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Drugmakers Play The Patent Game To Lock In Prices, Block Competitors

Kaiser Health News:Marketplace - October 02, 2018

David Herzberg was alarmed when he heard that Richard Sackler, former chairman of opioid giant Purdue Pharma, was listed as an inventor on a new patent for an opioid addiction treatment.

Patent No. 9861628 is for a fast-dissolving wafer containing buprenorphine, a generic drug that has been around since the 1970s. Herzberg, a historian who focuses on the opioid epidemic and the history of prescription drugs, said he fears the patent could keep prices high and make it more difficult for poor addicts to get treatment.

“It’s hard not to have that reaction of, like … these vultures,” said Herzberg, an associate professor at the University at Buffalo.

James Doyle, vice president and general counsel of Rhodes Pharmaceuticals, the Purdue subsidiary that holds the patent, said in an email statement that the company does not have a developed or approved product and “therefore no money has been made from this technology.”

“The invention behind the buprenorphine patent in question was developed more than a dozen years ago,” he wrote. “If a product is developed under this patent, it will not be commercialized for profit.”

Yet, the patenting of a small change in how an existing drug is made or taken by patients is part of a tried-and-true pharmaceutical industry strategy of enveloping products with a series of protective patents.

Drug companies typically have less than 10 years of exclusive rights once a drug hits the marketplace. They can extend their monopolies by layering in secondary patents, using tactics critics call “evergreening” or “product-hopping.”

Lisa Larrimore Ouellette, a patent law expert at Stanford University, said the pharmaceutical industry gets a greater financial return from its patent strategy than that of any other industry.

AztraZeneca in 2001 famously fended off generic versions of its blockbuster heartburn medicine Prilosec by patenting a tweaked version of the drug and calling it Nexium. When Abbott Laboratories faced multiple generic lawsuits over its big moneymaker Tricor, a decades-old cholesterol drug, it lowered the dosage and changed it from a tablet to a capsule to win a new patent.

And Forest Laboratories stopped selling its Alzheimer’s disease drug Namenda in 2014 after reformulating and patenting Namenda XR to be taken once a day instead of twice.

Another common strategy is to create what Food and Drug Administration Commissioner Scott Gottlieb calls “patent thickets,” claiming multiple patents for a single drug to build protection from competitors. AbbVie’s rheumatoid arthritis drug Humira has gained more than 100 patents, for example.

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The U.S. Patent and Trademark Office awards patents when an innovation meets the minimum threshold of being new and non-obvious. Secondary patents are routinely granted to established drugs when an improvement is made, such as making it a once-a-day pill instead of twice a day, said Kristina Acri, an economist and international intellectual property expert at the Fraser Institute and Colorado College.

“Is there a better way? Maybe, but that’s not what we’re doing,” Acri said.

The controversial patent that Sackler and five co-inventors obtained is widely known as a “continuation patent.” (The original patent application for the wafer was filed in August 2007.)

Continuation patents do not necessarily extend the patent life of a drug, but they can have other uses. In 2016, Rhodes filed a lawsuit against Indivior alleging patent infringement.

Indivior, formerly part of Reckitt Benckiser, sells a film version of the popular addiction treatment drug Suboxone that is placed under the tongue — an oral medicine similar to what Rhodes has patented. Indivior’s comes in a lime flavor.

Indivior’s film, which federal regulators approved in 2010, dominates the market with a 54 percent average market share, according to the company’s most recent financial report. And the company has vigorously fought rivals, including filing lawsuits against firms such as Teva Pharmaceutical Industries, which sought approval to manufacture generic versions. Indivior declined to comment.

The Rhodes Pharmaceuticals version would be a wafer that melts quickly in the mouth. The inventors list potential flavors including mint, raspberry, licorice, orange and caramel, according to the patent.

For opioid historian Herzberg, the patent battles between companies like Rhodes and Indivior are “absolute madness.”

Decisions on what is available on the market to treat addicts should be based on what is the best way to treat the people who have the problem, he said.

Patent battles, Herzberg said, are “not how you want drug policy getting made.”

Attempts to change the patent system have intensified over the past decade as prices of prescription drugs continue to climb.

In 2011, President Barack Obama signed the America Invents Act, which included the creation of the Patent Trial and Appeal Board. The PTAB is an alternative to using the cumbersome U.S. court system to challenge weak patents. Generic drug manufacturers have used the board’s “inter partes review” process and overturned 43 percent of the patents they challenged, according to recent research.

Critics of the administrative process, including the pharmaceutical industry trade group PhRMA, said it creates “significant business uncertainty for biopharmaceutical companies.” Often companies have to defend their products twice — both in the courts as well as before the PTAB, said Nicole Longo, PhRMA’s director of public affairs.

Drug giant Allergan attempted to overcome the PTAB’s review process by arguing that the patent couldn’t be challenged at the review board because they sold the patent to the St. Regis Mohawk Tribe, which had sovereign immunity. A federal appeals court ruled this summer that Allergan could not shield its patents from the PTAB review this way.

This year, several members of Congress proposed bills that would unwind or limit changes made by the America Invents Act, though nothing is likely to happen before the midterm elections. The STRONGER Patents Act, introduced in both the House and Senate, would weaken the PTAB board by aligning its claims standards with what has been established by court rulings.

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

Readout of Secretary Azar’s First Day in Brazil

HHS Gov News - October 01, 2018

As previously announced, Health and Human Services (HHS) Secretary Alex Azar traveled to Brazil over the weekend to participate in bilateral meetings with government officials and others to discuss the ongoing collaboration between the United States and Brazil towards global health security, our bilateral science partnership, and health sector reform. Later in the week, Secretary Azar will travel to Argentina for the G20 Health Ministerial Meeting.

Today, Secretary Azar began his meetings in Fortaleza, Brazil. First he visited the Urgent Care Center Praia do Futuro where he learned about the structure of 24-hour urgent care units and how such centers function as a part of Brazil’s decentralized public health system. Here he also saw first-hand how Fortaleza has used its decentralized model to manage patient flows for greater efficiency and improved outcomes.

Next, Secretary Azar attended a breakfast meeting with Ceará State Governor Camilo Santana, Ceará State Health Secretary Henrique Javi, and other key health officials to discuss the unique aspects of the healthcare system in the State of Ceará and how they have implemented innovative ways to increase access and improve outcomes. They also discussed the United States-Brazil collaboration on the Zika virus and how our two nations can work together to enhance and protect our citizens against global health threats.

Later in the morning, Secretary Azar met with Dr. Islane Verçosa of CAVIVER and her medical team. CAVIVER is a non-governmental organization (NGO) in Brazil that engages with the public health system and international partners. Secretary Azar and Dr. Verçosa discussed the partnership between the Centers for Disease Control and Prevention (CDC) and the Brazilian Ministry of Health on the CDC’s Zika Outcomes and Development in Infants and Children (ZODIAC) investigation and how the results of this study have informed the care of children impacted by Zika. This follow-up assessment of children aged 12-24 months conceived during the 2015-2016 Zika virus outbreak in Brazil provided a first-ever description of the longer-term health and developmental effects of congenital Zika virus infection in children with microcephaly. At CAVIVER, Secretary Azar met and spoke with children and families affected by congenital Zika syndrome.

In the afternoon, Secretary Azar met with additional children and families affected by congenital Zika syndrome at the Albert Sabin Infant Hospital. This hospital serves as a specialty care center in the Brazilian public health system and as a reference center for care of infants and children in the northeastern region of Brazil. Here Secretary Azar learned about the hospital’s partnership with CDC on Zika and about the services they provide to care for children affected by the range of problems caused by microcephaly, including hearing and vision problems and other neurological conditions.

Secretary Azar reaffirmed HHS’ and the CDC’s continued support for Zika activities and reiterated that the Zika story is not over for affected families who face  managing lifelong disabilities for affected children.  CDC continues to monitor the health outcomes and care of affected babies to learn how to best protect mothers and babies from Zika virus infection and other emerging threats. Zika remains a threat in over 100 countries and territories, and pregnant women should still avoid travel to areas with risk of Zika. For a full list of areas with risk of Zika, please visit

Later in the afternoon, Secretary Azar traveled to São Paulo, Brazil where he will participate in meetings on Tuesday, October 2. Additional information regarding the Secretary’s meetings and schedule will be forthcoming in news releases and social media posts.

HHS, Genentech join forces on medicines to combat influenza, other health security threats

HHS Gov News - October 01, 2018

To develop innovative medicines that combat diverse national health security threats, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) today announced a strategic partnership with Genentech, a member of the Roche Group, of South San Francisco.

The company and ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will jointly manage and share the cost to develop a portfolio of medicines that meet national health security requirements and have commercial uses. The partners will focus first on developing a first-in-class therapeutic for hospitalized influenza patients and a treatment for lung injuries caused by inhaling sulfur mustard gas.

“The United States faces a host of national health security threats requiring innovative solutions,” said BARDA Director Rick Bright, Ph.D. “Partnership agreements like this one allow flexibility to detect, prevent, or treat diverse illness and injury caused by these threats and at the same time decrease costs and maximize efficiency.”

BARDA will contribute $43 million over five years to support a study of the investigational oral medicine baloxavir marboxil in treating severely ill patients hospitalized with seasonal or pandemic influenza viruses. Influenza, or flu, is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. CDC estimates that influenza has resulted in between 140,000 and 900,000 hospitalizations and between 12,000 and 80,000 deaths in the United States annually since 2010.

BARDA also will provide $19 million over 18 months to advance the development of alteplase (tPA) for a new indication to treat acute lung injuries called cast formation caused by inhaling sulfur mustard gas. The medicine, known under the brand name Activase is approved and marketed to treat heart attacks, stroke, and pulmonary embolism.

There are currently no FDA-approved therapeutics for use by severely ill patients hospitalized with influenza or for treatment of inhalational injury due to sulfur mustard.

In addition to sharing development costs, BARDA will have joint oversight, help determine which medicines to develop, and collaborate on decisions about which products enter or leave the partnership’s portfolio.

The agreement also gives BARDA access to Genentech’s extensive portfolio of potential medical countermeasures, including diagnostics, therapeutics for influenza, and medicines to reduce the transmission of influenza, and other products to combat health security threats.

Rather than standard contracts, HHS entered into the agreement using other transaction authority that was granted to HHS under the Pandemic and All Hazards Preparedness Act of 2006. Although not a contract, grant or cooperative agreement, other transaction authority provides a funding and collaboration vehicle to promote innovation in technology for advanced research and development. The new partnership agreement is BARDA’s eighth under other transaction authority.

Feds Settle Huge Whistleblower Suit Over Medicare Advantage Fraud

Kaiser Health News:Marketplace - October 01, 2018

One of the nation’s largest dialysis providers will pay $270 million to settle a whistleblower’s allegation that it helped Medicare Advantage insurance plans cheat the government for several years.

The settlement by HealthCare Partners Holdings LLC, part of giant dialysis company DaVita Inc., is believed to be the largest to date involving allegations that some Medicare Advantage plans exaggerate how sick their patients are to inflate government payments. DaVita, which is headquartered in El Segundo, Calif., did not admit fault.

“This settlement demonstrates our tireless commitment to rooting out fraud that drains too many taxpayer dollars from public health programs like Medicare,” said U.S. Attorney Nick Hanna in announcing the settlement Monday.

Medicare Advantage plans, which now enroll more than 1 in 3 seniors nationwide, have faced growing government scrutiny in recent years over their billing practices. At least a half-dozen whistleblowers have filed lawsuits accusing the insurers of boosting payments by overstating how sick patients are. In May 2017, two Florida Medicare Advantage insurers agreed to pay nearly $32 million to settle a similar lawsuit.

The DaVita settlement cites improper medical coding by HealthCare Partners from early 2007 through the end of 2014. The company, according to the settlement agreement, submitted “unsupported” diagnostic codes that allowed the health plans to receive higher payments than they were due. Officials did not identify the health plans that overcharged as a result.

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One such “unsupported” code was for a spinal condition known as spinal enthesopathy that was improperly diagnosed in patients in Florida, Nevada and California from Nov. 1, 2011, to Dec. 31, 2014, according to the settlement. The agreement did not say how much health plans took in from the unsupported codes.

The company also contracted with a Nevada firm from 2010 through January 2016 that sent health care providers to visit patients in their homes, a controversial practice that critics have long held is done largely to inflate Medicare payments. These house calls also generated “unsupported or undocumented” diagnostic codes, according to the settlement.

Officials said that DaVita disclosed the practices to the government. It acquired HealthCare Partners, a large California-based doctors’ group, in 2012. They said the government agreed to a “favorable resolution” of the allegations payment because of the self-disclosure.

In a statement, DaVita said the settlement “reflects close cooperation with the government to address practices largely originating with HealthCare Partners.” DaVita said the settlement will be paid with escrow funds set aside by the former owners.

“This case involved illegal conduct in which patients’ medical conditions were improperly reported and were not corrected after further review — all for the purpose of boosting the bottom line,” reads the government’s statement.

The settlement also resolves allegations made by whistleblower James Swoben that HealthCare Partners knew that many of the diagnostic codes were unsupported, but failed to report them. The company reported only cases in which it deserved higher reimbursement, while ignoring codes that would slash payments, a practice known as “one-way” chart reviews.

Swoben, a former employee of a company that did business with DaVita, will receive just over $10 million for the settlement of the “one-way” allegations, under the federal False Claims Act, which rewards whistleblowers who expose fraud.

Immigrants’ Health Premiums Far Exceed What Plans Pay For Their Care

Kaiser Health News:Insurance - October 01, 2018

President Donald Trump has repeatedly condemned U.S. immigration policy, arguing that many immigrants pose a threat to the nation and drain U.S. resources. But a study released Monday about health insurance challenges the president’s portrayal.

The study in the journal Health Affairs found that immigrants covered by private health insurance and their employers contributed nearly $25 billion more in premiums in 2014 than was spent on their care. Those in the country without legal status contributed nearly $8 billion toward the surplus.

In contrast, U.S.-born enrollees spent nearly $25 billion more than they paid for in premiums.

These findings surface as the Trump administration’s immigration policies — including a plan to tie migrants’ efforts to get permission for permanent residency to their use of federal benefit programs — have come under scrutiny.

Earlier studies also found that immigrants contribute more to Medicare than they receive in benefits, but the authors of this study say it is the first to look at the effect in private insurance plans.

Leah Zallman, assistant professor of medicine at Harvard Medical School and lead author of the study, said her findings allude to the potentially negative consequences that tighter immigration policies could have on the health care industry.

“I think in today’s era … there’s so much concern about immigrants and immigration really sort of draining our resources in the U.S.,” Zallman said. “This really points to the critical role that immigrants have in actually subsidizing and maintaining our current systems.”

Researchers calculated the financial contributions and expenses of enrollees and their employers using two surveys created by the federal government. Plans sold on the federal health law’s insurance exchanges were not included because they “differ from other private insurance in important ways and are unavailable to undocumented people,” the study authors noted.

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Anyone born outside of the United States was categorized as an immigrant. However, the surveys did not ask non-citizens with private coverage about their legal status. Researchers used national data on undocumented immigrants to estimate how many people in the study group illegally resided in the country.

In 2014, immigrants and their employers contributed $88.7 billion in private insurance premiums, but spent only $64 billion for care, according to the study’s findings. Of that group, undocumented immigrants alone paid more than $17 billion to private insurers but used only $9.4 billion.

Native-born consumers paid $616 billion in premiums and received nearly $641 billion in insurers’ payments for care. They also consistently outspent immigrants across all age groups. Among enrollees 65 and older, the U.S.-born made a net contribution of nearly $10,000 more toward their care than those born overseas, according to the study.

The researchers reported that, on average, individual immigrants paid $1,123 more for premiums in 2014 than they received in insurance-covered care. U.S. natives instead cost insurers $163 on average.

Leighton Ku, director of the Center for Health Policy Research at George Washington University who was not involved in the study, said several factors contribute to immigrants’ low health care expenses. The group tends to be healthier and younger when they arrive in the United States. Cultural and language differences also hinder them from accessing care.

The study noted that immigrants’ health care expenditures increased the longer they remained in the country. But it added that since their premiums also increased at the same time, they continued to make a net contribution to their private health plans.

The findings come about a week after the Department of Homeland Security proposed redefining how it would determine “public charge,” a term used to describe a person likely to become dependent on the government for assistance. The proposal would make it harder for immigrants to live and work permanently in the U.S. if they receive certain types of federal assistance, such as Medicaid, food stamps and housing subsidies.

Trump has vowed to be tough on immigration standards. During his campaign, he berated U.S. health expenditures on immigrants, arguing that the U.S. spent $11 billion for care to people who were in the country without authorization, the study’s authors note.

But they point out that earlier research shows that immigrants have low rates of health care use and spending, compared with native residents. Their payments to private plans and Medicare in essence prop up care for patients who are U.S.-born, the authors say.

A study Zallman published earlier showed unauthorized immigrants contributed $35.1 billion more to Medicare from 2000 to 2011 than they used in services.

Benedic Ippolito, an economist at the American Enterprise Institute, cautioned using the study’s findings to draw conclusions on a large scale about immigrants and their role in health insurance. An estimated 20 percent of immigrants — including nearly half of the undocumented population — are uninsured, according to the study. Ippolito said the cost of their uncompensated care affects whether immigrants’ financial contributions actually lead to surpluses for health care overall.

“I would be careful about how much I extrapolate these results to a) other parts of the health insurance market and b) even further to what this means for immigration policy,” Ippolito said. “This paper alone does not tell us everything we need to know.”

Ku echoed the uncertainty. He said he is not certain how the Trump administration’s latest actions will affect immigrants enrolled in private insurance. Having a private plan may suggest they are employed with a certain income stability. However, if enough immigrants leave the insurance market, he added, it may have the unintended consequence of making health plans more expensive for everyone else.

“That does have the following implication that to the extent that we do things to suppress immigrants or make it harder for them to purchase insurance then in that case we may do harm to the citizens,” he said.

White Coats As Superhero Capes: Med Students Swoop In To Save Health Care

Kaiser Health News:Marketplace - October 01, 2018

NEW YORK — Each wall of the library reading room at the New York Academy of Medicine is lined with tall wooden bookshelves holding leather-bound medical tomes. Atop the shelves perch busts — seemingly all white, all male — lit by two large brass chandeliers. Floor-to-ceiling windows overlook New York City’s Central Park and Fifth Avenue.

This setting, which speaks to medicine’s staid past, recently became the backdrop for plotting medicine’s future.

On a gray Sunday in September, 150 medical and nursing students dragged themselves in before 9 a.m. to learn how to meld their chosen professional careers with societal and political activism.

“As doctors, we will have this tremendous opportunity to talk to people every day,” said Miriam Callahan, a second-year student at Columbia University medical school. “We’ll have the ability to organize with them, to bring people together.”

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While doctors have traditionally been branded a mostly conservative group, there is growing evidence that young doctors-to-be are leaning leftward. This year, the American Medical Association student caucus persuaded the organization to drop its decades-long opposition to single-payer health care and instead study the concept, for example.

The conference at the academy, which was organized by medical students and sponsored by the New York City Department of Health’s Center for Health Equity along with four New York medical schools, sought to help students navigate that path. It featured a panel discussion and speeches by public health workers and doctors, including Dr. Abdul El-Sayed, a physician who mounted an unsuccessful progressive campaign this year for governor of Michigan.

The Advocacy in Medicine Conference, held Sept. 23 in New York City, trained medical students to push progressive issues. On the agenda: combating gun violence, promoting single-payer and treating refugees.(Rachel Bluth/KHN)

Dressed in blazers and dress shirts reflecting their professional identity, some also donned Planned Parenthood Buttons or Democratic Socialists of America pins. The agenda had a clear progressive bent, with workshops on LGBTQ+ health, gun violence, abortion access and criminal justice reform.

Attendees gave each other advice about how to advocate for single-payer, for example. Don’t talk about socialism, focus on the inefficiency and inequality you see, some said. Forget the “decrepit old physicians only worried about money,” their minds will never change, advised others.

Some participants were motivated by a humanitarian streak. Others were galvanized by the conditions they saw at free clinics, where they work as part of their medical education, or by a goal to increase national student engagement on issues like gun violence.

All were struggling with what they perceived as the responsibility that comes with a white coat and grappling with their place in a health care system they saw as broken.

Keven Cabrera, a fourth-year medical student at the Zucker School of Medicine at Hofstra University/Northwell, said this notion became real to him when he and some of his classmates participated this year in the March for Our Lives, a rally against gun violence.

Accustomed to the student position at the bottom of the medical hierarchy, he was taken aback by how much the white coat, even a short one that marks a student instead of a full-fledged attending doctor, afforded him respect in the community.

“We were all surprised by how much our voices counted,” Cabrera said.

About 150 medical students from eight schools gather at the New York Academy of Medicine to discuss how to advocate for their patients as they enter the medical field.(Rachel Bluth/KHN)

Everyone came to the table with the general agreement that health care for all was a moral necessity and abortion access was a fundamental right.

So they discussed how best to move these ideas forward. How do you get better reproductive education into a conservative medical school syllabus? How can you organize other students to protest, call legislators and show up for marches?

In one noisy room after lunch, students crowded around tables where doctors with experience lobbying on behalf of Physicians for a National Health Program led role-playing conversations to demonstrate how best to communicate with congressional staff or state assembly members. They also learned how to use the stories of patients they saw on a daily basis to work within the system to advocate for single-payer health care.

The students fretted — at least a bit — about how activism could help or hinder their professional success. A group sat in a semicircle listening to a doctor tell his story of being arrested at a protest.

Students asked about how civil disobedience could affect their residency placements, or get them marked as agitators within their departments. Then another chimed in: “Would you even want to be in a residency program where they would disqualify you for a protest arrest?”

Judges In California Losing Sway Over Court-Ordered Drug Treatment

Kaiser Health News:Madicaid - October 01, 2018

SANTA CRUZ, Calif. — Dressed in jailhouse orange, with hands and feet shackled, Jimi Ray Haynes stood up in a Santa Cruz County courtroom and pleaded guilty to a felony weapons charge.

Haynes, then 32, had spent the previous two weeks in jail detoxing from methamphetamine and heroin. The judge told Haynes he could serve part of his yearlong jail sentence in a drug treatment program rather than locked in county jail.

Eileen Jao, an assistant district attorney, quickly interjected: “It has to be residential, not outpatient,” she said. “It’s residential or jail.”

Jao wanted the terms to be crystal-clear. Because of a new county policy that took effect at the beginning of the year, treatment for low-income residents like Haynes, with drug-related criminal charges, must be decided by clinicians and providers — not the court. Judges can order whatever they want in terms of treatment, and prosecutors can block designated treatment they deem too risky, but essentially the type and length of treatment deemed appropriate is out of their hands.

The official record online showing that Jimi Ray Haynes can only do a residential program.

When conflicts arise between what the court orders and the providers decide, felons can languish in jail with no treatment at all.

Court-ordered rehab is increasingly falling out of fashion in California as Santa Cruz and 18 other counties begin to treat addiction like any other health condition — with the Medicaid program relying on evidence-based practices and trained personnel to make decisions on care. That has upended the status quo for judges, attorneys and defendants who often had agreed to residential treatment in lieu of jail — or at least to reduced sentences so inmates could get that treatment.

The California program appears to be unique in many respects, but other states — including Utah, Indiana, Kentucky, West Virginia, Virginia, Maryland, New Jersey and Massachusetts — also have sought federal permission to experiment with innovations in Medicaid-funded drug treatment.

In California, “these changes are a tough pill to swallow for the criminal justice system,” said Gavin O’Neill, drug court manager for the Alameda County Superior Court, which implemented the policy in July. “In the past, some judges and attorneys have been able to use residential treatment as a sanction and long-term monitoring mechanism, as well as a chance to address the underlying drug problem,” said O’Neill. “That option has been shut down.”

Proponents say that evidence-based treatment will lead to better outcomes and that residential care should be reserved for those with the most severe addictions. Under Medi-Cal, it is limited to 90 days.

“From the provider’s perspective, the judge ordering services has always been a problem,” said Katie Mayeda, a Santa Cruz County Superior Court clinician. “Judges have good intentions to put someone in treatment rather than in jail, but they don’t know the whole story. They don’t work in that realm — they’re not a clinical professional.”

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Advocates of the new approach — a Medicaid-funded pilot program that eventually is expected to be implemented in 40 California counties — say residential treatment is the most expensive and invasive option, and in many cases, outpatient treatment works as well, if not better.

If clinicians don’t approve residential treatment and prosecutors or judges won’t allow a release to outpatient treatment, the case can stall and felons become doomed to spend more time in jail.

Nearly three months into his jail stay, Haynes still was waiting for someone from a drug treatment program even to evaluate him, let alone determine his care plan. In the meantime, Haynes said, he received no drug treatment.

Because of the policy change, some prosecutors say they are less likely to accept anything but jail time.

The sign for the Santa Cruz County main jail as seen from Water Street.

“We are more inclined to just say, ‘Hey, put him in the custody of the sheriff,’ and not worry trying to treat the substance abuse problem,” said Santa Cruz County assistant district attorney Archie Webber. “If you want to do a program, you can do it on your own time.”

Webber’s rationale: He doesn’t trust the care providers, drug treatment organizations that contract with the county, to act in the interest of the state.

“We don’t want someone else to come in after us — a care provider, who hasn’t been in the process — and make those decisions for us,” Webber said.

The new policy, operating now in a third of the state’s 58 counties, stems from the expansion of Medicaid under the Affordable Care Act. That increased access to health care, including drug treatment, to the more than 13 million low-income adults in California who qualify for Medicaid.

In the past, counties had to use general funds or “block grants” to pay for court-ordered drug treatment for those who couldn’t afford it. Now, counties can pay for a range of drug treatment services — outpatient, medication-assisted, detox and residential — through Medicaid, or Medi-Cal, as it is known in California. But the new policy requires everyone seeking residential treatment to have a clinical assessment to determine whether that setting suits their diagnosis.

The counties that have begun providing drug treatment services under the so-called Drug Medi-Cal Organized Delivery System represent nearly 75 percent of the state’s more than 13 million Medi-Cal enrollees, according to the California Health Care Foundation. (California Healthline is an editorially independent publication of the California Health Care Foundation.) The rules on clinical decisions apply to everyone, not just inmates.

Santa Cruz County Superior Court on May 18.

Proponents hope all 58 California counties will come on board eventually, although the pilot Medi-Cal program is approved only through 2020, after which the federal government would have to reapprove the experiment.

Los Angeles County implemented the new Medi-Cal program just over a year ago and indicates it is running relatively smoothly.

“L.A. County got in front of it early on,” said Albert Senella, president and CEO of Tarzana Treatment Centers. “Treatment is now driven by medical necessity.”

But educating the courts on the new procedures can be a time-consuming process, and experts say it may take months or longer in some counties before the new rules sink in.

Because of a new county policy that took effect at the beginning of the year, treatment for low-income residents like Jimi Ray Haynes, with drug-related criminal charges, must be decided by clinicians and providers. (Courtesy of Santa Cruz County Sheriff’s Office)

In addition, counties and drug treatment providers say they have been weighed down by an administrative and staffing burden unlike anything they’ve seen before.

“It has been a tremendous amount of work,” said Senella. “A huge sea change in the way things are done.”

Some offenders say delays in receiving care are tough.

Haynes said he just wanted treatment, ideally in a residential setting.

“I’ve tried the whole white-knuckling sobriety thing,” said Haynes, who has a 10-year history with methamphetamine and heroin addiction. “The only measure of success I’ve had being clean and sober was in a residential drug treatment program.”

He would like to be able to visit with his wife and three children in a setting more pleasant than jail. Haynes wasn’t much older than his school-age kids are now when he visited his own father, then behind bars. He shook his head as if to erase the image.

“I don’t want my kids to see me in jail,” he said.

Haynes was released from jail this summer. Court records say his probation was revoked on July 17 after he was discharged from a drug treatment program for defiance and non-compliance.

He was re-arrested and, as of late last month, jailed in Fresno County.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

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

HHS Gov News - September 28, 2018

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

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

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

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

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

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

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


About the HHS Office of the Chief Technology Officer

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

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

Kaiser Health News:HealthReform - September 28, 2018

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

Julie Rovner

Kaiser Health News


Read Julie's Stories Anna Edney



Read Anna's Stories Joanne Kenen



Read Joanne's Stories Alice Ollstein



Read Alice's Stories

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

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

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

Among the takeaways from this week’s podcast:

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

To hear all our podcasts, click here.

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

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

Kaiser Health News:Insurance - September 28, 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Kaiser Health News:Marketplace - September 27, 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

HHS Gov News - September 27, 2018

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

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

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

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

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

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

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

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

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

HHS Gov News - September 27, 2018

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

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

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

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

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

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

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

HHS Gov News - September 27, 2018

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

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

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

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

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

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

KHN Conversation On Overtreatment

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

Treatment Overkill

Mar 13

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

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

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

Our panelists were:

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

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

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

Kaiser Health News:States - September 27, 2018

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

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

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

Read The Story

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

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

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

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

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

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

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

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

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The Deregulation Game

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Kaiser Health News:HealthReform - September 27, 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

HHS Gov News - September 26, 2018

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

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

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

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

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

The grants announced this week are in addition to the more than $1 billion announced last week for opioid-specific grants for states to address the crisis affecting the country. To learn more about HHS’s recent actions to combat the opioid overdose epidemic visit

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

HHS Announces LEAP in Health IT Winner

HHS Gov News - September 26, 2018

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

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

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

The awardees are:

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

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

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

HHS partners to develop faster tests to identify bacterial infections

HHS Gov News - September 26, 2018

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

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

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

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

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

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

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

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

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


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

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