Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, HHS announced new actions to expand COVID-19 testing capacity across the country. Read more about the announcement and other news below.
I. Regulations, Notices & Guidance
On February 18, 2021, the Food and Drug Administration (FDA) issued a notice entitled,
Guidance Documents Related to Coronavirus Disease 2019; Availability. The FDA is announcing the availability of FDA guidance documents related to the COVID-19 public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this noti
Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, the House of Representatives began marking up legislative proposals for COVID-19 relief under the budget reconciliation process. Read more about this action and other news below.
I. Regulations, Notices & Guidance
On February 10, 2021, the Food and Drug Administration (FDA) issued guidance entitled,
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency. Due to the COVID-19 pandemic, the FDA has received a number of queries concerning compounding of alcohol-based hand sanitizers. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sani
Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, CMS issued several rules, while President-elect Biden announced the framework for his COVID-19 relief plan. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
On January 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled,
Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary.” This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCI
Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
On Wednesday, HHS finalized its review of Phase 3 Provider Relief Fund applications and began distribution of the funds. Read more about this action and other news below.
I. Regulations, Notices & Guidance
On December 14, 2020, the Department of Health and Human Services (HHS), along with several other agencies, issued a final rule entitled,
Equal Participation of Faith-Based Organizations in the Federal Agencies’ Programs and Activities. This rule provides clarity about the rights and obligations of faith-based organizations participating in the Agencies’ Federal financial assistance programs and activities. This rulemaking is intended to ensure that the Agencies’ Fed
Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, HHS issued a final rule intended to govern the administrative dispute process in the 340B Drug Pricing Program. Read more about the rule and other news below.
I. Regulations, Notices & Guidance
On December 8, 2020, the Food & Drug Administration (FDA) issued guidance entitled,
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. This draft guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The draft guidance also describes the framework FDA uses i