Category: Health and Fitness

Health Plans No Longer Have to Cover Preventive Care at No Cost. Here’s What to Know.

A ruling by a federal judge this week could set up yet another Supreme Court challenge to the Obamacare health law.

FDA Evaluates ‘Safety Concerns’ Over Dental Devices Featured in KHN-CBS Investigation

In the wake of a KHN-CBS News investigation, the FDA on Thursday said it is “evaluating safety concerns” over the use of a dental appliance that multiple lawsuits allege caused grievous harm to patients.

The federal agency told the public in a “safety communication” posted on its website that it is looking not only at that product, the Anterior Growth Guidance Appliance, or AGGA, but other similar dental devices as well, including the Anterior Remodeling Appliance, or ARA, identified in a recent KHN and CBS News article.

The FDA said it is “aware of reports of serious complications with use of these devices” and asked that patients and health care providers report any complications experienced with them to the agency.

The agency said it is aware the devices have been used to treat conditions including sleep apnea and temporomandibular joint disorder of the jaw, also known as TMD or TMJ, but noted that “the safety and effectiveness of these devices intended for these uses have not been established.”

The AGGA device alone has been fitted on more than 10,000 dental patients, according to court records. 

The KHN-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device — plus attorneys who said they represent or have represented at least 23 other patients — and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices. The FDA confirmed Thursday that the devices “are not cleared or approved by the FDA.”

The AGGA’s inventor, Tennessee dentist Dr. Steve Galella, has said in a sworn court deposition that the AGGA was never submitted to the FDA, which he believes wouldn’t have jurisdiction over it.

At least 20 AGGA patients have in the past three years filed lawsuits against Galella and other defendants claiming the AGGA did not — and cannot — work. Plaintiffs allege that instead of expanding their jawbones, the AGGA left them with damaged gums, loose teeth, and eroded bone.

Additionally, KHN and CBS News reported that the Las Vegas Institute, a company that previously taught dentists to use the AGGA, now trains dentists to use another device its CEO has described as “almost exactly the same appliance.” That one is called the Anterior Remodeling Appliance, or ARA.

KHN and CBS News reached out Thursday to attorneys for Galella, the Las Vegas Institute, and the manufacturers of the AGGA and the ARA but received no immediate response.

Galella has declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, previously said in a written statement that the AGGA “is safe and can achieve beneficial results.”

All the AGGA lawsuits are ongoing. Galella and the other defendants have denied liability in court filings. Cara Tenenbaum, a former senior policy adviser in the FDA’s device center, said reports of complications from these devices are of critical importance and can be submitted through FDA’s MedWatch portal.

“Whether that’s a dentist, an orthodontist, a surgeon, a patient, family member, or caregiver,” Tenenbaum said in a recent interview, “anyone can and should submit these reports so the FDA has a better understanding of what’s happening.”

In a court deposition, Galella said he personally used the AGGA on more than 600 patients and has for years trained other dentists how to use it. In video footage of one training session, produced in discovery in an AGGA lawsuit, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “remodel” forward, making them more attractive and “curing” common ailments, such as sleep apnea and TMJ.

“It’s OK to make a crapload of money,” Galella told dentists in the video. “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.”

In its Thursday announcement, the FDA said it is aware the devices have been used “to remodel the jaw in adults” but pointed out that devices like these called “fixed (non-removable) palatal expanders” are generally used on children and adolescents, “whose upper jaw bones are not yet fused.” By contrast, the FDA said, “an adult’s upper jaw bones are fused, and when a fixed palatal expansion device applies force, the palate is resistant to expansion. If forces are applied incorrectly to the teeth, serious complications can occur including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss.”

Patients interviewed by KHN and CBS News described experiencing many of those problems. One patient who has sued, former professional clarinetist Boja Kragulj, said specialists later had to pull her four front teeth. She now wears false teeth.

Reached Thursday, Kragulj said: “While it’s too late for me and many others, there is some comfort in knowing the FDA is investigating the AGGA/ARA/ORA product and its claims. I hope other patients are spared the injuries and lost years that many of us have now suffered.”

The FDA said it plans “to investigate potential violations” in connection with the use of the devices, and that it is “identifying and contacting responsible entities to communicate [its] concerns.”

The American Dental Association, which has 159,000 dentist members, said it “will inform dentists of the FDA’s evaluation, and will continue to monitor for FDA updates regarding these devices and issues.”

Readers and Tweeters Are Horrified by Harm Tied to Dental Device

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

Teeth-Gnashing History Repeats Itself

In reading about the AGGA (Anterior Growth Guidance Appliance) dental appliance and the associated problems (“This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth,” March 1), I noted in your article no reference to a similar problem with the proplast-teflon product to treat TMJ, or temporomandibular joint disorder, from the 1980s and ’90s, which caused equivalent damages. It amazes me that essentially the same story happened again. The proplast-teflon product even resulted in congressional-level investigations. And the product was summarily removed by FDA order throughout the United States.

Thank you for your good investigative work.

— Dr. Abbey Strauss, Boca Raton, Florida

— Dr. Joseph Ross, New Haven, Connecticut

This problem seems to expand beyond the AGGA device to the Las Vegas Institute’s entire methodology. The same thing was promised/done to me with braces by LVI-trained dental professionals. I was in braces for six years, and my teeth have spaces they cannot fill now all while I’m still paying off my debt and unable to afford additional work.

— Chrystal Wilson, Roanoke, Virginia

— Doug Hirsch, CEO of GoodRx, Santa Monica, California

Slipping Through a Billing Loophole

I help support the type of network that this article references (“Bill of the Month: Surprise-Billing Law Loophole: When ‘Out of Network’ Doesn’t Quite Mean Out of Network, Feb. 28). I think it is important for KHN to educate people on narrow-network products, which was the product the Laskey family selected for their medical insurance benefits. These products have lower monthly premium costs for people who select into them, like the Laskeys, but reduce their in-network provider options, hence the term “narrow network.”

These narrow networks may carry out educational webinars, attend open-enrollment fairs, and have a website (in addition to the payer’s website) so that members are educated about the narrow-network offering. With the adoption of more value-based care in the USA, narrow networks are likely to become more prevalent, and more people will need to understand the insurance products, and their networks.

— David Mayo, Denver

— Greg Slabodkin, Niagara Falls, New York

Chronic Pain Patients’ Chronic Rx Hurdles

Saw the article about how the Centers for Disease Control and Prevention guidelines the past few years have scared too many doctors until hardly any prescribe opioids anymore (“New CDC Opioid Guidelines: Too Little, Too Late for Chronic Pain Patients?” March 15).

Just wanted to chime in that I am having the exact same problem. I have chronic pain, arthritis throughout my body, a degenerative disc disorder, and even more documented medical problems. I recently broke my collarbone and was given only a two-day supply of opioid medication for it. And my pain doctor’s office doesn’t even prescribe me opioids.

I’ve also been treated horribly in the past when I was on an opioid. And if it weren’t for my family doctor’s understanding, I would still be living in so much pain that life seemed too hard to live with this much misery. I’m on what they call Tylenol 4, with codeine; it barely holds the pain back, but I still cannot handle cold weather (and I hate the heat) or even doing normal chores around my house without going into such a bad pain state I have to stay in bed. If I were able to get the pain medicine appropriate for my condition, I could actually enjoy things again. But because of the “opioid crisis,” that would make me an addict, by most doctor’s opinions. I know the CDC didn’t mean to make many chronic pain patients live in misery, but in my experience, that’s exactly what has happened. And there’s nothing I can do about it.

So I wanted to thank you for the article because I don’t think society or the medical community truly understands what the guidelines did to people like those in your article, or like me either. Thank you so much for writing that!

— Michelle Shivpuri, Cedar Hill, Texas

— Maia Szalavitz, New York City

Cost-Cutting Tools You Can Use

I am a 66-year-old female who had a colonoscopy and polyps removed at a hospital. This was my first screening of this kind, and upon completion I was billed $882 out-of-pocket. Luckily I was listening to your “Bill of the Month” coverage on South Carolina public radio. It educated me of my rights to preventive care under Obamacare. I was able to dispute the bill with success. But I must add here that my health insurance company tried to discourage me from challenging this bill. It made me feel that the bill was correct and that I should feel lucky that it was only that much. I was very disappointed, so I persisted to fill out another dispute in which I quoted KHN and threatened further action. Within a few weeks, my insurer rescinded the bill I had to pay $0. Big thanks to KHN-NPR’s “Bill of the Month”!

— Angela Thomas, Myrtle Beach, South Carolina

— Giuseppe Biondi-Zoccai, Rome

Warning: Painting a Graphic Picture of Drug Use

I recently came across your Kensington “tranq dope” article (“Postcard from a Philadelphia neighborhood: As Opioids Mixed With Animal Tranquilizers Arrive in Kensington, So Do Alarming Health Challenges,” Feb. 15). I have been in the health care field for 20-plus years and recently married a recovering addict, so it brought back a bad and vivid memory I’d like to share with the community of Kensington — the users, as well as the first responders, and health care providers, and wound care treatment teams who so graciously step in and up to help individuals suffering from xylazine’s horrific effects.

My husband, Joshua, who became addicted to opioids after being prescribed painkillers for shoulder surgery 20 years ago, was a previous xylazine user only because it was in just about all of the supposed “heroin” bags he bought. One day he said to me, “Why does it feel like something is crawling under my skin?” After looking at his arms, with big nasty-looking sores on them, I replied, “I have no clue.” Thinking he was just “high” and making it up or just hallucinating, I went back to bed. A few hours later, he woke me saying there were worms or maggots coming out of his arms. So, again, I go into the bathroom with him to see what he was talking about, and sure enough it certainly looked exactly like what he had described. Clearly, he needed to be checked out, but being a stubborn, bullheaded man — along with being labeled, judged, and treated poorly previously when seeking medical attention — he did not seek care. A few days later, he was still pulling these things out of his arms and, finally, I persuaded him to be seen by a doctor. The entire doctor’s office couldn’t believe what they were looking at, so after going over everything it could have been, we learned that it was, in fact, a parasite. The doctor’s best explanation was that the drug Josh had injected must have been contaminated with larvae, and it was producing parasites.

Now let’s take a minute and think about this. Hmm. Horse tranquilizer, horseflies, maggots, or worms … whichever you’d like to call them. It makes sense, doesn’t it? So just use caution when treating individuals and please watch for any possible parasites that may not be treated properly. My husband was given antibiotics, a steroid, and a cream to treat the problem and is doing fine now, but the critters have left nasty scars on his arms for him to have a daily reminder of, for sure.

“Tranq dope” is so hard to get off of, and the detox and withdrawal symptoms are extremely hard to handle and overcome, my husband says. Also, there’s not enough information on how to treat or counteract the symptoms. After being clean for just over a year, he relapsed again and went back to the streets of Philly. He is currently incarcerated at a Montgomery County correctional facility, helping his fellow inmates become aware of how serious and dangerous xylazine really is. Our dream is to someday open a fully functional safe house and outreach program within the Philadelphia area to assist as many individuals as possible and show them a better way of life and help them start their new journey.

— Jill Romanishan, Williamsport, Pennsylvania

—D.B. Pritt, Clayton, New York

Shoring Up Coverage Ahead of the Great Unwinding

Millions of Americans could lose Medicaid coverage soon (“Medicaid Health Plans Try to Protect Members — And Profits — During Unwinding,” March 9). This problem could be solved seamlessly by Congress expanding public option health insurance in all states in 2023. Do petition the White House, the entire U.S. Senate, and the entire House of Representatives to expand it in all 50 states to provide health care to millions of Americans still without health care or who are about to lose state Medicaid coverage soon.

— Piotr Sliwka, Manassas Park, Virginia

— Marcella Maguire, Philadelphia

In Texas, Medicaid Coverage Ends Soon After Childbirth. Will Lawmakers Allow More Time?

Victoria Ferrell Ortiz learned she was pregnant during summer 2017. The Dallas resident was finishing up an AmeriCorps job with a local nonprofit, which offered her a small stipend to live on but no health coverage. She applied for Medicaid so she could be insured during the pregnancy.

“It was a time of a lot of learning, turnaround, and pivoting for me, because we weren’t necessarily expecting that kind of life change,” she said.

Ferrell Ortiz would have liked a little more guidance to navigate the application process for Medicaid. She was inundated with forms. She spent days on end on the phone trying to figure out what was covered and where she could go to get care.

“Sometimes the representative that I would speak to wouldn’t know the answer,” she said. “I would have to wait for a follow-up and hope that they actually did follow up with me. More than 476,000 pregnant Texans are currently navigating that fragmented, bureaucratic system to find care. Medicaid provides coverage for about half of all births in the state — but many people lose eligibility not long after giving birth.

Many pregnant people rely on Medicaid coverage to get access to anything from prenatal appointments to prenatal vitamins, and then postpartum follow-up. Pregnancy-related Medicaid in Texas is available to individuals who make under $2,243 a month. But that coverage ends two months after childbirth — and advocates and researchers say that strict cutoff contributes to rates of maternal mortality and morbidity in the state that are higher than the national average.

They support a bill moving through the Texas legislature that would extend pregnancy Medicaid coverage for a full 12 months postpartum.

Texas is one of 11 states that has chosen not to expand Medicaid to its population of uninsured adults — a benefit offered under the Affordable Care Act, with 90% of the cost paid for by the federal government. That leaves more than 770,000 Texans in a coverage gap — they don’t have job-based insurance nor do they qualify for subsidized coverage on, the federal insurance marketplace. In 2021, 23% of women ages 19-64 were uninsured in Texas.

Pregnancy Medicaid helps fill the gap, temporarily. Of the nearly half a million Texans currently enrolled in the program, the majority are Hispanic women ages 19-29.

Texans living in the state without legal permission and lawfully present immigrants are not eligible, though they can get different coverage that ends immediately when a pregnancy does. In states where the Medicaid expansion has been adopted, coverage is available to all adults with incomes below 138% of the federal poverty level. For a family of three, that means an income of about $34,300 a year.

In Texas, childless adults don’t qualify for Medicaid at all. Parents can be eligible for Medicaid if they’re taking care of a child who receives Medicaid, but the income limits are low. To qualify, a three-person household with two parents can’t make more than $251 a month.

For Ferrell Ortiz, the hospitals and clinics that accepted Medicaid near her Dallas neighborhood felt “uncomfortable, uninviting,” she said. “A space that wasn’t meant for me” is how she described those facilities.

Later she learned that Medicaid would pay for her to give birth at an enrolled birthing center.

“I went to Lovers Lane Birth Center in Richardson,” she said. “I’m so grateful that I found them because they were able to connect me to other resources that the Medicaid office wasn’t.”

Ferrell Ortiz found a welcoming and supportive birth team, but the Medicaid coverage ended two months after her daughter arrived. She said losing insurance when her baby was so young was stressful. “The two-months window just puts more pressure on women to wrap up things in a messy and not necessarily beneficial way,” she said.

In the 2021 legislative session, Republican Gov. Greg Abbott signed a bill extending pregnancy Medicaid coverage from two months to six months postpartum, pending federal approval.

Last August, The Texas Tribune reported that extension request had initially failed to get federal approval, but that the Centers for Medicare & Medicaid Services had followed up the next day with a statement saying the request was still under review. The Tribune reported at the time that some state legislators believed the initial application was not approved “because of language that could be construed to exclude pregnant women who have abortions, including medically necessary abortions.”The state’s application to extend postpartum coverage to a total of six months is still under review.

The state’s Maternal Mortality and Morbidity Review Committee is tasked with producing statewide data reports on causes of maternal deaths and intervention strategies. Members of that committee, along with advocates and legislators, are hoping this year’s legislative session extends pregnancy Medicaid to 12 months postpartum.

Kari White, an associate professor at the University of Texas-Austin, said the bureaucratic challenges Ferrell Ortiz experienced are common for pregnant Texans on Medicaid.

“People are either having to wait until their condition gets worse, they forgo care, or they may have to pay out-of-pocket,” White said. “There are people who are dying following their pregnancy for reasons that are related to having been pregnant, and almost all of them are preventable.”

In Texas, maternal health care and Pregnancy Medicaid coverage “is a big patchwork with some big missing holes in the quilt,” White said. She is also lead investigator with the Texas Policy Evaluation Project (TxPEP), a group that evaluates the effects of reproductive health policies in the state. A March 2022 TxPEP study surveyed close to 1,500 pregnant Texans on public insurance. It found that “insurance churn” — when people lose health insurance in the months after giving birth — led to worse health outcomes and problems accessing postpartum care.

Chronic disease accounted for almost 20% of pregnancy-related deaths in Texas in 2019, according to a partial cohort review from the Texas Maternal Mortality and Morbidity Review Committee’s report. Chronic disease includes conditions such as high blood pressure and diabetes. The report determined at least 52 deaths were related to pregnancy in Texas during 2019. Serious bleeding (obstetric hemorrhage) and mental health issues were leading causes of death.

“This is one of the more extreme consequences of the lack of health care,” White said.

Black Texans, who make up close to 20% of pregnancy Medicaid recipients, are also more than twice as likely to die from a pregnancy-related cause than their white counterparts, a statistic that has held true for close to 10 years with little change, according to the MMMRC report.

Stark disparities such as that can be traced to systemic issues, including the lack of diversity in medical providers; socioeconomic barriers for Black women such as cost, transportation, lack of child care and poor communication with providers; and shortcomings in medical education and providers’ implicit biases — which can “impact clinicians’ ability to listen to Black people’s experiences and treat them as equal partners in decision-making about their own care and treatment options,” according to a recent survey.

Diana Forester, director of health policy for the statewide organization Texans Care for Children, said Medicaid coverage for pregnant people is a “golden window” to get care.

“It’s the chance to have access to health care to address issues that maybe have been building for a while, those kinds of things that left unaddressed build into something that would need surgery or more intensive intervention later on,” she said. “It just feels like that should be something that’s accessible to everyone when they need it.”

Extending health coverage for pregnant people, she said, is “the difference between having a chance at a healthy pregnancy versus not.”

As of February, 30 states have adopted a 12-month postpartum coverage extension so far, according to a KFF report, with eight states planning to implement an extension.

“We’re behind,” Forester said of Texas. “We’re so behind at this point.”

Many versions of bills that would extend pregnancy Medicaid coverage to 12 months have been filed in the legislature this year, including House Bill 12 and Senate Bill 73. Forester said she feels “cautiously optimistic.”

“I think there’s still going to be a few little legislative issues or land mines that we have to navigate,” she said. “But I feel like the momentum is there.”

Ferrell Ortiz’s daughter turns 5 this year. Amelie is artistic, bright, and vocal in her beliefs. When Ferrell Ortiz thinks back on being pregnant, she remembers how hard a year it was, but also how much she learned about herself.

“Giving birth was the hardest experience that my body has physically ever been through,” she said. “It was a really profound moment in my health history — just knowing that I was able to make it through that time, and that it could even be enjoyable — and so special, obviously, because look what the world has for it.”

She just wishes people, especially people of color giving birth, could get the health support they need during a vulnerable time.

“If I was able to talk to people in the legislature about extending Medicaid coverage, I would say to do that,” she said. “It’s an investment in the people who are raising our future and completely worth it.”

This story is part of a partnership that includes KERA, NPR, and KHN.