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NEJM—Health Policy and Reform

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https://www.readbyqxmd.com/read/28423291/addressing-the-opioid-epidemic-opportunities-in-the-postmarketing-setting
#1
Bruce M Psaty, Joseph O Merrill
The Food and Drug Administration (FDA) recently developed a multipart action plan in response to the opioid epidemic. As part of that initiative, it invited recommendations from the National Academy of Medicine about a regulatory framework that might allow public health considerations to be..
April 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28423282/good-riddance-to-big-insurance-mergers
#2
Leemore S Dafny
Eighteen months after four of the five largest U.S. health insurers announced multibillion-dollar merger deals, federal judges, siding with the Department of Justice (DOJ), have issued preliminary injunctions halting the two transactions. These decisions will cost the insurers: they spent over $2..
April 19, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402776/lessons-from-standing-rock-of-water-racism-and-solidarity
#3
David Goldberg
"I heard you were in Standing Rock." So began a visit with Mr. Y. and we leaned in toward one another. In the past, I’d felt off balance with Mr. Y. who often seemed to push me away. "Why can’t you just fix this?" he asked, referring to his diabetes. Mr. Y. is a traditional Navajo, or Diné. In the..
April 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402774/changes-in-france-s-deferral-of-blood-donation-by-men-who-have-sex-with-men
#4
LETTER
Pierre Tiberghien, Josiane Pillonel, François Toujas, Benoit Vallet
To the Editor: Since the advent of AIDS, men who have sex with men (MSM) have often been permanently deferred from blood donation in France and elsewhere. Such a ban, which is more stringent than deferrals for other risk exposures, can be considered to be discriminatory and often is misunderstood...
April 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402773/incidence-trends-of-type-1-and-type-2-diabetes-among-youths-2002-2012
#5
Elizabeth J Mayer-Davis, Jean M Lawrence, Dana Dabelea, Jasmin Divers, Scott Isom, Lawrence Dolan, Giuseppina Imperatore, Barbara Linder, Santica Marcovina, David J Pettitt, Catherine Pihoker, Sharon Saydah, Lynne Wagenknecht
Background Diagnoses of type 1 and type 2 diabetes in youths present a substantial clinical and public health burden. The prevalence of these diseases increased in the 2001-2009 period, but data on recent incidence trends are lacking. Methods We ascertained cases of type 1 and type 2 diabetes mellitus at five study centers in the United States. Denominators (4.9 million youths annually) were obtained from the U.S. Census or health-plan member counts. After the calculation of annual incidence rates for the 2002-2012 period, we analyzed trends using generalized autoregressive moving-average models with 2-year moving averages...
April 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402772/delays-in-emergency-care-and-mortality-during-major-u-s-marathons
#6
Anupam B Jena, N Clay Mann, Leia N Wedlund, Andrew Olenski
Background Large marathons frequently involve widespread road closures and infrastructure disruptions, which may create delays in emergency care for nonparticipants with acute medical conditions who live in proximity to marathon routes. Methods We analyzed Medicare data on hospitalizations for acute myocardial infarction or cardiac arrest among Medicare beneficiaries (≥65 years of age) in 11 U.S. cities that were hosting major marathons during the period from 2002 through 2012 and compared 30-day mortality among the beneficiaries who were hospitalized on the date of a marathon, those who were hospitalized on the same day of the week as the day of the marathon in the 5 weeks before or the 5 weeks after the marathon, and those who were hospitalized on the same day as the marathon but in surrounding ZIP Code areas unaffected by the marathon...
April 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402767/who-decides-when-a-patient-can-t-statutes-on-alternate-decision-makers
#7
Erin S DeMartino, David M Dudzinski, Cavan K Doyle, Beau P Sperry, Sarah E Gregory, Mark Siegler, Daniel P Sulmasy, Paul S Mueller, Daniel B Kramer
Many patients cannot make their own medical decisions, having lost what is called decisional capacity. The estimated prevalence of decisional incapacity approaches 40% among adult medical inpatients and residential hospice patients and exceeds 90% among adults in some intensive care units. Patients..
April 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402766/increase-in-the-incidence-of-diabetes-and-its-implications
#8
EDITORIAL
Julie R Ingelfinger, John A Jarcho
Diabetes mellitus is among the most prevalent and morbid chronic diseases, affecting the health of millions of persons worldwide. According to the Global Burden of Disease (GBD) report for 2015, the prevalence of diabetes rose from approximately 333 million persons in 2005 to approximately 435..
April 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402764/ensuring-access-to-injectable-generic-drugs-the-case-of-intravesical-bcg-for-bladder-cancer
#9
Benjamin J Davies, Thomas J Hwang, Aaron S Kesselheim
In November 2016, one of the two manufacturers of bacille Calmette–Guérin (BCG) informed health care providers that it planned to exit the market in mid-2017. Intravesical immunotherapy with BCG is the standard of treatment for preventing recurrence and disease progression in high-risk patients..
April 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402707/physicians-firearms-and-free-speech-overturning-florida-s-firearm-safety-gag-rule
#10
Wendy E Parmet, Jason A Smith, Matthew Miller
In February, the full U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited ruling in Wollschlaeger v. Governor, State of Florida, invalidating parts of Florida’s Firearm Owners’ Privacy Act (FOPA) and affirming that the First Amendment applies to the speech between physicians and..
April 12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28379807/thirty-miles-at-sea-providing-consistent-care-in-an-inconsistent-environment
#11
Margot Hartmann, Jason Graziadei
Small community hospitals throughout the United States are facing threats including low volume, declining reimbursements, and staffing challenges. Nantucket Cottage Hospital, a 19-bed facility and one of the smallest hospitals in Massachusetts, must also navigate the complexity of operating on an..
April 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28379803/the-maternal-health-compact
#12
Susan Mann, Kimberlee McKay, Haywood Brown
In a rural Minnesota town with fewer than 5000 residents, an 18-year-old woman with a term pregnancy goes into labor in a hospital that performs about 75 deliveries per year. Her pregnancy has been uncomplicated, but chorioamnionitis develops during labor and she undergoes a primary cesarean..
April 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28379798/regulatory-review-of-new-therapeutic-agents-fda-versus-ema-2011-2015
#13
LETTER
Nicholas S Downing, Audrey D Zhang, Joseph S Ross
To the Editor: The Food and Drug Administration (FDA) faces continual pressure to accelerate the regulatory review and approval of new medicines. Although the 21st Century Cures Act, which was signed into law in December 2016, includes several reforms that are intended to further streamline FDA..
April 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28379790/an-fda-viewpoint-on-unique-considerations-for-medical-device-clinical-trials
#14
Owen Faris, Jeffrey Shuren
Medical devices play a critical role in the lives and health of millions of people worldwide. From everyday household items such as oral thermometers to complex implantables such as deep-brain stimulators, patients and the general public rely on regulators to ensure that legally marketed medical..
April 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28379789/physicians-not-conscripts-conscientious-objection-in-health-care
#15
Ronit Y Stahl, Ezekiel J Emanuel
"Conscience clause" legislation has proliferated in recent years, extending the legal rights of health care professionals to cite their personal religious or moral beliefs as a reason to opt out of performing specific procedures or caring for particular patients. Physicians can refuse to perform..
April 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28379787/and-how-long-will-you-be-staying-doctor
#16
Heather Kovich
"Have I told you that I’m converting my garage into a workout room?" my friend asks. We are roaming the compound, our eyes fixed on the enormous, changing sky, oblivious to the tumbleweeds and empty plastic bottles skittering across our path. "I’m hiring one of the maintenance guys to put down..
April 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402249/the-art-of-repeal-republicans-health-care-reform-muddle
#17
Jonathan Oberlander
Failure is a familiar outcome in U.S. health policy. Presidents have long struggled to translate their promises and aspirations into legislative victory. Harry Truman’s national health insurance program never came close to becoming law. Richard Nixon’s universal coverage plan did not pass. Congress..
April 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402247/the-future-of-transgender-coverage
#18
Kellan E Baker
In tandem with the growing visibility and acceptance of transgender people in the United States, we have seen a rapid increase in insurance coverage for health care services related to gender transition. Despite ongoing court battles over federal nondiscrimination protections for transgender people..
April 5, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402244/medical-liability-prospects-for-federal-reform
#19
Michelle M Mello, Allen Kachalia, David M Studdert
Medical malpractice reform appears to be back on the federal policy agenda. The appointment of Tom Price, a long-time proponent of tort reform, as secretary of health and human services, in conjunction with Republican control of both houses of Congress, has created fertile conditions for several..
March 29, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402243/use-of-the-national-heart-lung-and-blood-institute-data-repository
#20
Sean A Coady, George A Mensah, Elizabeth L Wagner, Miriam E Goldfarb, Denise M Hitchcock, Carol A Giffen
Background Research on data sharing from clinical trials has focused on elucidating perceptions, barriers, and attitudes among trialists and study participants with respect to sharing data. However, little information exists regarding utilization or associated publication of articles once clinical trial data have been widely shared. Methods We analyzed administrative records of investigator requests for data access, linked publications, and bibliometrics to describe the use of the National Heart, Lung, and Blood Institute data repository...
March 29, 2017: New England Journal of Medicine
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