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
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
Two separate legislative proposals are aimed to tighten up the sober home industry. The Bills follow on the heels of legislation proposed last year, which did not become law. We have a couple weeks left till the Legislative session ends (May 1st), after which time we will see what regulation made its way through the process. Until then, it’s important to have an idea of what is on the horizon.
Creates “voluntary” certification for recovery residences;
A. Specifies the requirement of a “recovery residence administrator;”
B. Specifies that the credentialing entity of both the recovery residence and the recovery residence administrator will be a nonprofit organization (not necessarily one that is tax exempt) that “develops, administers professional, facility, or organization certification programs according to applicable nationally recognized certification or psychometric standards,” and requires the credentialing entity to:
Establish the recovery residence certification requirements. Interestingly, the Legislature, which states that those in recovery are vulnerable and need to be protected, is offloading to an unspecified nonprofit organization (which anyone can form in five minutes) the responsibility for developing certification requirements;
Establish procedures to, among other things, to monitor, inspect and insure compliance with the certification requirements established by this unspecified nonprofit organization entrusted by the state of Florida with this responsibility;
Require recovery residences (who are volunteering to be regulated) to submit documents such as job descriptions, drug testing procedures and requirements, to be managed by a “certified recovery residence administrator.”
The Bill also states that a recovery residence cannot be certified if an owner, director or CFO plead guilty, no contest or was found guilty of certain offenses. Moreover, the non-governmental, not for profit certifying body has authority to suspend or revoke a certification if the entity determines the residence isn’t complying with the law. No due process is required. Oh, and finally, as of July 1, 2016, a provider licensed under Chapter 397 may not refer a patient (current or discharged) to a recovery residence unless the residence, which is not required to be certified, actually becomes certified, making the voluntary certification requirement, ummm….mandatory! read more
March 25, 2015 Advisory Opinion No. 15-04 addresses a proposed arrangement involving a clinical/anatomic lab’s desire to position itself as the single lab recommended by practices.
The proposal arises in the context of the OIG Advisory Opinion process, which allows the OIG to opine on its view of how the federal anti-kickback statute might view a proposed arrangement. Though Advisory Opinions are not “law,” they do provide good insight into prosecutorial intent.
The clinical/anatomic lab (“Lab”) wanted to have agreements with physician practices to provide all their lab services. To deal with the fact that some commercial insurers have exclusive arrangements with labs, the Lab proposed that if a practice patient’s insurer required the patient to use another lab, the Lab would waive all fees for the affected practice patients and would not bill the patient, the medical practice or the patient. The Lab would provide its services to these “exclusive patients” for free, while billing all other patients (and/or their insurers, including governmental payers) its fee scheduled or contracted rates. The proposed arrangement would allegedly simplify things for the practices and keep lab results uniform. A practice patient would be required to use the Lab. The Lab’s services would simply be offered by the practices to their patients. The Lab stated that the provision of free services to certain practice patients would not provide any financial benefit to the practices, although the lab would provide the practice a limited-use interface. Samples would not be drawn in physician offices. read more
The past year has shown a trend towards empowering providers (and even patients) in their claims against payers. And these developments should serve to bolster the position of many patients and providers, especially behavioral health providers as they raise claims against payers.
This 2014 Arizona case addressed the issue of whether a provider had the legal ability (“standing”) to sue United to receive payment for services provided to insureds. United’s role was to process claims for certain plans. Spinedex was a physical therapy provider whose patients signed a patient responsibility form and also assigned to Spindex the right to receive payment. There were different levels of benefits based on whether the patient was insured by United. Spinedex treated patients, then submitted claims to United. When claims for payment were denied, Spindex sued.
At the heart of the case was the long-standing issue of whether a provider has standing to sue for services provided to insureds of so called ERISA plans. “We are aware,” the court wrote, “of no circuit court that has accepted defendant’s argument” [that because Spinedex didn’t seek payment from a patient, the patients don’t have an “injury,” which is required for the providers to sue the payer]. Nevertheless, the court said “yes,” which opened the door to potentially a slew of such lawsuits.
The Affordable Care Act is heading back to the Supreme Court this Spring. The issue presented to the Supreme Court on this occasion is whether the IRS is authorized promulgate regulations to extend tax credit subsidies for coverage purchased through Federal Government’s Health Care Exchange.
The Affordable Care Act allows individuals who purchased health coverage through State-established Health Care Exchanges to subsidize a portion of that coverage through the form of refundable tax credits. The United States treasury directly pays each eligible taxpayer to offset the cost of the taxpayer’s insurance premium. However, a majority of States (including Florida) have elected not to establish their own Health Care Exchanges. In order to provide coverage to persons in these States, the Federal Government set up its own Health Care Exchange marketplace. read more
When Horizon Blue Cross/Blue Shield of New Jersey blasted Avee Laboratories in connection with a variety of business practices, some of which included kickback violations (in connection with the provision of POCT cups), businesses in the drug and alcohol recovery space took notice. With the recent FBI raid on a Palm Beach County sober house and the amped up attention of managed care payers to clinical lab testing, the industry is reeling! The good news, however, is that these recent developments, along with increased payor scrutiny (and payment denial!), is a call to compliance that has long seemed inapplicable to an industry that has been able for many years to operate with simplicity not found in other segments of the healthcare business community. Where facilities once viewed DCF as the only regulatory parent they had to please, they are now learning there is a far greater degree of regulatory complexity to be considered; and they are rushing towards compliance. read more
The scope of Physician Assistants’ practice is a dynamic and hotly debated area of law which shares many similarities with the nurse supervision issues we covered in a recent article (available here). House Bill 1275 would have also allowed for an expansion in the PA field and was included on the “Health Train” compilation of bills introduced during the Florida legislature’s recent session. As we know nothing on the Train passed before the session ended and though it may gain forward momentum next time, here’ how the laws stand today: read more
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