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.
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… Continue Reading
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 … Continue Reading
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
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 … Continue Reading
Hospitals that are not ready for the Centers for Medicare & Medicaid Services (CMS) new transparency requirement must act quickly. CMS has advised that the new year will begin with new auditing and monitoring of these requirements.… Continue Reading
Anthem, Inc., (Anthem) and Express Scripts, Inc., (Express Scripts) had a big win this week, creating another setback for plaintiffs filing ERISA lawsuits against pharmacy benefits managers (PBMs). On December 7, 2020, the Second Circuit Court of Appeals upheld U.S. District Judge Edgardo Ramos’s decision that Anthem and Express Scripts did not violate fiduciary obligations under the Employer Retirement Income … Continue Reading
There has been a longstanding and regrettable practice in the healthcare industry of pharmaceutical and medical device companies giving physicians gifts as illegal inducements. Concerned about this continued trend, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services’ Office of Inspector General (OIG) issued important warnings regarding providing inducements to healthcare providers (HCPs) – just … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
The COVID-19 pandemic has led to urgent changes to how and where healthcare services are delivered. These changes could require expedited entry into new or modified arrangements for the delivery of essential healthcare goods and services, creating potential conflicts with the Stark Law (Section 1877 of the Social Security Act) and its regulations and potential Office of Inspector General (OIG) … Continue Reading
Despite Congress’ efforts to use riders to neutralize a provision of the Affordable Care Act (ACA or Act), the Federal government (Government) owes certain insurers $12 billion. On April 27, 2020, the Supreme Court of the United States (SCOTUS) ruled 8-1 that congressional riders added to appropriations bills that funded the Centers for Medicare & Medicaid Services (CMS) in 2014, … Continue Reading
While the CARES Act signals relief for many healthcare providers, it is important to remember that there are strings attached and reasons for providers to involve their compliance departments in the use and tracking of the CARES Act relief funds.
The CARES Act promised, through the Public Health and Social Services Emergency Fund, to provide $100 billion in relief funds … Continue Reading
Even in this time of crisis, nothing has changed about a hospital’s obligation to comply with the Emergency Medical Treatment and Labor Act (EMTALA). However, the Centers for Medicare and Medicaid Services (CMS) has issued guidance (available here) to, and some flexibility for, hospitals on how to provide care to the growing influx of patients during the COVID-19 pandemic.… Continue Reading
The COVID 19 epidemic is bound to overwhelm available medical resources in the United States. Healthcare institutions and practitioners will be forced to make impossible life-or-death decisions regarding the allocation of manpower and supplies. They must also be ready to defend those decisions against a backlash of grief—and lawsuits—once the crisis has passed.
A defensible triage protocol must enable reasonable … Continue Reading
The terms of a settlement that resolved antitrust litigation between the State of California and Sutter Health, the largest health system in Northern California, have now become public, almost two months after the settlement put an end to the case. The settlement, which was inked only days before a trial in the case was set to begin, includes both the … Continue Reading
The Florida Fifth District Court of Appeal harmonized the interpretation of state statutory and constitutional language in the first post Amendment 7 case dealing with access to adverse medical incident reports and their use at trial. The Florida statutory prohibition against the use and admissibility of certain incident reports was postulated to conflict with the state constitutional access to adverse … Continue Reading
To bill or not to bill, that is the question. Or, more appropriately, who to bill and when to bill, that is the question. Providers who bill patients under the circumstances described below may face liability. What is a provider to do?
A patient was injured in the course of her employment in December 2013 and applied for workers’ compensation … Continue Reading
We are all too aware of the horrors of the Parkland shooting. In response to that awful day, the Florida Legislature enacted Florida Statute Section 790.401 in 2018, “the Marjory Stoneman Douglas High School Safety Act.” Part of this new law is the “red flag” provision which allows courts to proactively remove firearms from individuals who pose a significant danger … Continue Reading
Last Thursday, September 5, 2019, Judge James Moody, Jr. of the United States District Court for the Middle District of Florida issued a positive ruling for hospitals dealing with patient safety organization (PSO) data. The opinion can be reviewed here. Note, while this decision is not binding on state courts, it is persuasive authority. It may be used to … Continue Reading