Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.
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. read more
By: Jeff Cohen, Florida Board Certified Healthcare Lawyer
Followers of the addiction treatment industry should be on high alert after the arrest of Christopher Hutson of Whole Life Recovery. The arrest marks the first arrest of any industry provider utilizing the state Patient Brokering Act (PBA). Relying solely on the allegations, the arrest is based on a business relationship between the provider and sober homes. Discussion in the “case management agreement” referred to in the arrest affidavit circles around some key allegations that include or imply (1) payment for patient referral, and (2) services by sober homes paid for by Whole Life which were not actually performed.
Serious industry providers absolutely MUST be well educated by lawyers who have years’ experience dealing daily with issues that include the federal Anti-Kickback Statute (and safe harbors), the bona fide employee exception to the AKS, the PBA and how insurers and regulators (inside Florida and outside Florida) interpret and apply such laws. Any contract (like the sort of agreement referred to in the arrest warrant affidavit) that isn’t preceded by careful client education about the laws, the options and risks of each option is just reckless. Clients who are well educated will understand things like— read more
Healthcare providers have heard the HIPAA disaster stories: a laptop containing patient information is left on the counter at the coffee shop; a thumb drive with patient files goes missing; a rogue employee accesses patient information she has no business accessing; hackers get into a practice’s server and hold the patient information for ransom.
HIPAA is a federal law designed for safe disclosure of patient’s protected health information. The news headlines showcase giant penalties for violations. However, Florida healthcare providers should also know that Florida has its own consumer protection statute, called the Florida Information Protection Act. So while you’re busy worrying about your HIPAA exposure in any of these situations, remember that there is potential State exposure as well.
So what should a healthcare provider do if it believes there has been a hack or some other unauthorized disclosure? Responses vary based on the situation presented, but below is a good jumping off point: read more
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
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
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
The 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).
Like a scene from the popular Netflix series, House of Cards, Governor Scott has requested that State agencies list critical services in light of a possible government shutdown over a battle of the budget. It is important to note that Floridians relying on Medicaid could be impacted and shifting their care from the Primary Care Doctors back to the Emergency Departments. Lawmakers will have a special session from June 1-20 with the goal of passing a budget.
In the meantime, hospitals have responded to Governor Scott’s challenge for profit sharing and likening healthcare to baseball. The Florida Hospital Association responded equating the profit sharing to an additional tax on hospitals. The Florida Hospital Association stated that hospitals already contribute roughly $1.3 billion to Medicaid as supported by a report commissioned by the State. Governor Scott also drew criticism from State Senator Don Gaetz in a talk radio interview where he likened the Governor’s profit sharing to government price controls.
Nearly half of U.S. States have already expanded the scope of nursing practice and several more are analyzing whether it is appropriate. The debate between physicians and nurses regarding how much autonomy a nurse should be given is a political hotbed that will likely be revisited by the legislature in the near future. Until that time, the Board of Medicine and the Board of Nursing will quietly continue to enforce the present requirements. Here’s how they stand today:
Under Florida’s current laws, in addition to the practice of professional nursing, an advanced registered nurse practitioner (“ARNP”) may perform acts of medical diagnosis, treatment and prescription. However, for the most part, such acts must be performed under the general supervision of a physician. The nature of such a supervisory relationship should be identified in a protocol which identifies the medical acts to be performed and the conditions for their performance. read more
A healthcare provider’s “billed charge” is usually the total charges billed before applying any contractual discounts. Where there are no contractual relations, a provider’s charge may be considered the equivalent of fair market value for the service provided. But what is fair market value? If the provider is contracted the rate is confidential and not subject to disclosure. If the provider is non-contracted, there is no standard billing rate for providers, making it difficult to get reliable rate data on what is fair market value for similar services or similar providers. One Florida court has found that “fair market value” is the price that a willing buyer will pay and a willing seller will accept in an arm’s length transaction. read more