The effort developed partly out of the realization that untreated mental health conditions negatively affect patients' physical health, thus costing the system more money.
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.
"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."
The company's former CEO has been indicted, and it has faced lawsuits from contractors alleging unpaid debts, including suits brought by two of its former doctors.
One of the largest pain management groups in the Southeast is closing multiple clinics amid worsening financial troubles and a federal criminal investigation that targeted its former chief executive.
This week, Tennessee-based Comprehensive Pain Specialists advised patients and employees about clinic closures, leaving patients scrambling to find new doctors willing to prescribe them opioids, according to a report on WSMV television.
Based in the Nashville area, CPS opened in 2005 and quickly grew into a powerhouse, which has treated as many as 48,000 pain patients a month, at more than 50 clinics in Tennessee and other states.
CPS did not respond to numerous requests for comment.
The doctor-owned company has endured a series of recent setbacks, including earlier clinic closures, pending lawsuits over alleged debts and the criminal case against former CEO John Davis.
In April, a federal grand jury in Tennessee indicted Davis on criminal kickback charges. He has pleaded not guilty. CPS also has faced nearly a dozen civil lawsuits from contractors alleging unpaid debts, including suits brought by two of its former doctors. A Justice Department official said the closure was not related to the criminal case against Davis.
The shutdown of the clinics comes amid growing backlash against the use of opioids for treating chronic pain. The opioid crisis has cost the U.S. economy more than $1 trillion since 2001, estimates Altarum, an economic research firm. Since 1999, at least 200,000 people have died nationwide from overdoses, according to the Centers for Disease Control and Prevention.
According to the company's website, CPS now operates 40 clinics in eight states: Arkansas, Illinois, Indiana, Kentucky, Mississippi, North Carolina, Ohio and Tennessee. Half are in Tennessee. The Tennessean reported Tuesday that all 21 clinics in the state would be closing by the end of the month.
CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized its Medicare billings for urine drug testing. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS' medical professionals stood among the nation's top such Medicare billers. One nurse practitioner at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billing that year, according to Medicare records analyzed by KHN.
Peter Kroll, an anesthesiologist and one of CPS' founders, said at the time that the tests were justified to monitor patients against risks of addiction or reduce chances the pills might be sold on the black market. Kroll, who is the company's current CEO and medical director, billed Medicare $1.8 million for urine tests in 2015, agency records showed.
Kroll took charge of the business when Davis left the company abruptly last summer. He could not be reached for comment Tuesday.
Federal prosecutors charged Davis with accepting more than $750,000 in illegal bribes and kickbacks in a scheme that billed Medicare $4.6 million for durable medical equipment.
"As CEO, Davis oversaw the substantial expansion of CPS, recruiting new physicians and clinics to join CPS, as well as directing various aspects of the company's overall treatment of patients," prosecutors wrote in a May court filing.
Davis has pleaded not guilty. The U.S. attorney's office has said in court filings that CPS and its employees are "victims" in the case.
The company also has been hit with civil suits. Anesthesiologist Donald E. Jones sued the company in May 2017, alleging that it failed to honor his employment contracts.
Jones said he joined the firm in 2012 to staff three Tennessee clinics at a salary of $30,000 a month plus a percentage of fees from laboratory and other services. Jones argued that he generated collections in excess of $9 million. In 2016, the clinics served 41,364 patients, the busiest of all the clinics, according to the suit.
But in April 2016, according to the suit, CPS quit paying him and in February 2017 the company began transferring his patients to other clinics and "making disparaging remarks" about him to patients.
CPS countered that Jones failed to deliver "safe and effective medical care, which CPS in court filings attributed to an "ongoing compensation dispute." The suit is pending.
Pain specialist William Wagner also is suing the company. He said he relocated from New Mexico to open a CPS clinic in Anderson, S.C., lured by the promise of $30,000 a month in salary and a share of the profits from urine tests and other services.
Instead, according to Wagner, CPS failed to collect bills for services he rendered and then closed the clinic. CPS denies Wagner's claims and says it fulfilled its obligations under the contract. In a counterclaim, CPS argues that Wagner owes it $190,000. The case is pending.
Several contractors, including companies that leased office space and medical software, also have taken CPS to court alleging unpaid bills and leases, according to court filings. The cases are pending.
Kroll told KHN last year that he and fellow anesthesiologist Steve Dickerson came up with the idea for CPS in August 2005, over a cup of coffee at a Nashville Starbucks. At the time, Tennessee was confronting an emerging opioid epidemic.
Kroll, raised in North Carolina, had moved to Nashville to launch a career in anesthesiology, a specialty he chose after watching his older brother die from an agonizing disease with little help from pain specialists.
Joined by two other doctors, Kroll and Dickerson opened with a single storefront in suburban Hendersonville. Dickerson, who was elected to the Tennessee Senate in 2012, remains at CPS, according to its website. Calls to Dickerson's office were not returned.
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.
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 fallout from Friday's federal court ruling that struck down the Medicaid work requirement in Kentucky was swift.
The decision by Judge James Boasberg immediately blocked Kentucky from enacting the provision in Campbell County, which had been set to start Sunday and roll out statewide later this year.
Within 36 hours, Kentucky Gov. Matt Bevin, a Republican, eliminated vision and dental benefits to nearly 500,000 Medicaid enrollees, saying the state could no longer afford it.
Meanwhile, Arkansas, New Hampshire and Indiana are moving ahead with the implementation of their versions of a Medicaid work requirement. It is not clear how or if Boasberg's ruling invalidating the Trump administration's approval of Kentucky's plan affects these states.
Arkansas is implementing its requirement this summer while New Hampshire and Indiana plan to phase in their rules beginning In January.
Virginia health officials say they still plan to seek federal permission to enact a work requirement but it isn't needed in order to expand Medicaid eligibility on Jan.1.
Virginia lawmakers approved Medicaid expansion in June with the condition the state apply for federal permission to include the new mandate.
"We remain focused on the work necessary to ensure that new health coverage for Virginia adults is available beginning on January 1, 2019," Dr. Jennifer Lee, director of the Virginia Department of Medical Assistance Services, said in a statement. "Developing a waiver is a separate and ongoing process, as described in the final state budget."
Virginia Medicaid is in discussions with the U.S. Centers for Medicare & Medicaid Services about its waiver, which has not yet been submitted.
Many Republican lawmakers in Virginia voted to expand Medicaid only after it was assured new enrollees would have to work or do volunteer service.
Dr. Scott Garrett, a Virginia House member from Lynchburg, Va., said he was under the impression the bill signed in June by Virginia Gov. Ralph Northam, a Democrat, meant the Medicaid expansion would begin only with a work requirement in place.
"The intent of the General Assembly … was that you could not do one absent the other," he said.
Garrett, a Republican, said he long opposed plans to add 400,000 adults to Medicaid because of cost concerns. He said requiring these enrollees to work or do volunteer service would make them healthier and improve their well-being.
Patricia Boozang, senior managing director for Manatt Health, a consulting firm, said she is not surprised states are moving ahead with work requirement plans regardless of the court ruling, which was specific to Kentucky.
She said the decision would cause the Trump administration to review the pending applications more closely so they could withstand a judicial review.
The federal court said Health and Human Services Secretary Alex Azar did not adequately take into account how many people would lose coverage for the work requirement and did not prove such a provision would improve enrollees' health.
"It's going to be challenging for them to make the case that health and well-being is going to be improved by the [work requirement] waiver," she said.
In Arkansas, some Medicaid enrollees face a Thursday deadline to register their status — that they worked, did volunteer service in June or meet one of the state's many exemptions.
"The ruling does not have an immediate effect on Arkansas' work requirement," said spokeswoman Marci Manley.
Advocates for low-income people are weighing whether to file lawsuits to stop the work requirement in other states that have won federal approval.
"We have … partnerships with state legal advocates in these states and are exploring enforcement and litigation options with them," said Jane Perkins, legal director of the National Health Law Program, which filed the suit on behalf of Medicaid enrollees in Kentucky to block the work requirements.
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.
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.
President Donald Trump has vowed that his nominees to the Supreme Court will vote to overturn Roe v. Wade, the landmark 1973 ruling that legalized abortion nationwide.
He seems to have made good on this promise with the appointment to the high court of Neil Gorsuch, whom experts expect to rule that way if given the chance.
Trump will now get another opportunity to reshape the bench with this week’s retirement announcement by Justice Anthony Kennedy.
But a Kaiser Family Foundation poll out early Friday suggests that’s not what most of the public wants.
The foundation's June tracking poll found that Americans oppose overturning Roe V. Wade by 38 percentage points — 67 vs. 29 percent.
Among Democrats and independents, support for keeping the ruling intact is even stronger, 81 percent and 73 percent respectively, according to the poll.
But the opposition does not hold across party lines.
A majority of Republicans — 53 percent — said they want the case reversed. (Kaiser Health News is an editorially independent program of the Kaiser Family Foundation.)
Respondents to the poll also opposed recent Trump administration efforts to restrict federal funding for Planned Parenthood on the grounds that it uses non-federal funds to perform abortions.
A total of 57 percent opposed the new rules, including 67 percent of Democrats and 55 percent of independents. Even a plurality of Republicans opposed the rules — 48 percent, compared with 46 percent who expressed support.
Gallup, which has been asking Americans about abortion since 1962 — more than a decade before Roe v. Wade was decided — found that unlike other social issues, for which public opinions have changed over time, abortion views have stayed relatively stable. And the public is equally divided between those who call themselves “pro-choice” (48 percent) and “pro-life” (48 percent).
Still, Gallup found that within those percentages, the public remains muddled, and generally in favor of restrictions, such as how long into a pregnancy an abortion can be performed or the reasons a woman is seeking the abortion. Just under 30 percent said abortion should be legal under any circumstances, while only 18 percent said it should be illegal under any circumstances. Fifty percent say it should be legal “only under certain circumstances.”
Like the Kaiser Family Foundation, Gallup found strong support for Planned Parenthood, with 62 percent saying they hold a “favorable opinion” of the reproductive health group.
Republicans were the only major demographic group with an unfavorable opinion of Planned Parenthood (63 percent) along with those who identify themselves as “pro-life” (59 percent).
But even in those groups more than a third of respondents approved of Planned Parenthood. Large majorities of Democrats, independents, men, women and people of all age groups have a favorable opinion of the organization, despite recent attacks on it by Trump and congressional Republicans.
Gallup said that support has remained relatively consistent since 2015, although margins have grown narrower since the 1990s.
The Kaiser Family Foundation poll was conducted June 11-20 among 1,492 adults. The margin of error is +/-3 percentage points for the full sample.
Gallup’s findings on abortion attitudes are based on its annual Values and Beliefs poll, conducted May 1-10. It has a margin of error of +/-4 percentage points. Its Planned Parenthood poll was done in June and has a margin of error of +/-3 percentage points.
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
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.
Dr. Atul Gawande, the famed surgeon-writer-researcher chosen to lead a joint health venture by three prominent employers to bring down health costs, said his biggest goal is to help professionals "make it simpler to do the right thing" in delivering care to patients.
His comments at the Aspen Ideas Festival came just days after being named chief executive of a health care partnership unveiled earlier this year by Amazon, Berkshire Hathaway and JP Morgan Chase & Co. The new enterprise will oversee health coverage for about 1.2 million employees of the companies and their families. Gawande said he will focus on the same behaviors by doctors and hospitals that he studies at his Boston-based think tank Ariadne Labs.
One of the biggest problems in health care is that "doing the right thing is incredibly complicated" and that one of the biggest sources of waste in the system is that patients are given "the wrong care in the wrong way at the wrong time," he said
He said he hopes to find specific ways to make health care more efficient and the solutions exportable.
"The opportunities are as long as my arm," he said. "So all we have to do in this new venture is pick a few of them and try to bat them out of the park."
For example, he said, even in countries where everyone is covered by insurance only about half of those with high blood pressure have it controlled. In the U.S. that percentage is closer to 40 percent. And while Americans spend "tons more money" to treat low back pain, he said, "the level of disability and pain has changed not at all."
Gawande, 52, was purposely vague about his new job — which he will add to his long list of activities, including teaching at Harvard and operating on patients at a university-affiliated hospital in Boston, writing for The New Yorker and serving as chairman of Ariadne Labs.
"We are going to come up with a name, it’s one of my first jobs," he joked to interviewer Judy Woodruff of "PBS NewsHour" during a session at Aspen on Saturday. On Monday, at another session, he told The New York Times’ David Leonhardt that he "had no idea" how many employees would eventually come to work for the organization, although it will be a stand-alone, not-for-profit entity. He declined a separate interview.
But Gawande did talk at length in both appearances about his approach to the new initiative.
"The largest concept here is I get to have a million patients that I as a doctor get to add to my responsibility," he said Saturday. "And my job to them is to figure out ways that we are going to drive better outcomes, better satisfaction with care and better cost efficiency with new models that can be incubated for all."
That is essentially what Ariadne already does — tests ways to make care more effective and efficient and spreading those practices in the U.S. and abroad.
As an example, he talked about his mother’s recent knee replacement. A total of 66 health workers saw her in the hospital — he counted — and often provided conflicting advice about whether she should be up or in bed or exactly what she should be doing.
"And you just want to say, ‘Is anybody in charge?’" he said. "That’s the broken system." The system is moving "from individual delivery of stuff … to team delivery of outcomes. And that’s a radically different place." He wants to help make that transition more effective.
Gawande said his research has also shown that "the right care" can’t just be dictated. He developed a now-famous surgical checklist that was later mandated for doctors in Canada. But he pointed out in his discussion Saturday that the requirement showed no reduction in surgery-related mortality. Yet in Scotland, where the implementation was more gradual and more data-driven, he said, "in the first three years we saw a more than 25 percent reduction in deaths."
Gawande said that although he is going to work for companies that provide insurance to their workers, "employer-based care is broken," with the vast majority of new jobs lackinghealth insurance.
And even those workers who are offered job-based health insurance are increasingly priced out of care. Some people he grew up with in Ohio, he said Monday, "are paying half their income in taxes and health care premiums and going bankrupt because of health care costs."
When workers have deductibles that are multiples larger than their bank accounts, they stop treating their chronic conditions. "And it has enormous harm for the future," he said.
Still, he was optimistic about the possibilities of making health care both better and less expensive.
"It’s feasible to do these things," he said Monday. "But it’s not sexy."
The growing number of 'food as medicine' programs nationally aim to improve nutrition among adults with serious illnesses to help them heal, recover from medical procedures, and control chronic diseases.
This article first appeared June 25, 2018 on Kaiser Health News. Listen to the audio here.
PHILADELPHIA — Feliciano Pagan stood at his front door when the MANNA food truck pulled up to his two-story brick row home.
Pagan, 48, greeted the driver with a smile as he carried in two large bags filled with frozen dinners and fresh fruit that would last a week. Among the goods were chicken fajitas with brown rice and zucchini; chicken dumplings, carrots and beets; and sweet-and-sour pork chops with turkey noodle soup.
These medically tailored meals — all with limited salt and carbohydrates — are designed to keep Pagan, who has congestive heart failure, out of the hospital. Health Partners Plans, the nonprofit company that runs the Medicaid health plan Pagan belongs to, is betting on it.
Since 2015, Health Partners has joined a small group of insurers around the country to offer some members specially designed meals to improve their health. The company paid the full cost for 560,000 meals to be delivered to more than 2,100 of its members with various conditions such as diabetes, heart disease and kidney failure.
The Metropolitan Area Neighborhood Nutrition Alliance (MANNA), a Philadelphia-based nonprofit organization that provides medically appropriate food for people with serious illnesses, prepares and delivers the meals.
The service covers three meals a day and typically lasts six weeks, although members can renew for two additional six-week cycles. It also provides nutritional counseling. MANNA provides the meals to everyone in the household to help family members support patients who need to change bad diets. Health Partners, which serves Philadelphia and nearby counties, said its investment is paying off.
With the kick-start that comes from receiving these free meals and continued counseling to shop better and prepare healthy meals, the members are better able to control their diabetes, use the hospital less and reduce their medical costs, according to the health plan.
"We wanted to see how this would work out and we are quite pleased that with the cooperation of our members we did see a dramatic reduction in their costs … and improved outcomes," said William George, CEO of Health Partners.
George would not disclose how much his health plan pays for meals, although one industry expert said it costs less than $15 a day per member.
The growing number of "food as medicine" programs nationally are aimed at improving nutrition among adults with serious illnesses to help them heal, recover from medical procedures and control chronic diseases.
Aetna and two other insurers also have added the benefit for their Medicaid enrollees in the Philadelphia area.
California's Medicaid program in May began a three-year pilot project to provide meals to several thousand adults with chronic diseases. In New York, the nonprofit group God's Love We Deliver provides medically tailored meals to two dozen Medicaid managed long-term care plans.
Despite the success of these food programs, they are not standard benefits in Medicare — the federal health program for seniors and disabled people — or Medicaid — the state-federal health program for low-income people. Advocates say efforts to expand the programs are stymied by concerns about the cost and public resistance to a government health program providing free food.
But private Medicaid and Medicare plans have discretion to spend their government funding on services outside direct medical care. Proponents of these meal services are trying to persuade more of the private plans to adopt the programs.
Karen Pearl, CEO of God's Love We Deliver, said while it may seem obvious that giving people healthy meals will help them get well, it's still a huge change for plans focused on paying for doctor visits, hospital care and drug benefits.
"For plans trying to care for high-cost members, sometimes it's hard to carve out money from the medical model, as nutrition has not always been front of mind," she said.
A recent shift among government and private insurers to pay doctors and hospitals to keep people out of the hospital could give this approach a boost, according to experts.
A study published in Health Affairs in April found providing tailored meals for at least six months in a Massachusetts Medicaid health plan reduced ER visits, hospital admissions and health spending compared with adults who did not receive an intervention.
Another study, published this month in the American Journal of Managed Care, found that when the Maine Medical Center offered specially tailored meals to 622 high-risk Medicare patients, the hospital's readmission rates dropped by 38 percent over two years, compared with patients without the intervention. The cost savings were more than $200,000, according to the research.
"Telling someone to go to the gym and eat healthy does not work anymore," George said. People either don't know how to eat nutritious meals, don't have easy access to healthy food or can't afford it, he said.
That was the case with Pagan, whose blue-collar neighborhood has fast-food restaurants but lacks a larger grocery store with a broad array of fruits and vegetables.
Pagan has had heart valve surgery and may soon need a heart transplant. His doctors have told him to cut back on greasy food, but he said he didn't know how until Health Partners offered him the special meals.
"It's hard not knowing what foods to eat," Pagan said during an interview in May just after he received his latest meals from MANNA.
MANNA uses a team of chefs and hundreds of volunteers to prepare the meals from scratch at its headquarters in downtown Philadelphia. Meals are tagged with a colored sticker depending on which of 11 types of diet they meet — such as low-calorie, high-protein or low-salt.
Unlike the popular Meals on Wheels America service, which provides meals to seniors across the country on a sliding fee scale, these specialized meals vary based on each person's health status.
"It's taken awhile for the concept to catch on that medically tailored meals are more than just food or a meal but high-tech specialty health care service for people living with complex medical needs," said Robert Greenwald, faculty director of Harvard Law School's Center for Health Law and Policy Innovation.
MANNA CEO Sue Daugherty said getting insurers to cover the cost of meals is vital to expanding her group's reach, which otherwise relies on philanthropic support. About 375 of its 1,300 clients are now covered by Medicaid health plans.
It has been challenging to get insurers to look at the meals as a way to save money, Daugherty said.
"We think of food as medicine and want folks to have access to their prescribed diet just like they do for a prescribed medication," she said.
For example, she added, cancer patients undergoing chemotherapy often have little appetite, so getting them meals rich in calories and protein is important to keep up their strength.
George said another key is nutritional counseling so members can learn to make better choices in the supermarket and prepare healthy meals themselves.
"We don't have the resources to feed everyone forever," he said.
There's little research on how people's health fares after they stop getting the medically tailored meals, said Seth Berkowitz, an assistant professor of medicine at the University of North Carolina, who co-authored the Health Affairs study. While there's little controversy that giving people nutritious meals is good for their health, more research is needed to determine who are the best candidates for these programs and how long they should last, he said.
Marina Rangel, 53, of Philadelphia, credited the meals she received in 2016 through Health Partners for getting her back on the road to health.
At the time, she weighed 400 pounds and could barely move around her home. After five months of receiving meals and counseling, she lost 45 pounds, which encouraged her doctors to give her a hip replacement. Today, her weight is down to 245, her diabetes is under control, and she works at home selling antiques on eBay.
"It's been amazing, lifesaving for me to be in the program," she said.
A group at Johns Hopkins took an innovative approach toward developing guidelines: matching the right number of opioid painkillers to specific surgical procedures.
What’s the right painkiller prescription to send home with a patient after gallbladder surgery or a cesarean section?
That question is front and center as conventional approaches to pain control in the United States have led to what some see as a culture of overprescribing, helping spur the nation’s epidemic of opioid overuse and abuse.
The answer isn’t clear-cut.
Surgeon Marty Makary wondered why and what could be done.
So, Makary, a researcher and a professor of surgery and health policy at Johns Hopkins School of Medicine in Baltimore, took an innovative approach toward developing guidelines: matching the right number of opioid painkillers to specific procedures.
After all, most doctors usually make this decision based on one-size-fits-all recommendations, or what they learned long ago in med school.
Even Makary admitted that for most of his career he “gave [painkillers] out like candy.”
In December, he gathered a group of surgeons, nurses, patients and other leaders, asking them: What should we be prescribing for operation X?”
The answer was illuminating.
“The head of the hospital’s pain services said, ‘You’re the surgeon, what do you think?’” recalled Makary.
Makary didn’t know. Nor did the resident. And the nurse practitioner, who often is the one who most closely follows up with patients, said it varies.
“Wow,” recalls Makary of that day when they first considered appropriate limits. “We’re the experts, the heads of this and that, and we don’t know.”
After a quick couple of weeks of intense discussion, Makary’s group reached consensus and gave its blessing to guidelines setting maximum numbers of opioid-containing pills for 20 different common surgical situations, from relatively minor procedures to coronary bypass surgery.
“We’re in a crisis,” said Makary, explaining why the group didn’t go a more traditional route and publish its findings in a medical journal first, which could take months.
Sometimes the right number of opioids is zero, concluded the group.
Indeed, it recommends no opioids for patients heading home after uncomplicated labor and delivery, or after cardiac catheterization, a procedure in which a thin, hollow tube is inserted into the heart through a blood vessel to check for blockages.
For certain types of knee surgery, such as arthroscopic meniscectomy, the guidelines recommend no more than 12 pills upon discharge, while a patient going home after an open hysterectomy could require as many as 20.
Optimally, “no one should be given more than five or 10 opioid tablets after a cesarean section,” Makary said.
Oh, and for cardiac bypass surgery? No more than 30 pills.
But What About The Pain?
Tens of thousands of Americans are dependent upon opioid medications. An increasing number are dying from overdoses, both from prescription medication and street drugs.
Knowing that, Makary, as well as other surgeons, hospitals and organizations, are taking steps to change how they practice medicine.
After all, many experts view the use of opioid prescription painkillers after surgery as a gateway to long-term use or dependence. A study published last year in the journal JAMA Surgery found that persistent use of opioids was “one of the most common complications after elective surgery.”
In that study, University of Michigan researchers found that 6 percent of people who had never taken opioids but received them after surgery were still taking the medications three to six months later.
With about 50 million surgeries that occur in the U.S. each year, “there are millions who may become newly dependent,” said Chad Brummett, the study’s lead author and an associate professor of anesthesiology at the University of Michigan Medical School.
Smokers, and those diagnosed with certain conditions such as depression, anxiety or chronic pain before their operations, were most at risk of long-term use.
Each refill or additional week of use makes for a greater risk of misuse, other studies have shown.
Additional research points to another reason for concern. If patients don’t take all the pills they are prescribed following an operation, those pills can be stolen or diverted to other people, who then run the risk of becoming dependent.
Still, there is debate in medical circles about just how effective recommendations and guidelines will be in stemming the epidemic.
For one thing, some experts worry that if the fight against opioids focuses only on safe prescribing at the expense of seeking alternatives, it may miss the bigger picture.
“Are there better methods than opioids in the first place?” asks Lewis Nelson, chair of emergency medicine at Rutgers New Jersey Medical School. “Could you put a lidocaine patch over the wound or is there a better way to immobilize a joint?”
Studies have shown that sometimes a combination of ibuprofen and acetaminophen can be just as good as or better than opioids.
Alternatives should always be considered first, agreed Makary.
Another concern is that guidelines for prescribing relief — even those aimed at short-duration, acute pain, such as that following surgery — have carryover effects on patients with long-term pain. Advocates say all the attention around prescribing limits have made it difficult for chronic pain patients to get the medications they need.
Some people even apply these concerns to recommendations about the treatment of acute pain.
“It’s important for a physician to have the ability, if they feel there’s a medical necessity, to write a prescription for a longer duration,” said Steven Santos, president of the American Academy of Pain Medicine. “It’s challenging to lump all patients into one basket.”
A Different Focus: Duration
Lawmakers — desperate to address overdose problems that are destroying families and communities — have gone where they usually don’t: setting specific rules for doctors.
Legislatures in more than a dozen states, including New Jersey, Massachusetts and New York, have set restrictions, often on the number of days’ worth of pills prescribed for acute pain.
“States said that since physicians haven’t self-regulated, we’re going to do it for them,” said Nelson at Rutgers.
Congress, too, is getting involved, holding a flurry of hearings this spring, and considering legislation that would, among other things, set limits on prescribing opioids for acute pain. The recently passed federal spending bill includes $3 billion in new funding to help states and local governments with opioid prevention, treatment and law enforcement efforts.
To be sure, the medical profession has also responded to the crisis — with medical societies and other expert groups offering a growing number of standards for prescribing opioids.
Some are fairly generic, recommending the lowest dose for the shortest period of time for acute pain. Some are more prescriptive.
None is meant to address the needs of chronic pain patients or those with cancer.
And state rules vary. New Jersey’s, for example, says patients with acute pain should, initially, get no more than a five-day supply, while Massachusetts sets the cap at seven days for a patient prescribed opiates for the first time.
Makary and some other experts say that, while well-intentioned, such durational rules are too blunt.
A day’s worth of pills can vary, depending on how often the doctor instructs patients to take them. Under many of the state rules, patients could still head home with more than 50 pills.
“No one should have 50 tabs sitting in their medicine cabinet” for acute pain, said Makary.
Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management, supports guidelines but wants states to take their rules a step further.
“I don’t think the way the states are going at this makes much sense because the issue with overprescribing was quantity, yet they’re passing laws around duration,” he said.
Instead, the laws should require that “if physicians are going to prescribe more than three days, they have to warn the patients that this is an addictive drug and that taking it every day for as little as five days may cause them to become physiologically dependent,” Kolodny said.
That would create a disincentive to prescribing more than three days’ worth of opioid painkillers, he added, and lead to more informed patients among those who need a longer supply.
Rutgers’ Nelson, who sat on the CDC panel that developed recommendations, said durational rules — like those adopted by the states — can be effective.
“I personally think three days is enough,” said Nelson. “That doesn’t mean pain goes away in three days, but most people get better within three to five days.”
That said, Nelson called the Hopkins’ approach an “excellent idea” and one he has tried to do. “It’s a lot harder than it sounds because of the large number of procedures and the diversity of patient needs,” he said.
To get around overprescribing — or setting one-size-fits-all guidelines — physicians at Dartmouth-Hitchcock Medical Center have a developed their own data-based approach.
Dr. Richard Barth, the chief of general surgery at Dartmouth, and colleagues studied 333 patients discharged from the hospital following six common surgeries that included bariatric procedures; operations on the stomach, liver, colon and pancreas; and hernia repair.
Surveying the patients, they asked how many opioid pills they went home with, how many they actually took, how many went unused and how much pain they experienced.
The data helped them land on a way to recommend a specific number of pills. “If they took none the day before discharge, then over 85 percent of patients did not take any when they went home,” said Barth.
Dartmouth-Hitchcock now uses that data as a recommended starting point for physicians.
Under the guidelines, patients taking no opioid pain pills the day before discharge go home with none. Those who take one to three pills get 15, an amount Barth’s study found satisfied 85 percent of patients, and those who took four or more get 30 pills.
“We came out with a very easy to implement and remember guideline,” said Barth. “We actually called patients and asked them how many [pills] they used. That’s what differentiates us from other places.”
Brummett, at Michigan, says the Opioid Prescribing Engagement Network, a collaboration of hospitals, insurers, physicians and others in his state, has used similar data methods to come up with procedure-specific guidelines.
“We’ve taken a data-driven approach,” he said. “We believe patient-reported outcomes are a better way to guide than expert consensus.”
For his part, Makary admitted it is harder to develop guidelines like those at Hopkins and Dartmouth, but he said the effort is vital.
“It’s mind-boggling to me” that so many opioid-prescribing guidelines do not specify the procedure, said Makary. “An ingrown toenail is not the same as cardiac bypass surgery.”