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Sunday, January 5, 2020

NextMind over matter at CES

NextMind announces $399 Dev Kit for first real-time ‘brain-sensing’ BCI wearable, wins two CES Innovation Awards
NextMind, a fast-growing neurotechnology startup specializing in noninvasive neural interfaces, today announced it is offering a $399 Dev Kit for its unique wearable that allows users to control anything in their digital world by using just their thoughts. The NextMind device, which is the world’s first noninvasive, hands-free brain-computer interface for real-time interaction, also won two CES Innovation Awards today —Best of Innovation in Augmented and Virtual Reality and Honoree in Wearable Technologies. NextMind is providing demonstrations in Booth No. 534 at CES Unveiled Las Vegas tonight from 5 p.m. to 8:30 p.m. at the Mandalay Bay and also at CES this week at LVCC, South Hall 1, Booth No. 21839.
NextMind is at CES 2020 this week debuting the first real-time ‘brain-sensing’ BCI wearable that let's you control your digital world with just your thoughts. (Photo: Business Wire)
NextMind is at CES 2020 this week debuting the first real-time ‘brain-sensing’ BCI wearable that let’s you control your digital world with just your thoughts. (Photo: Business Wire)
“We are honored to receive such recognition from the Consumer Technology Association for NextMind, and eager to get our Dev Kit out to developers and partners so that they can explore the many amazing ways this powerful real-time brain-computer interface will create new user experiences with the digital world,” said Sid Kouider, founder and CEO of NextMind. “We look forward to giving CES attendees a demo that will blow their minds when they fully realize the power and deep immersive experience that NextMind can provide in gaming, computer control and their personal interaction with the internet of things just by focusing their thoughts. And this is just the beginning for us, as we look forward to the future and further evolving this technology.”
NextMind’s lightweight wearable captures electrical brain signals from the user’s visual cortex, and by using machine learning algorithms, translates that output into direct digital commands for devices in real time, all while hands-free. The small, round device fits into the back of a cap or headband and rests gently on the user’s head, or it can be used via AR/VR headset.
Kouider first unveiled the NextMind BCI wearable onstage at the prestigious technology forum Slush 2019 in November.
NextMind is shipping Early Access Evaluation Kits to selected partners and developers this month. The company will begin shipping the first batch of $399 Dev Kits during the second quarter of 2020. Developers interested in being one of the first to receive a NextMind Dev Kit can sign up for the Pre-Order Waitlist at https://www.next-mind.com/waitlist/.
NextMind is a fast-growing technology startup specializing in groundbreaking, noninvasive neural interfaces. By combining innovative, noninvasive brain-sensing technology with machine learning algorithms, NextMind’s technology translates brain signals into digital commands in real time, making it easier for end users to interact and control computers and VR/AR headsets.

One Medical Files For $100M IPO

Healthcare startup One Medical filed its S-1 registration document with the U.S. Securities and Exchange Commission on Friday, one of a handful of companies to kick off the year’s initial public offering cycle.

The company, which has a membership model for patients to access care virtually or at One Medical Clinics, is aiming to raise $100 million through its IPO, according to the filing. One Medical applied to list its stock on the Nasdaq under the ticker “ONEM,” and J.P. Morgan and Morgan Stanley are acting as the lead underwriters for the IPO.

Company Stats

As a private company, One Medical raised $532.1 million in total funding, according to Crunchbase. The company, which was founded in 2007, last raised money in August 2018, when it raised $220 million in a private equity round led by the Carlyle Group. One Medical’s other investors also include GV and Benchmark.
One Medical had 397,000 members in nine markets in the U.S. as of September 30, 2019, according to the filing. It also had about 6,000 enterprise clients.
While the company, which is legally named 1Life Healthcare, is based in San Francisco, it has a physical presence in Boston, New York, Chicago, Los Angeles, Phoenix, San Diego, Seattle, Washington, D.C. and the greater Bay Area. One Medical has 77 offices, including employer on-site clinics.

The Money

The company reported net revenue of nearly $198.9 million for the first nine months of 2019. That represents a 29 percent increase from the same period last year, when net revenue was $154.6 million.
One Medical attributed the bump to a 23 percent increase in members between the first nine months of 2018 and the first nine months of 2019 (membership increased by 74,000 people from 323,000 people to 397,000 people). The company also doubled its spending on sales and marketing during the first three quarters of the year, going from $14.4 million in 2018 to $28.8 million in 2019.
Between the first three quarters of 2018 and 2019, the company’s net losses increased from about $26.9 million in 2018 to $34.2 million in 2019. Its net losses for the entirety of 2018 was $45.5 million, up nearly 44 percent from $31.7 million in 2017.

23andMe can open a Pandora’s Box of a family’s medical secrets

Unwrapping the holiday gift of a genetic testing kit could mean revealing a previously unknown world of health concerns — and complicated family questions.
By spitting in a test tube and sending it to companies like 23andMe or Ancestry.com, consumers might learn of potential genetic predispositions to Type 2 Diabetes, breast cancer, carrier status for cystic fibrosis and certain blood conditions.
‘I wanted to sound confident. I wanted to get across the most important thing.’
—Dorothy Pomerantz, a 49-year-old Los Angeles-area mother
It’s still not an easy conversation, something Dorothy Pomerantz knows all too well. The 49-year-old Los Angeles-area mother lost sleep and thought long about how she would inform her children, then ages 11 and 14, about a genetic mutation putting her at an elevated risk of breast and ovarian cancer.
“I wanted to sound confident. I wanted to get across the most important thing, which was I was going to be OK,” she told MarketWatch.
Pomerantz first learned of her BRCA1 mutation from a 23andMe test. She confirmed it with a genetic counselor. She had preventative surgery, including a mastectomy with implant reconstruction.
Pomerantz needed around three to four months before she could calmly relay the test results to her kids and speak about her surgery plans. She tried framing the presentation as, “I’m here to answer questions, but not giving more information than they need,” she said.
After the talk, her kids “both just sort of paused and went, ‘Okay, that sounds great. What’s for dinner?’” said Pomerantz, who is the managing editor of FitchInk, an editorial consulting and content company.
She also told her cousins, some of whom had daughters. Pomerantz didn’t want to browbeat anyone into getting tests, but wanted to tell them, because, “As hard as it is knowing, not knowing is much worse.”
But she respects someone who may choose not to share the news as it’s “a personal decision.”
The cousins were appreciative and Pomerantz remembers one, a doctor herself, telling her, “I can’t believe you got tested. I would never want to know. This does make me rethink wanting to get tested.”
As far as Pomerantz knows, none of her cousins has pursued further testing.

Such results, as Pomerantz discovered, can unleash all sorts of difficult medical questions about further verification, treatment and possible surgery. Those same results can also force personal dilemmas: With whom should users share surprising or unwelcome medical results? And how do they break such news?
‘It’s all in the realm of ethics, and not in the realm of law.’
—Ellen Wright Clayton, Vanderbilt Law School professor
These are emotionally-charged questions with few clear-cut answers, experts say.
“It’s all in the realm of ethics, and not in the realm of law,” said Ellen Wright Clayton, a professor who focuses on the law, medicine and genetics at Vanderbilt Law School.

The predicament is increasingly common as more people buy direct-to-consumer kits to identify their genetic makeup and heritage for starting prices of approximately $100. An estimated 26 million consumers took direct-to-consumer genetic tests by the start of 2019, according to MIT Technology Review estimates from earlier this year.
Clayton emphasized the direct-to-consumer tests only reveal so much compared to “comprehensive” results from genetic counselors, who are health-care professionals trained to provide risk assessment, counseling and support for individuals with inherited conditions.
‘You’re less likely to regret having communicated than having kept it a secret.’
—Gillian Hooker, president-elect of the National Society of Genetic Counselors
Clayton hopes people would eventually tell family members about results, and says a consensus of doctors share the same view. “We like for people to be able to share this information, so that other individuals can be tested if they choose to be. If they are found at risk, they can do something to try to prevent it,” said Clayton.
“You’re less likely to regret having communicated than having kept it a secret,” said Gillian Hooker, president-elect of the National Society of Genetic Counselors.
“More open conversations are happening,” she added. “I think our expectations of privacy around these things are certainly changing as more and more people get tested, and the public becomes more aware.”
What the results may, and may not, show
Direct-to-consumer testing “only looks for limited sets,” Clayton said. “I’m not telling people not to do it. They just need to know what they are going to get and not going to get.”
The Pentagon recently advised military members not use the direct-to-consumer tests, Yahoo! News reported VZ, -1.06%
‘I’m not telling people not to do it. They just need to know what they are going to get and not going to get.’
Vanderbilt Law School Professor Ellen Wright Clayton
“Until further assessment, it is advised that service members receive this information from a licensed professional rather than a consumer product,” Lt. Col. Uriah Orland, a Department of Defense spokesman, told MarketWatch in an email. There could be the “unintentional discovery of markers that affect readiness” and a service member’s career, Orland said.
“Testing performed by [direct-to-consumer] companies may or may not provide reliable, accurate results,” he said.
Representatives for 23andMe and Ancestry, which offers AncestryHealth, emphasized customer results are reliable and closely protected.
“All of our customers should be assured we take the utmost efforts to protect their privacy, and that the results we provide are highly accurate,” a 23andMe spokeswoman said. “Our FDA-authorized health reports have been tested to be over 99% accurate.” All testing is done in the United States and the company doesn’t share any information without clear consent from customers, she added.
23andMe’s website acknowledges its BRCA1/BRCA2 reports are not comprehensive and ”should not be used to make medical decisions.”
Likewise, an Ancestry spokeswoman said, “protecting our customers’ privacy and being good stewards of their data is Ancestry’s highest priority.” The company “does not share customer DNA data with insurers, employers, or third-party marketers. Ancestry will also not share customer personal information with law enforcement unless compelled to by valid legal process, such as a court order or search warrant.”
Important caveats to keep in mind
“Genetics rarely are a prediction of you will or won’t get a disease. It’s all about probabilities,” said Hooker, who is the vice president of clinical development at Concert Genetics, a health technology company near Nashville, Tenn.
It’s important to know the context surrounding any distressing diagnosis, like family history and lifestyle factors, Hooker said. “Take a breath and make sure you know what it means first,” or find someone who can explain results, she said.
‘Take a breath and make sure you know what it means first.’
—Gillian Hooker, president-elect of the National Society of Genetic Counselors
Anyone who wants to share the news should start with close relatives like siblings and parents, Hooker added. Talking to aunts, uncles and cousins are a different judgment call, she said.
Services like 23andMe and AncestryHealth emphasize that they give added information with results, and both can link customers with genetic counselors.
In addition to customer education, Invitae NVTA, -1.41%, a genetics test requiring a doctor’s order, can provide customers with wording for a letter to send to family members, said Kate Lynch, a genetics counselor at the company.
However people share the news, Lynch said, “a lot of personalities come into play. Some relatives will be happy to hear from you … and other relatives will not be happy to hear from you. And you can’t predict that very well.”
“For some people, information is immediately empowering,” causing them to do their own testing and research. For others, “It could feel stressful, it could feel confusing.”
Red flags, whether coming from a test kit or a genetic counselor, deal with risks of having a condition over the course of a lifetime, Hooker said. That’s an important piece of information to communicate to any relative.
What’s more, Hooker said you are giving your relatives choices about what their next step should be. It’s a dramatically different scenario than a negative prognosis from a doctor. “In most cases, you have time to think.”

Where Were the Women? Gender Parity in Clinical Trials

In 2017, a total of 19% of all new HIV infections in the United States and nearly half of infections globally were in cisgender (nontransgender) women. Women of childbearing potential shoulder a disproportionate burden, which raises further concerns about perinatal transmission of the virus. Preexposure prophylaxis — pharmacologic prevention of HIV acquisition with coformulated tenofovir disoproxil fumarate and emtricitabine (F/TDF) — has been shown to be effective in women, was approved by the Food and Drug Administration (FDA) in 2012 for women and men, and is a cornerstone of the national strategy for Ending the HIV Epidemic.
Coformulated tenofovir alafenamide and emtricitabine (F/TAF) is a sister prodrug of F/TDF that has the potential to cause less loss of bone mineral density and fewer renal toxic effects than F/TDF. A new drug application for F/TAF for the treatment of HIV infection in men and women was submitted to the FDA in April 2015 and approved in April 2016. The FDA reviewed a substantial amount of safety and efficacy data for F/TAF, as it does for all new medications, and confirmed that the supporting studies met its established criteria for statistical rigor, pharmacologic standards, and inclusion of diverse populations.
Two months after its approval for treatment, F/TAF’s manufacturer, Gilead Sciences, moved forward with an effort to expand the drug’s indications to include prevention of HIV infection. To do so, they collaborated with researchers, community members, and the FDA to develop a new preexposure prophylaxis trial protocol — the DISCOVER trial — and to work toward a supplemental new drug application for F/TAF. Designed as a noninferiority trial, DISCOVER compared F/TDF with F/TAF in more than 5000 men who have sex with men and 74 transgender women who have sex with men to evaluate the efficacy and safety of F/TAF when used for prevention. The trial specifically excluded cisgender women because of perceived challenges in enrollment and concern about reaching a meaningful end point. DISCOVER was registered with and posted to ClinicalTrials.gov (NCT02842086. opens in new tab) in June 2016.
The requirements for a supplemental new drug application are similar to those for a drug’s initial new drug application, and the new application is subjected to the same scientific and ethical standards. These include the FDA Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, which “requires sponsors to include a fair representation of both genders as participants in clinical trials so that clinically significant gender-related differences in response can be detected.”1 The guidance also specifies that trial participants must be representative of the patient population likely to be prescribed the drug once it is approved and that data must be presented for each relevant subgroup.1
In March 2019, the manufacturer reported in abstract form the initial efficacy and safety data from the DISCOVER trial. Despite the few new HIV infections that occurred during the study, F/TAF was found to be noninferior to F/TDF, with a similar adverse-event profile. Serum creatinine levels were significantly different between the two groups, although the difference probably did not carry any clinical significance: F/TAF resulted in a change of 0.01 mg per deciliter and F/TDF a change of 0.02 mg per deciliter.2
On August 7, 2019, the Antimicrobial Drugs Advisory Committee of the FDA discussed the recently reported and unpublished data from DISCOVER. They also reviewed the previously published pharmacokinetic data on F/TAF that demonstrated similar systemic levels of F/TAF in men and women with daily dosing of the medication.2 At the time of consideration, and nearly 3 years after the public notification of the launch of the DISCOVER Trial, no trial was actively examining (or had yet examined) F/TAF for use as preexposure prophylaxis in cisgender women. The committee acknowledged that differences in drug levels between rectal and vaginal mucosa may affect overall efficacy in HIV prevention and voted 16 to 2 for approval of F/TAF in men who have sex with men and transgender women and 8 to 10 against approval in cisgender women.3 Scientists and community advocates on the panel recognized the consequences of this decision, which was dictated by the inadequacy of prevention data for women, and were keenly aware of the impact the disapproval would have on access for cisgender women. The committee chair conveyed this frustration, saying, “We’ve failed women.” Ultimately, on October 3, 2019, the FDA approved F/TAF for HIV prevention in at-risk “adults and adolescents,” but “excluding those who have receptive vaginal sex.”4
This controversial story highlights numerous flaws in the drug-approval process. From the time the trial was first registered with ClinicalTrials.gov in 2016, through the approval of the protocol by human-subjects committees at 94 clinical sites, to the submission of a supplemental new drug application to the FDA with review by the Antimicrobial Drugs Advisory Committee in August 2019 and then final approval by the FDA, it was evident that the submission would never meet the gender-specific standards set forth by the FDA’s own guidance.
Equity and inclusion in clinical trial design are essential to scientific advancement, ensuring that the benefits of innovation and drug discovery safely reach everyone in need. Historically, women — especially those who were pregnant or had childbearing potential — were often considered a vulnerable population and therefore excluded from clinical trials; this practice limited our understanding of women’s health and the potential for diverse pharmacologic responses. The FDA’s Office of Good Clinical Practice first called for representation of all genders in clinical trials in 1993, simultaneously acknowledging that human-subjects committees should include these standards in their evaluation of protocols and surveillance of research.1
There are limited evidence-based reasons for excluding people from trials on the basis of gender. Just this year, the FDA posted draft guidelines on the inclusion of men in studies of new breast-cancer therapeutics, citing prior exclusion as a barrier to effective treatment options. Men account for less than 1% of all breast-cancer cases, but under these guidelines, the “FDA does not intend to consider low expected accrual rates of male patients with breast cancer to be a sufficient scientific rationale for excluding them from a clinical trial.”5 Meanwhile, in the same month these guidelines were published, the FDA advisory committee reviewed data on F/TAF for HIV prevention that intentionally excluded women — a population that accounts for nearly 20% of all new HIV infections in the United States and 46% of all infections globally. The manufacturer justified its decision by citing difficulty in identifying “a relevant female cohort.”2
The responsibility for the exclusion of women in the design of the DISCOVER trial and the gender-specific approval of F/TAF for HIV prevention rests on all of us. Clinical trial design requires diverse voices and intentional inclusion criteria. It is up to human-subjects committees to maintain vigilant oversight of study protocols with these FDA standards in mind, regardless of whether the studies in question are industry-sponsored. And when the FDA is presented with data that exclude half the world’s population, it can use the tools at its disposal to address the violation.
The current approval of F/TAF that excludes “those who have receptive vaginal sex” establishes a two-tier system in which men may be prescribed the medication with insurance approval, whereas women may receive it only off-label, in the absence of data, and without insurance coverage. The path forward should be clear: a well-designed, rapidly enrolled, robust clinical trial of efficacy in cisgender women is urgently needed.
In granting approval for the drug’s expanded indication, the FDA obligated the manufacturer to study the drug in cisgender women. In response, the company plans to undertake a limited study in 1500 women in sub-Saharan Africa focused on safety and noninferiority that is scheduled to begin enrollment by 2020. In short, a study involving women that was deemed infeasible in 2016 is finally being considered. The backlash from the scientific, global, and advocacy communities against the FDA’s limited approval of F/TAF suggests that they expected and deserved better; they are all watching for remediation. The responsibility now lies with the FDA and the scientific community to enforce the rapid completion and reporting of this study in women and, in the process, to work to revise the current regulations and drug-approval process to truly require equity and inclusion.
Disclosure forms provided by the authors are available at NEJM.org.
This article was published on October 30, 2019, at NEJM.org.

Author Affiliations

From the Division of Infectious Diseases, Department of Medicine (R.H.G., R.P.W.), and the Medical Practice Evaluation Center (R.P.W.), Massachusetts General Hospital, and the Harvard University Center for AIDS Research, Harvard Medical School (R.P.W.) — both in Boston.

Responsibility of Physicians to Maintain Competency

Physician education during residency and fellowship has shifted from a model based on how long a physician trains to one that emphasizes assessing and encouraging measurable competence.1 There needs to be a similar shift to ensuring competency for physicians who have completed their training, with an emphasis on maintaining knowledge and clinical skills to ensure patient safety. This leads to several questions. Who must be competent in what? Who decides? Does experience count? How does aging affect competence? In medicine, an expansive range of competencies are considered important, and not every physician maintains every competency. Achieving, assuring, and maintaining competency across medicine requires time and effort and involves perseverance for individual physicians and the health care system. In this Viewpoint, we discuss 2 forces that can lead to diminishing competence over time: deterioration in ability with age and decrease in opportunities for maintenance and self-improvement.
Deliberate practice, as described by Ericsson2 and demonstrated in many fields, including music, chess, and surgery, is the sequential, mindful repetition of a training task with feedback that leads to effective improvement in performance. Early in training, there is a rapid learning trajectory in which large gains in performance occur through intentional learning activities. However, for some individuals, when formal training ceases performance can eventually degrade and can be documented by a forgetting curve,3 in which the rate of decay depends on a number of factors, including the complexity of the skill in question, opportunities for practice, and support from the health system. For example, in many specialties, residents are intensively trained in procedural skills, such as intubation and central line placement; however, these skills decay without continued practice and repeated training.4 It is important to recognize that there is a threshold for competency that must be maintained. This skill decay over time may be compounded by the aging of the physician population, which has made maintenance of competency an important issue in medicine in the United States and around the world.5 The literature on aging and its effects on professional performance is mixed with evidence of cognitive and physical decline of abilities in some individuals. However, there is evidence that competency in medicine can be successfully maintained through intentional deliberate practice and mastery learning with procedural simulation training.2,4,6
Advances in medicine and clinical procedures continue to change practice, and some physicians may not have the opportunity to keep up with new diseases, diagnostics, and therapies or may not be able to achieve sufficient mastery of technical skills required for performance of new procedures.7 While physicians may retain the expertise from years of experience, in some areas (especially in procedurally oriented disciplines), some physicians may be subject to the trajectory of skill decay. Yet, their identity as physicians is an important self-concept and supports their professional credibility. As some physicians mature in their careers, they may choose to decrease their clinical time as they move toward retirement; spending more time with their family; or increasing professional administrative, research, or teaching activities. Even though these physicians have accumulated comprehensive expertise from thousands of patient encounters and a complementary understanding of the health care system, teamwork, and patient-centered care, physicians who decrease their clinical time must maintain a certain equipoise, balancing their nonclinical time against the important need to maintain skills in procedures they may be called on to perform, even if only rarely. For example, emergency physicians might need to refresh their skills in intubation, cricothyrotomy, central line placement, thoracotomy, or focused ultrasonography if they have not performed these procedures recently.
As physicians practice into their sixth, seventh, and eighth decades of life, there is a balance between their increasing depth of expertise gained through experience and the forces such as aging, other causes of cognitive decline, and decreased opportunity for deliberate practice that can lead to skill decay. Can the balance tip in a way that results in risks for the care of the patient? What can be done to mitigate risks and protect patients? The following 5 proposed considerations may be helpful to addressing competency decline.
First is the mandate for lifelong learning and the controversial issue of mechanisms to ensure maintenance of certification.8 Even though some aspects of maintenance of certification are unpopular and perhaps ineffectively implemented, the underlying principle is sound and reflects the importance of maintaining knowledge and competency as a professional responsibility. Physicians must continuously refresh their foundational knowledge and stay up-to-date with new and evolving knowledge as well as procedural competence. This continued learning can occur through formal continuing medical education courses, informal learning activities (such as listening to educational podcasts or reading), Just In Time Medicine clinical references, and interactions with consultants and colleagues. Helping physicians identify what they do not know and make knowledge gaps transparent is essential to this process.
Second is the responsibility to keep training. While some procedures are routine, there are uncommon and complicated procedures or new techniques for procedures that require additional training, especially in procedural specialties, such as surgical fields, emergency medicine, and critical care, all of which include common and rare procedures, such as cricothyrotomy, thoracotomy, and new laparoscopic techniques. These less commonly performed procedures require disproportionate time for maintenance of skill that must be acknowledged in physician work schedules. Simulation is widely available but unevenly used by practicing physicians and usually not considered part of the department’s or simulation center’s budget for simulation or the time physicians spend retraining, relying on the volunteerism of the physician. Retraining opportunities allow physicians to refresh their procedural skills and develop familiarity with new equipment and methods. There are some national-level pressures for maintenance of skills; for example, the Joint Commission requires appropriate credentials for procedural sedation. In addition, some departments have faculty-specific procedural training that is voluntary, or may be mandated, including annual procedural sedation certification. Also, some specialties, such as electrophysiology, have delineated the knowledge and procedural competencies expected.9
However, less clear is where the locus of responsibility should lie for ensuring competency through apportioning of work hours between the time demands of nonclinical work and time for retraining to maintain and enhance clinical skills. How can continued training opportunities be designed that are proactive, judicious, individualized and transparent? To what extent should retraining depend on the physician?
Third, physicians can choose practices that involve less exposure to procedures or content for which they believe are no longer expert, such as in lower acuity areas with parallel coverage of a procedural team, more reliance on colleagues to assist when needed, or both. Maximizing collective competence is in alignment with systems-based approaches, but requires policies that do not feel punitive. The optimal solution is likely to differ between settings. Meanwhile, there is the possibility that even with diminished competency, some physicians with perhaps limited skills for some procedures may still be needed in some areas.
Fourth is the importance of self-assessment and reflection. Honest and objective self-assessment at the individual level can be challenging to achieve, especially given that professional identity is wrapped in the physician persona, and for a physician to be able to admit that he or she is not competent in something is a loss of self. It is critical that physicians intentionally seek assessment data via external metrics, such as number of patient complications, patient morbidity, or peer feedback regarding their practice.
Fifth, beyond the individual physician, the health care system has a critical responsibility for ensuring competency of physicians and surgeons for performing procedures. As medical education becomes more capable of determining competency through work-based assessments, it may be possible to determine which physicians no longer meet a competency threshold. Heath care systems need to have triggers that initiate exploration of physician competence, which might include frequency of safety events and complications, low volume of complicated procedures, patient reported outcome measures, patient and staff complaints, and low referral patterns from colleagues.10 These triggers should launch a more extensive examination of practice, including peer assessments, direct observation, health record analytics, cognitive testing, procedural testing, and other methods of competency assessment.6 It is important to recognize that the competencies that allow a physician the ability to practice are complex and multifactorial and, therefore, difficult to measure. Once an issue becomes apparent, the physician and health care system have a joint responsibility to ensure that the physician can demonstrate the necessary competency for practice skills or procedural expertise, retrain for the necessary skills, or retire that procedure from his or her practice.
Given the reality of forgetting curves, the medical profession has an important responsibility to ensure quality of care and to protect patients from potential harms. This requires physicians to understand how they acquire and maintain expertise, including the time, practice, and self-challenge necessary to achieve and maintain peak performance. Physicians also must understand that when they cease to perform certain clinical activities, such as uncommon procedures, previous experience can only go so far and performance may decline unless deliberate retraining steps are taken. However, it is first essential for physicians to be willing to recognize that safety for patients requires complete transparency about competency in clinical skills and performance.
Article Information
Corresponding Author: Sally A. Santen, MD, PhD, Virginia Commonwealth University School of Medicine, 1201 E Marshall St, MMEC 4-214, PO Box 980565, Richmond, VA 23298 (sally.santen@vcuhealth.org).
Published Online: December 26, 2019. doi:10.1001/jama.2019.21081

Saturday, January 4, 2020

Reading new nutrition facts labels

The Food and Drug Administration has updated the Nutrition Facts label on packaged foods and beverages to reflect new scientific information, including the link between diet and chronic diseases. Manufacturers with $10 million or more in annual sales were required to switch to the new label by Jan. 1, 2020. Here, Angie Murad, a wellness dietitian with the Mayo Clinic Healthy Living Program, explains some of the key changes.
The new design of the Nutrition Facts label is meant to make it easier for consumers to make informed  choices. One of the most noticeable changes is the calories are now in a larger, bolder type.
“That can be helpful when you’re trying to identify how many calories are in a product,” Murad explains.
When comparing calories and nutrients in different foods, you should check the serving size. However, since how much people eat and drink has changed over the years, the food serving sizes are getting a reality check on the new labels.
“It may not be an example of what one serving is, but it may be more realistic of what someone really is eating so they can pinpoint exactly how many calories something has,” says Murad.
The new labels are now required to include vitamin D, potassium and added sugars. When making healthy , Murad says to look at the calories.
“They should look at added sugars. You want to be looking for things that have  and staying away from things that have high saturated fats.”

1 on 1 with CMS chief Seema Verma

KEY TAKEAWAYS

‘There’s a balance between making sure it’s easy for people to apply, but we also have to make sure that we do the appropriate work to make sure that they qualify for the programs.’
‘Medicare for All would strip Americans, 180 million Americans, of their private health insurance and put them on a government-run, bureaucratic program.’
‘As the head of the Medicare program, I see every day that government regulations kind of stand in the way.’

Seema Verma, administrator for the Centers for Medicare & Medicaid Services, sat down for a rare one-on-one interview with Kaiser Health News senior correspondent Sarah Varney.
They discussed her views on President Donald Trump’s plan for sustaining public health insurance programs, how the administration would respond if Obamacare is struck down by the courts in the future and her thoughts on how the latest “Medicare for All” proposals would affect innovation and access to care. A transcript follows, edited for length and clarity.
Sarah Varney: Thank you, Administrator Verma, for joining us. We really appreciate it. You spoke recently about this need to protect Medicaid as a lifeline, but also not to have people be entrapped, or trapped on, Medicaid and come to rely upon it too greatly. So, as I was mentioning, we were in Tennessee recently, and I know you can’t speak to specific cases —
Seema Verma: Mmm, hmm.
Varney: But, we did find a number of families who had been disenrolled, and then found it quite difficult to get back on. And I just wondered if there is a danger in taking this approach where there’s more frequent verification checks, a real focus on eligibility verification, that it could discourage some parents and kids who might be eligible for the program from signing up?
Verma: Well, our top priority is making sure that the beneficiaries in the Medicaid program have high-quality, accessible care, and we want to do everything that we can to improve the quality of their lives. In terms of the enrollment process, we also have an obligation to taxpayers to make sure that only the people that qualify for the programs are participating. And we also want to make sure that the programs are sustainable over the long term. I think there’s a balance between making sure it’s easy for people to apply, but we also have to make sure that we do the appropriate work to make sure that they qualify for the programs.
Varney: So, are you concerned, though, that there were a number of people, after the eligibility process kicked in again in 2017, after the ACA sort of put things on hold for a while, that there might have been families, though, that have been lost? That just don’t want to come back, or can’t come back? Or are hearing worries about the public charge rule, as well, and so are concerned about giving the government their information?
Verma: You know, our top priority is making sure that we focus on improving quality of care, high-quality care, accessible care, and making sure that we’re improving the quality of life for individuals. You know, when I think of the Medicaid program, and in every decision we make, I try to keep in mind the actual beneficiary. In my time spent on the Medicaid program, I’ve met a lot of Medicaid beneficiaries. I met a gentleman, Richard, who was in Indiana. He was a quadriplegic and literally requires 24-hour care. I met some parents of a child on the Medicaid program. This child had cerebral palsy and so severe that they require 24-hour care, and you can imagine the impact on the entire family. This is a child that will never be independent, will always require help. And so, when we’re creating our eligibility policies, we keep those individuals in mind. We don’t want to make it harder for them to apply for the program.
And so, we try to come up with policies that don’t put a lot of onerous requirements on the beneficiary, but we can have requirements for states that require them to do back-end processes, and back-end checks that don’t actually burden the actual recipient or their families, but that also ensure that we are putting the appropriate protections in place for taxpayers, so the program is sustainable over the long term. And we have only the people that qualify for the program participating.
Varney: We know that more health coverage leads to longer life expectancy; I think this has been well established. And I wonder if whether or not the administration should be emphasizing more finding those children who are not enrolled, who are eligible but not enrolled, and perhaps focusing on outreach, which we haven’t really heard your administration talk about?
Verma: Well, again. Our focus is on making sure, especially children, that they have access to high-quality health care. As a mom, I’ve got two kids, so I can personally attest to the fact that having health insurance is very important for children. Something very little, like an ear infection, can lead to deafness if it’s not, you know, treated appropriately. So having that access to high-quality health care is very, very important to their development. The Trump administration is very committed to the Children’s Health Insurance Program; the president signed legislation around that. Additionally, we have spent over $48 million on outreach efforts. We’re very focused on working with states, so that they can identify the best practices to make sure that those individuals, children that qualify, can enroll in the program, that they’re aware that this program exists.
Varney: Have you found that the reduction in the Navigator grants has made it more difficult to reach those families?
Verma: We, actually, we have not. If you look, the Navigator programs are really aimed at the Affordable Care Act programs and the exchange programs. So those are not aimed at children. Those are aimed at our adult population. And we have seen very minimal impact. What we have done is try to increase our digital communication, of, to help enrollment. And we’ve seen a very minimal impact on enrollment.
I think the issue around enrollment really comes back to affordability. Obamacare has had a direct impact on increasing premiums. Across the nation, we’ve seen premiums go up by 100%, 200%. [Editor’s note: PolitiFact rated this claim by the Trump administration “false.” ACA premiums were down by about 4% in 2019 compared with 2018.] And so the issue around enrollment is that health insurance has become so unaffordable for families that that’s why they can’t afford their coverage.
Varney: So we did hear from a number of federally qualified health centers that although the Navigator grants really were focused on, you know, ideally they were focused on exchanges, people buying private health insurance, that, in fact, there were a lot of people who came in, who became eligible for Medicaid and discovered that they were eligible for Medicaid in that way. So I wonder if there is additional outreach that needs to be done to those families, not just virtually or online, but some other way to reach those families?
Verma: The real problem around making sure that people have access to affordable coverage is really addressing the high cost of health care. And that’s what the president is focused on. His health care agenda isn’t just about putting out more subsidies and having the government pay more and more and creating unaffordable programs. But it is about addressing the underlying cost drivers in health care. That’s why he’s focused on prescription drug pricing, he’s focused on transparency, price transparency, so that there’s more competition in the market. We’re also focused on getting rid of burdensome regulations that we know drive up the cost of care.
I think by addressing that, that is going to result in decreased premiums, which will result in more people having access to affordable coverage.
Varney: But all those things that you just mentioned — they don’t necessarily affect the Medicaid population directly. Now, they may affect them indirectly by increasing overall health care costs, but in terms of the Medicaid population, really reaching out, ensuring that every single child who’s eligible for Medicaid is enrolled?
Verma: So, our focus is also on addressing the economy. Under the president’s leadership, we have a booming economy. We have one of the lowest unemployment rates. We have more people that are earning more money, and we have fewer people living in poverty. There’s been a reduction in the number of people living in poverty by 1.4 million people. And so, we are seeing people coming out of the Medicaid program, and because the economy’s doing so well. The issue is, though, they can’t afford coverage. And so, even as we increase our outreach efforts, we spent over $48 million on outreach, the issue is around affordability. Obamacare has impacted the market in such a way that it’s become unaffordable for people that don’t have subsidies.
Varney: So, we’re at this moment in our country and our national conversation where we’re talking about how do we ensure that more and more people are insured? And I wonder what the administration is doing to move the needle, to stop the growth in the uninsured, particularly among children?
Verma: I think our focus has been about addressing affordability of health care. The underlying issue in people not being able to afford their health insurance is that it’s too expensive. And the solution is not trying to throw more government money around subsidies, because that’s just going to increase taxes for everybody. Our approach is to address the underlying issues. President Trump is addressing long-standing issues in health care that haven’t been addressed by any administration. The blueprint that he put out on drug pricing was very historic. The work that he’s done on price transparency. And the work that we’re trying to do around the regulatory burden, getting rid of all kinds of unnecessary regulations that are actually increasing the cost of health care for providers. We spend over $200 billion on administrative costs every year. So what we’re trying to do is address the cost of health care, but also make sure that we continue to have the high-quality, innovative health care system that Americans are used to.
Varney: So there are some people who are advocating for a Medicare for All type of solution to this, to say that much of those costs are because the marketplace, in a sense, doesn’t work in health care. And I wonder what you say to people who are proposing that? Who are saying, this is all just, that the market doesn’t work when it comes to health care?
Verma: So, when it comes to health care and it comes to the solutions around Medicare for All. … Medicare for All would strip Americans, 180 million Americans, of their private health insurance and put them on a government-run, bureaucratic program. If we look at the programs that we have today, our government-run programs, our Medicare program is not affordable. The Medicare Trustees have indicated in the next seven years they’re gonna run out of money, they’re gonna have trouble paying their bills. The Medicaid program is the No. 1, No. 2 budget item for many states. And you’re hearing states every day — look at the situation in New York, where they can’t afford their Medicaid programs. And so, our track record on government-run programs isn’t strong. And I think our focus is on trying to unleash competition to drive down costs, but keep the innovation in the system. Our concern is that a government-run or more government is going to thwart innovation.
As the head of the Medicare program, I see every day that government regulations kind of stand in the way, that there are delays in our beneficiaries being able to access treatments. That’s why the president put out the Medicare Executive Order, which was focused on making sure we can do better with this. But I think, you know, putting more people on a government program is actually going to threaten the sustainability of the programs that we have in place today.
Varney: And do you think through the measures that you’re talking about, that you could reduce costs — 15%, 20% — in the health care system of the United States?
Verma: I think our goal is to try to reduce cost, and to make it more unaffordable [sic]. And we’ve had great success with this under President Trump’s leadership. If we look at the Medicare Advantage Program, for example, under his leadership, premiums have gone down by over 23% since he came into office. In the Part D program, premiums are down by 13%, the lowest level in seven years. Going back to Medicare Advantage, that’s the lowest level in 13 years. So, I think the president’s policies are working, because we demonstrated that we can lower premiums.
Same thing on the individual exchanges. For the very first time, the individual market has been stabilized and premiums went down last year by a percent, this year by 4%, and they’re still too high, there’s a new class of uninsured being created by Obamacare, but President Trump’s policies have actually resulted in more Americans, more seniors having money back in their pockets.
Varney: Now we’re waiting for a ruling from the courts on the future of the Affordable Care Act. If it’s struck down, what is your plan to replace it?
Verma: Well, the president’s been very clear that he wants to make sure that individuals with preexisting conditions have protections. And we have prepared for a variety of scenarios, and we want to make sure that there’s no disruption in coverage. And we’ll work with Congress to make sure that Americans have access to high-quality, affordable coverage. That is not what they have today. People with preexisting conditions do not have those protections. Individuals that don’t get subsidies and can’t afford coverage really don’t have those protections. And so the president wants to make sure that we’re addressing those individuals, and that people with preexisting conditions have the appropriate protections that they don’t have today.
Varney: But how do you guarantee those protections, also reduce costs and not lead to widespread uninsurance rates going up?
Verma: I think our focus is not just on costs, but it’s also making sure that we preserve quality and innovation in the system. One of the initiatives that we’ve had is around trying to pay our providers differently. Right now, we’re paying in a system where we just pay for people to get things done. And we want to change that paradigm, where we’re holding providers accountable for providing quality care, improving the quality of life, preventing disease and keeping people healthy.
Varney: So, just my final question. There have been these reports of a rift, a growing rift between you and Department of Health and Human Services Secretary Alex Azar. And I wonder if people should be concerned about whether or not that’s going to get in the way of the very ambitious slate of initiatives that you and President Trump have planned?
Verma: Well, Secretary Azar and I are both committed and have a shared goal around delivering on the president’s agenda.