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Saturday 17 June 2023

Ozempic Wegovy-maker hires lobbying firm to push for Medicare coverage


Novo Nordisk, which makes the blockbuster weight loss drugs Ozempic and Wegovy, hired law and lobbying firm Arnold & Porter to try to convince policymakers to allow Medicare to cover anti-obesity medications.

The high-cost medicines exploded in popularity when videos on TikTok highlighted the many celebrities taking them to lose weight. But their access to a key market — older Americans — is limited, as Medicare is banned from covering weight loss drugs as part of the Part D program.

Bipartisan lawmakers introduced legislation last Congress that would offer Medicare coverage for these drugs, but they have not reintroduced it.

Recently retired Rep. Ron Kind (D-Wis.), who sponsored the bill to allow for coverage, joined Arnold & Porter in February. However, ethics rules bar him from lobbying his former colleagues in Congress for one year.

The lobbyists working on the contract include Sonja Nesbit, who served as a senior HHS official during the Obama administration, and longtime GOP health care lobbyist Eugenia Pierson.

Novo Nordisk spent a total of $4.6 million on lobbying the federal government last year, and $1.3 million in the first three months of 2023. The company and its six outside lobbying firms listed lobbying on obesity medicine coverage this year in disclosure forms.

While both drugs contain the active ingredient semaglutide, Ozempic is only approved as a diabetes treatment, though it’s prescribed off-label as an anti-obesity drug. Wegovy is FDA-approved for weight loss.

Medicare Part D and most commercial insurers only cover Ozempic for the treatment of diabetes. Without coverage, the drugs can cost patients around $16,000 per year.

One study cited by the Kaiser Family Foundation found that coverage of weight loss drugs like Wegovy could lead to nearly $27 billion in additional Medicare Part D spending, should the 41 percent of Americans over 60 years old considered obese decide to take the drug.

Those estimates, however, do not include any savings Medicare might realize if obesity is reduced, which a USC Schaeffer Center paper from earlier this year found could be significant.

It’s the second lobbying registration so far this year to push for Medicare coverage of weight loss drugs. In January, Eli Lilly — which makes the diabetes drug Mounjaro, also prescribed off-label for weight loss — hired Todd Strategy Group to work on the issue.



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Democrats buy time in fight over New Hampshire primary


Top Democrats know they have a massive problem on their hands when it comes to the scheduling of the 2024 New Hampshire primary.

And when they convened this week to find ways to keep President Joe Biden from ceding the state’s early nominating contest to a fringe candidate, they settled on a tried and true resolution: putting it off to a later date.

The Democratic National Committee’s Rules and Bylaws Committee voted as expected on Friday to give New Hampshire until Sept. 1 to comply with the national party’s requirements to move its primary behind South Carolina’s in early February — or get kicked out of the official early state window for 2024.

“There’s some space between us and the folks in the state on this,” Minyon Moore, co-chair of the Rules and Bylaws Committee, said during Friday’s meeting in Minneapolis. “But as we’ve said all along, the president wants New Hampshire in the early state lineup. And this committee has long agreed that it is a critical state and should be part of the mix.”

But even as the committee gave New Hampshire another three months to get in line, there was little reason to expect a friendly resolution.

Biden pushed for changes to the party’s presidential nominating calendar for 2024 that stripped New Hampshire of its prized first-in-the-nation primary in an effort to reward South Carolina, which propelled him to the nomination in 2020. Under the DNC’s plan, New Hampshire would go second, on a shared date with Nevada.

But New Hampshire’s state law requires it hold the first primary a week before any other similar contest. And Republicans who control the governor’s office and state legislature are unwilling to change it. Nor are they willing to push through other voting-law changes the DNC is requiring for states in the early window for 2024.

So on Friday, Democrats were really buying themselves more time to decide whether and how they’re going to sanction New Hampshire Democrats if — and, most likely, when — the state goes rogue and holds the first primary, anyway. Under penalties the DNC’s Rules and Bylaws Committee passed last year, the state could lose half its delegates if it breaks with the party’s calendar. But there was no mention of sanctions during the rules committee’s brief discussion on New Hampshire on Friday.

New Hampshire Democratic Party Chair Ray Buckley didn’t comment on the latest extension beyond saying he looks “forward to hearing” from the DNC.

Biden is unlikely to appear on the ballot if New Hampshire goes first, creating an awkward situation in which the president could lose an unofficial early contest to Robert F. Kennedy Jr. or Marianne Williamson, both of whom have indicated they’re planning to compete in New Hampshire regardless of its status or sanctions. But Democrats could wage a write-in campaign for Biden, to help him avoid an early embarrassment en route to his inevitable renomination.

The president already isn’t getting the 2024 primary calendar he wants. Biden’s initial proposal had slated South Carolina for Feb. 6, New Hampshire and Nevada on Feb. 13, Georgia on Feb. 20 and then Michigan on Feb. 27. But Republican Georgia Secretary of State Brad Raffensperger defied Democrats’ wishes and set his state’s presidential primary for March 12 — after Super Tuesday.

And Iowa continues to give Democrats trying to knock the state out of the early nominating window a headache. Iowa Democrats submitted a plan for a “reimagined” caucus system that would let people participate by mail. But the Rules and Bylaws Committee rejected that plan on Friday — sending Iowa back to the drawing board.

Holly Otterbein contributed to this report.



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DOJ finds patterns of excessive force racial discrimination at Minneapolis Police Department


A two-year-long Department of Justice investigation into the Minneapolis Police Department found a pattern of "excessive force, including unjustified deadly force," racial discrimination and civil rights violations, all of which created the conditions that led to George Floyd's murder, according to a report released Friday.

The DOJ launched the investigation in April 2021, after Minneapolis Police Officer Derek Chauvin was convicted of murdering Floyd the year prior by pinning his knee onto Floyd's neck for 9 minutes and 29 seconds. The federal probe found “systemic problems” in the department, including the use of "unjustified deadly force" and unlawful discrimination against Black and Native American people.

"The patterns and practices we observed made what happened to George Floyd possible," Attorney General Merrick Garland said during a press conference Friday.

The investigation found "numerous incidents" in which officers responded to a person's claim that they were unable to breathe by telling them "some version of, 'You can breathe, you're talking right now,'" according to the report.

The report also details a pattern of violating the First Amendment rights of protesters and journalists and discrimination against people with behavioral health disabilities when responding to assistance calls, in violation of the Americans with Disabilities Act.

Officials from the City of Minneapolis and the Minneapolis Police Department in a statement Friday affirmed their willingness to collaborate with the Department of Justice to shape a consent decree.

“These findings are a major step in reforming this department into one that provides a level of service that will be a model for law enforcement agencies across the country. Moving forward, we will continue the process of changing the culture of the Minneapolis Police Department to ensure the safety and wellness of our police officers and the residents of this city,” Minneapolis Police Chief Brian O’Hara said in the statement. “And paramount to this is the rebuilding of trust between this department and the people it serves.”

Minneapolis Mayor Jacob Frey called the release of the report “an essential step forward for community trust and community safety.”



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Friday 16 June 2023

Blood on your hands: Duckworth blasts Sinema for pilot training proposal


Sen. Tammy Duckworth on Thursday blasted a proposal being pushed by Sen. Kyrsten Sinema, an independent who caucuses with the Democrats, that would alter how much training a pilot needs to fly a commercial aircraft, saying senators will have “blood on your hands” if they support the changes she is seeking.

“Now is not the time to put corporate profits ahead of the lives of our constituents who may want to board a commercial flight in the future,” said Duckworth (D-Ill.), an Army veteran helicopter pilot who chairs the subcommittee in charge of aviation in the Senate. “A vote to [change the training rules] for pilots will mean blood on your hands when the inevitable accident occurs as a result of an inadequately trained flight crew.”

Just hours before Duckworth’s speech, Sinema’s (I-Ariz.) proposal had forced the Senate Commerce Committee to postpone a vote on a major aviation policy bill. Because Democrats hold only a slim majority in the Senate, Sinema and the panel's Republicans could have amended the bill to include her training language. Democrats have largely opposed changing the training rules, and they have joined the Biden administration in targeting what they call corporate malfeasance in the airline industry.

Some smaller, regional airlines have been pushing for changes to the current rule requiring pilots to have 1,500 hours of training before they can fly for a commercial airline, arguing that the rule is contributing to ongoing pilot workforce problems. Sinema’s amendment, drafted with Sen. John Thune (R-S.D.), would have allowed certain kinds of airline training programs to be weighted more heavily toward that 1,500-hour requirement than they are at present — a proposal similar to those already rejected by the Biden administration.

Sinema did not immediately have any comment.

The issue broke into public view Thursday during a challenging time for the industry, with air travel climbing sharply toward pre-pandemic levels at the same time the system saw a spate of near-misses earlier this year. Though airlines and the Federal Aviation Administration appear to have, for now, arrested the near miss problem, even one more near-collision with half the year remaining would be a dire warning of freefall for an aviation system that has an otherwise enviable record of safety in recent years.

Duckworth alluded to the near-misses during her speech, calling 2023 “a chilling year” for aviation safety. She said her experience as “a pilot responsible for the lives of my crew and passengers in the most hazardous conditions” and leadership on the aviation safety subcommittee “means that I cannot be complicit in efforts to compromise on safety for the flying public.”

“There has never been a worse time to consider weakening pilot certification requirements to produce less experienced pilots,” she said.

Duckworth said the pilot shortage has been “real and painful” and that she understood “the temptation to cut corners or chase the false promise of a quick fix to a systemic challenge.” But she said she has asked for specifics on how many additional pilots would be available if the minimum hours were reduced and has received “no precise estimates, let alone any credible projections.”

The Regional Airline Association, the trade group for regional airlines that has been out front of proposed changes, did not immediately respond to a request for comment.

The issue itself has been long-running and freighted with emotion, considering that the 1,500 rule requirement stems from changes Congress made to shore up gaps in aviation safety revealed by a 2009 regional jet crash outside of Buffalo, N.Y. — the last multiple-casualty plane crash involving a U.S. airline. Regional carriers have been pushing for watering down that rule since it was enacted, arrayed against a group of family members of those lost on board who have pushed back.

“It is absolutely critical that we keep the current standards in place” said Karen Eckert, whose sister died in the crash. “They have led to an unassailable safety record. Nothing we can do will ever bring our loved ones back, but we are dedicated to making sure that what we experienced back in 2009 will not happen to anyone else.”

Alex Daugherty contributed to this report.



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Opinion | What the Pentagon Thinks About Artificial Intelligence


Artificial intelligence may transform many aspects of the human condition, nowhere more than in the military sphere. Although many Americans may only now be focusing on AI’s potential promise and peril, the U.S. Defense Department has worked for over a decade to ensure its responsible use. The challenge now is to convince other nations, including the People’s Republic of China, to join the United States in committing to norms of responsible AI behavior.

The Pentagon first issued a responsible use policy for autonomous systems and AI in 2012. Since that time, we’ve maintained our commitment even as technology has evolved. In recent years, we’ve adopted ethical principles for using AI, and issued a responsible AI strategy and implementation pathway. This January, we also updated our original 2012 directive on autonomy in weapon systems, to help ensure we remain the global leader of not just development and deployment, but also safety.


Where the Defense Department is investing in AI, we’re doing so in areas that provide us with the most strategic benefit and capitalize on our existing advantages. We also draw a bright line when it comes to nuclear weapons. The policy of the United States is to maintain a human “in the loop” for all actions critical to informing and executing decisions by the president to initiate and terminate the use of nuclear weapons.

Although we are swiftly embedding AI in many other aspects of our mission — from battlespace awareness, cyber and reconnaissance, to logistics, force support and other back-office functions — we do so mindful of AI’s potential dangers, which we’re determined to avoid. We don’t use AI to censor, constrain, repress or disempower people. By putting our values first and playing to our strengths, the greatest of which is our people, we’ve taken a responsible approach to AI that will ensure America continues to come out ahead.

Our current level of funding for AI reflects our present needs: the latest U.S. defense budget, for fiscal year 2024, invests $1.8 billion in artificial intelligence and machine learning capabilities, to continue our progress in modernization and innovation. That will change over time as we incorporate the technology effectively into how we operate — while also staying true to the principles that make ours the world’s finest fighting force.

Even as our use of AI reflects our ethics and our democratic values, we don’t seek to control innovation. America’s vibrant innovation ecosystem is second-to-none because it’s powered by a free and open society of imaginative inventers, doers and problem-solvers. While that makes me choose our free-market system over China’s statist system any day of the week, it doesn’t mean the two systems cannot coexist.

Chinese diplomats have said that the PRC “‘takes very seriously the need to prevent and manage AI-related risks and challenges,’” according to news reports. Those are good words; actions matter more. If China is indeed “ready to step up exchanges and cooperation ‘with all parties,’” the Pentagon would welcome such direct engagement.

Our commitment to values is one reason why the United States and its military have so many capable allies and partners around the world, and growingnumbers of commercial technology innovators who want to work with us: because they share our values.

Such values are owned by no country or company; others are welcome to embrace them. For example, if the PRC credibly and verifiably committed to maintaining human involvement for all actions critical to informing and executing sovereign decisions to use nuclear weapons, it might find that commitment warmly received by its neighbors and others in the international community. And rightfully so.

The United States does not seek an AI arms race, or any arms race, with China, just as we do not seek conflict, either. With AI and all our capabilities, we seek only to deter aggression and defend our country, our allies and partners, and our interests.

America and China are competing to shape the future of the 21st century, technologically and otherwise. That competition is one which we intend to win — not in spite of our values, but because of them.



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Multiple federal agencies hit by hack


Multiple federal agencies are responding to a large-scale breach affecting a product used to transfer sensitive data, a senior government official confirmed Thursday.

The breaches are connected to a file-transfer program called MOVEit, which has a security hole that Russian-speaking cybercriminals have recently exploited to steal data from companies and demand ransom payments.

“CISA is providing support to several federal agencies that have experienced intrusions affecting their MOVEit applications,” Eric Goldstein, executive assistant director for Cybersecurity at the Cybersecurity and Infrastructure Security Agency, said in a statement. “We are working urgently to understand impacts and ensure timely remediation.”

CISA and the National Security Council did not respond to a request for comment about which federal agencies had been hacked and whether any of the networks had been encrypted or if they’d received a ransom demand.

About a dozen U.S. agencies have active contracts with MOVEit, according to the federal data procurement system.

It was unclear who was behind the breach, which was first reported by CNN.

However, a Russian-speaking cybercriminal group called CL0P has been waging a widespread data extortion campaign involving a vulnerability in MOVEit. CISA did not respond to a query about whether CL0P was behind this breach. Representatives for the FBI and the NSA did not immediately respond to requests for comment on the attacks.

Last week, CISA and the FBI published a joint cybersecurity advisory detailing steps that federal agencies and private sector networks should take to protect their networks from CL0P’s exploitation of MOVEit’s software.

File-transfer applications have become popular targets for ransomware groups because they are a one-stop shop for victims to host sensitive data. CL0P has exploited vulnerabilities in two similar products in the past, CISA and the FBI said in their advisory.

An aide for Senate Homeland Security and Governmental Affairs Chair Gary Peters (D-Mich.) said via an email that Peters “is aware of this situation and our office has asked CISA for more information on the impacts of this vulnerability.” The aide was granted anonymity to discuss the evolving investigation.

CL0P is believed to have begun stealing the files of a number of unnamed victims on Labor Day weekend, according to the government advisory. It gave them until June 14 to respond to its ransom demand, and threatened to publish victims’ sensitive data if they did not, according to security researchers.

No federal agencies' data appears to have been leaked by CL0P thus far, said Allan Liska, a ransomware expert at Recorded Future who monitors the group’s online presence. However, Liska said that should not come as a surprise given the group’s likely ties to the Kremlin.

“They likely have to check with their handlers before releasing that type of information,” Liska said.

The breach is the latest of a series of cyber operations against federal agencies in recent years. Most famously, in 2020, at least a dozen agencies were compromised as part of the SolarWinds breach, in which Russian government hackers gained access to these systems for over a year through exploiting a vulnerability in an update in software from cybersecurity group SolarWinds.



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Biden praises companies for ending hidden fees


Several ticketing and travel companies are committing to get rid of hidden fees for buyers in the United States, President Joe Biden announced Thursday.

Biden made the announcement alongside representatives from private-sector companies including Airbnb, SeatGeek and Ticketmaster parent company Live Nation, all of which have pledged to provide consumers with the full price of their tickets upfront. The announcement marks a step forward in Biden’s plan to ban “junk fees” — the extra charges often applied to travel, ticket and banking transactions — as part of a broader appeal toward working-class voters.

“This deal shows collective bargaining works,” Biden said at the White House. “When employers and workers come together to agree on a deal that works for both of them, it’s good for the economy and keeping our supply chain open.”

The companies did not commit to eliminating the actual fees, promising instead to disclose them from the beginning of the transaction rather than in the final stage before payment. The issue came to national attention in November when Live Nation and its Ticketmaster subsidiary drew criticism for hidden fees, as well as widespread glitches, during sales for Taylor Swift’s latest tour.

In the last year, the president has made reducing these hidden surcharges a priority, calling for an end to junk fees in hisState of the Union address in February. He called on Congress to pass a “Junk Fee Prevention Act,” and has also asked the Consumer Financial Protection Bureau and the Transportation Department to increase their oversight on hidden charges.

“The companies represented here today are voluntarily committed to all-in, upfront pricing,” Biden said. “Some of them have used this process for years, like TickPick, Dice and the Newport Festival Foundation. Tens of millions of fans have already benefited from this decision. Others, like Airbnb, have started giving customers the option of seeing all-in prices since we called for action last year, and other businesses are committing today.”

The White House event followed aThursday-morning announcement from Biden that Live Nation had committed to introduce an “upfront all-in pricing experience” in September. Ticketing companies SeatGeek and xBk will also begin introducing all-in pricing models.

Biden has continued to call for action from Congress, requesting legislation that mandates upfront pricing for all ticketing companies and eliminates early termination fees from cable, internet and cellphone companies. Biden has also advocated for the elimination of family seating fees on airlines, and recently commended Alaska Airlines, Frontier Airlines and American Airlines for committing to fee-free family seating in light of his State of the Union address.



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