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.
The newest relief for small business and health care providers was passed by the Senate on April 21st, by the House on April 23rd, and became law on April 24, 2020. This new Act, provides for $484 billion in additional relief to small businesses and healthcare providers. $100 billion of the relief has been allocated to the Department of Health and Human Services and of that amount $75 billion is earmarked “to reimburse health care providers for health related expenses or lost revenues that are attributable to the coronavirus outbreak.” The remaining $25 billion will be used for expenses to research, develop, validate, manufacture, purchase, administer, and expand capacity for COVID-19 test to effectively monitor and suppress COVID-19.
The $75 billion provided under the Act will remain available until expended and will be used to prevent, prepare for, and respond to coronavirus to reimburse necessary expense or lost revenues incurred as a result of COVID-19. However, if a health care provider has already had expenses or lost revenues incurred due to COVID-19 reimbursed from other sources or that other sources are obligated to reimburse (like the CARES Act), any funds received from the $75 billion cannot be used as a “double dip” by that health care provider.
A big difference for health care providers with this Act, is that unlike the CARES Act that provided a direct deposit to health care providers based on Medicare fee for services reimbursement, no application necessary, this Act requires the health care provider to apply for relief funds. Eligible health care providers include public entities, Medicare or Medicaid enrolled suppliers and providers, profit and not-for-profit entities that provide diagnoses, testing, or care for individuals with possible or actual cases of COVID-19 (so as to accommodate the “lost revenues” provision, this could mean any patient treated since January 31, 2020, and is not necessarily limited to patients treated for COVID-19 symptoms without testing confirmation). Health care providers should act quickly and apply for funds as soon as possible as the HHS Secretary will review applications and make payments on a rolling basis. Payment may be a pre-payment, prospective payment, or a retrospective payment as determined by the HHS Secretary. Health care providers must submit an application that includes statements justifying the need of the provider for the payment. The provider must have a valid tax id number (could be an individually enrolled physician). As with the CARES Act, HHS will have the ability to audit how relief funds are expended and must start reporting obligations of funds to the House and Senates Committees on Appropriations within 60 days from the date of enactment of this Act. Reporting will continue every 60 days thereafter. read more
After more than a year of debate, edits, tabling and lobbying, the Florida Legislature passed multiple bills that would allow advanced practice registered nurses (APRN) to practice independently of physicians, as well as authorize certain pharmacists to test and treat patients for the flu and strep throat, among other conditions.
Prior to passage of these bills, APRNs were required to have some level of physician supervision in order to practice. While in many cases direct supervision is not required, Florida law required that an APRN enter into a supervisory relationship with a Florida licensed physician. Specifically, the providers must draft written protocols regarding scope of practice, as well as provide certain notices to their governing boards and patients. While the requirements vary based on the type of practice, they aren’t difficult to comply with in most cases. Finding a supervising physician outside of that physician’s primary practice, however, might prove to be more difficult than it seems. The requirements also carry certain mileage restrictions, prohibiting supervision outside mile limits based on the level and type of supervision.
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
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
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
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
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 HEREfor: SUBSTANCE ABUSE MARKETING SERVICE PROVIDER LICENSE APPLICATION
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
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