HHS ups prevention efforts as Zika confirmed in Florida

As Zika finds its way into the mainland U.S., with the infection having been found in Miami, Florida, HHS is working toward reducing the time needed to diagnose patients with recent Zika infections. With a $5.1 million award to InBios International, Inc,, HHS is supporting the development of a serological test, which detects a Zika virus-specific Immonoglobulin M (IgM), antibodies produced by the body’s immune response to the virus.

Faster Zika testing under development

Currently, the only serological test available was developed by the Centers for Disease Control and Prevention (CDC) and is being used under emergency use authorization issued by the FDA. The test requires two to three days before results are available. Providing a faster, easier, and commercially available test to clinical laboratories would increase Zika testing capacity significantly. The funding occurs under a two-year contract with the Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA). The funding supports refinement of the test’s design, manufacturing preparations, and clinical studies. The agreement can be extended to fund additional work on the test through 2021 and for total funding of approximately $9.5 million.

The FDA is working closely with companies that are making blood screening tests available under an Investigational New Drug application (IND) to ensure that they are prepared to expand testing as needed. Blood collection establishments in the U.S. may choose now or in the future to participate in testing under IND, even if mosquito-borne Zika transmission has not been confirmed locally.

Zika confirmed in Florida

Florida public health officials have found persistent mosquito populations and additional Zika infections in a Miami neighborhood where several Zika infections were previously confirmed. Information suggests a continued risk of active transmission of Zika virus in the area. Florida health officials and the CDC are issuing travel advisories, testing, and other recommendations for those who traveled to or lived in the designated areas of Florida on or after June 15, 2016, the earliest known date of a confirmed Zika infection in Florida. Among other recommendations, the CDC advises that pregnant women not travel to the identified area and that pregnant women and their partners living in the area should consistently follow steps to prevent mosquito bites and sexual transmission of Zika. Male and female sexual partners of pregnant women who live in or who have traveled to the area should consistently and correctly use a barrier method during sex or abstain from sex for the duration of the pregnancy.

To protect from mosquito bites, individuals including pregnant women and women planning to become pregnant should apply insect repellant containing DEET to uncovered skin, wear long-sleeved shirts and long pants, use or repair screens on windows and doors, use air conditioning when available, and remove standing water where mosquitoes lay eggs.

Kusserow on Compliance: DOJ announces record-breaking $1B Medicare fraud case

The Department of Justice (DOJ) in Miami reported what it called the largest single criminal health care fraud case ever brought against individuals. It involved a $1 billion scheme involving numerous Miami-based health care providers. The DOJ brought charges against the owner of more than 30 Miami-area skilled-nursing and assisted-living facilities, a hospital administrator, and a physician’s assistant. The charges included conspiracy, obstruction, money-laundering and health care fraud. Philip Esformes was named as having been at the top of a complex fraud scheme, along with Odette Barcha, and Arnaldo Carmouze. Using Esformes’ network of Miami-Dade skilled-nursing and assisted-living facilities, the scheme involved filing false Medicare claims over the last 14 years for services that were not necessary or in some instances not provided.

The DOJ reported that the network of skilled nursing homes and assisted living facilities provided access to thousands of Medicare and Medicaid beneficiaries. Many of these individuals did not qualify for skilled nursing home care or for placement in an assisted living facility, but were admitted anyway where they received medically unnecessary services that were billed to Medicare and Medicaid. Charges include allegations that they received kickbacks in order to steer these beneficiaries to other health care providers, who also performed medically unnecessary treatments that were billed to Medicare and Medicaid.

Ten years ago, Esformes paid $15.4 million to resolve civil federal health care fraud claims for unnecessarily admitting patients from his assisted living facilities into a Miami-area hospital. The fraudsters subsequently continued to engage in their fraudulent practices, employing sophisticated money laundering techniques to hide the scheme.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2016 Strategic Management Services, LLC. Published with permission.