The regulations, if enacted, would potentially help tens of millions of people who have medical debt on their credit reports, eliminating information that can depress consumers’ scores and make it harder for many to get a job, rent an apartment, or secure a car loan.

New rules would also represent one of the most significant federal actions to tackle medical debt, a problem that burdens about 100 million people and forces legions to take on extra work, give up their homes, and ration food and other essentials, a ºÚÁϳԹÏÍø News-NPR investigation found.

“No one in this country should have to go into debt to get the quality health care they need,” said Vice President Kamala Harris, who announced the new moves along with Rohit Chopra, head of the Consumer Financial Protection Bureau, or CFPB. The agency will be charged with developing the new rules.

“These measures will improve the credit scores of millions of Americans so that they will better be able to invest in their future,” Harris said.

Enacting new regulations can be a lengthy process. Administration officials said Thursday that the new rules would be developed next year.

Such an aggressive step to restrict credit reporting and debt collection by hospitals and other medical providers will also almost certainly stir industry opposition.

At the same time, the Consumer Financial Protection Bureau, which was formed in response to the 2008 financial crisis, is under fire from Republicans, and its future may be jeopardized by before the Supreme Court, whose conservative majority has been chipping away at federal regulatory powers.

But the move by the Biden administration drew strong praise from patients’ and consumer groups, many of whom have been pushing for years for the federal government to strengthen protections against medical debt.

“This is an important milestone in our collective efforts and will provide immediate relief to people that have unfairly had their credit impacted simply because they got sick,” said Emily Stewart, executive director of Community Catalyst, a Boston nonprofit that has helped lead national medical debt efforts. 

Credit reporting, a threat designed to induce patients to pay their bills, is the most common collection tactic used by hospitals, a ºÚÁϳԹÏÍø News analysis has shown.

“Negative credit reporting is one of the biggest pain points for patients with medical debt,” said Chi Chi Wu, a senior attorney at the National Consumer Law Center. “When we hear from consumers about medical debt, they often talk about the devastating consequences that bad credit from medical debts has had on their financial lives.”

Although a single black mark on a credit score may not have a huge effect for some people, the impact can be devastating for those with large unpaid medical bills. There is growing evidence, for example, that credit scores depressed by medical debt can threaten people’s access to housing and fuel homelessness in many communities.

At the same time, CFPB researchers that medical debt — unlike other kinds of debt — does not accurately predict a consumer’s creditworthiness, calling into question how useful it is on a credit report.

The three largest credit agencies — Equifax, Experian, and TransUnion — said they would stop including some medical debt on credit reports as of last year. The excluded debts included paid-off bills and those less than $500.

But the agencies’ voluntary actions left out millions of patients with bigger medical bills on their credit reports. And many consumer and patient advocates called for more action. 

The National Consumer Law Center, Community Catalyst, and some 50 other groups in March sent letters to the CFPB and IRS urging stronger federal action to rein in hospital debt collection.

State leaders also have taken steps to expand consumer protections. In June, Colorado enacted a that prohibits medical debt from being included on residents’ credit reports or factored into their credit scores.

Many groups have urged the federal government to bar tax-exempt hospitals from selling patient debt or denying medical care to people with past-due bills, practices that remain widespread across the U.S., ºÚÁϳԹÏÍø News found.

Hospital leaders and representatives of the debt collection industry have warned that such restrictions on the ability of medical providers to get their bills paid may have unintended consequences, such as prompting more hospitals and physicians to require upfront payment before delivering care.

Looser credit requirements could also make it easier for consumers who can’t handle more debt to get loans they might not be able to pay off, others have warned.

“It is unfortunate that the CFPB and the White House are not considering the host of consequences that will result if medical providers are singled out in their billing, compared to other professions or industries,” said Scott Purcell, chief executive of ACA International, the collection industry’s leading trade association.

About This Project

“Diagnosis: Debt” is a reporting partnership between ºÚÁϳԹÏÍø News and NPR exploring the scale, impact, and causes of medical debt in America.

The series draws on original polling by KFF, court records, federal data on hospital finances, contracts obtained through public records requests, data on international health systems, and a yearlong investigation into the financial assistance and collection policies of more than 500 hospitals across the country. 

Additional research was , which analyzed credit bureau and other demographic data on poverty, race, and health status for ºÚÁϳԹÏÍø News to explore where medical debt is concentrated in the U.S. and what factors are associated with high debt levels.

The JPMorgan Chase Institute  from a sampling of Chase credit card holders to look at how customers’ balances may be affected by major medical expenses. And the CED Project, a Denver nonprofit, worked with ºÚÁϳԹÏÍø News on a survey of its clients to explore links between medical debt and housing instability. 

ºÚÁϳԹÏÍø News journalists worked with KFF public opinion researchers to design and analyze the “.” The survey was conducted Feb. 25 through March 20, 2022, online and via telephone, in English and Spanish, among a nationally representative sample of 2,375 U.S. adults, including 1,292 adults with current health care debt and 382 adults who had health care debt in the past five years. The margin of sampling error is plus or minus 3 percentage points for the full sample and 3 percentage points for those with current debt. For results based on subgroups, the margin of sampling error may be higher.

Reporters from ºÚÁϳԹÏÍø News and NPR also conducted hundreds of interviews with patients across the country; spoke with physicians, health industry leaders, consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.

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The grant-funded initiative, administered by the Health Resources and Services Administration, began rolling out four years ago and, so far, has budgeted nearly $32 million to provide access and care for thousands of mothers and babies nationwide — for instance, Hispanic women along the Rio Grande or Indigenous mothers in Minnesota.

ºÚÁϳԹÏÍø News found that none of the sites funded by the agency serves mothers in the Southeast, where the U.S. Census Bureau shows the largest concentration of predominantly Black rural communities. That omission exists despite a to make Black maternal health a priority and statistics showing America’s maternal mortality rate has in recent years. Non-Hispanic Black women — regardless of income or education level — die at nearly three times the rate of non-Hispanic white women.

“There’s a responsibility to respond to the crisis in a way that is more intentional,” said Jamila Taylor, chief executive of the National WIC Association, a nonprofit advocacy group for the federal Special Supplemental Nutrition Program for Women, Infants, and Children.

“Why isn’t HRSA stepping up to the plate, especially with this rural moms’ program?” Taylor said. According to a 2021 analysis of federal data, Black women living in rural areas also are or experience more severe health complications during delivery than white women living in rural areas.

Experts say the failure of HRSA’s Rural Maternity and Obstetrics Management Strategies Program, or RMOMS, to reach predominantly Black communities in the rural South reveals structural inequities and underinvestment in a region where health care resources are scarce and have deteriorated.

The steady closure of hospitals in the region and widespread medical staffing shortages have hindered the ability of cash-strapped agencies and care providers to provide more than essential services. Many “don’t have sufficient resources” to apply for the grants, said Peiyin Hung, deputy director of the University of South Carolina’s Rural and Minority Health Research Center. Hung is also a member of the health equity advisory group for the maternal grant program.

“RMOMS really means to invest in the most underserved and the most disadvantaged communities,” she said, but because the program demands applicants have a network of hospitals and other care providers, she said, “the odds are not there for them to even try.”

Hung said she favors basing the awards on need and not solely on the quality of an application.

Where the Help Is Going

The rural program launched in 2019 and has awarded 10 maternal health grants nationwide to bolster telehealth and create networks between hospitals and clinics. Despite the disruption of care due to the covid-19 pandemic, the program’s earliest grant winners helped more than 5,000 women get medical treatment and recorded a decrease in preterm births during the second year of implementation, the agency reported.

When ºÚÁϳԹÏÍø News first asked Tom Morris, associate administrator for rural health policy at HRSA, about the lack of grants in the rural South, he said the agency has an “objective review process” and regularly reviews the program to ensure it reaches the people who need it most.

“The rural rates of maternal mortality for African Americans is a real concern,” Morris said, adding, “I think you raised a good point there, and something we can focus on moving forward.”

So far, the maternal grants have gone to health care providers in Arkansas, Maine, Minnesota, New Mexico, South Dakota, Texas, Utah, and West Virginia, as well as two awards in Missouri.

Among the initial 2019 awardees, Texas reports that 91% of people it served were Hispanic; New Mexico reported 59% of recipients were Hispanic; and the Missouri project, which was in the southeastern part of the state known as the Bootheel, said 22% of beneficiaries were Black patients. In all cases, the majority were Medicaid enrollees. No data was available for other grant awardees. (Hispanic people can be of any race or combination of races.)

States across the rural Southeast have not expanded Medicaid coverage to larger numbers of lower-income residents, which often means lower shares of patients have health coverage.

Where Help Is Most Needed

The lack of Medicaid expansion in the region is "all the more reason funding should be going to these areas,” said the WIC association’s Taylor. She said the program’s failure to reach into the southeastern U.S. seems “incredibly odd.”

“The South is a hotbed — to be quite honest — of a whole host of chronic diseases and health challenges, particularly for people of color,” Taylor said.

Taylor, who previously worked on similar programs with community-based organizations while at the Century Foundation, said grant applications are often long and tedious and require intense data collection, adding to the “real challenges and barriers in the process of applying for the grants in the first place.”

Rep. Robin Kelly (D-Ill.), whose district spans rural and urban areas, said it is her experience that “some of the neediest places don’t apply for the grants because they don’t have the personnel.”

“There needs to be special outreach,” said Kelly, who created legislation in 2018 to extend postpartum care after hearing from a constituent. “We need to take the extra steps that mean saving women’s lives.”

Several current grant winners said the federal agency does provide extensive technical assistance and is responsive to questions and concerns — but they also described how difficult it was to win the grants, which amounted to $1 million or less for .

“It’s an intimidating grant to apply for,” said Johnna Nynas, an obstetrician and gynecologist who wrote the maternal grant application for Sanford Bemidji Medical Center in Minnesota.

“I don’t want to admit how much of my own personal time I dedicated to this grant, writing it,” she said. Sanford won the grant in 2021.

Unlike applicants from smaller, cash-strapped health organizations, Nynas was able to solicit help from the internal grant team at Sanford Health, which operates a regional system including a health plan as well as hospitals, clinics, and other facilities in the Dakotas, Iowa, and Minnesota.

Nynas said four hospitals in the remote region of northern Minnesota, where Bemidji is located, have closed their labor and delivery units in recent years, leaving residents — including a significant number of Indigenous women — to drive 60 miles or more one way for care.

Meeting an application requirement to create a network that includes specific health clinics as partners in the grant was “the biggest challenge,” Nynas said, adding “when you look at the map, those can be very difficult to find.”

Try, Try Again

In South Dakota, Avera Health’s application stalled for two years because of grant criteria requiring state Medicaid agencies to sign on as network partners, said Kimberlee McKay, an OB-GYN and the program director for the South Dakota grant. Avera Health spans Iowa, Minnesota, Nebraska, North Dakota, and South Dakota.

It wasn’t until the third round, McKay said, and after “the climate around maternal health had changed,” when the state Medicaid agency committed to fully partnering on the maternity care grant.

South Dakota voters adopted Medicaid expansion in late 2022 and will implement it this summer. Avera’s South Dakota program will use grant money to reach in the eastern part of the state and the region’s tribal communities.

Among the previous grant winners, only the Texas winner is from a non-Medicaid expansion state. HRSA spokesperson Elana Ross said 10 of 38 applications won grants since 2019. She declined to release a list of unsuccessful applicants, citing privacy concerns.

Ross said the requirement to partner with Medicaid “increases the likelihood that the pool of applicants, if selected, will be able to sustain services at the end of federal funding.” Medicaid, she noted, pays for nearly half of all births nationally and a greater share of births in rural areas.

The goal for the grants is that applicants can keep the program operating even after several years of federal funding runs out, HRSA officials said.

Stoking Change

In May, after ºÚÁϳԹÏÍø News began reporting this article, the agency released and relaxed requirements. Only two awards will be given, and the applications, which demand detailed network plans, are due July 7.

.

Kelly, who works on Congress’ , said of the lack of grants in the rural South: “Money matters, resources matter.”

Despite the government-wide focus on maternal care, it wasn’t clear whether the rural program would award new grants in 2023. In April, Morris told ºÚÁϳԹÏÍø News the agency was “trying to figure out if we have enough funding to support our existing grantees and do a new competition.”

The rural maternity program’s initial fiscal year 2023 budget was $8 million — down from $10.4 million the year before, according to the . The release of grants in May came after the federal agency found an additional $2.4 million in its internal budget.

Even so, Kelly said, she “would love to see more money being put toward it” as well as evaluations of “where the money is being spent and where the holes are.”

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Multiple lawsuits allege the device has caused grievous harm to at least 20 patients and the FDA is now investigating its safety, ºÚÁϳԹÏÍø News and CBS News have reported.

The AGGA is a retainer-like device promoted by some dentists as an option for expanding adult patients’ jawbones, beautifying their faces, and curing common ailments like sleep apnea. The lawsuits have alleged patients suffered damaged gums, eroded bone, and, in some cases, lost teeth.

The criminal investigation of the use of the AGGA was revealed in a court motion that seeks to delay the largest of the lawsuits “pending the outcome of any criminal proceedings.” The motion was filed this month by attorneys for AGGA inventor Dr. Steve Galella, his company, the Facial Beauty Institute, and AGGA manufacturer Johns Dental Laboratories, who said the investigation is being conducted “for the purpose of potentially bringing criminal charges” against their clients.

The attorneys said in their court filing that there is “no doubt” the investigation arose from the ºÚÁϳԹÏÍø News-CBS News coverage of the AGGA.

“The U.S. Attorney’s Office for the Western District of Tennessee and the U.S. Department of Justice is currently conducting a criminal investigation which, it is anticipated, will ultimately result in the presentation of evidence to a grand jury relating to the facts in this case,” the attorneys state in the court filing in support of the motion.

None of the court records suggests what criminal charges could result from the investigation.

The U.S. Attorney’s Office in Memphis, which generally does not discuss ongoing investigations, declined to comment. Scott Charnas, an attorney representing many AGGA patients, also declined to comment. Attorneys for Galella, the Facial Beauty Institute, and Johns Dental did not respond to requests for comment on Tuesday.

The AGGA, which was recently rebranded as the Osseo-Restoration Appliance, uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021. Galella has said pressure from the device causes an adult’s jaw to “remodel” forward, which he described, in training footage produced in discovery in an AGGA lawsuit, as the key to possibly “curing” patients and making them more beautiful.

“You can sell good health. You can help people and at the same time you’re going to make a wheelbarrow full of money,” Galella tells dentists in the video footage. “And it’s all OK, and it’s all fair. We’re not cheating anybody and we’re not being greedy, but that just comes with the territory.”

The ºÚÁϳԹÏÍø News-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 others — and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation also found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices. Galella has said in a that the device was never submitted to the FDA, which he believes wouldn’t have jurisdiction over it.

The FDA announced late last month that it is “evaluating safety concerns” about the AGGA and other similar devices.

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

All the AGGA lawsuits are ongoing. Galella and the other defendants have denied liability in court filings.

The plaintiffs do not allege in their lawsuits that Galella treated them but allege he or his company consulted with each of their dentists about their AGGA treatment.

CBS News producer Nicole Keller contributed to this article.

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The federal agency told the public in a “safety communication” posted on 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 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 .

“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.”

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Rep. Lloyd Doggett (D-Texas) said he decided to introduce a bill that allows people accused or convicted of fraud to easily sidestep bans imposed by federal officials. Among those gaps is the Centers for Medicare & Medicaid Services’ lack of authority to deny or revoke National Provider Identifier, or NPI, numbers after federal regulators have prohibited a person or business from receiving payments from government programs.

Doctors, nurses, other practitioners, and health businesses use the unique, 10-digit NPI numbers to bill and file claims with insurers and others, including Medicare and Medicaid.

Taking away the NPI would “be equivalent of prohibiting a practitioner from practicing in total,” Dara Corrigan, director of CMS’ Center for Program Integrity, wrote in an email response to questions about KHN’s investigation. CMS declined to comment on Doggett’s proposed legislation.

The bill, , would give CMS the authority to deactivate NPIs tied to anyone convicted of waste, fraud, or abuse and whose name appears on the kept by the Office of Inspector General for the U.S. Department of Health and Human Services. The would also require CMS to implement recommendations that the inspector general has made to improve NPI reporting and provider transparency.

“This strikes me as what should be an easy bipartisan measure,” Doggett said, adding that he had presented the bill in a face-to-face meeting with Rep. Jason Smith (R-Mo.), who chairs the House Ways and Means Committee. Doggett also alerted that panel’s health subcommittee chair, Rep. Vern Buchanan (R-Fla.).

“They both talk about the need to eliminate fraud, and this is one modest but important way to do it,” Doggett said. Neither Smith’s nor Buchanan’s offices responded to requests for comment.

The OIG declined to comment.

Former Justice Department officials told KHN that repeat violators are savvy and find ways to circumvent the system. KHN examined a sample of 300 health care business owners and executives who are among more than 1,600 on the OIG’s exclusion list since January 2017. Journalists reviewed court and property records, social media, and other publicly available documents.

KHN found:

• Eight people appeared to be serving or served in roles that could violate their bans.
• Six transferred control of a business to family or household members.
• Nine had previous, unrelated felony or fraud convictions, and went on to defraud the health care system.
• And seven were repeat violators, some of whom raked in tens of millions of federal health care dollars before getting caught by officials after a prior exclusion.

Doggett’s bill is “a pretty smart step in the right direction in fixing this issue,” said John Kelly, a former assistant chief of health care fraud at the Department of Justice who is now a partner for the law firm Barnes & Thornburg. Kelly had previously recommended that NPIs should be “essentially wiped clean” when a person is on the exclusions list.

Kelly, who confirmed that Doggett’s office reached out to him after KHN’s investigation was published in December, said taking the NPI number away “certainly doesn’t eliminate all risk” but it’s a move “in the right direction.”

“If you want to bill Medicare, you have to have a valid NPI,” Kelly said.

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

The FDA’s interest in the AGGA was revealed by Cara Tenenbaum, a former senior policy adviser in the agency’s device center who has said the FDA should investigate the product, which has been fitted on more than 10,000 dental patients, according to court records.

Tenenbaum said that after KHN and CBS News published their report, she was contacted by “very concerned” FDA officials who said they have begun “looking into” the AGGA but have yet to determine how much legal authority the agency has to regulate it.

“The FDA is looking at what authorities they may have around this device — what they may be able to do,” Tenenbaum said. “Now, of course, whether or not this device is FDA regulated, it still needs to be safe.”

KHN and CBS News have reviewed online messages verifying that an FDA official has communicated with Tenenbaum about the AGGA. The FDA declined to comment on the AGGA or confirm whether it was evaluating the device.

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 others — and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation also found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices.

The AGGA’s inventor, Tennessee dentist Dr. Steve Galella, has said in a that the device was never submitted to the FDA, which he believes doesn’t have jurisdiction over it. Tenenbaum has said the lack of registration is “incredibly problematic” because that is one method by which the FDA collects reports of a device’s negative effects.

She encouraged anyone who has witnessed complications from the AGGA to assist the FDA by .

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

Victor Krauthamer, a former FDA official who worked in a division regulating medical devices at the agency for three decades, said it was normal for an FDA probe of a device to begin by researching the boundaries of the agency’s authority, ensuring any future action has a solid legal foundation.

Krauthamer said he expects the FDA to take regulatory action against the AGGA, including to the manufacturer and potentially taking custody of the devices.

“At this point, I would be surprised if there wasn’t some sort of compliance action, such as a seizure,” Krauthamer said, adding later, “I think that’s probably where the FDA is — trying to make a case that will hold in court and won’t be thrown out.”

Jeffrey Oberlies, an attorney for AGGA manufacturer , said in an email that the company “looks forward to resolving the allegations against it” and declined to comment on the AGGA or the FDA’s interest in the device.

Galella said in his deposition he personally used the AGGA on more than 600 patients and has for years trained other dentists how to use the appliance. 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 like sleep apnea and temporomandibular joint disorder, or 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.”

Dentists across the country have drawn from Galella’s teachings on their websites, often saying the AGGA can “grow,” “remodel,” or “expand” an adult’s jaw without surgery. At least 11 of those dentists’ websites appear to have removed any mention of the AGGA since the KHN-CBS News investigation was published March 1.

“I think that’s good to hear,” said Boja Kragulj, a former professional clarinetist who has that the AGGA did catastrophic harm to her teeth. “I think when you take away this information from patients that are searching for the appliance and seeing these claims, that’s generally a good thing.”

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

Some allege in lawsuits they will lose teeth because of the device and added in interviews that they no longer have enough healthy bone to replace those teeth with dental implants.

“I can take my finger now and I can literally wiggle my front teeth,” said Melanie Pappalardi, 28, who said she wore an AGGA for a year and filed a lawsuit in Indiana. “I can’t bite into absolutely anything.”

The plaintiffs do not allege in their lawsuits that Galella treated them but that he or his company consulted with each of their dentists about their AGGA treatment.

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

All the AGGA lawsuits are ongoing. Attorneys for Galella and his company, , have denied liability in court filings. Johns Dental Laboratories settled one lawsuit for an undisclosed amount but continues to fight allegations in the other cases. The , which previously held AGGA classes for dentists and , denied liability in court and has a to end claims in one lawsuit in which it is named as a defendant.

In a sworn deposition filed in that lawsuit, Las Vegas Institute CEO Dr. Bill Dickerson said that in 2020 he began to question the claims about what the AGGA could accomplish, then severed all ties with Galella.

However, that same year the Las Vegas Institute pivoted to the Anterior Remodeling Appliance, or ARA, according to by Dickerson. Dickerson has said in multiple Facebook posts over the past three years that the AGGA and ARA are very similar, including in a June 2021 post that described ARA as “almost exactly the same appliance.” He also said that most dentists associated with the Las Vegas Institute have switched to the ARA, which is made by a different dental laboratory than AGGA’s manufacturer.

“Different lab. Same thing,” Dickerson said in .

The Las Vegas Institute did not respond to requests for comment on the ARA. Institute attorney William Schuller has previously declined to discuss the ARA.

Dental specialists who have warned about the AGGA said they are also alarmed by the ARA.

Dr. Kasey Li, a California maxillofacial surgeon, and Dr. George Mandelaris, a Chicago-area periodontist, each of whom have said they’ve examined multiple patients harmed by the AGGA, said after looking at a photo of the ARA from the manufacturer’s website, it appears to be very similar to the AGGA.

“It is very similar to the AGGA,” Mandelaris said in an email. “Almost identical.”

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In letters to the and the , the groups call for new federal rules that among other things would prohibit debt for medically necessary care from appearing on consumer credit reports.

Advocates also want the federal government to bar nonprofit hospitals from selling patient debt or denying medical care to people with past-due bills, practices that remain widespread across the U.S., KHN found.

And the groups are pressing the IRS to crack down on nonprofit hospital systems that withhold financial assistance from low-income patients or make aid cumbersome to get, another common obstacle KHN documented.

“Every day people are having to make choices about housing and clothing and food because of medical debt,” said Emily Stewart, executive director of Community Catalyst, a Boston nonprofit leading the effort. “It’s really urgent the Biden administration take action to put protections in place.”

Among the more than 50 groups supporting the initiative are national advocates such as the National Consumer Law Center, the Arthritis Foundation, and the Leukemia & Lymphoma Society.

Nationwide, 100 million people have health care debt, according to a KHN-NPR investigation, which has documented a crisis that is driving Americans from their homes, draining their savings, and preventing millions from accessing care they need.

While some of the debt appears on credit reports, much of it is hidden elsewhere as credit card balances, loans from relatives, or payment plans to hospitals and other medical providers.

The scale of this problem and its toll have spurred several national and state efforts.

Last spring, the federal agencies to work on relieving medical debts for veterans and to stop considering medical debt in evaluating eligibility for some federally backed mortgages.

California, Colorado, Maryland, New York, and other states have enacted new laws to expand consumer protections and require hospitals within their borders to increase financial aid. And the three largest credit agencies — Equifax, Experian, and Transunion — said they would stop including some medical debt on credit reports as of last July.

But many consumer and patient advocates say the actions, while important, still leave millions of Americans vulnerable to financial ruin if they become ill or injured. “It is critical that the CFPB take additional action,” the groups wrote to the federal agency created in 2010 to bolster oversight of consumer financial products.

The major credit rating companies, for example, agreed to exclude only debts that have been paid off and unpaid debts of less than $500. Patients with larger medical bills they can’t pay may still see their credit scores drop.

The groups also are asking the CFPB to eliminate deferred interest on medical credit cards. This arrangement is common for vendors such as CareCredit, whose loans carry no interest at first but can exceed 25% if patients don’t pay off the loan in time.

Collection industry officials have lobbied against broader restrictions on credit reporting, saying limits would take away an important tool that hospitals, physicians’ offices, and other medical providers need to collect their money and stay in business.

“We appreciate the challenges, but a broad ban on credit reporting could have some unintended consequences,” said Jack Brown III, president of Florida-based Gulf Coast Collection Bureau, citing the prospect of struggling hospitals and other providers closing, which would reduce care options.

Brown, a past president of ACA International, the collection industry’s leading trade association, warned that more medical providers would also start demanding upfront payment, putting additional pressure on patients.

To further protect patients from out-of-pocket costs like these, many advocates say hospitals, particularly those that are exempt from taxes because they are supposed to serve the community, must make financial aid more accessible, a key demand in the group’s letters. “For too long, nonprofit hospitals have not been behaving like nonprofits,” said Liz Coyle, executive director of the nonprofit Georgia Watch.

Charity care is offered at most U.S. hospitals. And nonprofit medical systems must provide aid as a condition of being tax-exempt. But at many medical centers, information about this assistance is difficult or impossible to find.

Standards also vary widely, with aid at some hospitals limited to patients with income as low as $13,590 a year. At other hospitals, people making five or six times that much can get assistance.

The result is widespread confusion that has left countless patients who should have been eligible for aid with large bills instead. A 2019 KHN analysis of hospital tax filings found that nearly half of nonprofit medical systems were billing patients with incomes low enough to qualify for charity care.

The groups are asking the IRS to issue rules that would set common standards for charity care and a uniform application across nonprofit hospitals. (Current regulations for charity care do not apply to for-profit or public hospitals.)

The advocates also want the federal agency to strengthen limits on how much nonprofit hospitals can charge and to curtail aggressive collection tactics such as foreclosing on patients’ homes or denying or deferring medical care.

More than two-thirds of hospitals sue patients or take other legal action against them, such as garnishing wages or placing liens on property, according to a recent KHN investigation. A quarter sell patients’ debts to debt collectors, who in turn can pursue patients for years for unpaid bills. About 1 in 5 deny nonemergency care to people with outstanding debt.

“Charitable institutions, which have other methods of collection available to them, should not be permitted to withhold needed medical care as a means to pressure patients to pay,” the groups wrote.

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This summer, KHN, NPR, and CBS News spotlighted Dula in the Bill of the Month series. The initial $3,600 charge for Dula’s ambulance ride was significantly higher than the charges received by her two siblings, who were riding in her car at the time and were transported to the same hospital. The siblings rode in separate ambulances, each from a different nearby fire protection district. All three were billed different amounts for the same services. Dula’s injuries were the least serious, but her bill was the most expensive.

Even after Dula’s insurer paid $900, her bill from Pingree Grove and Countryside Fire Protection District was still roughly twice what each of her siblings had been charged.

Dula’s attempts to resolve the bill were unsuccessful.

Paramedic Billing Services, the company that handles billing for Pingree Grove, said she’d have to dispute charges directly with the fire protection district. But Dula said she couldn’t get a fire district representative on the phone. Then, in June, she received a letter from collections agency Wakefield & Associates seeking payment for her ambulance bill.

Dula remained resolute about not paying until the price was lowered to be more in line with what her siblings had been charged. But the collections agency was equally firm. And that’s where the bill stood for months, in a stalemate.

Last week, Dula called the hospital where she was transported after the crash. She had recently received a bill from the hospital saying she owed nearly $1,500, but when she called she was told her balance was zero. The surprise resolution of her hospital bill prompted her to call Wakefield & Associates to check on her ambulance bill. She said she was told the bill had been pulled back from collections and her balance was zero.

The apparent resolution came approximately a month after Dula’s Bill of the Month saga. Wakefield & Associates confirmed to KHN that the bill had been pulled back and that her balance with the agency is zero. Pingree Grove Fire Chief Kieran Stout did not return multiple requests for comment.

“It feels great,” Dula said. “It was a real monkey on my back.”

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The proposal is part of a package of legislation that the state Department of Public Health and Human Services will ask lawmakers to approve when they convene in January. It comes two years called on the department to play more of a watchdog role and nine months after a KHN investigation found some of Montana’s wealthiest hospitals lag behind state and national averages in community giving.

Montana state Sen. , a Republican who has questioned whether nonprofit hospitals deserve their charity status, said the proposal is a start that could be expanded on later.

“Transparency is the name of the game here,” Keenan said.

nonprofit hospitals to tally what they spend to “promote health” to benefit “the community as a whole.” How hospitals count such contributions to justify their tax exemptions is opaque and varies widely. National researchers who study community benefits have for what counts toward the requirement.

Montana is one of the most recent states to consider imposing new rules or increasing oversight of nonprofit hospitals amid questions about whether they pay their fair share. Dr. , president of the national health care think tank Lown Institute, said that both at a state and local level, people in California are exploring whether to monitor hospital community benefits and enforce new standards. Last year, that nonprofit hospitals must spend on community benefits. And Massachusetts updated its in recent years, pushing hospitals to give more detailed assessments of how the spending lines up with identified health needs.

Montana hospital industry officials said they want to work with the state to shape the proposed legislation, which they said the industry would support if it doesn’t conflict with federal rules. Saini said that to have an impact, any legislation would have to go beyond federal requirements.

In recent years, more people, like Keenan and Saini, have questioned whether nonprofit hospitals are contributing enough to their communities to deserve the major tax breaks they get while becoming some of the largest businesses in town.

“The hospitals are sort of the pillars of communities, but people are starting to ask these questions,” Saini said.

Saini’s institute reviews hospitals’ giving each year and has found that of nonprofit systems nationwide spend less on what the institute calls “meaningful” benefits than the estimated value of their tax breaks. Actions the institute counts include patient financial aid and community investments such as food assistance, health education, or services offered at a loss, including addiction treatment.

The 2020 Montana audit found that hospitals in the state report benefits vaguely and inconsistently, making it difficult to determine whether their charity status is justified. However, state lawmakers didn’t address the issue in their 2021 biennial legislative session, and a Legislative Audit Division issued in June found the state health department had “made no meaningful progress” toward developing oversight of nonprofit hospitals’ charitable giving since then.

KHN found that Montana’s nearly 50 nonprofit hospitals directed roughly 8% of their total annual expenses, on average, toward community benefits in the tax year that ended in 2019. The was 10%.

In some cases, hospitals’ giving percentages have declined since then. For example, in the tax year that ended in 2019, Logan Health-Whitefish — a small hospital that’s part of the larger Flathead Valley health system — reported that less than 2% of its overall spending went toward community benefits. In its latest available documents, for the period ending in 2021, the hospital reported spending less than 1% of its expenses on community benefits while it made $15 million more than it spent.

Logan Health spokesperson Mellody Sharpton said the medical system’s overall community benefit is equal to nearly 9% of its spending, reaching across its six hospitals. It also has clinics throughout the valley. “It’s important to consider our organization’s community benefit as a whole as our facilities collaborate to ensure the appropriate care is provided at the appropriate facility to meet our patients’ health needs,” Sharpton said.

State health officials asked lawmakers to allow the agency to draft a bill that would give the health department clear authority to require hospitals to submit annual reports that include community benefit and charity care data. The measure also would allow the department to develop standards for that community benefit spending, according to .

“We see a great need here to move the ball forward,” state health department leader Charlie Brereton told lawmakers in August.

Montana Hospital Association President said his organization wants to work with the health department in honing the legislation but said the definition of what counts as benefits should remain broad so hospitals can respond to their area’s most pressing needs.

Furthermore, he said, hospitals are already working on their own reporting standards. This year, the association created a handbook for members and set a 2023 goal for hospitals to uniformly report their community benefits, Rasmussen said. The association declined to provide a copy of the handbook, saying it would be available to the public once hospitals are trained on how to use it later this fall.

The association also plans to create a website that will serve as a one-stop shop for people who want to know how hospitals are reporting community benefits and addressing local health concerns, among other things.

Republican state Rep. said she supports increased health department oversight and the idea behind the association’s website but doesn’t think the hospital industry should produce that public resource alone. Gillette said she plans to introduce legislation to require hospitals to report community benefits data to a group outside the industry — such as the state — which would then post the information online.

In the past, hospitals have resisted attempts to impose new rules on community benefit spending. In an interview with KHN last year, Jason Smith, then Bozeman Health’s chief advancement officer, said the system supported efforts to improve reporting contributions “outside of new legislation,” adding that hospitals can do better work without “state oversight bodies being placed in the arena with us.”

Asked whether the health system still stands by that statement, Denise Juneau, Bozeman Health’s chief government and community affairs officer, said hospital officials hope any new legislation will align with existing federal guidelines. She said Bozeman Health will continue to work with the Montana Hospital Association to define and provide better community benefit information, with or without new legislation.

A lawmaker would have to back the state’s proposal by mid-December to keep it alive.

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The , introduced Jan. 26 by the powerful Georgia House Speaker , a Republican, is focused on improving the state’s mental health care system.

Tucked inside the legislation is a provision that would require the Medicaid managed-care companies to refund payments to the state if they don’t spend enough on medical care and quality improvements for patients.

Georgia Health News and KHN reported in September that Georgia was one of only a few states that doesn’t mandate a minimum level of medical spending for its Medicaid insurers.

Each year, Georgia pays three insurance companies — CareSource, Peach State Health Plan, and Amerigroup — a total of more than $4 billion to run the federal-state health insurance program for low-income residents and people with disabilities. For 2019 and 2020, the companies’ combined profits averaged $189 million per year, according to insurer filings reported by the National Association of Insurance Commissioners.

“Instead of ensuring adequate health care networks for Georgia’s children, Georgians with disabilities, and Georgians in nursing facilities, hundreds of millions of dollars go instead to the Georgia [insurers’] bottom lines,” said Roland Behm, a board member for the Georgia chapter of the .

Behm, who advised lawmakers on the bill, said the KHN and Georgia Health News article helped bring the issue to the attention of legislators crafting the bill.

Georgia is among more than 40 states that have turned to managed-care companies to run their Medicaid programs — and ostensibly control costs. According to an August report from the U.S. Department of Health and Human Services’ Office of Inspector General, 36 of those states and the District of Columbia set a benchmark “medical loss ratio” for the minimum spending by insurers on medical care. Besides Georgia, the report said, the five states not requiring a managed-care spending threshold were Kansas, Rhode Island, Tennessee, Texas, and Wisconsin.

Republican state Rep. Todd Jones, a co-sponsor of the new bill, told KHN that Georgia lawmakers should establish a strong benchmark for insurers to meet. “We should look at what other states are doing,” he said.

Most states with a spending requirement set that ratio at a minimum of 85% of premium dollars that insurers are paid. So when a Medicaid insurer spends less than that on medical care and quality improvements, it must return money to the government.

The Georgia bill also calls for setting the threshold at 85%. If the bill is approved, the Medicaid insurers would face the medical spending requirement in 2023.

If the benchmark had been in place in recent years, it could have forced a recoupment from the Peach State company, which has the largest Georgia Medicaid enrollment of the three insurers. State documents show it failed to reach the 85% mark from 2018 to 2020, KHN previously reported.

, a research professor at Georgetown University’s Center for Children and Families, called the 85% mark “a win for taxpayers, for Medicaid providers, and for Medicaid beneficiaries.” He also said it would be more than fair to the Medicaid insurers, which could keep 15% of what the state pays them for administrative costs and profit.

Because Ralston is the lead sponsor of the bill in the House, it’s expected to pass that chamber.

But the insurance industry likely will work to remove the medical spending provision.

An industry official, Jesse Weathington, executive director of the Georgia Quality Healthcare Association trade group, declined to comment on the legislation.

Fiona Roberts, a spokesperson for the state Department of Community Health, which oversees the Medicaid program, said the agency needs time to review the measure before commenting on it.

The main provisions of the bill require insurers to provide coverage for mental health care or substance use treatment at the same level as other physical health needs.

The legislation would provide education loan support for people training in the fields of mental health and substance use disorders and seek to expand behavioral health services for children. It would also facilitate “assisted outpatient treatment” — when a judge could order a person with a serious mental illness to follow a court-ordered treatment plan in the community.

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