HEALTH CARE BRIEFING: House to Vote on Omnibus with Covid Relief

Democrats and Republicans in Congress struck a deal on a long-delayed $1.5 trillion spending bill that would fund the U.S. government through the rest of the fiscal year and provide $15.6 billion for Covid-19 measures. Lawmakers released the text of the 2,741-page measure early Wednesday, with the House planning to pass it later in the day.

The legislation would provide $730 billion for non-defense discretionary spending, a 6.7% increase and a win for Democrats. In a last minute compromise, funding for pandemic-related measures was cut from the from the $22.5 billion the administration wanted, to $15.6 billion.

The coronavirus spending bill includes $10.6 billion for a Department of Health and Human Services emergency fund, $4.5 billion for global health programs, and $500 million for humanitarian services. Those funds would be offset by using $7 billion in aid to state and local governments in the March 2021 stimulus and nearly $3 billion in unused Paycheck Protection Program small business funds.

Democrats failed in their attempt to get rid of a decades-old provision that’s regularly attached to spending legislation. Known as the Hyde amendment, it bans federal money for abortion, except in cases of rape, incest, or to save the life of the woman. President Joe Biden had previously supported the restriction before changing his position during his campaign for president, and calling for it to be repealed.

The bill also includes the Weldon amendment, which bars funding for state and local government if those entities refuse to work with insurance plans or people that provide, pay for, cover, or refer abortions.

Sen. Roy Blunt (Mo.), the top Republican on the committee responsible for nearly all federal health funds, last month said he expected the omnibus to retain all the regular policy provisions, as Democrats didn’t have the votes to repeal them.

The funding bill also prohibits federal funds from going to buy sterile needles or syringes that would be used in needle exchanges for the injection of illegal drugs. The Biden administration has proposed funding for needle exchanges via grants in order to help treat opioid addiction. Those grants have come under fire largely from Republicans, who said they could be used to distribute free pipes for drug users, something HHS officials have disputed. Read more from Erik Wasson and Jack Fitzpatrick.

• The bill includes $1 billion for the creation of ARPA-H, an advanced research agency for health, which Biden touted in his State of the Union address as part of the effort to cut cancer mortality rates. Read more from Jack Fitzpatrick.
• The Food and Drug Administration will get new authorities to regulate synthetic nicotine, found in e-cigarettes popular among teenagers, as part of the government spending bill, a lawmaker confirmed yesterday. The provision in the omnibus appropriations legislation would give the FDA the authority to regulate products that contain nicotine but aren’t derived from tobacco, such as synthetic nicotine, according to a document obtained by Bloomberg. Senate Health, Education, Labor and Pensions Chairwoman Patty Murray (D-Wash.) and House Energy and Commerce Chair Frank Pallone (D-N.J.), along with Sens. Richard Burr (R-N.C.) and Dick Durbin (D-Ill.), led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. Read more from Alex Ruoff and Riley Griffin.

The Coronavirus Pandemic

GOP Plan Own Bill to Revamp Speedy Drug Approvals: House Energy and Commerce Republicans plan to counter a proposal by Democrats to revamp an FDA approval pathway that Biogen’s Alzheimer’s drug has thrust under the microscope. The draft bill, obtained by Bloomberg Law and confirmed by a Republican aide yesterday, would overhaul the accelerated approval process that’s designed to speed up access to medicines by relying on laboratory markers that can predict a drug’s clinical benefit. The bill, by Rep. Cathy McMorris Rodgers (R-Wash.), the top Republican on the committee, would allow the FDA to expedite withdrawals of drugs that ultimately don’t show a benefit to patients. Read more from Jeannie Baumann and Alex Ruoff.

Bipartisan Group Presses Mental Health Agency: Party leaders of the House Energy and Commerce Committee wrote to the Substance Abuse and Mental Health Services Administration yesterday to request information on the White House’s “efforts to address the increased levels of mental health issues” in the U.S. amid the pandemic. The letter, signed by Chair Pallone and top Republican Cathy McMorris Rodgers (Wash.), among others, cited CDC data showing that American adults in June 2020 reported elevated levels of mental health and substance use issues. Read their letter here.

Pfizer to Submit Data on Fourth Vaccine Dose Soon: Pfizer will soon submit data to U.S. regulators on a fourth dose of a Covid vaccine, Chief Executive Officer Albert Bourla said. Bourla said he spent yesterday reviewing new data from various vaccine trials, including one looking at the effects of a fourth dose of the currently available vaccine, as well as a new formulation that will help protect people against multiple variants of the coronavirus. “They look encouraging,” Bourla said in an interview on Bloomberg. Read more from Riley Griffin.

More Headlines:

• Covid-19 Health-Care Facility Inspection Plan Initiated by OSHA
• Covid-19 Death Claim Against Hospital Sent Back to State Court
• N.Y. Court Reporters Lose Religious Challenge to Vaccine Mandate
• Pulse of GOP Shot Mandate Pushback Weaker as Virus Risk Recedes

What Else to Know Today

Biden to Push Against Nursing Home Industry for Staff Minimums: The Biden administration is set on a plan to impose minimum staffing requirements on nursing homes, according to a top health official, even as industry groups say it won’t work without more funding. The staffing proposal is part of a broad agenda Biden released last week to bring greater scrutiny to a U.S. nursing-home industry whose patients and workers have been devastated by Covid-19. Read more from John Tozzi and Tony Pugh.

• Separately, a Louisiana nursing home failed to shake a suit alleging its mismanagement caused injuries that led to a patient’s death because the action wasn’t one for malpractice requiring presuit review, a federal court in the state said. Wilgot Jacobsson, the patient’s son, can proceed with the case because it didn’t meet Lousiana’s six-part test for determining when an action “sounds in” medical malpractice, the U.S. District Court for the Middle District of Louisiana said. Read more from Mary Anne Pazanowski.

PFAS-Free Foam Details Expected in Months, DOD Says: The Defense Department expects to release military specifications for liquid fuel firefighting foams manufactured without “forever chemicals” in around six months, a Pentagon official said yesterday. Those specifications will guide industries making and using such foams, Robin Nissan, program manager for two Department of Defense environmental research programs, told industry and other participants yesterday at a Green Chemistry and Commerce Council conference. Read more from Pat Rizzuto.

Drugmakers’ Input Sought on Easing FDA Reporting Rules: Medical product makers could have some discretion in how they measure the quality of their manufacturing under policy changes the FDA is proposing for industry feedback. The FDA is asking for input on proposed changes to the “Quality Metrics Reporting Program,” which has been in development since 2016 through various comment periods and pilot programs. Drugmakers under the latest proposal may choose from a range of metrics, such as lot release cycle time, to report the stability of their supply chain. Celine Castronuovo has more.

More Headlines:

• S.C. Loses Legal Push to End Planned Parenthood Medicaid Pay
• Surgeon Gets Testimony on Informed Consent Claims Trimmed
• Spinal Surgery Patients Lose Bid to Reopen Fraud, Hiring Cases
• Boston Scientific Patent Argument ‘Stupid,’ Appeals Judge Says

With assistance from Alex Ruoff

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com