TALLAHASSEE, Fla. — The Florida Supreme Court on Monday paved the way for a ban on abortions after six weeks of pregnancy, before many women know they are pregnant, while also giving voters a chance to remove restrictions in November and restore abortion rights in most cases.

The court that was reshaped by former presidential candidate and Republican Gov. Ron DeSantis ruled 6-1 to uphold the state’s ban on most abortions after 15 weeks of pregnancy, meaning a ban on six weeks could soon take effect. But under a separate ruling, the court allowed a ballot measure on abortions rights to go to voters.

Most abortions are obtained before the 15-week mark, so the current ban does not affect most people seeking abortion. But a six-week ban would likely have a major impact on women seeking abortions in Florida and throughout the South.

DeSantis, who signed the 15-week ban in 2022, appointed five of the court’s seven justices.

The lawsuit challenging the ban was brought by Planned Parenthood, the American Civil Liberties Union and others. They argued the Florida Constitution’s unique privacy clause for more than 40 years has explicitly protected a right to abortion in the state and should remain in force.

Lawyers for the state, however, said when the privacy clause was adopted by voter referendum in 1980, few people understood it would cover abortion. They told the justices the clause was mainly meant to cover “informational privacy” such as personal records and not abortion.

Since the U.S. Supreme Court overturned Roe v. Wade in June 2022, most Republican-controlled states have adopted bans or restrictions on abortions. Every ban has faced a court challenge.

A survey of abortion providers conducted for the Society of Family Planning, which advocates for abortion access, found that Florida had the second-largest surge in the total number of abortions provided since Roe v. Wade was overturned. The state’s data shows that more than 7,700 women from other states received abortions in Florida in 2023.

The neighboring or nearby states of Alabama, Louisiana and Mississippi are among the 14 states with bans now in place on abortion in stages of pregnancy, with limited exceptions. Georgia and South Carolina bar it once cardiac activity can be detected, which is generally considered to be around six weeks into pregnancy.

Associated Press writers Geoff Mulvihill in Cherry Hill, N.J.; Terry Spencer in Fort Lauderdale, Florida; Mike Schneider in Orlando; Curt Anderson in St. Petersburg; and David Fischer in Miami contributed to this report.

One January morning in 2021, Carol Rosen took a standard treatment for metastatic breast cancer. Three gruesome weeks later, she died in excruciating pain from the very drug meant to prolong her life.

Rosen, a 70-year-old retired schoolteacher, passed her final days in anguish, enduring severe diarrhea and nausea and terrible sores in her mouth that kept her from eating, drinking, and, eventually, speaking. Skin peeled off her body. Her kidneys and liver failed. “Your body burns from the inside out,” said Rosen’s daughter, Lindsay Murray, of Andover, Massachusetts.

Rosen was one of more than 275,000 cancer patients in the United States who are infused each year with fluorouracil, known as 5-FU, or, as in Rosen’s case, take a nearly identical drug in pill form called capecitabine. These common types of chemotherapy are no picnic for anyone, but for patients who are deficient in an enzyme that metabolizes the drugs, they can be torturous or deadly.

Those patients essentially overdose because the drugs stay in the body for hours rather than being quickly metabolized and excreted. The drugs kill an estimated 1 in 1,000 patients who take them — hundreds each year — and severely sicken or hospitalize 1 in 50. Doctors can test for the deficiency and get results within a week — and then either switch drugs or lower the dosage if patients have a genetic variant that carries risk.

Yet a recent survey found that only 3% of U.S. oncologists routinely order the tests before dosing patients with 5-FU or capecitabine. That’s because the most widely followed U.S. cancer treatment guidelines — issued by the National Comprehensive Cancer Network — don’t recommend preemptive testing.

The FDA added new warnings about the lethal risks of 5-FU to the drug’s label on March 21 following queries from KFF Health News about its policy. However, it did not require doctors to administer the test before prescribing the chemotherapy.

The agency, whose plan to expand its oversight of laboratory testing was the subject of a House hearing, also March 21, has said it could not endorse the 5-FU toxicity tests because it’s never reviewed them.

But the FDA at present does not review most diagnostic tests, said Daniel Hertz, an associate professor at the University of Michigan College of Pharmacy. For years, with other doctors and pharmacists, he has petitioned the FDA to put a black box warning on the drug’s label urging prescribers to test for the deficiency.

“FDA has responsibility to assure that drugs are used safely and effectively,” he said. The failure to warn, he said, “is an abdication of their responsibility.”

The update is “a small step in the right direction, but not the sea change we need,” he said.

Europe Ahead on Safety

British and European Union drug authorities have recommended the testing since 2020. A small but growing number of U.S. hospital systems, professional groups, and health advocates, including the American Cancer Society, also endorse routine testing. Most U.S. insurers, private and public, will cover the tests, which Medicare reimburses for $175, although tests may cost more depending on how many variants they screen for.

In its latest guidelines on colon cancer, the Cancer Network panel noted that not everyone with a risky gene variant gets sick from the drug, and that lower dosing for patients carrying such a variant could rob them of a cure or remission. Many doctors on the panel, including the University of Colorado oncologist Wells Messersmith, have said they have never witnessed a 5-FU death.

In European hospitals, the practice is to start patients with a half- or quarter-dose of 5-FU if tests show a patient is a poor metabolizer, then raise the dose if the patient responds well to the drug. Advocates for the approach say American oncology leaders are dragging their feet unnecessarily, and harming people in the process.

“I think it’s the intransigence of people sitting on these panels, the mindset of ‘We are oncologists, drugs are our tools, we don’t want to go looking for reasons not to use our tools,’” said Gabriel Brooks, an oncologist and researcher at the Dartmouth Cancer Center.

Oncologists are accustomed to chemotherapy’s toxicity and tend to have a “no pain, no gain” attitude, he said. 5-FU has been in use since the 1950s.

Yet “anybody who’s had a patient die like this will want to test everyone,” said Robert Diasio of the Mayo Clinic, who helped carry out major studies of the genetic deficiency in 1988.

Oncologists often deploy genetic tests to match tumors in cancer patients with the expensive drugs used to shrink them. But the same can’t always be said for gene tests aimed at improving safety, said Mark Fleury, policy director at the American Cancer Society’s Cancer Action Network.

When a test can show whether a new drug is appropriate, “there are a lot more forces aligned to ensure that testing is done,” he said. “The same stakeholders and forces are not involved” with a generic like 5-FU, first approved in 1962, and costing roughly $17 for a month’s treatment.

Oncology is not the only area in medicine in which scientific advances, many of them taxpayer-funded, lag in implementation. For instance, few cardiologists test patients before they go on Plavix, a brand name for the anti-blood-clotting agent clopidogrel, although it doesn’t prevent blood clots as it’s supposed to in a quarter of the 4 million Americans prescribed it each year. In 2021, the state of Hawaii won an $834 million judgment from drugmakers it accused of falsely advertising the drug as safe and effective for Native Hawaiians, more than half of whom lack the main enzyme to process clopidogrel.

The fluoropyrimidine enzyme deficiency numbers are smaller — and people with the deficiency aren’t at severe risk if they use topical cream forms of the drug for skin cancers. Yet even a single miserable, medically caused death was meaningful to the Dana-Farber Cancer Institute, where Carol Rosen was among more than 1,000 patients treated with fluoropyrimidine in 2021.

Her daughter was grief-stricken and furious after Rosen’s death. “I wanted to sue the hospital. I wanted to sue the oncologist,” Murray said. “But I realized that wasn’t what my mom would want.”

Instead, she wrote Dana-Farber’s chief quality officer, Joe Jacobson, urging routine testing. He responded the same day, and the hospital quickly adopted a testing system that now covers more than 90% of prospective fluoropyrimidine patients. About 50 patients with risky variants were detected in the first 10 months, Jacobson said.

Dana-Farber uses a Mayo Clinic test that searches for eight potentially dangerous variants of the relevant gene. Veterans Affairs hospitals use a 11-variant test, while most others check for only four variants.

Different Tests May Be Needed for Different Ancestries

The more variants a test screens for, the better the chance of finding rarer gene forms in ethnically diverse populations. For example, different variants are responsible for the worst deficiencies in people of African and European ancestry, respectively. There are tests that scan for hundreds of variants that might slow metabolism of the drug, but they take longer and cost more.

These are bitter facts for Scott Kapoor, a Toronto-area emergency room physician whose brother, Anil Kapoor, died in February 2023 of 5-FU poisoning.

Anil Kapoor was a well-known urologist and surgeon, an outgoing speaker, researcher, clinician, and irreverent friend whose funeral drew hundreds. His death at age 58, only weeks after he was diagnosed with stage 4 colon cancer, stunned and infuriated his family.

In Ontario, where Kapoor was treated, the health system had just begun testing for four gene variants discovered in studies of mostly European populations. Anil Kapoor and his siblings, the Canadian-born children of Indian immigrants, carry a gene form that’s apparently associated with South Asian ancestry.

Scott Kapoor supports broader testing for the defect — only about half of Toronto’s inhabitants are of European descent — and argues that an antidote to fluoropyrimidine poisoning, approved by the FDA in 2015, should be on hand. However, it works only for a few days after ingestion of the drug and definitive symptoms often take longer to emerge.

Most importantly, he said, patients must be aware of the risk. “You tell them, ‘I am going to give you a drug with a 1 in 1,000 chance of killing you. You can take this test. Most patients would be, ‘I want to get that test and I’ll pay for it,’ or they’d just say, ‘Cut the dose in half.’”

Alan Venook, the University of California-San Francisco oncologist who co-chairs the National Comprehensive Cancer Network, has led resistance to mandatory testing because the answers provided by the test, in his view, are often murky and could lead to undertreatment.

“If one patient is not cured, then you giveth and you taketh away,” he said. “Maybe you took it away by not giving adequate treatment.”

Instead of testing and potentially cutting a first dose of curative therapy, “I err on the latter, acknowledging they will get sick,” he said. About 25 years ago, one of his patients died of 5-FU toxicity and “I regret that dearly,” he said. “But unhelpful information may lead us in the wrong direction.”

In September, seven months after his brother’s death, Kapoor was boarding a cruise ship on the Tyrrhenian Sea near Rome when he happened to meet a woman whose husband, Atlanta municipal judge Gary Markwell, had died the year before after taking a single 5-FU dose at age 77.

“I was like … that’s exactly what happened to my brother.”

Murray senses momentum toward mandatory testing. In 2022, the Oregon Health & Science University paid $1 million to settle a suit after an overdose death.

“What’s going to break that barrier is the lawsuits, and the big institutions like Dana-Farber who are implementing programs and seeing them succeed,” she said. “I think providers are going to feel kind of bullied into a corner. They’re going to continue to hear from families and they are going to have to do something about it.”

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

Elizabeth Bauer was working out at the gym one morning last August when she got a phone call from her fertility nurse. It was a call that Bauer and her wife, Rebecca, had long been waiting for.

Elizabeth dialed in Rebecca so they could listen together: They were pregnant.

The Washington, D.C., couple decided before they got married three years ago that they wanted to have a child. Both wanted to play a biological part in the pregnancy. So, they used a process called reciprocal in vitro fertilization, through which eggs were retrieved from Rebecca and fertilized with donor sperm to create embryos. Then one of the embryos was implanted in Elizabeth’s uterus.

Elizabeth, a 35-year-old elementary school teacher, and Rebecca, a 31-year-old nonprofit consultant, had health insurance, but it wouldn’t cover the roughly $20,000 procedure, so they had to pay out of pocket.

But beginning next year, insurers providing coverage in D.C. will have to pay for IVF for beneficiaries, including same-sex couples, who can’t conceive on their own. Only seven states (Colorado, Delaware, Illinois, Maine, Maryland, New Jersey and New York) have similar mandates. However, a new definition of “infertility” could prompt other states to follow suit.

The American Society for Reproductive Medicine in October expanded the definition of infertility to include all patients who require medical intervention, such as use of donor gametes or embryos, to conceive as a single parent or with a partner. Previously, the organization defined infertility as a condition in which heterosexual couples couldn’t conceive after a year of unprotected intercourse.

The group emphasized the new definition should not “be used to deny or delay treatment to any individual, regardless of relationship status or sexual orientation.”

Dr. Mark Leondires, a reproductive endocrinologist and founder and medical director at Illume Fertility and Gay Parents To Be, said the new definition could make a huge difference.

“It gives us extra ammunition to say, ‘Listen, everybody who meets the definition of infertility, whether it’s an opposite-sex couple or same-sex couple or single person, who wants to have a child should have access to fertility services,’” he said.

At least four states (California, Connecticut, Massachusetts and Rhode Island) are currently weighing broader IVF coverage mandates that would explicitly include same-sex couples, according to RESOLVE: The National Infertility Association. Bills were introduced but failed to advance in Oregon, Washington and Wisconsin.

A recent policy shift at the federal level also might add to the momentum. Earlier this month, the departments of Defense and Veterans Affairs announced expanded IVF service benefits to patients regardless of marital status, sexual orientation or whether they are using donor eggs or sperm. The new policy follows a lawsuit filed in federal court last year.

“The federal government is the largest employer in the country, so if they’re providing these type of benefits, it definitely adds pressure on other employers and states to do the same,” said Betsy Campbell, RESOLVE’s chief engagement officer.

A total of 21 states have laws mandating that private insurers cover fertility treatments, but only 15 include at least one cycle of IVF in that mandate. Only New York and Illinois provide some fertility coverage for people who are insured through Medicaid, the state-federal program for people with low incomes and disabilities. Neither state covers IVF for Medicaid recipients.

100,000 babies

IVF involves collecting mature eggs from ovaries, using donated sperm to fertilize them in a lab, and then placing one or more of the fertilized eggs, or embryos, in a uterus. One full cycle of IVF can take up to six weeks and can cost between $20,000 and $30,000. Many patients need multiple cycles before getting pregnant.

Nearly 100,000 babies in the U.S. were born in 2021 through IVF and other forms of assisted reproductive technology, such as intrauterine insemination, according to federal data.

IVF continues to garner nationwide attention in the wake of the Alabama Supreme Court’s ruling last month that under state law, frozen IVF embryos are children, meaning patients or IVF facilities can be criminally charged for destroying them. The decision caused an uproar, and three weeks later Alabama Republican Gov. Kay Ivey signed a bill into law that provides criminal and civil immunity for IVF clinicians and patients.

Polly Crozier, director of family advocacy at GLBTQ Legal Advocates & Defenders, or GLAD, described the Alabama decision as “a shock to the system.” But Crozier said the reaction to it sparked a “bipartisan realization that family-building health care is important to so many people.”

Crozier praised the insurance mandates in Colorado, Illinois, Maine and Washington, D.C., for more explicitly including LGBTQ+ people. Maine’s law, for example, states that a fertility patient includes an “individual unable to conceive as an individual or with a partner because the individual or couple does not have the necessary gametes for conception,” and says that health insurers can’t “impose any limitations on coverage for any fertility services based on an enrollee’s use of donor gametes, donor embryos or surrogacy.”

Christine Guarda, financial services representative at the Center for Advanced Reproductive Services at the University of Connecticut School of Medicine, said more same-sex couples are seeking help starting families. One reason, she said, is that more large employers that provide insurance directly to their employees, such as Amazon, are including broad IVF coverage.

‘Elective procedure’?

But some lawmakers are skeptical of expanding the definition of infertility to include same-sex couples. That was evident at a hearing on the Connecticut bill earlier this month, where Republican state Rep. Cara Pavalock-D’Amato noted that “infertility isn’t necessarily elective, but having a baby is.”

“Now, we are changing definitions to cover elective procedures,” Pavalock-D’Amato said. “If we’re changing the definition for this elective procedure, then why not others as well?”

She added: “Infertility, whether you are straight or gay, up to this point has been a requirement. Now, is it through this bill that we are no longer requiring people to be sick? They no longer have to be infertile?”

But proponents of the change argue that extending IVF mandates to cover same-sex couples is a question of fairness.

“I don’t think anybody in the LGBTQ community is asking for more. They’re just asking for the same benefit, and it is discriminatory to say, ‘You don’t get the same benefit as your colleague simply because you have a same-sex partner,’” Leondires said in an interview.

“If you’re paying to the same health care system as the person sitting next to you, then you should have the same benefit,” he said.

Elizabeth and Rebecca Bauer, who are busy decorating a nursery and buying baby clothes, recognize that they were fortunate to have the money to pursue IVF even without insurance coverage, and that “there are plenty of people who don’t have the time or the ability.”

“There are so many ways that people who want to build a family might struggle,” Elizabeth said, adding that the previous infertility definition felt like a “pretty impossible barrier” for non-straight couples. “Insurance should make building a family possible for any person or persons who want to.”

Stateline is part of States Newsroom, a national nonprofit news organization focused on state policy.

©2024 States Newsroom. Visit at stateline.org. Distributed by Tribune Content Agency, LLC.

Online stores sprang up during the COVID-19 pandemic’s telehealth boom touting testosterone as a cure-all for men’s age-related illnesses — despite FDA rules issued years ago restricting such “low testosterone” advertising.

In ads on Google, Facebook, and elsewhere, testosterone telemedicine websites may promise a quick fix for sluggishness and low libido in men. But evidence for that is lacking, physicians said, and the midlife malaise for which testosterone is being touted as a solution is more likely caused by chronic medical conditions, poor diet, or a sedentary lifestyle. In fact, doctors urge caution— and the FDA recommends that all testosterone supplements carry a warning that they may increase the risk of heart attack and stroke.

Valid medical reasons do exist for treating some men with testosterone. The hormone as a medication has existed for decades, and today’s patients include men with hypogonadism, some transgender men who use it to help transition physically, and, sometimes, women dealing with menopausal symptoms. It has also been used for decades by bodybuilders and athletes to enhance strength.

However, online dispensaries can overplay the idea of what is sometimes called “male menopause,” or even “manopause,” to drive sales of highly profitable testosterone-boosting injectables, often ignoring safety guidelines that should prevent healthy men from using the hormone. Some of the websites target military veterans.

“I have seen ads online that do cross the line,” said Steven Nissen, a physician and the chief academic officer for the Heart, Vascular, and Thoracic Institute at the Cleveland Clinic. “For mood and low energy, prescribing testosterone provides little to no benefit. They are promoting testosterone for indications that are not on the label.”

Testosterone telehealth websites almost all cite one study published in 2002 by New England Research Institutes scientists who found testosterone levels drop 1% a year in men over 40. Stefan Schlatt, director of the Center for Reproductive Medicine and Andrology at the University of Muenster in Germany, said the data behind the statistic included older men in deteriorating health whose levels declined because of illnesses.

“Healthy men do not show a drop,” he said.

That 2002 study led to a flood of “low-T” ads on U.S. television — ads that were later banned by the FDA in a 2015 ruling that accused the pharmaceutical industry of exaggerating the low-T phenomenon to scare men into buying drugs. According to another study, the market for testosterone supplements stood at $1.85 billion in 2023.

The deluge of ads “has fueled demand for a largely uninsured product, allowing for high markups,” said Geoffrey Joyce, director of health policy at the USC Schaeffer Center for Health Policy & Economics and a research associate at the National Bureau of Economic Research. “The primary driver is manufactured demand.”

Barbara Mintzes, a professor of evidence-based pharmaceutical policy at the University of Sydney’s Charles Perkins Centre in Australia, said low testosterone should really be seen as a sign of a condition that needs to be treated. She said diabetes, heart disease, high blood pressure, obesity, exposure to toxic chemicals like PFAS, and stress can all reduce testosterone levels.

Male Excel’s ads on Google, for example, say TRT “improves mood” and “restores vitality.” And its site says testosterone treatment will provide “muscular definition,” “weight loss,” “explosive drive,” “deeper sleep,” and “restored energy” above a link to a free assessment on its online telehealth platform. Craig Larsen, the company’s CEO, did not reply to several attempts to contact him by phone and email.

Both Male Excel and Hone Health are among the sites that pitch to military veterans. Hone Health included a video of a veteran who said he was refused testosterone treatment by a Department of Veterans Affairs hospital.

Saad Alam, CEO and co-founder of Hone, said that his company is what he called a “conservative” player in the market. He said that Hone prescribes only to men who are hypogonadal and tests men every 90 days, unlike other companies that operate telehealth websites as what he called a “cash grab.”

“I agree that patients should be treated by their doctors. But the U.S. medical system isn’t at a point where it can service men who have this problem, and some endocrinologists would rather treat patients who are higher-profit,” Hone said. “That’s why people are coming to us.”

One popular form of TRT is injectable testosterone cypionate. According to the Medicare average sales price database, it costs $0.027 per milligram. Online purveyors who sell the drug directly to consumers in 200 mg/mL vials for an average price of $129 per month are charging the equivalent of $1.55 per mg — a markup of more than 50 times the average Medicare price.

According to a 2022 study, the TRT telehealth websites create a way to circumvent doctors who refuse to prescribe the hormone. In that study, Justin Dubin, a urologist at the Memorial Healthcare System in Florida, posed as an online mystery shopper. He reported an above-normal testosterone level, and stated his desire to start a family, even though such therapy can curb sperm production. But six of the seven unnamed online TRT clinics prescribed him testosterone via a medical professional.

“And that’s concerning,” Dubin said. “Telemedicine helps men with hypogonadism who might be too embarrassed to discuss erectile dysfunction. But we need to do a better job of understanding the appropriateness of care.”

Still, while the FDA doesn’t allow off-label marketing, it does allow such off-label prescriptions.

Off-label use of testosterone replacement has become especially commonplace among veterans. And among male service members who received TRT in 2017, fewer than half met the clinical practice guidelines, according to a report by the U.S. military.

Phil Palmer, a 41-year-old Marine Corps veteran who lives outside Charleston, South Carolina, said he pays out-of-pocket for bloodwork and prescriptions for a pellet skin-implant form of testosterone and for clomiphene, a drug that can help counter the male infertility that is a side effect of testosterone treatment. He said the treatment appeals to him and other veterans dealing with the aftermath of military service.

“The environment we served in and stress levels have a lot to do with it,” Palmer said. “We were exposed to burn pits. The military doesn’t teach you to eat well — we ate a lot of processed food.”

In medical settings, TRT can speed recovery of soldiers who have bone density issues or spinal cord injuries, said Mark Peterson, a professor of physical medicine and rehabilitation at the University of Michigan Medical School. But, he said, “for men in the normal-T range, using an online prescription to buy testosterone to reduce stomach fat can be counterproductive.”

Those who use it also risk having to take testosterone medication indefinitely, because TRT can cause the body to cease its own production of the hormone.

Palmer, who founded a nonprofit that helps veterans heal through exercise, nutrition, and mentorship, said the medication has been helpful for him but urges fellow veterans to seek care from their doctors rather than what he called “bro science” websites touting testosterone.

“It’s not a magic pill,” he said.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

Billy Abbott, a retired Army medic, wakes at 6 every morning, steps on the bathroom scale, and uses a cuff to take his blood pressure.

The devices send those measurements electronically to his doctor in Gulf Shores, Alabama, and a health technology company based in New York, to help him control his high blood pressure.

Nurses with the company, Cadence, remotely monitor his readings along with the vital signs of about 17,000 other patients around the nation. They call patients regularly and follow up if anything appears awry. If needed, they can change a patient’s medication or dosage without first alerting their doctor.

Abbott, 85, said he likes that someone is watching out for him outside his regular doctor appointments. “More doctors should recommend this to their patients,” he said.

Increasingly, they are.

Dozens of tech companies have streamed in, pushing their remote monitoring service to primary care doctors as a way to keep tabs on patients with chronic illnesses and free up appointment time, and as a new source of Medicare revenue.

But some experts say remote monitoring’s huge growth — spurred on during the covid-19 pandemic, when patients were hesitant to sit in crowded doctors’ waiting rooms — has outpaced oversight and evidence of how the technology is best used.

“It is the wild West where any patient can get it if a doctor decides it is reasonable or necessary,” said Caroline Reignley, a partner with the law firm McDermott Will & Emery who advises health providers.

In 2019, Medicare made it easier for doctors to bill for monitoring routine vital signs such as blood pressure, weight, and blood sugar. Previously, Medicare coverage for remote monitoring was limited to certain patients, such as those with a pacemaker.

Medicare also began allowing physicians to get paid for the service even when the monitoring is done by clinical staff who work in different places than the physician — an adjustment advocated by telemedicine companies.

In just the first two full years, remote monitoring services billed to Medicare grew from fewer than 134,000 to 2.4 million in 2021, according to federal records analyzed by KFF Health News.

Total Medicare payments for the four most common billing codes for remote monitoring rose from $5.5 million in 2019 to $101.4 million in 2021, the latest year for which data is available.

Part of the allure is that Medicare will pay for remote monitoring indefinitely regardless of patients’ health conditions as long as their doctors believe it will help.

For doctors with 2,000 to 3,000 patients, the money can add up quickly, with Medicare paying an average of about $100 a month per patient for the monitoring, plus more for setting up the device, several companies confirmed.

Medicare enrollees may face 20% in cost sharing for the devices and monthly monitoring, though certain private plans through Medicare Advantage and Medicare supplement policies may cover those costs. The government allowed insurers to waive the patient cost sharing during the pandemic.

About 400 doctors and other providers repeatedly billed Medicare for remote patient monitoring in 2019. Two years later, that had mushroomed to about 3,700 providers, according to Medicare data analyzed by KFF Health News. (The data tracks providers who billed more than 10 patients for at least one type of remote monitoring.)

Federal law enforcement officials say they are conducting investigations after a surge in complaints about some remote patient monitoring companies but would not provide details.

The Department of Health and Human Services’ Office of Inspector General in November issued a consumer alert about companies signing up Medicare enrollees without their doctors’ knowledge: “Unscrupulous companies are signing up Medicare enrollees for this service, regardless of medical necessity,” and bill Medicare even when no monitoring occurs.

In a statement to KFF Health News, Meena Seshamani, director of the federal Center for Medicare, part of the Centers for Medicare & Medicaid Services, did not say how CMS is ensuring only patients who can benefit from remote monitoring receive it. She said the agency balances the need to give patients access to emerging technology that can improve health outcomes with the need to combat fraud and make proper payments to providers.

While some small studies show remote monitoring can improve patient outcomes, researchers say it is unclear which patients are helped most and how long they need to be monitored.

“The research evidence is not as robust as we would like to show that it is beneficial,” said Ateev Mehrotra, a Harvard Medical School researcher.

A January report by the Bipartisan Policy Center, a Washington, D.C.-based think tank, warned about “a lack of robust evidence on the optimal use of remote monitoring” and said some policy and medical experts “question whether we are effectively ‘rightsizing’ the use of these services, ensuring access for patients who need it most, and spending health care dollars in effective ways.”

Denton Shanks, a medical director at the American Academy of Family Physicians, said remote monitoring helps patients manage their diseases and helps physician practices be more efficient. He has used it for the past two years as a doctor at the University of Kansas Health System.

It has worked well, he said, though sometimes it can be challenging to persuade patients to sign up if they have to pay for it.

“For the vast majority of patients, once they are enrolled, they see a benefit, and we see a benefit as their vital signs come in the normal range,” Shanks said.

The size of the market is tantalizing.

About two-thirds of the more than 66 million Medicare beneficiaries have high blood pressure, the most common metric monitored remotely, according to physicians and the monitoring companies.

“The patient need is so enormous,” Cadence CEO Chris Altchek said. The company has about 40 nurses, medical assistants, and other providers monitoring patients in 17 states. He said patients enrolled in remote monitoring experience a 40% reduction in emergency room visits. Cadence says 82% of its patients use the devices at least once every two days.

Timothy Mott, a family physician in Foley, Alabama, said valuable appointment times in his office open up as patients who previously needed vital signs to be checked there turn to remote monitoring.

Cadence nurses regularly contact Mott’s patients and monitor their readings and make changes as needed.

“I was concerned early on whether they were going to make the right decisions with our patients,” Mott said. “But over time the dosage changes or changes in medication they are making are following the best guidelines on effectiveness.”

At the six-month mark, about 75% of patients have stayed with the monitoring, Mott said.

The advantages are apparent even to some providers who do not get paid by Medicare to offer the service. Frederick Health, a Maryland health system, provides remote monitoring to 364 high-risk patients and estimates the program saves the nonprofit system $10 million a year by reducing hospital admissions and ER visits. That estimate is based on comparisons of patients’ Medicare claims before they started the program and after, said Lisa Hogan, who runs the program.

The hospital pays for the program and does not bill Medicare, she said.

___

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

A recent tweak to a Medicaid formula could be behind the shake-up to inhaler products, a series of changes that have both benefited and harmed patients with asthma and chronic obstructive pulmonary disease, or COPD.

Three of the four major inhaler manufacturers have announced plans to cap patient copays for all their inhalers at $35 a month in recent weeks, in addition to lowering the list prices of some of those products. But one drugmaker also withdrew two popular children’s inhalers from the market, and the alternative is in short supply.

Boehringer Ingelheim, AstraZeneca PLC and GlaxoSmithKline, also known as GSK PLC, all announced the $35 monthly copay cap, which could significantly extend the impact of their current patient assistance programs. The companies have simultaneously cut list prices — the initial price before health plans negotiate discounts and rebates — for some, but not all, of their inhalers.

The drug companies say they’ve made the changes because they’re committed to helping patients. Some Democrats on Capitol Hill say it happened because of public pressure. But some drug pricing experts are pointing to a recent change in the formula of Medicaid’s mandatory drug rebate program as the reason. It’s the same reason experts pointed to when insulin manufacturers lowered their list prices, although those reductions were more widespread.

The rebate change can force drugmakers to actually pay Medicaid in some cases if list prices on older products outpace inflation. The effect is less severe on asthma products than it was on insulin, thanks to a 2009 ban on chlorofluorocarbons, a common propellant in old inhalers, that resulted in a wave of new inhalers with new patents.

Because the change to the Medicaid rebate formula penalizes older drugs with higher prices the most, the newer inhalers are less affected than older insulin products.

“They’re still playing the same game,” said Anna Kaltenboeck, a former Senate Finance Committee staffer under Oregon Democrat Ron Wyden who now leads ATI Advisory’s Prescription Drug Reimbursement Practice. “It just brought the ceiling on the game down a little bit. And they’re sort of diffusing it vis-a-vis the patients by giving them these copay coupons.”

The rebate change is tied to the change in list prices, though, not copays. Copay caps are important because they limit what patients pay — including, at least in this case, uninsured patients — but reducing list prices helps cut behind-the-scenes costs that are absorbed by the health care system.

The rebate change took effect in January. GlaxoSmithKline in January reduced the list price for its Advair Diskus and Advair HFA inhalers, while AstraZeneca also reduced the list price of Symbicort. Boehringer Ingelheim is also planning to cut the list prices for Spiriva HandiHaler and Atrovent HFA.

Other factors like Medicare’s new penalty for raising prices faster than inflation could also be driving the changes.

“Inhalers are prime examples, like insulin, of products where manufacturers have raised list prices over very long periods of time,” said Will Feldman, a pulmonary doctor with Brigham and Women’s Hospital and an instructor at Harvard Medical School.

He pointed to Boehringer Ingelheim’s decision to drop list prices on Spiriva HandiHaler, an older inhaler that now faces generic competition, and not its newer product, Spiriva Respimat.

“That product is far less likely to be impacted by the Medicaid rebate cap policy change than Spiriva HandiHaler,” he said.

Both Boehringer Ingelheim and AstraZeneca refuted the idea that the Medicaid rebate was behind the decision to cut list prices.

“We continually look at market dynamics to assess what more we can do to address barriers to access and affordability of our medicines to help patients living with respiratory diseases lead healthier lives,” an AstraZeneca spokesperson said.

Not all the developments were positive for patients. GlaxoSmithKline in January also discontinued Flovent HFA and Flovent Diskus, two of the few inhalers approved for children. Insurance coverage for the authorized generics can vary, and the only other major alternative, Organon’s Asmanex, is now in shortage because of increased demand.

“It is the perfect storm of what is wrong with our pharmaceutical system,” Feldman said. “And the end result is patients in some cases are suffering and not getting the products they need.”

GlaxoSmithKline did not say whether the rebate was the driving factor behind its pricing changes or the decision to discontinue the two inhalers, saying it “had been planning to discontinue the branded products for some time.”

“The price reductions build on our strong track record of increasing access and improving the affordability of its medicines including an ongoing commitment to responsible pricing,” a company spokesperson said.

Capping patient copays could greatly increase access to consumers as well, even though the drugmakers already offer patient assistance programs. Kaltenboeck pointed to the ongoing access issues for insulin despite the insulin makers’ long-standing assistance programs.

“We know that people were dying because they weren’t getting insulin,” she said, “which suggests to me that copay coupons and patient assistance programs aren’t reaching people to the extent that you want them to be reached.”

Public pressure

Senate Health, Education, Labor and Pensions Chairman Bernie Sanders, I-Vermont, singled out the four major manufacturers in January as part of an investigation into inhaler prices. On Friday, he took a victory lap in the wake of the drugmakers’ announcements to cap copays, saying “they’re beginning to catch on to the fact that the American people are sick and tired of paying astronomical prices for the prescription drugs they need to stay alive.”

He acknowledged that the companies are only lowering list prices on some products but stressed the importance of the copay caps to patients. He also attributed the drug companies’ announcements to the committee’s investigation and public backlash, rather than Medicaid’s rebate program.

“In this instance, we think it’s public pressure,” he said.

Additionally, Sanders urged the last of the four major manufacturers that hasn’t capped copays, Teva Pharmaceutical Industries Ltd., to follow suit. The company is smaller and more focused on generics, he said, but he hoped Teva executives would come around.

“They are considering it,” he said.

Teva did not respond to requests for comment.

In November, the Federal Trade Commission warned a number of drugmakers, including Teva and the other major inhaler manufacturers, that they had improperly listed patents in the Food and Drug Administration’s registry known as the Orange Book, which can help block competition from generic rivals.

Teva was one of several companies that refused to pull any of the patents the FTC challenged. On Friday, the FTC took another step against the manufacturer, filing an amicus brief in a patent infringement suit Teva brought against Amneal Pharmaceuticals Inc. for attempting to bring a generic version of its ProAir HFA to market. The FTC argues the patents that Teva is claiming are improperly listed.

The issues underscore the broader dynamics that lawmakers and regulators still face in unwinding the tangled drug pricing system. The copay caps are good for patients, Feldman said, but not nearly enough.

“It’s a Band-Aid on a problematic drug pricing system in our country,” he said.

The post Experts say Medicaid rebate change is behind inhaler price cuts appeared first on Roll Call.

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Healthy Rural California, a nonprofit born of the Butte-Glenn Medical Society, announced the inaugural class for a residency program for psychiatrists in training who will come to Chico next year — when a second residency program launches for family medicine. HRC is exploring another residency, for internal medicine physicians, that could follow.

Thursday’s reveal culminated a process that began in 2019 involving a range of partners including Butte County Behavioral Health, Enloe Health and Assemblyman James Gallagher’s office, all represented at the announcement. Propelled by a $1.8 million state grant, HRC developed programs certified by the Accreditation Council for Graduate Medical Education.

“It’s important to do something to stabilize our medical community,” said Dr. Sean Maiorano, chief medical officer at Enloe Health. “We’re at a really unique opportunity (point) to grow our own and provide for our community and surrounding communities.”

Kristy Bird MaKieve, executive director of the Butte-Glenn Medical Society and CEO of HRC, introduced the first class of residents, who she nicknamed “the Fab Four” and noted all have connections to Northern California. Dr. Jasmine Gill is from El Sobrante; Dr. Leandra Padayachee, from Sacramento; Dr. Mira Parekh, Palo Alto, studying at UC Davis; and Dr. Nicole Wiecks, Sonoma County.

“These are pioneers,” MaKieve said.

The new program drew 500 residents from around the world — “Mind-blowing,” Maiorano said — and interviewed 50. The four selected will come to Chico for an orientation June 17, spend a year in Sacramento, then return for two years with Butte County Behavioral Health and the wrap-up of their four-year residency. Four family medicine residents will join them next year for three years of training, all in the north state.

Once both programs have full complements, Chico will host 28 residents a year with an economic impact of $5 million to $6 million. But that’s not the primary benefit; Scott Kennelly, director of Butte County Behavioral Health, explained that 50% of residents stay to practice where they train.

The residencies already are boosting recruitment: Kennelly said multiple candidates chose to come here after expressing, “I want to teach. I want to give back.” Maiorano sees the same enthusiasm among his hospital’s medical staff.

That’s particularly important because rural areas such as the north state feel the shortage of health care providers most acutely. Primary care and psychiatry are particular needs. Kennelly noted his department had 10 in-person psychiatrists before the Camp Fire, COVID pandemic and retirements depleted the ranks. Now, Behavioral Health relies on telemedicine. A residency program provides what Maiorano describes as “a place to land” for up-and-coming doctors.

HRC is exploring the addition of internal medicine and the potential for other education programs, such as partnering with Chico State’s nursing school.

“Lots of good things ahead,” Makieve said.

Almost all new parents go through it: the distress of hearing their child scream at the doctor’s office. They endure the emotional torture of having to hold their child down as the clinician sticks them with one vaccine after another.

“The first shots he got, I probably cried more than he did,” said Remy Anthes, who was pushing her 6-month-old son, Dorian, back and forth in his stroller in Oakland, California.

“The look in her eyes, it’s hard to take,” said Jill Lovitt, recalling how her infant daughter Jenna reacted to some recent vaccines. “Like, ‘What are you letting them do to me? Why?’”

Some children remember the needle pain and quickly start to internalize the fear. That’s the fear Julia Cramer witnessed when her 3-year-old daughter, Maya, had to get blood drawn for an allergy test at age 2.

“After that, she had a fear of blue gloves,” Cramer said. “I went to the grocery store and she saw someone wearing blue gloves, stocking the vegetables, and she started freaking out and crying.”

Pain management research suggests that needle pokes may be children’s biggest source of pain in the health care system. The problem isn’t confined to childhood vaccinations either. Studies looking at sources of pediatric pain have included children who are being treated for serious illness, have undergone heart surgeries or bone marrow transplants, or have landed in the emergency room.

“This is so bad that many children and many parents decide not to continue the treatment,” said Stefan Friedrichsdorf, a specialist at the University of California-San Francisco’s Stad Center for Pediatric Pain, speaking at the End Well conference in Los Angeles in November.

The distress of needle pain can follow children as they grow and interfere with important preventive care. It is estimated that a quarter of all adults have a fear of needles that began in childhood. Sixteen percent of adults refuse flu vaccinations because of a fear of needles.

Friedrichsdorf said it doesn’t have to be this bad. “This is not rocket science,” he said.

He outlined simple steps that clinicians and parents can follow:

• Apply an over-the-counter lidocaine, which is a numbing cream, 30 minutes before a shot.
• Breastfeed babies, or give them a pacifier dipped in sugar water, to comfort them while they’re getting a shot.
• Use distractions like teddy bears, pinwheels, or bubbles to divert attention away from the needle.
• Don’t pin kids down on an exam table. Parents should hold children in their laps instead.

At Children’s Minnesota, Friedrichsdorf practiced the “Children’s Comfort Promise.” Now he and other health care providers are rolling out these new protocols for children at UCSF Benioff Children’s Hospitals in San Francisco and Oakland. He’s calling it the “Ouchless Jab Challenge.”

If a child at UCSF needs to get poked for a blood draw, a vaccine, or an IV treatment, Friedrichsdorf promises, the clinicians will do everything possible to follow these pain management steps.

“Every child, every time,” he said.

It seems unlikely that the ouchless effort will make a dent in vaccine hesitancy and refusal driven by the anti-vaccine movement, since the beliefs that drive it are often rooted in conspiracies and deeply held. But that isn’t necessarily Friedrichsdorf’s goal. He hopes that making routine health care less painful can help sway parents who may be hesitant to get their children vaccinated because of how hard it is to see them in pain. In turn, children who grow into adults without a fear of needles might be more likely to get preventive care, including their yearly flu shot.

In general, the onus will likely be on parents to take a leading role in demanding these measures at medical centers, Friedrichsdorf said, because the tolerance and acceptance of children’s pain is so entrenched among clinicians.

Diane Meier, a palliative care specialist at Mount Sinai, agrees. She said this tolerance is a major problem, stemming from how doctors are usually trained.

“We are taught to see pain as an unfortunate, but inevitable side effect of good treatment,” Meier said. “We learn to repress that feeling of distress at the pain we are causing because otherwise we can’t do our jobs.”

Meier said she thinks the campaign to reduce needle pain and anxiety should be applied to everyone, not just to children.

“People with dementia have no idea why human beings are approaching them to stick needles in them,” she said. And the experience can be painful and distressing.

Friedrichsdorf’s techniques would likely work with dementia patients, too, she said. Numbing cream, distraction, something sweet in the mouth, and perhaps music from the patient’s youth that they remember and can sing along to.

“It’s worthy of study and it’s worthy of serious attention,” Meier said.

This article is from a partnership that includes KQED , NPR , and KFF Health News .

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

COVID-19 can damage your heart, even when the virus doesn’t directly infect cardiac tissue. That’s the latest from a recent study supported by the National Institutes of Health.

Published in the journal Circulation, the study observed the damaged hearts of patients with acute respiratory distress syndrome associated with the virus and determined that COVID-19 patients suffering from severe lung infections were at risk of heart damage. The findings may prove to be relevant to organs other than the heart and to viruses other than COVID-19, as well.

COVID-19 increases a person’s risk of heart attack and stroke. In fact, more than 50% of COVID-19 patients experience some inflammation or damage to the heart, according to imaging research.

But does the virus damage the heart because it directly infects heart tissue or because of systemic inflammation? The answer might save lives.

“This was a critical question and finding the answer opens up a whole new understanding of the link between this serious lung injury and the kind of inflammation that can lead to cardiovascular complications,” Michelle Olive, Ph.D., told the NIH. “The research also suggests that suppressing the inflammation through treatments might help minimize these complications.” Olive is associate director of the Basic and Early Translational Research Program at the National Heart, Lung, and Blood Institute.

To answer the question, researchers studied mice subjected to biological signals that mimicked lung inflammation.

©2024 The Atlanta Journal-Constitution. Visit at ajc.com. Distributed by Tribune Content Agency, LLC.

Being a newcomer at the time, I decided to get a sense of what was considered newsworthy and important by tracking age-related happenings in the print media. I clipped articles from four daily newspapers and occasional periodicals, cut and pasted them (literally) on a sheet of paper, noted the source and date, punched three holes in the single sheet of paper and inserted the sheet into a three-ring binder. (Yes, this is history.) In addition to reading research studies and reports, I felt this was one way to be informed about what was happening “on the ground.” 

In year one, I barely filled one binder. As time passed, I was filling three to four binders a year. Enter the Internet. Cut and past became digital. Today, there is not a day that goes by in print or digital news that does not have several age-related stories. These stories cover public policy, health, longevity, nutrition, ageism, life extension, scientific discoveries, anti-aging, senior housing, products, services and more. 

With more people living longer and with greater needs and opportunities, the explosion of age-related information will only grow. 

Here is a snapshot of 5 areas of aging that are filling print and digital media, podcasts, webinars and reports that are commanding our attention. Note this is a bird’s eye overview from just one person’s perspective and is not based on formal analytics.  

Products: Let’s just focus on a few assistive technology products that help older adults age in their own residence as safely and independently as possible. Smart stoves and ovens can be set to turn off after five minutes of inactivity. Smart pill organizers dispense pills, others use lights to signal which pills to take (Carroself) and how many (Elliegrid). Activity-based sensors can detect if someone is not getting out of bed, opening the refrigerator door or medicine cabinet. (Sensors). 

Management practices: There are now five generations in the workforce, a first in modern history. According to Forbes magazine, a multigenerational workforce is a competitive advantage for several reasons. It is reported to increase productivity, support innovation and drive creative solutions. It provides learning/mentoring opportunities, enhances knowledge transfer and retention and contributes to job satisfaction according to the Academy to Innovate HR.

Appearances: More older notables are proud of their untouched appearances, essentially meaning no cosmetic surgery. “My mother was a great beauty and never succumbed to plastic surgery. She thought it was best to grow old gracefully. I feel the same,” Sigourney Weaver said in an interview last year with El País. For many, retaining one’s natural gray hair is one indicator of aging naturally.

Retirement planning: This popular subject can be foreboding. AARP reports that nearly half of those age 55 and older have no retirement savings. And nearly half (46 percent) of American households have no retirement savings in retirement accounts. Four in 10 workers are projected to fall short of what they need in retirement. 

Where to live: There currently are over 30,000 assisted living communities in the U.S. The need will continue to grow as 70 percent of older adults are predicted to need some kind of care in their lifetime. That care comes with a price tag of just over $57,000 median annual cost in 2023. https://www.seniorliving.org/companies/statistics/ This industry brings in just over $94 billion in revenue. 

Here’s an added fact. The magazine published by AARP (which was previously called “Modern Maturity”) reaches just over 38 million readers, making it the magazine with the largest circulation in the U.S.  

The broad field of aging continues to attract entrepreneurs, students, businesspeople, policymakers, researchers, scientists and more. As the population ages, the stakeholders will only continue to grow with most looking for ways to age well with a sense of stability, health and possibilities. 

Stay well everyone and know every act of kindness counts. 

Helen Dennis is a nationally recognized leader on issues of aging and the new retirement with academic, corporate and nonprofit experience. Contact Helen with your questions and comments at Helendenn@gmail.com. Visit Helen at HelenMdennis.com and follow her on facebook.com/SuccessfulAgingCommunity