Kaiser Health News – Baltimore Sun https://www.baltimoresun.com Baltimore Sun: Your source for Baltimore breaking news, sports, business, entertainment, weather and traffic Mon, 09 Sep 2024 20:27:58 +0000 en-US hourly 30 https://wordpress.org/?v=6.6.1 https://www.baltimoresun.com/wp-content/uploads/2023/11/baltimore-sun-favicon.png?w=32 Kaiser Health News – Baltimore Sun https://www.baltimoresun.com 32 32 208788401 Patients suffer when Indian Health Service doesn’t pay for outside care https://www.baltimoresun.com/2024/09/09/patients-suffer-when-indian-health-service-doesnt-pay-for-outside-care/ Mon, 09 Sep 2024 20:26:30 +0000 https://www.baltimoresun.com/?p=10576044&preview=true&preview_id=10576044 By Arielle Zionts and Katheryn Houghton | KFF Health News

When the Indian Health Service can’t provide medical care to Native Americans, the federal agency can refer them elsewhere. But each year, it rejects tens of thousands of requests to fund those appointments, forcing patients to go without treatment or pay daunting medical bills out of their own pockets.

In theory, Native Americans are entitled to free health care when the Indian Health Service foots the bill at its facilities or sites managed by tribes. In reality, the agency is chronically underfunded and understaffed, leading to limited medical services and leaving vast swaths of the country without easy access to care.

Its Purchased/Referred Care program aims to fill gaps by paying outside providers for services patients might be unable to get through an agency-funded clinic or hospital, such as cancer treatment or pregnancy care. But resource shortages, complex rules, and administrative fumbles severely impede access to the referral program, according to patients, elected officials, and people who work with the agency.

The Indian Health Service, part of the Department of Health and Human Services, serves about 2.6 million Native Americans and Alaska Natives.

Native Americans qualify for the referred-care program if they live on tribal land — only 13% do — or within their nation’s “delivery area,” which usually includes surrounding counties. Those who live in another tribe’s delivery area are eligible in limited cases, while Native Americans who live beyond such borders are excluded.

Eligible patients aren’t guaranteed funding or timely help, however. Some of the Indian Health Service’s 170 service units exhaust their annual pool of money or reserve it for the most serious medical concerns.

Referred-care programs denied or deferred nearly $552 million in spending for about 120,000 requests from eligible patients in fiscal year 2022.

As a result, Native Americans might forgo care, increasing the risk of death or serious illness for people with preventable or treatable medical conditions.

The problem isn’t new. Federal watchdog agencies have reported concerns with the program for decades.

Connie Brushbreaker, a member of the Rosebud Sioux Tribe, has been denied or waitlisted for funding at least 14 times since 2018. She said it doesn’t make sense that the agency sometimes refuses to pay for treatment that will later be approved once a health problem becomes more serious and expensive.

“We try to do this preventative stuff before something gets to the point where you need surgery,” said Brushbreaker, who lives on her tribe’s reservation in South Dakota.

Many Native Americans say the U.S. government is violating its treaties with tribal nations, which often promised to provide for the health and welfare of tribes in return for their land.

“I keep having my elders here saying, ‘There’s treaty rights that say they’re supposed to be able to provide these services to us,’” said Lyle Rutherford, a council member for the Blackfeet Nation in northwestern Montana who said he also worked at the Indian Health Service for 11 years.

Native Americans have high rates of diseases compared with the general population, and a median age of death that’s 14 years younger than that of white people. Researchers who have studied the issue say many problems stem from colonization and government policies such as forcing Indigenous people into boarding schools and isolated reservations and making them give up healthy traditions, including bison hunting and religious ceremonies. They also cite an ongoing lack of health funding.

Congress budgeted nearly $7 billion for the Indian Health Service this year, of which roughly $1 billion is set aside for the referred-care program. A committee of tribal health and government leaders has long made funding recommendations that far exceed the agency’s budget. Its latest report says the Indian Health Service needs $63 billion to cover patients’ needs for fiscal year 2026, including $10 billion for referred care.

Brendan White, an agency spokesperson, said improving the referred-care program is a top goal of the Indian Health Service. He said about 83% of the health units it manages have been able to approve all eligible funding requests this year.

White said the agency recently improved how referred-care programs prioritize such requests and it is tackling staff shortages that can slow down the process. An estimated third of positions within the referred-care program were unfilled as of June, he said.

The Indian Health Service also recently expanded some delivery areas to include more people and is studying whether it can afford to create statewide eligibility in the Dakotas.

Jonni Kroll of the Little Shell Tribe of Chippewa Indians of Montana doesn’t qualify for the referred-care program because she lives in Deer Park, Washington, nearly 400 miles from her tribe’s headquarters.

She said tying eligibility to tribal lands echoes old government policies meant to keep Indigenous people in one place, even if it means less access to jobs, education, and health care.

Kroll, 58, said she sometimes worries about the medical costs of aging. Moving to qualify for the program is unrealistic.

“We have people that live all across the nation,” she said. “What do we do? Sell our homes, leave our families and our jobs?”

People applying for funding face a system so complicated that the Indian Health Service created flowcharts outlining the process.

Misty and Adam Heiden, of Mandan, North Dakota, experienced that firsthand. Their nearest Indian Health Service hospital no longer offers birthing services. So, late last year, Misty Heiden asked the referred-care program to pay for the delivery of their baby at an outside facility.

Heiden, 40, is a member of the Sisseton-Wahpeton Oyate, a South Dakota-based tribe, but lives within the Standing Rock Sioux Tribe’s delivery area. Native Americans who live in another tribe’s area, as she does, are eligible if they have close ties. Even though she is married to a Standing Rock tribal member, Heiden was deemed ineligible by hospital staff.

Now, the family has had to cut into its grocery budget to help pay off more than $1,000 in medical debt.

“It was kind of a slap in the face,” Adam Heiden said.

White, the Indian Health Service spokesperson, said many providers offer educational materials to help patients understand eligibility. But the Standing Rock rules, for example, aren’t fully explained in its brochure.

When patients are eligible, their needs are ranked using a medical priority list.

Connie Brushbreaker’s doctor at the Indian Health Service hospital in Rosebud, South Dakota, said she needed to see an orthopedic surgeon. But hospital staffers said the unit covers only patients at imminent risk of dying.

She said that, at one point, a worker at the referred-care program told her she could handle her pain, which was so intense she had to limit work duties and rely on her husband to put her hair in a ponytail.

“I feel like I am being tossed aside, like I do not matter,” Brushbreaker wrote in an appeal letter. “I am begging you to reconsider.”

The 55-year-old was eventually approved for funding and had surgery this July, two years after injuring her shoulder and four months after her referral.

Patients said they sometimes have trouble reaching referred-care departments due to staffing problems.

Patti Conica, a member of the Standing Rock Sioux Tribe, needed emergency care after developing a serious infection in June 2023. She said she applied for funding to cover the cost but has yet to receive a decision on her case despite repeated phone calls to referred-care staffers and in-person visits.

“I’ve been given the runaround,” said Conica, 58, who lives in Fort Yates, North Dakota, her tribe’s headquarters.

She now faces more than $1,500 in medical bills, some of which have been turned over to a collection agency.

Tyler Tordsen, a Republican state lawmaker and member of the Sisseton-Wahpeton Oyate in South Dakota, says the referred-care program needs more funding but officials could also do a “better job managing their finances.”

Some service units have large amounts of leftover funding. But it’s unclear how much of this money is unspent dollars versus earmarked for approved cases going through billing.

Meanwhile, more tribes are managing their health care facilities — an arrangement that still uses agency money — to try new ways to improve services.

Many also try to help patients receive outside care in other ways. That can include offering free transportation to appointments, arranging for specialists to visit reservations, or creating tribal health insurance programs.

For Brushbreaker, begging for funding “felt like I had to sell my soul to the IHS gods.”

“I’m just tired of fighting the system,” she said.

Have you had an experience navigating the Indian Health Service’s Purchased/Referred Care program that you’d like to share with KFF Health News for our reporting? Tell us here.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

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10576044 2024-09-09T16:26:30+00:00 2024-09-09T16:27:58+00:00
For pharma, Trump vs. Harris is a showdown between two industry foes https://www.baltimoresun.com/2024/08/27/for-pharma-trump-vs-harris-is-a-showdown-between-two-industry-foes/ Tue, 27 Aug 2024 19:10:57 +0000 https://www.baltimoresun.com/?p=10273143&preview=true&preview_id=10273143 Former President Donald Trump and Vice President Kamala Harris have a rare point of agreement in their otherwise bitter and divisive contest: It’s up to the government to cut high U.S. drug prices.

Harris cast the tie-breaking Senate vote in 2022 for legislation that allows Medicare to negotiate drug prices for its more than 60 million beneficiaries. Before that, she was an aggressive regulator of the drug industry as California attorney general.

As president, Trump would likely retain Medicare price negotiations unless the pharmaceutical industry can come up with something more compelling that they’d put on the table, people close to him say. In his first term, he proposed various policies aimed at reducing prescription costs but had limited success with their implementation.

The drug industry could benefit, though, if Trump remains unable to advance such proposals.

“His efforts were largely fragmented and faced resistance from both the industry and lawmakers,” said Sergio Jose Gutierrez, a political strategist who has primarily worked with Democrats in the U.S. “The lack of a cohesive strategy and the limited ability to implement significant changes made his approach less effective compared to what a Harris-Walz administration could offer.”

The industry is increasingly under attack by lawmakers from both parties for drug prices most Americans regard as unreasonable, according to KFF polling, so the election outcome could be pivotal to drug companies’ fortunes. Their predicament is a sharp reversal from years past, when the firms enjoyed a reputation as being almost untouchable. For more than a decade, manufacturers successfully fended off proposals to let Medicare negotiate lower drug prices before losing the battle two years ago.

The shift in their political standing shows up in pharmaceutical companies’ contributions to candidates. An industry that gave three or four times as much to GOP candidates as to Democrats in the 1990s and early 2000s is now hedging its bets. So far in the 2024 cycle, drug companies have given $4.89 million to Democrats and $4.35 million to Republicans, according to OpenSecrets, a nonpartisan research group.

Harris has received $518,571 from the industry and Trump has received $204,748.

At the Democratic National Convention in Chicago last week, Harris and fellow Democrats touted their records on curbing drug prices. Harris supporters point to her past and present.

While she was California’s attorney general, she joined cases that resulted in nearly $7.2 billion (about $22 per person in the U.S.) in fines for drug companies.

Her vote to pass President Joe Biden’s Inflation Reduction Act paved the way not only for Medicare price negotiation but also an annual $2,000 cap on Medicare beneficiaries’ total drug spending and a $35 cap on their monthly insulin supplies.

“In the United States of America, no senior should have to choose between either filling their prescription or paying their rent,” Harris said Aug. 15 in her first joint appearance with Biden since he exited the presidential race.

She has promised to extend both the annual drug spending cap and the insulin price cap to all Americans with insurance, not just those on Medicare, if elected president.

Harris also backed a contentious policy that, in some instances, would empower the federal government to inject more competition into the marketplace by seizing the patents on some high-cost drugs developed with federal funds.

Doug Hart, 77, of Tempe, Arizona, has been spending about $7,000 annually on prescription drugs. A drug he takes to prevent blood clots will cost less under the Medicare price negotiations. The retired labor union president said the decrease will be considerable and it is one reason he backs Harris.

“The Republicans all voted against Medicare negotiation. Harris broke the tie in the Senate to allow it,” said Hart, who is a board member for the Arizona Alliance for Retired Americans, which works to mobilize returned union members and activists on progressive issues.

While Republicans as a party remain more friendly to the pharmaceutical industry, Trump has been willing to challenge GOP orthodoxy by taking action to combat high drug costs.

He sought during his administration to tie drug prices in Medicare to lower international prices, a proposal that the PricewaterhouseCoopers health research institute estimated would cost five drugmakers as much as $500 million a year. What was known as the “most favored nation” interim final rule was blocked because of legal challenges and later rescinded by the Biden administration.

Trump issued a rule setting up a path to import drugs from Canada and other countries, with Florida this year becoming the first state to get federal approval to import some prescriptions from Canada. But the state has been stymied by pushback from Health Canada, the Canadian government department responsible for national health policy.

And on his campaign website, Trump posted a video in which he questioned whether childhood health problems are the result of “overprescription” of medications.

“Too often, our public health establishment is too close to Big Pharma — they make a lot of money, Big Pharma — big corporations, and other special interests, and does not want to ask the tough questions about what is happening to our children’s health,” he said. “If Big Pharma defrauds American patients and taxpayers or puts profits above people, they must be investigated and held accountable.”

Trump hasn’t said much about drug prices in his 2024 campaign, but allies and former advisers say he remains committed to knocking down prescription prices if reelected.

He would likely focus on increasing generic and biosimilar competition, importing drugs made in the U.S. but sold overseas back to the U.S., and capping out-of-pocket insulin costs, according to former Trump administration officials. Other goals may be lowering prices for drugs in the Medicare 340B program, which requires drugmakers to provide outpatient drugs at reduced prices to eligible health organizations that serve lower-income and uninsured patients.

“The No. 1 issue he cared about while I was in the White House, and I continue to hear him talk about, is lowering drug prices,” said Theo Merkel, a senior research fellow at conservative think tanks Paragon Health Institute and the Manhattan Institute. Merkel was also a special assistant in the Trump White House. “I’m confident that will be at the top of the agenda,” he added.

Catherine Hill, a spokesperson for Pharmaceutical Research and Manufacturers of America, or PhRMA, said the industry trade group looks forward to collaborating with any future presidential administration.

She criticized the Biden administration’s plan for Medicare price negotiation as well as Trump’s plan to align U.S. prices with those in foreign countries. This month, the administration announced new, reduced prices for 10 drugs in the program following negotiations between the federal government and drugmakers. The lower costs take effect in 2026.

“Previous price controls adopted by the Biden administration threaten to stifle that innovation,” Hill said. “Undermining intellectual property protections and borrowing other countries’ price controls will further undercut innovation and threaten patients’ access to medicine.”

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10273143 2024-08-27T15:10:57+00:00 2024-08-27T15:17:26+00:00
The new COVID vaccine is out. Why you might not want to rush to get it. https://www.baltimoresun.com/2024/08/27/the-new-covid-vaccine-is-out-why-you-might-not-want-to-rush-to-get-it/ Tue, 27 Aug 2024 18:48:00 +0000 https://www.baltimoresun.com/?p=10273121&preview=true&preview_id=10273121 The FDA has approved an updated COVID-19 shot for everyone 6 months old and up, which renews a now-annual quandary for Americans: Get the shot now, with the latest covid outbreak sweeping the country, or hold it in reserve for the winter wave?

The new vaccine should provide some protection to everyone. But many healthy people who have already been vaccinated or have immunity because they’ve been exposed to COVID enough times may want to wait a few months.

COVID has become commonplace. For some, it’s a minor illness with few symptoms. Others are laid up with fever, cough, and fatigue for days or weeks. A much smaller group — mostly older or chronically ill people — suffer hospitalization or death.

It’s important for those in high-risk groups to get vaccinated, but vaccine protection wanes after a few months. Those who run to get the new vaccine may be more likely to fall ill this winter when the next wave hits, said William Schaffner, an infectious disease professor at Vanderbilt University School of Medicine and a spokesperson for the National Foundation for Infectious Diseases.

On the other hand, by late fall the major variants may have changed, rendering the vaccine less effective, said Peter Marks, the FDA’s top vaccine official, at a briefing Aug. 23. He urged everyone eligible to get immunized, noting that the risk of long COVID is greater in the un- and undervaccinated.

Of course, if last year’s COVID vaccine rollout is any guide, few Americans will heed his advice, even though this summer’s surge has been unusually intense, with levels of the COVID virus in wastewater suggesting infections are as widespread as they were in the winter.

The Centers for Disease Control and Prevention now looks to wastewater as fewer people are reporting test results to health authorities. The wastewater data shows the epidemic is worst in Western and Southern states. In New York, for example, levels are considered “high” — compared with “very high” in Georgia.

Hospitalizations and deaths due to COVID have trended up, too. But unlike infections, these rates are nowhere near those seen in winter surges, or in summers past. More than 2,000 people died of COVID in July — a high number but a small fraction of the at least 25,700 COVID deaths in July 2020.

Partial immunity built up through vaccines and prior infections deserves credit for this relief. A new study suggests that current variants may be less virulent — in the study, one of the recent variants did not kill mice exposed to it, unlike most earlier COVID variants.

Public health officials note that even with more cases this summer, people seem to be managing their sickness at home. “We did see a little rise in the number of cases, but it didn’t have a significant impact in terms of hospitalizations and emergency room visits,” said Manisha Juthani, public health commissioner of Connecticut, at a news briefing Aug. 21.

Unlike influenza or traditional cold viruses, COVID seems to thrive outside the cold months, when germy schoolkids, dry air, and indoor activities are thought to enable the spread of air- and saliva-borne viruses. No one is exactly sure why.

“COVID is still very transmissible, very new, and people congregate inside in air-conditioned rooms during the summer,” said John Moore, a virologist and professor at Cornell University’s Weill Cornell Medicine College.

Or “maybe COVID is more tolerant of humidity or other environmental conditions in the summer,” said Caitlin Rivers, an epidemiologist at Johns Hopkins University.

Because viruses evolve as they infect people, the CDC has recommended updated COVID vaccines each year. Last fall’s booster was designed to target the omicron variant circulating in 2023. This year, mRNA vaccines made by Moderna and Pfizer and the protein-based vaccine from Novavax — which has yet to be approved by the FDA — target a more recent omicron variant, JN.1.

The FDA determined that the mRNA vaccines strongly protected people from severe disease and death — and would do so even though earlier variants of JN.1 are now being overtaken by others.

Public interest in COVID vaccines has waned, with only 1 in 5 adults getting vaccinated since last September, compared with about 80% who got the first dose. New Yorkers have been slightly above the national vaccination rate, while in Georgia only about 17% got the latest shot.

Vaccine uptake is lower in states where the majority voted for Donald Trump in 2020 and among those who have less money and education, less health care access, or less time off from work. These groups are also more likely to be hospitalized or die of the disease, according to a 2023 study in The Lancet.

While the newly formulated vaccines are better targeted at the circulating COVID variants, uninsured and underinsured Americans may have to rush if they hope to get one for free. A CDC program that provided boosters to 1.5 million people over the last year ran out of money and is ending Aug. 31.

The agency drummed up $62 million in unspent funds to pay state and local health departments to provide the new shots to those not covered by insurance. But “that may not go very far” if the vaccine costs the agency around $86 a dose, as it did last year, said Kelly Moore, CEO of Immunize.org, which advocates for vaccination.

People who pay out-of-pocket at pharmacies face higher prices: CVS plans to sell the updated vaccine for $201.99, said Amy Thibault, a spokesperson for the company.

“Price can be a barrier, access can be a barrier” to vaccination, said David Scales, an assistant professor of medicine at Weill Cornell Medical College.

Without an access program that provides vaccines to uninsured adults, “we’ll see disparities in health outcomes and disproportionate outbreaks in the working poor, who can ill afford to take off work,” Kelly Moore said.

New York state has about $1 million to fill the gaps when the CDC’s program ends, said Danielle De Souza, a spokesperson for the New York State Department of Health. That will buy around 12,500 doses for uninsured and underinsured adults, she said. There are roughly one million uninsured people in the state.

CDC and FDA experts last year decided to promote annual fall vaccination against covid and influenza along with a one-time respiratory syncytial virus shot for some groups.

It would be impractical for the vaccine-makers to change the COVID vaccine’s recipe twice every year, and offering the three vaccines during one or two health care visits appears to be the best way to increase uptake of all of them, said Schaffner, who consults for the CDC’s policy-setting Advisory Committee on Immunization Practices.

At its next meeting, in October, the committee is likely to urge vulnerable people to get a second dose of the same COVID vaccine in the spring, for protection against the next summer wave, he said.

If you’re in a vulnerable population and waiting to get vaccinated until closer to the holiday season, Schaffner said, it makes sense to wear a mask and avoid big crowds, and to get a test if you think you have COVID. If positive, people in these groups should seek medical attention since the antiviral pill Paxlovid might ameliorate their symptoms and keep them out of the hospital.

As for conscientious others who feel they may be sick and don’t want to spread the COVID virus, the best advice is to get a single test and, if positive, try to isolate for a few days and then wear a mask for several days while avoiding crowded rooms. Repeat testing after a positive result is pointless, since viral particles in the nose may remain for days without signifying a risk of infecting others, Schaffner said.

The Health and Human Services Department is making four free COVID tests available to anyone who requests them starting in late September through covidtest.gov, said Dawn O’Connell, assistant secretary for preparedness and response, at the Aug. 23 briefing.

The government is focusing its fall vaccine advocacy campaign, which it’s calling “Risk less, live more,” on older people and nursing home residents, said HHS spokesperson Jeff Nesbit.

Not everyone may really need a fall COVID booster, but “it’s not wrong to give people options,” John Moore said. “The 20-year-old athlete is less at risk than the 70-year-old overweight dude. It’s as simple as that.”

KFF Health News correspondent Amy Maxmen contributed to this report.

Healthbeat is a nonprofit newsroom covering public health published by Civic News Company and KFF Health News. Sign up for their newsletters here.

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10273121 2024-08-27T14:48:00+00:00 2024-08-27T15:10:02+00:00
Wins at the ballot box for abortion rights still mean court battles for access https://www.baltimoresun.com/2024/06/08/wins-at-the-ballot-box-for-abortion-rights-still-mean-court-battles-for-access/ Sat, 08 Jun 2024 14:00:51 +0000 https://www.baltimoresun.com/?p=10094505&preview=true&preview_id=10094505 Before Ohio voters amended their constitution last year to protect abortion rights, the state’s attorney general, an anti-abortion Republican, said that doing so would upend at least 10 state laws limiting abortions.

But those laws remain a hurdle and straightforward access to abortions has yet to resume, said Bethany Lewis, executive director of the Preterm abortion clinic in Cleveland. “Legally, what actually happened in practice was not much,” she said.

Today, most of those laws limiting abortions — including a 24-hour waiting period and a 20-week abortion ban — continue to govern Ohio health providers, despite the constitutional amendment’s passage with nearly 57% of the vote. For abortion rights advocates, it’s going to take time and money to challenge the laws in the courts.

Voters in as many as 13 states could also weigh in this year on abortion ballot initiatives. But the seven states that have voted on abortion-related ballot measures since the Supreme Court overturned federal abortion protections two years ago in Dobbs v. Jackson Women’s Health Organization show that an election can be just the beginning.

The state-by-state patchwork of constitutional amendments, laws, and regulations that determine where and how abortions are available across the country could take years to crystallize as old rules are reconciled with new ones in legislatures and courtrooms. And even though a ballot measure result may seem clear-cut, the residual web of older laws often still needs to be untangled. Left untouched, the statutes could pop up decades later, like an Arizona law from 1864 did this year.

Michigan was one of the first states where voters weighed in on abortion rights following the Dobbs decision in June 2022. In November of that year, Michigan voters approved by 13 percentage points an amendment to add abortion rights to the state constitution. It would be an additional 15 months, however, before the first lawsuit was filed to unwind the state’s existing abortion restrictions, sometimes called “targeted regulation of abortion providers,” or TRAP, laws. Michigan’s include a 24-hour waiting period.

The delay had a purpose, according to Elisabeth Smith, state policy and advocacy director at the Center for Reproductive Rights, which filed the lawsuit: It’s preferable to change laws through the legislature than through litigation because the courts can only strike down a law, not replace one.

“It felt really important to allow the legislative process to go forward, and then to consider litigation if there were still statutes that were on the books the legislature hadn’t repealed,” Smith said.

Michigan’s Democratic-led legislature did pass an abortion rights package last year that was signed into law by the state’s Democratic governor in December. But the package left some regulations intact, including the mandatory waiting period, mandatory counseling, and a ban on abortions by non-doctor clinicians, such as nurse practitioners and midwives.

Smith’s group filed the lawsuit in February on behalf of Northland Family Planning Centers and Medical Students for Choice. Smith said it’s unclear how long the litigation will take, but she hopes for a decision this year.

Abortion opponents such as Katie Daniel, state policy director for Susan B. Anthony Pro-Life America, are critical of the lawsuit and such policy unwinding efforts. She said abortion rights advocates used “deceptive campaigns” that claimed they wanted to restore the status quo in place before the Dobbs decision left abortion regulation up to the states.

“The litigation proves these amendments go farther than they will ever admit in a 30-second commercial,” Daniel said. “Removing the waiting period, counseling, and the requirement that abortions be done by doctors endangers women and limits their ability to know about resources and support available to them.”

A lawsuit to unwind most of the abortion restrictions in Ohio came from Preterm and other abortion providers four months after that state’s ballot measure passed. A legislative fix was unlikely because Republicans control the legislature and governor’s office. Preterm’s Lewis said she anticipated the litigation would take “quite some time.”

Dave Yost, the Ohio attorney general, is one of the defendants named in the suit. In a motion to dismiss the case, Yost argued that the abortion providers — which include several clinics as well as a physician, Catherine Romanos — lacked standing to sue.

He argued that Romanos failed to show she was harmed by the laws, explaining that “under any standard, Dr. Romanos, having always complied with these laws as a licensed physician in Ohio, is not harmed by them.”

Jessie Hill, an attorney representing Romanos and three of the clinics in the case, called the argument “just very wrong.” If Romanos can’t challenge the constitutionality of the old laws because she is complying with them, Hill said, then she would have to violate those laws and risk felonies to honor the new amendment.

“So, then she’s got to go get arrested and show up in court and then defend herself based on this new constitutional amendment?” Hill said. “For obvious reasons, that is not a system that we want to have.”

This year, Missouri is among the states poised to vote on a ballot measure to write protections for abortion into the state constitution. Abortions in Missouri have been banned in nearly every circumstance since 2022, but they were largely halted years earlier by a series of laws seeking to make abortions scarce.

Over the course of more than three decades, Missouri lawmakers instituted a 72-hour waiting period, imposed minimum dimensions for procedure rooms and hallways in abortion clinics, and mandated that abortion providers have admitting privileges at nearby hospitals, among other regulations.

Emily Wales, president and chief executive of Planned Parenthood Great Plains, said trying to comply with those laws visibly changed her organization’s facility in Columbia, Missouri: widened doorways, additional staff lockers, and even the distance between recovery chairs and door frames.

Even so, by 2018 the organization had to halt abortion services at that Columbia location, she said, with recovery chairs left in position for a final inspection that never happened. That left just one abortion clinic operating in the state, a separate Planned Parenthood affiliate in St. Louis. In 2019, that organization opened a large facility about 20 miles away in Illinois, where lawmakers were preserving abortion access rather than restricting it.

By 2021, the last full year before the Dobbs decision opened the door for Missouri’s ban, the number of recorded abortions in the state had dwindled to 150, down from 5,772 in 2011.

“At that point, Missourians were generally better served by leaving the state,” Wales said.

Both of Missouri’s Planned Parenthood affiliates have vowed to restore abortion services in the state as swiftly as possible if voters approve the proposed ballot measure. But the laws that diminished abortion access in the state would still be on the books and likely wouldn’t be overturned legislatively under a Republican-controlled legislature and governor’s office. The laws would surely face challenges in court, yet that could take a while.

“They will be unconstitutional under the language that’s in the amendment,” Wales said. “But it’s a process.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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10094505 2024-06-08T10:00:51+00:00 2024-06-08T10:01:16+00:00
Ketamine therapy for mental health a ‘Wild West’ for doctors, patients https://www.baltimoresun.com/2024/02/01/ketamine-therapy-for-mental-health-a-wild-west-for-doctors-patients/ Thu, 01 Feb 2024 20:41:12 +0000 https://www.baltimoresun.com/?p=9572274&preview=true&preview_id=9572274 By Dawn Megli | KFF Health News

In late 2022, Sarah Gutilla’s treatment-resistant depression had grown so severe, she was actively contemplating suicide. Raised in foster care, the 34-year-old’s childhood was marked by physical violence, sexual abuse, and drug use, leaving her with life-threatening mental scars.

Out of desperation, her husband scraped together $600 for the first of six rounds of intravenous ketamine therapy at Ketamine Clinics Los Angeles, which administers the generic anesthetic for off-label uses such as treating depression. When Gutilla got into an Uber for the 75-mile drive to Los Angeles, it was the first time she had left her home in Llano, California, in two years. The results, she said, were instant.

“The amount of relief I felt after the first treatment was what I think ‘normal’ is supposed to feel like,” she said. “I’ve never felt so OK, and so at peace.”

For-profit ketamine clinics have proliferated over the past few years, offering infusions for a wide array of mental health issues, including obsessive-compulsive disorder, depression, and anxiety. Although the off-label use of ketamine hydrochloride, a Schedule III drug approved by the FDA as an anesthetic in 1970, was considered radical just a decade ago, now between 500 and 750 ketamine clinics have cropped up across the nation.

Market researcher Grand View Research pegged industry revenues at $3.1 billion in 2022, and projects them to more than double to $6.9 billion by 2030. Most insurance doesn’t cover ketamine for mental health, so patients must pay out-of-pocket.

While it’s legal for doctors to prescribe ketamine, the FDA hasn’t approved it for mental health treatment, which means that individual practitioners must develop their own treatment protocols. The result is wide variability among providers, with some favoring gradual, low-dosage treatments while others advocate larger amounts that can induce hallucinations, as the drug is psychedelic at the right doses.

“Ketamine is the wild West,” said Dustin Robinson, the managing principal of Iter Investments, a venture capital firm specializing in hallucinogenic drug treatments.

Ketamine practitioners stress that the drug’s emergence as a mental health treatment is driven by a desperate need. Depression is the leading cause of disability in the United States for individuals ages 15-44, according to the National Institute of Mental Health, and around 25% of adults experience a diagnosable mental disorder in any given year.

Meanwhile, many insurance plans cover mental health services at lower rates than physical health care, despite laws requiring parity. Thus, many patients with disorders receive little or no care early on and are desperate by the time they visit a ketamine clinic, said Steven Siegel, chair of psychiatry and the behavioral sciences at the University of Southern California’s Keck School of Medicine.

But the revelation that “Friends” star Matthew Perry died in part from a large dose of ketamine, along with billionaire Elon Musk’s open use of the drug, has piqued fresh scrutiny of ketamine and its regulatory environment, or lack thereof.

Commercial ketamine clinics often offer same-day appointments, in which patients can pay out-of-pocket for a drug that renders immediate results. The ketamine is administered intravenously, and patients are often given blankets, headphones, and an eye mask to heighten the dissociative feeling of not being in one’s body. A typical dose of ketamine to treat depression, which is 10 times lower than the dosage used in anesthesia, costs clinics about $1, but clinics charge $600-$1,000 per treatment.

Ketamine is still shadowed by its reputation as the party drug known as “Special K”; Siegel’s first grant from the National Institutes of Health was to study ketamine as a drug of abuse. It has the potential to send users down a “K hole,” otherwise known as a bad trip, and can induce psychosis. Research in animals and recreational users has shown chronic use of the drug impairs both short- and long-term cognition.

Perry’s death in October raised alarms when the initial toxicology screening attributed his death to the acute effects of ketamine. A December report revealed Perry received infusion therapy a week before his death but that the fatal blow was a high dose of the substance taken with an opioid and a sedative on the day of his death — indicating that medical ketamine was not to blame.

Variety of protocols

Sam Mandel co-founded Ketamine Clinics Los Angeles in 2014 with his father, Steven Mandel, an anesthesiologist with a background in clinical psychology, and Sam said the clinic has established its own protocol. That includes monitoring a patient’s vital signs during treatment and keeping psychiatrists and other mental health practitioners on standby to ensure safety. Initial treatment starts with a low dose and increases as needed.

While many clinics follow the Mandels’ graduated approach, the dosing protocol at MY Self Wellness, a ketamine clinic in Bonita Springs, Florida, is geared toward triggering a psychedelic episode.

Christina Thomas, president of MY Self Wellness, said she developed her clinic’s procedures against a list of “what not to do” based on the bad experiences people have reported at other clinics.

The field isn’t entirely unregulated: State medical and nursing boards oversee physicians and nurses, while the FDA and Drug Enforcement Administration regulate ketamine. But most anesthesiologists don’t have a background in mental health, while psychiatrists don’t know much about anesthesia, Sam Mandel noted. He said a collaborative, multidisciplinary approach is needed to develop standards across the field, particularly because ketamine can affect vital signs such as blood pressure and respiration.

The protocols governing Spravato, an FDA-approved medication based on a close chemical cousin of ketamine called esketamine, are illustrative. Because it has the potential for serious side effects, it falls under the FDA’s Risk Evaluation and Mitigation Strategies program, which puts extra requirements in place, said Robinson. Spravato’s REMS requires two hours of monitoring after each dose and prohibits patients from driving on treatment days.

Generic ketamine, by contrast, has no REMS requirements. And because it is generic and cheap, drugmakers have little financial incentive to undertake the costly clinical trials that would be required for FDA approval.

That leaves it to the patient to assess ketamine providers. Clinics dedicated to intravenous infusions, rather than offering the treatment as an add-on, may be more familiar with the nuances of administering the drug. Ideally, practitioners should have mental health and anesthesia expertise, or have multiple specialties under one roof, and clinics should be equipped with hospital-grade monitoring equipment, Mandel said.

Siegel, who has researched ketamine since 2003, said the drug is especially useful as an emergency intervention, abating suicidal thoughts for long enough to give traditional treatments, like talk therapy and SSRI antidepressants, time to take effect. “The solutions that we have and have had up until now have failed us,” Mandel said.

The drug is now popular enough as a mental health treatment that the name of Mandel’s clinic is a daily sight for thousands of Angelenos as it appears on 26 Adopt-A-Highway signs along the 405 and 10 freeways.

And the psychedelic renaissance in mental health is accelerating. A drug containing MDMA, known as ecstasy or molly, is expected to receive FDA approval in 2024. A drug with psilocybin, the active ingredient in “magic mushrooms,” could launch as early as 2027, the same year a stroke medicine with the active ingredient of DMT, a hallucinogen, is expected to debut.

Robinson said many ketamine clinics have opened in anticipation of the expanded psychedelic market. Since these new drugs will likely be covered by insurance, Robinson advises clinics to offer FDA-approved treatments such as Spravato so they’ll have the proper insurance infrastructure and staff in place.

For now, Sarah Gutilla will pay out-of-pocket for ketamine treatments. One year after her first round of infusions, she and her husband are saving for her second. In the meantime, she spends her days on her ranch in Llano where she rescues dogs and horses, and relies on telehealth therapy and psychiatric medications.

While the infusions aren’t “a magic fix,” they are a tool to help her move in the right direction.

“There used to be no light at the end of the tunnel,” she said. “Ketamine literally saved my life.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Demócratas proponen ampliar beneficios de Medicare para la audición. ¿Qué pueden esperar los consumidores? https://www.baltimoresun.com/2021/11/11/demcratas-proponen-ampliar-beneficios-de-medicare-para-la-audicin-qu-pueden-esperar-los-consumidores/ https://www.baltimoresun.com/2021/11/11/demcratas-proponen-ampliar-beneficios-de-medicare-para-la-audicin-qu-pueden-esperar-los-consumidores/#respond Thu, 11 Nov 2021 14:16:58 +0000 https://www.baltimoresun.com?p=3606783&preview_id=3606783 El gigantesco proyecto de ley de gastos domésticos del presidente Joe Biden agregaría beneficios para servicios de audición al programa tradicional de Medicare, una de las tres principales prestaciones nuevas que los demócratas habían solicitado.

La administración Biden parece haberse quedado corta en su ambición de ampliar las prestaciones dentales y oftalmológicas junto con las auditivas.

El senador Bernie Sanders, independiente de Vermont, y otros progresistas llevan mucho tiempo presionando para que se concedan prestaciones más generosas a las personas mayores. Citando el costo, el senador Joe Manchin, demócrata de West Virginia, se opuso a dicha ampliación.

Biden y los líderes demócratas en el Congreso recortaron el alcance de los nuevos beneficios después de que el presupuesto total del proyecto de ley —que financia la salud y otras iniciativas nacionales— se redujera de los $3,5 mil millones propuestos a $1,75 mil millones para satisfacer las demandas de los moderados del partido. Los nuevos beneficios para la pérdida de la audición estarían disponibles en 2023.

Los demócratas tienen poco margen de maniobra en el proyecto de ley. Necesitan que los 50 senadores demócratas lo apoyen y sólo pueden perder a tres miembros de la Cámara de Representantes en una votación.

Esos estrechos márgenes han dificultado las negociaciones y han aumentado la capacidad de cualquier legislador para establecer condiciones. Las alas progresista y moderada del partido han estado en desacuerdo sobre el tema durante meses, y las negociaciones continúan.

No obstante, si la propuesta sobre la ayuda para los servicios de audición sigue adelante, sería un gran cambio. He aquí las respuestas a las preguntas que los mayores pueden tener sobre este beneficio.

¿Qué hace el plan?

El proyecto de ley presentado en la Cámara de Representantes propone añadir una cobertura al Medicare tradicional que incluya servicios de evaluación de la audición, gestión de la pérdida auditiva y tratamientos relacionados. Unas 36 millones de personas están inscritas en el Medicare original.

Muchos de los planes privados de Medicare Advantage a los que han optado otros adultos mayores ya ofrecen servicios auditivos similares. Según los Centros de Servicios de Medicare y Medicaid (CMS), aproximadamente 27 millones de personas mayores están inscritas en un plan Medicare Advantage este año. Los CMS prevén que esta cifra aumente a 29,5 millones el próximo año.

Las nuevas prestaciones incluyen la cobertura de determinados audífonos para “personas diagnosticadas con una pérdida de audición moderadamente grave, grave o profunda”, y permite a los mayores inscritos en el Medicare tradicional obtener un audífono para cada oído cada cinco años.

También cubren los dispositivos suministrados por orden escrita de un médico, audiólogo, audioprotesista u otro clínico. La Administración de Alimentos y Medicamentos (FDA) ha tomado medidas por separado para que los audífonos se puedan adquirir sin receta médica, en un intento de abaratarlos.

¿Por qué son necesarios estos beneficios?

Las investigaciones han demostrado que la pérdida de la audición puede socavar la calidad de vida de las personas mayores, lo que conduce a la soledad, el aislamiento, la depresión, la ansiedad, los trastornos de la comunicación y más.

Según la Encuesta Nacional de Entrevistas de Salud de los Centros para el Control y la Prevención de Enfermedades (CDC), en 2019 casi 1 de cada 3 personas de 65 años o más declaró tener dificultades para oír incluso con un audífono.

Funcionarios del gobierno de Biden dijeron al presentar el paquete, la primera semana de noviembre, que de los adultos mayores que podrían beneficiarse de los audífonos, solo el 30% de los mayores de 70 años los han usado.

Los adultos hispanos, de 65 años o más, son más propensos que otros grupos demográficos a informar que tienen problemas auditivos graves, según la encuesta.

Un análisis de KFF, en septiembre, encontró que los 4,6 millones de beneficiarios de Medicare que utilizaron servicios de audición en 2018 pagaron, en promedio, $914 de su bolsillo. Esa cifra incluye a los adultos mayores que reciben beneficios en el Medicare original o tradicional, así como a las personas inscritas en los planes de Medicare Advantage.

¿Cuántas personas se beneficiarían?

El total aún está en el aire ya que los demócratas siguen negociando los detalles, pero es posible que el número de beneficiarios sea de millones. Según los Institutos Nacionales de Salud (NIH), aproximadamente 1 de cada 3 estadounidenses de entre 65 y 74 años padece pérdida de audición, y casi la mitad de los mayores de 75 años tienen dificultades para oír.

Hasta la fecha, existe una importante diferencia entre los mayores inscritos en el Medicare tradicional y los inscritos en los planes Medicare Advantage. Una investigación publicada por el Commonwealth Fund, en febrero, encontró que casi todos los planes de Medicare Advantage ofrecían prestaciones dentales, visuales y auditivas.

Sin embargo, incluso con Medicare Advantage, las personas mayores pueden tener dificultades para pagar la atención médica, y lo que se cubre varía según el plan.

El análisis de KFF reveló que los adultos mayores, en los planes de Medicare Advantage, gastaron menos de su bolsillo para el cuidado dental y de la visión que los inscritos en el Medicare tradicional en 2018, pero no hubo diferencia en el gasto para el cuidado de la audición.

¿Se agregarán las prestaciones dentales y oftalmológicas?

No incluir los beneficios dentales y de visión decepcionará a los legisladores progresistas.

“En Vermont, y en todo el país, hay personas mayores a las que se les pudren los dientes, personas mayores que no pueden hablar con sus nietos porque no les oyen y no pueden permitirse un audífono, y personas que no pueden leer un periódico porque no pueden pagar por unos lentes”, dijo Sanders en la NBC a principios de este año. “Así que decir que la atención dental y los audífonos y los anteojos deberían formar parte de Medicare tiene todo el sentido del mundo”.

Según KFF, los 31,3 millones de beneficiarios de Medicare que necesitaron servicios dentales en 2018 pagaron, en promedio, $874 de su bolsillo. Los 20,3 millones que necesitaron atención visual gastaron $230.

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https://www.baltimoresun.com/2021/11/11/demcratas-proponen-ampliar-beneficios-de-medicare-para-la-audicin-qu-pueden-esperar-los-consumidores/feed/ 0 3606783 2021-11-11T14:16:58+00:00 2021-11-11T19:16:59+00:00
Why at-home rapid COVID tests cost so much, even after Biden’s push for lower prices https://www.baltimoresun.com/2021/09/15/why-at-home-rapid-covid-tests-cost-so-much-even-after-bidens-push-for-lower-prices/ https://www.baltimoresun.com/2021/09/15/why-at-home-rapid-covid-tests-cost-so-much-even-after-bidens-push-for-lower-prices/#respond Wed, 15 Sep 2021 13:06:22 +0000 https://www.baltimoresun.com?p=3626495&preview_id=3626495 Rapid at-home COVID-19 tests are flying off store shelves across the nation and are largely sold out online as the delta variant complicates a return to school, work and travel routines.

But at $10 or $15 a test, the price is still far too high for regular use by anyone but the wealthy. A family with two school-age children might need to spend $500 or more a month to try to keep their family — and others — safe.

For Americans looking for swift answers, the cheapest over-the-counter COVID-19 test is the Abbott Laboratories BinaxNOW two-pack for $23.99. Close behind are Quidel’s QuickVue tests, at $15 a pop. Yet supplies are dwindling. After a surge in demand, CVS is limiting the number of tests people can buy, and Amazon and Walgreen’s website were sold out as of Friday afternoon.

President Joe Biden said Thursday he would invoke the Defense Production Act to make 280 million rapid COVID-19 tests available. The administration struck a deal with Walmart, Amazon and Kroger for them to sell tests for “up to 35 percent less” than current retail prices for three months. For those on Medicaid, the at-home tests will be fully covered, Biden said.

An increased supply should help to lower prices. As schools open and much of the country languishes without pandemic-related restrictions, epidemiologists say widespread rapid-test screening — along with vaccination and mask-wearing — is critical to controlling the delta variant’s spread. Yet shortages, little competition and sticky high prices mean routine rapid testing remains out of reach for most Americans, even if prices drop 35%.

Consumers elsewhere have much cheaper — or free — options. In Germany, grocery stores are selling rapid COVID-19 tests for under $1 per test. In India, they’re about $3.50. The United Kingdom provides 14 tests per person free of charge. Canada is doling out free rapid tests to businesses.

Michael Mina, assistant professor of epidemiology at Harvard University, lauded Biden’s announcement on Twitter while saying he “had some reservations” about its scale and noted that 280 million tests represent “less than one test per person over the course of a year.”

Rep. Kim Schrier, D-Wash., for months has advocated for rapid testing at a lower cost. “In an ideal world, a test would either be free or cost less than a dollar so that people could take one a few times a week to every day,” she said in the days before Biden’s announcement.

Biden’s initiative “is a great start” for broader rapid testing, Schrier said Friday. “But there is a lot more to be done, and that must be done quickly, to use this really important tool to combat this virus.”

A nationwide survey released in February by the Harvard T.H. Chan School of Public Health and Hart Research found that 79% of adults would regularly test themselves at home if rapid tests cost a dollar. But only a third would do so if the cost was $25.

Billions in taxpayer dollars have been invested in these products. Abbott Laboratories, for instance, cashed in on hundreds of millions in federal contracts and gave its shareholders fat payouts last year, increasing its quarterly dividend by 25%. Even so, according to a New York Times investigation, as demand for rapid tests cratered in early summer, Abbott destroyed its supplies and laid off workers who had been making them.

More than a year ago, Abbott said the company would sell its BinaxNOW in bulk for $5 a test to health care providers, but that option is not available over the counter to the public. Even with the anticipated price decrease, a two-pack will be more than $15. Abbott did not comment further.

Schrier said in spring that test prices were high because “big companies are buying up all the supplies.” Also, “their profit is far higher making 1,000 $30 tests than 30,000 $1 tests” — in other words, they can make the same amount of money for many fewer tests.

In March, the Biden administration allocated $10 billion as part of the American Rescue Plan Act to perform COVID-19 testing in schools, leaving the rollout largely to states. This followed $760 million spent by the Trump administration to buy 150 million of Abbott’s rapid-response antigen tests, many of which went to schools. The rollout has been mixed, with states like Missouri mired in logistical challenges.

In late August, Schrier wrote a letter asking four federal agencies to update their distribution plans. She also urged the government to increase spending on rapid testing, saying “time is of the essence” as children returned to school.

Antigen tests can give real-time information to people exposed to COVID-19, said Dr. Dara Kass, an associate professor of emergency medicine at Columbia University Medical Center. Waiting for lab results from polymerase chain reaction (PCR) tests can take days, and many states — particularly in the hard-hit South — are seeing appointments fill up days in advance. At-home collection kits for PCR tests can cost over $100.

Rapid tests take under 15 minutes to detect COVID-19 by pinpointing proteins, called antigens. The tests are similar to a pregnancy test, with one or two lines displayed, depending on the result.

The Centers for Disease Control and Prevention recommends that fully vaccinated people exposed to COVID-19 wear a mask indoors for two weeks and get tested three to five days after exposure. The unvaccinated should quarantine for 14 days. But that leaves gray area for those vaccinated people hoping to attend classes or go about their lives, Kass said.

“Rapid tests give information,” she added, “that allows somebody to engage in society safely.” People can follow up with a PCR test, which is more sensitive, for confirmation of a diagnosis.

In Massachusetts, for example, a “Test and Stay” strategy for students exposed to COVID-19 allows them to remain in school: Students take BinaxNOW tests five days in a row following close contact with an infected person.

More than 30 antigen tests have been developed in the U.S. — though just six companies have FDA authorization for over-the-counter use. No rapid COVID-19 tests have full FDA approval. Two rapid molecular options, made by Lucira Health and Cue Health, also have emergency use authorization (EUA).

“Unfortunately, many submissions are incomplete or contain insufficient information for FDA to determine that they meet the statutory criteria,” FDA spokesperson James McKinney said.

The agency has taken a stricter stance than its European counterparts. In June, the FDA warned Americans to stop using Innova Medical Group’s rapid antigen test, stating that the agency had “significant concerns that the performance of the test has not been adequately established.” Yet in the U.K., which has contracts worth billions with the California company, the regulatory agency OK’d the product.

In Germany, regulators have given special authorization to dozens of antigen tests.

“As long as these tests are regulated as medical devices, the FDA has to regulate them not as critical public health tools, but as medical tools, with all of the onerous clinical trials that slow everything down 100-fold,” Mina said on Twitter.

With only a handful of rapid tests on the market, it is harder for companies that have not yet received FDA authorization to catch up and, in turn, drive the prices down, said Michael Greeley, co-founder and general partner at Flare Capital Partners, a venture capital firm focused on health care technology. “If we’re talking about people testing their kids every day going to school,” he added, “for many families, the current costs are a real burden.”

Broad adoption of rapid testing seems premature, he said, even with a mass purchase of tests by the U.S. government: “We can’t even get people to floss, so the idea that people are now going to start rapid testing as their standard operating procedure is a flawed assumption.”

Regardless, companies can’t keep up with demand.

Ellume said it saw a 900% spike in the use of its tests over the past month. Its at-home rapid test costs up to $38.99. On Walmart’s website, it was listed for $26.10 Friday but was out of stock.

The Australian manufacturer received $232 million from the U.S. Defense Department in February to scale up production, after the FDA authorized its at-home use late last year. But the federal Health Care Enhancement Act, which furnished the funding, does not impose pricing restrictions. Ellume said it will begin production at a Frederick, Maryland, plant this fall. For now, it is shipping tests from Australia.

This summer, Lucira Health stopped selling its about $50 molecular rapid test online to focus on larger clients, including San Francisco’s Chase Center, home to the Golden State Warriors, and the Olympics, Dan George, Lucira’s chief financial officer, said during a recent earnings call.

The company is still losing money as it ramps up production but hopes to return to selling directly on its website and Amazon later this year.

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.

(c)2021 Kaiser Health News. Distributed by Tribune Content Agency, LLC.

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Telehealth’s limits: Battle over state lines and licensing threatens patients’ options https://www.baltimoresun.com/2021/09/07/telehealths-limits-battle-over-state-lines-and-licensing-threatens-patients-options/ https://www.baltimoresun.com/2021/09/07/telehealths-limits-battle-over-state-lines-and-licensing-threatens-patients-options/#respond Tue, 07 Sep 2021 12:09:18 +0000 https://www.baltimoresun.com?p=3624646&preview_id=3624646 If you live in one state, does it matter that the doctor treating you online is in another? Surprisingly, the answer is yes, and the ability to conduct certain virtual appointments may be nearing an end.

Televisits for medical care took off during the worst days of the pandemic, quickly becoming commonplace. Most states and the Centers for Medicare & Medicaid Services temporarily waived rules requiring licensed clinicians to hold a valid license in the state where their patient is located. Those restrictions don’t keep patients from visiting doctors’ offices in other states, but problems could arise if those same patients used telemedicine.

Now states are rolling back many of those pandemic workarounds.

Johns Hopkins Medicine in Baltimore, for example, recently scrambled to notify more than 1,000 Virginia patients that their telehealth appointments were “no longer feasible,” said Dr. Brian Hasselfeld, medical director of digital health and telemedicine at Johns Hopkins. Virginia is among the states where the emergency orders are expiring or being rolled back.

At least 17 states still have waivers in effect, according to a tracker maintained by the Alliance for Connected Care, a lobbying group representing insurers, tech companies and pharmacies.

As those rules end, “it risks increasing barriers” to care, said Hasselfeld. Johns Hopkins, he added, hosted more than 1 million televisits, serving more than 330,000 unique patients, since the pandemic began. About 10% of those visits were from states where Johns Hopkins does not operate facilities.

The rollbacks come amid a longer and larger debate over states’ authority around medical licensing that the pandemic — with its widespread adoption of telehealth services — has put front and center.

“Consumers don’t know about these regulations, but if you all of a sudden pull the rug out from these services, you will definitely see a consumer backlash,” said Dr. Harry Greenspun, chief medical officer for the consultancy Guidehouse.

Still, finding a way forward pits high-powered stakeholders against one another, and consumers’ input is likely to be muted.

State medical boards don’t want to cede authority, saying their power to license and discipline medical professionals boosts patient safety. Licensing is also a source of state revenue.

Providers have long been split on whether to change cross-state licensing rules. Different state requirements — along with fees — make it cumbersome and expensive for doctors, nurses and other clinicians to get licenses in multiple states, leading to calls for more flexibility. Even so, those efforts have faced pushback from within the profession, with opposition from other clinicians who fear the added competition that could come from telehealth could lead to losing patients or jobs.

“As with most things in medicine, it’s a bottom-line issue. The reason telehealth has been blocked across state lines for many years related fundamentally to physicians wanting to protect their own practices,” said Greenspun.

But the pandemic changed the equation.

Even though the initial spike in telehealth visits has eased, utilization remains 38 times higher than before the pandemic, attracting not only patients, but also venture capitalists seeking to join the hot business opportunity, according to a report from consulting firm McKinsey and Co.

Patients’ experience with televisits coupled with the growing interest by investors is focusing attention on this formerly inside-baseball issue of cross-state licensing.

Greenspun predicts consumers will ultimately drive the solution by “voting with their wallets,” aided by giant, consumer-focused retailers like Amazon and Walmart, both of which in recent months made forays into telemedicine.

In the short term, however, the focus is on both the protections and the barriers state regulations create.

“The whole challenge is to ensure maximum access to health while assuring quality,” said Barak Richman, a Duke University law professor, who said laws and policies haven’t been updated to reflect new technological realities partly because state boards want to hang onto their authority.

Patients and their doctors are getting creative, with some consumers simply driving across state lines, then making a Zoom call from their vehicle.

“It’s not ideal, but some patients say they are willing to drive a mile or two and sit in a parking lot in a private space and continue to get my care,” said Dr. Shabana Khan, director of telepsychiatry at NYU Langone Health’s department of child and adolescent psychiatry and a member of the American Psychiatric Association’s Telepsychiatry Committee. She and other practitioners ask their patients about their locations, mainly for safety reasons, but also to check that they are in-state.

Still, for some patients, driving to another state for an in-person or even a virtual appointment is not an option.

Khan worries about people whose care is interrupted by the changes, especially those reluctant to seek out new therapists or who cannot find any clinicians taking new patients.

Austin Smith hopes that doesn’t happen to him.

After initial treatment for what he calls a “weird flavor of cancer” didn’t help reduce his gastrointestinal stromal tumors, he searched out other experts, landing in a clinical trial. But it was in San Diego and the 28-year-old salesman lives in Phoenix.

Although he drives more than five hours each way every couple of months for treatment and to see his doctors, he does much of his other follow-up online. The only difference is “if I was in person, and I said I was hurting here, the doctor could poke me,” he said.

And if the rules change? He’ll make the drive. “I’ll do anything to beat this,” he said of his cancer.

But will doctors, whose patients have spent the past year or more growing comfortable with virtual visits, also be willing to take steps that could likely involve extra costs and red tape?

To get additional licenses, for instance, practitioners must submit applications in every state where their patients reside, each of which can take weeks or months to process. They must pay application fees and keep up with a range of requirements such as continuing education, which vary by state.

States say their traditional role as overseer ensures that all applicants meet educational requirements and pass background checks. They also investigate complaints and argue there’s an advantage to keeping local officials in charge.

“It’s closer to home,” said Lisa Robin, chief advocacy officer with the Federation of State Medical Boards. “There’s a remedy for residents of the state with their own state officials.”

Doctor groups such as the American Medical Association agree.

Allowing a change that doesn’t put centralized authority in a patient’s home state would raise “serious enforcement issues as states do not have interstate policing authority and cannot investigate incidents that happen in another state,” said then-AMA President-elect Jack Resneck during a congressional hearing in March.

But others want more flexibility and say it can be done safely.

Hasselfeld, at Johns Hopkins, said there is precedent for easing multistate licensing requirements. The Department of Veterans Affairs, for example, allows medical staffers who are properly licensed in at least one state to treat patients in any VA facility.

The Alliance for Connected Care and other advocates are pushing states to extend their pandemic rules. A few have done so. Arizona, for example, made permanent the rules allowing out-of-state medical providers to practice telemedicine for Arizona residents, as long as they register with the state and their home-state license is in good standing. Connecticut’s similar rules have now been stretched until June 2023.

The alliance and others also back legislation stalled in Congress that would temporarily allow medical professionals licensed in one state to treat — either in person or via televisits — patients in any other state.

Because such fixes are controversial, voluntary interstate pacts have gained attention. Several already exist: one each for nurses, doctors, physical therapists and psychologists. Proponents say they are a simple way to ensure state boards retain authority and high standards, while making it easier for licensed medical professionals to expand their geographic range.

The nurses’ compact, enacted by 37 states and Guam, allows registered nurses with a valid license in one state to have it recognized by all the others in the pact.

A different kind of model is the Interstate Physician Licensure Compact, which has been enacted by 33 states, plus the District of Columbia and Guam, and has issued more than 21,000 licenses since it began in 2017, said Robin, of the Federation of State Medical Boards.

While it speeds the paperwork process, it does not eliminate the cost of applying for licenses in each state.

The compact simplifies the process by having the applicant physician’s home state confirm his or her eligibility and perform a criminal background check. If the applicant is eligible, the home state sends a letter of qualification to the new state, which then issues a license, Robin said. Physicians must meet all rules and laws in each state, such as requirements for continuing medical education. Additionally, they cannot have a history of disciplinary actions or currently be under investigation.

“It’s a fairly high bar,” said Robin.

Such compacts — especially if they are bolstered by new legislation at the federal level — could help the advances in telehealth made during the pandemic stick around for good, expanding access to care for both mental health services and medical care across the U.S. “What’s at stake if we get this right,” said Richman at Duke, “is making sure we have an innovative marketplace that fully uses virtual technology and a regulatory system that encourages competition and quality.”

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.

(c)2021 Kaiser Health News. Distributed by Tribune Content Agency, LLC.

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https://www.baltimoresun.com/2021/09/07/telehealths-limits-battle-over-state-lines-and-licensing-threatens-patients-options/feed/ 0 3624646 2021-09-07T12:09:18+00:00 2021-09-07T16:09:18+00:00
To quarantine or not: The hard choices schools are leaving to parents and staff https://www.baltimoresun.com/2021/09/07/to-quarantine-or-not-the-hard-choices-schools-are-leaving-to-parents-and-staff/ https://www.baltimoresun.com/2021/09/07/to-quarantine-or-not-the-hard-choices-schools-are-leaving-to-parents-and-staff/#respond Tue, 07 Sep 2021 11:47:28 +0000 https://www.baltimoresun.com?p=3624925&preview_id=3624925 On the second day of high school in Texas, Natosha Daniels’ 14-year-old daughter went all day without eating because she did not want to remove her mask.

The teen’s school has a couple of thousand students, and the cafeteria was crowded. Plus Round Rock Independent School District outside Austin didn’t require masks, so some students weren’t wearing them. Even her honors biology teacher was maskless.

Daniels said her daughter, who like her is fully vaccinated, is terrified of bringing home the virus because it could infect her 7-year-old sibling, who is too young for a shot.

“She was like, ‘Mama I’m going to pass out,'” said Daniels, a Round Rock Black Parents Association member and former assistant principal in the district.

“Every morning I wake up with knots in my chest, just like, ‘Am I making the right decision, putting myself and my child at risk for my older two to go to school?'” said Daniels, who is immunocompromised. “And my husband was like, ‘Well the option still stands for you to go get an Airbnb and move out’ with my youngest … Do we sacrifice our savings? It’s so hard.”

After a difficult year or more of virtual learning, parents are eager to have their children back in classrooms. But even as the highly transmissible delta variant surges, school districts like Daniels’ aren’t beefing up protocols to prevent infections. Masks aren’t mandated or enforced, according to teachers, parents and officials in several states. Physical distancing is nearly impossible. To top it off, students exposed to COVID may not be required to quarantine despite guidelines from the Centers for Disease Control and Prevention, risking an even more rapid spread among children, the youngest of whom aren’t yet eligible for vaccination.

The CDC advises quarantining up to 14 days for people who have had close contact with an infected person — within 6 feet for at least 15 minutes over a 24-hour period. (It exempts vaccinated people without symptoms.) This summer, the agency drafted an exception for schools: It’s not considered close contact if both the infected and exposed students “correctly and consistently” wore masks. That means an unvaccinated but masked student who was exposed wouldn’t have to quarantine.

But whether school districts follow CDC guidelines is an open question. And, in many cases, counties, states and the CDC don’t issue the same advice.

Even if districts follow CDC guidance, success hinges on whether students consistently wear masks. In Round Rock, for example, quarantine is “strongly” recommended for students and staff members who had close contact with those infected, essentially leaving it up to parents whether to take a child out of school.

“An optional quarantine just doesn’t work,” said Allison Stewart, lead epidemiologist at Williamson County and Cities Health District, which oversees 12 school districts including most Round Rock schools. When not required, “it seems that there’s only a cursory effort to actually identify contacts.” And then only “a cursory effort to quarantine.”

“There is more transmission occurring in a school setting than there is in the community right now,” Stewart said, “which is the exact opposite of what happened last year.”

The nation’s largest school districts are mostly not following the CDC’s close-contact exception for masked students, said Bree Dusseault, an analyst at the Center on Reinventing Public Education who is tracking state and district policies. The center reviewed 100 large and urban school districts and found that most of them gave students who are fully vaccinated and have close contact with an infected student an exemption from quarantine. Some require COVID testing for students to return earlier than recommended, while others exempt those who’ve recently recovered from COVID and, presumably, have antibodies.

“Districts are managing on-the-ground politics,” Dusseault said. “You may find leaders relying less on scientific recommendations and data and more on local preferences” and on “what they’re hearing.”

“We know that masks aren’t perfect,” said Debra Pace, superintendent of the School District of Osceola County in Florida. Fully vaccinated people without symptoms are exempt from quarantine, but Osceola schools require any exposed students to quarantine for four to 10 days, depending on whether they showed symptoms or had a negative test.

“The delta variant is very different,” Pace said. “As much as I hate to quarantine kids, if we don’t quarantine, we risk having to shut a school down, which we absolutely don’t want to do.”

Each school’s decision about who counts as a close contact affects contact tracing, a laborious process officials use to slow the spread of disease. The CDC’s guidance curtails the number of school-based contacts for follow-up. Epidemiologists support the CDC’s approach, said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists. She added that having clear consequences for not wearing masks seems to resonate with parents: Kids who don’t mask up will miss more school.

“So many parents are interested — and I think rightly so — in having their children have in-person learning,” Hamilton said.

But in Round Rock, protocols are squishy in part because state orders and guidelines conflict with federal recommendations. Only after the courts got involved did Round Rock ISD add a strong mask mandate last Thursday — a week into school and after dozens of new positive cases and hundreds of new close contacts among students were reported.

Ben Sterling, president of the local teachers union Education Round Rock, said staffers and students alike are not incentivized to follow COVID rules, particularly related to quarantine. For staff members, one round of quarantine would use all 10 days of personal and sick leave they get annually. Those days roll over, but Sterling knows of teachers with health issues who haven’t banked any. “The ones who are most vulnerable are going to get hit hardest, as per usual,” he said.

Dusseault said Round Rock’s policy is unusual because it’s optional. But the district is hardly alone — neighboring Leander ISD has a similar policy. Round Rock ISD requires anyone who tests positive for COVID or is a probable case to quarantine for 10 days. For close contacts, it’s merely suggested “because parents and students have a right to a free, appropriate public education under the federal law,” said Jenny LaCoste-Caputo, Round Rock ISD’s chief of public affairs and communications.

Leniency about COVID safety doesn’t sit well with Natosha Daniels. “I feel sick” about it, she said. “At best, they are, like, caving to this violent group of right-wing parents and, at worst, it’s like a blatant willingness to increase our community spread.”

Quarantine isn’t required for Round Rock employees because they would have to use personal and sick leave, LaCoste-Caputo said. The board of trustees approved COVID leave only for staff members who test positive.

It is also “just not having the backing of our state government,” said Amy Weir, president of the Round Rock ISD board of trustees.

The Texas legislature did not fund virtual learning, so school districts are covering the costs themselves. Weir said Round Rock ISD is paying $17.5 million to offer virtual learning for students younger than 12, who cannot get vaccinated. For older students, teachers upload handouts of curated lessons.

On the second day of classes, the middle school where Sterling teaches saw its first case. He and another teacher said the student who tested positive was sometimes maskless and around others without masks. Yet, they said, the school told the families of that child’s classmates that no one was a close contact.

The school, they said, is not requiring seating charts, which would help staff members track student movement, nor do school officials know who is vaccinated or unvaccinated, which factors into the school district’s close-contact definition. It’s all handled on the honor system.

“You’re saying, ‘Choose between going to work and quarantining your child for 10 days,'” Daniels said. “This is the world that we are in — creates these systems that leave parents with no choice.”

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.

(c)2021 Kaiser Health News. Distributed by Tribune Content Agency, LLC.

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https://www.baltimoresun.com/2021/09/07/to-quarantine-or-not-the-hard-choices-schools-are-leaving-to-parents-and-staff/feed/ 0 3624925 2021-09-07T11:47:28+00:00 2021-09-07T15:47:28+00:00
Headed away to school? Here’s what students with health issues need to know about insurance https://www.baltimoresun.com/2021/08/26/headed-away-to-school-heres-what-students-with-health-issues-need-to-know-about-insurance/ https://www.baltimoresun.com/2021/08/26/headed-away-to-school-heres-what-students-with-health-issues-need-to-know-about-insurance/#respond Thu, 26 Aug 2021 11:48:41 +0000 https://www.baltimoresun.com?p=3624550&preview_id=3624550 College is a time of transition, but for those managing chronic medical conditions, it may also be the first time they will be wholly responsible for their own health: setting appointments, securing supplies and pharmaceuticals, and monitoring symptoms.

For those heading to schools far from home, it can be especially tricky navigating the complex world of insurance to pay for such crucial care. Coverage networks from back home might not cover a patient’s new doctors or a trip to an urgent care clinic. New plans may not cover the same medicines or procedures.

“Insurance doesn’t make sense to even people in health care,” said Jenna Riemenschneider, director of advocacy and special projects at the Asthma and Allergy Foundation of America.

Ensuring continuity of care and having medical support at school allow students to better pursue their studies and enjoy the college experience, health experts said. They recommend students and their families study up before heading to campus. Make calls to local or university health center providers and secure appropriate insurance to help make a smooth transition.

“You have to do some real due diligence to make sure you have the right protections,” said Erika Emerson, executive director of the Diabetes Leadership Council. “There are some things that are OK to whiff on, like if some things don’t happen and you learn a hard lesson, fine. Health care isn’t one of those things where there is a whole lot of forgiveness for mistakes that can be costly in terms of health outcomes and, certainly, financially.”

Income-based plans

Sam Grover was turning 26 around the time he headed from Utah to New York City for a medical school program. Per federal law, he would no longer be eligible to remain on his parents’ insurance after his birthday.

Grover, who has Type 1 diabetes, needed to be able to pay for his medical supplies, including a continuous glucose monitor, pump and insulin that keep his blood sugar levels in a safe range. After exploring his options, he enrolled in Medicaid, the federal-state health insurance program for low-income Americans.

“Growing up, I never saw myself as someone who would be in need, but then times changed, and I got diabetes, and I turned 26, and I didn’t have a job,” said Grover, who has one year left in medical school before beginning his residency. He said he hopes his work as a doctor will help make good on the help he received as a student from the government-sponsored health program.

Medicaid coverage varies by state. Grover found that Medicaid in Utah didn’t cover continuous glucose monitoring, for example, but he said New York’s program covers all his medical needs.

“It’s been the biggest blessing,” he said, adding that the cost of equipment and supplies to manage diabetes is expensive. “Just knowing that I am able to manage my diabetes while I am a student alleviates a lot of stress and anxiety that comes with having diabetes.”

Medicaid benefits are typically valid only in the state where the plan originates, and not all states have expanded coverage to more adults under the Affordable Care Act. If Medicaid isn’t an option, experts said, individual coverage through ACA insurance exchanges can be good options for students, especially if they can use federal tax credits and subsidies to make those plans more affordable.

As with most insurance options, students must clearly understand whether coverage extends beyond the location of their university, and if it covers specialist care and required medications. They also need to be aware of which ongoing out-of-pocket costs they’re responsible for.

A parent’s insurance

For many students younger than 26, remaining on a parent’s or guardian’s insurance might be the best option. Experts said it is imperative to read the fine print to be certain coverage is comprehensive and extends to where they attend school.

Both of Kathy Przywara’s children have asthma, and one has food allergies. Both left California to attend schools in rural Pennsylvania. After doing research, the family kept both on their existing insurance policy, but they still had to find in-network providers near the two schools.

While they were able to transfer one student’s prescriptions to a national chain pharmacy, that was not an option for the other. Przywara, who is also senior community director for the Asthma and Allergy Foundation of America, worked with a local pharmacy to ensure prescriptions were filled. The pharmacy already had a delivery program in place to the school’s health center, making it easier for students to obtain medications.

Przywara said mail-order pharmaceuticals, if covered by insurance, might also be an option for students. Some insurance covers prescriptions for multiple months of medication.

“Know what’s in your policy and make sure that the things you are going to need are covered,” Przywara said. “It’s important to keep your condition managed. That means access to your physicians and to your medication, or else the financial burden gets worse.”

Despite one’s best efforts, Pryzwara and others cautioned, emergencies can happen. Therefore, it is important for students to determine whether urgent and emergency care centers nearest them are in their network. Under the Affordable Care Act, initial emergency care should be covered but other services might not be.

University-sponsored insurance

Many schools require students to have health insurance and offer university-sponsored plans, said Jake Baggott, a past president of the American College Health Association and an associate vice chancellor of student affairs at the University of Wisconsin-Madison. He said that while some university health programs are equipped to deal with more complex medical issues or diagnostics, others are not. Students need to be clear on the details, such as whether their policy covers off-campus care.

Shay Webb, 22, a University of North Carolina-Wilmington graduate student earning a master’s in clinical research and product development, thought she was covering her bases when she purchased a university-sponsored policy in 2017 as an undergrad. She got the policy to help offset the out-of-pocket expenses for her Type 1 diabetes not covered by a parent’s insurance policy.

After moving onto campus, Webb was diagnosed with rheumatoid arthritis. She believed the student policy would help cover her increasing medical expenses.

Several months later, she learned her claims weren’t being processed. The insurer told her it would not pay the claims because she was not attending class in person even though she had remained a full-time student, lived on campus and had no say in whether classes were online or in person. The online program was part of the university’s effort to simulate the real-world experience of professionals in her field.

“I was just in shock,” Webb said. “No one had ever told me.”

Webb and her family were left with thousands of dollars in unexpected medical bills.

“Unexpected health costs are a tremendous burden,” Baggott said, adding that for students who may be taking on tuition debt, unexpected health costs can make things much more difficult to manage. Baggott and others said students should seek assistance from campus staff members, advocacy organizations or other experts should any issues occur.

The bottom line: Know the details before signing

Before someone commits to an insurance plan, it is important to understand the specific type of plan, which entity is offering it and exactly how coverage works. If problems arise, students should be sure they can switch plans as needed.

The Partnership to Protect Coverage, a consortium of patient advocacy organizations, issued a report stating that insurance rules implemented during the Trump administration have allowed for the proliferation of plans that do not comply with the Affordable Care Act. These plans, such as short-term insurance options and health care sharing ministries, expose enrollees to financial risk, especially people with preexisting and chronic medical conditions.

“Exhaustively look through all of your options. Look through benefit plans. Call providers. Call the insurance company,” said Erin Hemlin, director of health policy and advocacy at Young Invincibles, a group based in Washington, D.C., that focuses on improving the economic security of young adults. “Double- and triple-check to ensure your child is going to be in a plan that is going to be there when they need it.”

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(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.)

(c)2021 Kaiser Health News. Distributed by Tribune Content Agency, LLC.

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