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KHN’s ‘What The Health?’: SCOTUS Punts On ACA Case — For Now

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The Supreme Court has declined to take up immediately a case out of Texas that could overturn the entire Affordable Care Act. But that is not likely to stop the case from becoming a major political issue in the 2020 presidential and congressional campaigns.

Meanwhile, the American College of Physicians, which represents internists, became one of the first major doctor groups to endorse “Medicare for All” — although the group also endorsed a somewhat less sweeping public option.

And the 47th anniversary of the Supreme Court’s landmark abortion ruling, Roe v. Wade, prompted activity on both sides of the contentious issue, including a change in policy from the Trump administration.

This week’s panelists are Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Alice Miranda Ollstein of Politico and Caitlin Owens of Axios.

Among the takeaways from this week’s podcast:

  • The uncertainty about the ACA’s future is a reminder that Republicans have promised to have a backup plan for consumers if the law is struck down in its entirety, but there is no indication that they have settled on an option. In fact, Alex Azar, secretary of the Department of Health and Human Services, recently told an interviewer that administration officials are not prioritizing the development of such a plan.
  • The endorsement by the American College of Physicians of a single-payer, Medicare for All plan — or, instead, a public option offered to consumers — points to major demographic changes for doctors: Where once the profession was made up of largely white, older men working in individual practices, today many more primary care physicians are women and people of color and work for practices owned by hospitals or other outside groups.
  • The coronavirus outbreak in China, which has sickened nearly 600 people, is raising fears about whether the United States is prepared for a major contagion. Some of the health industry’s financial incentives don’t necessarily help: They are not geared toward developing vaccines or antibiotics.
  • The ACA’s mandate for health insurance to cover contraceptives is getting another date in the Supreme Court. This time, the justices will determine whether the Trump administration’s new rules give more latitude to employers to cut such coverage if they have moral or religious objections to contraception.
  • In another development in reproductive health news, the administration told Texas on Wednesday — the anniversary of the Roe decision — that it can again get federal funds for its family planning programs, even though it specifically excludes Planned Parenthood facilities because the organization provides abortions at some centers.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: The Atlantic’s “America’s Most Powerful Medical-Debt Collector,” by Jared Bennett and Olga Khazan

Alice Miranda Ollstein: The New York Times’ “In Oval Office Meeting, Trump Expresses Regret of Vaping Policy,” by Maggie Haberman

Margot Sanger-Katz: Tradeoffs Podcast’s “The Price of Innovation,” by Dan Gorenstein

Caitlin Owens: Axios’ “Employers, Not Patients, Have the Most Health Insurance Choices,” by Caitlin Owens

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In-Home Teeth-Straightening Business Is Booming ― But Better Brace Yourself

Though Anna Rosemond, now 33, had braces when she was young, a couple of years ago she noticed her teeth were again starting to crowd. So when she saw a Groupon deal for SmileDirectClub, she jumped on it.

“I thought, ‘This looks like a really cool way to do braces,’” said Rosemond, who made her own teeth impressions with putty and used a “smile stretcher” ― a device that pulls apart the lips and cheeks ― to take pictures of her mouth. A few weeks after she submitted the items, plastic aligners arrived in the mail, beginning what the company describes as Rosemond’s “smile journey.”

On that trip, there would be no time-consuming visits to a dental office, as her treatment would be overseen online through a SmileDirectClub-affiliated dentist or orthodontist — at a current cost of only $85 a month and a $250 down payment, according to the firm’s website.

Initially, she said, the aligners sent in 2017 seemed to be working. But over time, Rosemond said, she grew concerned: “My teeth were literally moving at an angle.”

Rosemond is part of a wave of patients who have embraced this do-it-yourself approach to orthodontia, hoping to attain a perfect smile without the high out-of-pocket cost and potential inconvenience of traditional braces or tooth aligners.

To be sure, technology enables consumers to do more at home, and dental care ― with its limited insurance coverage ― offers a large potential market. Home teeth-whitening kits have largely displaced in-office treatments, for example.

Now, teeth straightening is the newest dental frontier, with startups like SmileDirectClub, Candid, Smilelove and SnapCorrect advertising their services aggressively on billboards and social media.

When results are good, the DIY approach can yield thousands of dollars in savings. But when the treatment plan doesn’t produce results or goes wrong, consumer-patients like Rosemond voice their frustrations in Facebook groups and complain to the Better Business Bureau or the Federal Trade Commission that they have nowhere to turn for help.

The companies do not make information public about success rates or problems — although SmileDirectClub says it has achieved a rating of 4.9 stars out of 5 on nearly 58,000 Google reviews — and there are few scientific studies of outcomes for direct-to-consumer orthodontics.

To get a simple refund after an initial 30-day period, patients are often asked to sign what SmileDirectClub calls a “release,” stating the consumer won’t complain publicly — which it says is fairly standard in business. A shareholder lawsuit against the firm says those releases suppress consumer complaints, leaving investors in the dark.

Consumer complaints to advocacy groups and regulators, including the FTC, the Food and Drug Administration and state attorneys general, as well as lawsuits, are accumulating.

Yet, SmileDirectClub, the company with the largest market share of direct-to-consumer orthodontics, says it’s achieving its aim of disrupting the entrenched orthodontia industry.

“We have provided consumers for the first time with an affordable option that is also far more convenient for those who cannot afford to miss school or work or are disabled and cannot get to multiple office visits,” said Susan Greenspon Rammelt, general counsel for SmileDirectClub.

Tiffanie Leatham, who worked as a dental assistant for SmileDirectClub for a year, felt the company pressured her to sign up patients whose teeth she thought were not suitable for aligners. “It was mostly sales with a small hint of dentistry,” she said.

Recent SEC filings show SmileDirectClub spent more than half its revenue on marketing.

They Saw The Opportunity

The direct-to-consumer teeth-alignment industry was enabled by the arrival two decades ago of Invisalign, clear plastic aligners that offered an alternative to the hated “metal mouth” look of braces so familiar to a generation of children. Invisalign, however, is dispensed by dentists or orthodontists during in-office visits, so it’s more costly for consumers.

While Invisalign sales remain high — its manufacturer, Align Technology, reported a record $2 billion in worldwide total revenue in 2018 — patents on the product began expiring in 2017.

SmileDirectClub saw the opportunity early and launched in 2014, with backing from Camelot Venture Group, a private investment group that also backed Quicken Loans and 1-800 Contacts. Initially, the startup’s aligners were made by Align Technology; now, SmileDirectClub does its own manufacturing.

Nashville-based SmileDirectClub, which says it has served more than 750,000 customers worldwide and represents 95% of the at-home clear-aligner industry, went public on Wall Street in September 2019. Its customers almost tripled ― from 90,000 to 258,000 ― from 2017 to 2018, according to SEC filings. But the company has yet to post a profit, also according to its SEC filings.

SmileDirectClub said customers initially used impression kits at home. Now, the company said, most customers visit one of more than 360 “SmileShop” locations, some inside CVS or Walgreens pharmacies, where technicians take a 3D scan of their mouths. The total cost starts at $1,895, although financing or additional items, such as retainers, can add to the price, according to the firm’s website.

With SmileDirectClub, most customers start by buying a kit to make their own mouth impressions. Others go to one of more than 360 “SmileShop” locations, some inside CVS or Walgreens pharmacies, where technicians take a 3D scan of their mouths.(Hannah Norman/Kaiser Health News)

Those impressions, photos and scans are sent to the firm’s facility in Costa Rica, where technicians develop treatment plans and one of 85 dentists employed there reviews it. For U.S. customers, treatment plans are also reviewed by a dentist or orthodontist licensed in the state where the customer lives, says SmileDirectClub.

Customers then receive an image of what their teeth might look like after treatment and can decide whether to proceed. If they do, the facility sends off the plastic aligners, which are worn sequentially over a few months for 22 hours a day.

If there is a question or problem with the aligners, billing or other issues during the months-long treatment process, customer service agents are the first stop. They can route concerns to the affiliated dentists, said company executives. Sometimes, according to a written statement, “the treating doctor will ask to see the patient in person, or work with the patient’s regular dentist.”

In the same statement, SmileDirectClub said it could not comment directly on specific patients’ experiences.

Direct-to-consumer aligners are clearly filling a niche, but one that makes some health care experts uncomfortable. “It’s a symptom of a broken health care system: getting dubious-quality online services without much accountability because mainstream services are unaffordable,” said Arthur Caplan, founding head of the division of medical ethics at NYU Grossman School of Medicine in New York.

As the industry has grown, so too have complaints from customers, pushback from dentistry’s professional trade groups and scrutiny from regulators. More than 1,600 complaints have been lodged nationally against SmileDirectClub with the Better Business Bureau (BBB) in the past three years. The FDA has received at least 72 complaints regarding SmileDirectClub’s products since 2017, according to a Kaiser Health News analysis of the agency’s device database.

KHN contacted all 51 state attorneys general offices. But, of the 34 offices that responded to the request, 19 reported a total of 75 complaints concerning SmileDirectClub. The FTC also has received 175 complaints against the firm, though the majority (148) are duplicates of the complaints received by the BBB and the state attorneys general. SmileDirectClub’s Instagram and Facebook posts also have generated many comments from dissatisfied consumers.

The other firms, all with far less market share, also figure in complaints filed with the BBB, including 54 against Candid, 10 against Smilelove and three against SnapCorrect.

Despite that, the BBB says it gives all the companies high grades because their business volume is high compared with the number of complaints filed and they demonstrate responsiveness to complaints. SmileDirectClub maintains an “A-minus” rating from the bureau. The other firms range from A to B-minus.

Many of the BBB, FTC and social media complaints focus on customer service issues, such as delays in receiving products or difficulty in obtaining answers to questions about treatment or getting refunds. Only a sliver of complaints ― 48 ― submitted to the BBB’s website centered on clinical problems, Dr. Jeffrey Sulitzer, SmileDirectClub’s chief clinical officer, said in a November interview.

One was submitted by Michael Anthony Johnson of Dallas, who alleges the company’s aligners harmed his teeth.

Johnson, a 57-year-old CEO of online Centertainment Radio & TV, said he saw the advertisements and stopped in at a SmileDirectClub retail location to see if he would qualify. A technician took a 3D scan of his teeth.

“She said, ‘I think you’ll be fine,’” he recalled. “Two days later, I was approved.”

For the first few months, all seemed well; but at month seven, several of his teeth broke, he said.

SmileDirectClub responded that the initial scans taken in their shop showed problems before he started treatment, including two broken teeth, fractures on one and a dark spot on another.

“Before you started remote clear aligners these areas of concern should have been addressed with your local dental provider,” Charlene, with the company’s dental team, wrote in response, according to the BBB website.

She also noted that Johnson had signed a consent form for his aligners, a document that includes one long paragraph declaring he had recently been to a dentist and taken care of any problems. Johnson said he did not read the multipage document before signing.

“The response back to me was, it’s your fault,” said Johnson. “No one said you need to go see the dentist. Yes, it’s my fault for not reading the fine print, but the person taking my imprints, she never mentioned it.” Johnson is now saving up money so he can get three teeth replaced with implants. For some, he said, the aligners may be a great product, but “I know, for me, it was not.”

The company has argued it isn’t liable for clinical problems raised by consumers, as it is not practicing dentistry but is merely a “dental support organization” ― essentially, the go-between. Rather, SmileDirectClub said its treating dentists and orthodontists are the responsible parties if something goes wrong.

Those treating dentists and orthodontists ― who earn an average of $50 per customer ― can review patients’ files, ask the customer to submit more information or seek X-rays and even request that the patient get a deep cleaning before treatment, said Greenspon Rammelt, SmileDirectClub’s general counsel.

However, SmileDirectClub dentists currently do not see the patient in person, and some experts say that is a problem. “A proper diagnosis cannot be done by a picture of teeth,” said Chad Gehani, a practicing dentist and the American Dental Association’s president. An examination, he added, is needed to detect things like cavities, shortened roots and gum disease, which could lead to problems, according to the ADA and the American Association of Orthodontists (AAO). Both groups discourage the use of online aligners.

SmileDirectClub announced on Jan. 14 that it would soon offer aligners through dentists and orthodontists.

Lawsuits And Turf Battles

Several lawsuits challenging SmileDirectClub — brought on behalf of consumers, dentists and shareholders — are ongoing.

One class-action case brought by dentists, orthodontists and consumers in Tennessee alleges the company engages in false advertising and unfair trade practices, although all of its consumer plaintiffs have withdrawn as of this month. SmileDirectClub had won a ruling that its customers all sign agreements to arbitrate disputes, rather than litigate. Shareholder lawsuits allege SmileDirectClub failed to disclose some concerns, including the level of consumer complaints, before the firm’s initial public offering.

In separate action, after dental boards in Georgia and Alabama set rules requiring dentists oversee any scans done in retail settings, SmileDirectClub went to court. In its filings, SmileDirectClub alleges the boards, made up mainly of dentists and orthodontists, were trying to stifle competition.

SmileDirectClub has also sued the Dental Board of California, arguing it directed an investigator to “conduct a series of coordinated raids” on its retail stores that amounted to harassment.

The California case is pending in federal court. The Georgia and Alabama cases are also ongoing, pending before the 11th U.S. Circuit Court of Appeals.

The cases have drawn much interest: The AAO has filed amicus briefs in support of the Georgia and Alabama dental boards, backing their jurisdiction and authority to set rules. The Federal Trade Commission weighed in on behalf of SmileDirectClub on a part of the case that involves whether Alabama state lawmakers exercise enough supervision over the state’s dental board.

As for Anna Rosemond, after sending multiple photos of her teeth to SmileDirectClub via Facebook Messenger, she said she was told to complete her treatment, despite her concerns about her teeth moving at an angle. Eventually, the company agreed to send her new aligners, but she said they didn’t fit.

Fed up, Rosemond said, she stopped her credit card payments to SmileDirectClub. She ignored calls and emails about being sent to collections.

She said she consulted an orthodontist who told her, based on his review of previous X-rays and photos, she had a crossbite because of the SmileDirectClub treatment and would need braces with rubber bands to correct the issue.

She recently finished nine months of traditional orthodontics treatment from that orthodontist and loves her smile now that the braces are off.

“I’m so much more confident,” said Rosemond. “And my bite feels great.”

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With Fate Of Roe V. Wade Unsure, Abortion Fight Shifts To New Territory

Jan. 22 marks the 47th anniversary of Roe v. Wade, the landmark case that legalized abortion nationwide. Those on both sides of the furious debate say this could be the year when everything changes.

In March, the Supreme Court will hear its first abortion case since Justice Brett Kavanaugh replaced Anthony Kennedy, who had been the swing vote on abortion cases. A decision is expected by summer.

The case, June Medical Services v. Gee, challenges a Louisiana law that requires doctors who perform abortions to have admitting privileges at a nearby hospital. It’s a reprise of a case decided in 2016, when a five-vote majority (including Kennedy’s) struck down a substantially similar Texas law in Whole Women’s Health v. Hellerstedt.

On Jan. 2, more than 200 Republican members of the House and Senate filed a brief in the Gee case urging the justices to use it to overturn Roe once and for all. “Forty-six years after Roe was decided, it remains a radically unsettled precedent,” the brief said. And the 1992 case that reiterated a curtailed right to abortion, Planned Parenthood of Southeastern Pennsylvania v. Casey, did not help, the members argued. “Casey clearly did not settle the abortion issue, and it is time for the Court to take it up again.”

The court is far more likely to rule narrowly in the case than to use it to overturn Roe and/or Casey because that’s what the Supreme Court tends to do.

Even if the court does not overturn Roe, it might do something that could hasten Roe’s demise: uphold the Louisiana law by ruling that abortion providers cannot sue on behalf of their patients, something the state of Louisiana is urging it to do. That would make it much more difficult to challenge state abortion restrictions because only women seeking abortions would be able to challenge those laws in court. Many pregnant women seeking abortions don’t want to go to the additional trouble of becoming part of a lawsuit that could take years.

“That would be a bigger deal” than finding some legal justification to uphold Louisiana’s law, said Mary Ziegler, a law professor at Florida State University who has written several books on abortion and abortion law.

It’s part and parcel of an anti-abortion strategy: make abortion more difficult to obtain even where it is technically legal. “A right is certainly important, but if you cannot access abortion care, that right is meaningless,” said Elisabeth Smith of the Center for Reproductive Rights, an abortion-rights law firm.

Since 2004, that center has periodically looked at what would happen to abortion laws in the states if the Supreme Court were to reverse its conclusion that abortion, at least in some cases, is a right guaranteed by the U.S. Constitution. In its original report, titled “What If Roe Fell,” and again in 2007 and 2017, the center assessed the likely legal status of abortion in the states, because in the absence of Roe, abortion’s legality would be determined by state lawmakers or state constitutions.

But in its 2019 version of “What If Roe Fell,” the group took a slightly different tack. This latest iteration looks at likely legality, but also at the relative availability of the procedure. The report concludes that if the Supreme Court eliminates federal protections for abortion, the procedure is likely to be immediately prohibited in 24 states, and remain legal and generally available in 21. The five other states and the District of Columbia have not established a right to abortion.

Smith said that, even with Roe still standing, some states, such as Mississippi and Missouri, are already abortion “deserts,” where the procedure is all but unavailable. But “the situation would be much worse if the federal right is limited or overturned,” she said. In fact, some states are “havens” that have made abortions easier to obtain. For now, “abortion is still legal. Every state has at least one abortion clinic,” Smith added.

This is far from the first time it appeared Roe was teetering on the brink. In 1992, after Justice Clarence Thomas replaced Thurgood Marshall, one of the original seven justices in the majority in Roe, the country braced for an overturn. It did not happen. In 2005, when abortion swing vote Justice Sandra Day O’Connor retired and was replaced by Justice Samuel Alito, the alarms were raised again. And again, it did not happen. Then in 2018, when O’Connor’s successor as the abortion swing vote, Kennedy, retired and was replaced by Kavanaugh, the bells rang once more.

The Louisiana case is the first chance for what would appear to be a clear five-vote anti-abortion majority to rule.

Ziegler, the Florida State law professor, warns that overturning Roe would not end the fight. “If this goes back to the states, it’s going to continue indefinitely,” she said. “The endpoint for people who oppose abortion is not just allowing states to decide.”

In other words, if you think the abortion issue is inflammatory now, just wait until Roe is gone.

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KHN’s ‘What The Health?’: Democrats Roll Dice On SCOTUS And The ACA

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

Democratic state attorneys general are asking the Supreme Court to intervene this term in a case that could invalidate the entire Affordable Care Act. In December, a federal appeals court panel ruled that the “individual mandate” provision of the health law is unconstitutional now that Congress has reduced the penalty for not having insurance to zero. But it sent the case back to the lower-court judge to determine how much else of the law can remain in light of that finding.

Democrats want the high court to rule on the case now, which would be unusual but not unprecedented.

Meanwhile, Republicans on Capitol Hill are asking the Supreme Court to use a Louisiana abortion case already on this year’s docket to overturn the landmark abortion rights case, Roe v. Wade. The Louisiana law — requiring doctors who perform abortions to have admitting privileges at nearby hospitals — is similar to a Texas law struck down by the court in 2016. But the court has added anti-abortion justices since then.

This week’s panelists are Julie Rovner from Kaiser Health News, Joanne Kenen of Politico, Stephanie Armour of The Wall Street Journal and Paige Winfield Cunningham of The Washington Post

Among the takeaways from this week’s podcast:

  • The Democratic push to get the Supreme Court to quickly review the latest ACA challenge could have political benefits for the party in the campaign season. Democrats are eager to be seen as protecting new health care benefits. And if President Donald Trump is elected next fall, the high court could well become more conservative as several liberal-leaning justices may leave the court in the next few years.
  • Some advocates for a “Medicare for All” health care system are convinced that if the Supreme Court were to strike down the ACA, the resulting vacuum would make a government-run program more attractive to Americans.
  • Amid increasing efforts by states to restrict abortions and a more conservative majority on the Supreme Court, abortion may become a more potent voting issue for Democrats. It has long motivated Republican voters, but Democrats have been less driven by that single issue.
  • The much-publicized administration rules to cut back on flavored vaping products include a lesser-known provision allowing companies to go through a Food and Drug Administration process to prove their products have a net health benefit: helping adults quit smoking.
  • States continue to seek Trump administration approval for work requirements for their Medicaid programs, but if Democrats win the presidency in 2020, those approvals are likely to be reversed. Meanwhile, most of the state plans are tied up in court.

Also this week, Rovner interviews NPR’s Richard Harris, who reported the latest KHN-NPR “Bill of the Month” installment about a very expensive laboratory bill for a New York woman who had a cold. If you have an outrageous medical bill you would like to share with us, you can do that here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: Stat News’ “Washington Took a Decade to Approve an Obscure Drug-Pricing Bill. That’s a Bad Omen for More Ambitious Reforms,” by Nicholas Florko

Joanne Kenen: The New Yorker’s “A World Without Pain,” by Ariel Levy

Stephanie Armour: The New York Times’ “In the U.S., an Angioplasty Costs $32,000. Elsewhere? Maybe $6,400,” by Margot Sanger-Katz

Paige Winfield Cunningham: KHN’s “Reduce Health Costs By Nurturing The Sickest? A Much-Touted Idea Disappoints,” by Dan Gorenstein and Leslie Walker. You can hear the episode of Dan’s podcast, “Tradeoffs,” about this study here.

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

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