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Firing Doctor, Christian Hospital Sets Off National Challenge To Aid-In-Dying Laws

DENVER — A Christian-run health system in Colorado has fired a veteran doctor who went to court to fight for the right of her patient to use the state’s medical aid-in-dying law, citing religious doctrine that describes “assisted suicide” as “intrinsically evil.”

Centura Health Corp. this week abruptly terminated Dr. Barbara Morris, 65, a geriatrician with 40 years of experience, who had planned to help her patient, Cornelius “Neil” Mahoney, 64, end his life at his home. Mahoney, who has terminal cancer, is eligible to use the state’s law, overwhelmingly approved by Colorado voters in 2016.

The growing number of state aid-in-dying provisions are increasingly coming into conflict with the precepts of faith-based hospitals, which oppose the practice on religious grounds.

Morris’ dismissal presents an early test of state laws. The Trump administration has moved to broaden the latitude of providers to refuse to participate in medical interventions they object to on religious grounds, though that has previously applied primarily to abortion and contraception.

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As hospitals across the country have consolidated, five of the top 10 hospital systems by net patient revenue are associated with the Roman Catholic Church, according to Definitive Health. That includes hospitals that did not previously have any religious affiliation. Meanwhile, there are 10 U.S. jurisdictions where aid-in-dying has been approved and public support for the option is increasing.

The Aug. 26 firing came days after Morris joined with Mahoney in filing a state lawsuit that alleges that Centura’s faith-based policy violates the law that allows doctors to prescribe lethal drugs to dying patients who want to end their own lives.

Officials at Centura, a system jointly run by Catholic and Seventh-day Adventist churches, told Morris on Monday that she had defied church doctrines that govern her employment.

“I was shellshocked,” Morris said in an exclusive interview with Kaiser Health News. “Because of all the things I expected them to do, that was not in the playbook. Because it seemed so obvious that they can’t do it.”

But in legal documents filed Friday that ask to elevate the case to federal court and invoke the First Amendment in defense of their actions, Centura officials said Morris had violated terms of her physician’s employment agreement and “encouraged an option that she knew was morally unacceptable to her employer.”

Neil Mahoney, the former manager of a landscape company, was recently diagnosed with stage 4 cancer that had already spread through his body. Mahoney wants to use Colorado’s End of Life Options Act, but his hospital won’t allow it.(Heidi de Marco/KHN)

For Mahoney, the firing deals yet another setback in his quest to use the law. Mahoney, who in July was given four to 14 months to live, said he watched his mother die a slow, painful death and hopes to avoid that for himself.

“Knowing that I could die at home is huge,” said Mahoney, who has lost 30 pounds since April, even as his belly swelled painfully with fluid as a result of the cancer. “This gets dragged out too long.”

The Trump administration in May approved a so-called conscience rule that strengthens the rights of hospitals and health workers to refuse to participate in patient care based on religious or moral grounds.

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At the same time, more doctors and patients in the country are providing and receiving health care subject to religious restrictions. About 1 in 6 acute care beds nationally is in a hospital that is Catholic-owned or -affiliated, said Lois Uttley, a program director for the consumer advocacy group Community Catalyst.

In Colorado, one-third of the state’s hospitals operate under Catholic guidelines.

In a letter hand-delivered to Morris, who has worked for the health care system since 2013, Centura president Vance McLarren said that she had violated the firm’s governing rules, the Ethical and Religious Directives for Catholic Health Care Services.

“Rather than encouraging patient Cornelius Mahoney to receive care consistent with that doctrine or transferring care to other providers, you have encouraged a morally unacceptable option,” the letter said.

The directives state that Catholic health care providers “may never condone or participate in euthanasia or assisted suicide in any way.” Such acts are described as “intrinsically immoral” and “intrinsically evil” in the document.

“Patients experiencing suffering that cannot be alleviated should be helped to appreciate the Christian understanding of redemptive suffering,” the document states.

Centura officials confirmed Thursday that Morris is no longer employed there, adding in a statement that the firm “expects all our caregivers to act in a manner consistent with our Mission and Core Values.”

Centura Health is a Catholic-run health system in Denver.(Heidi de Marco/KHN)

Company officials did not address claims that Centura violated state law but argued that its policy prohibiting doctors from prescribing drugs or otherwise participating in medical aid-in-dying is federally protected.

“We believe the freedom of religion doctrine at the heart of the First Amendment to the U.S. Constitution supports our policies as a Christian health-care ministry,” Centura spokeswoman Wendy Forbes said in an email. “We will vigorously defend our Constitutional rights.”

Legal experts said that Morris’ firing may be rare or even unprecedented, but the argument based on the First Amendment has gained support recently in conservative circles.

“In recent years, the radical right has gotten traction with the argument that religious peoples’ constitutional rights are violated if they have to follow the same law as everybody else,” said Robert Rivas, a Florida lawyer who serves as general counsel for the Final Exit Network, a nonprofit group that promotes right-to-die causes.

“When you look closely at what they are saying,” he said, “it turns out they really want to be empowered to force their religion on others.”

Officials with the Archdiocese of Denver said they supported Centura’s efforts to uphold church doctrine.

“Asking a Christian hospital to play any role in violating the dignity of human life is asking the Christian hospital to compromise its values and core mission,” spokesman Mark Haas said in a statement. “This is not the hospital forcing its beliefs upon others, but rather having outside views forced upon it.”

The issue is playing out against growing federal protections for religious views of health care, said Kathryn Tucker, executive director of the End of Life Liberty Project and co-counsel on the Centura lawsuit filed Aug. 21.

The Trump administration conscience rule, which was challenged by two dozen states and cities, including Colorado, has been delayed until Nov. 22.

“What’s getting lost here is the patient, and the doctor may hold equally strong ethical and religious views as Centura,” Tucker said. “Why should their views be overridden by the views of corporate religious medicine?”

Morris’ termination was immediate, according to the letter. She was asked to hand over her badge and her company laptop computer. The action abruptly halted her care of 400 geriatric  patients and left Morris worried about their future.

“These are complex, ill patients,” Morris said. “We have a pretty big thing in medicine about not abandoning patients, so that’s a pretty big issue.”

In the lawsuit, Morris joined with Mahoney, a Golden, Colo., nursery manager diagnosed in July with stage 4 metastatic cancer. The pair alleged that Centura’s policy prohibiting doctors from prescribing aid-in-dying drugs is broader than state law allows.

Colorado’s End of Life Options Act, approved by 65% of voters in 2016, allows hospitals and health systems to opt out of offering aid-in-dying drugs for use on their premises.

In addition, another Colorado law says health care facilities may not “limit or otherwise exercise control” over a physician’s medical judgment.

The suit asks a judge to rule that the hospital system may not bar Morris from prescribing the lethal drugs — or penalize her if she does.

Centura officials expressed sadness over Mahoney’s illness but said the institution promotes “the sacredness of every human life.”

After he received his grim diagnosis, Mahoney asked an oncologist and a social worker at his cancer center to help him access aid-in-dying. Both said no.

“I feel like I got slapped in the face,” Mahoney said.

Mahoney was advised to transfer his care to a secular provider, but he said he didn’t want to undergo additional tests, costs and travel as he struggled with debilitating symptoms.

Morris said she understood that Centura was religiously affiliated when she was hired but didn’t anticipate a problem.

“I didn’t think it was going to affect my general family practice,” she said. “Until these conversations about medical aid-in-dying, I hadn’t felt any interference.”

Once the law passed, however, a growing number of patients asked about the option.

“I’ve had patients as they face devastating illness or the end of life where they say, ‘Will you do this for me?’” she said, adding later: “At a certain point, we have to stand up for what’s right.”

Morris is considering her next steps, including separate legal action against Centura over her termination. Mahoney, who is scheduled for his third round of chemotherapy soon, said he’s not sure what to do in the wake of the firing.

Raised Catholic, he said, he rejected that theology long ago.

“I don’t believe in church. I don’t believe in religion,” he said. “I just think they’re getting way too much power.”

HHS Secretary Azar Declares Public Health Emergency for State of Florida Due to Hurricane Dorian

HHS Gov News - August 30, 2019

Health and Human Services Secretary Alex Azar today declared a public health emergency for the state in preparation for Hurricane Dorian and following President Trump’s emergency declaration for the state of Florida. The declaration gives the HHS Centers for Medicare & Medicaid Services (CMS) beneficiaries and their healthcare providers and suppliers greater flexibility in meeting emergency health needs in disasters.

“Hurricane Dorian has grown to be an extremely dangerous storm, posing a significant threat to health and safety,” Secretary Azar said. “This declaration will help ensure that Floridians who rely on Medicare and Medicaid have continuous access to the care they need in the days after this storm makes landfall.”

In declaring the public health emergency and authorizing flexibilities for CMS beneficiaries, Secretary Azar acted within his authority under the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to August 28, 2019.

HHS also staged personnel from the National Disaster Medical System and an Incident Management Team, along with caches of medical equipment, so these assets are available quickly to help health authorities and healthcare facilities respond to medical needs. HHS has additional personnel available from the National Disaster Medical System and the U.S. Public Health Commissioned Corps to assist, if needed.

To help meet the needs of vulnerable populations, the Office of the Assistant Secretary for Preparedness and Response and CMS are collaborating with the Florida Department of Health to provide data that the health department can use to assist Medicare beneficiaries who rely on electrically powered medical equipment, such as oxygen concentrators or wheelchairs, and home health services.

CMS also activated the Kidney Community Emergency Response Program to monitor dialysis access and needs of these facilities after the hurricane makes landfall. Through a CMS contract, this program provides technical assistance to End Stage Renal Disease Networks, kidney organizations, and other groups to ensure timely and efficient disaster preparedness, response and recovery for the kidney community.

To assist residents in the impacted area in coping with the stress of the disasters, the Substance Abuse and Mental Health Services Administration activated the Disaster Distress Helpline. The helpline provides immediate 24/7, 365-days-a-year crisis counseling and support to people experiencing emotional distress related to natural or human-caused disasters. This toll-free, multilingual, and confidential crisis support service is available to all residents in the United States and its territories. Stress, anxiety, and other depression-like symptoms are common reactions after a disaster. Residents in affected areas can call 1-800-985-5990 or text TalkWithUs to 66746 (for Spanish, press 2 or text Hablanos to 66746) to connect with a trained crisis counselor.

The Food and Drug and Administration’s current assessments have identified more than 12,000 FDA-regulated industries across all regulated product areas in Florida that may be impacted by this storm. FDA will continue to work with firms that produce critical medical products to help prevent any shortages resulting from the hurricane. Additionally, FDA recently updated its resources for food and animal food producers in Florida, as well as other states in the path of the storm.

HHS divisions will continue closely monitoring weather conditions arising from Hurricane Dorian and making detailed, practical information available to help the public protect themselves from threats before, during, and after the storm’s landfall. This information includes preventing carbon monoxide poisoning, unsafe food, water and medications, mold, and other health risks.

Guidance and other resources to assist in addressing such health hazards and risks are available from the Centers for Disease Control and Prevention (CDC) online and through CDC’s information service, CDC-INFO. Live agents provide up-to-date science-based health information. CDC-INFO can be reached Monday – Friday, 8:00 a.m. to 8:00 p.m. Eastern Time at 1-800-CDC-INFO (1-800-232-4636) or by submitting a web-based form. Services are available in English and Spanish.

Public health and safety information for Hurricane Dorian can be found on the HHS emergency website, https://www.phe.gov/dorian.

NOTE TO EDITORS: Public service announcements in multiple formats and languages are available for download for broadcast or website use and provide tips on protecting health and safety before, during and immediately after hurricanes.

HHS Secretary Azar Statement on Illnesses Associated with E-Cigarettes

HHS Gov News - August 30, 2019

As of August 27, 2019, health departments from 25 states have reported 215 possible cases of pulmonary illnesses from users of e-cigarette products, resulting in one death, and additional reports are under investigation. HHS Secretary Alex Azar issued the following statement:

“HHS and the Trump Administration are using every tool we have to get to the bottom of this deeply concerning outbreak of illnesses in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use. This situation, and the rising tide of youth tobacco use, is a top public health priority for the Trump Administration and every leader at HHS.”

Further Background from HHS

  • On Friday, CDC’s Health Alert Network sent out a bulletin with information gathered for the use of clinicians and Americans interested in following the issue.
  • No single substance or e-cigarette product has been consistently associated with these illness reports.
  • CDC and FDA are working closely with local health departments to investigate, including ongoing testing at FDA laboratories.
  • Clinicians should report any new cases as appropriate to their state or local health department.
  • The general public can report any unexpected issues with e-cigarettes to the FDA’s Safety Reporting Portal.
  • The CDC recommends that, while the investigation is ongoing, Americans who use e-cigarettes and are concerned about these specific, potential risks of illness should consider refraining from their use, and should not buy them off the street or modify them or add substances in ways not intended by the manufacturer.
  • In general, youth, young adults, and pregnant women should never be using e-cigarettes, and Americans who do not use tobacco products should not start using e-cigarettes.

Read the joint statement from CDC Director Robert Redfield and Acting FDA Commissioner Ned Sharpless: https://www.fda.gov/news-events/press-announcements/statement-federal-and-state-collaboration-investigate-respiratory-illnesses-reported-after-use-e.

Read CDC’s Health Alert Network bulletin: https://emergency.cdc.gov/han/han00421.asp.

Read CDC's information on Electronic Cigarrettes: https://www.cdc.gov/tobacco/basic_information/e-cigarettes

Secretary Azar Statement on Ebola Outbreak Reaching 3,000 Cases and 2,000 Deaths

HHS Gov News - August 30, 2019

This week, the Ebola outbreak that began in August 2018 in the Democratic Republic of the Congo (DRC) reached 3,000 cases and 2,000 deaths. HHS Secretary Alex Azar released the following statement:

“This week’s news is a tragic milestone in the course of a disease outbreak that has stolen far too many lives. The United States will continue its aggressive response to the outbreak, and has already led in providing access to the best available vaccines, therapeutics, diagnostics, and epidemiological expertise needed to stop the spread of Ebola and save lives. Security issues in the affected areas make this the most challenging Ebola outbreak in history, but the U.S. government and our local and international partners remain undeterred and will not rest until the outbreak is ended. Just recently, the Centers for Disease Control and Prevention doubled its number of experts on the ground in the DRC. Stopping this Ebola outbreak will remain a top global health priority for the Trump Administration. In close cooperation with the World Health Organization and Director-General Tedros, we look forward to continuing the work needed to end the outbreak.”

Background on HHS Work to End the Outbreak

The Centers for Disease Control and Prevention recently doubled the number of outbreak response experts in DRC and will have 30 responders on the ground by September 1 to work on case investigation, contact tracing, disease tracking, safe burials, community engagement and risk communication, laboratory testing, and border health. CDC staff have conducted more than 360 deployments in response to the outbreak.

CDC’s Emergency Operations Center continues to provide 24/7 technical assistance to the ministries of health of the DRC and its neighboring countries, in collaboration with international partners, to ensure the response is robust, well-coordinated, and focused on bringing the outbreak to an end.

On August 21, HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) announced that it would be providing an additional $23 million to Merck to produce doses of its investigational Ebola vaccine over the next year for use in the DRC and in other nations as warranted. This vaccine is currently being used in a ring vaccination strategy as part of the overall Ebola response strategy. ASPR’s Biomedical Advanced Research and Development Authority will continue to work with Merck on advanced development of the vaccine toward obtaining FDA licensure.

The recent commitment brings BARDA’s support for the Merck vaccine to approximately $176 million, on top of numerous pre-clinical and clinical research projects related to the vaccine’s development that received support from by the National Institutes of Health (NIH) and the Department of Defense.

On August 12, the NIH announced that two investigational treatments showed promise in a clinical trial taking place at Ebola treatment centers in the DRC, allowing the trial to be stopped early. Now all future patients in the trial will receive one of the two more promising investigational treatments: the monoclonal antibody mAb114, developed by NIH scientists, or REGN-EB3. The trial, which began in November 2018, has been co-sponsored and funded by the DRC government and NIH, and carried out by an international research consortium coordinated by the WHO.

They Got Estimates Before Surgery — And A Bill After That Was 50% More

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From a planning perspective, Wolfgang Balzer is the perfect health care consumer.

Balzer, an engineer, knew for several years he had a hernia that would need to be repaired, but it wasn’t an emergency, so he waited until the time was right.

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The opportunity came in 2018 after his wife, Farren, had given birth to their second child in February. The couple had met their deductible early in the year and figured that would minimize out-of-pocket payments for Wolfgang’s surgery.

Before scheduling it, he called the hospital, the surgeon and the anesthesiologist to get estimates for how much the procedure would cost.

“We tried our best to weigh out our plan and figure out what the numbers were,” Wolfgang said.

The hospital told him that the normal billed rate was $10,333.16 but that Cigna, his insurer, had negotiated a discount to $6,995.56, meaning his 20% patient share would be $1,399.11. The surgeon’s office quoted a normal rate of $1,675, but the Cigna discounted rate was just $469, meaning his copayment would be about $94. (Although the Balzers made four calls to the anesthesiologist’s office to get a quote, leaving voicemail, no one returned their calls.)

Estimates in hand, they budgeted for the money they would have to pay. Wolfgang proceeded with the surgery in November, and, medically, it went according to plan.

Then the bill came.

The bill for Wolfgang’s surgery turned out to be $2,304.51, $800 higher than he and his wife, Farren, had budgeted for, based on the estimates. “That’s a huge hit,” Farren says.(John Woike for KHN)

The Patient: Wolfgang Balzer, 40, an engineer in Wethersfield, Conn. Through his job, he is insured by Cigna.

Total Bill: The estimates the Balzers had painstakingly obtained were wildly off. The hospital’s bill was $16,314. After the insurer’s contracted discount was applied, the bill fell to $10,552, still 51% over the initial estimate. The contracted rate for the surgeon’s fee was $968, more than double the estimate. After Cigna’s payments, the Balzers were billed $2,304.51, much more than they’d budgeted for.

Service Provider: Hartford Hospital, operated by Hartford HealthCare

Medical Procedure: Bilateral inguinal hernia repair

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What Gives: “This is ending up costing us $800 more,” said Farren, 36. “For two working people with two children and full-time day care, that’s a huge hit.”

When the bill came on Christmas Eve, the Balzers called around, trying to figure out what went wrong with the initial estimate, only to get bounced from the hospital’s billing office to patient accounts and finally ending up speaking with the hospital’s “Integrity Department.”

They were told “a quote is only a quote and doesn’t take into consideration complications.” The Balzers pointed out there had been no complications in the outpatient procedure; Wolfgang went home the same day, a few hours after he woke up.

The couple appealed the bill. They called their insurer. They waited for collection notices to roll in.

Hospital estimates are often inaccurate and there is no legal obligation that they be correct, or even be issued in good faith. It’s not so in other industries. When you take out a mortgage, for instance, the lender’s estimate of origination charges has to be accurate by law; even closing fees — incurred many months later — cannot exceed the initial estimate by more than 10%. In construction or home remodeling, while estimates are not legal contracts, failure to live up to them can be a basis for liability or “a claim for negligent misrepresentation.”

In this case, Hartford Hospital produced an estimate for Balzer’s laparoscopic hernia repair, CPT (current procedural terminology) code 49650.

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The hospital ran the code through a computer program that produced an average of what others have paid. Cynthia Pugliese, Hartford HealthCare’s vice president of revenue cycle, said the hospital uses averages because more complicated cases may require additional supplies or services, which would add costs.

“Because it was new, perhaps the system doesn’t have enough cases to provide an accurate estimate,” Pugliese said. “We did not communicate effectively to him related to his estimate. It’s not our norm. We look at this experience and this event to learn from this.”

Efforts to make health care prices more transparent have not managed to bring down bills because the different charges and prices given are so often inscrutable or unreliable, said Dr. Ateev Mehrotra, an associate professor of health care policy and medicine at Harvard Medical School.

“The charges on there don’t make any sense. All it does is, people get pissed off,” Mehrotra said. “The charge has no link to reality, so it doesn’t matter.”

Resolution: “Because I roll over more easily than my wife does, I’m of the mindset to pay it and get done with it,” Wolfgang said. “My wife says absolutely not.”

Investigating prices, dealing with billing departments and following up with their insurer was draining for the Balzers.

“I’ve been tackling this since December,” Wolfgang said. “I’ve lost two or three days in terms of time.”

For the Balzers, there’s a happy ending. After a reporter made inquiries about the discrepancy between the estimate and the billed charges — six months after they got their first bill — Pugliese told them to forget it. Their bill would be an “administrative write-off,” they were told.

“They repeatedly apologized and ended up promising to adjust our bill to zero dollars,” Wolfgang wrote in an email.

Most patients aren’t as proactive as the Balzers in getting estimates for the cost of health care, and most wouldn’t know that the hospital, surgeon and anesthesiologist would each bill separately.(John Woike for KHN)

The Takeaway: It is a good idea to get an estimate in advance for health care if your condition is not an emergency. But it is important to know that an estimate can be way off — and your provider probably is not legally required to honor it.

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Try to request an estimate that is “all-in” — including the entire set of services associated with your procedure or admission. If it’s not all-inclusive, the hospital should make clear which services are not being counted.

Having an estimate means you can make an argument with your provider and insurer that you shouldn’t be charged more than you expected. It could work.

Laws requiring some degree of accuracy in medical estimates would help. In a number of other countries, patients are entitled to accurate estimates if they are paying out-of-pocket.

Most patients aren’t as proactive as the Balzers, and most wouldn’t know that the hospital, surgeon and anesthesiologist would each bill separately. And most wouldn’t fight a bill that they could afford to pay.

The Balzers say they wouldn’t have changed their medical decision, even if they’d been given the right estimate at the beginning. It’s the principle they fought for here: “There’s no other consumer industry where this would be tolerated,” Farren wrote in an email.

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!

Shopping At The Apotheke: Compare German Pharmacies With Your Corner Drugstore

HAMBURG, Germany — If you’re looking for bobby pins, cheap lipstick or a protein bar, well, sorry, Americans, the German pharmacy can’t help you.

It’s not the CVS, Rite Aid or Walgreens of home. Die Apotheke, as a pharmacy is known here, sells medications. German drugstores might have some high-end makeup (hypoallergenic, and for sensitive skin!), lotions or baby bottles. You’ll also definitely find magnesium supplements and vitamins.

But they aren’t convenience stores stocking hair dryers, cellphone chargers, toys or groceries. This is the place you go for health, and for medicine.

Germany’s health care system, with its negotiated low drug prices and robust universal insurance program, is hailed as a forward-looking model for the United States, which is hamstrung by ever-growing health care costs and leaves millions of people uninsured. Could we learn something from the pharmacies here, too?

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Carrying that question in mind, I wandered into three north Hamburg pharmacies, all within a five- to 15-minute walk of one another.

It turns out this is where the health landscape gets a little fuzzy. The pharmacies here offer a glimpse into how Germany’s drug pricing system, for the most part, keeps drugs relatively affordable for consumers. But while Apothekes present themselves as health-oriented hubs, they, like so much else in health care, are first and foremost businesses.

German pharmacies might sell some high-end makeup, lotions or baby bottles, but they aren’t stocked with the wide range of items found in American stores.(Shefali Luthra/KHN)

At Lillen Apotheke, in Hamburg’s upscale Eppendorf neighborhood, a pharmacist acknowledged that stores like hers sell skin lotion, high-end nail polish (allegedly better for your fingers) or pharmacy-exclusive mascara (also hypoallergenic) not primarily for health reasons but to make money.(Shefali Luthra/KHN)

Unlike in the United States, or even other European countries, German pharmacies must be owned by pharmacists. Most medications are prescription-based. And every purchase of medication — even something Americans consider “over-the-counter” like ibuprofen or cold medicine — requires a conversation with the pharmacist first, to make sure patients understand its effects.

Economists here aren’t sure the German way is better.

For starters, there’s no evidence that this specific requirement of a “talk” is somehow more efficient or leads to better health outcomes. While expert opinion is in some cases helpful, it can be superfluous, too. For instance, does someone with menstrual cramps or a muscle sprain need the pharmacist’s advice before getting ibuprofen?

“The benefits are meant to be safety,” said Tom Stargardt, a professor at the University of Hamburg who studies pharmaceutical economics. “The question is, ‘How much do you trust the consumer to be informed, to be able to judge the benefits of the drug?’”

Unlike in the United States or other European countries, German pharmacies must be owned by pharmacists. And every medication someone purchases at a German pharmacy requires a conversation with the pharmacist first, to make sure patients understand its effects.(Shefali Luthra/KHN)

Often, those conversations are quick and cursory. At La Vie Apotheke, on a crisp Friday morning, a pharmacy consultation for aspirin took about half a minute.

German pharmacists have a strict monopoly on dispensing medicine, and that undermines the potential for price competition, economists said.

Also, drugs here have a set price. A government-backed panel defines what public insurance plans will pay. Then, wholesalers can add a markup, defined by statute. Pharmacists can add one more, also legally prescribed. That’s it.

It’s a window into the ethos of the national health care system. “Every prescription drug costs the same in every pharmacy,” Stargardt said. “The reason is that every person should have the same access. Whether they live in a rural area [or a city], they shouldn’t be punished in terms of prices.”

Drugs here already cost less than in the United States. For instance, Humalog, a brand of insulin, lists a $55 price per vial, compared with an average of hundreds of dollars back home.

And German patients typically don’t even see that expense. If a doctor prescribed the drug, insurance typically must cover it, meaning patients pay virtually nothing. (When a cheaper generic is available here, pharmacists are legally required to provide that version, unless the physician explicitly says otherwise.) For insured Germans with chronic illnesses, the state caps health cost sharing at 2% of their household income.

The lozenges for sale at Lillen Apotheke in Hamburg’s upscale Eppendorf neighborhood are sandwiched between licorice candies and fruit gummies.(Shefali Luthra/KHN)

There are exceptions. One that’s in striking contrast to American health policy: Insurers aren’t required to cover birth control pills for women older than 22. Pharmacists said that expense can run up to 60 euros per month — about $67 U.S. dollars — depending on the brand a woman gets. Under the Affordable Care Act, American insurance plans must cover contraception as a form of preventive medicine, with no cost sharing.

And, pharmacists and economists alike will acknowledge, even with the health halo effect German pharmacies enjoy, die Apotheke and the Walgreens have a common motivation.

At Lillen Apotheke, in Hamburg’s upscale Eppendorf neighborhood, a pharmacist acknowledged that stores like hers sell skin lotion, high-end nail polish (allegedly better for your fingers) or pharmacy-exclusive mascara (also hypoallergenic) not primarily for health reasons — but rather, to drive profits.

Take the lozenges for sale. They’re sandwiched between licorice candies (of which sugar is the first ingredient) and fruit gummies made specially for pharmacies, which claim to have natural vitamins, too. And, of course, these are positioned next to the chocolate.

What’s the health value there?

“Oh. That’s just for fun,” the pharmacist said.

Shefali Luthra is currently reporting from Germany as a 2019 Arthur F. Burns Fellow. The fellowship is an exchange program for German, American and Canadian journalists operated by the International Center for Journalists and the Internationale Journalisten-Programme.

‘Locally Grown’ Insurance Companies Help Fortify Washington State Market

Kaiser Health News:Insurance - August 30, 2019

SEATTLE — Although few states have finalized their 2020 health insurance rates yet, preliminary reports suggest that increases in premiums for plans sold on the Affordable Care Act’s marketplaces will be moderate again this year.

One analysis of those early state filings, which noted some states appear poised to have lower premiums next year, found that Washington had a lower rate increase than almost half the other states.

Insurance premiums for Washington’s individual market are rising less than 1% on average next year, and the state’s insurance commissioner, Mike Kreidler, credits much of that moderation to homegrown insurance companies.

“We’ve had locally grown insurers that dominated the health insurance market for individuals,” Kreidler said. These insurers are tied to the local community and must succeed in Washington or in the Pacific Northwest region to stay in business. That motivates them to try harder to meet the needs of their customers, he said.

“Insurers that are local and tied to the community — not from out of state, coming in and out — they were ones that need to stay or they weren’t going to be in business,” Kreidler said.

Nearly 250,000 people who do not get coverage through their employers or the government buy health insurance in Washington’s individual market, most of them shopping on the state’s ACA exchange, the Washington Healthplanfinder.

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The individual insurance market here features companies that do business only in the Pacific Northwest, such as Asuris Northwest Health and Premera Blue Cross. Both nonprofits have been selling health insurance in the region for many years. Premera and its subsidiary LifeWise Health Plan have taken about 13% of the total health insurance market in Washington, selling to companies and individuals, both inside and outside of the Obamacare marketplace.

“Local plans can really make a difference in stabilizing their state-based marketplace,” said Emily Curran, a research fellow at the Center on Health Insurance Reforms at the Georgetown University Health Policy Institute in Washington, D.C. They help fill in geographical market gaps and build better partnerships with local doctors and hospitals, and are more effective at reaching underserved populations.

One key to their success, she said, is their commitment to a local market. They can succeed only if they make the business work locally.

“They have an incentive to make sure the market is stable,” she said.

Premera, based in Mountlake Terrace, a Seattle suburb, has been selling insurance in Washington for more than 80 years and is now an independent licensee of the Blue Cross Blue Shield Association. It sells plans in 38 of the state’s 39 counties and also operates in Alaska.

Asuris has been in the Washington market since 1933 and became part of Portland, Ore.-based Cambia in 1994. Asuris, which is too small to make the top 10 list of insurers in the state, sells health insurance outside the ACA marketplace. Its products are available in eastern Washington and Oregon as well as northern Idaho.

But the two largest companies in Washington’s health insurance market are based elsewhere: Kaiser Foundation Health Plan has seized 19% of the market and UnitedHealth Group controls 14%. Washington’s Healthplanfinder has shrunk slightly since 2014, from eight companies to six in 2019, but two new outside companies plan to join the market in 2020. (Kaiser Health News has no ties to Kaiser Permanente or the Kaiser Foundation Health Plan.)

Homegrown insurance companies aren’t as prominent in other states, where national companies dominate most markets. But Curran said New York is another example of a state with a base of local insurers.

Companies with a bigger footprint can afford more customer churn in their business. The smaller guys need to hang on to its customers, so they offer a wide variety of insurance options, in gold, silver and bronze tiers, both inside and outside of the state marketplace.

But buying from a local plan sometimes has disadvantages. Some companies’ plans limit consumers’ ability to get full health coverage in other parts of the nation. While local companies are more likely to have agents and brokers who know their customers and their plan offerings, they also have smaller teams than the big national companies and may not be available on weekends and at night, so they cannot respond as quickly to customers’ requests.

While Asuris has considered expanding — to the Seattle market, for example — Brady Cass, its president, said that just doesn’t make business sense. “Health insurance is personal and it’s very local,” he said, adding that companies that find their niche, as Asuris has, can more easily weather marketplace storms.

Asuris also markets itself to local companies. Cass, who is a Washington native and has worked for Asuris for 14 years, mentioned examples such as a concierge program Asuris started for both employers and individuals that is designed to help immigrants from Latin America. His company also sent crisis counselors to a workplace where an employee had died on the job.

Barry Baker, CEO of Baker Construction & Development in Spokane, Wash., said Asuris helped his company find economical options for both the company and its employees.

Baker also likes that Cass is involved in his community; they have served on several nonprofit boards together. “He’s super community-minded,” Baker said. They share business values, making a profit but also putting their profit back to work right where it was earned, he said.

Said Cass: “We’ve kept our feet squarely in the market that we have built.”

Surgeon General Releases Advisory on Marijuana’s Damaging Effects on the Developing Brain

HHS Gov News - August 29, 2019

Today, Surgeon General Vice Adm. Jerome M. Adams, issued an advisory emphasizing the importance of protecting youth and pregnant women from the health risks of marijuana use.

Marijuana, or cannabis, is the most commonly used illicit drug in the United States. Delta-9-tetrahydrocannabinol (THC), a component of marijuana, binds to receptors in the brain, producing euphoria and a variety of potentially harmful effects, including intoxication and memory and motor impairments. Newer strains of marijuana have also shown to be increasingly more potent, leading to other risks like anxiety, agitation, paranoia and psychosis.

“Marijuana is a dangerous drug, especially for young people and pregnant women,” said HHS Secretary Alex Azar. “This historic Surgeon General’s advisory is focused on the risks marijuana poses for these populations, which have been well-established by scientific evidence. As indicated by President Trump’s generous donation of his salary to support this advisory, the Trump Administration is committed to fighting substance abuse of all kinds, and that means continuing research, education, and prevention efforts around the risks of marijuana use.”

Pregnant women use marijuana more than any other illicit drugs. It is also commonly used by adolescents. The Substance Abuse and Mental Health Services Administration’s recently released 2018 National Survey on Drug Use and Health (NSDUH) data showed that marijuana continues to be the most widely used illicit drug and that further, frequent marijuana use, in both youths (12-17 years old) and young adults, appears to be associated with risks for opioid use, heavy alcohol use and major depressive episodes. In 2017 alone, approximately 9.2 million youth aged 12 to 25 reported using marijuana in the past month and 29% more young adults aged 18 to 25 started using the substance.

“There is a false perception that marijuana is not as harmful as other drugs. I want to be very clear – no amount of marijuana use during pregnancy or adolescence is known to be safe,” said Surgeon General Adams.

Compounding concerns regarding marijuana use and the developing brain is the surge in products with a higher THC concentration, and their accessibility. The risks of physical dependence, addiction, and other negative consequences increase with exposure to high concentrations of THC, daily use, and the younger the age of initiation.

As the advisory notes, it is “… intended to raise awareness of the known and potential harms to developing brains, posed by the increasing availability of highly potent marijuana in multiple, concentrated forms. These harms are costly to individuals and to our society, impacting mental and physical health and educational achievement and raising the risks of addiction and misuse of other substances.”

Read the U.S. Surgeon General’s Advisory: Marijuana Use and the Developing Brain.

HHS Secretary Azar Declares Public Health Emergency for Puerto Rico Due to Hurricane Dorian

HHS Gov News - August 29, 2019

Following President Trump’s emergency declaration for Puerto Rico, Health and Human Services Secretary Alex Azar today declared a public health emergency in the territory as Hurricane Dorian makes landfall. The declaration gives the HHS Centers for Medicare & Medicaid Services (CMS) beneficiaries and their healthcare providers and suppliers greater flexibility in meeting emergency health needs.

“While we continue to diligently work with officials in Puerto Rico to strengthen the healthcare system, we recognize that even the best prepared healthcare systems in the U.S. may need assistance when storms like Dorian threaten health and safety,” Secretary Azar said. “The actions we are taking today help ensure that our fellow citizens in the territory who rely on Medicare and Medicaid have continuous access to the care they need.”

In declaring the public health emergency and authorizing flexibilities for CMS beneficiaries, Secretary Azar acted within his authority under the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to August 26, 2019.

HHS also staged personnel from the National Disaster Medical System and an Incident Management Team, along with caches of medical equipment, in Puerto Rico so these assets are available quickly to help authorities in Puerto Rico and U.S. Virgin Islands respond to medical needs, including the needs of vulnerable populations. HHS has additional personnel available from the National Disaster Medical System and the U.S. Public Health Commissioned Corps to assist, if needed, in either territory or along the east coast of the continental United States.

CMS also activated the Kidney Community Emergency Response Program to monitor dialysis access and needs of these facilities after the hurricane makes landfall. Through a CMS contract, this program provides technical assistance to End Stage Renal Disease Networks, kidney organizations, and other groups to ensure timely and efficient disaster preparedness, response and recovery for the kidney community.

To assist residents in the impacted area in coping with the stress of the disasters, the Substance Abuse and Mental Health Services Administration activated the Disaster Distress Helpline. The helpline provides immediate 24/7, 365-days-a-year crisis counseling and support to people experiencing emotional distress related to natural or human-caused disasters.

This toll-free, multilingual, and confidential crisis support service is available to all residents in the United States and its territories. Stress, anxiety, and other depression-like symptoms are common reactions after a disaster. Residents in affected areas can call 1-800-985-5990 or text TalkWithUs to 66746 (for Spanish, press 2 or text Hablanos to 66746; from Puerto Rico, text Hablanos to 1-787-339-2663) to connect with a trained crisis counselor.

HHS divisions will continue closely monitoring weather conditions arising from Hurricane Dorian and making detailed, practical information available to help the public protect themselves from threats before, during, and after the storm’s landfall. This information includes preventing carbon monoxide poisoning, unsafe food, water and medications, mold, and other health risks.

Guidance and other resources to assist in addressing such health hazards and risks are available from the Centers for Disease Control and Prevention (CDC) online and through CDC’s information service, CDC-INFO. Live agents provide up-to-date science-based health information. CDC-INFO can be reached Monday – Friday, 8:00 a.m. to 8:00 p.m. Eastern Time at 1-800-CDC-INFO (1-800-232-4636) or by submitting a web-based form. Services are available in English and Spanish.

Public health and safety information for Hurricane Dorian can be found on the HHS emergency website, https://www.phe.gov/dorian.

NOTE TO EDITORS: Public service announcements in multiple formats and languages are available for download for broadcast or website use and provide tips on protecting health and safety before, during and immediately after hurricanes.

In India’s Slums, ‘Painkillers Are Part Of The Daily Routine’

A man stands outside Dr. Sunil Sagar’s clinic, which caters to residents of Bhagwanpur Khera.(Saumya Khandelwal/The Guardian)

This story is the second in a two-part series. Read part one here: “In India’s Slums, Painkillers Part Of Daily Routine.”

This story also ran on The Guardian. This story can be republished for free (details). NEW DELHI — In the crowded waiting room of Dr. Sunil Sagar’s clinic, in the working-class neighborhood of Bhagwanpur Khera, a toddler breathes from a nebulizer. Fever is widespread, and the air quality in Delhi has reached “severe-plus emergency.” The patients sit, motionless, but there is somehow tremendous noise. The clinic is a squat cement building draped in wires, a red cross on the door. Sagar sits behind a desk in a small, open room, as a squad of assistants escort patients to him. He seems utterly unflappable.

A father with a troubled look sits down next to the doctor, holding a baby. Sagar listens to the baby’s chest with a stethoscope, pulls out scrap paper and writes a prescription. The father hands over a few rupees, and Sagar places the bills into a money drawer under his desk. The entire exchange takes perhaps two minutes.

More From This Series

Beset By Lawsuits And Criticism In U.S., Opioid Makers Eye New Market In India

Read Part One

Medicine in India is transactional. A well-liked doctor hands over a prescription at the end of every visit. Why else have I paid cash to see the doctor, if not for relief? The precariousness of daily life leaves little room for downtime.

As the Indian government reluctantly loosens its prescription opioid laws after decades of lobbying by palliative care advocates desperate to ease their patients’ acute pain, the nation’s sprawling, cash-fed health care system is ripe for misuse. The sheer size of India’s system — tens of millions of doctors and pharmacies spread across the subcontinent — makes oversight difficult but presents a tantalizing opportunity for India’s burgeoning pain industry and multinational pharmaceutical companies seeking new markets.

A popular spot to purchase these bulk drugs is the Bhagirath Palace in the Chandni Chowk market, one of India’s largest wholesale markets that dates to the 17th century. It is a dense maze where men — and it almost entirely men — press their bodies into a current of commercial ecstasy, frequently thrown off course by honking auto rickshaw drivers. One after the next, stalls of drug distributors advertise on brightly painted signs “all types of medicines,” “life-saving anti-cancer drugs,” “deal in Glaxo … Johnson & Johnson.” Inside the stalls, boxes of medicine are stacked from floor to ceiling.

Dr. Sunil Sagar checks medicines after he examines a patient at his clinic. (Saumya Khandelwal/The Guardian)

An outside view from Dr. Sunil Sagar’s clinic.(Saumya Khandelwal/The Guardian)

One drug wholesaler in the market said the government has been cracking down lately on certain medicines. Recently, he had received a list of 328 drugs that he was not supposed to stock, including Sulpitac, an antipsychotic medication used to treat schizophrenia. The wholesaler said people had been taking it like “dal and rice” for headaches.

Like its rigid caste system, India’s pain industry is stratified. The well-to-do visit well-appointed pain clinics, the working class turn to their neighborhood doctors, and the lower castes, especially those living in India’s vast slums, scramble for relief at roadside pharmacies, called chemists.

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In the Mankhurd slum in Mumbai, where the average life expectancy is 39, toddlers wander bare-bottomed, defecating in the street. Children scratch at infections on their legs. Without any municipal water, hawkers sell plastic sandwich bags filled with dirty water for 2 rupees. In this place, pain remedies are readily available.

At Shiv Medical & General Stores, an older boy tending the stall wrote out a receipt for Ultracet, branded tramadol tablets — an opioid analgesic — made by a Johnson & Johnson subsidiary. “Doctor’s name?” he asked. Our guide, Mayur Helia, a community organizer, made one up. “Shagmu,” Helia said, giggling, and the shopkeeper wrote it down.

Helia and his colleagues are activists agitating for drinking water and sanitation in the Mumbai-area slums. “Painkillers are part of the daily routine,” said social worker Alfiya Mulla. “They have become more normalized.”

“You go to the chemist,” Helia added, “and you say, ‘I have this pain,’ and he will give you painkillers without any prescription.”

Daily life here is a pageant of hustle. For women in the slums, Mulla said, that means lugging 35-liter buckets of water. “You have to take that from half a kilometer away, and that’s why women have to take that” — she motioned to the box of Ultracet — “because they are hurting their backs.”

She turned the box over in her hands. “Women are more affected and are more addicted to this tablet.”

Shopkeepers work inside a pharmacy shop at the Bhagirath Palace pharmaceuticals market in Old Delhi.(Saumya Khandelwal/The Guardian)

Beautiful Laws, Lax Enforcement

As India flirts with liberalizing access to painkillers, government surveys show addiction to prescription opioids is on the rise. The northern state of Punjab, where heroin addiction is endemic, recently opened more than 160 outpatient opioid-assisted treatment clinics where addicts can receive substitute opioids like buprenorphine while they fight withdrawal.

But buprenorphine is also widely prescribed to treat chronic pain and has become a problem in its own right. Dr. Debasish Basu, a psychiatrist and professor at the Postgraduate Institute of Medical Education and Research in Chandigarh, one of India’s top medical institutes, said “the main prescription medicine that we’re seeing [people becoming addicted to] is buprenorphine.”

“The source for buprenorphine is a licit source; they are made in drug-manufacturing factories,” he said, but then “the diversion takes place.”

Basu echoed health experts across the country in saying the central government tightly regulates the production of narcotic painkillers, but there is little faith in its ability to control distribution. “The legal system is so lax, the monitoring system is so lax,” Basu lamented. “The laws are all there. Oh, there are beautiful laws. But the implementation is so lax that once something comes over here, it’s very difficult. It’s like a bonfire.”

A patient enters Dr. Sunil Sagar’s office at his clinic.(Saumya Khandelwal/The Guardian)

If there is a precursor to an American-style opioid epidemic in India, it is tramadol, a painkiller that became available here in the early 1990s. Drugmakers — often citing studies they had funded — touted tramadol as less addictive than other painkillers.

“Tramadol information would come to every single clinician,” said Dr. Bobby John, a Delhi-based health expert. “Why? Because there is some drug salesperson sitting outside your door saying, ‘Hey, there’s a new drug. It’s non-addictive.’ Standard playbook.”

Tramadol flourished in India. Unlike morphine, fentanyl and other painkillers, the government initially placed few restrictions on its sale. But in 2018, after reports of abuse in the state of Punjab and reports of illicit Indian tramadol being sold to Boko Haram militants in Nigeria and elsewhere in Africa, Indian regulators enacted stricter controls.

If you cannot see the direct influence of American pharmaceutical companies in India, you can detect their shadow. In October 2018, just months after the Indian government clamped down on tramadol, a group of pain specialists from seven Southeast Asian countries, including three from influential hospitals in India, published a paper in the Journal of Pain Research.

Loose pills at Dr. Sagar’s clinic dispensary.(Saumya Khandelwal/The Guardian)

“Tramadol: A Valuable Treatment for Pain in Southeast Asian Countries” made the case that “the weak opioid tramadol has become the analgesic most frequently used in the region to treat moderate to severe pain.” The paper concluded: “If it were to become a controlled substance, the standard of pain management in the region would decline.”

The paper was funded by Grünenthal GmbH of Germany, a company that signed a deal in May 2018 to allow Mundipharma to market and distribute its tramadol product, Tramal, in China. Authors included pain specialists who have received consulting and lecturing fees from Pfizer, Johnson & Johnson and Mundipharma, a network of companies controlled by the Sackler family, owners of Connecticut-based Purdue Pharma.

Dr. Pooja Garg runs an opioid-assisted addiction recovery clinic on the outskirts of Chandigarh, one of five in the area. Addicts in the area favor heroin, she said, but when they cannot find or afford heroin, “they take whatever they can get over the counter from chemists.” That tends to be tramadol, which, despite the new restrictions, remains widely available.

The bustling waiting room led into a peaceful inner courtyard where, on a weekday morning last November, dozens of young men, in their late teens and 20s, had come for inpatient treatment. In one bedroom, several men sat cross-legged on a pair of metal cots. The young men said they took tramadol or buprenorphine, whatever they could get. “It depends on the availability at that particular moment,” one said. They all agreed tramadol was easy to buy from local chemists.

India sits between the two largest illicit opium-growing regions, the Golden Crescent of Afghanistan, Iran and Pakistan, and the Golden Triangle of Laos, Myanmar and Thailand; and India itself is one of the largest producers of legal opium. Much of the heroin passes through Punjab, a state of 28 million in northwestern India that has struggled with opioid addiction.

That history of heroin addiction makes those in Punjab and other nearby states especially vulnerable to synthetic opioids, said Dr. Anshu Garg, an addiction counselor in Mohali. Heroin “is freely available in the villages,” he said. “People try it without knowing the consequences. They try it once or twice, they get addicted to it.”

A pharmacy shop in Bhagwanpur Khera, New Delhi.(Saumya Khandelwal/The Guardian)

Sharing The Spoils

Vijay Bhatia can attest to how the business acumen propelling India toward economic prosperity has been brazenly co-opted by eager pharmaceutical companies.

Bhatia worked in pharmaceutical sales for two decades for a handful of companies, including GlaxoSmithKline and Ranbaxy Laboratories, an Indian generics maker owned by Sun Pharma. He now works in Chandigarh, where he oversees sales for Atulaya Healthcare, a chain of diagnostic imaging centers. Bhatia was among several current or former pharma representatives interviewed who described how multinational drugmakers deploy sophisticated methods in India for getting their products prescribed.

Drugmakers routinely give sales representatives extra money to offer doctors cash or gifts — iPads, cars, trips to conferences — to prescribe the drug they’re selling, Bhatia said. He described how sales reps give influential doctors free products to test with patients and how some doctors, in turn, deliver lectures at all-expenses-paid symposia, often presenting research papers sponsored by the drug companies.

The multinational companies “have access to all these top opinion leaders,” Bhatia said. They will sponsor doctors to live “abroad for studies being done there. It is circumventing the entire marketing process. It’s another way of taking the doctor into the loop.”

“Suppose a product costs $100. To the company, it is costing $20. Now they have $80 to play with,” Bhatia explained. “So they’ll keep a safe margin, say, ‘OK, fine, this much money you can keep for ongoing practices or for sponsoring the doctor or, right or wrong, bribing the doctor.’”

Engendering loyalty with chemists is a top priority. To make his sales targets, Bhatia said, he would offer financial incentives to chemists who would “substitute [a product] with my product. In India, the chemist becomes king.”

Multinational pharmaceutical companies maintain they are ethical purveyors of their products. “Opioid pain medications play an essential role in the management of severe pain and it’s important they be recognized by health authorities as important therapeutic options, especially in cancer pain,” Manmohan Singh, a vice president at Modi-Mundipharma in New Delhi, said in a written statement. But, he said, “they need to be appropriately prescribed, monitored and reviewed to minimize the risks of misuse and abuse.”

In all sales promotions, Singh said, his company stresses that patients should be carefully selected, prescribed the lowest effective dosage, and made aware of both the treatment goals and potential side effects. “The exact prevalence of addiction with opioids is difficult to determine,” he said. “Signs of addictive behavior should be monitored and addressed.”

A woman looks out from a balcony of a house near Sagar’s clinic, which caters to residents of Bhagwanpur Khera.(Saumya Khandelwal/The Guardian)

In Thiruvananthapuram, in the southern state of Kerala, Dr. M.R. Rajagopal knows all too well that a powerful drug company, a greedy pharmaceutical salesman, an unscrupulous pain doctor, a reckless morphine addict or any whiff of scandal somewhere on the subcontinent could sink his life’s work. Widely viewed as the father of palliative care here, he is frankly tired of “opiophobia,” the “prejudice and misinformation” that the medical use of opioids will lead to addiction and crime. He is tired of reassuring Indian bureaucrats they are not ushering in a U.S.-style opioid epidemic. He has no time for doomsday scenarios; there are too many Indians in agony.

“This is a rather horrible country to die in,” Rajagopal told a roomful of doctors and medical students last fall at Sree Gokulam Medical College, on the outskirts of Thiruvananthapuram. He stood unassumingly at the front of a hospital conference room darkened by thick red drapes. Even with a microphone, his voice was gentle. “If a patient cries in pain for two weeks” at the end of his life, Rajagopal said, “it is hard to remember any good times.” When they are dying, he urged the crowd, “Give morphine.”

Despite the blossoming pain industry, Rajagopal estimates no more than 2% of Indians have access to palliative care. In his testimony for a three-year study of untreated pain published by the Lancet medical journal in 2018, he recounted the story of “Mr. S,” who came to a palliative care clinic in Calicut, Kerala, with crippling pain from lung cancer. He put the man on morphine, and a few hours later, Mr. S “surveyed himself with disbelief. He had neither hoped nor conceived of the possibility that this kind of relief was possible.”

When Mr. S returned the following month, the clinic had run out of morphine. The patient “told us with outward calm, ‘I shall come again next Wednesday. I will bring a piece of rope with me. If the tablets are still not here, I am going to hang myself from that tree.’

“He pointed to the window. I believed he meant what he said.”

Read part one of this two-part series: “Beset By Lawsuits And Criticism In U.S., Opioid Makers Eye New Market In India

OCR Issues Notice of Violation to the University of Vermont Medical Center After It Unlawfully Forced a Nurse to Assist in Abortion

HHS Gov News - August 28, 2019

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) is announcing that, after a thorough investigation and prolonged attempts to resolve the matter, OCR has issued a Notice of Violation letter finding that the University of Vermont Medical Center (UVMMC) violated the Church Amendments (42 U.S.C. 300a-7) by forcing a nurse to assist in an elective abortion procedure over the nurse’s conscience-based objections. OCR also found that UVMMC has discriminatory policies that assign or require employees to assist abortion procedures even after they have recorded their religious or moral objections to assisting in the performance of such abortions. OCR’s Notice of Violation letter asks UVMMC to conform its policies to the Church Amendments and take other corrective action, or face potential action by the HHS component from which UVMMC has received federal funding.

On May 9, 2018, a nurse at UVMMC filed a conscience and religious discrimination complaint with OCR against UVMMC, a medical center in Burlington, Vermont that receives HHS funds, contending that the nurse was forced to assist an abortion in violation of the nurse’s conscience rights. As part of its investigation, OCR contacted UVMMC repeatedly in a good faith effort to seek cooperation from UVMMC, but the hospital refused to conform its policies to federal conscience laws, provide all the documents requested by OCR, or produce witnesses for OCR interviews. Nevertheless, OCR interviewed multiple witnesses and gathered evidence concerning the allegations.

As a result of its investigation, OCR has specifically determined that:

  • UVMMC forced the nurse complainant to assist in an abortion against the nurse’s religious or moral objection. The nurse had expressed an objection for many years and was included in a list of objectors, but UVMMC knowingly assigned the nurse to an abortion procedure. The nurse was not told the procedure was an abortion until the nurse walked into the room, when the doctor—knowing the nurse objected to assisting in abortions—told the nurse, “Don’t hate me.” The nurse again objected, and other staff were present who could have taken the nurse’s place, but the nurse was required to assist with the abortion anyway. If the nurse had not done so, the nurse reasonably feared UVMMC would fire or report the nurse to licensing authorities.
  • OCR spoke with several other UVMMC health care personnel who, since at least the spring of 2017, have been intentionally, unnecessarily, and knowingly scheduled by UVMMC to assist with elective abortions against their religious or moral objections. Such personnel were often not told in advance that the procedures they were being assigned to assist with were abortions. Health care personnel who are coerced in that way suffer moral injury, are subjected to a crisis of conscience, and frequently experience significant emotional distress, even if they succeed in declining to assist in the procedure after the assignment is made.
  • UVMMC maintains a staffing policy that facially violates the Church Amendments because the policy admits to circumstances where UVMMC can and will force staff—on pain of adverse action or discipline—to participate in abortions against their moral or religious objections. The policy also violates UVMMC’s agreement, as a condition of receiving HHS funds, to comply with federal law, including the Church Amendments and HHS’s grants regulations.
  • Consequently, UVMMC is violating 42 U.S.C. § 300a-7(c)(1) of the Church Amendments by discriminating against health-care personnel who have religious or moral objections to abortion, and subjecting them to different terms or conditions of employment than other health-care personnel.

In the Notice of Violation, OCR asks that UVMMC notify OCR within thirty days whether UVMMC intends to work collaboratively with OCR to change its policies so it no longer requires health care personnel to participate in abortion against their religious or moral objections, and to take immediate steps to remedy the effect of its past discriminatory conduct. Otherwise, OCR indicates that it will forward the Notice to the Health Resources and Services Administration (HRSA), a component of HHS that provides grant funds to UVMMC, for consideration and possible additional procedures concerning UVMMC’s receipt of federal funds.  Since October 1998, UVMMC has received—and continues to receive—grants from HRSA.  For the most recently completed three-year project period, which ended April 30, 2018, UVMMC reported that it cumulatively expended $1.6 million of federal financial assistance.

Roger Severino, Director of OCR said, “Forcing medical staff to assist in the taking of human life inflicts a moral injury on them that is not only unnecessary and wrong, it violates longstanding federal law. Our investigation has uncovered serious discrimination by UVMMC against nurses and staff who cannot, in good conscience, assist in elective abortions.”  Severino concluded, “We stand ready to assist UVMMC in changing its policies and procedures to respect conscience rights and remedy the effects of its discrimination.” 

OCR is charged with helping ensure entities come into compliance with federal laws protecting conscience and prohibiting coercion in health care, including the Church Amendments.

#

Click to read the UVMMC Notice of Violation.*

To learn more about non-discrimination on the basis of sex, race, color, national origin, age and disability; conscience and religious freedom; and health information privacy laws, and to find information on filing a complaint, visit us at www.hhs.gov/ocr.

Follow OCR on Twitter at @HHSOCR.

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

Secretary Azar Attends Health Ministerial Meeting in Cucuta, Colombia on the Venezuelan Humanitarian and Refugee Crisis

HHS Gov News - August 28, 2019

Yesterday, August 26, Health and Human Services Secretary Alex Azar attended a ministerial meeting with fellow health ministers from the Americas region concerning the humanitarian crisis in Venezuela and its effects on public health in the hemisphere. During the morning, the health ministers visited many sites along the border that are assisting and providing care to Venezuelans who face significant health challenges from infectious diseases and non-communicable diseases that have gone untreated because the failed Maduro regime has destroyed the nation’s healthcare system.

First, Secretary Azar and the other health ministers, hosted by Colombian Minister of Health Juan Pablo

Uribe, visited the Erasmo Meoz University Hospital, the region’s largest hospital, which is under extreme strain due to the influx of Venezuelan refugees in need of emergency medical services. The hospital has seen a dramatic increase in births, primarily among young pregnant women.

Next they visited the Simon Bolivar International Bridge, where thousands of Venezuelans cross on a daily basis to the National Border Service Center (CENAF). At the center, humanitarian partners assist with family reunifications and attend to basic medical and child protection needs including vaccinations and mental health intervention. The ministers saw this heartbreaking crisis firsthand as Venezuelans begged for help as they crossed the bridge.

They then went to Comedor Divina Providencia, a communal kitchen run by the Dioceses of Cucuta, which provides over 13,000 meals a day to mostly Venezuelan refugees. It also offers showers and toilets, psychological support, and information on human rights and asylum seekers’ rights. Next, Secretary Azar and the health ministers visited the CATM Shelter which provides a transitory space for Venezuelan migrants arriving in Colombia, providing overnight accommodation and vital services.

In the afternoon, the health ministerial concluded with a formal meeting that helped underscore the solidarity among the Americas’ health ministers to address the current situation and the future need to rebuild Venezuela’s healthcare system. During the meeting, Secretary Azar stressed that addressing the humanitarian crisis created by the failed Maduro regime is one of the Trump administration’s top global health priorities. The United States has provided more than $256 million to partner nations to address the crisis, including more than $130 million to Colombia, in addition to technical assistance provided to a number of countries around the region. The USNS Comfort has been off the shore of Colombia to provide care on the ship and support on the shore, provided by a multinational team that includes members of the U.S. Public Health Service Commissioned Corps.

Secretary Azar urged the health ministers to look towards the future and work together to make plans for when the failed former Maduro regime is gone. The nations noted that they would work towards this goal at the next meeting in Panama where they will continue to discuss how to support the reestablishment of infrastructure, procure basic supplies and medication, and bring healthcare personnel home to Venezuela.

For more on Secretary Azar’s trip, please visit: https://www.hhs.gov/about/news/2019/08/25/secretary-azar-participates-closing-ceremony-usns-comfort.html

Secretary Azar Attends Health Ministerial Meeting in Cucuta, Colombia

Beset By Lawsuits And Criticism In U.S., Opioid Makers Eye New Market In India

Workers are packed into a pharmacy shop at the Bhagirath Palace pharmaceuticals market in Old Delhi, India.(Saumya Khandelwal/The Guardian)

This story is the first in a two-part series. Coming tomorrow: “In India’s Slums, Painkillers Part Of Daily Routine.”

This story also ran on The Guardian. This story can be republished for free (details). NEW DELHI — Pain, like death, is a universal phenomenon.

The sour grimace on the woman’s face, registering her bodily complaints to Dr. G.P. Dureja in his East Delhi office, would be recognized anywhere. Slouched shoulders, pinched forehead. She wore a willowy black kurta and cast a disapproving glance at the five pain physicians-in-training huddled behind Dureja, founder of Delhi Pain Management Centre and one of India’s pioneering pain physicians.

The five trainees, participants in the center’s acclaimed pain fellowship program, recorded the woman’s consultation on their smartphones, eager to see India’s famous pain doctor do his work. After their fellowships, they will return home, to Chennai, Kashmir, Rajasthan, ready to forge careers in India’s exploding pain industry.

The woman had been under Dureja’s care for some time now; he diagnosed her with fibromyalgia, a chronic neurological disorder of mysterious origin that causes pain throughout the body. But the regimen of Paracetamol and tramadol, an opioid analgesic, was not working and she was beyond fatigued. She wanted more relief.

Dr. G.P. Dureja, surrounded by medical trainees, consults with a patient in his office at Delhi Pain Management Centre, a chain of specialized medical centers dedicated to the minimally invasive treatment of chronic pain.(Saumya Khandelwal/The Guardian)

Indians once thought of pain relief as an indulgence of the West, Dureja said after the woman left his office gripping her new prescriptions. The old way of thinking was, “Nobody has time to complain about pain in our country. But I’m getting five to seven new patients per day.”

Storefront for-profit pain clinics like Delhi Pain Management Centre are opening by the score across Mumbai, Kolkata, Bangalore and other cities in this teeming nation. After decades of stringent narcotics laws, borne of debilitating opium epidemics of centuries past, India is a country ready to salve its pain.

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And American pharmaceutical companies — architects of the opioid crisis in the United States and avid hunters of new markets — stand at the ready to feed and fuel that demand.

For Indian cancer patients who once writhed in agony, there are fentanyl patches from a subsidiary of Johnson & Johnson.

For the country’s vast army of middle-class office workers wracked with back and neck pain, there is buprenorphine from Mundipharma, a network of companies controlled by the Sackler family, owners of Connecticut-based Purdue Pharma.

And for the hundreds of millions of aging Indians with aching joints and knees, there are shots of tramadol from Abbott Laboratories.

Behind the pharmacy counter at the Delhi Pain Management Centre.(Saumya Khandelwal/The Guardian)

A worker updates a register of medicines.(Saumya Khandelwal/The Guardian)

Palliative care advocates, who recount stories of patients enduring excruciating cancer pain or dying in agony, have persuaded reluctant government officials to allow high-powered opioid painkillers into doctors’ offices and onto chemists’ shelves in this nation of 1.37 billion people.

But what began as a populist movement to bring inexpensive, Indian-made morphine to the diseased and dying poor has given rise to a pain management industry that promises countless new customers to American pharmaceutical companies facing a government crackdown and mounting lawsuits back home.

The lure of a pain-free life is a revelation in a country where incomes are rising for many city dwellers and 300 million to 400 million people are approaching the middle class. Like other markers of the country’s post-colonial sprint into modernity, newly minted pain doctors promise aspiring Indians that life has more to offer in a body free from pain, and foreign brands are worth the extra rupees.

Dr. G.P. Dureja performs a short procedure on a patient at the Delhi Pain Management Centre.(Saumya Khandelwal/The Guardian)

“Don’t listen to your forefathers,” Dureja said, a mantra for the shifting mindset. “They said you should tolerate pain, you should not complain, you should not take painkillers. Now, everybody wants a better quality of life, and everybody wants to get rid of pain early.”

As major pharmaceutical companies look to capitalize on the opportunity, the playbook unfolding in India seems eerily familiar. Earnest advocates share heartbreaking stories of suffering patients; physicians and pharmaceutical companies champion pain relief for cancer patients and persuade regulators to grant greater access to ever more powerful opioids; well-meaning pain doctors open clinics; shady pain clinics follow; and a spigot of prescription opioids opens — first addressing legitimate medical uses but soon spilling into the streets and onto the black market.

A looming deluge of addictive painkillers terrifies some Indian medical professionals, who are keenly aware that despite government regulations most drugs are available for petty cash at the chemist shops that occupy nearly every city block and village center.

“Are people going to figure out every trick in the game to make [opioid painkillers] widely available?” asked Dr. Bobby John, a leading Indian public health expert based in New Delhi. “Of course it will happen.”

Shops advertise their drug supplies along a busy street in Old Delhi, India.(Saumya Khandelwal/The Guardian)

‘The Market For Pain Is Good’

The headquarters of the Pain Clinic of India operates out of a closet-size office in Chembur, a tree-lined suburb in eastern Mumbai. The company’s presence on the internet is so prominent that Dr. Kailash Kothari, the clinic’s founder, has turned down requests from people in South Africa, Australia, Europe and the United States seeking prescription opioids.

Down an alleyway, the clinic’s small white-red-and-blue sign is difficult to spot. Around the side of a faded-pink building is a larger sign showing a shirtless, muscular white man gripping his back, another gripping his neck, another clutching his knee; a white woman with an excruciating headache presses her forehead and another grabs her shoulder. Back Pain. Neck Pain. Headache. Knee Pain. Shoulder Pain. Cancer Pain. The sign promises “Towards Pain Free Life.”

One of the principal architects of pain medicine in India, Kothari runs several clinics in Mumbai, consults at numerous hospitals and flies to his clinic in Goa once a week. He co-founded the Indian Academy of Pain, an educational branch of the Indian Society for the Study of Pain that aims to create standardized training for pain medicine, in part by offering qualifying exams to prospective physicians. “This program is going to change the scenery of what we have in pain management,” Kothari said.

Asserting control over who can call themselves a “pain medicine doctor” in this fledgling industry is an urgent question. Spread across the subcontinent are nearly 10 million licensed physicians and a massive number of untrained medical providers. (In rural India, 70% of health care providers have no formal medical training.)

A man carries boxes of medicine through the Bhagirath Palace pharmaceuticals market in Old Delhi, India.(Saumya Khandelwal/The Guardian)

“General practitioners have started prescribing these drugs,” Dureja said. “And we’re not educating the population on when to use and not to use.”

At Dureja’s clinics, as at most medical offices in India, patients pay cash for services and prescriptions. Delhi Pain Management charges $10 for a consultation; $10 for a Johnson & Johnson fentanyl patch; $10 for a Mundipharma buprenorphine patch. Dureja’s office takes a 15% cut of sales.

There are hints of American pharma’s fingerprints in a glass cabinet in the waiting room of his East Delhi clinic: awards from Johnson & Johnson honoring Dureja for symposia on pain management; a plaque for “his valuable contribution as a speaker” about tapentadol, an opioid marketed by Johnson & Johnson in 2009. The dispensing counter does a brisk business in Ultracet, branded tramadol tablets made by a Johnson & Johnson subsidiary.

Dureja’s training fellowships, like Kothari’s, are broadly considered on the level; but many others are shady, and none are regulated.

Each year, some 20 fellows attend Kothari’s three- to six-month training programs, and by his calculation, he has trained 150 aspiring pain doctors. “There are more than 50 people who already have their pain clinics in different parts of India,” he said. Of those clinics, five or six “are training people, and it’s a chain reaction, which is going to benefit pain management as a specialty.”

Kothari remembers when only a few hospitals in Mumbai treated cancer patients and had access to opioids. “But every year, we are accessing more of these kinds of drugs,” he said. “Many chemists, hospitals and medical shops started acquiring the licenses for keeping these drugs, and availability is much, much better. Opioids are available in not just oral, but injectable, patches, syrups.”

Dr. G.P. Dureja in his office at the Delhi Pain Management Centre in New Delhi.(Saumya Khandelwal/The Guardian)

Storefront for-profit pain clinics like Delhi Pain Management Centre are opening by the score across Mumbai and other cities in India. After decades of restrictive narcotics laws, India is a country ready to salve its pain. (Sarah Varney/KHN)

Most large Indian hospitals have added pain management as a specialty in recent years. At the insistence of the professional societies that accredit hospitals in India, Kothari said, nurses and doctors now are required to assess pain as a fifth vital sign, along with pulse, temperature, breathing and blood pressure.

The pharmaceutical industry has kept pace. Twenty years ago, only a few pharmaceutical companies marketed pain medicines in India, Kothari said. “Today, almost every company is having pain management as a separate division. In the last five years alone, I must have met more than 15 or 20 companies that have started separate pain management divisions.”

A salesman for Sun Pharma, India’s largest drugmaker by sales, echoed the point during an interview in Chandigarh, the capital of Punjab and Haryana. The market for pain medications “has totally changed” in the past five years, he said. He shifted nervously and agreed to speak frankly only if his name wasn’t published, for fear of losing his job.

“Now everyone has a car, and [they get] back pain, and now they take medication.” Growing obesity rates in India were also fueling demand, he said, as patients look for relief from weight-related knee and back pain. “So the market for pain is good.”

Abbott Laboratories and Johnson & Johnson did not respond to requests for comment for this report.

Manmohan Singh, a vice president at Modi-Mundipharma in New Delhi, said opioid pain medications are an important therapeutic option, especially for cancer pain. He also said company promotions stress that physicians should familiarize themselves with product safety information. “Patients should be made aware of the clear treatment goals related to pain and function, as well as the potential opioid side effects and the potential for misuse, abuse and addiction,” he said in a written statement.

A man buys medicine from a pharmacy shop at the Bhagirath Palace pharmaceuticals market in Old Delhi.(Saumya Khandelwal/The Guardian)

One False Step

The ascendance of pain management in India comes at a fortuitous political moment. Ahead of his reelection earlier this year, Prime Minister Narendra Modi invested heavily in health care. Last fall, the Indian government launched the world’s biggest public health insurance program, called Ayushman Bharat. Dubbed “Modicare,” it guarantees half a billion poor Indians nearly $7,000 in hospital expenses, paid to private insurers, and, by 2020, the government is to open 150,000 primary care centers. The government has set aside $484 million to fund Modi’s signature program.

None of this would have been possible without the loosening of India’s strict narcotics laws.

The International Narcotics Control Board, established in 1968, and the Narcotic Drugs and Psychotropic Substances Act of 1985 codified the bureaucratic thicket for any doctor who wanted to prescribe opioid painkillers. Physicians feared fines, jail sentences and losing their medical license if they skirted regulations. While the government granted licenses to Indian farmers to grow poppies, most of the morphine produced from the crops was exported.

Dr. M.R. Rajagopal was a young medical student in Thiruvananthapuram at the time and remembers a neighbor with advanced cancer. “I [had] seen him screaming his way over weeks to death,” Rajagopal said. “It was horrendous, and there was nothing being done about it.” He chose to become an anesthesiologist because it was the only specialty then focused on pain.

Rajagopal is widely viewed as the father of palliative care in India; whispers of a Nobel Prize follow him. For decades, he has worked assiduously to convince national and state lawmakers that opioid medicines are not an indulgence but a humane refuge, and it is largely a function of his advocacy that morphine and other painkillers can be prescribed in India. “Two generations of doctors had not seen a tablet of morphine,” he said.

A pharmacy in New Delhi stocks painkillers.(Saumya Khandelwal/The Guardian)

The Narcotic Drugs and Psychotropic Substances Act, as amended in 2014, recognized that the need for pain relief was “an important obligation of the government.” The revised law created a class of medicines called the “essential narcotic drugs” list, which includes morphine, fentanyl, methadone, oxycodone, codeine and hydrocodone.

Rajagopal’s days are filled with the tedious work of building a movement: speaking at colleges and public forums, penning editorials and medical papers about palliative care and overseeing Pallium India, a nonprofit medical center and training institute that is singularly focused on palliative care.

Pallium’s pharmacy is a testament to Rajagopal’s persistence. Drugs once banned now fill the shelves: fentanyl injections and patches, oral morphine and, most recently, methadone, approved for pain relief in 2018.

Rajagopal seems aware that one false step would invite the government to clamp down on the availability of opioids, reversing decades of his work. He does not advise using oxycodone or hydrocodone, though they are included on the “essential narcotic drugs” list, and he does not accept funding from pharmaceutical companies, instead putting his hand out to temple trustees and for donations from families cared for by Pallium’s home visiting teams.

But the pharmaceutical industry is a wily adversary. American activists made many of the same arguments decades ago as they sought relief for dying patients. Drugs now commonly prescribed for chronic pain first were approved for use by cancer patients. One of the first formulations of fentanyl, for example, was a lollipop because chemotherapy left cancer patients too nauseated to eat. In India, pain physicians now prescribe fentanyl patches to patients with chronic muscular pain.

Purdue Pharma’s international affiliate, Mundipharma, “is very good at co-opting regulators,” said Keith Humphreys, a professor of psychiatry at Stanford University. “As happened in the U.S., they are easily converted into useful idiots.”

Coming tomorrow: “In India’s Slums, Painkillers Part Of Daily Routine.”

In Rural Utah, Preventing Suicide Means Meeting Gun Owners Where They Are

Kaiser Health News:States - August 28, 2019
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A gun show might not be the first place you would expect to talk about suicide prevention — especially in a place like rural northeastern Utah, where firearms are deeply embedded in the culture.

But one Friday at the Vernal Gun & Knife Show, four women stood behind a folding table for the Northeastern Counseling Center with precisely that in mind.

Amid a maze of tables displaying brightly varnished rifle stocks, shotguns and the occasional AR-15 assault-style rifle, they waited, ready to talk with show attendees.

“Lethal access to lethal means makes a difference,” said one of the women, Robin Hatch, a prevention coordinator with Northeastern Counseling for nearly 23 years.

Utah has one of the highest rates of suicide in the U.S. And from 2006 to 2015, 85% of firearm deaths in the state were suicides. According to Utah’s health department, suicide rates vary widely by location. For example, the suicide rate in this corner of Utah is 58% higher than the rest of the state.

Suicide by gun is a particular problem: The rate in rural areas is double that in urban areas, according to state officials. A major factor is the easy access to firearms in Utah — and the grim fact that suicide attempts involving guns have a higher mortality rate than by other means.

Northeastern Counseling Center prevention specialist Robin Hatch gave out gun socks screen-printed with the National Suicide Prevention Lifeline information at the Vernal Gun & Knife Show in Vernal, Utah.(Erik Neumann/KUER)

This was the first time Hatch and her colleagues at Northeastern Counseling did outreach at a gun show. As the auditorium filled with firearm sellers and hunters, the counselors stacked their folding tables with neat piles of free cable locks that thread into a gun to prevent rounds from being loaded, and water-resistant gun socks screen-printed with the National Suicide Prevention Lifeline number.

The idea behind distributing both devices is to slow a person down during a moment of crisis. “Anything that we can do to get people off track a little bit, thinking something different,” Hatch said. “We believe that will help make a difference in our suicide rates.”

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Unpredictable Employment Adds Stress

Northeastern Utah is home to oil and gas fields, cattle ranches and the Uintah and Ouray Indian reservation.

Health experts say factors contributing to the area’s high suicide rates include limited access to mental health services in rural communities and the unpredictability of the ranching and oil and gas industries. The boom-bust cycles, along with physical and mental stress, take a toll on workers.

“Injuries and accidents, keeping your job, having a job tomorrow — it’s so up and down,” said Val Middleton, a former oil and gas safety instructor at Uintah Basin Technical College in Vernal. “The guys don’t eat right, typically. No exercise, hard work, long hours, no sleep. That’s what adds up. The divorce rate is high, really high. The family life is low.”

Add high gun ownership and the risks rise.

Dee Cairoli is the pastor at Roosevelt Christian Assembly in a nearby town. He also works part time as an NRA concealed-carry handgun instructor. When hosting classes, Cairoli explains how gun owners can intervene if another gun owner shows signs of a mental health crisis.

“I’ve done it a couple of times as a pastor where I’ve gone to somebody’s house and said, ‘Look, maybe you need to listen to me for a minute. I know what I’m talking about. I promise I’ll keep it in my [gun] safe, but let me have your gun.'”

Cairoli speaks with authority. When he was 15, his father killed himself with a gun.

“It was very tragic, but I never hated the gun. I never blamed the gun. I knew that it was just his desperate moment and that he had just chosen that,” Cairoli said.

He believes that personal tragedy, along with the credibility he brings as a gun user and local pastor, allows people in crisis to trust him.

Gun socks with the National Suicide Prevention Lifeline information at the Vernal Gun & Knife Show in Vernal, Utah. Utah has one of the highest rates of suicide in the U.S.(Erik Neumann/KUER)

Not Just A Rural Issue

How to talk about suicide with guns isn’t just an issue in rural Utah. It’s a topic that state Rep. Steve Eliason of Sandy, a large Salt Lake City suburb, also tackles. The Republican has sponsored legislation focused on firearms, suicide prevention and mental health services. It is personal for him, too.

“I’ve lost three extended family members to suicide. All firearm suicides. Young men,” Eliason said.

This year, he worked on bills to fund firearm safety and suicide prevention programs, supply gun locks, create new mental health treatment programs and expand crisis response in rural Utah.

Eliason describes these issues as nonpartisan, but with Utah’s proud gun culture, he’s also careful with his approach. He describes advice he got from a politically liberal friend in public health about how to bring together opposing perspectives about firearms.

“Obviously, there’s kind of two schools of thought on firearms,” he said. “Those two schools of thought, if they were circles, they would overlap into a small oval — that oval is the culture of safety. And she says, ‘I would recommend that you dwell within that oval.’ That’s what I’ve tried to do.”

That perspective led the Utah legislature to appropriate money to fund a study by the Harvard T.H. Chan School of Public Health, in consultation with the Utah Shooting Sports Council.

That study spurred discussions about the problem of firearms and suicide and formed the basis of at least one of Eliason’s 2019 bills, to expand access to gun locks.

Like Eliason’s work at the state policy level, Hatch’s suicide prevention work in her community depends on relationships and trust.

Hatch’s table at the gun show was less busy than others. But the women gave out hundreds of gun locks and gun socks over the course of the day. And attendees said having them there was a fitting way to bring up the subject of suicide and firearms.

“You need to know your community, and you need to address it in a way that your community will accept it,” Hatch said.

If you or someone you know has talked about contemplating suicide, call the National Suicide Prevention Lifeline at 1-800-273-8255, or use the online Lifeline Crisis Chat, both available 24 hours a day, seven days a week.

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

Mysterious Vaping Lung Injuries May Have Flown Under Regulatory Radar

Kaiser Health News:States - August 27, 2019

It was the arrival of the second man in his early 20s gasping for air that alarmed Dr. Dixie Harris. Young patients rarely get so sick, so fast, with a severe lung illness, and this was her second case in a matter of days.

Then she saw three more patients at her Utah telehealth clinic with similar symptoms. They did not have infections, but all had been vaping. When Harris heard several teenagers in Wisconsin had been hospitalized in similar cases, she quickly alerted her state health department.

As patients in hospitals across the country combat a mysterious illness linked to e-cigarettes, federal and state investigators are frantically trying to trace the outbreaks to specific vaping products that, until recently, were virtually unregulated.

As of Aug. 22, 193 potential vaping-related illnesses in 22 states had been reported to the Centers for Disease Control and Prevention. Wisconsin, which first put out an alert in July, has at least 16 confirmed and 15 suspected cases. Illinois has reported 34 patients, one of whom has died. Indiana is investigating 24 cases.

Lung doctors said they had seen warning signs for years that vaping could be hazardous, as they treated patients. Medically it seemed problematic, since it often involved inhaling chemicals not normally inhaled into the lungs. Despite that, assessing the safety of a new product storming the market fell between regulatory cracks, leaving doctors unsure where to register concerns before the outbreak. The Food and Drug Administration took years to regulate e-cigarettes once a court determined it had the authority to do so.

“You don’t know what you’re putting into your lungs when you vape,” said Harris, a critical care pulmonologist. “It’s purported to be safe, but how do you know if it’s safe? To me, it’s a very dangerous thing.”

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Off The Radar

When electronic cigarettes came to market about a decade ago, they fell into a regulatory no man’s land. They are not a food, not a drug and not a medical device, any of which would have put them immediately in the FDA’s purview. And, until a few years ago, they weren’t even lumped in with tobacco products.

As a result, billions of dollars of vaping products have been sold online, at big-box retailers and in corner stores without going through the FDA’s rigorous review process to assess their safety. Companies like Juul, Blu and NJoy quickly established their brands of devices and cartridges, or pods. And thousands of related products are sold, sometimes on the black market over the internet or beyond.

“It makes it really tough because we don’t know what we’re looking for,” said Dr. Ruth Lynfield, the state epidemiologist for Minnesota, where several patients were admitted to the intensive care unit as a result of the illness. She added that if it turns out that the products in question were sold by unregistered retailers and manufacturers “on the street,” outbreak sleuths will have a harder time figuring out exactly what is in them.

With e-cigarettes, people can vape — or smoke — nicotine products, selecting flavorings like mint, mango, blueberry crème brûlée or cookies and milk. They can also inhale cannabis products. Many are hopeful that e-cigarettes might be useful smoking cessation tools, but some research has called that into question.

The mysterious pulmonary disease cases have been linked to vaping, but it’s unclear whether there is a common device or chemical. In some states, including California and Utah, all of the patients had vaped cannabis products. One or more substances could be involved, health officials have said. The products used by several victims are being tested to see what they contained.

Because e-cigarettes aren’t classified as drugs or medical devices, which have well-established FDA databases to track adverse events, doctors say there has been no clear way to report and track health problems related to vaping products.

And this has apparently been the case for years.

Multiple doctors described seeing earlier cases of severe lung problems linked to vaping that were not officially reported or included in the current CDC count.

Dr. Laura Crotty Alexander, a pulmonologist and researcher with the University of California-San Diego, said she saw her first case about two years ago. A young man had been vaping for months with the same device but developed acute lung injury when he switched flavors. She strongly suspected a link, but did not report the illness anywhere.

“It wasn’t that I didn’t want to report it, it’s that there’s no pathway” to do so, Alexander said.

She said she’s concerned that many physicians haven’t been asking patients about e-cigarette use and that there’s no way to document a case like this in the medical coding system.

Dr. John E. Parker of West Virginia University said he saw his first patient with pneumonia tied to vaping in 2015. Doctors there were intrigued enough to report on the case at the annual meeting of the American College of Chest Physicians. Parker and his team didn’t contact a federal agency, and Parker said it was unclear whom to call.

Numerous other cases have been reported in medical journals and at professional conferences in the years since. The FDA’s voluntary system for reporting tobacco-related health problems included 96 seizures and only one lung ailment tied to e-cigarettes from April through June of this year. The system appears to be utilized most by concerned citizens, rather than manufacturers or health care professionals.

But several lung specialists said that due to the patchwork nature of regulatory oversight over the years, the true scope of the problem is yet to be identified.

“We do know that e-cigarettes do not emit a harmless aerosol,” said Brian King, a deputy director in the Office on Smoking and Health at the CDC in a call with media on Aug. 23 about the outbreak. “It is possible that some of these cases were already occurring but we were not picking them up.”

Regulatory Limits

The FDA has had limited authority to regulate e-cigarettes over the years.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, empowering the FDA to oversee the safety and sale of tobacco products. But e-cigarettes, still new, were not top of mind.

Later that year, the FDA tried to block imports of e-cigarettes, saying the combination drug-device products were unapproved and therefore illegal for sale in the United States. Two vaping companies, Smoking Everywhere and NJoy, sued, and a federal judge ruled in 2010 that the FDA should regulate e-cigarettes as tobacco products.

It took the agency six years to finalize what’s become known as the “deeming rule,” in which it formally began regulating e-cigarettes and e-liquids.

By then, it was May 2016. The e-cigarette market had swelled to an estimated $4.1 billion, Wells Fargo Securities analyst Bonnie Herzog said at the time. Market researchers now project that the global industry could reach $48 billion by 2023.

Critics say the FDA took too long to act.

“I think the fact that FDA has been dillydallying [has made] figuring out what’s going on [with this outbreak] much harder,” said Stanton Glantz, a University of California-San Francisco professor in its Center for Tobacco Control Research and Education. “No question.”

The agency began by banning e-cigarette sales to minors and requiring all new vaping products to submit applications for authorization before they could come to market. Companies and retailers with thousands of products already on the market were granted two years to submit applications, and the FDA would get an additional year to evaluate the applications. Meanwhile, existing products could still be sold.

But when Dr. Scott Gottlieb arrived as the new FDA commissioner in 2017, the rule hadn’t been implemented and there was no formal guidance for companies to file applications, he said. As a result, he pushed the deadline back to 2022, drawing ire from public health advocates, who called foul over his previous ties to an e-cigarette retailer called Kure.

“I thought e-cigarettes at the time — and I still believe — that they represent an opportunity for currently addicted adult smokers to transition off of combustible tobacco,” he said in an interview, adding that other parts of the deeming rule went into effect as planned. “All I did was delay the application deadline.”

Gottlieb’s thinking changed the following year, when a national survey showed a sharp rise in teen vaping, which he called an “epidemic.” He announced that the agency would rethink the extended deadline and weigh whether to take flavors that appeal to kids off the market.

A judge ruled last month that e-cigarette makers would have only 10 more months to submit applications to the FDA. They’re now due in May 2020.

Asked about the lung injuries appearing now, Gottlieb, who left the FDA in April, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.

“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”

Juul, the leading e-cigarette maker, agreed that children shouldn’t be able to vape its products, and said curtailing access should be done “through significant regulation” and “enforcement.”

“When people say ‘Why aren’t these being regulated?’ They actually are all being regulated,” Gottlieb said.

For example, companies are required to label their products as potentially addictive, sell only to adults and comply with manufacturing standards. The agency has conducted thousands of inspections of e-cigarette manufacturers and retailers and taken enforcement actions against companies selling e-cigarettes that look like juice boxes, and a company that was putting the ingredients found in erectile dysfunction drugs into its vape liquid.

Health departments investigating the outbreak told Kaiser Health News that e-cigarettes’ niche as a tobacco product instead of a drug has presented challenges. Most weren’t aware that adverse events could be reported to a database that tracks problems with tobacco products. And, because e-cigarettes never went through the FDA’s “gold standard” approval process for drugs, doctors can’t readily look up a detailed list of known side effects.

But like other arms of the FDA, the tobacco office has tools and a team to investigate a public health threat just as the teams for drugs and devices do, Gottlieb said. It may even be better equipped because of its funding.

“I don’t think FDA is operating in any way with hands tied behind its back because of the way that the statute is set up,” he said.

Teen vaping has exploded during this regulatory tussle. In 2011, 1.5% of high school students reported vaping. By 2018, it was 20.8%, according to a CDC report.

Unknown Components

Still, doctors and researchers are concerned about the ingredients in e-cigarettes, and how little the public knows about the risks of vaping.

In Juul’s terms and conditions, posted on its website, it says, “We encourage consumers to do their own research regarding vapor products and what is right for them.” Many ingredients in e-cigarette products, however, are protected as trade secrets.

Since at least 2013, the flavor industry has expressed concern about the use of flavoring chemicals in vaping products.

The vast majority of the chemicals have been tested only by ingesting them in small quantities, as they’re encountered in foods. For most of these chemicals, there have been no tests to determine whether it is safe to inhale them, as happens daily by millions when they use e-cigarettes.

“Many of the ingredients of vaping products, including flavoring substances, have not been tested for … the exposure one would get from using a vaping device,” said John Hallagan, a senior adviser to the Flavor and Extract Manufacturers Association. The group has sent cease-and-desist letters to e-cigarette companies in previous years for using the food safety certification of the flavor industry to imply that the chemicals are also safe in e-cigarettes.

Some flavor chemicals are thought to be harmful when inhaled in high doses. Research suggests that cinnamaldehyde, the main component of many cinnamon flavors, may impair lung function when inhaled. Sven-Eric Jordt, a professor at Duke University, says he presented evidence of its dangers at an FDA meeting in 2015 — and its relative abundance in many e-cigarette vaping liquids. In response, one major e-cigarette liquid seller, Tasty Vapor, voluntarily took its cinnamon-flavored liquid off the shelves.

In 2017, when Gottlieb delayed the FDA application deadline, the product was back. A company email to its customers put it this way:

“Two years ago, Tasty Vapor allowed itself to be intimidated by scaremongering tactics. … We lost a lot of sales as well as a good number of long time customers. We no long see reason to disappoint our customers hostage for these shady tactics.”

At the time of publication, Tasty Vapor’s owner did not reply to a request for comment.

Jordt said he is frustrated by the delays in the regulatory approval process.

“As a parent, I would say that the government has not acted on this,” he said. “You’re basically left to act alone with your addicted kid. It’s kind of terrifying that this was allowed to happen. The industry needs to be held to account.”

KHN correspondents Cara Anthony, Markian Hawryluk and Lauren Weber and reporter Victoria Knight contributed to this report.

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

Pharma Cash Rolls Into Congress To Defend An Embattled Industry

In the heat of the most ferocious battle over drug prices in years, pharmaceutical companies are showering U.S. senators with campaign cash as sweeping legislation heads toward the floor.

Explore The Database Campaign Contributions Tracker

Pharma Cash To Congress

By Elizabeth Lucas and Sydney Lupkin Nov 29

A new Kaiser Health News database tracks campaign donations from drugmakers over the past 10 years.

In the first six months of this year alone, political action committees run by employees of drug companies and their trade groups have given the 30 senators expected to run for reelection nearly $845,000, the latest update to Kaiser Health News’ “Pharma Cash to Congress” database shows. That hefty sum stands out with Election Day more than 14 months away.

Lowering drug prices is one of the rare causes that has united Democrats and Republicans, and at least one proposal that would change the way the industry does business could get a vote in Congress this year. One of the most promising and aggressive updates would cap drug prices under Medicare so they do not outpace inflation.

The number of big contributions and the lawmakers receiving them signal the industry is building loyalty as voters push candidates to talk about drug prices in the 2020 elections.

For the drug industry, the stakes are high.

“If the Senate flips” to Democrats, “then PhRMA’s probably going to have to double its budget,” said Kent Cooper, a former Federal Election Commission official who has tracked political money for decades, referring to the industry’s biggest lobbying group, the Pharmaceutical Research and Manufacturers of America.

Most of the biggest donations in the first half of 2019 have gone to Republicans, who control the Senate and tend to be more reluctant to restrict drugmakers. And even those who do not serve on committees that oversee the industry or represent states with significant industry ties have benefited from drugmaker cash this year.

“We support candidates from both political parties who support innovation and patient access to medicines,” said PhRMA spokeswoman Holly Campbell.

Several senators facing tough reelection campaigns have raked in tens of thousands of dollars this year, with some collecting much more than the industry has given them in the past decade, if ever.

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“If it looks as though somebody is going to have a tough run — maybe a friend, maybe somebody you want to develop a better relationship with — you put some extra money in place,” said Steven Billet, a former AT&T lobbyist who teaches PAC management at George Washington University.

Thus far, senators running for reelection have together pulled in over $115,000 more than the 27 senators who were running for reelection in mid-2017.

The biggest single beneficiaries were Sens. Chris Coons, a Democrat from Delaware, and Thom Tillis, a North Carolina Republican, who took in a whopping $103,000 and $102,000 respectively in the first six months of the year. Tillis and Coons, the leaders of a Senate subcommittee on intellectual property, have been working on legislation to overhaul the patent system — perhaps the most powerful tool brand-name drugmakers have to keep prices, and profits, high.

Sen. John Cornyn (R-Texas) has been a vocal critic of the way some drugmakers use patents to extend their monopolies on drugs and block competitors, introducing a bill that would empower the government to sue drugmakers for gaming the system.

Cornyn, who faces a difficult reelection fight, received about $65,500.

Another top recipient was Sen. Cory Gardner of Colorado, who is considered the most vulnerable Republican up for reelection in 2020. John Hickenlooper, the state’s former governor who dropped out of the Democratic presidential primary on Aug. 15, has decided to challenge Gardner, further complicating his chances of being reelected.

Despite Gardner’s lack of pharma-related committee assignments, he received about $81,000 from drugmaker PACs this year, ranking him among the top 10 recipients of pharma cash in Congress. Another vulnerable Republican incumbent, Sen. Joni Ernst of Iowa, received about $35,500 — a huge bump for a lawmaker who, before this year, had collected about $15,000 total during her first term.

Sen. Gary Peters (D-Mich.) is also considered in danger as he runs for reelection in a state that voted for President Donald Trump in 2016. Like Gardner and Ernst, he does not serve on key committees, nor has he played a high-profile role in this year’s pushes on drug prices.

Peters received about $49,500 in campaign contributions from drugmaker PACs in the first half of the year, a personal record since being sworn in in 2015. Last year he received about $10,500 from drugmaker PACs in total.

Congressional leaders, who also help fund the campaigns of party members, are a common target of pharmaceutical industry contributions. And with Republicans controlling what legislation comes up in the Senate, Majority Leader Mitch McConnell, also running for reelection, has seen an uptick in donations: He received more than $85,000 during the first half of the year, a record for him over the course of the past eight years.

Drugmaker PACs typically give to most members of Congress, regardless of party. But with Democrats pushing some of the most aggressive proposals to regulate drugmakers, the industry may stand to lose more ground should Democrats regain control of Congress — and political experts say that is a possibility. Democrats are likely to make drug prices a key campaign issue.

“While it may not be true at this very moment, it may well be true that the Democrats will have enough seats in play to really fight for the majority,” said Jennifer Duffy, a senior editor at the nonpartisan Cook Political Report. “I think it’s a tossup at this point.”

The 19 Senate Republicans running in 2020 collected an average of more than $32,500 each from the pharmaceutical industry, while the 11 Democrats collected an average of nearly $20,500 each.

Sen. Bill Cassidy, a Louisiana Republican who is a gastroenterologist by trade and has been active on health care issues, received about $76,000 from drugmaker PACs in the first half of the year despite the likelihood he will be reelected next year.

Pharmaceutical company PAC contributions are only part of the picture, though. Dollars from individual drug company employees may flow in the same direction, as well as “dark money” spending that often dwarfs what must be disclosed.

“The PAC contribution is a signal to other folks who are associated with the industry,” Billet said.

PhRMA gives hard-to-trace millions to American Action Network and other conservative groups that buy TV ads and robocalls and engage in other political advocacy.

Drug prices have been among Americans’ top concerns for years. Large, bipartisan majorities favor policies to control drug costs, including importing drugs from Canada and government negotiations to lower prices paid by Medicare.

Prescription prices remain far higher in the U.S. than in other wealthy countries. Prices for hospital medicines continue to rise. High-deductible health plans have increased the number of patients who feel the drug-price sting directly before insurance kicks in.

New therapies such as genetically altered immune cells to fight cancer, which can cost $1 million per treatment, threaten to renew the cost spiral.

The House also saw an uptick in donations from drug industry PACs during the first half of the year, with the Republican leader, Rep. Kevin McCarthy of California, and the top Republican on the House Energy and Commerce Committee, Rep. Greg Walden of Oregon, taking in the most. McCarthy received about $89,000, while Walden collected about $86,500.

Speaker Nancy Pelosi of California, the powerful Democrat who controls the House and is working on a plan to empower federal health officials to negotiate drug prices, took in about $12,500.

How And When Immigrants’ Use Of Government Benefits Might Affect Their Legal Status

Kaiser Health News:States - August 27, 2019

A new rule to restrict legal immigration, published by the Trump administration this month, is sowing confusion and anxiety even among immigrants not directly affected by it, as fear spreads faster than facts, immigration and health policy experts say.

The rule would allow the federal government to more easily deny permanent residency status, popularly known as green cards, or entry visas to applicants who use — or are deemed likely to use — federally funded food stamps, housing assistance and Medicaid.

Immigrants seeking legal status are already required to prove they will not become a financial burden, or “public charge,” to U.S. taxpayers. Under existing law, a “public charge” is defined as somebody who is “primarily dependent on the government for subsistence,” which means they either receive cash aid or long-term institutional care at the government’s expense.

The new rule expands the list of public benefit programs federal officials can consider in deciding whether to deny permanent residency and other forms of legal immigration.

The rule is scheduled to take effect Oct. 15, but California and several other states have filed lawsuits to block it, as have the counties of San Francisco and Santa Clara. The office of California’s Attorney General Xavier Becerra said in a statement that the rule creates “unnecessary new barriers to lawful admission to the United States.”

Noncitizen immigrants account for only a small percentage of people who use the public benefit programs targeted by the new rule. They make up 6.5% of Medicaid enrollees, for example, and 8.8% of food aid recipients, according to an analysis of census data by the Associated Press.

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Misconceptions about whom the rule applies to have created a “chilling effect” that has prompted adults to withdraw themselves and their children from programs they need, said Mayra Alvarez, president of the Children’s Partnership, a statewide child policy and advocacy organization.

“As advocates for children, we know firsthand policy extends far beyond its intended recipients, and this rule is no exception,” Alvarez said.

Even when the rule was still a proposal, it caused disruption in county health and nutrition programs as well as in health centers, advocates have claimed.

A survey conducted by the Urban Institute, a liberal-leaning think tank, showed that in 2018, 1 in 7 adults from immigrant families reported that they or a family member opted not to apply for or withdrew from a non-cash benefit program out of fear of risking future green card status.

Enrollment in Medi-Cal, California’s version of the Medicaid program, has dropped over the past couple of years,  and some health policy experts say anti-immigrant policies and proposals have contributed to the decline.

The following answers to frequently asked questions should help clarify how the new Trump administration rule would work, while dispelling some common misconceptions.

Q: How will use of the designated public benefits weigh in the decisions of immigration authorities under the new rule?

The rule defines a “public charge” as a noncitizen who receives one or more of the benefits for more than 12 months within any 36-month period. Receipt of two different benefits in a given month would count as two months. In cases where a green card or visa applicant had not exceeded this benefit threshold, officers of the Department of Homeland Security would seek to determine whether they were “likely at any time” to do so. In reaching a decision, they would weigh the applicant’s age, health, financial status, education and employment history.

Q: Are any immigrant groups exempt from the new public charge rule?

Yes. The rule does not apply to refugees and asylum grantees or to certain members of the U.S. military. It also exempts Medicaid beneficiaries who are pregnant, new mothers or children under 21.

Q: Does a child’s use of Medicaid or food stamps affect her parents’ chances for a green card?

No. A child’s participation in the program does not count against her parents. Cathy Senderling-McDonald, deputy executive director of the California Welfare Directors Association, said there is a push to spread the word that children’s use of benefits does not diminish the chances of obtaining legal status for anyone in their family. But history has shown that children will miss out on benefits nonetheless because of confusion about the consequences of enrolling them. During the welfare overhaul in the 1990s, “there were declines in participation in Medicaid and the food stamps program by people who probably weren’t affected” by the actual legal changes, said Marianne Bitler, an economics professor at the University of California-Davis.

Q: In California, undocumented child immigrants are eligible for full Medi-Cal benefits. Can their use of Medi-Cal hurt their chances of getting legal papers later?

No, for two reasons. First, the new rule makes clear that children’s use of health benefits will not count against them. Second, these benefits are funded by the state, so they do not count. The same is true of young adults up to age 26, for whom California recently agreed to extend full Medi-Cal coverage, effective Jan. 1. And it is true for recipients of DACA (the Deferred Action for Childhood Arrivals) who are eligible for Medi-Cal, also paid by the state. Emergency services through Medi-Cal are partly funded by the federal government, but their use will not count against applicants.

Q: Will enrollment of kids in the free and reduced school lunch program be scrutinized by immigration authorities under the new rule?

No. The free and reduced school lunch program is not part of the new rule, and families should not be afraid to continue receiving this assistance, Senderling-McDonald said.

Q: If you are already a green card holder before this new rule takes effect, will you be subjected to a public charge test when it comes time to renew your card?

No. Your residency status is permanent. And you need to renew your actual green card every 10 years.

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

Judge Cites Opioid ‘Menace,’ Awards Oklahoma $572M In Landmark Case


An Oklahoma judge has ruled that drugmaker Johnson & Johnson helped ignite the state’s opioid crisis by deceptively marketing painkillers and must pay $572 million to the state.

Oklahoma sought $17 billion, blaming Johnson & Johnson’s marketing practices for fueling the crisis that has claimed the lives of 6,000 people in the state.

It’s the first ruling to hold a pharmaceutical company responsible for one of the worst drug epidemics in American history.

Judge Thad Balkman delivered his decision from the bench after presiding over an eight-week civil trial in the college town of Norman, Okla.

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“Defendants caused an opioid crisis that is evidenced by increased rates of addiction, overdose deaths and neonatal abstinence syndrome in Oklahoma,” Balkman said in the ruling.

Johnson & Johnson immediately released a statement saying that the company “plans to appeal the opioid judgment in Oklahoma.”

Oklahoma Attorney General Mike Hunter’s suit alleged that Johnson & Johnson, through its pharmaceutical subsidiary Janssen, helped ignite a public health crisis that has killed thousands of state residents.

Balkman, in the ruling, said the state made its case that Johnson & Johnson contributed to the state’s opioid crisis.

“The opioid crisis is an imminent danger and menace to Oklahomans,” Balkman said. “The state met its burden,” proving the company acted improperly with its “misleading marketing and promotion of opioids.”

The case is being closely watched by plaintiffs in other opioid lawsuits, particularly the roughly 2,000 cases pending before a federal judge in Ohio.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million, about $200 million of which will fund an addiction research and treatment center at Oklahoma State University in Tulsa. Soon afterward, Hunter dropped all but one of the civil claims, including fraud, against the two remaining defendants.

Just two days before the trial began, one of those two defendants, Teva Pharmaceuticals, based in Israel, announced an $85 million settlement with the state.

Both companies deny any wrongdoing.

Johnson & Johnson marketed the opioid painkillers Duragesic and Nucynta. Lawyers for the company say that its products were highly regulated by the Food and Drug Administration, among other agencies, and that the state did not provide any evidence showing that the company’s sales practices helped fuel the crisis.

This story is part of a reporting partnership that includes NPR, StateImpact Oklahoma and other member stations. 

Secretary Azar Participates in Closing Ceremony for USNS Comfort in Santa Marta, Colombia

HHS Gov News - August 26, 2019

Today, August 25, Health and Human Services Secretary Alex Azar participated in a closing ceremony for the USNS Comfort in Santa Marta, Colombia with Rear Admiral Steven D. Poulin, SOUTHCOM Director of Operations; Mark Wells, Chargé d'Affaires at the U.S. Embassy in Colombia; Dr. Juan Pablo Uribe, Colombian Minister of Health; Carlos Holmes Trujillo, Colombian Foreign Minister; and General Luis Fernando Navarro Jiménez of the Colombian Navy.

On the USNS Comfort’s journey throughout the Americas, the United States government is working with health and government partners in Central America, South America, and the Caribbean to provide care on the ship and at land-based medical sites. The USNS Comfort crew and volunteers provide basic medical, surgical, dental, and optometry services, as well as veterinary services. This is necessary not only because many forcibly displaced Venezuelan refugees are in desperate need of medical attention, but also because many nations’ medical systems have been strained by the arrival of these refugees.

Secretary Azar stressed in his remarks the importance of the USNS Comfort’s mission for President Trump and Vice President Pence as the United States government continues to work with the government and people of Colombia in their effort to meet the medical needs of both Colombians and Venezuelans. The United States has committed over $256 million dollars to helping our partners in Latin America provide humanitarian and development assistance to this vulnerable population. In Colombia, the United States has committed approximately $130 million dollars to the response. Secretary Azar also stated, “We can all eagerly look forward to the day when we turn our attention to helping Venezuelans rebuild their healthcare system and their country.”

After the ceremony, Secretary Azar and Minister Uribe signed a letter of intent to formalize an agreement that the United States, through PEPFAR, will provide additional support to Colombia in the form of a supply of antiretroviral treatment to help provide HIV/AIDS treatment to care for Venezuelans at Colombian public health facilities.

Later in the day, Secretary Azar, other senior HHS officials, and Mark Wells, Chargé d'Affaires at the U.S. Embassy in Colombia participated in a bilateral meeting with Iván Duque Márquez, President of Colombia; Dr. Juan Pablo Uribe, Colombian Minister of Health; Carlos Holmes Trujillo, Colombian Foreign Minister; Fabio Espitia Garzón, Attorney General of Colombia; and ​Iván Darío González, the Colombian Deputy Minister of Health. During the meeting they discussed the continued Venezuelan crisis and the United States and Colombia’s strong bilateral relationship. Colombia expressed thanks to the United States for the continued collaboration on public health, specifically for the technical assistance through the Centers for Disease Control and Prevention.

Secretary Azar’s participation in the closing ceremony and bilateral meeting followed a tour earlier in the day of the USNS Comfort and medical sites in Colombia where the Secretary spoke with and had the opportunity to thank the crew of the USNS Comfort, including members of the U.S. Public Health Service Commissioned Corps, who are providing critical medical services to those in need. Additional information regarding Secretary Azar’s meetings and schedule will be forthcoming in news releases and social media posts.

Left: Secretary Azar talks with Colombian President Ivan Duque and other officials. Right: Secretary Azar delivers remarks at the closing ceremony of USNS Comfort in Santa Marta, Colombia.

 

Why Red Wyoming Seeks The Regulatory Approach To Air Ambulance Costs

Wyoming, the reddest of Republican states and a bastion of free enterprise, thinks it may have found a way to end crippling air ambulance bills that can top $100,000 per flight.

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The state’s unexpected solution? Undercut the free market by using Medicaid to treat air ambulances like a public utility.

The issue has come to a head in Wyoming, where rugged terrain and long distances between hospitals forces reliance on these ambulance flights. Costs for such emergency transports have been soaring, with some patients facing massive unexpected bills as the free-flying air ambulance industry expands with cash from profit-seeking private-equity investors.

Other states dealing with the same dynamic have tried to rein in the industry but have continually run up against the Airline Deregulation Act, a federal law that preempts states from regulating any part of the air industry.

So, Wyoming officials are instead seeking federal approval to funnel all medical air transportation in the state through Medicaid, a joint federal-state program for residents with lower incomes. The state officials plan to submit their proposal in late September to Medicaid’s parent agency, the Centers for Medicare & Medicaid Services; the plan will still face significant hurdles there.

If successful, however, the Wyoming approach could be a model for the nation, protecting patients in need of a lifesaving service from being devastated by a life-altering debt.

“The free market has sort of broken down. It’s not really working effectively to balance cost against access,” said Franz Fuchs, a policy analyst for the Wyoming Department of Health. “Patients and consumers really can’t make informed decisions and vote with their dollars on price and quality.”

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Freewheeling Free-Market System

The air ambulance industry has grown steadily in the U.S. from about 1,100 aircraft in 2007 to more than 1,400 in 2018. During that same time, the fleet in Wyoming has grown from three aircraft to 14. State officials said an oversupply of helicopters and planes is driving up prices because air bases have high fixed overhead costs. Fuchs said companies must pay for aircraft, staffing and technology such as night-vision goggles and flight simulators, incurring 85% of their total costs before they fly a single patient.

But with the supply of aircraft outpacing demand, each air ambulance is flying fewer patients. Nationally, air ambulances have gone from an average of 688 flights per aircraft in 1990, as reported by Bloomberg, to 352 in 2016. So, companies have raised their prices to cover their fixed costs and to seek healthy returns for their investors.

A 2017 report from the federal Government Accountability Office notes that the three largest air ambulance operators are for-profit companies with a growing private equity investment. “The presence of private equity in the air ambulance industry,” the report said, “indicates that investors see profit opportunities in the industry.”

While precise data on air ambulance costs is sparse, a 2017 industry report said air ambulance companies spend an average of $11,000 per flight. In Wyoming, Medicare pays an average of $6,000 per flight, and Medicaid pays even less. So air ambulance companies shift the remaining costs — and then some — to patients who have private insurance or are paying out-of-pocket.

As that cost-shifting increases, insurers and air ambulance companies haven’t been able to agree on in-network rates. So the services are left out of insurance plans. When a consumer needs a flight, it’s billed as an out-of-network service. Air ambulance companies then can charge whatever they want. If the insurer pays part of the bill, the air ambulance company can still bill the patient for the rest — a practice known as balance billing.

“We have a system that allows providers to set their own prices,” said Dr. Kevin Schulman, a Stanford University professor of medicine and economics. “In a world where there are no price constraints, there’s no reason to limit capacity, and that’s exactly what we’re seeing.”

Nationally, the average helicopter bill has now reached $40,000, according to a 2019 GAO report, more than twice what it was in 2010. State officials say Wyoming patients have received bills as high as $130,000.

Because consumers don’t know what an air ambulance flight will cost them — and because their medical condition may be an emergency — they can’t choose to go with a lower-cost alternative, either another air ambulance company or a ground ambulance.

A Different Way of Doing Things

Wyoming officials propose to reduce the number of air ambulance bases and strategically locate them to even out access. The state would then seek bids from air ambulance companies to operate those bases at a fixed yearly cost, under a sort of Netflix model. It’s a regulated monopoly approach similar to the way public utilities are run.

“You don’t have local privatized fire departments springing up and putting out fires and billing people,” Fuchs said. “The town plans for a few fire stations, decides where they should be strategically, and they pay for that fire coverage capacity.”

Medicaid would cover all the air ambulance flights in Wyoming and then recoup those costs by billing patients’ insurance plans for those flights. A patient’s out-of-pocket costs would be capped at 2% of the person’s income or $5,000, whichever is less, so patients could easily figure out how much they would owe. Officials estimate they could lower private insurers’ average cost per flight from $36,000 to $22,000 under their plan.

State Rep. Eric Barlow, who co-sponsored the legislation, recognizes the irony of a GOP-controlled, right-leaning legislature taking steps to circumvent market forces. But the Republican said that sometimes government needs to make sure its citizens are not being abused.

“There were certainly some folks with reservations,” he said. “But folks were also hearing from their constituents about these incredible bills.”

Industry Pushback

Air ambulance companies have opposed the plan. They say the surprise-billing problem could be eliminated if Medicare and Medicaid covered the cost of flights and the companies wouldn’t have to shift costs to other patients. They question whether the state truly has an oversupply of aircraft and warn that reducing the number of bases would increase response times and cut access to the lifesaving service.

Richard Mincer, an attorney who represents the for-profit Air Medical Group Holdings in Wyoming, said that while 4,000 patients are flown by air ambulance each year in the state, it’s not clear how many more people have needed flights when no aircraft was available.

“How many of these 4,000 people a year are you willing to tell, ‘Sorry, we decided as a legislature you’re going to have to take ground ambulance?’” Mincer said during a June hearing on the proposal.

But Wyoming officials say it indeed might be more appropriate for some patients to take ground ambulances. The vast majority of air ambulance flights in the state, the state officials say, are transfers from one hospital to another, rather than on-scene trauma responses. The officials say they’ve also heard of patients being flown for nonemergency reasons such as a broken wrist or impending gallbladder surgery.

Air ambulance providers say such decisions are out of their control: They fly when a doctor or a first responder calls.

But those companies have ways of drumming up business. Air ambulance companies heavily market memberships that cover a patient’s out-of-pocket costs, eliminating any disincentive for the patient to fly. Companies also build relationships with doctors and hospitals that can influence the decision to fly a patient. Some have been reported to deliver pizzas to hospitals by helicopter to introduce themselves.

Mincer, the Air Medical Group Holdings attorney, said the headline-grabbing large air ambulance bills don’t reflect what patients end up paying directly. The average out-of-pocket cost for an air ambulance flight, he said, is about $300.

The industry also has tried to shift blame onto insurance plans, which the transporters say refuse to pay their fair share for air ambulance flights and refuse to negotiate in-network rates.

Doug Flanders, director of communications and government affairs for the medical transport company Air Methods, said the Wyoming plan “does nothing to compel Wyoming’s health insurers to include emergency air medical services as part of their in-network coverage.”

The Profit Model

Other critics of the status quo maintain that air ambulance companies don’t want to change, because the industry has seen investments from Wall Street hedge funds that rely on the balance-billing business model to maximize profits.

“It’s the same people who have bought out all the emergency room practices, who’ve bought out all the anesthesiology practices,” said James Gelfand, senior vice president of health policy for the ERISA Industry Committee, a trade group representing large employers. “They have a business strategy of finding medical providers who have all the leverage, taking them out of network and essentially putting a gun to the patient’s head.”

The Association of Air Medical Services counters that the industry is not as lucrative as it’s made out to be, pointing to the recent bankruptcy of PHI Inc., the nation’s third-largest air ambulance provider.

Meanwhile, Blue Cross Blue Shield of Wyoming is supportive of the state’s proposal and looks forward to further discussion about the details if approved, according to Wendy Curran, a vice president at the health insurance firm. “We are on record,” Curran said, “as supporting any effort at the state level to address the tremendous financial impacts to our [Wyoming] members when air ambulance service is provided by an out-of-network provider.”

The Wyoming proposal also has been well received by employers, who like the ability to buy into the program at a fixed cost for their employees, providing a predictable annual cost for air ambulance services.

“It is one of the first times we’ve actually seen a proposal where the cost of health care might actually go down,” said Anne Ladd, CEO of the Wyoming Business Coalition on Health.

The real challenge, said Fuchs, will be convincing federal officials to go along with it.

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