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Compliance Update
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Monday, 06 April 2020 00:00
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Last Updated on Monday, 06 April 2020 17:08
Surgical Device Company Charged in Whistleblower Case Involving Kickbacks Print E-mail
Written by Vitale Health Law   
Monday, 09 March 2020 00:00

The Justice Department this month intervened in two whistleblower cases involving SpineFrontier Inc., related entities and executives. It is alleged that kickbacks were paid to spine surgeons to induce them to use SpineFrontier's surgical devices, a violation of the Anti-Kickback Statute (AKS). The AKS prohibits offering, paying, soliciting, or receiving remuneration to induce referrals of items or services covered by Medicare, TRICARE, and other federally funded programs. It is intended to ensure that a physician's medical judgment is not compromised by improper financial incentives. It is alleged in the complaint that approximately surgeons were paid more than $8 million in sham consulting fees for product evaluations, which were, in reality, payments in exchange for using the devices. The surgeons, in turn, generated more than $100 million in revenue for SpineFrontier, according to the complaint.

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Last Updated on Tuesday, 10 March 2020 17:32
OIG Gives Drug Manufacturer Green Light to Cover Patient Expenses Print E-mail
Written by Vitale Health Law   
Monday, 03 February 2020 00:00

The Office of Inspector General (OIG) in a Jan. 21 Advisory Opinion (No. 20-02) approved an agreement under which a pharmaceutical manufacturer would provide travel, lodging and other expenses to financially needy patients prescribed the manufacturer's personalized medication. In doing so, the OIG noted that such an arrangement could potentially violate the Anti-Kickback Statute, (AKS) and the Beneficiary Inducements of the CMP. However, under the limited circumstances of this particular arrangement, the watchdog agency said it would not impose sanctions.
Last Updated on Tuesday, 18 February 2020 09:46
OCR Cracking Down on Providers Who Violate HIPAA's Right of Access Requirement Print E-mail
Written by Vitale Health Law   
Monday, 23 December 2019 00:00

HIPAA Privacy Rule's right of access requires healthcare providers to give patients access to their health records upon request and for a reasonable fee. However, many providers are either slow to respond, fail to respond, or when they do respond, have charged excessive amounts of money for those records. Although many providers have gotten away with ignoring their responsibility under this provision, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services is now vigorously enforcing this provision as evidenced by two recent actions the agency has taken in recent months. Earlier this month, OCR announced its second enforcement action of the year. Korunda Medical LLC, a Naples, Florida-based company that provides comprehensive primary care and interventional pain management services, agreed to take corrective action and pay $85,000 to settle potential violations of the right of access provision.

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Last Updated on Tuesday, 24 December 2019 16:07
Are Medical Marijuana Practices the New Pill Mills? Print E-mail
Written by Susan St. John   
Tuesday, 10 December 2019 18:14

With the legalization of medical marijuana, I could not help but think, could a medical marijuana practice be the next "pill mill" and how could that be possible with the strict requirements set forth in Section 381.986, Florida Statutes? Turns out, only a handful of physicians are prescribing the majority of medical marijuana. While this may at first blush indicate a problem, keep in mind that marijuana, even medical marijuana is still outlawed under federal law and many physicians are not willing to risk a DEA license or possibly a state license to become a physician that certifies a patient for using medical marijuana. If a physician does become a qualified physician and issues medical marijuana certifications, certain practices and behaviors should be avoided.

Last Updated on Tuesday, 10 December 2019 18:34
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