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Action for Health Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

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WASHINGTON, Oct. 23 – Christopher G. Sheeron, President of Action for Health, has made a public comment on the rule proposed by the Centers for Medicare and Medicaid Services, entitled “Requirements Regarding Air Ambulance Services, Agent and Broker Disclosures, and Provider Enforcement “published”. The comment was written on October 18, 2021 and published on October 19, 2021:

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Thank you for taking this opportunity to submit our comments on “Air Ambulance Services Requirements, Agent and Broker Disclosures, and Vendor Enforcement” (CMS-9907-P) ./1

We hope you find it useful. On June 30, September 1 and September 7, Action for Health issued the first three sets of recommendations on the regulatory implementation of the No Surprises Act, including in response to “Surprise Settlement Requirements; Part I”. The following public comments to the Office of Personnel Management (OPM), Internal Revenue Service (IRS), Employee Benefits Security Administration (EBSA), and Department of Health and Human Services (HHS) highlight several concerns we have with this Suggestions have rule.

introduction

Action for Health / 2 is a national, non-profit patient organization. In all of our work, we seek to educate policy makers, the media and concerned citizens about critical health issues. One of our main areas of focus right now is the fair implementation of the No Surprises Act, which was passed last year / 3 which, as you know, eliminates surprise medical bills for patients and an Independent Dispute Resolution (IDR) for health insurance announcing plans and doctors to settle Payment disputes outside the network (OON). We have been hard at work for the past two and a half years on the broader subject of surprise medical bills.

Problem areas

For the following comments, we highlight four (4) problem areas.

1.) Biased “evidence”

We remain concerned about the fact that the agencies that drafted this proposed rule are parroting what the health insurance industry is talking about. The prevailing idea that the tiny tariffs (d These tariffs are only profit-making at the expense of patients and health insurers, is absurd.

For example, the proposed rule quotes the USC-Brookings Schaffer Initiative for Health Policy./4

As we’ve emphasized over the years, this initiative is funded by Leonard Schaeffer, Founding Chairman and CEO of WellPoint, now known as Anthem. The initiative’s research is unquestionably commissioned and supervised by major health insurance interests to the direct disadvantage of the patient.

This proposed rule also starts with a quote from Dr. Zack Cooper / 5, an adjunct professor of public health and economics at Yale University. As described in an explosive revelation6 last summer, Dr. Cooper discreetly worked with UnitedHealthcare, the country’s largest health insurance company, to sway laws and regulations in the company’s benefit.

Regulators must recognize these facts and openly acknowledge them.

2.) Reasonable fees

In terms of a reasonable fee for OON ambulances, the agencies appear to be interested in examining what other OON ambulances charge, what other OON ambulance providers are being paid, and the administrative costs associated with such OON ambulances.

With this in mind, it is hoped that the agencies will allow the accredited IDR facilities set out in the provisions of Part II of this Act to consider similar fees for OON doctors.

3.) Penalties

In this rule proposal, the agencies have created a massive penalty fee structure for every violation by a provider. The proposed sanction for a provider failure to comply with this regulation is up to $ 10,000 per breach of Public Health Services Act (PHS) ./ 7

In this judgment, however, we have not found a single case that lists a specific sanction for every violation by a health insurance company. This is a textbook definition of unfair.

4.) Help patients

Unfortunately, the agencies seem eager to investigate every aspect of the health insurance issuance process that could add to the surprise medical bills problem – with the exception of the most obvious: gigantic, monopoly insurance companies.

The insurance cartel offers patients only one way to lower their annual premiums, which is either not to accept OON services for doctors or to accept extremely poor OON services, such as Medicare-linked payments. Patients could be given hundreds of ways to lower their premiums, apart from agreeing to a provision that they must see contracted doctors (i.e. doctors on the network) and that their doctors receive little compensation for their services.

This system, supported by the health insurance industry, is pushing independent doctors out of business and leading to a massive consolidation of our health system. This consolidation is the real driver of higher healthcare costs./8

diploma

Thank you again for the opportunity to provide you with these comments on this proposed rule. We will also be providing additional comments on Part II of these Regulations of the No Surprises Act in the coming weeks and months.

Unfortunately, the Second Provisional Definitive Rule (IFR) / 9 contains wording that completely skews the law’s IDR process in favor of health insurance plans. On behalf of patients across the country, we will not only raise the alarm as regulators blatantly ignored the intent of Congress by pre-weighing the Qualifying Payment Amount (QPA), but we will also offer the steps necessary to address these critical IDR regulations.

If we can assist you or your employees with this regulatory process later this year, please do not hesitate to contact me directly at (202) 823-2333.

Sincere,

Christopher G. Sheeron

president

Action for health

Cc: Ms. Padma Babubhai Shah, Human Resources Office

Mr. Matthew Meidell, Employee Benefits Safety Administration, Department of Labor

Ms. Kari DiCecco, Internal Revenue Service, Department of the Treasury

Pinar Shapiro, Employee Benefits Security Administration, Department of Labor

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Footnotes:

1 / Office of Human Resources, Internal Revenue Service, Employee Benefits Security Administration, Department of Health and Human Services, Proposed Rule, Air Ambulance Services Requirements, Agent and Broker Disclosure and Provider Enforcement, CMS-9907-P, Dec. . September, 2021, accessed: https://www.federalregister.gov/documents/2021/09/16/2021-19797/requirements-related-to-air-ambulanceservices-agent-and-broker-disclosures-and-provider -enforcement # open-comment.

2 / Action for Health, www.action4health.org.

3 / HR 133, Consolidated Appropriations Act (CAA), 2021, (PL 116-260), December 27, 2020, accessed at: https://www.congress.gov/bill/116th-congress/house-bill/133 / Text.

4 / Federal Register, Requirements Regarding Air Ambulance Services, Disclosure of Agents and Brokers and Enforcement by Providers, p. 38, accessed: https://www.govinfo.gov/content/pkg/FR-2021-09-16/pdf/ 2021-19797.pdf.

5 / Ibid., P. 5 4.

6 / Adams, Rose, UnitedHealthcare Guided Yale’s Groundbreaking Surprise Billing Study, The Intercept, August 10, 2021, accessed at: https://theintercept.com/2021/08/10/unitedhealthcare-yale-surprise-billing-study .

7 / Federal Register, Requirements Regarding Air Rescue Services, Disclosure of Agents and Brokers and Enforcement by Providers, p. 37, accessed: https://www.govinfo.gov/content/pkg/FR-2021-09-16/pdf/ 2021-19797.pdf.

8 / See Statement of the US House Judiciary Committee for the Record from Action for Health for additional perspectives on consolidation and cost increases, May 5, 2021, accessed at: https://docs.house.gov/meetings/JU/JU05/20210429 / 112518 /HHRG-117-JU05-20210429-SD009.pdf.

9 / Office for Personnel Management; Internal Revenue Service, Treasury Department; Employee Benefits Security Administration, Ministry of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services, Surprise Billing Requirements; Part II, Preliminary Final Rule, October 7, 2021, accessed at: https://www.federalregister.gov/documents/2021/10/07/2021-21441/requirements-related-tosurprise-billing-part-ii.

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The proposed rule can be viewed at: https://www.regulations.gov/document/CMS-2021-0147-0001

TARGETED NEWS SERVICE (founded in 2004) provides non-partisan “editorial journalistic” short news and information for news organizations, political groups and individuals; and “aggregated” public policy information, including press releases, reports, speeches. For more information, contact MYRON STRUCK, Editor, [email protected], Springfield, Virginia; 703 / 304-1897; https://targetednews.com

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FDA review finds Merck’s COVID pill effective, but flags concerns

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Federal health officials say an experimental COVID-19 pill developed by Merck is effective for the coronavirus, but they will seek independent counseling on the risks of birth defects and other potential problems during pregnancy.

The Food and Drug Administration released its analysis of the pill last week ahead of a public Tuesday meeting where a panel of experts will weigh its safety and effectiveness. The agency is not obliged to follow the advice of the panel.

FDA scientists said their review identified several potential risks, including potential toxicity to developing fetuses and birth defects, which were identified in animal studies with the pill.

Given these risks, the FDA will ask its advisors if the drug should never be given during pregnancy or if it could be made available in certain cases.

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In that scenario, the FDA said the drug would contain warnings of risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where the benefits might outweigh the risks to patients.

In light of the safety concerns, the FDA said Merck had agreed that the drug would not be used in children.

Other side effects were mild and rare, with about 2% of patients suffering from diarrhea.

Regulators also found that, overall, Merck collected far less safety data on its drug than it did for other COVID-19 therapies.

“Although the clinical safety database was small, no major safety concerns were identified,” the FDA reviewers concluded.

In addition, FDA scientists raised concerns that Merck’s drug caused small changes in the coronavirus’ characteristic spike protein that is used to penetrate human cells. In theory, these changes could lead to dangerous new variants, they warned.

The FDA will ask the advisory panel to discuss all of these questions and then vote on whether the overall benefits of the drug outweigh its risks.

All COVID-19 drugs currently approved by the FDA require an injection or IV and can only be administered by health care professionals. If approved, Merck’s drug would be the first drug US patients could take at home to relieve symptoms and speed recovery. It is already approved for emergency use in the UK.

The meeting will mark the first time regulators have publicly reviewed a new drug for COVID-19, reflecting intense interest and scrutiny on a pill that could soon be used by millions of Americans.

The drug molnupiravir has been shown to significantly reduce hospital admissions and deaths in people with mild to moderate cases of COVID-19.

Merck’s drug uses a novel approach to fighting the virus: it inserts tiny mutations into the coronavirus’ genetic code to stop the virus from multiplying.

However, this genetic effect has raised concerns that the drug could, on rare occasions, cause birth defects or even stimulate the development of more virulent strains of the virus.

Pregnant women were excluded from the Merck study, and both women and men in the study were instructed to use contraception or abstain from sex.

Merck says the results of two company studies in rodents show that the drug does not cause mutations or DNA damage at the doses studied.

FDA reviewers also confirmed previously reported interim results from Merck that the pill reduced hospitalization and death rates by about half in patients with early symptoms of COVID-19 who were at increased risk due to health problems.

However, on Friday, Merck announced updated results from the same study showing lesser benefit from the drug. The FDA said it is still reviewing the updated data and will come back with a new evaluation of the drug’s effectiveness on Tuesday.

Among more than 1,400 adults in a company study, molnupiravir reduced the combined risk of hospitalization and death by 30% – less than the 50% originally reported due to incomplete results.

Almost 7% of patients who received Merck’s drug within five days of developing COVID-19 symptoms ended up hospitalized and one died. Of the patients who received the placebo, 10% were hospitalized and nine died.

Merck has not tested its drug in people who were vaccinated against COVID-19. But the FDA will ask the advisory panel to recommend which patients could benefit most from the drug based on their vaccination status and underlying health issues.

While Merck’s drug is likely to be the first pill for COVID-19 in the United States, more are set to follow.

Competing drug maker Pfizer has submitted its own antiviral for FDA review after initial study results showed it reduced the combined rate of hospital admissions and deaths by nearly 90%.

Pfizer’s drug is part of a decade-old family of antiviral pills known as protease inhibitors that revolutionized the treatment of HIV and hepatitis C. They work differently from the Merck pill and have not been linked to the type of mutational concerns raised with Merck’s drug.

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Thousands ‘suffering in silence’ as sleep disorder clinic backlog balloons: Doctors Manitoba

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Sue Moon languishes on three or four hours of sleep a night while waiting for confirmation from something she has long known.

Her loud breathing keeps her husband awake at night. She wakes up exhausted and has little energy to play with her five grandchildren. She is tired all the time.

“I haven’t slept well in two and a half years,” said Moon, 62, who has now been diagnosed with sleep apnea and insomnia.

“It affects your life in some ways. You don’t have the energy to do much. You go out for a couple of hours and that’s it – you just have to get home. You’re just dog tired.”

Earlier this month, Moon arrived at the Sleep Disorder Center at the Misericordia Health Center in Winnipeg, more than two years after she was put on the waiting list.

Now that she has a diagnosis of sleep apnea, she will soon be getting a Continuous Positive Airway Pressure (CPAP) machine, which moves oxygen-rich air through the airways and can improve the quality of sleep.

This is promising for Moon, but she remains frustrated, her quality of life and that of thousands of other Manitobans suffering from the growing arrears.

“There are many patients who suffer in silence,” said Dr. Kristjan Thompson, President of Doctors Manitoba and ambulance at St. Boniface Hospital.

The Physician Advocacy Group estimates that nearly 4,800 fewer sleep disorder tests were performed during the pandemic as resources were diverted to hospitalized patients with COVID-19.

That represents a decrease of 70 to 80 percent and effectively doubled the waiting list to about 9,500, according to new estimates released by Doctors Manitoba last week.

It is said that there are now a total of 136,000 backward surgeries and diagnostic procedures in the province, about 6,000 more than last fall. According to Doctors Manitoba, a large part of the recent bump is being caused by research into lagging insomnia.

“I feel kind of guilty that I finally got my test,” said Moon. “How do you make up such a backlog?”

The province is expected to release details shortly on a task force to address the backlog. Earlier this year, $ 50 million was earmarked for issuance, but few other details have been released.

In an email, a spokesman for Winnipeg’s regional health agency confirmed that Doctors Manitoba’s estimate of the backlog of sleep disorder tests is accurate and sleep studies are now near full capacity.

“Respirologists identify and treat all patients who are considered to be most at risk,” the spokesman said.

Virtual appointments and devices for home studies are also used to deal with the backlog.

Waiting increases other risks

When people with sleep apnea try to rest, the muscles in the throat become relax and repeatedly clog the airways, resulting in poor quality sleep; Studies are needed to establish a diagnosis and treatment plan.

“If you don’t … treat it relatively quickly, a belated diagnosis can basically lead to a poor quality of life and poor work performance,” says sleep apnea expert Dr. Najib Ayas.

Without this intervention, persistent nightly low oxygen levels can lead to higher blood pressure, said Ayas, associate professor of medicine at the University of British Columbia.

Waiting for treatment for sleep apnea can cause or worsen existing mood disorders and create a “vicious circle” for those suffering from depression, says Dr. Najib Ayas. (Submitted by UBC)

Sleep apnea can also increase the chances of developing dementia and is associated with three times the normal risk of cardiovascular diseases such as strokes, heart attacks, arrhythmias, and aortic disease. It has also been shown that patients are three to five times more likely to be in a car or work-related accident, Ayas said.

Waiting for treatment can also cause or worsen existing mood disorders.

“Depression makes sleep worse, and sleep, once worse, makes depression worse,” Ayas said. “It can be a little vicious circle.”

Anxiety, depression worsens

Matthew Molnar, 40, knows it all too well.

“I haven’t slept well since I was … in my 20s,” he said. “I’m always exhausted.”

That exhaustion made his depression and anxiety worse, Molnar said. It is a challenge to keep a job, “to put additional strain on the people around me, my friends, my family”.

Matthew Molnar, 40, has been waiting for jaw surgery since spring 2020 that could resolve his sleep apnea. The latest estimate he’s received is that he could get the trial next spring, but he’s not confident it will happen before the end of 2022. (Jaison Empson / CBC)

He was diagnosed with sleep apnea about a decade ago and has lived with anxiety and depression for years.

He has tried a number of traditional pharmaceutical, behavioral, and physical interventions for all three conditions, but nothing appears to be very effective. He tried a CPAP machine but couldn’t sleep on it.

In 2017, his psychiatrist told him that he must first get his sleep apnea under control in order to qualify for state-of-the-art procedures that could help with his mental health problems. That meant a more recent sleep disorder test.

After waiting for an appointment for more than two years, he paid for a sleep study at a private clinic and was diagnosed with severe chronic sleep apnea. Molnar says that when he sleeps, he stops breathing about 55 times an hour.

He was on a waiting list for jaw surgery that might help early last year. The response to the pandemic prevented this.

Molnar, who has a degree in political science and public administration, wonders if a task force will have a great immediate impact.

“For me, a task force is the political equivalent of ‘thoughts and prayers’. They do not bring any real relief to the suffering people. “

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FSC criminology professor advocates for decriminalizing mental illness

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LAKELAND – Risdon Slate is believed to be a pillar of the Polk County Community, a college professor who advocates decriminalizing the mentally ill and helping train law enforcement officers to deal with someone who is experiencing a mental illness.

He also has a serious mental illness – bipolar disorder.

In addition to being a professor of criminology at Florida Southern College, 62-year-old Slate has testified before the United States Congress and Florida legislature about society’s poor work of caring for the mentally ill.

“The mental health system is more than happy that the criminal justice system has to deal with all of society’s problems relating to mental illness and mental health,” said Slate. “I think we need a better mental health system, and I think we need a better connection with psychiatric treatment – someone shouldn’t have to commit a crime to get adequate and appropriate psychiatric treatment.”

Slate said that due to a lack of insurance or money, people don’t have access to mental health providers or just don’t know where to start to find a counselor or psychiatrist.

“They cannot find adequate access to psychiatric treatment until they encounter a problem with the judicial authorities and then the authorities. It is up to them to determine if they can be associated with treatment, “Slate said at the time they did something so serious that they cannot be associated with appropriate treatment in the community.”

Slate knows all of this from personal experience.

Bipolar

In the 1980s when he was in his mid-20s, he developed bipolar disorder, a condition the National Institute of Mental Health says can cause unusual changes in mood, energy, activity, concentration, and ability. today’s tasks. It can sometimes require hospitalization and usually requires lifelong treatment.

“People who suffer from manic episodes feel extremely elated, nervous, or irritable. They talk about a lot of things very quickly and have maddened thoughts, ”says the NIMH website. “Depressive episodes include feelings of sadness, tiredness, too much sleep or difficulty falling asleep, difficulty concentrating or making decisions, and the feeling of not being able to do simple things.”

Slate’s bipolar symptoms first presented as insomnia. At the time he was serving as the administrative assistant to the director of a South Carolina prison, and for the first time in decades they had two executions in one year. He went to his family doctor who mistakenly diagnosed him as “situational depression” and prescribed amitriptyline, an antidepressant. At some point he stopped taking it, but then went back to insomnia and started taking the medication again. He also switched jobs and started working as a federal probation officer while having a stressful incident with probation.

Within weeks, he was arrested in Miami after treating himself to alcohol for a few days and quarreling with a man in a hotel bar.

“I go to the bar and start drinking and meet a man at the bar who I imagined to be my father,” said Slate. “I know he’s not my father, but I think he’s playing the role of my father – I think I’m on a movie set – so I start interacting with him like he’s my father and my father and i wouldn’t have had a good relationship. So before you know it, we’re in this dispute. ”

The police showed up and he was taken to Jackson Memorial Hospital, where he was tied to the bed when he yelled for help thinking spiders would perch on him. His wife was tracked down at the hotel and she was allowed to take him to Columbia, South Carolina, where he was hospitalized. He had to quit his job as a federal probation officer within two weeks, and his wife announced that she would divorce him.

His psychiatrist Dr. Roger Deal helped him get his life back on track, diagnosing him as bipolar and prescribing appropriate medication. He also told Slate that amitriptyline was the worst drug that could be prescribed for him

“He said it blows the mania out of your head – he said it was like putting kerosene on the fire,” Slate recalled. “So you have a mistake with the family doctor. And who prescribes most of the psychiatric drugs in the United States? Family doctors. And of course they get it from these pharmaceutical representatives who drive it. ”

Slate got a position as a teacher at a community college and eventually earned his Ph.D. in criminal law. He began teaching at Florida Southern College, but then another doctor in Lakeland made a critical mistake in his treatment.

“What does he decide after about four visits to this psychiatrist? He decides I’m not insane, ”said Slate. “He said, ‘Do you know what I’m thinking? You had brief reactive psychosis following a stressful event. ‘”

Last psychotic episode

And then he gave Slate the green light to stop using lithium. Within two months, Slate had another psychotic episode when he was in Columbia, South Carolina, for the first time in eight years over the 1994 Labor Day weekend.

“I’m at a soccer game with my new wife and I’m literally so delusional that I think I can control the players on the field – the South Carolina Gamecocks – and get them to overrun the Georgia Bulldogs and it will take care of it that they win the game, ”said Slate.

When his mind control failed, he became frustrated and he and his wife left the game. Then paranoia set in. He was beginning to wonder why he had been forced out of his job and lost his first wife if, as his new doctor said, he was not mentally ill.

“I was starting to think that – not rational, but I thought – well, then there must have been some sort of collusion between a federal judge, my supervisor of the federal probation officer, my wife’s father – who didn’t like me – and maybe even my wife “Slate said. And they were all there and three of them were in Columbia so I had to go undercover.”

His “undercover investigation” involved taking a thin dip in a condominium pool – twice. The first time, the police ordered his wife, who was not involved in his nightly swimming, to keep him indoors. The second time she pleaded with her for help.

“She said, ‘Look, this guy has a Ph.D. in criminal law. This guy worked as the federal probation officer in this town and he worked as the warden’s administrative assistant in the prison. He is mentally ill. He is bipolar. A doctor took his medication from him. Please help him, ‘”said Slate. “Your help for me? They took me straight to jail. You didn’t bother telling anyone in prison what conditions I was and what I was under. ”

He said prison guards beat him when he refused to be transferred to a solitary confinement cell for inmates with mental illness. He described the beating as an out-of-body experience and cannot recall feeling any pain, despite having photos of the bruises.

The only thing in the cell was a hole in the floor that served as a toilet. In his psychosis, he put his hand in the sewer hole and started fishing. He had read a book about an indigenous medicine man in college and the memory of it inspired him to smear human excrement on his face as war paint and dance around the cell.

He also found a former inmate’s broken bracelet in the hole.

“I thought, ‘Man, you killed someone here. They killed everyone who was that guy whose bracelet is in here. They’re going to kill me, ‘”Slate recalled. “And so I started to freak out. The hair started to stand up on the back of my neck. ”

He said at that moment the cell door opened. Ron Hudson, a former federal probation officer, heard what was going on and came to see Slate taken to a mental health facility.

“Ron came into this prison without any authority and told the prison, ‘You have Risdon Slate in here. He’s coming with me, ‘”said Slate, who saved Hudson’s life that day. “I think they were glad he came to get me because they didn’t know what to do with me.”

He was admitted to the hospital, received his medication again, and had no other incident. He said he took lithium for 30 years, but because it can cause kidney damage, he is now taking the generic form of Depakote.

Slate was speaking recently at his Lakeland Highlands home as he sat by his swimming pool on a fine fall day, his dog Teddy by his side and his wife Claudia on their way home from an errand. Her house is lined with Union and Confederate memorabilia and framed quotes from Dr. Martin Luther King Jr.

Several years after the last South Carolina incident, he testified before Congress and the Florida Senate Health Committee in 2005, urging them not to establish a preferred medication list that stipulates that only certain drugs are used for treatment People are allowed to be on Medicaid or in prisons and prisons. Slate said this can make treatment difficult and even cause people to relapse into psychosis again, as it can sometimes take a patient months to find the right medication.

Slate gives a bold face to mental illness because he wants people to know that treatment is available and that people can live full lives.

“I made a conscious decision that I was no longer ashamed or ashamed of having a mental illness,” said Slate. “What I am embarrassed about is how we treat people with mental illnesses in our society. It takes formal structures in place to help people. ”

to get help

The Peace River Center in Polk County has a 24-hour emotional support and crisis helpline: 863-519-3744 or toll-free at 800-627-5906

Ledger reporter Kimberly C. Moore can be reached at kmoore@theledger.com or 863-802-7514. Follow her on Twitter at @KMooreTheLedger.

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