The Daily Scan

September 25, 2018

Last Updated: 1:00 PM EST

Regulation

  • The Department of Health and Human Services (HHS) issued that following statement yesterday regarding a contract between Advanced Bioscience Resources, Inc. and the Food and Drug Administration to provide human fetal tissue to develop testing protocols: "HHS was not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements. As a result, that contract has been terminated, and HHS is now conducting an audit of all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations. In addition, HHS has initiated a comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved. Finally, HHS is continuing to review whether adequate alternatives exist to the use of human fetal tissue in HHS funded research and will ensure that efforts to develop such alternatives are funded and accelerated.” (HHS.gov)

 

  • Yesterday HHS announced three new grants to combat opioid addiction and improve access to mental health services for youth and young adults in Native American communities. HHS Deputy Secretary Eric D. Hargan commented: “Building on the strengths of tribal culture and customs, these grants to Fairbanks Native Association and Tanana Chiefs Conference, Inc., will reduce unmet treatment need and opioid related deaths in the Greater Fairbanks community. In addition, Tanana Chiefs Conference, Inc., was also awarded a grant to improve access to treatment and support services for youth and young adults living with serious mental disorders.” These grants awarded to Fairbanks Native Association and Tanana Chiefs Conference, Inc. are expected to total over $6.2 million over the next few years. These grants were announced in addition to the more than $1 billion announced last week for opioid specific grants for all states to address the crisis affecting the entire country. (HHS.gov)

Litigation

  • The owner of four pharmacies in Queens, New York, was arraigned yesterday in federal court in Brooklyn on an indictment charging her with submitting millions of dollars in claims as part of a scheme to defraud Medicare and Medicaid. As alleged in the indictment, Aleah Mohammed was the owner and operator of Superdrugs Inc., Superdrugs I Inc., Superdrugs II Inc. and S&A Superdrugs II Inc. Beginning in approximately May 2015 and continuing through June 2018, Mohammed executed a scheme in which she and others submitted fraudulent claims to Medicare Part D plans and Medicaid for reimbursement for prescription drugs that were not dispensed, prescribed as claimed, or medically necessary. The allegedly fraudulent claims included claims for prescription drugs for the treatment of the human immunodeficiency virus (HIV). From approximately May 2015 through January 2018, Mohammed’s pharmacies received approximately $7.9 million in reimbursements from Medicare and Medicaid.  The indictment further alleges that Mohammed used the proceeds of the scheme, among other things, to purchase luxury items such as a Porsche and jewelry. (Justice.gov)

 

  • The United States has entered into an agreement to settle civil fraud claims with Dr. Mark Fleckner, a Board Certified Ophthalmologist who maintains a practice in Garden City, New York. The agreement resolves allegations that, in contravention of Medicare regulations and in violation of the federal False Claims Act, Dr. Fleckner administered certain pharmaceutical products that he had purchased overseas, which the U.S. Food and Drug Administration had not evaluated nor approved for use in the United States. These products included aflibercept (“Eylea”) and ranibizumab (“Lucentis”), which Dr. Fleckner used to treat patients who had wet, age-related macular degeneration or other diseases and conditions of the eye.  The United States contends that the Unapproved Drugs were not eligible for reimbursement by Medicare. Under the terms of the civil settlement agreement, Dr. Fleckner will pay a total of $6,955,240.80. (Justice.gov)

Medicaid

  • The Trump Administration announced on Friday that it will review the state of Alabama's request to impose Medicaid work requirements. In a letter to Stephanie McGee Azar, Commissioner of the Alabama Medicaid Agency, Andrea Casart, Director of the CMS Division of Medicaid Expansion Demonstrations, wrote: "We have completed a preliminary review of your request in accordance with the requirements of 42 CFR 431.412(a) and have determined that the state’s application meets these requirements for a complete application. Alabama’s application will be posted on Medicaid.gov for a 30-day federal comment period as required by 42 CFR 431.416(b). We look forward to working with you and your staff on the proposed demonstration project." (Medicaid.gov)

Private Sector

  • Ochsner Health System announced a new partnership yesterday with the State of Louisiana and LSU Health Shreveport. In this first public private partnership agreement, they announced facility investment, investments in technology advancements, investments in people and programs to improve quality, expansion to improve access to care, advancement in digital and telehealth, and increased focus on the health and well being of the community. Louisiana Governor John Bel Edwards commented: “I’m excited about this opportunity for the people of North Louisiana and for our state. Our commitment has been to finding the right solutions that enable us to take care of more Louisianans, while preserving medical education in Northwest Louisiana. We are able to do that without additional financial burden on the state or our citizens. It takes innovative thinking and I believe this partnership will enable Ochsner and LSU to bring that same expertise to strengthening and growing the medical school, improving facilities, and ultimately delivering better health care to everyone in this region.” (Ochsner.org)

 

 

 

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