The laboratory market has become quite competitive in recent years, raising compliance concerns and investigations into lab relationships with referring physicians. Accordingly, on June 25, 2014, the OIG released a Special Fraud Alert (the “Fraud Alert”) which provides guidance about two different types of suspect arrangements: (1) Blood-Specimen Collection; and (2) Registry Payments. The concerns raised here by the OIG involve referring physicians receiving payments from laboratories who may not even be aware that these arrangements are violating the Anti-Kickback Statute due to their complicated nature.
The OIG explained that it is concerned about arrangements in which a lab pays a physician more than fair market value (“FMV”) for the physician’s services or for services the lab does not actually need or for which the physician is compensated. The four major concerns typically associated with kickbacks involving labs include: (1) corruption of medical judgment; (2) overutilization; (3) increased costs to the Federal health care programs and beneficiaries; and (4) unfair competition. These concerns arise because arrangements with labs could induce physicians to order tests from a lab that provides them with payment, rather than utilizing laboratories that provide the best, most clinically appropriate service. Indeed, the choice of which laboratory to use and whether to even order lab tests are decided by or at least strongly influenced by the physician. Continue reading
Posted in Anti-Kickback, Clinical Laboratory, Fraud and Abuse, Health & Human Services, Health Care, Health Care Providers, Medicare, OIG, Out-Patient Care, Payers, Physicians, Special Fraud Alert
The Department of Justice (“DOJ”) announced another multi-million dollar settlement of alleged False Claims Act violations on March 11, 2014. Specifically, Halifax Hospital Medical Center and Halifax Staffing, Inc. agreed to settle various issues with the DOJ for $85 million in order to resolve allegations that they violated the False Claims Act (“FCA”) by submitting claims to Medicare that violated the federal prohibition on physician self-referrals, 42 USC §1395nn (the “Stark Law”). United States ex rel. Baklid-Kunz v. Halifax Hospital Medical Center, et al., No. 09-cv-1002 (M.D. Fla.).
The Stark Law and the Bona Fide Employment Exception
The Stark Law prohibits a physician from referring a patient for certain designated health services (“DHS”) to an entity in which the physician, or an immediate family member, has a financial interest, such as an ownership or investment interest in the entity or a compensation arrangement with the entity. Certain exceptions for arrangements are permitted under Stark. However, because the Stark Law is a strict liability statute, the arrangement must fit completely within the criteria of the exception in order not to violate the statute. At issue in Halifax, as explained below, is the bona fide employment exception, Continue reading
Posted in Acute Care, Civil Litigation, Corporate Integrity Agreements, DHHS, Florida, Fraud and Abuse, Health Care, Health Care Providers, Hospital, Medicare, OIG, Physicians, Regulatory Compliance, Reimbursement, Self-Referral, Settlements
Tagged Neurosurgery, Oncology, Stark Law
The OIG has released a Supplemental Special Advisory Bulletin that “reiterates and amplifies” previous OIG Special Advisory Bulletin guidance from 2005. Pharmaceutical manufacturers and Patient Assistance Programs that provide independent, charitable support for patients’ drug expenses (PAPs) should be aware of this supplemental guidance, as the OIG notes that it may modify some previously-issued favorable advisory opinions. Specifically, in this bulletin the OIG expands on its previous guidance regarding disease funds, eligible recipients, and the conduct of donors.
PAPs provide cost-sharing assistance for patients who cannot afford their prescription medications. Continue reading
On May 12th, the Office of the Inspector General of the Department of Health and Human Services (OIG) issued a proposed rule which would amend the federal civil monetary penalty (CMP) regulations addressing new CMP authorities created under the Affordable Care Act. The revised regulations would allow for civil penalties, assessments, and exclusion from Medicare for :
- Failure to grant OIG timely access to records;
- ordering or prescribing while excluded;
- making false statements, omissions, or misrepresentations in an enrollment application;
- failure to report and return an overpayment; and
- making or using a false record or statement that is material to a false or fraudulent claim.
Comments on the proposed regulations can be submitted up until July 11, 2014. The proposed rule and instructions for submitting comments can be viewed here—> Proposed CMP Regulatory Revisions
For more information on the revisions to the CMP regulations, Fraud and Abuse, Compliance, Medicare Program Integrity initiatives or related issues, please feel free to contact Ari Markenson or any member of our health care practice group for a further discussion.
Posted in Civil Monetary Penalty, Compliance Programs, Fraud and Abuse, Health Care, Health Care Providers, Medicaid, Medicare, OIG, Program Integrity, Proposed Rule, Regulation, Regulatory Compliance