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HHS announces $2.6 million in prizes to redesign dialysis as part of KidneyX

HHS Gov News - September 28, 2018

The U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) have committed $2,265,000 in prize money for “KidneyX: Redesign Dialysis,” a prize competition that challenges the public to develop better treatment options for patients with kidney failure. This prize competition is the first in a planned series of Kidney Innovation Accelerator (KidneyX) prize competitions designed to develop innovative solutions that can prevent, diagnose, and/or treat kidney diseases.

“With this first prize, KidneyX: Redesign Dialysis, we are looking for solutions that completely disrupt the way kidney failure is currently treated,” said Ed Simcox, HHS Chief Technology Officer, “We are asking innovators like engineers and scientists to propose and develop new technologies to redesign treatment for kidney failure. We look forward to seeing what the best and brightest envision for the future of kidney failure treatment in the first phase of Redesign Dialysis.”

“In addition to redesigning dialysis, we are also redesigning how HHS tackles complex problems,” said Sandeep Patel, HHS KidneyX Program Director. “Innovators currently must navigate a disjointed and expensive path to bring new products and practices to market. KidneyX has brought together colleagues across our funding (National Institutes of Health), regulatory (Food and Drug Administration), and payment (Centers for Medicare & Medicaid Services) roles to offer a more coherent and transparent path for innovators.”

HHS and ASN designed this first prize after a year of gathering input from key stakeholders, including patients, nephrologists, investors, and researchers through listening sessions, Twitter chats and two Requests For Information.

The Redesign Dialysis prize will run in two phases with a total prize purse of $2,625,000. The first phase, which will award up to 15 prizes of $75,000 each, launching in late October and running through February 2019 asks participants to design solutions or components of solutions that can replicate normal kidney functions and improve patient quality of life. The second phase, planned to run from April 2019 to January 2020, will ask participants to develop initial prototypes; this phase will award up to 3 prizes of $500,000 each. Participants may compete in the second phase even if they do not submit a solution in the first phase.

Mark D. Okusa, MD, FASN, President of the American Society of Nephrology added, “The American Society of Nephrology is excited and honored to partner with HHS to collaborate on the first KidneyX Prize: Redesign Dialysis. We hope to attract new interest, potential collaborators, and ideas from across the medical and scientific communities to accelerate the development of disruptive new therapies.”

Submissions for the first phase of the Redesign Dialysis prize will launch on Thursday, October 25, 2018 at ASN Kidney Week 2018. For more information on the ReDesign Dialysis prize visit, hhs.gov/idealab

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About the HHS Office of the Chief Technology Officer

The HHS Office of the Chief Technology Officer (CTO) seeks to instill a culture of innovation at HHS through building innovative partnerships, harnessing the power of data and empowering HHS staff with the skills and tools to support a nimble government entity. The Office of the CTO’s open innovation pipeline shines a spotlight on opportunities for problem solvers everywhere. For more information, please visit www.hhs.gov/idealab

Podcast: KHN’s ‘What The Health?’ (Almost) Live from Austin!

Kaiser Health News:HealthReform - September 28, 2018

(From left) Julie Rovner, Joanne Kenen, Alice Ollstein and Anna Edney(Courtesy of The Texas Tribune Festival)

Julie Rovner

Kaiser Health News

@jrovner

Read Julie's Stories Anna Edney

Bloomberg

@annaedney

Read Anna's Stories Joanne Kenen

Politico

@JoanneKenen

Read Joanne's Stories Alice Ollstein

Politico

@AliceOllstein

Read Alice's Stories

President Donald Trump’s proposed rule that would make it more difficult for immigrants to gain permanent status if they use government aid programs could have a major impact in Texas, with its large immigrant population.

Texas is also ground zero for the health debate in this year’s midterm elections. Texas Attorney General Ken Paxton is the lead plaintiff in a case filed by 20 GOP state officials arguing that the entire Affordable Care Act is now unconstitutional in light of last year’s tax bill, which canceled the penalties for people who fail to obtain health insurance. The Trump administration does not agree that the whole law should fall, but says the parts protecting people with preexisting health conditions should be struck down. A federal district court judge in Fort Worth is expected to issue a decision in the case soon.

This week’s panelists for KHN’s “What the Health?,” are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Anna Edney of Bloomberg News and Alice Ollstein of Politico. Technical difficulties prevented us from bringing you the discussion taped Sept. 27 before a live audience in Austin as part of the 2018 Texas Tribune Festival. So, the panelists, back in D.C., joined Rovner, still in Austin, for a redo Sept. 28.

Among the takeaways from this week’s podcast:

  • The latest version of the new “public charge” regulations proposed by the Trump administration could penalize immigrants who use food stamps, Medicaid, housing assistance or Medicare prescription drug subsidies. But unlike an earlier version of the proposal, it would not take into account immigrants’ use of subsidies under the Affordable Care Act.
  • With less than six weeks to go before the critical midterm elections, federal protections for people with preexisting health conditions has become the top campaign health issue in many states, in many races eclipsing concerns about prescription drug pricing and other out-of-pocket health costs.
  • As hearings continued on the nomination of federal Judge Brett Kavanaugh to serve on the Supreme Court, a three-judge appeals court panel heard arguments on a case he decided earlier this year concerning the right of minor immigrants to obtain an abortion.
  • Increases in premiums for insurance under the Affordable Care Act appear to moderating, and some states are reporting decreases for plans that start Jan. 1, 2019. The Trump administration is now trying to take credit for “fixing” the ACA’s marketplaces. However, state insurance officials have noted that premiums are moderating in spite of, rather than because of, the administration’s actions.

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

‘Contraception Deserts’ Likely To Widen Under New Trump Administration Policy

Kaiser Health News:Insurance - September 28, 2018

LAWRENCEVILLE, Ga. — When Nikia Jackson needed to be screened for a sexually transmitted disease, she wanted a clinic that was reputable, quick and inexpensive.

After searching online, Jackson, 23, ended up at the Obria Medical Clinics’ sparkling new facility in an office park in suburban Atlanta. She was unaware that the clinic does not offer condoms or other kinds of birth control beyond so-called natural family planning methods.

Religious conservatives say these types of clinics are the future of women’s sexual health care in the United States.

“A woman needs choice, but you can’t have a choice if the only clinic that a woman can go to is Planned Parenthood,” said Kathleen Bravo, chief executive of the Obria Group and a devout Catholic.

Young women, she said, “don’t want to live every day having to take a carcinogen,” referring to hormonal contraception.

For decades, contraception drew widespread bipartisan support, but since the passage of the Affordable Care Act in 2010, religious conservatives trained their ire on the law’s contraception mandates, and the politics of abortion and birth control converged.

Bravo is positioning her company to become a nationwide alternative to Planned Parenthood and aims for it to qualify for millions of dollars in federal family planning funds next year. With 38 clinics and 22 more slated to open, Obria offers tests for pregnancy, STIs, HIV and cervical cancer and prenatal care.

But patients seeking to prevent pregnancy can receive only fertility planning methods that require women to track their periods and refrain from sex when most fertile. When followed exactly, the method is 76 percent effective, according to the Centers for Disease Control and Prevention.

That vision has found favor with the Trump administration, which has proposed sweeping changes to a $280 million federal program called Title X, the only source of federal funds for birth control for low-income women who lack health insurance.

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For more than four decades, thousands of women’s health clinics, including Planned Parenthood affiliates, that received these federal funds have been required to offer a full range of medically effective contraception, including condoms, birth control pills, intrauterine devices and implants. (The clinics cannot use federal funds to pay for abortion, and many Title X clinics do not offer the procedure.)

But with Title X now under the direction of Dr. Diane Foley, the former chief executive of Life Network, a Christian organization that operates anti-abortion pregnancy centers, the Trump administration is widely expected to adopt rules in the coming months that promote and direct federal dollars to clinics like Obria that do not offer condoms, hormonal contraception, intrauterine devices or abortion.

Called the “Protect Life Rule,” the new restrictions are aimed at narrowing women’s access to clinics that discuss or refer patients to abortion providers. The Trump administration has worked quickly to shape women’s reproductive health care, rolling back an Obama-era rule that required employers to cover contraception in their health insurance plans and nominating to the Supreme Court Judge Brett Kavanaugh, who referred to common forms of contraception as “abortion-inducing drugs” during his confirmation hearing.

With Vice President Mike Pence, an evangelical Christian, as a powerful ally and anti-abortion and abstinence advocates, including Foley, appointed by the Trump administration overseeing key federal health programs, religious conservatives are seizing this moment to shape women’s sexual health care.

In 2011, anti-abortion state lawmakers sought to shutter Planned Parenthood clinics and slashed state funding for family planning by 66 percent. As a result, more than 80 family planning clinics closed, and women across Texas suddenly found their birth control needs caught up amid the fight against abortion.

The impact was swift and widespread: Researchers found the number of women on the most effective forms of birth control ― IUDs, implants and injections ― plunged by a third, and births by poor women on Medicaid increased 27 percent from 2011 to 2014.

In the aftermath, family planning clinics in Texas became almost entirely dependent on Title X federal funds. Now many administrators here and around the country are bracing for the Trump administration’s new rules.

Kathryn Hearn, community services director at Access Esperanza in McAllen, Texas, said clinics that offer the full range of FDA-approved birth control could be replaced by those like Obria.

“Today a woman can come into a Title X clinic, any clinic in the United States, in Texas, and be offered a wide range of contraceptive methods,” she said. “With these proposed rules, she could only be offered abstinence. Well, she says, I’m married. Or I’m in a relationship. That does not work for me. I need real contraceptive care.”

Ofelia Alonso, a 22-year-old community organizer, said that because of deceptive tactics and lack of comprehensive sex education, young women in Texas already find it difficult to discern between medical clinics and crisis pregnancy centers, offices where women are counseled against abortion.

“It’s like abstinence only, and then, crisis pregnancy centers, anti-abortion propaganda, defunding our family clinics. So what is left for us?” Alonso said. “We’re going to have these weird centers where you can’t get anything?”

But women seeking contraception have to go somewhere, and one alternative, she said, is to cross the nearby border into Mexico to buy birth control over the counter.

“It shouldn’t have to be that way,” she said. “We shouldn’t have to travel to another country to get what we need.”

Some uninsured patients in Texas do find alternative ways to get birth control.

Claire Hammons runs an historic hotel in Llano, a small city an hour and half west of Austin with no full-service women’s health clinic.

The vast geography combined with widespread clinic closures means that some 10 million Texans live at least half an hour from a clinic, a common standard used to determine health care shortages. It’s a phenomenon some call “contraception deserts.”

Hammons lives in one of these contraception deserts and when she could no longer afford health insurance, she turned to the internet for help. Now, she gets her birth control delivered every three months to her mailbox from a San Francisco-based company called Nurx. She pays about $15 a month and can message Dr. Jessica Rubino, a Nurx physician in Austin. Rubino can review her patients’ medical histories and renew their prescriptions without additional cost.

Rubino said she sees what happens to women who live in contraception deserts.

“I’m also an abortion provider, and I do that outside of Nurx at another facility,” she said. “I had one [patient] last week who drove five hours to see me. And the entire reason that she came to see me for the abortion is because she didn’t have any access to contraception.”

That lack of access worries Kami Geoffray, CEO of the Women’s Health and Family Planning Association of Texas, the nonprofit group that has coordinated the state’s application for Title X funds.

If the Trump administration’s overhaul of Title X succeeds, Geoffray said, it will undermine the goal of the program that the federal government has operated since the 1970s.

“We know that every dollar we spend on Title X saves $7 across other government programs, including Medicaid,” said Geoffray. “We avert Medicaid births very frequently by [getting contraception for] clients and preventing unplanned pregnancies.”

But back in suburban Atlanta at the Obria Medical Clinic, Bravo has declared it’s time for companies like hers to put a bigger mark on reproductive health care. The company is launching a $240 million capital campaign to open more clinics.

“Obria is a comprehensive primary care clinic for women that is an alternative model to Planned Parenthood,” said Bravo. “We put huge amounts of money into marketing our clinics, like all medical clinics do, to make sure that women know that we’re here in their city.”

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation.

Buried In Congress’ Opioid Bill Is Protection For Personal Drug Imports

Kaiser Health News:Marketplace - September 27, 2018

WASHINGTON — The final version of the massive opioid bill Congress released Wednesday would grant the Food and Drug Administration new powers to crack down on drug imports, but it also includes a provision — nearly killed in the Senate — to shield people who are just trying to buy cheaper, needed prescription medication from other countries.

Broadly, the bill seeks to enlist the FDA in combating the opioid crisis by mandating that the agency take steps to accelerate development of non-opioid painkillers and to limit the supplies of the drugs, both illegal and legitimate, that claimed the lives of more than 49,000 people last year.

Among those steps, the bill expands the FDA’s power to “debar” people “from importing or offering for import into the United States a drug” if they are violating any of a number of regulations, including importing “mislabeled” medications, which includes any from overseas.

In the original House version of the bill, there was also a provision that defined those importers to exclude regular people who were importing personal prescriptions from foreign countries. That definition had been cut without explanation from the Senate’s version of the bill.

Congressional staffers who spoke on background to describe internal negotiations said the senators eliminated the protection because they believed it was unnecessary. The FDA already has discretion to look the other way on personal imports and told lawmakers it has no intention of changing the policy, staffers said.

Still, advocates for importation of cheaper drugs raised a red flag, noting that policies are not permanent and could be changed at any time absent legislation.

“I believe pharma lobbyists tried to piggyback language onto this bill to give FDA greater authority to stop importation of lower-cost, non-controlled medicines — ones having nothing to do with the opioid crisis, whether wholesale or personal,” said Gabriel Levitt, the president of PharmacyChecker.com, which serves as a clearinghouse for people trying to buy prescriptions from regulated foreign pharmacies. “If that’s the case, then they did not get everything they wanted.”

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PhRMA, the lobbying arm of the pharmaceutical industry, could not immediately respond to questions about the shifts in the bill, but praised the overall goal of the broader measure.

“We applaud Congress for producing bipartisan, bicameral legislation that is a comprehensive approach to combating the opioid addiction crisis,” spokeswoman Priscilla VanderVeer said in a statement. “We look forward to the final legislation moving swiftly through the House and Senate and then on to the President’s desk to be signed into law.”

Indeed, the definition appears to have been added back to help forestall any controversy that might have interfered with swift passage of a measure that lawmakers hope to tout for the rest of campaign season. The bill is expected to be passed by the House this week and the Senate next week.

While lawmakers who at first removed the language may have seen it as unnecessary, advocates saw it, if not as a major victory, at least as a significant step in recognizing the legitimacy of importing medication from places where it is less expensive.

“That this language was put back in the bill is very helpful because now personal drug importation has greater recognition under law as different from illegal wholesale importation and worthy of protection,” said Levitt. “For those people who rely on lower-cost personal imports from pharmacies in Canada and other countries, this is very good.”

Millions of Americans every year seek prescriptions from overseas and Canada. Many millions more don’t take or thin out their prescribed medications, often because of costs. According to the Centers for Disease Control and Prevention, almost 8 percent of Americans do not take their medication as prescribed, and more than 15 percent seek cheaper alternatives from their doctor.

The consequences of non-adherence are on a par with the opioid crisis. The failure of people to take medication properly kills about 125,000 every year and costs the health care system between $100 billion and $289 billion, according to studies.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

HHS Selects Pilot Projects to Demonstrate Better Approach to Disaster Medical Care

HHS Gov News - September 27, 2018

In a disaster, thousands of Americans may require immediate medical specialty care, surpassing the care available in the community. The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) today awarded two $3 million grants to demonstrate how a new Regional Disaster Health Response System could meet these needs, including trauma, burn or other specialty care, during a national emergency and save more lives.

“Our nation faces real and serious threats that represent a looming risk to healthcare delivery,” said HHS Assistant Secretary for Preparedness and Response Dr. Robert Kadlec. “This system offers a powerful way to form alliances and build specialized capabilities that save more lives in overwhelming, catastrophic emergencies. The system draws on the existing U.S. healthcare infrastructure, pulling together private sector and federal resources in a way that has never been done. I encourage all healthcare delivery facilities and providers to get involved.”

Nebraska Medicine in Omaha, Nebraska, and Massachusetts General Hospital in Boston, Massachusetts, received the grants from ASPR’s Hospital Preparedness Program to conduct pilot projects that show the potential effectiveness and viability of a Regional Disaster Health Response System.

The Regional Disaster Health Response System will build on local health care coalitions and trauma centers, creating a tiered system of disaster care. The system will integrate local medical response capabilities with emergency medical services, burn centers, pediatric hospitals, labs, and outpatient services, to meet the overwhelming health care needs created by disasters.

More than 31,000 health care organizations participate in health care coalitions nationwide, which are funded by the Hospital Preparedness Program. Coalitions create partnerships among health care facilities and providers in communities, primarily from the private sector, to prepare for disasters and respond.

In demonstrating a Regional Disaster Health Response System, each pilot project must:

  • build a partnership for disaster health response to support clinical specialty care;
  • align plans, policies, and procedures for clinical excellence in disasters;
  • increase state-wide and regional medical surge capacity;
  • improve state-wide and regional situational awareness, such as the availability of hospital beds; and
  • develop metrics and test the regional system’s capabilities.

Nebraska Medicine and Massachusetts General Hospital were selected from among 19 applicants nationwide by a panel of experts from professional associations, academia, and federal agencies.

Readout of Secretary Azar’s Second Day at the 73rd Session of the UN General Assembly

HHS Gov News - September 27, 2018

On Wednesday, Health and Human Services Secretary Alex Azar began his second day in New York City at the first-ever United Nations General Assembly (UNGA) High-Level Meeting on the fight against tuberculosis (TB). First he spoke at PATH, a Panorama and UN Foundation that reflects on the global community’s efforts to stem recent infectious disease outbreaks and support partner countries’ working to prevent, detect, and respond to outbreaks. The secretary reaffirmed the U.S. government’s commitment to the Global Health Security Agenda (GHSA) and emphasized that the U.S. will continue to work with partners to build and strengthen health security capabilities.

Immediately after, Secretary Azar participated in several bilateral meetings at the United Nations Headquarters. He met with France’s Minister of Social Affairs and Health, Agnes Buzyn, to discuss President Trump’s Drug Pricing Blueprint, G7 priorities, and their mutual commitment to prioritizing pandemic preparedness and global health security. Secretary Azar met with Minister of Health, Labour and Welfare, Katsunobu Kato, of Japan and discussed HHS priorities on key health issues such as anti-microbial resistance (AMR), pandemic influenza preparedness, and the GHSA.

Secretary Azar provided the national statement for the U.S. at the U.N. Plenary High-Level meeting on TB with remarks on how the world’s deadliest infectious disease is affecting global health, and called for collaboration across countries to commit their own resources to eradicating the disease within their own borders. At the meeting, Secretary Azar said, “Unless we are satisfied with today’s treatments for TB – and how could we be – we must be vigilant in avoiding measures that will discourage market actors from investing to create the needed therapies of tomorrow.”

During a working lunch, Secretary Azar met with Wellcome Trust to explore ways in which the government can deepen collaboration around novel approaches to addressing the challenge of TB. After lunch the secretary had a bilateral meeting with Colombia Minister of Health and Social Protection, Juan Pablo Uribe. Secretary Azar expressed gratitude to Minister Uribe for Colombia’s ongoing engagement in Zika research and discussed ways to address the impact of the Venezuelan crisis on the region. Next, Secretary Azar discussed the importance of protecting innovation and intellectual property in order to fuel the next generation of life-saving therapies with Emilio Santelices, Chile’s Minister of Health.

Secretary Azar concluded his day with opening remarks at a Centers for Disease Control and Prevention event entitled, “Preventing TB to End TB.” At the event he highlighted the U.S. government’s historic leadership on addressing TB globally, U.S. efforts on eliminating TB, how partners can join the fight against TB, and finally emphasized the importance of prioritizing prevention to end the TB epidemic.

To conclude the evening, Secretary Azar attended a working dinner with Ginette Petitpas Taylor, Minister of Health from Canada and reinforced the necessity of ongoing collaboration on the opioid crisis, mental health and AMR between the U.S. and Canada.

Readout of Secretary Azar’s First Day at the 73rd Session of the UN General Assembly

HHS Gov News - September 27, 2018

Yesterday, Health and Human Services Secretary Alex Azar traveled to New York City to participate in the first-ever United Nations General Assembly (UNGA) High-Level Meeting on the fight against tuberculosis (TB), convened by the UNGA at its 73rd session.

Secretary Azar participated in several bilateral meetings. He met with Health Minister Jane Aceng of Uganda where he acknowledged Uganda’s strong collaborative efforts in preventing and responding to infectious disease threats, including preparedness activities in response to the recent Ebola outbreak in the Democratic Republic of the Congo.

Next, Secretary Azar met with Health Minister Silvia Pessah of Peru to discuss the public health concerns in the region and to better understand the current impact in their country. Secretary Azar expressed his gratitude for the commitment they share with the U.S. to address anti-microbial resistance (AMR).

Later in the day, Secretary Azar met with representatives of the European Union to discuss efforts to fight AMR and President Trump’s commitment to lower prescription drug prices in the United States. Secretary Azar then met with South Africa Health Minister Aaron Motsoaledi to affirm the U.S. commitment to assisting in HIV treatment through the President’s Emergency Action Plan for Aids Relief. They discussed the importance of intellectual property rights in fighting TB and talked about past collaborations in biomedical and behavioral health research between the United States and South Africa.

In the evening, Secretary Azar delivered remarks at a CDC Foundation Corporate Roundtable reception on U.S. support for the Global Health Security Agenda and our commitment to fighting AMR. He then proceeded to his final bilateral meeting of the day, with the World Health Organization, to discuss global health security, pandemic preparedness, and a path forward for improving global public health.

Secretary Azar concluded his day with remarks announcing a new yearlong challenge to fight AMR at the CDC Foundation’s “The AMR Challenge: Launch Event and One Health Solutions Showcase.”

KHN Conversation On Overtreatment

Kaiser Health News:Marketplace - September 27, 2018
Special Reports

Treatment Overkill

Mar 13

In this series Kaiser Health News investigates the causes and consequences of medical overtreatment, both for patients and the health care system.

From duplicate blood tests to unnecessary knee replacements, millions of American undergo screenings, scans and treatments that offer little or no benefit every year. Doctors have estimated that 21 percent of medical care is unnecessary — a problem that costs the health care system at least $210 billion a year. Such “overtreatment” isn’t just expensive. It can harm patients.

Kaiser Health News senior correspondent Liz Szabo moderated a discussion a panel of experts to explore overtreatment.

Our panelists were:

  • Dr. Louise Davies,  An associate professor of  otolaryngology – head and neck surgery in The Dartmouth Institute for Health Policy & Clinical Practice
  • Dr. Saurabh Jha, an associate professor of radiology at the University of Pennsylvania
  • Dr. Barry Kramer, director of the division of cancer prevention at the National Cancer Institute
  • Dr. Jacqueline Kruser, a pulmonologist and critical care physician at Northwestern University Feinberg School of Medicine
  • Dr. Ranit Mishori, professor of family medicine at the Georgetown University School of Medicine.

KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.

Will Congress Bring Sky-High Air Ambulance Bills Down To Earth?

Kaiser Health News:States - September 27, 2018

Air ambulance rides are literal lifesavers. But how much should they cost?

Taken For A Ride: After ATV Crash, Doctor Gets $56,603 Bill For Air Ambulance Trip

After an accident in an all-terrain vehicle crushed a doctor’s left arm, he was whisked by air ambulance to the closest trauma center for specialized care. Soon he was fighting over the $56,603 bill.

Read The Story

In the ongoing, crowdsourced “Bill of the Month” investigation, Kaiser Health News and NPR received more than a dozen bills from people around the country on the hook for medevac helicopter rides that ranged from $28,000 to $97,000.

What gives? Why should a lifesaving flight come with a life-altering bill?

If an air ambulance service is not part of a patient’s insurance network, the operator can charge the patient for the portion of the bill the insurance company won’t cover — meaning the patient is on the hook for the undiscounted rate that the air carrier decides to charge.

“There’s nothing really they can turn to because of this regulatory blind spot, essentially, that air ambulances fall into,” said Erin Fuse Brown, an associate professor of law at Georgia State University who specializes in health care billing. “There’s nothing that would protect them, that would allow them to push back on the extraordinary charges that they are billed when they get home from the hospital.”

This happens because the federal government treats air ambulance companies more like air carriers — like Southwest or American Airlines — than like hospitals or clinics. They are regulated by the Federal Aviation Administration. By law, states cannot set rules for them. That has meant they haven’t been required to participate in insurance networks, their prices are not capped, and they can charge patients the balance of the bills even after insurance has paid.

Air Methods’ helicopter in Pocola, Okla. The company owns five other Oklahoma bases under the Tulsa Life Flight brand that it bought in 2009.(Jackie Fortier/StateImpact Oklahoma)

Congress now is hashing out its FAA reauthorization bill. The House passed an earlier version of the bill in May that would have allowed states to regulate air ambulances, including pricing and some billing practices. That provision was dropped from a House-Senate compromise bill that is expected to pass.

Some consumer protections remain in the new legislation. An aviation consumer advocate with the Department of Transportation would be responsible for handling patient complaints and could pursue enforcement or “corrective action” against unfair or deceptive practices, including air ambulance operators.

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The Deregulation Game

Air ambulances were in their infancy when air travel was deregulated in the 1970s. Since then, the air ambulance sector has had little oversight, especially of the positioning of bases. That has led to vast deserts of coverage and other areas, like on the Oklahoma border, with a saturated market and multiple carriers.

With no cap on pricing and high fixed costs, such as helicopters and trained personnel ready to fly at a moment’s notice, Greg Hildenbrand, executive director of Life Star of Kansas, a nonprofit air ambulance service and secretary of the Association of Critical Care Transport, said increased competition has driven prices up, instead of down.

“The numbers of patients per helicopter has dropped, but we still have to spread the same costs per base over fewer numbers of patients, and so that has driven costs up considerably,” he said.

The Federal Aviation Administration currently regulates all aspects of air ambulances, including the required onboard instruments.(Jackie Fortier/StateImpact Oklahoma)

The rise in price is dramatic. Take Air Methods, the nation’s largest air ambulance company, whose pricing greatly influences the market. Its average helicopter transport costs increased from $13,000 in 2007 to $49,800 in 2016, according to a Government Accountability Office report.

Because air ambulance providers accept much lower reimbursement rates from Medicare and Medicaid patients — and may not receive any payment from uninsured patients — the impact of these rate hikes has fallen almost entirely on private health care insurers and their members.

Hildenbrand, a 20-year veteran of the industry, said insurance companies are fed up.

“I think we’ve reached a tipping point in the industry where insurance companies are saying, ‘No, we’re not going to continue to pay these rates,’ and so then patients get balance-billed $40,000 or something after their insurance has paid. I don’t think it’s a sustainable system,” he said.

As billed charges have soared, more insurers have started limiting their reimbursements to air medical providers. Air Methods has responded by hiring patient advocates who go through the appeals process with the insurance company. Ultimately, if the insurance company won’t pay, the patient is on the hook.

The air ambulance can hold just four people: a pilot, a patient, a nurse and an EMT.(Jackie Fortier/StateImpact Oklahoma)

The House-Senate compromise bill would also set up a council of industry representatives, led by the Department of Transportation, which oversees air ambulances. The group would include air ambulance providers and insurance company representatives, among others, and would write and re-evaluate consumer protections, including balance-billing practices. The legislation also establishes a complaint hotline for patients, similar to one available for commercial airline passengers.

It’s a step in the right direction, said Fuse Brown of Georgia State University, but the regulatory council might not go far enough.

“The task of the committee would be to come up with additional consumer protections that haven’t been specified in the bill,” she said. “It’s unclear at this point whether the committee would come up with protections that would substantively provide consumer protections.”

This story is part of a reporting partnership between StateImpact Oklahoma, NPR and Kaiser Health News.

Threat To The ACA Turns Up The Heat On Attorney General Races

Kaiser Health News:HealthReform - September 27, 2018

For years, congressional Republicans have vowed to repeal the Affordable Care Act. Now, in a case sending shock waves through midterm election campaigns, Republican attorneys general across the country may be poised to make good on that promise.

The case, Texas v. United States, reveals just how high the stakes are for health care in this year’s attorney general races, elections that rarely receive much attention but have the power to reverberate through the lives of Americans.

“It just shows that nothing is safe,” said Xavier Becerra, California’s attorney general, who is leading 16 states and the District of Columbia in defending the ACA in the case.

Both parties expect record-breaking fundraising for this year’s 30 contested elections for state attorneys general. Democrats aim to translate public outrage over the threat to the ACA into the votes needed to seize a handful of posts currently held by Republicans.

This will be the first major election since Republicans tore up a deal brokered with Democrats roughly two decades ago not to challenge each other’s incumbents in attorney general races. That gentlemen’s agreement acknowledged the need for attorneys general from both parties to collaborate on investigations and lawsuits.

But some of the same partisan forces that have embittered Capitol Hill have spilled into these contests. With Republicans in control of the executive and legislative branches — and close to staking their claim on the Supreme Court — Democratic attorneys general are seen as a check on Trump administration policies. Similarly, their Republican counterparts frequently took the Obama administration to court.

That pressure is likely to increase should congressional Democrats fail to win control of at least one chamber of Congress in November.

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Raphael Sonenshein, the executive director of California State University’s Pat Brown Institute for Public Affairs in Los Angeles, compared the politics invigorating state attorneys general to a bar brawl.

“Two people have a fight, and then it spills out into the street, and 20 people join in,” he said. “Everybody gets off the bench and joins the fight.”

A banner on the Democratic Attorneys General Association’s website captures their mindset, while states are busy challenging the Trump administration on issues like sanctuary cities and family separations at the border: “This office has never been more important.”

Former Vice President Joe Biden recently endorsed six attorney general candidates in races Democrats think they can win, including Ohio and Wisconsin, and the association plans to raise a record-breaking $15 million for November’s elections, said Lizzie Ulmer, a spokeswoman for the group.

By mid-June, the Republican Attorneys General Association had raised $26.6 million, continuing to break its fundraising records.

Of this year’s 30 contested attorney general races, 18 posts are held by Republicans and 12 are held by Democrats. (Another five are in play this year, but those posts are appointed by the governor or state lawmakers.)

Unlike in Congress, there is no inherent advantage to one party claiming the majority of attorneys general posts. It takes just one attorney general to file a lawsuit.

But Democratic attorneys general see themselves as a firewall against an administration and their Republican counterparts dead set on revoking many federal protections. In that arena, every lawyer counts.

That is especially the case with health care, where fights over issues like access to abortion have multiplied since President Donald Trump took office, with others liable to end up in the courts at any time.

Earlier this month, a federal judge heard arguments in Texas v. United States on the constitutionality of the individual mandate, the ACA’s requirement that all Americans obtain health insurance or pay a penalty.

Citing the law passed late last year that eliminated the penalty, the plaintiffs — a Texas-led coalition of 20 states and two individuals — argued the individual mandate was now unconstitutional. By extension, so was the rest of the ACA, they said. They asked for a preliminary injunction that could halt the sweeping ACA in its tracks — including popular provisions such as protections for people with preexisting conditions.

Ken Paxton, the attorney general of Texas, has defended his decision to challenge protections that have broad support, including among Republicans, saying he has a duty to fight laws that harm Texans and defy the U.S. Constitution.

“The least compassionate thing we could do for those with preexisting health problems is to take away their access to high-quality care from doctors of their own choosing and place them entirely at the mercy of the federal government,” Matt Welch, Paxton’s campaign spokesman, said in a statement.

But the idea that insurers would no longer have to cover those with preexisting conditions has proven explosive, offering Democrats a powerful rallying cry beyond even attorney general races. In Missouri and West Virginia, states that Trump won in 2016 but are represented by Democratic senators, the issue has followed the Republican attorneys general — Missouri’s Josh Hawley and West Virginia’s Patrick Morrisey — as they run for Senate.

“We’re wasting millions and millions of dollars of taxpayer money trying to take away preexisting condition protections not just for all Texans but all Americans,” said Justin Nelson, Paxton’s Democratic challenger, who said he would withdraw Texas from the case should he win his long-shot bid.

In Wisconsin, the Republican attorney general, Brad Schimel, has also taken a leading role in Texas v. United States, as well as a 2016 challenge to a landmark Obama administration rule banning discrimination in health care based on a patient’s gender identity, among other cases.

This year, Schimel has drawn a formidable Democratic challenger, Josh Kaul. He’s a former assistant U.S. attorney who prosecuted federal drug crimes and has promised to focus on the state’s backlog of untested rape kits and take a more aggressive approach to the opioid epidemic. “We’re not going to beat that without ensuring our efforts are targeting large-scale drug traffickers,” he said.

Experts caution a changing of the guard would not spell the end of a big case like Texas v. United States. For instance, even if Paxton were to defy expectations and lose, Texas’ legal and financial backing for the case could easily be picked up by another state.

However, the message voters would send by electing a Democratic attorney general in Texas — where no Democrat has won statewide office since 1994 — could have profound implications for Republican morale.

“Without Ken Paxton leading the charge, many Republicans may soften their opposition to Obamacare,” said Brandon Rottinghaus, a political science professor at the University of Houston.

HHS awards $50 million to assist American Indian and Alaska Native tribal efforts combating the opioid overdose epidemic

HHS Gov News - September 26, 2018

The Department of Health & Human Service’s Substance Abuse and Mental Health Services Administration (SAMHSA) has awarded grants of about $50 million to American Indian and Alaska Native tribes Tuesday to strengthen their efforts to combat the opioid overdose epidemic.

The Tribal Opioid Response grant program aims to address the opioid overdose epidemic in tribal communities by increasing access to culturally appropriate and evidence-based treatment, including medication-assisted treatment using one of the three FDA-approved medications for the treatment of opioid use disorder (OUD). 

“The new Tribal Opioid Response grant program will help provide access to a wide array of treatment solutions for tribal communities, including medication-assisted treatment,” said HHS Deputy Secretary Eric Hargan. “Accessing treatment services can be especially challenging in rural areas like many parts of Indian Country. We will continue to engage with tribal nations through the Secretary’s Tribal Advisory Committee and community visits to hear concerns and develop programs that build on the strengths of tribal culture and customs.”

 “The intent of awarding the grants is unmistakable – we know people who have OUDs are not accessing effective, evidence-based treatment often enough,” said Elinore F. McCance-Katz, MD, PhD, the Assistant Secretary for Mental Health and Substance Use. “We want to reduce unmet treatment needs and opioid-related fatal overdoses by strengthening communities’ provision of treatment and psychosocial services.” 

Tuesday’s awards follow Monday’s announcement by HHS of disbursing three new grants totaling $6.2 million for treating opioid use disorder and for increasing access to mental health services for young people in Fairbanks, Alaska. The grants, also administered by SAMHSA, were awarded to Fairbanks Native Association and Tanana Chiefs Conference, Inc.

The grants announced this week are in addition to the more than $1 billion announced last week for opioid-specific grants for states to address the crisis affecting the country. To learn more about HHS’s recent actions to combat the opioid overdose epidemic visit https://www.hhs.gov/about/news/2018/09/19/hhs-awards-over-1-billion-combat-opioid-crisis.html.

Under President Donald J. Trump, in April 2017, HHS unveiled a five-point Opioid Strategy. The Strategy has prioritized efforts in five areas: 1) Improving access to prevention, treatment and recovery support services, including medication-assisted treatment; 2) Promoting the targeted availability and distribution of overdose-reversing drugs; 3) Strengthening public health data reporting and collection; 4) Supporting cutting-edge research on addiction and pain and 5) Advancing the practice of pain management. Over fiscal years 2017 and 2018, HHS will have invested  over $4 billion in opioid-specific funding, including funds to state and local governments as well as tribal, public, and nonprofit organizations to support treatment and recovery services, target availability of overdose-reversing drugs, train first responders, and more.

HHS Announces LEAP in Health IT Winner

HHS Gov News - September 26, 2018

The U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) today announced two awards totaling nearly $2 million in funding over two years to two awardees under the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT) funding opportunity.

The LEAP in Health IT awardees will address fast emerging and future challenges to advance the development and use of interoperable health IT. The funding opportunity solicited applications focused in one of two areas of interest: (1) expanding the scope, scale, and utility of population-level data-focused application programming interfaces (APIs); or (2) advancing clinical knowledge at the point of care. An API is technology that allows one software application to seamlessly access the services another software application.

“We expect these two awardees to demonstrate where healthcare interoperability can go next,” said Don Rucker, national coordinator for health information technology. “Their efforts should inform a new generation of health IT development.”

The awardees are:

  • Children’s Hospital Corporation, Boston MA
    • Children’s Hospital will expand the scope, scale, and utility of population-level APIs including enhancing the use of flat data files and creating a new population health analytics app allowing payors to access permitted data and metrics on covered populations through the use of those files.
  • MedStar Health Research Institute, Hyattsville MD
    • MedStar will advance clinical knowledge at the point of care by transforming isolated risk calculators into open standards-based applications that seamlessly and securely run across health IT platforms and provider organizations to optimize clinical workflow, improve care coordination, and support patient engagement.  

It is critical that the field of health care innovate and leverage the latest technological advancements and breakthroughs far quicker than it currently does to optimize real-time solutions, especially in areas that are ripe for acceleration. To do so, the awardees will further a new generation of health IT development and inform the innovative implementation and refinement of standards, methods, and techniques for overcoming major barriers and challenges as they are identified.

The LEAP in Health IT funding opportunity has a 3-year open application period and ONC may issue future awards to eligible applicants for new priority areas of interest. This will be contingent on the availability of funds and ONC priorities.

HHS partners to develop faster tests to identify bacterial infections

HHS Gov News - September 26, 2018

A test that may reduce, from days to hours, the time needed to diagnose patients with bacterial infections and determine how well an antibiotic will work against specific infections will receive advanced development support from the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).

The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, will sponsor the advanced development of the new testing technology under an 18-month, approximately $9.3 million contract with SeLux Diagnostic, Inc of Charlestown, Massachusetts.

SeLux is developing a phenotypic test; it identifies bacteria based on observable physical or biochemical characteristics of the bacteria. Based on the characteristics, the test identifies the class of bacteria and which antibiotics are best for treating that particular bacterial infection.

Faster information to select the best antibiotic can speed a patient’s recovery, which means fewer days spent in a hospital and better outcomes for patients. The ability to match bacteria more precisely to the drugs that will combat the infection also could curb antibiotic resistant infections.

“Antibiotic resistance is a growing threat to public health and to the health security of the United States,” said BARDA Director Rick Bright, Ph.D. “In a bioterrorism incident, antibiotic resistant infections could be devastating. We will need innovative tools for precision medicine to save lives.”

BARDA is sponsoring the development of two test systems from SeLux.  The company’s first-generation test system may be able to provide results using bacteria isolated from patient samples 24 hours faster than current state-of-the-art methods and may be able to provide results from blood samples three days faster than the current methods. The company’s second-generation test system may be able to provide results the same day that the test is started.

The tests are designed to be used in hospital and commercial laboratories. Rapid information on bacteria and how susceptible they are to antibiotics would help doctors make earlier, better-informed decisions about how best to treat infections.

BARDA funding will support necessary work for the company to apply for U.S. Food and Drug Administration (FDA) approval. The agreement can be extended to fund additional work up to a total of approximately $36 million through 2023.

In addition to SeLux’s diagnostic test systems, BARDA is supporting development of other antibiotic susceptibility tests that can distinguish between bacterial and viral infections. BARDA also is working with federal partners to develop other tests that identify bacterial infections and the bacteria’s susceptibility to specific antibiotics. These efforts are part of the HHS commitment to combat antimicrobial resistance and to support antibiotic stewardship. To encourage antimicrobial stewardship further, ASPR provides hospitals and health care coalitions with guidance and the latest information on antibiotic resistant infections and new tools to combat them.

About HHS, ASPR and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.

Learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, visit the HHS public health emergency website.

Taken For A Ride: After ATV Crash, Doctor Gets $56,603 Bill For Air Ambulance Trip

Kaiser Health News:Insurance - September 26, 2018

It was the first — and only — time Dr. Naveed Khan, a 35-year-old radiologist, ever rode in an all-terrain vehicle.

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Khan took the wheel from his friend and drove circles in the sand, on a trail along the Red River in Texas.

“As soon as I turned to the side where my body weight was, this two-seater vehicle … just tilted toward the side and toppled,” Khan recalled. It landed on his left arm.

“I had about a 6-inch-wide exposed flesh gap that I could see below, on my forearm,” he said. “And I could see muscle. I could see the fat. I could see the skin. The blood was pooling around it.”

Khan, feeling lightheaded, tied his jacket around his arm like a tourniquet. He and his friend managed to right the ATV, drive back toward the street and call 911.

When an ambulance delivered him to the emergency room at United Regional Health Care System in Wichita Falls, Khan was surprised to hear a doctor murmur that it was the worst arm injury he’d ever seen.

Khan needed immediate helicopter transport to a trauma center for surgery in Fort Worth, if there was any hope of saving the arm.

Groggy from painkillers, Khan managed to ask the doctors how much the flight would cost and whether it would be covered by his insurer. “I think they told my friend, ‘He needs to stop asking questions. He needs to get on that helicopter. He doesn’t realize how serious this injury is,'” Khan recalled.

Flown 108 miles to John Peter Smith Hospital in Fort Worth, the closest Level I trauma center, Khan was whisked into surgery to clean out the wound, repair his shattered bones and get blood flowing to the tissue.

He had a total of eight operations to try to save his left forearm before he finally gave up. After weeks in the hospital, he asked the doctors to amputate, so he could get on with his life.

And then the bill came.

Patient: Naveed Khan, 35, a radiologist and married father of three small children in Southlake, Texas.

Total bill: $56,603 for an air ambulance flight. Blue Cross Blue Shield of Texas, Khan’s insurer, paid $11,972, after initially refusing altogether; the medevac company billed Khan for the remaining $44,631.

Service provider: Air Evac Lifeteam, an air ambulance company that operates 130 bases in 15 states. It’s owned by Air Medical Group Holdings, a holding company that owns four other air ambulance companies and one ground ambulance company. Air Medical, in turn, is owned by the giant private equity firm Kohlberg Kravis Roberts, or KKR.

Medical service: Khan was flown from the United Regional Health Care System in Wichita Falls, Texas, to the John Peter Smith Hospital in Fort Worth.

What gives: Khan got his first call from Air Evac Lifeteam just three days after the accident, while he was still lying in the hospital. A company representative told him the helicopter ride would likely cost more than $50,000 and asked him how he planned to pay.

For Khan, rapid transportation to the trauma center was absolutely essential since the blood supply to his arm had been cut off, said Dr. Raj Gandhi, the medical director for trauma services at JPS Hospital.

“If there’s no blood going that means there’s no oxygen,” he said. “It there’s no oxygen, that means those cells are going to die.” Minutes are precious and the helicopter can get from Wichita Falls to Fort Worth in an hour or less, half the time it takes by ground ambulance, he said.

But complaints about sky-high bills to patients for air ambulance services are common. Since launching the “Bill of the Month” series in February, NPR and Kaiser Health News have received more than a dozen bills from critically ill patients like Khan who were charged tens of thousands of dollars for an air ambulance ride even after insurers’ payments.

Khan cooks lunch for his wife, Ayesha, and children, Nazneen, 7, Yasmeen, 4, and Rehan, 1, in their home in Southlake, Texas.(Shelby Knowles for NPR)

Air ambulance companies defend their charges.

Rick Sherlock, president of the Association of Air Medical Services, a trade group, said air ambulances require a more highly trained crew than a ground ambulance, because only the sickest or most seriously injured patients need air transport.

AAMS commissioned a study to determine the actual cost of a medevac ride. The report found it takes about $2.9 million a year to run a single helicopter base. Each base handles about 300 transports a year, and the rides cost about $11,000 each, according to the report.

A spokeswoman for Air Evac Lifeteam said the company bills people so much because it is trying to make up for what she said are meager payments from Medicare and Medicaid.

“Our real cost per flight is the $10,200 plus the unreimbursed cost on each flight for Medicare, Medicaid and patients without any coverage,” wrote Shelly Schneider, the company spokeswoman.

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The Centers for Medicare & Medicaid Services said it pays an average of $4,624 per ride, plus $31.67 a mile — which works out to an average Medicare reimbursement of $6,556 for helicopter ambulance rides for seniors. Medicaid in most states pays less.

The industry has been advocating hard to get Medicare to boost its reimbursements, Sherlock said. Legislation pending in both the House and Senate would do so, but there hasn’t been much movement on those bills.

Others say the industry’s cost estimates are inflated by profit-driven expansion of a lucrative industry. Ground ambulances often carry critically ill patients, too.

Too many air ambulances sit idle much of the time, said Dr. Ira Blumen, a professor of emergency medicine at the University of Chicago and medical director of the university’s Aeromedical Network.

Blumen said the industry — which is dominated by a few companies owned by private equity firms — expanded dramatically the last time Medicare boosted its payments, in 2002. And now there are too many helicopters — 908 as of last year — fighting for patients and profits at the same time.

“The number of helicopters is outrageous for the continental United States,” he said. In the 1990s, most helicopters ran more than 500 flights per year on average. At that rate, the cost per flight today would be less than $6,000.

"The biggest challenge for me was to see how I would be a father again," said Dr. Naveed Khan, who was injured while driving an all-terrain vehicle. (Shelby Knowles for NPR)

"With two able-bodied parents at home, it was easier," he said. (Shelby Knowles for NPR)

A BCBS of Texas spokesman said the insurer does have a contracted rate with an in-network air ambulance company, but it is not Air Evac Lifeteam. After initially refusing to pay anything for an out-of-network claim, it agreed to the $11,972 payment.

But in some sense, the reason ambulance companies charge so much is simply because they can: Air ambulances are largely regulated not as health care but as part of the aviation industry. Federal laws prevent states from limiting aviation rates, routes and services.

So many people have been hit with shockingly high air ambulance bills that members of Congress on both sides of the aisle are trying to do something about it. Legislation to reauthorize funding for the Federal Aviation Administration that is moving through Congress now would set up a council of industry experts to address balance billing and other issues, and set up a complaint line for consumers.

Resolution: Khan has allowed Air Evac Lifeteam to negotiate with BCBS of Texas over the remaining $44,000 air ambulance bill. The company has asked him to appeal to the state’s Department of Insurance, and though he first balked at the suggestion, he’s now considering doing so. Khan says he doesn’t understand why the helicopter flight, an integral part of the emergency medical care he received, is treated differently than his surgeries, nursing care and physical therapy.

“I thought that this was another piece of that puzzle,” he said. “It turns out that this was glaringly different.”

He is waiting for resolution as he gets accustomed to life with his disability. Holding his baby son, he asked in frustration: “How do I hold him while he’s crying and at the same time heat up his bottle?”

“It’s unfair,” Khan says. “It’s random, it’s arbitrary. It’s whatever price they want to set. And to put that onto a person who’s already been through what I’ve been through, I hate to say it, but it’s cruel.”(Shelby Knowles for NPR)

Khan, who has had to fight with his insurance company to get coverage for a prosthetic arm, is frustrated to learn that the air ambulance company expects him to pay far more than the actual cost of his flight.

“It’s unfair,” he said. “It’s random, it’s arbitrary. It’s whatever price they want to set. And to put that onto a person who’s already been through what I’ve been through, I hate to say it, but it’s cruel.”

Related Stories

The Takeaway: Most people with health problems serious enough to require a helicopter flight are in no position to ask if the medevac company is in-network or whether there’s a choice. But if you or a family member has time to ask, it could pay off.

Steps you should take if you’re faced with a huge bill for a medevac ride:

  • First, let your insurer’s process play out. Blue Cross Blue Shield of Texas first denied Khan’s claim altogether. But he looked closely at his policy and saw that the threat of loss of limb was explicitly covered. He appealed, and that’s when the insurer paid $11,972.
  • Second, negotiate! The air ambulance company might be willing to negotiate a settlement for a fraction of the bill to avoid turning to debt collectors, who would pay them pennies on the dollar.

Both Sherlock of the Association of Air Medical Services and Schneider of Air Evac Lifeteam said companies will try to determine what a patient can afford. So people with high incomes may find it hard to obtain a substantial reduction for their bill. Still, if patients know the true cost of the service they received, they may be better equipped to negotiate a discount.

Many air ambulance companies offer membership plans that can cost less than $100 a year, and guarantee that the company will accept whatever payment an insurance company makes without billing the patient for the rest. But buyer, beware: When someone needs an air ambulance, they are often not in a position to choose which company will respond to the call.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Medicare Eases Readmission Penalties Against Safety-Net Hospitals

Kaiser Health News:HealthReform - September 26, 2018

On orders from Congress, Medicare is easing up on its annual readmission penalties on hundreds of hospitals serving the most low-income residents, records released last week show.

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READMISSION PENALTIES BY HOSPITAL AND STATE

Medicare is penalizing hospitals that see patients return to the hospital too soon after being discharged. Medicare reduces what it pays each hospital per patient, per stay.

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Since 2012, Medicare has punished hospitals for having too many patients end up back in their care within a month. The government estimates the hospital industry will lose $566 million in the latest round of penalties that will stretch over the next 12 months. The penalties are a signature part of the Affordable Care Act’s effort to encourage better care.

But starting next month, lawmakers mandated that Medicare take into account a long-standing complaint from safety-net hospitals. They have argued that their patients are more likely to suffer complications after leaving the hospital through no fault of the institutions, but rather because they cannot afford medications or don’t have regular doctors to monitor their recoveries. The Medicare sanctions have been especially painful for this class of hospitals, which often struggle to stay afloat because so many of their patients carry low-paying insurance or none at all.

In a major change to its evaluation, the federal Centers for Medicare & Medicaid Services (CMS) this year ceased judging each hospital against all others. Instead, it assigned hospitals to five peer groups of facilities with similar proportions of low-income patients. Medicare then compared each hospital’s readmission rates from July 2014 through June 2017 against the readmission rates of its peer group during those three years to determine if they warranted a penalty and, if so, how much it should be.

The broader issue is whether medical providers that serve the poor can be fairly judged against those that care for the affluent. This has been a continuing topic of contention as the government seeks to accurately measure health care quality. It is particularly a concern in efforts to consider patient outcomes in setting pay rates for doctors, nursing homes, hospitals and other providers.

Overall, Medicare will dock payments to 2,599 hospitals — more than half in the nation— throughout fiscal year 2019, which begins Oct. 1, a Kaiser Health News analysis of the records found. The harshest penalty is 3 percent lower reimbursements for every Medicare patient discharged in fiscal year 2019. The number of hospitals and the average penalty — 0.7 percent of each payment — are almost the same as last year.

But the new method shifted the burden of those punishments. Penalties against safety-net hospitals will drop by a fourth on average from last year, the analysis found.

“It’s pretty clear they were really penalizing those institutions more than they needed to,” said Dr. Atul Grover, executive vice president of the Association of American Medical Colleges. “It’s definitely a step in the right direction.”

(Story continues below.)

Safety-net hospitals that will see their penalties cut by half or more include many urban institutions, such as Sutter Health’s Alta Bates Summit Medical Center in Oakland, Calif.; Providence Hospital in Washington, D.C.; and Hurley Medical Center in Flint, Mich. Sixty-five safety-net hospitals — including Franklin Medical Center in Winnsboro, La., Astria Toppenish Hospital in Toppenish, Wash., and Emanuel Medical Center in Swainsboro, Ga. — that had been penalized last year escaped punishment entirely this year.

Conversely, the average penalty for the hospitals with the fewest low-income patients will rise from last year, the analysis found.

Before the program began, roughly 1 in 5 Medicare beneficiaries were readmitted within a month. Hospitals were paid the same amount regardless of how their patients fared after being discharged. In fact, a readmission was financially advantageous as hospitals would be paid for the second hospital stay, even if it might have been avoidable. This story also ran on NPR. This story can be republished for free (details).

Since the sanctions began, Medicare has evaluated each year rates for readmitted patients who had originally been treated for heart failure, heart attacks and pneumonia. And it has reduced its payments to more than half of hospitals based on those rates. The evaluations have since expanded to cover chronic lung disease, hip and knee replacements and coronary artery bypass graft surgeries.

Medicare counts patients who returned to a hospital within 30 days, even if it is a different hospital than the one that originally treated them. The penalty is applied to the first hospital.

Medicare exempts hospitals with too few cases, those serving veterans, children and psychiatric patients, and critical-access hospitals, which are the only hospitals within reach of some patients. In addition, Maryland hospitals are excluded because Congress lets that state set its own rules on how it distributes Medicare money.

(Story continues below.)

In its revised method this year, Medicare distinguished hospitals that serve a high proportion of low-income patients by looking at how many of the hospital’s Medicare patients were also eligible for Medicaid, the state-federal program for the poor. American Hospital Association officials say that while they considered this an improvement, it isn’t a perfect reflection of poor patients. For one thing, they say, hospitals in states with more restrictive Medicaid coverage do not appear through this formula to have as challenging patient populations as do hospitals in states with higher Medicaid eligibility.

Akin Demehin, the association’s director of quality policy, said CMS might consider linking its records to Census records that show income and education level of patients.

“It might give you a more precise adjuster,” he said.

The hospital industry remains critical of the overall program, saying that stripping hospitals of revenue because of poor performance only makes it harder for them to care for patients.

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Congress’ Medicare Payment Advisory Commission in June concluded that the penalties from previous years successfully pressured hospitals to reduce the numbers of returning patients — and helped save Medicare about $2 billion a year.

In its analysis of the approach’s effectiveness, Congress’ advisory commission rejected some of the hospital industries’ complaints about Medicare’s Hospital Readmissions Reduction Program: that hospitals may have tried to get around the penalties by keeping patients under “observation status” and that discouraging rehospitalizations may have led to extra deaths.

The commission found that between 2010 and 2016 readmission rates fell by 3.6 percentage points for heart attacks, 3 percentage points for heart failure and 2.3 percentage points for pneumonia. At the same time, readmissions caused by conditions that do not factor into the penalties fell on average 1.4 percentage points, indicating hospitals were focusing on lowering unnecessary readmissions that could hurt them financially.

The commission wrote: “We conclude that the [penalties] contributed to a significant decline in readmission rates without causing a material increase in ED [emergency department] visits, a material increase in observation stays, or a net adverse effect on mortality rates.”

This fall, Medicare will attack the readmissions from another angle by issuing penalties on skilled nursing facilities that send recently discharged residents back to the hospital too frequently.

KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.

Readers And Tweeters Slice And Dice Precision Medicine, Step Therapy

Kaiser Health News:Insurance - September 26, 2018

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.

Precision Medicine: The Full Picture

Thank you for publishing Liz Szabo’s piece, “Much Touted For Cancer, ‘Precision Medicine’ Often Misses The Target” (Sept. 13). In calculating the pluses and minuses of precision medicine, please add attention to “side effects,” which can be more like full-frontal assaults. In my sweetheart’s four years of living with a terminal diagnosis, she had two experiences with precision medicine. The first probably extended her life, even though it brought a disabling side effect. The second sent her to the hospital with a pulmonary embolism and pneumonitis — it probably shortened her life. At best, 2 in 25 patients live five years with the diagnosis of metastatic lung cancer, instead of the estimated 1 in 25 about 10 years ago. Yes, it’s progress, but at great physical and emotional cost.

— Jack Hailey, Fair Oaks, Calif.

But cancer survivor @MarkstageIV exhorts others never to discount the hope that comes with treatment.

When DX. w/stageIV Metastatic Melanoma. 1st doc said "you're done" no cure no treatment , you have 6 months /2 years max. I went home that day to prepare to die. Thankfully I was referred to another Dr. This was 11 years ago! 9 plus NED. People need hope! Hope keeps us going.

— Mark Williams (@MarkstageIV) September 13, 2018

— Mark Williams, Portland, Ore.

By suggesting that positive characterizations of precision medicine’s potential “mislead the public,” Liz Szabo may undermine patients’ confidence in treatment approaches that save lives and inhibit future investment upon which improvement in cancer care depends.

While she is correct to note that precision medicine is not yet “addressing the needs of the majority of cancer patients,” she overlooks the considerable progress in the last two decades, when, beginning with Herceptin (trastuzumab) in 1998, targeted therapies began to redefine possible cancer treatment beyond surgery, chemotherapy and radiation.

Precision treatments targeting the “Philadelphia” genetic mutation in patients with chronic myeloid leukemia, for example, have more than doubled the overall five-year survival rate for patients with this disease over the past decade.

In total, the Food and Drug Administration has approved more than 40 precision medicines for the treatment of many types of cancer. On the labels of these drugs, the agency requires drugmakers to include information about their use in molecularly defined subsets of the patient population. This information underpins precision cancer care that is helping many — albeit not all — patients live longer and healthier lives.

— Edward Abrahams, president of Personalized Medicine Coalition, Washington, D.C.

Let’s not forget the unpleasant alternatives to “precision medicine,” says a California doctor:

How about the women who are spared of unnecessary chemo and its short & long term side effects? This article generalizes ‘precision medicine’ to targeted txs but completely overlooks tests like oncotypedx. Sometimes our own biases blind us to leveraging what good can be done.

— Ayse Tezcan

Putting Oversized Health Care Costs Upfront — On T-Shirts

Kaiser Health News:Marketplace - September 26, 2018

If only patients knew how expensive medical procedures are and how wildly prices vary by hospital, they could be smart shoppers and lower the cost of health care for everybody.

At least that’s what policy experts and health insurers keep saying as they promote “consumer-directed” health care and cost-comparison websites.

None of it has had much effect. Now, exasperated Maryland officials are presenting hospital cost information in a way they believe Americans might understand: on a T-shirt.

“We tried to focus it on a level most consumers are at,” said Ben Steffen, executive director of the Maryland Health Care Commission, which created the campaign. “It is an opportunity to wear a billboard in certain public settings” to get people to ask questions, he said.

You can get a black shirt that says “HIP REPLACEMENT $30,067” in big type from the commission’s WearTheCost.org website. Or one that says “HYSTERECTOMY $16,138.” Other shirts feature prices for a knee replacement or baby delivery.

“I sent an email to all my colleagues in the health-policy wonk world and said, ‘I just got your holiday gift,’” said Dr. Ateev Mehrotra, a Harvard Medical School professor who has studied medical price transparency and patient responses.

Social media for the campaign points people to the WearTheCost.org website, which shows huge differences in what the same procedures cost at different Maryland hospitals.

The hysterectomy expense of $16,138 on the T-shirt is just an average. In recent years, the operation cost as much as $20,635 at Johns Hopkins Hospital in Baltimore and as little as $12,798 at Anne Arundel Medical Center in Annapolis.

Hopkins was also the most expensive hospital in which to have a baby, at $14,578, compared with the average Maryland cost of $11,590.

“Our teams treat the most complex cases in the region,” making them more expensive, said Hopkins spokesman Ken Willis. Hopkins supports publishing data to help patients make informed decisions, he added, but he said the Wear the Cost site “does not yet achieve that goal.”

The website’s price quotes apply to commercial insurance rates and include hospital care as well as non-hospital spending, such as doctors’ fees and prescription drugs.

The reported expenses are adjusted so that “it would take account of differences in case severity,” Steffen said.

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Hospital-to-hospital results vary sharply even under Maryland’s health care finance system, which regulates what hospitals are paid. One reason is that hospitals make money from their mistakes. Those with high rates of avoidable complications, such as infections or drug reactions, end up delivering more care, for which they charge.

Wear the Cost’s software tries to measure this, flagging avoidable problems and calculating the expense. Potentially avoidable complications added $2,271 to the cost of a hysterectomy at Johns Hopkins.

Such costs were even higher at Baltimore’s Saint Agnes Hospital, adding $5,481 to a hysterectomy’s total cost of $18,433. (The hospital did not respond to requests for comment.)

A $4 million federal grant financed the Wear the Cost campaign, which was led by the commission’s analysis director, Linda Bartnyska, who died of breast cancer in August.

Economists like to note that health care lacks many attributes needed for a minimally functioning market, including customers who understand the product and know what it costs.

The price transparency movement was supposed to help fix that. If patients give more business to lower-cost institutions with fewer complications, the thinking goes, hospitals will work harder to contain costs and improve outcomes, slowing the increase in insurance premiums and government health expenses.

“The hope is that, over time, consumers will come to expect that prices are available … and use them regularly in making decisions about where to get care,” said Sarah Litton of Altarum, a research and consulting firm that worked on the campaign with the Maryland commission.

But it’s an uphill fight. Nobody checks hospital prices when they have a heart attack or get in a car crash, so Wear the Cost, which has given away more T-shirts than it has sold, focuses on elective procedures that people can shop for in advance. Even these patients, though, tend to go to wherever doctors suggest. Since insurance usually pays everything for in-network hospitals once out-of-pocket spending limits are met, they have little incentive to shop around when considering pricey procedures. The patient’s portion is likely to be similar whether a joint replacement is $25,000 or $50,000.

Federal authorities recently required hospitals to start posting their charges online, but these bear little relationship to what most patients and their insurers pay.

Just 3 percent of adults under age 65 compared costs between medical providers before getting care, found a 2017 survey led by Mehrotra.

“To date, price transparency initiatives that have been rigorously assessed have had little to no impact on prices in the health care system,” Mehrotra said. “The reason so far is few people are using those websites.”

Still, maybe the point of programs like Wear the Cost “is to shame” expensive hospitals, to say, ‘What the heck is going on here?’” Mehrotra said. “’Why are you 50 percent more’” than the hospital across town?

Statement from the Department of Health and Human Services

HHS Gov News - September 25, 2018

“After a recent review of a contract between Advanced Bioscience Resources, Inc. and the Food and Drug Administration to provide human fetal tissue to develop testing protocols, HHS was not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements. As a result, that contract has been terminated, and HHS is now conducting an audit of all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations. In addition, HHS has initiated a comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved. Finally, HHS is continuing to review whether adequate alternatives exist to the use of human fetal tissue in HHS funded research and will ensure that efforts to develop such alternatives are funded and accelerated.”

HHS announces $6.2 million in new grants in Fairbanks focusing on opioid and mental health services

HHS Gov News - September 25, 2018

Today, HHS Deputy Secretary Eric D. Hargan announced three new grants to combat opioid addiction and improve access to mental health services for youth and young adults. The grants funding by HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) were awarded to Fairbanks Native Association and Tanana Chiefs Conference, Inc., are expected to total over $6.2 million over the next few years.

“Building on the strengths of tribal culture and customs, these grants to Fairbanks Native Association and Tanana Chiefs Conference, Inc., will reduce unmet treatment need and opioid related deaths in the greater Fairbanks community,” said Deputy Secretary Hargan. “In addition, Tanana Chiefs Conference, Inc., was also awarded a grant to improve access to treatment and support services for youth and young adults living with serious mental disorders.”

Over the next five years, Tanana Chiefs Conference, Inc., is expected to receive just under $5 million for a Healthy Transitions Grant. The grant will be used to provide developmentally appropriate, culturally and linguistically competent services and supports to address serious mental disorders among youth and young adults16 – 25 years of age. The goal is maximize their potential to assume adult roles and responsibilities and lead full productive lives.

Both Tanana Chiefs Conference and Fairbanks Native Association were awarded a Tribal Opioid Response Grant. Over the next two years, Tanana Chiefs Conference is expected to receive just over $700,000 and Fairbanks Native Associations is expected to receive just over $500,000 to increase access to culturally appropriate and evidence-based treatment, including medication-assisted treatment (MAT), for opioid use disorders. 

“These three new grants are part of the $54 million in new investments SAMHSA plans to make in Alaska over the next several years to connect people with much needed prevention, treatment and recovery support services in their communities,” said Elinore F. McCance-Katz, MD, PhD., Assistant Secretary for Mental Health and Substance Use.

The grants announced today are in addition to the more than $1 billion announced last week for opioid-specific grants for states to address the crisis affecting the country. To learn more about HHS’s recent actions to combat the opioid epidemic visit https://www.hhs.gov/about/news/2018/09/19/hhs-awards-over-1-billion-combat-opioid-crisis.html.

For additional information on these and other SAMHSA grant awards please visit www.SAMHSA.gov/grants.

HHS Enlists MediWound to Develop Treatment for Sulfur Mustard Injury

HHS Gov News - September 25, 2018

The U.S. Department of Health and Human Services (HHS) will work with MediWound Ltd.of Yavne, Israel, to develop a new treatment for skin injuries caused by sulfur mustard, a potential terrorism threat. Currently, there are no treatments approved by the U.S. Food and Drug Administration for skin injuries caused by exposure to sulfur mustard.

“Mustard agents have been used in conflicts for over 100 years, yet there still are no approved treatments for the injuries they cause,” said Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. “At BARDA, we have a sense of urgency to develop innovative treatments to protect Americans against this and other national security threats.

Sulfur mustard was first used as a chemical weapon during World War I, and damages the skin, eyes, and lungs. Skin exposure to sulfur mustard can cause redness and blistering, similar to a second- or third-degree burn. The damage is slow to heal and can lead to scarring. Severe exposure can be fatal.

Under the three-year, $11.9 million contract with BARDA, MediWound will advance the development of NexoBrid as a treatment for chemically injured skin in adults and children exposed to sulfur mustard. NexoBrid is designed to remove chemically injured skin tissue in adults and children so that the wound can heal properly.  The contract can be extended for as long as five additional years and up to $31 million in additional funding.

Studies under the contract include animal model development, optimization of NixoBrid treatment conditions, and efficacy studies in animals to support FDA approval.

NexoBrid has been shown in animal models to help reduce and heal wounds caused by sulfur mustard. In these studies, the treatment appeared to be easy-to-use and effective for early and selective removal of dead and damaged tissue (called eschar) from sulfur mustard skin wounds. Currently, surgery or specialized lasers are required to remove skin tissue damaged by sulfur mustard.

NexoBrid has received orphan drug status in the United States, European Union, and South Korea and is commercially licensed in the European Union, Israel, and Argentina for the removal of dead or damaged eschar in adults with deep partial and full thickness thermal burns.

The contract announced today builds on development work completed under a 2015 agreement between BARDA and MediWound.

BARDA continues to seek proposals for development of effective products to treat injuries caused by chemical agents, including new products or new indications for products already in clinical use. The products must be easy to use in a mass casualty situation, and safe and effective for all segments of the population. Proposals are accepted through the Broad Agency Announcement BARDA- BAA-18-100-SOL-00003 at the Federal Business Opportunities website, www.fbo.gov.

About HHS, ASPR and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.

For more about ASPR and BARDA, visit www.phe.gov/aspr. To learn more about partnering with BARDA on advanced development of medical countermeasures – drugs, vaccines and devices for emergencies – visit www.medicalcountermeasures.gov.

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