Another looming major question mark for pharmacy profitability is a proposed new rule by the Department of Health and Human Services to exclude the rebates paid by drug manufacturers to PBMs, Medicare Part D plans and Medicaid organizations from safe harbor protection under the AntiKickback
Greenspan was found guilty of violating the federal antikickback
statute and related crimes.
Law to the Marketing and Promotional Practices of Drug and
Although FCA is the most prominent health care antifraud statute, there are many others, such as the antikickback
statute, the Stark Law, HIPAA, and general criminal statutes covering theft, embezzlement, obstruction of criminal investigations, false statements, mail /wire fraud, and so on.
Kass, a Washington area health law attorney who specializes in Stark and antikickback
A long-time "antikickback
law" prevented hospitals and doctors "from exchanging services, information, or products of value with each other," considering all such exchanges to be unethical.
If a Medicaid patient cannot access medications at the point of care via this type of technology because the state Medicaid system does not provide a mechanism for reimbursement (and the hospital or provider cannot provide the medication for free due to antikickback
and beneficiary inducement prohibitions), there is a real risk that the patient will not fill his prescription at all, because of transportation issues or other difficulties in getting to a local community pharmacy.
(11.) Watnik R, Antikickback
versus Stark: what's the difference?, Healthcare Financial Management, 54(3): 66-7, Mar.
* Laboratories excluded from EHR donation antikickback
statute safe harbor and Stark exceptic.
Issues of medical malpractice and federal antikickback
law have been identified (22); however, these issues are not themselves specific to digital pathology or telemedicine generally, and, with the possible exception of complicated conflict of law issues regarding medical malpractice, they can be informed by well-settled Internet and other laws, (23-25) and probably relatively easily dealt with as they arise.
She also counsels clients on health care fraud and abuse compliance issues, particularly those relating to the Antikickback
Statute, Stark Laws, and False Claims Act.