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stephenmccull · 4 years ago

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‘Not Quite on Board’: Parents Proving a Tough Sell on Covid Vax for Teens

Even as the U.S. prepares to roll out a covid-19 vaccine to elementary school-aged kids, its efforts to inoculate teenagers — who have been eligible for the shot since May — continue to meet with a lackluster response.

So far, about half of kids 12 to 17 are fully vaccinated in the U.S., compared with nearly 70% of Americans 18 and older. Pediatricians expect it will be even harder to persuade skeptical parents of younger children to get their kids inoculated. Many are concerned about the potential unknowns of a relatively new vaccine compared with the low risk of serious illness covid poses for children.

A recent poll from KFF found 27% of parents of children 5 to 11 said they plan to get them vaccinated “right away,” while 30% said they would “definitely not” get the vaccine for their 5- to 11-year-olds. More than three-quarters of parents of children in this age group reported they were “very” or “somewhat” concerned that not enough is known about the long-term effects of the vaccine in kids.

“I’m not quite on board with everybody getting vaccinated,” said Tara Currier, 42, a mother of four in Marysville, California, who decided not to vaccinate her three older children, ages 12, 14 and 16. She said she also plans to delay vaccinating her 10-year-old daughter.

While she is fully vaccinated herself, Currier said she won’t vaccinate her children until she can be certain the shot is “actually a protection and not something that’s going to affect their bodies later on. I don’t know that can be answered yet, because the vaccine hasn’t been seen in people for very long.”

Public health officials and leading experts have been increasingly vocal in emphasizing that while children are at lower risk of serious illness from covid, they are not at zero risk. Nearly 6.3 million children have tested positive for covid, and more than 580 have died, according to the American Academy of Pediatrics. A small percentage have developed long-term symptoms.

They also stress that vaccinating children is essential to slowing the spread of the virus in the broader population. Nationwide, more than 45 million people have been infected by SARS-CoV-2, which causes covid, and more than 745,000 have died.

The Food and Drug Administration authorized the Pfizer-BioNTech covid vaccine for emergency use in children ages 12-15 in May, after approving the same shot for teens 16 and older five months earlier. On Friday, the agency authorized for emergency use a smaller dose of the vaccine for children ages 5-11, and shots are expected to be available this week following signoff by the Centers for Disease Control and Prevention.

In clearing the Pfizer vaccine for children and teens, the FDA said ongoing clinical studies show children and adolescents face greater risks from covid and its potentially devastating side effects than they do from a rare side effect of the vaccine involving inflammation of the heart reported in some young adults.

Still, California offers a lens on the challenges health officials and pediatricians face in persuading parents nationwide to embrace the new shots. The state ranks in the nation’s top quartile in overall vaccination rates, with 72% of people 12 and older vaccinated, according to the CDC. But that number masks vast disparities among the older and younger age groups.

Statewide, just 59% of kids 12 to 17 were fully vaccinated by Oct. 24. By comparison, 71% of people 18 to 49 were vaccinated by that date; 80% of residents 50 to 64; and 75% of residents 65 and older.

In addition, teen vaccination rates vary hugely by region, another microcosm of the U.S. While many of the wealthier urban and suburban counties along the California coast boast vaccination rates upward of 70% for kids 12 to 17, multiple counties in the state’s rugged north report fewer than a quarter of that age group are vaccinated.

Marin County is one of the state’s success stories. Relatively wealthy, decidedly Democratic and overwhelming white, the county had vaccinated 93% of kids 12 to 17 as of Oct. 19, according to the California Department of Public Health. That’s more than twice the rate of 12- to 17-year-olds vaccinated in rural Madera County in the Central Valley; and it dwarfs the 16% of kids 12-17 vaccinated in Modoc County in the state’s mountainous northeast.

When younger teenagers became eligible in the spring, public health officials in Marin County set up two mass vaccination sites with “lots of fanfare and confetti and a ribbon-cutting kind of feeling,” said county public health officer Dr. Matt Willis. Families were eager, and within 10 days, the county had vaccinated half their adolescent population.

For parents who were more hesitant, “pediatricians were crucial,” Willis said. Dr. Nelson Branco, a pediatrician in Larkspur, said his practice waited a few weeks before opening its own vaccination clinic. They checked the vaccine registry for their 4,000 12- to 17-year-old patients, identified 800 who had not been vaccinated, then sent out an email blast inviting them to one of their weekly clinics and to call with any questions.

“We found that there were lots of parents of teenagers who are very anxious for their kids to get back to more normal activities,” said Branco. “We’re seeing the same things with parents of younger kids. The question is ‘When?’ not ‘Should I?’”

In a rural county like Madera, which hasn’t voted for a Democratic president since Jimmy Carter, the low vaccination rates reflect factors beyond a conservative political bent, said Dr. Nicole Webb, a pediatrician at Valley Children's Healthcare in Madera. Rather, many residents face logistical challenges that don’t exist for Californians in the suburbs and cities, where a pharmacy or doctor’s office is a short drive or transit ride away.

“I think the tempting thing is to try to make global generalizations based on political or ideological blinds, but I think it's actually a lot more complicated than that in a place like this,” Webb said.

Even in counties reporting high teen vaccination rates, there are pockets where pediatricians are struggling to convince wary parents. Santa Clara County has vaccinated 75% of kids 12 to 17, according to CDPH. But at her practice in central San Jose, Dr. Amna Khan said most of her patients are on the fence.

Santa Clara Valley Medical Center sees mostly Medi-Cal patients, and many of Khan’s patients are recent immigrants. “In my patient population, they have a lot of reason to distrust the government and medicine in general,” Khan said. “It’s not a political statement. It’s distrust from things they’ve heard from their family or church or neighbors.”

Often, these conversations are a “difficult dance” that Khan must navigate with cultural sensitivity and help from translators. Sometimes, she faces the minefield of parent-teen conflict, with arguments breaking out in the exam room between kids who want the vaccine and parents who refuse.

No matter where parents are raising their kids, pediatricians said, the common factor driving their decision to vaccinate — or not — is concern about their child’s safety.

Parents lining up to vaccinate their children are worried about the threat of covid. Parents hesitant about the shot are worried about possible side effects of the vaccine. Somewhere in the middle are parents unsure what to think because of the conflicting information they have gotten from social media or friends.

Even among parents who have unquestioningly vaccinated their children for other diseases, the choice on covid isn’t an obvious one.

“Parents are now saying, ‘You know what? I don't think this is right for my kid. I don't think I'm going to make this decision, or at the very least I'm going to wait at least six months, maybe a year or maybe longer before I even consider this for my child,’” said Jessica Calarco, a professor of sociology at Indiana University who has been monitoring a group of moms in Indiana throughout the pandemic.

“They'll say, ‘You know what, my kid wears masks. We wash our hands. We are responsible with play dates. And so, the vaccine just isn't necessary because we're doing enough, and my kid is healthy enough that they will probably be fine.’”

Doctors and public health officials say they find themselves regularly explaining to parents that covid is indeed harming kids.

“There have been more than 35 pediatric deaths in California alone, and this is more deaths than we see with flu,” Dr. Erica Pan, California’s state epidemiologist, told reporters last week. “This simply is not an acceptable number of child deaths when such effective and safe prevention is available.”

Covid has triggered multisystem inflammatory syndrome in children, a potentially life-threatening condition in which the immune system attacks the body and impedes organ function, in more than 660 California kids since March 2020, Pan said. Six have died.

California is slated to have more than 1.2 million doses of the weaker version of the vaccine for kids 5 to 11 the first week the vaccine is approved for emergency use, Pan said. Pediatricians will be crucial to the state’s efforts to vaccinate kids, along with clinics at school sites and door-to-door campaigns by community leaders.

In Yuba City, pediatrician Dr. Mark Sawyer tells patients, “If you want to stop hearing about covid on the radio and stop hearing about lockdowns and everything, then this is it, this is the way. Just get vaccinated.”

Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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stephenmccull · 4 years ago

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Labs With No One to Run Them: Why Public Health Workers Are Fleeing the Field

There were days, nights and weekends in the early months of the pandemic when Denise Von Bargen was the only person running covid tests at the public health lab in Ventura County. She once had eight or nine employees to assist her, but, one by one, they had all retired or left for other jobs.

Like other public health laboratories in California charged with broad-scale disease testing and surveillance, the Ventura lab received federal and state money for new equipment and short-term hires to bolster its response to covid-19. But the funding was temporary, and Von Bargen, the director, could not use it to increase the salaries of her employees, who could earn more money doing less work in the private sector.

Operations deteriorated further last month, after the lab lost its license to run routine tests that check the county’s ocean water for deadly bacteria. It appears to have been a clerical error: The licensing paperwork changed, and the staff typically responsible for submitting the application had quit.

“The biggest threat to [public health labs] right now is not the next emerging pathogen,” said Donna Ferguson, director of the public health lab in Monterey County, “but labs closing due to lack of staffing.”

Across California, public health departments are losing experienced staffers to retirement, exhaustion, partisan politics and higher-paying jobs. Even before the coronavirus pandemic throttled departments, staffing numbers had shrunk with county budgets. But the decline has accelerated over the past year and a half, even as millions of dollars in federal money has poured in. Public health nurses, microbiologists, epidemiologists, health officers and other staff members who fend off infectious diseases like tuberculosis and HIV, inspect restaurants and work to keep communities healthy are abandoning the field. It’s a problem that temporary boosts in funding can’t fix.

The brain drain is sapping community health oversight in ways big and small. The people who staff public health labs, for example, run complex tests for deadly diseases that require specialized training most commercial labs lack. While their work is largely unseen by the public, they touch almost every aspect of society. Public health labs sample shellfish to make sure it is safe for eating. They monitor drinking water and develop tests for emerging health threats such as antibiotic-resistant viruses. They also test for serious diseases, such as measles and covid. And they typically do it at a fraction of the cost of commercial labs — and faster.

Public lab directors are typically required to hold doctorates, and they must have appropriate credentials for their labs to be certified.

Ferguson said it feels like there’s a revolving door on her lab, as recent college graduates join for a few months to gain experience, at a starting pay of $19 an hour, and then move on to higher-paying jobs at hospitals. It’s all but impossible to hire qualified staffers for part-time roles, like the ones created with temporary bursts in funding, because of the training required. In California, many lab positions require a public health microbiologist certificate from the Department of Public Health.

California has 29 public health labs, down from nearly 40 before the 2008 recession. A lab in Merced has been without a director for months and could soon close. While there’s no official count of how much the field has shrunk, nearly every lab is missing key staff members, said Godfred Masinde, who is president of the California Association of Public Health Laboratory Directors, lab director for San Francisco and filling in as lab director in Fresno County. Dozens of public health microbiologist positions are unfilled around the state.

“We have funding now; we have equipment,” Masinde said. “But we don’t have the staff to run the equipment.”

His San Francisco lab typically runs 100,000 tests for gonorrhea and chlamydia each year, and 150 to 200 tests for syphilis every day, Masinde said. While California also has state-run labs, he noted, they simply don’t have the capacity to pick up the slack for shuttered county labs.

Counties are struggling to recruit and retain staffers for other positions as well. An informal survey conducted by the California Directors of Public Health Nursing found that at least 84 public health nurses have left their jobs since March 2020. Many retired, part of a graying workforce challenged with recruiting nurses into an obscure field requiring special accreditation.

Public health nurses are trained in nursing and community health, and often work with families, or community groups, not just individual clients. They do home visits after births, work on early childhood development and help respond to outbreaks of infectious disease. “So providing more of a holistic approach, and also addressing the social determinants of health,” said Michelle Curioso, public health nursing director for Kern County and president of the California Directors of Public Health Nursing. Like lab staffers, public health nurses must be specially certified to work in public health departments.

In California, the average annual salary for a registered nurse is more than $120,000, according to the Bureau of Labor and Statistics, while public health nurse job postings in several counties offer salaries starting around $65,000.

Nursing shortages have been particularly severe in rural California. In Butte County, several public health nurses retired earlier than expected, said Monica Soderstrom, Butte’s director of public health nursing, and two young nurses who went on pregnancy leave decided not to return after finding jobs with higher wages. “It has been difficult to fill our vacant positions,” said Soderstrom, “as we are competing with hospitals and clinics paying sign-on bonuses due to covid staffing needs.”

The loss of top county health leaders — department directors and health officers charged with leading the pandemic response in local communities — has been particularly stark, mirroring a sobering national trend. Seventeen of California’s 58 counties have lost their health officer since March 2020, and at least 27 have lost a director or assistant director. The director and deputy director of the state Department of Public Health also resigned.

The collective expertise lost with those departures is hard to overstate.

Take, for example, Dr. Robert Bernstein, who moved to California in 2018 to become health officer for rural Tuolumne County after more than two decades working in public health for the federal Centers for Disease Control and Prevention, the World Health Organization and the Florida Department of Health, among other organizations. In California, health officers must be physicians, and are charged with enforcing state and local statutes and protecting the public from health hazards.

In March 2020, just as the pandemic was making its first surge across the state, Bernstein was asked to resign by the county board of supervisors. According to Bernstein, supervisors were upset that he had ordered rabies vaccines for two children bitten by bats — including a bat that tested positive for rabies — against their parents’ wishes. The county declined to comment on the matter, saying it is legally prohibited from discussing personnel matters.

Bernstein moved to Butte County and became health officer after his predecessor resigned in May 2020. Bernstein watched as colleagues in neighboring counties, facing menacing public threats over covid-related health orders, began quitting, seemingly one after the next. In some communities, public health officers also faced rude and derisive pushback from local elected officials, even as law enforcement leaders openly refused to carry out their health directives.

“You might, as a public health officer, have the authority and responsibility to recommend or even mandate certain public health actions,” Bernstein said, “but you need a partnership with those in authority to carry [them] out.”

By September this year, Bernstein was disillusioned with the dynamic and the notion that his family could get caught up in the covid rancor. “I just decided that as a dad of 16-year-old triplets, I don’t need me or the kids to be threatened in any way, and I can do good public health work at the state level or federal level or even international level,” Bernstein said.

Michelle Gibbons, executive director of the County Health Executives Association of California, said local departments are seeing the cascading effects of those top-level defections, with midlevel managers hesitant to move into senior positions, even though top officials can command salaries of more than $200,000.

The state budget this year included $3 million for an assessment of California’s public health infrastructure, and public health leaders believe it will show that staffing and training are major issues. Still, the budget did not include additional long-term funding for health departments. Amid negative headlines and a lobbying blitz, Gov. Gavin Newsom eventually agreed to add $300 million a year for public health, a handshake deal not scheduled to begin until July.

Advocates warn that the timing matters: Many public health workers are hanging on to see their communities through the pandemic and will leave once it ebbs. “We’re going to see a huge wave of retirements when this is over,” said Kat DeBurgh, executive director of the Health Officers Association of California.

In Ventura County, Von Bargen, exhausted by the pandemic, has been trying to retire for a year. She didn’t want to abandon the lab she fought so hard to keep open, and it took that long to find a replacement. Her successor will start early next year, at which point Von Bargen, too, will join the ranks of former public health employees.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

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What Do We Really Know About Vaccine Effectiveness?

The politicization of covid vaccines — and, well, just about everything else having to do with the pandemic — has led to confusion, if not utter fatigue.

And some posts circulating on social media — this slickly edited piece on YouTube, for example — seem to build on these feelings, attempting to cast doubt on the effectiveness of the vaccines. This one intersperses comments from White House medical adviser Dr. Anthony Fauci extolling their protectiveness with screenshots of news headlines, starting with those citing 100% effectiveness, then moving through others reporting sharply lower percentages. Set to the rapidly increasing tempo of the orchestral piece “In the Hall of the Mountain King,” the video ends with headlines about drug company profits.

But slowing the video to parse the headlines reveals more complexity. Some are reporting on studies that looked only at infection rates; others, more serious outcomes, including hospitalization and death. Some are about vaccines not offered in the U.S.

In short, the video fosters misperceptions by mixing together dissimilar data points and leaving out key details.

Still, one can’t help but wonder what’s really going on with effectiveness — and is any of it a surprise?

If you don’t read any further, know this: No vaccine is 100% effective against any disease. The covid shots are no exception. Effectiveness in preventing infection — defined as a positive test result — appears in some studies to wane sharply the more time that goes by after completing the one- or two-shot regimen. But on key measures — prevention of serious illness, hospitalization and death — real-world studies from the U.S. and abroad generally show protection weakening slightly, particularly in older or sicker people, but remaining strong overall, even with the rise of the more infectious delta variant of the covid virus.

The bottom line? Getting vaccinated with any of the three vaccines available in the U.S. reduces the chance of getting infected in the first place, and significantly cuts the risk of hospitalization or death if you do contract covid-19. The Centers for Disease Control and Prevention recently published a study showing fully vaccinated people were more than 10 times less likely to die or be hospitalized than the unvaccinated.

“When it comes to what matters, vaccines hold up really well,” said Dr. Amesh Adalja, an infectious-disease physician and senior scholar at the Johns Hopkins Center for Health Security. “They were designed to tame the virus.”

So, what do “efficacy” and “effectiveness” mean, anyway?

Before a drug or vaccine is greenlighted by federal regulators, it is tested on volunteers randomly assigned to get either the product or a placebo. Then researchers compare how the groups fare. In the case of a vaccine, they look at how well it prevents infection, and whether it protects against serious illness, hospitalization or death. Those clinical trial results are often referred to as efficacy measures.

In the real world, however, a drug or vaccine’s performance is affected by numerous factors, including a much larger population receiving it, some of whom have underlying conditions or socioeconomic circumstances different from those in the clinical trial. That real-world performance measure is called effectiveness.

When authorized for emergency use following clinical trials, both the Pfizer-BioNTech and Moderna two-dose vaccines reported efficacy against symptomatic illness in the mid-90% range. The Johnson & Johnson single-dose shot — which was tested later, when there were more variants — reported overall efficacy in the high 60% range. Those numbers exceeded the 50% threshold health officials sought as a minimum for covid vaccine efficacy. Keep in mind, also, that the annual influenza vaccine’s real-world effectiveness is often 40% to 50%.

Another point: 95% effectiveness doesn’t mean 95% of vaccinated people will never get infected. What it means is that a fully vaccinated person exposed to the virus faces only 5% of the risk of infection compared with an unvaccinated person.

Have the effectiveness numbers changed?

Yes, decline in effectiveness against infection is seen in some studies. A few have also raised concerns that protection against serious illness may also be diminished, particularly in older people and patients with underlying medical conditions.

Reasons for the decline vary.

First, when the vaccines were authorized, much of the U.S. was under tighter pandemic-related stay-at-home rules. Nearly a year later, restrictions — including mask rules — have loosened in many areas. More people are traveling and going into situations they would have avoided a year ago. So, exposure to the virus is higher.

Some studies from the U.S. and abroad show that time elapsed since vaccination also plays a role.

The Lancet recently published a study of more than 3.4 million Kaiser Permanente members, both vaccinated and not, reviewing the effectiveness of the Pfizer vaccine. It showed an overall average 73% effectiveness against infection during the six months after inoculations, and an overall 90% effectiveness against hospitalization.

But protection against infection declined from 88% in the month after full vaccination to 47% at five to six months. Time since vaccination played a larger role than any changes in the virus itself, the researchers concluded.

“It shows vaccines are highly effective over time against severe outcomes,” said report lead author Sara Tartof, an epidemiologist with the Department of Research and Evaluation for Kaiser Permanente Southern California. “Against infection, it does decline over time, something that is not unexpected. We have boosters for many other vaccines.”

The virus, too, has mutated.

“Along came delta,” said Dr. William Schaffner, a professor of preventive medicine at Vanderbilt University School of Medicine. “Because this virus was so highly contagious, it changed the outcomes slightly.”

And some vaccinated people can fall seriously ill with covid, or even die, especially if they have an underlying medical problem, as was the case with Gen. Colin Powell. He died of covid complications even though he was fully vaccinated — likely because he also had a blood cancer called multiple myeloma, which can lower the body’s response to an invading virus as well as to vaccination.

What should we make of these changing numbers and the recent authorization of booster shots?

Most scientists, researchers and physicians say the vaccines are working remarkably well, especially at preventing serious illness or death.

And it’s not unusual to need more than one dose.

Vaccines for shingles and measles both require two shots, while people need to be revaccinated against tetanus every 10 years. Because influenza varies each year, flu shots are annual.

Immune response is often better when vaccines are spaced apart by a few months. But during the rollout of the covid vaccines, so many people were falling ill and dying of covid each day that the Food and Drug Administration and CDC decided not to delay, but to authorize the first and second doses within about a month of each other.

“We learn as we go along,” said Schaffner. “It was always anticipated there might have to be follow-up doses.”

Now, the recommendations call for a second dose for anyone who received a J&J shot at least two months prior. For those who received the two-dose Pfizer or Moderna vaccine, the recommendation is to wait six months after the second dose to get a booster, which is currently recommended for those who are 65 and older; have any of a variety of underlying health conditions; live in congregate settings, such as nursing homes; or have jobs that put them at higher risk. The booster recommendations may expand in the coming months.

Source list:

Centers for Disease Control and Prevention, “Monitoring Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Status — 13 U.S. Jurisdictions, April 4-July 17, 2021,”Sept. 17, 2021

Food and Drug Administration, “FDA Takes Key Action in Fight Against COVID-19 by Issuing Emergency Use Authorization for First COVID-19 Vaccine,” Dec. 11, 2020

Yahoo Finance, “Moderna COVID-19 Vaccine Recommended for Authorization by FDA Advisory Panel,” Dec. 17, 2020

CNBC, “Johnson & Johnson Requests Emergency Authorization From FDA for Covid Vaccine,” Feb. 4, 2021

Centers for Disease Control and Prevention, “CDCSeasonal Flu Vaccine Effectiveness Studies,” accessed Oct. 26, 2021

The Lancet, “Effectiveness of mRNA BNT162b2 COVID-19 Vaccine up to 6 Months in a Large Integrated Healthy System in the USA: A Retrospective Cohort Study,” Oct. 4, 2021

Phone interview with Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, Oct. 22, 2021

Phone interview with Sara Tartof, epidemiologist, the Department of Research and Evaluation at Kaiser Permanente Southern California, Oct. 25, 2021

Phone interview with Dr. William Schaffner, professor of preventive medicine at Vanderbilt University, Oct. 21, 2021

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‘An Arm and a Leg’: Need Surgery to Save Your Life? Tips for Getting Insurance to Pay

Can’t see the audio player? Click here to listen.

Laurie Todd calls herself the “Insurance Warrior.” She helps people get their health insurance companies to pay for treatment and has written books sharing her knowledge.

Hers is a wealth of knowledge that was hard-won. In 2005, Todd was diagnosed with a rare form of cancer. Although she found a doctor who could treat it, her health insurance said it wouldn’t be covered. But Todd didn’t accept that refusal and got her insurance company to pay for a lifesaving surgery.

Over the next 15 years, Todd honed her insurance-slaying powers. She has fought — and won — more than 200 insurance appeals on behalf of patients, she said.

Listen to the episode to hear some of her time-tested strategies.

Here’s a transcript of the episode.

“An Arm and a Leg” is a co-production of KHN and Public Road Productions.

To keep in touch with “An Arm and a Leg,” subscribe to the newsletter. You can also follow the show on Facebook and Twitter. And if you’ve got stories to tell about the health care system, the producers would love to hear from you.

To hear all KHN podcasts, click here.

And subscribe to “An Arm and a Leg” on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

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High Court Hears Cases on Novel Texas Law, but Outcome May Not Affect Abortion Access

The Supreme Court, whose conservative majority is considered poised to overturn decades-old decisions guaranteeing abortion rights, heard its first two abortion cases of the 2021-22 term Monday. But the court could decide this case without deciding the fate of abortion rights in America.

At stake is the future of a Texas law, which severely limits the procedure, that the high court refused to block from taking effect in September. The state law has cut the number of abortions in the state by half.

The Texas law — known as SB 8 — is similar to laws passed by several states over the past few years in that it bans abortion after fetal cardiac activity can be detected, which typically occurs about six weeks into pregnancy. That is in direct contravention of Supreme Court precedents in 1973’s Roe v. Wade and 1992’s Planned Parenthood of Southeastern Pennsylvania v. Casey, which say states cannot ban abortion until fetal “viability,” which is about 22 to 24 weeks. The law also makes no exception for pregnancies caused by rape or incest.

The Texas law, however, varies from other state “heartbeat” laws because it has a unique enforcement mechanism that gives state officials no role in ensuring that the ban is obeyed. Rather, it leaves enforcement to the general public, by authorizing civil suits against not just anyone who performs an abortion, but anyone who “aids and abets” the performance of an abortion, which could include those who drive patients to an abortion clinic or counsel them. Those who bring suits and win would be guaranteed damages of at least $10,000. Opponents of the law call that a “bounty” to encourage individuals to sue their neighbors.

Supporters of the law have said it was specifically designed to prevent federal courts from blocking the law since no state officials are involved in enforcement and therefore not responsible for it.

It is that enforcement mechanism that the Supreme Court considered during three hours of arguments Monday. The first case, Whole Woman’s Health et al. v. Jackson et al., was brought by a group of abortion providers, the second, U.S. v. Texas et al., by the Justice Department. The question before the justices was not directly whether the Texas ban is unconstitutional, but whether either the abortion providers or the federal government can challenge it in court.

Marc Hearron of the Center for Reproductive Rights, who represented the abortion providers, said the Texas law, if upheld, could influence far more than abortion. “To allow the Texas scheme to stand would provide a road map for other states to abrogate any decision of this court with which they disagree,” he told the justices.

U.S. Solicitor General Elizabeth Prelogar, in her first appearance before the court in that role, expressed similar sentiments, calling the Texas law “a brazen attack” on the other branches of government. States, she said, “are not free to place themselves above this court, nullify the court’s decisions and their borders, and block the judicial review necessary to vindicate federal rights.”

But Texas Solicitor General Judd Stone insisted that neither case should be allowed to proceed and that any legal actions should be handled by state courts. What both sets of plaintiffs want, he said “is an injunction against the law itself. But federal courts don’t enjoin state laws, they enjoin officials.” And because of the unique way the law was crafted, Texas officials are not involved in the law’s enforcement.

At least a few members of the court’s conservative majority, notably Justices Amy Coney Barrett and Brett Kavanaugh, seemed at least somewhat dubious about whether Texas could evade all federal court review and what that could mean for issues other than abortion. Several justices cited a “friend of the court” brief filed by a gun rights group that sided with the abortion providers, not because it agreed with the position on abortion, but because the group wrote “that the judicial review of restrictions on established constitutional rights, especially those protected under this Court’s cases, cannot be circumvented in the manner used by Texas.”

That was a point made repeatedly by the liberal-leaning justices, who have made it clear they oppose the Texas law. “Essentially, we would be inviting states, all 50 of them, with respect to their un-preferred constitutional rights, to try to nullify the law … that this Court has laid down as to the content of those rights,” said Justice Elena Kagan. “I mean, that was something that until this law came along no state dreamed of doing.”

The court has already demonstrated its division over the law when it voted 5-4 in September to allow it to take effect. Barrett and Kavanaugh were among the majority in that vote. The court also refused to block the law when it accepted the current case 10 days ago.

Typically, in major cases like this, decisions come at the end of the court term, which would be next spring or summer. However, this case was considered on the court’s “rocket docket,” in the fastest consideration of a case since the justices decided who should become president in 2000’s Bush v. Gore.

Another complication is that the court is scheduled to hear arguments next month in a separate Mississippi case in which they will consider the future of abortion rights. That case, Dobbs v. Jackson Women’s Health Organization, challenges a law that seeks to ban abortions after 15 weeks of gestation. The court has agreed in that case to consider whether states can ban abortion prior to viability.

The Texas case could be decided before the Mississippi case is heard, or after, or the cases could be decided together.

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Zeit lands $2M for stroke, seizure detecting headband system

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AI startup RwHealth lands €7.2M in Series A round

The funding will help clinicians manage elective recovery backlogs in the NHS. AI startup RwHealth lands €7.2M in Series A round published first on https://smartdrinkingweb.weebly.com/

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Study: Apps could improve communication between providers, pregnant patients

The study found only 46% of patients eligible for prophylactic low-dose aspirin due to high-risk factors for preeclampsia had gotten a provider recommendation by 16 weeks gestation. Study: Apps could improve communication between providers, pregnant patients published first on https://smartdrinkingweb.weebly.com/

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Why Jonathan Bush thinks digital will upend primary care

Bush discusses his new company Zus and what tech-first providers need right now. Why Jonathan Bush thinks digital will upend primary care published first on https://smartdrinkingweb.weebly.com/

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Balanced is catering to seniors with its new fitness platform

Balanced CEO Katie Reed said general virtual fitness platforms may not take seniors’ needs into account, and options geared toward older adults can be too clinical. Balanced is catering to seniors with its new fitness platform published first on https://smartdrinkingweb.weebly.com/

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California Law Aims to Strengthen Access to Mental Health Services

The number of people with symptoms of depression and anxiety has nearly quadrupled during the covid pandemic, which has made it even more maddeningly difficult to get timely mental health care, even if you have good insurance.

A California law signed Oct. 8 by Gov. Gavin Newsom could help. It requires that mental health and substance abuse patients be offered return appointments no more than 10 days after a previous session, unless their provider OKs less frequent visits.

Current insurance regulations already require giving patients an initial mental health visit no more than 10 days after they request it. But there’s been nothing on the books specifically about follow-up care until now.

The law doesn’t take effect until July, which lawmakers said will give health plans time to comply — mainly by hiring or contracting with more therapists. Proponents say that, with effective enforcement, the new law will help a lot of people get the care they need.

The law, SB 221, “will ensure that people can actually use their insurance to get mental health treatment,” says Sen. Scott Wiener (D-San Francisco), the law’s author. “For far too long, health plans have frequently made people wait long periods of time to get mental health appointments, which undermines their care.”

If you are not getting the care you need, there are already ways you can seek redress. When the law takes effect in eight months, it will strengthen your hand. More on that in a moment.

There are two competing explanations for why it’s so hard to get consistent mental health care. Insurers say there’s a shortage of therapists. Therapists say insurers are too cheap to pay them adequately. Many therapists decline to join insurance networks and set their own fees, which a lot of people can’t afford.

The National Union of Healthcare Workers, which sponsored the legislation, has been particularly critical of Kaiser Permanente, the state’s largest commercial health insurer, for its well-publicized mental health care deficiencies.

Kaiser Permanente, with over 9 million members in California, was fined $4 million by state regulators in 2013 for failure to provide timely mental health care. It was cited twice after that for failure to resolve the problems.

Former and current KP therapists say the managed-care giant has addressed the complaint by trying to ensure that members seeking mental health treatment get an initial appointment quickly. But that has only made it harder for those patients to get subsequent sessions, the therapists say.

“Any available appointment would be given to a person needing to initiate services,” says Susan Whitney, a marriage and family therapist who worked for Kaiser Permanente in Bakersfield for 18 years before leaving the organization in September. “Our schedules would be fully booked for six to eight weeks — so follow-up appointments were difficult to make, to say the least.”

The American Psychological Association recommends weekly therapy for people with depression and twice weekly for post-traumatic stress disorder. In a letter to California’s Department of Managed Health Care last year, the association said the long waits for follow-up care reported by KP patients and therapists “fall far below what is appropriate care for most patients.”

Because of the shortage of available therapists, Kaiser Permanente often refers its members to an outside network of providers for mental health treatment. But members, therapists and public officials say those networks often fail to deliver.

Maya Polon, a KP member in Sacramento, began feeling emotionally frayed in March, after caring for her terminally ill grandmother. She tried to get help through Kaiser but had to make numerous calls and kept getting conflicting information about how to get care.

Finally, after more than a month, a Kaiser Permanente therapist told Polon, 27, that her depression, anxiety and panic attacks qualified her for a year of therapy. But if she wanted to do it through Kaiser, it would take six months to get her first appointment.

KP referred her to an outside mental health contractor, Beacon Health Options, which took two weeks to send her a list of therapists. She called all 20 providers on the list, during breaks in her workday, and left messages.

“As someone with anxiety and who suffers from depression, having to actively sit down and call people who are over and over again telling you, ‘Oh, I’m not actually taking new patients,’ is an overwhelmingly defeating process,” Polon says. “I walked away from that thinking, ‘Do I even want to do therapy if this is what I am going to have to go through to even get there?’”

She ended up seeing the one therapist who had space for her, but she wasn’t contracted with Beacon. Polon had to wrangle with Kaiser Permanente for months over the paperwork.

In June, San Diego’s city attorney, Mara Elliott, sued Kaiser over what she termed “ghost networks” that “falsely describe the breadth of an insurer’s provider network, promising consumers access to health care that in reality is unavailable under the plan.” Elliott sued Molina Healthcare and Health Net on similar grounds.

Dr. Yener Balan, vice president of behavioral health and specialty services at Kaiser Permanente in Northern California, says the organization could do better, but claims that it meets the follow-up appointment recommendations of its mental health clinicians 84% of the time — a figure hotly contested by union officials and therapists.

Balan says SB 221’s July implementation date is helpful, “given the shortage of mental health clinicians faced by all health care organizations.”

Critics of the health insurance industry question whether a shortage of therapists is the main problem. Wiener says health plans aren’t paying mental health practitioners enough to join their networks.

A 2019 report by the California Future Health Workforce Commission projected that within a decade there would be 41% fewer psychiatrists than needed and 11% fewer psychologists, marriage and family therapists, and other mental health workers.

But a report the same year by the state Legislative Analyst’s Office said the number of graduates of mental health programs had grown significantly — although there was, it reported, a shortage of psychiatrists.

The Department of Managed Health Care, which regulates health plans covering a large majority of Californians, will monitor compliance with the new law and investigate consumer complaints, says Rachel Arrezola, an agency spokesperson.

What You Can Do

If you believe your health plan is shortchanging you on mental health treatment, you don’t have to wait for the new law. You can challenge your insurer under existing regulations. Once the law takes effect, however, it will offer additional ballast for any challenges and allow regulators to pursue health plans for violations.

To contest a lack of coverage, you must first appeal directly to your health plan. If you are in a private plan, you must file the appeal within six months of care being denied. The insurer must decide on your appeal within 30 days.

If you don’t get a satisfactory decision, take your case to the agency that regulates your insurer for an independent review. And if there’s an urgent health risk, you don’t need to wait 30 days. Contact your regulator immediately.

To find out what agency that is, call the customer service line of your health plan. If it is the Department of Managed Health Care, you can request an independent review by calling 888-466-2219 or logging on to HealthHelp.ca.gov. If your regulator is the California Department of Insurance, call 800-927-4357.

If you are in managed-care Medi-Cal and your plan is regulated by the Department of Managed Health Care, you can ask that department for an independent review. You can also seek a “fair hearing” through the state, as can any Medi-Cal beneficiary, by going online or calling 855-795-0634.

Of course, all this takes time and effort. But if the delay is making it impossible for you to get treatment, it may be worth it.

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Nursing Home Residents Overlooked in Scramble for Covid Antibody Treatments

Of the dozens of patients Dr. Jim Yates has treated for covid-19 at his long-term care center in rural Alabama, this one made him especially nervous.

The 60-year-old man, who had been fully vaccinated, was diagnosed with a breakthrough infection in late September. Almost immediately, he required supplemental oxygen, and lung exams showed ominous signs of worsening disease. Yates, who is medical director of Jacksonville Health and Rehabilitation, a skilled nursing facility 75 miles northeast of Birmingham, knew his patient needed more powerful interventions — and fast.

At the first sign of the man’s symptoms, Yates had placed an order with the Alabama Department of Public Health for monoclonal antibodies, the lab-made proteins that mimic the body’s ability to fight the virus. But six days passed before the vials arrived, nearly missing the window in which the therapy works best to prevent hospitalization and death.

“We’ve been pushing the limits because of the time frame you have to go through,” Yates said. “Fortunately, once we got it, he responded.”

Across the country, medical directors of skilled nursing and long-term care sites say they’ve been scrambling to obtain doses of the potent antibody therapies following a change in federal policy that critics say limits supplies for the vulnerable population of frail and elder residents who remain at highest risk of covid infection even after vaccination.

“There are people dying in nursing homes right now, and we don’t know whether or not they could have been saved, but they didn’t have access to the product,” said Chad Worz, CEO of the American Society of Consultant Pharmacists, which represents 1,500 pharmacies that serve long-term care sites.

Before mid-September, doctors and other providers could order the antibody treatments directly through drug wholesaler AmerisourceBergen and receive the doses within 24 to 48 hours. While early versions of the authorized treatments required hourlong infusions administered at specialty centers or by trained staff members, a more recent approach allows doses to be administered via injections, which have been rapidly adopted by drive-thru clinics and nursing homes.

Prompt access to the antibody therapies is essential because they work by rapidly reducing the amount of the virus in a person’s system, lowering the chances of serious disease. The therapies are authorized for infected people who’ve had symptoms for no more than 10 days, but many doctors say they’ve had best results treating patients by Day 5 and no later than Day 7.

After a slow rollout earlier in the year, use of monoclonal antibody treatments exploded this summer as the delta variant surged, particularly in Southern states with low covid vaccination rates whose leaders were looking for alternative — albeit costlier — remedies.

By early September, orders from seven states — Alabama, Florida, Georgia, Louisiana, Mississippi, Tennessee and Texas — accounted for 70% of total shipments of monoclonals.

Those Southern states, plus three others — Arkansas, Kentucky and North Carolina — ordered new courses of treatment even faster than they used their supplies. From July 28 to Sept. 8, they collectively increased their antibody stockpiles by 134%, according to a KHN analysis of federal data.

Concerned the pattern was both uncontrolled and unsustainable given limited national supplies, officials with the Department of Health and Human Services stepped in to equalize distribution. HHS barred individual sites from placing direct orders for the monoclonals. Instead, they took over distribution, basing allocation on case rates and hospitalizations and centralizing the process through state health departments.

“It was absolutely necessary to make this change to ensure a consistent product for all areas of the country,” Dr. Meredith Chuk, who is leading the allocation, distribution and administration team at HHS, said during a conference call.

But states have been sending most doses of the monoclonal antibody treatments, known as mAbs, to hospitals and acute care centers, sidestepping the pharmacies that serve long-term care sites and depleting supplies for the most vulnerable patients, said Christopher Laxton, executive director of AMDA, the Society for Post-Acute and Long-Term Care Medicine.

While vaccination might provide 90% protection or higher against serious covid in younger, healthier people, that’s not the case for the elders who typically live in nursing homes.

“You have to think of the spectrum of immunity,” Laxton said. “For our residents, it’s closer to 60%. You know that 4 out of 10 are going to have breakthrough infections.”

The mAb treatments have been authorized for use in high-risk patients exposed to the virus, and experts in elder care say that is key to best practices in preventing outbreaks in senior facilities. That could include, for example, treating the elderly roommate of an infected nursing home patient. But because of newly limited supplies, many long-term care sites have started to restrict use to only those who are infected.

Still, some states have worked to ensure access to mAbs in long-term care sites. Minnesota health officials rely on a policy that prioritizes residents of skilled nursing facilities for the antibody therapies through a weighted lottery. In Michigan, state Medical Director Dr. William Fales directed emergency medical technicians and paramedics to the Ascension Borgess Hospital system in Kalamazoo to help administer doses during recent outbreaks at two centers.

“The monoclonal antibodies made a huge difference,” said Renee Birchmeier, a nurse practitioner who cares for patients in nine of the system’s sites. “Even the patients in the assisted living with COPD, they’re doing OK,” she said, referring to chronic obstructive pulmonary disease. “They’re not advancing, but they’re doing OK. And they’re alive.”

Long-term care sites have accounted for a fraction of the orders for the monoclonal treatments, first authorized in November 2020. About 3.2 million doses have been distributed to date, with about 52% already used, according to HHS. Only about 13,500 doses have gone to nursing homes this year, according to federal data. That doesn’t include other long-term care sites such as assisted living centers.

The use is low in part because the treatments were originally delivered only through IV infusions. But in June, the Regeneron monoclonal antibody treatment was authorized for use via subcutaneous injections — four separate shots, given in the same sitting — and demand surged.

Use in nursing homes rose to more than 3,200 doses in August and nearly 6,700 in September, federal data shows. But weekly usage dropped sharply from mid-September through early October after the HHS policy change.

Nursing homes and other long-term care sites were seemingly left behind in the new allocation system, said Cristina Crawford, a spokesperson for the American Health Care Association, a nonprofit trade group representing long-term care operators. “We need federal and state public health officials to readjust their priorities and focus on our seniors,” she said.

In an Oct. 20 letter to White House policy adviser Amy Chang, advocates for long-term care pharmacists and providers called for a coordinated federal approach to ensure access to the treatments. Such a plan might reserve use of a certain type or formulation of the product for direct order and use in long-term care settings, said Worz, of the pharmacy group.

So far, neither the HHS nor the White House has responded to the letter, Worz said. Cicely Waters, a spokesperson for HHS, said the agency continues to work with state health departments and other organizations “to help get covid-19 monoclonal antibody products to the areas that need it most.” But she didn’t address whether HHS is considering a specific solution for long-term care sites.

Demand for monoclonal antibody treatments has eased as cases of covid have declined across the U.S. For the week ending Oct. 27, an average of nearly 72,000 daily cases were reported, a decline of about 20% from two weeks prior. Still, there were 2,669 confirmed cases among nursing home residents the week ending Oct. 24, and 392 deaths, according to the Centers for Disease Control and Prevention.

At least some of those deaths might have been prevented with timely monoclonal antibody therapy, Worz said.

Resolving the access issue will be key to managing outbreaks as the nation wades into another holiday season, said Dr. Rayvelle Stallings, corporate medical officer at PruittHealth, which serves 24,000 patients in 180 locations in the Southeast.

PruittHealth pharmacies have a dozen to two dozen doses of monoclonal antibody treatments in stock, just enough to handle expected breakthrough cases, she said.

“But it’s definitely not enough if we were to have a significant outbreak this winter,” she said. “We would need 40 to 50 doses. If we saw the same or similar surge as we saw in August and September? We would not have enough.”

Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

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