As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of...more
The Department of Labor (DOL), the Department of the Treasury, and the Department of Health and Human Services (HHS) are making good on their promise to issue more guidance and to aggressively enforce the federal Mental...more
The 21st Century Cures Act set the stage for additional guidance to be issued under the Mental Health Parity and Addiction Equity Act (MHPAEA) and increased enforcement of its requirements....more
Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more
On January 5, 2018, the United States Department of Health and Human Services released for public comment a draft Trusted Exchange Framework, which seeks to accomplish interoperability with respect to patients’ Electronic...more
Under the 21st Century Cures Act (Cures Act), the Health and Human Services (HHS) Secretary is mandated to have promulgated regulations by Dec. 13, 2017 that, among other requirements, prohibit “information blocking” as a...more
The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more
The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more
QSEHRAs are designed for employers that are not applicable large employers under the employer shared responsibility tax (Code section 4980H). QSEHRAs may only be offered by employers with fewer than 50 full-time employees (as...more
As stories and statistics of the opioid crisis become increasingly prevalent in our national discourse, we are seeing a stronger, more innovative, and more aligned push for interventions across communities, government...more
On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or, panel meetings). The document,...more
The U.S. Department of Labor (DOL) recently released a draft model form for plan participants to request disclosures from group health plans and insurers about restrictions on mental health coverage. The form is designed to...more
It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more
The Departments of Labor, Treasury, and Health and Human Services recently released a frequently asked question (“FAQ”) regarding the implementation of the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction...more
On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed...more
In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more
Employers can expect some challenging information requests about the mental health and substance abuse benefits offered to employees and their dependents through group health plans, if a draft form released by federal...more
The 21st Century Cures Act (“Cures Act”), signed into law by former President Obama on December 13, 2016, sets out a bold agenda for the Food and Drug Administration (“FDA”). Among other things, the Cures Act strives to...more
The Trump budget for the federal government would be a huge step back from investment in medical research with consequences for many years in progress on promoting health and fighting disease....more
Just under a century ago, a team of Canadian scientists made the breakthrough that led to widely available insulin as an effective treatment for diabetes, which then was a deadly disease. The researchers, who won the Nobel...more
The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
21st Century Cures Act Impacts Employers with 50 or More Employees - Employers with 50 or more employees need to watch developments under the 21st Century Cures Act (“Cures”) because in addition to the establishment of...more
Activist NLRB Created More Problems For All Employers in 2016 - What Happens Under President Trump? During 2016, the National Labor Relations Board (NLRB or the Board) maintained its generally pro-union, anti-employer...more
On December 13, 2016, President Obama signed the 21st Century Cures Act. One of the more relevant aspects of the law to estate and special needs planning is found in Section 5007 of the Act, which is called “Fairness in...more