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 may have heard, the State Hemp Plan, SB 1020, has passed the Florida House and Senate and is waiting for Governor DeSantis’ action (approval or veto) or inaction (no veto). The Governor’s approval or failure to veto SB 1020 means SB 1020 will become law. So what does this mean for Florida?
SB 1020 is meant to bring Florida’s laws regarding the cultivation and processing of hemp in line with the Federal Farm Bill of 2018 which removed hemp from the DEA’s list of controlled substances and legalized the industrial use of hemp. Currently, hemp is listed as a controlled substance under Florida law. SB 1020 will change that and allow cultivation of hemp and distribution and retail sale of hemp extract. read more
Monday, April 29, 2019, the Florida House and Senate came to agreement on a new Telehealth bill (HB 23). If signed by Governor DeSantis, the bill will become effective July 1, 2019.
The bill creates two new statutes: Section 456.47 and Section 627.42396, and amends Section 641.31.
Section 456.47 sets forth the standards of practice for telehealth providers, authorizes the use of telehealth encounters for patient evaluations, and allows certain providers to prescribe certain controlled substances in limited circumstances. The bill also allows non-physician providers to use telehealth without being deemed to be practicing medicine without a license. Further, the bill sets forth record keeping requirements and registration for out-of-state telehealth providers. It authorizes the Department of Health to establish rules for telehealth, including exemptions from registration requirements, and to set up disciplinary action against telehealth providers that violate the law or rules. read more
As the provision of health care services continues to evolve, many practitioners are contemplating creating membership-based services for their patients through Direct Primary Care Agreements (“DPCA”). Although DPCAs are not necessarily a new concept, the Florida Legislature enacted a bill during the 2018 legislative session making DPCA’s exempt from the Florida Insurance Code. Thus, DPCAs are not a form of insurance subject to regulations of insurance products but are private contracts between practitioner and patient for specified health care services. Here is how the DPCA concept works.
DPCAs are private contracts between patients and primary care providers. Section 624.27, Florida Statutes, defines primary care provider as a provider licensed pursuant to Chapters 458, 459, 460, and 464, or a primary care group practice, who provides primary care services to patients. Included under this broad definition of providers are: allopathic doctors, osteopathic doctors, physician assistants, anesthesiologist assistants, chiropractors, RNs, LPNs and ARNPs. read more
As noted in Opting Out of Medicare Part I, opting out of Medicare may be an option for some physicians and practitioners. After determining whether you are eligible for opt-out or if it is financially feasible, there are a few other considerations. Part I discussed the Private Contract a physician must enter into with each Medicare beneficiary he or she treats; here, we will address the opt-out affidavit and other nuances of opting out. Let’s get started!
The Medicare Opt Out Affidavit
Provisions in an Opt Out Affidavit are similar to provisions that must be included in the opted out physician’s or practitioner’s private contract with Medicare beneficiaries. The opt-out affidavit must state that the physician or practitioner will only provide services to Medicare beneficiaries with whom they have a written and signed private contract and that the physician or practitioner will not submit claims to Medicare on behalf of Medicare beneficiaries. Medicare does allow for an exception here, but that is only when an opted out physician or practitioner treats a Medicare beneficiary who is not under private contract, and that beneficiary presents with a medical emergency or urgent care problem. Keep in mind, that if a Medicare beneficiary presents with a medical emergency or urgent care problem, the physician or practitioner cannot require that patient to sign a private contract at that time. read more
Providers licensed or regulated by the Agency for Health Care Administration must make certain that their employees and/or contracted personnel have had Level 2 Background Screening (criminal history background check) pursuant to Florida Statutes and Administrative Code within 10 business days of being hired. Also, if a potential employee or contractor has not been employed within the previous 90 days, even if that individual previously had level 2 background screening, the individual will need to go through submitting fingerprints again. Further, each employee or contracted individual that is subject to Level 2 Background Screening must renew the background screening every 5 years to be eligible for employment or continued employment with an AHCA licensed or regulated provider.
Fingerprint Retention Period
The 5 year expiration from the date of retention of fingerprints is the date that the Florida Department of Law Enforcement (“FDLE”) will purge fingerprints from storage, meaning if fingerprint retention renewal has not occurred prior to this date, the whole screening process, that is fingerprinting, etc., starts over. There is no “grace period” if fingerprints have been purged, which means the individual is no longer “technically” eligible for employment with an AHCA licensed provider (and perhaps other providers licensed and regulated by other state agencies such as Department of Health, Department of Children and Families, or Department of Elder Affairs). Further if the provider is in the process of an AHCA survey, accreditation survey, or renewal licensure application, not having a current Level 2 Background Screening for an employee or contractor might subject the provider to a statement of deficiency, assessment of administrative fines or fees, or denial of a licensure renewal application. read more
So you are considering starting a home medical equipment aka durable medical equipment (HME or DME) business to provide products and services to patients in Florida (and perhaps in other states, but that’s a topic for another day). In addition to deciding what products and/or services you are going to provide and your physical location, there a few things you need to know, steps to be taken, and information to be collected, to apply for an HME/DME license in Florida to get up and going.
Florida defines an HME provider as “any person or entity that sells or rents or offers to sell or rent to or for consumers, any HME and service or HME that requires HME services.” Section 400.925(7), Florida Statutes. Further, HME “includes any product as defined by the Food and Drug Administration’s Federal Food, Drug, and Cosmetic Act, any products reimbursed under the Medicare Part B Durable Medical Equipment benefits, or any products reimbursed under the Florida Medicaid durable medical equipment program. HME includes oxygen and related respiratory equipment; manual, motorized, or customized wheelchairs and related seating and positioning, but does not include prosthetics or orthotics or any splints, braces, or aids custom fabricated by a licensed health care practitioner; motorized scooters; personal transfer systems; and specialty beds, for use by a person with a medical need.” Section 400.925(6), Florida Statutes. 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
Florida has long been a hot spot for medical malpractice lawsuits. Professionals debate the causes frequently, but the fact remains: Florida is a place where medicine has to be practiced defensively. And it’s likely to get worse because the Florida Supreme Court recently tossed out the state cap on non-economic damages.
Since the cap was found to be unconstitutional, the risk of expensive med mal suits is expected to rise. And the secondary effect will almost certainly be increased med mal insurance premiums. If the upcoming premium rise is like any from the past (this is a cyclic phenomenon), it’s a sure thing that more physicians will decide to self-insure (not carry professional liability insurance). The State of Florida doesn’t require physicians to carry professional liability insurance provided that they have adequate financial backing or provide necessary patient notices read more
If you have ever been the recipient of a Florida state agency’s (i.e. Department of Health, AHCA, etc.) notice regarding an adverse action, such as a Notice of Intent to Deny, licensure application, renewal or change of ownership, you probably received an Election of Rights form along with the agency’s notice. The Election of Rights form must be completed and returned to the agency within 21 days of receiving the agency’s notice. In completing the Election of Rights form, you are given three options to choose from in deciding how you want to respond to the agency’s notice.
Under Option One you admit to the allegations of facts and law contained in the agency’s notice of intended action and waive the right to object and have a hearing. This is akin to an admission of guilt, that the agency is right in its decision, and you agree to a final order that supports the agency’s actions, including imposition of fines and punishment against you. Option One is generally not in your best interest. read more
If you are having issues with Medicare telehealth claim matters then you want to hire an experienced legal team that can guide you through the process, ensuring the best possible outcome. You also have the benefit of knowing that you are getting the best counsel for any legal matters and do not have to rely on amateur advisement like blogs and forums. These are some of the questions you can get answers to:
What experience do you have? When you hire an attorney to handle a legal matter for your business, you want them to be experienced and have a well established presence in this industry because there’s a chance they will be going up against insurance companies who have a lot of money and an experienced team of their own.
How can you help me with this situation? When you are dealing with this matter you want to make sure that everything is taken under consideration. For example, are you compliant with all the rules and regulations, new changes in policy or anything else that comes up? Do you have all the licensing you need to conduct business and so forth? An experienced team will make sure you have everything you need to move forward.
How can you help me in the future? One of the biggest advantages of hiring a law firm rather than an individual attorney is that we can assist you with several legal matters that come up in the future. Today you may need assistance with a contract for hiring a new doctor but a year from now it may be to purchase or sell a practice.
With the rise in services provided to patients via telehealth entities, it is important that both practitioners and patients understand what criteria must be met in order to provide and bill telehealth on behalf of Medicare patients. Here are a few of the basics.
First, “telehealth service” for Medicare purposes means “professional consultations, office visits, and office psychiatry services, and any additional service specified by the Secretary. To be eligible for payment, telehealth services must be rendered to an eligible individual, that is, an individual enrolled in Medicare, who receives telehealth services at an originating site from a physician or practitioner at a distant site via telehealth communications system. An eligible individual does not need to be presented by a physician or practitioner at the originating site to a physician or practitioner at a distant site, unless it is medically necessary. Determination of whether a presenting physician or practitioner is necessary at the originating site is made by the physician or practitioner at the distant site.