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Nevada officials are exploring alternative avenues for insuring more than 26,300 children in the state covered under the Children’s Health Insurance Program if Congress doesn’t reauthorize the program, which is set to expire Saturday...Congress is expected to reauthorize the CHIP program through a bipartisan bill, though that could be weeks away. And with the turmoil in Congress lately, state officials are taking no chances...The Department of Health Care Financing and Policy is working with state partners to identify alternative sources of funding for the program if it is not reauthorized, deputy administrator Cody Phinney said ...“We would have to find other funding sources and we’d have to look at our options for limiting the services that are available, but our first role is to maintain those services,” Phinney said...the federal government pays nearly the entire annual $43 million cost of the program in Nevada...The state has ‘reserve funding’ to operate the health-care program for the next few months. However if Congress does not quickly reauthorize CHIP, states like Nevada will need to either send notices of termination to program beneficiaries or develop alternative funding...

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The Nevada Legislature has filed a motion to intervene as a defendant in a federal lawsuit that challenges a state law that requires disclosure of how insulin is priced...Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization say the Nevada law passed this year is unconstitutional. The groups maintain the legislation improperly interferes with federal patent law because the disclosure requirements it imposes penalize pricing decisions that are consistent with the patent rights granted by Congress...Gov. Brian Sandoval and Department of Health and Human Services Director Richard Whitley are named as defendants in the lawsuit. The Legislature on Tuesday filed its motion to defend the law.

A Native American tribe holding patents for drugmaker Allergan Plc...moved to dismiss a case brought by generic drug company Mylan NV challenging the patents...In a filing to the U.S. Patent Trial and Appeal Board, the Saint Regis Mohawk Tribe asked that Mylan’s case seeking to invalidate Allergan’s patents on dry-eye medicine Restasis be thrown out on the grounds that the board has no jurisdiction over the tribe...The move was expected after Allergan announced on Sept. 8 that it had transferred Restasis patents to the tribe in order to protect them from administrative challenges...the tribe said it is sovereign government that cannot face litigation in an administrative court unless it expressly waives its immunity or the U.S. Congress abrogates immunity...(Allergan) has said the transfer is only intended to shield the patents from review at the patent board, which it has called a flawed forum for patent disputes. Allergan has said it will not invoke tribal immunity in federal courts

An estimated three out of every 1,000 Americans ring up a bill of more than $50,000 in annual prescription drug costs last year, according to a new analysis of health plan members published...by Express Scripts... The number of people who meet this threshold for high pharmaceutical expenditures has risen sharply, by 35%, since the PBM's last report on the trend in 2014. While numerically small, this group of patients accounted for more than 20% of total U.S. spending on prescription drugs in 2016...higher utilization of pricey specialty medicines for cancer, multiple sclerosis and rare diseases was the primary driver of spending among patients with annual pharmacy costs over $50,000. Yet that was a change from 2014, when new hepatitis C drugs and compounded medicines goosed spending...Nearly 96% of the plan members who cleared the $50,000 in annual spending threshold used specialty medicines, most notably cancer therapeutics. While the average annual cost of oncology drugs was lower than some other specialty categories, a quarter of all spending by this group was on cancer treatments...

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Patients could experience "critical shortages" of key pharmaceuticals, the U.S. Food and Drug Administration is warning after Hurricane Maria brought Puerto Rico's drug manufacturing industry to a standstill...The FDA said...it is taking active measures to help redirect production and preserve existing treatments to avoid a ballooning health crisis from Maria's destruction...The agency did not identify any specific medications that could be at risk of a shortfall, and a spokesperson was not immediately available to provide details...But there are "several" cases where "we may soon face critical shortages if we don’t find a path for removal or ways to get production back up and running," FDA Commissioner Scott Gottlieb said in a statement...Some companies are beginning to move product off of the island, and they’ve been communicating with the FDA about that and what potential challenges and limiting factors they see ahead...Drugs made on the island include AstraZeneca's cholesterol treatment Crestor, Abbvie arthritis drug Humira and Johnson & Johnson-owned HIV drug Prezista. Those three companies have said supplies of their drugs are in good shape...the catastrophic storm wiped out electricity for the entire island, devastated telecommunications and made travel nearly impossible for many employees of the island's nearly 50 pharmaceutical factories...

Retroactive pharmacy payment reductions, a portion of direct and indirect remuneration fees, could cost the federal government $3.4 billion between 2018 and 2027. That’s according to a new study from Wakely Consulting...This...study is vitally important in showing that DIR legislation will actually save taxpayers $3.4 billion over 10 years without subtracting any benefits seniors currently receive...For pharmacies, banning these after-the-fact fees is the fair way to achieve predictability in the reimbursement for the medications they buy and dispense...The report evaluates the impact of the Improving Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, which has been introduced in both the Senate and House of Representatives and prohibits retroactive pharmacy payment reductions as claims without any defect, impropriety or fraud in Medicare Part D...The legislation is part of NCPA’s efforts to end DIR Fees, which make up a small amount of overall DIR within Medicare Part D, the majority of which is made up of manufacturer rebates

The European Medicines Agency...warned that it could lose a majority of its staff based on which of the 19 cities vying to host the medicines regulator is selected by the European Council in November, threatening the pace of new drug approvals even in best-case scenarios for at least two years...Based on the results of a survey completed by 92% of EMA’s staff earlier this month, the agency says it could lose between 19% and 94% of its staff depending on which city is selected as its future host. Politico first reported that Amsterdam is the top choice among EMA staff...After Amsterdam, just three additional unnamed cities are projected to provide enough cover to maintain the regulator’s basic safety monitoring mission. “For certain locations staff retention rates could be significantly less than 30% [retention]. This would mean that the Agency is no longer able to function and, as there is no backup, this would have important consequences for public health in the EU,” the EMA says...In the worst cases, EMA says it would be “unable to operate” and the EU and member states would need to implement emergency measures to protect public health, such as relying on third countries for approval decisions.

Business will continue as usual for Nevada’s Silver State Health Insurance Exchange during the upcoming open enrollment period despite uncertainty over its future in Congress...Insurance exchange officials, joined by Democratic state Sen. Yvanna Cancela, addressed advisers who will help with the enrollment process ...emphasizing the need for aggressive outreach to Nevada’s estimated 43,000 eligible but non-enrolled residents...They also said planning will continue ahead of the Nov. 1 beginning of the enrollment period despite the potential that Congress could eliminate the exchange by repealing the Affordable Care Act...