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 … 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 … 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 … 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 … 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 … 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 … 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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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, … 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 … 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 … 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 … Continue Reading
Facing unprecedented community spread of the 2019 Novel Coronavirus Disease (COVID-19), the Centers for Medicare and Medicaid Services (CMS) has provided additional guidance to a variety of health care providers that is designed to minimize further transmission of the disease. CMS responds to frequently asked questions related to the logistics for minimizing transmission of COVID-19 … 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 … Continue Reading
Hospitals will have a limited waiver of HIPAA sanctions and penalties during the COVID-19 outbreak as a result of a bulletin issued on March 16, 2020 by the U.S. Department of Health and Human Services. The Office of Civil Rights also issued a reminder that even during a medical emergency like the COVID-19 pandemic, all … Continue Reading
Healthcare providers have special concerns for their employees during the Coronavirus (COVID-19) global health pandemic. Because COVID-19 spreads primarily as a result of close exposure to an infected person, healthcare employees are at higher risk of infection. While OSHA has a standard to protect employees from the spread of bloodborne pathogens, it currently has no … 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 … Continue Reading
The Florida Legislature recently passed HB 369 (the Bill), which would tweak an important provision of the Florida Patient Brokering Act, Section 817.505 of the Florida Statutes (Patient Brokering Act). It seeks to clarify the exception to the Patient Brokering Act which incorporated by reference the criminal provisions of the federal Anti-Kickback Statute (42 U.S.C. … Continue Reading
The 8th Circuit Court of Appeals recently handed the Federal Trade Commission another appellate victory in its efforts to curtail anticompetitive mergers in the healthcare industry, affirming the FTC’s earlier District Court victory in Federal Trade Commission v. Sanford Health. The decision follows a number of other recent FTC appellate victories in healthcare merger cases … Continue Reading
Last summer The Centers for Medicare and Medicaid Services (CMS) solicited input on potential amendments to the federal Physician Self-Referral Law (the Stark Law). CMS intends the amendments to eliminate obstacles to its stated goal of enhancing coordinated care and transitioning from volume-based to value-based payment systems. By the end of last summer, almost 400 stakeholders … Continue Reading
Holders of Florida healthcare clinic license exemptions take note. Exemption certificates, which currently bear no expiration date, will expire every two years if a bill recently passed by the Florida Legislature becomes law. Senate Bill 622 will require exemption holders to renew their clinic license exemption biennially. The bill is silent as to treatment of … Continue Reading
Providers have just a couple more days to challenge Medicare’s proposed 2018 value modifier payment adjustments. On September 18, 2017, Medicare released quality reports and measures used to calculate quality-based payment adjustments affecting providers’ 2018 Medicare fees. Physicians, physicians assistants, nurse practitioners, clinical nurse specialists, and nurse anesthetists who believe such proposed payment adjustments are … Continue Reading
When is a treating physician considered an expert witness and therefore entitled to expert witness fees when he testifies at trial? Apparently, the Florida District Courts of Appeal have formulated the typical lawyer response – it depends!… Continue Reading
