Health Law Advisor

On September 20, 2018, the U.S. Food and Drug Administration (“FDA”) released draft guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank” (“Guidance”). The purpose of this Guidance is to explain FDA’s protocol in (1) determining how the centers will identify whether responsible parties failed to comply with submission and certification requirements to the ClinicalTrials.gov or submitted false or misleading documents to the data banks and (2) deciding when, why, and what civil monetary penalties will be assessed against the ...

Please join Epstein Becker Green attorneys for a fall webinar series—via five 45-minute sessions—that will address how proactive compliance initiatives are critical to a platform’s operations, expansion efforts, and eventual monetization upon exit.

Immediate Post-Closing Operational Fixes When:  October 2, 2018 at 12:00pm – 12:45pm People:  John Eriksen, Josh Freemire, Gary Herschman, and Marc Mandelman Location:  Webinar (ET)

Add-On Diligence Strategy When:  October 9, 2018 at 12:00pm – 12:45pm People:  Josh Freemire, Anjana ...

President Trump’s recently issued Executive Order entitled “Strengthening Retirement Security In America” (the “EO”) may be helpful to businesses that sponsor or participate in multiple employer retirement plans (“MEPs”), as well as single employer plans, even if the sponsors and employers are not small business owners. While the stated purpose of the EO, which was issued on August 31, 2018 (the “EO Date”), is to “promote retirement security for America’s workers,” the EO directs attention to small business owners (less than 100 employees), noting ...

Our colleagues Susan Gross Sholinsky, Nancy Gunzenhauser Popper, and Amanda M. Gómez at Epstein Becker Green has a post on the Retail Labor and Employment Law blog that will be of interest to our readers in the health care industry: “NYC Commission on Human Rights Issues Guidance on Employers’ Obligations Under the City’s Disability Discrimination Laws.”

Following is an excerpt:

The New York City Commission on Human Rights (“Commission”) recently issued a 146-page guide titled “Legal Enforcement Guidance on Discrimination on the Basis of Disability” ...

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, D.C., on September 6-7, 2018. The purpose of this and other public meetings of MedPAC is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. These meetings offer a comprehensive perspective on the current state of Medicare as well as future outlooks for the program.

As thought leaders in healthcare law, Epstein ...

Earlier this year, Florida Governor Rick Scott signed into law HB7099 and SPB7028 (collectively referred to as the “Bills”), ratifying emergency rules that require nursing homes and assisted living facilities to acquire alternative power sources- such as generators- and fuel in preparation of the upcoming hurricane season. See Rule 59A-4.1265 and Rule 58A-5.036. These rules were enacted after 14 residents died from heat-related illnesses and complications during Hurricane Irma last year when a Florida nursing home lost power to its air conditioning units for three days.

A variety of traditional and non-traditional investors are starting to capitalize on the stability of the Medicare Advantage Program and expansion of the Medicare Advantage Health Plan Market.  These companies are leveraging sophisticated technological interfaces, data, and telemedicine to help improve the patient experience and to maximize the Triple Aim.

Why Medicare Advantage?

Medicare Advantage plans are offered by private insurance companies subject to certain standards established by the Centers for Medicare & Medicaid Services (“CMS”).  While the Medicare ...

Financial sponsors commit substantial capital in establishing or acquiring physician/professional management platforms in sectors such as dermatology, orthopedics, gastroenterology, urology, pain management, radiology, ophthalmology/optometry, dentistry, etc. Thereafter, sponsors seek to consolidate and make the platform more operationally efficient and pursue platform growth through add-on and tuck-in deals, as well as organic expansion.

This webinar series will address how proactive compliance initiatives are critical to a platform’s operations ...

In 2018, we have seen important new wage and hour developments unfolding on a seemingly weekly basis. To help you stay up to date and out of the crosshairs of the plaintiffs’ bar, we invite you to join Epstein Becker Green’s Employment, Labor & Workforce Management Webinar Series presentation for September. Presented by our Wage and Hour practice group, this webinar will focus on wage and hour developments affecting the hospitality and home health care industries, although much of the information will also be of interest to employers in other industries.

With an eye toward the ...

In the tech world, blockchain technology appears to be the panacea to all problems.  As blockchain technology becomes increasingly popular, many industries are trying to determine the best way to use the new phenomenon. Healthcare is no different in this quest. Health care is an optimal candidate to benefit from development of innovative ways to solve its impending issues using transformational technology. Blockchain could be the technology that helps to alleviate some of health care’s problems, such as the incredibly fragmented delivery of care and the painstakingly slow ...