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.
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 Senate Finance Committee discussed making permanent COVID-19 flexibilities, including those related to telehealth. See the hearing and other news below.
I.Regulations, Notices & Guidance
On May 19, 2021, the Food and Drug Administration (FDA) issued draft guidance entitled,
Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus. The draft guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus. These medical de
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