Fifteen chemicals may be linked to earlier menopause.

Leading the News

Study: Fifteen chemicals may be linked to earlier menopause.

On its website, NBC News (1/29, Fox) reports that scientists “have identified 15 chemicals that may be linked to earlier menopause.” The study indicated that “women with the highest levels of these chemicals in their bodies went through menopause anywhere between two and four years earlier than women with the lowest levels.” The findings were published in PLoS ONE .

        TIME (1/29) reports that investigators “studied 31,575 women enrolled in the National Health and Nutrition Examination Survey conducted by the government. Every two years, the women were surveyed about various health and nutrition issues, including whether they had begun menopause.” All participants, “at some point between 1999 and 2008...provided at least one blood and urine sample which the scientists analyzed for the presence of various chemicals, including dioxins contained in pesticides, phthalates found in fragrance, plastics, cosmetics and hair spray, plant-derived estrogens, and polychlorinated biphenyls, among others.”

        AFP (1/29) reports that the investigators “found 15 chemicals that were significantly associated with earlier menopause and declines in ovarian function.” These chemicals “included nine polychlorinated biphenyls (PCBs), three pesticides, two phthalates --- which are typically found in plastics, common household items, pharmaceuticals, lotions, perfumes, makeup, nail polish, liquid soap and hair spray – and a toxic chemical known as a furan ‘that warrant closer evaluation,’ the study said.”

        HealthDay (1/29, Preidt) reports that “Even though many of the chemicals identified in the study are banned in the United States because of health risks, they are still produced in other countries and are common in the environment...added” senior study author Dr. Amber Cooper.

Government and Medicine

Treasury says six million taxpayers may have to pay ACA penalty.

Bloomberg News (1/29) reports that as many as 6 million US taxpayers “will have to pay a penalty of as much as 1 percent of income because they went without health insurance in part or all of 2014, the Treasury Department said.” The penalty, part of the Affordable Care Act, would affect about 2 percent to 4 percent of all taxpayers for 2014. Mark Mazur, the department’s assistant secretary for tax policy, said 10 percent to 20 percent of taxpayers weren’t insured for all or part of the year but will be able to claim an exemption.

        The Wall Street Journal (1/29, Armour, Subscription Publication) reports Andy Slavitt, the principal deputy administrator at the Centers for Medicare and Medicaid Services, said, “We hope for millions of Americans this time of year is a reminder to them, for people who don’t have coverage, to get coverage.”

        The Washington Times (1/28, Dinan) reports that up to 30 million taxpayers “will claim an exemption from Obamacare on their tax forms this year, the administration predicted Wednesday as officials tried to prepare the country and a skeptical Congress for the first wave of tax penalties under the Affordable Care Act.” Additionally, up to 5 percent of taxpayers bought health coverage using government subsidies “and will have to go through a complicated reconciliation process on their tax forms.”

        NBC News (1/29) reports that most taxpayers had health insurance through their employer or a government program in 2014 and will only have to check a box on their tax return saying they had coverage.

        Also covering the story are McClatchy (1/29, Pugh, Subscription Publication), Reuters (1/29), CNBC (1/29), CNN (1/28, Luhby), Congressional Quarterly (1/28, Subscription Publication), the Washington Examiner (1/29) and Forbes (1/28).

Democrats withdraw support from 21st Century Cures Act.

Modern Healthcare (1/29, Subscription Publication) reports that Democrats on the House Energy and Commerce Committee “have withdrawn support from legislation that would loosen regulatory requirements on a broad range of new healthcare technologies, sources close to the legislative discussions say.” The “sprawling” 21st Century Cures Act is intended to foster drug development and speed up the adoption of advanced medical technologies “by requiring the Food and Drug Administration to allow more ‘flexible’ clinical trial design and gives medical-device makers more ‘innovative device review pathways.’” Rep. Frank Pallone (D-NJ), the ranking member of the committee, said, “In its current form, I am concerned that the nearly 400-page draft could create more problems for our healthcare system than it solves.” He added, “Further, the draft does not include any real dollars to fund additional basic research at the National Institutes of Health.”

Drugmakers, insurers warn against Part D rebates ahead of White House budget.

The Wall Street Journal (1/29, Silverman) reports that nearly 400 organizations, including a coalition of pharmaceutical companies and health insurers, have written a letter to the US House, warning against forcing drug makers to give Medicare Part D rebates to low-income beneficiaries. The effort, led by the Council for Affordable Health Coverage, comes shortly before the Obama Administration releases its annual budget, which is expected to include mandated Part D rebates.

California proposes stricter control of e-cigarettes.

The AP (1/28, Nirappil) reports California Wednesday announced e-cigarettes are a health hazard “that should be strictly regulated like tobacco products, joining other states” across the US that seek stricter controls as the popularity of the device grows. The AP notes the California Department of Public Health unveiled a report that says “e-cigarettes emit cancer-causing chemicals and get users hooked on nicotine but acknowledges that more research needs to be done to determine the immediate and long-term health effects.”

        California’s move comes, according to Bloomberg News (1/28, Edney), amid growing skepticism among state officials “about manufacturers’ claims that the products are a healthier alternative to regular cigarettes and aren’t marketed to children.” Bloomberg notes California “plans a media and public education campaign to warn about the dangers of e-cigarettes,” according to Ron Chapman, director of the state Department of Public Health.

        The news was also covered by the Los Angeles Times (1/28, Brown) and Reuters (1/29, Bernstein).

Medical-Legal Landscape

Democratic leaders submit brief in defense of ACA subsidies.

The Washington Times (1/28, Dinan) reports congressional Democrats “involved in writing” the Affordable Care Act told the Supreme Court on Wednesday “that they intended for all consumers in all states to be eligible for subsidies,” arguing “that the law they drafted reflects that intention.” In a new brief filed in King v. Burwell, Sen. Harry Reid (D-NV), Rep. Nancy Pelosi (D-CA) and other lawmakers said leaving out some states goes against the purpose of the law, which is “to make health insurance affordable for all Americans.”

        The Hill (1/29, Viebeck) reports that Rep. Sandy Levin (D-MI), an “author of Obamacare” who led the House Ways and Means Committee when it was drafted, said there is no need to fix what some see as a drafting error in the health law that prompted the legal challenge to the subsidies. “We don’t think there is anything to be fixed,” Levin said at a press conference organized by Families USA. He added, “The assumption was that these tax provisions would apply across the board. ...There’s no problem.” Former Rep. George Miller (D-CA) also rejected the notion that lawmakers intended to limit the subsidies to state-run exchanges, saying, “It was never a point raised by those in opposition.”

        The Hill (1/29, Viebeck) reports in a similar article that Families USA President Ron Pollack “said his group never considered the subsidy challenges to be legally serious, calling them politically motivated attacks on ObamaCare.” He also accused the Supreme Court of failing to follow its usual guidelines when it decided to hear King v. Burwell, stating, “In this case there is no constitutional issue at all. There is no conflict between circuit courts of appeals.” According to Congressional Quarterly (1/28, Subscription Publication), Families USA also filed a brief Wednesday in defense of the ACA’s subsidies.

        Meanwhile, the Washington Post (1/29, Barnes) reports that the challengers in King v. Burwell “point to former Nebraska Sen. Ben Nelson as evidence of their claim that Congress intended that tax credits go only to qualified recipients in states that had established their own insurance exchanges.” While Congress debated the ACA, Nelson insisted that states take the lead in establishing their own exchanges. Challengers point to this as evidence that Congress intended to use the tax credits to induce states into creating the exchanges, rather than relying on the Federal government. But in the brief filed by Democratic congressional leaders on Wednesday, Nelson says, “I always believed that tax credits should be available in all 50 states regardless of who built the exchange, and the final law also reflects that belief as well.”

        The Oklahoman (1/29) adds that the document filed by Democrats on Wednesday “may be the key brief in the case.”

        US News & World Report (1/29), reporting more generally on King v. Burwell, says that the looming decision in the case “may overshadow” the ACA’s achievements this year.

        GOP lawmakers press Burwell on contingency planning for SCOTUS case. The Hill (1/29, Ferris) reports that Republican leaders of the House Energy and Commerce Committee sent a letter Wednesday to HHS Secretary Burwell, demanding that the Administration reveal its contingency plan in case the Supreme Court rules against the ACA this summer. “Given HHS’s responsibilities, we believe it is prudent that the Department plan for the full range of potential outcomes and consequences of the Court’s decision,” the lawmakers wrote. According to The Hill, Burwell has repeatedly said she is confident the high court will uphold the subsidies and, when “asked about how the administration is preparing states for the worst-case scenario, Burwell has flatly declined to discuss the plan.”

Health Coverage and Access

Study: People with HIV face price discrimination in some ACA plans.

The New York Times (1/29, Thomas, Subscription Publication) reports that drugs to treat HIV and AIDS “are being priced out of reach for many patients enrolled in insurance plans through the new health care exchanges, despite warnings that such practices are illegal under the Obama administration’s health care law, according to a new analysis by Harvard researchers.” The study, published in an article in The New England Journal of Medicine, examined 48 health plans in 12 states and found that a quarter of the plans “showed evidence of what researchers called ‘adverse tiering,’ or placing all of the drugs used to treat H.I.V. in a specialty tier where consumers are required to pay at least 30 percent of the cost of the drug.” Douglas B. Jacobs, the lead author of the study, said, “That’s really a large cost difference, and really is a very significant financial constraint for those with chronic conditions, particularly H.I.V.”

        Bloomberg News (1/29) reports that Jacobs and Benjamin Sommers, both of the Harvard T.H. Chan School of Public Health, wrote, “Our findings suggest that many insurers may be using benefit design to dissuade sicker people from choosing their plans.” Bloomberg notes that in November, HHS issued proposed guidance for 2016 “that would make it harder for insurers to require high out-of-pocket costs for all drugs for a chronic condition.”

        The AP (1/29, Kennedy) reports that nearly 300 patient groups sent a letter last month to HHS Secretary Burwell, urging the Federal government to ramp up enforcement. “We analyze plan information submitted by insurance companies to uncover discriminatory benefit designs, and work with outlier plans to update formularies so they do not discourage enrollment of consumers with specific medical conditions,” agency spokesman Aaron Albright said in an email.

        The Washington Post (1/29, Millman) reports in its “Wonkblog” that Carl Schmid, deputy executive director of the AIDS Institute, said the NEJM study “is a confirmation of what we saw in Florida...and why we’ve been pushing HHS to take some action on discrimination.”

        Also reporting on the study are Reuters (1/29, Begley), AFP (1/29) and HealthDay (1/29).

Covered California renewal rate reaches more than 90%.

The Los Angeles Times (1/29, Terhune) reports that California officials said yesterday, with its first release of Covered California renewal figures, that even though “more than 90% of Obamacare customers renewed their policy for 2015,” the state “still faces an uphill climb to reach its goal of 1.7 million enrolled before” the Feb. 15 open enrollment deadline. However, last year the state experienced “a huge surge of enrollment” at the deadline, “so officials remain optimistic.” Kaiser Permanente “led the state with a customer retention rate of 99%,” whereas Health Net Inc. “fared the worst with a net loss of 9,000 customers among renewals,” or a 90% retention rate.

        In its “2015” blog, the San Francisco Business Times (1/29, Rauber, Subscription Publication) points out that the 1.2 million people already enrolled in Covered California falls short of its state goal by 500,000, “with 18 days to go.” The blog also accuses Covered California of not being as “forthcoming” with its data as other state exchanges.

Senate panel approves bill to exempt veterans from employer mandate.

The AP (1/29, Fram) reports that the Senate Finance Committee, in “a rare show of bipartisanship over President Barack Obama’s health care law,” voted unanimously on Wednesday to exempt veterans from the 50-worker threshold under the ACA’s employer mandate. The panel voted 26-0 in favor of the bill, which passed the House “earlier this month 412-0 with White House support.”

        The Hill (1/29, Viebeck) reports Finance Committee Chairman Orrin Hatch (R-UT) said in a statement, “The Hire More Heroes Act will provide incentives for companies to hire more veterans by ensuring they don’t count against the 50 employee threshold if the veteran already has medical coverage through the TRICARE program or the VA.” The legislation, passed by the House on Jan. 6, was the first ACA-related measure considered by the new Congress.

        MedCity News (1/29) also reports the story.

Study suggests recession accelerated declines in employer-based coverage.

CNBC (1/29) says that two reports issued Thursday “shed new light on trends in job-based health insurance before the launch of Obamacare, and what happened to the ranks of the uninsured after that health-care reform law kicked into high gear.” The first study, by the Robert Wood Johnson Foundation, found that the economic recession “accelerated an ongoing trend of declines in the percentage of private-sector American workers who get health insurance through their employer.” The second report, by the Kaiser Family Foundation, found that 11 million adults received coverage as a result of the ACA.

        Modern Healthcare (1/29, Subscription Publication) reports, “Take-up of insurance by employees fell to 77.8% from 79.7% between 2005 and 2009 and then to 75.3% by 2013, according to the study” from the Robert Wood Johnson Foundation.

Quality and Safety

Op-Ed: Precision medicine may not lead to better health.

In an opinion piece for the New York Times (1/29, Joyner, Subscription Publication), Michael J. Joyner, an anesthesiologist and physiologist at the Mayo Clinic, writes that although President Obama’s “new budget is expected to include hundreds of millions of dollars for so-called precision medicine” and has bipartisan support, “precision medicine is unlikely to make most of us healthier.” Joyner writes “one of the major and unexpected findings of the Human Genome Project” was that “for widespread diseases like diabetes, heart disease and most cancers, no clear genetic story has emerged for a vast majority of cases.”

CDC: Half of US prescriptions for antibiotics unnecessary.

The Washington Post (1/29, Paquette) “Wonkblog” reports that according to the CDC, 80% of American are issued prescription antibiotics every year, and “up to half of the estimated 258 million prescriptions are unnecessary.” Jesse Goodman, director of Georgetown University’s Center on Medical Product Access, Safety and Stewardship and a former FDA chief scientist, says this is a “culture” problem and advises that “patient and doctor must understand these drugs are precious resources. The more we use them, and the more unwisely, the more resistance” will be built up against them. President Obama announced a plan this week “to nearly double the amount of federal funding dedicated to fighting antibiotic-resistant bacteria,” which the CDC says is responsible for an estimated two million illnesses and 23,000 deaths each year.

Public Health

Placebos believed to be expensive may work better than those believed to be cheaper.

The New York Times (1/29, Bakalar) “Well” blog reports that research published in Neurology suggests that “expensive drugs work better than cheap ones — or at least some people firmly believe they do.”

        TIME (1/29, Sifferlin) reports that in the study, investigators “told 12 people with Parkinson’s disease that they were receiving two variations of the same drug, but one was more expensive than the other.” Participants “were told that the study was meant to assess whether the two drugs were in fact similar in efficacy, and that one drug was $100 while the other was $1,500.” However, the investigators “gave them all saline solution, with no effect at all.”

        The Washington Post (1/29, Bernstein) “To Your Health” blog reports that the investigators “found that the patients performed better on motor skills tests when they believed they were on the expensive drug, an effect that increased when they were given the expensive placebo first.”

        The Los Angeles Times (1/29, Kaplan) “Science Now” blog reports that the investigators “also used functional MRI scans to assess the patients’ brain activity and found that the ‘cheap’ placebo prompted more action than the ‘expensive’ one.” The blog adds that “to the researchers, this was a sign that the patients expected less from the placebo they believed cost less, so their brains responded by doing more work.”

Physicians still puzzled by polio-like illness linked to paralysis in more than 100 US kids.

USA Today (1/29, Szabo) reports that physicians “have more questions than answers about a mysterious polio-like illness that has paralyzed at least 107 children in 34 states since August.” Researchers have “found that five of 11 paralyzed children had” enterovirus D68 “in their noses or throats, although” the “researchers can’t say for sure that it caused the paralysis.” Enterovirus D68 was not, however, found in spinal fluid. USA Today points out that just “one of the paralyzed children nationwide has fully recovered, according to the CDC.”

        On its website, NBC News (1/29, Fox) reports that in the Lancet, researchers wrote, “If further investigation confirms the link between EV-D68 and [acute flaccid paralysis] and cranial nerve dysfunction, EV-D68 will be added to the list of non-poliovirus enteroviruses capable of causing severe, potentially irreversible neurologic damage, and finding effective antiviral therapies and vaccines will be a priority.”

Measles cases grow to 95 in eight states and Mexico.

The Los Angeles Times (1/29, Xia) reports that yesterday healthcare officials said that the number of measles cases grew to 95 in eight states and Mexico. In California, there are now 79 cases, “of which 52 can be linked directly to Disneyland.” Additionally, “officials reported one case in Michigan that was connected to the California outbreak.” However, the outbreak has expanded beyond visitors of Disneyland and is now “infecting people in the broader community.” Officials across California are “scrambling to get ahead of the outbreak, identifying farmers markets, grocery stores, malls and other public locations where contagious people have been.” CNN (1/29) adds that “there are 16 cases linked to Disneyland outside California.”

        Another article in the Los Angeles Times (1/29, Rocha) reports that 66 “Palm Desert High School students who haven’t been fully immunized for measles are banned from classes for the next two weeks,” while “the classmate who may have exposed them to the highly contagious virus is being allowed to return.” The school district’s spokeswoman explained that “District officials are hoping the move will protect staff and other students from exposure to measles.”

        The Palm Springs (CA) Desert Sun (1/28) also reports on the 66 students who were sent home yesterday as a precaution. According to the school district, they will not be allowed to “return to school until Feb. 9 unless they confirm they’ve received immunization or show proof of resistance as determined by a Titer test.”

        NBC Nightly News (1/28, story 3, 1:55, Williams) broadcast covers the outbreak in California and Arizona, noting that “more cases in the outbreak” were just confirmed.

        NBC Nightly News (1/28, story 4, 0:35, Williams) later posed a question to their Chief Medical Editor Dr. Nancy Snyderman about whether adults “need to get a booster shot in this environment.” Snyderman replied: “Blanket recommendation, no. If you have not had measles, if you have not been vaccinated, then that’s a reason to consider getting a booster, or obviously if you live in one of these areas where the outbreaks are then of course talk to your doctor about getting a vaccination.”

        CNBC (1/29) says that “health officials are warning that those who choose not to vaccinate themselves or their children will almost certainly be infected if they are exposed to the disease.” They “warn that the outbreak has not yet been contained,” and some expect infections to grow. CNBC notes that “The outbreak is especially striking,” because “health authorities had thought the existence of a highly effective vaccine made measles a problem of the past.”

        Meanwhile, the Arizona Republic (1/28) highlights the measles outbreak Arizona, where public health officials said yesterday that “as many as 1,000 people across three Arizona counties may have been recently exposed to the measles virus.” The health officials urge “those who has been notified they have been exposed or believe they have come in contact with someone carrying the measles virus” to go into self-quarantine, particularly those who are unvaccinated or under-vaccinated.

        The AP (1/29, Fonseca) adds that of the 1,000 people possibly infected, nearly 200 children “could have been exposed at a Phoenix-area medical center.” However, it is not yet known “how many of the children were vaccinated, or their age ranges.” According to the AP. “Arizona is second to California in the number of cases traced to visits to Disney parks last month.” Fox News (1/29) also reports.

Heroin overdoses surge in Massachusetts.

The Boston Globe (1/29, MacQuarrie) reports that a surge last month of heroin overdoses in Massachusetts may be a “sign that the wave of opioid addiction is overwhelming some efforts to curb the crisis.” Authorities have developed several theories for why heroin use has seen a recent uptick, with one reason being a return of “heroin that is mixed with potentially deadly additives,” namely, fentanyl, “to produce an explosive high.” Medical officials have also said that another reason could be “tighter restrictions on prescription opioids are pushing more buyers to gamble with heroin, which generally is cheaper and more accessible.”

Weight training following weight loss may help people move more throughout the day.

The New York Times (1/28, Reynolds) “Well” blog reported that a study published in the January issue of the journal Medicine & Science in Sports & Exercise suggests that “weight training after weight loss prompts people to move more throughout the day.” The study “shows that exercise can crucially alter the body’s response to weight loss and potentially stop unwanted pounds from creeping back on.”

Study: Brain inflammation may be tied to clinical depression.

The Huffington Post (1/28, Gregoire) reported that new research suggests that “brain inflammation that occurs independently of physical illness may be highly correlated with clinical depression.” After conducting PET “brain scans on 20 study participants who had depression (but were otherwise healthy), and 20 healthy control participants,” researchers found that “depression patients display a 30 percent increase in certain markers of brain inflammation when compared with a control group without depression.”

        Newsweek (1/29, Main) reports that the study was published online Jan. 28 in JAMA Psychiatry. Previous research by the same study author “suggests that between 30 and 40 percent of people with depression have increased levels of inflammation, and that these people are unlikely to directly benefit from typical antidepressants, such as selective serotonin reuptake inhibitors...that don’t have anti-inflammatory properties, he says.”

Study: NFL players tackled before age 12 appear to have worse cognitive function.

On its front page, the New York Times (1/29, A1, Belson, Subscription Publication) reports that a study published online Jan. 28 in the journal Neurology suggests that “NFL retirees who began playing tackle football before they turned 12 were at increased risk of developing memory and thinking problems compared with players who began when they were 12 or older.” While “both groups scored below average on many memory and cognitive tests...there was a roughly 20 percent difference between the two groups on several measures.”

        In a related piece, the New York Times (1/29, B16, Belson, Subscription Publication) reports that researchers tested “42 former NFL players, ages 41 to 65, who had experienced cognitive problems for at least six months.”

        The Los Angeles Times (1/29, Netburn) “Science Now” blog reports that investigators gave the former players “a series of cognitive tests” designed to assess memory, “problem-solving skills” and “verbal intelligence.” The investigators found that “on all three tests, the players who had started playing tackle football before they turned 12 performed significantly worse than players of the same age who had taken up the sport later in life.”

        The Washington Post (1/29, Hobson) reports, “While the study’s authors cautioned their subject group was limited – all former NFL players who have complained of cognitive, behavioral or mood problems – their findings suggest football is unsafe for children.”

        The AP (1/29, Golen) reports that the study has limitations in that “it only looked at former NFL players; the conclusions cannot be generalized to a broader population.”

        Also covering the story are Bloomberg News (1/29, Bloomfield), Reuters (1/29, Kaminsky), the NBC News (1/29, Carroll) website, the Fox News (1/29) website, US News & World Report (1/29, Neuhauser), Forbes (1/29, Diamond), TIME (1/29, Worland), Vox (1/29, Stromberg), and HealthDay (1/29, Mozes).

Plans announced for comprehensive New York City mental healthcare review.

The New York Times (1/29, A22, Stewart, Subscription Publication) reports that yesterday, Chirlane McCray, the wife of New York City Mayor Bill de Blasio, “revealed...that she had been surrounded by mental illness most of her life — first as a child of parents who had depression and later as a mother of a daughter who is recovering from depression, anxiety and substance abuse.” McCray then “announced plans for a comprehensive review of the mental health problems that affect New Yorkers to help the city identify and address disparities in care.”

        The AP (1/29) reports, “McCray said the Mayor’s Fund to Advance New York City, which she heads, will team up with the city Department of Health and Mental Hygiene to develop ‘a more comprehensive and unified approach to mental illness.’” At a public health conference held in Brooklyn, McCray “told attendees...that the partners will develop a ‘road map’ for addressing mental health in the city and will release it this summer.” Also covering the story are the New York Daily News (1/29) and Newsday (1/29).

Health and Diet

Democrats introduce bill to create single food safety agency.

Reuters (1/29, Clarke) reports that yesterday Democratic lawmakers proposed a bill that would create a single food safety agency by combining the oversight functions of the Food and Drug Administration, US Department of Agriculture, and other agencies. The new agency’s administrator would be directly appointed by the President. The bill, the Safe Food Act of 2015, intends to elevate food safety as the US food supply is increasingly sourced from abroad. The bill gave no estimate about how much creating a single agency would cost, although said in the long run it would save money by improving efficiency.

        The Hill (1/29, Wheeler) adds that the new independent food safety agency would be “authorized to issue recalls, enforce safety regulations and require full traceability of foods.” One of the bill’s drafters, Sen. Dick Durbin (D-IL) expects some Republicans to be oppose the bill, but in response, he will point out the money and health savings that would result.

        The Connecticut Post (1/29) notes that the other co-sponsor of the bill, US Rep. Rosa DeLauro, (D-CT), called the current food-safety system “fragmented” and “outdated,” in addition to being “unreliable, as it offers no continuity in ensuring safety as food travels from production to retail sale.”

Pharma & Device Update

FDA to introduce stricter review process for AED manufacturers.

The Washington Post (1/29, Dennis) “Health & Science” blog reports the FDA has “said it would begin requiring manufacturers” of automated external defibrillators (AEDs) “to submit the devices to a more rigorous review before they hit the market,” due to the fact that “the devices malfunction so frequently.” William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, said, “We know that AEDs save lives, and they can be highly effective. ... But these devices also have a history of malfunction.” The agency “said it will not begin enforcing the new restrictions until July 29, 2016,” and that in the meantime, AEDs “currently on the market will remain available” so long as the manufacturer “says it intends to meet the new requirements.” On meeting the requirements, Maisel “said Wednesday he doesn’t expect the process to be ‘particularly onerous.’”

        The Wall Street Journal (1/29, Burton, Subscription Publication) reports that the FDA has received about 72,000 reports of AED failure between January 2005 through September 2014.

        Also reporting on the story are the AP (1/29), Reuters (1/29, Clarke), The Hill (1/29, Wheeler), HealthDay (1/29, Preidt), and MedPage Today (1/29, Phend).

Survey: FDA reviewing drugs more quickly, priority review times still lag.

Modern Healthcare (1/29, Johnson, Subscription Publication) reports that according to a survey of “100 pharmaceutical and life sciences company senior executives released this week” by PricewaterhouseCooper, the FDA review time for new drugs and biologics has decreased from “an average 13 months in 2008 to 10 months in 2010, 2011 and 2012.” Survey respondents, however, “did see problems with the average time the FDA took to approve products designated under its Priority Review process, which was designed to improve drug review time for” treatments deemed to have “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” as explained on the FDA’s website. Another significant finding of the survey was that the respondents’ stance concerning “whether the FDA should include cost-effectiveness within their evaluation of products has shifted...with 43% of respondents saying they were open to having economic value of their products included as a consideration compared to just 14% in 2010.”

Practice Management

Healthcare industry backs shift to value-based payments.

Modern Healthcare (1/29, Subscription Publication) reports that the nation’s largest health systems and insurers “are joining together in a new task force with the goal of shifting 75% of their business to contracts with incentives for quality and lower-cost healthcare.” The Health Care Transformation Task Force, which includes Ascension Health and insurance giant Aetna, hopes to reach its target by January 2020. The group’s announcement comes days after HHS Secretary Sylvia Mathews Burwell unveiled a plan to shift half of traditional Medicare payments to value-based arrangements.

Wednesday's Lead Stories

• Sugary drinks may be linked to earlier menstruation.  • Indiana wins Federal approval for Medicaid expansion alternative.  • HHS: 9.5M have enrolled in 2015 exchange plans.  • Industry coalition vows to make shift to value-based care.  • Single copy of gene variant may be associated with better executive function.  • FDA approves right-side heart pump.