Health Law Advisor

The passage of the 21^st Century Cures Act ("Cures Act") and revisions to the Common Rule (45 CFR Part 46) ("Common Rule") in the last year mandated significant changes to informed consent laws.  As a result of these changes, sponsors of research ("Sponsors"), institutions conducting research ("Institutions"), and the institutional review boards ("IRBs") approving research will need to review policies and practices involving informed consent.  As explained below, a recently published FDA guidance document makes a first step toward implementing some of these changes by ...

Employment Law This Week (Episode 88: Week of September 25, 2017) has released bonus footage of its interview with Michael McGahan, a Member of the Firm at Epstein Becker Green.

As Mike discusses, New York home care agencies typically pay sleep-in home health aides for 13 hours per day, relying on a 2010 opinion from the state Department of Labor. Two home health attendants who claimed they did not “live in” the homes of their clients filed suit against their employers, claiming that their patients’ need for 24-hour ...

Our colleague Robert F. Atlas, President of EBG Advisors, Inc., published an advisory that will be of interest to stakeholders in the health care industry: The After-Effects of Graham-Cassidy's Demise.

Following is an excerpt:

Taken together, the failure of the ACA repeal-and-replace effort (for now) bodes well for health care providers. The percentage of the population that's covered—and thus is less likely to represent uncompensated care for providers—will remain fairly high, notwithstanding some erosion if the individual market isn't bolstered.

Similarly, insurers ...

Pursuant to the 21st Century Cures Act of 2016, Congress mandated the Medicare Payment Advisory Commission (“MedPAC”) to provide a report to Congress by March 15, 2018, in which MedPAC has been asked to answer the following questions:

1. Under the Medicare Fee-for-Service program (Parts A and B), what is the current coverage of telehealth services?
2. Currently, what coverage do commercial health plans offer for telehealth services?
3. In what ways can the Medicare Fee-for-Service program adopt some or all the telehealth service coverage presently found in commercial health plans?

In New York, State Department of Labor (“DOL”) regulations provide that the minimum wage must be paid for each hour an employee is “required to be available for work at a place prescribed by the employer.” (12 NYCRR § 142-2.1(b)) (“Wage Order”). Exception is made for a “residential employee,” defined as one who lives on the premises of the employer, during his or her sleeping hours or any time he or she is free to leave the place of employment. Id.

On March 1, 2010, the DOL issued an Opinion Letter advising that sleep-in employees, whether or not they are residential ...

The Medicare Payment Advisory Commission ("MedPAC") met in Washington, DC, on September 7-8, 2017. The purpose of this and other public meetings of MedPAC is for the commissioners to review the issues and challenges facing the Medicare program and then make policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. MedPAC's meetings can provide valuable insight into the state of Medicare, the direction of the program moving forward, and the content of MedPAC's next report to Congress.

As thought leaders in ...

Connecticut employees using medical marijuana for certain debilitating medical conditions as allowed under Connecticut law for “qualified users” are protected under state law from being fired or refused employment based solely on their marijuana use. Employers who violate those protections risk being sued for discrimination, according to a recent federal district court decision.

Background

In Noffsinger v. SSC Niantic Operation Company (3:16-cv-01938; D. Conn. Aug. 8, 2017), the federal district court ruled that “qualified users” are protected from criminal ...

As we have previously reported, there has been an uptick of new employment decisions finding in favor of registered medical marijuana users.  In keeping with these decisions, an administrative law judge (“ALJ”) at New York City’s Office of Administrative Trials & Hearings (“OATH”) also issued a report and recommendation, subsequently adopted by the relevant City commissioner, to dismiss a petition against a taxi driver that would have stripped him of his driver license because of his lawful medical marijuana use.

In Taxi & Limousine Comm’n v. W.R., OATH Index. No ...

At the end of July, FDA released a tangible plan for promoting innovation in the development of digital health products. In this Digital Health Innovation Action Plan, FDA acknowledges that digital health technologies are critically important in advancing health care, and that traditional FDA pathways to market are not well suited for all of these technologies. Over the last few years, FDA has taken a deregulatory approach with respect to low risk digital health products and has issued guidance regarding its enforcement discretion approach to wellness products, medical device ...

Throughout the campaign season and the first months of Donald Trump’s presidency, the current Administration has voiced a commitment to furthering telehealth advancement. For example, during the campaign, then-candidate Trump emphasized the importance of telehealth tools in reforming the U.S. Department of Veterans Affairs ("VA"). More recently, both U.S. Department of Health and Human Services Secretary Tom Price and Centers for Medicare and Medicaid Services Administrator Seema Verma stated in their confirmation hearings that they were interested in promoting the ...