New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and Cosmetic Permits

Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come. When an applicant files for a change of ownership (“CHOW”) or change of location for one of the permits authorized by the Florida Department of Business Professional Regulation, Division of Drugs, Devices, and Cosmetics (affectionately, “DDC”) under Part 1 of Chapter 499, FS, they can now also request a temporary permit for 90 days.

Having the option to request a temporary permit is especially important with a CHOW.  In a normal health care CHOW process, the parties are hammering out the terms of the agreement while the health care due diligence team coordinates with state agency personnel to have them issue the health care entity permit exactly on the date that the parties wish to close. The problem is that the buyer’s and seller’s schedules may not completely coincide with statutory time frames and the schedules of the state agency permit processors. So, if the buyer and seller want to close in 10 days, but the state can’t process the application for 30 days, then if the parties close the deal there will be no permit for 20 days. The new owner loses business and the provider’s patients struggle to find a provider to serve them while the buyer awaits the new permit. Also, if there are drugs on the premises, what happens to them when the permit is no longer in effect? Continue Reading

Decision Reminds Providers of Limits on Restricting Employee Communications with Media

Posted in Health Care Providers, Healthcare Law, Hospitals & Health Systems, Physicians

Hospitals and medical groups that bar staff from communicating with the media should take another look at those prohibitions following a recent federal appellate decision finding such a policy unlawful under the National Labor Relations Act (NLRA).

Multiple news accounts have detailed incidents where doctors and nurses were disciplined or fired for speaking out about staffing issues or inadequate Personal Protective Equipment. However, hospitals and medical groups should recognize that such complaints may be protected under both the NLRA and the Occupational Safety and Health Act (OSH Act), or similar state laws.

In May, a Maine hospital was required to reinstate an activities coordinator in the rehabilitation department after firing her for writing a letter to the editor expressing support for nurses and doctors in their respective labor disputes and urging management to heed the nurses’ staffing demands and concerns about risk to patient safety. Her letter criticized management as out of touch with patient care and negatively affecting hospital staff and the local community. Continue Reading

Have Paper Prescriptions Gone the Way of the Horse and Buggy? Almost.

Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment, Physicians

For most Florida prescribers whose licenses haven’t renewed since 2019, it’s time to commence electronic prescribing. In 2019, the legislature enacted legislation that required electronic prescribing. However, this requirement became effective on the earlier of the prescriber’s license renewal date or July 1, 2021. Section 456.42(3), Florida Statutes requires health care practitioners to “electronically transmit prescription(s).”  This term is not defined and, while it likely was intended to mean “electronic prescribing,” it does not say that.

The requirement that practitioners electronically transmit prescriptions only applies to those health care practitioners licensed by law to prescribe (MDs, DOs, APRNs, PAs, podiatric physicians, dentists, and optometrists) who:

  • Maintain an electronic health records system (“EHR”); or
  • Prescribe medicinal drugs as an owner, employee or contractor of a licensed health care facility or practice that maintains EHR

Continue Reading

New Florida Laws Focus on Health Care

Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment, Physicians

Before closing its 2021 session, the Florida Legislature passed several bills that impact health care, summarized below.

The first bill discussed below regarding civil liability became effective on March 29, 2021. The majority of the other bills became effective on July 1, 2021. Continue Reading

Pelvic Examination Law – Florida Takes a Second Look

Posted in Health Care Providers, Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

The Florida medical community was left concerned and confused by the passage of the original 2020 pelvic examination law. As we discussed in our past blog, practitioners believed the law was overly burdensome, and they were unsure how to implement it. Senator Lauren Book’s new bill, SB 716, sought to make consent clear through an amendment to the original law. It became effective July 1, 2021.

The updated law revises the definition of “pelvic examination” and the situations in which consent is required for pelvic examinations. Unfortunately, the new law still misses the mark on clarifying when consent is and is not required. Due to the continued lack of clarity, it is essential that providers review policies and consent forms to ensure they understand what is required of them when conducting pelvic examinations. If appropriate policies and consent forms have not been implemented, now is the time to put them in place. Continue Reading

Group Health Plan Sponsors are Getting Serious About Pricing Transparency – Are You Keeping Up?

Posted in Health Care Providers, Health Insurers & Managed Care Organizations, Healthcare Law, Hospitals & Health Systems, Physicians

In early July, the Department of Health and Human Services (HHS), the Department of Labor (Labor), and the Department of the Treasury (Treasury) (collectively, the Departments), along with the Office of Personnel Management (OPM) released an interim final rule related to the No Surprises Act, legislation designed to protect patients from unexpected medical bills.

The Departments’ interim final rule arrives in the broader context of a number of new health cost transparency obligations imposed upon plan sponsors (the employers or organizations that offer group health plans to employees) beginning in early 2022. While third parties can implement many of the pricing transparency measures, plan fiduciaries must ultimately ensure compliance. As compliance deadlines for new pricing transparency requirements for group health plans draw near, plan sponsors will need to use the second half of 2021 to prepare. Continue Reading

Not Without Their Parents – No Pharmacy Services to Florida Minors without Parental Consent

Posted in Pharmacy, Drugs, Medical Devices & Equipment, Physicians

Pharmacists and other providers should beware of a medical consent requirement buried in the new “Parents’ Bill of Rights” signed by Governor Desantis. The law will be codified at Fla. Statutes § 1014.06 and became effective on July 1, 2021. While most see it as an educational bill that allows parents to be more involved in decisions about the education of their children, there are also requirements for “Health Care Practitioners.” The term “health care practitioners,” 456.001, F.S.,  is defined in Chapter 456, Florida Statutes, and includes all licensees and permittees authorized by the Department of Health, including pharmacists and pharmacies, physicians, nurses, etc. The law states that, except as otherwise required by law, health care practitioners, or persons employed by them, may not provide “health care services” or prescribe medicinal drugs to a minor, without first obtaining written parental consent. There is a similar requirement for health care facilities. This law does not affect most health care providers and facilities as most already seek and obtain such parental consents in advance of treating minors.  However, except for when they provide immunizations, pharmacies have not historically obtained written consents from a minor’s parents. Continue Reading

OIG Weighs In On COVID-19 Vaccination Incentives

Posted in Accountable Care Organizations, Health Care Providers, Health Insurers & Managed Care Organizations, Healthcare Law, Hospitals & Health Systems, Physicians

The media has widely reported that several governmental, non-profit, and private organizations, including entities in the healthcare sector, are offering a variety of incentives to encourage more individuals to take the COVID-19 vaccine. While this approach may increase the number of vaccinated individuals, it can also implicate the healthcare fraud and abuse laws when Federal healthcare program beneficiaries, e.g., Medicare participants, receive incentives to roll up their sleeves and get a shot (or two). Continue Reading

Hiding Data: Hospitals Fail to Comply with Price Transparency Requirements

Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

At first glance, it appeared that hospitals were complying with the Centers for Medicare & Medicaid Services’ (CMS) price transparency requirement, which became effective January 1, 2021. Upon a closer look; however, multiple deficiencies were found.

CMS previously advised that it would begin auditing compliance with the rule this past January. Interestingly, it was the published findings of a Wall Street Journal (WSJ) investigation that first identified non-compliance. The investigation uncovered hospitals technically posting such data but intentionally hiding it from online search engines.

The Rule

The new rule requires US hospitals to have detailed pricing information prominently displayed on their websites. The rule’s specific details are discussed in our recent blog.  Among the requirements are that standard charges be posted online. (45 CFR § 180.50).  Standard charges are “the regular rate[s] established by a hospital for an item or service provided to a specific group of paying patients.” (45 CFR § 180.20). Hospitals; however, were obscuring these standard charges from consumers. Continue Reading

Be Prepared For Increase In COVID-19 Inspections Under OSHA’s New National Emphasis Program

Posted in Health Care Providers, Healthcare Law, Hospitals & Health Systems, Senior Living

On March 12, 2021, the Occupational Safety and Health Administration (OSHA) announced a new National Emphasis Program (NEP) designed to significantly reduce worker exposure to COVID-19 by targeting industries and worksites where employees may have a high frequency of close-contact exposures. The new NEP on COVID-19 has two main components:

1. Increases OSHA inspections of high-hazard industries where COVID-19 exposure is expected to be prevalent. The employers will be chosen from the primary and secondary target lists as seen below:

a. Primary target list (Appendix A):

i. Healthcare industry (i.e., dentist, home health care, ambulance services, general medical and surgical hospitals, nursing care, retirement communities, assisted living facilities, etc.) Continue Reading