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Compliance Update
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
OIG Expects to Recover $5.9B in Fraud Investigations Print E-mail
Written by Tina Reed | Fierce Healthcare   
Tuesday, 03 December 2019 19:00

The Office of Inspector General (OIG) recovered $5.9 billion from fraud investigations during fiscal year 2019, according to a semiannual report (PDF) to Congress released Monday. That's more than double from last year when the agency reported pulling in $2.9 billion; officials said they saw fewer large settlements. The agency pointed to its "first-of-its-kind investigation" of a major genetic testing fraud scheme in 2019 which ultimately resulted in a $42.6 million settlement. They also pointed to charges against 24 telemedicine and medical equipment company executives and physicians for their alleged participation in a $1.2 billion healthcare fraud scheme.

Genetic Testing Scams on OIG Radar Print E-mail
Written by Jacqueline Bain   
Tuesday, 23 July 2019 10:24

On June 3, 2019, the Department of Health and Human Services Office of the Inspector General (the “OIG”) issued a Fraud Alert titled: Genetic Testing Scam. Though the alert is short, the fact that the alert itself was issued is important. The OIG doesn’t often issue fraud alerts, so taking an affirmative step like this shows an increased likelihood of regulatory action.

Physicians, take note. If you are working with a laboratory providing genetic testing services, be sure that laboratory is (1) running those specimens on its own equipment; (2) only sending out testing equipment after receiving your order; and (3) has in place policies and procedures designed to accurately bill for the services it performs and other compliance matters.

Laboratories, take note. You are working in a risky space. Prior to entering into new relationships with consultants or marketers for new tests or specialized tests, take the time to understand where these samples originate. Ensure that your relationships with these persons are compliant. Ensure that you are entering into partnerships based in trust and compliance.

Marketers, take note. If you are working with a laboratory providing genetic testing services, invest in learning how to structure a compliant relationship. You must not (1) target Medicare beneficiaries; (2) offer anything of value in exchange for a person utilizing your laboratory; or (3) be compensated per specimen referred or a percentage of revenue earned based on your efforts.

Genetic laboratory schemes are big money. Just recently (June 27, 2019) the OIG issued a press release detailing that a federal jury in Florida found a Tampa marketer guilty for his role in an over $2.2 million Medicare fraud scheme involving the payment of kickbacks to medical clinics in exchange for the referral of DNA swabs that were obtained from Medicare beneficiaries. Sentencing will be in October.

Importantly, scams like these can apply across the laboratory space (in addition to anywhere in the healthcare spectrum). These practices are likely to be subject to sanctions and penalties even if they are not based in genetic testing. Allergy testing, toxicology testing, and blood tests are all subject to the same laws. As recently as yesterday (July 8, 2019), a laboratory owner was sentenced to 30 months in prison and must pay nearly $3.5 million in restitution for paying illegal kickback to marketers for urine and saliva specimens.

The bottom line is this: if you (a lab owner, a physician, a marketer) are approached to add any specific tests to your line of services, consult with legal counsel first. A small investment at the outset could save you your license, your finances and your freedom later on.
Jacqueline Bain is part of a highly select group of Florida licensed attorneys with both deep healthcare industry experience and a certification in healthcare compliance by the Health Care Compliance Association. To learn more about the author, click HERE.
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