Medicare plans to expand its coverage of PET scans that are used to help diagnose Alzheimer’s disease, a major policy shift that could make it easier for patients to access new treatments entering the US market.

The proposal would abolish the current Medicare policy nationwide. Currently, the Seniors Program will cover one PET scan per age for patients participating in clinical trials.

Medicare’s proposal would allow regional organizations, called Medicare Administrative Contractors, to decide whether to cover the diagnostic tool. These regional contractors make coverage decisions based on whether the service is “reasonable and necessary” for a diagnosis.

Chiquita Brooks-LaSure, president of the Centers for Medicare and Medicaid Services, said in a statement Monday that the proposed policy “fulfills CMS’s commitment to allow broader coverage of this diagnostic test.” A CMS spokesperson said a final decision could come within 90 days.

Positron emission tomography scans are an important diagnostic tool that detects the presence of a protein amyloid in the brain associated with Alzheimer’s disease. Screenings are the most common way to help diagnose patients.

People on Medicare generally pay 20% of the cost of a PET scan after the deductible is met. The cost of a one-time scan would be about $313 per patient, according to one estimate in a study published in the medical journal JAMA Internal Medicine.

doctor. It’s possible for regional contractors to come to different coverage decisions for PET scans, said Sean Tunis, CMS’ former chief medical officer. But these organizations generally work together on key issues and there’s no reason to think their policies on PET scans will differ widely across the United States, said Tunis, now a consultant at Rubix Health.

Medicare’s coverage of PET scans should make it easier for patients to access new treatments like Leqembi, which was approved by the Food and Drug Administration earlier this month.

Medicare agreed to cover Leqembi’s treatment for Eisai and Biogen’s Alzheimer’s, but requires patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease with documented evidence of amyloid on the brain.

Most patients choose positron emission tomography to confirm the presence of amyloid because imaging is less invasive than alternative diagnostic tools such as spinal taps. Blood tests are also in development, and some are already in use, but not yet widely deployed.

Medicare said it would also cover other antibody therapies for Alzheimer’s with the same terms if they receive approval from the Food and Drug Administration. Eli Lilly The US Food and Drug Administration (FDA) expects to make a decision on its treatment, donanimab, by the end of the year.

The Alzheimer’s Association, a pressure group that advocates for people living with the disease, said the new policy proposed by Medicare would remove unnecessary barriers for patients. Maria Carrillo, the consortium’s chief scientific officer, called the decision “a huge step forward”.

The first over-the-counter birth control pill in the United States can remain out of reach for some women and girls because health insurance plans are not required to cover the drug in its over-the-counter form.

The U.S. Food and Drug Administration on Thursday approved Opill oral contraceptives for sale without a prescription, a landmark decision that would make the pill easier to obtain by eliminating the need to visit a doctor’s office and refill prescriptions.

A third of adult women who have tried to obtain prescription contraceptives encountered barriers to accessing them, according to a survey published in the Journal of Women’s Health in 2016.

Opel manufacturer perego It expects the pill to be available in major stores and online in early 2024. Perrigo will announce the price of Opill in two months before the pill hits stores, Perrigo CEO Fredrik Welgren said during a call with reporters Thursday.

Welgren said the company is committed to ensuring that Opel is affordable. Perrigo sets up a program to help patients, so the cost of birth control pills isn’t a barrier for women struggling to make ends meet.

But some women and girls still face obstacles in obtaining an Opel. The Affordable Care Act does not require private health insurance to cover the cost of birth control pills when used without a prescription. Most health insurance companies are required to offer birth control for free when a doctor prescribes it.

State Medicaid programs are generally not required to cover over-the-counter drugs, according to the federal Centers for Medicare and Medicaid Services.

Welgren said Perego is enlisting private insurance programs and state health care programs to offer over-the-counter Opill to women and girls for free. But she said the Affordable Care Act needs to be amended to ensure that health insurance pays for over-the-counter birth control.

It’s unclear whether insurance coverage for Opel will be in place when the pill is available in stores early next year, Welgren said. “We have some work to do to make that happen. It will take some time,” she said.

Congressional Democrats and President Joe Biden are pushing to expand access to birth control.

senator. Patty Murray, D-WA, reintroduced legislation called Accessible Affordability in the Senate in May that would require health insurance companies to offer over-the-counter oral contraceptives for free.

Biden ordered the US Department of Health and Human Services in June to ensure that all contraceptives approved by the Food and Drug Administration are available without out-of-pocket costs.

An agency spokesperson said Friday that CMS encourages health insurance to cover over-the-counter birth control products for free. The spokeswoman said the agency is working on ways to ensure that contraceptives approved by the Food and Drug Administration are available for over-the-counter use without sharing costs.

Opill is 93% effective in preventing pregnancy. It is the most effective form of over-the-counter birth control in the United States, and must be taken at the same time each day to ensure its effectiveness.

Welgren said that 15 million women in the United States who are sexually active and do not want to become pregnant use a method of contraception less effective than Opal or no method of contraception at all.

Nearly half of the 6 million pregnancies in the United States each year are unintended, according to the Food and Drug Administration. According to the agency, unintended pregnancies are associated with premature birth, which can lead to poor health outcomes for newborn babies.

American And Jet Blue One will stop selling seats on flights next Friday, two months after a federal judge ruled that the Northeast airline partnership violated antitrust laws.

The judge ordered the airlines to end their partnership of more than two years, which allowed them to share passengers and revenue, and coordinate schedules in the northeastern United States. Delta And united In busy airports serving New York and Boston.

The Department of Justice, six states, and the District of Columbia sued to block this partnership, winning their case on May 20.

““We are disappointed to end popular benefits such as codeshare and mutual loyalty benefits,” Dave Fintzen, JetBlue’s vice president of Northeast Alliance, said in a statement. With the recent court ruling and the termination of the NEA, we have to go down I say in short order.”

JetBlue said last week it would not appeal the ruling, so it could focus instead on its $3.8 billion acquisition. Spirit Airlines, a deal also challenged by the DOJ, though JetBlue said it did not agree with the judge’s ruling on the Northeast alliance. However, America said it still plans to appeal the ruling on the Northeast Alliance.

Earlier this week, airline websites still offered flight options on each other’s airlines during the year-end holidays, but those sales will only last through July 20.

Both airlines said they will work with customers who have existing reservations so that their plans are not disrupted.

“This is only the first step in the truce process that will take place over the coming months,” American said in a statement. “We will continue to work with the JetBlue team to ensure that customers with existing codeshare reservations can travel smoothly without disrupting their travel plans.”

Thursday is also the last day customers can use their American AAdvantage frequent flyer miles to book flights on JetBlue.

Uninsured Americans pay an average of nearly $98 for a bottle Eli Lillygeneric insulin, even after the company pledged to lower the product’s list price to $25 per vial, according to a report released Thursday by the senator. Elizabeth Warren.

Eli Lilly pledged earlier this year to lower the list price of the generic insulin, Lispro, from $82.42 per vial starting May 1. The Indianapolis-based pharmaceutical company is one of the largest insulin manufacturers in the world.

The Massachusetts senator’s report surveyed more than 300 pharmacy chains and independents in the United States between June 9 and 28 to determine whether the price reduction announced by Eli Lilly “translated into real patient relief.”

The survey found that a third of pharmacies charge uninsured patients $164 or more for a bottle of Eli Lilly’s Lispro.

Seven pharmacies charged $200 per bottle or more, and two sold the product for more than $300.

Chain pharmacies charged uninsured customers an average of $123 per vial for generic insulin, compared to an average of $63 at independent pharmacies.

Eli Lilly did not immediately respond to CNBC’s request for comment on the poll.

The study findings indicate that “Eli Lilly’s promises of affordable insulin have not been delivered to uninsured patients across the country,” Warren said in a statement.

She said the data also shows that Congress needs to take more steps to rein in excessive pricing, such as capping insulin fees at $35 per month for all patients, regardless of their insurance status.

President Joe Biden’s Inflation Reduction Act currently sets co-insulin amounts at $35 per month for people covered by Medicare.

“My new report confirms that far too many uninsured Americans do not have access or cannot afford to pay astronomical prices for life-saving universal insulin — lawmakers need to step up and take action,” Warren said in a press release.

Insured Americans usually pay a fraction of the list price of insulin. But uninsured people often have to pay the full cost, which could force them to ration or stop taking a life-saving diabetes treatment.

Nearly 30% of uninsured diabetics reported skipping insulin doses, taking less than prescribed or delaying purchases within the past year, Warren said, citing a 2022 study conducted by researchers from Harvard University and other institutions.

“No American should ever be forced to choose between life-saving medications, such as insulin, and their ability to pay for food, shelter, and their daily needs,” Warren said.

Earlier this year, Eli Lilly, Sanofi And Novo Nordisk is committed to reducing the list prices of the most commonly prescribed types of insulin by at least 70% later in 2023.

Eli Lilly and Sanofi also set monthly insulin costs at $35 for people with private insurance.

The three companies together control 90% of the global insulin market.

Their commitments were met with praise from lawmakers and Biden, who was pleased that the companies were finally heeding the calls to help make diabetes care more affordable in the United States.

But the Warren poll raises questions about the effectiveness of cost-cutting efforts.

About 37 million people in the United States, or 11.3% of the country’s population, have diabetes, according to the Centers for Disease Control and Prevention.

The American Diabetes Association said nearly 8.4 million people with diabetes are insulin dependent.

Medicare has agreed to pay for Leqembi’s treatment for Alzheimer’s disease, a major turning point for patients diagnosed with the early stages of the disease.

Leqembi is the only drug on the market now that has been shown to slow the progression of early-stage Alzheimer’s disease in a clinical trial. The monoclonal antibody, given twice monthly through an IV, slowed cognitive decline by 27% over the course of 18 months in the trial.

Leqembi is made by the Japanese pharmaceutical company Eisai and its partner Biogenheadquartered in Cambridge, Massachusetts.

Medicare’s decision to cover Leqembi, which came moments after the US Food and Drug Administration approved the drug Thursday, promises to make treatment more accessible to patients.

Medicare coverage is critical for most patients to have any hope of being able to afford Leqembi. Eisai priced Leqembi at $26,500 a year before insurance coverage, which is too expensive for Medicare patients, whose average income is about $30,000.

Medicare foots the majority of the bill, though many patients will still face several thousand dollars out of their own pockets.

Patients on traditional Medicare will pay 20% of Leqembi’s bill, according to the federal Centers for Medicare and Medicaid Services. That means those patients could see an annual bill of more than $5,000, according to an estimate from KFF, a nonprofit group that researches healthcare issues.

People with Medicare Advantage plans typically pay 20% more for drugs like Leqembi, up to the out-of-pocket limit, which was about $5,000 on average for in-network services, according to the KFF.

Patients with supplemental insurance such as Medigap or Medicaid may pay less, according to the KFF.

People with modest means may not be able to afford an out-of-pocket Leqembi even with Medicare coverage, said Tricia Newman, a Medicare expert at KFF.

Newman said this is particularly worrisome because blacks and Hispanics are more likely to develop Alzheimer’s disease but are likely to have lower incomes.

If demand for Leqembi is high, there are also concerns that patients could face long waiting times to see specialists and receive injections.

Medicare has certain conditions that must be met for patients to be eligible for Leqembi coverage.

To be diagnosed with Alzheimer’s disease or mild cognitive impairment, patients should undergo a cognitive assessment and undergo a positron emission tomography scan or a spinal tap to detect the amyloid protein associated with the disease. PET scans are the most common way to detect amyloid because they are less invasive.

Medicare currently covers one PET scan per age for amyloid detection. A spokesperson for the agency said CMS is reconsidering this policy and plans to release a proposed rule soon.

The requirement for clinicians to enter patient information into the registration system is controversial. The Alzheimer’s Association and some members of Congress are concerned that the requirement to collect data creates unnecessary red tape for patients to receive treatment.

The federal Centers for Medicare and Medicaid Services has created a nationwide portal that is supposed to make it easier for doctors to enter required information about their patients. CMS has released a video showing clinicians how to navigate the system:

Doctors can access free registration on this website.

doctor. The record is simple and unlikely to be burdensome for patients and doctors, said David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota.

Patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease need to talk to their doctor about whether Leqembi’s benefits outweigh the risks, according to CMS.

Although Leqembi slightly slowed cognitive decline in clinical trials, the treatment also carries serious risks of brain swelling and bleeding. In the trial, 13% of patients given Leqembi had swelling and 14% had bleeding.

Swelling and bleeding were usually mild, with no obvious symptoms, but these episodes can be fatal, according to an independent Food and Drug Administration review of clinical trial data. When symptoms do appear, they include headache, confusion, dizziness, vision changes, and nausea.

People who have two copies of a gene mutation called APOE4 are at increased risk of swelling and bleeding and patients should be tested to confirm if they have the mutation before taking Leqembi, according to the US Food and Drug Administration. A CMS spokesperson said Medicare covers testing for the APOE4 mutation.

And according to the Food and Drug Administration, patients who take anticoagulants appear to be more likely to have bleeding in the brain.

Three patients who received Leqembi died in the trial, although the Food and Drug Administration could not determine if these deaths were related to the treatment.

Patients who have been appropriately diagnosed and informed should be able to decide for themselves whether they want to take Leqembi after weighing the benefits of the treatment against the risks of potentially serious side effects, Knopman said.

The Food and Drug Administration on Thursday fully approved the Alzheimer’s treatment Leqembi, a pivotal decision that would expand access to the expensive drug for older Americans.

Medicare announced shortly after the US Food and Drug Administration (FDA) approval that it now covers antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply.

Leqembi is the first antibody treatment for Alzheimer’s disease to receive full approval from the Food and Drug Administration. It is also the first such drug to gain broad coverage through Medicare.

Leqembi is not a cure. The treatment slowed cognitive decline from early-onset Alzheimer’s disease by 27% over the course of 18 months during the Eisai clinical trial. The antibody, which is given twice a month by intravenous infusion, targets a protein called amyloid that is associated with Alzheimer’s disease.

Medicare coverage is a critical step in helping older Americans with early-onset Alzheimer’s disease pay for treatment. With a median income of about $30,000, most people on Medicare can’t afford Leqembi’s $26,500 annual rate set by Eisai without insurance coverage.

Medicare had previously agreed to cover Leqembi only for patients participating in clinical trials after the treatment received urgent approval in January. This policy has severely restricted access to the drug.

To be eligible for coverage, patients must be enrolled in Medicare, be diagnosed with mild cognitive impairment or mild Alzheimer’s disease, and have a physician participate in a data collection system set up by the federal government to monitor treatment benefits and risks.

Joanna Pike, president of the Alzheimer’s Association, a lobby group that advocates for people living with the disease, said that while Leqembi is not a cure, it will help patients in the early stages of the disease maintain their independence, manage their daily lives and spend more time with their families.

“This gives people months to get to know their spouses, children and grandchildren,” Paik said in a statement Thursday. “It also means more time for the person to drive safely, accurately, and quickly to take care of family finances and to participate fully in hobbies and interests.”

But the treatment carries serious risks of brain swelling and bleeding. Three patients who participated in the Esay study died. FDA scientists said it’s unclear if Leqembi played a role in these deaths.

Alzheimer’s disease is the most common cause of dementia among older adults and the sixth leading cause of death in the United States, according to the Food and Drug Administration.

doctor. David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota, said Leqembi clearly showed a benefit for patients in the Eisai trial, though he cautioned that the treatment’s efficacy was modest.

Adequately diagnosed and informed patients should be able to decide for themselves whether they want to take Leqembi after weighing the benefits and risks of treatment as well as the potential logistical challenges of finding a place to receive the twice-monthly injections, Knopman said.

To receive coverage, Medicare requires patients to find a healthcare provider who participates in a scoring system that collects factual data about the drug’s benefits and risks. The system is controversial. The Alzheimer’s Association and some members of Congress worry that this requirement will create barriers to treatment.

There are concerns that the number of healthcare providers participating in such registries will be limited, and that people in rural towns and other disadvantaged communities will have to travel many hours to find such a provider.

The Centers for Medicare and Medicaid Services has created a nationwide portal to make it easier for healthcare providers to provide required data on patients receiving Leqembi. The free-to-use portal went into effect moments after the FDA’s decision on Thursday.

representative. Anna Echo of California, ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Bargan, D-Calif., raised concerns in a letter to CMS last month that patients might struggle to find a physician involved in the system.

Alzheimer’s disease is usually diagnosed with the help of a positron emission tomography (PET) scan to detect the amyloid protein associated with the disease or in some cases with a spinal tap. Medicare currently covers one PET scan per age for dementia. It is not clear if the program plans to change that policy.

There is also concern that there may be too few specialist doctors and sites to administer the injection if Leqembi is widely adopted as a treatment and patient demand for the antibody is high.

Some studies have estimated that wait times for antibody treatments like Leqembi could range from months to years over the next decade depending on demand.

Thomas Phillipson, who advised the FDA commissioner and CMS official during the second Bush administration, said registration is an unnecessary hurdle and Medicare should drop it, but he doesn’t think the requirement will create an insurmountable barrier for patients arriving at Lekembe.

If Leqembi is in high demand, said Phillipson, an expert in health care economics at the University of Chicago, doctors will have an incentive to participate in the enrollment and drug companies will want to help.

He said how high the demand for Leqembi would be was uncertain. He said families concerned about serious side effects may choose not to take the treatment, while others will decide the benefits outweigh those risks.

Leqembi’s price and treatment benefit-risk profile are controversial.

Medicare patients treated with Leqembi will pay 20% of the medical bill after they meet the Part B deductible, according to CMS. Costs may vary depending on whether the patient has supplemental medical coverage or other secondary insurance, depending on the agency.

Patients can face up to $6,600 in annual costs for Leqembi even with Medicare coverage, according to a study published in JAMA Internal Medicine. The study estimated that the treatment could cost Medicare up to $5 billion a year depending on how many people get the injections.

senator. Bernie Sanders, chairman of the Senate Health Committee, called Leqembi’s price “unreasonable” and in a letter last month asked Health and Human Services Secretary Xavier Becerra to take action to reduce the cost.

Sanders said the patient’s out-of-pocket costs for Leqembi would amount to one-sixth of seniors’ total annual income, and he noted that the higher cost of treatment could increase premiums for everyone on Medicare.

Leqembi’s annual list price of $26,500 is lower than the company’s estimate of $37,600 for the total value of the treatment per patient, Eisai says. The Institute for Clinical and Economic Review, a nonprofit organization that analyzes healthcare costs, estimated in April that it should be between $8,900 and $21,500 a year.

Although Leqembi could be costly for Medicare, Philipson said delaying treatment coverage would dramatically increase health care spending as people with mild Alzheimer’s disease, which can be managed at home, progress to more serious illness requiring nursing home care. Expensive.

Phillipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of antibody therapies for Alzheimer’s disease by a year would lead to $6.8 billion in spending increases. By 2040, healthcare spending will increase by $248 billion.

Thursday’s full FDA approval comes after a panel of six outside advisors voted unanimously in June to support the drug’s clinical benefit for patients. The committee was unusually small because some members had recused themselves due to conflicts of interest.

The American Academy of Neurology said in a February letter to CMS that there is a consensus among its experts that Eisai’s clinical trial for Leqembi was well designed and that the results were “clinically and statistically significant.”

Some nonprofit groups such as Public Citizen, a consumer advocacy organization, have strongly opposed FDA approval of Leqembi. A representative from Public Citizen told the advisory committee that the evidence of the drug’s benefit did not outweigh the significant risks of brain swelling and bleeding.

Representatives from the National Center for Health Research and Physicians of America, also nonprofits, told the panel that the Eisai clinical trial did not include enough black patients, who are at a higher risk of developing Alzheimer’s disease.

Leqembi has been technically approved for the US market since January, when the US Food and Drug Administration (FDA) cleared the treatment under an accelerated course. The US Food and Drug Administration (FDA) uses accelerated approvals to save time and get drugs to critically ill patients faster.

But Medicare refused to cover Leqembi at the time, asking for more evidence that the expensive treatment had real clinical benefit for patients who outweigh the risks.

The program’s cautious coverage policy stems from the controversial Food and Drug Administration (FDA) approval in 2021 of another antibody treatment for Alzheimer’s disease called Aduhelm, which was also introduced by Eisai and Biogen.

An advisory committee for the US Food and Drug Administration (FDA) declined to approve Aduhelm because the data did not support a clinical benefit for patients. Three counselors resigned after the agency decided to approve the treatment anyway.

Knopman is one of the advisors who resigned because of the FDA’s decision on Adholm. He said that a date for Kimbe is different. Knopman said Esay ran a clean trial that showed the antibody had modest clinical benefit for patients.

A congressional investigation later found that the FDA’s approval of Adholm was “riddled with irregularities.”

In his letter to Becerra, Sanders said the FDA “has a special responsibility to restore the public’s trust following its inappropriate relationship with Biogen during the agency’s review of a previous Alzheimer’s disease drug, Aduhelm.”

Medicare said Friday it would allow drug companies to publicly discuss historical drug price negotiations for the program, ignoring a confidentiality requirement that the industry has argued violates the First Amendment in lawsuits filed this month.

In initial guidance issued in March, Medicare prohibited the industry from publicly disclosing information about the low price the federal government initially offered for targeted drugs under the program, as well as the government’s reasons for choosing that price point.

Medicare also prohibited the companies from disclosing any oral conversations during the negotiation period. It also requires companies to destroy any information within 30 days if the property is no longer selected for negotiations.

In revised guidance issued Friday, Medicare said the company “may choose to publicly disclose information related to ongoing negotiations at its discretion.”

The Inflation Reduction Act, passed last year, allowed Medicare to negotiate prices directly with drug companies for the first time. The program is a mainstay of the Biden administration’s efforts to control rising drug prices in the United States

merckAmerican Chamber of Commerce, Bristol-Myers Squibb The drug industry lobby group Pharmaceutical Research and Manufacturers in America asked federal courts this month to declare drug price negotiations unconstitutional.

Merck, Chamber, and Bristol Myers Squibb argued in their lawsuits that Medicare had imposed a gag order effectively banning companies from publicly disagreeing with the federal government’s position in violation of the First Amendment.

However, the industry lawsuits also focus on broader allegations that the software violates due process and expropriation of private property without fair compensation under the Fifth Amendment to the US Constitution.

Health and Human Services Secretary Xavier Becerra pledged on Friday to press ahead with negotiations despite lawsuits from the drug industry.

“Pharmaceutical companies have achieved record profits for decades,” Becerra said in a statement. “They are now lining up to block the work of this administration to negotiate better drug prices for our families.

“We will not back down,” Becerra said.

HHS will release a list of 10 high-cost drugs it has selected for negotiation by September. The companies have to decide whether to participate in the negotiations in the following month.

Drug makers who choose not to participate face severe financial penalties. They can avoid these penalties by ending their participation in Medicare and Medicaid drug discount programs.

The companies have argued that opting out of rebate programs is not a feasible alternative because the programs account for nearly half of the state’s annual spending on prescription drugs.

Bristol-Myers Squibb On Friday, he sued the Biden administration over new Medicare powers to lower drug prices, the third such lawsuit to be filed against the program in a matter of days.

The suit, filed in New Jersey federal district court, alleges that Medicare negotiations violated the First and Fifth Amendments to the US Constitution.

Bristol Myers Squibb asked the court to declare the program unconstitutional and prevent the Department of Health and Human Services from forcing the company into negotiations.

Bristol-Myers Squibb’s arguments mirror those he made last week merck, the first company to sue the federal government over drug negotiations. The US Chamber of Commerce also sued HHS over the program with similar arguments.

The Reducing Inflation Act, passed in 2022 in a narrow party-line vote, authorized Medicare to negotiate drug prices for the first time in the program’s six-decade history. The law is a central pillar of the Biden administration’s efforts to control soaring drug prices and has been a major victory for the Democratic Party.

Bristol-Myers Squibb said Elix, a drug used to treat stroke and stroke, will be subject to negotiations this year. The company brought in $11.8 billion in revenue from Eliquis last year, about 25% of the company’s total revenue of $46 billion for 2022.

The drug company also said Opdivo, which is used to treat several types of cancer, will be subject to Medicare negotiations in the future. Opdivo generated $8.2 billion in sales for the company in 2022, which made up about 18% of the drugmaker’s total revenue that year.

Bristol-Myers Squibb argued that the federal government is forcing the company into negotiations and eventually agreeing to a deeply discounted price. The company claims that this violates Fifth Amendment protections against government appropriation of private property without fair compensation.

The drug company also alleged that HHS is forcing the company to publicly offer the program as a negotiated fair price. The company called the negotiations a sham and alleged that the federal government was forcing the drug company to “imitate its preferred political message” in violation of the First Amendment.

HHS Secretary Xavier Becerra, in a statement after Merck’s lawsuit last week, vowed to vigorously defend the inflation-lowering law in court, saying, “The law is on our side.”

Also in a statement after Merck’s lawsuit, White House press secretary Karen Jean-Pierre said that the Biden administration is confident of its victory in court.

“There is nothing in the Constitution that prevents Medicare from negotiating lower drug prices,” Jean-Pierre said.

The Justice Department’s antitrust division has notified the PGA Tour that it will review the organization’s proposed merger with Saudi-funded LIV Golf, a source told NBC News Thursday.

The Department of Justice and LIV Golf declined to comment.

In a statement to CNBC, the PGA Tour said, “We are confident that once all stakeholders learn more about how the PGA TOUR will lead this new project, they will understand how it will benefit our players, fans, and our sport while protecting the American golf establishment.”

A source familiar with the situation says any interest by the DOJ would be an extension of the existing investigation, and it wouldn’t be unusual for US antitrust authorities to review a deal with this profile. They also say the review does not indicate that the transaction violated antitrust laws.

The Department of Justice was already conducting an investigation into professional golf, in light of the LIV litigation.

The announcement of the deal last week immediately raised antitrust concerns.

This week, the Democratic Senate. Elizabeth Warren of Massachusetts and Ron Wyden of Oregon have urged the Justice Department to open an investigation into the agreement. senator. Richard Blumenthal, D-Con, has also opened an investigation into the deal. Wyden launched his own investigation Thursday.

The PGA Tour’s once adversarial relationship with LIV is already under scrutiny by federal prosecutors who last year began investigating whether the PGA Tour engaged in anti-competitive behavior.

LIV, which is backed by the so-called Public Investment Fund controlled by Saudi Crown Prince Mohammed bin Salman, divided the world of professional golf when it emerged as a competitor to the PGA Tour.

The emerging league’s links to the kingdom, with its sordid human rights record, have sparked a bevy of controversy. But with the help of $2 billion in investment from the Crown Prince’s Fund, LIV has offered huge prizes and perks and has been able to attract high-profile golfers to play in its tournaments.

Former President Donald Trump hosted a LIV tournament at a New Jersey golf club last summer, infuriating the kingdom’s critics — including families and survivors of the 9/11 terrorist attacks.

The PGA Tour and LIV Golf have shut mouths on and off the court, and PGA Tour commissioner Jay Monahan has publicly criticized the rival league, making the announcement of the proposed merger all the more surprising. The announcement last week indicated that the association would lead to a mutual termination of all pending lawsuits.

If a merger takes place, the two entities will combine their businesses and interests into a new for-profit corporation. Monahan told the players in a memo that the PGA Tour Policy Board would have to approve the agreement.

The PGA Tour revealed Tuesday that Monahan is currently recovering from an unspecified medical issue and is taking a leave of absence.