News at a Glance – Oct 2015

Millennium Settles False Claims Allegations for $256 Million. Millennium Health announced it will pay $256 million and enter into a corporate integrity agreement with the Department of Justice to resolve False Claims Act and Anti-kickback statute allegations. Payment of $227 million settles False Claims allegations of unnecessary urine drug testing through use of custom profiles and standing orders rather than individualized patient need assessment and claims that point of care testing (POCT) cups were provided to physicians in exchange for referral of urine specimens in violation of the Anti-kickback statute and Stark Law (see GCA, Sept. 2015, p. 4). Millennium will also pay $10 million to settle False Claims allegations relating to genetic testing the government claimed was routinely performed without regard to individualized need assessment. Finally, a $19.2 million settlement payment to the Centers for Medicare and Medicaid Services concerns urine drug test billing. The settlement of the claims, however, involves no determination of liability and Millennium Chief Executive Officer Brock Hardaway indicated the company “may debate some of the merits of the DOJ’s allegations” but respects the government’s enforcement role and sought to bring closure to a lengthy investigation. The organization has also revamped its board of directors with mostly new independent members and indicated intentions to pursue financial restructuring.

Proposed Changes to Research Rules Affect Biospecimens. The Office for Human Research Protections held a town hall this month to discuss proposed changes to rules governing human research. The proposed changes require a general informed consent for secondary research using a stored biospecimen (for example, the remains of a blood sample originally drawn for clinical purposes) even when the investigator isn’t given information that can identify the donor. Separate consent wouldn’t be required for each specific research use of the biospecimen. Consent would also be subject to public scrutiny and privacy safeguards would be required for research using biospecimens. The storing or maintaining of biospecimens and identifiable private information for future unspecified research, or the research itself, would be exempt from IRB review. Consent will not be waived for research involving biospecimens except in “very rare circumstances.” Public comments to the proposed rule changes are due by Dec. 7, 2015.

OIG Advisory Opinion Reacts Favorably to Free Transport for Health System Patients. A program designed to provide transportation within a healthcare system, in the absence of public transportation, won’t be subject to sanction according to Office of Inspector General Advisory Opinion 15-13. The free van shuttle service would transport patients to medical facilities within an integrated health system, including a medical center, two small community hospitals and an ambulatory surgical center. The system also includes a multispecialty clinic comprised of 1,000 physicians. Limited public transportation and private taxi services were locally available and the health system argued the “lack of affordable transportation … constitutes a barrier to health care access.” Transportation would be provided to patients of the system facilities without regard to ability to pay for health care services, health insurance status, or reference to volume of federal health care program business for the system. The OIG also found transport wasn’t advertised to the general public, would only serve the system’s facilities, didn’t bring patients from outside the system’s primary service area and wasn’t likely to “subsidize the practices of Private Physicians.” Therefore, the OIG indicated that while the arrangement could provide prohibited remuneration, there was minimal risk of fraud and abuse, so it wouldn’t impose sanctions.