Ransomware Targeting Hospitals and Healthcare Providers

Posted in HIPAA, Privacy, and Data Security, Hospitals & Health Systems

While fighting a surge of new coronavirus infections in many parts of the country, healthcare providers must also be prepared to defend against ransomware. On October 28, 2020, the FBI, the U.S. Department of Health and Human Services (HHS), and the Cybersecurity and Infrastructure Security Agency (CISA) issued a joint alert warning of  “credible information of an increased and imminent” cybercrime threat to U.S. hospitals and healthcare providers.  Cybercriminals are using Trickbot malware to infect the IT systems of health systems and providers with Ryuk ransomware.

The alert notes that responding to this threat will be particularly challenging for healthcare organizations during the COVID-19 pandemic, particularly those organizations currently experiencing surges in coronavirus cases. Further, the alert acknowledges the reality that organizations will have to balance the risk posed by the pandemic against this new cyber threat when determining cybersecurity investments.

According to reports, healthcare systems across the country have already been affected by this threat. In addition, there are likely organizations whose IT systems are infected with the Trickbot malware who do not yet realize it.  The alert warns those organizations that have indicators of a Trickbot network compromise to immediately back up and secure sensitive or proprietary data, as the infection may be an indicator of imminent ransomware attack. Continue Reading

What Consent for Which “Pelvic Examination”?

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

Healthcare practitioners, including medical students, are now prohibited from performing pelvic examinations on female patients without first obtaining written consent, but many specific, logistical questions were left unanswered. The new law became effective July 1, 2020. “[P]elvic exams will now require specific consent, except in cases of emergency, finally halting the wholly inappropriate practice of unapproved pelvic exams on unconscious women…where at best, these exams have been wrongful learning experiences for medical students or at worst, the equivalent of a sexual assault.” (Statement by Senator Lauren Book, a co-introducer of the bill).

Determining how to implement the new requirements has been extremely difficult. The whole spectrum of the Florida medical community (medical doctors, osteopaths, nurses and medical students) have expressed criticism, concerned that the law is overly burdensome and left many questions unanswered. The final order (the Order) issued by the Florida Board of Medicine (the Board) on October 9, 2020, in response to the Petition for Declaratory Statement filed by the Florida Medical Association (FMA), four other medical associations, and one physician offers some clarity. The Order reflects the Board’s opinion that the pelvic examination consent requirement only applies to female patients and does not apply to mere visual examinations, or routine non-diagnostic medical care, treatments, or surgical procedures. Continue Reading

Telehealth Physical Examinations: Turn on your camera and show me your “rash.”

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

Physician offices have seen a dramatic increase in telehealth visits during the COVID-19 pandemic. This development has raised questions regarding the appropriate standard of care when performing a telehealth examination, in particular the “physical examination.” Naturally this blog can never supplant the physician’s expertise in evaluating patients. As in other contexts, physicians practicing telemedicine should strive to act reasonably to provide quality patient care.

Reasonableness

Physicians must always follow this standard of care when conducting examinations.  To avoid potential medical malpractice claims, physicians are obligated to act “in accordance with the prevailing professional standard of care by a reasonably prudent similar health care provider.” See, e.g., Fla. Stat. § 766.102(2)(a).  The standard for telehealth examinations is no different. The Florida telehealth statute states: “A telehealth provider has the duty to practice in a manner consistent with his or her scope of practice and the prevailing professional standard of practice for a health care professional who provides in-person health care services to patients in this state.” Fla. Stat. § 456.47(2)(a). Continue Reading

House Passes Bill that Would Repeal Health Insurer Antitrust Exemption

Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Healthcare Reform Legislation

The U.S. House of Representatives passed H.R. 1418, the “Competitive Health Insurance Reform Act,” by a voice vote on September 21. The legislation, which was introduced back in early 2019 by Congressman Peter DeFazio (D-Oregon), would reduce the scope of the McCarran Ferguson Act’s antitrust exemption, which currently provides insurers with an exemption from the federal antitrust laws. Notably, similar legislation has repeatedly been introduced over the last ten years (by Congressman DeFazio, and others), but never enacted into law. Given the very small amount of time left before Congress adjourns (and other pressing matters that Congress must address, including the budget), it seems unlikely that the bill will be taken up by the Senate, much less passed by that body. However, if enacted into law, H.R. 1418 could have a profound impact on health insurers, given the significant reduction in the scope of the exemption that will remain if the bill becomes law. Continue Reading

HHS Issues Guidelines to Address Disturbing Trend of Racial Disparities in COVID-19 Testing and Treatment

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

Data collected during the coronavirus pandemic shows a disturbing trend of inequities in testing and treatment for COVID-19 among people of color. On July 20, 2020 the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued a Bulletin for healthcare providers, hospitals, and state and local agencies that receive Federal financial assistance to address “Civil Rights Protections Prohibiting Race, Color and National Origin Discrimination During COVID-19.”

In this Bulletin, the OCR reminded healthcare providers, hospitals, and state and local agencies that receive Federal financial assistance that they must comply with Title VI of the Civil Rights Act of 1964, which states that  “[n]o person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.” Continue Reading

DOJ Antitrust Division Grants Green Light for Pharma Companies Sharing COVID-19 Treatment Drug Production Information

Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

The Department of Justice Antitrust Division has advised several pharmaceutical companies that they can share competitive information regarding the status of their respective efforts to develop a COVID-19 treatment without running afoul of the federal antitrust laws.  Specifically, in a letter issued on July 23, the Antitrust Division stated that it had no intention to challenge a proposal by a group of pharmaceutical companies to exchange information about the parties’ ability to manufacture monoclonal antibodies that might be used to treat COVID-19. Continue Reading

CARES Act Provider Relief Funds – The Requirements Are Taxing

Posted in Healthcare Law, Healthcare M&A, Joint Ventures, Transactions & Health Ventures, Hospitals & Health Systems, Physicians

The Internal Revenue Service (“IRS”) recently clarified that CARES Act Provider Relief Funds (“Relief Funds”) are considered taxable income for for-profit providers, including physician practices. This news comes as a surprise as many thought such funds would be considered “qualified disaster relief payments” and therefore not includible in gross income under Section 139 of the Internal Revenue Code (the “Code”). As a result, for-profit healthcare providers who accepted Relief Funds need to assess the tax consequences and plan accordingly. Continue Reading

Novartis’ Simultaneous Settlements Break Records

Posted in Fraud & Abuse & False Claims Act, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment, Physicians

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an Anti-Kickback Statute lawsuit brought by a whistleblower pursuant to the False Claims Act’s (FCA) qui tam provision, Novartis, a pharmaceutical company based in East Hanover, New Jersey, has agreed to pay $678 million to settle a lawsuit alleging that it made improper payments to physicians through sham physician education programs to encourage them to prescribe its medications from 2002-2011. In a separate but simultaneous settlement, Novartis paid $51.25 million to settle claims that it improperly paid patients’ co-pays through charitable patient assistance programs (PAPs). Continue Reading

As COVID-19 Spreads, Florida Pharmacists’ Scope of Practice Expands

Posted in Health Care Providers, Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment

Florida has been contemplating ways to increase patient access to care, especially in light of the COVID-19 pandemic and the anticipated increase in cases. Recognizing the accessibility of pharmacies, Florida is now authorizing certain qualified pharmacists to perform testing, screening, and treatment of nonchronic diseases and specific treatment of certain chronic conditions. Continue Reading

California Legislature Responds to COVID-19 Crisis With Legislation that Would Require State Approval of Healthcare Mergers and Acquisitions

Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Healthcare M&A, Joint Ventures, Transactions & Health Ventures

As healthcare providers around the country struggle to respond to patient needs during the Covid-19 crisis, many are reportedly struggling financially as well. In the past, this scenario has led to an increase in merger and acquisition activity, and many healthcare analysts are predicting an increase in such activity for the second half of the year and into 2021.

In light of this development, the California Legislature is considering a bill that would require the California Attorney General’s pre-approval of most healthcare transactions in the state. Specifically, the bill, SB 977 (as amended on May 19), would require that when a healthcare system, private equity group, or hedge fund seeks to acquire or affiliate with a hospital or provider in the state, the parties must obtain the prior approval of the California Attorney General to do so. Continue Reading

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