This article was first published on Monday, July 15, 2019 in MedPage Today.
By Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today
Some 570 medical residents and fellows are in limbo as the shuttering Hahnemann University Hospital in Philadelphia has announced plans to sell its training programs for $7.5 million to Tower Health – a smaller system that can't accommodate all of the trainees.
Given the limited availability, many have sought new offers -- but they can't accept them until hospital administrators can release them along with the federal funding that follows each trainee. That can't happen until the deal is approved by a U.S. bankruptcy court.
Hahnemann – the primary teaching hospital affiliated with Drexel University College of Medicine – announced on June 26 that it was filing for bankruptcy and closing its doors in September. The safety-net hospital, which is more than 170 years old, primarily serves Philadelphia's low-income and vulnerable patients.
"We are not officially 'orphaned.' That was halted during one of the bankruptcy court hearings," one medical resident who spoke on the condition of anonymity told MedPage Today, saying hospital administrators have told residents not to speak to reporters. "Hence, those of us with offers are on hold."
That's frustrating because competition for those spots is fierce: Jason Martinez, MD, a PGY3 general surgery resident at Hahnemann, said in a tweet that "we're all competing with our co-residents, some people with multiple offers actively hurt the next doc in line, as they're NOT getting that offer."
At issue is the federal funding that helps pay for residency training. Medicare covers part of the expense of training residents, and that funding stays with each program until the resident completes training, according to the Accreditation Council for Graduate Medical Education (ACGME).
A spokesperson for the American Academic Health System, Hahnemann's parent company, didn't return a request for comment on when its administrators might be able to approve residents' transfer requests. Another court hearing is set for later this week.
Last week, Tower Health said it would pay $7.5 million for the training programs; that too is subject to bankruptcy court approval. Yet Tower currently has only 118 trainees across its six hospitals, in just five of the 15 specialties offered at Hahnemann, according to the Philadelphia Inquirer.
In the meantime, the ACGME says it has located 1,000 available positions for displaced residents and fellows. "The ACGME accreditation teams and Review Committees are expediting the consideration of requests related to Hahnemann's closure, including temporary and permanent complement increase requests from programs that would like to accommodate the transfer of displaced residents/fellows," the organization said in a statement.
But programs may be hesitant to go forward with offers if there is no guarantee of funding, said Ivy Baer, JD, MPH, senior director and regulatory counsel for healthcare affairs at the Association of American Medical Colleges (AAMC).
"If a hospital receiving displaced residents wanted certainty that it would get those slots, and many do as risk is difficult, then that hospital would need to wait," Baer told MedPage Today.
Both the AAMC and the ACGME have filed motions in bankruptcy court to help ensure timely placement of residents.
"We really feel terribly for them, and that's why we want to make sure they remain in the minds of everyone as this is proceeding," Baer said. "It could be hard finding new spots, especially as residencies started July 1. Everyone was set for the year, and then this happened."
On Monday, Bernie Sanders appeared at a rally at Hahnemann with hundreds of supporters, urging administrators not to close the hospital.
"At a time when our country faces a major health care crisis, when 80 million Americans are either uninsured or underinsured, including tens of thousands of people here in the Philadelphia area, we should be moving, we must be moving forward to guarantee health care to all the people as a right," the presidential candidate said during the rally.
Physicians' group and others file suit claiming laws force physicians to mislead patients.
This article was first published on Tuesday, July 9, 2019 in MedPage Today.
By Shannon Firth, Washington Correspondent, MedPage Today.
The American Medical Association last month filed suit against two North Dakota laws that they say violate physicians' First Amendment rights by requiring them to "mislead and misinform" patients seeking abortions.
In the late-June filing, the AMA and its co-plaintiffs argue that the laws could "inflict irreparable harm on patients" and undermine physicians' responsibility to deliver "honest and informed advice," according to an AMA press release.
"North Dakota's law undermines [the patient-physician] relationship by requiring physicians to mislead and misinform their patients with messages that contradict reality and science," said AMA President Patrice Harris, MD, in the release.
In particular, the laws infringe on physicians' and other care team members' freedom of speech by inserting "government scripted information" of an "ideological" nature into the patient-physician relationship under the guise of informed consent, notes the complaint filed by the AMA and its co-plaintiffs, the Center for Reproductive Rights, Red River Women's Clinic in Fargo, and Kathryn Eggleston, MD, the clinic's medical director.
"The AMA will always defend science and open conversations about all health care options available to patients," Harris said.
'Indoctrinate, Shame and Stigmatize'How SPOT works
The first law, which has already been enacted, requires physicians to tell patients that an abortion terminates "the life of a whole, separate, unique, living human being." The plaintiffs call this law the "Compelled Personhood Mandate."
"Effectively through the Compelled Personhood Mandate, the State attempts to use Physicians to indoctrinate, shame and stigmatize patients seeking abortion," the complaint notes.
The second law, which the AMA and co-plaintiffs dubbed the "Compelled Reversal Mandate," requires physicians to provide what they describe as "a controversial, ideological, and non-medical message" regarding abortion reversals. The lawsuit was filed in the U.S. District Court for the District of North Dakota, and the law is slated to take effect on Aug. 1, 2019.
The law requires that "the physician or the physicians' agent" verbally tell a patient "[t]hat it may be possible [to] reverse the effects of an abortion-inducing drug if she changes her mind, but time is of the essence, and information and assistance with reversing the effects of an abortion-inducing drug are available in the printed materials given to her," according to the complaint.
This information must be delivered within 24 hours before either surgical or medical abortions, the AMA complaint states.
Seven other states -- Arkansas, Idaho, Kentucky, Oklahoma, Nebraska, South Dakota, and Utah -- have passed similar legislation requiring doctors to inform patients about medication-abortion "reversal" methods, according to the AMA press release.
The aim of the lawsuit is to block enforcement of the state's "compelled speech laws," as the AMA and co-plaintiffs refer to them.
'I Cringe Because I Don't Believe It'
Red River is the state's only clinic that provides abortion services. Clinic Director Tammi Kromenaker said she's currently required to state the "whole, separate, unique, living human being" language to patients, but each time she says it, "I cringe because I don't believe it."
While patients, especially in red states like North Dakota, are used to having to overcome multiple hurdles before receiving an abortion -- including hearing such statements -- that does not mean such policies are inevitable, Kromenaker said.
"I don't want to lie to our patients without putting up a fight," she told MedPage Today.
North Dakota has made it clear that it doesn't support abortion and does not want anyone to make the decision to have an abortion, Kromenaker added. She stressed that "by giving [patients] this false information, it's almost like the state is ... encouraging women to make the decision without being confident ... 'Oh go ahead and take the first pill because you can always just reverse it.'"
She said she is also concerned that if she's forced to share information about abortion reversals, problems and confusion are likely to ensue.
"What happens when a patient says, 'Wait, hold on ... what does [abortion reversal] mean?' Then, what do I say? I'm not going to quote the New England Journal of Medicine," Kromenaker said, referring to a 2018 article refuting claims about abortion reversals by Daniel Grossman, MD, and Kari White, PhD, MPH.
A 2015 systemic review by Grossman and colleagues concluded that the "evidence is insufficient" to show that receiving progesterone after mifepristone (Korlym and Mifeprex) leads to a higher proportion of continued pregnancies than "expectant management."
"We believe very strongly that women should be confident in their decision before they take the pill or undergo the abortion procedure," Kromenaker said.
'Legal Personhood'
Donna Harrison, MD, executive director for the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), argued that both North Dakota laws are sound.
"It's ridiculous to argue that it's government scripted" information, Harrison said.
Regarding the law that the AMA calls Compelled Personhood Mandate, "It isn't an issue of assigning legal personhood; it's an issue of stating scientific fact," she said. "Full informed consent is the medical standard of care prior to a procedure, and all this law is doing is requiring that abortionists comply with full informed consent."
"If they want to admit that what they're doing is not medical, [that] it's in fact an elective procedure ... abortion treats no disease ... Then they can't hide behind an argument that what they're doing is actually providing any kind of medical care," she added.
As for the evidence for abortion reversal, Harrison said it's "well-established" that the effects of mifepristone can be reversed with progesterone.
She highlighted a 1989 study on the effects of mifepristone and progesterone in pregnant rats, a 2017 systematic review of embryo survival after mifepristone, and a 2018 observational case seriesof 754 patients who tried abortion reversal using progesterone, which concluded that the "reversal of the effects of mifepristone using progesterone is safe and effective."
"It's the same principal that we use when someone comes in with an opioid overdose, and you give them naloxone," she told MedPage Today.
Progesterone has been used in the fertility industry for decades and has already been proven safe, Harrison added.
Harrison also said it was "bizarre" that the AMA decided "without consulting its membership, to become a pro-abortion activist organization. I don't think that they represent the AMA membership in this."
The AMA indicated to MedPage Today that the North Dakota lawsuit does not represent a change in policy, and is grounded in an opposition to government interference in the practice of medicine, including "the use of government-mandated physician recitations."
Molly Duane, JD, the lead attorney on the case for the Center for Reproductive Rights, countered that the main studies used to bolster anti-abortion arguments have questionable methodology, small sample sizes, or data from self-selected patients for "continued survival." She also said that some of these studies lacked control groups or did not have the approval of institutional review boards.
Medication abortion is a two-drug regimen in which patients take one pill orally and then a second 24 to 48 hours later, Duane said.
"What we know from the real literature is that mifepristone, on its own, will cause termination of pregnancy in around half of cases, and so there's no evidence that taking progesterone after mifepristone, instead of misoprostol [synthetic prostaglandin E1 analogue], is any better or worse for survival of the pregnancy than doing nothing at all," Duane said.
"Every major mainstream medical organization in the country rejects the idea that abortion reversal is possible," she added.
Also, the medical abortion regimen is FDA-approved, whereas the FDA has never approved any form of abortion reversal, Duane said.
"Just because one physician has a theory about something doesn't mean that it works in practice," she said.
Harrison countered that the studies submitted to the FDA for approval of mifepristone were not randomized, blinded, or controlled. Moreover, randomizing a study for patients who want progesterone wouldn't be ethical, she said.
'All Physicians Should Be Worried'
Duane stressed that the reason for the current lawsuit is the "imminent danger to physicians' free speech right," noting the August 1 planned enactment of the abortion-reversal law. (A press representative was present during the phone interview.)
A handful of other states have either amended or enacted laws requiring physicians to tell patients that abortion can be reversed, and most of those laws were passed just in the last year.
Duane emphasized that "this is something that all physicians should be worried about, because if the state can force physicians to act as a mouthpiece for a controversial and patently false statement in the abortion context, what's to stop them from doing that in other contexts as well?" Duane asked.
That decision "highlights that physicians have First Amendment rights just like everybody else, and they don't lose those constitutional rights just because they're speaking in a physician's office or because they're providing abortion care," Duane said.
Such rights are "paramount" when it comes to the patient-provider relationship, she continued.
"Physicians need to be able to develop a relationship of trust with their patients, which they can't do if the state is forcing them to lie to their patients and effectively to violate their own medical ethics as a condition of providing abortion care, which is exactly what this law does," Duane said.
Violators of North Dakota's laws would be subject to criminal penalties, including imprisonment, a fine, or both, Duane said.
She said she expects to have more information from the courts regarding the implementation of the abortion-reversal law "in the weeks to come."
Default orders can help physicians de-implement low-value treatments.
This article was first published on Monday, July 1, 2019 in MedPage Today.
By Ian Ingram, Deputy Managing Editor, MedPage Today.
Adding a default order to the electronic health record (EHR) halved the use of unnecessary daily imaging before palliative radiation therapy in advanced cancer patients, a randomized trial found.
Before the EHR "nudge" at five University of Pennsylvania Health System radiation oncology centers, daily imaging was used 68% of the time prior to palliative care. This number dropped to 32% after implementation (adjusted OR 0.43, 95% CI 0.24-0.77), reported Sonam Sharma, MD, of the Icahn School of Medicine at Mount Sinai in New York City, and colleagues in JAMA Oncology.
"I was surprised by how quickly these types of nudges can work," Sharma told MedPage Today. "Almost as soon as we implemented the nudge -- very, very quickly thereafter -- we saw large and sustained drops in the number of imaging orders that were used in palliative radiation."
According to background information in the study, it's estimated that about 250,000 patients with advanced cancer receive palliative radiation therapy each year to control pain or bleeding, or improve patients' quality of life. Since 2016, however, national guidelines have recommended for weekly rather than daily imaging in the palliative setting.
Sharma, who took part in the research while at the Perelman School of Medicine at the University of Pennsylvania, said daily imaging, which is required during curative radiation interventions, was being used almost reflexively in the palliative setting as well.
"It was a habit that we identified, and at first struggled in ways at our own clinic to change, until we identified this sort of behavioral economics tool that might be very effective, and proved itself to be very effective at changing that behavior," she said.
Over a 4-month period, a default imaging order in the EHR was added to specify no daily imaging during palliative radiotherapy, first at the university and then in community-based clinics in New Jersey and Pennsylvania. This was "preceded by a department-wide session with intervention group physicians and therapy staff announcing the initiation of the intervention," according to the study's protocol. Physicians retained the option to select a different frequency for imaging.
Similar declines after the nudge versus the pre-intervention period were observed across settings:
University (67.2% to 28.8%, adjusted OR 0.33, 95% CI 0.14-0.76)
Community (69.4% to 42.3%, adjusted OR 0.45, 95% CI 0.22-0.89)
Sharma noted that EHR nudges also could improve use of guideline-recommended hypofractionated radiation therapy for common cancers such as breast and prostate, with the potential to standardize care and reduce low-value care.
"It's really hard to change clinical practice, and innovative tools like nudges that are baked into the electronic health record seem not only promising, but now in cancer care have been shown to help physicians practice more patient-centered care," co-author Justin E. Bekelman, MD, director of the Penn Center for Cancer Care Innovation in Philadelphia, told MedPage Today.
He pointed out that the"Choosing Wisely" initiative has targeted low- or no-value healthcare, yet literature has shown that simply giving physicians or patients information on what these are doesn't typically yield change. The findings from the current study could be translatable to other areas of low-value care identified by "Choosing Wisely" and other organizations, he said.
"Not only do we know that nudges can help doctors pick up high-value treatments, but what this shows is that nudges can help doctors de-adopt or de-implement low-value treatments," said Bekelman.
His group's study was a stepped-wedge cluster randomized trial from 2016 to 2018 that involved 21 radiation oncologists who performed at least 10 palliative courses during the trial period. Daily imaging was defined as occurring at least 80% of the time.
In all, 1,019 adults received 1,188 courses of palliative radiation therapy for metastases of the bone, soft tissue, brain, or multiple sites. The bulk of the treatments took place in the academic setting (n=747). Secondary analyses that adjusted for patients' age, sex, race, type of insurance, and other clinical and treatment factors yielded similar findings.
The study was funded, in part, by grants from the National Cancer Institute and the University of Pennsylvania Health System's Penn Medicine Nudge Unit and Department of Radiation Oncology.
Sharma reported no conflicts of interest. Bekelman has served as a consultant for the Centers for Medicare and Medicaid Services. Another co-author reported ownership of Catalyst Health and serving on the advisory boards for Life.io, HealthMine Services, and Holistic Industries.
EEG study points to possible prognostic tool early after acute brain injury.
This article was first published on Thursday June 27, 2019 in MedPage Today.
By Judy George, Senior Staff Writer, MedPage Today.
About one in six clinically unresponsive ICU patients showed electroencephalography (EEG) patterns of brain activity when spoken to soon after acute brain injury, a single-center study showed.
In 16 of 104 (15%) unresponsive patients, a machine-learning algorithm that analyzed EEG recordings detected brain activation following researchers' verbal commands a median of 4 days after injury, according to Jan Claassen, MD, of Columbia University in New York City, and colleagues.
Half of these 16 patients improved to the point that they were physically able to follow commands a median of 6 days later, the researchers reported in the New England Journal of Medicine. The injured patients who showed early brain activity were four times more likely to achieve partial independence at 12 months than similar patients with no activity, they added.
If confirmed, these findings "could inform prognostication of acute brain injury and potentially provide a means of communication with patients who seem unresponsive on the basis of a conventional clinical examination," wrote David Menon, MD, PhD, and Srivas Chennu, PhD, both of the University of Cambridge in England, in an accompanying editorial.
Not being able to follow commands early after an acute, severe brain injury traditionally has been thought to mean either that damage is too severe for consciousness to return or that the ability to follow commands and other signs of consciousness may recover over time as injury and sedative effects fade, Menon and Chennu noted.
"However, a third possibility exists: there is activation of cerebral neural circuits for perception of commands that is not accompanied by corresponding motor responses," they wrote.
This phenomenon, known as cognitive–motor dissociation, is seen in about 15% of chronically unresponsive patients, with fMRI or EEG indicating cerebral activation during motor imagery tasks in patients who demonstrated no motor responses to commands. Other studies in chronic disorders of consciousness have shown a related phenomenon known as "covert cognition," when brain activation occurs in unresponsive patients during cognitive tasks that do not require the patient to attempt to move.
In this study, Claassen and colleagues looked for cognitive-motor dissociation in patients shortly after brain injury, since the absence of an ability to follow commands at that point may affect decisions about withdrawing life-sustaining therapies.
They identified 104 patients with acute brain injury from 2014 to 2107 who were unable to follow spoken commands, excluding patients with seizures, hyperglycemia, abnormal sodium, and renal or fulminant liver failure. Before each EEG assessment, they rated each patient on the 23-point Coma Recovery Scale–Revised (CRS-R), and classified sedation as minimal, low, or moderate. If deemed safe, sedation was reduced for an EEG assessment.
The researchers acquired a total of 240 EEG recordings while issuing verbal commands such as "open and close your hand." During half (52%) of the recordings patients were comatose; 54 recordings occurred (22%) while patients were in a vegetative state, and 60 (25%) while patients were in a minimally conscious state–minus category.
The machine-learning algorithm (support vector machine) detected cognitive–motor dissociation on at least one recording a median of 4 days after ICU admission in 16 of 104 (15%) patients. These 16 patients had injury from subarachnoid hemorrhage (five people), traumatic brain injury (three), intracerebral hemorrhage (four), cardiac arrest (two), neurosarcoidosis (one), and bupropion overdose (one).
Eight of these 16 patients (50%) and 23 of 88 patients (26%) without brain activity improved to the point where they were able to follow commands before discharge. At 12 months, 7 of 16 patients (44%) with brain activity and 12 of 84 patients (14%) without brain activity had a Glasgow Outcome Scale–Extended level of 4 or higher, indicating they were able to function independently for 8 hours (OR 4.6; 95% CI 1.2-17.1).
Six patients with cognitive–motor dissociation (38%) and 50 without (60%) were dead at 12 months. Four of six patients with cognitive–motor dissociation who died did so after life-sustaining therapy was withdrawn.
While some responses were inconsistent, the findings are intriguing, especially since EEG is more easily used and more widely available than fMRI in the ICU, Menon and Chennu wrote. The verbal commands used were similar to ones used in bedside clinical examination to determine whether a patient is unresponsive, they pointed out: "It is noteworthy that [the researchers'] methods were designed to reduce the risk of false discovery of cognitive–motor dissociation."
But questions remain and replicating this study is essential, they said. "Future studies should explore spatial patterns of EEG activation, quantify false positive detection rates of the EEG classifier, understand the basis of inconsistent responses within patients, and provide details and evaluation of the specifics of support vector algorithms," Menon and Chennu wrote. It's also unclear whether sedation or arousal played a role in the outcomes.
"A better understanding of the neural substrates for cognitive–motor dissociation could identify neurotransmitter systems as targets to restore behavioral responsiveness," they added.
Last Updated June 28, 2019
This study was supported by the Dana Foundation and the James S. McDonnell Foundation.
Nearly half of the rest of respondents reported feeling stressed and having less energy, while only 23.7% reported enjoying their work.
This article was first published on Monday, June 24, 2019 in MedPage Today.
By Ashley Lyles, Staff Writer, MedPage Today
Few cardiologists in a survey said they liked their jobs, with a majority reporting feelings of stress or burnout.
More than 25% of U.S. cardiologists indicated they were burned out, reported Laxmi Mehta, MD, of Ohio State University in Columbus, and colleagues in the Journal of the American College of Cardiology.
Nearly half of the rest of respondents reported feeling stressed and having less energy, while only 23.7% reported enjoying their work, the investigators found.
Prior research has shown lower burnout rates among cardiologists than in other medical specialties, which calls for further assessment of possible protective factors, noted the researchers. "By identifying modifiable drivers of burnout, our data may inform efforts to understand the causes of burnout, and to design solutions at an individual and organizational level."
Mid-career cardiologists, those practicing for 8 to 21 years, were more likely to experience burnout when compared with late-career and early-career cardiologists and fellows-in-training (39% vs 28%, 23%, and 10%, respectively; P≤0.01).
Women reported burnout more often than men (31% vs 24%; P≤0.001).
Notably, 57% of respondents experiencing burnout reported increased at-home electronic medical record (EMR) use. However, self-reported poor EMR efficiency was not associated with burnout. Fully 72% reported documentation time demands.
"As cardiologists we should be spending more of our time with out patients face to face addressing their needs and less of the time with the bureaucratic and clerical burden that we are facing now," Mehta emphasized in an interview.
Atop the shortage of physicians, "those who are practicing are increasingly burdened by the bureaucratic, emotional and physical stress of the job. This is an existential threat to the core of our healthcare system," agreed Rachel Bond, MD, of Sun State Cardiology in Chandler, Arizona, who was not involved in the study.
Mehta's group assessed the answers to the Mini-Z survey, a 10-question supplement to the American College of Cardiology's Professional Life Survey sent to its members and fellows-in-training. Surveys were sent to 10,798 physicians and the response rate was about 21%.
The Mini-Z survey addressed personal wellness and the emotional exhaustion aspects of burnout. The 2,274 respondents included 42% women.
Burnout was determined by reporting at least 1 symptom of it, complete burnout feelings, or constant feelings of burnout. Those reporting only feelings of stress, but not burnout, were not included in that group.
The American College of Cardiology has efforts underway to address burnout and to identify where its members stand, where their needs are, and what can be done to help, noted Mehta.
"We are looking at wellness and burnout and how do we address it, and coming up with tool kits and mechanisms, so that the state chapters can use them to address it or engage in the conversation with their members," she told MedPage Today.
"But it's not solely for an organization to hold the burden of burnout on their shoulders. It is an issue for everyone. It's a predominately systemic issue, and not just a resiliency issue," she continued.
However, the study may have underestimated the level of burnout in cardiology, speculated Rachel Bond, MD, of Sun State Cardiology in Chandler, Arizona, who was not involved in the study.
"Those most likely to respond to a survey are the ones less likely to be overwhelmed with clinical, procedural, or administrative duties," Bond noted in an interview with MedPage Today.
Other study limitations included lack of questions related to the consequences of burnout, like intent to lessen productivity or depression, and missing demographic information on survey nonresponders.
Mehta and Bond reported no relevant relationships to disclose.
WASHINGTON -- Although Senate Health, Education, Labor & Pensions (HELP) Committee members sounded very harmonious Tuesday at a hearing on their bipartisan bill to lower healthcare costs, disagreements among witnesses at the hearing indicate that the solutions may not be easy to come by.
Take the matter of "surprise bills," in which patients at an in-network hospital receive an unexpectedly large bill later on because one of the treating physicians was out of network. To solve that problem, "the 'in-network guarantee' is the best option," said Benedic Ippolito, PhD, research fellow in economic policy studies at the American Enterprise Institute, a right-leaning think tank here. Under that option, every provider at a hospital would have to agree to be "in-network" for whatever networks the hospital belonged to.
"By tasking hospitals with ensuring that physicians are in-network for insured patients, market actors would [negotiate] prices themselves, rather than having prices set by arbitration," said Ippolito. Arbitration, in which the insurance company and the doctor each submit what they think is a fair price for the service to an independent arbiter for a decision, "represents an inferior version of setting a simple benchmark. ... The process is less transparent, includes unnecessary expenses, and can be unpredictable ... and it doesn't stop surprise bills from occurring in the first place."
Not so fast, said Tom Nickels, executive vice president of the American Hospital Association. "The network-matching approach ... interferes with fundamental relationships with hospitals and their physician partners, and interferes with our ability to negotiate," he said.
Nickels sounded more favorable to arbitration, noting that a bill introduced by HELP Committee member Sen. Bill Cassidy, MD (R-La.), would have out-of-network claims paid at a median in-network rate; physicians who are dissatisfied with that amount could request arbitration. However, he added, "we do believe automatic payment prior to initiating dispute resolution undermines fair reimbursement."
Elizabeth Mitchell, president and CEO of the Pacific Business Group on Health, in San Francisco, said her group, which represents Bay Area employers concerned about healthcare issues, favors basing out-of-network payments at 125% of Medicare rates. "We believe this fairly captures cost and is the most straightforward, transparent approach to prices."
Surprise billing is just one of the elements addressed in the bipartisanLower Health Care Costs Act that the committee is working on. Committee chairman Sen. Lamar Alexander (R-Tenn.) noted in his opening remarks that the bill contains more than three dozen proposals agreed to by both Republicans and Democrats, including measures that would:
End surprise billing.
Create more transparency. "There are seven bipartisan proposals in the bill that will eliminate gag clauses and anti-competitive terms in insurance contracts, designate a non-profit entity to unlock insurance claims for employers, ban pharmacy benefit managers (PBMs) from charging more for drugs than the PBM paid for the drug, and require patients to be given more information on the costs and quality of their care," said Alexander. "You can't lower your healthcare costs until you know what your healthcare costs actually are."
Increase prescription drug competition. "There are nine bipartisan proposals to bring more lower cost generic and biosimilar drugs to patients; that's about 90% of all the drugs that are prescribed," he said.
Sean Cavanaugh, chief administrative officer at Aledade, a company here that helps physicians work under value-based payment models like accountable care organizations, urged senators to do everything they could to support independent physician practices. "Anything you can do to support physicians in independent physician practices -- loan repayment programs, even for those who work in private practices -- would be great," he said.
"And we believe hospitals should be required to share patient-centric data," he continued. "There's literature that shows when a patient is discharged from a hospital and sees a primary care physician shortly thereafter, they do better -- they have fewer comorbidities and fewer readmissions. ... We think hospitals ought to be compelled to share these data."
Drug pricing also played a prominent role in the conversation. "Reports show that median drug company CEO pay increased by 39% in 2018, with some of the highest-paid executives making $20 million to $50 million per year," said Sen. Tammy Baldwin (D-Wis.). Baldwin, along with several Republican and Democratic co-sponsors, sponsored the Fair Drug Pricing Act, which requires transparency from drug companies when they raise prices on existing drugs; she urged the committee to add her bill to the Lowering Health Care Costs Act.
Drugmakers "work hard to defend and often distract from price increases, often citing industry-sponsored statistics showing large investments in developing new cures," Baldwin said, "[but] one study found that 80% of every dollar spent by drug companies goes to something other than research and development, like marketing and stock buybacks."
Frederick Isasi, executive director of Families USA, a left-leaning healthcare consumer group, said his organization supports Baldwin's bill. "This industry is currently broken," he said. "These drugs are life-saving; at the very least, companies should be able to justify why they're charging what they're charging and what the increases are for."
Mitchell said the members of her large employer coalition "are trying to offer [drug] discounts. ... They're basing those on estimates because they can't get insights into the actual price of the drug. We need transparency, but that's just a starting point."
"Prescription drugs are an area where an opportunity is apparent for us to help the American consumer," said committee member Mitt Romney (R-Utah). He said that he and another committee member, Sen. Mike Braun (R-Ind.), are working on language requiring drug copays to be "determined on the net price, not the retail price of the drug, so when rebates are provided, that the consumer has the advantage of that. We hope that becomes part of the final bill."
BALTIMORE -- Several dozen community members demanded Monday that Johns Hopkins Hospital stop chasing after former hospital patients -- most of them low-income -- who still owe money for their treatment.
The Coalition for a Humane Hopkins, a community group that includes members of National Nurses United (NNU), a labor union for nurses, is "[calling] on Johns Hopkins Hospital to immediately suspend the filing of new medical debt lawsuits and drop current lawsuits against former and current patients," the NNU said in a press release.
In particular, the protesters cited what they said was "harassment" of former patient Lakesha Spence, whose last $152 the hospital garnished from her bank account in April. Spence went to court to get her money returned and the judge ruled in her favor, but Hopkins sought a second garnishment, and Spence found out last week that money had again been taken from her account.
"As nurses we take our responsibility as patient advocates seriously and that advocacy does not end when our patients leave the hospital," Meredith Zoltick, a registered nurse at Johns Hopkins, said in a statement. "We are saying enough is enough to the exploitative practice of suing low-income patients which causes unnecessary suffering, hardship, and distress and discourages people from seeking the care they need."
"To think that Johns Hopkins would go after Lakesha Spence after the court already found seizing her assets would cause undue financial harm is unconscionable. This is a bully tactic designed to silence those who are seeking to change Johns Hopkins' morally abhorrent behavior," Rev. Ty Hullinger, a pastor at three Catholic parishes in Baltimore and a member of the Coalition for a Humane Hopkins, said in the statement.
The coalition presented a letter -- as well as petitions signed by more than 1,000 people -- to the presidents of the hospital, Johns Hopkins Health System and Johns Hopkins Medicine. The letter demanded that the hospital suspend the filing of medical debt lawsuits and drop all current medical debt lawsuits against patients; review prior cases in order to reimburse those patients who have been billed more than they should have paid; and screen all patients for charity care eligibility at admissions and increase signage and notifications about charity care.
A report released in May by the coalition, the NNU, and the AFL-CIO found that since 2009, the hospital filed more than 2,400 lawsuits in Maryland courts seeking the repayment of $4.8 million in alleged medical debt from former patients, with a median amount of $1,438. The numbers came from a review of thousands of electronic case dockets and hundreds of case files. Many of these lawsuits seek to recover only the amount outstanding after insurance coverage is applied, including Medicare and Medicaid, the report noted. Looking at sampled postal zip codes of cases involving patients who lived in a 3-mile radius of the hospital, researchers found that 86% of patients for whom demographics were known were African American.
These patients "often are working people who already are likely to struggle with debt in the hundreds or thousands of dollars," the report said. "These lawsuits can exacerbate existing personal financial hardship and often have dire consequences for patients and their families."
When asked to comment, Johns Hopkins spokesperson Kim Hoppe sent a statement saying that "It is always our priority to provide the best possible care to every patient who comes to us. We have an extraordinary community benefits program, and it is our policy to inform our patients about our programs for free and discounted services. For patients who choose not to pursue those options or who have a demonstrated ability to pay, we will still make every effort to reach out to them and to accommodate their schedule and needs. In those rare occasions when a patient who has the ability to pay chooses not to, we then honor our obligation as a hospital in the state of Maryland, with its unique payer model, to pursue reimbursement."
Regarding Spence, she continued, "Patient privacy laws prevent us from sharing information about any patient even acknowledging whether someone sought care with us. However, every patient who receives services is provided information about the availability of financial assistance and charity care and every effort is made to reach out to our patients in the event of billing issues and to accommodate any special circumstances that would affect their ability to pay."
Voluntary gatherings that meet for the purpose of sharing stories, relieving distress and secondary trauma.
This article was first published on Thursday, June 13, 2019 inMedPage Today.
By Shannon Firth, Washington Correspondent, MedPage Today.
CHICAGO -- Physician wellness programs will be encouraged to consider developing peer support groups, following a new policy passed during the AMA's House of Delegates meeting that concluded this week.
Such groups should be "voluntary, confidential, and non-discoverable."
The policy also called for the AMA in collaborating with other interested groups to encourage study in any future surveys of the prevalence and potential impact of the "second victim phenomenon."
"We're not asking for major legislation or a lot of money here," said Albert Hsu, MD, an American Society for Reproductive Medicine delegate and the author of the resolution, which he brought forward on behalf of the Young Physicians Section.
"We're asking for local physician wellness programs, whether it's at an institution or state or county-based, to consider having peer support groups ... because we do know it's an important part of [preventing] burnout," he told MedPage Today.
Hsu is a reproductive endocrinologist at the University of Missouri Health Care and a member of the "forYOU" team, which is focused on addressing the second victim phenomenon and more broadly, "caring for caregivers."
Second victimization or secondary traumatization occurs when a healthcare provider experiences an unanticipated patient event, a medical error, or a patient-related injury and becomes traumatized by that event, explained Hsu, in a committee discussion on Sunday, prior to passage of the resolution.
When he was taking a paramedic course, Hsu recalled one of the trainers sharing the story of a first responder, who had to clamp his hand over a patient's neck, which was gushing blood.
Once he was relieved by a colleague, the first responder went over to a corner and vomited, Hsu was told.
"But while he's there he's doing his job," Hsu said, and that kind of compartmentalization is a critical part of the job for anyone on the front lines of patient care.
"They have to put their feelings aside every day and not react," Hsu said.
In addition to keeping their cool in emergencies, being a good clinician also requires a measure of compassion, he noted.
"If all we did was deliver clinical information and medications and treatments, you could replace us all in probably 10 or 20 years with robots and artificial intelligence," Hsu said.
"But what makes us effective as physicians, clinicians, providers in general, is the fact that we do the hand-holding necessary, when we're in the context of helping patients ... that's a positive for us ... but then sometimes we get affected," he said.
The second victim phenomenon doesn't affect only physicians, Hsu added. Nurses, mid-level-staff, anyone involved in patient care can be impacted, he said.
"There was a highly publicized case of a nurse who felt so badly about something that happened while a patient was under her care, she actually committed suicide," Hsu noted, recalling the death of Kimberly Hiatt.
While his own experience was far less public, Hsu still remembers a 30-year-old patient who died from HIV while he was in medical school.
"For a good 2 to 3 years after, I felt that I missed something that contributed to her death," Hsu acknowledged.
In reality he knows that he had no clinical responsibilities at that stage in his career and his fears are "foolish," but for a long time he couldn't shake them.
Another friend of Hsu's was working when her own co-resident and friend was brought to the hospital with a blood clot. The friend died.
"These are things that stay with you and drive people to bad places," Hsu said.
Up to half of all healthcare providers, at some point in their professional lives, experience the second victim phenomenon. And even among clinicians for whom the secondary trauma is unrelated to any type of medical error or litigation, they can harbor feelings of anxiety, stress, shame, and guilt around other adverse events, Hsu said during a reference committee discussion, focused on weighing the pros and cons of new policies.
Robert Tortolani, MD, a geriatrician from Vermont and a Vietnam veteran, speaking on his own behalf, said he has been part of an informal, five-person peer support group for more than 20 years.
The group meets once a month at one member's house. Each meeting begins with a meditation and then members are given a few minutes to share with the group, with extra time reserved for the most serious or pressing problems, he told MedPage Today in a phone call.
"I think everybody should have a peer support group. I don't know what I would do without it," Tortolani told the committee.
Virginia Hall, MD, a delegate for the Pennsylvania Medical Society, said she supported the concept of peer support groups, but worried about "discoverability" in legal situations.
"A peer group is only as good as the silence of that peer group," she said, in explaining her recommendation to refer the resolution back to the AMA committee that oversees this particular set of policies.
"I'd like to have some attention paid to the legal issues that go with the peer support groups," she said.
Tortolani countered that his own group never keeps minutes and in 20 years, "nothing has ever left the room."
Hsu said that he shared Hall's concerns about "discoverability" initially, but after speaking to the General Counsel and Risk Management staff of his health system, those fears have been allayed.
"We've been doing this for 8 years. No one once has come to us and asked to get information from the peer support group," Hsu said he was told.
"You see, the plaintiff's attorneys are not remotely interested in hearing that the defendant is a human, and asking for support."
In addition to passing policy to advocate for the growth of peer support groups, the AMA also passed a report this week calling for the association to make efforts to collect more data on the suicides of medical students, residents, and fellows "to identify patterns that could predict such events," according to an AMA press release.
Increasing body fat accumulation significantly raised men's odds of developing advanced and fatal prostate cancer, data from a large prospective study of men in Iceland showed.
Higher concentrations of visceral and thigh fat increased the odds of aggressive or fatal prostate cancer by 30%-40% as compared with leaner men. The prostate cancer risk associated with increased visceral fat accumulation carried over to men who had a lower BMI, reported Barbra A. Dickerman, PhD, of the Harvard T. H. Chan School of Public Health in Boston, and colleagues.
Higher BMI and waist circumference also were associated with an increased risk of aggressive and fatal prostate cancer. None of the measured parameters had significant associations with total prostate cancer or cancer grade, they stated in Cancer.
"To our knowledge, this is the first prospective study of directly measured fat distribution and the risk of advanced prostate cancer," the authors wrote. "Previous retrospective and cross-sectional studies incorporating CT measures of adiposity have reported mixed findings."
The findings relative to BMI were consistent with prior studies, whereas previous evaluations of waist circumference and prostate cancer yielded mixed results, they added.
The findings added to and extended knowledge about the relationship between obesity and prostate cancer, according to authors of a related editorial. However, Celina H. Shirazipour, PhD, and Stephen J. Freedland, MD, of Cedars-Sinai Medical Center in Los Angeles, noted a couple of factors that might limit the generalizability of the results: use of a median BMI of 27, which encompassed both normal-weight and overweight men; and the observation that fat accumulation in more than one body area was associated with advanced prostate cancer, supporting existing evidence linking body fatness, irrespective of location, to the risk of advanced prostate cancer.
"The findings from [the] research, in addition to existing evidence on obesity and prostate cancer, highlight the need to examine lifestyle interventions that target fat loss in promoting optimal prostate cancer outcomes," they wrote.
"In light of the strong emphasis in the article on the findings associated with visceral fat and advanced prostate cancer among men with lower BMIs, and in light of existing knowledge on the detrimental impact of visceral fat, there is also a need to determine what behavior may be most effective in targeting this regional fat distribution," they added.
Multiple studies have shown a consistent association between obesity (as measured by BMI or waist circumference) and an increased risk of advanced prostate cancer, as well as a poorer prognosis after cancer diagnosis. More recently, studies have suggested that specific patterns of body fat distribution may have prognostic importance for prostate cancer.
Body fat distribution has attracted interest as a research subject because of its potential as a marker for different metabolic, hormonal, and inflammatory processes that may contribute to prostate carcinogenesis, Dickerman and colleagues noted. Visceral fat, for example, has an inverse association with bioavailable testosterone and strong associations with insulin resistance and proinflammatory cytokines. Increased intramuscular thigh fat has a strong association with poorer glucose tolerance, whereas subcutaneous thigh fat is associated with a more favorable metabolic profile.
Few studies examined associations between directly measured body fat distribution and prostate cancer risk, the authors continued. Some cross-sectional studies showed associations between CT measures of visceral fat and both total and high-grade prostate cancer. However, prior studies were limited by small sample sizes and did not account for the potential effects of the cancer or treatment on adiposity.
Dickerman and colleagues reported findings from 1,832 men participating in theAge, Gene/Environment Susceptibility-Reykjavik study. At enrollment during 2002 to 2006, study participants had baseline CT imaging of fat distribution, bioimpedance analysis, and measurements of BMI and waist circumference. Investigators calculated accumulation of abdominal visceral fat, abdominal subcutaneous fat, thigh intramuscular fat, and thigh subcutaneous fat.
The 1,832 men had a mean age of 75-76 at enrollment, median BMI of 27, and median waist circumference of 102 cm. Follow-up for prostate cancer endpoints continued through 2015, during which time 172 of the men had prostate cancer diagnoses, 43 had high-grade prostate cancer (Gleason ≥8), and 41 had advanced disease at diagnosis or died of prostate cancer (31 prostate cancer deaths). BMI correlated with waist circumference and total body fat. Abdominal subcutaneous fat had a strong correlation with both BMI and waist circumference. Abdominal visceral fat had a lesser correlation with BMI and waist circumference.
The data showed that the risk of having advanced prostate cancer at diagnosis increased by 31% for each standard deviation increase in visceral fat. The risk of dying of prostate cancer increased by 37% for each standard-deviation increase in subcutaneous thigh fat. Visceral fat accumulation increased the risk of both advanced and fatal prostate cancer among with a BMI <27 (HR 1.95, 95% CI 1.07-3.54; HR 2.13, 95% CI 1.12-4.05) but did not significantly increase the risk of total, high-grade, advanced, or fatal prostate cancer among men with a BMI ≥27.
Each 5 kg/m2 increase in BMI was associated with a 50% increase in the hazard for advanced prostate cancer and fatal prostate cancer. Each standard-deviation increase in waist circumference led to a 40% rise in the hazard for advanced and fatal prostate cancer.
Study limitations included the fact that exposures were measured once at cohort entry, so the authors were unable to assess changes in fat depots over time. Also, the study population was predominantly older white men, so the results may not be generalizable to younger, more diverse groups of men.
The study was supported by the National Cancer Institute, Harvard University, and the Icelandic Cancer Society. The AGES-Reykjavik study is supported by the National Institute on Aging, the Icelandic Heart Association, and the Icelandic Parliament.
Clinically significant cancers detected in up to 33% more men.
This article was first published on Wednesday, June 13, 2019, in MedPage Today.
By Ian Ingram, Deputy Managing Editor, MedPage Today.
Combined use of systematic and MRI-guided targeted biopsy was better able to detect clinically significant prostate cancers than either method alone, the PAIREDCAP trial found.
Among nearly 250 men with MRI-visible prostate lesions, the detection rate for these cancers reached 70.2% with both methods combined, reported Leonard S. Marks, MD, of the University of California, Los Angeles, and colleagues in JAMA Surgery.
Detection rates for clinically significant tumors (Gleason score ≥3 + 4) were 46.8% for visual or cognitive targeted biopsy, 60.1% with systematic transrectal ultrasound-guided (TRUS) sampling, and 62.1% for either cognitive or software fusion. Of the 174 clinically significant cancers detected overall, anywhere from 11.5% to 33.3% would have been missed with one type of biopsy method alone.
"Our research suggests that the different biopsy methods identify different tumors," Marks said in a statement. "Our cancer detection rate, while using different methods in tandem, surpasses that from using either method alone. In this case, one plus one equals three."
In 20.9% of men, systematic biopsy found tumors that were missed on targeted biopsy while in 9.7%, targeted biopsy found tumors that were missed on systematic biopsy.
Regardless of the method used, detection rates of Gleason score ≥3 + 4 tumors were higher among men with Prostate Imaging Reporting & Data System (PI-RADS) scores of 4 (64%) or 5 (80.2%) compared to those with a score of 3 (23%; P=0.006).
Certain factors predicted better detection rates, including increasing PSA density (low 35%, moderate 56%, high 77.8%) and prostate volume (low 77%, moderate 62.8%, high 42%).
The researchers also biopsied 48 consecutive patients without MRI-visible lesions to test the false-negative rate of multiparametric MRI for prostate cancer diagnosis. Here, systematic sampling turned up clinically significant cancers in 15% of the patients.
"Even if the MRI is negative for lesions, men at risk -- including those with elevated levels of prostate-specific antigen, a prostate nodule, or family history -- should still receive a traditional, systematic biopsy," said Marks.
Together, the results suggest a risk-assessment model that incorporates PSA density with MRI findings and other information that could be of use, the authors said. For example, 90% of men with a PI-RADS lesion score of 5 and high PSA density (>0.15 ng/mL/cm3) had clinically significant prostate cancer compared with 8% of those with a negative MRI and a low or moderate PSA density (<0.15 ng/mL/cm3).
PAIREDCAP (Prospective Assessment of Image Registration in the Diagnosis of Prostate Cancer) was a paired cohort trial that enrolled 300 consecutive men undergoing their first prostate biopsy. The study was conducted from 2015 to 2018 at a single academic institution and used investigators with extensive experience in MRI-guided biopsy (>10 years).
Of the 300 men, 248 had lesions visible on multiparametric MRI -- PI-RADS version 2 lesion of grade 3 or greater -- and subsequently underwent TRUS biopsy (12 cores), MRI-lesion visual or cognitive targeted biopsy (3 cores), and MRI-lesion software-assisted targeted biopsy (3 cores).
Detection of clinically significant prostate cancer has been improved with the introduction of multiparametric MRI in this setting, said Ahmad Shabsigh, MD, and Cheryl T. Lee, MD, both of the Ohio State University Wexner Medical Center in Columbus, in an invited commentary.
The PRECISION trial showed that MRI-guided biopsy could detect nearly 50% more clinically significant cancers than ultrasound-guided biopsy (38% vs 26%), and led to a 13% absolute reduction in detection of clinically insignificant cancers. And the PROMIS trial showed that multiparametric MRI was more sensitive and less specific than TRUS biopsy. In the two studies, 28% and 27% of patients, respectively, would have been able to avoid prostate biopsy with use of multiparametric MRI.
"Still, a critical question went unanswered by these studies: is it better to do a standard TRUS biopsy in addition to the MRI-targeted biopsy?" Shabsigh and Lee wrote, a question that PAIREDCAP was designed to address.
"A few important lessons can be learned from this study: first, relying on targeted biopsy alone is suboptimal; second, if the urologist does not have a fusion machine, cognitive biopsy is still essential," they wrote. "The results reflect the reality that multiparametric MRI is better than what clinicians have had, but there is still a way to go."
The study was supported by the University of California, the Los Angeles Clinical and Translational Science Institute, the Jean Perkins Foundation, the Kent Kresa Family Foundation, the Steven C. Gordon Family Foundation, and a grant from the National Cancer Institute.
Marks and another co-author disclosed that they co-founded Avenda Health.
Shabsigh and Lee reported no conflicts of interest.