Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

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Debra A. McCurdy

Arielle Lusardi

Latest from Health Industry Washington Watch

Health Industry Washington Watch

Florida joins the ranks of states offering protections to businesses and health care providers from COVID-19 related lawsuits

By Jessica Christensen

April 5, 2021

During a press conference on Monday, March 29, 2021, Florida Governor Ron DeSantis signed Senate Bill 72, which grants civil immunity to corporations, hospitals, nursing homes, government entities, schools, and churches from COVID-19-related lawsuits, except in cases of gross negligence or intentional misconduct. Plaintiffs who file suit in Florida alleging coronavirus-related injuries will face robust legal hurdles. These plaintiffs must: Provide a physician’s affidavit stating with reasonable certainty that the injury or death from…

Health Industry Washington Watch

Congress considers the future of telehealth in the wake of COVID-19

By Alexandra Hussey

March 11, 2021

It is no secret that the coronavirus pandemic has driven our daily lives digital—work, education, social gatherings, and, of course, health care. Congress and CMS responded to the public health emergency by waiving limitations on reimbursement for telehealth services rendered to Medicare patients. These waivers introduced new flexibility and vastly expanded Medicare patients’ access to telehealth. However, it is unclear what role telehealth will play in the Medicare program after the pandemic. On March 2,…

Health Industry Washington Watch

President Biden implements policies to expand access to health care and coverage

By Lauren Bentlage

February 8, 2021

On January 28, 2021, the White House issued President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act (the “Executive Order”), which seeks to increase access to affordable health insurance and strengthen Medicaid and the Affordable Care Act, particularly in light of the ongoing COVID-19 pandemic. In addition to this Executive Order, the White House also announced President Biden’s Presidential Memorandum on Protecting Women’s Health at Home and Abroad (the “Presidential Memorandum”). The…

Health Industry Washington Watch

Congress passes legislation impacting the Provider Relief Fund

By Caitlin Chambers

December 22, 2020

In the evening of December 21, 2020, both Houses of Congress passed the Consolidated Appropriations Act, 2021, H.R. 133. The sprawling, 5,593-page legislation includes the most significant health care-related provisions to be passed since the CARES Act. The President is expected to sign the legislation shortly. Of note, in the course of appropriating billions of additional dollars to combat COVID-19, division H, title II of the legislation alters certain requirements of the Provider Relief Fund…

Health Industry Washington Watch

HHS proposes important changes to key aspects of HIPAA Privacy Rule

By Ryan Bass, Nancy Halstead, Brad Rostolsky & Vicki Tankle

December 14, 2020

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), is the latest federal agency to jump on the HHS rulemaking bandwagon issuing a Notice of Proposed Rulemaking (NPRM) on December 10, 2020, that proposes pivotal changes to key standards, definitions, and patient rights under the HIPAA Privacy Rule, which are geared toward promoting care coordination and…

Health Industry Washington Watch

Open for business in 2021

By Kelly Kearney & Andrew Lu

December 11, 2020

With 2020 coming to a close, businesses are looking ahead to 2021 and evaluating how they can stay open while keeping their employees and patrons safe. In an effort to resolve this seemingly open question, just this week, the National Institutes of Health (“NIH”) unveiled an innovative online mechanism that may give businesses the tools they need to choose a COVID-19 testing strategy for the year ahead. This mechanism, developed by a branch of the…

Health Industry Washington Watch

Marketers Beware: As COVID-19 cases increase, FDA, FTC increase efforts to crack down on fraudulent and deceptive marketing and sales of purported ‘Virus Cures’

By Kevin Madagan & Alison Peters

December 1, 2020

The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising of health care devices, household cleaners, nutrition supplements, and other health care products promising to protect or mitigate the effects of the virus for pandemic-wary consumers since March 2020. Despite these efforts, false and misleading marketing related to COVID-19 seems to be even more brazen this fall. Last month—on the heels of the first FDA-authorized …

Health Industry Washington Watch

CMS finalizes rule to ensure no-cost COVID-19 vaccine

By David Hartmann

November 6, 2020

On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an effort to ensure that participants in CMS programs have no-cost access to any forthcoming Food and Drug Administration (FDA or Agency) authorized or approved COVID-19 vaccine. The IFR governs any vaccine that is licensed by FDA under a Biologics License Application (BLA), or, significantly, receives an Emergency Use Authorization (EUA) from the…

Health Industry Washington Watch

HHS further delays compliance for Interoperability and Information Blocking Rule

By Nancy Halstead Vicki Tankle & Lauren Bentlage

November 2, 2020

Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) were set to take effect, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) issued an an advanced copy of an interim final rule with comment period (the “Interim Final Rule”) extending the compliance…

Health Industry Washington Watch

New Executive Order seeks to address COVID-19 impact on mental health

By Lauren Bentlage & Arielle Lusardi

October 13, 2020

On October 5, 2020, the White House issued President Trump’s Executive Order on Saving Lives Through Increased Support for Mental- and Behavioral-Health Needs (the “Executive Order”), which seeks to provide federal support to address mental and behavioral health concerns arising from the COVID-19 pandemic. The Executive Order acknowledges the exacerbating effects that the COVID-19 pandemic has had on mental and behavioral health conditions due to “stress from prolonged lockdown orders, lost employment, and social isolation,”…