Pence Group Files SCOTUS Brief Opposing Biden Vaccine Mandate

Pence group files SCOTUS brief opposing Biden vaccine mandate | TheHill

Source: The Hill, by Brett Samuels

Former Vice President Mike Pence on Monday announced his advocacy group has filed an amicus brief urging the Supreme Court to reject the Biden administration’s attempt to require large businesses to mandate the COVID-19 vaccine for its workers or require frequent testing.

Pence filed the brief, which was shared with The Hill, through his political advocacy group Advancing American Freedom. In the document, Pence’s organization argues the Biden White House’s mandate is unconstitutional and would exceed previous examples of the Occupational Safety and Health Administration’s (OSHA) use of emergency authority.

“America is about freedom and the ability to make the best decision for your family or business, and Joe Biden’s vaccine mandate must be stopped in its tracks in order to preserve freedom, protect American livelihoods and businesses, and to safeguard our constitution,” Pence said in a statement.

The brief outlines nine previous cases where OSHA used an emergency temporary standard to expedite the standard rule-making process. Pence’s brief argued there is a distinction in that the previous instances sought to regulate workplace dangers like asbestos or other chemicals that threatened workers’ safety, not require employees to get vaccinated or get some other medical treatment.

The brief from Pence’s group argues that the OSHA rule requiring vaccinations suggests “the Biden Administration is not truly seeking to mitigate workplace hazards through the [emergency temporary standard], but rather is attempting to use OSHA to accomplish an end that it has been unable to persuade Congress to support: the mandatory vaccination of the American public.”

The Biden White House has said it does not support making the COVID-19 vaccine mandatory for the public.

Pence’s group has previously filed amicus briefs with the Supreme Court outlining positions on prominent cases on abortion and school choice. The former vice president is the latest conservative politician to weigh in against the Biden administration’s push for large businesses to require vaccinations or regular testing for employees as part of an aggressive strategy to end the pandemic.

The workplace mandate is scheduled to take effect this month and could affect an estimated 84 million employees. It generally requires larger businesses with more than 100 employees to adopt written policies requiring workers to be vaccinated against COVID-19 or wear masks and undergo regular testing.

The Biden administration on Thursday urged the Supreme Court to leave intact a workplace vaccine-or-test mandate as public health officials contend with the surging COVID-19 pandemic.

DOJ lawyers argued that the 1970 law that established the Occupational Safety and Health Administration (OSHA) makes plain that the policy “falls squarely within OSHA’s statutory authority.”

But conservatives, including several interest groups and governors, have argued in court that the OSHA rule is an example of government overreach and that the White House should not have the power to require certain groups to get vaccinated against COVID-19, which has spread rapidly in recent weeks thanks to the highly contagious omicron variant.

FDA Authorizes First Covid-19 Booster Shot For Teens Aged 12 To 15

FDA authorizes Covid boosters for teens 12-15 - POLITICO

Source: STAT, by Helen Branswell

The Food and Drug Administration on Monday extended the emergency use authorization for the Pfizer and BioNTech Covid-19 booster shot to include teens aged 12 to 15, paving the way for them to be eligible for the jabs later this week.

It is the first booster shot to be authorized for this age group.

A panel of independent experts that advises the Centers for Disease Control and Prevention on vaccination policy will meet Wednesday to discuss the policy change. It’s possible the ACIP will issue what’s known as a permissive recommendation — saying youths aged 12 to 15 may get a booster if they wish, but stopping short of urging them to do so.

If the committee goes this route, it will likely be because of still outstanding questions about the risk of myocarditis and pericarditis — inflammation of the heart and tissue surrounding the heart, respectively — that may be associated with getting a booster shot for this age group. The ACIP’s recommendation must be approved by CDC Director Rochelle Walensky before it can come into effect.

Janet Woodcock, the acting FDA commissioner, said in a call with reporters that the FDA expects that myocarditis would be “extremely rare” in a third dose given to 12- to 15-year-olds, and that data collected from the use of the vaccine in Israel seems to back up that idea.

Peter Marks, the director of the FDA’s Center for Drug Evaluation and Research, told reporters that the myocarditis risk seems to peak in 16- to 17-year-old males. Ninety-eight percent of cases have been mild, and among males between 16 and 30, the rate of myocarditis is about one in 1,000 vaccine recipients. The risk appears to be lower, he said, with a third booster shot than with a second dose. Marks said the FDA would continue to monitor the condition.

The Biden administration is pushing to get booster shots into as many Americans as possible as the highly transmissible Omicron variant sweeps across the country. Though infections associated with this latest variant of concern appear to be mild to moderate for many people, the transmissibility of the virus is pushing case counts to new heights. Even if most cases are mild, having hordes of people sick at once is already wreaking havoc on many sectors, including air travel and health care.

As 12- to 15-year-olds became eligible to be vaccinated in May of last year, many will be ready for a booster when Walensky approves the expanded EUA.

The extension will only apply to the Pfizer vaccine, which is the sole Covid vaccine in this country authorized for use in anyone under the age of 18.

The FDA also announced that it is shortening the interval after which people are eligible for a booster shot, moving it to five months post-completion of a primary vaccination series from six months. This relates to adults, teens, and preteens eligible for a booster who have received the two-dose series of the messenger RNA vaccines made by Pfizer or Moderna. People who received the one-dose Johnson & Johnson vaccine are urged to get a second shot two months after the first jab.

The FDA also announced that children aged 5 to 11 who are moderately or severely immunocompromised will be able to get a third dose of the Pfizer vaccine 28 days after they receive their second dose. Third doses for moderately or severely immunocompromised people 12 and older were previously approved by the FDA and the CDC.

The Big-Ticket Drugs That Have Higher Prices In 2022

Source: Axios, by Bob Herman

Drug companies raised the prices on hundreds of medications on Jan. 1, with most prices up 5% to 6% on average.

Why it matters: The start of the new year is the most popular time for drug companies to hike prices, and even though high drug prices remain one of the biggest political health care issues, increases in 2022 are tracking in line with other recent years.

By the numbers: Pharmaceutical companies increased prices on 460 drugs on Jan. 1, according to drug prices monitored by research firm 46brooklyn.

  • * The number of drugs that had price increases on Jan. 1 of prior years according to 46brooklyn: 629 (2021), 385 (2020), 359 (2019), 538 (2018) and 494 (2017).
  • * Many drugmakers implement price hikes on other days throughout January, so expect more increases in the coming days.

Between the lines: Several blockbuster drugs were included in this initial batch of 2022 price hikes.

  • * Gilead: ⬆️ 5.6% on HIV drugs Biktarvy and Descovy.
  • * Pfizer: ⬆️ 6.9% on breast cancer drug Ibrance, ⬆️ 6.9% on its Prevnar vaccine and ⬆️ 4.4% on the costly heart drugs Vyndamax and Vyndaqel.
  • * Purdue: ⬆️ 5% on opioid poster child OxyContin.
  • * Vertex: ⬆️ 4.9% on Trikafta, a blockbuster cystic fibrosis medication that has no competitors and already has a list price of more than $311,000 per year.

Yes, but: These actions affect the drugs’ list prices. Pharmacy benefit managers negotiate lower drug prices in the form of rebates, so drugmakers often collect lower net prices.

  • * However, list prices still matter because they are what the uninsured pay, and deductibles and coinsurance rates are often based on a drug’s list price.
  • * Drug companies also capture most or all of a list price increase for patented drugs that have little competition, like those mentioned above.

What they’re saying: “We expect net prices to continue to decline due to increased rebates and discounts,” a Gilead spokesperson said in response to the company’s price hikes. The spokesperson did not answer specific questions about the rebates for those drugs.

  • * “The modest increase is necessary to support investments that allow us to continue to discover new medicines and deliver those breakthroughs to the patients who need them,” a Pfizer spokesperson said. When posed specific questions about Ibrance’s rebates, the spokesperson said: “We do not disclose detail at the product-level.”
  • * Vertex’s price increases on Trikafta and its other cystic fibrosis drugs “are the first price increases for a Vertex medicine since 2017, and the first ever for … Trikafta, and they “reflect the significant value these medicines bring to patients.” Vertex similarly did not respond to questions about rebates.

Our thought bubble: List price increases don’t tell the entire story about U.S. drug pricing, but drug company claims about how net prices are falling right now distort how much prices have increased over time.

Biogen Halves Price Of Alzheimer’s Drug To $28,200

FILE - The Biogen Inc., headquarters is shown March 11, 2020, in Cambridge, Mass. Biogen is slashing the price of its Alzheimer’s treatment months after the drug debuted to widespread criticism for an initial cost that can reach $56,000 annually. The

Source: Reuters, by Amruta Khandekariogen

Biogen Inc (BIIB.O) on Monday cut the price of its Alzheimer’s drug by about half to $28,200 for an average weight person after facing slower-than-expected U.S. sales on complaints from hospitals that its high cost was not worth its benefits.

The U.S. Food and Drug Administration (FDA) approved the drug, Aduhelm, in June to treat the brain-wasting disease despite the view of its outside advisory panel that Biogen had not proven the treatment’s clinical benefit.

The U.S. Medicare program, which pays for health services for people over 65 years, has scheduled a January meeting for a national policy for the drug, making reimbursement more difficult in the interim.

Biogen’s $56,000 per year treatment price for an average weight person was seen as a significant cost burden on Medicare, which covers more than 60 million people.

The company said it hoped the new annual price of $28,200 will expand access to the drug among patients.

Biogen has been betting on Aduhelm, the first new treatment for the memory-robbing disease in nearly 20 years, to buffer a hit from its main revenue drivers facing rising competition.

Aduhelm brought in sales of $300,000 in the latest quarter, missing analysts’ estimates.

“We are big fans of Biogen’s decision to cut the price of Aduhelm, and, in our view, this makes some level of reasonable Medicare reimbursement more likely,” Stifel analyst Paul Matteis said.

Biogen said with insurance coverage and access to diagnostics and specialized centers roughly 50,000 patients may begin treatment with Aduhelm in 2022.

The FDA had initially approved the drug for all Alzheimer’s patients, but later recommended its use only in patients with mild cognitive impairment or mild dementia.

Biogen also announced cost-reduction measures for 2022 that could result in annual savings of about $500 million.

Source: Reuters, by Amruta Khandekar

Biogen Inc (BIIB.O) on Monday cut the price of its Alzheimer’s drug by about half to $28,200 for an average weight person after facing slower-than-expected U.S. sales on complaints from hospitals that its high cost was not worth its benefits.

The U.S. Food and Drug Administration (FDA) approved the drug, Aduhelm, in June to treat the brain-wasting disease despite the view of its outside advisory panel that Biogen had not proven the treatment’s clinical benefit.

The U.S. Medicare program, which pays for health services for people over 65 years, has scheduled a January meeting for a national policy for the drug, making reimbursement more difficult in the interim.

Biogen’s $56,000 per year treatment price for an average weight person was seen as a significant cost burden on Medicare, which covers more than 60 million people.

The company said it hoped the new annual price of $28,200 will expand access to the drug among patients.

Biogen has been betting on Aduhelm, the first new treatment for the memory-robbing disease in nearly 20 years, to buffer a hit from its main revenue drivers facing rising competition.

Aduhelm brought in sales of $300,000 in the latest quarter, missing analysts’ estimates.

“We are big fans of Biogen’s decision to cut the price of Aduhelm, and, in our view, this makes some level of reasonable Medicare reimbursement more likely,” Stifel analyst Paul Matteis said.

Biogen said with insurance coverage and access to diagnostics and specialized centers roughly 50,000 patients may begin treatment with Aduhelm in 2022.

The FDA had initially approved the drug for all Alzheimer’s patients, but later recommended its use only in patients with mild cognitive impairment or mild dementia.

Biogen also announced cost-reduction measures for 2022 that could result in annual savings of about $500 million.

Lawmakers Blast Pharma For ‘Outrageous’ Prices And ‘Anticompetitive Conduct’ In Culmination Of 3-Year Probe

Lawmakers blast pharma for 'outrageous' prices and 'anticompetitive conduct'  in culmination of 3-year probe | FiercePharmaSource: Fierce Healthcare, by Fraiser Kansteiner

For years, drugmakers have targeted “weaknesses” in the U.S. healthcare system to reap dividends on older meds, The House Oversight Committee said Friday.

The “outrageous prices” and “anticompetitive conduct” that dictate the market make a strong case for the passing of President Joe Biden’s Build Back Better Act, which would allow Medicare to petition for lower prices on certain drugs like insulin, committee chairwoman Rep. Carolyn Maloney (D-NY) argued.

The findings mark the culmination of an almost three-year probe into the industry’s pricing strategies, launched by the late Rep. Elijah Cummings in 2019. The report cites more than 1.5 million pages of internal company documents that shed light on “the decision-making of many of the world’s most profitable drug companies,” the Oversight Committee said. The investigation specifically focused on 12 drugs from companies such as Sanofi, Eli Lilly, Pfizer and Novo Nordisk.

“Drug companies have raised prices relentlessly for decades while manipulating the patent system and other laws to delay competition from lower-priced generics,” Rep. Maloney said in a statement.

Looking at just seven of the dozen drugs in the probe—Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica—the committee’s analysis found that U.S. taxpayers could have saved more than $25 billion over a five-year stretch if private Medicare Part D plans had the same negotiating power as their foreign counterparts.

Meanwhile, pharma companies “abuse” the U.S. patent system and FDA market exclusivity to stifle competition, the Oversight Committee said. Its investigation turned up more than 600 patents on the 12 drugs examined.

The committee also chided the industry on its use of patient-assistance programs. Drugmakers often see these programs as potent public relations tools to boost sales, especially for drugs heading toward a patent cliff, the committee said. Internal documents suggest companies’ spending on these programs is eclipsed by the “enormous” amount of revenue the associated drugs bring in.

“These programs often do not provide sustainable support for patients and do not address the burden that the company’s pricing practices have placed on the U.S. health care system,” the committee said.

The report also homed in on insulin titans Eli Lilly, Novo Nordisk and Sanofi. The triumvirate controls some 90% of the insulin market in the U.S., Reuters points out. Medicare could have saved more than $16.7 billion between 2011 and 2017 on purchases of the insulin products Humalog, Lantus and NovoLog, had it been able to angle for discounts.

Meanwhile, despite the Build Back Better Act’s promise to curb pricey prescription drug costs, Evercore ISI analysts recently branded the Medicare framework “negotiation in name only.” The plan will empower Medicare to hash out costs on just 10 of the country’s most-expensive medicines starting in 2025, with more drugs to be added gradually down the line.

Nearly One-Third Of Americans Skipped Care In Past Three Months Due To Cost: Poll

Poll: Nearly Half of the Public Say They or a Family Member Skipped or  Delayed Care Due to Coronavirus, But Most Plan to Get Care in the Coming  Months | KFFSource: The Hill, by Justine Coleman

Almost one-third of Americans skipped necessary medical care in the past three months because they could not afford it, according to a poll released Tuesday.

The survey from the West Health Policy Center and Gallup found that 30 percent of participants said they opted out of health care due to the cost — a percentage that tripled from nine months ago, reaching its highest point during the pandemic.

One-fifth of respondents said they or a household member saw their health problem worsen after delaying care because of the cost.

Twenty percent of those from households that earn more than $120,000 also reported they postponed health care due to financial reasons — an increase from 3 percent in March.

Tim Lash, president of the West Health Policy Center, told The Hill that the data showing those earning “significantly higher” than the median income struggling “tells you that we have a real problem.”

“It tells me that we’re at a breaking point and that it’s not just … those that are desperate are not just low-income  individuals but even those that are more affluent,” he said. “And we’re gonna have to find a way out of that.”

Almost a third of respondents said they would not have access to affordable care if they needed it today, compared to a spring survey in which 18 percent said the same. Plus, 42 percent said they worry they won’t be able to pay for necessary medical care within the next year.

“Decades of failed action and the current weakening of bold measures to lower costs, have left Americans at the close of the year viewing the future as bleak as the past,” a statement alongside the poll said.

The COVID-19 pandemic worsened almost half of Americans’ views of the health care system, with 15 percent saying they had more trouble paying for care. Regardless of their political affiliation, two-thirds of Americans don’t expect policies to result in lower costs.

The survey shows the pandemic “compounded” issues of equity, Lash said. One of 20 respondents reported knowing a friend or relative who died over the past year after not getting needed care due to the cost, with Black Americans being twice as likely as white Americans to say they knew someone for whom that was true.

“It shows you how fragile our health care system is and how fragile families can be when they’re trying to access it,” Lash said.

The West Health-Gallup poll surveyed 6,663 American adults from all 50 states and D.C. between Sept. 27 and 30 and Oct. 18 and 21. The margin of error amounted to 1.5 percentage points.

Omicron Variant More Resistant To Vaccine But Causes Less Severe COVID, Major South African Study Concludes

Omicron study concludes variant more resistant to coronavirus vaccines, causes  less severe covid - The Washington PostSource: The Washington Post, by Lesley Wroughton

Omicron appears to cause less severe illness than earlier variants of the coronavirus but is more resistant to the two-dose Pfizer-BioNTech vaccine widely used in South Africa, according to the first major private study since omicron was first detected last month.

The study by Discovery Health, South Africa’s largest health insurer, of 211,000 positive coronavirus cases, of which 78,000 were attributed to omicron, showed that risk of hospital admissions among adults who contracted covid-19 was 29 percent lower than in the initial pandemic wave that emerged in March 2020.

However, the study, released Tuesday, found that the vaccine from U.S. pharmaceutical giant Pfizer and German partner BioNTech provided just 33 percent protection against infection, much less than the level for other variants detected in the country.

At the same time, the vaccine may offer 70 percent protection against being hospitalized with omicron, the study found, describing that level of protection as “very good.”

The protection was maintained across all age groups, Ryan Noach, Discovery Health’s chief executive, told a news briefing. He said the disease may be less severe in South Africa because more than 70 percent of the population had already been exposed to the coronavirus.

He cautioned, however, that it was still in the early days and hospital admissions could rise sharply as the variant evolves.

“The omicron-driven fourth wave has a significantly steeper trajectory of new infections relative to prior waves,” Noach said in a statement. “National data show an exponential increase in both new infections and test positivity rates during the first three weeks of this wave, indicating a highly transmissible variant with rapid community spread of infection.”

“What is encouraging at this stage is a flatter trajectory of hospital admissions indicating likely lower severity of this wave,” he told a news briefing later.

Noach said anecdotal evidence gathered from doctors treating omicron patients outside hospitals showed a high reinfection rate and multiple breakthrough infections in vaccinated people that emerge after a short incubation period of three to four days.

Most infections are described as mild, with recoveries usually within three days, he said. The most common early symptom reported is a scratchy throat, followed by nasal congestion, a dry cough and myalgia, or aches, manifesting in lower back pain.

He said private hospitals reported that most patients were unvaccinated and many were initially admitted for non-covid-related illnesses. There was less evidence of respiratory infections in omicron-infected patients, compared to the other variants, with fewer patients requiring oxygen, Noach added.

Shirley Collie, chief health analytics actuary at Discovery Health, said doctors were reporting a higher number of children testing positive with omicron, but cautioned that closer examination of the issue was needed. Discovery Health’s data indicated that children under the age of 18 have a 20 percent higher risk of admissions for complications when infected with omicron compared to the other variants, she said.

Most children infected with omicron complained of a headache, sore throat, nasal congestion and a fever, that was usually over within three days, Collie said.

The study did find “good protection” by the vaccine across a range of chronic conditions, she added, including diabetes, hypertension and heart disease, that have proved so dangerous in the course of the disease.

The research comes as omicron has become the dominant variant in South Africa less than three weeks since its existence was confirmed on Nov. 25. The World Health Organization warned Monday that omicron, now detected in 63 countries, poses a “very high” global risk.

In a separate briefing Tuesday, Matshidiso Moeti, the World Health Organization’s director for Africa, declared that Africa was now officially in the fourth wave of the pandemic primarily driven by omicron, with an 83 percent surge in new cases this week compared to the previous week.

“This is the fastest surge recorded since May last year,” Moeti said. “We are cautiously optimistic, as we are seeing fewer deaths during the early weeks of this current wave when compared to previous surges.”

In South Africa, the drop in the protection of two doses of the Pfizer-BioNTech vaccine against any symptomatic infection is similar to what a British preprint study released late last week showed, namely that it dipped below 40 percent.

The British study, however, could not answer pressing questions about whether vaccine protection against severe disease would erode just as steeply. The South African data provides the first hint, showing that protection against severe illness requiring hospitalization after two doses was diminished from its more than 90 percent protection against the delta variant but remained relatively robust, at 70 percent.

As the world watches South Africa closely for signs of how omicron could evolve elsewhere, there are a lot of questions around population differences and how much the previous infection protects people.

Glenda Gray, president of the South African Medical Research Council, said it was hard to answer those questions right now.

“South Africa has a quite high seroprevalence of prior infection, particularly after delta, and in some parts of South Africa up to 80 percent of people were exposed to previous infection,” she said. “We don’t think it’s a question of virulence, but more a question of exposure to vaccination and prior infection, so we would be cautious to try and interpret that this is a less virulent strain. We’ll have to see what happens in other parts of the world before we make a call on this.”

Touting His Spending Bill, Biden Shifts Focus to Drug Prices

Biden Touts Savings on Insulin and Other Drugs for Americans | Business  News | US News

Source: The New York Times, by Zolan Kanno-Youngs and Margot Sanger-Katz

As Democrats race to finalize a sweeping social spending package, President Biden on Monday tried to sell the bill by focusing on a specific benefit: lowering the cost of insulin for those with diabetes.

“I think it’s safe to say that all of us, all of us, whatever our background, our age, where we live, we can agree that prescription drugs are outrageously expensive in this country,” Mr. Biden said after he was introduced by a woman who said she had fallen into a coma after rationing her insulin.

The president said one of the most “egregious examples” of the high prices of prescription drugs was how much those suffering from diabetes must pay for the medication they need.

“Shame on us,” Mr. Biden said. “We can do better as a nation.”

It was the latest attempt by the president to promote the package, which has been stuck in congressional gridlock. Mr. Biden previously sought to build support for the social policy bill by highlighting how it would create jobs, tax the rich and address the global threat of climate change. On Monday, he homed in on the ways the package would address prescription drug costs, an issue that the administration believes will appeal to a wide range of voters.

But significant differences over the package must still be resolved, even as Senator Chuck Schumer of New York, the majority leader, insisted to his colleagues in a letter on Monday that the package would pass the Senate by Christmas. Senator Joe Manchin III, Democrat of West Virginia, has sought to pare down provisions in the package, including its paid family leave program, a methane fee on emissions, a plan to tax billionaires and an expansion of Medicare to cover hearing aids. Mr. Manchin has signaled support for the proposal to lower the costs of prescription drugs.

Mr. Biden dodged a question on Monday about whether he was confident that the package would be ready by Christmas.

“As early as we can get it,” Mr. Biden said. “We want to get it done no matter how long it takes.”

The social spending bill that passed the House would, for the first time, allow Medicare to directly regulate the price of drugs prescribed for its beneficiaries. Under the legislation, Medicare would be allowed to lower the price of 20 drugs a year once they have been on the market for several years. It also would change Medicare’s drug benefit to limit how much seniors can be asked to pay for their medication. It would establish a spending cap of $2,000 a year, a provision that would lower costs for the 2.5 million Medicare beneficiaries who currently pay more.

The bill would also make changes to drug prices for patients outside Medicare, by limiting the amount drug makers can raise their prices each year and by capping co-payments for insulin at $35 a month. The package, which was subject to extensive negotiations, targets fewer drugs than many House Democrats had hoped.

Prescription drugs cost substantially more in the United States than in other developed nations, a point Mr. Biden repeated in his speech. According to recent estimates from the Rand Corporation, American drug prices are more than 250 percent of prices paid by other nations in the Organization for Economic Cooperation and Development.

The White House views the provision to lower prescription drugs as one that can build support among a diverse group of voters for a legislative package that would also combat climate change and invest in the social safety net. After Democrats lost the governor’s race in Virginia last month, a White House official said the administration intended to focus on the progress made on negotiations to empower Medicare to galvanize suburban voters who may have supported Glenn Youngkin, the Republican who won the race.

But the portions of the drug plan that were highlighted in the event — limits on cost sharing for insulin, and a ban on high price hikes — both face challenges. Senate Republicans are arguing that the provisions violate the budget rules Democrats must follow to pass their legislation with a simple majority. The survival of those provisions depends on the ruling of the Senate’s parliamentarian, who is expected to consider the issue in the next few weeks.

Hospitals Eye Spending Bill to Stop Cuts

Medicare Expansion Clashes With Health Care for the Poor as Budget Bill  Shrinks - The New York TimesSource: Bloomberg Government, by Brandon Lee

Hospital groups are asking lawmakers to prevent billions of dollars in Medicare pay reductions next year as part of a government funding bill that’s on Congress’s agenda for this week.

The Coalition to Protect America’s Health Care, which represents hospital groups, announced yesterday it will launch a television ad campaign in Washington, D.C., urging Congress to stop the cuts.

Some of those same hospital lobbies, such as the American Hospital Association and the Federation of American Hospitals, sent a letter to congressional leaders asking for action before the end of the year and warning that hospitals already face increasing supply costs due to the Covid-19 pandemic.

“Additional Medicare reductions to providers are not sustainable and put our members’ ability to care for their patients at risk,” the groups warned in their letter.

One hospital lobbyist said the groups are pushing for action this week to stop cuts set to take effect at the end of the year. Congress must pass legislation to fund the government by Dec. 3 or the government will partially shut down. Leaders are considering a measure that would run to mid-to-late January.

Medicare fee-for-service payments could be reduced by $14.1 billion in 2022 unless there’s action by the end of the year, according to the AHA, because of mandatory spending sequestration under the Budget Control Act and statutory pay-as-you-go (PAYGO) requirements — two mechanisms meant to limit federal spending.

Hospitals are asking Democratic and Republican leaders to agree to waive PAYGO, something Congress has done to prevent across-the-board cuts to federal programs triggered when lawmakers pass bills that add to government spending without some kind of offset.

They’re also asking lawmakers to postpone sequestration — automatic cuts to federal spending meant to help with the deficit — to the end of the federal public health emergency around Covid-19, which is set to expire in mid-January but is likely to be extended further into 2022. Read more from Alex Ruoff.

Facing Omicron Threat, CDC Says All Adults Should Get COVID-19 Booster Vaccine

CDC says all adults should get COVID-19 booster vaccine - Los Angeles TimesSource: Los Angeles Times, by Rong-Gong Lin II & Luke Money

The U.S. Centers for Disease Control and Prevention on Monday strengthened its recommendations on who should get boosters.

In a statement, CDC Director Dr. Rochelle Walensky said that all vaccinated adults should get a booster as long as they received their second dose of the Pfizer or Moderna shot at least six months ago or they received their Johnson & Johnson shot at least two months ago.

“The recent emergence of the Omicron variant (B.1.1.529) further emphasizes the importance of vaccination, boosters, and prevention efforts needed to protect against COVID-19,” Walensky said. “Early data from South Africa suggest increased transmissibility of the Omicron variant.”

The CDC‘s previous guidelines, last updated Nov. 19, recommended booster shots for adults 50 and older, and made all younger, healthier adults age 18 to 49 eligible for booster shots but stopped short of recommending them. The agency’s newest recommendations — to urge boosters for all adults — is identical to the recommendations issued by the California Department of Public Health a week and a half ago.

The CDC’s previous, complicated stance came under criticism by some experts as still being overly confusing. Dr. Eric Topol, director of the Scripps Research Translational Institute in La Jolla, called the CDC’s earlier guidance issued in mid-November a “big mistake.”

While many people have spoken of the Delta variant as “a pandemic of the unvaccinated,” it’s also important to realize that those being infected now include vaccinated people whose immunity has waned, Topol wrote with Michael Osterholm, director of the Center for Infectious Disease Research and Policy, in an op-ed published in the Washington Post.

“Multiple studies have shown that fully vaccinated people can spread the Delta variant. This is more likely when the vaccine-induced immune response has faded,” Topol and Osterholm wrote. “Since booster shots strongly reduce symptomatic infections, they could help stem the increased spread that we are experiencing.”

The CDC’s move came three days after the World Health Organization identified a new variant in southern Africa as a “variant of concern,” calling it Omicron.

U.S. infectious disease experts have voiced concern about Omicron because its appearance in South Africa was accompanied by a big surge in coronavirus cases, following a time of low infection levels, suggesting that it is highly transmissible. It’s not clear, however, whether Omicron will overtake Delta as being the most transmissible variant of the coronavirus.

It’ll probably take two weeks to know whether the vaccines would be less effective against the Omicron variant. Lab tests are underway. Still, Dr. Anthony Fauci, President Biden’s chief medical advisor for the pandemic, “continues to believe that existing vaccines are likely to provide a degree of protection against severe cases of COVID,” the White House said in a statement.

“I don’t think there’s any possibility that this [Omicron variant] could completely evade any protection by a vaccine. It may diminish it a bit, but that’s the reason why you boost,” Fauci said in an interview on ABC.

Fauci reiterated that booster shots for fully vaccinated individuals provide the strongest available protection against COVID-19 and that it’s important that anyone who is unvaccinated — including children 5 and older — get their shots.

During a briefing Monday, Biden characterized Omicron as “a cause for concern, not a cause for panic.”

“The best protection against this new variant — or any of the variants out there, the ones we’ve been dealing with already — is getting fully vaccinated and getting a booster shot,” he told reporters.

Biden said he’d be releasing a detailed strategy later this week detailing the winter battle plan against COVID-19 — “not with shutdowns and lockdowns, but with more widespread vaccinations, boosters, testing and more.”

“We’ve moved forward in the face of COVID-19. We have moved forward in the face of the Delta variant, and we move forward now in the face of the Omicron variant, as well,” the president said.

According to the California Department of Public Health, Omicron “has many mutations in important areas of the virus that impact infectiousness and the ability for immune systems to protect from infection. Some of the mutations are concerning to scientists because they are very different from other variants previously detected, and some are similar.”

“We do not know at this time if this new variant causes more severe COVID-19 illness than other variants or how it might impact response to treatment,” state health officials wrote.

Biden said Monday that his administration is already working with pharmaceutical companies to formulate updated vaccines if necessary. However, he emphasized, “we do not yet believe that additional measures will be needed,” adding that he has no plans for new restrictions on travel or businesses.

Officials for Pfizer and Moderna told CNBC on Monday that work is underway for vaccine versions specifically designed to deal with Omicron. Such a vaccine would take a few months to develop, but it’s not a certainty it would be needed.

New versions of COVID-19 vaccines were developed specifically for the Beta and Delta variants but were never released publicly because initial vaccination formulas retained their effectiveness against those variants.

The potential threat posed by Omicron further underscores the importance of both vaccinating as many people as possible and ensuring adults get their booster doses as soon as they are eligible, Los Angeles County health officials said.

“Since transmission remains substantial across the county, this additional boost makes a difference,” Public Health Director Barbara Ferrer said in a statement.

In L.A. County, 98% of skilled nursing facilities have administered booster doses to residents and staff members between mid-October and mid-November. In that time period, there was a 63% drop in new coronavirus cases in skilled nursing facilities; countywide, new cases fell by only 6% during that time.

“Clearly boosters, along with very high vaccination coverage with two doses among staff and residents, make a difference,” Ferrer said.

At skilled nursing facilities in L.A. County, 96% of staff members and 90% of residents are fully vaccinated. All skilled nursing facility staff were required to be fully vaccinated by the end of September under a state health officer order.

Last Updated 01/19/2022

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