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The Federal Opioid Fraud and Abuse Detection Unit: An Enforcement Initiative Lacking in Resources for Prevention and Treatment of Opioid Abuse

by admin on August 17, 2017 No comments

By: Jacqueline Bain

Earlier this month, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit, which is a pilot program of the United Stated Department of Justice. AG Sessions noted that there are three components to approach the opioid crisis that our nation faces: prevention, treatment and enforcement.

  1. Prevention. AG Sessions noted briefly that the DOJ is undertaking that component through raising awareness, through drug take-back programs, and through DEA’s 360 Strategy program, which incorporates law enforcement, diversion control and community outreach to tackle the cycle of violence and addiction in US cities. He also stated that law enforcement is a component of prevention.
  2. Treatment. AG Sessions articulated that treatment can help break the cycle of addiction and crime and help people get their lives back together.
  3. Enforcement. AG Sessions dove deep in the area of enforcement, reasoning that enforcing our laws helps keep drugs out of the hands of our citizens, decreases their availability, drives up their price, and reduces their purity and addictiveness. He added, “Enforcement will make a difference in turning the tide in this epidemic.”
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Medical Marijuana Law: Medical Use in Florida Part II

by admin on August 17, 2017 No comments

florida law marijuanaBy: Susan St. John

The Board of Medicine and Board of Osteopathic Medicine Joint Committee on Medical Marijuana (the “Committee”) have started the journey to developing rules pursuant to the Medical Marijuana Use Act, Senate Bill 8A, Chapter 2017-232, Laws of Florida, Section 381.986, Florida Statutes). The Committee’s first conference was held July 14, 2017, with a follow-up conference being held August 3rd. A third conference is scheduled for August 25th during the Board of Osteopathic Medicine’s monthly meeting.

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Clinical Research & Healthcare Regulatory Compliance

by admin on August 17, 2017 No comments

clinical research organizationBy: Jeff Cohen

Doctors often consider the idea of clinical research to be an easy “add on” to their practices.  The usual idea is “I already have the patients.  This’ll be easy.”  But that’s not the case when you start to look at the healthcare regulatory compliance issues!

Pharmaceutical companies (“Sponsors”) are often looking for resources for clinical research.  They usually turn to clinical research organizations (CROs) to find research centers (Sites) and to manage some of the healthcare regulatory compliance issues in a way that creates enough distance between the Sponsor and the Site in hopes that the metrics from the patients enrolled in the study will provide clarity re the efficacy of a tested drug.

Medical practices that think it’ll be easy to become a Site will be very surprised by some of the key challenges, which include–

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Starting Healthcare Business: What to Consider

by admin on August 1, 2017 No comments

By: Jeff Cohen

As a healthcare business lawyer, I’ve seen nearly everything entrepreneurs think might be a good idea.  They usually come to me when starting a healthcare business with questions like:

  1. Do you like an LLC better than an Inc., and if so why;
  2. Does the Stark Law (or the Anti-Kickback Statute) allow us to do this?;
  3. Is it ok to allocate ownership and profit distribution differently?;
  4. Will insurers pay for this?; and
  5. WWMT?  (What Would Medicare Think?).

These are great questions.  And they’re off base.  In fact, they’re not only off base. They’re also out of order.  Here’s one for you–

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Medical Marijuana Law: Medical Use in Florida Part I

by admin on July 12, 2017 No comments

medical marijuana law FloridaBy: Susan St. John

As you have probably heard, Governor Scott signed Senate Bills 6A and 8A on June 23, 2017. What this means for practitioners is an increased opportunity to help patients that might derive benefit from treatment with medical marijuana. However, with increased opportunity comes increased scrutiny. Although these laws open up treatment options, practitioners need to ensure they strictly abide by the statutes and rules to be implemented by the Department of Health (“Department”). The Department has already published notice of the first conference call on Senate Bill 8A and emergency rule making authority, with the first conference call scheduled for Friday, July 14, 2017. Practitioners should also keep in mind that marijuana is still a schedule 1 controlled substance under federal law, thus, insurance companies are not covering treatment with medical marijuana.

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Florida Health Law: Physicians Required to Have Open Houses Now?

by admin on July 6, 2017 No comments

A new Florida health law passed by the Florida Legislature requires healthcare facilities and physician offices to allow patients to bring a person to their appointment. Florida law CS/HB 1253 changes the existing Patient Bill of Rights to give to each patient the right to bring to the “patient accessible areas” of a doctor’s office any person the patient chooses.  There is an exception for the new provision, which applies if bringing the person would “risk the health of the patient, other patients, or staff” of the office IF that can’t be reasonably accommodated.  Oh boy!  The provision is reminiscent of the access (and confusion) created by the ADA‘s applicability to physician offices for hearing and visually impaired patients.

Physicians will need to implement new policies to deal with the expansion of patients’ rights, since failing to comply can form the basis for a lawsuit.

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Impaired Practitioner Program: Greater Treatment Access for Impaired Physicians

by admin on July 5, 2017 No comments

impaired practitioner programBy: Jeff Cohen

A new law passed by the Florida Legislature shaves off some of the sharp edges of Florida law that applies to physicians who are impaired by substance abuse or mental illness.  The hub of treatment referenced in the law is the Impaired Practitioner Program (IPP).  Over the years, the IPP (a quasi-governmental entity) has come under fire for being too aggressive in how it deals with impaired physicians, by acting more like law enforcement than a healthcare provider.  Allegations in the past include physicians feeling “hauled off” to treatment before the demonstrated need was clear and being directed to providers that were expensive or inconvenient with reasonable alternatives exist.

The new law rounds out the IPP operations in creating additional accountability through the appointment by the Department of Health (DOH) of one or more consultants.  It also:

  1. allows certain providers to report an impaired practitioner to a consultant instead of the DOH.  Some in the program felt they were being leveraged into cooperating when they felt it was counter-indicated.  This measure might help balance the issues by interposing an independent consultant that is not under the IPP;
  2. prevents the consultant from reporting to DOH a practitioner who is self referring for treatment, but keeps intact features of accountability to help ensure the practitioner completes treatment;
  3. requires the consultant to copy the patient and any legal representative on any information release; and
  4. protects the consultant by extending sovereign immunity to him/her.

Healthcare professionals interacting with the IPP need to know their rights and options.  The new law helps facilitate that.

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Addiction Treatment Law Changes Management Relationships

by admin on July 3, 2017 No comments

healthcare regulatory complianceBy: Jeff Cohen

Passage of the new and comprehensive Florida addiction treatment industry legislation (CS/CS/HB 807) will send addiction treatment facility management relationships back to the drawing board.  Prior to the new law, some DCF licensed facilities were managed by management companies, some of which were owned by people who either did not qualify to be on the DCF license or who did not want to be visible on the license.

The new addiction treatment law requires all such arrangements to be reconsidered.  Here’s why:  There are several sections in the new law where management is the subject of intensive focus.   Newly created 397.410 requires DCF to establish minimum licensure requirements for each service component limited in part to the number and qualifications of all personnel, including management.  Newly created 397.415(1)(d)1 authorizes DCF to deny, suspend or revoke licensure of any license based on a “false representation of a material fact in the licensure application or omission of any material fact from the application.”  Finally, 397.415 creates an entire category of potentially punishing fines and, in some cases, exposure to criminal prosecution.

The new law will create heavy regulatory suspicion for any non-transparent management relationship, even a third party relationship.  Worse, it’s conceivable that any suspicious or arguably noncompliant relationship could form the basis for recoupment by insurers.  When the state Health Care Clinic Law was created some years ago, payers took advantage of situations where facilities that required a license but didn’t have one.  Under a threat of insurance fraud (e.g. an unlicensed healthcare facility receiving compensation for services), some payers were able to extract huge recoupments.

Any DCF licensed facility with a third party management relationship needs to reconsider it in light of the new addiction treatment law.  Moreover, all interested parties should pay close attention to (and monitor and participate in) the new law’s rulemaking process which began at the end of June.

CLICK HERE for: SUBSTANCE ABUSE MARKETING SERVICE PROVIDER LICENSE APPLICATION

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Ugh, Healthcare Compliance.

by admin on June 20, 2017 No comments

compliance planBy: Jacqueline Bain

I had a law school professor who repeatedly referred to his class as “Doom at Noon.”  The topic was dry, the cases were boring and, if not for the professor himself, the class would have been unbearable. I think of that, all these years later, every time I have to counsel a client on a topic that makes his or her eyes glaze over, like healthcare compliance.

Compliance means that you’re operating within the bounds of law. Sure, it sounds boring, but it’s a giant undertaking for any business, and especially for one so regulated as healthcare. Over the last three decades, the Department of Health and Human Services’ Office of the Inspector General has urged the private healthcare community in to take steps to combat fraudulent conduct and prevent the submission of erroneous claims.

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Expanding the Reach of your Medical Practice through Telemedicine

by admin on June 19, 2017 No comments

“Wherever the art of Medicine is loved, there is also a love of Humanity.” ― Hippocrates

telemedicine lawBy: Shobha Lizaso

The need for healthcare services is growing at an exponential rate throughout the US and across the world while the number of healthcare providers is dwindling in comparison which paves the perfect way for telemedicine. The ease of healthcare access should be standard for all people, but many go without healthcare because of their geographic location or lack of funds. From these circumstances, technology has risen as the new champion for the provision of healthcare; technology is building necessary connections between healthcare providers and patients through telemedicine. The field of telemedicine complements traditional medical care in various ways already, and it is expected to continue to expand through the healthcare industry. Some current uses are as follows:

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