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EKRA Affects Marketing Relationships with Labs and Addiction Treatment Businesses

January 15th, 2019 by

By: Jeff Cohen

For those following the federal legislative developments on the issue of compensating marketing people who market the services of labs and addiction treatment facilities there is a new update to take note of. Congress passed on October 24, 2018 the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act.”  Yes, that’s a real name!  Part of the law is the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”).

The core aspect of EKRA has to do with how to properly compensate marketing personnel who market the services of labs, addiction treatment facilities and recovery homes.   For those of you already familiar with existing federal law pertaining to compensation arrangements (e.g. the bona fide employee exception (the “BFE”) and the personal services arrangement and management contract safe harbor (the “PSA”)), the EKRA provisions will look familiar!  Key aspects of this law (which has to be read together with similar existing laws) include— read more

Second Proposed Stem Cell Bill Goes to Florida House of Representatives

January 2nd, 2019 by

stem cell billBy: Matt Fischer

On November 29, 2018, Florida Representative Chuck Clemons proposed house bill 65 (“HB 65”) that would significantly tighten regulation on the use of stem cells.  If the stem cell bill is signed into law, Florida will join other states (e.g. California, Texas and Washington) in passing some type of stem cell regulation.  While some bills around the country have centered the regulation on informing prospective customers of the risks associated with these treatments, HB 65 takes a more stringent approach with the threat of criminal exposure and includes certain protections for providers in the form of a “right-to-try” law.

Some of the highlights of HB 65 include: read more

Big Rule Changes Proposed for DCF Licensed Substance Abuse Treatment Centers

January 9th, 2018 by

substance abuse licensingBy: Jacqueline Bain

On December 29, 2017, the Department of Children and Families (DCF) submitted comments for proposed changed to rule 65D-30, governing licensed substance abuse service providers. The proposed rule includes significant changes as compared to old 65D-30, and should be reviewed as soon as possible by all DCF-licensed substance abuse service providers.  Comments must be received by DCF on or before January 19, 2018, and can be submitted via the form at the bottom of THIS LINK .The proposed changes are substantial, and we strongly recommend someone in each licensed service provider reviews them as soon as possible in order to ensure timely compliance.

This article will focus on changes in the licensing component of DCF’s rules. read more

Regenerative Medicine: Navigating New FDA Guidance for HCT/P

December 7th, 2017 by

stem cell therapyBy: Matt Fischer & Susan St. John

The U.S. Food and Drug Administration (FDA) has issued new guidance for regenerative medicine manufacturers and healthcare providers.  At the core of the guidance are two central interpretations: 1) the FDA’s current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271; and 2) the FDA’s current view on the same surgical procedure exception under 21 CFR 1271.15(b).  Additionally, the FDA issued a notice to all interested stakeholders that the FDA intends to initiate increased discretionary enforcement over the next 36 months for human cell and tissue-based products.  Given these developments, healthcare companies and providers impacted by this guidance are strongly encouraged to ensure compliance with the FDA’s new interpretations. read more

Addiction Treatment Law Changes Management Relationships

July 3rd, 2017 by

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

Medical Malpractice Update: No More Caps

June 14th, 2017 by

By: Dave Davidson

On June 8, 2017 the Florida Supreme Court, in a 4-3 opinion, ruled that the legislatively-established caps on non-economic damages (such as awards for pain and suffering) in medical malpractice cases are unconstitutional.  In 2014 the Florida Supreme Court determined the cap established for wrongful death claims was unconstitutional.  The 2017 decision now does away with the remaining caps. read more

PAs and ARNPs and Prescribing Controlled Substances

July 12th, 2016 by

ARNP controlled substancesBy: Jacqueline Bain

For many years, medical providers and regulators have wrestled with whether Advance Registered Nurse Practitioners (“ARNPs”) and Physician Assistants (“PAs”) should be able to prescribe controlled substances.  This past legislative session, several bills were signed into law allowing ARNPs and PAs to prescribe controlled substances subject to several limitations and restrictions. This article will set forth a broad overview of the bills. However, if your practice intends to use ARNPs or PAs to prescribe controlled substances, we strongly recommend that each practitioner is educated about the boundaries set forth in the new law. For instance, there are restrictions on prescribing certain controlled substances in certain circumstances, prescribing controlled substances within a pain management clinic, and prescribing controlled substances for persons under age 18. It is important that all practitioners are properly educated prior to engaging in prescribing or dispensing any controlled substances.

Advance Registered Nurse Practitioners

ARNPs may prescribe or dispense Schedule II, III or IV controlled substances if they have graduated from a program leading to a master’s or doctoral degree in a clinical nursing specialty area with training in specialized skills and have completed 3 hours of continuing education on the safe and effective prescription of controlled substances. ARNPs must limit their prescriptions of Schedule II controlled substances to a 7-day supply. However, this restriction does not apply to psychiatric ARNPs who are prescribing psychiatric medications. read more

T’was the night before the First Tuesday after the First Monday in March, and all through the House (and the Senate…)

November 6th, 2015 by

FLBy: Dave Davidson

It’s that time of year.  People are scrambling around, deciding what they want to give and what they want to get.  Brand new packages are being wrapped up and filed away.  Excitement and tension fill the air. Everyone can’t wait for the big day; but in this season that big day doesn’t happen until the first Tuesday after the first Monday in March.  But it’s never too early to start getting ready, right?  In fact, the Florida Legislature is currently in session, drafting and filing bills that the sponsors hope will be considered in March and will become law in 2016.  And as usual, health care is on a lot of legislative wish lists.  Although all of these bills are subject to significant revision, and some may never make it out of a subcommittee, here’s a sneak peek of some of the proposed health care legislation (without editorial – for now).

Scope of Practice Expansion

Three categories of health care professionals may see significant expansion of the scope of their practice.

Both Advanced Registered Nurse Practitioners and Physician Assistants would gain the right to prescribe controlled substances pursuant to Senate Bill 676.  Most of the details about specific medications and dosages is left to an administrative committee, but the bill seems to anticipate broad authority.  The bill also adds references to ARNPs and PAs throughout the Florida Statutes, indicating a willingness to accept these professionals into a significant role in the delivery of care.  Additionally, SB 572 would add PAs and ARNPs to the list of providers who can certify that an individual meets Baker Act criteria to justify a patient’s involuntarily confinement for mental health reasons. read more

Medicare Physician Fee Schedule Full of Surprises

August 19th, 2015 by

Bill Tracking SpyglassBy: Jeff Cohen

When new healthcare regs come out, we all get excited.  “What sort of nuggets will I find that could be useful?”  Sometimes the regs have useful things and sometimes, they’re just disappointing and frustrating.  The proposed changes to the 2016 Medicare Physician Fee Schedule are a mixed bag.  Allow me to illustrate:

The incident to rules may be changed to require only the ordering physician to supervise the performance of the service.  Currently, any physician in a group practice could supervise the performance of an incident to service (which allows the practice to bill for the service as though it had been performed by the ordering physician);

Qualified telemedicine services that are furnished via an interactive telecom system can be furnished by a physician or authorized practitioner for an additional list of services, including CRNAs.  This is a big change that expands the list of authorized providers;

The feds propose to characterize certain Stark Law violations as “technical,” which means they pose no financial risk to the Medicare program.  Examples include unsigned or expired agreements; read more

Florida 2015 Legislature Weighs in on Key Issues

May 26th, 2015 by

florida-legislature1The 2015 Florida legislative session was especially dynamic in terms of changes that will impact the state’s physicians and other healthcare professionals.  These changes include:

Vaccinations.  Expansion of vaccine administration by registered pharmacist interns who have completed at least 20 hours of coursework and who are directly supervised by a pharmacist (CS/HB 279);

Health care surrogates.  Clarification of the laws pertaining to healthcare surrogates, which includes expansion of their scope of authority, their authority to act on behalf of a minor, and great specificity as it relates to (a) specifying one’s primary physician in a durable power of attorney, and (b) authorizing a surrogate to act on behalf of a person who is not incapacitated (CS/CS/CSHB 889);

Experimental treatments for terminally ill patients.  Enactment of the “Right to Try Act.”  Allows for use of an “investigational drug, biological product, or device” by a terminally ill patient’s physician (confirmed by a second physician).  The licensure of physicians who follow the new is protected.  While the hold harmless issue (as between physician and patient) is not addressed, one would expect treating physicians concerned with liability to the patient to provide releases (CS/CS/HB 269);

Pharmacists right to clinical lab services.  Requires a clinical lab to make services available to consulting pharmacists and doctors of pharmacy (CS/CS/HB 655);

State HME licensure for selling/renting TENS units.  Exempting from the state HME licensure requirement M.D.s, D.O.s and chiropractors who sell or rent electrostim medical equipment or supplies to their patients (HB 1305).