Category Archives: Hospitals & Health Systems

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Second Circuit Sends PBM “Clawback” Litigation Plaintiffs Back to the Drawing Board

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

Healthcare Providers: Please Be Wary of Accepting Those Gifts!

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

Federal Trade Commission Challenge to Northern Philadelphia Hospital Merger Fails

The Federal Trade Commission (“FTC”) has failed – at least for now – in its efforts to derail a merger between Thomas Jefferson University Health System and Albert Einstein Health System, two Philadelphia-area health systems. In a decision announced on December 8, Judge Pappert, District Judge for the Eastern District of Pennsylvania, ruled that the FTC, which was joined in … Continue Reading

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

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 … Continue Reading

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

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

Is A Safer Healthcare System Within Reach?

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

HIPAA Says To Give Me My Medical Records…NOW!

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

Ransomware Targeting Hospitals and Healthcare Providers

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” … Continue Reading

What Consent for Which “Pelvic Examination”?

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

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

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

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

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 … Continue Reading

CARES Act Provider Relief Funds – The Requirements Are Taxing

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”). … Continue Reading

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

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

Limited Stark and Anti-Kickback Sanction Waivers Issued for Provider Payments During the Pandemic

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

CMS Issues Additional Waivers and Guidance on Telehealth

To ensure Medicare beneficiaries have access to necessary care without risking exposure to COVID-19, the Centers for Medicare & Medicaid Services (CMS) has further expanded telehealth services and relaxed certain requirements related to the same with the issuance of additional waivers (available here) and an interim final rule (IFR) available here. … Continue Reading

Pharmacy Testing Centers: A Prescription for Fighting COVID-19 in Florida

Pharmacists can now engage in a new role in the battle against COVID-19 – testing patients for the virus.  Recognizing the advanced health care training that pharmacists receive and the unique consumer access to community pharmacies during the Pandemic, the Florida Department of Health has designated pharmacists as medical professionals authorized to order and provide COVID-19 tests. Additionally, pharmacies, as … Continue Reading

Buyer Beware – FBI Warns of Fraud Involving Procurement of PPE and Other COVID-19 Supplies

Many employers are now making plans to have their employees return to the workplace. Based on recent alerts from the FBI, part of preparing to protect workers from COVID-19 at work should include protecting the company from falling prey to fraudsters. To do that, employers should put in place procedures to carefully screen vendors from whom they will purchase COVID-19 … Continue Reading

Accepting CARES Act Relief Funds for Health Care Providers? Tell Your Compliance Department

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

Prescribing in Florida During the Pandemic-What is allowed, What are the gaps, and How do we fill them?

The catchphrase of the day is “social distancing” and it is the primary means of flattening the COVID-19 pandemic (the “Pandemic”) curve by keeping contagious and healthy people apart. However, there is another kind of distancing that may play a role in fighting the Pandemic – “health care distancing.” Health care distancing is a mechanism to keep the sick patients, … Continue Reading

Some Things Never Change: EMTALA in the Time of COVID-19

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

COVID-19 Isn’t the Only Virus to Fear: Cybersecurity Attackers Target Hospitals Amidst COVID-19

Among the many obstacles facing businesses as a result of the COVID-19 pandemic are new cyberattacks targeting key infrastructure and industry in the United States. With all the compounding factors making this threat even more dangerous, the spike in cyberattacks was so significant that the International Criminal Police Organization (INTERPOL) has become involved and issued a “purple notice” alert to Continue Reading

It’s More than PPE – Infection Control in Different Facility Settings

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 in various patient settings. Specifically, … Continue Reading

California Telehealth Updates

California has joined the growing ranks of states, as well as the federal government, in efforts to facilitate the efficient provision of healthcare services during the pandemic. Accordingly, in response to federal agency updates with respect to relaxations to existing requirements related to telehealth services, California’s Governor Gavin Newsom issued an Executive Order No. 43-20 on April 3, 2020 (the … Continue Reading

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