expire Oct. 22, until Jan. 28, 2022. Earlier this month, the White House asked to permanently place all fentanyl-analogues on the list of the most controlled narcotics to give law enforcement agencies the power to prosecute anyone caught in possession of them illegally. Some lawmakers, namely Sen. Cory Booker (D-NJ), wanted these authorities to expire earlier this year, arguing that they contribute to over-policing of people struggling with addiction. The measure also included reduced funding in the Medicare Improvement Fund to help pay for other provisions.

A standalone debt limit suspension bill that passed the House 219-212 on Tuesday (Sept. 28) could be considered in the Senate as soon as next week, Majority Leader Chuck Schumer (D-NY) said, though it is expected to fail given Republican opposition. Schumer and other Democratic Senate leaders are resistant to using the budget reconciliation process to suspend the debt ceiling, while Democratic House leaders have noted that it is a possibility.

Tri-Agencies issue details on IDR process for "Surprise Billing." On Thursday (September 30), the Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury ("the Departments") released released an interim final rule with comment period, "Requirements Related to Surprise Billing; Part II," which details the Independent Dispute Resolution (IDR) process to settle out-of-network (OON) rates between providers and payers in "surprise billing" situations and outlines requirements for health care cost estimates for uninsured (or self-pay) individuals. The rule is the third in a series implementing the No Surprises Act, a bipartisan piece of legislation passed at the end of 2020 intended to protect patients from surprise OON billing. On July 13, 2021, the Departments issued a rule outlining consumer protections against surprise billing and in early September, the Departments issued a rule to help collect data on the air ambulance provider industry. Collectively, these rules take effect January 1, 2022 and ban surprise billing for emergency services, air ambulance services provided by OON providers, and certain non-emergency care provided by OON providers at in-network facilities.

For more information, see this Fact Sheet, Press Release, and the Interim Final Rule.

HHS now accepting PRF Phase 4 funding requests. HHS is now accepting applications for the fourth tranche of Provider Relief Fund (PRF) funding. $25.5 billion is available for Phase 4 funding, which includes the $8.5 billion appropriated for rural Medicaid providers in the American Rescue Plan, as well as $17 billion for other providers who can document revenue loss and expenses associated with the pandemic between July 1, 2020, and March 31, 2021. According to the landing page, "Phase 4 will also include new elements specifically focused on equity, including reimbursing smaller providers for their changes in operating revenues and expenses at a higher rate compared to larger providers, and bonus payments based on the amount of services providers furnish to Medicaid/CHIP and Medicare beneficiaries." The application will close on October 26, 2021 at 11:59 p.m. ET.

Pfizer and BioNTech submit data to FDA for younger children while booster campaign is underway. Earlier this week, Pfizer and BioNTech submitted data to the Food and Drug Administration (FDA) on their COVID-19 vaccine for children ages 5 to 11, and said they'd formally ask within weeks that the shot be authorized for children in that age group. If regulators follow the same timeline they took to review the shots for older children, kids could start getting vaccinated as soon as late October. The FDA is also reportedly considering authorizing a half-dose of Moderna Inc.'s COVID-19 vaccine as a booster shot, indicating regulators think that the lower dosage level offers substantial protection. White House COVID-19 Coordinator Jeff Zients said the booster campaign is off to a "strong start" with more than 400,000 Americans getting a booster at pharmacies last weekend. He said the U.S. hit a milestone last week with 200 million adults with at least one shot.

Biden HHS retracts rule on CHC insulin and epinephrine discounts. On Thursday (Sept. 30), the Biden administration retracted a Trump-era rule that would have required community health centers (CHCs) to pass all insulin and epinephrine discounts to patients or lose federal grant money. Biden's HHS withdrew the rule "due to the excessive administrative costs and burdens that implementation would have imposed on health centers." The Trump-era rule was finalized right before former President Donald Trump left office. Health officials said the intent of the rule was to make it easier for low-income patients to afford their insulin, however facilities argued they already pass on discounts and the rule was an unnecessary administrative burden.


House Judiciary Committee advances drug pricing legislation. On Wednesday and Thursday (Sept. 29-30), the House Judiciary Committee approved four bills aimed at increasing competition and enhancing access to lower-prices drugs, homing in on drug maker activity involving patents and other anti-competitive behavior. The bills are related to measures advanced by the Senate Judiciary Committee over the summer, however those have yet to come to the floor for a vote.

  • Stop Stalling Access to Affordable Medications (H.R. 2883), by a vote of 31-9. The bill would enable the FTC to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar.
  • Preserve Access to Affordable Generics and Biosimilars Act (H.R. 2891), by a vote of 28-13. The bill would prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.
  • Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (H.R. 2873), by a vote of 27-16. The bill would amend the FTC Act to prohibit product hopping, and for other purposes.
  • Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 2884), by voice vote. The bill would amend title 35, United States Code, to clarify and improve the process for subsection (k) applicants to resolve patent infringement claims for biological products (commonly known as the "patent dance"), and for other purposes.

For more information, visit the markup landing page.

Reports, Studies, and Journals

Kaiser Family Foundation: How Marketplace Costs and Premiums will Change if Rescue Plan Subsidies Expire. If Congress extends the ARPA subsidies or makes them permanent, federal costs will increase. On the other hand, if Congress does not extend these subsidies, premium payments will rise sharply for nearly all marketplace enrollees.

U.S. Office of the National Coordinator for Health IT: Individuals' Access and Use of Patient Portals and Smartphone Health Apps, 2020. About six in 10 individuals nationwide were offered access to their patient portal and nearly 40 percent accessed their record at least once in 2020.

Urban Institute: Strengthening Long-Term Services and Supports. A report finds that generous funding to support policies related to home- and community-based services (HCBS) eligibility, caregiver wages, and services could drastically improve the lives of people in need and the workers who serve them.


Contact Information
For additional information concerning this Alert, please contact:
Washington Council Ernst & Young
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