Category Archives: Physicians

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Hiding Data: Hospitals Fail to Comply with Price Transparency Requirements

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.

CMS previously advised that it would begin auditing compliance with the rule this past January. Interestingly, it was the published findings of … Continue Reading

Providers: Help is Here to Avoid HIPAA Right of Access Headaches

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

Valentine’s Day: Listen to Your Heart, But Not On a Cell Phone

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

CMS Tells States and Providers: Value-Based Care is the Answer

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

New Supreme Court Ruling Affirms State Regulation of PBM Reimbursement Pricing

The U.S. Supreme Court ruled against pharmacy benefit managers (“PBMs”) last month, in a decision that marks a major win for state regulators. (See Rutledge v. Pharmaceutical Care Management Association, 2020 WL 7250098 (U.S. 2020)). On December 10, 2020, the U.S. Supreme Court held that Arkansas’s Act 900, which “effectively requires PBMs to reimburse Arkansas pharmacies at a … Continue Reading

Florida Pharmacy Collaborative Practice Agreements: Defining the Scope of Practice

While the COVID-19 pandemic made 2020 a trying year, one unintended benefit was that the Florida legislature allowed pharmacists to further expand their scope of practice to help patients with certain chronic conditions through collaborative practice agreements. Though, as discussed below, they did not make it easy.… Continue Reading

Physicians: Beware of FTC Rules for Product Endorsements

It has become increasingly common for physicians and other healthcare professionals to share medical information with the public via video platforms, blogs, and social media sites. That can be a great public service, especially during the pandemic, but when public communications include a positive review or other favorable mention of medical products or services, such statements can unwittingly come within … Continue Reading

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

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

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

Novartis’ Simultaneous Settlements Break Records

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 … 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

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

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

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

Taking Triage to Trial

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

OCR COVID-19 Updates on HIPAA and Anti-Discrimination Laws

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 health care providers must comply … Continue Reading

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