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 | GCR July-August Full PDF Issue |
| FDA cracking down on DTC genetic tests
Legal issues in laboratory outreach
Lab groups seek exemption from PHI requirement
Direct compliance reporting to board more likely in health care: see Perspectives
Cincinnati Health Alliance agrees to $108 million FCA settlement
Providers can expect more Stark law litigation from DOJ, attorney says
Regence BlueCross investigating billing fraud
News in brief Full Article |
 | Legal Issues in Laboratory Outreach |
| Though outreach laboratories function as part of a hospital or health system and thus are distinct in many ways from independent laboratories, in terms of compliance and fraud and abuse, the issues are much the same regardless of setting. Full Article |
 | FDA Cracking Down on DTC Genetic Tests |
| In a sign that it is cracking down on companies that sell genetic tests directly to consumers, the Food and Drug Administration (FDA) in early June issued formal letters to five companies informing them that their tests are medical devices and may require premarket approval. Full Article |
 | Lab Group Seeks Exemption From PHI Requirement |
| New accounting of disclosure requirements for personal health information (PHI) should not apply to clinical laboratories, says the American Clinical Laboratory Association (ACLA), which argues that a laboratory information system (LIS) does not constitute an electronic health record (EHR). Full Article |
 | Direct Compliance Reporting to Board More Likely in Health Care Industry, Survey Finds More Progress Still to Be Made |
| More than half of all health care industry chief ethics and compliance officers (CECOs), or 58 percent, reported having a direct reporting relationship with their board of directors, a higher rate than that of all other industries, according to report by the Society of Corporate Compliance and Ethics and the Health Care Compliance Association (HCCA). Full Article |
 | Providers Can Expect More Stark Law Litigation Cases From DOJ, Attorney Says |
| No Stark law cases are too small or too large for the attention of the Department of Justice (DOJ), and providers can expect an aggressive DOJ litigation policy designed to seek massive damages, T. Reed Stephens, an attorney with the Washington office of McDermott Will & Emery, said June 8. Full Article |
 | Regence BlueCross Investigating Billing Fraud |
| Regence BlueCross BlueShield is investigating medical billing fraud involving a multilevel vitamin marketing operation in several western states, according to a Regence anti-fraud specialist. Full Article |
 | The Back Page: OIG Clears Patient Assistance Program: |
| A recent advisory opinion from the Department of Health and Human Services Office of Inspector General (OIG) said there was no violation of the anti-kickback statute regarding a donor-funded patient assistance program (PAP) that provided financial assistance to the underinsured for their prescription drug copayments. Full Article |
 | The Back Page: HHS, DOJ Call for State Fraud Education: |
| Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius June 8 called on all state attorneys general to create outreach programs this summer to educate seniors on Medicare fraud prevention and protection. Full Article |