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CMS Drug Pricing Transparency Fact Sheet

HHS Gov News - May 08, 2019

“If we want to have a real market for drugs, why not have [companies] disclose their prices in the ads, too? Consumers would have much more balanced information, and companies would have a very different set of incentives for setting their prices.” – HHS Secretary Alex Azar

In May 2018, President Trump and Secretary Azar introduced the American Patients First blueprint to bring down prescription drug prices. Less than a year later, we are publishing the first final rule to implement the vision laid out in the blueprint.

  • The blueprint laid out four strategies for solving the problems patients face: boosting competition, enhancing negotiation, creating incentives for lower list prices, and bringing down out-of-pocket costs.
  • To create better incentives for lower list prices, the blueprint called for HHS to consider requiring the inclusion of list prices in direct-to-consumer advertising.

Right now, drug companies are required to disclose the major side effects a drug can have—but not the effect that buying the drug could have on your wallet. Patients deserve more transparency, and this administration is committed to shining a light on what pharmaceutical companies have been hiding from patients.

Drug companies will now be required to disclose to patients the list price for prescription drugs in TV ads.

  • This final rule will require direct-to-consumer television advertisements for prescription drug and biological products covered by Medicare or Medicaid to include the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy, with the prices updated quarterly.
  • The 10 most commonly advertised drugs have list prices ranging from $488 to $16,938 per month or usual course of therapy. Patients deserve to know what a drug costs as they discuss their options with their doctor.
  • The final rule will go into effect 60 days after it was published in the Federal Register.
  • If a manufacturer simply includes price information in a direct-to-consumer advertisement as required by § 403.1202, that information in the advertisement will not require review by the FDA Office of Prescription Drug Promotion (ODPD). OPDP does not review price information in prescription drug advertisements and does not intend to do so in the future, unless the price information explicitly or implicitly incorporates safety or efficacy information about the drug, or makes express or implied claims about the safety or efficacy of the drug.

List prices matter to patients: Many patients either pay list price or pay prices calculated based on list price.

  • 47 percent of Americans have high-deductible health insurance plans, under which they often pay the list price of a drug until they have spent through their deductible.
  • A growing number of Part D plans offered use a deductible.
  • All seniors on Medicare Part D have coinsurance for certain types of drugs, which means their out-of-pocket expenses are calculated as a share of list price.
  • List prices are also what patients pay if a drug is not on their insurance formulary.
  • The rules allow drug companies to provide additional information about expected costs for insured patients and other helpful information, if they choose.

HHS will continue to deliver solutions as laid out in the blueprint to improve drug price transparency and inform consumer decision making.

  • As Secretary Azar has said, “You ought to know how much a drug costs and how much it’s going to cost you, long before you get to the pharmacy counter or get the bill in the mail.”
  • In addition to drugs, HHS is reviewing comments on a number of other proposed rules to deliver more transparency and fix opaque systems and perverse incentives for a range of items and services.

Increased transparency will also incite competition – a major step forward in bringing free market forces to a system full of perverse incentives.

Click here to view the final rule*

Read the news release

* People using assistive technology may not be able to fully access information in this file. For assistance, please contact Michael Pratt at digital@hhs.gov.

HHS Finalizes Rule Requiring Manufacturers Disclose Drug Prices in TV Ads to Increase Drug Pricing Transparency

HHS Gov News - May 08, 2019

Less than a year after the release of President Trump’s American Patients First blueprint, HHS finalizes first rule implementing the blueprint, aimed at increasing transparency for patients and bringing down overall drug costs both for patients and for the Medicare and Medicaid programs.

On Wednesday, Health and Human Services Secretary Alex Azar announced a final rule from the Centers for Medicare & Medicaid Services (CMS) that will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy.

“Requiring the inclusion of drugs’ list prices in TV ads is the single most significant step any administration has taken toward a simple commitment: American patients deserve to know the prices of the healthcare they receive,” said HHS Secretary Alex Azar. “Patients who are struggling with high drug costs are in that position because of the high list prices that drug companies set. Making those prices more transparent is a significant step in President Trump’s efforts to reform our prescription drug markets and put patients in charge of their own healthcare.”

“Patients have the right to know the prices of healthcare services, and CMS is serious about empowering patients with this information across-the-board,” said CMS Administrator Seema Verma. “Today’s final rule is an important step toward achieving President Trump’s vision for lowering prescription drug prices by bringing much-needed pricing transparency to the convoluted market for prescription drugs. Equipped with information on prescription drug prices, patients will be better able to make informed decisions and demand value from pharmaceutical companies.”

In May 2018, President Trump and Secretary Azar introduced the American Patients First blueprint to bring down prescription drug prices. The blueprint laid out four strategies for solving the problems patients face: boosting competition, enhancing negotiation, creating incentives for lower list prices, and bringing down out-of-pocket costs.

To create better incentives for lower list prices, the blueprint called for HHS to consider requiring the inclusion of list prices in direct-to-consumer advertising. Less than a year later, this final rule has been published to implement the vision laid out in the blueprint.

Up until now, drug companies were required to disclose the major side effects a drug can have—but not the effect that buying the drug could have on your wallet. Patients deserve more transparency, and this Administration is committed to delivering it.

List prices matter to patients, many of whom either pay the list price or prices based on the list price. For the forty-seven percent of Americans who have high-deductible health insurance plans, the price they see in ads essentially is the price they pay, until they meet their deductible. All seniors on Medicare Part D have coinsurance for certain types of drugs, which means their out-of-pocket expenses are calculated as a share of list price. List prices are also what patients pay if a drug is not on their insurance formulary.

President Trump has already done more than any President to lower drug prices for American patients, and HHS will continue to deliver solutions as laid out in the American Patients First blueprint to improve drug price transparency and inform consumer decision making. HHS is reviewing comments on a number of other proposed rules to fix opaque systems, change perverse incentives, and put American patients first.

Click here to view the final rule*

Click here for a fact sheet about the final rule

* People using assistive technology may not be able to fully access information in this file. For assistance, please contact Michael Pratt at digital@hhs.gov.

A Plan To Cover Immigrants Would Divert Public Health Dollars

California Gov. Gavin Newsom wants the state to provide health coverage to low-income young adults who are in the country illegally, but his plan would siphon public health dollars from several counties battling surging rates of sexually transmitted diseases and, in some cases, measles outbreaks.

Public health officials describe the proposed reallocation of state dollars as a well-meaning initiative that nonetheless would have “dire consequences” to core public health services.

There have been 764 confirmed cases of measles this year through May 3 in 23 states, including California, the highest number since 1994, the Centers for Disease Control and Prevention reported Monday. State public health officials also are struggling to address record rates of sexually transmitted diseases, with more than 300,000 cases of gonorrhea, chlamydia and syphilis reported in 2017.

The reallocation of state money “would exacerbate our already limited capacity to respond to outbreaks and public health emergencies,” said Jeff Brown, director of Placer County’s Health and Human Services Department, which has responded to three measles cases so far this year.

California already allows eligible immigrant children up to age 19 to participate in Medi-Cal, the state’s Medicaid program for low-income residents, regardless of their immigration status. The current budget sets aside $365.2 million to pay for the coverage.

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In his 2019-20 budget plan, Newsom proposes expanding eligibility to unauthorized young adult immigrants from age 19 through 25.

His office estimates it would cost nearly $260 million to cover them in 2019-20. While state and federal governments usually share Medicaid costs, California would have to bear the full cost of covering this population.

To help pay for it, Newsom proposes to redirect about $63 million in state funds from 39 counties, arguing they would no longer need to provide health benefits to low-income young adults covered by the state.

“As the state takes on responsibility for providing health care to undocumented adults, counties’ costs and responsibilities on indigent health care are expected to decrease,” Jenny Nguyen, a budget analyst at the state Department of Finance, told lawmakers at a recent legislative hearing.

Under the governor’s 2019-20 budget plan, which requires legislative approval, 35 mostly small and rural counties expect to lose about $45 million in state money that funds health services for uninsured residents, including undocumented immigrants. Those counties — which participate in something called the County Medical Services Program — aren’t expected to feel an immediate financial impact because the program has a budget surplus.

But four counties — Placer, Sacramento, Santa Barbara and Stanislaus — would take big and immediate hits to their public health budgets, officials say.

The amount of money the governor wants to divert from them to cover unauthorized immigrants under Medi-Cal is far more than the counties now spend on comprehensive health services for those immigrants, local health officials said.

“The idea that these dollars would be offset is just not accurate,” said Mary Ann Lee, managing director of Stanislaus County Health Services Agency, who described the governor’s budget proposal as “alarming.”

For example, Stanislaus County estimates it would lose $2.5 million under the governor’s budget plan. When officials studied the population served by their health centers, they found only 18 individuals were young adults who might not have legal immigration status. The total cost to provide care to them: just $1,700 a year.

Sacramento County, which reported a 300% increase in syphilis cases in the past four years, would have to shutter its newly opened STD clinic if the county loses an estimated $7.5 million in state funding, Dr. Peter Beilenson, the county Health Services Director, told lawmakers.

And while Sacramento County provides primary health care to an estimated 4,000 undocumented immigrant adults, just 100 are ages 19 to 25, and they are the least expensive to cover, Beilenson said.

“We agree with the idea behind this, increasing coverage for [those who are] undocumented,” Beilenson said. But losing those funds would force the county to close its STD clinic and terminate some communicable disease investigators “at a time when we now have measles cases in the region and we don’t want to be shutting those services down.”

The 40 confirmed cases of measles reported in California as of May 1 include three in Sacramento County.

As a result of the reduced funding, Sacramento County also would have to slash health services to its unauthorized immigrant residents — the very people Newsom aims to help — by an estimated 75%, Beilenson added.

Whether lawmakers will approve the governor’s proposal is unclear.

Several already have expressed concern, including state Assemblywoman Eloise Reyes (D-Grand Terrace), who said, “I think it is clear that this would be terrible for those counties.”

Officials with the Department of Finance told lawmakers at the hearing that they were aware of counties’ concerns but that the “governor’s budget stands as it is.”

The governor is scheduled to release a revised budget proposal by May 14, before the legislature votes on it this summer.

“I hope there will be some reconsideration,” said state Sen. Richard Pan (D-Sacramento), chairman of the Senate Health Committee. “There’s a disconnect there.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Effects Of Surgery On A Warming Planet: Can Anesthesia Go Green?

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It was early morning in an operating theater at Providence Hospital in Portland, Ore. A middle-aged woman lay on the operating table, wrapped in blankets. Surgeons were about to cut out a cancerous growth in her stomach.

But first, an anesthesiologist — Dr. Brian Chesebro — put her under by placing a mask over her face.

“Now I’m breathing for her with this mask,” he said. “And I’m delivering sevoflurane to her through this breathing circuit.”

Sevoflurane is one of the most commonly used anesthesiology gases. The other big one is desflurane. There are others too, like nitrous oxide, commonly known as laughing gas.

Whichever gas a patient gets is inhaled, but only about 5% is metabolized. The rest is exhaled. And to make sure the gas doesn’t knock out anyone else in the operating room, it’s sucked into a ventilation system.

And then? It’s vented up and out through the roof, to mingle with other greenhouse gases.

The two frequently used gases are fairly similar medically; sevoflurane needs to be more carefully monitored and meted out in some patients, but that’s not difficult, Chesebro said.

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Generally, unless there’s a reason in a particular case to use one over the other, anesthesiologists simply tend to pick one of the two gases and stick with it. Few understand that one — desflurane — is much worse for the environment.

And that bothered Chesebro. He grew up on a ranch in Montana that focused on sustainability.

“Part of growing up on a ranch is taking care of the land and being a good steward,” he said.

Now he lives in the city with his three kids and has gradually started to worry about their environmental future.

“When I look around and I see the stewardship on display today, it’s discouraging,” he said.

“I got depressed for a while, and so I hit the pause button on myself and said, ‘Well, what’s the very best that I can do?'”

He spent hours of his own time researching anesthesiology gases. And he learned desflurane is 20 times more powerful than sevoflurane in trapping heat in the Earth’s atmosphere. It also lasts for 14 years in the atmosphere, whereas sevoflurane breaks down in just one year.

Opening a big, black notebook filled with diagrams and tiny writing, he showed how he computed the amount of each gas the doctors in his group practice used. Then he shared their carbon footprint with them.

“All I’m doing is showing them their data,” Chesebro said. “It’s not really combative. It’s demonstrative.”

One of the doctors he shared his analysis with was Dr. Michael Hartmeyer, who works at the Oregon Anesthesiology Group with Chesebro.

“I wish I had known earlier,” Hartmeyer said. “I would have changed my practice a long time ago.”

Hartmeyer said he was stunned when Chesebro explained that his use of desflurane was the greenhouse-gas equivalent of driving a fleet of 12 Hummers for the duration of each surgical procedure. It’s “only” half a Hummer if he uses sevoflurane. Hartmeyer noted that outside the operating room he drives a Prius, a hybrid electric car.

“You try to be good,” he said. “You take shorter showers or [don’t] leave lights on, or whatever else. But you know there’s always more that we could probably do. But this was, far and away, a relatively easy thing that I could do that made a huge impact.”

The anesthesiology carts that get brought into operating theaters tend to have a row of gases to choose from. Hartmeyer was able to switch pretty much overnight.

Other anesthesiologists made the switch, too. And it didn’t hurt that sevoflurane is considerably cheaper.

Hartmeyer’s change saved his hospital $13,000 a year.

When Chesebro shared his findings with the anesthesia departments at all eight Providence Health hospitals in Oregon, they prioritized the use of sevoflurane. They now save about $500,000 a year.

Providence’s chief executive, Lisa Vance, said the hospital system didn’t change its use of the gas because of the money. It changed because the World Health Organization now says climate change is the No. 1 public health issue of the 21st century — and because of Chesebro.

Vance said Chesebro teared up in front of 2,000 people when talking about the gas, his children and the Lorax character created by Dr. Seuss.

“Unless someone like you cares a whole awful lot, nothing’s going to get better — it’s not,” said Vance, quoting the book “The Lorax.”

Dr. Jodi Sherman, an associate professor of anesthesiology at Yale School of Medicine, called Chesebro’s efforts remarkable and important.

She said several hospitals around the country have tried to make this shift, but with mixed results. Some just gave anesthesiologists the information and not much changed. Other hospitals took desflurane away, but that left many anesthesiologists feeling disrespected and angry.

Chesebro succeeded, she said, because he chose to persuade his colleagues using data. He showed doctors their choice of gas plotted against their greenhouse impact. And it helped that he showed them over and over, so doctors could compare their progress to their peers.

“Providing ongoing reports to providers is the best way for this movement to catch on and grow,” she said. It can reinforce over time, she added, not just what their carbon footprint is, but also what progress they’re making.

Sherman said efforts such as Chesebro’s are sorely needed because the U.S. health sector is responsible for about 10% of the nation’s greenhouse gases.

“We clinicians are very much focused on taking care of the patient in front of us,” she said. “We tend to not think about what’s happening to the community health, public health — because we’re so focused on the patient in front of us.”

In an emailed statement, one of the largest manufacturers of both the anesthesia gases — Baxter International — said it’s important to provide a range of options for patients. The company also said inhaled anesthetics have a climate impact of 0.01% of fossil fuels.

“The overall impact of anesthetic agents on global warming is low, relative to other societal contributors, especially when you consider the critical role these products have in performing safe surgical procedures,” the statement reads.

It’s a fair point, Chesebro said, but he has a counterargument.

“Well, if it’s there, it’s bad. And if I can reduce my life’s footprint by a factor of six … why wouldn’t you do it?'”

The surgery Chesebro was involved in that morning at Providence was a success. Chesebro estimates that by using sevoflurane on his patient, the amount of greenhouse gases produced was the same as in a 40-mile drive across the Portland region. If he’d used desflurane instead, he said, it would have been like driving the more than 1,200 miles from Seattle to San Diego.

Now Chesebro’s hospital bosses are hoping other doctors will follow his lead, research their own pet peeve and maybe solve a problem no one’s thinking about.

This story is part of a partnership that includes Oregon Public BroadcastingNPR and Kaiser Health News.

Drug Industry Patents Go Under Senate Judiciary Committee’s Microscope

Congress isn’t making much headway in finding a solution to the problem of soaring prescription drug prices, but lawmakers from both parties are tinkering on the edges with legislation that aims to increase competition among drugmakers.

A comprehensive piece of drug-pricing legislation is a high priority for Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Ron Wyden (D-Ore.). And it could be introduced by mid-June, according to congressional staff.

But while that is hashed out, a slate of options to reform drug patents is working its way through the Senate Judiciary Committee, which had a hearing Tuesday featuring academics, patient advocates and a representative from the pharmaceutical industry. Their mission: to increase competition without decreasing innovation in the industry.

“I think we’re dangerously close to building a bipartisanship consensus around change,” Sen. Dick Durbin (D-Ill.) said during the hearing.

The four proposed bills share a common goal: avoiding some of the thorny issues around drug pricing, like whether the government will set drug prices or negotiate with manufacturers on what federal programs will pay. Instead, the patent reform proposals get at the ways branded drug manufacturers use patents, and the legal monopolies that are granted with patents, to keep lower-priced generic competitors from reaching patients.

“A package of patent reforms are important because they fix systemic problems that allow prices to go up and keep them high,” testified David Mitchell, the president of Patients for Affordable Drugs, a Washington, D.C.-based advocacy group focused on lowering prescription drug prices.

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Sen. John Cornyn (R-Texas) offered specific examples of drugs that have benefited from system issues, including Humira, an expensive drug for arthritis and psoriasis that is protected by 136 patents.

That’s called a “patent thicket,” because it prevents a generic alternative from entering the market for more years — in this case, until 2023 for a drug first approved for use in the United States in 2002. “Is there anyone on the panel who’d like to defend the status quo?” he asked.

“There is no way a biosimilar can deal with a hundred patents,” testified Michael Carrier, a professor at Rutgers Law School. “This is an abuse of the system.”

Among the proposed bills, the Stop STALLING (“Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics”) Act — the bipartisan brainchild of Sen. Amy Klobuchar (D-Minn.) and Grassley — is supposed to put a stop to “sham” citizen petitions to the FDA. Critics say these petitions are often introduced by drugmakers under the guise of patient advocacy to slow FDA approval of new generic medicines. “Nearly every one of these citizen petitions is brought by a brand company. None are filed by individuals. I love the legislation. I would go even stronger,” Carrier said.

Grassley is also the lead sponsor on the bipartisan Prescription Pricing for the People Act of 2019. It directs the Federal Trade Commission to investigate mergers of pharmacy benefit managers, the middlemen that negotiate between drugmakers and health plans.

Klobuchar and Grassley teamed up again on another measure, the Preserve Access to Affordable Generics and Biosimilars Act, which they  say would end “anti-competitive behavior” — specifically, deals struck between branded companies and generic companies to keep a generic, or a biosimilar, off the market. Klobuchar, a Democratic presidential candidate, has frequently discussed her opposition to this practice on the campaign trail.

James Stansel — the executive vice president and general counsel of the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, and the lone voice of the pharmaceutical industry on the panel — cautioned against moving too aggressively on this point. “We want to make sure we don’t do something that’s anti-competitive in the hopes it would be pro-competitive,” he said.

There’s also the CREATES (“Creating and Restoring Equal Access to Equivalent Samples”) Act, introduced by Sen. Patrick Leahy (D-Vt.) with 31 bipartisan co-sponsors and endorsed by nearly every witness on Tuesday’s panel. It’s supposed to crack down on branded companies that refuse to sell samples of their drugs to generic companies, a necessary step to increasing the number of generics on the market.

Versions of all four of those bills have also been introduced in the House and advanced out of the House Judiciary Committee.

“The American people are being played for chumps,” said Sen. John Kennedy (R-La.). “Just chumps. And it’s got to stop.”

Feds Want To Show Health Care Costs On Your Phone, But That Could Take Years

Federal officials are proposing new regulations that for the first time could allow patients to compare prices charged by various hospitals and other health care providers using data sent to their smartphones.

Donald Rucker, who coordinates health information technology policy for the Department of Health and Human Services, said he expects that the rules, first proposed in March, will give patients new power to shop for care based on price and quality.

Consumers have long sought more knowledge about health care prices, but administration officials cautioned it could take two years or more for it to appear in a user-friendly form on a phone app. Many specifics, including how patients would make sense of complex pricing policies for purchasing health care and insurance and assessing quality via an app, remain unclear.

Rucker said in remarks prepared for a Senate Health, Education, Labor & Pensions Committee hearing Tuesday that patients “have few ways if any to anticipate or plan for costs, lower or compare costs, and, importantly, measure their quality of care or coverage relative to the price they pay.”

The Trump administration proposal comes amid growing outrage from patients hit with seemingly exorbitant “surprise” medical bills. One study found that these bills — which are for amounts far more than the patient anticipated or for care not covered by insurance — have bedeviled more than half of American adults.

The Senate committee is reviewing regulations proposed under the 21st Century Cures Act, a law passed in 2016 to promote innovation in health care.

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Dr. Kate Goodrich, the chief medical officer for the federal government’s Centers for Medicare & Medicare Services, said the agency wants every American to have an electronic health record (EHR) that will follow them as they move through the health care system, “giving them the data they need to make the best decisions for themselves and their families.”

Everyone, Goodrich said in her prepared statement to the committee, “should be able, without special effort or advanced technical skills, to see, obtain, and use all electronically available information that is relevant to their health care, and choices — of plans, providers, and specific treatment options.”

Meeting these goals could prove to be a tall order. For well over a decade, federal officials have struggled to set up a digital records network capable of widespread sharing of medical data and patient records. In 2004, President George W. Bush said he hoped to have a digital record for most Americans within five years. In early 2009, the Obama administration picked up the challenge and funneled billions of dollars in economic stimulus money into a campaign to help doctors and hospitals buy the software needed to replace paper medical files.

Critics argue that poor oversight over the stimulus spending and objectives has saddled many doctors and hospitals with flawed software that typically cannot share information across health networks as promised. It has also caused new types of errors that compromise the safety of patients.

Botched Operation,” a recent investigation published by Kaiser Health News and Fortune, found that the federal government has spent more than $36 billion on the EHR initiative. Thousands of reports of deaths, injuries and near misses linked to digital systems have piled up in databases over the past decade — while many patients have reported difficulties getting copies of their complete electronic files, the investigation found.

Despite the slow progress, federal officials remain optimistic that digital records will save the nation billions of dollars while reducing medical errors, unnecessary medical testing and other waste — and encouraging more Americans to take a bigger role in managing their health care by comparing prices.

But Sen. Lamar Alexander, R-Tenn., the committee’s chairman, said the results would have been better had officials not rushed out the stimulus plan. “I am especially interested in getting where we want to go with input from doctors, hospitals, vendors, and insurers, so we have less confusion, make the fewest possible mistakes, and make sure we don’t set some kind of unrealistic timeline,” he said in a statement.

Anger over the lack of easy access to health care has dominated public comments on the proposed regulation posted on a government website.

“The proposed policy to mandate disclosure of health care pricing by hospitals, insurance companies, etc. is one of the most important in American history. That is not hyperbolic,” one anonymous commenter wrote, adding: “The only way to save money on healthcare in America is to never receive it.”

Tennessee diagnostic medical imaging services company pays $3,000,000 to settle breach exposing over 300,000 patients’ protected health information

HHS Gov News - May 07, 2019

Touchstone Medical Imaging (“Touchstone”) has agreed to pay $3,000,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Security and Breach Notification Rules. Touchstone, based in Franklin, Tennessee, provides diagnostic medical imaging services in Nebraska, Texas, Colorado, Florida, and Arkansas. 

In May 2014, Touchstone was notified by the Federal Bureau of Investigation (FBI) and OCR that one of its FTP servers allowed uncontrolled access to its patients’ protected health information (PHI).  This uncontrolled access permitted search engines to index the PHI of Touchstone’s patients, which remained visible on the Internet even after the server was taken offline. 

Touchstone initially claimed that no patient PHI was exposed.  However, during OCR’s investigation, Touchstone subsequently admitted that the PHI of more than 300,000 patients was exposed including names, birth dates, social security numbers, and addresses.  OCR’s investigation found that Touchstone did not thoroughly investigate the security incident until several months after notice of the breach from both the FBI and OCR.  Consequently, Touchstone’s notification to individuals affected by the breach was also untimely.  OCR’s investigation further found that Touchstone failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its electronic PHI (ePHI), and failed to have business associate agreements in place with its vendors, including their IT support vendor and a third-party data center provider as required by HIPAA.

“Covered entities must respond to suspected and known security incidents with the seriousness they are due, especially after being notified by two law enforcement agencies of a problem,” said OCR Director Roger Severino.  “Neglecting to have a comprehensive, enterprise-wide risk analysis, as illustrated by this case, is a recipe for failure.” 

In addition to the monetary settlement, Touchstone will undertake a robust corrective action plan that includes the adoption of business associate agreements, completion of an enterprise-wide risk analysis, and comprehensive policies and procedures to comply with the HIPAA Rules. 

The resolution agreement and corrective action plan may be found at https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/tmi/index.html.

Meth Vs. Opioids: America Has Two Drug Epidemics, But Focuses On One

Kaiser Health News:States - May 07, 2019

Kim had been wine tasting with a friend in Sonoma, Calif. They got into an argument in the car that night and Kim thought someone was following them. She was utterly convinced. And she had to get away.

“I jumped out of the car and started running, and I literally ran a mile. I went through water, went up a tree,” she said. “I was literally running for my life.”

Kim was soaking wet when she walked into a woman’s house, woke her from bed and asked for help. When the woman went to call the police, Kim left and found another woman’s empty guesthouse to sleep in — Goldilocks-style.

“But then I woke up and stole her car,” said Kim, who is 47 and now in recovery. (KHN is using her first name only because she has used illicit drugs.) Kim had been high on Xanax and methamphetamine. “I was crazy. Meth causes people to act completely insane.”

While public health officials have focused on the opioid epidemic in recent years, another epidemic has been brewing quietly, but vigorously, behind the scenes. Methamphetamine use is surging in parts of the U.S., particularly the West, leaving first responders and addiction treatment providers struggling to handle a rising need.

Across the country, overdose deaths involving meth more than quadrupled from 2011 to 2017. Admissions to treatment facilities for meth are up 17%. Hospitalizations related to meth jumped by about 245% from 2008 to 2015. And throughout the West and Midwest, 70% of local law enforcement agencies say meth is their biggest drug threat.

But policymakers in Washington, D.C., haven’t kept up, continuing to direct the bulk of funding and attention to opioids, said Steve Shoptaw, an addiction psychologist at UCLA in Los Angeles, where he hears one story after another about meth destroying people’s lives.

“But when you’re in D.C., where people are making decisions about how to deploy resources, those stories are very much muffled by the much louder story about the opioid epidemic,” he said.

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Even within drug treatment circles, there’s a divide. Opioid addiction advocates are afraid their efforts to gain acceptance for measures like needle-exchange programs and safe injection sites will be threatened if meth advocates demand too much.

“The bottom line is, as Americans, we have just so much tolerance to deal with addiction,” Shoptaw said. “And if the opioid users have taken that tolerance, then there’s no more.”

So, lawmakers in San Francisco are trying to get a grip on the toll meth is taking on their city’s public health system on their own. The mayor recently established a task force to combat the epidemic.

“It’s something we really have to interrupt,” said Rafael Mandelman, a San Francisco district supervisor who will co-chair the task force. “Over time, this does lasting damage to people’s brains. If they do not have an underlying medical condition at the start, by the end, they will.”

Since 2011, emergency room visits related to meth in San Francisco have jumped 600% to 1,965 visits in 2016, the last year for which ER data is available. Admissions to the hospital are up 400% to 193, according to city public health data. And at San Francisco General Hospital, of 7,000 annual psychiatric emergency visits last year, 47% were people who were not necessarily mentally ill — they were high on meth.

“They can look so similar to someone that’s experiencing chronic schizophrenia,” said Dr. Anton Nigusse Bland, medical director of psychiatric emergency services at San Francisco General. “It’s almost indistinguishable in that moment.”

They have methamphetamine-induced psychosis.

“They’re often paranoid, they’re thinking someone might be trying to harm them,” he said. “Their perceptions are all off.”

If the person is extremely agitated, doctors might administer a sedative or even an antipsychotic medicine. Otherwise, the treatment is just waiting 12 to 16 hours for the meth to wear off. No more psychosis.

“Their thoughts are more organized, they’re able to maintain adequate clothing. They’re eating, they’re communicating,” Nigusse Bland said. “The improvement in the person is rather dramatic because it happens so quickly.”

Trends In Drug Use Come In Waves

The trend in rising stimulant use is nationwide: cocaine on the East Coast, meth on the West Coast, said Dr. Daniel Ciccarone, a professor of medicine and substance use researcher at the University of California-San Francisco.

“It is an epidemic wave that’s coming, that’s already here,” he said. “But it hasn’t fully reached our public consciousness.”

Drug preferences are generational, Ciccarone said. They change with the hairstyles and clothing choices, like bell-bottoms or leg warmers. It was heroin in the 1970s, cocaine and crack in the ’80s. Then opiate pills. Then methamphetamine. Then heroin. And now meth again.

“The culture creates this notion of let’s go up, let’s not go down,” Ciccarone said. “New people coming into drug use are saying, ‘Whoa, I don’t really want to do that. I hear it’s deadly.'”

Kim has been with meth through two waves. When she got into speed in the 1990s, she was hanging out with bikers, going to clubs in San Francisco.

“Now what I see, in any neighborhood, you can find it. It’s not the same as it used to be where it was kind of taboo,” Kim said. “It’s more socially accepted now.”

Dying From Meth

A hint about who uses meth now comes from the data on deaths.

Meth is not as lethal as opioids: 47,600 people died of opioid-related overdoses in 2017 compared with 10,333 deaths involving meth. But the death rate for meth has been rising. Meth-related deaths in San Francisco doubled since 2011, another indication that more people are using meth and that today’s supply is very potent, said the UCSF’s Ciccarone.

Another hypothesis to explain the growth in meth-related overdoses is that meth users are aging. Most meth deaths are from a brain hemorrhage or a heart attack, which would be unusual for a 20-year-old.

“Because your tissue is so healthy at that age,” said Dr. Phillip Coffin, a physician and the director of substance use research at the San Francisco Department of Public Health. “Whereas when you’re 55 years old and using methamphetamine, you might be at higher risk for bursting a vessel and bleeding and dying from that.”

Another explanation for the rising death rate is that meth has become contaminated. And that affects everyone, old and young. Last year, three young people in San Francisco died after smoking meth together. It turns out the meth had fentanyl in it. The synthetic opioid has been causing waves of heroin overdoses across the country, but now it’s showing up mixed into cocaine and meth.

Most researchers believe the contamination happens accidentally, when a dealer uses the same equipment to bag fentanyl and later meth, Ciccarone said.

A meth overdose alert from the Drug Overdose Prevention and Education Project.(April Dembosky/KQED)

Relapses Are Common

Over her two decades of meth use, Kim has been through drug treatment more than a dozen times. Relapse is part of recovery, and among meth users, 60% will start using again within a year of finishing treatment. Unlike opioids, there are no medication treatments for meth addiction, which makes it particularly hard to treat.

In April, Kim completed a six-month residential treatment program for women in San Francisco called the Epiphany Center. She came directly from jail, after serving time for her housewarming-and-car-theft spree in Sonoma. She said that in the first 30 days all she could do was try to clear the chaos from her mind.

“You have to get used to sitting with yourself, which is essential for life, is to get along with your own self,” she said.

Kim, who has four children, is hopeful that this round of treatment will stick. She is living in transitional housing now, has a job and has been accepted to a program at the University of California-Berkeley to finish her college degree.

“I’ve gone through 12 different programs and it’s been for my children, for my mom, for the courts. I’ve never come to be there for myself,” Kim said. “So it’s like I’ve come to a place where it has to be for me.”

This story is part of a partnership that includes KQED, NPR and Kaiser Health News.

Putting A Face To Surprise Bills: Among Specialists, Plastic Surgeons Most Often Out-Of-Network

Bob Ensor didn’t see the boom swinging violently toward him as he cleaned a sailboat in dry dock on a spring day two years ago. But he heard the crack as it hit him in the face.

He was transported by ambulance to an in-network hospital near his home in Middletown, N.J., where initial X-rays showed his nose was broken as were several bones of his left eye socket. The emergency physician summoned the on-call plastic surgeon, who admitted him to the hospital and scheduled him for surgery the next day.

Shortly before surgery, the doctor introduced Ensor to a second plastic surgeon who would assist in the 90-minute procedure. Entering through Ensor’s nose, the physicians realigned his facial bones, temporarily sewing Ensor’s left eye shut so that the lids would stay in place as the bones knitted back together.

Six weeks later, as Ensor, then 65, continued to make an uneventful recovery, a collection agency called to inquire how he and his wife planned to pay the $71,729 bill for the assistant surgeon. Ensor’s company health plan had denied payment because the surgeon wasn’t part of its contracted physician network.

There was more bad news. Ensor received notice that the health plan wouldn’t cover the $95,885 charged by the first plastic surgeon either because he also was out-of-network.

“The hospital knew these doctors were out-of-network and didn’t bother to tell us,” said his wife, Linda Ensor, noting they faced more than $167,000 in charges. “We were panicked.”

Riverview Medical Center in Red Bank, N.J., where Ensor was treated, said that it “empathizes with patients who are trying to navigate the complexity of the health care billing system” and that transparency in billing has not always been optimal for emergency department patients.

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As surprise out-of-network billing becomes a politically charged issue, Americans want the federal government to take action. In an April survey, more than three-quarters of consumers said the government should protect them from such bills, according to the Kaiser Family Foundation’s monthly health tracking poll. (KHN is an editorially independent program of the foundation.)

An analysis of insurance claims from more than 350 commercial carriers found that plastic and maxillofacial surgeons billed out-of-network more frequently than any other type of specialist in an inpatient setting. Examining hospital admissions in 2016, researchers at Johns Hopkins Bloomberg School of Public Health found that plastic and maxillofacial surgeons billed their services out-of-network 23% of the time, more than any of the other 50 specialties analyzed.

That leaves patients like Ensor, whose care requires plastic or maxillofacial surgery, extremely vulnerable. It also catches patients off guard: When a parent brings in a child with a cut and a triage nurse asks if they’d prefer a plastic surgeon, many reflexively answer “yes” not understanding whether there is an actual need nor anticipating the charges.

According to one survey of emergency department directors at more than 440 hospitals, 81% reported they had inadequate plastic surgery coverage, a higher percentage than reported shortages of any other type of surgical specialty.

The reasons these specialists are such frequent out-of-network billers are fairly straightforward.

Many plastic surgeons don’t participate in health plans because they have flexibility other physicians may not have — their practices often focus on elective cosmetic procedures like nose reshaping and breast augmentation that patients pay for on their own.

Also, general surgeons and heart surgeons generally want to maintain good relations with the hospitals — and be on call for the ER  — since the ER is a source of patient referrals and their patients often require inpatient care. In contrast, plastic surgeons often operate at outpatient centers.

“Fortunately for some plastic surgeons with alternative revenue streams, they don’t need to participate with insurance companies,” said Dr. Gregory Greco, the board vice president for health policy and advocacy of the American Society of Plastic Surgeons, who has a solo practice in New Jersey and Manhattan. Greco participates in the employee plans at the institutions where he has hospital privileges, but he doesn’t accept other insurance plans.

The society did not respond to a request for information regarding the percentage of plastic surgeons who participate in insurance networks.

That can spell trouble in emergency care. Under the federal Emergency Medical Treatment and Labor Act (EMTALA), hospital emergency departments are required to screen and stabilize any patient who walks through the door, whether or not they can afford to pay. Hospitals often rely on a roster of on-call specialists to treat emergency patients, but studies show many specialists are reluctant to be on call, and low rates of insurance reimbursements may play a role in those decisions.

Data from a New York state program to arbitrate surprise medical bills — a 2015 state law holds patients harmless for such charges — highlights the scope of the problem with plastic surgery coverage.

Emergency care involving out-of-network plastic surgery services was by far the most common type of bill reviewed, according to figures from the state Department of Financial Services. By late 2018, there had been 543 decisions regarding such bills, compared with 335 for emergency physician care and 263 for orthopedists.

In New York, the surprise billing law has discouraged plastic surgeons from charging extremely high fees for out-of-network work, said Dr. Andrew Kleinman, a plastic surgeon in suburban New York City who is a former president of the Medical Society of the State of New York. Under the program, which uses a process called “baseball arbitration,” the insurer and provider each submits a proposed dollar amount and the arbitrator picks one.

“Baseball arbitration gives the physician an incentive not to bill an outrageous rate because they’re going to lose,” Kleinman said. If a doctor charges $20,000 for services provided, but the insurer offers $500, “the insurer will win every time,” he said.

More than two dozen states have passed laws that address surprise bills to some extent — although they do not protect the many patients covered by plans regulated by national rules. Congress is debating measures that would address surprise bills at the national level.

Dr. Meghan Candee of Salt Lake City was stunned when a plastic surgeon charged her insurance company more than $25,000 for a single stitch after daughter Maeve cut her face in a fall.(Courtesy of Meghan Candee)

In the meantime, patients remain vulnerable. Dr. Meghan Candee was visiting family in Riverhead, N.Y., last summer when her daughter, who was 4 at the time, fell against a wooden bench and got a small cut underneath her left eyebrow. Candee, a pediatric neurologist in Salt Lake City, took her to the emergency department nearby, where she opted for a plastic surgeon, who put in a single stitch, without any sedation.

Candee paid the $100 copayment for the emergency department visit and took the stitch out herself five days later.

A few weeks later, Candee’s insurer sent a $25,175 check to pass on to the out-of-network plastic surgeon, who had charged that amount for his work.

Assuming there was an error, Candee called the plastic surgeon’s billing office but was told the amount was correct. Even though she wasn’t herself on the hook, Candee was “outraged.”

“This is why people have issues with physicians, and they think most of us are out there trying to get money,” she said.

In New York, the average out-of-network charge at a hospital or other setting for an injury like Candee’s daughter’s — a simple repair of a superficial wound on the face that is 2.5 centimeters or less in length — is $438.01, according to FAIR Health, a national, independent nonprofit organization that collects and manages an extensive database of insurance claims. In the Great Neck/Port Washington area of Long Island, the area with the highest charges for that repair nationwide, the average charge is $1,067.25.

Patients should know that a plastic surgeon may not be covered in-network and is not necessary in many cases. “It’s not uncommon for a family to say they would like a plastic surgeon,” said Dr. William Jaquis, president-elect of the American College of Emergency Physicians. “But, in the vast majority of cases, a well-trained emergency physician can do most of the repairs.” A plastic surgeon makes sense when there’s extensive, deep-tissue damage and the skin is not cleanly torn, especially on the face, he said. A dog bite or an eye socket injury like Ensor’s is a classic example.

Luckily for the Ensors, the sailing club stepped in to take up his case with the out-of-network plastic surgeons. Since sailing club members were required to volunteer on work projects to keep membership costs in check, the club’s insurer agreed to cover the accident as a workers’ compensation case. It paid 100% of the outstanding bill.

A Boat Crushed His Face, Then Plastic Surgeons Hit Him With $167,000 In Bills

Bob Ensor didn’t see the boom swinging violently toward him as he cleaned a sailboat in dry dock on a spring day two years ago. But he heard the crack as it hit him in the face.

He was transported by ambulance to an in-network hospital near his home in Middletown, N.J., where initial X-rays showed his nose was broken as were several bones of his left eye socket. The emergency physician summoned the on-call plastic surgeon, who admitted him to the hospital and scheduled him for surgery the next day.

Shortly before surgery, the doctor introduced Ensor to a second plastic surgeon who would assist in the 90-minute procedure. Entering through Ensor’s nose, the physicians realigned his facial bones, temporarily sewing Ensor’s left eye shut so that the lids would stay in place as the bones knitted back together.

Six weeks later, as Ensor, then 65, continued to make an uneventful recovery, a collection agency called to inquire how he and his wife planned to pay the $71,729 bill for the assistant surgeon. Ensor’s company health plan had denied payment because the surgeon wasn’t part of its contracted physician network.

There was more bad news. Ensor received notice that the health plan wouldn’t cover the $95,885 charged by the first plastic surgeon either because he also was out-of-network.

“The hospital knew these doctors were out-of-network and didn’t bother to tell us,” said his wife, Linda Ensor, noting they faced more than $167,000 in charges. “We were panicked.”

Riverview Medical Center in Red Bank, N.J., where Ensor was treated, said that it “empathizes with patients who are trying to navigate the complexity of the health care billing system” and that transparency in billing has not always been optimal for emergency department patients.

Email Sign-Up

Subscribe to KHN’s free Morning Briefing.

Sign Up Please confirm your email address below: Sign Up

As surprise out-of-network billing becomes a politically charged issue, Americans want the federal government to take action. In an April survey, more than three-quarters of consumers said the government should protect them from such bills, according to the Kaiser Family Foundation’s monthly health tracking poll. (KHN is an editorially independent program of the foundation.)

An analysis of insurance claims from more than 350 commercial carriers found that plastic and maxillofacial surgeons billed out-of-network more frequently than any other type of specialist in an inpatient setting. Examining hospital admissions in 2016, researchers at Johns Hopkins Bloomberg School of Public Health found that plastic and maxillofacial surgeons billed their services out-of-network 23% of the time, more than any of the other 50 specialties analyzed.

That leaves patients like Ensor, whose care requires plastic or maxillofacial surgery, extremely vulnerable. It also catches patients off guard: When a parent brings in a child with a cut and a triage nurse asks if they’d prefer a plastic surgeon, many reflexively answer “yes” not understanding whether there is an actual need nor anticipating the charges.

According to one survey of emergency department directors at more than 440 hospitals, 81% reported they had inadequate plastic surgery coverage, a higher percentage than reported shortages of any other type of surgical specialty.

The reasons these specialists are such frequent out-of-network billers are fairly straightforward.

Many plastic surgeons don’t participate in health plans because they have flexibility other physicians may not have — their practices often focus on elective cosmetic procedures like nose reshaping and breast augmentation that patients pay for on their own.

Also, general surgeons and heart surgeons generally want to maintain good relations with the hospitals — and be on call for the ER  — since the ER is a source of patient referrals and their patients often require inpatient care. In contrast, plastic surgeons often operate at outpatient centers.

“Fortunately for some plastic surgeons with alternative revenue streams, they don’t need to participate with insurance companies,” said Dr. Gregory Greco, the board vice president for health policy and advocacy of the American Society of Plastic Surgeons, who has a solo practice in New Jersey and Manhattan. Greco participates in the employee plans at the institutions where he has hospital privileges, but he doesn’t accept other insurance plans.

The society did not respond to a request for information regarding the percentage of plastic surgeons who participate in insurance networks.

That can spell trouble in emergency care. Under the federal Emergency Medical Treatment and Labor Act (EMTALA), hospital emergency departments are required to screen and stabilize any patient who walks through the door, whether or not they can afford to pay. Hospitals often rely on a roster of on-call specialists to treat emergency patients, but studies show many specialists are reluctant to be on call, and low rates of insurance reimbursements may play a role in those decisions.

Data from a New York state program to arbitrate surprise medical bills — a 2015 state law holds patients harmless for such charges — highlights the scope of the problem with plastic surgery coverage.

Emergency care involving out-of-network plastic surgery services was by far the most common type of bill reviewed, according to figures from the state Department of Financial Services. By late 2018, there had been 543 decisions regarding such bills, compared with 335 for emergency physician care and 263 for orthopedists.

In New York, the surprise billing law has discouraged plastic surgeons from charging extremely high fees for out-of-network work, said Dr. Andrew Kleinman, a plastic surgeon in suburban New York City who is a former president of the Medical Society of the State of New York. Under the program, which uses a process called “baseball arbitration,” the insurer and provider each submits a proposed dollar amount and the arbitrator picks one.

“Baseball arbitration gives the physician an incentive not to bill an outrageous rate because they’re going to lose,” Kleinman said. If a doctor charges $20,000 for services provided, but the insurer offers $500, “the insurer will win every time,” he said.

More than two dozen states have passed laws that address surprise bills to some extent — although they do not protect the many patients covered by plans regulated by national rules. Congress is debating measures that would address surprise bills at the national level.

Dr. Meghan Candee of Salt Lake City was stunned when a plastic surgeon charged her insurance company more than $25,000 for a single stitch after daughter Maeve cut her face in a fall.(Courtesy of Meghan Candee)

In the meantime, patients remain vulnerable. Dr. Meghan Candee was visiting family in Riverhead, N.Y., last summer when her daughter, who was 4 at the time, fell against a wooden bench and got a small cut underneath her left eyebrow. Candee, a pediatric neurologist in Salt Lake City, took her to the emergency department nearby, where she opted for a plastic surgeon, who put in a single stitch, without any sedation.

Candee paid the $100 copayment for the emergency department visit and took the stitch out herself five days later.

A few weeks later, Candee’s insurer sent a $25,175 check to pass on to the out-of-network plastic surgeon, who had charged that amount for his work.

Assuming there was an error, Candee called the plastic surgeon’s billing office but was told the amount was correct. Even though she wasn’t herself on the hook, Candee was “outraged.”

“This is why people have issues with physicians, and they think most of us are out there trying to get money,” she said.

In New York, the average out-of-network charge at a hospital or other setting for an injury like Candee’s daughter’s — a simple repair of a superficial wound on the face that is 2.5 centimeters or less in length — is $438.01, according to FAIR Health, a national, independent nonprofit organization that collects and manages an extensive database of insurance claims. In the Great Neck/Port Washington area of Long Island, the area with the highest charges for that repair nationwide, the average charge is $1,067.25.

Patients should know that a plastic surgeon may not be covered in-network and is not necessary in many cases. “It’s not uncommon for a family to say they would like a plastic surgeon,” said Dr. William Jaquis, president-elect of the American College of Emergency Physicians. “But, in the vast majority of cases, a well-trained emergency physician can do most of the repairs.” A plastic surgeon makes sense when there’s extensive, deep-tissue damage and the skin is not cleanly torn, especially on the face, he said. A dog bite or an eye socket injury like Ensor’s is a classic example.

Luckily for the Ensors, the sailing club stepped in to take up his case with the out-of-network plastic surgeons. Since sailing club members were required to volunteer on work projects to keep membership costs in check, the club’s insurer agreed to cover the accident as a workers’ compensation case. It paid 100% of the outstanding bill.

Readers And Tweeters Parse Ideas — From Snakebites To Senior Suicide

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.

Could ‘Aid-In-Dying’ Stem Tide Of Senior Suicide?

Lethal Plans: When Seniors Turn To Suicide In Long-Term Care” (April 9), by Melissa Bailey and JoNel Aleccia, was a significant, interesting, thoughtful article with wonderful stories and solid information. However, the emphasis seems to be on the role of caregivers and various involved institutions to create “safer” environments to foster prevention of elder suicides through better assessment, better trained and more empathetic caregivers, and stronger monitoring and/or oversight.

To me, assessment is the vital piece of the puzzle. If the suicide drive is triggered by depression or other mental health issue, then treatment, well-trained personnel, monitoring, etc. are all on point, with the hope that the suicide ideation will subside as life improves.

However, if loving, thoughtful and professional interactions with the elder reveal that physical or emotional suffering has become unbearable subsequent to a serious, life-threatening illness, the issues involved are very different. They should now be addressed in a patient-centric manner in keeping with the underlying principle of self-determination.

In the article, these issues are only vaguely alluded to, as if medical aid-in-dying is an insubstantial fad or a “rare” policy exception. On the contrary, almost 20% of the U.S. population has legal access to aid-in-dying now that New Jersey’s new aid-in-dying law will take effect Aug. 1.

I wonder about the differences in elder suicide rates in Oregon and Washington, where medical aid-in-dying has been legal for decades. And I wonder if candid, loving discussions about advance care planning and sharing among loved ones about the value of longevity vs. quality of life, etc. are part of the solution. At least it would keep suicide survivors from unending questions, recriminations and flat-out guilt that may be undeserved.

So, my challenge to the incredibly capable and terrific authors is to try and tie these threads together and make the focus about informed decision-making, advance care planning, policies that maximize options (including medical aid-in-dying) and the inevitability of death for the elderly. We all die. Thanks for caring so much.

— Barak Wolff, NM End of Life Options Coalition, Santa Fe, N.M.

Elaborating on her tweet, reader Sharon Moon told KHN: “This is going to become more and more pressing as baby boomers age. I was in risk management in hospitals. In my view, hospitals err on the side of not reporting things. There is a huge culture of retaliation and seeking to sweep problems under the rug. … I can only imagine the way it is in nursing homes that are largely for-profit and without as many M.D.’s to speak out for patients.”

Who can blame them? We have lost our humanity. A nursing home chain owner (4 profit and private) hosted Trump’s CA fundraiser. We need to turn away from money and towards community.

— UnChatUnChat (@CriUnChatUnChat) April 10, 2019

— Sharon Moon, Yardley Borough, Pa.

Is There A ‘Dr.’ In The House Style?

Kaiser Health News’ “Lethal Plans: When Seniors Turn To Suicide In Long-Term Care” was an interesting and informative piece on a topic that deserves more public exposure. Thank you for writing it. But would it be possible for KHN to change its style and use the “Dr.” honorific when referring to psychologists? There are many people who describe themselves as psychologists without having a doctorate. And there are other mental health practitioners who are not psychologists at all — social workers and counselors, for example — who are frequently referred to in news accounts as “therapists,” just as a doctoral-level psychologist might be. You may not be aware that psychologists must complete seven years of education, plus post-doctoral work, and that practitioners must go through state licensing. The level of training is on par with doctors of dental surgery, M.D.’s, doctors of optometry, doctors of osteopathic medicine, doctors of podiatric medicine and doctors of veterinary medicine — all of whom are routinely accorded the “Dr.” honorific.

— Kim I. Mills, American Psychological Association, Washington, D.C.

I appreciated Melissa Bailey and JoNel Aleccia’s piece on long-term care suicide. But unclear why you refer to physicians as “Dr.” and not psychologists? Is that KHN editorial policy? Perpetuates stigma.

— Benjamin A. Bensadon, Ed.M., Ph.D., associate professor, University of Florida College of Medicine, Gainesville, Fla.

[Editor’s note: KHN follows Associated Press style for titles and honorifics. Its guideline on medical doctors — with our blanket apologies to Ph.D.’s — reads: “Use Dr. in first reference as a formal title before the name of an individual who holds a doctor of dental surgery, doctor of medicine, doctor of optometry, doctor of osteopathic medicine, doctor of podiatric medicine or doctor of veterinary medicine. … Do not use Dr. before the names of individuals who hold other types of doctoral degrees.”]

After Snakebite, Swift Action (And Taylor Swift) — But Skip Tourniquet

I am the director of The Rattlesnake Conservancy. We are thrilled that you are covering snakebites and educating people without fear-mongering (“Bill Of The Month: Summer Bummer: A Young Camper’s $142,938 Snakebite,” April 30). However, I am concerned that in the radio report on NPR your team mentioned the young lady used a tourniquet and did not mention how dangerous that can be. Many snakebite experts agree that using a tourniquet is dangerous, leading to potentially life-threatening consequences when the tourniquet is removed. Absent loss of life, it also leads to venom accumulation in the limb and significant tissue damage. The best course of action is immobilizing the affected limb and emergency care as soon as possible. No snakebite kits, tourniquets or other devices will help. The only effective treatment for snakebite is antivenom.

The Facebook group “National Snakebite Support” is a crucial tool for anyone who may have been envenomated. The group is staffed by the United States’ top venom specialists and snakebite medical doctors. Their team quickly responds to patients and will communicate with hospital staff on behalf of a patient as needed.

That being said, remember that venom has saved more lives than it has taken. Many medications, including several for blood pressure, arterial clotting and experimental medications, are developed from venomous snakes. For more information, check out our website.

— Anthony Daly-Crews, Buckeye, Ariz.

A hunter weighs in with advice on Twitter:

I'm horribly sad for that family's financial burden. That's the biggest reason I wear knee high snake boots…not scared of dying…I'm scared of the bill!!!!

— Bowhunter Metalhead (@BowHunt13773425) May 1, 2019

— Mark Frye, Ash, N.C.

Re: your 9-year-old girl snakebite story: Where was your question about why the girl was wearing open-toed sandals in the woods? Why do you not cover the personal responsibility angle: What did the girl learn? Will she be wearing more protective gear on her return visit this summer?

— Dick Crawford, Anaheim, Calif.

Nothing Like A Good Blood Boiling With My Morning Coffee

I just wanted to convey to the editors of KHN and NPR’s Shots that the “Bill of the Month” series is amazing and I appreciate your work. Normally something I read that gets my blood boiling this easily in the morning is not something I would seek out. However, I appreciate the intent of these articles to call out the ridiculousness of health care charges. What is even more infuriating is the majority of these articles seem to cover individuals who have some sort of health insurance. The reader can only infer what someone without any sort of health coverage would be dealing with!

— Mike Morse, Grand Junction, Colo.

Further Steps To Guard Against ‘Shameful’ Amputations

Thank you for drawing much-needed attention to disparities in unnecessary limb amputations for communities of color (“Diabetic Amputations A ‘Shameful Metric’ Of Inadequate Care,” May 1). While I applaud your article’s focus on diabetes, understanding related diseases like peripheral artery disease (PAD) is just as important.

As a limb salvage specialist in the Mississippi Delta, I know firsthand that African American patients with diabetes are over three times more likely to have their limbs surgically removed — with even higher rates in Mississippi. Sadly, a majority of the estimated 200,000 annual non-traumatic amputations —many stemming from PAD, a complication of diabetes –– can be avoided with the proper care.

Tragically, even though PAD is as serious as cancer, more than 90% of the amputees I have met have never had a diagnostic test for PAD or an appropriate vascular evaluation to salvage their limbs. Most have never even heard of PAD until it is too late.

To stop these troubling trends in my community, I created a team to aggressively screen, diagnose and treat each one of our 10,000 patients early and often. With no institutional or outside financial support, our practice was able to decrease PAD-related amputation rates in the region by 87.5%.

More must be done on the federal level to address America’s “amputation lottery.” The United States Preventive Services Task Force (USPSTF), for example, should change its recommendation for screening at-risk patients including racial and ethnic minorities and low socioeconomic populations who have a disproportionately higher prevalence of PAD and amputation rates. The current recommendation makes the USPSTF complicit in perpetuating current PAD-related amputation disparities in treatment and outcomes.

There also needs to be broad adoption of non-amputation treatment measures such as revascularization in all algorithms for wounds to heal properly before amputation is ever needed. Finally, policymakers should advance a comprehensive strategy that combines increased public awareness, robust screening and better access to multidisciplinary care for at-risk populations. Together, these steps could go far in reducing limb loss, especially among minority communities.

— Dr. Foluso Fakorede, co-chair of the PAD Initiative for the Association of Black Cardiologists and CEO of Cardiovascular Solutions of Central Mississippi, Cleveland, Miss.

This hits close to home: my grandfather, like thousands of Black and Latinx Californians, suffered a lower leg amputation due to lack of access to quality health care and diabetes. Diabetes is a manageable condition and does not *have* to result in amputation. #HealthDisparities https://t.co/miDR4LBfIz

— Jazzmin Williams (@jazzminciara) May 1, 2019

— Jazzmin Williams, San Francisco

I am 69, Caucasian and was diagnosed with Type 1 diabetes 57 years ago. Both of my legs were amputated above the knee in 2014. My overall health has deteriorated since about 2000: heart disease, heart attack, quad bypass, pacemaker, peripheral circulatory disease. Eyes and kidneys are good.

Types 1 and 2 are vastly different, and while the ultimate goal is the same — normalizing blood sugar — Type 1 must be totally controlled with food, injections and exercise. A change in any one changes the others, often drastically. I am a retired engineer and know how to control my diabetes well, but life is tough. I cannot leave home without wheelchair-access transportation. I eat one meal a day, a casserole of sorts of beaten eggs, green beans and a small can of chicken breast. Every day.

My injection sites are badly worn, from 20 years of porcine insulin, and I must choose sites I formerly avoided, to get consistent uptake. One must roll the dice with every injection, particularly the fast insulins. Knowledge and extreme discipline are the keys to longevity.

— Mike Kemp, McComb, Miss.

A cousin I grew up with had her leg amputated last summer. It forced me to take better care of myself, but the stats & reasons for this surgery make me sad

— You Are Enough (@KeirstenBrager) April 26, 2019

— Keirsten Brager, Houston

Models Of Superbug Warfare

Reading “How To Fight ‘Scary’ Superbugs? Cooperation — And A Special Soap” (April 12), I wondered: What about other nations? How are they dealing with MRSA and the like? I’ve read that northern European nations and the Department of Veterans Affairs have made excellent progress in decreasing MRSA, or methicillin-resistant Staphylococcus aureus, infections and death rates by screening, isolation and disinfection, while most U.S. health care facilities have not. What is it that other nations (and the VA) are doing to exercise control? Seems they’ve been a lot less freehanded with handing out antibiotics and using antibiotics in low doses in stock animals (chickens, steers in feedlots, etc.). Let’s hear how the rest of the world’s health care systems are dealing with the problem — the U.S. might learn something. Just as we’d do well to adopt a system for providing health care from at least one of 10 other nations, who get better results with less expenditure/capital than the U.S. does.

— Susan Hogg, Newport, Ore.

Clearly dealing with the most dangerous pathogens, but I wonder if the chlorhexidine also kills protective, beneficial bacteria and introduces new risks to the patients and caregivers.

— Gary Lindsay (@GaryLindsay27) April 3, 2019

— Gary Lindsay, Bellingham, Wash.

The Long And Winding Road To Mental Health Care For Your Kid

For several months last spring and summer, my teen daughter, Caroline, experienced near-daily bouts of depression and debilitating panic attacks. During those episodes, she became extremely agitated, sobbing uncontrollably and aggressively rebuffing my attempts to comfort or reason with her.

My daughter was in a dark place, and I was worried.

But I have excellent health insurance, and I thought that would help me find a good therapist.

I dutifully dialed everyone on my health plan’s list. Some of them even called me back — only to say they weren’t taking new patients, or couldn’t see Caroline for three months, or didn’t have the training to match her symptoms.

I ultimately found a great therapist who isn’t in my health plan’s network — and after many months of weekly sessions, Caroline is doing much better.

I’m luckier than most parents, because my health plan covers a significant portion of Caroline’s out-of-network therapy. I pay only $45 per session, while some parents shell out north of $200 every week.

Think about how perverse this is. Mental health professionals say that with children, early intervention is crucial to avoid more severe and costly problems later on. Yet even parents with good insurance struggle to find care for their children.

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The U.S. faces a growing shortage of mental health professionals trained to work with young people — at a time when depression and anxiety are on the rise. Suicide was the No. 2 cause of death for children and young adults from age 10 to 24 in 2017, after accidents.

There is only one practicing child and adolescent psychiatrist in the U.S. for about every 1,800 children who need one, according to data from the American Academy of Child & Adolescent Psychiatry.

Not only is it hard to get appointments with psychiatrists and therapists, but the ones who are available often don’t accept insurance.

“This country currently lacks the capacity to provide the mental health support that young people need,” says Dr. Steven Adelsheim, director of the Stanford University psychiatry department’s Center for Youth Mental Health and Wellbeing.

Alison Bloeser, a Seal Beach, Calif., mom, has struggled for nearly a decade to find effective care for her now 15-year old son’s obsessive-compulsive disorder and attention deficit hyperactivity disorder, known as ADHD. In that time, Bloeser says, she has taken him to over 20 therapists and had him on medication — spending more than $20,000 along the way.

“We have a growing number of young people in this country crying out for help at a young age,” Bloeser says. “Why are we not addressing that full force?”

There’s no one-size-fits-all solution because people’s financial and personal situations vary widely.

So let me begin with tips for all parents, even those with skimpy insurance or none at all. A good place to start is the pediatrician’s office — whether it’s a private practice or a low-cost community clinic.

“When your children reach adolescence, you should be asking their pediatricians to screen for both anxiety and depression,” advises Dr. Bhavana Arora, chief medical officer of the Children’s Hospital Los Angeles Health Network. A number of pediatricians in her program are becoming increasingly comfortable treating mild to moderate mental health problems in their offices, Arora says.

If your finances are constrained, try a community health clinic that offers mental health services regardless of a family’s ability to pay.

For instance, Los Angeles-based AltaMed (www.altamed.org) has 12 clinics in L.A. and Orange counties where children and teens with mild to moderate mental health disorders can get short-term therapy. Medi-Cal picks up the tab for most of those kids. For kids not on Medi-Cal, the clinics charge on a sliding scale.

One way to find a community clinic near you is to search https://findahealthcenter.hrsa.gov/.

Your child’s school is another place to seek help.

Caroline’s high school has a mental health counselor whom she visits when she is anxious or feeling blue. She always feels better afterward. If your kid’s school doesn’t have a mental health counselor, nurses and regular school counselors will likely know of outside options. Talk to them.

Faith-based organizations are increasingly engaged in mental health care. Saddleback Church, with numerous locations around Southern California, offers support groups and counseling. Jewish Family Service agencies nationwide provide counseling on a sliding scale. Muslims can try the Khalil Center, which has branches in Chicago, L.A., the San Francisco Bay Area, New York and Toronto.

If you, like me, have insurance and find a good therapist who is not in your network, try to make it work — if you can possibly afford it.

Start by checking whether you have coverage for out-of-network providers. If not, or if it’s not enough, ask if your health plan is willing to treat the therapist as an in-network provider just for your child — an arrangement known as a single-case agreement.

The therapist likely will have to agree to a lower payment.

For many parents, the most productive thing is meeting others who are experiencing similar problems.

“Grassroots support groups, finding other parents going through what they’re going through, is the launch pad of everything,” says Debra Ann Afarian, coordinator of the Orange County, Calif., chapter of Children and Adults With Attention-Deficit/Hyperactivity Disorder.

If you need help and peer support, check with the National Alliance on Mental Illness. It offers a six-week course, “NAMI Basics,” which educates parents and puts them in touch with others in the same boat. Go to www.nami.org to find the chapter in your area.

Janis Thereault, of Santa Ana, Calif., whose adult son lives at home and has obsessive-compulsive disorder, searched the website of the International OCD Foundation (www.iocdf.org), which has affiliates around the country, and found local therapists specializing in the illness. They directed her to a support group.

After her son refused therapy for months, Thereault and her husband, Brian, followed the advice of one of the therapists: They told their son if he did not agree to counseling, they would evict him from the house. Members of the support group, some of whom had made similar decisions, offered them a sympathetic ear.

“It’s not an easy thing for us to do as parents,” Thereault says.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices

The Food and Drug Administration announced it is shutting down its controversial “alternative summary reporting” program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.

The agency said it will open past records to the public within weeks.

A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016. The program, which began about 20 years ago, was so little-known that forensic medical device experts and even a recent FDA commissioner were unaware of its existence.

Former FDA official Dr. S. Lori Brown said ending the program now is a “victory for patients and consumers.”

“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” Brown said.

FDA principal deputy commissioner Dr. Amy Abernethy and its device center director, Dr. Jeff Shuren, announced the decision to terminate the program in a statement on increasing transparency about the safety of breast implants.

The agency has for years allowed makers of breast implants to report hundreds of thousands of injuries and malfunctions out of the public eye, federal records show.

“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” Abernethy and Shuren said in a Thursday statement. “This is part of a larger effort to end the alternative summary reporting program for all medical devices.”

Related Investigation Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

FDA spokeswoman Angela Stark said the agency will also end “alternative summary reporting” exemptions still in place for makers of implantable cardiac defibrillators, pacemakers and tooth implants. The FDA has said the program was originally designed to allow for more efficient internal review of well-known risks.

The agency said it began winding down the program in mid-2017, revoking many reporting exemptions, including those for saline breast implants and for balloon pumps used inside patients’ blood vessels.

At that point, the agency required device makers with ongoing exemptions to file quarterly reports in its public device-harm database known as MAUDE, short for the Manufacturer and User Facility Device Experience.

Still, FDA data provided to KHN shows that during the first nine months of 2018 the FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under the hidden “alternative summary reporting” program.

Ronni Solomon, vice president and chief policy officer of the ECRI Institute, which studies device safety, said the staff uses the FDA’s open data on a daily basis to look for signals that might show heightened risks with a particular device.

“We think it’s really vital for the sake of transparency, for the sake of policy, for sake of science,” she said. “We’re really glad to see this, the sooner the better.”

The agency said its forthcoming data release will be for the alternative summary reports filed before mid-2017. The FDA for years reached agreements with makers of about 100 devices, allowing them to cease public reports of certain types of problems. The agency previously said the agreements and resulting records were available only by filing a Freedom of Information Act request, a process that can take months or even years.

Going forward, device makers will be required to file individual reports describing each case of patient harm related to a medical device.

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The FDA has not said it will stop allowing device makers to file other types of device-harm exemption reports that are withheld from the public, such as when there is mass litigation over a device or when a company is submitting reports from an independent device-tracking registry. Nor has a plan been announced to open those records, which contain reports of harm related to pelvic mesh and surgical robots and reports of deaths related to several cardiac devices.

The FDA had granted Covidien, now a division of Medtronic, a long-standing “alternative summary reporting” exemption for its surgical staplers, a device used to cut tissues and vessels and quickly seal them during a variety of surgeries.

In 2016, when just 84 reports of stapler-related harm were disclosed in the FDA’s MAUDE database, almost 10,000 more malfunction reports were sent directly to the FDA’s in-house database, the agency acknowledged.

The device has been subject to numerous lawsuits over patient deaths and grave harm.

Doris Levering alleged in court that a stapler malfunction during liver surgery caused profuse bleeding that left her husband, Mark, 62, with serious brain damage and unable to walk. She applauded the agency’s decision to open the database. “It’s just wonderful to know that this information is going to be out in the open and not covered up,” she said. “Now doctors who need to find the information will be able to find it.”

The surgeon, hospital and device maker have all denied wrongdoing in an ongoing legal case.

The FDA has announced a May 30 advisory board meeting to review the agency’s oversight of surgical staplers.

The FDA will leave in place a newer summary-reporting program that allows makers of more than 5,500 types of devices to send the agency spreadsheets logging device malfunctions. Unlike the “alternative summary reporting” program, device makers will not be allowed to report serious injuries using that approach.

Over the years, the FDA has had an uneven record of disclosing its “exemption” reports to advisers who review the safety of individual devices.

In February, FDA officials presented an advisory panel on gynecological devices with data showing 476 adverse events in 2017 related to a certain type of pelvic mesh. That panel was not briefed on nearly 12,000 reports filed by eight mesh makers in 2017, under a special exemption for lawsuit-related reports, according to an agency spokeswoman and a review of public records.

FDA spokeswoman Deborah Kotz said in an email that those “litigation” summary reports did not contain enough detail for the FDA to determine whether they shed any light on the safety question at hand.

The FDA ultimately took decisive action, though, ordering makers of the type of mesh under review to stop marketing those products, which were used to support sagging pelvic organs.

In late March, after KHN’s investigation landed, the FDA convened another panel to review breast implant-related injuries and a rare form of lymphoma. For that meeting, the agency did provide a full tally of previously unreported injury and malfunction reports related to breast implants.

As of Thursday, though, the agency said it would leave the textured breast implants linked to a rare lymphoma on the market.

Matt Baretich, a Denver-area biomedical engineer who advises health systems on device safety, is eager to examine the hidden reports as they’re released by the FDA.

“I’m really interested to see what information has been hidden so I can go back,” Baretich said. “I may have been looking for that information and not found anything and thought there was not a problem.”

Short-Staffed Nursing Homes See Drop In Medicare Ratings

The federal government accelerated its crackdown on nursing homes that go days without a registered nurse by downgrading the rankings of a tenth of the nation’s homes on Medicare’s consumer website, new records show.

In its update in April to Nursing Home Compare, the Centers for Medicare & Medicaid Services gave its lowest star rating for staffing — one star on its five-star scale — to 1,638 homes. Most were downgraded because their payroll records reported no registered-nurse hours at all for four days or more, while the remainder failed to submit their payroll records or sent data that couldn’t be verified through an audit.

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“Once you’re past four days [without registered nursing], it’s probably beyond calling in sick,” said David Grabowski, a health policy professor at Harvard Medical School. “It’s probably a systemic problem.”

It was a tougher standard than Medicare had previously applied, when it demoted nursing homes with seven or more days without a registered nurse.

“Nurse staffing has the greatest impact on the quality of care nursing homes deliver, which is why CMS analyzed the relationship between staffing levels and outcomes,” the agency announced in March. “CMS found that as staffing levels increase, quality increases.”

The latest batch of payroll records, released in April, shows that even more nursing homes fell short of Medicare’s requirement that a registered nurse be on-site at least eight hours every day. Over the final three months of 2018, 2,633 of the nation’s 15,563 nursing homes reported that for four or more days, registered nurses worked fewer than eight hours, according to a Kaiser Health News analysis. Those facilities did not meet Medicare’s requirement even after counting nurses whose jobs are primarily administrative.

CMS has been alarmed at the frequency of understaffing of registered nurses — the most highly trained category of nurses in a home — since the government last year began requiring homes to submit payroll records to verify staffing levels. Before that, Nursing Home Compare relied on two-week snapshots nursing homes reported to health inspectors when they visited — a method officials worried was too easy to manipulate. The records show staffing on weekends is often particularly anemic.

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CMS’ demotion of ratings on staffing is not as severe as it might seem, however. More than half of those homes were given a higher rating than one star for their overall assessment after CMS weighed inspection results and the facilities’ own measurement of residents’ health improvements.

That overall rating is the one that garners the most attention on Nursing Home Compare and that some hospitals use when recommending where discharged patients might go. Of the 1,638 demoted nursing homes, 277 were rated as average in overall quality (three stars), 175 received four stars, and 48 received the top rating of five stars.

Still, CMS’ overall changes to how the government assigns stars drew protests from nursing home groups. The American Health Care Association, a trade group for nursing homes, calculated that 36% of homes saw a drop in their ratings while 15% received improved ratings.

“By moving the scoring ‘goal posts’ for two components of the Five-Star system,” the association wrote, “CMS will cause more than 30 percent of nursing centers nationwide to lose one or more stars overnight — even though nothing changed in staffing levels and in quality of care, which is still being practiced and delivered every day.”

The association said in an email that the payroll records might exaggerate the absence of staff through unintentional omissions that homes make when submitting the data or because of problems on the government’s end. The association said it had raised concerns that salaried nurses face obstacles in recording time they worked above 40 hours a week. Also, the association added, homes must deduct a half-hour for every eight-hour shift for a meal break, even if the nurse worked through it.

“Some of our member nursing homes have told us that their data is not showing up correctly on Nursing Home Compare, making it appear that they do not have the nurses and other staff that they in fact do have on duty,” LeadingAge, an association of nonprofit medical providers including nursing homes, said last year.

Kaiser Health News has updated its interactive nursing home staffing tool with the latest data. You can use the tool to see the rating Medicare assigns to each facility for its registered nurse staffing and overall staffing levels. The tool also shows KHN-calculated ratios of patients to direct-care nurses and aides on the best- and worst-staffed days.

For Those With Developmental Disabilities, Dental Needs Are Great, Good Care Elusive

When Ava Terranove began feeling oral pain last July, her parents took her to her regular dentist. The dentist determined that Ava, who has an autism-like condition, needed two root canal procedures to treat infected teeth.

Because of her developmental disability, Ava, now 15, requires general anesthesia for non-routine dental work. The dentist, like most of his peers, was not equipped to provide it.

The girl’s parents, schoolteachers who live in Huntington Beach, Calif., called other dental offices in the region. They were turned down dozens of times before finally finding a dentist prepared to work with an anesthesiologist to treat their daughter.

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But there was a hitch: Insurance would not cover general anesthesia for root canals. So Ava’s parents decided to pay the $2,400 from their savings to ensure their daughter received prompt care.

“What about kids who don’t have parents who are professionals or who have no one to advocate for them?” wondered Donny Terranove, Ava’s father.

People with autism, cerebral palsy and other developmental disorders face enormous barriers to adequate and timely dental care — on top of their other challenges. Many dentists either avoid treating these patients or lack the skills needed to do so. Some patients with developmental disabilities are unable to endure even regular dental exams or cleanings without general anesthesia.

Ava Terranove (left) needed two root canals, so her parents took $2,400 out of their savings to pay for the general anesthesia for the procedure. Ava, pictured with her twin sister, Zoe, has a developmental disability that requires her to have general anesthesia for advanced dental work.

But most dentists don’t offer it and getting insurance to cover it for routine dental work is often a struggle.

Because it is difficult for them to get treatment, people with developmental disorders suffer “a high burden of dental disease,” according to a 2012 study of over 4,700 patients published in the Journal of the American Dental Association. One-third of the patients studied suffered from untreated cavities, and 80% from serious gum infections.

“Many individuals with developmental disabilities cannot personally maintain their own dental hygiene,” according to a September study by the California Legislative Analyst’s Office (LAO). “Often they need extra appointments or special accommodations that dentists are unable or unwilling to provide.”

In many cases, patients need these extra appointments to help them get accustomed to the environment of a dental office, including the equipment, procedures and personnel. This can help minimize their anxiety and reduce the need for deep sedation or general anesthesia.

But sometimes there is no alternative to anesthesia.

Mike Loughran, 54, of Tacoma, Wash., has a 14-year-old son with Down syndrome and autism. After years of failed attempts to complete a basic checkup, Loughran and a willing dentist concluded that the child should have general anesthesia for any and all dental work. That led to hefty charges.

For one routine, 45-minute exam that uncovered no problems, the anesthesia bill was $1,155. Loughran’s insurer, Tricare, adjusted it down to $912 — a sum he described as “very reasonable.” But the hospital charged nearly $21,000 for the operating suite. Tricare agreed to coverage and negotiated the price down to about $15,000. That left Loughran with a $2,500 out-of-pocket copayment. He later got the state’s Medicaid program to cover most of that amount as his son’s secondary insurer.

Still, Loughran was taken aback by the astronomical amount charged for his son’s care. “The whole idea of it costing that much to get a dental exam, and you’re supposed to do that a couple of times a year — it was just stunning when I got the bill,” he said. “I don’t think I would take him to the operating room anymore.”

Without access to regular cleanings and other preventive care, “you get to the point that you need anesthesia because you’ve had a little problem that’s gotten big,” said Eileen Crumm, executive director of Family Resource Navigators, an advocacy group in Alameda County.

To accommodate the many patients who do need general anesthesia, some hospitals and regional centers for the disabled allocate a limited amount of surgical time for dental care. But because of the strong demand for these services, it can take many months or even more than a year to reserve an available operating slot, patient advocates say.

Like the Terranoves, Mariana Murillo had trouble finding appropriate care a few years ago for son Oscar, 20, who has cerebral palsy and cannot communicate verbally. Oscar, a teenager at the time, was in pain from impacted wisdom teeth, and his regular dentist said an oral surgeon would have to extract them. But Murillo, who lives in Lompoc, Calif., had difficulty finding one who would accept Denti-Cal, the state’s Medicaid-funded dental coverage for low-income people.

Murillo ended up paying $1,600 out-of-pocket to an oral surgeon. The surgeon agreed to extract Oscar’s four wisdom teeth while the boy was already under general anesthesia for the removal of a benign growth on his tongue — a procedure covered by Oscar’s medical insurance.

Mariana Murillo ended up paying $1,600 out-of-pocket to an oral surgeon so that son Oscar, who has cerebral palsy and cannot communicate verbally, could have his wisdom teeth extracted while under general anesthesia for another medical procedure.

“Our financial situation is not great, but it was not too bad,” said Murillo. “Knowing Oscar was going to be free of that pain, we decided to do it.”

In some states, officials and private-sector organizations are trying to address this large unmet need among patients who may suffer in silence, unable to articulate their distress.

New Mexico, for example, has a specific Medicaid billing code that entitles dentists who have completed a special training program to an extra fee of $90 each time they treat a patient with developmental disabilities. And New York University’s College of Dentistry recently opened a center strictly for the care of people with disabilities.

In California, most patients with developmental disabilities are eligible for care under Denti-Cal, but only a fifth of dentists in the state accept it. And only a fifth of developmentally disabled patients with Denti-Cal received even one dental service in 2014, 2015 or 2016, according to the LAO report.

Last year, the state allocated $210 million in tobacco tax funds to increase payments to Denti-Cal providers for the 2018-19 fiscal year — up $70 million from the amount of tobacco tax money it had earmarked for that purpose the previous year. Federal matching dollars bring the total amount of new money for the program to as much as $600 million. The most recent boost will help pay for the additional time needed to treat patients with special needs, as well as for anesthesia.

A particularly difficult challenge for patients with developmental disabilities is the transition from pediatric to general dentists as they age, said Dr. Joseph Castellano, president of the American Academy of Pediatric Dentistry, who practices in Laredo, Texas. That’s because pediatric specialists generally receive some training in working with that population, whereas general dentists tend to have little or no such experience.

“A lot of times [patients] will just stay in the [pediatric] practice,” Castellano said. “We know the patients and are comfortable with them, and they and the families are comfortable with us.”

Dr. Wade Banner, a Southern California dentist, took the matter into his own hands in 2014, when he launched a mobile dental program and began making house calls to patients with developmental disabilities. Banner, who has a nephew with autism, said he wanted patients to receive basic care in an environment where they felt most comfortable and were less likely to require major sedation.

Noting the paucity of providers for patients who need general anesthesia, Banner said, “one of my main goals in starting house-call dentistry was to prevent them from having to be put to sleep, if at all possible.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

HHS Announces Final Conscience Rule Protecting Health Care Entities and Individuals

HHS Gov News - May 03, 2019

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced today the issuance of the final conscience rule that protects individuals and health care entities from discrimination on the basis of their exercise of conscience in HHS-funded programs. Just as OCR enforces other civil rights, the rule implements full and robust enforcement of approximately 25 provisions passed by Congress protecting longstanding conscience rights in healthcare.  

The final rule fulfills President Trump’s promise to promote and protect the fundamental and unalienable rights of conscience and religious liberty, a promise he made when he signed an executive order in May 2017 protecting religious liberty.  In October 2017, the Department of Justice issued guidance encouraging other Departments, including HHS, to implement and enforce all relevant religious freedom laws.  

As a result, in January 2018, following the launch of its new Conscience and Religious Freedom Division, HHS announced the proposed conscience rule.  OCR received over 242,000 public comments, and analyzed and carefully considered all comments submitted from the public on the proposed conscience regulation before finalizing it.

This final rule replaces a 2011 rule that has proven inadequate, and ensures that HHS implements the full set of tools appropriate for enforcing the conscience protections passed by Congress.  These federal laws protect providers, individuals, and other health care entities from having to provide, participate in, pay for, provide coverage of, or refer for, services such as abortion, sterilization, or assisted suicide.  It also includes conscience protections with respect to advance directives.

The final rule clarifies what covered entities need to do to comply with applicable conscience provisions and requires applicants for HHS federal financial assistance to provide assurances and certifications of compliance. The rule also specifies compliance obligations for covered entities, including cooperation with OCR, maintenance of records, reporting, and non-retaliation requirements.

“Finally, laws prohibiting government funded discrimination against conscience and religious freedom will be enforced like every other civil rights law.” said OCR Director Roger Severino. “This rule ensures that healthcare entities and professionals won’t be bullied out of the health care field because they decline to participate in actions that violate their conscience, including the taking of human life. Protecting conscience and religious freedom not only fosters greater diversity in healthcare, it’s the law,” Severino concluded.

Click here to read the Final Conscience Rule.

Click here to read the Final Conscience Rule Factsheet.

###

*This HHS-approved document is being submitted to the Office of the Federal Register (OFR) for publication and has not yet been placed on public display or published in the Federal Register.  This document may vary slightly from the published document if minor editorial changes are made during the OFR review process.  The document published in the Federal Register is the official HHS-approved document. 

*People using assistive technology may not be able to fully access information in these files.  For assistance, please email OCR at OCRMail@hhs.gov or contact the OCR Call Center at (800) 368-1019.

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‘Like A Ghost Town’: Erratic Nursing Home Staffing Revealed Through New Records

Daily nursing home payroll records just released by the federal government show the number of nurses and aides dips far below average on some days and consistently plummets on weekends.

Podcast: KHN’s ‘What The Health?’ Bye-Bye, ACA, And Hello ‘Medicare-For-All’?

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Kaiser Health News

@jrovner

Read Julie's Stories Erin Mershon

STAT

@eemershon

Read Erin's Stories Margot Sanger-Katz

The New York Times

@sangerkatz

Read Margot's Stories Paige Winfield Cunningham

The Washington Post

@pw_cunningham

Read Paige's Stories

The Department of Justice on Wednesday submitted a brief to a federal appeals court making its case as to why the entire Affordable Care Act should be struck down in the wake of the congressional repeal of the tax penalty for failing to have insurance.

Meanwhile, the House Rules Committee held a historic hearing on a “Medicare-for-all” bill, kicking off what is likely to be a lengthy debate that will span the 2020 election.

And while abortion opponents are counting on the newly configured U.S. Supreme Court to uphold legislation curtailing the procedure, the Supreme Court in Kansas found that the state constitution includes a right to abortion for women.

This week’s panelists are Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Paige Winfield Cunningham of The Washington Post and Erin Mershon of Stat News.

Also, Rovner interviews KHN’s Carmen Heredia Rodriguez, who wrote the latest “Bill of the Month” feature about a pricey snakebite.

If you have an exorbitant or inexplicable medical bill you’d like to submit for our series, you can do that here.

Among the takeaways from this week’s podcast:

  • Even as the Trump administration is arguing in court that the entire ACA should fall, it is relying on provisions in the law for a number of health care initiatives, including efforts to cut fraud, fight the opioid crisis and transform the Medicaid system.
  • The House Rules Committee might have been an unusual venue for a hearing on setting up a single-payer, “Medicare-for-all” health system, but the discussion this week before the panel was surprisingly thoughtful and measured.
  • The Congressional Budget Office report on a switch to a single-payer health system points out that although two bills before Congress would establish a “Medicare-for-all” plan, there are numerous ways to get universal health care and other countries have tried a variety of options that may be worth considering.
  • The House bill for health spending seeks to block the Trump administration’s efforts to cut Title X reproductive health funding for Planned Parenthood.
  • Meanwhile, two separate federal courts have issued nationwide injunctions barring the family planning regulations while court proceedings continue.
  • That spending bill also would add $50 million for research on gun violence. Public health advocates hope researchers can identify factors that may lead to gun deaths. That could mimic some of the success highway experts have had in finding ways to reduce traffic deaths.

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

Julie Rovner: Vice News’ “There’s No Proof ‘Abortion Reversals’ Are Real. This Study Could End the Debate,” by Carter Sherman

Paige Winfield Cunningham: The Washington Post’s “Why Vermont’s Single-Payer Effort Failed and What Democrats Can Learn From It,” by Amy Goldstein

Margot Sanger-Katz: The New York Times’ “They Want It to Be Secret: How a Common Blood Test Can Cost $11 or Almost $1,000,” by Margot Sanger-Katz

Erin Mershon: The New York Times’ “In Washington, Juul Vows to Curb Youth Vaping. Its Lobbying in States Runs Counter to That Pledge,” by Sheila Kaplan

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle Play or Spotify.

Even Doctors Can’t Navigate Our ‘Broken Health Care System’

Navigating Aging

Navigating Aging focuses on medical issues and advice associated with aging and end-of-life care, helping America’s 45 million seniors and their families navigate the health care system.

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Dr. Hasan Shanawani was overcome by frustration. So, last week he picked up his cellphone and began sharing on Twitter his family’s enraging experiences with the U.S. health care system.

It was an act of defiance — and desperation. Like millions of people who are sick or old and the families who care for them, this physician was disheartened by the health care system’s complexity and its all-too-frequent absence of caring and compassion.

Shanawani, a high-ranking physician at the Department of Veterans Affairs, had learned the day before that his 83-year-old father, also a physician, was hospitalized in New Jersey with a spinal fracture. But instead of being admitted as an inpatient, his dad was classified as an “observation care” patient — an outpatient status that Shanawani knew could have unfavorable consequences, both medically and financially.

On the phone with a hospital care coordinator, Shanawani pressed for an explanation. Why was his dad, who had metastatic stage 4 prostate cancer and an unstable spine, not considered eligible for a hospital admission? Why had an emergency room doctor told the family the night before that his father met admission criteria?

Sidestepping Shanawani’s questions, the care coordinator didn’t provide answers. Later, another senior nurse in the hospital unit didn’t respond when he asked her to find out what was going on.

Inflamed, Shawanami let loose on Twitter.

The threads I will share w/U will be about the RIDICULOUS stuff I have had 2 navigate in my dad's care.

The theme:
MY DAD THE MD & ME, THE MD BUREAUCRAT, 2 ADVOCATES, WHO NAVIGATE THIS EVERY DAY 4 PATIENTS, can BARELY HANDLE THE CRAZINESS. & that means lay people R IN TROUBLE pic.twitter.com/9Nlw37Ifzf

— Hasan Shanawani MD (@hshanawaniMD) April 26, 2019

Within hours, Shanawani’s posts were widely shared and other people, some of them also doctors, recounted similar experiences. Within days, he had thousands of followers, up from fewer than 100 before his tirade.

LITERALLY was holding off tagging @danweissmann until end of thread. @hshanawaniMD Thank you for sharing your dad’s story! If the system is broken for you, it is broken for the rest of us.

Thanks for the shoutouts to PT and the RN.

— Liz Salmi (@TheLizArmy) April 27, 2019

Thanks for this. For all of us who have to deal with the medical system regularly, it is horrific to navigate and heartbreaking how much one person has so much authority. Please keep fighting. And sharing.

— Jane (@janewarlick) April 27, 2019

So happy for you. Hope your father is doing better. Navigating the insurance insanity is a FT job. Now imagine that you don't speak English well, you can't miss work, you can't afford to fill the Rx… smh.

— Eleanor (@edabny62) April 27, 2019

Physicians wrote that Shanawani’s posts about observation care opened their eyes to the adverse impact it can have on patients and families. (When someone is in observation care, he or she can face copayments for individual tests and medical services under Medicare Part B — expenses that can quickly add up. Also, Medicare will not pay for short-term rehabilitation in a skilled nursing facility for observation care patients.)

Thanks so much for sharing this experience—I will be ever more sensitive to these admission criteria. Sad that these obstacles consume so much of from our time and energy.

— Prad Tummala (@PradTummala) April 27, 2019

Really interesting. Thanks. Now I understand why I get pressured sometimes to make patients “obs” by hospital administration.

— David Saenger (@saenger_david) April 27, 2019

Shanawani’s distress revolved around three key issues, he explained in a lengthy conversation.

  • Hospital staff didn’t acknowledge his family’s concerns or address them adequately: How can an old man with terminal prostate cancer and a broken back be sent home without measures to ensure his safety?
  • No one seemed to care or be willing to listen: When family members asked that lower doses of painkillers be administered to Shanawani’s father, who had become delirious during previous hospitalizations, they felt nurses were disapproving and disrespectful.
  • And the decision to put his father in observation care was misguided and handled curtly.

There were two options for his father, the physician said: vertebroplasty, a surgery in which a bone cement is injected into the spine, or a fitted spinal brace. Shanawani’s father and the family decided against surgery but were told that he couldn’t receive a brace in the hospital because that option was available only to inpatients. Outside the hospital, it would take time to arrange an appointment with a spine specialist and get a brace. In the meantime, with an unstable spine, “my father was at risk of permanent paralysis,” Shanawani told me.

Because Shanawani has declined to identify the hospital in question, indicating only that it placed highly in U.S. News and World Report’s rankings and was based in New Jersey, the institution’s perspective on these issues cannot be shared. It is possible that the hospital’s explanations would cast the physician’s story in a different light.

But Shanawani’s experiences are, by all accounts, widespread. “I wish I could say that this was in any way unique or an isolated event,” said Dr. Richard Levin, chief executive of the Arnold P. Gold Foundation, which focuses on humanism in health care, who reviewed the physician’s Twitter stream. “But his description of a broken system is so common.”

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Theresa Edelstein, vice president of post-acute care policy and special initiatives at the New Jersey Hospital Association, acknowledged that “we need to focus on and be better at” attending to the “humaneness and patient-centeredness of care.” She made it clear this was a general comment, not a response to the situation Shanawani had described.

“If a patient is expressing concern about their observation status, the whole [hospital] team should be involved in understanding what the concerns of the patient and the family are,” Edelstein said.

Currently, patients with Medicare coverage cannot appeal a hospital’s decision to place them in observation care. The Center for Medicare Advocacy and Justice in Aging have filed a class-action suit in U.S. District Court in Connecticut seeking to establish such an appeal right. After years of litigation, a trial date has been set for mid-August, according to Alice Bers, the lead lawyer for the plaintiffs and litigation director at the Center for Medicare Advocacy.

But all patients have the right to a safe discharge under a separate set of regulatory requirements, and that can be grounds for an expedited appeal, Edelstein noted.

Ultimately, a physical therapist made it possible for Shanawani’s father to be admitted to the hospital once he failed a test she administered. And a palliative care nurse gave the family the sense of being cared for, which they so desperately needed. “She was a ‘one-in-a-million’ person,” said Shanawani, weeping as he spoke of her. “She said ‘We will fix this, we will figure this out with you, we’re working on the same side of the table.’”

“It takes just one person to really listen to make a profound difference in a patient’s care,” said Grace Cordovano, a professional patient advocate at Enlightening Results LLC in West Caldwell, N.J.

Social media outlets such as Twitter and Facebook are a powerful new avenue for people to seek redress for health care grievances, Cordovano noted. “If you tag a facility, a customer service representative typically responds quickly with ‘Please message me. We’re sorry you’re experiencing this, we’d like to help.’ Often, you get a better response than by going through the normal chain of command.”

Shanawani’s position — he’s deputy chief informatics officer for quality and safety at the VA — helped generate a high-level response to his tweets. New Jersey’s commissioner of health, Dr. Shereef Elnahal, a former colleague of his, reached out to the hospital’s leadership, and meetings with the CEOs of the hospital and its parent system followed. Also, the U.S. Senate Committee on Health, Education, Labor & Pensions has asked Shanawani for his input.

“I have incredible privilege, and I know how to navigate bureaucracies,” the physician told me. “But still, hospital staff provided us no guidance, no assurance, no knowledge, until two people willing to help came along. I don’t know how to fix this.”

For now, this physician has other things on his mind: On April 30, his father took a turn for the worse and was rehospitalized. Shanawani knew this was likely at some point, but he had hoped it wouldn’t be so soon. “It starts all over again,” he wrote to me in an email.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

Secretary Azar Visits Peruvian Hospital and Meets with Venezuelan Healthcare Professionals

HHS Gov News - May 02, 2019

Wednesday, May 1, Health and Human Services Secretary Alex Azar visited Hospital Maria Auxiliadora in Lima, Peru, with Minister of Health Zulema Tomás to learn about the hospital and the unique challenges they face treating migrants and refugees from Venezuela. The hospital currently supports the South Zone of Lima and treats a population of approximately 3 million patients with only 540 beds.

On average, the hospital sees 400 patients daily and up to 100 may be admitted each day. Hospital leaders detailed the strain on the hospital and Peruvian healthcare system created by the recent influx of Venezuelan migrants and refugees. Secretary Azar, Minister Tomás, U.S. Ambassador to Peru Krishna R. Urs, and Centers for Disease Control and Prevention (CDC) Director Robert Redfield visited the maternity ward, neonatal unit, emergency room, and Tuberculosis ward.

After the hospital visit, Secretary Azar, Ambassador Urs, Director Redfield, and other U.S. officials met with Venezuelan medical healthcare professionals to get a better understanding of the healthcare needs and challenges Venezuelan migrants and refugees face, particularly those serving in health professions. They described many situations they and others have faced as a direct result of Venezuela’s collapsed health system—including, but not limited to, human trafficking, absence of mental health support, lack of access to medications and vaccinations, and the spread of illnesses.

Secretary Azar thanked the participants for sharing their stories and expressed that the U.S. government recognizes the desperate humanitarian need inside and outside Venezuela. The U.S. has provided nearly $257 million in assistance ($213 million in humanitarian assistance and approximately $43 million in development and economic assistance) to support the most vulnerable Venezuelans living in 17 countries in the region.

In the afternoon, Secretary Azar and other HHS officials visited the U.S. Naval Medical Research Unit - 6 (NAMRU-6) which conducts research on and surveillance of a wide range of infectious diseases that are of public health significance in the region, including malaria and dengue fever, yellow fever, viral encephalitides, leishmaniasis, Chagas disease, and enteric diseases such as shigellosis and typhoid fever.

During the visit, Secretary Azar learned about their robust research agenda that includes work in prevention strategies, clinical management trials, immuno- and molecular rapid diagnostics, epidemiology, and ecology as well as projects measuring the social and economic impact of disease.​​

Tonight, Secretary Azar will travel home to the United States. This serves as the final update of his meetings in Lima, Peru.

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