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It may not feel like it, but Nevadans who get their health insurance courtesy of the Affordable Care Act can consider themselves relatively lucky as 2017 comes into focus...Yes, they will pay an average of 11 percent more in premiums for their coverage than they did this year. And, yes, many will only be able to pick from plans offered by a single insurer...But it could have been far worse. Proof lies just across the border in Arizona, where some premiums are skyrocketing by triple digits and most insurers have fled the market...A new federal report on insurance premium prices released earlier this week and a county-level analysis published...by the Associated Press and consulting firm Avalere Health painted a comprehensive picture of the state of ACA health care insurance entering 2017...It wasn’t pretty...report by the Department of Health and Human Services showed that premiums for a midlevel benchmark plan will increase an average of 25 percent in 2017 across the 39 states served by the federally run online market, including Nevada...HHS officials noted that a majority of those who purchase plans through HealthCare.gov and its state-run counterparts – including Nevada’s Silver State Health Insurance Exchange — receive financial assistance and may not see their out-of-pocket expenses increase much, if at all. It may not feel like it, but Nevadans who get their health insurance courtesy of the Affordable Care Act can consider themselves relatively lucky as 2017 comes into focus.

Humana says it plans to fight the Obama administration over a large reduction in the ratings of its 4-star Medicare Advantage plans for coverage starting in 2018...Star ratings are a key quality measure under Medicare, and lower ratings could result in reduced reimbursement rates for Humana...Not having 4-stars on a significant portion of your plans will hurt you financially because you will not be able to achieve the bonus reimbursement that higher rated plans receive…The company said issues resulting in reduced stars included delays in resolving enrollee complaints over claims...Clearly Humana is going to fight this...it's too early to determine what the real impact of the star rating reduction could be on Humana's earnings in 2018...They're raising the bar, in the sense that it is becoming increasingly demanding...to get the highest ratings on Medicare plans...In other words, insurers are not getting worse, but rather facing tougher comparisons...The good news is that the quality of everyone is improving, but [CMS] still wants to mark on a curve… so, by definition, not everyone can be a five-star...

Humana, UnitedHealthcare, WellCare, Blue Cross and Blue Shield of Florida, Blue Cross and Blue Shield Northern Plains Alliance and CVS Health are among those participating in the Part D model that gives insurers financial incentives when they offer innovative programs that encourage seniors to take their medications...The experiment comes out of the Affordable Care Act…Evidence suggests that medication therapy services currently offered by Part D plans don't improve quality or reduce unnecessary medical expenditures. That's likely due to misaligned financial incentives and regulatory constraints…The focused approach is critical Medicare Advantage plans currently have more of an incentive than stand-alone Part D plans to work with patients to take their medications because they are on the hook for hospitalizations…The Medicare Advantage value-based insurance design model will begin Jan. 1, 2017, and run for five years…

Once again, drug makers and European regulators are clashing over disclosing information...the European Medicines Agency is appealing two different rulings by the General Court of the European Union that prevent it from releasing data to third parties…

• ... first order blocked release of a case study report for Translarna...which is sold by PTC Therapeutics...Until PTC objected, the EMA planned to provide access to the report in response to a request, albeit with redactions that agency officials maintain are in accordance with their own regulations…
• ...second order blocked the release of three toxicity studies for Bravecto...sold by Merck’s animal health unit, which also objected to disclosure.

Our approach to transparency has been welcomed by many of our stakeholders, and these court cases are a good opportunity to test our rules on making available to the general public the documents on which EMA’s scientific opinions on medicines are based...The episode was closely watched because it arose as the pharmaceutical industry faced growing disclosure pressure following scandals over safety or effectiveness data that were not publicly shared. Drug makers have argued that disclosing certain data may compromise trade secrets or patient privacy. Consumer groups counter such information is kept out of reach at the expense of patients...

Pharmaceutical sales representatives working in Chicago might soon have to carry a special license to operate within the city limits...city officials have proposed an ordinance that would require pharmaceutical reps to record and report to the city the number of health care professionals they've contacted, the types of drugs promoted, any samples provided, and if doctors were paid for their time...The ordinance might also require sales reps reps to keep a list of names of doctors they've contacted and potentially give those names to the city if requested. The new licensing requirements are part of a broader effort to fight prescription opioid abuse…The proposed pharmaceutical sales rep license would likely carry a $750 annual fee, the Tribune reported. In addition to the new reporting requirements, sales reps also would have to take city-certified training classes on prescription drug abuse, ethics and marketing standards...The...ordinance...would generate another stream in the flow of occupational licensing fees that go into city coffers...The city is looking for money, if I had to guess…

While much of the attention over prescription drug prices is focused on consumers, a survey released on Tuesday finds that hospitals are also spending much more than in the past. Between 2013 and 2015, the average annual drug spending for patients who stay in community hospitals increased by of 23.4 percent...And on a per admission basis, hospital spending on drugs jumped nearly 39 percent, to $990...the increase in prices outpaced reimbursement rates from payers, retail spending on medicines, and the pharmaceutical price inflation...the survey found that more than 90 percent of the hospitals surveyed reported that recent price hikes for inpatient drugs had a moderate or severe effect on managing costs...The furor has put the pharmaceutical industry on the defensive as many drug makers are scrambling to justify their price hikes. Some drug makers are pointing fingers at pharmacy benefits managers, and the convoluted pricing system in which rebates that are paid to win coveted placement on lists of drugs for which insurance coverage is provided...The drugs that are increasing in price generally are not new and are off patent. There is no competition, so hospitals are forced to pay in order to make the best patient care decisions...These price increases are unsustainable for hospitals who are taking care of sicker and sicker patients…

In the latest instance of alleged insider trading in the pharmaceutical industry, a former Puma Biotechnology executive was charged with illegally making more than $1.1 million by taking advantage of confidential information about clinical trials for a cancer drug...Robert Gadimian, who was senior director of regulatory affairs, bought and sold Puma stock after learning about favorable study results for a medicine that was being tested to treat breast cancer…This alleged episode of insider trading is only the latest instance involving the pharmaceutical industry or those working with drug makers. The issue has increasingly raised concerns in connection with clinical trial work, as well as deal-making and the drug approval process, which some fear can be distorted by such activities.

Pfizer’s divide-and-conquer approach to Lyrica in the U.K. just hit a wall. The Court of Appeal upheld a ruling that struck down key patent claims on Lyrica and cleared Actavis’ generic of infringing it...The...case centered on a “carve-out” approval for Actavis’ Lyrica generic, a type of regulatory nod that branded drugmakers see as a threat...drugmakers want to prolong their monopoly access to patients, and they use follow-up patents to extend their protection past the time when IP coverage expires on the original compounds...some recent “skinny” regulatory nods--from the FDA as well as international regulatory agencies--that clear generics only for particular indications have complicated those efforts, because they give generics makers an entreé onto the market while so-called method-of-use patents remain in effect...The patent at issue in this case covered Lyrica’s use as a pain treatment; the patent on pregabalin itself, the active ingredient...had already expired. These days, Lyrica is used more often for pain than for its original indication as a seizure drug...The company hopes to now take its fight to the U.K. Supreme Court...Pfizer maintains its strong belief in the validity and importance...of the patent…

Mylan reached a $465 million settlement on Friday with the US Department of Justice and other government agencies over accusations that it shortchanged Medicaid...The move comes after a month of controversy over charges that Mylan improperly classified its EpiPen allergy device in reports to the Medicaid Drug Rebate Program. Under this program, companies must accurately report — and pay — a rebate on drugs paid for by the agency...Mylan, however, had been reporting EpiPen as a generic product for nearly a decade. And this is an important distinction, because classifications are used to determine the size of rebates that companies pay Medicaid. Rebates, which companies pay in exchange for having their products covered, are lower for generics — 13 percent versus 23 percent for a brand-name product.

Drug makers are constantly foraging for deals to bulk up their pipelines, but not all go according to plan...Consider the nasty spat between Teva Pharmaceuticals and two Mexican brothers, Fernando and Leopoldo Espinosa...they have filed dueling lawsuits after their $2.3 billion deal went sour…At issue was a move made last year by Teva...to expand in Mexico by purchasing Rimsa, one of the country’s largest independent pharmaceutical manufacturers, from the Espinosa brothers. At the time, Teva hailed its acquisition...as a "significant platform for growth" in the second-largest market in Latin America...Teva claims the brothers engaged in chicanery, ploys, and misrepresentations about their business in order to walk away with huge profits, according to its lawsuit...Rimsa was "was engaged in a years-long scheme to sell defective and unlawful products and to conceal those violations from Mexican regulators...Teva lawsuit goes on to claim that Rimsa submitted fraudulent information to regulators about ingredients suppliers and lied about laboratory tests, including the stability tests that must ensure the stated shelf life of each product was accurate and that the product would remain stable, and, therefore, safe and effective…