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The Office of Nevada Governor Steve Sisolak announced that they are investigating the State Board of Pharmacy for allegedly failing to do background checks on pharmacy wholesalers...The governor's office says since 2007, the State Board of Pharmacy has been collecting fees, but has not been doing background or fingerprint checks as required by a law passed in 2005...The Governor announced today that he is authorizing the recommendations proposed by the Audit Division:

1. Lifting the temporary moratorium on granting wholesale pharmacy licenses to eligible applicants.

2. Directing the BOP to return unspent fingerprint fees to the appropriate applicants and licensees and transfer any fees that cannot be returned or tied to an individual or entity to the State Treasurer’s Unclaimed Property Account.

3. Requesting that the BOP hold accountable those who failed in their statutory obligations to protect the health and safety of Nevadans...READ MORE

Nevada regulators are investigating marijuana testing laboratories to figure out how cannabis with exceedingly high levels of yeast and mold made it to store shelves, as well as for possibly doctoring THC levels to make cannabis products appear more potent to consumers...the state sent out a notice that several batches of marijuana flower and pre-rolls showed levels of yeast and mold that exceeded the state’s allowable limit after a secondary test. A follow-up test conducted by the state’s Department of Agriculture found that some of the products had yeast and mold levels of 390,000 colony-forming units per gram, which is nearly 40 times higher than the state’s legal threshold of 10,000 cfu/g...READ MORE

The Nevada Department of Health and Human Services is threatening to levy roughly $20 million in fines on more than two dozen drug manufacturers that have yet to submit cost and profit reports to the state as required by a 2017 law aimed at better understanding the rising costs of treating diabetes...under Nevada law...companies can be assessed a fine of up to $5,000 a day for noncompliance. With 143 days since the manufacturer reports were due on April 1, each company that has yet to submit a report is facing a fine of up to $715,000...READ MORE

Chamber of commerce and trade association health plans are in legal limbo after a federal judge ruled earlier this year that the Trump administration rule allowing them violates the Affordable Care Act...Some associations in Nevada have stopped allowing new businesses into their health plans out of an abundance of caution as the case goes up on appeal, while others have chosen to press forward. The heterogeneous response is the result of the fact that the court’s decision only affects some association health plans and the state Division of Insurance, which oversees the plans, doesn’t know which ones those are...READ MORE

The state is imposing $17.4 million in fines on 21 diabetes drug manufacturers that have either failed to comply with or were many months late in complying with a drug pricing transparency law passed two years ago...The fines, which the state is allowed to assess at $5,000 a day, range from $735,000 for one company that submitted the required drug pricing data the same day it received a final notice from the state — but 147 days after the reporting deadline — to $910,000 for eight companies that still have yet to report the required information. The Department of Health and Human Services told the companies in letters sent this week that they have 30 days to either pay the fines in full or 10 days to request an informal dispute resolution meeting with the state...READ MORE

Canada’s main pharmaceutical industry lobby group, along with 16 of its member companies, filed a lawsuit...to block new regulations meant to lower patented drug prices, the second legal challenge to a new regime that could eventually reduce prices in the United States as well...Canada published the final regulations in August, despite heavy lobbying from drug companies, which stand to lose revenue as prices drop. The federal government estimates the new rules will save Canadian patients, employers and insurers, including governments, C$13.2 billion ($10 billion) over a decade...lawsuit was filed in federal court and led by Innovative Medicines Canada, which represents major drugmakers in Canada. It is separate from a lawsuit filed last month and focuses on federal patent law, arguing that Canada cannot use regulations to “fundamentally alter” the role of its federal drug price regulator...READ MORE

About five years ago, Nevada started taking high-profile steps toward tackling the opioid crisis. There were bills to curb doctor-shopping and over-prescribing in 2015 and 2017, a statewide opioid summit in 2016 and a cascade of lawsuits against opioid manufacturers from the state and local governments in the past few years...But has the growing awareness and response made a dent in the epidemic?...Scores of law enforcement, treatment professionals, elected officials and others gathered in Las Vegas this week for a two-day conference where they assessed progress and exchanged ideas on how to better tackle opioid abuse...Here are some takeaways from the event:...READ MORE

The top U.S. consumer and trade regulator said...it had warned three companies selling products infused with cannabidiol that it was illegal to advertise that such products could fight disease without providing credible scientific evidence...CBD, has been touted as alleviating countless physical ailments...The Federal Trade Commission said the three unidentified companies claimed, without providing substantiation, that CBD can treat more than two dozen conditions including cancer, Alzheimer’s, multiple sclerosis, schizophrenia, epilepsy, diabetes, psoriasis, and AIDS...READ MORE

The Trump administration issued a new rule that aims to prevent payments to Medicare and Medicaid fraudsters by boosting revocation powers and extending the time before troublesome organizations can rejoin the programs...The Centers for Medicare & Medicaid Services said that the final rule...marks a major turnaround from the agency’s normal approach of attempting to recoup fraudulent payments after the fact...“For too many years, we have played an expensive and inefficient game of ‘whack-a-mole’ with criminals⁠—going after them one at a time⁠—as they steal from our programs,”...READ MORE

Medicare and Medicaid will cover CAR-T cell therapies...a decision that helps address, but doesn't fully solve, the reimbursement challenges that have hampered uptake of the pricey cancer drugs...One major hang-up is reimbursement. Kymriah costs $475,000 for pediatric and young adult patients with leukemia and both therapies are priced at $373,000 to treat lymphoma in adults...Under regulations published this month, Medicare will reimburse at least 65% of the treatment's cost, or about $242,000, through Part B...That will give hospitals surety they will receive payment for the drug, yet doesn't necessarily make whole the full cost of treating a patient with CAR-T. The cell therapies are also still reimbursed via billing codes for bone marrow and stem cell transplants, rather than using a separate identifier...READ MORE