Wednesday, May 31, 2023
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Following a full-scale revolt by physicians, the American Board of Internal Medicine (ABIM) is considering dropping its expensive 10-year maintenance of certification (MOC) exam. Instead, physicians could be required to take shorter, more frequent tests that could be done online.[1] ABIM has made significant changes to MOC, but one of the outstanding grievances is the exam, which must be taken once every 10 years. Failure can mean loss of job or hospital privileges.
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A more intensive strategy of blood pressure management reduces the risk for death and cardiovascular events when compared with a strategy that lowers systolic blood pressure to the conventional target of 140 mm Hg, a large study found. In the Systolic Blood Pressure Intervention Trial (SPRINT), investigators reported in a September media briefing that treating high-risk hypertensive adults aged 50 years and older to a target of 120 mm Hg significantly reduced cardiovascular events by 30% and all-cause mortality by nearly 25%. The study, which was funded by the National Institutes of Health, was stopped early because of the benefit of the intensive strategy, according to investigators.[2] However, absolute risk reductions were small and some adverse effects were higher in the intensive-treatment group. The SPRINT investigators said it is too early to speculate on how the results will change clinical practice; the data need to be reviewed and updated guidelines incorporating the results still need to be written.
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In April Congress passed a bipartisan bill that repealed Medicare's sustainable growth rate (SGR) formula for calculating physician reimbursement for Medicare patients. The law, called the Medicare Access and CHIP Reauthorization Act (MACRA), averted a 21% Medicare pay cut this year. MACRA will shift Medicare compensation from fee-for-service to pay-for-performance.[3] The law was supposed to increase Medicare rates by 0.5% in the second half of the year and continue to increase it 0.5% each year from 2016 through 2019. However, the promised raise turned into a 0.3% pay cut in the fine print of the final 2016 Medicare fee schedule. The reason? The Affordable Care Act (ACA) and several other laws trumped MACRA.[4]
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The Institute of Medicine (IOM) is taking chronic fatigue syndrome seriously. An IOM report called it a "serious, complex, multisystem disease" that physicians and other healthcare professionals need to view as "real" and diagnose. The report proposed calling it "systemic exertion intolerance disease."[5]
"It's time to stop saying that this is a just figment of people's imagination. This is a real disease, with real physical manifestations that need to be identified and cared for," said Committee Chair Ellen Wright Clayton, MD, JD. She is a professor of pediatrics and director of the Center for Biomedical Ethics and Society at Vanderbilt University. Elsewhere in the world the illness is called "myalgic encephalomyelitis."
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The ICD-10 transition did not turn out to be the disaster everyone predicted. Created by the World Health Organization, it replaced the last set of codes — ICD-9 — as of October 1. Insurance claims now must bear one or more of the new diagnostic codes. And with nearly 70,000 choices, roughly five times the number in ICD-9, physicians worried not only that ICD-10 would add to their workload, but also that coding and claims-processing errors would delay payments from third-party insurers.[6] In the end, the transition caused little more than a blip for most physicians. The vast majority of practices are successfully submitting claims with the new codes and getting reimbursed.[7]
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Little progress has been made in reducing diagnostic errors, which can have fatal consequences, according to a new report. Consequently, "most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences." The report, Improving Diagnosis in Health Care, from the IOM, found that 5% of US adults who seek outpatient care each year receive incorrect diagnoses. Diagnostic errors contribute to approximately 10% of patient deaths. Causes include poor collaboration among clinicians, patients, and their families; a healthcare system that does not support the diagnostic process; limited feedback to clinicians about their diagnostic performances; and a culture that discourages disclosure of errors.[8]
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On October 7, the US Department of Health and Human Services released its final rule for stage 3 of the electronic health record (EHR) incentive program, along with changes to stages 1 and 2, and 2015 EHR certification criteria.[9] In early November, a coalition of 111 medical societies called on Congress to refocus stage 3 of the EHR meaningful use incentive program. The coalition, led by the American Medical Association, asked for legislation to prevent the repetition of what it considers the failure of stage 2.[10] According to the coalition, only 12% of physicians had successfully attested in stage 2 by early November. This was partly because of the difficulty of exchanging data between providers, as well as what it called "excessive documentation requirements." All eligible professionals must begin stage 3 in 2018 at the latest. Physicians who do not attest face reductions in their Medicare payments.
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Patients with type 2 diabetes and established cardiovascular disease receiving the glucose-lowering agent empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), a sodium glucose cotransporter-2 (SGLT-2) inhibitor, were less likely to die than those taking placebo in the large, much-anticipated EMPA-REG OUTCOME study, hailed at a major European diabetes meeting in September as a landmark trial.[11] In the study, 39 patients needed to be treated with empagliflozin for 3 years to prevent one cardiovascular death.
This is the first time a glucose-lowering drug has shown superiority in a cardiovascular-outcomes trial — similar trials with diabetes drugs from other classes have demonstrated only neutrality (ie, cardiovascular safety). Senior author of the study Silvio Inzucchi MD, of the Yale Diabetes Center, New Haven, Connecticut, and the other investigators urged prudence, however, noting that they had only recently seen the results of EMPA-REG and that extensive work is still needed to unravel the mechanisms by which this SGLT-2 inhibitor is exerting its seemingly beneficial effects. In addition, the trial population studied in EMPA-REG — type 2 diabetes patients with existing cardiovascular disease — is not representative of all patients with the condition.[12]
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French physicians spontaneously responded to the November 13 terrorist attacks that devastated Paris, racing to hospital accident and emergency departments to offer their help. Private practice physicians immediately halted a strike, called Black Friday, to give priority to emergency care. Over a period of just a few hours, the Parisian medical world made the transition from Black Friday to the White Plan, triggered by the Paris hospitals authority. The White Plan has been enshrined in law since 2004 and enables additional means and human resources to be mobilized, nonessential activities to be rescheduled, and additional beds to be opened. At least 132 people died in the attacks and more than 250 were injured.[13]
Image courtesy of Pourya Pashootan, MD
The US Supreme Court, by a 6-3 vote, rescued the ACA from a potential deathblow in June. It ruled that citizens of the 34 states that did not establish their own insurance marketplaces are eligible for federally subsidized premiums. The decision affects some 5.4 million Americans. The issue kept the healthcare industry and political world on a low boil of anxiety for months. The challenge to the 2010 law focused on a section that said the subsidies were intended for people buying healthcare plans through an exchange "established by a state." Only 16 states opted for their own exchange. The High Court concluded that the law's intent was to make insurance affordable for everyone. "Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them," the majority opinion stated.[14]
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People taking psychotropic medications have a significantly increased risk for homicide, new research shows. Jari Tiihonen, MD, PhD, professor, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden, and colleagues found that antidepressants increase the homicide risk by 31% and that benzodiazepines increase the risk by 45%. The use of opiate and nonopiate analgesics was associated with a two- and threefold increased risk for homicide, respectively. Antipsychotics were not associated with an increased homicide risk, the study found. Benzodiazepines can weaken impulse control, Dr Tiiohnen explained. Also, according to earlier research, painkillers affect emotional processing.[15]
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Indiana Governor Mike Pence declared a public health disaster in southern Indiana this March following the worst HIV outbreak in the state's history.[16] More than 170 people tested positive for the disease, almost all of whom were also infected with hepatitis C. In previous years, Scott County, where the epidemic was centered, reported fewer than five new HIV cases each year. Authorities said the majority of cases were caused by syringe sharing among people who injected prescription oral pain medication, primarily oxymorphine. In the wake of the epidemic, Indiana — as well as Kentucky, which experienced an increase in hepatitis C cases — passed laws permitting needle exchanges, which helped control the outbreak.[17]
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More than 40,000 people signed up for an ongoing global research study via smartphone app over the course of just 2 weeks in March. The study measures how activity affects heart health. Stanford University researchers, along with the American Heart Association, designed the free smartphone app called MyHeart Counts. Anyone aged 18 years or older with an iPhone 5s, 6, or 6 Plus can download the app, give consent to be included in the study, answer survey questions about risk factors, and then let sensors record their movements for 7 days.[18]
Image courtesy of MyHeart Counts/Stanford University
In October, the American Cancer Society updated its breast cancer screening guidelines for women at average risk of developing the disease. It now says that women should start annual screening with mammography at age 45, not 40 as previously recommended. At age 55, women can transition to screening every 2 years. An update from the International Agency for Research on Cancer Working Group found that women between 50 and 69 years of age who undergo screening mammography have about a 40% reduced risk for death from breast cancer.[19] Another report by the Breast Cancer Surveillance Consortium suggested that women with high-density breasts who have an elevated 5-year breast cancer risk score would benefit from supplemental imaging.[20]
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This summer, the US Food and Drug Administration (FDA) approved two drugs in a new drug class that is expected to be a game-changer in managing cholesterol. The drugs are alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen).[21,22] The two new drugs, which are proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors, differ from statins in their mechanism and mode of delivery. Statins have been the most recent means of lowering LDL-cholesterol levels. The PCSK9 inhibitors have potential to change the way physicians treat and manage a wide range of patients with elevated LDL-cholesterol levels.[23] However, the costs of the drugs have been controversial.[24,25]
Images courtesy of Amgen (L) and Sanofi (R)
In October, California became the fifth state to permit physician-assisted suicide. Gov. Jerry Brown signed into law a bill approving the controversial, yet growing, practice called assisted dying. The four other states are Montana, Oregon, Vermont, and Washington. Many other states, including Colorado, have bills pending. Passage of the California law came after the California Medical Association changed its position from opposition to neutrality on the issue.[26] This trend has been seen in other states as well. Organized medicine has traditionally opposed physician-assisted suicide, calling it a violation of the imperative to "do no harm."
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The FDA agreed to let 23andMe sell directly to consumers a test designed to identify healthy people who carry a gene that could cause Bloom syndrome. People can order the test, which they can use at home. The approval is a significant shift for the agency. In 2013, the FDA sent 23andMe a warning letter directing the company to stop selling a personal genome service. The letter said the company had not obtained proper approval or demonstrated that their tests were accurate and clinically meaningful.[27]
Image courtesy of 23andMe
Both branches of Congress have launched investigations into high drug prices. In November, a US Senate panel began a bipartisan probe into companies that have hiked prices on life-saving drugs.[28] A House of Representatives committee said it would hold a 2016 hearing on the issue.[29] The inquiries come as a result of huge price increases for several drugs, including a 5000% price increase for pyrimethamine (Daraprim), a decades-old drug that treats toxoplasmosis, by its manufacturer Turing Pharmaceuticals, from $13.50 to $750 a tablet.[30] In an early campaign promise, Democratic presidential candidate Hillary Clinton said she would cap prescription drug costs at $250 per month.[31] Clinton also urged regulators to determine how to quickly bring lower-cost generic drugs to market.[32] Turing has since said it would lower the price to a more reasonable level.[33]
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Noninvasive prenatal testing (NIPT), which identifies abnormalities in the fetus, can also identify cancer in pregnant women before they experience any symptoms. A review of three case reports was published online in JAMA Oncology. NIPT analyzes cell-free DNA present in maternal plasma. In pregnant women, the plasma contains fetal DNA, which is analysed for abnormalities in the fetus, but in women who also have cancer, the plasma also contains cancer DNA, explained lead author Joris Robert Vermeesch, PhD, of the Center for Human Genetics, in Leuven, Belgium. The findings could potentially change clinical practice, he said.[34]
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The FDA ordered Custom Ultrasonics to recall all of its endoscope reprocessors. Persistent regulatory violations could increase the risk of transmitting infection, the FDA said. The recall is the agency's latest move to reduce the spread of antibiotic-resistant bacteria via dirty endoscopes, particularly duodenoscopes.[35] In recent years, there have been at least six outbreaks of multidrug-resistant bacteria — some lethal — tied to duodenoscopes, even when the proper reprocessing instructions were followed.[36] The device's many small, hidden parts make it particularly difficult to clean. The problem topped the 2016 list of healthcare technology hazards identified by the nonprofit ECRI Institute.[37]
Image from FDA/Associated Press
A new program that takes a "real-world" approach to first-episode psychosis shows significant improvement in young patients. Investigators at the Albert Einstein School of Medicine in New York City found that patients who underwent the NAVIGATE program experienced greater improvement in quality of life and psychopathology, according to a report published online October 20 in the American Journal of Psychiatry. Patients who received the intervention were more involved in work and school than those who received standard community care. The study combined different aspects of treatment that have been studied elsewhere and can be easily implemented in community clinics. They included personalized medication management, family education, individual therapy focused on resilience, and supported employment and education.[38]
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Columbia University should fire television personality Mehmet Oz, MD, a group of physicians from an independent group wrote in a letter to the university in April.[39] The 10 physicians cited his "disdain for science and for evidence-based medicine," his opposition to genetically modified foods and his promotion of "quack treatments." Dr. Oz is a cardiothoracic surgeon and medical professor at the university. He accused the doctors of silencing his right to free speech and of conflicts of interest.[40] The physicians are part of a group called the American Council on Science and Health (ACSH), which some critics say is a "front group" for large corporations that fund it in exchange for ACSH defending products and practices that threaten public health, such as e-cigarettes and fracking.[41]
This is not the first time Dr. Oz has been in the hot seat over his TV show. In 2014, a US senator accused him of perpetrating fraud for pushing bogus diet products. Later that year, an online article in the BMJ found that half of his TV recommendations had no scientific validity.
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In May, eight states joined the interstate compact of the Federation of State Medical Boards.[42] Seven states were enough to set in motion the compact, an agreement designed to make it easier for physicians to be licensed in multiple states — an important step in making telemedicine workable and accessible.
In addition, a majority of states now have telemedicine parity laws, which require private insurers to cover remote consultations the same way they cover in-person medical visits. Many of these states also mandate telemedicine coverage by their Medicaid programs and, in some cases, by their state employee health insurance plans.[43] Earlier in the year, telemedicine — in which clinicians encounter patients remotely via real-time audio and/or video — got a big boost when the Obama administration waived burdensome Medicare restrictions.[44] A survey released by the National Business Group on Health found that telemedicine services will be offered in health insurance plans sponsored by 74% of large employers during the next year in states where it is legal.[45]
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In January the FDA approved a new device for treating obesity. The vBloc vagal blocking therapy is delivered via a rechargeable device implanted into the chest wall. It intermittently blocks the vagus nerve, reducing hunger and increasing feelings of satiety. The first-of-kind device, made by EnteroMedics, is for the treatment of obese adults who have tried and failed at least one supervised weight management program within the past 5 years. The concept came from the fact that patients who undergo surgical vagotomy experience temporary weight loss. Vagotomy is a procedure once commonly used to treat problematic stomach ulcers. The vBloc therapy is reversible and can be noninvasively adjusted or turned off when necessary.[46]
Separately, the FDA also approved two minimally invasive gastric balloons for weight loss this year, the ReShape Dual Balloon (ReShape Medical) in July and the Orbera Intragastric Balloon System (Apollo Endosurgery) in August.[47,48]
Image courtesy of Entero Medics
In September, the US Government Accountability Office (GAO) announced that it would launch an investigation into power morcellators.[49] The controversial device shreds uterine fibroids for easy removal through laproscopic incisions. Studies have long established that the use of power morcellators poses a high risk for spreading undiagnosed uterine cancer. In October, 12 members of Congress asked the GAO to find out why the FDA took so long to issue warnings.[50] In April 2014, the FDA recommended that surgeons stop using power morcellators for fibroid removal. The agency blamed the devices for hundreds, if not thousands, of deaths.
Image courtesy of the National Institutes of Health
In March, the White House released the first national plan to fight antibiotic resistance. President Barack Obama's 2016 budget also doubled federal funding for antibiotic-resistance efforts to more than $1.2 billion. The National Action Plan for Combating Antibiotic-Resistant Bacteria coordinates federal agencies and sets goals for reducing antibiotic-resistant disease and inappropriate antibiotic use. The new action plan is organized around five main goals: preventing the spread of antibiotic resistance, strengthening surveillance efforts, advancing diagnostic testing, accelerating the development of new antibiotics, and improving global collaboration.[51,52] According to the Centers for Disease Control and Prevention, antibiotic-resistant infections are associated with 23,000 deaths, 2 million illnesses, and billions in healthcare costs in the United States every year.[53]
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Lawmakers in Georgia and Texas legalized medical marijuana in 2015. A total of 25 states and the District of Columbia now allow marijuana use in some form — or at least have decriminalized possession of it. In February US Surgeon General Vivek Murthy, MD, said that medical marijuana can help some patients. Murthy said that preliminary data shows that marijuana can be helpful for certain medical conditions and symptoms. The data should be used to drive policymaking, Dr Murthy said.[54] Marijuana is still illegal at the federal level. Meanwhile in October, the American Academy of Family Physicians (AAFP) voted to support decriminalizing the possession of marijuana for personal use but stopped short of supporting legalization.[55]
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Last month Broward Health agreed to pay $70 million to settle allegations that it engaged in "improper financial relationships" with doctors under laws prohibiting kickbacks in return for patient referrals. The settlement stemmed from a federal whistleblower lawsuit filed by Michael Reilly, MD, and the US Justice Department against the nonprofit healthcare system. Giving doctors incentives to generate medical revenue is widely deemed unethical because it tempts them to order unneeded treatment or send patients to lower-quality providers. Physicians with a financial interest in a medical facility tend to order more procedures than those who don't, studies show. Dr. Reilly, a Fort Lauderdale, Florida, orthopaedic surgeon, said the trend of hospital buying up medical practices is bad for physicians, patients and society.[56]
Hospital employment for physicians, as opposed to running independent practices, was a continuing trend this year[57] and can present professional challenges that range from loss of autonomy to pressure to boost productivity.[58]
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Questions about military medicine will now be on the medical licensing exam. The move was spearheaded by a small group of medical professionals who wanted to ensure that in the future physicians will at least be aware of the possible medical problems of veterans. Brian Baird, PhD, a former Democratic member of Congress from Washington and a licensed clinical psychologist, said he was inspired by some of his own patients who returned from duty in need of help. "We don't even ask, 'Have you or a loved one been deployed overseas,'" he said. "And I thought, what a terrible oversight."[59]
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Four leading US healthcare associations applauded the Supreme Court decision that same-sex marriage is a constitutional right. The organizations are the American Psychiatric Association, the American Medical Association (AMA), the American Academy of Pediatrics, and the American College of Physicians. "The AMA is pleased by today's Supreme Court decision that marriage is a right for all Americans because it ends a form of discrimination and will help reduce health care disparities among same-sex couples and their families," AMA board member Jesse M. Ehrenfeld, MD, said. The 5-4 ruling guarantees gay and lesbian couples the right to marry in all 50 states.[60]
Image from AP Photo/Manuel Balce Ceneta
Surgeons, nurses, and other healthcare professionals from around the world responded to a magnitude 7.8 earthquake in Nepal, which struck near Kathmandu on April 25. More than 6000 people were killed, and at least 14,000 were injured. The quake caused widespread destruction across a huge geographic area. Some of the worst-hit communities were remote mountainside villages. Access to these hard-to-reach areas remained the single biggest hurdle to providing critical services. In many places, medical teams had to be flown in by helicopter or walk in by foot, according to Margaret Traub, head of Global Initiatives, International Medical Corps.[61]
Image from Niranjan Shresta/AP
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