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On May 19, 2021, the Food and Drug Administration (FDA) issued draft guidance entitled,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 The draft guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic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
/PRNewswire/ Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that the Centers for Medicare and Medicaid Services (CMS) has.
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 several efforts to boost COVID-19 vaccination rates in the U.S. Read more about these initiatives and other news below.
I. Regulations, Notices & Guidance
Event Notices
May 11-12, 2021: The Food and Drug Administration (FDA) announced a public meeting entitled,
Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the subcommittee is to provide advice and recommendations to FDA on regulatory issues.
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At first glance, it appeared that hospitals were complying with the Centers for Medicare & Medicaid Services’ (CMS) price transparency requirement, which became effective January 1, 2021. Upon a closer look; however, multiple deficiencies were found.
CMS previously advised that it would begin auditing compliance with the rule this past January. Interestingly, it was the published findings of a
Wall Street Journal (WSJ) investigation that first identified non-compliance. The investigation uncovered hospitals technically posting such data but intentionally hiding it from online search engines.
The Rule
The new rule requires US hospitals to have detailed pricing information prominently displayed on their websites. The rule’s specific details are discussed in our recent blog. Among the requirements are that standard charges be posted online. (45 CFR § 180.50). Standard charges are “the regular rate[s] establish