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Less than one month following Walgreens decision to terminate its relationship with Theranos, the blood-testing lab on Thursday announced that the Centers for Medicare & Medicaid Services has revoked the company's CLIA certificate, among other sanctions. The revocation of Theranos' CLIA certificate precludes the owners and operators of Theranos from owning, operating or directing a lab until at least July 2018...In addition to the revocation of Theranos' CLIA certificate, the full list of CMS sanctions include:

• Limitation of the laboratory’s CLIA certificate for the specialty of hematology;
• A civil money penalty;
• A directed portion of a plan of correction;
• Suspension of the laboratory’s approval to receive Medicare and Medicaid payments for any services performed for the specialty of hematology; and
• Cancellation of the laboratory’s approval to receive Medicare and Medicaid payments for all laboratory services.

Renown Health is paying $9.5 million to settle allegations of Medicare fraud after its former compliance director-turned whistleblower accused management of encouraging "systemic" overcharging — and sometimes double-billing — of hundreds of patients...U.S. Attorney Daniel Bogden announced the settlement agreement...between the Justice Department and...Renown Regional Medical Center, the largest hospital and health care network in northern Nevada with more than $1 billion in annual revenue...Cecilia Guardiola, a registered nurse and law school graduate, said in a federal whistleblower lawsuit filed in 2012 that she began to discover the "billing deficiencies" shortly after Renown hired her as its director of clinical documentation in June 2009...

Indonesian lawmakers...urged authorities to seize from hospitals and health clinics all vaccines made by unapproved manufacturers, after police exposed a syndicate selling fake child vaccines for more than a decade...In a country where counterfeit drugs are widespread, the case deals a blow to government health regulators whom many believed to have kept a tight leash on the distribution of vaccines...Authorities have shut some private health facilities after police smashed a drug-making ring last week that sold fake and potentially harmful booster vaccines for measles, hepatitis B and other viruses in Jakarta and the island of Java...Police uncovered the syndicate after a pharmacist in Bekasi...was arrested in May for selling medicine without a license. The drugs turned out to be fake and led to the arrest of 14 distributors and makers of the fake vaccines, whose ingredients included the antibiotic gentamicin and saline...

Paris prosecutors...have begun an involuntary manslaughter investigation into a failed drug trial that left one dead and five hospitalized in January...The prosecutors' office said the investigation had been opened to determine whether there was a criminal element in any mistakes made or whether it was simply the result of clinical risks involved...France's Health Ministry said last month that Portuguese drugmaker Bial and French laboratory Biotrial were at fault "on several counts" for the drug trial...

CVS Pharmacy has agreed to pay $3.5 million to settle allegations that dozens of its Massachusetts pharmacies violated federal law by filling forged prescriptions for addictive painkillers and other controlled substances...Attorney Carmen Ortiz announced the settlement...CVS says it entered into the agreement to avoid the expense and uncertainty of further legal proceedings...settlement resolves two investigations by the Drug Enforcement Administration after reports of forged oxycodone prescriptions. One involved hundreds of forged prescriptions at 40 CVS stores in Massachusetts and New Hampshire. The other involved 120 forged prescriptions at 10 CVS stores in and around Boston.

...two Chinese companies　with ties to Western drugmakers have been called on the mat to account for problems in their manufacturing. The FDA has issued warning letters to plants operated by Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical, slamming them both for manipulating testing and turning in falsified batch test results on APIs...

• Shanghai Desano Chemical Pharmaceutical - FDA...criticized the facility for conducting "unofficial" tests of drug batches that it kept out of its official record...also disturbed by finding many electronic logs of production deviations in a folder titled "GMP Anomalies" that had never been investigated…
• Chongqing Lummy Pharmaceutical...FDA...warning letter slams the drugmaker for widespread and serious data manipulation of batch analyses...In one egregious case, the FDA...an analyst set the gas chromatography personal computer clock back to make it appear as if testing had been done...7 months earlier. The analyst then performed 5 injections to produce falsified results for long-term stability for a finished API lot, deleted four and reported only the results of the final injection as passing in the quality-control...

Prescription drug addiction, the downward spiral of lives ruined, loved ones lost, and the cost to society were the focus of a daylong meeting convened...by Gov. Brian Sandoval, who called the problem a crisis...Without question this is one of the most important health challenges we currently face...calling prescription drug abuse "one of the deadliest epidemics" in the United States...Statistics are sobering. While overdose deaths related to opiates in Nevada have declined from 517 in 2010 to 382 last year, at least one Nevadan dies every day from an opiate overdose...From 2010 to 2014, hospital inpatient admissions related to opioids jumped to 3,783 from 2,993...Sandoval said he wants the panel to focus on duties and responsibilities of health care licensing boards; coordination among law enforcement; substance abuse treatment; and sale and availability of pharmaceuticals..."We seek answers, not excuses,"...

Two compounding pharmacists from Alabama will spend a year in prison for distributing tainted drugs... The adulterated drugs were compounded at Advanced Specialty Pharmacy, which did business as Meds IV... David Allen...and William Timothy Rogers...pleaded guilty...to 2 misdemeanor violations of the Federal Food, Drug and Cosmetic Act...the 2...were sentenced to 12 months and 10 months in prison, respectively...also...1 year of supervised release after they get out of prison, and they’ll each have to pay a $5000 fine...Meds IV compounded...its own amino acid solution, then mixed it with other ingredients to create TPN (Total Parenteral Nutrition)...The amino acid solution happened to be contaminated with Serratia marcescens, and the TPN was prepared, packed, or held in insanitary conditions...the amino acid was prepared by Meds IV outside a laminar airflow workbench and was kept unrefrigerated, in a room that was not sterile, in a large pot sitting on the floor, sometimes overnight, before it was sterilized and used...Nine patients developed bloodstream infections and died, while others developed S. marcescens bloodstream infections but survived.

Drug Enforcement Administration released the 2016 National Heroin Threat Assessment Summary – Updated...The report outlines the expanding public health crisis afflicting America due to the use and abuse of heroin and other opioid drugs. Some key facts:

• The number of people reporting current heroin use nearly tripled between 2007 (161,000) and 2014 (435,000).
• Deaths due to synthetic opioids, such as fentanyl and its analogues, increased 79 percent from 2013 to 2014.
• Deaths involving heroin more than tripled between 2010 (3,036) and 2014 (10,574) – a rate faster than other illicit drugs.

A former Food and Drug Administration official was accused of insider trading...by the Securities and Exchange Commission, which said he was paid hundreds of thousands of dollars for his efforts...The charges came...after Gordon Johnston...pleaded guilty to securities fraud and three other crimes as part of a scheme to provide information to a high-profile hedge fund about upcoming agency approvals of generic drugs...Between 2005 and 2011, Johnston...provided information about generic drug applications to Visium Asset Management by tapping FDA contacts...Insider trading appears to be a growing problem in the pharmaceutical industry as several cases have emerged. The issue has raised concerns in connection with clinical trial work, as well as deal-making and the FDA approval process, which some fear can be distorted by such activities...