HEALTH CARE BRIEFING: Covid Aid Bid Revived With Ukraine Request

President Joe Biden has broad support in Congress for a massive $33 billion Ukraine aid package, but the proposal risks getting tangled in a long-simmering partisan spat over Covid-19 funding and pandemic border rules.

The Senate could vote on the emergency spending package next week, but the House will be on recess. Congress could finish by the week of May 9 and send it to Biden for his signature. But if Democrats insist on attaching long-stalled funding for Covid vaccinations and treatment to the package, action could be delayed indefinitely.

“That’s not going to happen. That’s an awful way to do business,” the Senate Foreign Relations Committee’s ranking member, Jim Risch (R-Idaho), said about combining the two spending requests. Biden urged lawmakers to tie the two together in his request. “Let’s get both of these critical tasks done,” he said Thursday at the White House.

Senate Democrats and Republicans previously hashed out a $10 billion compromise on Covid funding, but that effort stalled earlier this month when Republicans demanded a vote on an amendment that would reverse a decision to lift pandemic-related restrictions on migration across the Mexican border, known as Title 42. And vulnerable swing-state Senate Democrats have also come out against lifting Title 42 and might feel compelled to back a related amendment. Once the provision is part of the bill, that could poison the measure with Democrats in the closely divided House.

Sen. Mitt Romney (R-Utah), who negotiated the Covid aid measure with Majority Leader Chuck Schumer (D-N.Y.) said senators still want to vote on extending Title 42. “I think the prospects of each being passed would be greater if they were kept separate and if each had the potential for amendments,” Romney told reporters Thursday. Read more from Erik Wasson.

Becerra Faces Heat for Slow Response to Hill Demands

Health and Human Services Secretary Xavier Becerra was on Capitol Hill this week getting hand shakes, hugs and some berating from his old colleagues in the House over a lack of responsiveness from his agency.

Becerra’s relationship with his former colleagues on both sides of the aisle is being tested by the demands of his new job, lawmakers say. Becerra and his team have “some catch up work here because on both sides of the aisle, members have made reference to writing, but they haven’t had their questions answered,” Rep. Anna Eshoo (D-Calif.) told Becerra during a hearing Wednesday.

Lawmakers say they are facing slow, unsubstantial, or no responses from the HHS, even though Becerra was a longtime member of Congress before joining the Biden administration and faced the same issues.

Senate Republicans blame a slow administration response about how Covid funds have been spent for delays in negotiating new pandemic money. Becerra’s allies in Congress say he has been available to them for input in key policy matters but isn’t leading HHS to act at the whims of his old friends.

After two days of hearings where he was repeatedly asked about responding to letters from lawmakers or requests for information, Becerra said in an interview he gives members his personal cell number and talks regularly with lawmakers. He said he tries to respond to each one.

“As a former member, I know how important it is to respond,” Becerra said. “At the same time, I hope I can make clear to them that where I’m allowed to respond, I will.” Read more from Shira Stein and Alex Ruoff.

Also Happening on the Hill

Opioid Makers May Face Higher Bar With New FDA Powers: Opioid makers who want to put new painkillers on the market should have to prove their drug works better than what’s already out there, the FDA chief said on Thursday in calling for new legal authority for the agency. “Opioids don’t work like other drugs, and I think that’s something that I would like to see happen,” Food and Drug Administration Commissioner Robert Califf said at a Senate Appropriations Committee hearing. His proposal would tighten standards for drugmakers seeking to sell new opioids.

It’s one of several moves the U.S. drug regulator is considering to curb one of the nation’s most pressing public health challenges. The agency can’t act on its own, however. Congress would have to give the FDA the power to impose such a requirement. “Right now the FDA doesn’t have legal authority when it comes to a new drug application to require that it provides superiority to drugs that are already on the market,” he said. “The legal comparative standard is compared to a placebo or nothing.” Read more from Jeannie Baumann.

Bipartisan Pair Wants Opioid Label Updates: Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) urged the FDA to update its policies for labeling opioid prescriptions as overdoses in their states remain high. “In 2021 alone, at least 216 Granite Staters lost their lives due to opioid overdoses, and 1,512 Hoosiers lost their lives due to opioid overdoses in Indiana,” the lawmakers told FDA chief Califf in a letter. “The FDA continues to permit doctors to prescribe these drugs to be sold under misleading and inaccurate labels.” Read their letter here.

Abbott Workers Faked Records, Whistleblower Says: Employees at an Abbott Laboratories plant at the center of a recall of infant formula falsified records and hid information during a government probe, among other violations, a whistleblower said in a report. House Appropriations Chair Rosa Delauro (D-Conn.) Thursday released the report from a former worker at the Michigan plant that makes powdered infant formula. Abbott voluntarily recalled formula tied to the factory in February. Read more from Maeve Sheehey.

What Else to Know Today

Moderna Seeks Clearance for Vaccine in Kids: Moderna applied for emergency use authorization for its vaccine in children from six months to under 6 years old after a successful trial showed two doses generate high levels of viral antibodies. The highly anticipated application comes just over a month after Moderna said a large trial showed two low doses produced powerful immune responses in young kids. Though its effectiveness against omicron infections was modest, the application will put pressure on the FDA to quickly make a decision. Robert Langreth has more.

• The FDA will proceed with reviewing Moderna’s request even as a similar vaccine from Pfizer faces delays, the agency’s head told reporters.“Most of the experts that I’ve talked with would say it would be ideal if they could be considered together,” Califf told reporters after the appropriations hearing. “But if they don’t come in at the same time, then there’s not going to be a hold up on the Moderna application.” Politico reported that regulators wanted to wait to authorize the two shots together. Jeannie Baumann has more.

More Coronavirus Headlines:

• New Omicron Sublineages Likely Evade Vaccines, Natural Immunity
• All About Paxlovid and Other Covid-19 Treatments: QuickTake

FDA Proposes Menthol Cigarette Ban: Menthol-flavored cigarettes and cigars would be banned from sale under two proposed rules published Thursday, marking a long-sought step in the FDA’s efforts to address tobacco-related health disparities. The agency issued new product standards targeting menthol and other flavored tobacco products that can make smoking harder to quit, particularly among younger users. These products are often disproportionately used by Black Americans and other minority groups. Read more from Celine Castronuovo, Jeannie Baumann, and Ian Lopez.

Private Medicare Plans Scrutinized for Coverage Denials: A U.S. watchdog agency wants the Centers for Medicare and Medicaid Services to issue new regulations and update its audit protocols to address the improper denial of prior authorization and payment requests by Medicare managed care plans. A report from the HHS inspector general said that 13% of prior authorization requests denied by private Medicare Advantage plans actually met Medicare coverage rules. The plans provide benefits to about 27 million beneficiaries. Tony Pugh has more.

ACA Discrimination Ban Delayed in Insurer Rule: The HHS delayed a controversial ban on discrimination in health care that would strengthen protections for the LGBT community in a Thursday final rule establishing parameters for insurers under Obamacare. Health insurers will need to post standardized costs for plans offered on Healthcare.gov under the rule. The Department of Health and Human Services is set to come out with a separate rule strengthening Section 1557 of the Affordable Care Act in the coming months. Read more from Shira Stein.

Employers Cautioned as COBRA Notices Add Up: A rising threat of litigation is prompting benefits attorneys to caution employers to pay closer attention to the details of notices they provide about how former workers can continue their health coverage. Lawsuits against companies such as Amazon, GM, and Target allege deficiencies in COBRA notices that could deter individuals from signing up. COBRA allows former employees to keep their health insurance for limited periods, but few do because they must pay the full cost. Sara Hansard has more.

More Headlines:

• Eli Lilly to Ask for Accelerated Approval of Alzheimer’s Drug in July
• Celgene Must Face Humana Suit on ‘Supracompetitive’ Drug Price
• Widow Calls for Rehearing Over Lung Transplant Coverage Denial

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