Until the Medicare Part D benefit was implemented in 2006, Medicare beneficiaries had access to a limited number of prescription drugs through the Medicare Part B benefit.
With Medicare Part D, all Medicare beneficiaries have access to the Medicare drug benefit through private plans approved by CMS. The drug benefit is offered through stand-alone prescription drug plans (PDPs) and Medicare Advantage prescription drug (MA-PD) plans. Part D is a market model, transferring risk to private plan sponsors, which then act as the insurers for Part D benefits.
Through Medicare Drug Integrity Contractors, or “MEDICs,” CMS developed a strategy to investigate and recommend prosecution for Part D fraud and abuse. MEDICs’ responsibilities include, but are not limited to: fulfilling requests for information from law enforcement agencies; investigating potential Part D fraud and abuse; referring cases and making immediate advisements regarding potential Part C and Part D fraud and abuse to the Office of Inspector General (OIG); recommending appropriate administrative actions to CMS; identifying program vulnerabilities; and auditing the fraud waste and abuse programs that are part of plan sponsors’ compliance plans.
Potential Part D False Claims Act violations for whistleblower claims include: submitting claims or other false documentation for drugs not provided; submitting claims or other false documentation for brand name drugs when generics are dispensed; submitting claims or other false documentation for non-covered drugs as covered; submitting claims or other false documentation to multiple payors for the same prescription (except as required for coordination of benefit transactions); failure to apply “maximum allowable cost” pricing to drugs, submitting claims or other false documentation concerning drugs containing other false representations to CMS, including but not limited to: false physician identifiers, and brand-name drugs when generics were dispensed.
Manufacturer Part D fraud can also take the form of unlawful kickbacks, to either the dispensing provider or the Part D Plan, or the submission of false information in connection with its obligation under the Discount Program Agreement.
Kathleen Hawkins, RN MSN, had been employed by Defendant, Catholic Healthcare West (CHW) for approximately 6 years when she decided she had had enough of trying to change the hospital system from within.
CHW, a California not-for-profit corporation that operated hospitals in California, Arizona, and Nevada, was at the time the eighth largest hospital system in the nation and the largest not-for-profit hospital provider in California.
Joe Strom contacted us in 2005. We were very grateful that he did. We immediately formed an all-star legal team and a process to stop a very harmful pharmaceutical marketing strategy. It was this process we set into motion that ultimately returned hundreds of millions of dollars to the U.S. Treasury, and a portion of that, very well-deserved, into Joe’s bank account.
Joe told us a very troubling story about the off-label promotion of a pharmaceutical drug for patients who already suffered from chronic heart failure.
“I collaborated with Nolan, Auerbach and White on a broad variety of cases where whistleblowers stepped forward to disclose tactics employed by large companies to influence physicians' medical decision-making in patient care. They and their medical consultants, have consistently leveraged biomedical research and best medical evidence to advance patient safety, optimize clinical outcomes, and control precious resource utilization.”
— Fred Polsky M.D.,, Former Medical Director, CMS Zone 7 Integrity Contractor
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