COVID-19 and Possible Silver Bullets: Update on Vaccine Development

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

As the world continues to grapple with the COVID-19 pandemic that has taken the lives of over 250,000 Americans, and worldwide over 1 million people, this year, an effective vaccine has emerged as our silver bullet – a way for the nation, and the world, to fight back and, in time, begin to return to some semblance of normalcy. There is some encouraging news on that front, as there are two promising separate clinical trials that have produced potentially viable vaccine candidates in the pipeline for potential emergency approval by the US Food and Drug Administration (FDA), with others possibly coming soon as well.

Clinical Trials – The Latest

Pfizer, and its partner, BioNTech, a German biotech company, announced that the data from phase three of its clinical trial shows their developed vaccine to have an effective rate of approximately 95%. For a vaccine to earn FDA approval, generally, a minimum threshold of 50% effectiveness is generally sought. By way of comparison, an annual flu vaccine is 40-60% effective, and a dual dose of a Measles vaccine is 97% effective. The numbers reported by Pfizer, therefore, are encouraging. Pfizer plans to submit an application to the FDA for emergency use authorization (EUA) on November 20, 2020.

Separately, Moderna, an American biotechnology company based in Cambridge, MA, announced this week that early data from its phase three trial shows an efficacy rate of 94.5%, also encouraging and significantly above the FDA baseline for consideration for approval.

Both vaccines were developed using a new technology called messenger RNA, or mRNA. Because it is a new method of vaccine development, there may be questions raised by both the FDA and the CDC regarding safety.

What’s Next – The EUA Approval Process

Normally a vaccine’s development and approval takes years. To have a potentially viable vaccine available in less than a year’s time is unprecedented. In this case, the Vaccines and Related Biological Products Advisory Committee, a group of independent advisors to the FDA comprised of independent experts and a consumer representative, will be the first to review an EUA application. This committee may have additional follow-up questions, including possible concerns about the mRNA process. If the committee ultimately votes to approve the vaccine, then the FDA considers whether to accept the committee’s guidance.

Then, the Advisory Committee on Immunization Practices, an advisory committee for the CDC, will make recommendations as to which groups would be initially eligible to receive the vaccine, with the CDC’s priority likely going first to front line health professionals, then to the elderly and immunosuppressed, and then to the general public.

Challenges Ahead

Keep in mind that the process that is outlined above is if all reviews go smoothly. Once the vaccine is approved, the manufacturers have to make the doses in large quantities, so the best-case scenario is that a vaccine is available to the general public in the spring of 2021, at the earliest. Another concern is that at least one of the promising vaccines must be stored at a temperature of nearly -100 degrees Fahrenheit, presenting a significant logistical challenge for providers. While the vaccine trial results present promising news for all of us, the challenges ahead, both in regulatory approval and in the logistical hurdles of delivering the vaccine to patients’ arms worldwide, present the next set of challenges to overcome. We will keep you apprised of developments as they roll out.

Florida: Do You Know Where Your “Minor” Is?

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

During the COVID-19 pandemic, telehealth usage has dramatically increased, as discussed in a recent Health Law Rx post. Telehealth makes it easier for individuals who cannot drive, including many minors, to seek necessary care, leading to many questions regarding when “minors” (individuals under 18 years of age) can consent to treatment – when the “disability of nonage” has been removed. Read more here and here. The following overview of the relevant Florida laws is meant to help healthcare providers determine when minors can and cannot consent to their own treatment.

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“Historic” Settlement of Blue Cross Blue Shield Association Antitrust Action May Significantly Boost Competition in Health Insurance Markets in 2021

Posted in Antitrust, Health Insurers & Managed Care Organizations, Healthcare Law, Healthcare Litigation

After over 8 years of hard-fought litigation, the Blue Cross and Blue Shield Association, together with its 36 Blue Cross/Blue Shield members (“the Blues”), recently announced a proposed settlement of class action antitrust litigation (In re Blue Cross Blue Shield Antitrust Litigation) brought against them by a nationwide class of subscriber members. The settlement terms, summarized in the plaintiffs’ motion seeking the Court’s approval of the settlement, includes both the payment of substantial monies to the plaintiff class ($2.67 billion) and significant agreed-to changes to the way in which the Blues operate. Continue Reading

Is A Safer Healthcare System Within Reach?

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

COVID-19 has made healthcare organizations acutely aware of the need to fine-tune their internal safety systems. The National Steering Committee for Patient Safety (NSC), comprised of 27 organizations, has come to the rescue. NSC recently released guidance entitled, “Safer Together: A National Action Plan to Advance Patient Safety” (the Plan). The Plan provides a methodology for improving safety and reducing harm by outlining 17 recommendations within 4 foundational areas throughout healthcare.

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HIPAA Says To Give Me My Medical Records…NOW!

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

Healthcare providers are generally required by HIPAA to provide patients or their legal representatives with the ability to inspect or obtain copies of their medical records within 30 days of a request (state specific requirements are not addressed herein.) The Office of Civil Rights (OCR) has been enforcing this requirement through its Right of Access Initiative, which it announced in 2019, “promising to vigorously enforce the rights of patients to receive copies of their medical records promptly and without being overcharged.” Continue Reading

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

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