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Pharmacy CMO Excluded from Federal Healthcare Programs for 6 Years

The former Chief Marketing Officer (CMO) of the New Castle, DE-based pharmacy BioTek reMEDys Inc. (BioTek) has been added to the HHS-OIG exclusions list for 6 years. Carla Sparkler agreed to the 6-year exclusion from Federal healthcare programs to resolve allegations she violated the False Claims Act by paying kickbacks to patients and physicians and waiving co-pays to ensure that BioTek’s revenue stream was protected.

Certain medications covered by Medicare require beneficiaries to pay a proportion of the cost in the form of a copayment, coinsurance, or deductible (copays), which were included in the Medicare program by Congress in order to reduce healthcare costs. The Federal Anti-Kickback Statute prohibits the inducement of physicians to prescribe specific medications, payment of remuneration to physicians in exchange for patient referrals, and companies are not permitted to routinely waive the copays of Medicare patients without determination of financial need.

Sparkler was alleged to have orchestrated a scheme to provide inducements to physicians and to cover up kickbacks for patient referrals by waiving copays. From at least August 2015 to May 2020, while CMO for BioTek, Sparkler is alleged to have routinely waived copayments of Medicare and TRICARE patients without regard for whether they were experiencing financial hardship to induce them to purchase the company’s drugs and services. BioTek is an integrated infusion therapy provider focused on providing support to people with rare diseases and many of the drugs and services provided are expensive and have large copays.

Sparkler is also alleged to have provided remuneration to physicians in the form of free dinners, gifts, and free administrative and clinical support services to induce them to refer patients to BioTek. One of those physicians, Dr. David Tabby, who operated a neurology practice in Bala Cynwyd, PA, was alleged to have knowingly solicited and accepted remuneration in exchange for referring patients to BioTek. Separately, Dr. Tabby settled the allegations and agreed to pay a $480,000 penalty, and Biotek and its CEO, Chaitanya Gadde, previously settled allegations they violated the False Claims Act by paying kickbacks to patients and physicians and paid a penalty of $20 million.

HHS OIG Exclusions List
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“Kickbacks impose hidden costs on the health care system and compromise medical decision-making,” said Special Agent in Charge Maureen R. Dixon for the Department of Health and Human Services Office of the Inspector General (HHS-OIG). “Alongside our law enforcement partners, HHS-OIG is committed to safeguarding the integrity of federal health care programs by, in part, holding individuals who unlawfully bill the programs accountable for their actions.”

The case stemmed from claims made by the former BioTek employees Shantae M. Wyatt and Latoya Sparrow, who under the whistleblower protections for the False Claims Act, were permitted to file an action on behalf of the United States and receive a portion of any recovery.

Author: Steve Alder is the editor-in-chief of The HIPAA Journal. Steve is responsible for editorial policy regarding the topics covered in The HIPAA Journal. He is a specialist on healthcare industry legal and regulatory affairs, and has 10 years of experience writing about HIPAA and other related legal topics. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics. Steve shapes the editorial policy of The HIPAA Journal, ensuring its comprehensive coverage of critical topics. Steve Alder is considered an authority in the healthcare industry on HIPAA. The HIPAA Journal has evolved into the leading independent authority on HIPAA under Steve’s editorial leadership. Steve manages a team of writers and is responsible for the factual and legal accuracy of all content published on The HIPAA Journal. Steve holds a Bachelor’s of Science degree from the University of Liverpool. You can connect with Steve via LinkedIn or email via stevealder(at)hipaajournal.com

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