Health Law Advisor

On October 24, 2016 the Food and Drug Administration ("FDA") in conjunction with the Centers for Medicare & Medicaid Services ("CMS") announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required for receiving Medicare coverage nationally.  Sounds good.  So, why have so few manufacturers taken advantage of the program to date?

Despite its admirable goals, the current Parallel Review Process is too limited in scope ...

On November 4, 2016, the Western District of Pennsylvania held that the “because of sex” provision in Title VII of the Civil Rights Act prohibits discrimination on the basis of sexual orientation. In doing so, the court broke from the recent trend of federal courts that have felt compelled by prior precedent to dismiss sexual orientation discrimination claims.

In EEOC v. Scott Medical Health Center, P.C., the plaintiff (a gay male) alleged that he was subjected to repeated and unwelcome offensive comments regarding his sexual orientation and his relationship with a male ...

Kyler Prescott was a 14 year old transgender boy who was receiving puberty-delaying medication to help him transition.  Shortly before Kyler’s death he had “suicidal ideation” and was taken to Rady Children’s Hospital - San Diego in April 2015.  The hospital has a Gender Management Clinic to provide services to children with gender dysphoria and related issues.  A lawsuit under the ACA’s non-discrimination provision, § 1557, alleges that after admission, despite assurances that he would be referred to with masculine pronouns, hospital employees referred to Kyler as a ...

Featured on Employment Law This Week: The Occupational Safety and Health Administration (OSHA) has issued a final rule for handling retaliation under the Affordable Care Act (ACA).

The ACA prohibits employers from retaliating against employees for receiving Marketplace financial assistance when purchasing health insurance through an Exchange. The ACA also protects employees from retaliation for raising concerns regarding conduct that they believe violates the consumer protections and health insurance reforms in the ACA. OSHA’s new final rule establishes procedures ...

Much of the recent media scrutiny may suggest that Texas has gotten a bad rap when it comes to telehealth. But have recent reports painted an incorrect or unfair picture of telehealth innovation in Texas? The TexLa Telehealth Resource Center (“TexLa TRC”) certainly thinks so.

Recent media attention focused on Texas telehealth innovation suggests Texas is behind the telehealth curve. In a recent report, the Texas Business Association said, “Texas lags behind other states in establishing a supportive regulatory environment for the expansion of these services,” while the ...

The Medicare Payment Advisory Commission ("MedPAC") met in Washington, DC, on October 6-7, 2016. 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 health ...

Recently, the Federal Trade Commission ("FTC") faced major losses in challenging hospital mergers.  However, it is clear that the FTC is not backing down, especially given its tendency to conclude that proposed efficiencies do not outweigh the chance of lessening competition.

In July of this year, the FTC abandoned a challenge to the proposed merger of St. Mary's Medical Center and Cabell Huntington Hospital in West Virginia after state authorities had changed West Virginia law and approved the merger despite the FTC's objections. This year as well, the FTC failed to enjoin the Penn ...

In less than three weeks, health care providers covered by the Affordable Care Act must meet various posting obligations required by the recently issued Section 1557 regulations. Epstein Becker & Green, P.C. has written extensively about the Final Rule, including the expansive nondiscrimination standards and the upcoming October 16 deadlines. While we encourage you to review these publications for more detail, covered entities urgently need to prepare by October 16, 2016, nondiscrimination notices and taglines to be posted (1) in significant publications or communications; ...

Health care providers, life sciences companies and other entities subject to regulation by the Food and Drug Administration ("FDA") or the Centers for Medicare & Medicaid Services ("CMS") should be aware that the U.S. Department of Health and Human Services ("HHS") is increasing the maximum civil monetary penalty amounts that may be assessed by the agency.

The new maximum adjusted penalty amounts may have a significant impact on entities that violate or fail to meet mandatory reporting requirements set by FDA or CMS. Of the 299 enumerated increased fines, 137 fines (45.8%) have ...

When: Tuesday, October 18, 2016 8:00 a.m. – 4:00 p.m.

Where: New York Hilton Midtown, 1335 Avenue of the Americas, New York, NY 10019

Epstein Becker Green’s Annual Workforce Management Briefing will focus on the latest developments in labor and employment law, including:

• Latest Developments from the NLRB
• Attracting and Retaining a Diverse Workforce
• ADA Website Compliance
• Trade Secrets and Non-Competes
• Managing and Administering Leave Policies
• New Overtime Rules
• Workplace Violence and Active-Shooter Situations
• Recordings in the Workplace
• Instilling Corporate Ethics