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Compliance Update
Consultant & Lawyer Fatigue No More! Print E-mail
Written by Jeff Cohen | Florida Healthcare Law Firm   
Sunday, 11 June 2017 00:00

Healthcare regulatory compliance is often performed by consultants who are not lawyers. This can create tension between the professionals, since they may see the same issue differently. Moreover, since healthcare consultants often deliver their services directly to clients (not through healthcare legal counsel), the process loses the protection of the attorney client privilege.

Clients might not appreciate the need for both consultant and legal services, especially given the expense. And many times lawyers will likely tell their clients they lack the expertise to weigh in on the consultant's service, which can leave all parties feeling like they are working without a net. Additionally, many consultants are rare enough to have to be brought in from out of state. Which may lead to them providing terrific federal compliance guidance and missing issues of state law based regulatory compliance altogether. Moreover, given the web of healthcare regulatory compliance requirements, it's easy for a client to think their coding consultant is all they need.

It's just unrealistic to expect a healthcare professional or healthcare business to even know all the questions to ask. The fact is there are key differences between legal and regulatory compliance and legal and regulatory consultants. They bring difference experiences and unique perspectives to the table. And misunderstanding the gap between the different regulatory landscapes they cover can create serious gaps in compliance and liability for healthcare providers and healthcare businesses.

The best possible product for a healthcare client will involve BOTH expert consulting in a specific area and also expert healthcare legal counsel review and input. Given the risks associated with missing issues like HIPAA, self-referral, kickback, brokering and current "environmental factors," clients can't afford to oversimplify their legal and regulatory compliance  processes. Without the combination, the consulting process is vulnerable to scrutiny and risky gaps.

Someone once said something like "To a carpenter, everything is a nail." We all tend to view challenges and solutions in our work world through a perspective of specific (and limited) experience. It's therefore essential to healthcare professionals and businesses that they have around their table people who collectively bring the broadest applicable perspective and experience to ask the right questions, the ones clients may not even know to ask. A HIPAA expert, for instance, will dig deep into the patient privacy issue, but may not think to ask about exposure the client may have to payers. A coding expert would likely not think to inquire about or identify exposure on issues related to self-referral, or safe harbor compliance.

The best possible legal and regulatory compliance product for a healthcare client is one that blends expert consulting services with expert healthcare legal compliance.

With over 30 years of healthcare law experience, Mr. Cohen is board certified by The Florida Bar as a specialist in healthcare law.  With a strong background and expertise in healthcare law corporate matters, particularly as they relate to healthcare professionals and businesses, Mr. Cohen’s practice immerses him and the lawyers of the firm in regulatory, contract, corporate and compliance.  As Founder of The Florida Healthcare Law Firm, he has distinguished himself and his firm for providing exceptional legal services with the right pricing, responsiveness and ethics. He can be reached at

Last Updated on Monday, 12 June 2017 18:34
A Hospital's Deserving Stark and AKS Victory-But At What Cost? Print E-mail
Written by   
Monday, 05 June 2017 00:00

This April, providers cheered when a federal district court in the Middle District of Florida found insufficient evidence to support a relator's theory that a hospital had provided free parking to physicians, in violation of the Stark Law and Anti-Kickback Statute (AKS). In the Report and Recommendation for United States ex rel. Bingham v. BayCare Health Systems, 2017 WL 126597, M.D. Fla., No. 8:14-cv-73, Judge Steven D. Merryday of the Middle District of Florida endorsed magistrate judge Julie Sneed's recommendation that Plaintiff Thomas Bingham's Motion for Partial Summary Judgment be denied and that Defendant BayCare Health System's Motion for Summary Judgment be granted.

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Why you need a HIPAA-compliant business associate agreement Print E-mail
Written by Vitale Health Law   
Monday, 01 May 2017 00:00

The recent announcement by The Department of Health and Human Services' Office for Civil Rights (OCR) that it agreed to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) with The Center for Children's Digestive Health (CCDH) should serve as a lesson to other healthcare organizations about the need to obtain signed, HIPAA-compliant business associate agreements with all vendors before disclosing any protected health information.

Last month, CCDH, a seven-center pediatric subspecialty practice based in Park Ridge, Illinois, agreed to pay OCR $31,000 to resolve potential HIPAA violations. CCDH also agreed to adopt a corrective action plan which includes updating policies and procedures, conducting staff training on said policies and procedures and ensuring one or more employees are made responsible for ensuring HIPAA-compliant business associate agreements obtained from all business associates.

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New OIG Rules Change Patient Incentive Program Landscape: Where Are the Limits Now? Print E-mail
Written by   
Thursday, 13 April 2017 00:00
With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are increasingly being tied to quality outcomes, a provider's ability to engage and improve patients' access to care may both improve patient outcomes and increase providers' payments. In December 2016, the Office of Inspector General of the US Department of Health and Human Services (OIG) issued a final regulation implementing new "safe harbors" for certain patient incentive arrangements and programs, and released its first Advisory Opinion (AO) under the new regulation in March 2017. Together, the new regulation and AO provide guardrails for how patient engagement and access incentives can be structured to avoid penalties under the federal civil monetary penalty statute (CMP) and the anti-kickback statute (AKS). 

Last Updated on Friday, 14 April 2017 17:28
OIG Opinion Applies Access to Care Exception Print E-mail
Written by Vitale Health Law   
Monday, 27 March 2017 00:00

Can a hospital system provide free or reduced-cost lodging and meals to certain financially needy patients, or would such an arrangement (a) constitute either a violation of the federal anti-kickback statute or (b) constitute grounds for the imposition of civil monetary penalties because it would violate a provision of the Social Security Act that prohibits remuneration to a federal healthcare program beneficiary that might influence the beneficiary's selection of a particular provider?

That was the question recently answered in an Advisory Opinion issued by the U.S. Department of Health and Human Services Office of the Inspector General (OIG).

The requestor, whose name is redacted, owns and operates an academic medical center consisting of four hospitals and a number of hospital-based clinics. One of those hospitals operates a Level I trauma center and provides care to patients, some of whom live in rural and medically underserved areas. 

Last Updated on Tuesday, 28 March 2017 14:39
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