By: Susan St. John
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
By: Susan St. John
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
A new law passed by the Florida Legislature shaves off some of the sharp edges of Florida law that applies to physicians who are impaired by substance abuse or mental illness. The hub of treatment referenced in the law is the Impaired Practitioner Program (IPP). Over the years, the IPP (a quasi-governmental entity) has come under fire for being too aggressive in how it deals with impaired physicians, by acting more like law enforcement than a healthcare provider. Allegations in the past include physicians feeling “hauled off” to treatment before the demonstrated need was clear and being directed to providers that were expensive or inconvenient with reasonable alternatives exist.
The new law rounds out the IPP operations in creating additional accountability through the appointment by the Department of Health (DOH) of one or more consultants. It also:
- allows certain providers to report an impaired practitioner to a consultant instead of the DOH. Some in the program felt they were being leveraged into cooperating when they felt it was counter-indicated. This measure might help balance the issues by interposing an independent consultant that is not under the IPP;
- prevents the consultant from reporting to DOH a practitioner who is self referring for treatment, but keeps intact features of accountability to help ensure the practitioner completes treatment;
- requires the consultant to copy the patient and any legal representative on any information release; and
- protects the consultant by extending sovereign immunity to him/her.
Healthcare professionals interacting with the IPP need to know their rights and options. The new law helps facilitate that.
By: 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
By: Jackie Bain
Section 13411 of the HITECH Act authorizes and requires the Department of Health & Human Services Office for Civil Rights (“OCR”) to provide for periodic audits to ensure that covered entities and business associates comply with the HIPAA Privacy and Security Rules. OCR conducted its first round of those audits in 2011 and 2012, and has announced that it will begin a second phase. Unlike the first phase of audits, which were limited to covered entities, both covered entities and business associates are intended to be audited during this second phase.
How will audited businesses be selected?
This fall, OCR will deliver pre-audit surveys to between 550 and 800 covered entities. OCR is attempting to obtain a fair snapshot of all covered entities, so these pre-audit surveys will be sent to health care providers, health plans, and health clearinghouses. Moreover, the audits will span the gamut of business sizes, from large corporations to solo practitioners. After pre-audit surveys are returned, OCR will randomly select 350 of those covered entities for a full audit. As a part of these full audits, covered entities will be asked to identify their business associates. OCR will then select 50 business associates to participate. read more
How physicians became the gatekeepers between cannabis and the public and how physicians should approach cannabis as a form of treatment
By: Jacqueline Bain
The Federal Government lists marijuana as a “Schedule I” controlled substance, meaning it has a high potential for abuse and no currently accepted medical use. 21 USC § 812(b)(1). Because there is no current accepted medical use, Federal law prohibits physician from issuing prescriptions for marijuana. 21 CFR § 1306.04(a). However, the Federal Government has traditionally deferred to the States to prosecute small-scale marijuana violations. This lack of Federal enforcement has encouraged the States to enact less stringent controls on the marijuana industry. read more
Since its passage in 1989, the now ubiquitous federal law known as the Stark Law has driven the business behavior of health care providers of many kinds. Recent developments, however, make us wonder whether the end of Stark is near, and if so, whether that’s a good thing.
By way of background, the Stark law has two components: part one, a self referral prohibition, generally forbids physicians from referring to a provider of any “designated health service” (DHS) (e.g. MRI, PT, clinical lab) if the physician or his/her immediate family member has a financial relationship (including ownership interest) with the provider of the service. Part two mandates that certain compensation arrangements between healthcare providers meet certain requirements. Things like medical director agreements, management agreements, employment and independent contractor arrangements have been regulated by the law since its inception. Most notably, for purposes of this article, one provision (the “In Office Ancillary Services” exception or “IOAS”, also known as the “Group Practice Exception”) has allowed medical practices to provide all sorts of “ancillary services” to their own patients. That is the key aspect of the law that is lately coming under serious attack. read more
The Stark Regs (1) forbid doctors and their immediate family members from referring their patients to businesses they own which provide “designated health services,” and (2) contains a long list of permitted financial relationships between health care providers. The list of what constitutes a “designated health service” (DHS) includes PT, rehab, diagnostic imaging, clinical lab, DME, and home health. A “physician” means an M.D., D.O., chiropractor, podiatrist, optometrist or dentist. An “immediate family member” is a husband or wife; birth or adoptive parent, child, or sibling; stepparent, stepchild, stepbrother, or stepsister; father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law; grandparent or grandchild; and spouse of a grandparent or grandchild. In short, if you or your family member owns a DHS, don’t refer to it. Unless of course your situation falls within one or more of the gazillion exceptions.
A few key changes from the third set of revisions (so called Stark III) which affect physicians are helpful to keep in mind. For instance, the way fair market value of physician compensation is determined in the Stark II regs has been simplified and now depends on an amorphous consideration of the transaction, its location and other factors. The clear formulas contained in Stark II was dropped and this makes the need for an expert FMV study even more compelling. read more
Licensed healthcare providers and facilities (including many drug and alcohol recovery businesses) who enter into arrangements with clinical labs to provide services to their patients and who then wish to charge more for those lab services will be very disappointed to learn about the restrictions under Florida law.
Section 456.054, Florida Statutes prohibits “kickbacks” and reads—
(1) As used in this section, the term “kickback” means a remuneration or payment, by or on behalf of a provider of health care services or items, to any person as an incentive or inducement to refer patients for past or future services or items, when the payment is not tax deductible as an ordinary and necessary expense.
(2) It is unlawful for any health care provider or any provider of health care services to offer, pay, solicit, or receive a kickback, directly or indirectly, overtly or covertly, in cash or in kind, for referring or soliciting patients.
(3) Violations of this section shall be considered patient brokering and shall be punishable as provided in s. 817.505.
The issue involved in a provider or facility charging more for lab services than they were charged by the lab itself is that the prohibition above applies to healthcare providers and “any provider of healthcare services.” Regulators may find any reduced fee by the lab to constitute a kickback in exchange for a volume of patient referrals.
A related issue has to do with Florida insurance laws that pertain to charging more for an item or service than the provider or facility was charged. For instance, if Lab 1 charges the provider/facility $10 for lab work, and the provider/facility charges an insurer $20, that can be found to constitute insurance fraud.
The key Florida prohibition, however, is found in the Florida Administrative Code, which reads—
59A-7.037 Rebates Prohibited – Penalties.
(1) No owner, director, administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person either directly or indirectly, shall pay or receive any commission, bonus, kickback, rebate or gratuity or engage in any split fee arrangement in any form whatsoever for the referral of a patient. Any violation of Rule 59A-7.037, F.A.C., by a clinical laboratory or administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person acting on behalf of the clinical laboratory will result in action by the agency under Section 483.221, F.S., up to and including revocation of the license of the clinical laboratory. In the case of any party or individual not licensed by the agency acting in violation of this Rule, a fine not exceeding $1,000 shall be levied and, as applicable, the agency shall recommend that disciplinary action be taken by the entity responsible for licensure of such party or individual.
(2) No licensed practitioner of the healing arts or licensed facility is permitted to add to the price charged by any laboratory except for a service or handling charge representing a cost actually incurred as an item of expense. However, the licensed practitioner or licensed facility is entitled to fair compensation for all professional services rendered. The amount of the service or handling charge, if any, shall be set forth clearly in the bill to the patient.
(3) Each licensed laboratory shall develop a fee schedule for laboratory services which shall be available to the patient, the authorized person requesting the test or agency upon request and shall be subject to subsection 59A-7.037(2), F.A.C.
In this era where healthcare providers and facilities are struggling to hold onto dwindling profit margins, it is understandable why some are considering arrangements with clinical labs. Still, Florida providers and facilities have to be extremely cautious when entering into such arrangements.