Author: Peter

• Assembly Bill 474
• National Pharmacy Compliance News
• FDA Issues Final Guidance Policy on Outsourcing Facilities
• EU-US Mutual Recognition Agreement Now Operational Between FDA and 12 Member States
• US Surgeon General Advisory Urges More Individuals to Carry Naloxone
• Expanding Pharmacists’ Scope of Practice Linked to Improved Cardiovascular Outcomes
• Pharmacists Are Critical to Drug Supply Chain Integrity, States FIP
• Emergency Department Visits for Opioid Overdoses Rose 30%

When it comes to non-drug therapies for back pain, U.S. insurance plans vary widely in what they will cover, a new study finds...Private and public insurers are missing important opportunities to promote alternatives to opioids...insurers often provide little or no coverage for evidence-backed interventions for chronic pain such as acupuncture and psychological counseling...“Insurers can be part of the problem or part of the solution,” said study coauthor Dr. Caleb Alexander...at the Center for Drug Safety and Effectiveness...“All too often doctors reach for the quick solution, prescription drugs, especially opioids, to manage pain that would be more effectively and safely treated with non-pharmacological approaches,” Alexander said. “This is a system that is designed with, and fosters, the idea that there is a pill for every ill...

Despite improvements in several areas, Nevada is once again listed at the bottom of a new national health care ranking...Nevada ranked 50th nationwide in a review of more than 100 population-level and patient-level measures published by the Agency for Healthcare Research and Quality. Only the District of Columbia scored lower overall than the Silver State...“There (are) actually areas where Nevada does fairly well — chronic disease care, diabetes, heart failure, stroke...Access to care remains a big problem. Nevada’s physician workforce hasn’t kept up with the state’s ballooning population, causing a doctor shortage...issues in accessing care, including getting an appointment with a primary care physician, having enough time in a doctor’s office and finding a specialist.

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

The number of new clinical trials started in Britain last year was 25 percent lower than the average for 2009-16, as anxiety about Brexit’s impact on future medicines regulation made companies hesitate about running studies in the country...Drugmakers’ confidence has been dented by fears research data collected in Britain might not be acceptable to the European Medicines Agency after the UK leaves the European Union...The pharmaceuticals industry has long warned that Brexit could have a serious impact on research and access to medicines, unless London and Brussels hammer out a deal for regulatory continuity and close liaison with the EMA...If there is no deal, the UK’s Medicines and Healthcare products Regulatory Agency would have to operate as a stand-alone regulator and there is no clarity over how UK data would be treated by the EMA...

...Mesa View Regional Hospital closed its labor and delivery unit last week...The hospital’s labor unit and nursery closed...despite a 2002 development agreement under which the city provided the land for the hospital for $1 in exchange for it providing a list of services, obstetrics included...Since the closure, moms-to-be must now travel to deliver their babies in a hospital, either to St. George, Utah, about 40 miles northeast, or to a hospital in Las Vegas, 82 miles southwest...Mesquite residents...voiced concerns at...a...City Council meeting, saying that the closure of the town’s labor and delivery unit would drive out young families and keep new ones from moving to a city where more than half of the residents are over 50...Mesa View’s new CEO Ned Hill announced the closure, saying demand is “simply not there.”...deliveries at Mesa View have decreased by 74 percent in the last decade, dwindling to 63 in 2017...“Discontinuing elective deliveries will allow our hospital to continue building up the services most needed in our community,” Hill said, adding that the hospital hired five new practitioners in other specialties with the money saved from the closure...Rural hospitals nationwide are shutting down their obstetrics units...7.2 percent of rural hospitals ditched obstetric care between 2010 and 2014...

Gottlieb has made speeding generics to market one feature of his tenure, with some harsh warnings to pharmas not playing by the rules...One tactic used by drugmakers is using the FDA citizen petition process, created to allow individuals and community groups to make requests for changes to health policy. Pharma companies have been using this route to counter the impact of the Drug Price Competition and Patent Term Restoration Act...citizen petitions have rarely delayed specific generic drug approvals, there's no doubt that the process requirements associated with 505(q) petitions can add to resource burdens on the generic drug review process and the FDA's regulatory decision making...This increased burden on the FDA can take resources away from the daily work of application review...The FDA will now publish the factors it will consider to determine whether to allow the petition through. If the agency determines a petition has been set up with the primary purpose of delaying the approval of a generic drug application, it will look to deny it and explicitly note the reason...effectively naming and shaming the company in question. The FDA will also consider referring the company to the Federal Trade Commission, which oversees anticompetitive business practices...

President Trump signed bipartisan legislation...that would free pharmacists to tell consumers when they could actually save money by paying the full cash price for prescription drugs rather than using health insurance with large co-payments, deductibles and other out-of-pocket costs...The legislation on gag clauses has been praised by lawmakers in both parties...The legislation...also includes a provision to combat agreements between drug makers that stifle competition by delaying the marketing of lower-cost copycat versions of expensive biotechnology medicines. Such biologic medicines account for a rapidly growing share of drug spending...Under the new law, manufacturers of the original product and the copy, known as a biosimilar, will have to report such agreements to the Federal Trade Commission, which can challenge them as violations of antitrust laws. The agreements are known as pay-for-delay deals because the branded drug company pays a potential competitor to delay entering the market...

The expansion of Medicaid in Nevada in 2014 made mental health care much more widely available in a state ranked last in the nation for access to such services. It also provided a great opportunity for bad actors...catching those who abuse the Medicaid system is a tortuous process that can either come too late or result in relatively minor penalties...fraudsters are undoubtedly adding to the $56 million deficit Nevada Medicaid predicts it will face in the 2019 fiscal year, up from last year’s $30 million forecast at this time...The Medicaid expansion has certainly “exacerbated” the problem of fraudulent or improper claims in the field of behavioral health...Suspicious claims from mental health providers led Nevada Medicaid to investigate $73 million paid out in the 2018 fiscal year...So far, about $10 million — or 13 percent — has been recovered...

GlaxoSmithKline, which five years ago stopped paying doctors for promoting its drugs, said...it would allow such payments once again in limited circumstances...The British group’s 2013 no-payment pledge marked a first for an industry battling past scandals over sales practices. But other drugmakers failed to follow suit, leaving it at a competitive disadvantage...Drugmakers have long used so-called key opinion leaders to promote the benefits of their products to other prescribing physicians and the decision to abandon this strategy was questioned by a number of analysts...GSK’s new updated policy...will now permit payments to global experts who speak about the science behind novel new medicines...“These changes are being made for a select number of innovative products in a limited number of countries and apply to restricted time periods in a product’s lifecycle,” the drugmaker said.