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The FDA will consider creating a list of “essential drugs” and financial incentives to drugmakers that manufacture them as it continues to grapple with the drug shortages that plague U.S. hospitals and caregivers...FDA Commissioner Scott Gottlieb, M.D...announced the formation of a new Drug Shortages Task Force and named Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives to lead it...“I’m charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge,” Gottlieb said. “The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages.”...The FDA is already taking steps to support new technologies that can improve manufacturing and help reduce the chance that supply disruptions will occur...the FDA may want to consider “more significant interventions” than it currently employs. “We want to make sure we aren’t discouraging investment for manufacturing drugs that are more likely to go into shortage, and thus working against our own goals." One suggestion is to grant the FDA authority to require applicants of certain drugs to conduct a “risk assessment to identify the vulnerabilities in their drug supply that could cause a shortage," and to establish risk mitigation plans in advance to address those weaknesses...

NACDS RxImpact pharmacy advocates are urging Senators to sign a letter to Health and Human Services Sec. Alex Azar that...describes the negative effects on Medicare patients and on pharmacies of the rapid expansion of the use of direct and indirect remuneration, or DIR, fees...urging Sec. Azar to not allow the current focus on drug prices to pass without taking meaningful action on this...issue...DIR fees were originally intended to capture and report rebate amounts paid by manufacturers at the end of the plan year during the reconciliation process in Part D. In recent years...the fees have become a catch-all category used increasingly by payers to include various pharmacy price concessions, such as fees related to performance-based programs or fees for participation in a preferred network. As a result, pharmacies find themselves in the untenable position of being paid by plan sponsors for prescription services, only to find out later that some of the payment must be returned...

Nevada plans to execute death row inmate Scott Dozier next week using the powerful painkiller fentanyl as well the sedative midazolam — a drug that critics have blamed for executions in other states in which prisoners were seen struggling for breath before they died...The Nevada Department of Corrections offered up formal notice...that it would be putting Dozier to death next Wednesday at 8 p.m. at Ely State Prison. They also released the new lethal injection drug protocol, which comes as the state’s supply of a drug formerly in the combination — diazepam — expired...Attorneys for Dozier didn’t immediately return requests for comment on Tuesday about whether they would take any steps to challenge the protocol, or whether Dozier approves of the method...

Two national drug lobbying organizations dropped a lawsuit Thursday challenging the constitutionality of Nevada’s first-in-the-nation insulin pricing transparency law a little less than a month after the state approved regulations allowing drug companies to protect certain information they turn over to the state from public disclosure...Attorneys representing two associations and the state agreed in a joint court filing that the newly adopted regulations resolve drug companies’ concerns that the new law would require manufacturers of diabetes drugs to disclose trade secret-protected information in conflict with federal law and in violation of the U.S. Constitution. The decision to abandon a legal fight comes nine months after the Pharmaceutical Researchers and Manufacturers of America and the Biotechnology Innovation Organization challenged the law in U.S. District Court.

Industry groups like easier quality reporting and advance applications of telehealth, but some say docs shouldn't have to make expensive EHR upgrades for 2019..."historic changes" announced...by the Centers for Medicare & Medicaid Services, promising big adjustments to its policies around the Physician Fee Schedule and the Quality Payment Program, already have the healthcare industry talking...CMS says it wants to incentivize the use of and access to virtual care and telehealth, to ease the quality reporting burden on physicians by focusing on the most important and impactful measures...also wants to spur better information sharing among healthcare providers, regardless of what electronic health record vendor they happen to use...CMS notes that these proposals will modernize Medicare payment policies to promote access to virtual care, saving Medicare beneficiaries time and money while improving their access to high-quality services no matter where they live...the new proposal would "help shift the nation’s electronic documentation away from overly long, form-driven, hard-to-read documents written primarily to satisfy billing requirements to what it was originally intended for – providing high- quality care to patients."...

The Trump administration...halted billions of dollars in payments to health insurers under the Obamacare healthcare law, saying that a recent federal court ruling prevents the money from being disbursed...The Centers for Medicare and Medicaid Services, which administers programs under the Affordable Care Act, said the action affects $10.4 billion in risk adjustment payments...President Donald Trump’s administration has used its regulatory powers to undermine Obamacare after the Republican-controlled Congress last year failed to repeal and replace the law. About 20 million Americans have received health insurance coverage through the program...The payments are intended to help stabilize health insurance markets by compensating insurers that had sicker, more expensive enrollees in 2017. The government collects the money from health insurers with relatively healthy enrollees, who cost less to insure...

Britain’s public health service has started “significant planning” to ensure medicines are still supplied to patients if the government fails to negotiate a Brexit deal with the European Union, its head said on Sunday...Simon Stevens, chief executive of the National Health Service, said Britain’s health department was working with pharmaceutical companies to make sure there will be no breakdown in supply if there is no deal with the EU...The EU warned Britain again last week that time was running out for Prime Minister Theresa May to negotiate a deal and stop the country from crashing out of the bloc...

Alvogen has won a court order preventing the Nevada Department of Corrections from using its sedative drug product, midazolam, in an execution...A temporary restraining order has blocked the Nevada Department of Corrections from using Alvogen’s midazolam in an execution due to take place yesterday (7/11). The drug was intended to be used as a sedative, prior to delivery of the lethal injections...Alvogen had claimed the Department fraudulently obtained the drug. “Alvogen does not accept direct orders from prison systems or departments of correction,”...“Alvogen also works with its distributors and wholesalers to restrict any sale, either directly or indirectly, of our midazolam product to any prison system or department of corrections,”...Alvogen “does not condone the use of any of its drug products, including midazolam, for use in state sponsored executions,”...

• Return of Dispensed Drugs to a Pharmacy

National Pharmacy Compliance News

• DEA Launches New Tool to Help Distributors Make Informed Decisions About Customers
• PTCB Launches Certified Compounded Sterile Preparation Technician Program
• DEA Enables Mid-level Practitioners to Prescribe and Dispense Buprenorphine
• New CDC Training Offers CPE on Antibiotic Stewardship
• Walmart to Provide Free Solution to Dispose of Medications With Schedule II Prescriptions
• ASHP Research and Education Foundation Predicts Trends to Affect Pharmacy in 2018
• USP Encourages Pharmacists to Help Patients Find Quality Dietary Supplements
• New CPE Monitor Subscription Plan Helps Pharmacists Track Compliance Via Mobile App

Nevada State Board of Pharmacy News

• Controlled Substance Prescription DEA Number Requirement

A policy change proposal that could affect Medicaid's behavioral health patients drew plenty of public opposition...The policy would require prior authorization for Neurotherapy and Psychotherapy Medicaid patients to demonstrate medical necessity before they receive treatment...The Department of Health and Human Services and the Division of Health Care Financing and Policy held a workshop to hear feedback from the public about their proposal. The department says they are now revising this policy proposal, after hearing those concerns...Officials said this policy would help both the most vulnerable patients as well as the administrative staff; but opponents strongly disagreed...