12/29/2020 6:23:07 PM Congress’s approval of Competitive Health Insurance Reform Act (CHIRA) could mean significant antitrust changes for health insurers By William Sheridan Gregory Vose The U.S. Senate recently voted unanimously to approve the Competitive Health Insurance Reform Act (Act), which the House of...
12/22/2020 6:40:47 PM Congress passes legislation impacting the Provider Relief Fund By Caitlin Chambers In the evening of December 21, 2020, both Houses of Congress passed the Consolidated Appropriations Act, 2021, H.R. 133. The sprawling,...
12/14/2020 7:46:21 PM HHS proposes important changes to key aspects of HIPAA Privacy Rule By Nancy Halstead Brad Rostolsky Vicki Tankle The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), the agency that enforces the Health Insurance...
12/11/2020 3:43:37 PM Open for business in 2021 By Kelly Kearney Andrew Lu With 2020 coming to a close, businesses are looking ahead to 2021 and evaluating how they can stay open while keeping their employees and...
12/10/2020 9:43:20 PM Long-Awaited issuance of Section 340B ADR final rule By Joseph Metro James Segroves In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an...
12/1/2020 6:27:34 PM 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 The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising...
11/24/2020 12:20:10 AM Final Rules Modernizing Stark Law and Anti-Kickback Statute Released By Selina Coleman Hatmaker Pawlitz James Segroves Nicole Aiken-Shaban James Hennessy Andrew Lu +3 more... Show less The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and...
11/6/2020 8:08:45 PM CMS finalizes rule to ensure no-cost COVID-19 vaccine By David Hartmann On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an...
11/2/2020 8:32:21 PM HHS further delays compliance for Interoperability and Information Blocking Rule By Nancy Halstead Vicki Tankle Lauren Bentlage Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information...
10/13/2020 4:59:39 PM New Executive Order seeks to address COVID-19 impact on mental health By Lauren Bentlage Arielle Lusardi On October 5, 2020, the White House issued President Trump’s Executive Order on Saving Lives Through Increased Support for Mental- and...
10/2/2020 7:36:05 PM Patient access to health information at the forefront of government initiatives and scrutiny By Nancy Halstead Vicki Tankle Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in...
9/18/2020 7:11:35 PM CMS releases roadmap for states to accelerate adoption of value-based care By Andrew Lu Kelly Kearney On September 15, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance to state Medicaid directors on how to advance...
9/16/2020 4:28:08 PM FDA issues draft guidance regarding principles for selecting, developing, modifying, & adapting patient-reported outcome instruments for use in medical device evaluation By John Kendzior Ryan Pate On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing,...
9/8/2020 8:50:44 PM CMS issues proposed rule that would expedite approval of “breakthrough” devices and codify the standards for “reasonable and necessary” determinations By Lara Parkin Carrie Gorner The October 3, 2019 Executive Order 13890 (“EO 13890”), entitled “Executive Order on Protecting and Improving Medicare for our Nation’s...
8/31/2020 5:26:40 PM CMS unveils additional COVID-19 LTC facility testing and reporting rules during public health emergency By James Hennessy Shaylynn Veeder On August 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) filed an interim final rule with comment period (“IFC”),...
8/24/2020 8:37:25 PM Federal Court stays repeal of “On the Basis of Sex” definition in recent nondiscrimination final rule one day before regulations take effect By Carol Loepere Rebecca Dittrich Taber Rueter With only one day left before the final rule scaling back nondiscrimination regulations took effect, the U.S. District Court for the...