Automakers say U.S. Senate bill will 'jeopardize' 2030 EV targets

 

A group representing General Motors, Toyota Motor, Volkswagen and other major automakers said a $430 billion bill approved Sunday by the U.S. Senate will put achieving U.S. electric-vehicle adoption targets for 2030 in jeopardy.

The Alliance for Automotive Innovation had warned late Friday that most EV models would be ineligible for a $7,500 tax credit for U.S. buyers under the bill and had unsuccessfully lobbied to change sourcing requirements for battery components and critical minerals.

"Unfortunately, the EV tax credit requirements will make most vehicles immediately ineligible for the incentive," said the group's chief executive, John Bozzella.

The change "will also jeopardize our collective target of 40-50% electric vehicle sales by 2030."

https://www.marketscreener.com/quote/stock/TOYOTA-MOTOR-CORPORATION-6492484/news/Automakers-say-U-S-Senate-bill-will-jeopardize-2030-EV-targets-41234224/

Tandem lines up FDA review of new pint-sized insulin pump amid lower-than-expected sales

 After stumbling a bit in the second quarter of the year, Tandem Diabetes is getting back on its feet, multi-quarter recovery plan already in place.

While those three months saw Tandem’s global sales jump 16% compared to last year, reaching a company record of just over $200 million, that wasn’t enough to keep the diabetes tech developer on track toward its 2022 goals. In an earnings report Wednesday afternoon, the company said it would lower its full-year sales forecast to represent growth of between 19% and 20% over 2021, totaling between $835 million and $845 million.

That’s a mood shift from just a quarter ago, when Tandem took a much more optimistic approach by bumping up estimates from the beginning of the year. It kicked off 2022 with an eye toward total sales between $845 million and $860 million, but after a successful first quarter, it ratcheted up that forecast to land between $850 million and $865 million, which would’ve marked an improvement of up to 23% over 2021’s numbers.

Alongside the lower-than-expected sales, the San Diego-based devicemaker reported an operating loss of more than $12 million and a net loss of $15.1 million—numbers that had been solidly in the black this time last year.

In a call with investors on Wednesday, CEO John Sheridan attributed the downturn to a trio of factors: ongoing “pandemic-related pressures,” growing competition within the U.S. and economic challenges including inflation and the looming recession, according to a transcription of the call.

But with the troubles of the second quarter solidly in the rearview mirror, Tandem is back in optimist mode, with a rosy outlook toward sales of both existing and upcoming technologies.

Chief among the latter category is the Mobi insulin pump. The device is about half the size of Tandem’s flagship t:slim pump and can be fully controlled by a user’s smartphone. It’ll also represent “the first novel form factor launched in our space since we introduced t:slim a decade ago,” Sheridan said on the call.

“We are in the final stages of testing, as well as drafting the submission, and intend to submit a 510(k) to the FDA this quarter,” the chief executive said. He noted that Tandem is already preparing for the pint-sized pump’s commercial launch following FDA clearance, which it’s tentatively expecting to snag in the first half of 2023.

In the meantime, Sheridan said Tandem is also working closely with partners Dexcom and Abbott to integrate its insulin pumps with their newest continuous glucose monitors: Abbott’s FreeStyle Libre 3, which was cleared by the FDA just a few months ago, and Dexcom’s G7 device, whose own FDA review is still underway after an agency request for more information.

It’s already been a busy year for Tandem. It kicked off 2022 with FDA clearance for its t:connect mobile app, which can be downloaded to a user’s smartphone to remotely program bolus dosing through the company’s t:slim X2 insulin pumps.

And just last month, Tandem further expanded its portfolio with the acquisition of Capillary Biomedical, an L.A.-area maker of extended-wear infusion set technology. Financial terms of the deal weren’t disclosed.

https://www.fiercebiotech.com/medtech/tandem-lines-fda-review-new-pint-sized-insulin-pump-amid-lower-expected-sales

Galapagos tosses another 4 programs to make room for CAR-T ambitions

 You’d be forgiven for thinking that Galapagos had already trimmed all the fact it could off its pipeline, but the Belgian biotech has managed to find another four early-stage programs worthy of being culled in favor of its CAR-T strategy.

The dropped assets include JAK1/TYK2 inhibitor GLPG3121 for inflammatory diseases, JAK1 inhibitor GLPG0555 for osteoarthritis and GLPG4716, a chitinase inhibitor designed to treat idiopathic pulmonary fibrosis.

The final phase 1 program being discontinued as part of Galapagos’ “ongoing scientific and strategic exercise” is GLPG4586, a compound with an undisclosed mode of action directed toward fibrosis. The company revealed the cuts as part of its second-quarter earnings announcement Thursday afternoon.

The biotech has been spring cleaning its pipeline for a few months, including pulling out of metabolic diseases and osteoarthritis R&D in May, followed by handing back the rights to a respiratory disease drug to Molecure a month later. Under new CEO Paul Stoffels, M.D., the company was able to use these savings to acquire CAR-T platform developer CellPoint and human antibody library owner AboundBio.

The biotech’s pipeline was in urgent need of replenishment after a string of poor data readouts almost emptied the closet. Its osteoarthritis therapy failed to make the grade in a phase 2 trial in 2020, while late-stage results ended hopes of an FDA approval for its pulmonary fibrosis candidate last year.

Stoffels told Fierce Biotech in June that the focus of Galapagos’ CAR-T ambitions will initially be the “more straightforward” target of hematological cancers. But there is also a longer-term plan to see whether it can address severe long-term solid cancers with the technology.

In yesterday’s earnings report, the company said enrollment is ongoing for phase 1/2a trials of a CD19 CAR-T obtained through its CellPoint buy in both relapsed/refractory non-Hodgkin lymphoma and relapsed/refractory chronic lymphocytic leukemia. Top-line results are expected in the first half of next year.

“Our near-term goal is to bring three additional differentiated, next-generation CAR-T candidates in the clinic over the next three years,” Stoffels said in a statement.

The company has also decided to roll on with a TYK2 inhibitor called GLPG3667, which it plans to enter into a phase 2 study in dermatomyositis before the end of 2022.

According to yesterday’s earnings announcement, Galapagos is continuing to explore “additional business development opportunities to further leverage our internal capabilities and renew our portfolio,” it said. “We look forward to presenting an in-depth update on our corporate strategy later this year.”

In the meantime, the company seems to have enough funds to power forward, with current investments, cash and cash equivalents totaling €4.43 billion ($4.53 billion) as of June 30.

https://www.fiercebiotech.com/biotech/galapagos-sends-another-4-programs-extinction-pivot-car-t-continues

7 Dems vote for GOP amendment, forcing Democratic scramble

 Maverick Sen. Kyrsten Sinema (D-Ariz.) on Sunday backed a Republican amendment to shield businesses that rely on capital investment from private equity groups from the 15 percent corporate minimum tax that Senate Majority Leader Schumer (D-N.Y.) included in the Inflation Reduction Act. 

Sens. Catherine Cortez Masto (D-Nev.), Maggie Hassan (D-N.H.), Mark Kelly (D-Ariz.), Jon Ossoff (D-Ga.), Jacky Rosen (D-Nev.) and Raphael Warnock (D-Ga.) also voted for the amendment.

The amendment was sponsored by Senate Republican Whip John Thune (R-S.D.) who says the 15 percent corporate minimum tax would raise taxes on businesses with less than $1 billion in profits because it would apply to private equity groups that have partnership interests in those businesses.  

The amendment would be paid for by a one-year extension of the cap on state and local tax deductions (SALT) that was a key feature of the 2017 Trump tax cut and which Schumer pledged to repeal as majority leader.  

The amendment could have imperiled final passage of the bill as it would hit residents of high-tax blue states such as New York, New Jersey, Connecticut and California.  

However, Democrats quickly offered an amendment from Sen. Mark Warner (D-Va.) after passage of the other amendment to make changes to the bill that would make it more palatable.

The Warner amendment replaced the SALT cap extension with a different tax provision raising revenue.

Warner’s amendment was approved, with Vice President Harris casting a tie-breaking vote.

Some Democratic senators privately expressed frustration on Sunday morning that Sinema was backing away from the deal she announced with Schumer last week to narrow the 15 percent corporate minimum tax by allowing companies to continue to fully expense major capital investments.  

They said the amendment could scuttle the deal after Democrats stuck together throughout more than 14 hours of vote-a-rama to defeat amendments on both sides of the aisle, including an amendment from Sen. Bernie Sanders (I-Vt.) to provide a $300-a-month expanded child tax credit for the next five years.  

“If any Democratic senator signed on to any of the amendments, it could be problematic,” warned one Democratic senator who was dismayed to find out that Sinema is pushing for a change to the underlying bill.  

Proponents of the Thune amendment, however, argue that the minimum tax included in the Inflation Reduction Act will wind up netting potentially thousands of businesses that accepted investment partnerships with private equity firms during the pandemic when credit from regular banks was tight.  

Sinema is concerned that small businesses such as plant nurseries and car detailing shops in Arizona could be caught up in the corporate minimum tax if they have a partnership relationship with a private equity firm that together with all its subsidiaries exceeds $1 billion in profits, according sources familiar with the discussions.

A source familiar with the tense behind-the-scenes negotiations say Schumer added language to the underlying bill Saturday that expanded the scope of the $15 percent corporate minimum tax.  

Technically, the revenue-raising provision is called a book minimum tax because it would require companies to declare income based on generally accepted accounting practices, which are stricter than what is required under current law, which includes various tax breaks and shelters that makes it easier for businesses to shield income from the IRS.  

One person familiar with the timeline of changes to the Inflation Reduction Act said when senators first saw the new text of the bill on Saturday it included for the first time language on “common control” that would apply the minimum tax on partnerships made up of many companies that by themselves don’t earn $1 billion in annual profits.  

The added language would raise an additional $35 billion in revenue over 10 years.  

Thune had proposed to strip that language out and pay for it by extending the SALT deduction cap for one year — but that could imperil passage of the bill in the Senate by making it unacceptable to Schumer or another Democrat from a high-tax state such as Sen. Bob Menendez (D-N.J.).  

https://thehill.com/homenews/senate/3591786-sinema-mulling-gop-amendment-that-democrats-warn-could-derail-tax-climate-health-bill/

Sinema votes for GOP amendment Dems warn could derail entire bill

 Sen. Kyrsten Sinema (D-Ariz.) on Sunday voted for a Republican amendment to shield businesses that rely on capital investment from private equity groups from the 15 percent corporate minimum tax that Senate Majority Leader Schumer (D-N.Y.) included in the Inflation Reduction Act. 

She was the only Democrat to vote for the measure as the Senate clerk called the roll as somber-faced Democratic senators sat at their desks. 

The amendment is sponsored by Senate Republican Whip John Thune (R-S.D.) who says the 15 percent corporate minimum tax would raise taxes on businesses with less than $1 billion in profits because it would apply to private equity groups that have partnership interests in those businesses.  

The amendment would be paid for by a one-year extension of the cap on state and local tax deductions (SALT) that was a key feature of the 2017 Trump tax cut and which Schumer pledged to repeal as majority leader.  

Sinema’s support of the amendment could imperil final passage of the bill as it would hit residents of high-tax blue states such as New York, New Jersey, Connecticut and California.  

Some Democratic senators privately expressed frustration on Sunday morning that Sinema was backing away from the deal she announced with Schumer last week to narrow the 15 percent corporate minimum tax by allowing companies to continue to fully expense major capital investments.  

They said Sinema could scuttle the deal by supporting the GOP-sponsored amendment after Democrats stuck together throughout more than 14 hours of vote-a-rama to defeat amendments on both sides of the aisle, including an amendment from Sen. Bernie Sanders (I-Vt.) to provide a $300-a-month expanded child tax credit for the next five years.  

“If any Democratic senator signed on to any of the amendments, it could be problematic,” warned one Democratic senator who was dismayed to find out that Sinema is pushing for a change to the underlying bill.  

Proponents of the Thune amendment, however, argue that the minimum tax included in the Inflation Reduction Act will wind up netting potentially thousands of businesses that accepted investment partnerships with private equity firms during the pandemic when credit from regular banks was tight.  

Sinema is concerned that small businesses such as plant nurseries and car detailing shops in Arizona could be caught up in the corporate minimum tax if they have a partnership relationship with a private equity firm that together with all its subsidiaries exceeds $1 billion in profits, according sources familiar with the discussions.  

A source familiar with the tense behind-the-scenes negotiations say Schumer added language to the underlying bill Saturday that expanded the scope of the $15 percent corporate minimum tax. 

Technically, the revenue-raising provision is called a book minimum tax because it would require companies to declare income based on generally accepted accounting practices, which are stricter than what is required under current law, which includes various tax breaks and shelters that makes it easier for businesses to shield income from the IRS.  

One person familiar with the timeline of changes to the Inflation Reduction Act said when senators first saw the new text of the bill on Saturday it included for the first time language on “common control” that would apply the minimum tax on partnerships made up of many companies that by themselves don’t earn $1 billion in annual profits.  

The added language would raise an additional $35 billion in revenue over 10 years. 

Thune is proposing to strip that language out and pay for it by extending the SALT deduction cap for one year — but that could imperil passage of the bill in the Senate by making it unacceptable to Schumer or another Democrat from a high-tax state such as Sen. Bob Menendez (D-N.J.).  

Schumer could strip the language without including a pay-for to offset the cost but that would reduce how much the bill will cut into the deficit over the next decade. Republicans are already mocking the legislation as misnamed because they say it will have a relative small impact on deficits and a negligible hit on inflation.  

A Democratic aide expressed hope the impasse can be resolved Sunday afternoon but a GOP aide warned this could postpone the bill into the evening or Monday.

https://thehill.com/homenews/senate/3591786-sinema-mulling-gop-amendment-that-democrats-warn-could-derail-tax-climate-health-bill/

AHA asks fed court to closely scrutinize how CMS repays hospitals over 340B payment cuts

 Hospitals that weren't affected by cuts to the 340B drug discount program shouldn’t be required to repay any of those funds now that the Supreme Court ruled such cuts were unlawful, a key industry group said. 

The American Hospital Association (AHA) made several filings in the U.S. District Court for the District of Columbia outlining its requests for how the Department of Health and Human Services (HHS) can repay cuts that started in 2018. The filings underscore the concerns the industry has over how HHS will make hospitals whole. 

The AHA said that any repayments to hospitals should not factor in budget neutrality requirements, which would mandate that any new payments to affected 340B hospitals would have to come from somewhere else. 

Federal law requires hospital payments under the Outpatient Prospective Payment System (OPPS) be budget neutral, but AHA argues that requirement applies only for future payments and not repayments.

“Nowhere does the OPPS statute speak of budget neutrality in connection with retrospective changes,” the filing said. The federal government has “no authority to recoup past payments to achieve budget neutrality.”

Any changes for a retrospective budget neutrality would also disrupt Congress’ “carefully crafted prospective payment system,” AHA wrote. 

The Centers for Medicare & Medicaid Services can instead use data to refine projections for future payments, but it cannot adjust rates for prior years to “achieve budget neutrality simply because it ended up paying more (or less) than it expected to,” according to the motion.

AHA was particularly worried about certain rural and children’s hospitals that were exempt from getting their 340B payments cut. If CMS did apply budget neutrality to its repayment formula, then it could try to recoup payments from such entities, the group argued.

Starting in 2018, CMS imposed a 22.5% cut to payments to covered entities in the 340B program, where drugmakers agree to offer discounts to safety-net providers in exchange for participation in Medicare and Medicaid. 

The AHA and other hospital groups sued over the cuts, with the case reaching the Supreme Court this past term. The court unanimously ruled in June that CMS did not have the statutory authority to install the cuts and sent the case back to the lower court to decide how to settle repayments. 

How those repayments are done is a major priority for the hospital industry, and it wants the district court to “closely supervise” the process.

“Fairness dictates that the government not penalize other hospitals—which have long spent the funds that the government may seek to recoup—for [CMS’] own mistakes,” the motion said.

AHA also appealed to the lower court to find that payment cuts in 2020, 2021 and 2022 were also unlawful, even though the Supreme Court ruling only touched on 2018 and 2019.

CMS did not propose the cuts in the latest proposed OPPS rule and wrote it is still trying to figure out how to repay hospitals.

https://www.fiercehealthcare.com/providers/aha-asks-federal-court-closely-scrutinize-how-cms-repays-hospitals-over-340b-payment-cuts

NY bonuses to 'hands-on' healthcare workers

 New York is taking healthcare workforce retention into its own hands with a $3,000 payout to certain employees who stay at their post for at least six months, Governor Kathy Hochul’s office announced this week.

“Our bonus program is about more than just thanks, this is an investment in healthcare and with it, we will retain, rebuild and grow our health care workforce and ensure we deliver the highest quality care for New Yorkers," the governor said in the announcement.

The newly launched Health Care and Mental Hygiene Worker Bonus Program is backed by $1.3 billion from the state’s fiscal year 2023 budget.

It authorizes the bonuses to workers providing “hands-on healthcare services” at Medicaid-participating provider organizations or certain other licensed entities, according to the announcement. Alongside healthcare and mental hygiene practitioners, this can include technicians, assistants, support staff and aides, the state said.

The employees must be receiving an annualized base salary of $125,000 or less to be eligible. Although the payments cap at $3,000 per full-time employee, the state is also offering lower payouts to part-time workers commensurate with the number of hours worked per week—for instance, $500 to those working between 20 and 30 hours per week.

Employers will be responsible for submitting eligible employees for the payments via an online portal. The state’s Medicaid program said it will be working with provider associations “to make sure all employers understand and are comfortable with the process.”

New York healthcare leaders said in the announcement that the program is intended to reward frontline healthcare workers while ensuring services can still be delivered to the state’s residents. Hochul has previously discussed her team’s goal to grow New York’s healthcare workforce by 20% over the next five years.

Included in the announcement were statements of support from a selection of the state’s provider associations, healthcare worker labor unions and individual healthcare organizations.

"Since the beginning of the COVID-19 pandemic, health care workers did the impossible in order to take care of patients and their families,” NewYork-Presbyterian president and CEO Steven Corwin, M.D., said in an included statement. “They are heroes, and their unwavering commitment to all New Yorkers has been critical throughout this pandemic. By investing in our frontline workers, we are investing in the health of every New Yorker."

Workforce shortages have been a sore spot for the healthcare industry with many being forced to pay out for pricey contract labor during COVID-19 surges. Recent reports suggest those financial stressors are recovering more slowly than expected while the supply of nurses and other workers will remain strained, or even worsen, during the next several months.

https://www.fiercehealthcare.com/providers/new-york-distributing-3000-bonuses-hands-healthcare-workers-statewide