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Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Indivior Plc lost nearly three-quarters of its stock market value...and former parent Reckitt Benckiser also fell after the U.S. Justice Department accused the British drugmaker of illegally boosting prescriptions for its blockbuster opioid addiction treatment Suboxone...An indictment...alleged Indivior made billions of dollars by deceiving doctors and healthcare benefit programs into believing the film version of Suboxone was safer and less susceptible to abuse than similar drugs...The indictment charged Indivior and its subsidiary Indivior Inc with conspiracy, health care fraud, mail fraud and wire fraud. The U.S. government said it would seek to have it forfeit at least $3 billion...READ MORE

No one loved a bill heard in committee...that would keep emergency room patients from getting socked with surprise medical bills from an out-of-network provider that treats them...But no one hated the bill enough to oppose it...The bill...would bar an out-of-network provider treating an ER patient with “medically necessary emergency services” from charging more than the patient’s insurance co-payment, co-insurance or deductible. It also establishes procedures for insurers and third-party providers to work out payments between them, without putting the patient in the middle, and for transferring patients from an out-of-network facility where they were initially treated to one within their network within 24 hours of becoming stable...READ MORE

SB262: Asthma drug pricing transparency

...Democratic Sen. Yvanna Cancela...has introduced a bill that would apply the same standards toward drugs that treat asthma...SB262 largely copies provisions of Cancela’s 2017 legislation on diabetes drug transparency, which requires the drug manufacturer to submit information to the state related to the cost of the pricing of the drug, and explain to the state whether the drug has undergone a substantial price increase in the past two years...SB262

SB378: Drug pricing board

Proposed by Democratic Sen. Yvanna Cancela, this measure would establish a statewide Prescription Drug Affordability Board, charged with identifying certain prescription drugs with pricing that creates challenges for insurers and patients and that would recommend an upper price and payment limit on the drug...The bill lays out the structure, make-up and abilities of the board, funded by taxes on prescription drug manufacturers based on their market share and the required costs of the board. It also lays out a process for setting upper recommendations on prescription drug prices, including requiring the suggested limits become mandatory after 2024...SB378

AB303: Regulation of kratom products

Sponsored by Assembly Republican Leader Jim Wheeler, this bill would require the state pharmacy board to regulate and oversee the sale of kratom, a Southeast Asian tropical tree with leaves that contain psychotropic effects...The bill would also prohibit the sale of kratom products to children under the age of 18, or to sell any kratom products that have been altered to become “injurious” to a consumer. It sets a $1,000 fine and separate civil penalty up to $1,000 for violations...AB303

AB239: Opioid clarification bill

...this bill would make changes to the opioid prescribing law passed in the 2017 legislative session that prompted complaints by physicians in the interim. The legislation would, among other things:
- Codify certain definitions from pharmacy board regulations, including course of treatment and acute pain
- Allow providers to still prescribe a controlled substance after reviewing a patient utilization report if they determine the prescription is medically necessary
- Allow providers to prescribe a longer initial prescription for a controlled substance for the treatment of acute pain than normally allowed by law if medically necessary
- Remove a requirement that a provider make a good faith effort to attempt to review a patient’s medical records before issuing an initial prescription of a controlled substance for the treatment of pain unless the initial prescription is for more than 30 days or the medical records are relevant to the prescription
- Repeal requirements that providers consider certain factors — including whether there is reason to believe the patient is not using drugs as prescribed, the number of attempts by a patient to obtain an early refill of a prescription and the number of times a patient claims a prescription has been lost or stolen — before prescribing a controlled substance...AB239

A Democratic-controlled Senate rejected...an amendment backed by their Republican colleagues that would have removed a carveout in state trade secret law long opposed by the national drug lobby...Senate Republican Leader James Settelmeyer framed the amendment as an attempt to codify an agreement reached between drug companies and the state following a lawsuit over Nevada’s first-in-the-nation diabetes drug pricing transparency law...As part of that agreement, the state mapped out a process in regulation to protect information that drug companies believe to be trade secret protected from public disclosure...“The framework for protection of trade secrets in the regulations adopted for diabetes transparency reporting applies to disclosures under statute but were written by referencing the specific bill that created those sections,”...Pharmaceutical Research and Manufacturers of America said in a statement opposing the asthma bill. “The confidentiality language in the regulations for the diabetes transparency bill should be adopted in SB 262 to clarify that the requirements and considerations apply to disclosures required by those sections of statute generally and not just pursuant to any specific bill.”...Sen. Yvanna Cancela, who sponsored both the diabetes and asthma drug pricing bills, said on the floor that she believed the proposed amendment would weaken the state’s drug pricing transparency statute and pointed to the existing regulatory framework in place...READ MORE

The U.S. Supreme Court...cast aside pharmaceutical company Allergan Plc’s unorthodox bid to shield patents from a federal administrative court’s review by transferring them to a Native American tribe...The justices left in place a lower court ruling upholding the authority of a U.S. Patent and Trademark Office tribunal to decide the validity of patents covering Allergan’s dry eye drug Restasis, refusing to hear the company’s appeal. Allergan had argued that the tribe’s sovereign status under federal law made the patents immune from administrative review by the agency...Allergan, which has its headquarters in Dublin, in September 2017 transferred the patents to New York’s Saint Regis Mohawk Tribe, which took legal ownership of the patents and then licensed them back to Allergan in exchange for ongoing payments...Allergan said it was protecting itself from the patent court, which it called a flawed and biased forum...READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The people charged across 11 federal districts, include 31 doctors, seven pharmacists, eight nurse practitioners, and seven other licensed medical professionals...The cases involve more than 350,000 prescriptions for controlled substances across Ohio, Kentucky, Tennessee, Alabama, and West Virginia...The Justice Department said six individuals, including two doctors and three registered pharmacists were charged with several counts, including unlawful distribution of controlled substances and conspiracy to obtain controlled substances by fraud...One arrest...involved a doctor in Kentucky who allegedly prescribed opioids to friends on Facebook, who would then come to his home to pick up prescriptions...Another case involved a doctor in Tennessee who branded himself the “Rock Doc.” He allegedly prescribed combinations of dangerous combinations of opioids and benzodiazepines, a class of psychoactive drugs, sometimes in exchange for sexual favors...READ MORE

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

A physician ally of Purdue Pharma LP...has agreed to testify against the OxyContin maker and other drug companies, newly disclosed court records show...Dr. Russell Portenoy, a professor at the Albert Einstein College of Medicine, was an early advocate for the use of opioids for chronic pain...He also was named as a defendant in some of the lawsuits filed by cities, counties and states seeking to hold opioid makers - including Endo and Mallinckrodt Plc...But Portenoy...struck a deal with the plaintiffs to serve as a cooperating witness, the records show. In exchange for his dismissal from the suits, Portenoy provided the plaintiffs with documentation of opioid makers’ payments to him over the years, as well as a 36-page declaration that lays out what he would say on the witness stand...READ MORE