The effort developed partly out of the realization that untreated mental health conditions negatively affect patients' physical health, thus costing the system more money.

This article first appeared July 05, 2018 on Kaiser Health News.

By Caroline Covington

AUSTIN, Texas — Kerstin Taylor fought alcohol and substance abuse problems for two decades. She periodically sought help through addiction and psychiatric treatments to stay sober, but she continued to relapse.

That unrelenting roller coaster, and the emotional and mental fallout, left her with little energy or resources to take charge of her overall health. Taylor, 53, has asthma and doctors told her she was at risk of developing diabetes.

"I wasn't doing anything to help myself," she said about her physical health.

Then an opportunity to get coordinated mental and physical health care services helped turn life around for Taylor, who also lives with bipolar and obsessive-compulsive disorders.

Until recently, health care professionals, in general, treated the mind and body separately and cared for them under different systems. That meant someone like Taylor, who relies on public transportation, had trouble getting to referrals for physical care at locations far away from her psychiatric appointments. That made follow-ups unlikely.

In 2012, Integral Care in Austin offered Taylor a holistic approach, with access to physical health care and a program to manage chronic disease, on top of her regular psychiatric care. Many of the services were available either at the clinic or in her home, and one case manager would help Taylor handle it all.

The seamless care made a big difference, Taylor said, because her recovery depends on addressing all aspects of her health, not just her mental state.

"With chronic-disease [management], resting well, good nutrition, that's a full package right there," Taylor said. "It has really built me up to be a better woman."

Now she has her own efficiency apartment in south Austin and plans to volunteer for a local animal charity. She walks regularly with a chronic-disease case manager and has taken courses to learn how to cook healthful food on a budget.

Efforts to provide integrated care are spreading, especially in public health clinics.

It developed partly out of the realization that untreated mental health conditions negatively affect patients' physical health, thus costing the system more money.

And in 2010, the Affordable Care Act established a mandate to give parity to mental health services.

A desire to reduce costly emergency room visits also is driving the trend.

A 2007 survey conducted by the Agency for Healthcare Research and Quality indicated that 1 in 8 emergency room visits were related to a mental health or substance abuse diagnosis. Those patients were also more than twice as likely to be admitted to the hospital during that visit.

Over the past decade, the federal government has bet on integrated care to help relieve the problem. From 2009 to 2015, the Substance Abuse and Mental Health Services Administration (SAMHSA) awarded 187 grants worth over $162 million to implement integrated care models.

The Centers for Medicare & Medicaid Services also is investing in integrated care. A 2013 report by SAMHSA found that Medicaid is the largest single payer for mental health services, and nearly a quarter of the inpatient hospital stays covered by the program were for mental health and substance abuse issues.

In Texas, 64 of the state's 73 federally qualified health centers offer some mental health services, according to data from the Health Resources and Services Administration. That's a jump from just 36 clinics over a decade ago.

Integrated health care is "fundamental" to achieving state goals such as reducing suicide rates, lowering incarceration rates for people with mental health issues and developing a savvier mental health care workforce, according to the state's behavioral health strategic plan.

Learning To Be Flexible And Multitask

Austin's CommUnity Care is a federally qualified health care clinic that serves mostly low-income and uninsured patients in several locations around the city. Pediatrician Tracy Lama-Briseño sees the benefits and challenges of integrated care there every day.

She said the average person would be surprised to learn how many young children and teens deal with mental health issues.

"We do have some pretty young kids that start to present at an early age with symptoms of anxiety or sadness," she said. "Parents separating … the loss of a loved one. All that can be pretty confusing to a young child."

Lama-Briseño's clinic sees about 23,000 medical patients per year, approximately 1,700 of whom use mental health services.

Sometimes the boundaries of responsibility can get blurred between mental and physical health care, she said. "I feel like I do a little bit more social work than I would like," she said. "But in the end, it's about taking care of the kids and the families."

Addressing mental health in primary care gives access to people who might never seek it out, but it also opens the door to additional responsibilities for Lama-Briseño. For instance, CommUnity Care administers a two-question depression screening to every new patient older than 12 and repeats it for existing patients once a year. The results can prompt further action.

Lama-Briseño describes how her young patients can come in for one thing, like an earache, and then the visit turns into something completely different. She said it all happens quickly.

"You can't say ‘OK, make another appointment,'" she added. "It has to be, you know, dealt with then and there. And so I definitely had to learn how to be flexible and sort of multitask."

Lack Of Mental Health Specialists

One of the challenges for the integrated model is recruiting mental health professionals. Approximately 1 million adults statewide have a "serious mental illness," according to the Texas Health and Human Services Commission, and more than 80 percent of Texas' 254 counties don't have enough mental health professionals to care for patients.

The Department of State Health Services also reports that the majority of counties, especially in the western half of the state and in the Panhandle, have no practicing psychiatrists.

"My concern, actually, is that we don't have a big enough pipeline to fill these jobs that are gonna be available," said Neftali Serrano, executive director of the Collaborative Family Healthcare Association, an advocacy group for integrated care.

Serrano likened the problem to trying to build a plane while flying it. The health care system can't just stop, so people need to be trained in this new way so that, as integrated care becomes more common, they'll be ready to work, he said.

"This is not just about plopping a mental health professional in a primary care setting," he said. "It takes … a certain kind of behavioral health professional, and well-trained physicians and nurse practitioners and [physician assistants] to do this work well."

Buy-in from primary care doctors is another piece to the complicated puzzle of integrated care. While surveys show many support integrating mental health professionals with primary care, some lack the incentive to change their practices.

Dr. Ernest Buck is chief medical officer of Driscoll Health Plan, which serves mostly kids and families on Medicaid in a highly rural area that spans 26,000 square miles from south of San Antonio all the way down to Brownsville. Buck said most practices in his network aren't willing to bring on a therapist.

"It's hard to start a new model where a physician's practice could be put at risk, particularly at Medicaid rates," which tend to be lower than private insurance plan payments, he said.

Also, many primary care doctors simply weren't trained to work this way — collaboratively, on a team with mental health professionals.

Bill Tierney, head of Population Health at the University of Texas-Austin's Dell Medical School, said that when he was a practicing family doctor he rarely worked with mental health professionals.

"For 15 years, I practiced with no mental health support," he said. "If I sent [patients] to the mental health clinic, I didn't know whether they got there. They had a separate information system, I couldn't see how they were being treated, and patients often didn't want to go to see the shrink."

A growing number of nurse practitioners—typically, registered nurses who have completed a master's degree in nursing—are adding up to a year of clinical and other training, often in primary care.

This article first appeared July 03, 2018 on Kaiser Health News.

By Michelle Andrews

The patient at the clinic was in his 40s and had lost both his legs to Type 1 diabetes. He had mental health and substance abuse problems and was taking large amounts of opioids to manage pain. He was assigned to Nichole Mitchell, who in 2014 was a newly minted nurse practitioner in her first week of a one-year postgraduate residency program at the Community Health Center clinic in Middletown, Conn.

In a regular clinical appointment, “I would have been given 20 minutes with him, and would have been without the support or knowledge of how to treat pain or Type 1 diabetes,” she said.

But her residency program gives the nurse practitioners extra time to assess patients, allowing her to come up with a plan for the man’s care, she said, with a doctor at her side to whom she could put all her questions.

A few years later, Mitchell is still at that clinic and now mentors nurse practitioner residents. She has developed a specialty in caring for patients with HIV and hepatitis C, as well as transgender health care.

The residency program “gives you the space to explore things you’re interested in in family practice,” Mitchell said. “There’s no way I could have gotten that training without the residency.”

Mitchell is part of a growing cadre of nurse practitioners — typically, registered nurses who have completed a master’s degree in nursing — who tack on up to a year of clinical and other training, often in primary care.

Residencies may be at federally qualified health centers, Veterans Affairs medical centers or private practices and hospital systems. Patients run the gamut, but many are low-income and have complicated needs.

Proponents say the programs help prepare new nurse practitioners to deal with the growing number of patients with complex health issues. But detractors say that a standard training program already provides adequate preparation to handle patients with serious health care needs. Nurse practitioners who choose not to do a residency, as the vast majority of the 23,000 who graduate each year do not, are well qualified to provide good patient care, they say.

As many communities, especially rural ones, struggle to attract medical providers, it’s increasingly likely that patients will see a nurse practitioner rather than a medical doctor when they need care. In 2016, nurse practitioners made up a quarter of primary care providers in rural areas and 23 percent in non-rural areas, up from 17.6 and 15.9 percent, respectively, in 2008, according to a study in the June issue of Health Affairs.

Depending on the state, they may practice independently of physicians or with varying degrees of oversight. Research has shown that nurse practitioners generally provide care that’s comparable to that of doctors in terms of quality, safety and effectiveness.

But their training differs. Unlike the three-year residency programs that doctors must generally complete after medical school in order to practice medicine, nurse practitioner residency programs, sometimes called fellowships, are completely voluntary. Like medical school residents, though, the nurse practitioner residents work for a fraction of what they would make at a regular job, typically about half to three-quarters of a normal salary.

Advocates say it’s worth it.

“It’s a very difficult transition to go from excellent nurse practitioner training to full scope-of-practice provider,” said Margaret Flinter, a nurse practitioner who is senior vice president and clinical director of Community Health Center, a network of community health centers in Connecticut.

“My experience was that too often, too many junior NPs found it a difficult transition, and we lost people, maybe forever, based on the intensity and readiness for seeing people” at our centers.

Flinter started the first nurse practitioner residency program in 2007. There are now more than 50 postgraduate primary care residency programs nationwide, she said. Mentored clinical training is a key part of the programs, but they typically also include formal lectures and clinical rotations in other specialties.

Not everyone is as gung-ho about the need for nurse practitioner residency programs, though.

“There’s a lot of debate within the community,” said Joyce Knestrick, president of the American Association of Nurse Practitioners. Knestrick practices in Wheeling, W.Va., a rural area about an hour’s drive from Pittsburgh. She said that there could be a benefit if a nurse practitioner wanted to switch from primary care to work in a cardiology practice, for example. But otherwise she’s not sold on the idea.

A position statement from the Nurse Practitioner Roundtable, a group of professional organizations of which AANP is a member, offered this assessment: “Forty years of patient outcomes and clinical research demonstrates that nurse practitioners consistently provide high quality, competent care. Additional post-graduate preparation is not required or necessary for entry into practice.”

“We already have good outcomes to show that our current educational system has been effective,” Knestrick said. “So I’m not really sure what the benefit is for residencies.”

The issue of conflicts of interest has become more pressing in recent years as drug prices soar and health care companies reach out to the academic and policy community for advice.

This article first appeared June 29, 2018 on Kaiser Health News.

By Sarah Jane Tribble

When Dr. Mark McClellan sat for an in-depth 30-minute question-and-answer session at an April health policy forum, the audience was filled with top researchers, advocates and Capitol Hill staffers eager to hear what insight the former head of the Food and Drug Administration would dispense.

He did not disappoint.

In response to a question about how competition might drive down the cost of new drugs made from living cells, McClellan said, "That is a great example of where more clarity from FDA about what exactly is required could potentially open up more biosimilar competition."

McClellan is director of the Margolis Center for Health Policy at Duke University, the academic position by which he’s commonly identified. But he frequently has not disclosed another position he’s held since late 2013: He earned $285,000 last year on the board of pharmaceutical giant Johnson & Johnson, a company accused of blocking the sale of Pfizer’s Inflectra biosimilar, which competes against J&J’s blockbuster Remicade, a rheumatoid arthritis drug.

According to corporate financial filings, McClellan has been compensated with more than $1 million in cash and stock awards since taking that post.

McClellan also receives compensation as a member of the advisory board of privately held Alignment Healthcare, which employs doctors and provides chronic-care management for Medicare Advantage plans in three states. Alignment Healthcare declined to disclose his compensation.

The issue of conflicts of interest has become more pressing in recent years as drug prices soar and health care companies reach out to the academic and policy community for advice — often with generous payments attached, ethics experts say.

Sen. Claire McCaskill (D-Mo.) introduced a bill in June that would require drugmakers to report payments to patient advocacy groups and professional societies. If passed, it would toughen the Sunshine Act, which requires pharmaceutical companies to report payments to teaching hospitals and physicians, detailing how much was paid annually to doctors for travel, speaking and food.

As a board member to these for-profit health care companies, McClellan has a fiduciary obligation "not to injure them" when writing articles and speaking, said Stephen Bainbridge, law professor at UCLA.

And while there is no legal requirement to disclose board memberships when writing for journals or speaking, Bainbridge and other experts agreed there is an ethical obligation.

"There’s certainly a potential conflict of interest there," Bainbridge said, adding that while serving on the board of Johnson & Johnson "you are dealing with an enormous company that has fingers in a lot of different pies."

McClellan said in an emailed statement that he provides specific disclosures on topics on which his interests might give the appearance of conflict, including in medical journals and at speaking engagements.

"My board memberships are public information and are broadly known within the field, and I stand by the independence and integrity of all my work," McClellan said.

Ellen de Graffenreid, director of communications at the Duke-Margolis Center, said it was "clear that Dr. McClellan disclosed his position on the Johnson & Johnson Board when a potential conflict of interest existed — that is, when the publication mentions drugs or devices that may intersect with J&J’s business." She said that while he serves on the J&J board, he "does not advocate for any positions on behalf the company."

McClellan is a prolific writer and speaker about how the U.S. health care system operates. He left his work at the Brookings Institution to become the founding director of Duke-Margolis in 2015. He ran the FDA from 2002 to 2004 and served as administrator of the U.S. Centers for Medicare & Medicaid Services from 2004 to 2006 before joining Brookings.

In a majority of the articles McClellan wrote for the Journal of the American Medical Association, he did not disclose his corporate connections when he filled out forms concerning potential conflicts of interest. Of 15 papers he wrote since 2013, McClellan disclosed his relationship with Johnson & Johnson three times.

Johnson & Johnson is a Fortune 500 health care giant, with more than $76 billion in annual sales and a range of products including pharmaceuticals, medical devices and consumer products that include brand names Aveeno, Tylenol and Neutrogena.

"I don’t think there’s any reason to cover up or ignore those [corporate] relationships," said Arthur Caplan, a professor of bioethics at New York University School of Medicine. "In general … I would say disclose more."

Journals, conferences and policy forums generally ask contributors to list their potential conflicts of interest — financial relationships that might in some way sway their opinion or color the audience’s perception of information they relay. But the experts themselves decide which connections to list.

At the April forum addressing high drug prices, which was hosted by Kaiser Permanente’s Institute for Health Policy, neither the forum’s agenda, nor the speaker’s introduction at the event mentioned McClellan’s Johnson & Johnson role. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Kaiser Permanente’s John Nelson said speakers at the forums typically have extensive backgrounds and "thus we only provide abbreviated biographies when introducing them." Kaiser Permanente declined to say whether they knew of McClellan’s corporate roles.

Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, said he favors disclosure of corporate roles and thinks "many [people] would argue that it should be for the reader and not the author" to determine whether there is a conflict of interest.

The question of when to disclose industry or nonprofit funding has been debated for decades, said Dr. Sandro Galea, who wrote about conflicts of interest and schools of public health last year in JAMA.

"There are public and private actors and both importantly shape the environment in which we are in," Galea said, adding that it has been "relatively standard practice" for those in academia to determine for themselves whether there is a conflict to disclose.

Bioethics professor Caplan said he could understand why some authors would choose not to disclose a board membership in every article, particularly if the article wasn’t directly related to the company or its products. Caplan serves as an unpaid chair of a compassionate use advisory committee based at New York University and funded by Janssen, which is a division of Johnson & Johnson.

"Just because you have a connection to a company, in my opinion, you don’t necessarily generate a conflict for everything that you do," Caplan said. "We have to get more sophisticated" about conflicts of interest, though he advocates personally for full disclosure.

Elite medical journals, including JAMA and the New England Journal of Medicine, have streamlined the conflicts of interest question by using a standard disclosure form created by the International Committee of Medical Journal Editors.

JAMA media relations manager Deanna Bellandi declined to release McClellan’s ICMJE forms and said, "We publish what authors provide."

The New England Journal of Medicine publishes the ICMJE forms with its manuscripts. McClellan disclosed his role at Johnson & Johnson in a 2015 letter to NEJM about the 21st Century Cures Act, a sweeping law that increases funding for disease research and alters the regulatory system for drugs and medical devices. But he did not disclose any corporate roles in two recent articles for NEJM Catalysts, a separate publication that requires authors to fill out a separate disclosure form. Those 2017 articles focused on payment reform and private-sector entrepreneurship in health care.

When completing the standard ICMJE disclosure form, an author fills out a series of sections. Section 3 notes: "You should disclose interactions with ANY entity that could be considered broadly relevant to the work." And it tells the author to report "all sources of revenue paid (or promised to be paid) directly to you or your institution on your behalf over the 36 months prior to submission of the work."

The Duke-Margolis Center and McClellan have been at the forefront of discussions on the merits of using real-world evidence, a somewhat controversial topic that could alter the way drugs are regulated and approved. The idea is that once a drug is on the market, the patients’ experience might in part supplant rigorous and expensive clinical trials.

Johnson & Johnson, whose executives are open proponents of the use of real-world evidence, did not respond to requests for comment.

McClellan did not disclose his J&J board membership in a 2017 white paper about real-world evidence, which was funded in part by the FDA. In September 2017, McClellan's role at J&J was not disclosed during a public event done in coordination with the FDA. In December, Duke-Margolis announced a Real-World Evidence Collaborative, which is funded by pharmaceutical companies including Johnson & Johnson.

In May, a $4.2 million FDA grant was reposted for bids after concerns that Duke-Margolis was the sole bidder listed on the grant. The grant focuses on the drug approval process and research initiatives in the 21st Century Cures Act, including the potential benefits of using real-world evidence to analyze whether a drug works instead of rigorous and expensive clinical trials.

"Billions of dollars ride on the evidence that the FDA will accept for whether or not a drug is safe and effective," said Avorn, whose center does similar research on drug pricing.

A poll showed 7 in 10 people think insurance companies should not be permitted to deny coverage because of a person's medical history or charge them higher rates

This article first appeared June 27, 2018 on Kaiser Health News.

By Jordan Rau

Even as many Republicans continue to back a repeal of the Affordable Care Act, a majority of GOP voters want to retain a core consumer protection of the law that prohibits insurers from denying care or charging more to people with histories of health problems, according to a poll released Wednesday.

The requirement that insurers treat people with preexisting conditions the same as those with pristine health histories allowed the law to expand coverage to millions of previously uninsurable people starting in 2014.

But the Trump administration has refused to defend it in a legal challenge against the law brought by 20 Republican state attorneys general. The administration called for the protections guaranteeing coverage to be nullified.

The poll from the Kaiser Family Foundation showed 7 in 10 people think insurance companies should not be permitted to deny coverage because of a person’s medical history or charge them higher rates. Support for the preexisting conditions provision included 58 percent of Republicans. (Kaiser Health News is an editorially independent program of the foundation.)

As the 2018 congressional elections near, Democratic and independent voters identify health care as "the most important issue" for candidates to discuss. Support for the provision is especially strong among households where someone has a preexisting condition. But it remains a second-tier priority for Republican voters, according to the poll, nearly tied with immigration and behind the economy and jobs. Nearly 6 in 10 Republican voters place a priority on a candidate’s support for repealing the health law.

There is more partisan agreement on President Donald Trump’s proposal to require that drugmakers publish list prices for their drugs in television commercials. Three-fourths of the public support the idea.

Those drug ads are ubiquitous on TV, and 14 percent of people who said they saw an ad said they had talked with a doctor about the specific medicine, the poll found. More than half said the physician gave them the drug and 48 percent said they discussed the cost of the medicine with the doctor.

The poll was conducted June 11-20 among 1,492 adults. The margin of error is +/-3 percentage points for the full sample.