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

Providers: Cyberattacks Are Still Coming–Are You Prepared?

Posted in Health Care Providers, Healthcare Law, Healthcare Litigation, HIPAA, Privacy, and Data Security, Hospitals & Health Systems

Cyberattacks against healthcare providers accounted for 79% of all reported data breaches in 2020. (See here). The U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) responded last month by releasing a comprehensive guide to protect providers against this growing vulnerability entitled “Healthcare System Cybersecurity Readiness & Response Considerations” (ASPR Report).

The goal of the ASPR Report is to help providers understand what must occur before, during, and after a large-scale cybersecurity incident. We have provided below a brief overview of the major strategies discussed in the ASPR Report that various types of healthcare facilities can use for a range of cybersecurity incidents.  The key points of the report can be summarized by three key concepts: Think, Remember, and Anticipate. Continue Reading

Providers: Help is Here to Avoid HIPAA Right of Access Headaches

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

The Office of Civil Rights (OCR) continues to take seriously all allegations of violations of the HIPAA right of access to patient medical records. As discussed in a previous blog, the OCR is enforcing patient rights by issuing enforcement actions against healthcare providers who fail to provide patients with timely access to their medical records, in accordance with 45 CFR § 164.524(b). It is essential that providers take steps now to avoid future penalties. For purposes of this article the term “provider” refers to a “Covered Entity” under HIPAA, which includes health plans, health care providers (e.g., physicians, hospitals), and health care clearinghouses. Continue Reading

The Sun is Rising on COVID Liability Protection for Florida Healthcare Providers

Posted in Government Affairs, Licensure & Regulatory, Health Care Providers, Healthcare Law, Hospitals & Health Systems

Good news is here for healthcare providers worried about being left out of COVID-19-related liability protections during the 2021 Florida Legislative Session! The Republican-led Legislature, supported by Governor Ron DeSantis, is upholding its commitment to protect businesses, including healthcare providers, from frivolous lawsuits filed because of exposure to COVID-19. While only a Senate-version of legislation for healthcare providers has been filed, the chair of the House Health & Human Services committee, Representative Colleen Burton (R-Lakeland), has unveiled a committee bill (PCB HHS 21-1) that has garnered early support from House Speaker Chris Sprowls (R-Palm Harbor).

In the meantime, Senate measure SB 74, recently-filed by Senator Jeff Brandes (R-St. Petersburg), was heard last week in its first committee of reference – Senate Judiciary, which is chaired by Senator Brandes. As filed, SB 74 provides immunity from civil liability for healthcare providers (including, but not limited to, hospitals, nursing homes, assisted living facilities, home health providers, and doctors) if supplies or personnel were not available to comply with government health standards or guidance related to the pandemic. Continue Reading

Valentine’s Day: Listen to Your Heart, But Not On a Cell Phone

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

Physicians at Henry Ford Hospital in Detroit made a “stunning” heart-altering discovery. New and improved magnets in the iPhone 12 (“12”) may cause heart defibrillators and pacemakers to malfunction, particularly when carried in a breast pocket (See publication).

Continue Reading

Klobuchar Antitrust Bill Could Have Significant Impact on Healthcare Industry

Posted in Antitrust, Government Affairs, Licensure & Regulatory, Hospitals & Health Systems

In early February, Senator Amy Klobuchar, new Chair of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, introduced the “Competition and Antitrust Law Enforcement Reform Act of 2021″(S225). While the legislation is widely understood to be intended to address perceived shortcomings in the ability of federal authorities to regulate the largest and most dominant companies in the information technology industry (Big Tech) under the antitrust laws, the legislation is not limited to that industry, and if enacted, the legislation could have a significant impact on larger health systems and health insurers as well. Continue Reading

CMS Tells States and Providers: Value-Based Care is the Answer

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

The Centers for Medicare & Medicaid Services (CMS) has sent a clear message to states and providers: they already have the tools to improve healthcare. Through a combination of value-based arrangements and already existing services and supports, states and providers can address the social determinants of health (SDOH). This will lead to an improvement in health outcomes, a reduction in health disparities, and lowered healthcare costs. Continue Reading