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POLITICO New York Health Care: Novartis settlement; Legionnaires' source confirmed

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written by Dan Goldberg and Josefa Velasquez

KICKED BACK — The pharmaceutical giant Novartis has agreed to a $370 million settlement of a lawsuit that accused it of paying pharmacies kickbacks for promoting its prescription drugs, the offices of Attorney General Eric Schneiderman and U.S. Attorney Preet Bharara announced Friday. New York, which had sued last year on behalf of the state's Medicaid program, will receive about $10.2 million of the total settlement, which will be split between the federal government and 41 states, Schneiderman said. The bulk, $286.9 million, will go to the federal government, according to Bharara. [PRO]

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SOURCE CONFIRMED — The late-September Legionnaires’ outbreak in the east Bronx was traced to a cooling tower at the Bronx Psychiatric Center. The center was in compliance with the health commissioner’s August order, which required it to be inspected.The Legionella strain found in the cooling tower matched samples taken from four patients, according to the city health department.

Flashback, POLITICO New York, Sept. 28: “The city's health department on Monday reported a new cluster of Legionnaires' disease, highlighting both the ubiquity of the bacteria and the challenge public health officials face when trying to respond. … Health department officials are now awaiting the results of those tests but the suspicion of the cooling towers — so soon after they had been cleaned — goes to show the limits of the law that de Blasio called a "powerful response."

TRACKING — Over the weekend, Gov. Andrew Cuomo signed several pieces of health care-related legislation into law, including measures regarding outreach programs for victims of sexual assault or childhood pornography, public education about female genital mutilation, making assault of a patient in a health care setting a Class D felony and updating the “breastfeeding mother’s bill of rights.” The governor vetoed bills relating to social adult day care programs and a bill related to appointments and duties of the Developmental Disabilities Advisory Council and to the submission and posting of a statewide plan for services. Read more about all the bills here.

NOW WE KNOW — Sleeping in may feel incredible, but studies show it may be bad for your health over the long term. A study in the Journal of Clinical Endocrinology & Metabolism found that sleeping later is associated with an increased risk of heart disease and diabetes.

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CHIPOTLE TROUBLE — The Erie County Department of Health is investigating a local resident’s case of Shiga toxin-producing Escherichia coli O26. The county health department, in a press release, said the evidence points to a Chipotle Mexican Grill.

OPINION — Ken Davis, president and CEO of Mount Sinai Health, and Ram Raju, president and CEO of the city’s public hospital system, have an op-ed detailing the virtues of LegalHealth. “Its attorneys assist hospital patients on a range of issues, including securing coverage and resolving disputes with insurance providers. They also help patients deal with the threat of eviction, other landlord-tenant issues, foreclosure or unemployment, and help secure Social Security disability and other -benefits.”

DON’T DO THAT — Michelle Marie Kelly, a Chittenango dental assistant who stole painkillers from a dental office for her own use, has been suspended from practicing, according to the Syracuse Post-Standard.

ACROSS THE RIVER — Earlier this month, Gov. Chris Christie signed a bill that would allow pharmacies to substitute biosimilars for biological medicines, or biologics. But pharmacists in New Jersey won’t actually be substituting biosimilars for their brand-name counterparts any time soon. The new law (A2477) has created a state-level regulatory pathway for the dispensation of biosimilars, but there is still a lot of guidance that’s needed on the federal level before patients will actually see a benefit. “This legislation provides the important framework that is required by the Affordable Care Act," Dean Paranicus, the president and CEO of the HealthCare Institute of New Jersey (HINJ) said. “As biosimilars come on the marketplace and as the FDA establishes a process to review and approve biosimilars as interchangeable, we would need to have this framework in place in order for New Jersey patients to have access to what will ultimately become interchangeable biologics.” POLITICO New Jerse’ys Katie Jennings has more: [PRO]

PHARMA REPORT — A cancer vaccine being developed by Celldex Theraputics reduced the risk of death in glioblastoma patients by nearly half in a small — 73-patient — study, according to the Wall Street Journal. “It marks the first time an immunotherapy treatment has improved survival in a randomized trial of glioblastoma patients, researchers said. It is also among the first cancer vaccines to show a survival benefit.”

-ABOUT LAST NIGHT — The board of Pfizer and Allergan agreed to a merger Sunday. The deal, worth more than $150 billion, will create the world’s biggest drug maker and move one of the top names in corporate America to a foreign country, according to The Wall Street Journal reports. “The final terms include 11.3 Pfizer shares for every Allergan share and the deal also contains a small cash component.”


-TURNED DOWN FOR TREATMENT — Kaiser Health News reports: “Researchers at the University of Pennsylvania’s Perelman School of Medicine analyzed the hepatitis C prescriptions from 2,342 patients in Maryland, Delaware, Pennsylvania and New Jersey that were submitted between November 2014 and April 2015 to a large specialty pharmacy that serves the region. … Overall, insurers denied 16 percent of prescriptions for the drugs. (The figure incorporates the results of appeals that were filed after initial denials.) The proportion of Medicaid denials, however, was much higher: 46 percent. In contrast, only 10 percent of patients with private insurance and 5 percent of Medicare patients were denied the drugs.”

-ANTHEM ISN’T UNITED — Anthem on Friday said it is committed to the health insurance exchanges, one day after UnitedHealth warned it was having second thoughts.

-PLEASE LOOK AT INSURANCE MERGERS — David Balto, an antitrust lawyer and former federal regulator, on Friday asked the National Association of Insurance Commissioners, composed of state officials, to create a working group to help regulators conduct their reviews, according to The New York Times.

-THE BATTLE TO SAVE CHILDREN’S LIVES — STAT looks at the ethical implications of pressuring the Food and Drug Administration to move quicker or allow patients, who have severe illness, to try unapproved drugs. “Patients suffering from an array of rare conditions are now putting huge pressure on the FDA, hoping to shape deliberations about the risks and benefits of new medicines. That worries some experts who fear that emotional pleas from patients — or their mothers — could compromise scientific judgment.”

-BIRTH CONTROL WITHOUT A PRESCRIPTION — Women in California and Oregon will soon be able to obtain birth control by getting the prescription directly from their pharmacist, the New York Times reports. “Pharmacists will be authorized to prescribe contraceptives after a quick screening process in which women fill out a questionnaire about their health and medical histories. The contraceptives will be covered by insurance, as they are now. The laws are the latest effort to make birth control more accessible, a longstanding goal of medical professionals and policy makers. But unlike other recent debates over contraception — including the firestorm over the Obama administration’s requirement under the Affordable Care Act that all health plans pay for contraceptives — these legislative efforts have been largely free of political rancor.”

-ENROLLMENT, ELECTIONS COINCIDE — The Wall Street Journal reports: “The next sign-up season for 2017 health coverage under the Affordable Care Act will begin just as the 2016 election campaigns draw to a close, under draft rules released by the Obama administration on Friday afternoon. The open enrollment period for people buying insurance on their own for 2017 will start Nov. 1, 2016, and end Jan. 31, 2017, federal officials outlined in the draft rules. In earlier iterations of regulations, they had suggested starting as early as Oct. 1, before appearing to settle on the same dates they are using for this year’s open enrollment period, which is now three weeks under way. That will leave millions of individuals to start considering their options under the law — and renewed publicity about it — shortly before voters go to the polls Nov. 8, 2016 to determine the next president, as well as congressional and state offices.”

-CYSTIC FIBROSIS DRUG SAVES LIVES BUT STRAINS BUDGETS — A newly approved breakthrough drug for cystic fibrosis, a genetic disease that clogs lungs with mucus, making it difficult to breathe, is straining state budgets at a cost of about $710 a day per patient. The Associated Press reports: “The treatment takes a bite out of Medicaid programs that are already facing big budget problems, and a small state like Vermont will be on the hook next year for $3.6 million for a drug expected to treat only 40 people.Orkambi — taken as two pills, twice daily — is a combination of two cystic fibrosis drugs that won approval from the Food and Drug Administration on July 2. Federal law requires Medicaid programs to cover FDA-approved drugs, and the U.S. government picks up more than half the tab. But what's left over will make up nearly 7 percent of Vermont's estimated $54 million Medicaid budget deficit next fiscal year.”

-SLASHING ANTI-SMOKING PROGRAMS — Amid news that the adult smoking rate in the U.S. has fallen to a new low, the New York Times editorial board writes how important it is to keep funding anti-smoking programs and educational measures despite a push from House Republicans to slash the government programs.

TODAY'S TIP — Comes from North Shore-LIJ. Adding fruits and vegetables that are dark in color have more antioxidants and could help prevent cancer


-PURSUIT OF HAPPINESS — Researchers at Kyoto University found that overall happiness is a combination of happy emotions and satisfaction in a region of the brain that becomes active when experiencing consciousness.

-ADHD AND BULLYING — Children and teenagers who take medications, such as Ritalin, to treat attention deficit hyperactivity disorder are twice as likely to be bullied by their peers than those who don’t have ADHD, a University of Michigan study found. The study, published in the Journal of Experimental Child Psychology, found that minors who sold or shared their medication were four and a half times more likely to be bullied by their peers.

MISSED A ROUNDUP? Get caught up here: 11/20, 11/19, 11/18, 11/17, 11/16

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