5th Circuit rules DACA is unlawful, but limits its ruling to Texas

 A federal appeals court Friday upheld a lower court ruling that found protections for so-called Dreamers to be unlawful, suspending the program in Texas while otherwise limiting its ruling in the event of an appeal.

The ruling upholds a lower court ruling that found Biden administration efforts to codify the Deferred Action for Childhood Arrivals (DACA) program violated immigration law.

The ruling leaves more than half a million DACA recipients in another period of uncertainty.

While the Biden administration would ordinarily appeal the decision, possibly launching the case before the Supreme Court, it’s not clear how the incoming Trump administration will proceed.

“The [Immigration and Nationality Act] ‘expressly and carefully provides legal designations allowing defined classes of aliens to be lawfully present.’ In the INA, Congress enacted a ‘comprehensive federal statutory scheme for regulation of immigration and naturalization’ and ‘set the terms and conditions of admission to the country,’” the 5th Circuit Court of Appeals wrote in its decision.

“Because it chose not to include DACA recipients in that comprehensive scheme, ‘Congress’s rigorous classification scheme forecloses the contrary scheme in the DACA Memorandum.’” 

The ruling largely upholds an earlier decision from U.S. District Judge Andrew Hanen.

Hanen had found that the coalition of states led by Texas had standing and ruled in September 2023 against the Biden administration’s revamp of DACA as a memorandum replacing Obama’s 2012 executive order.

The Friday ruling also created another complex dynamic in the case. The suspension of DACA is only applicable in Texas, but other Dreamers are protected while the case proceeds.

And the court also found that work authorizations could be legally separated from the protection from deportations provided by DACA, remanding that issue back to the lower court.

Hanen has ruled against DACA multiple times.

In 2015, Hanen ruled against an expansion of DACA and a partner program Deferred Action for Parents of Americans, and in 2021 he ruled that DACA itself was unlawful.

That 2021 ruling was bounced back to Hanen after the Biden administration’s memorandum, which Hanen ruled illegal, maintaining an injunction that allows current DACA beneficiaries to remain in status while the courts process the issue.

https://thehill.com/regulation/court-battles/5092787-federal-appeals-court-daca-texas/

TikTok says it will ‘go dark’ Sunday without Biden support

 Video-sharing app TikTok said it will “go dark” on Sunday, Jan. 19, following the Supreme Court’s unanimous decision to uphold a federal ban unless President Biden steps in.

“The statements issued today by both the Biden White House and the Department of Justice have failed to provide the necessary clarity and assurance to the service providers that are integral to maintaining TikTok’s availability to over 170 million Americans,” the company wrote in a Friday statement on the social media platform X. 

U.S.’s highest court issued a unanimous ruling on Friday, upholding the legislation that requires TikTok’s parent company ByteDance, which is based in China, to divest from the popular app and set up for it to be banned nationwide starting on Sunday. 

Following the announcement, the White House and Department of Justice applauded the court’s decision. Biden’s spokesperson reiterated calls for divestment, calling for the law to be implemented under President-elect Trump given his term begins Monday. Biden’s White House will not move to enforce the ban. 

“Unless the Biden Administration immediately provides a definitive statement to satisfy the most critical service providers assuring non-enforcement, unfortunately TikTok will be forced to go dark on January 19,” TikTok added. 

Although users will be able to keep the app on their devices, the app likely will become unusable with the legislation, that was signed by Biden in April last year, preventing app stores such as App Store and Google Play Store from dishing out updates or distributing it.

The judges found that the law, which garnered bipartisan support in Congress, did not violate the First Amendment, one of the main arguments TikTok’s legal team hedged since the legislation was signed into law. 

Trump has pushed for the deadline to be extended so that he could potentially broker a deal.

https://thehill.com/policy/technology/5093032-tiktok-ban-joe-biden-donald-trump/

Mexico Pitches Auto Suppliers ‘Task Force’ to Curb China Imports

 

Mexico is planning to establish a “task force” to involve US companies in the process of reducing imports from China, the country’s economy minister told a group of auto suppliers at a private meeting Friday in Detroit.

Careful not to “speculate” about what would happen on Monday when US President-elect Donald Trump takes office, minister Marcelo Ebrard said the government wanted to pitch a task force that would include the “most important companies” operating in Mexico to assess how to respond to Trump’s next moves, which could include tariffs of 25% if he makes good on his threats.

https://www.bloomberg.com/news/articles/2025-01-18/mexico-pitches-auto-suppliers-task-force-to-curb-china-imports

Alignment Healthcare sues CMS over star ratings, disapproves of federal contractor's role

 Alignment Healthcare is the latest Medicare Advantage (MA) insurer to accuse the Centers for Medicare & Medicaid Services (CMS) of wrongly calculating the company’s star rating scores.

The plaintiffs are challenging the Tukey Outlier Deletion Rule, a technical calculation from the CMS that removes high-performing outliers from the raw data and pushes cutpoints higher, making strong scores more difficult to obtain. The CMS does this to prevent large, yearly fluctuations to scores.

“But as Alignment explained in its comments at the time, the rule is based on objectively bad data science, and it produces arbitrary and capricious results,” the company argued in the suit, demanding a recalculation.

Alignment further alleged its ratings were calculated incorrectly. Two Alignment contracts had a lower response rate from Spanish-language Consumer Assessment of Healthcare Providers and Systems surveys. The plaintiffs claim this is because of a CMS-inflicted sampling error or members were sent surveys in English rather than Spanish, which would be the mistake of the CMS or its survey contractor, Maximus.

Additionally, Alignment argues the CMS’ claims appeals process wrongly classified one of its appeals, resulting in a two-star drop on one measure from five stars to three stars. The CMS also wrongfully overturned a claim denial, Alignment said.

The company blames Maximus for many of its criticisms and believes the contractor should not play a big role in these calculations because it has been given an unconstitutional delegation of regulatory authority from the CMS.

The CMS is on the back foot in recent star ratings cases, as pointed out by Alignment in the lawsuit.

UnitedHealth Group and Centene received improved 2025 star ratings scores, reported numerous news publications, following lawsuits last fall. Humana filed its own lawsuit in October, as did Blue Cross Blue Shield of Louisiana, reported Bloomberg.

Most recently, Blue Cross and Blue Shield of Florida alleged the federal government did not fairly factor in extreme weather hitting the state when calculating its scores.

It’s not the first year the CMS has faced backlash over star ratings calculations, which have a substantial impact on a health plan’s financial prospects for upcoming years. In June, the CMS announced it would rework the program’s quality ratings for the 2024 plan year after SCAN Health Plan and Elevance Health won lawsuits against the agency.

Star ratings are a contentious issue for health plans, in part because the system is designed to be difficult for top scores. Star ratings dipped for the third consecutive year in October, and the CMS estimated in its recent MA advance notice bonus payments to insurers from star ratings decreased by 0.69%.

https://www.fiercehealthcare.com/payers/alignment-healthcare-sues-cms-over-star-ratings-disapproves-federal-contractors-role

CMS faces renewed legal pressure on drug price negotiation program

 Teva Pharmaceuticals is suing the Centers for Medicare & Medicaid Services (CMS) for its implementation of the drug price negotiation program under the Inflation Reduction Act (IRA).

Teva claims the program is a “fiction” and “upsets the delicate balance between innovation and affordability,” in its lawsuit (PDF). The company argues CMS guidance contradicts key elements of the IRA, which dictate drugs are only eligible for the program if they’ve been marketed for a specified amount of time or declares they are exempt when non-branded competitors enter the market.

Another source of contention is the agency’s definition of a qualifying single source drug, or a drug eligible for negotiation.

“Under CMS’ made-up definition, the agency can decide that two or more drugs approved under distinct FDA applications held by the same entity should be treated as one Qualifying Single Source Drug because they have the same active moiety—that is, the same active molecule,” the lawsuit reads.

Austedo, a brand-name drug from Teva that treats neurological diseases, is a candidate for the next round of negotiations, researchers wrote in the Journal of Managed Care & Specialty Pharmacy in September.

The second round of drugs selected for the program is expected to be announced by Feb. 1. It’s possible the Biden administration will release the next round of drugs before he leaves office, but, if not, President-elect Donald Trump won’t have long to decide how to move forward with the program.

The CMS said in October it expects the first round of negotiations to save individuals $1.5 billion in out-of-pocket costs in 2026.

While the federal government says the program brings down drug costs, pharma manufacturers and other critics say the program disincentivizes innovation. Drug manufacturers also counter the program reflects price controls more closely than real negotiations.

As of December, at least nine active lawsuits were taking aim at the CMS and aspects of the program, reported the KFF. Most attempts to pare back or eliminate the program through the courts have proven unsuccessful so far.

https://www.fiercehealthcare.com/payers/cms-faces-more-legal-pressure-drug-price-negotiation-program

ArgenX cut to Sell by Deutsche Bank

 from Hold

https://finviz.com/quote.ashx?t=ARGX&ty=c&ta=1&p=d

Madrigal Pharmaceuticals gains amid takeover speculation

 Madrigal Pharmaceuticals (NASDAQ:MDGL) rose 2% in after hours trading amid some takeover speculation.

There's speculation that Madrigal (MDGL) may have attracted interest from a large pharmaceutical company, according to a Betaville "uncooked" alert that circulated on Friday. 

Madrigal (MDGL) has a market cap of $6.6 billion and short interest of 18.6%.

The latest speculation comes after a Bloomberg report in 2018 that the company received takeover interest from other drugmakers eyeing treatments for a liver disease linked to obesity. 

https://www.msn.com/en-us/money/markets/madrigal-pharmaceuticals-gains-amid-takeover-speculation/ar-AA1ualBJ