The Daily Scan

September 6, 2018

Last Updated: 8:55 AM EST

Litigation

  • A federal judge blocked Texas laws requiring the burial or cremation of aborted fetal tissue, saying in a decision on Wednesday the measures placed substantial and unconstitutional obstacles in the path of a woman’s right to choose an abortion. U.S. District Judge David Ezra in Austin, Texas, issued a permanent injunction preventing the measures from going into effect.“The evidence in this case overwhelmingly demonstrated that if the challenged laws were to go into effect now, they would likely cause a near catastrophic failure of the healthcare system designed to serve women of childbearing age within the State of Texas,” Ezra wrote in a decision posted in online records. (Reuters.com)

 

  • Kristie Ann Mollohan, formerly of Kalamazoo, MI, pled guilty before the Hon. Phillip J. Green, U.S. Magistrate Judge, to two counts of tampering with a consumer product. This federal offense prohibits tampering with a drug or other consumer product with reckless disregard for the risk of death or bodily injury and under circumstances manifesting extreme indifference to the risk of injury or death. Mollohan faces a maximum sentence of 10 years of imprisonment on each count, and she will be required to serve a term of supervised release after any prison term has been completed. Mollohan admitted at the plea hearing that, while working as home health nurse in two homes in Allegan and Barry Counties in August 2016, she removed liquid diazepam (valium) from the medication bottles prescribed to three different patients. All three patients were totally incapacitated at the time from serious brain impairment and required twenty-four hour care. Mollohan admitted that she replaced the diazepam with water or saline solution, resulting in the patients’ diazepam containing less than 10% of the declared diazepam concentration in one case, less than 6% of the declared diazepam concentration in the second case, and less than 1% of the declared diazepam concentration in the third case. Mollohan acknowledged that she knew that she put the patients at risk of serious bodily injury or death given that the diazepam was prescribed, in part, to suppress life-threatening seizures. (Justice.gov)

 

  • A prescribing physician with SKS Associates, an opioid treatment facility located in Johnstown, PA, guilty in federal court to charges of dispense and distribution of controlled substances, conspiracy to distribute controlled substances and health care fraud, United States Attorney Scott W. Brady announced today. Dr. Michael Cash of Indiana, PA pleaded guilty to three counts before United States District Judge Cathy Bissoon. In connection with the guilty plea, the court was advised that Cash conspired to create and submit unlawful prescriptions for buprenorphine, and then unlawfully dispensed those controlled substances to other persons. Cash also committed health care fraud by submitting fraudulent claims to Medicare, for payments to cover the costs of the unlawfully prescribed buprenorphine. (Justice.gov)

Regulation

  • The U.S. Government Accountability Office released a new report yesterday on the Medicaid program titled: "CMS Needs to Better Target Risks to Improve Oversight of Expenditures." GAO was asked to examine CMS’s oversight of state-reported Medicaid expenditures. In this report, GAO examined how CMS assures that (1) expenditures are supported and consistent with requirements; and (2) the correct federal matching rates were applied to expenditures subject to a higher match. GAO also examined the financial impact of resolved errors. GAO reviewed documentation for the most recently completed quarterly reviews by 3 of CMS’s 10 regional offices for six states that varied by Medicaid program expenditures and design. GAO also reviewed policies, procedures, and data on resolved errors; and interviewed CMS and state officials. GAO assessed CMS’s oversight processes against federal standards for internal control. (GAO.gov)

 

  • FDA Commissioner Scott Gottlieb, M.D. released a statement yesterday on the U.S. Food and Drug Administration’s efforts to establish framework to help assure that drug products all meet the same high-quality standards. The steps taken by the FDA include, but are not limited to, updated internal policy, mutual recognition agreement, modernized structure of their field organization, product quality and guidance documents. Gottlieb commented: “We’ll continue to take new steps to address the challenges posed by a globalized drug supply chain. These actions are key parts of our commitment to ensure high-quality manufacturing, and to make sure Americans have confidence in the quality of products sold in the U.S. regardless of where a drug is manufactured.” (FDA.gov)

 

 

 

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