Thirty-three million US adults may be affected by problem drinking.

Editor's Note

Yesterday's story, "Increasing number of US workers testing positive for illicit drugs, prescription painkillers" should have clarified that, while the Quest Diagnostics study found an overall increase in positive drug tests, the study noted decreasing prescription opioid use between 2010 and 2014.

Leading the News

Study: Thirty-three million US adults may be affected by problem drinking.

The AP (6/4, Tanner) reports, “Alcohol problems affect almost 33 million adults and most have never sought treatment,” according to a study published online June 3 in JAMA Psychiatry. The research conducted by investigators at the National Institute on Alcohol Abuse and Alcoholism also suggests that “rates have increased in recent years.” NIAAA director George Koob, PhD, “said it’s unclear why problem drinking has increased but that many people underestimate the dangers of excessive alcohol.” Koob also pointed out that effective behavioral treatments and medications exist to help people overcome problem drinking. He said, “There’s a lore that there’s only Alcoholics Anonymous out there and that’s not true.”

        TIME (6/4, Sifferlin) reports that the study examined “the prevalence of drinking issues based on a new definition for alcohol use disorders in the” American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). That “definition classifies problem drinkers as those who have two of 11 symptoms including continuing to drink even if it harms relationships, drinking harming performance at work of school, or inability to quit,” with problem severity being “classified by the number of symptoms a person has.”

        Newsweek (6/4, Main) reports that “researchers surveyed more than 36,000 Americans and asked them about their drinking habits,” also finding that “binge drinking is becoming more common and intense.” Koob said, “There has been this cultural shift – people are drinking more when they drink.”

        Yahoo! News (6/4, Chan) quotes Koob, who said, “These findings underscore that alcohol problems are deeply entrenched and significantly under-treated in our society.”

        The NPR (6/4, Hurt, Shute) “Shots” blog points out that “Native Americans face the greatest risk overall” for problem drinking, “and men are still drinking more than women, with 36 percent of men reporting alcohol use disorder at some point in their lives, compared to 22.7 percent of women.” Among young people, “drinking problems were worst...with 26.7 percent of young adults under 30 saying they’d had trouble in the past year, compared to 16 percent of 30- to 44-year-olds.”

Government and Medicine

New Medicare data include payments that were redacted from previous release.

The Wall Street Journal (6/4, Weaver, McGinty, Subscription Publication) reports that newly disclosed Medicare data reveal $12.4 billion in 2012 payments to providers that were redacted from an earlier data release. Citing privacy concerns, the Centers for Medicare and Medicaid Services had previously excluded payments for any service providers performed for fewer than 11 Medicare beneficiaries. The Journal adds that a spokeswoman for the American Medical Association reiterated the group’s concerns that limitations in the Medicare data could lead to misperceptions about individual physicians’ practices.

        Meanwhile, Bloomberg News (6/4, Chen, Bloomfield) reports that the new Medicare data show “life-threatening complications from bacterial infections are on the rise among hospital patients, increasing at a double-digit rate as the population ages and costing U.S. health-care programs billions of dollars a year.” The three sepsis-related codes included in Monday’s data “accounted for about $7.2 billion of Medicare payments to hospitals, up 9.5 percent from the previous year.”

        The Newark (NJ) Star-Ledger (6/4, Darragh) reports that the Medicare data release on Monday “gives an idea of how much money ambulance companies” in New Jersey have been receiving in payments. The article notes that authorities began cracking down on payments last December over concerns “about some New Jersey ambulance companies overbilling for non–emergency transport.”

Florida Senate sends expansion bill to skeptical House.

The Tampa Bay (FL) Times (6/4) reports that the Florida Senate on Wednesday “gave bipartisan approval to a plan that draws federal Medicaid money into a privately run program to provide subsidized health insurance to low-income, working Floridians.” The measure, called the Florida Health Insurance Affordability Exchange program, passed by a 33-3 vote on the third day of a three-week special legislative session. The Senate “adopted a series of last-minute changes aimed at quieting concerns from House Republicans,” but early counts show the bill may be 11 votes short of passage when the 120-member House votes on Friday. Meanwhile, a spokesman for Gov. Rick Scott (R) said after the Senate vote that the governor “has not revised” his opposition to the plan.

        The Orlando (FL) Sentinel (6/4) reports that the bill, SB 2A, “offers those making up to 138 percent of poverty wages, or about $33,000 for a family of four, to shop for private plans on a state-run exchange starting in January.” It was amended Wednesday to allow for more state regulation of plans and to create a commission to review the program after three years. In a statement, House Speaker Steve Crisafulli (R) “thanked the Senate for the changes, but said it didn’t change the fact that it draws federal funds to expand coverage for ‘able-bodied’ people.”

        The Florida Times-Union (6/4) reports that state Rep. Mia Jones (D) will act as the bill’s “de facto sponsor” in the House. Jones “is not completely sold on the Senate proposal, which would require participants to pay premiums and meet a work requirement in order to enroll in government-subsidized private insurance plans.” She said Wednesday, however, that she would support the plan “in the spirit of compromise, in the interests of advancing good ideas for the people of Florida.”

        According to the Palm Beach (FL) Post (6/4), the House “is poised to kill” the measure unless legislators reach a “grand bargain” on healthcare.

Senate panel advances bill to revamp Medicare appeals process.

The Hill (6/4, Ferris) reports that the Senate Finance Committee on Wednesday “advanced a bipartisan bill to reform the Medicare appeals process with the hopes of reducing the ever-growing backlog of requests.” Under the legislation from Chairman Orrin Hatch (R-UT) and ranking member Ron Wyden (D-OR), the Centers for Medicare and Medicaid Services “would create an independent Ombudsman for Medicare Reviews and Appeals to help people considering appeals.” CMS would also be able to hire more people to help deal with the existing backlog.

        According to Congressional Quarterly (6/4, Subscription Publication), the measure would also “enhance coordination between CMS and audit contractors by ensuring that both receive data about appeal outcomes and review practices.”

Lawmakers seek to clarify HIPAA rules as importance of health data grows.

Congressional Quarterly (6/4, Subscription Publication) reports that lawmakers “are mulling how to overhaul medical privacy rules in a world where health data is increasingly shared.” The House this month may consider a bill from the Energy and Commerce Committee “that includes language intended to clarify the boundaries set by the main federal medical privacy law, the Health Insurance Portability and Accountability Act (PL 104-191), or HIPAA.” A provision in the 21st Century Cures package passed by the committee addresses “misunderstandings about HIPAA that now sometimes impede the flow of information among medical practices caring for the same patient.” Separately, the Centers for Medicare and Medicaid Services on Tuesday announced that it will allow businesses to access its data for approved research projects. The information “will not allow patients’ identities to be determined, but will reveal that of the doctors and other providers of care, CMS said in a statement.”

House passes bill prohibiting Federal government from interfering with state medical marijuana programs.

The AP (6/4, Taylor) reports that the House of Representatives approved legislation rendering the Federal government “unable to block state laws permitting the use of medical marijuana” by a 242-186 vote, but “narrowly rejected an amendment that would stop the Justice Department from interfering with states like Colorado and Washington that permit the recreational use of marijuana” by a 206-222 vote. The bill, which was opposed by many Republicans, now advances to a GOP-controlled Senate for consideration.

        The Hill (6/4, Devaney) reports that “a marijuana amendment that was rejected...has pot advocates even more excited.” One “provision that would have blocked the Justice Department from interfering with state laws permitting the use of recreational marijuana came just a few votes shy of passing.” Such a measure “would have essentially ended the federal prohibition on pot, advocates say.”

Senate bill seeks to empower VA nurse practitioners.

Modern Healthcare (6/4, Robeznieks, Subscription Publication) reports that the Frontlines to Lifelines Act of 2015, sponsored by Sen. Mark Kirk (R-IL), seeks “to empower nurse practitioners across the Veterans Affairs Department to practice independently of physicians, regardless of laws in individual states,” with the goal of mitigating “physician shortages and reduc[ing] patient wait times that have been plaguing the VA.” The proposed legislation “would allow nurse practitioners – including midwives and mental healthcare clinical nurse specialists – to prescribe some drugs and treat patients without a supervising physician.”

Medical-Legal Landscape

AP analysis considers Supreme Court’s thinking on King v. Burwell.

In an analysis, the AP (6/4, Sherman) considers the Supreme Court’s thinking ahead of its decision on King v. Burwell, noting the court has, since the New Deal, “almost always upheld major new government programs and legislation as allowable under the Constitution.” However, the subsidies case “turns not on some great constitutional question but a matter of statutory interpretation.” If the court decides the ACA’s language restricts the tax credits to only state-run exchanges, between 7 million and 9 million Americans could lose their subsidies. The AP adds that “there are few comparable examples in recent history where the court has taken away a benefit from so many people.”

        Report: Impact of SCOTUS ruling would vary widely by state. The Washington Post (6/3, Chokshi) “Govbeat” blog reports that about 6.4 million Americans would lose their subsidies if the Supreme Court rules against the ACA, “but the potential effect of a ruling varies dramatically by state.” Costs would rise in each of the 34 states on the Federal exchange, “with the largest spikes in Mississippi, Utah and Alaska, where the cost of the average monthly premium would rise by more than 500 percent, according to a new Kaiser Family Foundation” analysis.

Appeals court to decide regulatory path for biosimilar approval.

Bloomberg News (6/4, Decker) reports that Amgen, Inc. and Novartis AG made oral arguments before the US Court of Appeals for the Federal Circuit on Wednesday “over when a copycat version of Amgen’s cancer treatment Neupogen (filgrastim) can be sold in the US, in the first case of its kind.” The ruling, expected in the next few weeks, would clarify “how to interpret a 2010 law that created a path to approve copies of biologic drugs that are based on living organisms,” or “biosimilars.” According to Amgen lawyer Nick Groombridge of Paul Weiss in New York , a decision is “integral to how the regime is going to work going forward.”

        Reuters (6/4, Bartz) reports that Novartis AG is seeking to remove a preliminary injunction prohibiting it from marketing its biosimilar, Zarxio (filgrastim-sndz), while Amgen maintains the drug infringes on its patent.

Health Coverage and Access

Patients in coverage gap turn to free health clinics.

Kaiser Health News (6/4, Tomsic) reports that staff at community health clinics in many states say “demand has surged” since the ACA was passed. The article explains that in states that didn’t expand Medicaid, many people are stuck in a coverage gap. In North Carolina, for example, about 319,000 people “make too much money to qualify for Medicaid but not enough to qualify for insurance subsidies.”

Quality and Safety

Health systems seek to manage their online reputations.

A front-page story in the Washington Post (6/4, A1, Sun) reports on “a new and urgent effort by hospitals and health systems to track and control their online reputations,” noting that the effort comes as “people are increasingly shopping for their medical care and comparing reviews.” Patients are now rating hospitals and physicians on a number of websites, including Healthgrades.com and ZocDoc.com. The Post adds that patient satisfaction is also a “strategic priority” for the healthcare industry because it’s playing a more important role in determining how the government pays hospitals. Over the last three years “the government has been taking into account patient satisfaction data when determining how much to reimburse hospitals for Medicare patients.”

DOJ subpoenas documents in duodenoscope probe.

USA Today (6/4, Eisler) reports in continuing coverage that the Justice Department is seeking thousands of documents in its investigation of duodenoscopes, which have been “tied to a deadly series of superbug outbreaks at hospitals across the country.” Sources say the three manufacturers of the scopes, Olympus, Pentax and FujiFilm, have all “received subpoenas in recent weeks as part of the probe.” Also subpoenaed was “Virginia Mason Hospital in Seattle, which suffered one of the largest and deadliest outbreaks of antibiotic-resistant bacterial infections linked to contamination in the scopes.”

Opinion: Medicare debates should focus on issues besides cost.

In a piece for the New York Times (6/3) “Opinionator” blog, Sharon R. Kaufman, the chairwoman of the department of anthropology, history and social medicine at the University of California, San Francisco, says Medicare’s 50th anniversary next month “is an opportunity to consider what the goals of medicine should be in our aging society and how we want to live in relation to medicine’s evolving tools.” She writes that while the “often contentious” debates about Medicare have centered on cost control and privatization, focusing on these issues alone “deflects us from considering larger problems such as high-tech treatments run amok and the low priority given to the kinds of social and low-tech services that would enable people to continue living and finding meaning in their lives as long as possible.” As policymakers consider Medicare’s future, Kaufman adds, “it may be more productive to focus on the kinds of health care older Americans are actually receiving and are claiming to want.”

Public Health

International panel says mammograms most beneficial for women in their 50s and 60s.

The AP (6/4, Marchione) reports that “a new, international panel of experts has studied the most recent evidence on mammograms to screen for breast cancer and says they” are most beneficial “for women in their 50s and 60s.” Meanwhile, “women 70 to 74 also benefit to a lesser extent.” This “new advice gives a global perspective, coming from 29 cancer experts from 16 countries, convened by the International Agency for Research on Cancer.” Their report was published online in the New England Journal of Medicine.

Exposure to pyrethroid pesticides may be associated with AD/HD in boys.

The Fox News (6/3) website reports that a study of 687 children ranging in age from eight to 15 has associated pyrethroid pesticides to attention-deficit/hyperactivity disorder (AD/HD) in youngsters and adolescents, “specifically males.” The study, published online May 28 in the journal Environmental Health, reveals that “boys with detectable urinary 3-PBA, a biomarker of exposure to pyrethroids, were three times as likely to have AD/HD as those without a biomarker.”

        HealthDay (6/4, Preidt) reports that “for every 10-fold increase in 3-PBA levels in boys, there was a 50 percent increased risk for hyperactivity and impulsivity – both symptoms of AD/HD.” In contrast, “levels of 3-PBA were not associated with increased risk of AD/HD or symptoms of the disorder” in girls.

Surgery may not always be necessary for certain patients with DCIS.

The NPR (6/4, Hobson) “Shots” blog reports that while “surgery (lumpectomy and in some cases mastectomy) is the standard of care” for ductal carcinoma in situ (DCIS), a study in JAMA Surgery “may support some women’s decision to skip the surgery, which comes with physical, emotional and financial costs.” The blog points out that “some physicians and researchers, including a working group convened by the National Cancer Institute, say it’s not accurate to call DCIS a form of cancer at all, and that the terminology is contributing to overly aggressive treatment.”

        Health Day (6/4, Preidt) reports that investigators “found that for women with low-grade DCIS, the 10-year survival rate was 98.8 percent for those who had surgery at the time of diagnosis or shortly after, and 98.6 percent for those who did not have surgery.” But, “for women with intermediate- or high-grade DCIS, the survival rate did differ significantly between those who had surgery and those who did not.”

Mouse study: FDA-approved medications may be able to cure Ebola.

The Los Angeles Times (6/4, Kaplan) reports that a study published in the journal Science Translational Medicine on Wednesday found that Zoloft, an antidepressant, and Vascor, a heart drug, were found to save the lives of mice infected with Ebola. The researchers analyzed the efficacy of over 2,600 medications against the Ebola and related Marburg viruses. Of the medicines tested, 25 compounds were shown to stop the Ebola virus from entering cells. According to the Times, the study found that Zoloft “cured 70% of mice that had the virus in their blood” and Vascor “cured 100% of the infected mice.”

        The Washington Post (6/4, Cha) reports that Gene Olinger, National Institute of Allergy and Infectious Diseases scientist, said in an interview, “It was quite shocking that some of these drugs worked,” adding, “To be honest, we didn’t think some of these would.” However, according to the Post, Olinger warned that “a lot of drugs that look miraculous in mice end up doing nothing in humans.”

DOD: Live anthrax samples sent to more labs than previously thought.

David Muir reported on ABC World News (6/3, story 5, 1:20, Muir, 5.84M) that “many more samples” of live anthrax spores were sent out by the Pentagon than first thought. The Defense Department first said that samples were sent to nine states, but tonight word came that samples were sent to at least 51 labs across 17 states.

        On the CBS Evening News (6/3, story 3, 1:45, Rose, 5.08M), David Martin reported that the live samples were also sent to “the District of Columbia and three foreign countries, and Deputy Defense Secretary Robert Work admitted that is probably not the final count.” Work said in a press briefing, “We expect this number may rise because the scope of the investigation is going on.”

        Jim Miklaszewski reported on NBC Nightly News (6/3, story 2, 2:25, Holt, 7.86M) that the Pentagon’s announcement “was a shocker,” adding that “two labs, one in Maryland, the other [in] Canada, actually received live anthrax spores.” The samples “are irradiated to kill any live spores before they are shipped to other labs for research into how to protect against a bioterror attack,” but “the killing technique failed. Four large batches retested in the past two weeks contained live anthrax.”

        The Washington Post (6/3) reports, “Ten samples in nine states have tested positive for live anthrax so far, defense officials said.” In each case, the samples “originated at Dugway Proving Ground in Utah, the Army laboratory that irradiated them and shipped them across the country, believing they were dead.” Meanwhile, “other suspected samples are either still in testing or are set to be tested in coming days in Atlanta by the” CDC.

        USA Today (6/4, Young, Vanden Brook) reports that Navy Cdr. Franca Jones, chief of medical programs for chemical and biological defense, “judged the threat to the general public and commercial shippers who handled the boxes containing live anthrax as ‘zero.’” That is because “the concentration of live anthrax in a vial is too low to infect a healthy person, and it is in liquid form and not breathable, she said.” In addition, “the packaging in which it is sent has redundant features to prevent leaking.”

        The New York Times (6/4, A13, Cooper, Subscription Publication) notes that this was “the third time that the Pentagon had increased its estimate of the number of anthrax samples that it said were inadvertently sent out.” The anthrax shipment incident adds to the “spate of recently documented mistakes in federal laboratories involving anthrax, flu and smallpox” that “have raised fears about how carefully the government and laboratories handle dangerous pathogens.” For example, “last July, vials of smallpox and other infectious agents were discovered in a government lab on the campus of the National Institutes of Health after being stored and apparently forgotten” approximately five decades ago.

Pharma & Device Update

FDA advisory committee meets Thursday to examine benefits, risks of female libido treatment.

In continuing coverage, the CBS Evening News (6/3, story 7, 2:00, Rose, 5.08M) reported that on Thursday, “an FDA panel” will reconsider a treatment “that promises to increase a woman’s desire.”

        The Washington Post (6/4) reports that a Food and Drug Administration advisory committee will “examine the risks and rewards” of the experimental drug flibanserin, designed to treat women’s sexual dysfunction. The drug has “created a political stir,” with women’s group accusing the FDA of sexism and critics accusing pharmaceutical companies of “medicalizing sex.” The committee’s recommendation “could influence the final FDA decision, due in August.”

        According to the Los Angeles Times (6/4, Healy), FDA officials are concerned that side effects of the drug, such as hypotension and syncope, are heightened when the drug is taken with alcohol, leading the FDA to ask the advisory committee to decide whether “avoiding alcohol indefinitely while using flibanserin” is a necessary requirement. If approved, flibanserin would be indicated for women with decreased libido “due to menopausal changes,” childbirth, or caused by “physical disease or relationship troubles.”

Physician says drug prices should be linked to performance.

As part of a series on the cost of cancer drugs on NBC Nightly News (6/3, story 8, 3:00, Holt, 7.86M), Anne Thompson reported on Lauren Bowman, who relies on the drug Gleevec (imatinib) to “manage her chronic myeloid leukemia,” noting that even with insurance, her “monthly co-pay can run as high as $2,200, twice the average mortgage payment.” Memorial Sloan Kettering’s Dr. Peter Bach “says the US cancer drug market is completely broken.” Bach: “Essentially companies set the prices high as they think they can get away with and they say it’s the cost of research or something like that, but there’s no evidence of that.” Thompson added, “Bach says drug prices should be tied to performance.”

        Meanwhile, Bloomberg View (6/3) columnist Megan McArdle writes, “there are lots of reasons that cancer drugs cost so much, but one reason is, ironically, that they don’t work very well.” She adds that since “so many cancers don’t have particularly effective treatments,” physicians “tend to keep throwing one thing after another at them.” McArdle writes, “We often talk about the purpose of research as being ‘finding a cure for cancer’ – but we rarely ask if that wouldn’t create problems of its own. “

Practice Management

CMS asked to delay moving forward with Stage 3 of Meaningful Use EHR program.

Government Health IT (6/4) reports, “The influential American Medical Association (AMA) has told” CMS that “it should delay moving forward with Stage 3 of the meaningful use electronic health record program.”

        Medscape (6/4, Terry) reports that in its 23-page statement, the AMA agreed with a stance taken by the Medical Group Management Association that “CMS should consider new meaningful use requirements as it implements” the merit-based incentive payment system. In the statement, AMA CEO and executive vice president James L. Madara, MD, said, “This will save physicians from the heavy lift of a new program that is subsequently altered again in future rule making.”

Wednesday's Lead Stories

• CDC: Incidence of melanoma has doubled in the US in the last 30 years.  ? House committee votes to repeal medical device tax, IPAB.  ? Lawsuits over access to hepatitis C medications likely to continue as insurers contain costs.  ? HHS: 10.2 million currently enrolled in ACA coverage.  ? AMA Foundation confers 2015 Excellence in Medicine Awards.  ? Use of SSRIs late in pregnancy may be linked to higher risk of PPHN in offspring.  ? AMA submits comments to CMS on proposed Stage 3 Meaningful Use program.